sv4za
As
filed with the Securities and Exchange Commission on August 7, 2008
Reg. No. 333-152309
SECURITIES AND EXCHANGE COMMISSION
Amendment No. 1
to
FORM S-4
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
CYTRX CORPORATION
(Exact name of registrant as specified in its charter)
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Delaware
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58-1642750 |
(State or other jurisdiction of
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(I.R.S. Employer |
incorporation or organization)
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Identification No.) |
CytRx Corporation
11726 San Vicente Boulevard, Suite 650
Los Angeles, California 90049
(Address, including zip code, and telephone number, including area code, of Registrants principal executive offices)
Steven A. Kriegsman
President and Chief Executive Officer
CytRx Corporation
11726 San Vicente Boulevard., Suite 650
Los Angeles, California 90049
(310) 826-5648
(Name, address, including zip code, and telephone number, including area code, of agent for service)
With copies to:
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Benjamin S. Levin, Esq.
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Dale E. Short, Esq.
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Alexander M. Donaldson, Esq. |
CytRx Corporation
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TroyGould PC
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Wyrick Robbins Yates & Ponton LLP |
11726 San Vicente Boulevard, Suite 650
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1801 Century Park East, Suite 1600
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4101 Lake Boone Trail, Suite 300 |
Los Angeles, California 90049
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Los Angeles, California 90067
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Raleigh, North Carolina 27607 |
Fax: (310) 826-6139
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Fax: (310) 201-4746
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Fax: (919) 781-4865 |
Approximate date of commencement of proposed sale to public: As soon as practicable after
this Registration Statement becomes effective and upon completion of the merger described in the
enclosed proxy statement/prospectus.
If the securities being registered on this form are to be offered in connection with the
formation of a holding company and there is compliance with General Instruction G, check the
following box. o
If this Form is filed to register additional securities for an offering pursuant to Rule
462(b) under the Securities Act, check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same offering. o
If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities
Act, check the following box and list the Securities Act registration statement number of the
earlier effective registration statement for the same offering. o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
a non-accelerated filer, or a smaller reporting company.
See the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act. (Check one):
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Large accelerated filer o |
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Accelerated filer þ |
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Non-accelerated filer o
(Do not check if a smaller reporting company) |
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Smaller reporting company o |
THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR DATES AS MAY BE NECESSARY
TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL FILE A FURTHER AMENDMENT WHICH SPECIFICALLY
STATES THAT THIS REGISTRATION STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH
SECTION 8(A) OF THE SECURITIES ACT OF 1933 OR UNTIL THIS REGISTRATION STATEMENT SHALL BECOME
EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SAID SECTION 8(A), MAY DETERMINE.
MERGER PROPOSED YOUR VOTE IS VERY IMPORTANT
Dear Stockholders:
We cordially invite you to attend a special meeting of stockholders of Innovive
Pharmaceuticals, Inc., a Delaware corporation, at our offices located at 555 Madison Avenue,
25th Floor, New York, New York, on September 19, 2008, at 10:00 a.m., local time.
At the special meeting, we will ask you to consider and vote upon a proposal to approve an
Agreement and Plan of Merger, dated as of June 6, 2008, pursuant to which CytRx Corporation, a
Delaware corporation, has agreed to acquire Innovive as a wholly owned subsidiary. The acquisition
will be effected by the merger of Innovive with CytRx Merger Subsidiary, Inc., with Innovive as the
surviving corporation. CytRx Merger Subsidiary, Inc. was formed by CytRx solely for purposes of
entering into the merger agreement and completing the transactions contemplated by the merger
agreement.
A copy of the merger agreement is attached as Appendix A to the accompanying proxy
statement/prospectus. Pursuant to the terms of the merger agreement, Merger Subsidiary will merge
with and into Innovive with Innovive to be the surviving corporation in the merger. As a result of
the merger, Innovive will become a wholly owned subsidiary of CytRx and will change its corporate
name to CytRx Oncology Corporation. Shares of Innovive common stock will no longer be publicly
traded after the merger.
In the merger, CytRx will pay initial merger consideration of $3,000,000 in the form of shares
of CytRx common stock valued at $0.94 per share, which equals the average daily volume-weighted
closing price of CytRx common stock as reported on The Nasdaq Capital Market over the 10 trading
days prior to the signing of the merger agreement. CytRx also will pay future earnout merger
consideration of up to $18,253,462, subject to the achievement of specified net sales under
Innovives existing license agreements. Subject to specified conditions, any earnout merger
consideration will be payable in shares of CytRx common stock or, at CytRxs election, in cash, or
by a combination of shares of CytRx common stock and cash. CytRx common stock will be valued for
purposes of any earnout merger consideration based upon the average of the daily market price
during the 10-trading day period ending on the second trading day prior to payment of the earnout
merger consideration. If Innovives stockholders approve the merger agreement and the merger is
completed, all of the outstanding shares of Innovive common stock immediately prior to the
effective time of the merger (other than shares held by Innovive, CytRx and Merger Subsidiary and
by Innovive stockholders, if any, who properly exercise their rights as dissenting stockholders
under Delaware law) will be converted into the right to receive an allocable portion of the merger
consideration based upon the fully diluted shares of Innovive at the effective time of the merger.
After careful consideration, Innovives board of directors, by a unanimous vote of the
directors, has determined that the merger agreement is advisable, fair to, and in the best
interests of the stockholders of Innovive, has approved and authorized in all respects the merger
agreement, and recommends that you vote FOR the approval of the merger agreement.
The accompanying proxy statement/prospectus provides you with detailed information about the
proposed merger and the special meeting. Please give this material your careful attention. You may
also obtain more information about Innovive and CytRx from documents filed with the Securities and
Exchange Commission. We encourage you to obtain current market quotations for CytRx common stock,
which is traded on The Nasdaq Capital Market under the symbol CYTR.
We would like you to attend the special meeting. HOWEVER, WHETHER OR NOT YOU PLAN TO ATTEND
THE SPECIAL MEETING, IT IS IMPORTANT THAT YOUR SHARES BE REPRESENTED. Accordingly, please sign,
date, and return the enclosed proxy card in the postage-paid envelope or submit your
proxy by the Internet prior to the special meeting. If you attend the special meeting and
vote in person, your vote by ballot will revoke any proxy previously submitted. If your shares are
held in street name, you must instruct your broker in order to vote. Remember, failing to vote
has the same effect as a vote against the approval of the merger agreement.
We look forward to seeing you on September 19, 2008.
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Sincerely, |
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Steven Kelly |
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President and Chief Executive Officer |
See Risk Factors on page 11 for a discussion of important factors that you should consider
before you return your proxy or vote at the special meeting.
Neither the Securities and Exchange Commission nor any state securities commission has approved or
disapproved of the merger or of the securities to be issued in connection with the merger or
determined if this proxy statement/prospectus is accurate or complete. Any representation to the
contrary is a criminal offense.
This proxy statement/prospectus is dated August , 2008 and is first being mailed to
Innovive stockholders on or about August , 2008.
INNOVIVE PHARMACEUTICALS, INC.
555 Madison Avenue, 25th Floor
New York, New York 10022
NOTICE OF SPECIAL MEETING OF STOCKHOLDERS
To Be Held on September 19, 2008
To our Stockholders:
Notice is hereby given that a special meeting of stockholders of Innovive Pharmaceuticals,
Inc., a Delaware corporation, will be held on September 19, 2008, at 10:00 a.m., local time, at
our offices located at 555 Madison Avenue, 25th Floor, New York, New York, in order to:
(1) Consider and vote upon a proposal to approve the Agreement and Plan of Merger, dated as of
June 6, 2008, among Innovive, CytRx Corporation, a Delaware corporation, CytRx Merger Subsidiary,
Inc., a Delaware corporation and a wholly owned subsidiary of CytRx, which we refer to as Merger
Subsidiary, and Steven Kelly, as stockholder representative. A copy of the merger agreement is
attached as Appendix A to the accompanying proxy statement/prospectus. Pursuant to the terms of
the merger agreement, Merger Subsidiary will merge with and into Innovive, with Innovive to be the
surviving corporation in the merger. As a result of the merger, Innovive will become a wholly
owned subsidiary of CytRx and will change its corporate name to CytRx Oncology Corporation. Shares
of Innovive common stock will no longer be publicly traded after the merger.
In the merger, CytRx will pay initial merger consideration of $3,000,000 in the form of shares
of CytRx common stock valued at $0.94 per share, which equals the average daily volume-weighted
closing price of CytRx common stock as reported on The Nasdaq Capital Market over the 10 trading
days prior to the signing of the merger agreement. CytRx also will pay future earnout merger
consideration of up to $18,253,462, subject to the achievement of specified net sales under
Innovives existing license agreements. Subject to specified conditions, any earnout merger consideration will be payable in shares of
CytRx common stock or, at CytRxs election, in cash, or by a combination of shares of CytRx common
stock and cash. CytRx common stock will be valued for purposes of any earnout merger consideration
based upon the average of the daily market price during the 10-trading day period ending on the
second trading day prior to payment of the earnout merger consideration. If Innovives
stockholders approve the merger agreement and the merger is completed, all of the outstanding
shares of Innovive common stock immediately prior to the effective time of the merger (other than
those shares held by Innovive, CytRx and Merger Subsidiary and by Innovive stockholders, if any,
who properly exercise their rights as dissenting stockholders under Delaware law) will be converted
into the right to receive an allocable portion of the merger consideration based upon the
fully-diluted shares of Innovive at the effective time of the merger; and
(2) Approve the adjournment of the special meeting, if necessary or appropriate, to solicit
additional proxies if there are insufficient votes at the time of the special meeting to approve
the merger agreement; and
(3) Transact such other business that may properly come before the special meeting or any
adjournment or postponement of the special meeting.
Only stockholders of record of our common stock at the close of business on July 31, 2008
are entitled to notice of and to vote at the special meeting and at any adjournment or postponement
of the special meeting. All stockholders of record are cordially invited to attend the special
meeting in person.
The approval of the merger agreement requires the approval of the holders of a majority of the
outstanding shares of Innovive common stock entitled to vote, with each share having a single vote
for this purpose. Directors and officers of Innovive and their affiliates who own beneficially an
aggregate of approximately 22% of the shares of Innovive common stock entitled to vote at the
special meeting have agreed to vote all shares that they control in favor of the merger agreement.
Whether or not you plan to attend the special meeting, we urge you to vote your shares by
completing, signing, dating, and returning the proxy card as promptly as possible in the
postage-paid envelope and thus ensure that your shares will be
represented at the special meeting
if you are unable to attend. If you sign, date, and mail your proxy card without indicating how you
wish to vote, your proxy will be voted in favor of the approval of the merger agreement. If you
fail to return your proxy card or fail to submit your proxy by the Internet and do not vote in
person at the special meeting, it will have the same effect as a vote against the approval of the
merger agreement. Any stockholder attending the special meeting may vote in person even if he or
she has returned a proxy card; such vote by ballot will revoke any proxy previously submitted. If,
however, you hold your shares through a bank or broker or other custodian, you must obtain a legal
proxy issued from such custodian in order to vote your shares in person at the special meeting.
Each Innovive stockholder who does not vote in favor of the approval of the merger agreement
will have the right to require Innovive to purchase his or her shares, in cash, for the fair value
of the shares, but only if (i) the merger is completed and (ii) the stockholder complies with the
requirements of Delaware law for the exercise of dissenters rights that are summarized in the
accompanying proxy statement/prospectus. The completion of the merger is subject to the condition,
among others, that the holders of not more than 5% of Innovives common stock properly exercise
their rights as dissenting stockholders.
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By Order of the Board of Directors |
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Eric Poma, Ph.D.
Corporate Secretary |
August , 2008
Please do not send your stock certificates at this time. If the merger is completed, the
disbursing agent will provide you with instructions regarding the surrender of your stock
certificates
TABLE OF CONTENTS
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APPENDIX A Agreement and Plan of Merger |
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A-1 |
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APPENDIX B Form of Support Agreements |
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B-1 |
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APPENDIX C Opinion of Chartered Capital Advisers, Inc. |
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C-1 |
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APPENDIX D Section 262 of the Delaware General Corporation Law |
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D-1 |
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APPENDIX E CytRx Financial Statements and Financial Statement Schedule |
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E-1 |
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APPENDIX F Innovive Financial Statements |
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F-1 |
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EXHIBIT 23.2 |
EXHIBIT 23.3 |
EXHIBIT 99.2 |
iv
QUESTIONS AND ANSWERS ABOUT
THE SPECIAL MEETING AND THE MERGER
The following questions and answers address briefly some questions you may have regarding the
special meeting and the proposed merger. These questions and answers may not address all questions
that may be important to you. Please refer to the more detailed information contained elsewhere in
this proxy statement/prospectus, the appendices to this proxy statement/prospectus, and the
documents referred to in this proxy statement/prospectus. References in this proxy
statement/prospectus to you refer to Innovive stockholders and references to we, us, or our
mean Innovive. References in this proxy statement/prospectus to CytRx mean CytRx before the
merger, or CytRx and its subsidiaries, including Innovive, after the merger, as the context
requires.
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Q:
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What is the proposed transaction? |
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A:
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We are proposing that Innovive be acquired by CytRx pursuant to the
merger agreement. If the merger agreement is approved by Innovives
stockholders and the other closing conditions under the merger
agreement have been satisfied or waived, Merger Subsidiary, a wholly
owned subsidiary of CytRx, will merge with and into Innovive, with
Innovive to be the surviving corporation in the merger. As a result
of the merger, Innovive will become a wholly owned subsidiary of CytRx
and will change its corporate name to CytRx Oncology Corporation.
Shares of Innovives common stock will no longer be publicly traded
after the merger. |
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Q:
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What is the consideration payable in the merger? |
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A:
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In the merger, CytRx will pay initial merger consideration of
$3,000,000 in the form of shares of CytRx common stock valued at $0.94
per share, which equals the average daily volume-weighted closing
price of CytRx common stock as reported on The Nasdaq Capital Market
over the 10 trading days prior to the signing of the merger agreement.
CytRx also will pay future earnout merger consideration of up to
$18,253,462, subject to the achievement of specified net sales under
Innovives existing license agreements, as follows: |
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Net Sales |
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Earnout Merger Consideration |
$ 2,000,000 |
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$ |
2,000,000 |
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$15,000,000 |
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$ |
5,000,000 |
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$30,000,000 |
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$ |
5,000,000 |
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$40,000,000 |
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$ |
6,253,462 |
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Subject to specified conditions, any earnout merger consideration will be payable in shares
of CytRx common stock or, at CytRxs election, in cash, or by a combination of shares of
CytRx common stock and cash. CytRx common stock will be valued for purposes of any earnout
merger consideration based upon the average of the daily market price during the 10-trading
day period ending on the second trading day prior to payment of the earnout merger
consideration. |
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Q:
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What is my share of the merger consideration? |
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A:
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In the merger, you will be entitled to receive for each share of
Innovive common stock you hold immediately prior to the effective time
of the merger an amount equal to the quotient determined by dividing
the sum of the initial merger consideration and the earnout merger
consideration (to the extent the earnout merger consideration becomes
payable) by the fully diluted shares immediately prior to the
effective time of the merger. For purposes of the merger agreement,
fully diluted shares means the sum of all issued and outstanding
shares (including any dissenting shares) of Innovive common stock and
all shares of Innovive common stock issuable upon the exercise, in
full, |
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of all outstanding Innovive warrants that, by their terms, will
remain outstanding following the merger. As of the date of this proxy
statement/prospectus, there were 19,382,913 fully diluted shares. This does not include the option for 2,000,000 shares that we granted to CytRx pursuant to the loan and security agreement as described under Ancillary Agreements Loan and Security Agreement. The
initial merger consideration and any earnout merger consideration paid
or payable for each share of Innovive common stock are sometimes
collectively referred to in this proxy statement/prospectus as the
merger consideration. Your right to receive any earnout merger
consideration will not be transferable, except by operation of law.
No fractional shares of CytRx common stock will be issued in the
merger. In lieu of any fractional share, you will receive cash equal
to the value in the merger of such fractional share, less any
applicable withholding. |
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Q:
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What is this document? |
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A.
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This document constitutes a proxy statement and a notice of meeting with respect to the
special meeting of Innovive stockholders at which you will be asked to consider and vote on
the proposal to approve the merger agreement. This document also constitutes a prospectus of
CytRx with respect to the shares of CytRx common stock to be issued to you pursuant to the
merger agreement. |
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Q:
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Where and when is the special meeting? |
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A:
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The special meeting will be held at 10:00 a.m., local time, on September 19, 2008, at our offices located at 555 Madison
Avenue, 25th Floor, New York, New York. |
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Q:
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Are all Innovive stockholders as of the record date entitled to vote at the special meeting? |
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A:
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Yes. All stockholders who own Innovive common stock at the close of business on July 31, 2008, the record date for the
special meeting, are entitled to receive notice of the special meeting and to vote the shares of Innovive common stock that
they held on that date at the special meeting, or at any adjournments or postponements of the special meeting. |
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Q:
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Are all Innovive stockholders as of the record date entitled to attend the special meeting? |
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A:
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Yes. Innovive stockholders as of the record date, or their legally authorized proxies named in the proxy card, may attend
the special meeting. Seating, however, is limited. Cameras, recording devices, and other electronic devices will not be
permitted at the meeting. If your shares are held in the name of a broker, trust, bank, or other nominee, you should bring
a proxy or letter from the broker, trustee, bank, or nominee confirming your beneficial ownership of the shares. |
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Q:
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What vote of Innovives stockholders is required to approve the merger agreement? |
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A:
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For us to complete the merger, stockholders holding a majority of the outstanding shares of Innovive common stock at the
close of business on the record date must vote FOR the approval of the merger agreement, with each share having a single
vote for these purposes. Accordingly, failure to vote or abstaining from voting will have the same effect as a vote against
the merger agreement. |
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Q.
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How do the Innovive insiders intend to vote their shares? |
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Steven Kelly, Neil Herskowitz, J. Jay Lobell and Eric Poma, M.D., each of whom is a director
or officer of Innovive, and their affiliates, Lindsay A. Rosenwald, M.D., and Lester
Lipshutz, as investment manager or trustee of trusts established for the benefit of Dr.
Rosenwald and his family, along with Angelo De Caro, who recently resigned as a director,
have agreed pursuant to support agreements that they have entered into with CytRx and Merger
Subsidiary to vote all Innovive shares that they control in favor of the merger agreement.
These directors and officers and their affiliates own beneficially an aggregate of
approximately 22% of the shares of common stock entitled to vote at |
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the special meeting. To
facilitate the support agreements, these beneficial owners also granted CytRx proxies to
vote their shares with respect to the merger and the merger agreement. |
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Q:
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Does our board of directors
recommend that our stockholders vote FOR
the approval of the merger agreement? |
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A:
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Yes. After careful consideration, the board of directors, by a
unanimous vote of the directors, recommends that you vote FOR the
approval of the merger agreement. You should read The
MergerInnovives Reasons for the Merger beginning on
page 43 of this proxy
statement/prospectus for a discussion of the factors that our board of
directors considered in deciding to recommend the approval of the
merger agreement. |
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In considering the recommendation of the board of directors with respect to the merger
agreement, you should be aware that some of Innovives directors and executive officers who
participated in meetings of the board of directors have interests in the merger that are
different from, or in addition to, the interests of our stockholders generally. See The
Merger Interests of Certain Persons in the Merger beginning
on page 47. |
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Q:
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What do I need to do now? |
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A:
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We urge you to read this proxy statement/prospectus carefully, including its appendices, and to consider how the merger
affects you. If you are a stockholder as of the record date, then you can ensure that your shares are voted at the special
meeting by completing, signing, dating, and returning each proxy card in the postage-paid envelope provided or submitting
your proxy by the Internet prior to the special meeting. |
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Q:
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If my shares are held in street name by my broker, will my broker vote my shares for me? |
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A:
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Your broker will vote your shares on your behalf only if you provide instructions to your broker on how to vote. You
should follow the directions provided by your broker regarding how to instruct your broker to vote your shares. Without
those instructions, your shares will not be voted, which will have the same effect as voting against the merger. |
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Q:
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How do I change or revoke my vote? |
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A:
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You can change your vote at any time before your proxy is voted at the special meeting. You may revoke your proxy prior to
the special meeting by notifying us in writing or by submitting a later-dated new proxy by the Internet or by mail to
Innovive Pharmaceuticals, Inc., 555 Madison Avenue, 25th Floor, New York, New York 10022, Attention: Corporate
Secretary. You also may revoke your proxy by attending the special meeting and voting in person. Simply attending the
special meeting, however, will not be sufficient to revoke your proxy. If you have instructed a broker to vote your
shares, these options for changing your vote do not apply, and instead you must follow the instructions received from your
broker to change your vote. |
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Q:
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What does it mean if I get more than one proxy card or vote instruction card? |
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A:
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If your shares are registered differently and are in more than one account, you will receive more than one proxy card.
Please sign, date, and return all of the proxy cards you receive (or submit your proxy by the Internet) to ensure that all
of your shares are voted. |
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Q:
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When do you expect the merger to be completed? |
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A:
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We are working toward completing the merger as quickly as possible, and we anticipate that it will be completed in
September 2008, assuming satisfaction or waiver of all of the conditions to the merger described under The Merger
Agreement Conditions to the Merger beginning on
page 70 of this proxy statement/prospectus. However, because the
merger is subject to certain conditions, the exact timing of the completion of the merger and the likelihood of the
consummation of the merger cannot be predicted with certainty. If any of the conditions in the merger agreement is not
satisfied, the merger agreement may terminate as a result. |
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Q.
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Are there risks associated with the merger? |
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A.
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Yes. The merger involves risks, including the following: |
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the merger is subject to a number of conditions, and there is no assurance that the
merger will be completed; |
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the expected benefits of the merger to the combined company are subject to
post-merger challenges, including maintaining the listing of CytRx common stock on The
Nasdaq Capital Market to promote liquidity for stockholders of the combined company and
potentially greater access to capital and using the assets and resources of the
combined company to successfully develop the existing product candidates of the
combined company, and these and benefits may not be realized; |
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if the costs associated with the merger exceed the benefits, the combined company
may experience adverse financial results, including increased losses; |
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CytRx expects to continue to incur operating losses, and the combined company will
need to raise additional funds to cover the cost of operating or it may have to reduce
or stop operations; |
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the merger agreement limits our ability to pursue alternatives to the merger, and
CytRx will be entitled to exercise its option to purchase Innovive common stock if we
do so, which would be materially dilutive to our stockholders; |
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the support agreements may deter competing bids; |
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because the market price of CytRx common stock may fluctuate, you cannot be sure of
the market value of CytRx common stock that you will receive in the merger; |
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you cannot be sure when you will receive any earnout merger consideration, and you
may never receive any earnout merger consideration; |
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the merger may be a taxable transaction for U.S. federal income tax purposes, in
which case you will recognize taxable gain or loss to the extent that the value of the
merger consideration you receive is greater or less than your tax basis in your
Innovive shares, and even if the merger otherwise qualifies as a tax-free
reorganization for U.S. federal income tax purposes, you will recognize taxable income
or gain to the extent of any earnout merger consideration
characterized as imputed interest and to the extent the balance of
any earnout merger consideration received in the form of cash is
greater than your tax basis in your Innovive shares allocable to that
earnout merger consideration; |
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if the merger is not completed, we will have incurred substantial expenses without
realizing the expected benefits of the merger and will have to repay CytRx for advances
under the loan and security agreement, which we may not to be able to do; |
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our officers and directors have financial interests in the merger that may be
different from, or in addition to, the interests of our stockholders, generally; |
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if the merger is not consummated by September 30, 2008, either we or CytRx may
choose not to proceed with the merger; |
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the fairness opinion obtained by us from our financial advisor will not reflect
changes in circumstances subsequent to the date of the merger agreement; and |
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the shares of CytRx common stock to be received in the merger will have different
rights from the shares of Innovive common stock that you now hold. |
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Q:
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Who will bear the cost of this solicitation? |
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A:
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The expenses of preparing, printing, and mailing this proxy
statement/prospectus and the proxies solicited hereby will be borne by
Innovive. Additional solicitation may be made by telephone,
facsimile, or other contact by certain directors, officers, employees,
or agents of Innovive, none of whom will receive additional
compensation for those activities. Innovive will, upon request,
reimburse brokerage houses and other custodians, nominees, and
fiduciaries for their reasonable expenses for forwarding material to
the beneficial owners of shares held of record by others. |
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Q:
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Will a proxy solicitor be used? |
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A:
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No. However, the directors, officers, employees, and other agents of
Innovive may solicit proxies on our behalf from stockholders by
telephone, by other electronic means, or in person. |
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Q:
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Should I send in my stock certificates now? |
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A:
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No. Shortly after the merger is completed, you will receive a letter
of transmittal with instructions informing you how to surrender your
stock certificates or book-entry shares to the disbursing agent in
order to receive the merger consideration. Please do not send in your
stock certificates with your proxy card. |
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Q:
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Who can help answer my other questions? |
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A:
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If you have more questions about the merger, need assistance in
submitting your proxy or voting your shares, or need additional copies
of the proxy statement/prospectus or the enclosed proxy card, you can
call our Chief Financial Officer, J. Gregory Jester, at (212)
716-1814. If your broker holds your shares, you should also call your
broker for additional information. |
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SUMMARY OF THE PROXY STATEMENT/PROSPECTUS
This summary highlights selected information from the proxy statement/prospectus and may not
contain all of the information that is important to you. You should carefully read the entire proxy
statement/prospectus to fully understand the proposed transaction. We encourage you to read the
merger agreement that is attached as Appendix A, because it is the legal document that governs the
parties agreement pursuant to which CytRx will acquire Innovive in a merger if all of the
conditions to the merger are satisfied or waived. Certain items in this summary include page
references directing you to a more complete description of the items in this proxy
statement/prospectus.
The
Parties to the Merger (pages 40, 79 and 127)
CytRx Corporation
CytRx Corporation was organized in 1985 as a Delaware corporation. CytRx is a clinical-stage
biopharmaceutical company engaged in developing human therapeutic products based primarily upon its
small-molecule molecular chaperone amplification technology. Through February 2008, CytRx owned a
majority of the outstanding shares of common stock of RXi Pharmaceuticals Corporation, which CytRx
refers to as RXi. RXi was founded in April 2006 by CytRx and four researchers in the field of
ribonucleic acid interference, or RNAi, including Dr. Craig Mello, recipient of the 2006 Nobel
Prize for Medicine for his co-discovery of RNAi. In March 2008, CytRx distributed to its
stockholders approximately 36% of RXis outstanding shares, which reduced CytRxs ownership to less
than 50% of RXi. RXi is focused solely on developing and commercializing therapeutic products based
upon RNAi technologies for the treatment of human diseases.
CytRxs executive officers are located at 11726 San Vicente Boulevard, Suite 650, Los Angeles,
California 90049, and its telephone number is (310) 826-5648. CytRx common stock is listed for
trading on The Nasdaq Capital Market under the symbol CYTR. The common stock of RXi is listed on
The Nasdaq Capital Market under the symbol RXII.
Innovive Pharmaceuticals, Inc.
Innovive Pharmaceuticals, Inc. was organized in 2004 as a Delaware corporation. Innovive is a
development-stage biopharmaceutical company engaged in the development of compounds for the treatment
of cancer. Innovives executive offices are located at 555 Madison Avenue, 25th Floor,
New York, New York 10022, and its telephone number is (212) 716-1810. Innovive common stock is
quoted on the Over-the-Counter Bulletin Board, or OTCBB, under the symbol IVPH.
CytRx Merger Subsidiary, Inc.
CytRx Merger Subsidiary, Inc. was organized in 2008 as a Delaware corporation and wholly owned
subsidiary of CytRx. Merger Subsidiary was formed by CytRx solely for purposes of entering into
and completing the transactions contemplated by the merger agreement. It has not conducted any
activities to date other than activities incidental to its organization and in connection with the
transactions contemplated by the merger agreement. Merger Subsidiarys business address and
telephone number are the same as those of CytRx.
The
Merger (page 40)
You are being asked to vote your shares of Innovive to approve the merger agreement. The
merger agreement provides that Merger Subsidiary will be merged with and into Innovive, and that
the outstanding shares of Innovive common stock (other than shares that are owned by Innovive,
CytRx and Merger
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Subsidiary and shares that are owned by stockholders, if any, who properly exercise
dissenters rights under Delaware law) will be cancelled and converted into the right to receive
the merger consideration.
After the completion of the merger, you will have no ownership interest in Innovive and shares
of Innovives common stock will no longer be publicly traded.
The
Special Meeting of Stockholders (page 58)
Place, Date, and Time
The special meeting of stockholders will be held at 10:00 a.m., local time, on September 19,
2008, at our offices located at 555 Madison Avenue, 25th Floor, New York, New York.
Vote
Required for Approval of the Merger Agreement (page 58)
Approval of the merger agreement requires stockholders holding a majority of the outstanding
shares of Innovive common stock at the close of business on the record date to vote FOR the
approval of the merger agreement, with each share having a single vote for this purpose. The
failure to vote has the same effect as a vote against the approval of the merger agreement.
Who
Can Vote at the Special Meeting (page 58)
You may vote at the special meeting all of the shares of Innovive common stock you own of
record as of the close of business on July 31, 2008. If you own shares that are registered in
someone elses name (for example, a broker), you need to direct that person to vote those shares on
your behalf or obtain an authorization from them to vote the shares yourself at the special
meeting. As of the close of business on July 31, 2008, there were 14,610,003 shares of Innovive
common stock outstanding held by 171 holders of record. We believe that a number
of our stockholders hold their shares in street name and, as a result, that the number of
beneficial holders of Innovive common stock is greater than the number of record holders.
Procedure
for Voting (page 59)
You may vote your shares by attending the special meeting and voting in person, or you may
submit a proxy by the Internet or by mailing the enclosed proxy card. You can change your vote at
any time before your proxy is voted at the special meeting. You may revoke your proxy prior to the
special meeting by notifying us in writing or by submitting a later-dated proxy by the Internet or
by mail to Innovive Pharmaceuticals, Inc., 555 Madison Avenue, 25th Floor, New York, New
York 10022, Attention: Corporate Secretary. In addition, you may revoke your proxy by attending
the special meeting and voting in person. However, simply attending the special meeting will not
revoke your proxy. If you have instructed a broker to vote your shares, these options for changing
your vote do not apply, and instead you must follow the instructions received from your broker to
change your vote.
If your shares are held in street name by your broker, please follow the directions provided
by your broker in order to instruct your broker as to how to vote your shares. If you do not
instruct your broker to vote your shares, it will have the same effect as a vote against the
approval of the merger agreement.
Board
Recommendation (page 60)
After careful consideration, our board of directors, by unanimous vote:
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has determined that the merger agreement is advisable, fair to, and in the best
interests of Innovive and its stockholders; |
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has approved and authorized in all respects the merger agreement, the merger, and
the other transactions contemplated by the merger agreement; and |
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recommends that Innovives stockholders vote FOR the approval of the merger
agreement. |
Neither Innovive nor any of our officers or directors has an ownership interest in CytRx or is
otherwise affiliated with CytRx, and we have had no dealings with CytRx or its officers or
directors other than in connection with the merger agreement and related matters. However, in
considering the recommendation of the board of directors with respect to the merger agreement, you
should be aware that some of Innovives directors and executive officers who participated in
meetings of the board of directors have interests in the merger that are different from, or in
addition to, the interests of our stockholders, generally. See The Merger Interests of Certain
Persons in the Merger beginning on page 47.
Fairness
Opinion (page 49 and Appendix C)
In connection with the merger, our board of directors received a written opinion, dated
June 6, 2008, from Chartered Capital Advisers, Inc., Innovives financial advisor, which we refer
to as Chartered, as to the fairness, from a financial point of view and as of the date of the
opinion, of the merger consideration to be received by holders of our common stock. The full text
of Chartereds written opinion is attached to this proxy statement/prospectus as Appendix C. We
encourage you to read the opinion carefully in its entirety for a description of the assumptions
made, procedures followed, matters considered, and limitations on the review undertaken.
Chartereds opinion was provided to our board of directors in connection with our board of
directors evaluation of the merger consideration from a financial point of view and does not
address any terms or other aspects or implications of the merger, other than the merger
consideration to the extent expressly specified in the opinion, or any aspects or implications of
any other agreement, arrangement or understanding entered into in connection with the merger or
otherwise. Chartereds opinion is not intended to be, and does not constitute, a recommendation to
any stockholder as to how such stockholder should vote or act on any matters relating to the
proposed merger.
Shares
Held by Directors and Officers; Support Agreements (pages 48 and 155 and Appendix B)
As of July 31, 2008, the directors and officers of Innovive beneficially owned
approximately 3% of the shares of Innovive common stock entitled to vote at the special meeting.
Steven Kelly, Neil Herskowitz, J. Jay Lobell and Eric Poma, M.D., each of whom is a director or
officer of Innovive, and their affiliates, Lindsay A. Rosenwald, M.D., and Lester Lipshutz, as
investment manager or trustee of trusts established for the benefit of Dr. Rosenwald and his
family, along with Angelo De Caro, who recently resigned as a director, have agreed pursuant to
support agreements that they have entered into with CytRx and Merger Subsidiary to vote all
Innovive shares that they control in favor of the merger agreement. These directors and officers
and their affiliates own beneficially an aggregate of approximately 22% of the shares of common
stock entitled to vote at the special meeting. To facilitate the support agreements, these
beneficial owners also granted CytRx proxies to vote their share with respect to the merger and the
merger agreement. The full text of the form of the support agreements, including the form of
proxy, is attached to this proxy statement/prospectus as Appendix B. We encourage you to read the
form of the support agreements in its entirety.
Material
United States Federal Income Tax Consequences (page 55)
The treatment of the merger for U.S. federal income tax may be uncertain. If the merger is a
taxable exchange, each U.S. holder of Innovive common stock will recognize income, gain or loss for
U.S. federal income tax purposes measured by the difference between the fair market value of the
merger consideration received in the merger and the holders tax basis in the Innovive common
stock. If, on the other hand, the
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merger constitutes a tax-free reorganization, each U.S. holder of Innovive common stock will
not recognize gain or loss on the receipt of CytRx common stock, but will recognize (i) taxable
income on the portion of any earnout merger consideration characterized as imputed interest and
(ii) taxable gain on the receipt of the balance of any earnout merger consideration received in the
form of cash, to the extent it exceeds the U.S. holders adjusted tax basis in the Innovive common
stock allocable to such earnout merger consideration. You should consult your personal tax
advisor, however, for a full understanding of the tax consequences related to the merger that are
particular to you.
Stock
Exchange Listing of CytRx Common Stock (page 49)
It is a condition to the completion of the merger that the shares of CytRx common stock
issuable to Innovive stockholders in payment of the initial merger consideration be approved for
listing on The Nasdaq Capital Market. It is also a condition to the payment of any earnout merger
consideration that CytRx may elect to pay in shares of CytRx common stock that such shares be
listed on The Nasdaq Capital Market or other trading market.
Comparative
Market Prices of Common Stock (page 49)
CytRx common stock is listed on The Nasdaq Capital Market and our common stock is quoted on
the OTCBB. On June 6, 2008, the last full trading day before the public announcement of the merger
agreement, the closing price of CytRx common stock as reported on The Nasdaq Capital Market was
$0.99. On June 6, 2008, the last full trading day before the public announcement of the merger
agreement, the closing price of shares of our common stock as reported on the OTCBB was $0.15.
If the merger is completed, there is no assurance as to what the market price of CytRx common stock
will be at that or any other time.
Regulatory
Requirements (page 49)
The merger is not subject to any federal or state regulatory requirements.
Dissenters
or Appraisal Rights (page 157 and Appendix D)
If you do not vote your shares in favor of approval of the merger agreement, you will be
entitled to receive in cash an amount equal to the fair value of your shares, provided that you
comply with the procedures set forth in Section 262 of the Delaware General Corporation Law. The
ultimate amount you receive as a dissenting stockholder may be more or less than, or the same as,
the merger consideration you would have received in the merger. Your failure to follow exactly the
procedures specified under Delaware law will result in the loss of your dissenters rights.
The completion of the merger is subject to the condition, among others, that the holders of
not more than 5% of Innovives common stock properly exercise their rights as dissenting
stockholders.
Interests
of Certain Persons in the Merger (page 47)
In considering the recommendation of our board of directors with respect to the merger
agreement, you should be aware that some of our directors and executive officers have interests in
the merger that may be different from, or in addition to, the interests of our stockholders,
generally. These interests include indemnification and insurance arrangements with our officers
and directors and severance benefits that may become payable to some of our officers. Our board of
directors was aware of these interests and considered them, among other matters, in approving the
merger agreement.
CytRxs officers and directors own CytRx common stock and have been granted stock options to
purchase CytRx common stock, none of which will vest or be adjusted or otherwise changed as a
result of the
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merger. Except for the interests inherent in their ownership of CytRx common stock and stock
options, CytRxs officers and directors do not have any material interests in the merger.
Comparison
of Rights of Innovive Stockholders and CytRx Stockholders
(page 165)
Your rights as Innovive stockholders are currently governed by our certificate of
incorporation, our bylaws and Delaware law. Upon completion of the merger, you will become
stockholders of CytRx and your rights will be governed by CytRxs restated certificate of
incorporation, CytRxs restated bylaws, the Shareholder Protection Rights Agreement, dated
April 16, 1997, as amended, between CytRx and American Stock Transfer & Trust Co., as rights agent,
which we refer to in this proxy statement/prospectus as the CytRx rights agreement, and Delaware
law.
Procedure
for Receiving the Merger Consideration (page 62)
CytRx will appoint a disbursing agent reasonably acceptable to us to coordinate the payment of
the initial merger consideration following the merger. Promptly after the completion of the
merger, the disbursing agent will mail a letter of transmittal with instructions to you and the
other stockholders. The letter of transmittal and instructions will tell you how to surrender your
stock certificates or book-entry shares in order to receive the merger consideration. Please do
not send in your share certificates now.
Stock
Options (page 62)
At or prior to the completion of the merger, the administrator of our stock plans will resolve
under the stock plans that each Innovive stock option outstanding immediately prior to the
effective time of the merger, whether or not then vested or exercisable, will be cancelled
immediately prior to the effective time, with any consideration due to the holders thereof being
paid at such time. All of our stock options currently are underwater, so we expect that our
option holders will receive no payments or other consideration in connection with the merger.
After the merger, such stock options will no longer be outstanding and the holders of the options
will no longer have any rights to purchase Innovive stock or other securities.
Warrants
(page 62)
Each Innovive warrant outstanding immediately prior to the effective time of the merger that,
by its terms, does not expire upon the effective time, will remain outstanding in accordance with
its terms, and the holder thereof will thereafter have the right to purchase and receive (in lieu
of the shares of Innovive common stock) the merger consideration payable with respect to the number
of shares of Innovive common stock purchasable under the warrant immediately prior to the effective
time of the merger. To the extent Innovive warrants outstanding at the effective time of the
merger are subsequently cancelled, or terminate, without being exercised in full, the merger
consideration otherwise payable with respect to such cancelled or terminated warrants will become
the property of CytRx. If required by the terms of the warrants, CytRx will cause to be issued
promptly after the completion of the merger replacement warrants for the Innovive warrants that, by
their terms, will remain outstanding after the merger.
No
Solicitation by Us of Alternative Acquisition Transactions
(page 67)
The merger agreement contains restrictions on our ability to solicit or engage in discussions
or negotiations with any third party relating to an acquisition transaction, which generally
means (1) a license or sublicense of our intellectual property under our existing license
agreements, (2) acquisition of 10% or more of our assets, (3) acquisition of at least 10% of our
common stock, (4) a tender offer or exchange offer that would result in any person beneficially
owning 10% or more of our common stock, or (5) merger, consolidation or similar transaction. We
have agreed that, prior to the completion of the merger or the earlier termination of the merger
agreement, we will not (i) initiate, solicit, or provide non-public or confidential information to
facilitate any inquiry that constitutes, or may reasonably be expected to lead to, a proposal or
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offer relating to an acquisition transaction, or (ii) enter into, continue, or otherwise
participate in any discussions or negotiations with any third party regarding, or furnish to any
person any non-public information, or provide access to our properties, books, or records with
respect to, any inquiries that constitute, or may reasonably be expected to lead to, an acquisition
transaction.
However, prior to receipt of our stockholders approval of the merger agreement, if we receive
any bona fide written offer or proposal with respect to a potential or proposed acquisition
transaction that was not solicited, initiated, or knowingly encouraged by us in violation of the
merger agreement and which our board of directors determines is or could reasonably be expected to
result in a proposal that is superior to the terms of the merger agreement, we are allowed to (1)
furnish (subject to the execution of a confidentiality agreement) confidential or non-public
information to, and negotiate with, the potential third party acquirer and (2) upon compliance by
us with the termination provisions of the merger agreement with CytRx, including the payment to
CytRx of a $1,500,000 termination fee, enter into an agreement relating to the superior proposal.
Conditions
to the Merger (page 70)
Before we can complete the merger, a number of conditions must be satisfied, including:
|
|
|
approval of the merger agreement by our stockholders; |
|
|
|
|
none of the parties to the merger agreement being subject to any law, order,
injunction, judgment, or ruling by any governmental authority that prohibits the
consummation of the merger or makes the consummation of the merger illegal; |
|
|
|
|
the effectiveness under the Securities Act of 1933, as amended, of the registration
statement of which this proxy statement/prospectus is a part; |
|
|
|
|
the exemption, qualification or registration under applicable state securities laws
of the shares of CytRx common stock issuable in payment of the initial merger
consideration; |
|
|
|
|
the listing on The Nasdaq Capital Market of the shares of CytRx common stock
issuable in payment of the initial merger consideration; |
|
|
|
|
the absence of any lawsuit (1) seeking to restrain or prohibit the consummation of
the merger or seeking to obtain damages from Innovive, CytRx, or Merger Subsidiary, (2)
seeking the disposition of any material assets or businesses of Innovive, or (3)
otherwise seeking to limit the actions of CytRx with respect to the material assets or
business of Innovive after the merger; |
|
|
|
|
the continued accuracy of the representations and warranties of us and CytRx that
are contained in the merger agreement; |
|
|
|
|
the resignation, effective as of the effective time of the merger, of each of our
directors and officers; |
|
|
|
|
the performance by us and CytRx of all of the obligations that we and CytRx are
required to perform under the merger agreement prior to the time of the merger; and |
|
|
|
|
the holders of not more than 5% of the outstanding shares of our common stock having
properly exercised their rights as dissenting stockholders. |
6
Termination
of the Merger Agreement (page 71)
We and CytRx may agree at any time to terminate the merger agreement without completing the
merger. The merger agreement may also be terminated in certain other circumstances specified in
the merger agreement, including, without limitation and subject to the detailed terms and
conditions specified in the merger agreement:
|
|
|
by either us or CytRx, if the merger has not been completed by September 30, 2008
other than due to the fault of the party seeking to terminate the merger agreement and
other than due to the failure of the condition regarding effectiveness of the
registration statement of which this proxy statement/prospectus is a part; |
|
|
|
|
by either us or CytRx, if the other party is in material breach of its
representations, warranties, or covenants contained in the merger agreement; |
|
|
|
|
by either us or CytRx following the entry of any final and non-appealable judgment,
injunction, order, or decree by a court or governmental agency restraining or
prohibiting the completion of the merger; |
|
|
|
|
by us, if our board of directors decides to accept an unsolicited superior proposal
for an acquisition transaction and pays the termination fee described below to CytRx; |
|
|
|
|
by CytRx, if our board of directors changes or withdraws, or fails to reaffirm, its
recommendation to Innovives stockholders that they approve the merger agreement; |
|
|
|
|
by CytRx, if we receive a proposal regarding an acquisition transaction from any
person and our board of directors takes a neutral position or makes no recommendation
with respect to the proposal and does not publicly reaffirm its recommendation in favor
of the merger agreement; and |
|
|
|
|
by either us or CytRx, if our stockholders fail to approve the merger agreement at
the special meeting. |
Termination
Fee (page 72)
The merger agreement provides that, upon termination of the merger agreement under specified
circumstances, we will be obligated to pay CytRx a termination fee of $1,500,000. We will owe the
termination fee if the merger agreement is terminated because (1) our board of directors decides to
accept an unsolicited superior proposal for an acquisition transaction, (2) our board of directors
changes or withdraws, or fails to reaffirm, its recommendation to our stockholders that they
approve the merger agreement, (3) if we receive a proposal regarding an acquisition transaction
from any person and our board of directors takes a neutral position or makes no recommendation with
respect to the proposal and does not publicly reaffirm its recommendation in favor of the merger
agreement, (4) we breach specified provisions in the merger agreement, or (5) our stockholders fail
to approve the merger agreement and we enter into another acquisition transaction within one year
after the termination of the merger agreement with a party that made a proposal for such
acquisition transaction prior to the special meeting of stockholders.
Indemnification
and Offset (page 73)
The merger agreement contains indemnification rights for the benefit of CytRx (1) to the
extent that our actual net liabilities (as defined in the merger agreement) as of June 6, 2008
exceeded our estimated net liabilities of $3,746,538 on that date as represented by us in the
merger agreement, (2) for all losses (including the first $50,000 of any such losses) to CytRx
resulting from breaches of our representations and warranties once such losses exceed a $50,000
threshold and (3) actual deposits returned to or recovered by CytRx or the
7
surviving corporation are less than the deposits previously disclosed by us. CytRxs recourse
for indemnification will be limited to its right of offset against any earnout merger
consideration. The termination fee and indemnification provisions of the merger agreement and
right of offset are generally the sole remedies for CytRx with respect to any breaches of
Innovives representations and warranties in the merger agreement.
Stockholder
Representative (pages 60 and 73)
If the merger agreement is approved at the special meeting, you will be deemed to have
irrevocably appointed Steven Kelly, our President and Chief Executive Officer, as your agent and
attorney-in-fact for purposes of the merger agreement if the merger is completed. You will be
bound by all actions taken by the stockholder representative in connection with the merger
agreement, and CytRx will be entitled to rely on any action or decision of the stockholder
representative as being your decision, act, consent or instruction. With some exceptions, CytRx
will be relieved from any liability to any person for any acts done by it in accordance with such
decision, act, consent or instruction of the stockholder representative. The stockholder
representative will not be required to take any action involving any expense to the stockholder
representative unless the payment of such expense is made or provided for in a manner satisfactory
to him. The reasonable legal fees and other expenses, if any, incurred by the stockholder
representative in performance of his duties, not to exceed $20,000 in the aggregate, will be
advanced by CytRx. CytRx also will compensate the stockholder representative at the rate of $250
per hour, not to exceed $10,000 in the aggregate, for the performance of his duties.
The stockholder representative will establish and maintain a register of our stockholders and
warrant holders for purposes of payment and distribution of any earnout merger consideration. Your
right to receive any earnout merger consideration will not be transferable, except by operation of
law.
Loan
and Security Agreement (page 76)
In connection with the merger agreement, we entered into a loan and security agreement with
CytRx pursuant to which CytRx made an initial advance to us of approximately $1,725,000, which was
used to pay some of our current accounts payable and accrued expenses. Under the loan agreement,
we may request that CytRx make additional advances in the cumulative aggregate principal amount of
up to approximately $3,775,000 to fund our working capital requirements pending the special meeting
and the completion of the merger. All additional advances requested by us will be at CytRxs
discretion. As of July 31, 2008, we had requested, and CytRx had made, approximately $662,000 of
additional advances under the loan and security agreement.
All advances under the loan agreement are secured by a lien on all or substantially all of our
assets, bear interest at the rate of 12.5% per annum, and generally are due and payable, in full,
together with accrued interest, on the earlier of the date of termination of the merger agreement
or September 30, 2008.
In consideration for entering into the loan agreement and making the initial advance, we
granted CytRx under the loan agreement a one-year option to purchase up to 2,000,000 shares of
common stock of Innovive at an exercise price of $0.01 per share. The option will become
exercisable only if we terminate the merger agreement to pursue a superior proposal as permitted by
the merger agreement.
8
Selected Historical Financial Information of CytRx
Set forth below is selected historical financial information of CytRx as of and for the years
ended December 31, 2003 through 2007 and as of and for the three months ended March 31, 2008 and
2007. The results of operations for the three months ended March 31, 2008 and 2007 are not
necessarily indicative of the results of operations for the full year or any other interim period.
CytRx management prepared the unaudited information on the same basis as it prepared CytRxs
audited consolidated financial statements. In the opinion of CytRx management, the unaudited
information reflects all adjustments, consisting of only normal recurring adjustments, necessary
for a fair presentation of this information. You should read the following information in
conjunction with CytRxs historical financial statements and related notes included as Appendix E
to this proxy statement/prospectus.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
|
|
|
|
Ended March 31, |
|
|
Years Ended December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2007 |
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
|
2003 |
|
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands, except per share information) |
|
Statement of Operations Information: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Service revenue |
|
$ |
2,181 |
|
|
$ |
1,447 |
|
|
$ |
7,242 |
|
|
$ |
1,859 |
|
|
$ |
83 |
|
|
$ |
|
|
|
$ |
|
|
Licensing revenue |
|
|
|
|
|
|
|
|
|
|
101 |
|
|
|
101 |
|
|
|
101 |
|
|
|
428 |
|
|
|
94 |
|
Grant revenue |
|
|
|
|
|
|
116 |
|
|
|
116 |
|
|
|
106 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
2,181 |
|
|
$ |
1,563 |
|
|
$ |
7,459 |
|
|
$ |
2,066 |
|
|
$ |
184 |
|
|
$ |
428 |
|
|
$ |
94 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deemed dividend for
anti-dilution adjustments
made to outstanding
common stock warrants |
|
|
(757 |
) |
|
|
|
|
|
|
|
|
|
|
(488 |
) |
|
|
(1,076 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss applicable to
common stock |
|
$ |
(6,131 |
) |
|
$ |
(4,546 |
) |
|
$ |
(21,890 |
) |
|
$ |
(17,240 |
) |
|
$ |
(16,169 |
) |
|
$ |
(16,392 |
) |
|
$ |
(17,845 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss
per share applicable to
common stock |
|
$ |
(0.07 |
) |
|
$ |
(0.06 |
) |
|
$ |
(0.26 |
) |
|
$ |
(0.25 |
) |
|
$ |
(0.28 |
) |
|
$ |
(0.48 |
) |
|
$ |
(0.65 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance Sheet Information: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents
and short-term
investments |
|
$ |
43,539 |
|
|
$ |
36,352 |
|
|
$ |
60,450 |
|
|
$ |
30,381 |
|
|
$ |
8,299 |
|
|
$ |
2,999 |
|
|
$ |
11,644 |
|
Total assets |
|
$ |
50,540 |
|
|
$ |
38,072 |
|
|
$ |
64,146 |
|
|
$ |
31,636 |
|
|
$ |
9,939 |
|
|
$ |
5,049 |
|
|
$ |
12,324 |
|
Total stockholders equity |
|
$ |
33,391 |
|
|
$ |
12,794 |
|
|
$ |
40,224 |
|
|
$ |
5,150 |
|
|
$ |
7,208 |
|
|
$ |
1,595 |
|
|
$ |
10,193 |
|
9
Selected Historical Financial Information of Innovive
Set forth below is selected historical financial information of Innovive as of and for the
years ended December 31, 2005 through 2007, for the period March 24, 2004 (inception) to December
31, 2007, for the period March 24, 2004 (inception) to March 31, 2008, and as of and for the three
months ended March 31, 2008 and 2007. The results of operations for the three months ended March
31, 2008 and 2007 are not necessarily indicative of the results of operations for the full year or
any other interim period. Innovive management prepared the unaudited information on the same basis
as it prepared Innovives audited financial statements. In the opinion of Innovive management, the
unaudited information reflects all adjustments, consisting of only normal recurring adjustments,
necessary for a fair presentation of this information. You should read the following information in
conjunction with Innovives historical financial statements and related notes included as
Appendix F to this proxy statement/prospectus.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
|
|
|
|
|
|
March 24, 2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 24, 2004 |
|
|
|
|
|
|
|
|
|
|
|
(inception) to |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(inception) to |
|
|
|
Three Months Ended March 31, |
|
|
March 31, |
|
|
Year Ended December 31, |
|
|
December 31, |
|
|
|
2008 |
|
2007 |
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
|
2005 |
|
|
2007 |
|
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands, except per share information) |
|
|
|
|
|
Statement of Operations Information: |
|
|
|
|
|
|
|
Research and development |
|
$ |
732 |
|
|
$ |
2,727 |
|
|
$ |
31,040 |
|
|
$ |
14,274 |
|
|
$ |
12,237 |
|
|
$ |
3,628 |
|
|
$ |
30,308 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
|
686 |
|
|
|
964 |
|
|
|
10,116 |
|
|
|
4,154 |
|
|
|
3,420 |
|
|
|
1,656 |
|
|
|
9,430 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
1,418 |
|
|
|
3,691 |
|
|
|
41,156 |
|
|
|
18,428 |
|
|
|
15,657 |
|
|
|
5,284 |
|
|
|
39,738 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(1,418 |
) |
|
|
(3,691 |
) |
|
|
(41,156 |
) |
|
|
(18,428 |
) |
|
|
(15,657 |
) |
|
|
(5,284 |
) |
|
|
(39,738 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
18 |
|
|
|
55 |
|
|
|
477 |
|
|
|
286 |
|
|
|
156 |
|
|
|
16 |
|
|
|
459 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
|
|
|
|
|
|
|
|
1,606 |
|
|
|
|
|
|
|
1,189 |
|
|
|
411 |
|
|
|
1,606 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other expense |
|
|
177 |
|
|
|
|
|
|
|
220 |
|
|
|
43 |
|
|
|
|
|
|
|
|
|
|
|
43 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
(1,576 |
) |
|
|
(3,636 |
) |
|
|
(42,505 |
) |
|
|
(18,185 |
) |
|
|
(16,690 |
) |
|
|
(5,679 |
) |
|
|
(40,928 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Imputed preferred stock dividends |
|
|
|
|
|
|
|
|
|
|
809 |
|
|
|
|
|
|
|
809 |
|
|
|
|
|
|
|
809 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss applicable to common shares |
|
$ |
(1,576 |
) |
|
$ |
(3,636 |
) |
|
$ |
(43,314 |
) |
|
$ |
(18,185 |
) |
|
$ |
(17,499 |
) |
|
$ |
(5,679 |
) |
|
$ |
(41,737 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share basic and diluted |
|
$ |
(0.11 |
) |
|
$ |
(0.40 |
) |
|
|
|
|
|
$ |
(1.41 |
) |
|
$ |
(2.74 |
) |
|
$ |
(1.83 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding basic
and diluted |
|
|
14,610,003 |
|
|
|
9,147,068 |
|
|
|
|
|
|
|
12,902,475 |
|
|
|
6,391,802 |
|
|
|
3,107,338 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance Sheet Information: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents and short-term investments |
|
$ |
302 |
|
|
$ |
464 |
|
|
|
|
|
|
$ |
2,670 |
|
|
$ |
2,545 |
|
|
$ |
134 |
|
|
|
|
|
Working capital (deficiency) |
|
|
(3,671 |
) |
|
|
(2,020 |
) |
|
|
|
|
|
|
(2,222 |
) |
|
|
1,330 |
|
|
|
(4,039 |
) |
|
|
|
|
Total assets |
|
|
948 |
|
|
|
1,573 |
|
|
|
|
|
|
|
3,241 |
|
|
|
4,228 |
|
|
|
500 |
|
|
|
|
|
Deficit accumulated during the development stage |
|
|
(43,313 |
) |
|
|
(27,188 |
) |
|
|
|
|
|
|
(41,737 |
) |
|
|
(23,552 |
) |
|
|
(6,053 |
) |
|
|
|
|
Total stockholders equity (deficiency) |
|
|
(3,526 |
) |
|
|
(1,895 |
) |
|
|
|
|
|
|
(2,074 |
) |
|
|
1,456 |
|
|
|
(5,134 |
) |
|
|
|
|
10
RISK FACTORS
In addition to the other information contained in this proxy statement/prospectus, we urge you
to consider the following factors before deciding how to vote on the approval and adoption of the
merger agreement.
Risks Associated with the Merger
There is no guarantee that the merger will be completed.
The merger is subject to a number of conditions, including approval by Innovive stockholders.
There is no assurance that the merger will be approved or that the other conditions to the
completion of the merger will be satisfied. If the merger is not completed, we will either need to
complete another strategic transaction or file for bankruptcy protection.
Innovive and CytRx may not achieve the benefits they expect from the merger, which may have a
material adverse effect on the combined companys business, financial, and operating results.
Innovive and CytRx entered into the merger agreement with the expectation that the merger will
result in benefits to the combined company. Post-merger challenges include the following:
|
|
|
maintaining the listing of CytRx common stock on The Nasdaq Capital Market to
promote liquidity for stockholders of the combined company and potentially greater
access to capital; and |
|
|
|
|
using the assets and resources of the combined company to successfully develop the
existing product candidates of the combined company. |
If the combined company is not successful in addressing these and other challenges, then the
benefits of the merger may not be realized and, as a result, the combined companys operating
results and the market price of CytRxs common stock may be adversely affected.
If the costs associated with the merger exceed the benefits, the combined company may
experience adverse financial results, including increased losses.
Innovive and CytRx will incur significant transaction costs as a result of the merger,
including legal and accounting fees that may exceed their current estimates. In addition, Innovive
and CytRx expect that the combined company will incur integration expenses, which cannot be
precisely estimated at this time. Actual transaction costs may substantially exceed the current
estimates of Innovive and CytRx and may adversely affect the combined companys financial condition
and operating results. If the benefits of the merger do not exceed the costs associated with the
merger, the combined companys financial results could be adversely affected, resulting in, among
other things, increased losses, and decreased trading prices for CytRx common stock.
CytRx expects to continue to incur operating losses, and the combined company will need to
raise additional funds to cover the cost of operation. If the combined company is not able to raise
necessary additional funds, it may have to reduce or stop operations.
CytRx has had no commercial revenues to date and cannot predict when it will. CytRx had an
accumulated deficit of approximately $170.5 million as of March 31, 2008. CytRx cannot be certain
that the combined company after the merger will achieve or sustain profitability in the future.
Until the combined company begins generating significant revenue, it will be required to obtain
funding through the sale of equity securities, which may result in dilution to CytRxs
then-existing stockholders, or other means. Additional funding may not be available to the
combined company on acceptable terms, or at all. If the combined
11
company is unable to obtain adequate financing on a timely basis, it may be required to delay,
reduce or stop operations, any of which would have a material adverse effect on its business.
The merger agreement limits our ability to pursue alternatives to the merger, and if we do so,
CytRx would be entitled to exercise its option to purchase Innovive common stock granted in the
loan and security agreement, which would be dilutive to our stockholders.
The merger agreement contains no-shop provisions that, subject to specified exceptions,
limit our ability to discuss, facilitate or commit to competing acquisition transactions. In
addition, a termination fee of $1,500,000 is payable by us if we terminate the merger agreement to
pursue a superior proposal. These provisions might discourage a potential competing acquirer that
might have an interest in acquiring all or a significant part of Innovive from considering or
proposing that acquisition even if it were prepared to pay consideration greater than the merger
consideration proposed in the merger, or might result in a potential competing acquirer proposing
to pay less consideration to acquire Innovive than it might have been willing to pay absent these
no-shop provisions.
If we were to terminate the merger agreement to pursue a superior proposal, CytRx would be
entitled to exercise its option granted in the loan and security agreement to purchase up to
2,000,000 shares of our common stock at an exercise price of $0.01 per share. CytRx would be
likely to exercise its option in connection with the completion of a superior proposal transaction,
which would materially reduce the amount of the consideration that otherwise would be received in
the transaction by our other stockholders.
The support agreements may deter competing bids.
Our directors and officers and their affiliates who are entitled to vote approximately 22% of
the shares of Innovive common stock entitled to vote at the special meeting have agreed in the
support agreements to vote their shares in favor of the merger agreement and against any competing
acquisition transaction. The support agreements may discourage other potential acquirers and would
make it more difficult for a competing acquirer to obtain approval of its bid.
Because the market price of CytRx common stock may fluctuate, you cannot be sure of the market
value of CytRx common stock that you will receive in the merger.
Upon completion of the merger, CytRx will pay initial merger consideration of $3,000,000 in
the form of shares of CytRx common stock valued at $0.94 per share, which equals the average daily
volume-weighted closing price of CytRx common stock as reported on The Nasdaq Capital Market over
the ten trading days prior to the signing of the merger agreement, and is not subject to change.
The market price of CytRx common stock will likely be different, and may be lower, than $0.94 on
the date that this proxy statement/prospectus is mailed to you, or the date of the special meeting,
and on the date you receive shares of CytRx common stock in the merger. Differences in CytRxs
stock price may result from a variety of factors, including factors beyond CytRxs control. For a
discussion of factors that may affect CytRxs stock price, see Risk Factors Associated with
CytRxs Business, Risk Factors Associated with CytRxs Investment in RXi and Risk Factors
Associated with CytRx Common Stock below in this section.
You cannot be sure when you will receive any earnout merger consideration, and you may never
receive any earnout merger consideration.
In addition to the initial merger consideration, CytRx will pay future earnout merger
consideration of up to $18,253,462, subject to the achievement of specified net sales under
Innovives existing license agreements. No Innovive products have been approved for marketing, and
we believe that we are at least two years away from obtaining marketing approval for any products
under our existing license agreement. CytRx may be unable to obtain marketing approval for any
Innovive products. Even if CytRx obtains such approvals, there is no assurance that it will be
able to achieve sufficient net sales to require payment of all or any portion
12
of the earnout merger consideration, so you may never receive any earnout merger
consideration. The earnout merger consideration also is subject to possible offset by CytRx for
indemnification claims under the merger agreement.
The merger might be a taxable transaction for U.S. federal income tax purposes, in which event
you will recognize gain or loss to the extent that the value of the merger consideration you
receive is greater or less than your tax basis in your Innovive shares.
The merger might constitute a fully taxable exchange, in which case each U.S. holder of
Innovive common stock will recognize income, gain or loss for U.S. federal income tax purposes
measured by the difference between the fair market value of the merger consideration received in
the merger and the holders tax basis in the Innovive common stock. Even if the merger constitutes
a tax-free reorganization, each U.S. holder of Innovive common stock will recognize (i) taxable
income on the portion of any earnout merger consideration characterized as imputed interest and
(ii) taxable gain on the receipt of any earnout merger consideration received in the form of cash,
to the extent it exceeds the U.S. holders adjusted tax basis in the Innovive common stock
allocable to such earnout merger consideration.
If the merger is not completed, we will have incurred substantial expenses without realizing
the expected benefits of the merger. We also will have to repay CytRx for advances under the loan
and security agreement, and may not to be able to do so.
We have incurred substantial expenses in connection with the merger described in this proxy
statement/prospectus, the payment of all or substantially all of which was funded by our borrowings
from CytRx under the loan and security agreement. We expect to borrow additional amounts prior to
the special meeting and the completion of the merger. The completion of the merger depends on the
approval of our stockholders and the satisfaction of the other conditions to the merger. If the
merger is not completed, we would not have realized the expected benefits of the merger.
If the merger is not completed, our borrowings under the loan and security agreement, plus
accrued interest, will become immediately due and payable to CytRx. As of July 31, 2008, CytRx had
advanced to us under the loan and security agreement a total of approximately $2,387,000, and we
may request additional advances of up to $3,113,000 under the loan and security agreement. We have
no commitments and arrangements for any financing to repay such advances, so we expect that we
would be unable to repay such advances if the merger agreement is not approved at the special
meeting or the merger is not completed. In this event, CytRx would be entitled to pursue all of
its remedies under the loan and security agreement, including the possible foreclosure sale of all
or substantially all of our assets.
Our officers and directors may have financial interests in the merger that may be different
from, or in addition to, the interests of our stockholders, generally.
Some of our officers may receive severance benefits under their existing employment
agreements, and our officers and directors may have other financial interests in the merger that
may be different from, or in addition to, the interests of our stockholders, generally. Our board
of directors was aware of these interests and took them into account in its decision to approve and
adopt the merger agreement. For information concerning these interests, please see the discussion
under the caption The Merger Interests of Innovives Directors and Officers in the Merger.
If the merger is not consummated by September 30, 2008, either we or CytRx may choose not to
proceed with the merger.
Either we or CytRx may terminate the merger agreement if the merger has not been completed by
September 30, 2008, unless the failure of the merger to be completed by such date has resulted from
the failure
13
of the party seeking to terminate the merger agreement to perform its obligations or the
failure of the condition regarding effectiveness of the registration statement of which this proxy
statement/prospectus is a part.
The fairness opinion obtained by us from our financial advisor will not reflect changes in
circumstances subsequent to the date of the merger agreement.
We have obtained a fairness opinion dated as of June 6, 2008 from our financial advisor,
Chartered Capital Advisers, Inc. We did not seek or obtain from Chartered an updated opinion as of
the date of this proxy statement/prospectus. Changes in the operations and prospects of CytRx or
us, general market and economic conditions and other factors that may be beyond the control of
CytRx and us, and on which the fairness opinion was based, may alter our value or the price of
shares of our common stock or of CytRx common stock by the time the merger is completed.
Chartereds opinion does not speak to the time the merger will be completed or to any other date
other than the date of such opinion. As a result, the opinion will not address the fairness of the
merger consideration, from a financial point of view, at the time the merger is completed. For a
description of the opinion that we received from Chartered, please refer to Opinion
of Innovives Financial Advisor beginning on page 49 of this proxy statement/prospectus.
The shares of CytRx common stock to be received in the merger will have different rights from
the shares of Innovive common stock.
Upon completion of the merger, our stockholders will become CytRx stockholders. Your rights
as CytRx stockholders will be governed by the restated certificate of incorporation and restated
bylaws of CytRx and the CytRx rights agreement, which are different from the rights associated with
Innovive common stock. See Comparison of Rights of Holders of CytRx Common Stock and Innovive
Common Stock beginning on page 165 for a discussion of the different rights associated with CytRx
common stock.
Risks Associated with CytRxs Common Stock
CytRx common stock may be delisted from The Nasdaq Capital Market if the stock price does not
increase.
CytRx received notice from The Nasdaq Stock Market on May 28, 2008, that CytRx common stock
had closed below $1.00 per share for 30 consecutive business days, and CytRx was therefore not in
compliance with the minimum bid price required by Nasdaq Marketplace Rule 4310(c)(4). In
accordance with Marketplace Rule 4310(c)(8)(D), CytRx may regain compliance if at any time by
November 24, 2008, CytRx common stock closes at or above $1.00 for 10 consecutive business days and
CytRx otherwise meets the Nasdaqs continuing listing requirements. Nasdaq also informed CytRx
that if CytRx does not regain compliance by November 24, 2008, CytRx will be granted up to an
additional 180 calendar days to regain full compliance while continuing to trade during this time
on The Nasdaq Capital Market if at that time CytRx meets the Nasdaqs initial listing requirements
other than the minimum bid price rule. If CytRx eventually fails to comply with this condition for
continued listing and CytRx common stock is delisted from The Nasdaq Small Capital Market, there is
no assurance that CytRx common stock will be listed for trading or quoted elsewhere and an active
trading market for CytRx common stock may cease to exist, which would materially and adversely
impact the market value of CytRx common stock.
CytRxs outstanding options and warrants and the availability for resale of CytRxs shares
issued in CytRxs private financings may adversely affect the trading price of CytRxs common
stock.
As
of June 30, 2008, there were outstanding stock options and warrants to purchase
approximately 18.2 million shares of CytRxs common stock at a weighted-average exercise price of
$1.73 per share. CytRxs outstanding options and warrants could adversely affect CytRxs ability to
obtain future financing or engage in certain mergers or other transactions, since the holders of
options and warrants can be expected to exercise them at a time when CytRx may be able to obtain
additional capital through a new
14
offering of securities on terms more favorable to CytRx than the terms of outstanding options
and warrants. For the life of the options and warrants, the holders have the opportunity to profit
from a rise in the market price of CytRxs common stock without assuming the risk of ownership. The
issuance of shares upon the exercise of outstanding options and warrants will also dilute the
ownership interests of CytRxs existing stockholders. Many of CytRxs outstanding warrants contain
anti-dilution provisions pertaining to dividends or distributions with respect to CytRxs common
stock. CytRxs outstanding warrants to purchase approximately 800,000 shares also contain
anti-dilution provisions that are triggered upon any issuance of securities by CytRx below the
prevailing market price of CytRxs common stock, and CytRxs outstanding warrants to purchase
approximately 11.5 million shares contain anti-dilution provisions that are triggered upon any
dividend of cash or property. CytRxs recent distribution to CytRxs stockholders of shares of RXi
common stock triggered a reduction in the exercise price and an increase in the number of shares
underlying these warrants. In the event that these anti-dilution provisions are triggered by CytRx
in the future, CytRx would be required to further reduce the exercise price and increase the number
of shares underlying these warrants, which would have a dilutive effect on CytRxs stockholders.
CytRx has registered with the SEC the resale by the holders of all or substantially all shares
of CytRx common stock issuable upon exercise of its outstanding options and warrants. The
availability of these shares for public resale, as well as actual resales of these shares, could
adversely affect the trading price of CytRxs common stock.
CytRx may issue preferred stock in the future, and the terms of the preferred stock may reduce
the value of CytRxs common stock.
CytRx is authorized to issue shares of preferred stock in one or more series. CytRxs board of
directors may determine the terms of future preferred stock offerings without further action by
CytRxs stockholders. If CytRx issues preferred stock, it could affect the rights of CytRx
stockholders at that time or reduce the value of CytRx common stock. In particular, specific rights
granted to future holders of preferred stock may include voting rights, preferences as to dividends
and liquidation, conversion and redemption rights, sinking fund provisions, and restrictions on
CytRxs ability to merge with or sell CytRxs assets to a third party.
CytRx may experience volatility in its stock price, which may adversely affect the trading
price of CytRxs common stock.
The market price of
CytRxs common stock has ranged from a low of approximately
$0.43 to a high of approximately $5.49 per share since
January 1, 2007, and it may continue to experience significant volatility from time to time.
Factors such as the following may affect such volatility:
|
|
|
announcements of regulatory developments or technological innovations by CytRx or
CytRxs competitors; |
|
|
|
|
changes in CytRxs relationship with CytRxs licensors and other strategic partners; |
|
|
|
|
changes in CytRxs stock holdings or other relationships with RXi; |
|
|
|
|
CytRxs quarterly operating results; |
|
|
|
|
litigation involving or affecting CytRx; |
|
|
|
|
shortfalls in CytRxs actual financial results compared to CytRxs guidance or the
forecasts of stock market analysts; |
|
|
|
|
developments in patent or other technology ownership rights; |
15
|
|
|
acquisitions or strategic alliances by CytRx or CytRxs competitors; |
|
|
|
|
public concern regarding the safety of CytRxs products; and |
|
|
|
|
government regulation of drug pricing. |
Other factors which may affect CytRxs stock price are general changes in the economy, the
financial markets or the pharmaceutical or biotechnology industries.
CytRxs anti-takeover provisions may make it more difficult to change CytRxs management, or
may discourage others from acquiring CytRx, and thereby adversely affect stockholder value.
CytRxs rights plan and provisions in CytRxs bylaws are intended to protect CytRxs
stockholders interests by encouraging anyone seeking control of CytRx to negotiate with CytRxs
board of directors. These provisions may discourage or prevent a person or group from acquiring
CytRx without the approval of CytRxs board of directors, even if the acquisition would be
beneficial to CytRxs stockholders.
CytRx has a classified board of directors, which means that at least two stockholder meetings,
instead of one, will be required to effect a change in the majority control of CytRxs board of
directors. This applies to every election of directors, not just an election occurring after a
change in control. The classification of CytRxs board increases the amount of time it takes to
change majority control of CytRxs board of directors and may cause potential acquirers to lose
interest in a potential purchase of CytRx, regardless of whether such purchase would be beneficial
to CytRx or its stockholders. The additional time and cost to change a majority of the members of
CytRxs board of directors makes it more difficult and may discourage CytRxs existing stockholders
from seeking to change CytRxs existing management in order to change the strategic direction or
operational performance of CytRxs company.
CytRxs restated bylaws provide that directors may only be removed for cause by the
affirmative vote of the holders of at least a majority of the outstanding shares of CytRxs capital
stock then entitled to vote at an election of directors. This provision prevents stockholders from
removing any incumbent director without cause. CytRxs bylaws also provide that a stockholder must
give CytRx at least 120 days notice of a proposal or director nomination that such stockholder
desires to present at any annual meeting or special meeting of stockholders. Such provision
prevents a stockholder from making a proposal or director nomination at a stockholder meeting
without CytRx having advance notice of that proposal or director nomination. This could make a
change in control more difficult by providing CytRxs directors with more time to prepare an
opposition to a proposed change in control. By making it more difficult to remove or install new
directors, these bylaw provisions may also make CytRxs existing management less responsive to the
views of CytRxs stockholders with respect to CytRxs operations and other issues such as
management selection and management compensation.
CytRx does not intend to pay cash dividends on its common stock in the foreseeable future.
CytRx has not declared or paid any cash dividends on CytRxs common stock or other securities,
and CytRx currently does not anticipate paying any cash dividends in the foreseeable future.
Because CytRx does not anticipate paying cash dividends for the foreseeable future, CytRxs
stockholders will not realize a return on their investment in CytRxs common stock except to the
extent of any appreciation in the value of CytRxs common stock. CytRxs common stock may not
appreciate in value, or may decline in value.
16
Risks Associated With CytRxs Business
CytRx has operated at a loss and will likely continue to operate at a loss for the foreseeable
future.
CytRx has operated at a loss due to its substantial expenditures for research and development
of its product candidates and for general and administrative purposes and its lack of significant
recurring revenue. CytRx incurred net losses of $21.9 million, $16.8 million and $15.1 million,
respectively, for the years ended December 31, 2007, 2006 and 2005 and a net loss of $5.4 million
for the three months ended March 31, 2008. CytRx had an accumulated deficit as of March 31, 2008
of approximately $170.5 million. CytRx is likely to continue to incur losses unless and until it is
able to commercialize one or more of its product candidates. These losses, among other things, have
had and will continue to have an adverse effect on CytRxs stockholders equity and working
capital. Because of the numerous risks and uncertainties associated with its product development
efforts, CytRx is unable to predict when CytRx may become profitable, if at all. If CytRx is unable
to achieve and maintain profitability, the market value of its common stock will likely decline.
Because CytRx has no source of significant recurring revenue, CytRx must depend on financing
to sustain its operations.
Developing products and conducting clinical trials require substantial amounts of capital. To
date, CytRx has relied primarily upon proceeds from sales of its equity securities and the exercise
of options and warrants, and to a much lesser extent, upon payments from its strategic partners and
licensees, to generate funds needed to finance its business and operations. CytRx will need to
raise additional capital to, among other things:
|
|
|
fund CytRxs clinical trials and pursue regulatory approval of CytRxs existing and
possible future product candidates; |
|
|
|
|
expand CytRxs research and development activities; |
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|
|
|
finance CytRxs general and administrative expenses; |
|
|
|
|
acquire or license other technologies; |
|
|
|
|
prepare, file, prosecute, maintain, enforce and defend CytRxs patent and other
proprietary rights; and |
|
|
|
|
develop and implement sales, marketing and distribution capabilities to successfully
commercialize any product for which CytRx obtains marketing approval and which CytRx
chooses to market itself. |
CytRxs revenues were approximately $7.5 million, $2.1 million and $0.2 million, respectively,
for years ended December 31, 2007, 2006 and 2005, and approximately $2.2 million for the three
months ended March 31, 2008. CytRxs revenues for the years ended December 31, 2007 and 2006 and
the three months ended March 31, 2008 included approximately $7.2 million, $1.9 million, and $2.2
million, respectively, of deferred revenue recognized from CytRxs sale in August 2006 of a one
percent royalty interest in worldwide sales of arimoclomol for the treatment of amoyotrophic
lateral sclerosis, which is commonly known as ALS, or Lou Gehrigs disease. CytRx will have no
significant recurring revenue unless it is able to commercialize one or more of its product
candidates in development, which may require CytRx to first enter into license or other strategic
arrangements with third parties.
At March 31, 2008, CytRx had cash, cash equivalents and short-term investments of
approximately $43.5 million. CytRx believes that its current resources will be sufficient to
support its currently planned level
17
of operations into the second half of 2009. This estimate is based, in part, upon CytRxs
currently projected expenditures for the remainder of 2008 and the first three months of 2009 of
approximately $23.9 million, including approximately $1.5 million of direct expenditures for
CytRxs planned clinical program for arimoclomol for ALS and related studies, approximately
$0.5 million of direct expenditures for its planned clinical program for arimoclomol for stroke
recovery and related studies, approximately $6.1 million of direct expenditures for its planned
Phase II clinical trial of iroxanadine for diabetic ulcers, approximately $7.7 million for the
operations of its research laboratory in San Diego, California, and approximately $8.1 million for
other general and administrative expenses. CytRxs projected expenditures are based on CytRxs
recently announced plan to conduct additional animal toxicology studies prior to the resumption of
its Phase II clinical program for arimoclomol for ALS that currently is on clinical hold by the FDA
and prior to any initiation of its Phase II clinical trial for arimoclomol for stroke recovery.
Those animal toxicology studies are expected to take approximately one year. As described in the
risk factor that follows below in this section, these projected expenditures are based upon
numerous other assumptions and subject to many uncertainties, and CytRxs actual expenditures may
be significantly different from these projections. These projected expenditures also do not
consider the effects of the merger on CytRxs operations and financial condition. However, CytRx
will need additional funds to advance any of Innovives product candidates.
If CytRx obtains marketing approval as currently planned and successfully commercializes its
current product candidates, CytRx anticipates it will take a minimum of three years, and possibly
longer, for CytRx to generate significant recurring revenue, and CytRx will be dependent on future
financing until such time, if ever, as it can generate significant recurring revenue. CytRx has no
commitments from third parties to provide CytRx with any additional financing, and CytRx may not be
able to obtain future financing on favorable terms, or at all. If CytRx raises additional funds by
issuing equity securities, dilution to CytRxs then-existing stockholders may result and new
investors could have rights superior to holders of CytRx common stock, including holders who
receive shares in the merger. In addition, debt financing, if available, may include restrictive
covenants. If adequate funds are not available to CytRx, it may have to liquidate some or all of
its assets or to delay or reduce the scope of or eliminate some portion or all of its development
programs or clinical trials. CytRx also may have to license to other companies its product
candidates or technologies that it would prefer to develop and
commercialize on its own.
If CytRx does not achieve its projected development goals in the time frames CytRx announces
and expects, or if CytRxs financial projections prove to be materially inaccurate, the
commercialization of its products may be delayed and CytRxs stock price may significantly decline.
From time to time, CytRx estimates the timing of the accomplishment of various scientific,
clinical, regulatory and other product development goals, which CytRx sometimes refers to as
milestones. These milestones may include the commencement or completion of scientific studies and
clinical trials and the submission of regulatory filings. For example, CytRx has disclosed
elsewhere in this proxy statement/prospectus the expected timing of certain milestones relating to
CytRxs arimoclomol and iroxanadine clinical development program.
CytRx also may disclose projected expenditures or other forecasts for future periods. For
example, CytRx has stated above in this section that it currently projects that its total
expenditures for the remainder of 2008 and the first three months of 2009 will be approximately
$23.9 million, without considering the effects of the merger. CytRxs financial projections are
based on CytRx managements current expectations and do not contain any cushion for any specific
uncertainties, or for the uncertainties inherent in all financial forecasting. The assumptions
CytRx management has used to produce these projections may change significantly or prove to be
inaccurate. Accordingly, you should not unduly rely on any of these projections.
The actual timing of milestones and actual expenditures or other financial results of CytRx
can vary dramatically compared to CytRxs estimates, in some cases for reasons beyond CytRxs
control. If CytRx does not meet milestones or financial projections as announced from time to time,
the development and commercialization of CytRxs products may be delayed and CytRxs stock price
may decline significantly.
18
If CytRxs products are not successfully developed and approved by the FDA, CytRx may be
forced to reduce or curtail its operations.
All of CytRxs product candidates in development must be approved by the U.S. Food and Drug
Administration, or FDA, or corresponding foreign governmental agencies before they can be marketed.
The process for obtaining FDA and foreign government approvals is both time-consuming and costly,
with no certainty of a successful outcome. This process typically includes the conduct of extensive
pre-clinical and clinical testing, including post-approval testing, which may take longer or cost
more than CytRx or its licensees, if any, anticipate, and may prove unsuccessful due to numerous
factors. Product candidates that may appear to be promising at early stages of development may not
successfully reach the market for a number of reasons. The results of preclinical and initial
clinical testing of these product candidates may not necessarily be predictive of the results that
will be obtained from later or more extensive testing. Companies in the pharmaceutical and
biotechnology industries have suffered significant setbacks in advanced clinical trials, even after
obtaining promising results in earlier trials.
Numerous factors could affect the timing, cost or outcome of CytRxs product development
efforts, including the following:
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difficulty in securing centers to conduct trials; |
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difficulty in enrolling patients in conformity with required protocols or projected
timelines; |
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unexpected adverse reactions by patients in trials; |
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difficulty in obtaining clinical supplies of the product; |
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changes in or CytRxs inability to comply with FDA or foreign governmental product
testing, manufacturing or marketing requirements; |
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regulatory inspections of clinical trials or manufacturing facilities, which may,
among other things, require CytRx or CytRxs manufacturers or licensees to undertake
corrective action or suspend or terminate the affected clinical trials if investigators
find them not to be in compliance with applicable regulatory requirements; |
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inability to generate statistically significant data confirming the safety and
efficacy of the product being tested; |
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modification of the product during testing; and |
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reallocation of CytRxs limited financial and other resources to other clinical
programs. |
In addition, the FDA and other regulatory agencies may lack experience in evaluating product
candidates to treat ALS. For example, CytRx is aware of only one drug that the FDA has approved to
treat ALS, and that no new drug application, or NDA, based upon molecular chaperone amplification
has ever been approved by the FDA. This inexperience may lengthen the regulatory review process,
increase CytRxs development costs and delay or prevent commercialization of arimoclomol or CytRxs
other product candidates. It is possible that none of the product candidates CytRx develops will
obtain the regulatory approvals necessary for it to begin selling them. The time required to obtain
FDA and foreign governmental approvals is unpredictable, but often can take years following the
commencement of clinical trials, depending upon the complexity of the product candidate. Any
analysis CytRx performs on data from clinical activities is subject to confirmation and
interpretation by regulatory authorities, which could delay, limit or prevent regulatory approval.
Furthermore, even if CytRx obtain regulatory approvals, CytRxs products and the manufacturing
facilities used to produce them will be subject to continual review, including periodic
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inspections and mandatory post- approval clinical trials by the FDA and other CytRx and
foreign regulatory authorities. Any delay or failure in obtaining required approvals or to comply
with post-approval regulatory requirements could have a material adverse effect on CytRxs ability
to generate revenue from the particular product candidate. The failure to comply with any
post-approval regulatory requirements also could also result in the rescission of the related
regulatory approvals or the suspension of sales of the offending product.
CytRxs current and planned clinical trials of its molecular chaperone amplification product
candidates may fail to show that these product candidates are clinically safe and effective.
The results of CytRxs Phase IIa clinical trial and open-label extension clinical trial of
arimoclomol for the treatment of ALS indicated that arimoclomol was safe and well-tolerated in
patients. However, the results of the open-label extension clinical trial indicated only a
non-statistically significant trend of improvement in the ALS Functional Rating Scale, or ALSFRS,
in the arimoclomol high-dose group as compared with reports of previous studies of untreated
patients. Because this trial did not have concurrent placebo control group, CytRx can draw no
definitive conclusions with respect to efficacy. CytRx plans to initiate a Phase II clinical trial
of iroxanadine for diabetic ulcers in the first quarter of 2009. In December 2007, CytRx initiated
a Phase IIb efficacy trial of arimoclomol for the treatment of ALS, which was subsequently placed
on clinical hold by the FDA. CytRx plans to conduct additional animal toxicology studies to address
issues raised by the clinical hold, and depending on the outcome of those studies and other
factors, to thereafter resume the Phase IIb efficacy trial. CytRx also plans to undertake a second
efficacy trial of arimoclomol for ALS, possibly overlapping with the Phase IIb efficacy trial, to
provide additional data to support possible FDA approval. In addition, contingent upon the results
of the planned animal toxicology studies and other factors, CytRx plans to conduct a Phase II
clinical trial of arimoclomol in stroke patients. The FDA may also require additional, larger Phase III clinical trials before CytRx may submit an application for marketing approval. None of these
trials may yield favorable safety and efficacy data, and the FDA may disagree with how CytRx
interprets the data from these clinical trials. For example, CytRx may not obtain data from its
planned animal toxicology studies of arimoclomol that enable it to proceed with further clinical
development, the favorable safety data CytRx observed in earlier trials may not be reproduced in
these later trials, and these later trials may not yield statistically significant data indicating
that the product candidates are clinically effective. Accordingly, CytRx may ultimately be unable
to provide the FDA with satisfactory data on clinical safety and efficacy sufficient to persuade
the FDA to approve arimoclomol or iroxanadine for these indications.
The FDA has placed a clinical hold on CytRxs Phase IIb efficacy trial of arimoclomol, which
will delay the trial and could lead to a requirement that CytRx conduct additional toxicology
studies or alter the trial design.
In January 2008, the FDA placed a clinical hold on CytRxs Phase IIb clinical efficacy trial
of arimoclomol for the treatment of ALS due to concerns relating to previous toxicology studies of
arimoclomol in rats. CytRx received a formal determination letter from the FDA
in July 2008. In light of the ongoing clinical hold, CytRx recently announced plans to conduct additional
preclinical toxicology studies of arimoclomol, which are expected to take up to one year to
complete, before any possible resumption or initiation of clinical trials of arimoclomol. CytRx
cannot predict the outcome of those additional animal toxicology studies. Depending on the outcome,
CytRx may be:
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required to conduct additional toxicology or human studies prior to or in parallel
with the resumption of CytRxs clinical trial, which would result in substantial
additional expenses and possible significant delays in completing the clinical trial; |
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required to alter the design including reducing the dosage of arimoclomol, of the
clinical trial, which could significantly delay the completion of the trial, increase
the cost of the trial, adversely affect CytRxs ability to demonstrate the efficacy of
arimoclomol in the trial or cause CytRx to cancel the trial altogether due to one or
more of these considerations; or |
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prohibited by the FDA from resuming CytRxs current planned clinical trial or
initiating any other clinical trial of arimoclomol for the treatment of ALS or any
other indication due to safety concerns. |
CytRxs development of arimoclomol for stroke recovery is subject to similar risks.
Even if CytRx obtains regulatory approval for arimoclomol or iroxanadine, these product
candidates may not achieve market acceptance or be profitable.
CytRx does not expect to receive regulatory approvals for the commercial sale of arimoclomol
or iroxanadine, its candidate for the treatment of diabetic ulcers, for several years, if at all.
Even if CytRx does receive regulatory approvals, the future commercial success of these drug
candidates will depend, among other things, on their acceptance by physicians, patients, healthcare
payors and other members of the medical community as therapeutic and cost-effective alternatives to
commercially available products. If CytRxs product candidates fail to gain market acceptance,
CytRx may not be able to earn sufficient revenues to continue its business.
Any drugs CytRx develops may become subject to unfavorable pricing regulations, third-party
reimbursement practices or healthcare reform initiatives, which could have a material adverse
effect on CytRxs business.
CytRx intends to sell its products primarily to hospitals which receive reimbursement for the
health care services they provide to their patients from third-party payors, such as Medicare,
Medicaid and other domestic and international government programs, private insurance plans and
managed care programs. Most third-party payors may deny reimbursement if they determine that a
medical product was not used in accordance with cost-effective treatment methods, as determined by
the third-party payor, or was used for an unapproved indication. Third-party payors also may refuse
to reimburse for experimental procedures and devices. Furthermore, because CytRxs programs are in
the early stages of development, CytRx is unable at this time to determine their cost-effectiveness
and the level or method of reimbursement. Increasingly, the third-party payors who reimburse
patients are requiring that drug companies provide them with predetermined discounts from list
prices, and are challenging the prices charged for medical products. If the price CytRx is able to
charge for any products CytRx develops is inadequate in light of its development and other costs,
CytRxs profitability could be adversely effected.
CytRx currently expects that any drugs it develops may need to be administered under the
supervision of a physician. Under currently applicable law, drugs that are not usually
self-administered may be eligible for coverage by the Medicare program if:
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they are incidental to a physicians services; |
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they are reasonable and necessary for the diagnosis or treatment of the illness or
injury for which they are administered according to accepted standard of medical
practice; |
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they are not excluded as immunizations; and |
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they have been approved by the FDA. |
CytRxs current financial resources may be diminished if it elects to provide RXi
Pharmaceuticals Corporation with additional funding.
CytRx has no obligation to provide any additional funding to RXi, but CytRx might seek to
provide funding to RXi in order to protect CytRxs current investment in RXi if RXi is unable to
obtain sufficient funding on its own, or in order for CytRx to maintain its relative ownership
interest in RXi if RXi undertakes a
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financing. If CytRx provides RXi with any additional funding, CytRx will have less funds
available for its own business and operations.
CytRx may rely upon third parties in connection with the commercialization of its products.
CytRx plans to retain the services of one or more site management and clinical research
organizations to help conduct CytRxs planned clinical trials. CytRx may seek to complete the
development and marketing of arimoclomol, if it is approved by the FDA. However, the completion of
the development of arimoclomol and CytRxs other product candidates, as well as the marketing of
these products, may require CytRx to enter into strategic alliances, license agreements or other
collaborative arrangements with other pharmaceutical companies under which those companies will be
responsible for one or more aspects of the commercial development and eventual marketing of CytRxs
products.
CytRxs products may not have sufficient potential commercial value to enable CytRx to secure
strategic arrangements with suitable companies on attractive terms, or at all. If CytRx is unable
to enter into such arrangements, CytRx may not have the financial or other resources to complete
the development of any of its products and may have to sell its rights in them to a third party or
abandon their development altogether.
To the extent CytRx enters into collaborative arrangements with respect to its product
candidates, CytRx will be dependent upon the timeliness and effectiveness of the development and
marketing efforts of its contractual partners. If these companies do not allocate sufficient
personnel and resources to these efforts or encounter difficulties in complying with applicable FDA
and other regulatory requirements, CytRx may not obtain regulatory approvals as planned, if at all,
and the timing of receipt or the amount of revenue from these arrangements may be materially and
adversely affected. These arrangements also would reduce the potential profitability of these
product candidates to CytRx.
CytRx has reported several material weaknesses in the effectiveness of its internal controls
over financial reporting, and if CytRx cannot maintain effective internal controls or provide
reliable financial and other information, investors may lose confidence in CytRxs SEC reports.
In
its most recent annual report and its quarterly report for the
quarter ended March 31, 2008 filed with the
Securities and Exchange Commission, or SEC, CytRx reported material weaknesses in the effectiveness
of CytRxs internal controls over financial reporting related to failures on the part of CytRxs
accounting personnel to follow established practices and procedures and a failure to keep current
CytRxs legal database for contracts relating to CytRxs arimoclomol development program.
Additionally, within the past three years:
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CytRx identified a material weakness related to CytRxs accounting for an equity
transaction by RXi and CytRxs tax withholding in connection with exercises of employee
stock options. As a result, CytRx restated its financial statements for the quarter
ended June 30, 2007 and extended the filing of its quarterly report for the quarter
ended September 30, 2007; |
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CytRx identified a material weakness related to its accounting for transactions at
its former laboratory facility in Worcester, Massachusetts. As a result, CytRx restated
its financial statements for the quarters ended March 31, 2006, June 30, 2006 and
September 30, 2006; |
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CytRx improperly applied generally accepted accounting principles related to its
accounting for deemed dividends incurred in connection with anti-dilution adjustments
made to its outstanding warrants. This misapplication of accounting principles
constituted a material weakness and caused CytRx to twice restate its financial
statements for the quarters ended March 31, 2005, June 30, 2005 and September 30, 2005
and for the year ended December 31, 2005, as well as restate its financial statements
for the quarters ended March 31, 2006, June 30, 2006 and September 30, 2006; and |
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CytRx miscalculated pro forma employee stock option compensation figures disclosed
in the footnotes to its financial statements. As a result, CytRx restated its financial
statements for the quarters ended March 31, 2005, June 30, 2005 and September 30, 2005
and for the year ended December 31, 2005. |
In addition, CytRx concluded in its annual report for the year ended December 31, 2007 and
quarterly reports for the quarters ended March 31, 2008, September 30, 2007 and June 30, 2007 that
CytRxs disclosure controls and procedures were ineffective as of those dates. Disclosure controls
generally include controls and procedures designed to ensure that information required to be
disclosed by CytRx in the reports it files with the SEC is recorded, processed, summarized and
reported within the time periods specified in the SECs rules and forms.
Effective internal controls over financial reporting and disclosure controls and procedures
are necessary for CytRx to provide reliable financial and other reports and effectively prevent
fraud. If CytRx cannot maintain effective internal controls or provide reliable financial or SEC
reports or prevent fraud, investors may lose confidence in CytRxs SEC reports, its operating
results and the trading price of its common stock could suffer and CytRx may become subject to
litigation.
CytRx may be unable to protect its intellectual property rights, which could adversely affect
CytRxs ability to compete effectively.
CytRx believes that obtaining and maintaining patent and other intellectual property rights
for its technologies and potential products is critical to establishing and maintaining the value
of its assets and its business. CytRx will be able to protect its technologies from unauthorized
use by third parties only to the extent that CytRx has rights to valid and enforceable patents or
other proprietary rights that cover them. Although CytRx has patents and patent applications
directed to its molecular chaperone amplification technologies, these patents and applications may
not be effective to prevent third parties from developing or commercializing similar or identical technologies. In
addition, CytRxs patents may be held to be invalid if challenged by third parties, and CytRxs
patent applications may not result in the issuance of patents.
The patent positions of pharmaceutical and biotechnology companies can be highly uncertain and
involve complex legal and factual questions for which important legal principles remain unresolved.
No consistent policy regarding the breadth of claims allowed in biotechnology patents has emerged
to date in the United States and in many foreign countries. The application and enforcement of
patent laws and regulations in foreign countries is even more uncertain. Accordingly, CytRx may not
be able to effectively file, protect or defend its proprietary rights on a consistent basis. In
particular, the patents and patent applications related to its molecular chaperone amplification
product candidates were issued or filed by third parties prior to the time CytRx acquired rights to
them, and they begin to expire in 2016. The validity, enforceability and ownership of those patents
and patent applications may be challenged, and if a court decides that CytRxs patents are not
valid, CytRx will not have the right to stop others from using CytRxs inventions. There is also
the risk that, even if the validity of CytRxs patents is upheld, a court may refuse to stop others
on the ground that their activities do not infringe CytRxs patents.
Any litigation brought by CytRx to protect CytRxs intellectual property rights could be
costly and have a material adverse effect on CytRxs operating results or financial condition, make
it more difficult for CytRx to enter into strategic alliances with third parties to develop CytRxs
products, or discourage CytRxs existing licensees from continuing their development work on
CytRxs potential products. If CytRxs patent coverage is insufficient to prevent third parties
from developing or commercializing similar or identical technologies, the value of CytRxs assets
is likely to be materially and adversely affected.
CytRx also relies on certain proprietary trade secrets and know-how, especially where CytRx
believes patent protection is not appropriate or obtainable. However, trade secrets and know-how
are difficult to protect. Although CytRx has taken measures to protect CytRxs unpatented trade
secrets and know-how,
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including the use of confidentiality and invention assignment agreements with CytRxs
employees, consultants and some of CytRxs contractors, it is possible that these persons may
disclose CytRxs trade secrets or know-how or that CytRxs competitors may independently develop or
otherwise discover CytRxs trade secrets and know-how.
If CytRxs product candidates infringe the rights of others, CytRx could be subject to
expensive litigation or be required to obtain licenses from others to develop or market them.
CytRxs competitors or others may have patent rights that they choose to assert against CytRx
or CytRxs licensees, suppliers, customers or potential collaborators. Moreover, CytRx may not know
about patents or patent applications that CytRxs products would infringe. For example, because
patent applications can take many years to issue, there may be currently pending applications,
unknown to us, that may later result in issued patents that CytRxs arimoclomol, iroxanadine or
other product candidates would infringe. In addition, if third parties file patent applications or
obtain patents claiming technology also claimed by CytRx in issued patents or pending applications,
CytRx may have to participate in interference proceedings in the U.S. Patent and Trademark Office
to determine priority of invention. If third parties file oppositions in foreign countries, CytRx
may also have to participate in opposition proceedings in foreign tribunals to defend the
patentability of its foreign patent applications.
If a third party claims that CytRx infringes the third partys proprietary rights, any of the
following may occur:
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CytRx may become involved in time-consuming and expensive litigation, even if the
claim is without merit; |
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CytRx may become liable for substantial damages for past infringement if a court
decides that CytRxs technology infringes a competitors patent; |
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a court may prohibit CytRx from selling or licensing CytRxs product without a
license from the patent holder, which may not be available on commercially acceptable
terms, if at all, or which may require CytRx to pay substantial royalties or grant
cross licenses to CytRxs patents; and |
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CytRx may have to redesign CytRxs product candidates or technology so that it does
not infringe patent rights of others, which may not be possible or commercially
feasible. |
If any of these events occurs, CytRxs business and prospects will suffer and the market price
of CytRxs common stock will likely decline substantially.
CytRx is subject to intense competition, and CytRx may not compete successfully.
CytRx and its strategic partners or licensees may be unable to compete successfully against
CytRxs current or future competitors. The pharmaceutical, biopharmaceutical and biotechnology
industries are characterized by intense competition and rapid and significant technological
advancements. Many companies, research institutions and universities are working in a number of
areas similar to CytRxs primary fields of interest to develop new products. There also is intense
competition among companies seeking to acquire products that already are being marketed. Many of
the companies with which CytRx competes have or are likely to have substantially greater research
and product development capabilities and financial, technical, scientific, manufacturing,
marketing, distribution and other resources than CytRx and at least some of its present or future
strategic partners or licensees.
As a result, these competitors may:
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succeed in developing competitive products sooner than CytRx or CytRxs strategic
partners or licensees; |
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obtain FDA or foreign governmental approvals for their products before CytRx can
obtain approval of any of CytRxs products; |
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obtain patents that block or otherwise inhibit the development and commercialization
of CytRxs product candidate candidates; |
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develop products that are safer or more effective than CytRxs products; |
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devote greater resources than CytRx to marketing or selling products; |
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introduce or adapt more quickly than CytRx to new technologies and other scientific
advances; |
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introduce products that render CytRxs products obsolete; |
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withstand price competition more successfully than CytRx or CytRxs strategic
partners or licensees; |
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negotiate third-party strategic alliances or licensing arrangements more effectively
than CytRx; and |
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take better advantage than CytRx of other opportunities. |
CytRx is aware of only one drug, Rilutek, which was developed by Aventis Pharma AG, that has
been approved by the FDA for the treatment of ALS. Many companies are working to develop
pharmaceuticals to treat ALS, including Aeolus Pharmaceuticals, Celgene Corporation, Mitsubishi
Tanabe Pharma Corporation, Ono Pharmaceuticals, Trophos SA, Knopp Neurosciences Inc., Faust
Pharmaceuticals SA, Oxford BioMedica plc, Phytopharm plc and Teva Pharmaceutical Industries Ltd.,
as well as RXi. ALS patients often take over-the-counter supplements, including vitamin E, creatine
and coenzyme Q10, or drugs such as lithium that are approved for other indications. ALS belongs to
a family of neurodegenerative diseases that includes Alzheimers, Parkinsons and Huntingtons
diseases. Due to similarities between these diseases, a new treatment for one such disease
potentially could be useful for treating others. There are many companies producing and developing
drugs used to treat neurodegenerative diseases other than ALS, including Amgen, Inc., Biogen Idec,
Boehringer Ingelheim, Cephalon, Inc., Ceregene, Inc., Elan Pharmaceuticals, plc, Forest
Laboratories, Inc., H. Lundbeck A/S, Phytopharm plc, UCB Group and Wyeth.
Current drug classes used to treat stroke include antiplatelet agents, anticoagulants,
salycylates, neuroprotectants and thrombolytic agents. Prescription antiplatelet agents include
Aggrenox by Boehringer Ingelheim, Plavix by Sanofi-Aventis and Bristol-Myers Squibb, and Ticlid by
Roche Pharmaceuticals. Coumadin by Bristol-Myers Squibb and Jantoven by Upsher-Smith Laboratories
are branded forms of warfarin, an anticoagulant. Moreover, salicylates, like aspirin, are commonly
used to treat patients after stroke. In Europe, Ferrer Grupo markets the neroprotectant, Somazina.
Activase, also known as tissue plasminogen activator, or t-PA, is a thrombolytic agent marketed by
Genentech. Many new drug candidates are in development by pharmaceutical and biotech companies,
including GlaxoSmithKline, Indeveus Pharmaceuticals, Ipsen, Merck & Co., Neurobiological
Technologies, Ono Pharmaceuticals, PAION AG and Wyeth. In addition to drug therapy, companies such
as Medtronic and Northstar Neurosciences are developing neurostimulation medical devices to aid in
recovery after stroke.
The wound care market is highly competitive, and there are many products available for
treating skin wounds, including diabetic foot ulcers. Prescription and over-the-counter products
for the prevention and treatment of infections include topical anti-infectives, such as Betadine,
silver sulfadiazine, hydrogen peroxide,
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Dakins solution and hypochlorous acid, and topical antibiotics, such as Neosporine, Mupirocin
and Bacitracin. Skin substitute products include Apligraf, manufactured by Organogenesis, Inc.,
which is an FDA-cleared product using human dermal and epidermal cells placed on a collagen matrix,
for the treatment of both venous stasis and diabetic foot ulcers, and Dermagraft, produced by
Advanced BioHealing, Inc., which uses human derived dermal cells placed on a polyglactin matrix and
is FDA cleared to treat diabetic foot ulcers. In addition, a number of companies are working to
develop proprietary pharmaceuticals and cell-based therapies to treat diabetic wound healing,
including Agennix, Inc., BioSyntech, Inc., CardioVascular BioTherapeutics, Inc., Cardium
Therapeutics, Inc., Genentech Inc., KeraCure, Inc., King Pharmaceuticals, Inc., MacroChem
Corporation, Oculus Innovative Sciences, Inc., Rovi Pharmaceutical Laboratories, SanuWave, Inc. and
Wyeth.
Most of CytRxs competitors have substantially greater research and product development
capabilities and financial, technical, scientific, manufacturing, marketing, distribution and other
resources than CytRx.
CytRx may be required to pay milestone and other payments relating to the commercialization of
its products.
The agreement by which CytRx acquired rights to arimoclomol and CytRxs other molecular
chaperone amplification product candidates provides for milestone payments by CytRx upon the
occurrence of certain regulatory filings and approvals related to the acquired products. In the
event that CytRx successfully develops arimoclomol or any of these other product candidates, these
milestone payments could aggregate as much as $3.7 million, with the most significant payments due
upon the first commercialization of any of these products. In addition, CytRxs agreement with the
ALS Charitable Remainder Trust requires CytRx to pay a one-percent royalty interest on worldwide
sales of arimoclomol for the treatment of ALS. Also, any future license, collaborative or other
agreements CytRx may enter into in connection with its development and commercialization activities
may require CytRx to pay significant milestone, license and other payments in the future.
CytRx will rely upon third parties for the manufacture of its clinical product supplies.
CytRx does not have the facilities or expertise to manufacture supplies of any of its product
candidates, including arimoclomol or iroxanadine. Accordingly, CytRx is dependent upon contract
manufacturers, or potential future strategic alliance partners, to manufacture these supplies.
CytRx has manufacturing supply arrangements in place with respect to some of the clinical supplies
needed for its planned development programs for arimoclomol for ALS and stroke recovery and for
iroxanadine for diabetic ulcers. However, CytRx has no supply arrangements for the commercial
manufacture of these product candidates or any manufacturing supply arrangements for any other
potential product candidates, and CytRx may not be able to secure needed supply arrangements on
attractive terms, or at all. CytRxs failure to secure these arrangements as needed could have a
materially adverse effect on its ability to complete the development of its products or to
commercialize them.
CytRx is subject to potential liabilities from clinical testing and future product liability
claims.
If any of CytRxs products are alleged to be defective, they may expose CytRx to claims for
personal injury by patients in clinical trials of CytRxs products or, if CytRx obtains marketing
approval and commercializes its products, by patients using CytRxs commercially marketed products.
Even if the commercialization of one or more of CytRxs products is approved by the FDA, users may
claim that such products caused unintended adverse effects. CytRx currently does not carry product
liability insurance covering the commercial marketing of its product candidates. CytRx obtained
clinical trial insurance for CytRxs Phase IIa clinical trial and Phase IIb efficacy trial of
arimoclomol for the treatment of ALS, and CytRx plans to seek to obtain similar insurance for any
other clinical trials that CytRx conducts, as well as liability insurance for any products that
CytRx may market. However, CytRx may not be able to obtain additional insurance in the amounts it
seeks, if at all. In addition, any insurance maintained by CytRx or CytRxs licensees may not prove
adequate in the event of a claim against CytRx. Even if claims asserted
26
against CytRx are unsuccessful, they may divert managements attention from CytRxs
operations, and CytRx may have to incur substantial costs to defend such claims.
CytRx may be unable to acquire products approved for marketing.
In the future, CytRx may seek to acquire products from third parties that already are being
marketed or have been approved for marketing. CytRx has not currently identified any of these
products, however, and CytRx does not have any prior experience in acquiring or marketing products
and may need to find third parties to market any products that CytRx might acquire. CytRx may also
seek to acquire products through a merger with one or more companies that own such products. In any
such merger, the owners of CytRxs merger partner could be issued or hold a substantial, or even
controlling, amount of stock in CytRxs company or, in the event that the other company is the
surviving corporation, in that other company.
CytRx uses hazardous materials and must comply with environmental, health and safety laws and
regulations, which can be expensive and restrict how CytRx does business.
CytRxs research and development and manufacturing processes involve the controlled storage,
use and disposal of hazardous materials, including biological hazardous materials. CytRx is subject
to federal, state and local regulations governing the use, manufacture, storage, handling and
disposal of these materials and waste products. Although CytRx believes that its safety procedures
for handling and disposing of these hazardous materials comply with the standards prescribed by law
and regulation, CytRx cannot completely eliminate the risk of accidental contamination or injury
from hazardous materials. In the event of an accident, CytRx could be held liable for any damages
that result. CytRx could incur significant costs to comply with current or future environmental
laws and regulations.
Risks Associated With CytRxs Investment in RXi
The recent distribution of RXi common stock to CytRxs stockholders is taxable to CytRx.
On March 11, 2008, CytRx distributed to CytRxs stockholders 4,526,624 shares of RXi common
stock. CytRx will recognize gain on the distribution for income tax purposes of approximately
$32.9 million, which is the amount of the excess of the fair market value of the RXi shares
distributed over CytRxs basis. This gain will be included in determining whether CytRx has current
year earnings and profits subject to taxation. Although CytRx has ascribed a value to RXi shares in
the distribution for tax purposes, CytRxs valuation will not be binding on the Internal Revenue
Service or any state taxation agency, which could ascribe a different valuation to the distributed
RXi shares.
CytRxs ownership interest in RXi may be diluted.
RXi raised approximately $8.7 million of gross proceeds in a private placement on June 25,
2008. Prior to this recent financing, RXi had indicated that it had sufficient working capital to
fund its planned expenditures into the second quarter of 2009 and that it will need to raise
substantial amounts of money in the future to fund a variety of activities integral to the
development of its business. Under CytRxs agreement with RXi and RXis other founding
stockholders, with some exceptions, CytRx will have preemptive rights to acquire a portion of any
new securities sold or issued by RXi in the future so as to maintain CytRxs percentage ownership
of RXi. Depending upon the terms and provisions of any proposed sale of new securities by RXi,
CytRxs financial condition and other factors, CytRx may be unwilling or unable to exercise CytRxs
preemptive rights. CytRx agreed to waive its preemptive rights in connection with RXis recent
financing, which resulted in a reduction of CytRxs percentage ownership in RXi from approximately
49% to approximately 45%. If RXi raises funds through further issuances of additional equity
securities in which CytRx does not participate, CytRxs percentage ownership interest in RXi may be
diluted further.
27
CytRx may elect to dispose of some of its remaining RXi shares, and may not be able to do so
on attractive terms.
As
of July 31, 2008, CytRx owned 6,268,881 shares of common stock of RXi, which had a market
value of approximately $45.4 million based upon the market price of RXi common stock as reported on
The Nasdaq Capital Market on that date. This compares to CytRxs total assets as of March 31, 2008
of approximately $50.5 million. CytRx may be deemed to be an investment company within the
meaning of the Investment Company Act of 1940, and become subject to the stringent regulations
applicable to investment companies, if the value of CytRxs RXi shares, when taken together with
the value of any other investment securities CytRx holds, continues to exceed 40% of the value of
CytRxs assets for a period of one year, unless CytRx obtains a declaration from the SEC that it is
not an investment company. If CytRx is unable to obtain such a declaration, then CytRx would
likely seek to sell or otherwise dispose of some of CytRxs RXi shares in order to avoid being an
inadvertent investment company.
CytRx also may desire to sell its RXi shares in the future in order to raise funds for the
conduct of CytRxs business and operations. If it becomes necessary or advisable for any reason
for CytRx to sell its RXi shares, CytRx would have to sell RXi shares pursuant to Rule 144 under
the Securities Act, which includes manner of sale and volume limitations applicable to sales by
affiliates such as CytRx, or negotiate private sales with third parties. CytRx may be unable to
sell or divest of RXi shares at attractive prices, if at all. In addition, any sale or other
disposition of RXi shares by CytRx, or the possibility of such sale or disposition, could adversely
affect the market price of CytRxs RXi shares.
RXi retains discretion over its use of the funds that CytRx has provided to it.
All funds previously provided by CytRx to RXi may be used by RXi in any manner its management
deems appropriate. None of these uses may yield a significant or any return at all for RXi
stockholders, including CytRx.
CytRx does not and will not control RXi, and the officers, directors and other RXi
stockholders may have interests that are different from those of CytRx.
Although CytRx currently owns a significant portion of RXis outstanding common stock, CytRx
does not control RXis management or operations. RXi has its own board of directors and management,
who are responsible for the affairs and policies of RXi and its development plans. CytRx has
entered into letter agreements with the University of Massachusetts Medical School, or UMMS, RXi
and RXis other founding stockholders under which CytRx agrees to vote its shares of RXi common
stock for the election of directors of RXi and to take other actions to ensure that a majority of
RXis board of directors are independent of CytRx. The other stockholders of RXi may have interests
that are different from CytRxs, and RXi may engage in actions in connection with its business and
operations that CytRx believes are not in CytRxs best interests.
Products developed by RXi could eventually compete with CytRxs products for ALS, type 2
diabetes, obesity and other disease indications.
RXi is focusing its initial efforts on developing ribonucleic acid interference, or RNAi,
therapeutics for the treatment of a specific form of ALS caused by a defect in the SOD1 gene.
Although CytRx is developing arimoclomol for treatment for all forms of ALS, it is possible that
products developed by RXi for the treatment of ALS could compete with ALS products that CytRx may
develop. RXi also plans to pursue the development of RNAi therapeutics for the treatment of other
neurodegenerative diseases and type 2 diabetes, which could compete with products that CytRx may
develop for the treatment of these diseases. The potential commercial success of any products that
CytRx may develop for these and other diseases may be adversely affected by competing products that
RXi may develop.
28
Risks Associated With Innovives Business
We have an immediate need for capital and will need to raise additional capital in the future
to continue our business.
To date, we have generated no product revenues, yet we have had operating and capital
expenditures to in-license and begin development of our product candidates. As a result of these
expenses and lack of revenue, at March 31, 2008, we had a working capital deficit of approximately
$3.7 million. In addition, as a result of our financial position at December 31, 2007, we received
a going concern opinion from our independent registered public accounting firm, which is included
in our financial statements included as Appendix F to this proxy statement/prospectus. Until, and
unless, we receive approval from the FDA or foreign regulatory authorities for our product
candidates, we cannot sell our drugs and will not have product revenues. Currently, our only
product candidates are INNO-406, tamibarotene, INNO-206, and INNO-305, and none of them have been
approved by the FDA or any foreign regulatory authority for sale. Therefore, for the foreseeable
future, we will have to fund all of our operations and capital expenditures from existing cash and
short-term investments or future financings. At March 31, 2008, we had cash and short-term
investments of only $301,962. We have insufficient funds to meet our current obligations or future
operating expenses. As a result, we have been seeking and will continue to seek additional sources
of financing for our operations, which might not be available on favorable terms, if at all. If we
do not succeed in raising additional funds on acceptable terms, we will be unable to complete
planned pre-clinical and clinical trials or obtain approval of any of our product candidates from
the FDA or any foreign regulatory authorities. In addition, we could be forced to discontinue
product development, reduce or forego sales and marketing efforts and forego attractive business
opportunities. Any additional sources of financing will likely involve the issuance of our equity
securities, which would have a dilutive effect on our then current stockholders.
Our internal control over financial reporting is not adequate and may result in financial
statements that are incomplete or subject to restatement.
Section 404 of the Sarbanes Oxley Act of 2002 requires significant procedures and review
processes of our system of internal controls. Section 404 required that we evaluate and report on
our system of internal control over financial reporting beginning with the year ended December 31,
2007. In addition, our independent registered public accounting firm will be required to report on
those controls for the year ending December 31, 2009. The additional
costs associated with this process may be significant.
After documenting and testing our system, we have identified a material weakness in our
accounting and financial functions due to a lack of a segregation of duties among these functions.
As a result, our internal control over financial reporting is not effective. As a result of our
internal control over financial reporting being ineffective, investors could lose confidence in our
financial reports, and our stock price might be adversely affected. In addition, remedying this or
any future material weaknesses that we or our independent registered public accounting firm might
identify, could require us to incur significant costs and expend significant time and management
resources. We cannot assure you that any of the measures we might implement to remedy any such
deficiencies would effectively mitigate or remedy such deficiencies.
If we are unable to satisfy our obligations under current and future license agreements, we
could lose license rights which would adversely affect our business.
We are a party to various license agreements, each of which requires us to make periodic
payments, which in our current financial condition is likely to be difficult or even impossible.
We may enter into additional licenses in the future. Our existing licenses impose, and we
expect future licenses will impose, various milestone payments, royalty payments and other
obligations on us. If we fail to comply with our obligations in our intellectual property licenses
with third parties, we could lose license rights
29
that are important to our business. If a licensor challenges our license position, our
competitive position and business prospects could be harmed.
We might not obtain the necessary U.S. or worldwide regulatory approvals to commercialize
INNO-406, tamibarotene, INNO-206, and INNO-305 or any future product candidate.
We cannot assure you that we will receive the approvals necessary to commercialize and sell
our current product candidates, INNO-406, tamibarotene, INNO-206, and INNO-305, or any product
candidate we acquire or develop in the future. We will need FDA approval to commercialize any
product candidate in the U.S. and approvals from the equivalent regulatory authorities in foreign
jurisdictions to commercialize any product candidate in those jurisdictions. In order to obtain FDA
approval of any product candidate, we must submit to the FDA an NDA demonstrating that the product
candidate is safe for humans and effective for its intended use. This demonstration requires
significant research and animal tests, which are referred to as pre-clinical studies, as well as
human tests, which are referred to as clinical trials. Satisfaction of the FDAs regulatory
requirements typically takes many years, depends upon the type, complexity and novelty of the
product candidate and requires substantial resources for research, development and testing. We
cannot predict whether our research and clinical approaches will result in drugs that the FDA
considers safe for humans and effective for indicated uses, including our current product
candidates.
Even if we comply with all FDA requests, the FDA may ultimately reject any of our NDAs. We
cannot be sure that we will ever obtain regulatory clearance for our current product candidates or
any other product. Failure to obtain FDA approval of our product candidates will severely undermine
our business by leaving us without a saleable product, and therefore without any source of
revenues, until another product candidate can be developed. There is no guarantee that we will ever
be able to develop or acquire another product candidate.
In foreign jurisdictions, we must receive approval from the appropriate regulatory authorities
before we can commercialize any drugs. Foreign regulatory approval processes generally include all
of the risks associated with the FDA approval procedures described above. We cannot assure you that
we will receive the approvals necessary to commercialize any product candidate for sale outside the
United States.
Delays in the regulatory approval process might harm our ability to commercialize any product
candidate.
The FDA has substantial discretion in the drug approval process and may require us to conduct
additional pre-clinical and clinical testing or to perform post-marketing studies for any of our
current product candidates or any product candidate we acquire or develop in the future. The
approval process might also be delayed by changes in government regulation, future legislation or
administrative action or changes in FDA policy that occur prior to or during our regulatory review.
Delays in obtaining regulatory approvals might:
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delay commercialization of, and our ability to derive product revenues from, any
product candidate; |
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impose costly procedures on us; and |
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diminish any competitive advantages that we might otherwise enjoy if competing
products are able to be marketed before our products. |
Delays in the regulatory approval process in foreign jurisdictions could have the same
negative impact on our drug commercialization plans in those jurisdictions.
30
Our current product candidates are in the early stage of clinical trials or are still in
pre-clinical trials.
Our current product candidates, INNO-406, tamibarotene, INNO-206, and INNO-305, are still in
various stages of development and require some additional pre-clinical testing and extensive
clinical testing. That testing might show that these compounds have little or no efficacy. Even if
pre-clinical or clinical trials for these compounds are positive, we cannot predict with any
certainty if or when we might submit a new drug application, or NDA, for regulatory approval of any
of them or whether such an NDA will be accepted. Failure to submit or receive approval of an NDA
for any of our current product candidates or any other product candidate we might acquire will
severely undermine our business by leaving us with few or no saleable products, and therefore with
limited or no sources of revenues, until another product candidate can be developed. Delays in the
approval of an NDA could:
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delay commercialization of, and our ability to derive product revenues from, any
product candidate; |
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impose costly procedures on us; and |
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diminish any competitive advantages that we might otherwise enjoy if competing
products are able to be marketed before our products. |
Our INNO-406 IND was allowed on June 15, 2006. Our Phase I study for INNO-406 began in July
2006 and is ongoing. Our expectations for this product are based on preclinical studies conducted
on animals and Phase I clinical study results to date.
An IND for INNO-305 was allowed in October 2006. The Phase I study for INNO-305 began in
October 2006 and is ongoing. Our expectations for INNO-305 are based on pre-clinical studies and on
analogous programs in Germany and Japan which showed positive clinical outcomes in Phase I and II
clinical testing.
An IND for tamibarotene was allowed in May 2007. The Phase II pivotal clinical study began in
September 2007 and is ongoing.
Given the early stages and limited scope of these various studies, we have very limited safety
and efficacy data on our products. We cannot determine whether the prior or current studies,
including any preliminary positive data, for the products are predictive of clinical safety or
efficacy. These same risks are true for our planned development of INNO-206 for which an IND was
allowed in April 2007.
Clinical trials are very expensive, time-consuming and difficult to design and implement.
Human clinical trials are very expensive and difficult to design and implement, in part
because they are subject to rigorous regulatory requirements. The clinical trial process is also
time consuming. We estimate that clinical trials of our product candidates will take at least
several years to complete. Further, failure can occur at any stage of the trials, and we could
encounter problems that could delay or cause us to abandon or repeat clinical trials. The
commencement and completion of clinical trials, including those for our current product candidates
or any future compound, might be delayed by several factors, including:
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unforeseen safety issues; |
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determination of dosing issues; |
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lack of effectiveness during clinical trials; |
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slower than expected rates of patient recruitment; |
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inability to monitor patients adequately during or after treatment; and |
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inability or unwillingness of medical investigators to follow our clinical
protocols. |
In addition, we or the FDA might suspend any of our clinical trials at any time if it appears
that we are exposing participants to unacceptable health risks or if the FDA finds deficiencies in
the IND submission or the conduct of that trial. Therefore, we cannot predict with any certainty
the schedule for future clinical trials.
The results of our clinical trials might not support our product candidate claims.
Even if our clinical trials are completed as planned, we cannot be certain that their results
will support our product candidate claims. Success in pre-clinical testing and early clinical
trials does not ensure that later clinical trials will be successful, and we cannot be sure that
the results of later clinical trials will replicate the results of prior clinical trials and
pre-clinical testing. The clinical trial process may fail to demonstrate that our product
candidates are safe for humans and effective for indicated uses. This failure may cause us to
abandon a product candidate and might delay development of other product candidates. Any delay in,
or termination of, a clinical trial will delay the filing of the related NDA with the FDA and,
ultimately, our ability to commercialize that product candidate and generate product revenues from
that product. In addition, our Phase I clinical trials for INNO-406 and INNO-305 and our Phase II
pivotal clinical trial for tamibarotene involve, and future trials for these and our other product
candidates might involve, a small number of patients. Because of the small sample size, the results
of these clinical trials might not be indicative of future results.
Physicians and patients might not accept and use our drugs.
Even if the FDA approves our current product candidates, physicians and patients might not
accept and use them or any other product we might develop. Acceptance and use of our products will
depend upon a number of factors including:
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perceptions by members of the health care community, including physicians, about the
safety and effectiveness of our drug; |
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cost-effectiveness of our products relative to competing products; |
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availability of reimbursement for our products from government or other healthcare
payers; and |
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effectiveness of marketing and distribution efforts by us and our licensees and
distributors, if any. |
Because we expect sales of our product candidates, if approved, to generate substantially all
of our product revenues for the foreseeable future, the failure of these drugs to find market
acceptance would harm our business and could require us to seek additional financing.
Our product candidates might have unintended results, which might not be discovered until
after commercialization.
Any of our product candidates, even if successfully tested, approved and commercialized, could
result in unintended consequences in consumers. Any consequence might not be discovered for many
years after commercialization of a product. Such a development could have a negative impact on our
earnings and operations.
32
Our drug development program depends upon third-party researchers who are outside our control.
We depend upon independent investigators and collaborators, such as universities, medical
institutions and clinical research organizations, to conduct our pre-clinical and clinical trials
under agreements with us. These collaborators are not our employees and we cannot control the
amount or timing of resources that they devote to our programs. These investigators might not
assign as great a priority to our programs or pursue them as diligently as we would if we were
undertaking such programs ourselves. If outside collaborators fail to devote sufficient time and
resources to our drug development programs, or if their performance is substandard, the approval of
our FDA applications, if any, and our introduction of new drugs, if any, will be delayed. These
collaborators might also have relationships with other commercial entities, some of whom might
compete with us. If our collaborators assist our competitors at our expense, our competitive
position would be harmed.
We will rely exclusively on third parties to formulate and manufacture our product candidates.
We have no experience in drug formulation or manufacturing and do not intend to establish our
own manufacturing facilities. We lack the resources and expertise to formulate or manufacture our
own product candidates. For INNO-406, we have ongoing production contracts for clinical material
for our current Phase I clinical trial. Product for future trials will require additional contracts
with our current suppliers. We have contracted with a third party to supply, store and distribute
tamibarotene for our clinical trials and any possible commercialization. We currently do not have
contracts for product supply for our planned future clinical trials for INNO-206 but have
identified vendors with the capability to perform the development and manufacturing steps necessary
to manufacture the product. We believe we currently have ample supplies of INNO-305 for its
continuing Phase I trial. If any of our current product candidates or any other product candidate
we might develop or acquire in the future, receives FDA approval, we will rely on one or more
third-party contractors to manufacture our products. Our reliance on third-party manufacturers
exposes us to the following risks:
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we might not be able to retain current third party manufacturers or other service
providers or attract new ones due to our financial condition; |
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we might be unable to identify manufacturers on commercially reasonable terms or at
all because the number of potential manufacturers is limited and the FDA must approve
any replacement contractor. This approval would require new testing and compliance
inspections. In addition, a new manufacturer would have to be educated in, or develop
substantially equivalent processes for, production of our products after receipt of FDA
approval, if any; |
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our third-party manufacturers might be unable to formulate and manufacture our drugs
in the volume and of the quality required to meet our clinical needs and commercial
needs, if any; |
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our future contract manufacturers might not perform as agreed or might not remain in
the contract manufacturing business for the time required to supply our clinical trials
or to successfully produce, store and distribute our products; |
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drug manufacturers are subject to ongoing periodic unannounced inspection by the
FDA, the Drug Enforcement Administration, and corresponding state and foreign agencies
to ensure strict compliance with good manufacturing practice and other government
regulations and corresponding foreign standards. We do not have control over
third-party manufacturers compliance with these regulations and standards; and |
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if any third-party manufacturer makes improvements in the manufacturing process for
our products, we might not own, or might have to share, the intellectual property
rights to the innovation. |
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Each of these risks could delay our clinical trials, the approval, if any, of our product
candidates by the FDA or the commercialization of our product candidates or result in higher costs
or deprive us of potential product revenues. Any of these events could impair our earnings and
financial condition.
We have no experience selling, marketing or distributing products and no internal capability
to do so.
We currently have no sales, marketing or distribution capabilities. Currently, we intend to
perform selling and marketing activities ourselves which will require significant capital
expenditures, management resources and time to establish and develop an in-house marketing and
sales force with technical expertise. We do not currently have the resources to allocate to the
sales and marketing of our proposed products. To the extent that we decide not to, or are unable to
establish sales and marketing activities for our products, our future success will depend, in part,
on our ability to enter into and maintain collaborative relationships for such capabilities, the
success of which will be dependent upon the collaborators strategic interest in the products under
development and the collaborators ability to successfully market and sell any such products. If we
do pursue collaborative arrangements regarding the sales and marketing of our products, there can
be no assurance that we will be able to establish or maintain such collaborative arrangements, or
if able to do so, that they will have effective sales forces. There can also be no assurance that
we will be able to establish or maintain relationships with third-party collaborators or develop
in-house sales and distribution capabilities. To the extent that we depend on third parties for
marketing and distribution, any revenues we receive will depend upon the efforts of such third
parties, and there can be no assurance that such efforts will be successful. In addition, there can
also be no assurance that we will be able to market and sell our products in the United States or
overseas.
Our potential future earnings may be reduced should we decide to out-license one or more of
our drug product candidates.
We may decide to out-license one or more of our drug product candidates, reducing future
profits available to us. Should we license any one of our drug candidates to another
pharmaceuticals company, it would allow the partner to market and sell our compounds in any of the
markets allowable under the license agreement governing the product. If one of our products is
out-licensed, the profit available to us may be substantially reduced from what might otherwise be
possible should we retain all rights to the product and market and sell it directly.
If we cannot compete successfully for market share against other drug companies, we might not
achieve sufficient product revenues and our business will suffer.
The market for each of our current product candidates, as for most drugs, is characterized by
intense competition and rapid technological advances. If any product candidate receives FDA
approval, it will compete with a number of existing and future drugs and therapies developed,
manufactured and marketed by others. The most significant competitors for INNO-206 are Poniard
Pharmaceuticals and Celgene, each of which is developing a compound for small cell lung cancer.
Cell Genesys is developing a vaccine for acute leukemia that may be competitive with INNO-305.
Novartis and Bristol-Myers Squibb have each developed a treatment for chronic myelogenous leukemia
that may be competitive with INNO-406. The most significant competitors for tamibarotene are
treatment with ATRA, a generic compound, and Cephalons arsenic trioxide. These or other future
competing products might provide greater therapeutic convenience or clinical or other benefits for
a specific indication than our products, or might offer comparable performance at a lower cost. If
our products fail to capture and maintain market share, we might not achieve sufficient product
revenues, if at all, and our business will suffer.
We will compete against fully integrated pharmaceutical companies and smaller companies that
are collaborating with larger pharmaceutical companies, academic institutions, government agencies
and other public and private research organizations. Many of these competitors have oncology
compounds already
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approved or in development. As noted above, Poniard Pharmaceuticals and Celgene are each
developing a compound for small cell lung cancer that would compete with INNO-206. Cell Genesys is
developing a vaccine for acute leukemia that would compete with INNO-305. Novartis and
Bristol-Myers Squibb have each developed a treatment for chronic myelogenous leukemia that would
compete with INNO-406. ATRA and arsenic trioxide could both compete with tamibarotene. These
competitors, either alone or together with their collaborative partners, operate larger research
and development programs or have substantially greater financial resources than we do, as well as
significantly greater experience in:
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developing drugs; |
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undertaking pre-clinical testing and human clinical trials; |
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obtaining FDA and other regulatory approvals of drugs; |
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formulating and manufacturing drugs; and |
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launching, marketing and selling drugs. |
We might not be able to compete successfully with these entities due to our limited operating
history and limited resources.
Developments by competitors might render our products or technologies obsolete or
non-competitive.
Companies that currently sell both generic and proprietary compounds for the treatment of
cancer and related diseases include but are not limited to Amgen, Sanofi-Aventis, Bristol-Myers
Squibb, Genentech, Eli Lilly, Johnson & Johnson and Celgene. Alternative technologies are being
developed to treat cancer and related diseases by numerous companies including Bristol-Myers
Squibb, MGI Pharma, Merck and Genentech, several of which are in advanced clinical trials. There
also are cancer tumor inhibiting therapies that are in the late stage of development, and that are
being developed by larger established companies: Alimta (Eli Lilly), Avastin (Genentech), Eloxatin
(Sanofi-Aventis), Erbitux (Bristol-Myers Squibb and Imclone Systems) and Tarceva (Genentech). Cell
Genesys is developing a vaccine for acute leukemia. Poniard Pharmaceuticals and Pharmion are
developing compounds for small cell lung cancer. Novartis and Bristol-Myers Squibb have each
developed a treatment for chronic myelogenous leukemia that would compete with INNO-406. ATRA and
arsenic trioxide could compete with tamibarotene. In addition, companies pursuing different but
related fields represent substantial competition. Any of these competing therapies could prove to
be more effective than INNO-406, tamibarotene, INNO-206, or INNO-305 or any future therapy of ours.
In addition, many of these organizations competing with us have substantially greater capital
resources, larger research and development staffs and facilities, longer drug development history
in obtaining regulatory approvals and greater manufacturing and marketing capabilities than we do.
These organizations also compete with us to attract qualified personnel and parties for
acquisitions, joint ventures or other collaborations. Any or all of these competitors might inhibit
or prevent entirely the successful commercialization of our products.
If we fail to adequately protect or enforce our intellectual property rights or secure rights
to patents of others, the value of our intellectual property rights would diminish.
Our success, competitive position and future revenues will depend in part on our ability and
the abilities of our licensors to obtain and maintain patent protection for our products, methods,
processes and other technologies, to preserve our trade secrets, to prevent third parties from
infringing on our proprietary rights and to operate without infringing the proprietary rights of
third parties.
We currently hold exclusive patent rights, including rights under U.S. patents and U.S. patent
applications as well as rights under foreign patents and patent applications on our current product
candidates.
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However, we cannot predict for our current product candidates or any other proprietary
property we might acquire:
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the degree and range of protection any patents will afford us against competitors,
including whether third parties will find ways to invalidate or otherwise circumvent
our patents; |
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if and when patents will issue; |
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whether or not others will obtain patents claiming aspects similar to those covered
by our patents and patent applications; or |
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whether we will need to initiate litigation or administrative proceedings to protect
or defend other intellectual property rights which might be costly whether we win or
lose. |
Our success also depends upon the skills, knowledge and experience of our scientific and
technical personnel, our consultants and advisors as well as our licensors and contractors. To help
protect our proprietary know-how and our inventions for which patents might be unobtainable or
difficult to obtain, we rely on trade secret protection and confidentiality agreements. To this
end, it is our policy to require all of our employees, consultants, advisors and contractors to
enter into agreements which prohibit the disclosure of confidential information and, where
applicable, require disclosure and assignment to us of the ideas, developments, discoveries and
inventions important to our business. These agreements might not provide adequate protection for
our trade secrets, know-how or other proprietary information in the event of any unauthorized use
or disclosure or the lawful development by others of such information. If any of our trade secrets,
know-how or other proprietary information is disclosed, the value of our trade secrets, know-how
and other proprietary rights would be significantly impaired and our business and competitive
position would suffer.
If we infringe the rights of third parties we could be prevented from selling products, forced
to pay damages, and defend against litigation.
If our products, methods, processes and other technologies infringe the proprietary rights of
other parties, we could incur substantial costs and we might have to:
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obtain licenses, which might not be available on commercially reasonable terms, if
at all; |
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abandon an infringing drug candidate; |
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redesign our products or processes to avoid infringement; |
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stop using the subject matter claimed in the patents held by others; |
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pay damages; or |
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defend litigation or administrative proceedings that might be costly whether we win
or lose, and which could result in a substantial diversion of our financial and
management resources. |
Any of these events could substantially harm our earnings, financial condition and operations.
Our ability to generate product revenues will be diminished if our drugs sell for inadequate
prices or patients are unable to obtain adequate levels of reimbursement.
Our ability to commercialize our drugs, alone or with collaborators, will depend in part on
the extent to which reimbursement will be available from:
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government and health administration authorities; |
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private health maintenance organizations and health insurers; and |
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other healthcare payers. |
Significant uncertainty exists as to the reimbursement status of newly approved healthcare
products. Healthcare payers, including Medicare, are challenging the prices charged for medical
products and services. Government and other healthcare payers increasingly attempt to contain
healthcare costs by limiting both coverage and the level of reimbursement for drugs. Even if our
product candidates are approved by the FDA, insurance coverage might not be available, and
reimbursement levels might be inadequate, to cover our drugs. If government and other healthcare
payers do not provide adequate coverage and reimbursement levels for our product, once approved, it
might inhibit or prevent market acceptance of such product.
We might be exposed to liability claims associated with the use of hazardous materials and
chemicals.
Our research and development activities might involve the controlled use of hazardous
materials and chemicals. Although we believe that our safety procedures for using, storing,
handling and disposing of these materials comply with federal, state and local laws and
regulations, we cannot completely eliminate the risk of accidental injury or contamination from
these materials. In the event of such an accident, we could be held liable for any resulting
damages and any liability could materially adversely affect our business, financial condition and
results of operations. In addition, the federal, state and local laws and regulations governing the
use, manufacture, storage, handling and disposal of hazardous or radioactive materials and waste
products might require us to incur substantial compliance costs that could materially adversely
affect our business, financial condition and results of operations.
We might incur substantial liabilities and might be required to limit commercialization of our
products in response to product liability lawsuits.
The testing and marketing of medical products entail an inherent risk of product liability. If
we cannot successfully defend ourselves against product liability claims, we might incur
substantial liabilities or be required to limit commercialization of our products. Our inability to
obtain sufficient product liability insurance at an acceptable cost to protect against potential
product liability claims could prevent or inhibit the commercialization of our products. While we
carry clinical trial insurance that includes product liability insurance, the coverage might not be
sufficient to cover any claims. We intend all our agreements with our collaborators to indemnify us
for their errors and omissions. However, we might not be able to obtain such contractual
protection. Even if our agreements with any future collaborators entitle us to indemnification
against losses, such indemnification might not be available or adequate should any claim arise.
Changes in either patent laws or in interpretations of patent laws in the United States and
other countries may diminish the value of our intellectual property or narrow the scope of our
patent protection.
The laws of foreign countries may not protect our rights to the same extent as the laws of the
United States. Therefore, enforceability or scope of our patents in the United States or in foreign
countries cannot be predicted with certainty, and, as a result, any patents that we own or license
may not provide sufficient protection against competitors.
Some jurisdictions have laws that permit the government to force a patentee to grant a license
to a third party for commercialization of a patented product if the government concludes that the
product is not sufficiently developed or not meeting the health needs of the population. Such
compulsory licensing laws are very rarely invoked outside of South America and Africa. In addition,
a number of countries limit the enforceability of patents against government agencies or government
contractors. In these countries, the patent
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owner may be limited to monetary relief and may be unable to enjoin infringement, which could
materially diminish the value of the patent. Such compulsory licenses could be extended to include
some of our product candidates, which may limit our potential revenue opportunities.
Because of the extensive time required for development, testing and regulatory review of a new
drug, it is possible that any related patent may expire before any of our product candidates can be
commercialized or remain in force for only a short period following commercialization. In either
case, this would reduce any advantages of the patent.
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CAUTIONARY STATEMENT CONCERNING FORWARD-LOOKING INFORMATION
This proxy statement/prospectus contains a number of forward-looking statements, including
statements about the financial conditions, results of operations and the prospects of Innovive and
CytRx, and may include statements relating to the period following the completion of the merger.
Forward-looking statements are typically identified by words such as plan, believe, expect,
anticipate, intend, outlook, estimate, forecast, project and other similar words and
expressions.
The forward-looking statements involve certain risks and uncertainties. The ability of
Innovive and CytRx to predict results or the actual effects of their respective plans and
strategies is subject to inherent uncertainty. Factors that may cause actual results to differ
materially from such forward-looking statements include, among others, those set forth under Risk
Factors in this proxy statement/prospectus, as well as those discussed and identified in public
filings with the SEC made by Innovive and CytRx.
Because these forward-looking statements are subject to assumptions and uncertainties, actual
results may differ materially from those expressed or implied by these forward-looking statements.
You are cautioned not to place undue reliance on these statements, which speak only as of the date
of this proxy statement/ prospectus.
All subsequent written and oral forward-looking statements concerning the merger or other
matters addressed in this proxy statement/prospectus and attributable to Innovive or CytRx or any
person acting on behalf of Innovive or CytRx are expressly qualified in their entirety by the
cautionary statements contained or referred to in this proxy statement/prospectus. Except to the
extent required by applicable law or regulation, Innovive and CytRx undertake no obligation to
update these forward-looking statements to reflect events or circumstances after the date of this
proxy statement/prospectus or to reflect the occurrence of unanticipated events.
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THE MERGER
The following discussion of the merger is qualified in its entirety by reference to the merger
agreement, which is attached to this proxy statement/prospectus as Appendix A. You should read the
merger agreement carefully.
Background of the Merger
Innovive is a development-stage company with several therapeutic candidates in development. As a
development-stage company without any marketable product, we do not have a revenue stream.
Consequently, Innovive, like many such companies, is dependent on a steady source of cash infusions
to continue operations.
The only sources of funds available to us are equity or debt financings that would provide a
cash infusion or partnerships or other strategic alliances with third parties that would provide a
revenue stream.
Since 2005, our board of directors and management have worked to secure our future by
expanding our drug candidate pipeline and obtaining the funds necessary to develop and
commercialize these drug candidates. As part of this process, our board and management have
considered a range of strategic alternatives, including public and private equity and debt
financings, corporate partnering and licensing strategies and more recently a merger strategy, all
with a view to increasing stockholder value.
Innovive completed a private placement of convertible notes in June 2005, a private placement
of Series A preferred stock in June 2006 and a private placement of common stock in April 2007,
raising net proceeds of $2,249,984, $12,501,135 and $13,872,046, respectively. As is normal with
many development-stage companies, these financings were completed when we were low on cash, because
these financings tend to provide operating funds for a relatively short period of time during which
the company conducts pre-clinical and/or clinical studies to advance the development of one or more
drug candidates.
After the completion of our common stock financing in April 2007, we had funds to allow us to
operate to approximately October 2007 if all programs were to be pushed forward at full speed.
These funds were deployed primarily to the development of INNO-406, INNO-206 and tamibarotene,
supporting dosing studies for INNO-406, a phase II study for INNO-206 and a pivotal phase II study
for tamibarotene.
Shortly after the closing of the April 2007 financing, management began planning the pursuit
of another larger financing. In addition, management considered other strategic alternatives,
including merger and acquisition opportunities and strategic partnerships for the development of
one or more of our product candidates.
Beginning in May 2007, management began interviewing investment bankers to conduct a common
stock financing. By August 2007, the board authorized the engagement of one investment banker to
serve as lead agent and two other investment bankers to act as co-agents in a private placement of
Innovive common stock. These investment banks were engaged in August 2007.
During the summer and early fall of 2007, the investment banks attempted to put together an
investor pool. However, by October 2007, no definitive investor group or terms were established.
One obstacle to a financing was a price protection provision that was agreed to in the April 2007
common stock financing. This price protection provision provided that in the event that we issued
shares of our common stock at a price per share less than the purchase price of the offering, which
was $2.73, at any time prior to October 24, 2007, then each investor would have the right to
receive a number of additional shares of our common stock equal to (i) the aggregate purchase price
per unit paid by the investor in the offering, divided by the subsequent share purchase price, (ii)
less the number of shares of common stock purchased by the investor in the offering.
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Also during the summer and early fall of 2007, management sought other strategic alternatives
and held discussions with interested parties. Based on these inquiries, in October 2007, our board
of directors began considering other strategic alternatives. At this point, the investment banks
had found only one lead investor for the private placement, which was not significant enough to
attract other investors. While the investment banks continued to seek investors for the financing,
management held conversations with three potential investors, two of which were interested in
bringing in its own investor group and the other of which was interested in a significant
investment on its own. In addition, management had identified four strategic partnership
candidates for INNO-406.
In early November 2007, our board determined that a strategic partnership for INNO-406 was
increasingly unlikely without further clinical data, based on feedback received by management in
its discussions with the interested parties. At a special meeting on November 13, 2007, our board
authorized management to negotiate a written term sheet with one of the entities that had expressed
interest in developing its own investor group to invest in the companys stock. A term sheet from
this investor, with two other investors, was signed on November 26, 2007. The term sheet allowed
the investor group 10 days to complete due diligence. At the conclusion of the 10 days, on
December 7, 2007, the investor group informed Mr. Kelly, our President and Chief Executive Officer,
that it had decided not to proceed with the investment.
Subsequent to the expiration of the above term sheet, negotiations with an entity in the
investor group noted above and an additional investor proceeded and at a special meeting on
December 21, 2007, our board approved the execution of a term sheet with that investor group. One
of the conditions to the term sheet was that at least three institutional investors were to be
secured before the investor group would commit to the investment. This condition was not met and
on January 11, 2008 the investors informed Mr. Kelly that they would not be proceeding with an
investment in Innovive.
At a regular meeting on January 15, 2008, our board considered possible strategic
alternatives, including an equity or debt financing, a sale of assets or a sale of the company, and
considered the discussions held by management with third parties to date on all of these
alternatives. Our board authorized seeking a bridge financing with Paramount Biocapital, Inc. as
placement agent. Paramount Biocapital had successfully conducted our 2005 bridge financing and our
two equity financings.
At this point, we did not have sufficient funds to cover our current obligations or future
operating expenses, a situation that first developed in October 2007. On January 17, 2008, we
terminated four employees, which represented approximately one-half of our employees. In addition,
our ongoing clinical programs were reduced to include only essential steps necessary to obtain new
data. At a special board meeting on January 29, 2008, management updated our board on potential
merger or acquisition parties. Our board also was advised by bankruptcy lawyers on the process and
impact of bankruptcy and our boards and Innovives duties were Innovive to declare bankruptcy. At
the end of the meeting, our board authorized management to continue negotiating with Paramount
Biocapital to act as placement agent in a bridge financing of debt.
At a regular meeting held on February 13, 2008, our board reviewed the status of possible
transactions and considered the benefits and challenges of a financing, a merger or acquisition, or
a sale of company assets. After deliberation, our board approved a placement agreement with
Paramount Biocapital. Paramount Biocapital, however, was not able to find investors willing to
invest a sufficient amount of capital, and it ceased its efforts on our behalf in March. During
this time, management continued to contact third parties about a possible strategic transaction
with Innovive.
Throughout March and April, our management contacted several companies who subsequently
expressed interest in conducting additional due diligence on our product candidates. One of these
companies was CytRx. CytRx was introduced to the company through one of our directors, J. Jay
Lobell, by means of a telephone call on April 2, 2008. Mr. Lobell knew Steven A. Kriegsman, the
President and Chief Executive Officer of CytRx, and had contacted him earlier on April 2, 2008 to
determine if CytRx had any interest in a
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transaction with Innovive. During the call, David Haen, Vice President Business Development
of CytRx, expressed interest in learning more about us and sent over a mutual confidentiality
agreement that we and CytRx executed on April 4, 2008. CytRx also provided a diligence checklist
to us at that time and, in response, CytRx was granted access to our virtual data room that day.
Our management facilitated the diligence process by providing the requested information to all
of the companies that requested information. Three of these companies provided term sheets in
April that provided for the acquisition of certain of our assets for equity in the acquiring
company. None of the term sheets addressed acquiring the company as a whole.
Mr. Lobell arranged for a telephone call on April 23, 2008 among himself, Mr. Kriegsman and
Mr. Haen of CytRx, and Lindsay Rosenwald, an affiliate and major stockholder of Innovive. On the
call, the parties discussed the terms of a possible offer by CytRx to acquire Innovive and related
matters.
On April 25, 2008, at a regular meeting of our board, management reviewed with the board term
sheets that had been received from these three companies. Management also informed the board that
it believed that term sheets were imminent from four other companies, one of which was CytRx. Our
board reviewed each term sheet it had received, as well as the expected terms to be contained in
the term sheets expected from the other four entities, including CytRx. Our board concluded that
it needed more time to consider the current and expected term sheets and noted that a decision
would have to be made in the early part of the next week, given our cash position.
During subsequent diligence discussions with CytRx, our management expressed the need to
receive either a term sheet or letter agreement from CytRx and the desire or our board of directors
to move quickly in order, among other things, to demonstrate to TMRC Inc., the licensor of
tamibarotene, and Medpace, Inc., a contract research organization working on the clinical
development of three Innovive products, that we were making progress on a possible transaction and
would be able to meet our financial obligations to them.
On May 1, 2008, CytRx provided Mr. Kelly a term sheet for the acquisition of Innovive pending
certain remaining due diligence, including face-to-face meetings scheduled for May 6 and 7. On
or about this time, Mr. Lobell spoke with Mr. Kriegsman and Mr. Haen regarding the term sheet and
suggested that CytRx discuss further with Innovive management the clinical development assumptions
underlying CytRxs term sheet.
On May 6 and 7, 2008, CytRx management, including Mr. Kriegsman, Jack Barber, Ph.D., Chief
Scientific Officer, Benjamin S. Levin, General Counsel, Vice President of Legal Affairs and
Secretary, Scott Wieland, Ph.D., Vice President of Clinical and Regulatory Affairs, and Mr. Haen,
met with our management at our offices in New York City. On May 8, 2008, Mr. Kelly informed
Mr. Haen by telephone that Innovive had received another offer for the entire company and
encouraged CytRx to revise the term sheet prior to the special meeting of our board of directors
scheduled for the next day. CytRx, however, declined to revise its offer.
At the special meeting held on May 9, 2008, our board of directors voted unanimously to accept
the CytRx term sheet and authorized management to negotiate a binding merger agreement.
Mr. Kelly then contacted several prospective investment advisors, including Chartered Capital
Advisers, Inc., to act as the companys financial advisor in connection with the possible merger
with CytRx. We engaged Chartered on May 29, 2008.
From May 9 through June 5, 2008, we and CytRx negotiated the final terms of the merger
agreement. CytRx also conducted additional due diligence, including at a meeting on May 28, 2008
between Dr. Wieland and representatives of Medpace, Inc. Mr. Haen, Dr. Wieland and John Caloz,
CytRxs Chief Accounting
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Officer, also met and conducted further diligence with our management at our offices in New
York on May 28 through 30.
Our board of directors formally met on June 6, 2008 in a special meeting, at which all the
members of our board were in attendance, for the purpose of reviewing the terms of the proposed
merger agreement. Also in attendance were Ronald Quintero of Chartered, our financial advisor, and
David Mannheim of Wyrick Robbins Yates & Ponton LLP, our legal counsel. At this meeting, Mr. Kelly
provided a report and analysis related to the terms of the proposed transaction, including, without
limitation, the value of the consideration to be received in the transaction by our stockholders as
of that date and the conditions to closing the transaction. Mr. Kelly and J. Gregory Jester, our
Chief Financial Officer, also reported on the status of our recent financing efforts and financial
condition. Mr. Mannheim reviewed the terms of the merger agreement and the loan and security
agreement and the relevant legal approvals necessary to consummate the merger. Mr. Quintero
reviewed with the board Chartereds analysis of Innovive and the merger proposal, at the conclusion
of which he presented the board with Chartereds written opinion that the merger is fair, from a
financial point of view, to the stockholders of Innovive. After deliberating, our board determined
that the merger agreement and the transactions contemplated thereby, including the merger, were
fair to, advisable and in the best interests of the Innovive stockholders and each other relevant
corporate constituency and unanimously voted to approve the terms of the merger agreement and the
merger.
Innovives Reasons for the Merger
After careful consideration, our board of directors, by a unanimous vote of the directors, has
determined that the merger agreement is advisable, fair to, and in the best interests of Innovive
and its stockholders, has approved and authorized in all respects the merger agreement, and
recommends that you vote FOR the approval of the merger agreement.
In considering the recommendation of our board of directors with respect to the merger
agreement, you should be aware that some of our directors and executive officers who participated
in meetings of the board of directors have interests in the merger that are different from, or in
addition to, the interests of our stockholders generally. See The Merger Interests of Certain Persons
in the Merger beginning on page 47.
In the course of deliberations, our board reviewed Innovives historical, present and
projected financials under various scenarios, and its historical and short and long-term strategic
objectives, the opportunities in the marketplace that Innovive is pursuing and the risks associated
therewith.
In reaching the decision to approve and authorize the merger, the merger agreement, the loan
and security agreement and the other transactions contemplated under the merger agreement, our
board of directors consulted with senior management and Innovives financial and legal advisors,
and considered a number of factors, including, but not limited to, those set forth below.
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Innovive stockholders will have the opportunity to participate in the potential
growth of CytRx after the merger; |
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the increased ability of the combined company to secure investment capital and
financing for expansion of the combined companys business; |
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the market potential for the combined companys drug development pipeline; |
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the historical, current and prospective financial condition, results of operations
and cash flows of CytRx; |
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CytRxs seasoned management team, greater financial resources and access to capital; |
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the shares of CytRx common stock issued to Innovive stockholders as merger
consideration will be registered with the SEC and will be freely tradable for Innovive
stockholders who are not affiliates of CytRx; |
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Innovives prospects to continue as an independent company; |
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the historic, current and prospective financial condition, results of operations and
cash flows of Innovive, particularly the fact that due to cash limitations, Innovive
has decreased, and most likely will have to cease, its research and clinical
operations; |
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without the completion of a strategic transaction like the merger, Innovive will
likely be forced to file for federal bankruptcy protection; |
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based on our historical efforts over a period of nearly a year to attract capital
and to pursue alternative transactions, the low probability that any alternative
transaction would be available to Innovive that would provide the same or greater value
to our stockholders within a reasonable time frame; |
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the terms and conditions of the merger agreement and the loan and security
agreement, including the merger consideration and closing conditions; |
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the belief that the terms of the merger agreement, including the parties
representations, warranties and covenants and the conditions to the parties respective
obligations, are reasonable; |
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the terms of the transaction, including the merger consideration and the loan and
security agreement, as compared to the terms that might be achieved with other similar
transactions with other potential merger partners; |
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dissenters rights would be available to Innovive stockholders under applicable
state law; |
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apart from the approval by stockholders, completion of the merger would not require
any material consents or approvals; |
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the likelihood that the merger will be consummated on a timely basis; |
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the fact that the merger agreement permits our board of directors to change its
recommendation of the transaction to stockholders in connection with an unsolicited
superior proposal by a third party for an alternative transaction if the failure to do
so would be reasonably likely to violate the board of directors fiduciary obligations
under applicable law, provided that Innovive complies with certain requirements,
including payment of a $1.5 million termination fee to CytRx; |
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the amount of the termination fee payable by us and the circumstances under which it
is payable are typical for transactions of this size and type and were necessary to
induce CytRx to enter into the merger agreement; |
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Chartereds financial analysis and its written opinion to our board of directors
that as of June 6, 2008, and based upon and subject to the factors and assumptions set
forth in its opinion, the merger is fair from a financial point of view to the Innovive
stockholders; and |
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the support agreements of our directors and officers and their affiliates who own
beneficially an aggregate of approximately 22% of the shares of our common stock
entitled to vote at the special meeting to vote all shares that they control in favor
of the merger agreement, as well as their |
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willingness to grant CytRx proxies to vote such shares in favor of the approval of the
merger agreement, and the fact that the support agreements can be terminated by our
directors and officers and their affiliates if the merger agreement is terminated by us. |
Our board of directors also considered the following potentially negative factors in reaching
its decision to approve and authorize in all respects the merger agreement, the merger, and the
other transactions contemplated under the merger agreement:
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restrictions in the merger agreement on solicitation generally prohibit us from
soliciting any acquisition proposal or offer for a merger or business combination with
any other party, including a proposal that might be advantageous to our stockholders
when compared to the terms and conditions of the merger, and further prohibit us from
entering into discussions regarding unsolicited proposals unless certain requirements
are met; |
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if the merger is not completed for whatever reason we will have incurred substantial
expenses, and will have to repay CytRx for advances under the loan and security
agreement, which we may not be able to pay, in which event CytRx would be entitled to
pursue its remedies under the loan and security agreement, including a possible
foreclosure sale of all or substantially all of our assets; |
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if the merger is not completed under certain circumstances specified in the merger
agreement, we may be required to repay to CytRx any funds loaned to Innovive pursuant
to the loan and security agreement, which may deter third parties from proposing or
pursuing alternative business combinations that might result in greater value to our
stockholders than the merger; |
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the interests of our directors and officers may be different in certain respects
from the interests of our stockholders, generally, as described under The Merger -
Interests of Innovives Directors and Executive Officers in the Merger; |
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the restrictions on the conduct of our business prior to the consummation of the
merger, which, subject to specific limitations, may delay or prevent us from taking
certain actions during the time that the merger agreement remains in effect; |
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the requirement under the terms of the merger agreement that we pay CytRx a
termination fee if we terminate the merger agreement to accept a superior proposal for
the acquisition of Innovive, if our board of directors changes its recommendation
concerning the merger agreement, or in certain other circumstances (including, in some
instances, if stockholders do not vote to approve the merger agreement), and that our
obligation to pay the termination fee might discourage other parties from proposing a
business combination with, or an acquisition of, Innovive; |
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the risk that, while the merger is expected to be completed, there is no assurance
that all conditions to the parties obligations to complete the merger will be
satisfied and, as a result, it is possible that the merger may not be completed even if
approved by our stockholders; |
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additional advances under the loan and security agreement are at the discretion of
CytRx and may affect our working capital; and |
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other risk factors described under the section entitled Risk Factors. |
Our board of directors considered all of these factors as a whole and considered the factors
in their totality to favor and support the decision to approve and authorize in all respects the
merger agreement, the merger, and the other transactions contemplated under the merger agreement
and to recommend that Innovives stockholders approve the merger agreement.
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In view of the variety of factors considered in connection with its evaluation of the merger,
our board of directors did not find it practicable to, and therefore did not, quantify, rank, or
otherwise assign relative or specific weight or values to any of these factors. In addition, each
individual director may have given different weights to different factors.
The foregoing discussion of our board of directors considerations concerning the merger is
forward looking in nature. This information should be read in light of the discussions under the
heading Cautionary Statement Concerning Forward-Looking Information.
Recommendation of the Board of Directors
After careful consideration, our board of directors, by unanimous vote:
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has determined that the merger agreement is advisable, fair to, and in the best
interests of Innovive and its stockholders; |
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has approved and authorized in all respects the merger agreement, the merger, and
the other transactions contemplated by the merger agreement; and |
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recommends that our stockholders vote FOR the approval of the merger agreement. |
CytRxs Reasons for the Merger
In reaching the decision to approve and authorize the merger, the merger agreement, and the
ancillary agreements, the board of directors of CytRx consulted with senior management and CytRxs
legal advisors, and considered a number of factors, including, but not limited to, those set forth
below.
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the acquisition of Innovive will expand CytRxs portfolio of product candidates to
include Innovives four current product candidates for the treatment of cancer and may
facilitate obtaining additional funding by CytRx; |
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Innovives product candidates, including tamibarotene, which is marketed in Japan
for the treatment of relapsed or refractory acute promyelocytric leukemia, or APL, and
is in a pivotal Phase II clinical trial in APL, are expected to accelerate by several
years the time to CytRxs first potential new drug application, subject to the
successful completion of Innovives clinical trials; |
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the prior experience of some of CytRxs management team in the development of drugs
for the treatment of cancer, and managements belief that CytRx can integrate
Innovives and CytRxs product candidates and drug development efforts and achieve
economies of scale in general and administrative expenses and perhaps other costs; |
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the terms and conditions of the merger agreement and the loan and security
agreement, including the fact that the merger consideration includes a relatively
modest payment of initial merger consideration and that the larger earnout merger
consideration is subject to the achievement of specified future net sales of Innovives
products; |
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apart from the approval by Innovives stockholders, completion of the merger would
not require any material consents or approvals; |
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the amount of the termination fee payable to CytRx and the circumstances under which
it is payable to CytRx; and |
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the support agreements of Innovive directors and officers and their affiliates who
own beneficially an aggregate of approximately 22% of the shares of Innovive common
stock entitled to vote at the special meeting to vote all shares that they control in
favor of the merger agreement, as well as their willingness to grant CytRx proxies to
vote such shares in favor of the approval of the merger agreement. |
In view of the variety of factors considered in connection with its evaluation of the merger,
CytRxs board of directors did not find it practicable to, and therefore did not, quantify, rank,
or otherwise assign relative or specific weight or values to any of these factors. In addition,
each individual director may have given different weights to different factors.
The foregoing discussion of CytRxs board of directors considerations concerning the merger
is forward-looking in nature. This information should be read in light of the discussions under the
heading Cautionary Statement Concerning Forward-Looking Information.
Effects of the Merger
If the merger agreement is approved by our stockholders and if the merger is completed, Merger
Subsidiary will be merged with and into Innovive, with Innovive continuing as the surviving
corporation and wholly owned subsidiary of CytRx. All of the shares of Innovive common stock
outstanding immediately prior to the effective time of the merger (other than shares that are owned
by Innovive, CytRx and Merger Subsidiary and shares that are owned by stockholders, if any, who
properly exercise dissenters rights under Delaware law) will be cancelled and converted into the
right to receive the merger consideration.
After the completion of the merger, Innovive will be a wholly owned subsidiary of CytRx and
its name will be changed to CytRx Oncology Corporation, our current stockholders will have no
ownership interest in Innovive and shares of Innovive common stock will no longer be publicly
traded.
Management and Operations After the Merger
Management of CytRx will manage the business and operations of Innovive after the merger.
CytRx intends to undertake a comprehensive review of Innovives development activities after the
merger with a view to optimizing the clinical and development programs and eliminating any cost
inefficiencies and redundancies of the combined company.
Interests of Certain Persons in the Merger
Neither Innovive nor any of our officers or directors has an ownership interest in CytRx or is
otherwise affiliated with CytRx, and we had no dealings with CytRx or its officers or directors
other than in connection with the merger agreement and related matters. However, in considering
the recommendation of our board of directors with respect to the merger agreement, you should be
aware that some of our directors and executive officers who participated in meetings of our board
of directors have interests in the merger that are different from, or in addition to, the interests
of our stockholders, generally. These interests, to the extent material, are described below. Our
board of directors was aware of these interests and considered them, among other matters, in
approving the merger agreement and the merger.
CytRxs officers and directors own CytRx common stock and have been granted stock options to
purchase CytRx common stock, none of which will vest or be adjusted or otherwise changed as a
result of the merger. Except for the interests inherent in their ownership of CytRx common stock
and stock options, CytRxs officers and directors do not have any material interests in the merger.
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Severance Benefits
We have entered into employment agreements with Steven Kelly and J. Gregory Jester, which
provide that, if the employment of either officer is terminated by us without cause (as defined in
the agreement), or either officer terminates his employment with us for good reason (as defined in
the agreement), he will be entitled to receive a severance payment equal to six times his monthly
salary and we will be obligated to continue his health insurance benefits for six months following
his termination.
In February 2008, we instituted an employee retention program to ensure that we could retain
the services of Mr. Jester and Dr. Poma. Pursuant to the program, we agreed to pay each officer
severance equal to six months of his salary if he is terminated by us, CytRx or Merger Subsidiary
without cause (as defined in the program) at any time after June 30, 2008. No such severance will
be due the officer to the extent that he is eligible to receive severance payments in an equal or
greater amount pursuant to his employment agreement or other agreement with us or CytRx.
Set forth below is an estimate of the pre-tax amount of the severance benefits that would be
owed to each such officer under his employment agreement assuming that the officer is terminated on
the day following the completion of the merger:
|
|
|
|
|
|
|
|
|
|
|
Estimated Severance |
|
Estimated Value of Health |
Name |
|
Payment |
|
Insurance Benefits |
Steven Kelly |
|
$ |
187,500 |
|
|
$ |
7,746 |
|
J. Gregory Jester |
|
|
95,000 |
|
|
$ |
-0- |
(1) |
Eric Poma, Ph.D. |
|
|
125,000 |
|
|
$ |
-0- |
|
|
|
|
(1) |
|
Mr. Jester does not participate in our health insurance plan.
Consequently, we are not required to provide him with continued benefits under
the terms of his employment agreement. |
The merger agreement provides that the directors of Merger Subsidiary will become the
directors of Innovive upon the closing of the merger. Therefore, we do not anticipate that any of
our directors will continue to serve as directors of Innovive or will serve as directors of CytRx
after the completion of the merger.
Release of Personal Guarantee
Mr. Kelly, our President and Chief Executive Officer, currently serves as a guarantor of our
rental payments under our lease for our executive offices. Pursuant to the merger agreement, CytRx
has agreed to use its commercially reasonable efforts to remove Mr. Kelly as the guarantor,
effective at the effective time of the merger. If the removal is not effective at that time, CytRx
and Merger Subsidiary will enter into a written agreement satisfactory to Innovive and Mr. Kelly to
indemnify Mr. Kelly under the guarantee and to obtain the removal of Mr. Kelly as guarantor as soon
as possible after the effective time of the merger.
Stock, Stock Options and Warrants
As of the record date for the special meeting of stockholders, our directors and officers held
in total 435,957 shares of our common stock. As of the record date for the special meeting of
stockholders, our directors and officers held options and warrants to purchase a total of 512,747
shares of our common stock. See Security Ownership by Certain Beneficial Owners and
Management of Innovive for details on the ownership of our equity securities by our directors and
officers.
All shares of common stock, stock options and warrants held by our directors and officers will
be treated in the merger in the same manner as those held by our other stockholders.
48
Indemnification and Insurance
In the merger agreement, CytRx and Merger Subsidiary have generally agreed to indemnify our
current and former directors and officers and directors for acts or omissions in their capacity as
directors or officers occurring on or before the effective time of the merger and to provide for
liability insurance for a period of three years from and after the effective time of the merger,
subject to certain conditions. The terms of the liability insurance policies must be no less
favorable than the policies of Innovive, unless the cost of the policies would exceed the current
policies annual premium, in which case the coverage will be the greatest amount of coverage
available for an amount not exceeding 125% of the current premium.
Stock Exchange Listing of CytRx Common Stock
It is a condition to the completion of the merger that the shares of CytRx common stock
issuable to Innovive stockholders in payment of the initial merger consideration be approved for
listing on The Nasdaq Capital Market. It is also a condition to the payment of any earnout merger
consideration that CytRx may elect to pay in shares of CytRx common stock that such shares be
listed on The Nasdaq Capital Market or other trading market.
Comparative Market Prices of Common Stock
CytRx common stock is listed on The Nasdaq Capital Market and our common stock is quoted on
the OTCBB. On June 6, 2008, the last full trading day before the public announcement of the merger
agreement, the closing price of CytRx common stock as reported on The Nasdaq Capital Market was
$0.99. On June 6, 2008, the last full trading day before the public announcement of the merger
agreement, the closing price of shares of our common stock as reported on the OTCBB was $0.15.
If the merger is completed, there is no assurance as to what the market price of CytRx common stock
will be at that or any other time.
Regulatory Requirements
The merger is not subject to any federal or state regulatory requirements.
OPINION OF INNOVIVES FINANCIAL ADVISOR
Innovive has retained Chartered Capital Advisers, Inc., or Chartered, to act as Innovives
financial advisor in connection with the merger. Chartered provides merger and acquisition,
valuation, and corporate financial advisory services on behalf of corporate clients, investors,
financial institutions, attorneys, accountants, and participants in employee benefit plans.
Chartered is regularly engaged in the valuation of securities and other financial advisory work in
connection with mergers and acquisitions, recapitalizations, private placements, financial
restructuring, shareholder transactions, financial reporting, estate and gift taxes, litigation,
and for other purposes. Innovive selected Chartered to act as Innovives financial advisor in
connection with the merger on the basis of Chartereds experience in transactions similar to the
merger.
On June 6, 2008, at a meeting of the board of directors of Innovive held to evaluate the
merger, Chartered delivered to the board of directors Chartereds written opinion dated June 6,
2008, to the effect that, as of the date of the opinion and based on and subject to various
assumptions and limitations described in its opinion, the merger consideration to be received by
holders of Innovive common stock was fair, from a financial point of view, to such holders.
The full text of Chartereds written opinion to the Board of Directors of Innovive, which
describes, among other things, the assumptions made, procedures followed, factors considered and
limitations on the review undertaken, is attached as Appendix C to this proxy statement/prospectus and
is incorporated by reference in its entirety into this proxy statement/prospectus. The following
summary of Chartereds opinion is qualified in its entirety by reference to the full text of the
opinion. Chartered
49
delivered its opinion to the board of directors of Innovive for the benefit and use of the
board of directors in connection with and for purposes of its evaluation of the merger
consideration from a financial point of view. Chartereds opinion does not address any other aspect
of the merger and does not constitute a recommendation to any stockholder as to how to vote or act
in connection with the proposed merger.
In connection with rendering its opinion, Chartered:
|
|
|
reviewed the merger agreement and various documents relating thereto; |
|
|
|
|
conferred with Innovives management, its legal advisors, and the management of
CytRx; |
|
|
|
|
reviewed various documents and other information prepared by or in connection with
Innovive including, but not limited to, documents filed with the SEC, historical
financial statements, Innovives balance sheet as of May 31, 2008, financial
projections, a summary of financing contacts, an investor presentation dated as of May
2008, technical documentation, and Innovives website; |
|
|
|
|
reviewed various documents and other information prepared by or in connection with
CytRx including, but not limited to, documents filed with the SEC, historical financial
statements, analyst reports, and CytRxs website; |
|
|
|
|
analyzed the historical financial performance and financial condition of Innovive
and CytRx; |
|
|
|
|
analyzed the Innovive financial projections prepared by its management; |
|
|
|
|
analyzed the historical stock prices of Innovive and CytRx; |
|
|
|
|
considered Innovives current capitalization, financial condition, and risks
relating thereto; |
|
|
|
|
evaluated the proposed consideration to Innovive equity holders reflected in the
proposed merger, taking into consideration various valuation benchmarks including: |
|
o |
|
net book value; |
|
|
o |
|
current and historical market price of Innovive common stock; |
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|
o |
|
premiums paid in mergers deemed to be relevant to Innovive; |
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o |
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discounted cash flow analysis; |
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|
o |
|
capitalization multiples of guideline public companies; and |
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|
o |
|
capitalization multiples paid in acquisitions deemed to be relevant to Innovive; |
|
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|
considered the historical experience of Innovives management and the investment
bankers that it retained to pursue capital infusions and other potential transactions; |
|
|
|
|
considered the potential perception of Innovive and its investment prospects from
the vantage point of investors capable of committing the amount of capital required by
Innovive, and the amount of dilution that may result from a potential capital infusion; |
50
|
|
|
considered the current financing environment for financing development-stage
companies similar to Innovive; |
|
|
|
|
considered the process employed by Innovives management to negotiate the proposed
merger; |
|
|
|
|
considered the risks of rejecting the proposed merger in order to seek an enhanced
transaction with CytRx or an improved transaction with an alternative investor or
acquirer; and |
|
|
|
|
considered such other information, financial studies, and analyses as it deemed
relevant, and performed such analyses, studies, and investigations as it deemed
appropriate. |
In arriving at its opinion, Chartered assumed and relied upon, without independent
verification, the accuracy and completeness of the information reviewed by it that was obtained
from Innovives management, CytRx, and from public sources that are routinely used in its
profession. Chartered also assumed that the representations of Innovive management and its
advisors were made in good faith, and that they reflect the best currently available management
judgments as to the matters covered and that the distributions of initial merger consideration and
earnout merger consideration would be made on a timely basis in accordance with the provisions of
the merger agreement.
Chartereds opinion was necessarily based upon economic, market, and other conditions as in
effect on, and the information made available to Chartered as of, the date of its opinion.
Chartered disclaims any undertaking or obligation to advise any person of any change in any fact or
matter affecting its opinion which may come up or be brought to its attention after the date of its
opinion. In the event that there is any change of fact or matter affecting Chartereds opinion
after its date and prior to the consummation of the proposed merger, Chartered reserves the right
to change, modify, or withdraw its opinion.
The following represents a brief summary of the material financial analyses presented by
Chartered to the board of directors of Innovive in connection with its opinion. The financial
analyses summarized below include information presented in tabular format. In order to fully
understand the financial analyses performed by Chartered, the tables must be read together with the
text of each summary. The tables alone do not constitute a complete description of the financial
analyses performed by Chartered. Considering the data set forth in the tables below without
considering the full narrative description of the financial analyses, including the methodologies
and assumptions underlying the analyses, could create a misleading or incomplete view of the
financial analyses performed by Chartered.
Considerations Underlying Chartered Fairness Opinion
Neither Innovive nor CytRx has historical revenues to which customary analyses can be applied.
In addition, due to the absence of historical revenues for either Innovive or CytRx, no
projections of operations could be or were developed for either Innovive or CytRx because any such
projections would be speculative in nature. As a result, many of the analyses typically performed
to value companies that are at more advanced stages of development could be credibly performed in
connection with the proposed merger. Consequently, Chartered relied heavily on qualitative factors
in arriving at its opinion. The following are the principal considerations relied upon by
Chartered in its analysis:
|
|
|
Consideration |
|
Comments |
Steps leading to
merger
|
|
Innovives management hired four leading investment banks over an 18-month
period to explore transaction alternatives;
Contacts were made with more than 65 potential investors; and
The proposed merger is the culmination of an extensive undertaking by
well-recognized firms. |
51
|
|
|
Consideration |
|
Comments |
Urgency of current
situation
|
|
Innovive is insolvent and has been insolvent for several months;
Trade debt is significantly in arrears, research and development, or R&D,
activities have been halted, and personnel have been laid off pending
additional funding; and
Absent necessary financing, there is risk that Innovive may be compelled
to relinquish some or all of the licenses upon which the success of
Innovive depends, and all remaining value could be lost. |
|
|
|
Alternative
potential
transactions
|
|
None. |
|
|
|
Market
capitalization of
Innovive and CytRx
common stock
|
|
Innovive $1.46 million (as of 5/30/08); and
CytRx $79.9 million (as of 5/30/08). |
|
|
|
Potential value of
merger
consideration to
Innovive
stockholders
|
|
Initial merger considerationCytRx common stock valued at $3.0 million; and
Earnout merger consideration (if earned)CytRx common stock valued at $2.0
million to $18.25 million. |
|
|
|
Relative liquidity
of Innovive and
CytRx stock
|
|
Innovive common stock is relatively illiquid, trading a median of 3,500
shares/day; and
CytRx common stock is more liquid than that of Innovive, trading in excess
of 500,000 shares/day. |
|
|
|
Institutional
ownership of stock
|
|
Innoviveminimal ; and
CytRxapproximately 30%. |
|
|
|
Analysts covering
stock
|
|
Innovivenone; and
CytRxfive analysts. |
|
|
|
Impact of proposed
merger on Innovive
stockholder risk
|
|
Risk would be reduced because: (1) CytRx is better capitalized than
Innovive; (2) CytRx has historically been more successful than Innovive in
raising capital; and (3) CytRx has additional products in the pipeline
that provide diversification benefit. |
|
|
|
Impact of proposed
merger on potential
Innovive
stockholder return
|
|
Potential returns are enhanced by an increased ability to fund R&D;
Dilution from proposed merger may not be significantly different than the
dilution that would occur if Innovive remained independent and obtained
funding from investors (although it has been unsuccessful in doing so);
and Innovive stockholders are also able to participate in the potential return
from CytRx R&D. |
|
|
|
Implied merger
premium
|
|
At least 105% (based on 5/30/08 Innovive stock price), but potentially in
excess of 1,000%, depending upon the amount of earnout merger
consideration paid; and
Implied merger premium is high in comparison to premiums generally paid in
M&A transactions, including premiums paid since the beginning of 2007 in
the acquisition of biotech stocks (median 65.17%) and companies with sales
below $10 million (median 34.23%). |
|
|
|
Innovive
stockholders share
of post-merger
combined company
|
|
Innovive stock represented 1.80% of the combined market capitalization of
Innovive and CytRx as of 5/30/08; and
Initial merger consideration (without regard to earnout merger
consideration) would give Innovive stockholders 3.61% of the post-merger
capitalization of the combined companies. |
|
|
|
Innovive pro forma
value
|
|
An analysis of Innovive stockholders share of the pro forma future value
of Innovive if it were to remain an independent company and obtain a
highly dilutive financing is less than what may be realized from their
share of the pro forma future value of the combined Innovive and CytRx
after the merger; and
The pro forma analysis was based, in part, upon discounted cash flow
analysis, and price/revenue multiples of publicly traded biotech
companies, as well as price/revenue multiples paid in acquisitions of
biotech companies. |
|
|
|
Innovive net book
value
|
|
Preliminary unaudited internal financial statements indicated Innovive had
a stockholders deficit of $3.678 million as of 5/30/08. |
52
|
|
|
Consideration |
|
Comments |
Risk of rejecting
the proposed merger
|
|
The only available transaction may be lost if CytRx chose to withdraw;
Innovive common stock may become worthless; and
Innovive may be liable to CytRx for a $1.5 million termination fee (nearly
equal to the aggregate market capitalization of Innovive common stock as
of 5/30/08), as well as for repayment of advances made by CytRx. |
Miscellaneous
As noted above, the discussion set forth above is a summary of the material financial analyses
presented by Chartered to the board of directors of Innovive in connection with its opinion and is
not a comprehensive description of all analyses undertaken by Chartered in connection with its
opinion. The preparation of a financial opinion is a complex analytical process involving various
determinations as to the most appropriate and relevant methods of financial analysis and the
application of those methods to the particular circumstances and, therefore, a financial opinion is
not readily susceptible to partial analysis or summary description. Chartered believes that its
analyses summarized above must be considered as a whole. Chartered further believes that selecting
portions of its analyses and the factors considered or focusing on information presented in tabular
format without considering all analyses and factors or the narrative description of the analyses,
could create a misleading or incomplete view of the processes underlying Chartereds analyses and
opinion. The fact that any specific analysis has been referred to in the summary above is not meant
to indicate that such analysis was given greater weight than any other analysis referred to in the
summary.
In performing its analyses, Chartered considered industry performance, general business and
economic conditions and other matters, many of which are beyond the control of Innovive and CytRx.
The estimates of the future performance of Innovive and CytRx in or underlying Chartereds analyses
are not necessarily indicative of actual values or actual future results, which may be
significantly more or less favorable than those estimates or those suggested by Chartereds
analyses. These analyses were prepared solely as part of Chartereds analysis of the fairness, from
a financial point of view, of the merger consideration and were provided to the board of directors
of Innovive in connection with the delivery of Chartereds opinion. The analyses do not purport to
be appraisals or to reflect the prices at which a company might actually be sold or the prices at
which any securities have traded or may trade at any time in the future. Accordingly, the estimates
used in, and the ranges of valuations resulting from, any particular analysis described above are
inherently subject to substantial uncertainty and should not be taken to be Chartereds view of the
actual values of Innovive or CytRx.
The type and amount of consideration payable in the merger was determined through negotiations
between Innovive and CytRx, rather than by any financial advisor, and was approved by the board of
directors of Innovive. The decision to enter into the merger agreement was solely that of the board
of directors of Innovive. As described above, Chartereds opinion and analyses were only one of
many factors considered by the board of directors of Innovive in its evaluation of the proposed
merger and should not be viewed as determinative of the views of the board of directors of Innovive
or management with respect to the merger or the merger consideration.
Innovive paid Chartered $25,000 for its services in rendering its opinion and also will
reimburse Chartered for reasonable out-of-pocket expenses incurred in connection with Chartereds
engagement. Innovive has agreed to indemnify and hold harmless Chartered and its shareholders and
employees against any costs incurred by Chartered in connection with any litigation to which
Chartered or its shareholders and employees may become subject as a consequence of its services to
Innovive in the proposed merger. In addition, Innovive has agreed that the maximum liability of
Chartered for any and all losses, claims, damages, or liabilities to which Chartered may become
subject in connection with the services rendered by it to Innovive will be limited to $25,000,
other than in matters involving Chartereds gross negligence, willful misconduct, fraud or
deliberate malfeasance.
53
Chartered or its affiliates have not provided financial advisory or any other services to
Innovive in the past. In the ordinary course of business, Chartered and its affiliates have never
owned any securities of Innovive or CytRx for their own accounts.
54
MATERIAL UNITED STATES FEDERAL INCOME TAX CONSEQUENCES
The following is a summary of certain material U.S. federal income tax consequences of the
merger that are relevant to CytRx and holders of Innovive common stock who will receive the merger
consideration in the merger.
CytRx will recognize no gain or loss in connection with the merger. However, CytRx will be
entitled to deductions for such portion of each payment of earnout merger consideration, if any, as
and when made, that represents imputed interest (see U.S. Holders Earnout Merger Consideration,
below).
The following discussion is for general information only and does not purport to consider all
aspects of U.S. federal income taxation that might be relevant to holders of Innovive common stock.
The discussion is based on current provisions of the Internal Revenue Code of 1986, as amended, or
the Code, existing, proposed, and temporary regulations promulgated under the Code, and rulings,
administrative pronouncements, and judicial decisions as in effect on the date of this proxy
statement/prospectus, changes to which could materially affect the tax consequences described below
and could be made on a retroactive basis. The discussion applies only to holders of Innovive
common stock in whose hands the shares are capital assets within the meaning of Section 1221 of the
Code, and may not apply to holders who acquired their shares pursuant to the exercise of employee
stock options or other compensation arrangements with Innovive or who hold their shares as part of
a hedge, straddle, conversion, or other risk reduction transaction or who are subject to special
tax treatment under the Code (such as dealers in securities or foreign currency, insurance
companies, other financial institutions, regulated investment companies, tax-exempt entities, S
corporations, partnerships, and taxpayers subject to the alternative minimum tax). In addition,
except as specifically discussed below, this discussion does not consider the effect of any state,
local, or foreign tax laws.
The following discussion is not binding on the Internal Revenue Service, or the IRS, or the
courts and, therefore, could be challenged. Neither we nor CytRx will seek any ruling from the IRS
with respect to the merger.
For purposes of this discussion, the term U.S. holder means a holder of Innovive common
stock that is, for U.S. federal income tax purposes: a citizen or individual resident of the
United States; a corporation, or other entity treated as a corporation for U.S. federal income tax
purposes, created in or under the laws of the United States or of any state (including the District
of Columbia); an estate, the income of which is subject to U.S. federal income taxation regardless
of its source; or a trust, if a court within the United States is able to exercise primary
supervision over the administration of the trust and one or more U.S. persons have the authority to
control all substantial decisions of the trust, or a trust that has a valid election in effect
under applicable U.S. Treasury regulations to be treated as a U.S. person. For purposes of this
discussion, the term non-U.S. holder means a holder of Innovive common stock (other than a
partnership) that is not a U.S. holder.
U.S. Holders
It is uncertain under current authorities whether the merger will qualify as a tax-free
reorganization under Section 368 of the Code or as a taxable exchange. Innovive and CytRx have not
yet determined whether they will report the merger as a taxable event or as a reorganization under
Code Section 368, and that determination may not be able to made until after the closing of the
merger. Because of the complexity of the tax issues arising from the structure of the earnout
merger consideration and the uncertainty under current authorities of the tax treatment of the
merger, you are strongly advised to consult your own tax advisor regarding the tax consequences of
the merger to you.
55
Merger as Taxable Exchange
If the merger fails to qualify as a reorganization under Code Section 368, it will constitute
a taxable exchange, and the tax consequences set forth below would generally apply.
Initial Merger Consideration. The receipt of the initial merger consideration will be a
taxable transaction for U.S. federal income tax purposes. In general, a U.S. holder will recognize
gain or loss for federal income tax purposes measured by the difference, if any, between the value
of the shares of CytRx common stock (plus any cash receive in lieu of a fractional share) received
as initial merger consideration and the portion of the U.S. holders adjusted tax basis in the
shares of Innovive common stock surrendered pursuant to the merger (which basis may have to be
allocated, in part, to the earnout merger consideration). Gain or loss will be determined
separately for each block of Innovive shares (i.e., shares acquired at the same price per share in
a single transaction). Such gain or loss will be capital gain or loss and will be long-term
capital gain or loss if the U.S. holders holding period for such shares is more than one year at
the time of consummation of the merger. The maximum federal income tax rate on net long-term
capital gain recognized by individuals is 15% under current law. Deduction of capital losses may
be subject to certain limitations.
Earnout Merger Consideration. In connection with the payment of earnout merger consideration,
if any, a U.S. holder generally will recognize capital gain or loss measured by the difference, if
any, between (i) the value of the shares of CytRx common stock (plus any cash received in lieu of a
fractional share), or cash, or combination of CytRx shares and cash, received as earnout merger
consideration, and (ii) any portion of the U.S. holders adjusted tax basis in the shares of
Innovive common stock surrendered pursuant to the merger allocable to the earnout merger
consideration. A portion of each earnout merger consideration payment, however, will be
characterized as interest under the Codes imputed interest rules, and treated as ordinary interest
income to the U.S. holder, based on the applicable federal rate in effect on the date of the merger
for the term from the date of the merger to the payment date.
Installment Method. Because the common shares of Innovive are quoted and tradable on the
Over-the-Counter Bulletin Board, the installment method of reporting under Code Section 453 will
generally not be available for Innovive stockholders, other than possibly for certain
officers, directors or significant stockholders whose ability to sell shares in the public markets
is limited under SEC rules and regulations (as discussed below). Accordingly, for ordinary
Innovive stockholders that are not eligible for the installment method, the earnout merger
consideration generally would be taxable in the year of the merger based on the fair market value,
as of the date of the merger, of the rights to any future earnout merger consideration. For such
stockholders ineligible for the installment method, however, an exception might be available to the
general rule of taxation in the year of merger either under the open-transaction doctrine or, for
Innovive stockholders who are cash-method taxpayers, based on the cash-method-taxpayer doctrine.
If applicable, the judicially created open-transaction doctrine or the cash-method-taxpayer
doctrine might permit an Innovive stockholder to recover all of the holders basis in the exchanged
Innovive stock before recognizing capital gain from the merger. The IRS views the open-transaction
doctrine, though, as being rarely available and applying only in those rare and extraordinary
cases where a contingent payment obligation is considered to have no ascertainable value.
Innovive stockholders should consult their own tax advisors regarding the availability of either
the open-transaction doctrine or the cash-method-taxpayer doctrine in connection with the merger,
and how it might apply to them if available.
In the case of Innovive officers, directors or significant stockholders whose ability to sell
all of their Innovive shares in the public markets is limited under SEC Rule 144 or similar
restrictions, IRS private letter rulings have held that the installment method might be available
to such a stockholder, in light of the securities laws restrictions on the salability of the
stockholders shares. Such Innovive stockholders should consult their own tax advisors regarding
the availability of the installment method for some or all of their Innovive shares and, if the
installment method is otherwise applicable, the effects of the installment method on them and
whether the stockholder should adopt or elect out of the installment method with respect to any
merger consideration.
56
Tax-Free Reorganization
If the merger instead is held to constitute a reorganization within the meaning of Section
368(a) of the Code, then, subject to the limitations and qualifications described herein, the
following tax consequences would generally apply to stockholders who exchange Innovive common stock
for shares of CytRx common stock and any earnout merger consideration:
|
|
|
no gain or loss will be recognized by the Innovive stockholders upon their receipt
of the initial merger consideration in the form of CytRx common stock; |
|
|
|
|
taxable gain or, in certain cases, loss will be recognized by Innovive stockholders
with respect to any cash they may receive as consideration in the merger, including in
lieu of fractional shares; |
|
|
|
|
taxable income or gain will be recognized upon the receipt of any earnout merger
consideration that is paid in the form of cash, and a portion of any earnout merger
consideration will be recharacterized under the imputed-interest provisions of the Code
as being interest for federal income tax purposes, regardless of whether the underlying
earnout merger consideration is received in the form of cash or CytRx shares, as
discussed more fully above under Merger as Taxable Exchange Earnout Merger
Consideration; |
|
|
|
|
the aggregate tax basis of the CytRx common stock received in the merger will be the
same as the aggregate tax basis of the holders Innovive common stock surrendered in
exchange therefor, reduced by (i) an amount of basis allocable to any fractional share
interests for which cash was received and (ii) the portion of such basis, if any,
allocable to any portion of the earnout merger consideration not received in the form
of shares of CytRx common stock; and |
|
|
|
|
the holding period of the CytRx common stock received in the merger will include the
period during which the holders Innovive common stock surrendered in exchange therefor
was held, provided that the holders Innovive common stock is held as a capital asset
at the time of the merger. |
Exercise of Appraisal Rights
The discussion above does not apply to stockholders of Innovive who exercise appraisal rights
under Delaware law. An Innovive stockholder who exercises appraisal rights with respect to the
merger and receives cash for shares of Innovive stock will generally recognize capital gain (or
loss) measured by the difference between the amount of cash received and the stockholders basis in
those shares, provided that (i) the Innovive shares are capital assets in the hands of such
stockholder and (ii) the payment is treated as a redemption pursuant to Section 302 of the Code,
and not otherwise equivalent to a dividend with respect to the stockholder. A sale of all Innovive
shares held by a stockholder, based on an exercise of appraisal rights or otherwise, will not be
treated as a dividend if the stockholder exercising appraisal rights owns no shares of Innovive or
CytRx immediately after the merger, after giving effect to the constructive ownership rules
pursuant to the Code. The capital gain or loss will be long-term capital gain or loss if the
holders holding period for the Innovive shares surrendered is more than one year. If a
stockholder exercising appraisal rights or exchanging Innovive shares solely for cash will own
shares in CytRx immediately following the merger, the stockholder should consult his, her or its
own tax advisers as to the tax consequences to the stockholder of the Merger.
Non-U.S. Holders
A non-U.S. holder generally will not be subject to U.S. federal income tax with respect to any
taxable gain on merger consideration received pursuant to the merger, unless one of the following
applies:
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the taxable gain is effectively connected with a non-U.S. holders conduct of a
trade or business within the United States and, if a tax treaty applies, the gain is
attributable to a non-U.S. holders U.S. permanent establishment. In such case, the
non-U.S. holder will, unless an applicable tax treaty provides otherwise, generally be
taxed on its net gain derived from the merger at regular graduated U.S. federal income
tax rates, and in the case of a foreign corporation, may also be subject to the branch
profits tax; or |
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a non-U.S. holder who is an individual and holds Innovive stock as a capital asset,
is present in the United States for 183 or more days in the taxable year that the
merger occurs and certain other conditions are met. In such a case, the non-U.S.
holder will be subject to a flat 30% tax on the taxable gain derived from the merger,
which may be offset by certain U.S. capital losses. |
Backup Withholding
Certain non-corporate holders of Innovive common stock may be subject to backup withholding at
a 28% rate on any cash payments received in connection with the merger or upon the exercise of
appraisal rights. Backup withholding will not apply, however, to a holder who (1) furnishes a
correct taxpayer identification number and certifies that he, she, or it is not subject to backup
withholding on the substitute IRS Form W-9 or successor form, (2) provides a certification of
foreign status on an IRS W-8 series Form or successor form, or (3) is otherwise exempt from
backup withholding.
The discussion set forth above is included for general information only. Each Innovive
stockholder should consult his, her or its own tax advisor with respect to the specific tax
consequences of the merger to him, her or it, including the application and effect of state, local,
and foreign tax laws.
THE SPECIAL MEETING OF STOCKHOLDERS
Time, Place, and Purpose of the Special Meeting
This proxy statement/prospectus is being furnished to our stockholders as part of the
solicitation of proxies by our board of directors for use at a special meeting to be held at 10:00
a.m., local time, on September 19, 2008, at our offices located at 555 Madison Avenue,
25th Floor, New York, New York, or at any postponement or adjournment of the meeting.
The purpose of the special meeting is to consider and vote on the proposal to approve the merger
agreement (and to approve the adjournment of the special meeting, if necessary or appropriate to
solicit additional proxies). If the stockholders fail to approve the merger agreement, the merger
will not occur. A copy of the merger agreement is attached to this proxy statement/prospectus as
Appendix A.
Who Can Vote at the Special Meeting
You may vote at the special meeting all of the shares of Innovive common stock you owned of
record as of the close of business on July 31, 2008. If you own shares that are registered
in someone elses name (for example, a broker), you need to direct that person to vote those shares
on your behalf or obtain an authorization from them to vote the shares yourself at the special
meeting. As of the close of business on July 31, 2008, there were 14,610,003 shares of
Innovive common stock outstanding held by 171 holders of record. We believe
that a number of our stockholders hold their shares in street name and, as a result, that the
number of beneficial owners of Innovive common stock is greater than the number of record holders.
Vote Required for Approval of the Merger Agreement
Approval of the merger agreement requires stockholders holding a majority of the outstanding
shares of Innovive common stock at the close of business on the record date to vote for the
approval of the merger
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agreement, with each share having a single vote for this purpose. Failure to vote will have
the same effect as a vote against the approval of the merger agreement.
Steven Kelly, Neil Herskowitz, J. Jay Lobell and Eric Poma, M.D., each of whom is a director
or officer of Innovive, and their affiliates, Lindsay A. Rosenwald, M.D., and Lester Lipshutz, as
investment manager or trustee of trusts established for the benefit of Dr. Rosenwald and his
family, along with Angelo De Caro, who recently resigned as a director, have agreed pursuant to
support agreements that they have entered into with CytRx and Merger Subsidiary to vote all
Innovive shares that they control in favor of the merger agreement. These directors and officers
and their affiliates own beneficially an aggregate of approximately 22% of the shares of common
stock entitled to vote at the special meeting. To facilitate the support agreements, these
beneficial owners also granted CytRx proxies to vote their shares with respect to the merger and
the merger agreement. The full text of the form of support agreements is attached to this proxy
statement/prospectus as Appendix B.
Brokers who hold shares in street name for customers are precluded from exercising their
voting discretion with respect to the approval of matters such as the approval of the merger
agreement and, as a result, absent specific instructions from the beneficial owner of such shares,
brokers are not empowered to vote those shares, referred to generally as broker non-votes.
Abstentions and broker non-votes will be treated as shares that are present and entitled to vote at
the special meeting for purposes of determining whether a quorum exists and will have the same
effect as votes against approval of the merger agreement.
The holders of a majority of the outstanding shares of Innovive common stock entitled to be
cast as of the record date, represented in person or by proxy, will constitute a quorum for
purposes of the special meeting. A quorum is necessary to hold the special meeting. Once a share
of Innovive common stock is represented at the special meeting, it will be counted for the purpose
of determining a quorum and any adjournment of the special meeting, unless the holder is present
solely to object to the special meeting. However, if a new record date is set for an adjourned
meeting, then a new quorum will have to be established.
Voting By Proxy
This proxy statement/prospectus is being sent to you on behalf of our board of directors for
the purpose of requesting that you allow your shares of Innovive common stock to be represented at
the special meeting by the persons named in the enclosed proxy card. All shares of Innovive common
stock represented at the special meeting by proxies voted by the Internet or by properly executed
proxy cards will be voted in accordance with the instructions indicated on that proxy. If you sign
and return a proxy card without giving voting instructions, your shares will be voted as
recommended by our board of directors.
The persons named in the proxy card will use their own judgment to determine how to vote your
shares regarding any matters not described in this proxy statement/prospectus that are properly
presented at the special meeting. Innovive does not know of any matter to be presented at the
special meeting other than the proposal to approve the merger agreement (and the proposal described
below to approve the adjournment of the special meeting, if necessary or appropriate, to solicit
additional proxies).
You may revoke your proxy at any time before the vote is taken at the special meeting. To
revoke your proxy, you must (1) send a signed written notice of revocation to us at Innovive
Pharmaceuticals, Inc., 555 Madison Avenue, 25th Floor, New York, New York 10022,
Attention: Corporate Secretary, (2) submit a proxy by mail or by the Internet dated after the date
of the earlier proxy you wish to change, or (3) attend the special meeting and vote your shares in
person. Merely attending the special meeting without voting will not be sufficient to revoke your
earlier proxy.
If your shares of Innovive common stock are held in street name, you will receive instructions
from your broker, bank, or other nominee that you must follow in order to have your shares voted.
If you do not
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instruct your broker to vote your shares, it has the same effect as a vote against the
approval of the merger agreement.
Innovive will pay the cost of this proxy solicitation. In addition to soliciting proxies by
mail, directors, officers, and employees of Innovive may solicit proxies by telephone, by other
electronic means, or in person. None of these persons will receive additional or special
compensation for soliciting proxies. Innovive will also, upon request, reimburse brokers, banks,
and other nominees for their expenses in sending proxy materials to their customers who are
beneficial owners and obtaining their voting instructions.
Adjournments and Postponements
Although it is not currently expected, the special meeting may be adjourned or postponed for
the purpose of soliciting additional proxies. Any adjournment may be made without notice (if the
adjournment is not for more than 30 days), by an announcement made at the special meeting of the
time, date, and place of the adjourned meeting. If no quorum exists, the chairman of the meeting
will have the power to adjourn the meeting from time to time, without notice other than
announcement at the meeting, until a quorum is present or represented. If a quorum exists, holders
of a majority of the shares of Innovive common stock present in person or represented by proxy at
the special meeting and entitled to vote at the meeting may adjourn the special meeting. Any
signed proxies received by Innovive in which no voting instructions are provided on such matter
will be voted in favor of an adjournment in these circumstances. Any adjournment or postponement
of the special meeting for the purpose of soliciting additional proxies will allow Innovives
stockholders who have already sent in their proxies to revoke them at any time prior to their use
at the special meeting as adjourned or postponed.
After careful consideration, our board of
directors, by a unanimous vote of all of the directors, recommends a vote FOR the approval of the
adjournment of the special meeting.
Stockholder Representative
If the merger agreement is approved at the special meeting, you will be deemed to have
appointed Steven Kelly, our President and Chief Executive Officer, as your agent and
attorney-in-fact for purposes of the merger agreement if the merger is completed.
THE MERGER AGREEMENT
This section describes the material terms of the merger agreement. The description in this
section and elsewhere in this proxy statement/prospectus is qualified in its entirety by reference
to the merger agreement, itself, a copy of which is attached to this proxy statement/prospectus as
Appendix A. This summary does not purport to be complete and may not contain all of the
information about the merger agreement that is important to you. We encourage you to read
carefully the merger agreement in its entirety.
The merger agreement has been included to provide you with information regarding its terms and
is not intended to provide any other factual information about Innovive, CytRx or Merger
Subsidiary. Furthermore, the merger agreement contains representations and warranties made by and
to Innovive, CytRx and Merger Subsidiary for the purposes of that contract and which are subject to
qualifications and limitations agreed to by the parties in connection with negotiating the terms of
that contract.
Effective Time of the Merger
The effective time of the merger will occur at the time that Innovive and Merger Subsidiary
file a certificate of merger with the Secretary of State of the State of Delaware on the closing
date of the merger or on a later date agreed to by CytRx and Innovive. The closing of the
transactions contemplated by the merger agreement will occur on the second business day after all
of the conditions to the merger set forth in the merger agreement have been satisfied or waived, or
on such other date as CytRx and Innovive may agree.
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Structure of the Merger
At the effective time of the merger, Merger Subsidiary will merge with and into Innovive in
accordance with the Delaware General Corporation Law. The separate existence of Merger Subsidiary
will cease, and Innovive will survive the merger and continue to exist after the merger as a wholly
owned subsidiary of CytRx. All of Innovives and Merger Subsidiarys rights and properties and all
of their debts and liabilities will become those of the surviving corporation.
Following completion of the merger, Innovive common stock will be deregistered under the
Securities Exchange Act of 1934 and no longer quoted on the OTCBB or publicly traded.
Merger Consideration
In the merger, CytRx will pay initial merger consideration of $3,000,000 in the form of shares
of CytRx common stock valued at $0.94 per share, which equals the average daily volume-weighted
closing price of CytRx common stock as reported on The Nasdaq Capital Market over the 10 trading
days prior to the signing of the merger agreement. CytRx also will pay future earnout merger
consideration of up to $18,253,462, subject to the achievement of specified net sales under
Innovives existing license agreements, as follows:
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Net Sales |
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Earnout Merger Consideration |
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2,000,000 |
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$ |
2,000,000 |
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$ |
15,000,000 |
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$ |
5,000,000 |
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$ |
30,000,000 |
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$ |
5,000,000 |
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$ |
40,000,000 |
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$ |
6,253,462 |
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Subject to specified conditions, any earnout merger consideration will be payable in shares of
CytRx common stock or, at CytRxs election, in cash, or by a combination of shares of CytRx common
stock and cash. CytRx common stock will be valued for purposes of any earnout merger consideration
based upon the average of the daily market price during the 10-trading day period ending on the
second trading day prior to payment of the earnout merger consideration. Your right to receive any
earnout merger consideration will not be transferable, except by operation of law.
The earnout merger consideration is subject to offset by CytRx as described under
Indemnification and Offset below in this section.
Fractional Shares
No fractional shares of CytRx common stock will be issued in the merger. In lieu of any
fractional share, you will receive cash equal to the value in the merger of such fractional share,
less any applicable withholding.
Treatment of Stock, Options and Warrants in the Merger
Innovive Common Stock
At the effective time of the merger, all outstanding shares of Innovive common stock (other
than shares that are owned by Innovive as treasury stock, or by CytRx and Merger Subsidiary, and
other than shares that are owned by Innovive stockholders, if any, who properly exercise
dissenters rights under Delaware law) will be cancelled and converted into the right to receive
the merger consideration. Any of our shares that are owned by Innovive, CytRx and Merger
Subsidiary will be cancelled without the payment of any consideration. After the effective time
of the merger, each outstanding stock certificate or book-entry share representing
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shares of Innovive common stock converted in the merger will represent only the right to
receive the merger consideration with respect to each share of Innovive common stock.
Conversion of Merger Subsidiary Capital Stock
At the effective time of the merger, all of the outstanding shares of the capital stock of
Merger Subsidiary will be converted into one share of the common stock of Innovive, and such
converted share will constitute the only outstanding capital stock of Innovive as of the effective
time of the merger.
Innovive Stock Options
Each Innovive stock option outstanding as of the effective time of the merger, whether or not
then vested or exercisable, will, by its terms, automatically be cancelled, with any consideration
due to the holders thereof being paid at such time. After the merger, such stock options will no
longer be outstanding and the holders of the options will no longer have any rights to purchase
Innovive common stock. As of the record date for the special meeting, we had outstanding options to purchase an aggregate of 1,213,601 shares of our common stock at a weighted-average
exercise price of $3.32 per share. This does not include the option for 2,000,000 shares that
we granted to CytRx pursuant to the loan and security agreement as described under
Ancillary Agreements Loan and Security Agreement.
All of our stock options currently are underwater, so we expect that our option holders will
receive no payments or other consideration in connection with the merger. After the merger, such
stock options will no longer be outstanding and the holders of the options will no longer have any
rights to purchase Innovive stock or other securities.
Innovive Warrants
Each Innovive warrant outstanding immediately prior to the effective time of the merger that,
by its terms, does not expire upon the effective time will remain outstanding in accordance with
the terms thereof and the holder thereof will thereafter have the right to purchase and receive (in
lieu of the shares of Innovive common stock) the merger consideration payable with respect to the
number of shares of Innovive common stock purchasable under the warrant immediately prior to the
effective time of the merger. To the extent Innovive warrants outstanding at the effective time of
the merger are subsequently cancelled, or terminate, without being exercised in full, the merger
consideration otherwise payable with respect to such cancelled or terminated warrants will become
the property of CytRx.
If required by the terms of the warrants, CytRx will cause to be issued promptly after the
completion of the merger replacement warrants for the Innovive warrants that, by their terms, will
remain outstanding after the merger.
Exchange and Payment Procedures
Prior to the effective time of the merger, CytRx will deposit with a disbursing agent selected
by CytRx and reasonably acceptable to us shares of CytRx common stock (and cash in lieu of any
fractional shares) sufficient to pay the initial merger consideration.
Promptly after the effective time of the merger, the disbursing agent will mail to each
stockholder who is entitled to receive the merger consideration a letter of transmittal and
instructions for use in effecting the surrender of the stockholders stock certificates or
book-entry shares in exchange for payment of the merger consideration. Upon surrender to the
disbursing agent of the stockholders stock certificates or book-entry shares, together with the
letter of transmittal duly executed and such other documents as may be reasonably required by the
disbursing agent, the stockholder will be paid promptly in exchange therefor the merger
consideration. No interest will be paid or accrued on the merger consideration.
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A stockholder should not return a stock certificate with the enclosed proxy card, and a
stockholder should not send a stock certificate to the disbursing agent without a signed letter of
transmittal.
The merger consideration may be paid to a person other than the person in whose name the
corresponding certificate is registered if the certificate is properly endorsed or is otherwise in
the proper form for transfer. In addition, the person who surrenders the certificate must either
pay any transfer or other applicable taxes or establish to the satisfaction of the surviving
corporation that such taxes have been paid or are not applicable.
After the effective time of the merger, there will be no transfers on our stock transfer books
of shares of our common stock that were outstanding prior to the effective time of the merger.
If, after the effective time of the merger, certificates are presented to us for transfer, they
will be canceled and exchanged for the merger consideration.
If a stockholder has lost a stock certificate, or if it has been stolen or destroyed, then
before the stockholder will be entitled to receive any portion of the merger consideration, he or
she will need to make an affidavit of the fact of such loss, theft, or destruction and, if required
by the surviving corporation, post a bond in a reasonable amount sufficient to protect the
surviving corporation and CytRx against any claim that may be made against either of them with
respect to such certificate.
No fractional shares of CytRx common stock will be issued in the merger. In lieu of any
fractional share, you will receive cash equal to the value in the merger of such fractional share,
less any applicable withholding.
Any portion of the merger consideration deposited with the disbursing agent that remains
undistributed to former holders of our common stock more than six months after the effective time
of the merger will be delivered, upon demand, to CytRx. Former holders of our common stock who
have not complied with the above-described exchange and payment procedures will thereafter be
entitled to look only to CytRx for payment of the merger consideration. The disbursing agent,
CytRx, and Innovive will not be liable to any former holders of our common stock for any cash that
is delivered to a public official pursuant to any applicable abandoned property, escheat, or
similar laws.
The disbursing agent is entitled to deduct, withhold, and pay to the appropriate taxing
authorities any applicable taxes from the merger consideration. Any sum that is withheld and paid
to a taxing authority by the paying agent will be deemed to have been paid to the person with
regard to whom it is withheld.
Representations and Warranties
The merger agreement contains customary representations and warranties of the parties to the
merger agreement, which are made to and solely for the benefit of each other. The assertions
embodied in the representations and warranties are qualified and modified by information contained
in a confidential disclosure schedule that the parties exchanged in connection with the signing of
the merger agreement. Accordingly, you should not rely on the representations and warranties as
characterizations of the actual state of facts about us or CytRx because (1) they were made only as
of the date of the merger agreement or a prior specified date, (2) in some cases they are subject
to qualifications with respect to materiality and knowledge, and (3) they are modified in important
part by the underlying disclosure schedule. The disclosure schedule contains information that has
been included in our prior public disclosures, as well as non-public information. Moreover,
information concerning the subject matter of the representations and warranties may have changed
since the date of the merger agreement, and such subsequent information may or may not be fully
reflected in our public disclosures.
Our representations and warranties in the merger agreement relate to, among other things:
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our due incorporation, valid existence, good standing, and qualification to do
business; |
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our certificate of incorporation and bylaws; |
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our capitalization, including the number of shares of Innovive common stock, stock
options and warrants outstanding; |
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our corporate power and authority to enter into the merger agreement and to
consummate the transactions contemplated by the merger agreement; |
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the approval and recommendation by our board of directors of the merger agreement
and the merger and the other transactions contemplated by the merger agreement; |
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the absence of certain specified violations of, or conflicts with, our governing
documents, applicable law, and certain agreements as a result of entering into the
merger agreement and consummating the merger; |
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the required consents and approvals of governmental entities in connection with the
execution, delivery, and performance of the merger agreement, the merger, and the other
transactions contemplated by the merger agreement; |
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our SEC forms, documents, registration statements, and reports filed since January
1, 2007, including the financial statements contained therein; |
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our compliance with the Sarbanes-Oxley Act of 2002, including our internal control
over financial reporting; |
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the absence of certain undisclosed liabilities and an estimate of our net
liabilities (as defined) as of June 6, 2008; |
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the absence of a material adverse effect and certain other changes or events related
to us since December 31, 2007; |
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the absence of undisclosed legal proceedings and governmental orders against us; |
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the accuracy of the information supplied by us for inclusion in this proxy
statement/prospectus; |
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compliance with applicable laws and permits; |
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material contracts and compliance with contracts; |
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taxes; |
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employment matters affecting us, including matters relating to our employee benefit
plans; |
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leasehold interests, tangible personal property, and title to assets; |
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the required vote of our stockholders in connection with the approval of the merger
agreement; |
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intellectual property; |
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insurance policies; |
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absence of improper payments; |
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the absence of undisclosed brokers fees; and |
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the receipt by our board of directors of a fairness opinion from Chartered. |
Many of our representations and warranties are qualified by a material adverse effect
standard. For purposes of the merger agreement, a material adverse effect relating to us means
any change, event, circumstance, development, or occurrence (other than an effect arising out of or
resulting from the entering into, or the public announcement or disclosure of, the merger agreement
and the transactions contemplated by the merger agreement) that, individually or in the aggregate,
(1) has a material adverse effect on our business, financial condition, or ongoing operations or
(2) has a material adverse effect on our ability to complete the merger.
The merger agreement also contains various representations and warranties made jointly and
severally by CytRx and Merger Subsidiary that are subject, in some cases, to exceptions and
qualifications. The representations and warranties by CytRx and Merger Subsidiary relate to, among
other things:
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their due incorporation, valid existence, and good standing; |
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their certificates of incorporation and bylaws; |
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their capitalization, including the number of shares of CytRx common stock, stock
options and warrants outstanding; |
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their power and authority to enter into the merger agreement and to consummate the
transactions contemplated by the merger agreement; |
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the approval by their boards of directors of the merger agreement and the merger and
the other transactions contemplated by the merger agreement; |
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the absence of specified violations of, or conflicts with, their governing
documents, applicable law, and certain agreements as a result of entering into the
merger agreement and consummating the merger; |
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the required consents and approvals of governmental entities in connection with the
execution, delivery, and performance of the merger agreement and the merger and the
other transactions contemplated by the merger agreement; |
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CytRxs SEC forms, documents, registration statements, and reports filed since
January 1, 2007, including the financial statements contained therein; |
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the accuracy of the information supplied by CytRx and Merger Subsidiary for
inclusion in this proxy statement/prospectus; |
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compliance with applicable laws and permits; |
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material contracts and compliance with contracts; |
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the absence of undisclosed brokers fees; and |
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the absence of liabilities, obligations, business activities, and operations of
Merger Subsidiary. |
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Some of the representations and warranties by CytRx and Merger Subsidiary are qualified by a
material adverse effect standard. For purposes of the merger agreement, a material adverse
effect relating to CytRx or Merger Subsidiary means any change, event, circumstance, development,
or occurrence that is materially adverse to (1) the business, financial condition, or ongoing
operations of CytRx, or (ii) the ability of CytRx to complete the merger.
The representations and warranties in the merger agreement of Innovive will survive the
effective time of the merger. The representations and warranties in the merger agreement of CytRx
and Merger Subsidiary will terminate at the effective time of the merger.
Conduct of Our Business Prior to the Merger
Under the merger agreement, we have agreed that, subject to certain exceptions, between
June 6, 2008 and the completion of the merger, unless CytRx gives its prior written consent:
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we will conduct our business in the ordinary course, consistent with past practice; |
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we will consult with CytRx, in advance, regarding the conduct and management of our
clinical trials and other development activities; |
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we will use our commercially reasonable efforts to mitigate or compromise our
liabilities from time to time; and |
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we will use reasonable efforts to preserve intact our business organizations and
goodwill, keep available the services of our officers and key employees, and preserve
the goodwill and business relationships with customers and others having business
relationships with us. |
We have also agreed that, during the same time period and subject to certain exceptions, we
will not take any of the following actions, unless CytRx gives its prior written consent:
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amend our certificate of incorporation or bylaws; split, combine, subdivide or
reclassify any shares of our outstanding capital stock; declare or pay any dividend or
distribution payable in cash, stock, property, or otherwise; or make any other
distribution in respect of any shares of our capital stock; or repurchase or otherwise
acquire, or modify or amend, any shares of capital stock or any rights, warrants, or
options to acquire any such shares; |
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issue, sell, pledge, or dispose of any additional shares of, or any options,
warrants or rights of any kind to acquire any shares of, our capital stock of any class
or any debt or equity securities convertible into or exchangeable for such capital
stock, except that we may issue shares upon the exercise of currently outstanding
warrants; |
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incur indebtedness for borrowed money; redeem or purchase or offer to purchase
shares of our capital stock or rights to acquire our capital stock or securities
convertible into or exchangeable for our capital stock; make any acquisition of any
capital stock, assets, or businesses of any other person other than expenditures for
current assets in the ordinary course of business and expenditures for fixed or capital
assets in the ordinary course of business; or sell, pledge, or encumber any assets or
businesses that are material to us, subject to specified exceptions; |
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enter into, amend, or renew any employment, consulting, severance or similar
agreement with, or pay any bonus or grant any increase in salary, wage, or other
compensation or any increase in any employee benefit to, any of our directors, officers
or employees, except in each such case (1) as may be required by applicable law or
(2) to satisfy existing obligations; |
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enter into, establish, or amend any pension, retirement, stock purchase, savings,
profit sharing, deferred compensation, consulting, bonus, group insurance, or other
employee benefit, incentive, or welfare plan, agreement, program or arrangement, in
respect of any of our directors, officers, or employees, except, in each such case
(1) as may be required by applicable law or pursuant to the terms of the merger
agreement or (2) to satisfy existing obligations; |
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except to the extent required under existing employee and director benefit plans,
agreements, or arrangements, accelerate the payment, right to payment, or vesting of
any bonus, severance, profit sharing, retirement, deferred compensation, stock option,
insurance or other compensation or benefits; |
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make capital expenditures or enter into any contract to make capital expenditures,
subject to specified exceptions; |
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make, change, or revoke any material tax election unless required by law, or make
any agreement or settlement with any taxing authority regarding any material amount of
taxes; |
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make any changes in financial or tax accounting methods, principles, or practices
(or change an annual accounting period), except insofar as may be required by a change
in generally accepted accounting principles or applicable law; |
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adopt a plan or agreement of complete or partial liquidation or dissolution; |
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pay, discharge, or satisfy any material claims, material liabilities, or material
obligations, (1) other than in the ordinary course of business and (2) other than
obligations reflected or reserved against in, or contemplated by, the financial
statements (or the notes thereto) contained in our reports filed with the SEC; |
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agree to the settlement of any material claim, litigation, investigation, or other
action; |
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enter into any agreement that restrains, limits, or impedes the ability of us or the
surviving corporation in the merger to compete with or conduct any business or line of
business; |
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materially amend or terminate any material contract, or waive or terminate any
material right or material claim, or enter into any material contract; |
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incur transaction costs and expenses in connection with the merger agreement and the
merger and the other transactions contemplated by the merger agreement, including the
fees payable to Chartered, in excess of $200,000 in the aggregate; or |
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agree to take any of the foregoing actions. |
No Solicitation by Us of Alternative Acquisition Proposals
The merger agreement contains restrictions on Innovives ability to solicit or engage in
discussions or negotiations with any third party relating to an acquisition transaction, which
means:
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any license, sublicense or similar arrangement involving any intellectual property
of Innovive under any of our license agreements; |
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any acquisition of assets of Innovive and our subsidiaries (including securities of
subsidiaries, but excluding sales of assets in the ordinary course of business) equal
to 10% or more of our |
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consolidated assets or to which 10% or more of our revenues or earnings on a
consolidated basis are attributable; |
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any acquisition of 10% or more of our outstanding common stock; |
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any tender offer or exchange offer that if completed would result in any third party
beneficially owning 10% or more of our outstanding common stock; or |
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any merger, consolidation, share exchange, business combination, recapitalization,
liquidation, dissolution, or similar transaction involving Innovive and a third party. |
An offer or proposal made to us by a third party with respect to a potential or proposed
acquisition transaction is referred to in the merger agreement as an acquisition proposal.
We have agreed that, prior to the effective time of the merger or the earlier termination of
the merger agreement, we will cease any existing discussions or negotiations with any third party
regarding an acquisition transaction and will request the prompt return or destruction of all
confidential information relating to us or any of our subsidiaries previously furnished to any such
person. We have also agreed to cause our and our subsidiaries respective directors, officers and
investment bankers, attorneys, accountants, financial advisors and other advisors, agents, and
representatives to comply with the covenants that are described in the preceding sentence.
We have agreed that, prior to the effective time of the merger or the earlier termination of
the merger agreement, we will not, and will not permit any of our subsidiaries or representatives
to, directly or indirectly:
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initiate, solicit, induce, negotiate, encourage, or provide non-public or
confidential information to facilitate any inquiry that constitutes, or may reasonably
be expected to lead to, an acquisition proposal; or |
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enter into, continue, or otherwise participate in any discussions or negotiations
with any third party regarding, or furnish to any third party any non-public
information, or afford access to our properties, books, or records with respect to, any
inquiries that constitute, or may reasonably be expected to lead to, an acquisition
transaction, or otherwise knowingly facilitate any effort to attempt to make or
implement any acquisition transaction, except as described below. |
We are required by the merger agreement to notify CytRx promptly after our receipt of any
acquisition proposal, indication of interest, or request for non-public information relating to us
or our subsidiaries in connection with an acquisition proposal or for access to our or our
subsidiaries properties, books, or records by any third party that informs us that it is
considering making, or has made, an acquisition proposal. We are also required to continue to keep
CytRx informed of the status of the acquisition proposal. The merger agreements restrictions on
our activities regarding an acquisition proposal do not prevent us from making disclosures about an
acquisition proposal that are required by applicable federal securities laws.
Prior to approval of the merger agreement by our stockholders, if we receive a written
acquisition proposal from a third party that did not result from a breach of our non-solicitation
covenants described above, we may take the following actions notwithstanding the above-described
restrictions imposed by the merger agreement:
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furnish confidential or non-public information to the third party who made the
acquisition proposal and negotiate with the third party with respect to the acquisition
proposal (but only after the third party has signed a confidentiality agreement that is
no less favorable to us than the confidentiality agreement that CytRx signed); |
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resolve to accept, or recommend, the third partys acquisition proposal if our board
of directors determines that the acquisition proposal constitutes a superior
proposal, which means a proposal to acquire, for consideration consisting of cash or
securities, all of our equity securities or all, or substantially all, of our
consolidated assets and which is otherwise on terms that our board of directors
determines in good faith (after consultation with our financial advisor and outside
legal counsel) to be more favorable to our stockholders from a financial point of view
than the merger and the other transactions contemplated by the merger agreement, taking
into account any offer by CytRx to amend the terms of the merger agreement as described
below; and |
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terminate the merger agreement and enter into an agreement with the third party with
respect to its superior proposal. |
We may take the actions listed in the preceding paragraph only if (1) our board of directors
determines, in good faith and after consultation with our financial advisor and outside legal
counsel, that the acquisition proposal is or could reasonably be expected to result in a superior
proposal and (2) our board determines, in good faith and after consultation with our financial
advisor and outside legal counsel, that such action or actions are necessary to comply with our
board of directors fiduciary duties to our stockholders under applicable law. Furthermore, we may
not terminate the merger agreement in order to accept the third partys acquisition proposal unless
we give CytRx at least four days prior written notice of our intention to terminate, in which
event CytRx will have the right, but not the obligation, to offer to amend the terms of the merger
agreement and our board of directors will be obliged to review and determine whether any such
amended proposal would result in such superior proposal ceasing to be a superior proposal (and, if
so, we must amend the merger agreement to reflect CytRxs amended terms), and we pay a termination
fee of $1,500,000 to CytRx. In addition, the merger agreement prohibits our board of directors
from withdrawing or modifying its recommendation in this proxy statement/prospectus that our
stockholders approve the merger agreement unless the board determines in good faith, based on those
matters as it deems appropriate after consulting with our financial advisor and outside legal
counsel, that taking such action is necessary to comply with its fiduciary duties under applicable
law.
Merger Subsidiarys Activities
CytRx has agreed to cause Merger Subsidiary to perform its obligations under the merger
agreement, and Merger Subsidiary is prohibited from carrying on any business operations prior to
the completion of the merger.
Stockholders Meeting
As promptly as practicable, we are required to establish a record date for, give notice of,
and hold a special meeting of stockholders to consider the proposal to approve the merger agreement
and to use our reasonable best efforts to obtain the approval of our stockholders, including by
recommending in the proxy statement/prospectus that our stockholders approve the merger agreement.
However, we will be relieved of our obligations with respect to the special meeting if, in
accordance with the provisions described below under Termination of the Merger Agreement, our
board of directors terminates the merger agreement after receiving a superior proposal, reviewing
any offer by CytRx to amend the terms of the merger agreement and paying CytRx a termination fee of
$1,500,000.
Cooperation by the Parties
Each of the parties to the merger agreement has agreed to use all reasonable best efforts to
do anything necessary or advisable to consummate and make effective the transactions contemplated
by the merger agreement, including using its reasonable best efforts to obtain all necessary or
appropriate waivers, consents, or approvals of third parties and to effect all necessary
registrations, filings, and submissions. The parties to the merger agreement have agreed to
cooperate with each other in connection with the satisfaction of the
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conditions to the completion of the merger, including our agreement to assist CytRx in the
preparation and filing of the registration statement of which this proxy statement/prospectus is a
part.
Indemnification of Our Directors and Officers
Under the terms of the merger agreement, CytRx and Merger Subsidiary have agreed that, to the
fullest extent permitted under applicable law, after the completion of the merger Innovive will
indemnify each of our current and former officers, employees, and directors for acts or omissions
in his or her capacity as an officer, employee, or director occurring on or before the effective
time of the merger.
For a period of three years after the effective time of the merger, CytRx must cause to be
maintained (or must cause Innovive to maintain) in effect the current policies of directors and
officers liability insurance maintained by us, provided that CytRx may substitute policies,
including a tail policy, of at least the same coverage and amounts containing terms and conditions
that are no less advantageous to the indemnified parties and which coverage and amounts must be no
less than the current coverage and amounts. If the aggregate annual premiums for such insurance
would exceed the current aggregate annual premium, then CytRx may provide or cause to be provided a
policy for the applicable individuals with the best coverage as is then available at an annual
premium of not more than 125% of the current aggregate annual premium.
Other Agreements
The merger agreement contains additional agreements among us, CytRx and Merger Subsidiary
relating to, among other things:
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giving the other parties access to its offices, properties, books, and records; |
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giving the other parties notices of certain events; |
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preparing and filing with the SEC the registration statement containing this proxy
statement/prospectus and cooperating in investor meetings and road show
presentations; |
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coordination of press releases; |
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entering into the loan and security agreement; and |
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obtaining the removal of Steven Kelly as a guarantor of our existing office lease. |
Conditions to the Merger
The obligations of the parties to complete the merger are subject to the satisfaction or
waiver of the following mutual conditions:
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Stockholder Approval - The approval of the merger agreement by Innovives
stockholders must have been obtained in accordance with the Delaware General
Corporation Law; |
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No Law or Orders - None of the parties to the merger agreement shall be subject to
any law, order, injunction, judgment, or ruling by any governmental authority that
prohibits the consummation of the merger or makes the consummation of the merger
illegal; |
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Effective Registration Statement - The registration statement of which this proxy
statement/prospectus is a part must be effective under the Securities Act of 1933, as
amended, and there must be no pending stop order issued or proceeding for purpose
initiated by the SEC; |
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Blue Sky Exemption - The issuance of the shares of CytRx common stock issuable in
payment of the initial merger consideration shall be exempt from registration, or shall
have been appropriately registered or qualified, under applicable state securities
laws; |
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Nasdaq Listing - The shares of CytRx common stock issuable in payment of the initial
merger consideration shall have been listed on The Nasdaq Capital Market; and |
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No Lawsuits - There must not be pending any action, suit, or other proceeding (1)
seeking to restrain or prohibit the consummation of the merger or seeking to obtain
damages from Innovive, CytRx, or Merger Subsidiary, (2) seeking the disposition of any
material assets or businesses of Innovive, or (3) otherwise seeking to limit the
actions of CytRx with respect to Innovive after the completion of the merger. |
The obligations of CytRx and Merger Subsidiary to complete the merger are subject to the
satisfaction or waiver of the following additional conditions:
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Representations and Warranties - Our representations and warranties contained in the
merger agreement must be true and correct, except for specified immaterial failures; |
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Performance of Covenants - We must have performed in all material respects all
obligations required to be performed by us by the effective time of the merger under
the merger agreement, except for specified immaterial failures; |
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Officers Certificate - We must have delivered to CytRx and Merger Subsidiary an
officers certificate with respect to the satisfaction of the conditions relating to
our representations, warranties, and covenants; |
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Resignations - CytRx must have received the resignations, effective as of the
effective time of the merger, of each of our directors and officers; and |
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Dissenters Rights - Dissenting shares, if any, must constitute not more than 5% of
the outstanding shares of Innovive common stock. |
Our obligation to complete the merger is subject to the satisfaction or waiver of the
following additional conditions:
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Representations and Warranties - The representations and warranties of CytRx and
Merger Subsidiary contained in the merger agreement must be true and correct, except
for specified immaterial failures; |
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Performance of Covenants - CytRx and Merger Subsidiary must have performed in all
material respects all obligations required to be performed by them by the effective
time of the merger under the merger agreement; and |
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Officers Certificate - CytRx and Merger Subsidiary must have delivered to Innovive
an officers certificate with respect to the satisfaction of the conditions relating to
their representations, warranties, and covenants. |
Termination of the Merger Agreement
The merger agreement may be terminated and the merger may be abandoned at any time prior to
the effective time of the merger (notwithstanding any approval of the merger agreement by our
stockholders) as follows:
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by the mutual written consent of us and CytRx; |
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by either us or CytRx, if the merger has not been completed by September 30, 2008;
provided, however, that the right to terminate the merger agreement for this reason is
not available to a party whose failure to perform its covenants has caused the failure
of the merger to occur by this date; and provided further, that the right to terminate
for this reason is not available to any party if the closing has not occurred due
solely to the failure of the condition relating to effectiveness of the registration
statement of which this proxy statement/prospectus is a part notwithstanding CytRxs
performance of its obligations relating to the filing and effectiveness of the
registration statement; |
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by either us or CytRx, if (1) there has been a breach by the other party of any
representation or warranty contained in the merger agreement which would reasonably be
expected to have a material adverse effect and which breach is not curable or, if
curable, the breaching party is not using on a continuous basis its reasonable best
efforts to cure in all material respects such breach, or (2) there has been a breach of
any of the covenants set forth in the merger agreement on the part of the other party
which would reasonably be expected to have a material adverse effect and which breach
is not curable or, if curable, the breaching party is not using on a continuous basis
its reasonable best efforts to cure such breach; |
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by either us or CytRx following the entry of any final and non-appealable judgment,
injunction, order, or decree by a court or governmental agency restraining or
prohibiting the consummation of the merger; |
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by us, if, prior to receipt of stockholder approval of the merger agreement, we
receive a superior proposal described above under No Solicitation by Us of Alternative
Acquisition Proposals, we resolve to accept the superior proposal as described below
under Termination Fees, and we give CytRx at least four days prior written notice of
our intention to terminate the merger agreement and comply with our obligations with
respect to any offer by CytRx to amend the terms of the merger agreement and we pay
CytRx a termination fee of $1,500,000; |
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by CytRx, if our board of directors fails to recommend that our stockholders approve
the merger agreement, or if our board withdraws, modifies, or amends in a manner
adverse to CytRx in any material respect the boards recommendation to our stockholders
to approve the merger agreement, or if our board recommends another acquisition
proposal, or if our board resolves to accept a superior proposal or recommends to our
stockholders that they tender their shares in a tender or an exchange offer commenced
by a third party; or |
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by CytRx, if we receive an acquisition proposal from any person and our board of
directors takes a neutral position or makes no recommendation with respect to such
acquisition proposal and does not publicly reaffirm its recommendation to approve the
merger agreement after a reasonable amount of time (and in no event more than five
business days following such receipt) elapses for our board of directors to review and
make a recommendation with respect to such acquisition proposal; or |
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by CytRx or us, if our stockholders fail to approve the merger agreement at the
special meeting of stockholders (including any adjournment or postponement of the
meeting). |
Termination Fee
We will owe CytRx a termination fee of $1,500,000 if:
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we terminate the merger agreement because, prior to receipt of stockholder approval
of the merger agreement, we receive a superior proposal described above under No
Solicitation by Us of Alternative Acquisition Proposals and resolve to accept the
superior proposal; |
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CytRx terminates the merger agreement because (1) our board of directors fails to
recommend that our stockholders approve the merger agreement, or if our board
withdraws, modifies, or amends in a manner adverse to CytRx in any material respect our
boards recommendation to our stockholders to approve the merger agreement, or if our
board recommends another acquisition proposal, or if our board resolves to accept a
superior acquisition proposal or recommends to our stockholders that they tender their
shares in a tender or an exchange offer commenced by a third party, or (2) Innovive
receives an acquisition proposal from another person and our board of directors takes a
neutral position or makes no recommendation with respect to such acquisition proposal
and does not publicly reaffirm its recommendation to approve the merger agreement after
a reasonable amount of time elapses for our board of directors to review and make a
recommendation with respect to such acquisition proposal; |
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CytRx terminates the merger agreement because we have breached our covenants in the
merger agreement regarding the solicitation of competing acquisition proposals
described above under No Solicitation by Us of Alternative Acquisition Proposals; or |
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we or CytRx terminates the merger agreement because our stockholders fail to approve
the merger agreement at the special meeting; provided, however, that the termination
fee described in this paragraph will be owed by us only if (1) we enter into another
acquisition transaction within one year after the termination of the merger agreement
and (2) the proposal for such acquisition transaction was made prior to the date of the
special meeting of stockholders. |
Indemnification and Offset
The merger agreement contains indemnification rights for the benefit of CytRx (1) to the
extent our actual net liabilities (as defined) as of June 6, 2008 exceeded our estimated net
liabilities of $3,746,538 as represented by us in the merger agreement and (2) for all losses
(including the first $50,000 of any such losses) to CytRx resulting from breaches of our
representations and warranties once such losses exceed a $50,000 threshold and (3) actual deposits
returned to or recovered by CytRx or the surviving corporation are less than the deposits
previously disclosed by us. CytRxs recourse for indemnification will be limited to its right of
offset against any earnout merger consideration. The termination fee and indemnification
provisions of the merger agreement and right of offset are generally the sole remedies for CytRx
with respect to any breaches of Innovives representations and warranties in the merger agreement.
Amendment and Waiver
Any provision of the merger agreement may be amended or waived prior to the effective time of
the merger if, and only if, such amendment or waiver is in writing and signed, in the case of an
amendment, by Innovive, CytRx, and Merger Subsidiary or, in the case of a waiver, by the party
against whom the waiver is to be effective.
Stockholder Representative
If the merger agreement is approved at the special meeting, you will be deemed to have
appointed Steven Kelly, our President and Chief Executive Officer, as your agent and
attorney-in-fact for purposes of the merger agreement if the merger is completed. The stockholder
representative will have the power to agree to, negotiate, enter into settlements and compromises
of, and comply with orders of courts and awards of arbitrators with respect to, the determination
of our liabilities as of the date of the merger agreement, our net sales and any losses (as
those terms are used in the merger agreement) and to resolve any disputes with
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respect to the same and take all actions necessary in the judgment of the stockholder
representative for the accomplishment of the terms, conditions and limitations of the merger
agreement. You will be bound by all actions taken by the stockholder representative in connection
with the merger agreement, and CytRx will be entitled to rely on any action or decision of the
stockholder representative as being your decision, act, consent or instruction. With some
exceptions, CytRx will be relieved from any liability to any person for any acts done by it in
accordance with such decision, act, consent or instruction of the stockholder representative. The
stockholder representative also will have no liability with respect to any action taken or suffered
by him in reliance upon any notice, direction, instruction, consent, statement or other document
believed by him to be genuine and to have been signed by the proper person (and shall have no
responsibility to determine the authenticity thereof), nor for any other action or inaction, except
his own willful misconduct or gross negligence. The stockholder representative may rely on the
advice of counsel, and will not be liable to any person for anything done, omitted to be done or
suffered in good faith by the stockholder representative based on such advice.
The stockholder representative will not be required to take any action involving any expense
to the stockholder representative unless the payment of such expense is made or provided for in a
manner satisfactory to him. The reasonable legal fees and other expenses, if any, incurred by the
stockholder representative in performance of his duties hereunder, not to exceed $20,000 in the
aggregate, will be advanced by CytRx. CytRx also will compensate the stockholder representative at
the rate of $250 per hour, not to exceed $10,000 in the aggregate, for the performance of his
duties. All such legal fees and expenses and compensation of the stockholder representative,
including any such legal fees and expenses in excess of $20,000, will be paid or reimbursed to
CytRx or the stockholder representative, as the case may be, from the earnout merger consideration,
if any.
The stockholder representative will establish and maintain a register of our stockholders and
warrant holders for purposes of payment and distribution of any earnout merger consideration.
CytRx will be entitled to rely conclusively on such register for purposes of determining the
persons to whom the earnout merger consideration will be payable.
The stockholder representative may resign by giving 30 days prior notice to CytRx and appoint
a successor stockholder representative.
CytRx has agreed in the merger agreement to indemnify and hold harmless the stockholder
representative from and against any and all loss, liability, cost, damage and expense, which the
stockholder representative may suffer or incur by reason of any action, claim or proceeding brought
against the stockholder representative, in his capacity as such (but not in any other capacity),
arising out of or relating in any way to the merger agreement or the performance of the stockholder
representatives duties pursuant thereto unless such action, claim or proceeding is the result of
the willful misconduct or gross negligence of the stockholder representative.
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Accounting Treatment
Under accounting principles generally accepted in the United States and the regulations of the
Securities and Exchange Commission, since Innovive is a development-stage company, it is not
considered a business. Accordingly, the merger will be accounted for by CytRx in accordance with
Statement of Financial Standard No. 142, Goodwill and Other Intangible Assets, for transactions
other than a business combination. Management of CytRx has further determined it is not required to
include in the proxy statement/prospectus pro forma financial statements of CytRx giving effect to
the merger.
The initial merger consideration, together with direct costs incurred to effect the merger,
will be allocated to the individual assets acquired, including identifiable intangible assets, and
liabilities assumed based on their relative fair values. No goodwill will be recorded. Consolidated
financial statements of CytRx issued after the merger will reflect these fair values and will not
be restated retroactively to reflect the historical financial position or results of operations of
Innovive. CytRx will use a period of time beginning two days before and ending two days after the
date that the terms of the acquisition were agreed to and announced in determining the fair value
of the CytRx shares to be issued to Innovive stockholders. It is anticipated that CytRx will record
a one-time expense for in-process research and development it acquires, as well as the amount, if
any, the initial merger consideration paid by CytRx in excess of the fair market values of the
acquired assets and liabilities.
Additional merger consideration that is contingent upon certain events, none of which has
occurred as of the date of this proxy statement/prospectus, will be excluded from the initial
merger consideration.
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ANCILLARY AGREEMENTS
In connection with entering into the merger agreement, CytRx and some of Innovives directors
and officers and their affiliates entered into support agreements. The form of the support
agreements is attached to this proxy statement/prospectus as Appendix B. In connection with
entering into the merger agreement, we also entered into a loan and security agreement with CytRx.
This section summarizes the material terms of the support agreements and the loan and security
agreement. We encourage you to read carefully the form of the support agreements and the loan and
security agreement in their entirety, because this section may not contain all of the information
about the support agreements and the loan and security agreement that is important to you.
Support Agreements
In connection with the merger agreement, and concurrently with the execution of the merger
agreement, Steven Kelly, Neil Herskowitz, J. Jay Lobell and Eric Poma, M.D., each of whom is a
director or officer of Innovive, and their affiliates, Lindsay A. Rosenwald, M.D., and Lester
Lipshutz, as investment manager or trustee of trusts established for the benefit of Dr. Rosenwald
and his family, along with Angelo De Caro, who recently resigned as a director, have agreed
pursuant to support agreements that they have entered into with CytRx and Merger Subsidiary to vote
all Innovive shares that they control in favor of the merger agreement. These directors and
officers and their affiliates own beneficially an aggregate of approximately 22% of the shares of
common stock entitled to vote at the special meeting. They also agreed in the support agreements
to vote such shares (1) against any action or agreement that would result in a breach of any
representation, warranty, or covenant of Innovive under the merger agreement, (2) against any
competing acquisition proposal, and (3) against any agreement or other action that is intended, or
could reasonably be expected to, prevent or delay the completion of the merger, and not to solicit
proxies or participate in a solicitation with respect to a competing acquisition proposal.
In order to facilitate the support agreements, concurrently with the signing of the support
agreements, these beneficial owners delivered to CytRx irrevocable proxies to vote all of the
Innovive shares that they control in favor of the approval of the merger agreement.
Under the support agreements, these beneficial owners agreed that, for the duration of the
support agreements, they will not sell, pledge, or otherwise transfer any shares of Innovive common
stock that they beneficially own, other than transfers for estate planning or charitable purposes
if the transferee agrees to comply with the support agreement.
The support agreements will terminate upon the earlier of the completion of the merger and the
date of termination of the merger agreement in accordance with its terms.
Loan And Security Agreement
Concurrently with entering into the merger agreement, we entered into a loan and security
agreement with CytRx pursuant to which CytRx made an initial advance to us of approximately
$1,725,000, which was used to pay some of our current accounts payable and accrued expenses. Under
the loan agreement, we may request that CytRx make additional advances in the cumulative aggregate
principal amount of up to approximately $3,775,000. All additional advances requested by us will
be at CytRxs discretion. Additional advances may be used by us for working capital and general
corporate purposes consistent with our covenants under the merger agreement, including for
professional and other fees and expenses and other transaction costs incurred by us in connection
with the merger agreement. We must state in each advance request the specific intended uses of the
advance, and any actual use of an advance that differs materially from the intended use will
constitute a material breach of the loan agreement. As of July 31, 2008, we had requested, and
CytRx had made, approximately $662,000 of additional advances under the loan and security
agreement.
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All advances under the loan agreement are secured by a lien on all or substantially all of our
assets, bear interest at the rate of 12.5% per annum, and generally are due and payable, in full,
together with accrued interest, on the earlier of the date of termination of the merger agreement
or September 30, 2008. We may prepay advances under the loan agreement, without premium or
penalty, in whole or in part, at any time or from time to time.
Upon the occurrence and during the continuance of an event of default (as defined in the loan
and security agreement), the interest rate on the outstanding principal under the loan agreement
will be increased by 200 basis points.
The following events will constitute an event of default under the loan agreement:
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if we fail to make any payment of principal or of interest under the loan agreement
or other obligations (as defined in the loan and security agreement) when such payment
is due and payable; |
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if we fail to perform, comply with or observe any other covenant or undertaking
contained in the loan agreement and such failure continues for ten days; |
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if any warranty, representation or other statement by or on behalf of us contained
in or pursuant to the loan agreement, or in any related document, agreement or
instrument, is false, erroneous, or misleading in any material respect when made; |
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if any provision of the loan agreement or any material term of the merger agreement
is declared void, or the validity or enforceability thereof is contested by us or any
governmental authority having jurisdiction over us; or |
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if there is a seizure or attachment of, or a levy on, any of the collateral under
the loan agreement; |
provided, that an event of default will not include any of the foregoing events that result from
CytRxs failure or refusal, in the exercise of its discretion, to make an additional advance
requested by us.
In the event of default, CytRx may, in its discretion, terminate the loan agreement, and
generally will have all rights and remedies granted or available to CytRx under the loan agreement
or available at law or in equity.
In consideration for entering into the loan agreement and making the initial advance, we
granted CytRx under the loan agreement an option to purchase up to 2,000,000 shares of common stock
of Innovive at an exercise price of $0.01 per share. CytRx may exercise the option at any time
after we terminate the merger agreement to pursue a superior proposal as permitted by the merger
agreement and prior to the first anniversary of our completion of a superior proposal. The initial
exercise price and the number of option shares purchasable upon exercise of the option will be
subject to adjustment in case of any reclassification, capital reorganization, consolidation,
merger, sale of all or substantially all of our assets or any other change in Innovive common
stock.
77
COMPARATIVE MARKET PRICES AND DIVIDEND INFORMATION
Market Prices
CytRx
common stock is listed on The Nasdaq Capital Market and our common stock is quoted on
the OTCBB. The following table sets forth the high and low sales prices of shares of CytRx common
stock and high and low bid prices of our common stock as reported on The Nasdaq Capital Market and
the OTCBB, respectively. The quotations for our common stock represent inter-dealer prices,
without retail mark-up, mark-down or commission, and may not represent actual transactions.
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CytRx Common Stock |
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Innovive Common Stock |
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High |
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Low |
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High |
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Low |
2006 |
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$ |
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$ |
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$ |
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$ |
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First Quarter |
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1.92 |
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1.01 |
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NA |
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NA |
Second Quarter |
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2.30 |
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1.06 |
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NA |
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NA |
Third Quarter |
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1.94 |
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0.87 |
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NA |
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NA |
Fourth Quarter |
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2.04 |
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1.21 |
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4.25 |
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3.25 |
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2007 |
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First Quarter |
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5.49 |
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1.74 |
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6.00 |
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2.90 |
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Second Quarter |
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5.36 |
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2.97 |
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4.50 |
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2.50 |
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Third Quarter |
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4.09 |
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3.00 |
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3.50 |
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1.55 |
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Fourth Quarter |
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4.70 |
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2.60 |
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2.10 |
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0.70 |
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2008 |
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First Quarter |
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2.98 |
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1.00 |
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1.25 |
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0.12 |
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Second
Quarter (Through July 31, 2008) |
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1.27 |
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0.43 |
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0.65 |
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0.05 |
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On June 6, 2008, the last full trading day before the public announcement of the merger
agreement, the closing price of CytRx common stock as reported on The Nasdaq Capital Market was
$0.99. On August , 2008, the last full trading day before the date of this proxy
statement/prospectus, the closing price of shares of CytRx common stock as reported on The Nasdaq
Capital Market was $ .
On June 6, 2008, the last full trading day before the public announcement of the merger
agreement, the closing price of shares of our common stock as reported on the OTCBB was $0.15.
On August , 2008, the last full trading day before the date of this proxy
statement/prospectus, the closing price of our common stock as reported on the OTCBB was $ .
As
of July 31, 2008, there were approximately 743 registered holders of CytRx common stock and 171 registered holders of our
common stock. CytRx and Innovive believe that a number of investors in CytRx common stock and our
common stock hold their shares in street name and that the number of beneficial owners to CytRx
common stock and our common stock is greater than the number of registered holders.
You are advised to obtain current market quotations for CytRx common stock and our common
stock. The market prices of CytRx common stock and our common stock will fluctuate between the
date of this proxy statement/prospectus and the special meeting date and the completion of the
merger. No assurance can be given concerning the market price of CytRx common stock and our common
stock before or after the effective date of the merger.
78
Dividends
Neither we nor CytRx has ever paid any cash dividends on its common stock, and we and CytRx do
not expect to pay any cash dividends in the foreseeable future.
BUSINESS OF CYTRX
Overview
CytRx is a clinical-stage biopharmaceutical company engaged in developing human therapeutic
products based primarily upon its small-molecule molecular chaperone amplification technology.
Molecular chaperone proteins occur normally in human cells and are key components of the bodys
defenses against potentially toxic mis-folded cellular proteins. Since damaged toxic proteins
called aggregates are thought to play a role in many diseases, CytRx believes that amplification of
molecular chaperone proteins could have therapeutic efficacy for a broad range of indications.
Currently, CytRx is using its chaperone amplification technology to develop treatments for
neurodegenerative disorders and diabetic complications. In addition, CytRx has been applying
molecular chaperone technology to the identification of drug candidates for oncology by adapting
its proprietary chaperone screening assay to identify inhibitors (rather than amplifiers) of
chaperone activity.
In December 2007,
CytRx began enrolling patients in a Phase IIb efficacy clinical trial of its
lead product candidate, arimoclomol, for ALS. That Phase IIb clinical trial was placed on clinical
hold by the FDA in January 2008. Based on written correspondence CytRx received from the FDA,
their decision pertained to a previously completed animal toxicology study in rats and was not
related to data generated from any human studies with arimoclomol. CytRx received a formal determination
letter from the FDA in July 2008. In light of the ongoing clinical hold,
CytRx recently announced plans to conduct additional animal toxicology studies of arimoclomol,
which are expected to take up to one year to complete, before any possible resumption or initiation
of clinical trials of arimoclomol. Depending on the outcome of those preclinical toxicology
studies and other factors, CytRx plans to thereafter resume the Phase IIb efficacy trial. CytRx
currently anticipates that data regarding the primary efficacy endpoint of this trial would be
available approximately 18 months following the resumption of the trial. The results from CytRxs
completed Phase IIa clinical trial and open-label trial extension indicated that arimoclomol was
safe and well tolerated by ALS patients. Based on preliminary discussions with the FDA, CytRx plans
to conduct a second efficacy trial of arimoclomol for ALS, possibly overlapping with the Phase IIb
efficacy trial, to provide additional data to support a possible approval decision by the FDA.
Arimoclomol for treating ALS has received Orphan Drug and Fast Track designation from the FDA and
orphan medicinal product status from the European Medicines Agency.
The results from preclinical efficacy studies completed by CytRx in April 2007 indicated that
arimoclomol accelerated recovery time, and improved recovery, in experimental animal models of
stroke, even when administered as long as 48 hours after onset. Contingent upon the results of the
planned animal toxicology studies of arimoclomol and other factors, CytRx plans to conduct a
Phase II clinical trial of arimoclomol in stroke patients.
Iroxanadine, CytRxs second small-molecule product candidate, has completed Phase I clinical
trials. The results from the Phase I trials indicated that orally-administered iroxanadine was safe
and well tolerated in healthy volunteers. The results from an open-label Phase II clinical trial in
patients with chronic high blood pressure indicated that oral iroxanadine improved the functioning
of endothelial cells that line the interior of blood vessels and are thought to be damaged by
conditions of stress such as chronic high blood pressure and diabetes. Animal studies completed by
CytRx in May 2007 indicated that iroxanadine accelerated the healing of skin wounds in diabetic
animals. Subject to FDA clearance, CytRx plans to initiate a Phase II clinical trial of oral
iroxanadine for diabetic ulcers in the first quarter of 2009.
79
CytRx also owns several other small-molecule compounds that it believes may amplify molecular
chaperone proteins in human cells. In July 2007, CytRx opened a research and development facility
in San Diego, California, to serve as a dedicated laboratory to accelerate development of CytRxs
pipeline of molecular chaperone amplification product candidates. In April 2008, CytRx announced
that its scientists had discovered a novel series of compounds that amplify the natural cellular
chaperone response to toxic misfolded proteins in cell culture, providing potential pipeline leads
for next-generation drug candidates in a number of disease indications, including cancer,
cardiovascular disease, diabetes and neurodegenerative diseases.
CytRxs Molecular Chaperone Amplification Platform
The synthesis of proteins is a normal part of essential human cell activity. In order to
function normally, proteins must fold into particular three-dimensional shapes. In response to
trauma or other stressful conditions, proteins can fold improperly, resulting in the aggregation of
mis-folded proteins that can be toxic to the cell and cause or contribute to disease. It is
believed, for example, that mis-folding and aggregation of certain mutated forms of a particular
protein known as superoxide dismutase 1, or SOD1, leads to the death of motor neurons that causes
certain forms of ALS. Similar protein aggregates also are present in motor neurons of all other ALS
patients.
In nature, the cell has developed molecular chaperone proteins to respond to mis-folded
proteins. As a cell comes under stress, proteins begin to mis-fold into toxic shapes, and the cell
responds by increasing the synthesis of molecular chaperone proteins that detect the mis-folded
proteins and refold them into the appropriate, non-toxic shape, or identify, or tag, the toxic
protein for destruction by the cell.
By boosting the cells own molecular chaperone response to higher levels, CytRx believes that
the progression of chronic diseases such as ALS that are thought to be caused by protein
mis-folding may be slowed or halted, or perhaps even reversed. In in-vitro studies, for example,
mammalian cells engineered to have increased amounts of molecular chaperone proteins showed
resistance to a variety of otherwise lethal stresses. Increased molecular chaperone proteins also
significantly extended the lifespan of mice with spinal and bulbar muscular atrophy, a disease with
a pathology believed to be similar to ALS.
Some potential drug candidates have been reported in scientific papers as activating molecular
chaperone expression, but they appear to activate the response of molecular chaperone proteins in
all cells, including normal cells. CytRx is not aware of another pharmaceutical company engaged in
developing small-molecule amplifiers of molecular chaperone proteins that are activated only in
stressed or diseased cells.
CytRxs Product Candidate Pipeline
The following tables summarize the current pipeline of CytRxs product candidates:
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Product |
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Technology |
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candidate |
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Indication |
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Development Status |
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Arimoclomol
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ALS (Lou Gehrigs disease)
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Phase IIb Pending |
Molecular
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Arimoclomol
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Stroke recovery
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Phase II Pending |
chaperone
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Iroxanadine
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Diabetic foot ulcers
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Phase II (Q1 2009) |
amplification
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Novel Compound Series
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Multiple indications
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Preclinical |
CytRxs Clinical Development Programs
CytRxs clinical development programs consist of CytRxs ongoing efforts to develop
arimoclomol for ALS and stroke recovery and to develop iroxanadine for diabetic ulcers.
Arimoclomol. Arimoclomol is an orally-administered small-molecule product candidate that CytRx
believes functions by stimulating a normal cellular protein repair pathway by amplifying activated
molecular chaperone proteins implicated in neurological disorders.
80
Arimoclomol for the treatment of ALS. ALS, or Lou Gehrigs disease, is a debilitating and
ultimately deadly disease involving the progressive degeneration of motor neurons believed to be
caused by toxic mis-folding of proteins. According to the ALS Association, approximately 30,000
people in the United States are living with ALS and 5,600 new cases are diagnosed each year.
Worldwide, an estimated 120,000 people are living with ALS. According to the ALS Survival Guide,
50% of ALS patients die within 18 months of diagnosis and 80% die within five years of diagnosis.
The following is a summary of CytRxs clinical development of arimoclomol for treating ALS:
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in July 2006, CytRx completed an 84-patient, multi-center, double-blind,
placebo-controlled, multi-dose Phase IIa clinical trial of safety and tolerability of
arimoclomol in volunteers with ALS, which CytRx refer to as the Phase IIa trial; |
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|
in May 2007, CytRx completed an open-label extension of the Phase IIa trial in
approximately 70 ALS patients from the trial who were administered the highest
investigational dose (100 mg three times daily) of arimoclomol for an additional six
months; |
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in June 2007, CytRx completed a multiple ascending-dose clinical trial of safety and
tolerability involving 40 healthy volunteers; |
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in November 2007, CytRx completed a 28-day safety clinical trial with 400 mg of
arimoclomol three times daily involving 16 healthy volunteers; and |
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in December 2007, CytRx initiated patient screening in a double blind,
placebo-controlled Phase IIb clinical study. In this trial, CytRx expects to enroll 390
ALS patients at 30 to 40 clinical sites in the United States and Canada. The primary
purpose of this trial is to evaluate the safety and efficacy of up to a 400 mg dose of
arimoclomol administered orally three times daily. The Phase IIb clinical trial was
placed on clinical hold by the FDA in January 2008. Based on written correspondence
CytRx received from the FDA, their decision pertained to a previously completed animal
toxicology study in rats and was not related to data generated from any human studies
with arimoclomol. CytRx received a formal determination letter
from the FDA in July 2008. In light of the ongoing clinical hold, CytRx recently announced plans
to conduct additional preclinical toxicology studies of arimoclomol, which are expected
to take up to one year to complete, before any possible resumption or initiation of
clinical trials of arimoclomol. |
Phase IIa clinical trial. Participants in the Phase IIa clinical trial of arimoclomol were
administered either a placebo capsule, or one of three dosage levels of arimoclomol capsules, three
times daily for a period of 12 weeks, immediately followed by a one-month period without the drug.
The primary endpoints of the Phase IIa trial were safety and tolerability. Secondary endpoints
included a preliminary evaluation of efficacy using two widely accepted disease-progression
markers. The first marker, the revised ALS Functional Rating Scale, or ALSFRS-R, is used to
determine patients overall functional capacity and independence in 13 activities. The second
marker measures vital capacity, an assessment of lung capacity, which is an important disease
indicator since ALS sufferers eventually lose the ability to breathe on their own. The trial was
designed to be able to detect only extreme responses in these two markers.
The results from CytRxs Phase IIa trial and open-label extension clinical trial indicated
that arimoclomol was safe and well-tolerated in ALS volunteers, even at the highest administered
dose. Arimoclomol was detected in participants cerebral spinal fluid, demonstrating that it passed
the so-called blood:brain barrier, and participants treated with arimoclomol experienced a
statistically significant decrease in adverse events of weakness compared with the placebo group.
As would be expected based upon the small size and short duration of the Phase IIa trial, CytRx
observed no statistically significant effects in disease progression markers. CytRx did, however,
observe a trend toward slower disease progression in the highest dosage group. Since there was no
concurrent placebo control group in CytRxs open-label extension clinical
81
trial, CytRx compared the results with results in an untreated placebo group with similar
characteristics in a prior ALS clinical trial published in July 2006 in Annals of Neurology. The
results indicated a trend toward a slower average progression in every disease marker in the
patients treated with arimoclomol compared to the historical placebo control. In particular, CytRx
observed a decrease of 21% in the rate of decline for ALSFRS-R, 8% for vital capacity, 23% for
total body weight and 20% for body mass index when compared with that historical control. No
definitive conclusions can be drawn from these data without a concurrent placebo control group, and
investors are cautioned against relying on these data as an indication of arimoclomols potential
efficacy.
The favorable
safety and tolerability profile observed in CytRxs Phase IIa trial, open-label
extension clinical trial and animal toxicology studies of arimoclomol suggested that CytRx may be
able to safely increase the dose of arimoclomol without causing significant side effects. The
results from the subsequent multiple ascending-dose study indicated that arimoclomol was safe and
well-tolerated, even at doses of 600 mg three times daily (six times higher than the highest dose
used in the Phase IIa and open-label studies), when administered to healthy volunteers over a
seven-day period. Results from the 28-day safety clinical trial in healthy volunteers indicated
that the dosage of 400 mg administered three times daily also was safe and well tolerated.
Phase IIb efficacy trial. If resumed, the Phase IIb efficacy trial is expected to evaluate
the safety and efficacy in ALS patients of up to a 400 mg dose of arimoclomol administered orally
three times daily. CytRx expects to enroll in the trial 390 ALS patients in two stages. CytRx first
expects to enroll 24 patients in a four-week safety lead-in stage involving weekly clinical
monitoring to assure that the safety previously observed in healthy volunteers is also observed in
the ALS volunteers. Unless serious safety issues are observed during this lead-in stage, CytRx
plans to continue uninterrupted dosing for these participants, but clinical monitoring would be
reduced to a four-week basis for the remainder of the study. An independent data monitoring
committee will review all safety data from the four-week lead-in stage. If no substantial safety
issues are identified, CytRx expects to enroll the remaining 366 ALS volunteers in the second
stage. With the exception of the 24 participants in the first stage of the trial, all of the ALS
trial volunteers will be monitored every four weeks for the initial nine-month trial period. After
collecting primary efficacy endpoint data, CytRx plans to continue double-blind administration of
arimoclomol in trial patients with monitoring at eight-week intervals for an additional nine months
in order to provide additional data on secondary endpoints and on long-term safety and efficacy.
The Phase IIb clinical trial was placed on clinical hold by the FDA in January 2008. Based on
written correspondence CytRx received from the FDA, their decision pertained to a previously
completed animal toxicology study in rats and was not related to data generated from any human
studies with arimoclomol. CytRx received a formal determination letter from
the FDA in July 2008. In light of the ongoing clinical hold, CytRx recently announced plans to conduct
additional preclinical toxicology studies of arimoclomol, which are expected to take up to one year
to complete, before any possible resumption or initiation of clinical trials of arimoclomol.
Depending on the outcome of those preclinical toxicology studies and other factors, CytRx plans to
thereafter resume the Phase IIb efficacy trial. Assuming no significant modifications are made to
the trial protocol, CytRx currently expects to complete patient enrollment in the Phase IIb
efficacy trial approximately nine months following the resumption of the trial, and anticipate and
that data regarding the trials primary efficacy endpoint would be available approximately 18
months following the resumption of the trial.
Based on preliminary discussions with the FDA, CytRx plans to conduct a second efficacy
clinical trial for ALS, possibly overlapping with the Phase IIb efficacy trial, to provide
additional data to support possible FDA approval.
Arimoclomol for the treatment of stroke. Stroke results from an acute loss of normal blood
flow to the brain caused most often by a blockage in a blood vessel (ischemic) or due to leaking of
blood from a vessel (hemorrhagic). According to the American Heart Association; stroke is the third
leading cause of death and the
82
number one cause of long-term disability in the United States; between 50% and 70% of stroke
survivors regain functional independence, but between 15% and 30% are permanently disabled and 20%
require institutional care within three months after stroke; and the direct and indirect stroke
cost in the United States totaled approximately $58 billion in 2006.
After the normal flow of blood is restored to the brain after the initial event, post-stroke
neurological function continues to decline. CytRx believes that this continuing decline in
neurological function is the consequence of mis-folded protein aggregates generated as a result of
oxygen deprivation during the original event.
Preclinical efficacy studies completed by CytRx in April 2007 indicated that arimoclomol
accelerated the time to recovery, and improved recovery, in experimental animal models of stroke.
These results were obtained even when arimoclomol was administered as long as 48 hours after onset.
By comparison, tissue plasminogen activator, or t-PA, the only treatment currently approved in
the United States for acute ischemic stroke, must be administered within three hours of stroke,
which substantially limits the number of patients who qualify for this treatment. Contingent upon
the results of the planned animal toxicology studies or arimoclomol and other factors, CytRx plans
to conduct a Phase II clinical trial of arimoclomol in stroke patients.
Iroxanadine. Iroxanadine also is an orally-administered small-molecule product candidate.
CytRx believes it functions by stimulating the molecular chaperone protein response in the
endothelium, the thin layer of cells that line the interior surface of human blood vessels.
Iroxanadine for the treatment of diabetic ulcers. Type 2 diabetes is a major health problem
with significant secondary complications. The American Diabetes Association estimates that there
are 21 million type 2 diabetes sufferers in the United States. The World Health Organization
estimates that there are more than 162 million cases of type 2 diabetes worldwide. According to the
American Diabetes Association, 15% of all diabetics will develop a foot ulcer during their
lifetime, and over 82,000 non-traumatic lower-limb amputations were performed on diabetics in the
United States in 2002 due to such ulcers and other complications. CytRx believes there is strong
support in the scientific literature for the assertion that diabetic foot ulcers fail to heal
efficiently, in part, due to the dysfunction of endothelial cells lining the blood vessels caused
by protein mis-folding.
Animal studies completed by CytRx in May 2007 indicated that iroxanadine significantly
decreased the time it took for wounds to heal in diabetic mice without affecting healing in healthy
mice. Wound healing in the diabetic mice, which normally required twice the time to heal as healthy
mice, was accelerated to the extent that healing time of diabetic mice treated with iroxanadine was
indistinguishable from that in untreated healthy mice.
In Phase I clinical trials in healthy volunteers and Phase II clinical trials in patients with
chronic high blood pressure conducted prior to CytRxs acquisition of iroxanadine, iroxanadine was
determined to be safe and well tolerated and demonstrated significant improvement in the function
of endothelial cells in the brachial artery, a major blood vessel of the upper arm. Based on
CytRxs preclinical results and the earlier clinical study data, CytRx plans to commence a Phase II
clinical trial with oral iroxanadine for the treatment of diabetic foot ulcers in the first quarter
of 2009, subject to FDA clearance.
CytRxs Research Programs and Other Technologies
CytRx is actively conducting scientific research at CytRxs research and development facility
in San Diego, California. CytRxs research is aimed at discovering and validating novel drug
targets, analyzing CytRxs current product candidates and library of related compounds and
developing backup compounds and new therapies based on the amplification of molecular chaperone
proteins. In April 2008, CytRx announced
83
that its scientists had discovered a novel series of compounds that amplify the natural
cellular chaperone response to toxic misfolded proteins in cell culture, providing potential
pipeline leads for next-generation drug candidates in a number of disease indications, including
cancer, cardiovascular disease, diabetes and neurodegenerative diseases.
CytRxs other current technologies, which it acquired or developed prior to the acquisition of
CytRxs molecular chaperone amplification technology, are CRL-5861, an intravenous agent for
treatment of sickle cell disease and other acute vaso-occlusive disorders, and TranzFect, a
delivery technology for DNA-based and conventional vaccines and other potential uses.
CytRxs Separation from RXi Pharmaceuticals Corporation
RXi Pharmaceuticals Corporation, or RXi, was founded in April 2006 by CytRx and four
researchers in the field of RNAi, including Dr. Craig Mello, recipient of the 2006 Nobel Prize for
Medicine for his co-discovery of RNAi. RNAi is a naturally occurring mechanism for the regulation
of gene expression that has the potential to selectively inhibit the activity of any human gene. As
evidenced by Kim and Rossis review published in March 2007 in Nature Reviews Genetics, it is
believed that this inhibition may potentially treat human diseases by silencing genes that lead
to disease.
In January 2007, CytRx transferred to RXi substantially all of CytRxs RNAi-related
technologies and assets in exchange for shares of common stock of RXi, and RXi began operating on a
stand-alone basis for the purpose of accelerating the discovery of RNAi therapeutics previously
sponsored by CytRx. RXis initial focus is on developing RNAi-based product candidates for treating
neurological and metabolic disorders and cancer.
Until recently, CytRx owned approximately 85% of the outstanding shares of common stock of RXi
and CytRxs consolidated financial statements, including CytRxs consolidated financial statements
as of and for the year ended December 31, 2007 included in Appendix E to this proxy
statement/prospectus, reflected the consolidated financial condition and results of operations of
RXi. On February 14, 2008, CytRxs board of directors declared a dividend, payable to CytRxs
stockholders as of March 6, 2008, the record date, of one share of RXi common stock for each
approximately 20.05 shares of CytRxs common stock held by such stockholders. The dividend was paid
on March 11, 2008. As a result of the dividend, CytRx owned less than a majority of the outstanding
shares of RXi common stock and CytRxs financial statements no longer consolidate the financial
condition and results of operation of RXi. Instead, CytRxs ongoing investment in RXi is accounted
for based on the equity method of accounting as discussed in the CytRxs Managements Discussion
and Analysis of Financial Condition and Results of Operations section of this proxy
statement/prospectus.
In connection with CytRxs distribution of RXi shares to CytRxs stockholders, RXi became a
public reporting company and its common stock was listed for trading on The Nasdaq Capital Market
under the symbol RXII.
On February 15, 2007, CytRx entered into a letter agreement with RXi and certain of RXis
current stockholders under which RXi agreed to grant to CytRx preemptive rights to acquire any new
securities (as defined) that RXi proposes to sell or issue so that CytRx may maintain its
percentage ownership in RXi at any time that CytRx owns less than 50% of the outstanding shares of
RXi common stock. CytRxs preemptive rights will expire on January 8, 2012 or such earlier time at
which CytRx owns less than 10% of RXis outstanding common stock.
Under this letter agreement, CytRx agreed that it will vote its RXI shares for the election of
RXi directors and take other actions to ensure that a majority of the board of directors of RXi are
independent of us. CytRx further agreed to approve of actions that may be adopted and recommended
by the RXi board of directors to facilitate any future financing by RXi.
84
Manufacturing
CytRx has no capability to manufacture supplies of any of CytRxs products, and relies on
third-party contract manufacturers to produce materials needed for research and clinical trials,
including clinical supplies of iroxanadine for CytRxs planned Phase II trial. To be
commercialized, CytRxs products also must be capable of being manufactured in commercial
quantities in compliance with stringent regulatory requirements and at an acceptable cost. CytRx
intends to rely on third-party manufacturers to produce commercial quantities of any products for
which CytRx is able to obtain marketing approval. CytRx has not commercialized any product, and so
has not demonstrated that any of CytRxs product candidates can be manufactured in commercial
quantities in accordance with regulatory requirements or at an acceptable cost.
If CytRxs product candidates cannot be manufactured in suitable quantities and in accordance
with regulatory standards, CytRxs clinical trials, regulatory approvals and marketing efforts for
such products may be delayed. Such delays could adversely affect CytRxs competitive position and
CytRxs chances of generating significant recurring revenues. If CytRxs products are not able to
be manufactured at an acceptable cost, the commercial success of CytRxs products may be adversely
affected.
Patents and Proprietary Technology
CytRx actively seeks patent protection for CytRxs technologies, processes, uses, and ongoing
improvements and considers its patents and other intellectual property to be critical to its
business. CytRx acquired patents and patent applications, and has filed several new patent
applications, in connection with CytRxs molecular chaperone program.
CytRx regularly evaluates the patentability of new inventions and improvements developed by
CytRx or CytRxs collaborators, and, whenever appropriate, will endeavor to file United States and
international patent applications to protect these new inventions and improvements. CytRx cannot be
certain that any of the current pending patent applications it has filed or licensed, or any new
patent applications CytRx may file or license, will ever be issued in the United States or any
other country. There also is no assurance that any issued patents will be effective to prevent
others from using CytRxs products or processes. It is also possible that any patents issued to
CytRx, as well as those CytRx has licensed or may license in the future, may be held invalid or
unenforceable by a court, or third parties could obtain patents that CytRx would need to either
license or to design around, which CytRx may be unable to do. Current and future competitors may
have licensed or filed patent applications or received patents, and may acquire additional patents
and proprietary rights relating to molecular chaperone amplification and other small molecule
technology, RNAi technology, DNA-based vaccines or other compounds, products or processes that may
be competitive with those of CytRx.
In addition to patent protection, CytRx attempts to protect CytRxs proprietary products,
processes and other information by relying on trade secrets and non-disclosure agreements with
CytRxs employees, consultants and certain other persons who have access to such products,
processes and information. Under the agreements, all inventions conceived by employees are CytRxs
exclusive property, but there is no assurance that these agreements will afford significant
protection against misappropriation or unauthorized disclosure of CytRxs trade secrets and
confidential information.
Competition
CytRx is aware of only one drug, Rilutek, which was developed by Aventis Pharma AG, that has
been approved by the FDA for the treatment of ALS. Many companies are working to develop
pharmaceuticals to treat ALS, including Aeolus Pharmaceuticals, Celgene Corporation, Mitsubishi
Tanabe Pharma Corporation, Ono Pharmaceuticals, Trophos SA, Knopp Neurosciences Inc., Faust
Pharmaceuticals SA, Oxford BioMedica plc, Phytopharm plc and Teva Pharmaceutical Industries Ltd.,
as well as RXi. ALS patients often take over-the-counter supplements, including vitamin E, creatine
and coenzyme Q10, or drugs such as lithium that are approved for other indications. ALS belongs to
a family of neurodegenerative diseases that includes
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Alzheimers, Parkinsons and Huntingtons diseases. Due to similarities between these
diseases, a new treatment for one such disease potentially could be useful for treating others.
There are many companies producing and developing drugs used to treat neurodegenerative diseases
other than ALS, including Amgen, Inc., Biogen Idec, Boehringer Ingelheim, Cephalon, Inc., Ceregene,
Inc., Elan Pharmaceuticals, plc, Forest Laboratories, Inc., H. Lundbeck A/S, Phytopharm plc, UCB
Group and Wyeth.
Current drug classes used to treat stroke include antiplatelet agents, anticoagulants,
salycylates, neuroprotectants and thrombolytic agents. Prescription antiplatelet agents include
Aggrenox by Boehringer Ingelheim, Plavix by Sanofi-Aventis and Bristol-Myers Squibb, and Ticlid by
Roche Pharmaceuticals. Coumadin by Bristol-Myers Squibb and Jantoven by Upsher-Smith Laboratories
are branded forms of warfarin, an anticoagulant. Moreover, salicylates, like aspirin, are commonly
used to treat patients after stroke. In Europe, Ferrer Grupo markets the neroprotectant, Somazina.
Activase, also known as tissue plasminogen activator, or t-PA, is a thrombolytic agent marketed by
Genentech. Many new drug candidates are in development by pharmaceutical and biotech companies,
including GlaxoSmithKline, Indeveus Pharmaceuticals, Ipsen, Merck & Co., Neurobiological
Technologies, Ono Pharmaceuticals, PAION AG and Wyeth. In addition to drug therapy, companies such
as Medtronic and Northstar Neurosciences are developing neurostimulation medical devices to aid in
recovery after stroke.
The wound care market is highly competitive, and there are many products available for
treating skin wounds, including diabetic foot ulcers. Prescription and over-the-counter products
for the prevention and treatment of infections include topical anti-infectives, such as Betadine,
silver sulfadiazine, hydrogen peroxide, Dakins solution and hypochlorous acid, and topical
antibiotics, such as Neosporine, Mupirocin and Bacitracin. Skin substitute products include
Apligraf, manufactured by Organogenesis, Inc., which is an FDA-cleared product using human dermal
and epidermal cells placed on a collagen matrix, for the treatment of both venous stasis and
diabetic foot ulcers, and Dermagraft®, produced by Advanced BioHealing, Inc., which uses human
derived dermal cells placed on a polyglactin matrix and is FDA cleared to treat diabetic foot
ulcers. In addition, a number of companies are working to develop proprietary pharmaceuticals and
cell-based therapies to treat diabetic wound healing, including Agennix, Inc., BioSyntech, Inc.,
CardioVascular BioTherapeutics, Inc., Cardium Therapeutics, Inc., Genentech Inc., KeraCure, Inc.,
King Pharmaceuticals, Inc., MacroChem Corporation, Oculus Innovative Sciences, Inc., Rovi
Pharmaceutical Laboratories, SanuWave, Inc. and Wyeth.
Many companies, including large pharmaceutical and biotechnology firms with financial
resources, research and development staffs, and facilities that may be substantially greater than
those of CytRx or its strategic partners or licensees, are engaged in the research and development
of pharmaceutical products that could compete with CytRxs potential products. To the extent that
CytRx seeks to acquire, through license or otherwise, existing or potential new products, CytRx
will be competing with numerous other companies, many of which will have substantially greater
financial resources, as well as large acquisition and research and development staffs that may give
those companies a competitive advantage over CytRx in identifying and evaluating these drug
acquisition opportunities. Any products that CytRx acquires will be competing with products
marketed by companies that in many cases will have substantially greater marketing resources than
CytRx has. The pharmaceutical industry is characterized by rapid technological advances and
competitors may develop their products more rapidly and such products may be more effective than
those currently under development or that may be developed in the future by CytRxs strategic
partners or licensees. Competitive products for a number of the disease indications that CytRx has
targeted are currently being marketed by other parties, and additional competitive products are
under development and may also include products currently under development that CytRx is not aware
of or products that may be developed in the future.
Government Regulation
The United States and other developed countries extensively regulate the preclinical and
clinical testing, manufacturing, labeling, storage, record-keeping, advertising, promotion, export,
marketing and distribution of drugs and biologic products. The FDA, under the Federal Food, Drug,
and Cosmetic Act, the
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Public Health Service Act and other federal statutes and regulations, regulates pharmaceutical
and biologic products.
To obtain approval of CytRxs product candidates from the FDA, CytRx must, among other
requirements, submit data supporting safety and efficacy for the intended indication as well as
detailed information on the manufacture and composition of the product candidate. In most cases,
this will require extensive laboratory tests and preclinical and clinical trials. The collection of
these data, as well as the preparation of applications for review by the FDA, involves significant
time and expense. The FDA also may require post-marketing testing to monitor the safety and
efficacy of approved products or place conditions on any approvals that could restrict the
therapeutic claims and commercial applications of these products. Regulatory authorities may
withdraw product approvals if CytRx fails to comply with regulatory standards or if CytRx
encounters problems at any time following initial marketing of CytRxs products.
The first stage of the FDA approval process for a new biologic or drug involves completion of
preclinical studies and the submission of the results of these studies to the FDA. This data,
together with proposed clinical protocols, manufacturing information, analytical data and other
information submitted to the FDA, in an investigational new drug application, or IND, must become
effective before human clinical trials may commence. Preclinical studies generally involve FDA
regulated laboratory evaluation of product characteristics and animal studies to assess the
efficacy and safety of the product candidate.
After the IND becomes effective, a company may commence human clinical trials. These are
typically conducted in three sequential phases, but the phases may overlap. Phase I trials consist
of testing of the product candidate in a small number of patients or healthy volunteers, primarily
for safety at one or more doses. Phase II trials, in addition to safety, evaluate the efficacy of
the product candidate in a patient population somewhat larger than Phase I trials. Phase III trials
typically involve additional testing for safety and clinical efficacy in an expanded population at
multiple test sites. A company must submit to the FDA a clinical protocol, accompanied by the
approval of the Institutional Review Boards at the institutions participating in the trials, prior
to commencement of each clinical trial.
To obtain FDA marketing authorization, a company must submit to the FDA the results of the
preclinical and clinical testing, together with, among other things, detailed information on the
manufacture and composition of the product candidate, in the form of a new drug application, or
NDA, or, in the case of a biologic, a biologics license application, or BLA.
The amount of time taken by the FDA for approval of an NDA or BLA will depend upon a number of
factors, including whether the product candidate has received priority review, the quality of the
submission and studies presented, the potential contribution that the compound will make in
improving the treatment of the disease in question, and the workload at the FDA.
The FDA may, in some cases, confer upon an investigational product the status of a fast track
product. A fast track product is defined as a new drug or biologic intended for the treatment of a
serious or life-threatening condition that demonstrates the potential to address unmet medical
needs for this condition. The FDA can base approval of an NDA or BLA for a fast track product on an
effect on a surrogate endpoint, or on another endpoint that is reasonably likely to predict
clinical benefit. If a preliminary review of clinical data suggests that a fast track product may
be effective, the FDA may initiate review of entire sections of a marketing application for a fast
track product before the sponsor completes the application. The FDA has granted fast track
designation and orphan drug status to arimoclomol for the treatment of ALS.
CytRx anticipates that its products will be manufactured by its strategic partners, licensees
or other third parties. Before approving a BLA, the FDA will inspect the facilities at which the
product is manufactured and will not approve the product unless the manufacturing facilities are in
compliance with the FDAs cGMP, which are regulations that govern the manufacture, holding and
distribution of a product. Manufacturers of biologics also must comply with the FDAs general
biological product standards. CytRxs manufacturers also
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will be subject to regulation under the Occupational Safety and Health Act, the Environmental
Protection Act, the Nuclear Energy and Radiation Control Act, the Toxic Substance Control Act and
the Resource Conservation and Recovery Act. Following approval, the FDA periodically inspects drug
and biologic manufacturing facilities to ensure continued compliance with the good manufacturing
practices regulations. CytRxs manufacturers will have to continue to comply with those
requirements. Failure to comply with these requirements subjects the manufacturer to possible legal
or regulatory action, such as suspension of manufacturing or recall or seizure of product. Adverse
patient experiences with the product must be reported to the FDA and could result in the imposition
of marketing restrictions through labeling changes or market removal. Product approvals may be
withdrawn if compliance with regulatory requirements is not maintained or if problems concerning
safety or efficacy of the product occur following approval.
The labeling, advertising, promotion, marketing and distribution of a drug or biologic product
also must be in compliance with FDA and Federal Trade Commission requirements which include, among
others, standards and regulations for off-label promotion, industry sponsored scientific and
educational activities, promotional activities involving the internet, and direct-to-consumer
advertising. CytRx also will be subject to a variety of federal, state and local regulations
relating to the use, handling, storage and disposal of hazardous materials, including chemicals and
radioactive and biological materials. In addition, CytRx will be subject to various laws and
regulations governing laboratory practices and the experimental use of animals. In each of these
areas, as above, the FDA has broad regulatory and enforcement powers, including the ability to levy
fines and civil penalties, suspend or delay issuance of product approvals, seize or recall
products, and deny or withdraw approvals.
CytRx will also be subject to a variety of regulations governing clinical trials and sales of
CytRxs products outside the United States. Whether or not FDA approval has been obtained, approval
of a product candidate by the comparable regulatory authorities of foreign countries and regions
must be obtained prior to the commencement of marketing the product in those countries. The
approval process varies from one regulatory authority to another and the time may be longer or
shorter than that required for FDA approval. In the European Union, Canada and Australia,
regulatory requirements and approval processes are similar, in principle, to those in the United
States.
Employees
As of June 30, 2008, CytRx had 35 employees, 23 of whom were engaged in research and
development activities and 12 of whom were involved in management and administrative operations.
Properties
CytRxs headquarters are located in leased facilities in Los Angeles, California. The lease
covers approximately 4,700 square feet of office space and expires in June 2012.
CytRx also leases approximately 10,000 square feet of office and laboratory space in San
Diego, California. The lease expires in July 2010, subject to CytRxs option to extend the lease
for up to two additional three-year terms. CytRxs headquarters and laboratory facilities are
sufficient for CytRxs current purposes.
Legal Proceedings
CytRx is occasionally involved in claims arising in the normal course of business. As of the
date of the proxy statement/prospectus, there were no such claims that CytRx expects, individually
or in the aggregate, to have a material adverse affect on it.
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CYTRX MANAGEMENTS DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of CytRxs financial condition and results of operations
should be read together with the selected historical financial
information of CytRx on page 9 and
CytRxs consolidated financial statements and related notes included as Appendix E to this proxy
statement/prospectus. This discussion contains forward-looking statements, based on current
expectations and related to future events and CytRxs future financial performance, that involve
risks and uncertainties. CytRxs actual results may differ materially from those anticipated in
these forward-looking statements as a result of many important factors, including those set forth
under the captions Risk Factors and Cautionary Statement Concerning Forward-Looking
Statements in this proxy statement/prospectus.
Overview
General
CytRx is a clinical-stage biopharmaceutical company engaged in developing human therapeutic
products based primarily upon CytRxs small-molecule molecular chaperone amplification technology.
Molecular chaperone proteins occur normally in human cells and are key components of the bodys
defenses against potentially toxic mis-folded cellular proteins. Since damaged toxic proteins
called aggregates are thought to play a role in many diseases, CytRx believes that amplification of
molecular chaperone proteins could have therapeutic efficacy for a broad range of indications.
Currently, CytRx is using CytRxs chaperone amplification technology to develop treatments for
neurodegenerative disorders and diabetic complications. In addition, CytRx has been applying
molecular chaperone technology to the identification of drug candidates for oncology by adapting
its proprietary chaperone screening assay to identify inhibitors (rather than amplifiers) of
chaperone activity.
Through February 2008, CytRx owned a majority of the outstanding shares of common stock of RXi
Pharmaceuticals Corporation, which was founded in April 2006 by CytRx and four researchers in the
field of ribonucleic acid interference, or RNAi, including Dr. Craig Mello, recipient of the 2006
Nobel Prize for Medicine for his co-discovery of RNAi. RNAi is a naturally occurring mechanism for
the regulation of gene expression that has the potential to selectively inhibit the activity of any
human gene. RXi is focused solely on developing and commercializing therapeutic products based upon
RNAi technologies for the treatment of human diseases, including neurodegenerative diseases,
cancer, type 2 diabetes and obesity.
While RXi was majority-owned, CytRxs consolidated financial statements reflected 100% of the
assets and liabilities and results of operations of RXi, with the interests of the minority
shareholders of RXi being recorded as minority interests. In March 2008, CytRx distributed to its
stockholders approximately 36% of RXis outstanding shares, which reduced CytRxs ownership to less
than 50% of RXi. As a result of the reduced ownership, CytRx began to account for its investment in
RXi using the equity method, under which CytRx records only its pro-rata share of the financial
results of RXi against its historical basis investment in RXi. For the quarter ended March 31,
2008, the investment in RXi is shown as investment in unconsolidated subsidiary on the condensed
consolidated balance sheet and the related earnings are shown as equity in loss of unconsolidated
subsidiary on the condensed consolidated statement of operations. Because only a portion of RXis
financial results for March 2008 were recorded by CytRx under the equity method, CytRxs results of
operations for the first quarter of 2008 are not directly comparable to results of operations for
the same period in 2007. The future results of operations of CytRx also will not be directly
comparable to corresponding periods in prior years during which CytRxs financial statements
reflected the consolidation of RXi.
In January 2008, the FDA placed a clinical hold on CytRxs Phase IIb clinical efficacy trial
of arimoclomol for the treatment of ALS due to concerns relating to previous toxicology studies of
arimoclomol in rats. CytRx received a formal determination letter from the FDA
in July 2008. In light of the
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ongoing clinical hold, CytRx recently announced plans to conduct additional preclinical
toxicology studies of arimoclomol, in development for ALS and stroke recovery, which are expected
to take up to one year to complete, before any possible resumption or initiation of clinical trials
of arimoclomol. CytRx cannot predict the outcome of those additional animal toxicology studies.
Depending on the outcome, CytRx may be:
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required to conduct additional toxicology or human studies prior to or in parallel
with the resumption of CytRxs clinical trial, which would result in substantial
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required to alter the design including reducing the dosage of arimoclomol, of the
clinical trial, which could significantly delay the completion of the trial, increase
the cost of the trial, adversely affect CytRxs ability to demonstrate the efficacy of
arimoclomol in the trial or cause CytRx to cancel the trial altogether due to one or
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prohibited by the FDA from resuming CytRxs current planned clinical trial or
initiating any other clinical trial of arimoclomol for the treatment of ALS or any
other indication due to safety concerns. |
CytRxs development of arimoclomol for stroke recovery is subject to similar risks.
CytRx has relied primarily upon proceeds from sales of its equity securities and the exercise
of options and warrants, and to a much lesser extent upon payments from strategic partners and
licensees, to generate funds needed to finance its business and operations. At March 31, 2008,
CytRx had cash, cash equivalents and short-term investments of approximately $43.5 million. CytRx
believes that its current resources will be sufficient to support its currently planned level of
operations into the second half of 2009. This estimate is based, in part, upon CytRxs currently
projected expenditures for the remainder of 2008 and the first three months of 2009 of
approximately $23.9 million, including approximately $1.5 million of direct expenditures for
CytRxs planned clinical program for arimoclomol for ALS and related studies, approximately
$0.5 million of direct expenditures for its planned clinical program for arimoclomol for stroke
recovery and related studies, approximately $6.1 million of direct expenditures for its planned
Phase II clinical trial of iroxanadine for diabetic ulcers, approximately $7.7 million for the
operations of its research laboratory in San Diego, California, and approximately $8.1 million for
other general and administrative expenses. CytRxs projected expenditures are based on CytRxs
recently announced plan to conduct additional animal toxicology studies prior to the resumption of
its Phase II clinical program for arimoclomol for ALS that currently is on clinical hold by the FDA
and prior to any initiation of its Phase II clinical trial for arimoclomol for stroke recovery.
Those animal toxicology studies are expected to take approximately one year. If CytRx is required
to alter the design of its Phase II clinical trial, including the possible reduction of the dosage
of arimoclomol, or is prohibited by the FDA from resuming the current planned clinical trial or
initiating any other clinical trial of arimoclomol for the treatment of ALS or stroke recovery at
the desired dose, or at all, due to safety concerns, then CytRxs actual expenditures will vary,
perhaps significantly, from its current projections. These projections also do not consider the
effects of the merger on CytRxs operations and financial condition. However, CytRx will need
additional funds to advance any of Innovives product candidates.
CytRx will be required to obtain additional funding in order to execute its long-term business
plans. CytRx does not have commitments from any third parties to provide it with funding, and there
is no assurance that additional funding will be available on favorable terms, or at all. If CytRx
fails to obtain additional funding when needed, it may not be able to execute its business plans
and its business may suffer, which would have a material adverse effect on CytRxs financial
position, results of operations and liquidity.
Recent Developments
On June 6, 2008, CytRx entered into the merger agreement with Innovive. Under accounting
principles generally accepted in the United States and the regulations of the Securities and
Exchange Commission, since Innovive is a development-stage company, it is not considered a
business. Accordingly, the merger will be accounted for by CytRx in accordance with Statement of
Financial Standard No. 142, Goodwill and Other Intangible Assets, for transactions other than a
business combination. Management of CytRx has further determined it is not required to include in
the proxy statement/prospectus pro forma financial statements of CytRx giving effect to the merger.
The initial merger consideration, together with direct costs incurred to effect the merger,
will be allocated to the individual assets acquired, including identifiable intangible assets, and
liabilities assumed based on their relative fair values. No goodwill will be recorded. Consolidated
financial statements of CytRx issued after the merger will reflect these fair values and will not
be restated retroactively to reflect the historical financial position or results of operations of
Innovive. CytRx will use a period of time beginning two days before and ending two days after the
date that the terms of the acquisition were agreed to and announced in determining the fair value
of the CytRx shares to be issued to Innovive stockholders. It is anticipated that CytRx will record
a one-time expense for in-process research and development it acquires, as well as the amount, if
any, the initial merger consideration paid by CytRx in excess of the fair market values of the
acquired assets and liabilities.
Additional merger consideration that is contingent upon certain events, none of which has
occurred as of the date of this proxy statement/prospectus, will be excluded from the initial
merger consideration.
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Research and Development
Expenditures for research and development activities related to continuing operations were
$18.8 million, $9.8 million and $9.1 million for the years ended December 31, 2007, 2006, and 2005,
respectively, with research and development expenses representing approximately 55%, 50% and 58%,
respectively, of CytRxs total expenses for these years. For the quarters ended March 31, 2008 and
2007, these expenditures were $3.2 million and $4.0 million, respectively, which represented
approximately 41.6% and 61.7%, respectively, of CytRxs total expenses for these periods. Research
and development expenses are discussed further below in this section under Critical Accounting
Policies and Estimates and Results of Operations.
CytRxs currently projected expenditures for the remainder of 2008 and the first three months
of 2009 include approximately $1.5 million of direct expenditures for CytRxs planned clinical
program for arimoclomol for ALS and related studies, approximately $0.5 million of direct
expenditures for its planned clinical program for arimoclomol for stroke recovery and related
studies, and approximately $6.1 million of direct expenditures for its planned Phase II clinical
trial of iroxanadine for diabetic ulcers. The actual cost of CytRxs clinical programs could differ
significantly from CytRxs current projections due to any additional requirements or delays imposed
by the FDA in connection with CytRxs planned trials, or if actual costs are higher than current
management estimates for other reasons. In the event that actual costs of CytRxs clinical program,
or any of CytRxs other ongoing research activities, are significantly higher than CytRxs current
estimates, CytRx may be required to significantly modify CytRxs planned level of operations.
There is a risk that any drug discovery and development program may not produce revenue,
because of the risks inherent in drug discovery and development. Moreover, there are uncertainties
specific to any new field of drug discovery, including CytRxs molecular chaperone amplification
technology. The successful development of any product candidate is highly uncertain. CytRx cannot
reasonably estimate or know the nature, timing and costs of the efforts necessary to complete the
development of, or the period in which material net cash inflows are expected to commence from any
product candidate, due to the numerous risks and uncertainties associated with developing drugs,
including the uncertainty of:
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CytRxs ability to advance product candidates into pre-clinical and clinical trials; |
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the scope, rate and progress of CytRxs pre-clinical trials and other research and
development activities; |
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the scope, rate of progress and cost of any clinical trials that CytRx may commence; |
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the cost of filing, prosecuting, defending and enforcing any patent claims and other
intellectual property rights; |
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future clinical trial results; |
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the terms and timing of any collaborative, licensing and other arrangements that
CytRx may establish; |
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the cost and timing of regulatory approvals; |
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the cost and timing of establishing sales, marketing and distribution capabilities; |
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the cost of establishing clinical and commercial supplies of CytRxs product
candidates and any products that CytRx may develop; and |
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the effect of competing technological and market developments. |
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Any failure to complete any stage of the development of CytRxs products in a timely manner
could have a material adverse effect on CytRxs financial position, results of operations and
liquidity. A discussion of material risks and uncertainties associated with CytRxs business is
set forth in the Risk Factors section of this proxy statement/prospectus. This discussion does
not consider the effects of the merger on CytRxs operations and financial condition. However,
CytRx will need additional funds to advance any of Innovives product candidates. See Risk
Factors Risks Associated with the Merger.
Critical Accounting Policies and Estimates
Managements discussion and analysis of CytRxs financial condition and results of operations
are based on CytRxs consolidated financial statements, which have been prepared in accordance with
accounting principles generally accepted in the United States. The preparation of these financial
statements requires management to make estimates and judgments that affect the reported amounts of
assets, liabilities, revenues and expenses, and related disclosure of contingent assets and
liabilities. On an ongoing basis, management evaluates its estimates, including those related to
revenue recognition, stock options, impairment of long-lived assets, including finite-lived
intangible assets, accrued liabilities and certain expenses. Management bases its estimates on
historical experience and on various other assumptions that are believed to be reasonable under the
circumstances, the results of which form the basis for making judgments about the carrying values
of assets and liabilities that are not readily apparent from other sources. Actual results may
differ materially from these estimates.
CytRxs significant accounting policies are summarized in note 2 of the notes to consolidated
financial statements for the year ended December 31, 2007 included as part of Appendix E to this
proxy statement/prospectus. CytRx believes the following critical accounting policies are affected
by CytRxs more significant judgments and estimates used in the preparation of CytRxs consolidated
financial statements:
Revenue Recognition
CytRxs revenues consist of license fees from strategic alliances with
pharmaceutical companies as well as service and grant revenues. Service revenues consist of
contract research and laboratory consulting. Grant revenues consist of government and private
grants.
Monies received for license fees are deferred and recognized ratably over the performance
period in accordance with Staff Accounting Bulletin (SAB) No. 104, Revenue Recognition. Milestone
payments will be recognized upon achievement of the milestone as long as the milestone is deemed
substantive and CytRx has no other performance obligations related to the milestone and
collectability is reasonably assured, which is generally upon receipt, or recognized upon
termination of the agreement and all related obligations. Deferred revenue represents amounts
received prior to revenue recognition.
Revenues from contract research, government grants, and consulting fees are recognized over
the respective contract periods as the services are performed, provided there is persuasive
evidence or an arrangement, the fee is fixed or determinable and collection of the related
receivable is reasonably assured. Once all conditions of the grant are met and no contingencies
remain outstanding, the revenue is recognized as grant fee revenue and an earned but unbilled
revenue receivable is recorded.
In August 2006, CytRx received approximately $24.3 million in proceeds from the privately
funded ALS Charitable Remainder Trust, or ALSCRT, in exchange for the commitment to continue
research and development of arimoclomol and other potential treatments for ALS and a one percent
royalty in the worldwide sales of arimoclomol for the treatment of ALS. Under the arrangement,
CytRx retains the rights to any products or intellectual property funded by the arrangement and the
proceeds of the transaction are non-refundable. ALSCRT has no obligation to provide any further
funding to CytRx. CytRx has concluded that, due to the research and development components of the
transaction, it is properly accounted for under Statement of Financial Accounting Standards, or
SFAS, No. 68, Research and Development Arrangements.
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Accordingly, CytRx has recorded the value received under the arrangement as deferred service
revenue and will recognize service revenue using the proportional performance method of revenue
recognition, meaning that service revenue will be recognized on a dollar-for-dollar basis for each
dollar of expense incurred for the research and development of arimoclomol and other potential ALS
treatments. CytRx believes that this method best approximates the efforts expended related to the
services provided. CytRx adjusts its estimates of expense incurred for this research and
development on a quarterly basis. For the years ended December 31, 2007 and 2006, CytRx recognized
approximately $7.2 million and $1.8 million, respectively, of service revenue related to the ALSCRT
transaction. Any significant change in ALS related research and development expense in any period
from prior periods will affect the recognition of revenue for that period and, consequently, the
comparability or revenue from period to period.
Deferred revenue, current portion is the amount of deferred revenue that is expected to be
recognized in the next 12 months and is subject to fluctuation based upon managements estimates.
Managements estimates include an evaluation of what pre-clinical and clinical trials are
necessary, the timing of when trials will be performed and the estimated clinical trial expenses.
These estimates are subject to change, which could have a significant effect on the amount and
timing of deferred revenues recognized.
Research and Development Expenses
Research and development expenses consist of costs incurred for direct and overhead-related
research expenses and are expensed as incurred. Costs to acquire technologies, including licenses,
that are utilized in research and development and that have no alternative future use are expensed
when incurred. Technology developed for use in CytRxs products is expensed as incurred until
technological feasibility has been established.
Clinical Trial Expenses
Clinical trial expenses, which are included in research and development expenses, include
obligations resulting from CytRxs contracts with various clinical research organizations in
connection with conducting clinical trials for CytRxs product candidates. CytRx recognizes
expenses for these activities based on a variety of factors, including actual and estimated labor
hours, clinical site initiation activities, patient enrollment rates, estimates of external costs
and other activity-based factors. CytRx believes that this method best approximates the efforts
expended on a clinical trial with the expenses CytRx records. CytRx adjusts its rate of clinical
expense recognition if actual results differ from CytRxs estimates. If CytRxs estimates are
incorrect, clinical trial expenses recorded in any particular period could vary.
Stock-based Compensation
CytRxs share-based employee compensation plans are described in note 12 of the notes to
consolidated financial statements. Effective January 1, 2006, CytRx adopted the provisions of SFAS
123(R), Share-Based Payment. SFAS 123(R), which requires that companies recognize compensation
expense associated with stock option grants and other equity instruments to employees in the
financial statements. SFAS 123(R) applies to all grants after the effective date and to the
unvested portion of stock options outstanding as of the effective date. CytRx adopted SFAS 123(R)
using the modified-prospective method and uses the Black-Scholes valuation model for valuing
share-based payments. CytRx will continue to account for transactions in which services are
received from non-employees in exchange for equity instruments based on the fair value of such
services received in accordance with SFAS 123(R), Emerging Issues Task Force Issue No. 96-18 (EITF
96-18), Accounting for Equity Instruments that are Issued to other than Employees for Acquiring,
or in Conjunction with Selling Goods or Services and EITF 00-18, Accounting Recognition for Certain
Transactions involving Equity Instruments Granted to Other Than Employees, as amended.
CytRxs statements of operations as of and for the years ended December 31, 2007 and 2006
reflect the impact of SFAS 123(R). In accordance with the modified prospective transition method,
CytRxs results of
93
operations for prior periods have not been restated to reflect the impact of SFAS 123(R).
Prior to January 1, 2006, CytRx accounted for share-based compensation under the recognition and
measurement provisions of Accounting Principles Board No. 25, Accounting for Stock Issued to
Employees (APB 25), and related interpretations for all awards granted to employees. Under APB
25, when the exercise price of options granted to employees under these plans equals or exceeds the
market price of the common stock on the date of grant, no compensation expense is recorded. When
the exercise price of options granted to employees under these plans is less than the market price
of the common stock on the date of grant, compensation expense is recognized over the vesting
period.
Non-employee share-based compensation charges generally are amortized over the vesting period
on a straight-line basis. Where option grants to non-employees are immediately vested and have no
future performance requirements by the non-employee, the total share-based compensation charge is
recorded in the period of the measurement date.
The fair value of each CytRx common stock option grant, and of grants by RXi of RXi common
stock options, is estimated using the Black-Scholes option pricing model, which uses certain
assumptions related to risk-free interest rates, expected volatility, expected life of the common
stock options and future dividends. Compensation expense is recorded based upon the value derived
from the Black-Scholes option pricing model, based on an expected forfeiture rate that is adjusted
for actual experience. If CytRxs Black-Scholes option pricing model assumptions or CytRxs actual
or estimated forfeiture rates are different in the future, it could materially affect compensation
expense recorded in future periods.
Impairment of Long-Lived Assets
CytRx reviews long-lived assets, including finite-lived intangible assets, for impairment on
an annual basis, as of December 31, or on an interim basis if an event occurs that might reduce the
fair value of such assets below their carrying values. An impairment loss would be recognized based
on the difference between the carrying value of the asset and its estimated fair value, which would
be determined based on either discounted future cash flows or other appropriate fair value methods.
If CytRxs estimates used in the determination of either discounted future cash flows or other
appropriate fair value methods are not accurate as compared to actual future results, CytRx may be
required to record an impairment charge.
Earnings Per Share
Basic and diluted loss per common share is computed based on the weighted-average number of
common shares outstanding. Common share equivalents (which consist of options and warrants) are
excluded from the computation of diluted loss per share where the effect would be antidilutive.
Common share equivalents which could potentially dilute basic earnings per share in the future, and
which were excluded from the computation of diluted loss per share, totaled approximately 17.1
million shares, 30.2 million shares and 24.7 million shares at December 31, 2007, 2006 and 2005,
respectively, and 16.2 million shares and 22.7 million shares at March 31, 2008 and 2007,
respectively.
In connection with CytRxs adjustment to the exercise terms of certain outstanding warrants to
purchase common stock on March 11, 2008, March 2, 2006 and January 20, 2005, CytRx recorded deemed
dividends of $757,000, $488,000 and $1.1 million, respectively. These deemed dividends are
reflected as an adjustment to net loss for the first quarter of 2008, the first quarter of 2006 and
the year ended 2005 to arrive at net loss applicable to common stockholders on the consolidated
statement of operations and for purposes of calculating basic and diluted earnings per shares.
94
Quarterly Financial Data
The following table sets forth unaudited consolidated statements of operations data for each
quarter during CytRxs most recent two fiscal years. This quarterly information has been derived
from CytRxs unaudited consolidated financial statements and, in the opinion of management,
includes all adjustments, consisting only of normal recurring adjustments, necessary for a fair
presentation of the information for the periods covered. The quarterly financial data should be
read in conjunction with CytRxs consolidated financial statements and related notes. The operating
results for any quarter are not necessarily indicative of the operating results for any future
period.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quarters Ended |
|
|
|
March 31 |
|
|
June 30 |
|
|
September 30 |
|
|
December 31 |
|
|
|
(In thousands, except per share data) |
|
2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
1,563 |
|
|
$ |
2,371 |
|
|
$ |
2,046 |
|
|
$ |
1,479 |
|
Net loss |
|
|
(4,546 |
) |
|
|
(6,285 |
) |
|
|
(4,597 |
) |
|
|
(6,462 |
) |
Deemed dividend for anti-dilution
adjustments made to outstanding common
stock warrants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss applicable to common stockholders |
|
$ |
(4,546 |
) |
|
$ |
(6,285 |
) |
|
$ |
(4,597 |
) |
|
$ |
(6,462 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share
applicable to common stock |
|
$ |
(0.06 |
) |
|
$ |
(0.07 |
) |
|
$ |
(0.05 |
) |
|
$ |
(0.07 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
61 |
|
|
$ |
|
|
|
$ |
776 |
|
|
$ |
1,229 |
|
Net loss |
|
|
(4,166 |
) |
|
|
(5,465 |
) |
|
|
(2,972 |
) |
|
|
(4,148 |
) |
Deemed dividend for anti-dilution
adjustments made to outstanding common
stock warrants |
|
|
(488 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss applicable to common stockholders |
|
$ |
(4,654 |
) |
|
$ |
(5,465 |
) |
|
$ |
(2,972 |
) |
|
$ |
(4,148 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share
applicable to common stock |
|
$ |
(0.07 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.06 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Quarterly and yearly loss per share amounts are computed independently of each other.
Therefore, the sum of the per-share amounts for the quarters may not equal the per-share amounts
for the year. In 2006, CytRx adopted SFAS 123(R), and in 2007 and 2006 CytRx incurred $2.7 million
and $1.2 million, respectively, in employee non-cash compensation expenses. No corresponding
expense was recorded in 2005.
In connection with CytRxs adjustment to the exercise terms of certain outstanding warrants to
purchase common stock on March 2, 2006 and on January 20, 2005, CytRx recorded deemed dividends of
$488,000 and $1.1 million, respectively. These deemed dividends are reflected as an adjustment to
net loss for the first quarter of 2006 and the year ended 2005 to arrive at net loss applicable to
common stockholders on the consolidated statements of operations and for purposes of calculating
basic and diluted earnings per share.
Fourth Quarter Adjustment
During the fourth quarter of 2007, CytRx recorded adjustments for (i) additional compensation
expense of $236,000 related to previously granted non-employee stock options, (ii) additional
compensation expense of $350,000 related to stock options previously granted to directors and (iii)
additional general and administrative expense of $192,000 related to legal fees rendered during the
third quarter. Management concluded the effect of these adjustments was not material to any
previously reported quarterly period.
Liquidity and Capital Resources
General
CytRx has relied primarily upon proceeds from sales of its equity securities and the exercise
of options and warrants, and to a much lesser extent upon payments from strategic partners and
licensees, to
95
generate funds needed to finance its business and operations. At March 31, 2008, CytRx had
cash, cash equivalents and short-term investments of approximately $43.5 million. CytRx believes
that its current resources will be sufficient to support its currently planned level of operations
into the second half of 2009. This estimate is based, in part, upon CytRxs currently projected
expenditures for the remainder of 2008 and the first three months of 2009 of approximately $23.9
million, including approximately $1.5 million of direct expenditures for CytRxs planned clinical
program for arimoclomol for ALS and related studies, approximately $0.5 million of direct
expenditures for its planned clinical program for arimoclomol for stroke recovery and related
studies, approximately $6.1 million of direct expenditures for its planned Phase II clinical trial
of iroxanadine for diabetic ulcers, approximately $7.7 million for the operations of its research
laboratory in San Diego, California, and approximately $8.1 million for other general and
administrative expenses. CytRxs projected expenditures are based on CytRxs recently announced
plan to conduct additional animal toxicology studies prior to the resumption of its Phase II
clinical program for arimoclomol for ALS that currently is on clinical hold by the FDA and prior to
any initiation of its Phase II clinical trial for arimoclomol for stroke recovery. Those animal
toxicology studies are expected to take approximately one year. If CytRx is required to alter the
design of its Phase II clinical trial, including the possible reduction of the dosage of
arimoclomol, or is prohibited by the FDA from resuming the current planned clinical trial or
initiating any other clinical trial of arimoclomol for the treatment of ALS or stroke recovery at
the desired dose, or at all, due to safety concerns, then CytRxs actual expenditures will vary,
perhaps significantly from its projections.
CytRx has no significant revenue, and expects to have no significant revenue and to continue
to incur significant losses over the next several years. CytRxs net losses may increase from
current levels primarily due to expenses related to its ongoing and planned clinical trials,
research and development programs, possible technology acquisitions, and other general corporate
activities. In the event that actual costs of CytRxs ongoing and planned activities are
significantly higher than its current estimates, CytRx may be required to significantly modify its
planned level of operations.
In the future, CytRx will be dependent on obtaining financing from third parties in order to
maintain its operations. CytRx cannot assure that additional funding will be available on
satisfactory terms, or at all. If CytRx fails to obtain additional funding when needed in the
future, it would be forced to scale back, or terminate, its operations, or to seek to merge with or
to be acquired by another company.
Three Months Ended March 31, 2008 and 2007
CytRxs net loss, which includes non-cash charges relating to (1) common stock, stock option
and warrants issued for services and (2) expenses related to employee stock options, increased by
approximately $0.8 million from the quarter ended March 31, 2007 to the quarter ended March 31,
2008. This increase was due to several factors, including an additional $0.9 million of
professional and consulting fees associated with ongoing compliance with the Sarbanes-Oxley Act and
professional fees and other costs related to RXis registration statement filed with respect to
CytRxs distribution of shares of RXi common stock to CytRx stockholders in March 2008. Research
and development expenses decreased by approximately $0.5 million, principally because RXis
expenses for the month of March were excluded. CytRxs total expenses were partially offset by an
increase of $0.6 million in service revenue.
In the three-month period ended March 31, 2008, $0.6 million of cash was used in investing
activities, compared to $3,000 used in the same period in 2007. The 2008 period included $10.0
million of funds provided by RXis short-term investments to cash equivalents. However, RXis cash
of $10.4 million (inclusive of this $10.0 million) is no longer available to CytRx due to the
partial distribution of RXi shares. The remainder of the investing activity for both the 2008 and
2007 periods related primarily to cash used for the purchase of equipment. CytRx manages its cash,
cash equivalents and short-term investments interchangeably, and at the present time anticipates no
significant changes to its current holdings in cash equivalents. CytRx expects capital spending to
continue due to additional laboratory equipment necessary for its San Diego, California,
laboratory.
96
Cash provided by financing activities in the three months ended March 31, 2008 and 2007 was
$0.9 million and $11.1 million, respectively, which consisted almost exclusively of funds received
from the exercise of stock options and warrants.
CytRx is evaluating other potential future sources of funding, as it does not currently have
commitments from any third parties to provide any funding. The results of CytRxs technology
licensing efforts and the actual proceeds of any fund-raising activities will determine its ongoing
ability to operate as a going concern. CytRxs ability to obtain future funding through joint
ventures, product licensing arrangements, royalty sales, equity financings, gifts, and grants or
otherwise is subject to market conditions and its ability to identify parties that are willing and
able to enter into such arrangements on terms that are satisfactory to CytRx. Depending upon the
outcome of its fundraising efforts, the accompanying consolidated financial information may not
necessarily be indicative of CytRxs future operating results or future financial condition.
CytRx expects to incur significant losses for the foreseeable future, and there can be no
assurance that CytRx will become profitable. If CytRx becomes profitable, it may not be able to
sustain that profitability.
Discussion of Operating, Investing and Financing Activities
Three Months Ended March 31, 2008 and 2007
Net loss for the three-month period ended March 31, 2008 was $5.4 million, and cash used for
operations for that period was $7.3 million. Major adjustments to reconcile net loss to net cash
used in operating activities included $0.6 million of employee stock option expense, offset by a
net change in assets and liabilities of $2.9 million. For the three-month period ended March 31,
2007, net loss was $4.5 million, and cash used for operations for that period was $5.1 million.
Major adjustments to reconcile net loss to net cash used in operating activities included $1.1
million in stock option and warrant expense, offset by a net change in assets and liabilities of
$0.5 million.
In the three-month period ended March 31, 2008, there was $0.6 million of cash used in
investing activities, compared to $3,000 used in the respective 2007 period. The 2008 period
included $10.0 million of funds provided by RXi converting short-term investments to cash
equivalents. However, RXis cash of $10.4 million (inclusive of this $10.0 million) is no longer
available to CytRx due to the deconsolidation. The remainder of the investing activity for both the
2008 and 2007 periods primarily related to cash used for the purchase of equipment.
Cash provided by financing activities in the three months ended March 31, 2008 and 2007 was
$0.9 million and $11.1 million, respectively, which consisted almost exclusively of funds received
from the exercise of stock options and warrants.
Three Years Ended December 31, 2007, 2006 and 2005
Net loss for the year ended December 31, 2007 was $21.9 million, and cash used for operating
activities for that period was $22.4 million. The net loss for the year reflects $7.2 million of
non-cash revenue recognized under the 2006 agreement with ALSCRT and $3.5 million for stock option
and warrant expense.
Net loss for the year ended December 31, 2006 was $16.8 million, and cash provided from
operating activities for that period was $9.4 million. The cash provided from operating activities
includes net proceeds of $24.3 million received from ALSCRT reflected in August 2006 in connection
with the sale of a one percent royalty interest in CytRxs worldwide sales of arimoclomol for ALS.
Reflected in the net loss of $16.8 million is $1.8 million of revenue recognized in 2006 in
connection with that sale. The remaining $22.5 million of the net proceeds from that sale were
recorded as deferred revenues. Other non-cash items included in CytRxs net loss necessary to
reconcile cash provided from operating activities include $1.7 million in stock option expense
related to options granted to employees and consultants, of which $1.2 million of expenses for
employee
97
options was recorded under SFAS 123(R), which CytRx adopted in 2006. Accordingly, no
corresponding amount was recorded in earlier periods.
Net loss for the year ended December 31, 2005 was $15.1 million, which resulted in net cash
used in operating activities of $14.5 million. Adjustments to reconcile net loss to net cash used
in operating activities for the year ended December 31, 2005 were primarily $586,000 of stock
option expense related to options granted to consultants, as well as $217,000 of depreciation and
amortization, which was substantially offset by a net change in assets and liabilities of $210,000.
For the year ended December 31, 2007, $11.1 million was used in investing activities. Of this
amount, RXi used $9.8 million for the purchase of short-term investments. The remaining $1.2
million was used for the purchase of equipment and furnishings, primarily associated with equipping
CytRxs San Diego laboratory. For the year ended December 31, 2006, an immaterial amount of cash
was used in investing activities. For the year ended December 31, 2005, CytRx redeemed an
approximately $1.0 million certificate of deposit. Other investing activities consisted primarily
of the purchase of small amounts of computers and laboratory equipment
Cash provided by financing activities for the year ended December 31, 2007 was $53.5 million
compared to $12.8 million and $19.8 million in the years ended December 31, 2006 and 2005,
respectively. During 2007, CytRx raised $34.2 million in a private placement of CytRxs common
stock and an additional $18.8 million from the exercise of previously outstanding stock options and
warrants. During 2006, CytRx raised $12.4 million through a private placement of CytRxs common
stock and an additional $0.4 million from the exercise of stock options and warrants. During the
year ended December 31, 2005, CytRx raised $19.6 million through a private placement of common
stock.
Contractual Obligations
CytRx has in the past acquired assets still in development pursuant to arrangements with third
parties that require milestone payments or royalty payments to the third party contingent upon the
occurrence of certain future events linked to the progress or success of the product development
efforts. Milestone payments may be contingent upon the successful achievement of an important
point in the development life cycle of the product such as approval of the product for marketing by
a regulatory agency. CytRx also may have to make royalty payments based upon a percentage of the
sales of the product in the event that regulatory approval for marketing is obtained. These
milestone payments may be material. Because of the contingent nature of these payments, however,
they are not included in the table of contractual obligations.
As a result of RXis separation from CytRx in March 2008, each of CytRx and RXi are
responsible for their respective future contractual obligations. Accordingly, the following table
omits the contractual obligations of RXi, including obligations under agreements assigned and
contributed to RXi by CytRx for which CytRx remains secondarily liable.
98
CytRxs current contractual obligations that will require future cash payments are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-Cancelable |
|
|
Cancelable |
|
|
|
|
|
|
Operating |
|
|
Employment |
|
|
|
|
|
|
Research and |
|
|
License |
|
|
|
|
|
|
|
|
|
Leases |
|
|
Agreements |
|
|
Subtotal |
|
|
Development |
|
|
Agreements |
|
|
Subtotal |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(In thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
|
(2) |
|
|
|
|
|
|
(3) |
|
|
|
|
|
|
|
|
|
Total |
|
2008 |
|
$ |
446 |
|
|
$ |
900 |
|
|
$ |
1,346 |
|
|
$ |
4,035 |
|
|
$ |
|
|
|
$ |
4,035 |
|
|
$ |
5,381 |
|
2009 |
|
|
236 |
|
|
|
650 |
|
|
|
886 |
|
|
|
3,279 |
|
|
|
|
|
|
|
3,279 |
|
|
|
4,165 |
|
2010 |
|
|
145 |
|
|
|
|
|
|
|
145 |
|
|
|
3,045 |
|
|
|
|
|
|
|
3,045 |
|
|
|
3,190 |
|
2011 |
|
|
11 |
|
|
|
|
|
|
|
11 |
|
|
|
2,188 |
|
|
|
|
|
|
|
2,188 |
|
|
|
2,199 |
|
2012 and thereafter |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
681 |
|
|
|
|
|
|
|
681 |
|
|
|
681 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
838 |
|
|
$ |
1,550 |
|
|
$ |
2,388 |
|
|
$ |
13,228 |
|
|
$ |
|
|
|
$ |
13,228 |
|
|
$ |
15,616 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Operating lease obligations are primarily facility lease related obligations, as well as
equipment and software lease obligations with third party vendors. |
|
(2) |
|
Employment agreement obligations include management contracts, as well as scientific advisory
board member compensation agreements. Certain agreements, which have been revised from time to
time, provide for minimum salary levels, adjusted annually at the discretion of CytRxs
Compensation Committee, as well as for minimum bonuses. |
|
(3) |
|
Research and development obligations relate primarily to clinical trials. Most of these
purchase obligations are cancelable. |
Net Operating Loss Carryforwards
At December 31, 2007, CytRx had United States federal and state net operating loss
carryforwards of $109 million and $52 million, respectively, available to offset against future
taxable income, which expire in 2010 through 2027. As a result of a change in-control that occurred
in CytRxs stockholder base in July 2002, approximately $45 million in federal net operating loss
carryforwards became limited in their availability to $0.7 million annually. Management of CytRx
believes that the remaining $64 million in federal net operating loss carryforwards, and the $52
million in state net operating loss carryforwards, are unrestricted. In March 2008, CytRx
distributed approximately 4.5 million shares of RXi common stock to CytRx stockholders. CytRx will
recognize approximately a $32.9 million gain for income tax purposes on the distribution of RXi
shares, which is the amount of the excess of the fair market value of the shares distributed over
CytRxs basis. The gain will be included in determining whether CytRx has current year earnings
and profits subject to taxation. Based upon CytRxs anticipated loss from operations for 2008 and
currently available loss carryforwards, CytRx expects to pay no regular income taxes in connection
with the distribution; however, CytRx has recorded a tax provision of $342,000 related to the
estimated Alternative Minimum Tax resulting from this gain. Additionally, due to the
change-in-control, approximately $6.3 million of research and development tax credits will not be
available for utilization and were written off. As of December 31, 2007, CytRx also had research
and development and orphan drug credits for federal and state income tax purposes of approximately
$3 million and $2 million, respectively, which will expire in 2023 through 2027. Based on an
assessment of all available evidence including, but not limited to, CytRxs limited operating
history in CytRxs core business and lack of profitability, uncertainties of the commercial
viability of CytRxs technology, the impact of government regulation and healthcare reform
initiatives, and other risks normally associated with biotechnology companies, CytRx has concluded
that it is more likely than not that these net operating loss carryforwards and credits will not be
realized and, as a result, a 100% deferred income tax valuation allowance has been recorded against
these assets.
99
Results of Operations
Three Months Ended March 31, 2008 and 2007
CytRx recorded a net loss of approximately $5.4 million for the three-month period ended March
31, 2008, as compared to $4.5 million for the same period in 2007.
CytRx recognized $2.2 million of revenue for the three-month period ended March 31, 2008, and
$1.6 million for the same period in 2007. CytRx recognized $2.2 million and $1.4 million during
those periods, respectively, from its $24.3 million sale to the ALSCRT of a 1% royalty interest in
worldwide sales of arimoclomol in August 2006. All future licensing fees under CytRxs current
licensing agreements are dependent upon successful development milestones being achieved by the
licensor. During 2008, CytRx does not anticipate receiving any significant licensing fees. CytRx
will continue to recognize the balance of the deferred revenue recorded from the royalty
transaction with the ALSCRT over the development period of its arimoclomol research.
Three Years Ended December 31, 2007, 2006 and 2005
CytRx recorded net losses of $21.9 million, $16.8 million and $15.1 million during the years
ended December 31, 2007, 2006 and 2005, respectively.
During fiscal 2007, CytRx recognized $7.2 million in service revenues relating to its $24.3
million sale to the ALSCRT of a one percent royalty interest in the worldwide sales of arimoclomol
in August 2006. This compares to $1.9 million in services revenues in the year ended December 31,
2006, of which $1.8 million related to the sale of royalty interest sold to ALSCRT. During 2007 and
2006, CytRx earned an immaterial amount of license fees and grant revenue. In the year ended
December 31, 2005, CytRx earned an immaterial amount of service and license fee revenue. All future
licensing fees under CytRxs current licensing agreements are dependent upon successful development
milestones being achieved by the licensor. During fiscal 2008, CytRx is not anticipating the
receipt of any significant service or licensing fees, although CytRx estimates that it will
recognize an additional $8.4 million in service revenues from that arimoclomol royalty transaction
with ALSCRT. CytRx will continue to recognize the balance of the deferred revenue recorded from the
royalty transaction with the ALSCRT based on actual research and development costs incurred over
the development period of CytRxs arimoclomol research.
Research and Development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
Years Ended December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2007 |
|
|
2006 |
|
|
2005 |
|
|
|
(In thousands) |
|
|
Research and
development expense |
|
$ |
3,125 |
|
|
$ |
3,209 |
|
|
$ |
14,212 |
|
|
$ |
8,649 |
|
|
$ |
8,662 |
|
Non-cash research
and development
expense |
|
|
(243 |
) |
|
|
695 |
|
|
|
3,778 |
|
|
|
674 |
|
|
|
220 |
|
Employee stock
option expense |
|
|
199 |
|
|
|
37 |
|
|
|
592 |
|
|
|
249 |
|
|
|
|
|
Depreciation and
amortization |
|
|
111 |
|
|
|
67 |
|
|
|
242 |
|
|
|
209 |
|
|
|
205 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
3,192 |
|
|
$ |
4,008 |
|
|
$ |
18,824 |
|
|
$ |
9,781 |
|
|
$ |
9,087 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research expenses are expenses incurred by CytRx in the discovery of new information that will
assist CytRx in the creation and the development of new drugs or treatments. Development expenses
are expenses incurred by CytRx in its efforts to commercialize the findings generated through
CytRxs research efforts.
Research and development expenses incurred during the three-month periods ended March 31, 2008
and 2007 and during 2007, 2006 and 2005 related primarily to (i) CytRxs Phase II clinical program
for
100
arimoclomol in ALS, (ii) CytRxs ongoing research and development related to other
molecular chaperone amplification drug candidates, (iii) the acquisition of technologies covered by
RXis license agreements with UMMS, (iv) CytRxs prior collaboration and invention disclosure
agreement pursuant to which UMMS had agreed to disclose certain inventions to CytRx and provide
CytRx with the right to acquire an option to negotiate exclusive licenses for those disclosed
technologies, and (v) the small molecule drug discovery and development operations at CytRxs
former Massachusetts and new San Diego, California laboratories. All research and development costs
related to the activities of CytRxs former laboratory were expensed.
As compensation to members of CytRxs and RXis scientific advisory board, or SAB, and
consultants, and in connection with the acquisition of technology, CytRx and RXi sometimes issue
shares of common stock, stock options and warrants to purchase shares of common stock. For
financial statement purposes, CytRx values these shares of common stock, stock options, and
warrants at the fair value of the common stock, stock options or warrants granted, or the services
received, whichever is more reliably measurable. The value of the non-employee option grants are
marked to market using the Black-Scholes option pricing model, and the compensation expense
recognized or recovered is adjusted accordingly. CytRx recorded charges (recovery) of ($243,000)
and $695,000 in this regard during the three-month periods ended March 31, 2008 and 2007,
respectively, and $3.8 million, $0.7 million, and $0.2 million in this regard during 2007, 2006,
and 2005, respectively. Included in the research and development charges for 2007 were $2.3 million
of expense related to RXis issuance of 462,112 shares of common stock to UMMS for certain license
agreement rights and a new invention disclosure agreement and $1.0 million for non-qualifying stock
options to SAB members of RXi. CytRx recorded $0.2 million and $37,000 of employee stock option
expense during the three-month periods ended March 31, 2008 and 2007, respectively, and for the
year ended December 31, 2007, recorded $0.6 million of employee stock option expense as compared to
$0.2 million in 2006 and none in 2005.
In 2008, CytRx expects its research and development expenses to remain relatively steady as a
result of decreased expenses related to CytRxs clinical program with arimoclomol for ALS and
related studies, offset by increased expenses related to CytRxs planned clinical trial for
iroxanadine for diabetic foot ulcers and expenses of CytRxs San Diego laboratory.
General and Administrative Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
Years Ended December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2007 |
|
|
2006 |
|
|
2005 |
|
|
|
(In thousands) |
|
|
General and administrative expenses |
|
$ |
3,603 |
|
|
$ |
2,369 |
|
|
$ |
12,636 |
|
|
$ |
8,604 |
|
|
$ |
6,045 |
|
Non-cash general and
administrative expenses |
|
|
189 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock, stock option and warrant
expenses to non-employees and
consultants |
|
|
|
|
|
|
|
|
|
|
2 |
|
|
|
60 |
|
|
|
367 |
|
Employee stock option expense |
|
|
659 |
|
|
|
112 |
|
|
|
2,154 |
|
|
|
975 |
|
|
|
|
|
Depreciation and amortization |
|
|
22 |
|
|
|
4 |
|
|
|
30 |
|
|
|
18 |
|
|
|
12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
4,473 |
|
|
$ |
2,485 |
|
|
$ |
14,822 |
|
|
$ |
9,657 |
|
|
$ |
6,424 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative expenses include all administrative salaries and general corporate
expenses, including legal expenses associated with the prosecution of CytRxs intellectual
property. CytRxs general and administrative expenses, excluding common stock, stock options and
warrants issued, and excluding depreciation expense, were $12.7 million in 2007, $8.6 million in
2006 and $6.1 million in 2005. General and administrative expenses increased by $4.1 million in
2007 as compared to 2006 primarily due to increased audit, legal and consulting fees and higher
employment costs. Audit fees increased by approximately $1.1 million primarily related to CytRxs
annual audit, compliance with the internal control provisions of the Sarbanes-Oxley Act and RXis
registration statement relating to CytRxs partial spin-off of
RXi. Legal fees increased by approximately $0.9 million primarily related to RXis registration statement,
increased patent
101
work, license negotiation fees and other legal matters, including possible
financing transactions. Recruiting and consulting fees increased by approximately $0.7 million
related to recruiting officers, financial and scientific personnel and consultants assisting with
the preparation of RXis registration statement. Employment costs increased by approximately $1.4
million related to wages and bonuses for additional personnel for RXi and annual increases for
other employees. General and administrative expenses increased by $2.6 million in 2006 as compared
to 2005 as a result of initial Sarbanes-Oxley Act compliance efforts and increases in
administrative salaries and legal expenses. The legal expense increase of $0.6 million was
associated with maintenance of CytRxs patent portfolio and the formation of RXi. In CytRxs
efforts to comply with the Sarbanes-Oxley Act for the year ended December 31, 2006, CytRx incurred
approximately $0.8 million in consulting, audit and accounting system conversion expense. CytRx was
required to comply with the attestation requirements under Section 404 of the Sarbanes-Oxley Act
for the first time for the year ended December 31, 2006; therefore, there are no corresponding
expenses in 2005. In 2006, CytRxs general and administrative salaries increased by $0.6 million
over the 2005 expense level as a result of higher bonuses, additional regulatory and accounting
personnel and annual salary increases.
General and administrative expenses, excluding stock option expense and depreciation expense,
were $3.6 million for the first three months of 2008, compared to $2.4 million for the related
period in 2007. General and administrative expenses increased by $1.9 million in the first quarter
of 2008 as compared to 2007 primarily due to increased audit, legal and consulting fees and higher
employment costs. Audit fees associated with CytRxs annual audit, compliance with the internal
control provisions of the Sarbanes-Oxley Act and RXis registration statement relating to CytRxs
partial spinoff of RXi increased by approximately $550,000. Legal fees increased by approximately
$160,000 primarily related to RXis registration statement, increased patent work and other legal
matters, including possible financing transactions. Recruiting and consulting fees increased by
approximately $190,000 related to the recruitment of additional officers, financial and scientific
personnel and the engagement of consultants to assist with the preparation of RXis registration
statement. Employment costs increased by approximately $121,000 related to wages and bonuses for
additional personnel for RXi and annual increases for other employees. Printing costs and other
expenses relating to the filing of RXis registration statement totaled approximately $180,000.
From time to time, CytRx issues shares of common stock or warrants or options to purchase
common stock to consultants and other service providers in exchange for services. For financial
statement purposes, CytRx values these shares of common stock, stock options, and warrants at the
fair value of the common stock, stock options or warrants granted, or the services received,
whichever CytRx can measure more reliably. CytRx recorded no such charges during 2007 and recorded
$0.1 million during 2006 and $0.4 million during 2005 related primarily to common stock, stock
options and warrants issued for licensing fees and in connection with the engagement and retention
of financial, business development and scientific advisors.
CytRx recorded approximately $659,000 of employee stock option expense during the three-month
period ended March 31, 2008 as compared to approximately $112,000 during the three-month period
ended March 31, 2007. Of this increase, approximately $370,000 related to RXi and $177,000 related
to CytRx. In March 2008, CytRx awarded RXi common stock to directors and certain employees and
recorded the $189,000 fair value as non-cash compensation expense. There were no comparable awards
in the 2007 period.
Since CytRxs adoption of SFAS 123(R) during 2006, CytRx recorded $2.7 million in fiscal 2007
and $1.0 million in fiscal 2006 of employee stock option expense. No corresponding expense existed
in 2005. The increase in 2007 over 2006 primarily related to stock options granted by RXi to
recruit and retain directors, officers and additional employees.
Depreciation and amortization
Depreciation expense reflects the depreciation of equipment and furnishings and the
amortization expenses related to CytRxs molecular library, which was placed in service in March
2005. These expenses are
102
classified as research and development or general and administrative expenses, depending upon
the associated business activity.
Depreciation
and amortization expenses were $272,000, $227,000 and $217,000 in 2007, 2006 and
2005, respectively. The depreciation expense reflects the depreciation of CytRxs fixed assets and
the amortization expenses related to CytRxs molecular library, which was placed in service in
March 2005.
Other Income
In June 2007, CytRx recognized $1.5 million of income arising from a fee received pursuant to
a change-in-control provision included in the purchase agreement for CytRxs 1998 sale of its
animal pharmaceutical unit. Management concluded that the fee did not represent revenue generated
in the normal course of CytRxs business and, accordingly, CytRx recorded this fee as other income.
In March 2008, CytRx recognized $218,000 of other income related to gain on shares of RXi stock
awarded as bonuses to certain CytRx employees and directors.
Interest income
Interest income was $2,664,000 in 2007, as compared to $997,000 in 2006 and $206,000 in 2005.
The variances between years were attributable primarily to the amount of funds available for
investment each year and, to a lesser extent, changes in prevailing market rates.
Interest income was $0.5 million for the three months ended March 31, 2008, compared to $0.4
million for the comparable period in 2007. The difference between periods is attributable primarily
to the cash available for investment each year.
Minority interest in losses of subsidiary
CytRx recorded $81,000 in 2005 related to the 5% minority interest in losses of CytRxs former
CytRx Laboratories subsidiary. There was no minority interest in losses recorded in 2006, since on
June 30, 2005 CytRx repurchased the 5% minority interest. On September 30, 2005, CytRx merged CytRx
Laboratories into CytRx. CytRx recorded $0.4 million in 2007 related to the 15% minority interest
in losses of RXi.
CytRx offset $88,000 of minority interest in losses of RXi against CytRxs net loss for the
months of January and February 2008. For March 2008, CytRx did not record a minority interest in
the losses of RXi, as RXis gain and losses were accounted for under the equity method following
CytRxs distribution to its stockholders of RXi shares. CytRx offset $2,000 of minority interest
in losses of RXi against its net loss for the three months ended March 31, 2007.
Income Taxes
In March 2008, CytRx distributed approximately 4.5 million shares of RXi common stock to CytRx
stockholders. CytRx will recognize approximately a $32.9 million gain for income tax purposes on
the distribution of RXi shares, which is the amount of the excess of the fair market value of the
shares distributed over CytRxs basis. The gain will be included in determining whether CytRx has
current year earnings and profits subject to taxation. Based upon CytRxs anticipated loss from
operations for 2008 and currently available loss carryforwards, CytRx expects to pay no regular
income taxes in connection with the distribution, however, CytRx has recorded a tax provision of
$342,000 related to the estimated Alternative Minimum Tax resulting from this gain.
103
Recent Accounting Pronouncements
In July 2006, the Financial Accounting Standards Board (FASB) issued Interpretation No. 48,
Accounting for Uncertainty in Income Taxes, an interpretation of FASB Statement No. 109 (FIN No.
48), to create a single model to address accounting for uncertainty in tax positions. FIN No. 48
clarifies the accounting for income taxes by prescribing a minimum recognition threshold in which a
tax position be reached before financial statement recognition. FIN No. 48 also provides guidance
on derecognition, measurement, classification, interest and penalties, accounting in interim
periods, disclosure and transition. FIN No. 48 is effective for fiscal years beginning after
December 15, 2006. CytRx adopted FIN No. 48 as of January 1, 2007, as required. The adoption of FIN
No. 48 did not have an impact on CytRxs financial position and results of operations.
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements (SFAS No. 157).
SFAS No. 157 defines fair value, establishes a framework for measuring fair value in accordance
with generally accepted accounting principles, and expands disclosures about fair value
measurements. The Statement was effective for fiscal periods beginning after November 15, 2007.
SFAS No. 157 does not expand the use of fair value in any new circumstances. In February 2008, the
FASB issued Staff Position No. FAS 157-1, which amended SFAS No. 157 to exclude SFAS No. 13,
Accounting for Leases, and other accounting pronouncements that address fair value measurements for
purposes of lease classification or measurement under Statement 13. However, this scope exception
does not apply to assets acquired and liabilities assumed in a business combination. Also in
February 2008, the FASB issued Staff Position No. FAS 157-2, which delayed the effective date of
SFAS No. 157 for non-financial assets and liabilities, except those items recognized at fair value
on an annual or more frequently recurring basis to fiscal years beginning after November 15, 2008
and interim periods within those fiscal years. The adoption of SFAS No. 157 did not have a
significant impact on CytRxs financial statements.
In February 2007, the FASB issued SFAS No. 159, Fair Value Option for Financial Assets and
Financial Liabilities (SFAS No. 159). SFAS No. 159 permits entities to choose to measure many
financial assets and financial liabilities at fair value. Unrealized gains and losses on items for
which the fair value option has been elected are reported in earnings. SFAS No. 159 is effective
for fiscal years beginning after November 15, 2007. The adoption
of SFAS No. 159 did not have a
significant impact on CytRxs financial statements.
In June 2007, the FASB ratified the consensus on Emerging Issues Task Force (EITF) Issue No.
06-11, Accounting for Income Tax Benefits of Dividends on Share-Based Payment Awards (EITF
06-11). EITF 06-11 requires companies to recognize the income tax benefit realized from dividends
or dividend equivalents that are charged to retained earnings and paid to employees for non-vested
equity-classified employee share-based payment awards as an increase to additional paid-in capital.
EITF 06-11 is effective for fiscal years beginning after September 15, 2007. The adoption of EITF
06-11 did not have a significant impact on CytRxs financial statements.
In June 2007, the FASB ratified the consensus reached on EITF Issue No. 07-3, Accounting for
Nonrefundable Advance Payments for Goods or Services Received for Use in Future Research and
Development Activities (EITF 07-3), which requires that nonrefundable advance payments for goods
or services that will be used or rendered for future research and development activities be
deferred and amortized over the period that the goods are delivered or the related services are
performed, subject to an assessment of recoverability. EITF 07-3 will be effective for fiscal years
beginning after December 15, 2007. The adoption of EITF 07-3 did not have a significant impact on
CytRxs financial statements.
In December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in Consolidated
Financial Statements (SFAS No. 160) and a revision to SFAS No. 141, Business Combinations (SFAS
No. 141R). SFAS No. 160 modifies the accounting for noncontrolling interest in a subsidiary and
the deconsolidation of a subsidiary. SFAS No. 141R establishes the measurements in a business
combination of
104
the identifiable assets acquired, the liabilities assumed and any noncontrolling interest in
the acquiree. Both of these related statements are effective for fiscal years beginning after
December 15, 2008. CytRx has not yet determined the impact that the recent adoption of these two
statements may have on CytRxs financial statements.
In December 2007, the SEC issued Staff Accounting Bulletin 110 (SAB 110), which expresses
the views of the Staff regarding use of a simplified method, as discussed in SAB 107, in
developing an estimate of expected term of plain vanilla share options in accordance with
Statement of Financial Accounting Standards No. 123. SAB 110 will allow, under certain
circumstances, the use of the simplified method beyond December 31, 2007 when an issuer is unable
to rely on the historical exercise data. CytRx does not expect the adoption of SAB 110 to have a
material impact on CytRxs financial statements.
Off-Balance Sheet Arrangements
CytRx has not entered into off-balance sheet financing arrangements, other than operating
leases.
Quantitative And Qualitative Disclosures About Market Risk
CytRxs exposure to market risk is limited primarily to interest income sensitivity, which is
affected by changes in the general level of interest rates in the United States, particularly
because a significant portion of CytRxs investments are in short-term debt securities issued by
the U.S. government and institutional money market funds. The primary objective of CytRxs
investment activities is to preserve principal. Due to the nature of CytRxs short-term
investments, CytRx believes that it is not subject to any material market risk exposure. CytRx
does not have any derivative financial instruments or foreign currency instruments. Had interest
rates varied by 10% in the year ended December 31, 2007, there would have been no material effect
on CytRxs results of operations or cash flows for that period.
105
CYTRX DIRECTORS AND EXECUTIVE OFFICERS
The following table sets forth information concerning CytRxs directors and executive
officers:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of |
|
|
Name |
|
Age |
|
Director(1) |
|
Position |
Max Link, Ph.D.
|
|
|
67 |
|
|
III
|
|
Director, Chairman of the Board(2)(3) |
Steven A. Kriegsman
|
|
|
66 |
|
|
II
|
|
Director, Chief Executive Officer, President |
Marvin R. Selter
|
|
|
80 |
|
|
II
|
|
Director, Vice Chairman of the Board(2)(3)(4) |
Louis Ignarro, Ph.D.
|
|
|
67 |
|
|
I
|
|
Director |
Joseph Rubinfeld, Ph.D.
|
|
|
75 |
|
|
I
|
|
Director(2)(4) |
Richard L. Wennekamp
|
|
|
65 |
|
|
II
|
|
Director(2)(3)(4) |
Mitchell K. Fogelman
|
|
|
56 |
|
|
|
|
Chief Financial Officer, Treasurer |
Jack R. Barber, Ph.D.
|
|
|
52 |
|
|
|
|
Chief Scientific Officer |
Shi Chung Ng, Ph.D.
|
|
|
54 |
|
|
|
|
Senior Vice President Research and Development |
Benjamin S. Levin
|
|
|
32 |
|
|
|
|
General Counsel, Vice President Legal Affairs
and Corporate Secretary |
John Y. Caloz
|
|
|
56 |
|
|
|
|
Chief Accounting Officer |
|
|
|
(1) |
|
The Class III director serves until the 2009 annual meeting of stockholders, Class I
directors serve until the 2010 annual meeting of stockholders and Class II directors serve
until the 2011 annual meeting of stockholders. |
|
(2) |
|
Members of our Audit Committee. Mr. Selter is the Chairman of the Committee. |
|
(3) |
|
Members of Nominating and Corporate Governance Committee. Mr. Wennekamp is Chairman of the
Committee. |
|
(4) |
|
Members of Compensation Committee. Dr. Rubinfeld is Chairman of the committee. |
Max Link, Ph.D. has been a director since 1996. Dr. Link has been retired from business since
2003. From March 2002 until its acquisition by Zimmer Holdings, Dr. Link served as Chairman and
Chief Executive Officer of Centerpulse, Ltd. From May 1993 to June 1994, Dr. Link served as the
Chief Executive Officer of Corange Ltd. (the holding company for Boehringer Mannheim Therapeutics,
Boehringer Mannheim Diagnostics and DePuy International). From 1992 to 1993, Dr. Link was Chairman
of Sandoz Pharma, Ltd. From 1987 to 1992, Dr. Link was the Chief Executive Officer of Sandoz Pharma
and a member of the Executive Board of Sandoz, Ltd., Basel. Prior to 1987, Dr. Link served in
various capacities with the United States operations of Sandoz, including President and Chief
Executive Officer. Dr. Link also serves as a director of Alexion Pharmaceuticals, Inc., Celsion
Corporation and Discovery Laboratories, Inc., each of which is a public company.
Steven A. Kriegsman has been a director and President and Chief Executive Officer since July
2002, and serves as the President and Chief Executive Officer and a director of Merger Subsidiary.
He also serves as a director of RXi and of Hythiam, Inc., both of which are publicly held
companies. He previously served as Director and Chairman of Global Genomics from June 2000 until
our merger with Global Genomics in July 2002. Mr. Kriegsman is the Chairman of the Board and
founder of Kriegsman Capital Group LLC, a financial advisory firm specializing in the development
of alternative sources of equity capital for emerging growth companies in the healthcare industry.
He has advised such companies as SuperGen Inc., Closure Medical Corporation, Novoste Corporation,
Miravant Medical Technologies, and Maxim Pharmaceuticals. Mr. Kriegsman has a B.S. degree with
honors from New York University in accounting and completed the Executive Program in Mergers and
Acquisitions at New York University, The Management Institute. Mr. Kriegsman was formerly a
Certified Public Accountant with KPMG in New York City. From June 2003 until February 2008, he
served as a Director, and he is the former Chairman of the Audit Committee of, Bradley
Pharmaceuticals, Inc. In February 2006, Mr. Kriegsman received the Corporate Philanthropist of the
Year
106
Award from the Greater Los Angeles Chapter of the ALS Association and in October 2006, he
received the Lou Gehrig Memorial Corporate Award from the Muscular Dystrophy Association. Mr.
Kriegsman has been active in various charitable organizations including the Biotechnology Industry
Organization, the ALS Association, the Los Angeles Venture Association, the Southern California
Biomedical Council, and the Palisades-Malibu YMCA.
Marvin R. Selter has been a director since October 2003. He has been President and Chief
Executive Officer of CMS, Inc. since he founded that firm in 1968. CMS, Inc. is a national
management consulting firm. In 1972, Mr. Selter originated the concept of employee leasing. He
serves as a member of the Business Tax Advisory CommitteeCity of Los Angeles, Small Business
BoardState of California and the Small Business Advisory CommissionState of California. Mr.
Selter also serves on the Valley Economic Development Center as past Chairman and Audit Committee
Chairman, the Board of Valley Industry and Commerce Association as past Chairman, the Advisory
Board of the San Fernando Economic Alliance and the California State UniversityNorthridge as
Chairman of the Economic Research Center. He has served, and continues to serve, as a member of
boards of directors of various hospitals, universities, private medical companies and other
organizations. Mr. Selter attended RutgersThe State University, majoring in Accounting and
Business Administration. He was an LPA having served as Controller, Financial Vice President and
Treasurer at distribution, manufacturing and service firms. He has lectured extensively on finance,
corporate structure and budgeting for the American Management Association and other professional
teaching associations.
Louis Ignarro, Ph.D. has been a director since July 2002. He previously served as a director
of Global Genomics from November 20, 2000. Dr. Ignarro serves as the Jerome J. Belzer, M.D.
Distinguished Professor of Pharmacology in the Department of Molecular and Medical Pharmacology at
the UCLA School of Medicine. Dr. Ignarro has been at the UCLA School of Medicine since 1985 as a
professor, acting chairman and assistant dean. Dr. Ignarro received the Nobel Prize for Medicine in
1998. Dr. Ignarro received a B.S. degree in pharmacy from Columbia University and his Ph.D. degree
in pharmacology from the University of Minnesota.
Joseph Rubinfeld, Ph.D. has been a director since July 2002. He co-founded SuperGen, Inc. in
1991 and has served as its Chief Executive Officer and President and as a director since its
inception until December 31, 2003. He resigned as Chairman Emeritus of SuperGen, Inc. on February
8, 2005. Dr. Rubinfeld was also Chief Scientific Officer of SuperGen from 1991 until September
1997. Dr. Rubinfeld is also a founder of, and currently serves as the Chairman and Chief Executive
Officer of, JJ Pharma. Dr. Rubinfeld was one of the four initial founders of Amgen, Inc. in 1980
and served as a Vice President and its Chief of Operations until 1983. From 1987 until 1990, Dr.
Rubinfeld was a Senior Director at Cetus Corporation and from 1968 to 1980, Dr. Rubinfeld was
employed at Bristol-Myers Company, International Division in a variety of positions. Dr. Rubinfeld
received a B.S. degree in chemistry from C.C.N.Y. and M.A. and Ph.D. degrees in chemistry from
Columbia University.
Richard L. Wennekamp has been a director since October 2003. He was the Senior Vice
President-Credit Administration of Community Bank from October 2002 until June 2008. From September
1998 to July 2002, Mr. Wennekamp was an executive officer of Bank of America Corporation, holding
various positions, including Managing Director-Credit Product Executive for the last four years of
his 22-year term with the bank. From 1977 through 1980, Mr. Wennekamp was a Special Assistant to
former President of the United States, Gerald R. Ford, and the Executive Director of the Ford
Transition Office. Prior to that time, he served as Staff Assistant to the President of the United
States for one year, and as the Special Assistant to the Assistant Secretary of Commerce of the
United States. Mr. Wennekamp received his M.B.A. in finance from the University of Southern
California and his B.S. degree from California State University, Long Beach.
Mitchell K. Fogelman joined CytRx as Chief Financial Officer and Treasurer in September 2007.
He also serves as Chief Financial Officer and a director of Merger Subsidiary. Previously, he
served as Senior Vice President-Finance of International Aluminum Corporation, a New York Stock
Exchange listed
107
manufacturer of commercial and residential building products, where he had worked for
twenty-five years. Mr. Fogelman is a CPA who worked at PricewaterhouseCoopers LLP as a Senior
Manager. He earned his M.B.A. in finance and quantitative analysis from the Anderson School of
Business at the University of California, Los Angeles, and his B.A. degree in mathematics from the
University of California, Los Angeles.
Jack R. Barber, Ph.D. has been Senior Vice President Drug Development since July 2004, and
was named Chief Scientific Officer in February 2007. He previously served as Chief Technical
Officer and Vice President of Research and Development at Immusol, a biopharmaceutical company
based in San Diego, California, since 1994. Prior to that, Dr. Barber spent seven years in various
management positions at Viagene, most recently serving as Associate Director of Oncology. Dr.
Barber received both his S.B. and Ph.D. degrees in biochemistry from the University of California,
Los Angeles. He also carried out his post-doctoral fellowship at the Salk Institute for Biological
Studies in La Jolla, California.
Shi Chung Ng, Ph.D. joined CytRx as Senior Vice President Research and Development in April
2007. Previously, he served as Vice President of Molecular Oncology at Ligand Pharmaceuticals,
directing the cancer discovery efforts as well as genomics biomarker studies for Targretin. Prior
to that, he served as Vice President of Drug Discovery Biology and Preclinical Development of
ArQule, Inc., leading novel cell cycle checkpoint activation drug discovery and development efforts
for ARQ-197. From 1993-2004, Dr. Ng co-led efforts in the discovery and development of multiple
oncology drug candidates at Abbott, including a Bcl-2 inhibitor, farnesyl transferase inhibitors,
and novel anti-mitotics as a founding member of Abbott oncology, a Senior Group Leader and a
Volwiler Associate Fellow. Prior to his tenure at Abbott, Dr. Ng worked at Pfizer, Bristol-Myers
Squibb and Harvard Medical School. He was adjunct Assistant Professor at the Chicago Medical
School, and adjunct Faculty Member at Northwestern University. He had also served as a visiting
Professor at Rutgers University, a visiting Research Staff Member at Princeton University, and an
Instructor in Medicine at Harvard Medical School. Dr. Ng received a Ph.D. in Biochemistry from
Purdue University, and a Postdoctoral Fellowship from Howard Hughes Medical Institute and Harvard
Medical School. Dr. Ng has published over 200 papers, abstracts and patent applications and he was
the recipient of multiple scholarships and awards.
Benjamin S. Levin has been General Counsel, Vice President Legal Affairs and Corporate
Secretary since July 2004. He also serves as Corporate Secretary and a director of Merger
Subsidiary. From November 1999 to June 2004, Mr. Levin was an associate in the transactions
department of the Los Angeles office of OMelveny & Myers LLP. Mr. Levin received his S.B. in
economics from the Massachusetts Institute of Technology, and a J.D. degree from Stanford Law
School.
John Y. Caloz joined CytRx as Chief Accounting Officer in October 2007. Before joining CytRx,
he most recently served for one year as Chief Financial Officer of Occulogix, Inc., a NASDAQ-listed
medical-therapy company. Prior to that, Mr. Caloz served for three years as Chief Financial Officer
of IRIS International Inc., a California medical device manufacturer. Before that, he served as
Chief Financial Officer of Synarc, Inc., a medical imaging company, and from 1993 to 1999 he was
Senior Vice President, Finance and Chief Financial Officer of Phoenix International Life Sciences
Inc. of Montreal, Canada, which was acquired by MDS Inc. in 1999. From 1983 to 1993, Mr. Caloz was
a partner at Rooney, Greig, Whitrod, Filion & Associates of Saint Laurent, Quebec, Canada, a firm
of Chartered Accountants specializing in research and development and technology companies. Mr.
Caloz is a Chartered accountant and holds a degree in Accounting from York University, Toronto,
Canada.
108
CYTRX EXECUTIVE COMPENSATION
Compensation Discussion and Analysis
Overview of Executive Compensation Program
The Compensation Committee of the CytRx board of directors has responsibility for
establishing, implementing and monitoring CytRxs executive compensation program philosophy and
practices. The Compensation Committee seeks to ensure that the total compensation paid to CytRxs
named executive officers is fair, reasonable and competitive. Generally, the types of compensation
and benefits provided to the named executive officers are similar to those provided to CytRxs
other officers.
Throughout this section, the individuals included in the Summary Compensation Table on
page 114 of this proxy statement/prospectus are referred to as the named executive officers.
Compensation Philosophy and Objectives
The components of CytRxs executive compensation consist of salary, annual cash bonuses
awarded based on the Compensation Committees subjective assessment of each individual executives
job performance during the past year, stock option grants to provide executives with longer-term
incentives, and occasional special compensation awards (either cash or stock options) to reward
extraordinary efforts or results.
The Compensation Committee believes that an effective executive compensation program should
provide base annual compensation that is reasonable in relation to individual executives job
responsibilities and reward the achievement of both annual and long-term strategic goals of our
company. The Compensation Committee uses annual and other periodic cash bonuses to reward an
officers achievement of specific goals and employee stock options as a retention tool and as a
means to align the executives long-term interests with those of our stockholders, with the
ultimate objective of improving stockholder value. The Compensation Committee evaluates both
performance and compensation to maintain CytRxs ability to attract and retain excellent employees
in key positions and to assure that compensation provided to key employees remains competitive
relative to the compensation paid to similarly situated executives of comparable companies. To that
end, the Compensation Committee believes executive compensation packages provided by CytRx to the
named executive officers should include both cash compensation and stock options.
Because of CytRxs size, the small number of executive officers, and CytRxs financial
priorities, the Compensation Committee has decided not to implement or offer any pension benefits,
deferred compensation plans, or similar plans for the named executive officers.
As a biopharmaceutical company engaged in developing potential products that, to date, have
not generated significant revenues and are not expected to generate significant revenues or profits
for several years, the Compensation Committee also takes CytRxs financial and working capital
condition into account in its compensation decisions. Accordingly, the Compensation Committee
generally has weighted bonuses more heavily with stock options rather than cash, although it did
not do so for 2007. The Compensation Committee may periodically reassess the proper weighting of
equity and cash compensation in light of CytRxs working capital situation from time to time.
Role of Executive Officers in Compensation Decisions
The Compensation Committee makes all compensation decisions for the named executive officers
and approves recommendations regarding equity awards to all of CytRxs officers. Decisions
regarding the non-equity compensation of CytRxs other officers are made by CytRxs President and
Chief Executive Officer.
109
The Compensation Committee and the President and Chief Executive Officer annually review the
performance of each named executive officer (other than the President and Chief Executive Officer,
whose performance is reviewed only by the Compensation Committee). The conclusions reached and
recommendations based on these reviews, including with respect to salary adjustments and annual
award amounts, are presented to the Compensation Committee. The Compensation Committee can exercise
its discretion in modifying any recommended adjustments or awards to executives.
Setting Executive Compensation
Based on the foregoing objectives, the Compensation Committee has structured CytRxs annual
cash and incentive-based cash and non-cash executive compensation to seek to motivate the named
executives to achieve the business goals set by CytRx, to reward the executives for achieving such
goals, and to retain the executives. In doing so, the Compensation Committee historically has not
employed outside compensation consultants. However, during 2007, the Compensation Committee did
obtain and use in its compensation deliberations several third-party industry compensation surveys
to establish cash and equity compensation for CytRxs executive officers. The Compensation
Committee utilized this data to set compensation for the named executive officers at levels
targeted at or around a range of compensation amounts provided to executives at comparable
companies considering, for each individual, their individual experience level related to their
position with us. There is no pre-established policy or target for the allocation between either
cash and non-cash incentive compensation.
2007 Executive Compensation Components
For 2007, the principal components of compensation for the named executive officers were:
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base salary; |
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annual bonuses; and |
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equity incentive compensation |
Base Salary
CytRx provides the named executive officers and other employees with base salary to compensate
them for services rendered during the year. Base salary ranges for the named executive officers are
determined for each named executive officer based on his position and responsibility.
During its review of base salaries for executives, the Compensation Committee primarily
considers:
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the negotiated terms of each executive employment agreement; |
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internal review of the executives compensation, both individually and relative to
other named executive officers; and |
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individual performance of the executive. |
Salary levels are typically considered annually as part of CytRxs performance review process,
as well as upon a change in job responsibility. Merit-based increases to salaries are based on the
Compensation Committees assessment of the individuals performance. Base salaries for the named
executive officers in 2007 were increased from the base salaries in effect during the prior year by
amounts ranging from 7% for CytRxs prior Chief Financial Officer to 25% for CytRxs Chief
Scientific Officer. Unless increased by the Compensation Committee, the salary for Mr. Kriegsman
will remain in effect until the expiration of his employment agreement on December 31, 2009, while
the salaries of the other named executive officers will
110
remain in effect until the expiration of their respective employment agreements. The salaries
and other terms of employment of Dr. Barber, CytRxs Chief Scientific Officer, and Mr. Levin,
CytRxs General Counsel, Vice President Legal Affairs and Corporate Secretary, are in the process
of being negotiated with our compensation committee, as their employment is now month-to-month
following the expiration of their employment agreements on December 31, 2007.
Annual and Special Bonuses
The Compensation Committee has not established an incentive compensation program with fixed
performance targets. Because CytRx does not generate significant revenues and has not commercially
released any products, the Compensation Committee bases its discretionary compensation awards on
the achievement of product development targets and milestones, effective fund-raising efforts, and
effective management of personnel and capital resources, among other criteria. During 2007, the
Compensation Committee granted Mr. Levin and Mr. Natalizio special bonuses of 10,000 and 5,000
shares of RXi common stock, respectively, in recognition of their efforts in establishing RXi as a
stand-alone company. During 2007, the Compensation Committee granted Mr. Kriegsman an annual cash
bonus of $400,000 and granted cash bonuses to the other named executive officers ranging from
$15,000 to $151,000, each in conjunction with the end of their employment contract years, because
of their efforts in helping us advance the development of CytRxs products, raise working capital
and achieve other corporate goals.
On March 11, 2008, the record date for CytRxs distribution of RXi shares to its stockholders,
CytRx awarded approximately 27,700 shares of RXi to its directors, officers and other employees,
including the named executive officers, in connection with CytRxs separation from RXi to
compensate those directors, officers and other employees for services performed in connection with
the separation. Each of CytRxs directors, officers and other employees who held stock options to
purchase CytRx common stock received that number of RXi shares that such individual would have
received in the separation, assuming such individual had, on the record date for the separation,
exercised, in full, on a net-exercise basis, all such stock options to the extent then
exercisable.
Equity Incentive Compensation
As indicated above, the Compensation Committee also aims to encourage CytRxs executive
officers to focus on long-term company performance by allocating to them stock options that vest
over a period of several years. In 2007, the Compensation Committee granted to Mr. Kriegsman a
nonqualified option to purchase 350,000 shares of CytRx common stock at a price of $4.51 per share,
which equaled the closing market price on the date of grant. The option vests monthly over three
years, provided that Mr. Kriegsman continues in CytRxs employ through such monthly vesting
periods. In addition, in connection with the hiring of Mitchell K. Fogelman as Chief Financial
Officer, and the annual review of the other named executive officers, the Compensation Committee
also granted stock options to those named executive officers. All of these other stock options had
an exercise price equal to the closing market price on the date of grant, and also vest monthly
over three years, provided that such executives remain in CytRxs employ through such monthly
vesting periods.
Retirement Plans, Perquisites and Other Personal Benefits
CytRx has adopted a tax-qualified employee savings and retirement plan, the 401(k) Plan, for
eligible United States employees, including the named executive officers. Eligible employees may
elect to defer a percentage of their eligible compensation in the 401(k) Plan, subject to the
statutorily prescribed annual limit. CytRx may make matching contributions on behalf of all
participants in the 401(k) Plan in an amount determined by the CytRx board of directors. Matching
and profit-sharing contributions, if any, are subject to a vesting schedule; all other
contributions are at all times fully vested. CytRx intends the 401(k) Plan, and the accompanying
trust, to qualify under Sections 401(k) and 501 of the Code so that contributions by employees to
the 401(k) Plan, and income earned (if any) on plan contributions, are not taxable to employees
until
111
withdrawn from the 401(k) Plan, and so that CytRx will be able to deduct its contributions, if
any, when made. The trustee under the 401(k) Plan, at the direction of each participant, may invest
the assets of the 401(k) Plan in any of a number of investment options.
CytRx does not provide any of the executive officers with any other perquisites or personal
benefits, other than benefits that it offers Mr. Kriegsman provided for in his employment
agreement. As required by his employment agreement, during 2007 CytRx paid insurance premiums with
respect to a life insurance policy for Mr. Kriegsman which had a face value of approximately $1.4
million as of December 31, 2007 and under which Mr. Kriegsmans designee is the beneficiary.
CytRxs stock option plans provide that all unvested options held by its employees, including
the named executive officers, immediately vest upon a change of control. In addition, under CytRxs
employment agreement with Mr. Kriegsman, and if, during the term and within two years after the
date on which the change in control occurs, Mr. Kriegsmans employment is terminated by CytRx
without cause or by him for good reason (each as defined in his employment agreement), then, to
the extent that any payment or distribution of any type by CytRx to or for the benefit of Mr.
Kriegsman resulting from the termination of his employment is or will be subject to the excise tax,
CytRx has agreed to pay Mr. Kriegsman an additional amount that, after the imposition of all
income, employment, excise and other taxes, penalties and interest thereon, is equal to the sum of
(i) the excise tax on such payments plus (ii) any penalty and interest assessments associated with
such excise tax. Except as described above, CytRx does not have in effect any change of control
provisions for payment to any named executive officer in the event of a change in control of CytRx.
Ownership Guidelines
The Compensation Committee has no requirement that each named executive officer maintain a
minimum ownership interest in CytRx.
CytRxs long-term incentive compensation consists solely of periodic grants of stock options
to the named executive officers. The stock option program:
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links the creation of stockholder value with executive compensation; |
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provides increased equity ownership by executives; |
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functions as a retention tool, because of the vesting features included in all
options granted by the Compensation Committee; and |
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maintains competitive levels of total compensation. |
The Compensation Committee normally grants stock options to new executive officers when they
join CytRx based upon their position with CytRx and their relevant prior experience. The options
granted by the Compensation Committee generally vest monthly over the first three years of the
10-year option term. Vesting ceases upon termination of employment and exercise rights cease 90
days thereafter, except in the case of death (subject to a one-year limitation), disability or
retirement. Prior to the exercise of an option, the holder has no rights as a stockholder with
respect to the shares subject to such option, including voting rights and the right to receive
dividends or dividend equivalents. In addition to the initial option grants, the Compensation
Committee may grant additional options to retain CytRxs executives and reward, or provide
incentive for, the achievement of corporate goals and strong individual performance. The CytRx
board of directors has granted CytRxs President and Chief Executive Officer discretion to grant up
to 100,000 options to employees upon joining the company, and to grant an additional discretionary
pool of up to 100,000 options during each annual employee review cycle. Options are granted based
on a combination of individual contributions to CytRx and on general corporate achievements, which
may include the attainment of product development
112
milestones (such as commencement and completion of clinical trials) and attaining other annual
corporate goals and objectives. On an annual basis, the Compensation Committee assesses the
appropriate individual and corporate goals for the new executives and provides additional option
grants based upon the achievement by the new executives of both individual and corporate goals. The
Compensation Committee expects that it will continue to provide new employees with initial option
grants in the future to provide long-term compensation incentives and will continue to rely on
performance-based and retention grants to provide additional incentives for current employees.
Additionally, in the future, the Compensation Committee may consider awarding additional or
alternative forms of equity incentives, such as grants of restricted stock, restricted stock units
and other performance-based awards.
It is CytRxs policy to award stock options at an exercise price equal to The Nasdaq Capital
Markets closing price of CytRx common stock on the date of the grant. In certain limited
circumstances, the Compensation Committee may grant options to an executive at an exercise price in
excess of the closing price of the common stock on the grant date. The Compensation Committee has
never granted options with an exercise price that is less than the closing price of CytRx common
stock on the grant date, nor has it granted options which are priced on a date other than the grant
date. For purposes of determining the exercise price of stock options, the grant date is deemed to
be the first day of employment for newly hired employees, or the date on which the Compensation
Committee or the Chief Executive Officer, as applicable, approves the stock option grant to
existing employees.
CytRx has no program, practice or plan to grant stock options to executive officers, including
new executive officers, in coordination with the release of material nonpublic information. CytRx
also has not timed the release of material nonpublic information for the purpose of affecting the
value of stock options or other compensation to executive officers, and has no plan to do so. CytRx
has no policy regarding the adjustment or recovery of stock option awards in connection with the
restatement of financial statements, as its stock option awards have not been tied to the
achievement of specific financial goals.
Tax and Accounting Implications
Deductibility of Executive Compensation
As part of its role, the Compensation Committee reviews and considers the deductibility of
executive compensation under Section 162(m) of the Code, which provides that corporations may not
deduct compensation of more than $1,000,000 that is paid to certain individuals. The Compensation
Committee believes that compensation paid to CytRx executive officers generally is fully deductible
for federal income tax purposes.
Accounting for Share-based Compensation
CytRx accounts for share-based compensation in accordance with the requirements of FASB
Statement 123(R), Share-Based Payment. This accounting treatment has not significantly affected
CytRxs compensation decisions. The Compensation Committee takes into consideration the tax
consequences of compensation to the named executive officers, but tax considerations are not a
significant part of the companys compensation policy.
Compensation Committee Interlocks and Insider Participation in Compensation Decisions
There are no interlocks, as defined by the SEC, with respect to any member of the
Compensation Committee. Joseph Rubinfeld, Ph.D., Marvin R. Selter and Richard L. Wennekamp served
as the members of the Compensation Committee during all of 2007.
113
Summary Compensation Table
The following table presents summary information concerning all compensation paid or accrued
by CytRx for services rendered in all capacities during 2007 and 2006 by Steven A. Kriegsman,
Mitchell K. Fogelman and Matthew Natalizio, who are the only individuals who served as CytRxs
principal executive and financial officers during the year ended December 31, 2007, and its three
other most highly compensated executive officers who were serving as executive officers as of
December 31, 2007:
Summary Compensation Table
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Option |
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Bonus |
|
Awards |
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All Other |
|
Total |
Name and Position |
|
Year |
|
Salary ($) |
|
($) (1) |
|
($) (2) |
|
Compensation ($) |
|
($) |
Steven A. Kriegsman
President and Chief Executive Officer |
|
|
2007 |
|
|
|
524,767 |
|
|
|
300,000 |
|
|
|
295,534 |
|
|
|
|
|
|
|
1,120,301 |
|
|
|
|
2006 |
|
|
|
417,175 |
|
|
|
800,000 |
|
|
|
340,426 |
|
|
|
|
|
|
|
1,557,601 |
|
Mitchell K. Fogelman
Chief Financial Officer and Treasurer (3) |
|
|
2007 |
|
|
|
76,763 |
|
|
|
100,000 |
|
|
|
35,665 |
|
|
|
|
|
|
|
212,428 |
|
Matthew Natalizio
Chief Financial Officer and Treasurer (3) |
|
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2007 |
|
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175,573 |
|
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|
|
|
|
|
|
|
|
5,224 |
(5) |
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|
180,797 |
|
|
|
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2006 |
|
|
|
204,115 |
|
|
|
83,000 |
|
|
|
78,472 |
|
|
|
|
|
|
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365,587 |
|
Jack R. Barber, Ph.D.
Chief Scientific Officer |
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2007 |
|
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327,074 |
|
|
|
125,000 |
|
|
|
168,876 |
|
|
|
|
|
|
|
620,950 |
|
|
|
|
2006 |
|
|
|
261,750 |
|
|
|
218,750 |
|
|
|
90,544 |
|
|
|
|
|
|
|
571,044 |
|
Benjamin S. Levin General Counsel,
Vice President Legal Affairs and
Secretary |
|
|
2007 |
|
|
|
250,000 |
|
|
|
100,000 |
|
|
|
84,438 |
|
|
|
|
|
|
|
434,428 |
|
|
|
|
2006 |
|
|
|
208,170 |
|
|
|
219,750 |
|
|
|
120,550 |
|
|
|
|
|
|
|
548,470 |
|
Tod Woolf, Ph.D.
President and Chief Executive Officer of
RXi Pharmaceuticals Corporation (4) |
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2007 |
|
|
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216,347 |
|
|
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87,500 |
|
|
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236,433 |
(6) |
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33,302 |
(7) |
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573,582 |
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2006 |
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115,830 |
(7) |
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115,830 |
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(1) |
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Bonuses to the named executive officers reported above relating to 2007 were paid in April
2008. Bonuses to the named executive officers reported above relating to 2006 were paid in
both June 2006, in connection with the contractual year end for those officers, and also in
April 2007, following CytRxs decision to determine and award bonuses in connection with each
fiscal year end. For purposes of this table, the entire amount of the bonus paid as attributed
to 2006 has been presented as a 2006 amount. The bonus for Dr. Woolf was paid by RXi on
January 10, 2008. |
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(2) |
|
The values shown in this column represent the dollar amount recognized for financial
statement reporting purposes with respect to the 2006 and 2007 fiscal years for the fair value
of stock options granted in 2006 and 2007 and prior fiscal years in accordance with SFAS
123(R). Pursuant to SEC rules, the amounts shown exclude the impact of estimated forfeitures
related to service-based vesting conditions. The amount recognized for these awards was
calculated using the Black Scholes option-pricing model, and reflect grants from our 2000
Long-Term Incentive Plan, which is described in Note 12 of the Notes to Consolidated Financial
Statements. |
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(3) |
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Mr. Natalizio served as Chief Financial Officer and Treasurer through September 7, 2007, and
Mr. Fogelman has served in that capacity since September 11, 2007. |
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(4) |
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As of March 11, 2008, CytRx no longer owned a majority of the outstanding common stock of
RXi, and thus Mr. Woolf was no longer considered an executive officer of CytRx. Amounts
reported above with respect to Dr. Woolf were paid by RXi unless otherwise noted. |
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(5) |
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Represents premiums paid for medical, dental and vision insurance for Mr. Natalizio following
his resignation in September 2007. |
114
|
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(6) |
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Represents the fair value of RXi employee stock options issued to Dr. Woolf. |
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(7) |
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Consists of $33,000 and $115,830 in consulting fees paid by CytRx in 2007 and 2006,
respectively, and $302 of life insurance premiums paid by RXi in 2007. |
2007 Grants of Plan-based Awards
In 2007, CytRx granted stock options to the named executive officers under CytRxs 2000
Long-Term Incentive Plan as follows:
2007 Grants of Plan-Based Awards
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All Other |
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Grant Date |
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Option Awards |
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Exercise Price of |
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Fair Value of |
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(# of CytRx |
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Option Awards |
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Option Awards |
Name |
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Grant Date |
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Shares) |
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($/Sh) |
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($) |
Steven A. Kriegsman |
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|
4/18/2007 |
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350,000 |
|
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$ |
4.51 |
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$ |
1,328,600 |
|
President and Chief Executive Officer |
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Mitchell K. Fogelman |
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9/11/2007 |
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150,000 |
|
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$ |
3.40 |
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|
$ |
426,600 |
|
Chief Financial Officer and Treasurer |
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Matthew Natalizio |
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Chief Financial Officer and Treasurer |
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Jack R. Barber, Ph.D. |
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4/18/2007 |
|
|
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200,000 |
|
|
$ |
4.51 |
|
|
$ |
759,200 |
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Chief Scientific Officer |
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Benjamin S. Levin |
|
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4/18/2007 |
|
|
|
100,000 |
|
|
$ |
4.51 |
|
|
$ |
379,600 |
|
General Counsel, Vice President
Legal Affairs and Secretary |
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Tod Woolf, Ph.D. (1) |
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President and Chief Executive
Officer of RXi Pharmaceuticals
Corporation |
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(1) |
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No stock options were awarded by CytRx to Dr. Woolf in 2007. On May 23, 2007, RXi granted to
Dr. Woolf ten-year options to purchase 316,994 shares of RXis common stock under the RXi
Pharmaceutical Corporation 2007 Incentive Plan at an exercise price of $5.00 per share. |
2000 Long-term Incentive Plan
General
The purpose of CytRxs 2000 Long-Term Incentive Plan is to promote CytRxs success and enhance
its value by linking the personal interests of employees, officers, consultants, and directors to
those of stockholders, and by providing employees, officers, consultants, and directors with an
incentive for outstanding performance. The Plan was originally adopted by the CytRx board of
directors on August 24, 2000 and by CytRxs stockholders on June 7, 2001, with certain amendments
to the Plan having been subsequently approved by the board of directors and stockholders.
The Plan authorizes the granting of awards to CytRxs employees, officers, consultants and
directors and to employees, officers, consultants and directors of its subsidiaries, which will
include Innovive if the merger is completed. The following awards are available under the Plan:
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options to purchase shares of common stock, which may be incentive stock options or
non-qualified stock options; |
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stock appreciation rights; |
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restricted stock; |
115
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performance units; |
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dividend equivalents; and |
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other stock-based awards. |
The aggregate number of shares of CytRx common stock reserved and available for awards under
the Plan is 10,000,000 shares. As of March 28, 2008, there were 6,075,300 shares previously issued
or subject to outstanding Plan awards and 2,116,253 shares were reserved for issuance pursuant to
future awards under the Plan. The maximum number of shares of common stock with respect to one or
more options and stock appreciation rights that CytRx may grant during any one calendar year under
the Plan to any one participant is 1,000,000; except that in connection with his or her initial
employment with CytRx or an affiliate, a participant may be granted options for up to an additional
1,000,000 shares. The maximum fair market value of any awards that any one participant may receive
during any one calendar year under the Plan, not including the value of options and stock
appreciation rights, is $1,000,000 (less any consideration paid by the participant for such award).
CytRx also has two other plans, the 1994 Stock Option Plan and the 1998 Long Term Incentive Plan,
which include 9,167 and 100,041 shares subject to outstanding stock options. As the terms of the
plans provide that no options may be issued after 10 years, no options are available under the 1994
Plan. Under the 1998 Long Term Incentive Plan, 29,517 shares are available for future grant.
Administration
The Plan is administered by the Compensation Committee of the CytRx board of directors. The
Compensation Committee has the power, authority and discretion to:
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designate participants; |
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determine the types of awards to grant to each participant and the number, terms and
conditions of any award; |
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establish, adopt or revise any rules and regulations as it may deem necessary or
advisable to administer the Plan; and |
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make all other decisions and determinations that may be required under, or as the
Compensation Committee deems necessary or advisable to administer, the Plan. |
Awards
The following is summary description of financial instruments that may be granted to
participants by the Compensation Committee of the CytRx board of directors. The Compensation
Committee to date has only granted stock options to participants in the Plan.
Stock Options. The Compensation Committee is authorized to grant both incentive stock options
and non-qualified stock options. The terms of any incentive stock option must meet the requirements
of Section 422 of the Code. The exercise price of an option may not be less than the fair market
value of the underlying stock on the date of grant, and no option may have a term of more than 10
years from the grant date.
Stock Appreciation Rights. The Compensation Committee may grant stock appreciation rights to
participants. Upon the exercise of a stock appreciation right, the participant has the right to
receive the excess, if any, of (1) the fair market value of one share of common stock on the date
of exercise, over (2) the grant price of the stock appreciation right as determined by the
Compensation Committee, which will not be less than the fair market value of one share of common
stock on the date of grant.
116
Restricted Stock. The Compensation Committee may make awards of restricted stock, which will
be subject to such restrictions on transferability and other restrictions as the Compensation
Committee may impose (including limitations on the right to vote restricted stock or the right to
receive dividends, if any, on the restricted stock).
Performance Units. The Compensation Committee may grant performance units on such terms and
conditions as may be selected by the Compensation Committee. The Compensation Committee will have
the complete discretion to determine the number of performance units granted to each participant
and to set performance goals and other terms or conditions to payment of the performance units
which, depending on the extent to which they are met, will determine the number and value of
performance units that will be paid to the participant.
Dividend Equivalents. The Compensation Committee is authorized to grant dividend equivalents
to participants subject to such terms and conditions as may be selected by the Compensation
Committee. Dividend equivalents entitle the participant to receive payments equal to dividends with
respect to all or a portion of the number of shares of common stock subject to an option or other
award, as determined by the Compensation Committee. The Compensation Committee may provide that
dividend equivalents be paid or distributed when accrued or be deemed to have been reinvested in
additional shares of common stock, or otherwise reinvested.
Other Stock-Based Awards. The Compensation Committee may grant other awards that are payable
in, valued in whole or in part by reference to, or otherwise based on or related to shares of
common stock, as deemed by the Compensation Committee to be consistent with the purposes of the
Plan. These stock-based awards may include shares of common stock awarded as a bonus and not
subject to any restrictions or conditions, convertible or exchangeable debt securities, other
rights convertible or exchangeable into shares of common stock, and awards valued by reference to
book value of shares of common stock or the value of securities of or the performance of our
subsidiaries. The Compensation Committee will determine the terms and conditions of any such
awards.
Performance Goals. The Compensation Committee in its discretion may determine awards based on:
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the achievement by CytRx or a parent or subsidiary of a specific financial target; |
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CytRxs stock price; |
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the achievement by an individual or a business unit of CytRx or a subsidiary of a
specific financial target; |
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the achievement of specific goals with respect to (i) product development
milestones, (ii) corporate financings, (iii) merger and acquisition activities, (iv)
licensing transactions, (v) development of strategic partnerships or alliances, or (vi)
acquisition or development of new technologies; and |
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any combination of the goals set forth above. |
The Compensation Committee has the right for any reason to reduce (but not increase) any
award, even if a specific goal has been achieved. If an award is made on the basis of the
achievement of a goal, the Compensation Committee must have established the goal before the
beginning of the period for which the performance goal relates (or a later date as may be permitted
under Code Section 162(m)). Any payment of an award for achieving a goal will be conditioned on the
written certification of the Compensation Committee in each case that the goals and any other
material conditions were satisfied.
117
Limitations on Transfer; Beneficiaries. Awards under the Plan may not be transferred or
assigned by Plan participants other than by will or the laws of descent and distribution and, in
the case of an incentive stock option, pursuant to a qualified domestic relations order, provided
that the Compensation Committee may (but need not) permit other transfers where the Compensation
Committee concludes that such transferability (1) does not result in accelerated taxation, (2) does
not cause any option intended to be an incentive stock option to fail to qualify as such, and (3)
is otherwise appropriate and desirable, taking into account any factors deemed relevant, including
any state or federal tax or securities laws or regulations applicable to transferable awards. A
Plan participant may, in the manner determined by the Compensation Committee, designate a
beneficiary to exercise the participants rights and to receive any distribution with respect to
any award upon the participants death.
Acceleration Upon Certain Events. In the event of a Change in Control of CytRx, which is a
term defined in the Plan, all outstanding options and other awards in the nature of rights that may
be exercised will become fully vested and exercisable and all restrictions on all outstanding
awards will lapse. The Compensation Committee may, however, in its sole discretion declare all
outstanding options, stock appreciation rights and other awards in the nature of rights that may be
exercised to become fully vested and exercisable, and all restrictions on all outstanding awards to
lapse, in each case as of such date as the Compensation Committee may, in its sole discretion,
declare. The Compensation Committee may discriminate among participants or among awards in
exercising such discretion.
Termination and Amendment
The CytRx board of directors or the Compensation Committee may, at any time and from time to
time, terminate or amend the Plan without stockholder approval; provided, however, that the board
of directors or the Compensation Committee may condition any amendment on the approval of our
stockholders if such approval is necessary or deemed advisable with respect to tax, securities or
other applicable laws, policies or regulations. No termination or amendment of the Plan may
adversely affect any award previously granted without the written consent of the participants
affected. The Compensation Committee may amend any outstanding award without the approval of the
participants affected, except that no such amendment may diminish the value of an award determined
as if it has been exercised, vested, cashed in or otherwise settled on the date of such amendment,
and, except as otherwise permitted in the Plan, the exercise price of any option may not be reduced
and the original term of any option may not be extended.
Holdings of Previously Awarded Equity
Equity awards held as of December 31, 2007 by each of the named executive officers were issued
under our 2000 Long-Term Incentive Plan. The following table sets forth outstanding equity awards
held by the named executive officers as of December 31, 2007:
118
2007 Outstanding Equity Awards at Fiscal Year-End
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Option Awards |
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Number of |
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Securities |
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Underlying |
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Unexercised |
|
Option |
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Options |
|
Exercise |
|
Option |
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(#) |
|
Price |
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Expiration |
Name |
|
Exercisable |
|
Unexercisable |
|
($) |
|
Date |
Steven A. Kriegsman |
|
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77,854 |
|
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(1 |
) |
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272,146 |
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4.51 |
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4/18/17 |
|
President and Chief Executive Officer |
|
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100,028 |
|
|
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(1 |
) |
|
|
99,972 |
|
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1.38 |
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6/16/16 |
|
|
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258,307 |
|
|
|
(1 |
) |
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41,693 |
|
|
|
.79 |
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5/17/15 |
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|
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|
250,000 |
|
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(2 |
) |
|
|
|
|
|
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2.47 |
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6/19/13 |
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750,000 |
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(2 |
) |
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2.47 |
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6/20/13 |
|
Mitchell K. Fogelman |
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12,539 |
|
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(1 |
) |
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137,461 |
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3.40 |
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9/11/17 |
|
Chief Financial Officer and Treasurer |
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|
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|
|
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Matthew Natalizio |
|
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Chief Financial Officer and Treasurer |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Jack R. Barber, Ph.D. |
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|
44,488 |
|
|
|
(1 |
) |
|
|
155,512 |
|
|
|
4.51 |
|
|
|
4/18/17 |
|
Chief Scientific Officer |
|
|
50,014 |
|
|
|
(1 |
) |
|
|
49,986 |
|
|
|
1.38 |
|
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6/16/16 |
|
|
|
|
129,154 |
|
|
|
(1 |
) |
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|
20,846 |
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|
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.79 |
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5/17/15 |
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|
|
|
100,000 |
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(2 |
) |
|
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1.13 |
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7/06/14 |
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Benjamin S. Levin |
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22,244 |
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(1 |
) |
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77,756 |
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4.51 |
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4/18/17 |
|
General Counsel, Vice President Legal |
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45,013 |
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(1 |
) |
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44,987 |
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1.38 |
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6/16/16 |
|
Affairs and Secretary |
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|
141,652 |
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(1 |
) |
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8,348 |
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.79 |
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5/17/15 |
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160,000 |
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(2 |
) |
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1.39 |
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7/15/14 |
|
Tod Woolf, Ph.D. (3) |
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President and Chief Executive Officer
of RXi Pharmaceuticals Corporation |
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(1) |
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These options vest in 36 equal monthly installments, subject to the option holders remaining
in CytRxs continuous employ through such dates. |
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(2) |
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These options vest in three annual installments, subject to the option holders remaining in
CytRxs continuous employ through such dates. |
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(3) |
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Dr. Woolf has not been issued any equity by CytRx. On May 23, 2007, RXi granted to Dr. Woolf
10-year options to purchase 316,994 shares of RXis common stock under the RXi Pharmaceutical
Corporation 2007 Incentive Plan at an exercise price of $5.00 per share. As of December 31,
2007, 61,709 of those stock options were exercisable, and the remaining 255,285 options were
not exercisable. |
119
Option Exercises and Stock Vested
The following table provides information regarding exercises of stock options by each of the
named executive officers during 2007:
2007 Exercises of Plan-Based Awards
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Number of |
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|
Shares Acquired |
|
Value Realized |
Name |
|
on Exercise |
|
On Exercise ($)(1) |
Steven A. Kriegsman |
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|
|
$ |
|
|
President and Chief Executive Officer |
|
|
|
|
|
|
|
|
Mitchell K. Fogelman |
|
|
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|
|
$ |
|
|
Chief Financial Officer and Treasurer |
|
|
|
|
|
|
|
|
Matthew Natalizio |
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|
237,496 |
|
|
$ |
582,437 |
|
Chief Financial Officer and Treasurer |
|
|
|
|
|
|
|
|
Jack R. Barber, Ph.D. |
|
|
|
|
|
$ |
|
|
Chief Scientific Officer |
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|
|
|
|
|
|
Benjamin S. Levin |
|
|
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|
|
$ |
|
|
General Counsel, Vice President Legal Affairs and Secretary |
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|
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|
Tod Woolf, Ph.D. |
|
|
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$ |
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|
President and Chief Executive Officer of RXi Pharmaceuticals
Corporation |
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|
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|
|
|
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|
(1) |
|
Represents the difference between the exercise price and the fair market value of the common
stock on the date of exercise. |
Employment Agreements and Potential Payment Upon Termination or Change in Control
Employment Agreement with Steven A. Kriegsman
Mr. Kriegsman is employed as CytRxs Chief Executive Officer and President pursuant to an
employment agreement that was amended as of May 2007 to continue through December 31, 2009. The
employment agreement will automatically renew in December 2009 for an additional one-year period,
unless either Mr. Kriegsman or CytRx elects not to renew it.
Under his employment agreement as amended, Mr. Kriegsman is entitled to receive an annual base
salary of $550,000. The CytRx board of directors (or its Compensation Committee) will review the
base salary annually and may increase (but not decrease) it in its sole discretion. In addition to
his annual salary, Mr. Kriegsman is eligible to receive an annual bonus as determined by the board
of directors (or its Compensation Committee) in its sole discretion, but not to be less than
$150,000. Pursuant to his employment agreement, CytRx has agreed that he shall serve on a full-time
basis as Chief Executive Officer and President and that he may continue to serve as Chairman of the
Kriegsman Group only so long as necessary to complete certain current assignments.
Mr. Kriegsman is eligible to receive grants of options to purchase shares of CytRx common
stock. The number and terms of those options, including the vesting schedule, will be determined by
the CytRx board of directors (or its Compensation Committee) in its sole discretion.
Under Mr. Kriegsmans employment agreement, CytRx has agreed that, if he is made a party, or
threatened to be made a party, to a suit or proceeding by reason of his service to CytRx, CytRx
will indemnify and hold him harmless from all costs and expenses to the fullest extent permitted or
authorized by CytRxs certificate of incorporation or bylaws, or any resolution of the CytRx board
of directors, to the extent not inconsistent with Delaware law. CytRx has also agreed to advance to
Mr. Kriegsman such costs and expenses upon his request if he undertakes to repay such advances if
it ultimately is determined that he is not entitled to
120
indemnification with respect to the same. These employment agreement provisions are not
exclusive of any other rights to indemnification to which Mr. Kriegsman may be entitled and are in
addition to any rights he may have under any policy of insurance maintained by CytRx.
In the event CytRx terminates Mr. Kriegsmans employment without cause (as defined), or if
Mr. Kriegsman terminates his employment with good reason (as defined), (i) CytRx has agreed to
pay Mr. Kriegsman a lump-sum equal to his salary and prorated minimum annual bonus through to his
date of termination, plus his salary and minimum annual bonus for a period of two years after his
termination date, or until the expiration of the amended and restated employment agreement,
whichever is later, (ii) he will be entitled to immediate vesting of all stock options or other
awards based on CytRx equity securities, and (iii) he will also be entitled to continuation of his
life insurance premium payments and continued participation in CytRx health plans through to the
later of the expiration of the amended and restated employment agreement or 24 months following his
termination date. Mr. Kriegsman will have no obligation in such events to seek new employment or
offset the severance payments to him by any compensation received from any subsequent reemployment
by another employer.
Under Mr. Kriegsmans employment agreement, he and his affiliated company, The Kriegsman
Group, are to provide CytRx during the term of his employment with the first opportunity to conduct
or take action with respect to any acquisition opportunity or any other potential transaction
identified by them within the biotech, pharmaceutical or health care industries and that is within
the scope of the business plan adopted by our board of directors. Mr. Kriegsmans employment
agreement also contains confidentiality provisions relating to CytRxs trade secrets and any other
proprietary or confidential information, which provisions shall remain in effect for five years
after the expiration of the employment agreement with respect to proprietary or confidential
information and for so long as CytRxs trade secrets remain trade secrets.
Potential Payment Upon Termination or Change in Control for Steven A. Kriegsman
Mr. Kriegsmans employment agreement contains no provision for payment to him in the event of
a change in control of CytRx. If, however, a change in control (as defined in our 2000 Long-Term
Incentive Plan) occurs during the term of the employment agreement, and if, during the term and
within two years after the date on which the change in control occurs, Mr. Kriegsmans employment
is terminated by CytRx without cause or by him for good reason (each as defined in his employment
agreement), then, in addition to the severance benefits described above, to the extent that any
payment or distribution of any type by CytRx to or for the benefit of Mr. Kriegsman resulting from
the termination of his employment is or will be subject to the excise tax imposed under Section
4999 of the Code, CytRx has agreed to pay Mr. Kriegsman, prior to the time the excise tax is
payable with respect to any such payment (through withholding or otherwise), an additional amount
that, after the imposition of all income, employment, excise and other taxes, penalties and
interest thereon, is equal to the sum of (i) the excise tax on such payments plus (ii) any penalty
and interest assessments associated with such excise tax.
Employment Agreement with Mitchell K. Fogelman
Mitchell K. Fogelman is employed as Chief Financial Officer and Treasurer pursuant to an
employment agreement dated as of September 11, 2007 that expires on December 31, 2008. Mr. Fogelman
is entitled under his employment agreement to receive an annual base salary of $275,000 and is
eligible to receive an annual bonus as determined by the CytRx board of directors (or its
Compensation Committee) in its sole discretion. As an incentive to enter into his employment
agreement, Mr. Fogelman was granted as of September 11, 2007, a 10-year, nonqualified option under
CytRxs 2000 Long-Term Incentive Plan to purchase 150,000 shares of CytRx common stock at a price
of $3.40 per share. This option will vest as to 1/36th of the shares covered thereby each month
after the date of the employment agreement, provided that Mr. Fogelman remains in CytRxs
continuous employ.
121
In the event CytRx terminates Mr. Fogelmans employment without cause (as defined), CytRx has
agreed to pay him a lump sum equal to his accrued but unpaid salary and vacation, plus an amount
equal to six months salary under his employment agreement.
Employment Agreement with Jack R. Barber, Ph.D.
Jack R. Barber, Ph.D. is employed as Chief Scientific Officer on a month-to-month basis
following the expiration of an employment agreement that is in the process of being renegotiated
after expiring on December 31, 2007. Dr. Barber is paid an annual base salary of $360,000 and is
eligible to receive an annual bonus as determined by the CytRx board of directors (or its
Compensation Committee) in its sole discretion.
In the event CytRx terminates Dr. Barbers employment without cause (as defined), CytRx has
agreed to pay him a lump sum equal to his accrued but unpaid salary and vacation, plus an amount
equal to three months base salary.
Employment Agreement with Benjamin S. Levin
Benjamin S. Levin is employed as Vice President Legal Affairs, General Counsel and Secretary
on a month-to-month basis following the expiration of an employment agreement that is in the
process of being renegotiated after expiring on December 31, 2007. Mr. Levin is paid an annual base
salary of $275,000 and is eligible to receive an annual bonus as determined by the CytRx board of
directors (or its Compensation Committee) in its sole discretion.
In the event CytRx terminates Mr. Levins employment without cause (as defined), CytRx has
agreed to pay him a lump sum equal to his accrued but unpaid salary and vacation, plus an amount
equal to six months base salary.
Employment Agreement with Tod Woolf, Ph.D.
CytRx and RXi entered into an employment agreement with Tod Woolf, Ph.D. dated February 22,
2007, under which Dr. Woolf is engaged to continue his employment as RXis President and Chief
Executive Officer through December 31, 2008. Dr. Woolf is entitled under his employment agreement
to receive an annual base salary of $250,000 and has been granted by RXi a 10-year option to
purchase 316,994 shares of RXi common stock at an exercise price of $5.00 per share. This option
will vest in equal monthly installments over three years, subject to accelerated vesting in certain
events.
In the event Dr. Woolfs employment is terminated without cause (as defined) or Dr. Woolf
terminates his employment for good reason (as defined), RXi has agreed to pay him a lump sum
equal to his base salary for the longer of 12 months and the remainder of the term of his
employment agreement, but in no event less than $125,000.
Quantification of Termination Payments and Benefits
The table below reflects the amount of compensation to each of the named executive officers in
the event of termination of such executives employment by his voluntary resignation or
termination, by a termination of the executives employment without cause or his resignation for
good reason, termination following a change in control and in the event of the executives
permanent disability or death of the executive. The amounts assume that such termination was
effective as of December 31, 2007, and thus includes amounts earned through such time and are
estimates of the amounts, which would be paid out to the executives upon their termination. The
actual amounts to be paid out can only be determined at the time of such executives separation.
122
Termination Payments and Benefits
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|
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|
|
|
|
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|
|
|
|
Termination w/o Cause or |
|
|
|
|
|
|
|
|
|
|
|
|
for Good Reason |
|
|
|
|
|
|
|
|
|
|
|
|
Before Change in |
|
After Change in |
|
|
|
|
|
Disability |
|
Change in |
Name |
|
Benefit |
|
Control ($) |
|
Control ($) |
|
Death ($) |
|
$ |
|
Control ($) |
Steven A. Kriegsman
|
|
Severance Payment
|
|
|
1,000,000 |
|
|
|
1,000,000 |
|
|
|
1,000,000 |
|
|
|
1,000,000 |
|
|
|
|
|
President and Chief
|
|
Stock Options (1)
|
|
|
231,430 |
|
|
|
|
|
|
|
231,430 |
|
|
|
231,430 |
|
|
|
231,430 |
|
Executive Officer |
|
Health Insurance (2)
|
|
|
45,704 |
|
|
|
45,704 |
|
|
|
45,704 |
|
|
|
45,704 |
|
|
|
|
|
|
|
Life Insurance
|
|
|
11,350 |
|
|
|
11,350 |
|
|
|
|
|
|
|
11,350 |
|
|
|
|
|
|
|
Bonus
|
|
|
300,000 |
|
|
|
300,000 |
|
|
|
300,000 |
|
|
|
300,000 |
|
|
|
|
|
|
|
Tax Gross Up (3) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mitchell K. Fogelman |
|
Severance Payment |
|
|
125,000 |
|
|
|
125,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Chief Financial Officer
and Treasurer |
|
Stock Options (1) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Jack R. Barber, Ph.D. |
|
Severance Payment |
|
|
68,750 |
|
|
|
68,750 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Chief Scientific Officer |
|
Stock Options (1) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
115,714 |
|
Benjamin S. Levin |
|
Severance Payment |
|
|
125,000 |
|
|
|
125,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
General Counsel, Vice
President Legal
Affairs and Secretary |
|
Stock Options (1) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
82,793 |
|
Tod Woolf, Ph.D.(4) |
|
Severance Payment |
|
|
250,000 |
|
|
|
250,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
President and Chief |
|
Stock Options (1) |
|
|
449,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
978,098 |
|
Executive Officer of RXi |
|
Benefits |
|
|
14,500 |
|
|
|
14,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Represents the aggregate value of stock options that vest and become exercisable immediately
upon each of the triggering events listed as if such events took place on December 31, 2007,
determined by the aggregate difference between the stock price as of December 31, 2007 and the
exercise prices of the underlying options. |
|
(2) |
|
Represents the cost as of December 31, 2007 for the family health benefits provided to Mr.
Kriegsman for a period of two years. |
|
(3) |
|
Mr. Kriegsmans employment agreement provides that if a change in control (as defined in
CytRxs 2000 Long-Term Incentive Plan) occurs during the term of the employment agreement, and
if, during the term and within two years after the date on which the change in control occurs,
Mr. Kriegsmans employment is terminated by CytRx without cause or by him for good reason
(each as defined in his employment agreement), then, to the extent that any payment or
distribution of any type by CytRx to or for the benefit of Mr. Kriegsman resulting from the
termination of his employment is or will be subject to the excise tax imposed under Section
4999 of the Code, CytRx will pay Mr. Kriegsman, prior to the time the excise tax is payable
with respect to any such payment (through withholding or otherwise), an additional amount
that, after the imposition of all income, employment, excise and other taxes, penalties and
interest thereon, is equal to the sum of (i) the excise tax on such payments plus (ii) any
penalty and interest assessments associated with such excise tax. Based on Mr. Kriegsmans
past compensation and the estimated payment that would result from a termination of his
employment following a change in control, CytRx estimates that a gross-up payment would not be
required. |
|
(4) |
|
As of March 11, 2008, CytRx no longer owned a majority of the outstanding common stock of
RXi, and thus Mr. Woolf was no longer considered an executive officer of CytRx. Amounts
reported above with respect to Dr. Woolf would be payable by RXi. Stock option amounts for Dr.
Woolf relate to options to purchase RXi common stock granted pursuant to the RXi 2007
Incentive Plan. |
In connection with Mr. Natalizios resignation as Chief Financial Officer in September 2007,
CytRx paid approximately $5,000 of premiums for continuing medical, dental and vision insurance.
123
Compensation of Directors
The following table sets forth the compensation paid to CytRxs directors other than CytRxs
Chief Executive Officer for 2007:
Director Compensation Table
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fees Earned or |
|
Option |
|
|
|
|
Paid in Cash |
|
Awards |
|
Total |
Name (1) |
|
($) (2) |
|
($) (3) |
|
($) |
Max Link, Ph.D. |
|
|
108,173 |
|
|
|
70,000 |
|
|
|
178,173 |
|
Chairman |
|
|
|
|
|
|
|
|
|
|
|
|
Marvin R. Selter |
|
|
169,834 |
|
|
|
70,000 |
|
|
|
239,834 |
|
Vice Chairman |
|
|
|
|
|
|
|
|
|
|
|
|
Louis Ignarro, Ph.D. |
|
|
26,750 |
|
|
|
70,000 |
|
|
|
96,750 |
|
Director |
|
|
|
|
|
|
|
|
|
|
|
|
Joseph Rubinfeld, Ph.D. |
|
|
80,066 |
|
|
|
70,000 |
|
|
|
150,066 |
|
Director |
|
|
|
|
|
|
|
|
|
|
|
|
Richard Wennekamp |
|
|
76,990 |
|
|
|
70,000 |
|
|
|
146,990 |
|
Director |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Steven A. Kriegsman does not receive additional compensation for his role as a director. For
information relating to Mr. Kriegsmans compensation as President and Chief Executive Officer,
see the Summary Compensation Table above. |
|
(2) |
|
The amounts in this column represent cash payments made to Non-Employee Directors for
attendance at meetings during the year. |
|
(3) |
|
In July 2007, CytRx granted stock options to purchase 25,000 shares of its common stock at an
exercise price equal to the current market value of CytRx common stock to each non-employee
director, which had a grant date fair value of $2.80 calculated in accordance with SFAS
123(R). Pursuant to SEC rules, the amounts shown exclude the impact of estimated forfeitures
related to service-based vesting conditions. The amount recognized for these awards was
calculated using the Black Scholes option-pricing model, and reflect grants from our 2000
Long-Term Incentive Plan, which is described in Note 12 of the Notes to Consolidated Financial
Statements. |
CytRx uses a combination of cash and stock-based compensation to attract and retain qualified
candidates to serve on its board of directors. Directors who also are employees of CytRx currently
receive no compensation for their service as directors or as members of board committees. In
setting director compensation, CytRx considers the significant amount of time that directors
dedicate to the fulfillment of their director responsibilities, as well as the competency and
skills required of directors. The directors current compensation schedule has been in place since
May 2007. The directors annual compensation year begins with the annual election of directors at
the annual meeting of stockholders. The annual retainer year period has been in place for directors
since 2003. Periodically, the CytRx board of directors reviews director compensation policies and,
from time to time, makes changes to such policies based on various criteria the board deems
relevant.
Effective April 7, 2007, CytRxs non-employee directors receive a quarterly retainer of $6,000
($18,500 for the Chairman of the Board and $11,000 for the Chairman of the Audit Committee and
$7,500 for the Chairman of the Compensation Committee and the Chairman of the Nomination and
Governance Committee), a fee of $3,000 for each board meeting attended ($750 for board actions
taken by unanimous written consent), $2,000 for each meeting of the audit committee attended, and
$1,000 for each other committee meeting attended. Non-employee directors who serve as the chairman
of a board committee receive an additional $2,000 for each meeting of the nomination and governance
committee or the compensation committee attended and an additional $2,500 for each meeting attended
of the audit committee. In July 2007,
124
CytRx granted stock options to purchase 25,000 shares of our common stock at an exercise price
equal to the current market value of its common stock to each non-employee director. The options
were vested, in full, upon grant.
CERTAIN CYTRX RELATIONSHIPS AND RELATED TRANSACTIONS
Director Independence
The CytRx board of directors has determined that Messrs. Link, Rubinfeld, Selter, Ignarro and
Wennekamp are independent under the current independence standards of both The Nasdaq Capital
Market and the SEC, and have no material relationships with CytRx (either directly or as a partner,
shareholder or officer of any entity) which could be inconsistent with a finding of their
independence as members of the board of directors or as the members of the Audit Committee. In
making these determinations, the CytRx board of directors has broadly considered all relevant facts
and circumstances, recognizing that material relationships can include commercial, banking,
consulting, legal, accounting, and familial relationships, among others.
Transactions with Related Persons
General
The CytRx Audit Committee is responsible for reviewing and approving, as appropriate, all
transactions with related persons, in accordance with its Charter and Nasdaq Marketplace Rules.
Transactions between CytRx and one or more related persons may present risks or conflicts of
interest or the appearance of conflicts of interest. CytRxs Code of Ethics requires all employees,
officers and directors to avoid activities or relationships that conflict, or may be perceived to
conflict, with our interests or adversely affect our reputation. It is understood, however, that
certain relationships or transactions may arise that would be deemed acceptable and appropriate so
long as there is full disclosure of the interest of the related parties in the transaction and
review and approval by disinterested directors to ensure there is a legitimate business reason for
the transaction and that the transaction is fair to us and our stockholders.
As a result, the procedures followed by the CytRx Audit Committee to evaluate transactions
with related persons require:
|
|
|
that all related person transactions, all material terms of the transactions, and
all the material facts as to the related persons direct or indirect interest in, or
relationship to, the related person transaction must be communicated to the Audit
Committee; and |
|
|
|
|
that all related person transactions, and any material amendment or modification to
any related person transaction, be reviewed and approved or ratified by the Audit
Committee, as required by Nasdaq Marketplace Rules. |
|
|
The Audit Committee will evaluate related person transactions based on: |
|
|
|
|
information provided by members of the CytRx board of directors in connection with
the required annual evaluation of director independence; |
|
|
|
|
pertinent responses to the Directors and Officers Questionnaires submitted
periodically by officers and directors and provided to the Audit Committee by
management; |
|
|
|
|
background information on nominees for director provided by the Nominating and
Corporate Governance Committee of the CytRx board of directors; and |
125
|
|
|
any other relevant information provided by any of CytRxs directors or officers. |
In connection with its review and approval or ratification, if appropriate, of any related
person transaction, the Audit Committee is to consider whether the transaction will compromise
standards included in CytRxs Code of Ethics. In the case of any related person transaction
involving an outside director or nominee for director, the Audit Committee also is to consider
whether the transaction will compromise the directors status as an independent director as
prescribed in Nasdaq Marketplace Rules.
All related person transactions will be disclosed in CytRxs filings with the SEC in
accordance with SEC rules.
Exemption Clause
Item 404(a)(7)(a) of Securities and Exchange Commission Regulation S-K states that: Disclosure
need not be provided if the transaction is one where the rates or charges involved in the
transaction are determined by competitive bid, or the transaction involves rendering of services as
a common or contract carrier, or public utility, at rates or charges fixed in conformity with law
or governmental authority.
Applicable Definitions
For purposes of the CytRx Audit Committees review:
|
|
|
related person has the meaning given to such term in Item 404(a) of Securities and
Exchange Commission Regulation S-K (Item 404(a)); and |
|
|
|
related person transaction means any transaction for which disclosure is required
under the terms of Item 404(a) involving CytRx and any related persons. |
Recent and Proposed Transactions
There are no transactions currently proposed for 2008. Set forth below is a description of
CytRxs transactions with related persons during the past three fiscal years.
RXi was incorporated jointly in April 2006 by CytRx and the four current members of RXis
scientific advisory board for the purpose of pursuing the possible development or acquisition of
RNAi-related technologies and assets.
On January 8, 2007, CytRx entered into a Contribution Agreement with RXi under which CytRx
assigned and contributed to RXi substantially all of CytRxs RNAi-related technologies and assets.
The assigned assets consisted primarily of licenses from UMMS and from the Carnegie Institute of
Washington relating to fundamental RNAi technologies, as well as equipment situated at CytRxs
former Worcester, Massachusetts, laboratory. In connection with the contribution of the licenses
and other assets, RXi assumed primary responsibility for all payments to UMMS and other obligations
under the contributed licenses and assets.
On January 8, 2007, CytRx entered into a letter agreement with RXi under which RXi has agreed
to reimburse CytRx, following its initial funding, for all organizational and operational expenses
incurred by CytRx in connection with the formation, initial operations and funding of RXi.
Tod Woolf, Ph.D., the President and Chief Executive Officer of RXi, is a former executive
officer of CytRx. As described above in the Executive Compensation section of this proxy
statement/prospectus, CytRx and RXi entered into an employment agreement with Dr. Woolf under which
he is entitled to base
126
annual compensation and other employee benefits, including the right to receive, upon
completion of RXis initial funding, a grant by RXi of stock options to purchase shares of RXi
common stock.
Dr. Woolf may be deemed to have had a material interest in CytRx transactions with RXi
described above and in CytRxs subsequent dealings with RXi, by reason of his status as RXis
President and Chief Executive Officer and in light of any stock options granted to him by RXi upon
completion of its initial funding or otherwise.
BUSINESS OF INNOVIVE
Overview
We
are a development-stage biopharmaceutical company engaged in the development of compounds for
the treatment of cancer. We currently have four product candidates in our pipeline; INNO-406,
tamibarotene, INNO-206, and INNO-305.
INNO-406 is a small molecule that we licensed from Nippon Shinyaku in December 2005.
Pre-clinical and Phase I clinical data demonstrate that INNO-406 significantly inhibits both the
Bcr-Abl tyrosine kinase and the Lyn kinase. These kinases are believed to play a major role in
chronic myelogenous leukemia, or CML. Our data suggests that this product candidate has application
in therapy intolerant CML due to its anticipated lack of side effects as well as application in
refractory CML as the predominant forms of resistance come about due to Bcr-Abl amplification,
Bcr-Abl point mutations and up-regulation of other pathways such as Lyn. Preclinical findings
suggest that this product candidate is active against and targets cells exhibiting Bcr-Abl and Lyn
activation, which would give INNO-406 a competitive profile against other compounds for treating
this disease. We began our Phase I clinical study with INNO-406 in July 2006, established a dose
for the study in the third quarter of 2007. We are currently evaluating our options for further
studies for this product candidate. In January 2007, the FDA granted orphan drug status to INNO-406
for the treatment of CML.
Tamibarotene is a synthetic retinoid to which we acquired the North American rights and
European rights in exclusive licenses from TMRC Co., Ltd. in December 2006 and September 2007,
respectively, for the treatment of acute promyelocytic leukemia, or APL. Differentiation therapy
with all-trans retinoic acid, or ATRA, is the basis for the treatment of APL. Tamibarotene was
developed to specifically overcome resistance to ATRA. We initiated a pivotal study in APL under a
special protocol assessment, or SPA, from the FDA in patients who have developed resistance to ATRA
and arsenic trioxide in the second half of 2007. We believe that this study, if successful, and in
combination with the data from two completed Japanese studies, would form the basis of a U.S. New
Drug Application, or NDA, that we would expect to file with the FDA in late 2009, subject to
obtaining adequate funding.
INNO-206 (formerly DOXO-EMCH) is a prodrug for doxorubicin. Doxorubicin has demonstrated
efficacy in a wide variety of cancers including breast cancer, lung cancer, sarcomas, and
lymphomas. INNO-206 is a complex of doxorubicin attached to an acid sensitive linker. We believe
this novel agent has attributes that improve on native doxorubicin, including reduction of adverse
events, improvement in efficacy and the ability to preferentially reach the tumor. We intend to
initially develop INNO-206 as a therapeutic for solid tumors, first pursuing small cell lung
cancer, or SCLC, patients who are resistant to or have relapsed after initial chemotherapy. We
received an IND from the FDA in the second quarter of 2007. We were granted the rights to INNO-206
in an exclusive license from from KTB Tumorforschungs GmbH in August 2006.
INNO-305 is a WT1 peptide immunotherapeutic to which we were granted the rights in an
exclusive license from the Memorial Sloan Kettering Cancer Center in December 2005. Pre-clinical
data suggests that the multi-peptide therapy may be used to treat certain solid tumors and certain
leukemias including acute myelogenous leukemia, or AML. We believe that INNO-305 may be able to
overcome many of the challenges that other cancer vaccines have faced for several reasons including
its ability to target WT1, AML being an
127
immune responsive tumor, and ease of manufacture at a commercial scale. Additionally, the
literature indicates that leukemia responds favorably to treatment with similar compounds. We began
a Phase I clinical study of INNO-305 in October 2006 and the study is expected to be completed in
late 2008, subject to obtaining adequate funding.
We previously were developing INNO-105, a pentapeptide that we licensed from the Pennsylvania
State University in March 2005, as an anti-cancer agent in pancreatic cancer. We began our own
Phase I clinical study with INNO-105 in November 2005. The results of that clinical trial showed
that INNO-105 appeared unlikely to achieve targeted plasma levels without demonstrating adverse
side effects. Consequently, we discontinued development of INNO-105 in late September 2006 and
terminated the license agreement in December 2006.
We plan to develop and commercialize our product candidates. In addition, we intend to
leverage our development infrastructure by acquiring and developing additional clinical candidates
in the areas of oncology and hematology. Our success will depend our ability to raise the capital
necessary to develop our current and any future product candidates, on the clinical and regulatory
success of our product candidates, which we are in the early stages of development, and our ability
to retain on commercially reasonable terms financial and managerial resources of which we currently
have only a limited amount. To date, we have not received regulatory approval for any of our
product candidates nor have we derived any revenues from their sale.
We have retained a management team with core competencies and expertise in numerous fields,
including research, clinical, regulatory, finance and business development. Our management and
advisors are comprised of experienced pharmaceutical and biotechnology industry veterans and
respected experts. We are led by our Chief Executive Officer, Steven Kelly, an industry veteran who
has over 18 years of pharmaceutical experience.
The Oncology Therapeutics Market
The American Cancer Society estimates that over 1.4 million people in the U.S. will be
diagnosed with cancer in 2008, excluding basal and squamous cell skin cancers and in situ
carcinomas except urinary bladder carcinomas. This is an increase of approximately 12.5% from the
estimated number of new cancer diagnoses of approximately 1.2 million in 2000. We believe this
growth rate is unlikely to decrease in the foreseeable future as the causes of cancer are multiple
and poorly understood.
Despite continuous advances made in the field of cancer research every year, there remains a
significant unmet medical need as the overall five-year survival rate for a newly diagnosed cancer
patient averages 66% according to the American Cancer Society. According to that same source,
cancer is the second leading cause of mortality in the U.S. behind heart disease. The American
Cancer Society estimates that one in four deaths in the U.S. is due to cancer.
One of the main treatments for cancer is chemotherapy. There is often, however, a debilitating
effect resulting from chemotherapy treatment or lingering morbidity associated with the
chemotherapy treatment of cancer. Our goal is to develop compounds that can lengthen survival times
and improve the quality of life of patients and cancer survivors.
Even though there are a large number of patients, the treatment and management of cancer is
performed by a limited number of professionals. According to information contained in a 2005 report
of the American Medical Association, approximately 8,700 physicians treat the majority of cancer
patients in the U.S. We plan to reach this prescriber base using a relatively small commercial
infrastructure that we intend to develop in the future by either hiring internally or contracting
with one or more third-party entities with an established sales force. These development plans are
dependent on our raising additional capital, the success of tamibarotene, INNO-406, INNO-206, and
INNO-305 and any technologies we might acquire in the future, and successful negotiation of
commercial relationships for the commercialization of tamibarotene, INNO-406,
128
INNO-206, and INNO-305 and any technologies we might acquire in the future, none of which we
have completed to date.
INNO-406
Overview of Bcr-Abl Inhibition in CML
Chronic myelogenous leukemia, or CML, is a type of blood cancer that occurs in approximately
4,570 patients per year in the United States. Approximately 95% of CMLs contain a genetic
translocation known as Bcr-Abl. This gene variant signals the cells to proliferate. Bcr-Abl does
not exist in normal cells.
In 2001, Novartis AG, a large multi-national pharmaceutical company, won approval in the U.S.
for its drug Gleevec. Gleevec is a chemical molecule specifically designed to stop Bcr-Abl from
emitting its signals for cell growth. Gleevec proved effective in treating patients with CML by
inhibiting Bcr-Abl. Patients remain on Gleevec as chronic therapy. The reported five-year survival
rate for patients with CML has gone from approximately 35% before the approval of Gleevec in 2001
to approximately 90% in 2006. Worldwide sales of Gleevec in 2007 were $3.1 billion.
Unfortunately, resistance to Gleevec has begun to occur. Resistance to Gleevec appears to
occur due to amplification of the Bcr-Abl gene and in many cases mutations in the Bcr-Abl gene. In
other cases, some of the genes that Bcr-Abl signals to turn on are becoming turned on independently
of Bcr-Abl, making inhibition of the gene by Gleevec ineffective. Lyn is a member of the Src family
of kinases. These kinases are known to be involved in sending out signals that drive cell growth.
Lyn has been shown to be one of the genes that is turned on by Bcr-Abl and, in many
Gleevec-resistant CMLs, it is known that Lyn is active. Activation of Lyn is therefore suspected of
being another one of the mechanisms by which cells become resistant to Gleevec.
The development of resistance to Gleevec means that a second generation of drugs is required
to treat CML. These new drugs need to be able to inhibit Bcr-Abl even in its mutated form and
should also independently turn off some other genes that Bcr-Abl normally activates.
Dasatinib from Bristol-Myers Squibb, was the first of the second-generation Bcr-Abl inhibitors
to gain U.S. marketing approval from the FDA. It obtained conditional U.S. marketing approval in
June 2006 and was launched in July 2006. Dasatinib has high potency in inhibiting Bcr-Abl and also
inhibits Src, a family of kinases known to be involved in cell growth. In clinical studies,
dasatinib has shown good activity in Gleevec-resistant patients. However, there have also been
concomitant side effects, including serious and life threatening pleural effusion, which is excess
fluid around the lungs, and Grade 3/4 myelosuppression, which is significantly decreased blood cell
production. In fact, it is estimated that two-thirds of patients experience dose reductions or
interruptions and in data provided by Bristol-Myers Squibb 20% to 30% of patients that initiate
dasatinib therapy discontinue due to intolerance. As a result of this side effect profile,
Bristol-Myers Squibb gained approval for a lower dose regime of dasatinib in November 2007, hoping
to reduce the adverse events experienced at the higher dose. This side effect profile is believed
to be specific to dasatinib as other agents in this class have not shown this profile. It is not
clear that a Bcr-Abl and Lyn inhibitor would have these side effects.
Nilotinib, another second generation Bcr-Abl inhibitor developed by Novartis AG, gained
conditional U.S. marketing approval from the FDA in October 2007. Nilotinib has potent activity
against Bcr-Abl. In its Phase I clinical trial, nilotinib showed good activity in Gleevec-resistant
patients. In Phase II clinical data presented at the American Society for Hematology conference in
2006, nilotinib showed efficacy similar to dasatinib in Gleevec resistant patients. Discontinuation
from nilotinib due to resistance and/or intolerance occurred at a similar rate as with dasatinib.
129
INNO-406
INNO-406 is a novel drug developed by the Japanese pharmaceutical company Nippon Shinyaku. It
was specifically designed to overcome the limitations of Gleevec in resistant CML. INNO-406 is
roughly 25 to 55 times more potent at inhibiting Bcr-Abl in vitro than Gleevec. INNO-406 is also
capable of inhibiting many of the mutated forms of Bcr-Abl in CML that are resistant to Gleevec. In
addition, INNO-406 is capable of shutting down the expression of the gene Lyn. This ability to shut
down the expression of Lyn is independent of INNO-406s ability to inhibit Bcr-Abl.
We believe that these properties of INNO-406, including its higher potency than Gleevec, the
ability to inhibit the mutated forms of Bcr-Abl and the addition of Lyn inhibition, might make it
an effective treatment for CML, although we are in the early stages of the product clinical testing
and none of INNO-406s effects have been clinically proven.
Pre-clinical Data
In pre-clinical cell-based studies, INNO-406 has consistently been shown to be 25 to 55 times
more potent than Gleevec in blocking Bcr-Abl. The potency of INNO-406 extends to a series of
Bcr-Abl mutations known to occur in Gleevec-resistant patients. INNO-406 showed good activity
against 19 of 20 known mutations tested.
In mice-leukemia models, INNO-406 has been shown to markedly extend the survival of animals
implanted with Gleevec-resistant leukemic cells.
In toxicology studies done in mice, rats, and dogs, INNO-406 appeared to be safe and well
tolerated. A dose was described in dogs where no side effects were seen, which we used to calculate
a starting dose in humans for our Phase I clinical trials.
Clinical Data
With the exception of the results from our Phase I study described below, there are no other
clinical data to date for INNO-406. In general, however, pre-clinical results for Bcr-Abl
inhibitors in CML have translated well into clinical outcomes. We initiated the first human
clinical studies with INNO-406 in July 2006.
Development Plan
Our primary focus for the development of INNO-406 is a speed-to-market strategy where we hope
to receive accelerated FDA approval of INNO-406 in dasatinib and nilotinib intolerant or refractory
patients. In addition, we also might pursue INNO-406 as a treatment for other hematological
diseases as well as solid cancer tumors. Our accelerated approval strategy for INNO-406 will focus
on winning a subpart H approval in the U.S. in dasatinib and nilotinib intolerant and refractory
patients. Subpart H approval is a federally mandated approval process reserved for life-threatening
diseases in which a single study using surrogate endpoints can be used for approval. In oncology,
subpart H strategies typically involve using response rates (tumor shrinkage) as the major endpoint
of a study instead of the more traditional survival analysis generally used.
Novartis used a subpart H strategy for the approval of Gleevec. Novartis used cytogenetic
response to imatinib as the surrogate marker of drug efficacy for Gleevec. Bristol-Myers Squibb
also used a subpart H strategy for the approval of dasatinib. We believe that INNO-406 can be
approved using the same approach for CML patients that are intolerant or refractory to dasatinib or
nilotinib. In addition, we also believe we can gain approval in Gleevec resistant patients by
demonstrating an improved adverse event profile versus dasatinib. Any approval of INNO-406 will be
dependent on whether we can prove its safety and efficacy.
130
Phase I Study. Our Phase I clinical study used a modified continual dose reassessment method
at six sites, the MD Anderson Cancer Center at the University of Texas, the H. Lee Moffit Cancer
Center in Tampa, Florida, the Johann Wolfgang Goethe University Hospital in Germany, the
Universitat Heidelberg in Germany, Charite Hospital, in Germany and Sheba Medical Center in Israel.
Gleevec (imatinib) resistant or refractory patients have been enrolled in cohorts of three to six
patients with a starting dose of 30 mg per day. After all patients in a cohort were treated for two
weeks and no serious or life-threatening adverse events were seen, the dose was escalated by 100%.
The study used both a once-a-day and twice-a-day oral treatment schedule. The endpoints of the
Phase I study were the safety and toxicology profile of INNO-406 as well as its efficacy as
measured by hematological, cytogenetic and molecular responses.
Preclinical data showed that 19 out of 20 mutations of the disease associated with
Gleevec-resistance are sensitive to INNO-406, and this preclinical data was demonstrably predictive
of the clinical activity reviewed to date. Results from our Phase I study indicate that evidence of
the following clinical activity has been demonstrated in heavily pretreated patients who are
intolerant or resistant to imatinib and multiple second-generation tyrosine kinase inhibitors:
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INNO-406 was generally well tolerated in these heavily pre-treated patients; |
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No Grade 3/4 pleural effusions, peripheral edema, or pericardial effusions were
observed; |
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There was a low rate of hematological toxicity; and |
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There was a minimal mean QTc effect. |
In January 2007, the FDA granted orphan drug status to INNO-406 for the treatment of
Gleevec-resistant or intolerant CML.
Phase II Pivotal Study. We intend to conduct a Phase II clinical study of approximately 240
chronic phase patients that cannot tolerate or are not responding dasatinib or nilotinib (third
line). We submitted a special protocol assessment, or SPA, with the FDA for this study and
resubmitted it in Mid-2008 based on FDA comments. An SPA is typically an agreement between a
company and the FDA on the study design, the endpoints of the study and the data analysis. An SPA
is intended to provide assurance that if pre-specified trial results are achieved, they may serve
as the primary basis for an efficacy claim in support of a New Drug Application, or NDA, by a
company.
We believe that recruitment can be completed within one year, based on an aggressive
recruitment strategy using 50 to 60 sites worldwide. We expect to use hematologic and cytogenetic
response data from these patients to prepare an NDA.
The ability to commence this study or any other further testing on this product candidate is
contingent upon us obtaining adequate funding.
Tamibarotene
Background
Acute promyelocytic leukemia, or APL, is a specific type of acute myeloid leukemia
characterized by the t(15;17) translocation, which fuses the promyelocytic leukemia, or PML, gene
on chromosome 15 to the retinoic acid receptor, or RAR, g gene on chromosome 17. This fusion causes
abnormal cell growth.
Differentiation therapy with all-trans retinoic acid, or ATRA, is the basis for the treatment
of APL. Differentiation therapy causes leukemic promyelocytes to mature and undergo cell death.
Patients typically receive ATRA in combination with chemotherapy as the initial therapy followed by
anthracycline-based
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consolidation therapy designed to produce complete remission. The majority of patients treated
this way generally experience a complete remission of disease. Current National Comprehensive
Cancer Network guidelines recommend patients then undergo one to two years of maintenance therapy
with ATRA to prevent a recurrence. ATRA therapy is associated with several toxicities, the most
serious of which is retinoic acid syndrome, or RAS, a serious and potentially fatal complication
characterized by fever, dyspnea (breathing difficulties), weight gain, pulmonary infiltrates
(abnormal accumulation in the lungs), and pleural or pericardial effusions (excess fluid around the
lungs or heart), that occurs in up to 25% of patients treated with ATRA.
Unfortunately, the duration of remission induced by treatment with ATRA alone is typically
short. In addition, patients often fail to respond to a second course of treatment with ATRA.
Currently, patients who fail ATRA-based therapy are treated with arsenic trioxide, a compound
administered intravenously and associated with significant toxicity including irregular heartbeat.
There is no standard of care for patients who do not respond to ATRA and arsenic trioxide.
Tamibarotene was developed to specifically overcome resistance to ATRA. In vitro, tamibarotene
is approximately 10 times more potent than ATRA at causing APL cells to differentiate and die. In
addition, tamibarotene has a lower affinity for cellular retinoic acid binding protein, or CRABP,
which we believe should allow for sustained plasma levels during administration, resulting in
increased efficacy because patients can experience benefits from the drug over a longer period of
time. Tamibarotene does not bind the
RAR-g receptor, the major retinoic acid receptor in the dermal
epithelium, which should lessen the occurrence of RAS. In clinical studies, the rate of RAS
appeared to be low.
Pre-clinical data
In a variety of preclinical models, tamibarotene was superior to ATRA with regard to the
ability to cause APL cells to differentiate and die. In the clinical setting, in vitro response to
tamibarotene appeared predictive of clinical response, including activity in patients who had a
poor response to ATRA.
Clinical data
Tamibarotene is approved in Japan under the brand name Amnolake® for use in recurrent APL. The
approval was based on data from two studies in Japanese patients. In the pivotal study, the
effectiveness of orally administered tamibarotene was evaluated in 39 patients with APL, including
patients who had never received treatment for APL and patients who had been previously treated with
ATRA. Tamibarotene was administered orally at a dose of 6 mg/m2/day for eight weeks. The overall
response rate in these patients was 61.5%. In patients who had a recurrence of APL following ATRA
therapy, the response rate was 81%. RAS was reported in three patients, or 7.3% of the patient
group.
Development Plan
We initiated a pivotal study in ATRA and arsenic trioxide refractory APL under an SPA from the
FDA in the fourth quarter of 2007. The study is designed to collect pharmacokinetic, safety and
efficacy data in approximately 50 patients. We anticipate that this study will take approximately
18 months to complete. We believe that this study, in combination with the data from the two
Japanese studies, would form the basis of an NDA. If the results of the study are positive, we
believe that we would be able to file the NDA with the FDA in late 2009.
The ability to continue and conclude this study or any other further testing on this product
candidate is contingent upon us obtaining adequate funding.
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In addition, a Phase III study is currently being conducted in Japan by the Japan Adult
Leukemia Group comparing ATRA to tamibarotene for the maintenance treatment of APL. If positive,
data from this study could potentially form the basis of a supplemental NDA application.
INNO-206
Background
Anthracyclines are a class of drugs that are among the most commonly used agents in the
treatment of cancer. Doxorubicin, the first anthracycline to gain FDA approval, has demonstrated
efficacy in a wide variety of cancers including breast cancer, lung cancer, sarcomas, and
lymphomas. However, due to the uptake of doxorubicin by various parts of the body, it is associated
with side effects such as cumulative cardiotoxicity, myelosuppression (decreased production of
blood cells by bone marrow), gastrointestinal disorders, mucositis (inflammation of the mucous
membranes lining the digestive tract, including the mouth), stomatitis (inflammation of the mouths
soft tissue), and extravasation (the leakage of intravenous drugs from the vein into the
surrounding tissue).
INNO-206 (formerly DOXO-EMCH) is a prodrug for doxorubicin. Specifically, it is the
(6-Maleimidocaproyl) hydrazone of doxorubicin. Essentially, this chemical name describes
doxorubicin (DOXO) attached to an acid sensitive linker (EMCH). We believe this novel agent has
attributes that improve on native doxorubicin, including reduction of adverse events, improvement
in efficacy and the ability to reach the tumor more quickly.
Our anticipated mechanism of action for INNO-206 is as follows:
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after administration, INNO-206 rapidly binds endogenous circulating albumin through
the EMCH linker; |
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circulating albumin preferentially accumulates in tumors, bypassing uptake by other
non-specific sites including the heart, bone marrow and the gastrointestinal tract; |
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once albumin-bound INNO-206 reaches the tumor, the acidic environment of the tumor
causes cleavage of the acid sensitive linker; and |
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free doxorubicin is released at the site of the tumor. |
Pre-clinical data
In a variety of preclinical models, INNO-206 was superior to doxorubicin with regard to
ability to increase dosing, antitumor efficacy and safety, including a reduction in cardiotoxicity.
Clinical data
A Phase I study of INNO-206 that demonstrated safety and objective clinical responses in a
variety of tumor types was completed in 2005 and presented at the March 2006 Krebskongress meeting
in Berlin. In this study, doses were administered at up to six times the standard dosing of
doxorubicin without an increase in observed side effects over historically seen levels with
doxorubicin. Objective clinical responses were seen in patients with sarcoma, breast, and lung
cancers.
Development Plan
Based on the objective clinical responses seen in the Phase I study, we intend to initially
develop INNO-206 as a therapeutic for solid tumors. The first indication we intend to pursue is
small cell lung cancer,
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or SCLC, patients who are resistant to or have relapsed after initial chemotherapy. This
indication has a very poor prognosis with the current standard of care, topotecan, which is used in
approximately 30% of patients. Based on the existing preclinical and clinical data for INNO-206, we
believe there is the potential to demonstrate superiority to topotecan in the second-line SCLC
setting.
Phase II Study. We received an IND from the FDA in the second quarter of 2007. The first study
we intend to conduct will be a single arm study in SCLC patients who are resistant to or have
relapsed after initial chemotherapy. The objectives of the study will be to establish response
rate, overall survival and side effect profile in this indication. There is currently no timeframe
for the start of this study as it is contingent upon our obtaining financing and/or partnerships as
well as available therapies for this indication at the time of initiation.
Beyond this initial indication, we intend to explore the utility of INNO-206 in chemotherapy
regimens that currently include doxorubicin, both for solid tumor and other indications. If the
Phase I data were to hold up in larger randomized studies, we believe the potential exists for
INNO-206 to replace doxorubicin, based on higher efficacy and improved side effect profile,
although this has not been proven.
INNO-305
Immunotherapy Overview
Immunotherapy, simply, is the use of an external substance to stimulate an individuals immune
system with the intent of fighting off a corresponding disease. The immune system is composed of a
network of immune cells that include T lymphocytes (T cells) and B lymphocytes (B cells). There are
also specific subtypes of each. For example, two kinds of T cells are the cytotoxic T cells (CTL)
and the helper T cells (HTL). Each has a specific role to play in fighting off disease. CTLs are
the part of the immune system that is programmed to identify and kill cells that contain a specific
antigen. HTLs are a different part of the immune system that release chemical messengers called
cytokines that recruit other immune cells to the site of attack. HTLs also help CTLs do their job.
Immunotherapy, generally, harnesses these different parts of the immune system to assist the body
in warding off disease.
Commonly recognized examples of immunotherapy include childhood immunizations, where children
receive vaccines against measles, mumps, and rubella among others. In these cases, weakened or
inactivated viruses are injected into the body and become recognized by the immune system as
foreign antigens and therefore candidates for elimination. If the individual is subsequently
exposed to this virus, the immune system knows to eliminate it before it becomes a potential health
threat.
Cancer immunotherapy works in a similar way, although the goal here is treatment not
prevention. Cancerous cells or small proteins known to be part of cancerous cells are introduced to
the body in the hope of generating an immune response against the particular cancer.
INNO-305 (WT1) Immunotherapy
Wilms tumor protein, or WT1, is a well known and well characterized protein found in the human
body. WT1 is normally produced at the embryonic stage of human development and, as people age,
expression of the protein is reduced and nearly eliminated. In normal adults, WT1 is present but at
very low levels. However, in the case of certain cancers, including acute myelogenous leukemia, or
AML, chronic myelogenous leukemia, non-small cell lung cancer and mesothelioma, the protein is
found in very high levels. Because normal levels of WT1 are low and cancer levels of WT1 are high,
we believe WT1 is an attractive target for cancer immunotherapy.
In collaboration with David Scheinberg, M.D., Ph.D. at the Memorial Sloan-Kettering Cancer
Center, New York, New York, we have designed a series of four small protein fragments or peptides
that mimic
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different parts of the whole naturally occurring WT1. The intent is to administer these
peptides, designated as INNO-305, and to stimulate the immune system specifically the T cell
response to recognize WT1 as foreign and kill the cells that contain and produce WT1. Two of the
peptides are designed to activate CTLs and the other two are designed to activate the HTLs. We
believe this dual modality activation of the immune system will lead to an enhanced immune response
against the native WT1 protein, however, we have not proven this. The immunotherapy peptides that
we believe will activate the HTLs and CTLs include both normal and slightly altered fragments from
the WT1 protein, so called heteroclitic peptides. Heteroclitic peptides are designed to interact
with CTLs much more efficiently than normal protein fragments, thereby activating the immune system
in a more robust fashion.
Our initial disease target for INNO-305 is AML. AML is a disease of white blood cells.
Abnormal white cells or leukemic blasts grow in the blood and bone marrow leading to anemia,
bruising, bleeding and infections. As the leukemic blasts highly express WT1, we believe that
INNO-305 has potential as a therapy against AML, although this has not been proven. WT1 expression
is not limited to AML. Other tumors that express high levels of WT1 include non-small cell lung
cancer, mesothelioma, gliomas, multiple myeloma and ovarian cancer. Each of these areas represents
potential future indications for INNO-305.
Pre-clinical Data
To date, several peptides taken directly from the WT1 protein have been shown in pre-clinical
studies to be able to activate CTLs. In these pre-clinical studies, these activated CTLs directly
kill WT1-expressing leukemia cells, confirming that the target is present and can be recognized by
the immune system in leukemic cells.
These data led us to experiment with a heteroclitic approach. In this approach, normal WT1
peptides are altered by substituting amino acids to make a new fragment that activates CTLs more
efficiently. Through numerous pre-clinical assays, we were able to identify two heteroclitic
peptides of WT1 that resulted in much stronger activation than was seen with previously reported
WT1 peptides. These two peptides were included in INNO-305.
In addition, there are reports published in Blood and in abstract 5-9 from the 2nd
International Conference on WT1 in Human Neoplasia of using larger peptide fragments to stimulate a
HTL response against WT1. The reports have shown that these HTLs are capable of directly killing
leukemic cells expressing WT1. We have identified two larger peptides that appear efficient at
activating HTLs against WT1-expressing leukemic cells. These two larger peptides have also been
incorporated in INNO-305.
Clinical Data
Prior to our licensing of INNO-305, the safety profile and clinical activity of similar but
not identical WT1 immunotherapies had been reported in 37 AML patients (Table 1). INNO-305 is
designed to activate both CTLs and HTLs unlike the German and Japanese therapies discussed below,
which only stimulate a CTL response, which we believe is a potential disadvantage for these agents.
A team led by Professor Sugiyama of Osaka University, Japan has studied a natural and modified
WT1 peptide immunotherapy at Phase I in 13 AML patients and a modified WT1 peptide immunotherapy at
Phase II. Of the 13 patients studied at Phase I, nine had an immune response to the immunotherapy.
Four of these patients had complete responses of 6, 30+, 31+ and 31 months duration, respectively.
In a Phase II study using the modified peptide in eight patients, six patients were in complete
remission at the start of study but had high levels of WT1 making them more susceptible to relapse.
Following immunotherapy, three of these patients had stabilization of WT1 levels lasting for 6+, 6
and 4 months.
Dr. Anne Letsch and colleagues of Charité Hospital, Berlin, Germany, have administered a
natural WT1 peptide to 16 patients with AML (four at Phase I, 12 at Phase II). In two of the Phase
I patients with
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blasts counts of 5-10% on study entry, a complete remission was induced for 6 and 30+ months,
respectively. In both patients, raised CTL levels indicated an immune response to the therapy. In
the 12 Phase II AML patients, eight out of 12 had an immune reponse to the immunotherapy as
measured by raised CTL levels. Two patients with active disease were induced into complete
remission for 12 and 30+ months, respectively.
In the first three studies in Table 1, 19 out of 29 patients demonstrated an immune response.
Immune responses have not yet been analyzed for the fourth study. As a result, we believe that the
clinical data suggest that WT1 immunotherapy can successfully generate an immune response, although
we need to prove this in clinical studies. If this can be proven, we also hope to prove that
INNO-305 can achieve clinically meaningful responses especially in patients with low levels of
leukemic disease, which are those patients with durable complete remissions ranging from six to 31
months or more. We believe that prolonged treatment with INNO-305 needs to be explored to determine
whether it prolongs survival. We plan to study the effects of prolonged treatment in clinical
studies.
Table 1.
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Investigator |
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Country |
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Disease |
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Phase |
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No. of Patients |
Letsch et al. |
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Germany |
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AML |
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I |
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4 |
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Letsch et al. |
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Germany |
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AML/MDS |
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II |
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12 |
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Sugiyama et al. |
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Japan |
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AML |
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I |
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13 |
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Sugiyama et al. |
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Japan |
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AML |
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II |
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8 |
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The clinical benefit of WT1 immunotherapy has also been demonstrated in other diseases
including breast cancer, myelodysplasia, glioma and multiple myeloma. Clinical trials are currently
being conducted by third parties in some of these disease areas including a Phase I study on WT1
immunotherapy led by Dr. Satoshi Murita that was published showing good safety and evidence of
efficacy.
In the ongoing Phase I clinical study at Memorial Sloan Kettering, the vaccine appears to be
safe and well tolerated.
Development Plan
Phase I Study. We engaged Memorial Sloan-Kettering Cancer Center to conduct, on our behalf, a
first in-human Phase I study of INNO-305 in patients with AML, myelodysplastic syndrome and lung
cancer at Memorial Sloan-Kettering. The purpose of this study, which began in October 2006, is to
identify the safety of the immunotherapy and to determine whether an immune response to INNO-305 is
induced and to establish any clinical effect of INNO-305. This study is expected to be completed in
late 2008, subject to obtaining adequate funding.
Phase II/III Pivotal Study. As noted above, data from the Japanese and German researchers
shows the potential for the clinical benefit from a WT1 immunotherapy and suggests that INNO-305
will be most effective when there is a low disease burden, such as following positive hematological
response in patients with AML, where minimal residual disease may still pose a relapse risk.
However, this has not been proven.
Based on our understanding of the data, we intend to move to a pivotal Phase II/III
registration study in elderly patients with AML, comparing the effect on survival between INNO-305
and best supportive care. We have chosen this patient group to study for two reasons. First, they
have a high risk of relapse and the eradication of minimal residual disease, or MRD, should improve
their survival. Second, the elderly tend to poorly tolerate conventional chemotherapy, which we
believe makes a low toxicity therapy such as INNO-305 a desirable therapeutic option. Based on
these characteristics, we believe the regulatory authorities will look favorably at a registration
study in elderly AML patients. There is currently no timeframe for the start of this study as it is
contingent upon us obtaining financing and/or partnerships as well as available therapies for this
indication at the time of initiation.
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Competition
INNO-406. There are currently two main competitors to INNO-406 in the Gleevec-resistant CML
market. These are dasatinib and nilotinib. Although both of these drugs recently completed clinical
testing and have begun commercialization, we believe the head-start in development will not prove
critical in the commercial setting because CML is becoming a chronic condition much like HIV or
depression and that the market for treatment is large enough to accommodate several drugs.
Dasatinib from Bristol-Myers Squibb is the furthest ahead of the second-generation Bcr-Abl
inhibitors. Dasatinib gained conditional U.S. marketing approval from the FDA in June 2006 and
Bristol-Myers Squibb began distributing the product in July 2006. Dasatinib has high potency in
inhibiting Bcr-Abl and also inhibits Src, a family of kinases known to be involved in cell growth.
In clinical studies, dasatinib has shown good activity in Gleevec-resistant patients. However,
there have also been concomitant side effects, including serious and life threatening pleural
effusion. In various studies presented to date, roughly 20% to 30% of the patients that start
therapy are discontinuing. We believe a significant number of these patients are discontinuing due
to the side effect profile of the drug. This side effect profile may be related to Src inhibition,
but that has not yet been proven.
Nilotinib from Novartis AG gained conditional U.S. marketing approval from the FDA in October
2007. Nilotinib has potent activity against Bcr-Abl. In its Phase I clinical trial, Nilotinib
showed good activity in Gleevec-resistant patients. In Phase II clinical data presented and the
American Society for Hematology conference in 2006, nilotinib showed efficacy similar to dasatinib
in Gleevec resistant patients with similar rates of resistance and intolerance in patients.
Other clinical compounds in development for refractory CML include:
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Wyeths SKI-606 which is a Src inhibitor similar to dasatinib and is currently in a
Phase III trial; and |
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Ceflatoninâ from Chemgenex, a plant alkaloid primarily targeting a single Bcr-Abl
mutation known as T315I, which is in a Phase II/III clinical trial. |
Tamibarotene. To the best of our knowledge, there are no competitors in clinical development
for refractory APL. Currently, treatment of APL is based on induction and maintenance therapy with
ATRA and chemotherapy (typically idarubicin). ATRA and idarubicin are both generic compounds.
Arsenic trioxide, currently marketed by Cephalon, is approved for use in patients who have relapsed
after ATRA-based therapy in APL. There are no FDA approved therapies for patients who have failed
arsenic trioxide. In practice, it appears that patients who fail arsenic trioxide are retreated
with ATRA or receive Mylotarg®, which is marketed by Wyeth Pharmaceuticals.
INNO-206. We are aware of two compounds in late stage testing for SCLC. The first compound is
picoplatin from Poniard Pharmaceuticals. Picoplatin is a platinum agent that is currently in a
Phase III study in SCLC. The Phase III study looks to compare picoplatin in combination with best
supportive care alone in patients who were refractory to platinum therapy or failed to respond to
platinum therapy within six months. Assuming financing, we plan to test INNO-206 in patients who
initially had a response on platinum therapy.
The second compound in development in SCLC is amrubicin from Celgene. Amrubicin is a synthetic
anthracycline currently approved in Japan for use in lung cancer. Celgene initiated a Phase III
study in October 2007 in relapsed and refractory SCLC patients based on Phase II data from Japan,
which is showing a survival of between 9.2 and 11.7 months in this population.
Amrubicin and doxorubicin are both anthracyclines. We believe that the albumin-binding ability
of INNO-206 will allow the compound to overcome many of the side effect issues typically associated
with
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anthracyclines. We also believe that using albumin as a carrier will allow for higher dosing
and greater efficacy.
INNO-305. To the best of our knowledge, there are currently two WT1-specific peptide
immunotherapies in clinical development. A Japanese academic group (Sugiyama, et. al.) has
developed a heteroclitic approach for WT1 that appears to activate only CTLs. The Japanese approach
is specific only for patients with the HLA*A2402 haplotype (a haplotype refers to the genetic
makeup of a persons immune system). The HLA*A2402 is a haplotype common in Japanese patients but
relatively uncommon outside of Asia.
A German academic group (Keilholz, et. al.) has developed a native peptide WT1 immunotherapy
that is currently in Phase II. There appears to be no intellectual property protection for the
peptide being used, which we believe makes its commercial development unlikely.
A peptide immunotherapy approach against proteinase 3 called PR1 has entered a Phase III study
in AML after promising Phase I data. Although this immunotherapy is further ahead in development,
we believe INNO-305 is superior for the following reasons. First, WT1 appears to be a superior
target for AML since it is directly involved in leukemic cell growth and has been shown clinically
to be a poor prognosticator for AML. Second, INNO-305 involves a heteroclitic approach which should
induce a stronger CTL response. The PR1 candidate does not use a heteroclitic approach. Third,
INNO-305 involves both a CTL and HTL response. It appears that the PR1 approach stimulates only a
CTL response. In addition, because PR1 targets a different protein, there is the potential to
combine it with INNO-305 in therapy. Assuming our studies are successful, the clinical data we
generate will determine the best way to use each immunotherapy in patients.
Cell Genesys is developing GVAX®, a vaccine for acute leukemias. GVAX for leukemia is
comprised of a patients own cancer cells mixed with cells from cultured cell lines. All cells are
then genetically modified to express granulocyte-macrophage colony-stimulating factor or GM-CSF.
GM-CSF is a naturally occurring substance that is made by the body in response to infection or
inflammation. GVAX for leukemia is currently in a Phase II study. We believe that the
autologous/allogeneic immunotherapy approach is a difficult process to commercialize because of
logistical and quality control problems that arise with the harvesting of a persons cells,
transferring those cells to a centralized manufacturing site, growing and/or modifying those cells
and shipping them back to be administered to the individual. It is also unclear what the
immunotherapy specifically targets for immune recognition, which makes it difficult, in our view,
to determine if the correct immune responses are being made. For these reasons, we believe INNO-305
immunotherapy is a superior approach, assuming we can prove its efficacy.
General. Competition in the pharmaceutical industry is intense and we expect it to increase.
Technological developments in our field of research and development occur at a rapid rate and we
expect competition to intensify as advances in this field are made. We will be required to continue
to raise and devote substantial resources and efforts to our research and development activities.
Our most significant competitors, among others, are fully integrated pharmaceutical companies such
as Novartis (Gleevec), Eli Lilly (Alimta), Bristol-Myers Squibb (Erbitux) and Sanofi-Aventis
(Eloxatin), and more established biotechnology companies such as Genentech (Avastin and Tarceva)
and Imclone Systems (Erbitux), which have substantially greater financial, technical, sales,
marketing, and human resources than we do. These companies might succeed in obtaining regulatory
approval for competitive products more rapidly than we can for our products. In addition,
competitors might develop technologies and products that are cheaper, safer or more effective than
those being developed by us or that would render our technology obsolete.
Other Compounds Building Our Pipeline
In order to leverage the infrastructure that we plan to develop and to better mitigate risk,
we plan to in-license other clinical stage product candidates. We also plan to license pre-clinical
technologies that appear promising, making decisions to fully commit resources only after
pre-defined clinical endpoints are achieved.
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We believe this will allow us to replicate the target identification/therapeutic candidate
development function without taking on the significant overhead costs usually associated with
research and development. Additionally, we will not commit our product pipeline to a single
platform or approach (i.e., monoclonal antibodies, antisense, recombinant DNA technology, cell
culture technology, etc.), which we believe will better diversify our risk. All plans to leverage
our infrastructure are dependent on us raising additional capital or attracting partners.
License Agreements and Intellectual Property
Our goal is to procure, maintain and enforce robust patent protection for our products,
formulations, processes, methods and other proprietary technologies, preserve our trade secrets,
and make, use and sell our products without infringing the proprietary rights of third parties,
both in the United States and abroad. It is our continued mission to actively seek the broadest
intellectual property protection available for our current product candidates, which are INNO-406,
tamibarotene, INNO-206, INNO-305, future product candidates and any other proprietary technologies
and/or assets through a combination of strategic contractual alliances and diversified intellectual
property protection and enforcement, worldwide. We believe we accomplish our goals through a
thorough business, technical and legal review of the intellectual property rights we intend to
license, the inclusion of favorable and protective provisions in our license agreements and our
entry into non-disclosure and intellectual property assignment agreements with the persons and
entities with whom we contract, including our employees.
We also depend upon the skills, knowledge and experience of our scientific and technical
personnel, as well as that of our advisors and consultants, which collectively represent a highly
valued intangible asset. To help protect our proprietary know-how and other inventions for which
patent protection may be difficult to enforce or easy to design around, we continue to rely upon
trade secret protection. To this end, we require all of our employees, consultants, advisors and
other contractors to enter into agreements that prohibit the disclosure of confidential information
and, where applicable, require disclosure and assignment to us of the ideas, developments,
discoveries and inventions conceived during service with our company.
INNO-406
In December 2005, we entered into an exclusive worldwide (with the exception of Japan)
royalty-bearing license agreement with Nippon Shinyaku, including the right to grant sub-licenses,
for the intellectual property relating to INNO-406 in any field. The Nippon Shinyaku license
agreement expires on a country-by-country basis upon expiration of the subject patent rights. The
INNO-406 license covers two PTC applications filed in 2003 and 2004, respectively.
In consideration for the grant of the license to INNO-406, in January 2006 we paid Nippon
Shinyaku an initial license fee of $600,000, and agreed to make additional payments in the
aggregate amount of $13,350,000 (including $5,000,000 upon the products first final marketing
approval) upon the achievement of clinical and regulatory milestones up to and including approvals
in the U.S. and Europe. We also issued to Nippon Shinyaku 400,000 shares of our common stock. We
also agreed to pay:
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commercially reasonable royalties based on a percentage of net sales (as defined in
the Nippon Shinyaku license agreement), dependent on reaching certain revenue
thresholds; |
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annual minimum payments if sales of INNO-406 do not meet specified levels; and |
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a percentage of non-royalty sub-licensing income (as defined in the Nippon Shinyaku
license agreement). |
The Nippon Shinyaku license agreement includes covenants that require us to, among other
things: file an NDA by a specific date and use our commercially reasonable efforts to bring a
licensed product to
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market. In the event that we breach a material term of the Nippon Shinyaku license agreement,
Nippon Shinyaku has the option to terminate the agreement following the giving of notice and an
opportunity to cure any such breach.
Tamibarotene
On December 6, 2006, we entered into a license agreement with TMRC Co., Ltd. for the license
of patent rights held by TMRC for the North American development and commercialization of
tamibarotene. The license granted to us is exclusive, applies to all products that may be subject
to the licensed intellectual property and may be used in the treatment of acute promyelocytic
leukemia, or APL. We may sublicense the intellectual property in our sole discretion. TMRC granted
us an option to include within the license the use of the drug in other fields in oncology
including multiple myeloma, myelodysplastic syndrome, and solid tumors.
We paid TMRC a license issue fee of ¥10,000,000 (approximately $85,000 at time of payment) on
execution of the agreement. Under the license agreement, we must pay TMRC royalties based on net
sales and make payments to TMRC in the aggregate of ¥490,000,000 (approximately $4,400,000 as of
December 31, 2007) upon meeting clinical, regulatory and sales milestones up to and including the
first commercial sale of the product for the treatment of APL.
Under the agreement, we must use commercially reasonable efforts to conduct the research and
development activities we determine are necessary to obtain regulatory approval to market the
product in those countries in North America that we determine are commercially feasible.
The license agreement expires with the expiration of the subject patent rights or 15 years
from the date of first commercial sale of product in North America, whichever is later. The
agreement may be terminated if either party is in breach and the breach is not cured within a
required amount of time. We may also terminate the agreement in the event of a material change in
the safety profile of the technology that makes continued development impossible.
On September 10, 2007, we entered into a license agreement with TMRC for the license of patent
rights held by TMRC for the European development and commercialization of tamibarotene. The license
granted us is exclusive, applies to all products that may be subject to the licensed intellectual
property and may be used in the treatment of acute promyelocytic leukemia and human hematological
malignancies, including multiple myeloma, myelodysplastic syndrome, chronic myelocytic leukemia,
acute myelocytic leukemia and solid tumors other than hepatocellular carcinoma. We may sublicense
the intellectual property in Europe at our sole discretion.
We were required to pay TMRC a license issue fee of approximately ¥80,000,000, of which
¥18,000,000 (approximately $160,000 at time of payment) was due and paid within 30 days of
executing the agreement. We must pay the remaining ¥62,000,000 (approximately $552,000 as of
December 31, 2007) upon the earlier of a funding event or March 31, 2008. In addition, we are
required to pay ¥60,000,000 (approximately $535,000 as of December 31, 2007) upon the earlier of
June 30, 2008 or the achievement of one-half of the patients enrolled in its tamibarotene STAR
clinical study. The license issue fee and the non-contingent milestones were all recorded as
research and development expense, at prevailing currency rates at the time of the agreement, for
the year ended December 31, 2007. The non-contingent milestones are included in accrued expenses as
of December 31, 2007 and have been marked to market based on prevailing currency rates as of
December 31, 2007. Under the license agreement, we must pay TMRC royalties based on net sales and
make additional payments, other than those discussed above, to TMRC in the aggregate of
approximately ¥420,000,000 (approximately $3.7 million as of December 31, 2007) upon meeting
various clinical and regulatory milestones.
All payments due under this agreement, as well as our agreement for the North American rights
to tamibarotene with TMRC, are required to be made in Japanese Yen. The ultimate United States
dollar amount
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paid under these agreements will depend on the foreign currency exchange rates at the time of
payment. We do not currently employ any hedging strategies related to these payments.
INNO-206
On August 18, 2006, we entered into a license agreement with KTB Tumorforschungs GmbH for the
license of patent rights held by KTB for the worldwide development and commercialization of
INNO-206. The license granted to us is exclusive and worldwide, applies to all products that may be
subject to the licensed intellectual property and may be used in all fields of use. We may
sublicense the intellectual property in our sole discretion. KTB granted us an option to include
within the license any technology that is claimed or disclosed in the licensed patents and patent
applications for use in the field of oncology. We also have the right of first refusal on any
license that KTB wishes to make to a third party regarding any technology that is claimed or
disclosed in the licensed patents and patent applications for use in the field of oncology.
We paid KTB a license issue fee of $500,000 on execution of the agreement. Under the license
agreement, we must make payments to KTB in the aggregate of $7,500,000 upon meeting clinical and
regulatory milestones up to and including the products second final marketing approval. We also
agreed to pay:
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commercially reasonable royalties based on a percentage of net sales (as defined in
the KTB license agreement); |
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a percentage of non-royalty sub-licensing income (as defined in the KTB license
agreement); and |
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milestones of $1,000,000 for each additional final marketing approval should we
pursue them. |
In the event that we must pay a third party in order to exercise our rights to the
intellectual property under the agreement, we will deduct a percentage of those payments from the
royalties due KTB, up to an agreed upon cap. This deduction includes a percentage of any payments
that might be required to be made by us to Bristol-Myers Squibb. Bristol-Myers Squibb holds a
patent on technology that might be considered to block the patents and patent applications that are
the subject of the license agreement with KTB. We have begun discussions with Bristol-Myers Squibb
to develop a mutually beneficial arrangement.
Under the agreement, we must use commercially reasonable efforts to conduct the research and
development activities we determine are necessary to obtain regulatory approval to market the
product in those countries that we determine are commercially feasible. Under the agreement, KTB
will use its commercially reasonable efforts to provide us with access to suppliers of the active
pharmaceutical ingredient of the product on the same terms and conditions as may be provided to KTB
by those suppliers.
The license agreement expires on a product-by-product basis upon expiration of the subject
patent rights. We have the right to terminate the agreement on 30 days notice, provided we pay a
cash penalty to KTB. KTB may terminate the agreement if we are in breach and the breach is not
cured within a required amount of time or if we fail to use diligent and commercially reasonable
efforts to meet various clinical milestones.
INNO-305
In December 2005, we entered into an exclusive worldwide royalty-bearing license agreement
with the Sloan-Kettering Institute for Cancer Research, or SKI, including the right to grant
sub-licenses, for the intellectual property relating to INNO-305 for all diseases, disorders and/or
conditions, including but not limited to, oncology. The SKI license agreement expires on a
country-by-country basis upon expiration of the subject patent rights. The INNO-305 license
agreement includes a PTC patent application published in 2005;
141
three U.S. provisional patent applications filed in 2005; and a U.S. continuation patent
application claiming priority to an application filed in 2003.
In consideration for the grant of the license to INNO-305, in January 2006 we paid SKI an
initial license fee of $200,000 and agreed to make additional payments in the aggregate amount of
$3,600,000 upon the achievement of clinical and regulatory milestones through the products first
approval. We also agreed to pay:
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commercially reasonable royalties based on a percentage of net sales (as defined in
the SKI license agreement); |
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an annual license maintenance fee of $100,000 beginning on the first anniversary of
the agreement and ending on the first commercial sale of INNO-305 (but not required to
be paid in any year in which we make a milestone payment); |
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annual minimum payments for sales of INNO-305 for specified indications; |
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a percentage of non-royalty sub-licensing income (as defined in the SKI license
agreement); and |
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milestones of $750,000 for each additional final marketing approval should we pursue
them. |
The SKI license agreement includes covenants that require us to, among other things: initiate
clinical trials by specific dates or pay financial penalties, which could be severe; use our
commercially reasonable efforts to bring a licensed product to market; and prosecute and maintain
patents related to INNO-305. In the event that we breach a material term of the SKI license
agreement, SKI has the option to terminate the agreement following the giving of notice and an
opportunity to cure any such breach.
Clinical Research Organizations
Our clinical trials are conducted by third-party clinical research organizations with whom we
contract. We strive to negotiate terms with these third-parties that allow us to transfer the data
and other results of the trials that they might perform for us to us or to another third party so
that in the event the third-party provider stops performing or we wish to replace the third party
for any reason, we will be entitled to the data and can transfer it quickly to another party to
complete the trial. We believe that there is a sufficient number of clinical research organizations
that should we need to replace any with whom we might have contracted we will be able to do so. We
have contracted with Memorial Sloan Kettering Cancer Center to conduct our INNO-305 Phase I study
and contracted with a third-party clinical research organization to conduct our Phase I trial for
INNO-406 and our Phase II study for tamibarotene. We have a transfer of data clause in each of
these contracts.
Manufacturing and Marketing
We own no manufacturing facilities. We have contracted with various contract manufacturing
facilities for supply of our active pharmaceutical ingredient, or API, and finished product for
each of our products currently in a clinical study. We currently have agreements in place with
these manufacturers for the supply of product for all of our current clinical studies. Pursuant to
the license with TMRC, TMRC will provide us with tamibarotene at a fixed price and in a quantity
sufficient to meet our clinical and commercial needs. We entered into a definitive supply agreement
for these needs, on the commercial terms established in the license agreement in the first half of
2007. We plan to continue to use third-party manufacturers to produce material for use in future
clinical trials and, if any of our products are approved for marketing, for commercial product.
This manufacturing strategy will enable us to direct our financial resources to product
development, without devoting resources to the time and cost associated with building large
manufacturing plants. Other than noted above, we do not have any supply contracts for our product
candidates in place at this time.
142
We plan to establish our own sales and marketing infrastructure and commercialize the products
ourselves in the U.S. We intend to seek a third party marketing partner for commercialization
outside of the U.S. Any such infrastructure or third party marketing agreement would be established
only once one or more of our drug candidates is close enough to being approved for marketing.
Employees
As of March 31, 2008, we had a total of four employees. In January and February 2008 we
terminated four employees to conserve financial resources. We believe our relationships with our
employees are satisfactory. None of our employees is represented by a labor union.
Scientific Advisory Board
We retain the services of several qualified individuals on our Scientific Advisory Board. The
Scientific Advisory Board meets on an as needed basis if significant developments or new
information become available and require expert review. These meetings serve primarily as an
opportunity to review our scientific, research and clinical development plans from the perspective
of key opinion leaders in the medical community. The meetings also provide a forum in which members
provide specific advice concerning the design of clinical research protocols that we intend to
utilize for the development of our drug candidates. Meetings also provide us with an opportunity to
test the validity of any assumptions regarding the attitudes of the medical community relative to
the importance of various drug characteristics that might be highlighted during development. Our
Scientific Advisory Board consists of the following individuals:
Peter Anthony Jones, Ph.D. Dr. Jones is Director of the USC/Norris Comprehensive Cancer
Center, Distinguished Professor of Urology, Biochemistry and Molecular Biology, Keck School of
Medicine at the University of Southern California and is the former President of the American
Association for Cancer Research (AACR). Dr. Jones is a pioneer in the study of DNA methylation in
human cancer, a process associated with controlling tumor suppressor genes in a wide variety of
tumors.
Alan F. List, M.D. Dr. List is Chief of the Hematologic Division at the H. Lee Moffitt Cancer
Center & Research Institute, Tampa, Florida, and Professor of Medicine and Oncology at the
University of South Florida College of Medicine. Dr. List is an internationally recognized
investigator in the biology and treatment of acute myeloid leukemia (AML) and myelodysplastic
syndrome (MDS). He serves on the Board of Directors for the MDS Foundation and the Aplastic Anemia
and MDS International Foundation.
Edward A. Sausville, M.D., Ph.D. Dr. Sausville is Associate Director for Clinical Research,
Greenbaum Cancer Center, University of Maryland. Dr. Sausville has served as associate director of
the National Cancer Institutes Developmental Therapeutics Program, which has played a key role in
developing many currently used anti-cancer drugs. He was instrumental in bringing to clinical
study, Velcade, the first of a new class of medicines approved for treatment of multiple myeloma.
Howard I. Scher, M.D. Dr. Scher is the Chief of the Genitourinary Oncology Service and the D.
Wayne Calloway Chair in Urologic Oncology at the Memorial Sloan Kettering Cancer Center. He is an
investigator in the field of genitourinary cancers. He is currently overseeing the development of
new therapies for prostate cancer, including the use of novel therapies such as monoclonal
antibodies, vaccines, and drugs that target specific signaling pathways. His research has focused
on the use of prognostic models to select treatments for individual patients, the use of
combination therapy approaches, and early markers of response to treatment. Dr. Scher received his
M.D. from New York University School of Medicine and completed fellowships at Memorial Sloan
Kettering Cancer Center and The New York Hospital-Cornell Medical Center.
Daniel D. Von Hoff, M.D. Dr. Von Hoff is Senior Investigator and Head of Translational
Research at the Translational Genomics Research Institutes Translational Drug Development Division
and Head, Pancreatic Cancer Research Program in Phoenix, Arizona. He also is Chief Scientific
Officer for US
143
Oncology. Dr. Von Hoff and his colleagues were involved in the beginning of the development of
many anti-cancer agents including mitoxantrone, fludarabine, paclitaxel, docetaxel, gemcitabine,
and CPT-11. He was appointed by the President to the National Cancer Advisory Board. He is past
President of the American Association for Cancer Research, a founder of ILEX Oncology, Inc.
(recently acquired by Genzyme), founder and the Editor Emeritus of Investigational New Drugs The
Journal of New Anticancer Agents, and Editor-in-Chief of Molecular Cancer Therapeutics.
Properties
We sublease approximately 5,526 square feet of office space at 555 Madison Avenue, New York,
New York, pursuant to a sublease dated March 14, 2005. This lease currently requires us to make
monthly payments of approximately $17,499, subject to increase to $18,420 in the sixth year of the
lease. The lease expires August 30, 2012. We do not own any real property. We believe that our
existing facilities are adequate to meet our needs for the foreseeable future.
Legal Proceedings
We are not subject to any pending legal proceeding nor are we aware of any threatened claims
against us.
144
INNOVIVE MANAGEMENTS DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATION
The following discussion and analysis of Innovives financial condition and results of
operations should be read together with the selected historical financial information of Innovive
on page 10 and Innovives financial statements and related notes included as Appendix F to this
proxy statement/prospectus. This discussion contains forward-looking statements, based on current
expectations and related to future events and Innovives future financial performance, that involve
risks and uncertainties. Innovives actual results may differ materially from those anticipated in
these forward-looking statements as a result of many important factors, including those set forth
under the captions Risk Factors and Cautionary Statement Concerning Forward-Looking
Statements in this proxy statement/prospectus.
Overview
Since our inception in March 2004, we have focused our efforts and resources primarily on
acquiring and developing our current pharmaceutical technologies, INNO-406, tamibarotene, INNO-206,
and INNO-305, and one former product candidate, INNO-105, raising capital and recruiting personnel.
We are a development stage company and have no product sales to date and we will not receive any
product sales until we receive approval from the FDA or equivalent foreign regulatory authorities
to begin selling our pharmaceutical candidates. Assuming we do not encounter any unforeseen safety
issues during the course of developing our product candidates and subject to our having sufficient
financial resources, we do not expect to complete the development of INNO-406 until the second half
of 2009, tamibarotene until the first half of 2009, INNO-206 until 2010 or INNO-305 until 2010 at
the earliest.
Drug development is an expensive effort, and the expenses related to the research and
development of our current candidates will be significant from now through their anticipated
approval, if ever. Accordingly, our success will depend not only on the safety and efficacy of our
product candidates, but also on our ability to finance the development of the products. Through
March 31, 2008, our major sources of working capital have been proceeds from a private sale in June
2005 of senior convertible promissory notes, advances from a related party under a future advance
promissory note, a private sale in June 2006 of our shares of Series A preferred stock, which
shares subsequently converted into shares of our common stock in August 2006, and a private
placement of common stock units in April 2007.
Immediate Need for Operating Funds
To date, we have not generated any revenues from operations. At March 31, 2008, we had cash
and short-term investments of $301,962 and a working capital deficiency of $3,671,227. As a result,
we have insufficient funds to meet our current obligations or future operating expenses. To
conserve funds, we have suspended all expenditures on the development of INNO-206 and suspended all
other non-essential expenditures, including reduction of headcount. We have continued to incur
costs associated with the licensing and development of tamibarotene including costs associated with
our pivotal Phase II clinical trial in acute promeylocytic leukemia, costs associated with the
completion of our Phase I clinical study for INNO-406 in chronic meyelogenous leukemia, which
enrolled its last patient in November 2007, and regulatory documentation for the FDA to support a
Phase II pivotal clinical study on INNO-406. If we are unable to obtain capital or enter into a
strategic transaction, we will not be able to continue our current operations.
We have an immediate need for additional capital to be able to continue our operations. We
currently do not have sufficient funds to satisfy our current obligations or finance our current
operations. The continued development and potential commercialization of our product candidates and
all other aspects of our operations are and will continue to be contingent on raising sufficient
capital to continue to pursue pre-clinical and clinical trials and, thereafter, the successful
testing and commercialization of each compound. Without additional capital, we will not be able to
pursue development of our product candidates. We have been exploring several alternatives,
including licensing opportunities, the sale to or merger into another company,
145
the sale of one or more of our product candidates and debt and equity financing, and in June
2008, we entered into an agreement to be acquired by CytRx. If we are unable to secure additional
capital on reasonable terms or unable to generate sufficient sources of capital through
collaborative arrangements, we will not have the ability to continue as a going concern.
Lack of Revenue
We had not generated any revenue from any source through March 31, 2008 and we do not expect
to generate revenue within the foreseeable future, if ever. None of our existing product candidates
is expected to be commercially available until late 2009 at the earliest, if at all.
Results of Operations
Three Months Ended March 31, 2008 and 2007
Research and development expense. Research and development expenses decreased $1,995,541 or
73% from $2,727,152 for the three months ended March 31, 2007 to $731,611 for the three months
ended March 31, 2008. The decrease is the result of our current financial condition which has not
enabled us to pursue development of our product candidates to the same extent as in the prior year.
Lower development costs for our product candidates of $1,525,264 and lower payroll and related
costs of $193,518 drove the decrease in research and development costs. Lower development costs are
primarily the result of lower spending on INNO-406 and INNO-206 partially offset by higher spending
on tamibarotene, as we continued to enroll our Phase II pivotal study for that product. Lower
headcount and related costs are the result of decreased headcount as we sought to conserve cash
through terminations and attrition.
General and administrative expense. General and administrative expenses decreased $277,733 or
29% from $963,375 for the three months ended March 31, 2007 to $685,642 for the three months ended
March 31, 2008. The decrease is primarily the result of lower stock-based compensation and lower
legal fees.
Interest income. Interest income decreased $37,225 or 68% from $54,996 to $17,771 due to a
decrease in our average cash balance for the three months ended March 31, 2008 versus the prior
year.
Other expense. Other expense of $176,661 represents our realized and unrealized foreign
exchange loss in the current three-month period. Of this amount, $159,164 of foreign exchange loss
is related to milestones on our license agreements with TMRC, which we are required to pay in
Japanese yen. We recorded a realized foreign exchange loss of $17,356 for certain milestones
recorded in September 2007 and paid in January 2008 and recorded an unrealized foreign exchange
loss $141,808 for certain milestones recorded in September 2007 that remained outstanding on March
31, 2008 and revalued at that date.
Net loss. Net loss decreased $2,059,388 or 57% from $3,635,531 for the three months ended
March 31, 2007 to $1,576,143 for the three months ended March 31, 2008. The decrease in net loss
was attributable to the decrease in research and development and general and administrative
expenses, partially offset by an increase in other expense, which is discussed above.
Year Ended December 31, 2007 Compared to Year Ended December 31, 2006
Research and development expense. Research and development expense increased $2,037,595 or 17%
from $12,236,862 for the year ended December 31, 2006 to $14,274,457 for the year ended December
31, 2007. The increase was primarily attributable to $3,377,888 in higher spending on development
and licensing/milestone costs of tamibarotene, to which we acquired the North American rights in
December 2006 and European rights in September 2007. Included in the 2007 costs for tamibarotene
are approximately $1,755,000 in licensing and milestone payments including $1,055,000 in
noncontingent milestone payments due in the first half of 2008 and $544,000 for the first patient
enrolled in the Phase II study. The higher
146
spending on tamibarotene was partially offset by $873,742 in lower licensing/milestone
payments related to the license of INNO-406 and $587,476 in lower milestone and development costs
related to INNO-105, which we discontinued development on in September 2006.
General and administrative expense. General and administrative expenses increased $734,202 or
21% from $3,419,749 for the year ended December 31, 2006 to $4,153,951 for the year ended December
31, 2007. The increase is primarily related to $265,404 in higher legal fees, primarily associated
with increased regulatory filing requirements, $230,691 in higher headcount and stock option costs,
$141,569 in higher board of director fees, primarily due to a greater number of board members in
the current year as well as higher administrative costs, including consulting and insurance as we
expanded our operations in support of our development programs.
Interest expense. There was no interest expense in the current year compared to interest
expense of $1,189,493 for the year ended December 31, 2006 due to the conversion of all debt into
equity in 2006.
Interest income. Interest income increased $130,510 or 84% from $155,877 for the year ended
December 31, 2006 to $286,387 for the year ended December 31, 2007. The increase was primarily
attributable to higher average cash and cash equivalents and short-term investments for the current
year.
Net loss. Net loss increased $1,494,645 or 9% from $16,690,227 for the year ended December 31,
2006 to $18,184,872 for the year ended December 31, 2007. The increase in net loss was primarily
attributable to increases in research and development expense and general and administrative
expense, which were partially offset by a decrease in interest expense discussed above.
Year Ended December 31, 2006 Compared to Year Ended December 31, 2005
Research and development expense. Research and development expense increased $8,608,472 or
237% from $3,628,390 for the year ended December 31, 2005 to $12,236,862 for the year ended
December 31, 2006. The increase was primarily attributable to $7,138,557 in higher spending on the
development of INNO-406, $1,253,920 in milestone payments and development costs for INNO-206, which
we licensed in August 2006, and $809,490 in higher headcount and employee option costs. The higher
spending on these projects was slightly offset by $965,000 in lower milestone payments and
development costs related to INNO-105, which we discontinued development on in September 2006, and
$521,675 in lower milestones related to the license of INNO-406. Higher development costs for
INNO-406 are due to initiation of the Phase I clinical trial as well as product development and
manufacturing costs to support the clinical study. Higher headcount and employee option costs are
primarily attributable to additional headcount in 2006 to support additional products in
development. Lower milestone payments related to INNO-406 is primarily due to the prior year
including an upfront license fee of $600,000.
General and administrative expense. General and administrative expenses increased $1,763,556
or 106% from $1,656,193 for the year ended December 31, 2005 to $3,419,749 for the year ended
December 31, 2006. The increase is primarily related to $790,856 in higher headcount and stock
option costs as well as higher administrative costs, including rent, consulting and insurance as we
expand our operations in support of our development program.
Interest expense. Interest expense increased $778,920 or 190% from $410,573 for the year ended
December 31, 2005 to $1,189,493 for the year ended December 31, 2006. The increase was due to
several factors, including:
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a $788,086 non-cash amortization charge for the recognition of the beneficial
conversion feature on the senior convertible notes; |
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the increase in borrowings related to the future advance promissory note issued to
Paramount BioCapital Investments LLC, or PBI, and a PBI-related party in June 2004; and |
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the issuance of the 5% senior convertible notes in June 2005, non-cash amortization
of debt issuance costs and debt discount related to the senior convertible notes offset
by a gain due to the change in value of the warrant liability. |
Interest income. Interest income increased $139,660 or 861% from $16,217 for the year ended
December 31, 2005 to $155,877 for the year ended December 31, 2006. The increase was attributable
to higher average cash and cash equivalents and short-term investments for the current year.
Net loss. Net loss increased $11,011,288 or 194% from $5,678,939 for the year ended December
31, 2005 to $16,690,227 for the year ended December 31, 2006. The increase in net loss was
attributable to the increase in research and development expense, general and administrative
expense and interest expense discussed above.
Contractual Obligations and Commitments
The following table sets forth our contractual obligations and commitments as of December 31,
2007.
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Payments due by period |
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Less than 1 |
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More than 5 |
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Total |
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year |
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1-3 years |
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4-5 years |
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years |
Operating lease obligations |
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$ |
1,014,993 |
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$ |
218,328 |
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$ |
428,265 |
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$ |
368,400 |
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$ |
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Off-Balance Sheet Arrangements
At December 31, 2007, we did not have any off-balance sheet arrangements.
Market Risk
Due to the nature of our short-term investments and our lack of marketable debt, we have
concluded that we face no material risk exposure.
Liquidity and Capital Resources
From inception to March 31, 2008, we have incurred an aggregate net loss of $42,504,522,
primarily as a result of expenses incurred through a combination of acquisition costs and research
and development activities related to tamibarotene, INNO-406, INNO-206, INNO-305, and INNO-105 and
expenses supporting those activities.
Under the terms of each of our license agreements we may be obligated to pay our partners
milestone payments upon achieving certain milestones in connection with the development of our
candidates. These payments are as follows:
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an aggregate amount of $3,600,000 for INNO-305 upon the achievement of clinical and
regulatory milestones through the products first approval and an annual license
maintenance fee of $100,000 beginning on December 15, 2006, and ending on the first
commercial sale of INNO-305; we are not required to pay this fee in any year in which
we make a milestone payment under the agreement; |
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an aggregate amount of $7,500,000 for INNO-206 upon meeting clinical and regulatory
milestones up to and including the products second final marketing approval; |
148
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an aggregate amount of $13,350,000 for INNO-406 upon meeting clinical and regulatory
milestones up to and including the products final marketing approval in the U.S. and
Europe (including $5,000,000 upon the products first final marketing approval); |
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an aggregate remaining amount of approximately $4,536,000 for tamibarotene upon
achieving clinical, regulatory and sales milestones through the first commercial sale
of the product for the treatment of APL in North America; and |
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an aggregate remaining amount of approximately $5,262,000 for tamibarotene
(including amounts included in our accrued expenses at March 31, 2008 of approximately
$1,230,000) upon certain future dates and/or achieving clinical and regulatory
milestones through the products approval for the treatment of APL in Europe. |
Our obligations under the license of North American and European rights to tamibarotene
require us to pay the milestone payments in Japanese yen and the amounts represented above for
tamibarotene represent the approximate US dollar equivalent as of March 31, 2008. We currently have
not entered into any hedging arrangements related to these licenses.
We intend to fund these payments by raising capital or entering into strategic alliances,
which will be dependent on the success of our testing of those product candidates and any other
technologies we might acquire at each stage.
We have financed our operations since inception through debt and equity financing. From
inception through March 31, 2008, we had a net increase in cash of $301,962. This increase
primarily resulted from net cash provided by financing activities of $33,602,472, of which
$2,249,984 was derived from the sale of our senior convertible promissory notes in June 2005,
$5,167,000 was derived from our related party note, $12,501,135 was derived from the sale of our
Series A convertible preferred stock in June 2006 and $13,872,046 was derived from the private
placement of common stock units in April 2007. The increase in cash provided by financing
activities was offset by net cash used in operating activities of $33,190,624 and net cash used in
investing activities of $109,886 for the period from inception to March 31, 2008. The senior
convertible promissory notes and the related party note converted to Series A convertible preferred
stock on June 29, 2006, and all of the Series A convertible preferred stock converted into common
stock on August 10, 2006.
In order to continue to fund our operations we need to immediately complete a debt or equity
financing or need to immediately generate revenue from the licensing of one or more of our product
candidates or enter into strategic alliances for our products. Thereafter, future financings will
be dependent upon the type of financing or strategic transaction we are currently contemplating, if
successful, as well as our financial position and the progress, if any, of our product candidates
in pre-clinical and clinical trials.
The significant operating and capital expenditures for product licensing and development for
our current product candidates and any future products, including pre-clinical trials and
FDA-approved clinical trials, will require additional funding. Our continued operations will depend
on whether we are able to raise additional funds. Such additional funds might not be available on
acceptable terms, if at all, and there can be no assurance that any additional funding that we are
able to obtain will be sufficient to meet our needs, including any milestone payments.
We will consider raising additional funds through all viable means.
Immediate and Future Financing Needs
We have an immediate need for capital and must raise additional funds to finance our current
operations. We have been exploring all viable opportunities, including the sale of common and or
preferred
149
stock as well as strategic transactions, and in June 2008, we entered into an agreement
to be acquired by CytRx. If we raise funds by selling additional shares of stock or other
securities convertible into stock, the ownership interest of our existing stockholders will be
diluted. If we are not able to obtain financing we will not be able to carry out our business plan
and, as a result, will have to significantly limit or terminate our operations and our business,
financial condition and results of operations would be materially harmed.
We have incurred negative cash flow from operations since we started our business. We have
spent, and expect to continue to spend, substantial amounts in connection with implementing our
business strategy, including our planned product development efforts and our clinical trials.
The amount of funds we will need to operate in the future is subject to many factors, some of
which might be beyond our control. These factors include the following:
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the progress of our research activities; |
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our financial condition; |
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the progress of our pre-clinical and clinical development activities; |
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the state of the economy and the financial markets; |
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the number and scope of our research programs; |
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our ability to maintain current research and development programs and to establish
new research and development and licensing arrangements; |
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our ability to achieve our milestones under licensing arrangements; |
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opportunities to sub-license our existing compounds to others; |
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the costs involved in prosecuting and enforcing patent claims and other intellectual
property rights; and |
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the costs and timing of regulatory approvals. |
We have based our capital needs on assumptions that might prove to be incorrect. We might need
to obtain additional funds sooner or in greater amounts than we currently anticipate. Our access to
the public or private equity markets will depend on whether conditions are favorable for our equity
or debt securities. We do not have any committed sources of financing at this time, and it is
uncertain whether additional funding will be available now or in the future on terms that will be
acceptable to us, or at all.
Critical Accounting Policies
Our managements discussion and analysis of our financial condition and results of operations
is based on our financial statements, which have been prepared in accordance with U.S. generally
accepted accounting principles, or GAAP. Our significant accounting policies are more fully
described in Note 1 to the financial statements included in this report. The following accounting
policies are critical to fully understanding and evaluating our financial results.
Research and Development Expense
We expense our research and development costs as they are incurred. Research and development
expenses consist primarily of costs associated with determining feasibility, licensing and
pre-clinical and
150
clinical testing of our licensed pharmaceutical candidates. These costs primarily
include fees paid to consultants and outside service providers for drug manufacture and development
and other expenses.
We often contract with third parties to facilitate, coordinate and perform agreed upon
research and development activities. To ensure that research and development costs are expensed as
incurred, we measure expense based on work performed for the underlying contract, utilizing
information provided to us by certain vendors and our own internal estimates, typically based on
time to complete the underlying activity. We record prepaid assets or accrued expenses on a monthly
basis for such activities based on the measurement of liability from expense recognition and the
receipt of invoices.
These contracts may call for the payment of fees for services at the initiation of the
contract and/or upon the achievement of certain milestones. In the event that we prepay fees for
future milestones, we record the prepayment as a prepaid asset and amortize the asset into research
and development expense over the period of time the contracted research and development services
are performed. Most fees are incurred throughout the contract period and are expensed based on
their percentage of completion at a particular date.
These contracts generally include pass through fees. Pass through fees include, but are not
limited to, regulatory expenses, investigator fees, travel costs, and other miscellaneous costs
including shipping and printing fees. Because these fees are incurred at various times during the
contract term and they are used throughout the contract term, we record a monthly expense
allocation to recognize the fees during the contract period. Fees incurred to set up the clinical
trial are expensed during the setup period.
License fees and pre-approved milestone payments due under each research and development
arrangement that are paid prior to regulatory approval are expensed when the license is entered
into or the milestone is achieved if the payment is contingent upon reaching the milestone. If a
product receives regulatory approval, we will record any subsequent milestone payments as
intangible assets.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires our management
to make estimates and assumptions that affect the reported amounts of assets and liabilities and
the disclosure of contingent liabilities at the date of the financial statements as well as the
reported revenue and expenses during the reporting periods. On an ongoing basis, management
evaluates their estimates and judgments. Management bases estimates on historical experience and on
various other factors that they believe are reasonable under the circumstances, the results of
which form the basis for making judgments about the carrying value of assets and liabilities that
are not readily apparent from other sources. Actual results might differ from these estimates under
different assumptions or conditions.
Accounting for Stock-Based Compensation
We account for restricted common stock issued to our employees using the fair value method of
Statement of Financial Accounting Standards, or SFAS, No. 123(R), Share-Based Payment, or SFAS
123(R). In determining the fair value of the shares of restricted stock we issued in 2005, we
considered, among other factors, (1) the advancement of our technology, (2) our financial position
and (3) the fair value of our common stock as determined in arms-length transactions. Our results
include non-cash compensation expense as a result of the issuance of the restricted common stock
utilizing this method. We expect to record additional non-cash compensation expense in the future,
which might be significant, particularly if our stock price increases.
We account for stock options granted to employees and non-employees on a fair value basis in
accordance with SFAS 123(R), Share-Based Payment, and for stock issued to non-employees in
accordance with Emerging Issues Task Force, or EITF, Issue No. 96-18, Accounting for Equity
Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling,
Goods or Services. Any
151
options issued to non-employees are recorded in the financial statements
using the fair value method and then amortized to expense over the applicable service periods.
Pursuant to EITF Issue No. 96-18, the non-cash charge to operations for non-employee options with
vesting or other performance criteria is affected each reporting period by changes in the fair
value of the options.
We account for the value of warrants and the intrinsic value of beneficial conversion rights
arising from the issuance of convertible debt instruments with non-detachable conversion rights
that are in-the-money at the commitment date pursuant to the consensuses for EITF Issue No. 98-5,
EITF Issue No. 00-19 and EITF Issue No. 00-27. Such values are determined by first allocating an
appropriate portion of the proceeds received from the debt instruments to the warrants or any other
detachable instruments included in the exchange. The fair value of the warrants is allocated to
warrant liability and to debt discount, which is charged to interest expense over the term of the
debt instrument. The warrant liability is adjusted to its fair value at the end of each reporting
period. The intrinsic value of the beneficial conversion rights at the commitment date may also be
recorded as additional paid-in capital and debt discount as of that date or, if the terms of the
debt instrument are contingently adjustable, may only be recorded if a triggering event occurs and
the contingency is resolved.
New Accounting Pronouncements
In September 2006, the Financial Accounting Standards Board (FASB) issued Statement of
Financial Accounting Standards (SFAS) No. 157 (SFAS 157), Fair Value Measurements, which
defines fair value, establishes a framework for measuring fair value in generally accepted
accounting principles, or GAAP, and expands disclosure about fair value measurements. The statement
is effective for fiscal years beginning after November 15, 2007. The adoption of SFAS 157 did not
have a material effect on our consolidated financial statements.
In February 2007, the FASB issued SFAS No. 159 (SFAS 159), The Fair Value Option for
Financial Assets and Financial Liabilities, providing companies with an option to report selected
financial assets and liabilities at fair value. The statements objective is to reduce both
complexity in accounting for financial instruments and the volatility in earnings caused by
measuring related assets and liabilities differently. GAAP has required different measurement
attributes for different assets and liabilities that can create artificial volatility in earnings.
SFAS 159 helps to mitigate this type of accounting-induced volatility by enabling companies to
report related assets and liabilities at fair value, which would likely reduce the need for
companies to comply with detailed rules for hedge accounting. SFAS 159 also establishes
presentation and disclosure requirements designed to facilitate comparisons between companies that
choose different measurement attributes for similar types of assets and liabilities. The statement
requires companies to provide additional information that will help investors and other users of
financial statements to more easily understand the effect of a Companys choice to use fair value
on its earnings. It also requires entities to display the fair value of those assets and
liabilities for which they have chosen to use fair value on the face of the balance sheet. SFAS 159
is effective for fiscal years beginning after November 15, 2007. Although we will continue to
evaluate the application of SFAS 159, management does not currently believe that the adoption of
SFAS 159 will have a material effect on our consolidated financial statements.
In June 2007, the Emerging Issues Task Force (EITF) reached a consensus on EITF Issue No.
07-3 (EITF 07-3), Accounting for Advance Payments for Goods or Services to be Received for Use
in Future Research and Development Activities. EITF 07-3 provides clarification surrounding the
accounting for nonrefundable research and development advance payments, whereby such payments
should be recorded as an asset when the advance payment is made and recognized as an expense when
the research and development activities are performed. EITF 07-3 is effective for interim and
annual reporting periods beginning after December 15, 2007. Although we will continue to evaluate
the application of EITF 07-3, management does not
currently believe that the adoption of EITF 07-3 will have a material effect on our
consolidated financial statements.
152
In December 2007, the Emerging Issues Task Force (EITF) issued EITF Issue No. 07-1 (EITF
07-1) Accounting for Collaborative Arrangements. EITF 07-1 affects entities that participate in
collaborative arrangements for the development and commercialization of intellectual property. The
EITF affirmed the tentative conclusions reached on (1) what constitutes a collaborative
arrangement, (2) how the parties should present costs and revenues in their respective income
statements, (3) how the parties should present cost-sharing payments, profit-sharing payments, or
both in their respective income statements, and (4) disclosure in the annual financial statements
of the partners. EITF 07-1 should be applied as a change in accounting principle through
retrospective application to all periods presented for collaborative arrangements existing as of
the date of adoption. EITF 07-1 is effective for financial statements issued for fiscal years
beginning after December 15, 2008. We are currently evaluating the impact that adopting EITF 07-1
will have on our consolidated financial statements.
153
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS
AND MANAGEMENT OF CYTRX
The following table sets forth certain information regarding the beneficial ownership of
CytRxs common stock as of June 30, 2008 by (1) each person who is known to CytRx to beneficially
own more than five percent of the outstanding shares of CytRxs common stock, (2) each of CytRxs
directors, (3) each of CytRxs executive officers, and (4) all directors and executive officers of
CytRx as a group. Except as indicated in the footnotes to the table, CytRx believes that each
person named in the table has sole voting and investment power with respect to all shares shown as
beneficially owned by such person, subject to community property laws where applicable. Beneficial
ownership is determined in accordance with SEC rules and generally means the possession of voting
or investment power with respect to securities. The percentages of ownership set forth below are
based upon 90,770,553 shares of CytRx common stock that were outstanding on June 30, 2008. An
asterisk (*) denotes beneficial ownership of less than 1%.
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Number of Shares |
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Percentage of Class |
Name and Address of Beneficial Owner |
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Beneficially Owned |
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Beneficially Owned |
Steven A. Kriegsman(1) |
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5,655,830 |
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6.1 |
% |
Louis Ignarro, Ph.D.(2) |
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538,916 |
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* |
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Max Link, Ph.D.(3) |
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189,519 |
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* |
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Joseph Rubinfeld, Ph.D.(4) |
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127,000 |
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* |
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Marvin R. Selter(5) |
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472,451 |
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* |
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Richard L. Wennekamp(6) |
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120,000 |
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* |
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Mitchell K. Fogelman(7) |
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56,960 |
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* |
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Jack R. Barber, Ph.D.(8) |
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413,902 |
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* |
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Shi Chung Ng, Ph.D.(9) |
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62,505 |
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* |
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Benjamin S. Levin(10) |
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425,282 |
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* |
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All directors and executive
officers as a group (ten
persons)(11) |
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8,062,365 |
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8.6 |
% |
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(1) |
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Includes 1,634,730 shares subject to options or warrants. Mr. Kriegsmans address is c/o
CytRx Corporation, 11726 San Vicente Boulevard, Suite 650, Los Angeles, California 90049. |
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(2) |
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Includes 477,000 shares subject to options or warrants. |
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(3) |
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Includes 134,543 shares subject to options or warrants. |
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(4) |
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Consists of shares subject to options or warrants. |
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(5) |
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The shares shown are owned, of record, by the Selter Family Trust or Selter IRA Rollover.
Includes 115,000 shares subject to options or warrants owned by Mr. Selter. |
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(6) |
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Includes 115,000 shares subject to options or warrants. |
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(7) |
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Consists of shares subject to options or warrants. |
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(8) |
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Consists of shares subject to options or warrants. |
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(9) |
|
Consists of shares subject to options or warrants. |
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(10) |
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Consists of shares subject to options or warrants. |
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(11) |
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Includes 3,578,575 shares subject to options or warrants. |
154
SECURITY OWNERSHIP BY CERTAIN BENEFICIAL OWNERS
AND MANAGEMENT OF INNOVIVE
The following table sets
forth certain information regarding the beneficial ownership of
Innovives common stock as of July 31, 2008 by (1) each person who is known to us to beneficially
own more than five percent of the outstanding shares of our common stock, (2) each of our
directors, (3) each of our executive officers, and (4) all directors and executive officers as a
group. Except as indicated in the footnotes to the table, we believe that each person named in the
table has sole voting and investment power with respect to all shares shown as beneficially owned
by such person, subject to community property laws where applicable. Beneficial ownership is
determined in accordance with SEC rules and generally means the possession of voting or investment
power with respect to securities. The percentages of ownership set forth below are based upon
14,610,003 shares of our common stock that were outstanding on July 31, 2008. An asterisk (*)
denotes beneficial ownership of less than 1%.
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Number of Shares |
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Percentage of Class |
Name and Address of Beneficial Owner |
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Beneficially Owned |
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Beneficially Owned |
RA Capital Management, LLC(1) |
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1,923,075 |
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12.6 |
% |
111 Huntington Avenue, Suite 610
Boston, Massachusetts 02199 |
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Lindsay A. Rosenwald, M.D.(2) |
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1,627,774 |
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10.9 |
% |
c/o Paramount BioSciences, LLC
787 Seventh Avenue, 48th Floor
New York, New York 10019 |
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Lester Lipschutz(3) |
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1,399,129 |
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9.6 |
% |
c/o Wolf Block Schorr and Solis Cohen
1650 Arch Street
Philadelphia, Pennsylvania 19103 |
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Philip Frost(4) |
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10,000 |
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* |
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Steven Kelly(5) |
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389,301 |
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2.6 |
% |
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Neil Herskowitz(6) |
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73,043 |
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|
|
* |
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|
|
|
|
|
|
|
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J. Jay Lobell(7) |
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183,200 |
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|
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1.3 |
% |
c/o Paramount BioSciences, LLC
787 Seventh Avenue, 48th Floor
New York, New York 10019 |
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|
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|
|
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|
|
|
|
|
|
|
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Antony Pfaffle(8) |
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|
20,000 |
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|
|
* |
|
c/o Paramount BioSciences, LLC
787 Seventh Avenue, 48th Floor
New York, New York 10019 |
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|
|
|
|
|
|
|
|
|
|
|
|
|
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|
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J. Gregory Jester(9) |
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105,000 |
|
|
|
* |
|
|
|
|
|
|
|
|
|
|
Eric Poma,
Ph.D.(10) |
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|
178,160 |
|
|
|
1.2 |
% |
|
|
|
|
|
|
|
|
|
All current directors and executive
officers as a group (seven persons)(11) |
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|
958,704 |
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|
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6.3 |
% |
155
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|
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(1) |
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Based on information reported in Schedule 13G filed on February 14, 2008 by Richard H.
Aldrich, Peter Kolchinsky, RA Capital Management, LLC, RA Capital Biotech Fund, L.P. and RA
Capital Biotech Fund II, L.P. Mr. Aldrich and Mr. Kolchinsky are the managers of RA Capital
Management, LLC, which is the sole general partner of each of RA Capital Biotech Fund, L.P.
and RA Capital Biotech Fund II, L.P. Includes 1,282,050 shares of common stock and 641,025
shares issuable upon the exercise of warrants to purchase common stock. |
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(2) |
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Includes 1,028,634 shares held by Paramount Biosciences LLC, of which Dr. Rosenwald is the
sole member, and 265,215 shares issuable upon the exercise of warrants to purchase common
stock. |
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(3) |
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Mr. Lipschutz is the investment manager or trustee of four trusts established for the benefit
of Dr. Lindsay Rosenwald, three of which own 68,709 shares each and one of which owns 185,514
shares of common stock. Mr. Lipschutz also serves as the trustee for the Rosenwald 2000 Family
Trust, a trust established for the benefit of Dr. Rosenwalds children, which owns 1,007,488
shares of common stock. Mr. Lipschutz might be deemed to beneficially own the shares held by
the aforementioned trusts as he has the sole control over the voting and disposition of any
shares held by such trust. Dr. Rosenwald disclaims beneficial ownership of these shares except
to the extent of any pecuniary interest (as defined in Rule 16a-1(a)(2) promulgated under the
Securities Exchange Act of 1934, as amended) that he may have in the aforementioned trusts. |
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(4) |
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Consists of 10,000 shares issuable upon the exercise of options to purchase common stock. |
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(5) |
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Includes 231,301 shares issuable upon the exercise of options to purchase common stock. |
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(6) |
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Includes 52,127 shares of common stock owned by a limited liability company of which Mr.
Herskowitz is the manager and an equity owner. Includes 916 shares issuable upon the exercise
of warrants to purchase common stock, all of which are owned by the limited liability company
and 20,000 shares issuable upon the exercise of options to purchase common stock. |
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(7) |
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Includes 530 shares issuable upon the exercise of warrants to purchase common stock and
20,000 shares issuable upon the exercise of options to purchase common stock. |
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(8) |
|
Consists of 20,000 shares issuable upon the exercise of options to purchase common stock. |
|
(9) |
|
Consists of 105,000 shares issuable upon the exercise of options to purchase common stock. |
|
(10) |
|
Includes 115,000 shares issuable upon the exercise of options to purchase common stock. |
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(11) |
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Includes 522,747 shares issuable upon the exercise of options and warrants to purchase common
stock. |
156
DISSENTERS RIGHTS
Under Section 262 of the Delaware General Corporation Law, or DGCL, any holder of Innovive
common stock who does not wish to accept the merger consideration may elect to exercise
dissenters, or appraisal, rights in lieu of receiving the merger consideration. A stockholder who
exercises appraisal rights may petition the Delaware Court of Chancery to determine the fair value
of his, her or its shares, exclusive of any element of value arising from the accomplishment or
expectation of the merger, and receive payment of fair value in cash, together with a fair rate of
interest, if any. However, the stockholder must comply with the provisions of Section 262 of the
DGCL.
The following discussion is a summary of the law pertaining to appraisal rights under the
DGCL. The full text of Section 262 of the DGCL is attached to this proxy statement/prospectus as
Appendix D. All references in Section 262 of the DGCL to a stockholder and in this summary to a
stockholder are to the record holder of the shares of Innovive common stock who exercises appraisal
rights.
Under Section 262 of the DGCL, when a merger is submitted for approval at a meeting of
stockholders, as in the case of the merger agreement, the corporation, not less than 20 days prior
to the meeting, must notify each of its stockholders entitled to appraisal rights that appraisal
rights are available and include in the notice a copy of Section 262 of the DGCL. This proxy
statement/prospectus constitutes such notice, and the applicable statutory provisions are attached
to this proxy statement/prospectus as Appendix D. This summary of appraisal rights is not a
complete summary of the law pertaining to appraisal rights under the DGCL and is qualified in its
entirety by the text of Section 262 of the DGCL attached as Appendix D. Any holder of Innovive
common stock who wishes to exercise appraisal rights, or who wishes to preserve the right to do so,
should review the following discussion and Appendix D carefully. Failure to comply with the
procedures of Section 262 of the DGCL in a timely and proper manner will result in the loss of
appraisal rights. If you lose your appraisal rights, you will be entitled to receive the merger
consideration described in the merger agreement.
Stockholders wishing to exercise the right to seek an appraisal of their shares of Innovive
common stock must do ALL of the following:
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The stockholder must not vote in favor of the proposal to adopt and approve the
merger agreement and the transactions contemplated thereby. Because a proxy that does
not contain voting instructions will, unless revoked, be voted in favor of the
proposal, a stockholder who votes by proxy and who wishes to exercise appraisal rights
must vote its shares against the proposal or abstain from voting, or not vote, its
shares. A vote in favor of the merger, by proxy or in person, will constitute a waiver
of the stockholders appraisal rights in respect of the shares so voted and will
nullify any previously filed written demands for appraisal. |
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|
The stockholder must deliver to Innovive a written demand for appraisal before the
vote on the merger agreement at the special meeting. This written demand for appraisal
must be in addition to and separate from any proxy or vote abstaining from or voting
against the merger. Voting against or failing to vote for the merger itself does not
constitute a demand for appraisal under Section 262. The written demand for appraisal
should specify the stockholders name and mailing address, the number of shares owned,
and that the shareholder is demanding appraisal of his or her shares. The demand must
reasonably inform Innovive of the identity of the stockholder and that the stockholder
intends to demand appraisal of his, her or its common stock. |
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|
The stockholder must continuously hold the shares from the date of making the demand
through the effective time of the merger. A stockholder will lose appraisal rights if
the stockholder transfers the shares before the effective time of the merger. |
157
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|
|
The stockholder must file a petition in the Delaware Court of Chancery requesting a
determination of the fair value of the shares within 120 days after the effective time
of the merger. The surviving corporation is under no obligation to file any petition
and has no intention of doing so. |
To be effective, a demand for appraisal by a holder of Innovive common stock must be made by,
or in the name of, such record stockholder, fully and correctly, as the stockholders name appears
on his or her stock certificates and cannot be made by the beneficial owner if he or she does not
also hold the shares of record. The beneficial holder must, in such cases, have the record owner
submit the required demand in respect of such shares.
If shares are owned of record in a fiduciary capacity, such as by a trustee, guardian or
custodian, execution of a demand for appraisal should be made in such capacity; and if the shares
are owned of record by more than one person, as in a joint tenancy or tenancy in common, the demand
should be executed by or for all joint owners. An authorized agent, including an authorized agent
for two or more joint owners, may execute the demand for appraisal for one or more stockholders of
record; however, the agent must identify the record owner or owners and expressly disclose the fact
that, in executing the demand, he or she is acting as an agent for the record owner or owners. In
such case, the written demand should state the number of shares as to which appraisal is sought.
Where no number of shares is expressly mentioned, the demand will be presumed to cover all shares
held in the name of such record owners.
A holder of shares held in street name who desires appraisal rights with respect to those
shares must take such actions as may be necessary to ensure that a timely and proper demand for
appraisal is made by the record owner of the shares. Shares held through brokerage firms, banks
and other financial institutions are frequently deposited with and held of record in the name of a
nominee of a central security depositary, such as Cede &Co., the Depository Trust Companys
nominee. If an Innovive stockholder holds its shares of Innovive common stock in a brokerage or
bank account or in other nominee form and the stockholder wishes to exercise appraisal rights, the
stockholder should consult with its broker or bank or such other nominee to determine the
appropriate procedures for the making of a demand for appraisal by such nominee. Any holder of
shares desiring appraisal rights with respect to such shares who held such shares through a
brokerage firm, bank or other financial institution is responsible for ensuring that the demand for
appraisal is made by the record holder.
STOCKHOLDERS WHO HOLD THEIR SHARES IN BROKERAGE ACCOUNTS OR OTHER NOMINEE FORMS, AND WHO
DESIRE APPRAISAL RIGHTS, SHOULD CONSULT WITH THEIR BROKERS TO DETERMINE THE APPROPRIATE PROCEDURES
FOR THE NOMINEE HOLDER TO MAKE A DEMAND FOR APPRAISAL OF THOSE SHARES. A PERSON HAVING A
BENEFICIAL INTEREST IN SHARES HELD OF RECORD IN THE NAME OF ANOTHER PERSON, SUCH AS A BROKER OR
NOMINEE, MUST ACT PROMPTLY TO CAUSE THE RECORD HOLDER TO FOLLOW PROPERLY AND IN A TIMELY MANNER THE
STEPS NECESSARY TO PERFECT APPRAISAL RIGHTS.
A stockholder who elects to exercise appraisal rights under Section 262 of the DGCL should
mail or deliver a written demand to:
Innovive Pharmaceuticals, Inc.
555 Madison Avenue, 25th Floor
New York, New York 10022
Attention: Corporate Secretary
The surviving corporation will give written notice of the effective time of the merger within
10 days after such effective time to each former Innovive stockholder who did not vote in favor of
the merger agreement and who made a written demand for appraisal in accordance with Section 262 of
the DGCL. Within
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120 days after the effective time of the merger, but not later, either the surviving
corporation or any dissenting stockholder who has complied with the requirements of Section 262 of
the DGCL may file a petition in the Delaware Court of Chancery demanding a determination of the
value of the shares of Innovive common stock held by all dissenting stockholders. The surviving
corporation will be under no obligation to file any petition and has no intention of doing so.
Stockholders who desire to have their shares appraised should initiate any petitions necessary for
the perfection of their appraisal rights within the time periods and in the manner prescribed in
Section 262 of the DGCL. The failure of a stockholder to file such a petition within the period
specified could nullify such stockholders previous written demand for appraisal.
Within 120 days after the effective time of the merger, any stockholder who has complied with
the provisions of Section 262 of the DGCL to that point in time may receive from the surviving
corporation, upon written request, a statement setting forth the aggregate number of shares not
voted in favor of the merger agreement and with respect to which Innovive has received demands for
appraisal, and the aggregate number of holders of those shares. The surviving corporation must mail
this statement to the stockholder within the later of 10 days of receipt of the request or 10 days
after expiration of the period for delivery of demands for appraisal. If a petition for appraisal
is duly filed by a stockholder and a copy of the petition is delivered to the surviving
corporation, the surviving corporation will be obligated within 20 days after receiving service of
a copy of the petition to provide the Delaware Chancery Court with a duly verified list containing
the names and addresses of all stockholders who have demanded appraisal of their shares and with
whom agreements as to the value of their shares have not been reached.
If any party files a petition for appraisal in a timely manner, the Delaware Court of Chancery
will determine which stockholders are entitled to appraisal rights and may require the stockholders
demanding appraisal who hold certificated shares to submit their stock certificates to the court
for notation of the pendency of the appraisal proceedings and any stockholder who fails to comply
with such direction may be dismissed from such proceedings. If the stockholder fails to comply with
the courts direction, the court may dismiss the proceeding as to such stockholder. The Delaware
Court of Chancery will thereafter determine the fair value of the shares of Innovive common stock
held by dissenting stockholders, exclusive of any element of value arising from the accomplishment
or expectation of the merger, but together with a fair rate of interest, if any, to be paid on the
amount determined to be fair value. If no party files a petition for appraisal in a timely manner,
then stockholders will lose the right to an appraisal, and will instead receive the merger
consideration described in the merger agreement.
In determining the fair value, the Delaware Court of Chancery will take into account all
relevant factors. In Weinberger v. UOP, Inc., the Delaware Supreme Court discussed the factors that
could be considered in determining fair value in an appraisal proceeding, stating that proof of
value by any techniques or methods which are generally considered acceptable in the financial
community and otherwise admissible in court should be considered and that fair price obviously
requires consideration of all relevant factors involving the value of a company. The Delaware
Supreme Court stated that in making this determination of fair value the court must consider
market value, asset value, dividends, earnings prospects, the nature of the enterprise and any
other facts which were known or which would be ascertained as of the date of merger which throw any
light on future prospects for the merged corporation... In addition, Delaware courts have decided
that the statutory appraisal remedy, in cases of unfair dealing, may or may not be a dissenters
exclusive remedy.
The Delaware Court of Chancery may determine the fair value to be more than, less than or
equal to the merger consideration that the dissenting stockholder would otherwise receive under the
merger agreement. A fairness opinion of an investment banking firm does not in any manner address
fair value under Section 262 of the DGCL.
Costs of the appraisal proceeding may be imposed upon the surviving corporation and the
stockholders participating in the appraisal proceeding by the Chancery Court as the Chancery Court
deems equitable in the circumstances. Upon application of a stockholder, the Delaware Court of
Chancery may order
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all or a portion of the expenses incurred by any stockholder in connection with the appraisal
proceeding, including reasonable attorneys fees and the fees and expenses of experts, to be charged
pro rata against the value of all shares entitled to appraisal.
Any stockholder who has duly demanded an appraisal in compliance with Section 262 of the DGCL
may not, after the effective time of the merger, vote the shares subject to the demand for any
purpose or receive any dividends or other distributions on those shares, except dividends or other
distributions payable to holders of record of shares as of a record date prior to the effective
time of the merger.
Any stockholder may withdraw a demand for appraisal and accept the merger consideration by
delivering to the surviving corporation a written withdrawal of the demand for appraisal, except
that any attempt to withdraw made more than 60 days after the effective time of the merger will
require written approval of the surviving corporation, and no appraisal proceeding in the Delaware
Court of Chancery will be dismissed as to any stockholder without the approval of the Delaware
Court of Chancery, and may be conditioned on such terms as the Delaware Court of Chancery deems
just. If the stockholder fails to perfect, successfully withdraws or loses the appraisal right, the
stockholders shares will be converted into the right to receive the merger consideration.
FAILURE TO FOLLOW THE STEPS REQUIRED BY SECTION 262 OF THE DGCL FOR PERFECTING APPRAISAL
RIGHTS MAY RESULT IN THE LOSS OF APPRAISAL RIGHTS. IN THAT EVENT, YOU WILL BE ENTITLED TO RECEIVE
MERGER THE CONSIDERATION FOR YOUR DISSENTING SHARES IN ACCORDANCE WITH THE MERGER AGREEMENT. IN
VIEW OF THE COMPLEXITY OF THE PROVISIONS OF SECTION 262 OF THE DGCL, IF YOU ARE AN INNOVIVE
STOCKHOLDER AND ARE CONSIDERING EXERCISING YOUR APPRAISAL RIGHTS UNDER THE DGCL, YOU SHOULD CONSULT
YOUR OWN LEGAL ADVISOR.
The completion of the merger is subject to the condition, among others, that Innovive
stockholders holding in total not more than 5% of Innovives common stock properly exercise their
rights as dissenting stockholders.
DESCRIPTION OF CYTRX CAPITAL STOCK
The following is only a summary of the material terms of CytRxs common stock, preferred stock
and stock options and warrants. As a summary, it does not contain all the information that may be
important to you. You should carefully read the more detailed provisions of CytRxs restated
certificate of incorporation and CytRxs restated bylaws, each of which has been filed with the
SEC, as well as applicable provisions of Delaware law.
Authorized Capitalization
CytRx is authorized to issue up to 175,000,000 shares of common stock, $0.001 par value per
share, and 5,000,000 shares of preferred stock, $0.01 par value per share, of which 15,000 shares
have been designated as Series A Junior Participating Preferred Stock. As of Junes 30, 2008,
90,770,553 shares of common stock were issued and outstanding. Cytrx has no preferred stock
outstanding. All of CytRxs outstanding shares of common stock, including the shares offered by
this proxy statement/prospectus, are or will be fully paid and non-assessable.
Subject to CytRxs restated bylaws and Delaware law, CytRxs board of directors has the power
to issue any of CytRxs unissued shares as it determines, including the issuance of any shares or
class of shares with preferred, deferred or other special rights.
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Common Stock
Holders of common stock are entitled to one vote per share on all matters submitted to a vote
of CytRxs stockholders, including with respect to the election of directors, are entitled to
receive dividends in cash or in property on an equal basis, if and when dividends are declared on
the common stock by CytRxs board of directors, subject to any preference in favor of outstanding
shares of preferred stock, if there are any.
In the event of CytRxs liquidation, all holders of common stock will participate on an equal
basis with each other in CytRxs net assets available for distribution after payment of CytRxs
liabilities and any liquidation preference in favor of outstanding shares of preferred stock, if
there are any.
Holders of common stock are not entitled to preemptive rights, and the common stock is not
subject to redemption.
The rights of holders of common stock are subject to the rights of holders of any preferred
stock that CytRx designate or have designated. The rights of preferred stockholders may adversely
affect the rights of the common stockholders.
Preferred Stock
CytRxs board of directors has designated 15,000 shares of CytRxs authorized preferred stock
as Series A Junior Participating Preferred Stock, which have the rights, preferences and privileges
summarized below. There are no outstanding shares of Series A Junior Participating Preferred Stock.
CytRx has reserved all of the shares of CytRxs Series A Junior Participating Preferred Stock for
issuance upon exercise of the rights under CytRxs Shareholder Protection Rights Agreement
described below.
Holders of Series A Junior Participating Preferred Stock will be entitled to vote on any
matter with the holders of common stock. The number of votes per whole share of Series A Junior
Participating Preferred Stock will be equivalent to the number of votes to which a holder of 100
shares, as adjusted from time to time, of CytRxs common stock would be entitled.
Holders of Series A Junior Participating Preferred Stock will be entitled to receive dividends
on each date dividends are paid to the holders of common stock in an amount per whole share of
Series A Junior Participating Preferred Stock equivalent to the amount a holder of 100 shares, as
adjusted from time to time, of CytRxs common stock would receive. Holders of Series A Junior
Participating Preferred Stock also will be entitled to receive an additional quarterly dividend in
an amount per whole share equal to the excess (if any) of $1.00 over the aggregate dividends paid
per whole share of Series A Junior Participating Preferred Stock during the quarter. Dividends on
the Series A Junior Participating Preferred Stock shall be cumulative.
As long as any shares of Series A Junior Participating Preferred Stock are outstanding, no
dividend on CytRxs common stock (other than a dividend in common stock or other stock ranking
junior to Series A Junior Participating Preferred Stock) may be paid, unless the full cumulative
dividends on all outstanding shares of Series A Junior Participating Preferred Stock have been
paid.
In the event of a merger, consolidation, reclassification or other transaction where CytRxs
common stock is exchanged for other stock, securities, cash or any other property, any outstanding
shares of Series A Junior Participating Preferred Stock will similarly be exchanged in an amount
per whole share equal to the aggregate amount of stock, securities, cash, or other property a
holder of 100 shares, as adjusted from time to time, of common stock would receive.
In the event of CytRxs liquidation, before any distribution or payment is made to the holders
of common stock or to any other stock ranking junior to the Series A Junior Participating Preferred
Stock, a holder of Series A Junior Participating Preferred Stock will be entitled to, per whole
share of Series A Junior
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Participating Preferred Stock, the greater of $1.00 or the equivalent of the aggregate amount
distributed or to be distributed to the holder of 100 shares, as adjusted from time to time, of
common stock.
The Series A Junior Participating Preferred Stock is not redeemable.
Shares of Series A Junior Participating Preferred Stock may be issued by CytRxs board of
directors without the approval of CytRxs stockholders. The issuance of Series A Junior
Participating Preferred Stock would adversely affect the voting power, liquidation rights and other
rights held by owners of common stock.
In addition to Series A Junior Participating Preferred Stock, CytRxs board of directors is
authorized to issue shares of CytRxs authorized preferred stock in one or more other series and to
fix the voting rights, liquidation preferences, dividend rights, conversion rights, redemption
rights and terms, including sinking provisions, and other rights and preferences. CytRxs board of
directors determination to issue preferred stock could make it more difficult for a third party to
acquire control of CytRx, or could discourage any such attempt. CytRx has no present plan or
intention to issue any preferred stock.
Shareholder Rights Protection Agreement
On April 16, 1997, CytRxs board of directors declared a distribution of one right for each
outstanding share of CytRxs common stock, payable to shareholders of record at the close of
business on May 15, 1997 and with respect to each share of common stock (including treasury shares)
issued by CytRx thereafter and prior to the separation time. Each right entitles the registered
holder to purchase from CytRx one ten-thousandth (1/10,000th) of a share of CytRxs Series A Junior
Participating Preferred Stock, at a purchase price of $30 per share, subject to adjustment. The
description and terms of the rights are set forth in a shareholder protection rights agreement, or
rights agreement, between CytRx and American Stock Transfer & Trust Co., as Rights Agent, dated
April 16, 1997, as amended. The rights agreement will expire on April 16, 2017, unless renewed or
extended by CytRxs board of directors.
The separation time will occur on earlier of (i) 10 business days (unless otherwise
accelerated or delayed by CytRxs board) following public announcement that a person or group of
affiliated or associated persons, referred to as an acquiring person, has acquired, obtained the
right to acquire, or otherwise obtained beneficial ownership of 15% or more of the then outstanding
shares of CytRxs common stock, or (ii) 10 business days (unless otherwise delayed by CytRxs
board) following the commencement of a tender offer or exchange offer that would result in the
person or group beneficially owning 15% or more of CytRxs then outstanding shares of common stock.
Until the separation time, the rights will be evidenced by certificates representing
outstanding shares of CytRxs common stock, and transfer of any certificates representing
outstanding common stock will also constitute the transfer of the rights associated with the common
stock represented by such certificate.
The rights are not exercisable until the separation time, and will expire at the close of
business on the tenth anniversary of the Rights Agreement, unless earlier terminated by CytRx as
described below.
If the separation time occurs, separate rights certificates will be mailed to holders of
record of common stock as of the close of business on the date the separation time occurs.
Thereafter, the separate rights certificates alone will represent the rights.
If the flip-in date occurs, that is, the close of business 10 business days following CytRxs
announcement that a person has become an acquiring person, and if CytRx have not terminated the
rights as described below, then the rights will entitle the holders to acquire shares of common
shares (rather than Series A Junior Participating Preferred Stock) having a value equal to twice
the rights exercise price. Instead of issuing shares of common stock upon exercise of the rights
following a flip-in-date, CytRx may substitute a combination of cash, property, a reduction in the
exercise price of the rights, common stock or other securities
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(or any combination of the above) with a value equal to the common stock which would otherwise
be issuable. In addition, at the option of CytRxs board of directors prior to the time that any
person becomes the beneficial owner of more than 50% of CytRxs outstanding common stock, and
rather than payment of the cash purchase price, each right may be exchanged for one share of common
stock if a flip-in-date occurs. Notwithstanding any of the foregoing, all rights that are, or
(under certain circumstances set forth in the rights agreement) were, beneficially owned by any
person on or after the date such person becomes an acquiring person will be null and void.
Following the flip-in-date, if CytRx is acquired in a merger or consolidation where CytRx does
not survive or CytRxs common stock is changed or exchanged, or 50% or more of CytRxs assets or
assets generating 50% or more of CytRxs operating income or cash flow is transferred, in one or
more transactions to persons who at that time control us, then each right will entitle the holder
to acquire for the exercise price shares of the acquiring party having a value equal to twice the
rights exercise price.
The exercise price payable with respect to the rights, and the number of rights outstanding,
are subject to adjustment from time to time to prevent dilution in the event of a stock dividend,
stock split or reverse stock split, or other recapitalization, which would change the number of
shares of CytRxs common stock outstanding.
At any time until the close of business on the flip-in-date, CytRxs board of directors may
terminate the rights without any payment to the holders thereof. CytRxs board of directors may
condition termination of the rights upon the occurrence of a specified future time or event.
Until a right is exercised, the holder, as such, will have no rights as a stockholder,
including, without limitation, any right to vote or to receive dividends.
Any provisions of the rights agreement may be amended at any time prior to the close of
business on the flip-in-date without the approval of holders of the rights. Thereafter, the rights
agreement may be amended without approval of the rights holders in any way, which does not
materially adversely affect the interests of the rights holders.
The rights may have certain anti-takeover effects. The rights will cause substantial dilution
to a person or group that attempts to acquire CytRx on terms not approved by CytRxs board of
directors (with, where required by the rights agreement, the concurrence of a majority of the
continuing directors), unless the offer is conditioned on a substantial number of rights being
acquired. However, the rights should not interfere with any merger, statutory share exchange or
other business combination approved by a majority of CytRxs directors, since the rights may be
terminated by CytRxs board of directors at any time on or prior to the close of business 10
business days after CytRxs announcement that a person has become an acquiring person. Thus, the
rights are intended to encourage persons who may seek to acquire control of Cytrx to initiate such
an acquisition through negotiations with CytRxs board of directors. The effect of the rights may
nonetheless be to discourage a third party from making a partial tender offer for CytRxs common
stock, or otherwise attempting to obtain a substantial ownership in CytRxs common stock, or
seeking to obtain control of Cytrx. To the extent any potential acquirors are deterred by the
rights, the rights may have the effect of preserving incumbent management in office.
Options and Warrants
As
of June 30,
2008, there were outstanding stock options and warrants to purchase
approximately 18.2 million shares of CytRxs common stock at weighted-average exercise
price of $1.73
per share. CytRxs outstanding options and warrants could adversely affect
CytRxs ability to obtain future financing or engage in certain mergers or other transactions,
since the holders of options and warrants can be expected to exercise them at a time when CytRx may
be able to obtain additional capital through a new offering of securities on terms more favorable
to CytRx than the terms of outstanding options
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and warrants. For the life of the options and warrants, the holders have the opportunity to
profit from a rise in the market price of CytRxs common stock without assuming the risk of
ownership. To the extent the trading price of CytRxs common stock at the time of exercise of any
such options or warrants exceeds the exercise price, such exercise will also have a dilutive effect
on CytRxs stockholders.
All or substantially all of CytRxs outstanding warrants contain antidilution provisions
pertaining to dividends or distributions with respect to CytRxs common stock that could be
triggered upon CytRxs intended dividend or distribution of RXi shares. CytRxs outstanding
warrants to purchase approximately 800,000 shares contain antidilution provisions
that are triggered upon any issuance of securities by CytRx below the prevailing market price of
CytRxs common stock. In the event that these antidilution provisions are triggered by CytRx in
the future, CytRx would be required to reduce the exercise price, and increase the number of shares
underlying, those warrants, which would have a dilutive effect CytRxs stockholders.
In the event of CytRxs consolidation or merger, a sale of all or substantially all of CytRxs
assets or a compulsory share exchange, the holders of the warrants will be entitled to receive upon
exercise of the warrants the same kind and amount of cash, securities or other property which would
be receivable by the holder of a number of shares of CytRxs common stock for which the warrants
are then exercisable.
Holders of options and warrants do not have any of the rights or privileges of CytRxs
stockholders, including voting rights, prior to exercise of the options and warrants. CytRx has
reserved sufficient shares of authorized common stock to cover the issuance of common stock subject
to CytRxs outstanding options and warrants.
As
of June 30,
2008, Cytrx had registered with the SEC for resale by CytRxs
stockholders all of the shares of CytRxs common stock issuable upon exercise of outstanding
options and warrants. The availability of these shares for public resale, as well as actual
resales of these shares, could adversely affect the trading price of CytRxs common stock.
Transfer Agent and Registrar
The transfer agent for CytRxs common stock is American Stock Transfer & Trust Co., 40 Wall
Street, New York, New York 10005.
Certain Anti-Takeover Provisions
Certain provisions of Delaware law, CytRxs restated certificate of incorporation and CytRxs
restated bylaws may make it more difficult to acquire control of Cytrx by various means. These
provisions could deprive CytRx stockholders of opportunities to realize a premium on the shares of
common stock owned by them. In addition, they may adversely affect the prevailing market price of
CytRx stock. For more information about these provisions, see Comparison of Rights of Holders of
CytRx Common Stock and Innovive Common Stock.
CytRx is subject to the anti-takeover provisions of Section 203 of the DGCL. In general,
Section 203 prohibits a publicly-held Delaware corporation from engaging in a business
combination with an interested stockholder for a period of three years after the date of the
transaction in which the person became an interested stockholder, unless the interest stockholder
attained that status with the approval of the board of directors or unless the business combination
is approved in a prescribed manner. Business combinations include mergers, asset sales and other
transactions resulting in a financial benefit to the interested stockholder. Generally, an
interested stockholder is a person who, together with his affiliates and associates, owns, or
within the prior three years did own, 15% or more of the corporations voting stock.
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COMPARISON OF RIGHTS OF HOLDERS OF
CYTRX COMMON STOCK AND INNOVIVE COMMON STOCK
Upon completion of the merger, the stockholders of Innovive will become stockholders of CytRx,
and the DGCL, CytRxs restated certificate of incorporation (CytRxs certificate), CytRxs
restated bylaws (CytRxs bylaws), and the CytRx rights agreement will govern the rights of former
Innovive stockholders. The rights of Innovive stockholders are currently governed by the DGCL,
Innovives second amended and restated certificate of incorporation (Innovives certificate), and
Innovives bylaws (Innovives bylaws). Both companies are Delaware corporations, so many of the
rights of Innovive stockholders will be similar to their rights as CytRx stockholders. The
following is a summary of material differences between the rights of CytRx stockholders and the
rights of Innovive stockholders. It is not a complete statement of the provisions affecting, and
the differences between, the rights of Innovive stockholders and CytRx stockholders. The summary
is qualified in its entirety by reference to the DGCL, CytRxs certificate, CytRxs bylaws, the
CytRx rights agreement, Innovives certificate, and Innovives bylaws.
Authorized Stock
The authorized capital stock of CytRx consists of 175,000,000 shares of common stock, par
value $.001 per share and 5,000,000 shares of preferred stock, par value $.01 per share. CytRx
currently has one series of preferred stock designated the Series A Junior Participating Preferred.
As of June 30, 2008, CytRx had 90,770,553 shares of common stock outstanding and no shares of
Series A Junior Participating Preferred Stock outstanding. Each share of common stock of CytRx,
including the shares to be issued in the merger, is accompanied by a right (as defined in the
CytRx rights agreement) to purchase a fractional share of the Series A Junior Participating
Preferred Stock. See Description of CytRx Capital Stock Preferred Stock for more information
about the Series A Junior Participating Preferred Stock of CytRx and the CytRx rights agreement.
The authorized capital stock of Innovive consists of 75,000,000 shares of common stock, par
value $.001 per share, and 10,000,000 shares of preferred stock, par value $.001 per share. As of
June 30, 2008, Innovive had 14,610,003 shares of common stock outstanding and no shares of
preferred stock outstanding.
CytRxs certificate and Innovives certificate authorize the board of directors to provide for
the issuance of the shares of preferred stock in series, to establish from time to time the number
of shares to be included in each such series, and to fix the designations, powers, preferences, and
rights of the shares of each such series, any qualifications, limitations or restrictions thereof.
Stockholders Rights Plan
See Description of CytRx Capital Stock Stockholders Rights Plan for a description of the
CytRx rights agreement. The CytRx rights agreement will not be affected by the merger.
Innovive does not have a stockholders rights plan or any similar poison pill plan in place.
Terms of Preferred Stock
CytRxs board of directors has designated 15,000 shares of CytRxs authorized preferred stock
as Series A Junior Participating Preferred Stock, which have the rights, preferences and privileges
summarized under Description of CytRx Capital Stock Preferred Stock. There are no outstanding
shares of Series A Junior Participating Preferred Stock. CytRx has reserved all of the shares of
its Series A Junior Participating Preferred Stock for issuance upon exercise of the rights under
the CytRx rights agreement.
Innovive has not designated any series of preferred stock.
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Size of Board of Directors
CytRxs bylaws provide that the total number of directors shall be fixed by resolution of the
board of directors. The number of directors on CytRxs board of directors is currently set at
seven.
Innovives bylaws provide that Innovives board of directors shall consist of up to seven
members, which number can be changed from time to time by resolution of the board of directors.
The Innovive board of directors currently consists of six directors.
Classes of Directors
CytRxs certificate and CytRxs bylaws provide for the classification of directors into three
classes, with each class to consist as nearly as possible of an equal number of directors. One
class of directors is to be elected at each annual meeting of stockholders to serve for a term of
three years. The classification of CytRxs board of directors increases the amount of time it
takes to change majority control of its board of directors and may cause potential purchasers to
lose interest in the potential purchase of CytRx, regardless of whether such purchase would be
beneficial to CytRx or its stockholders. The additional time and cost to change a majority of the
members of CytRxs board of directors makes it more difficult and may discourage its existing
stockholders from seeking to change existing management in order to change the strategic direction
or operational performance of CytRx.
Innovives certificate and Innovives bylaws do not provide for a classified board of
directors. Innovives directors are elected for a term of one year.
Cumulative Voting
The directors of both CytRx and Innovive are elected according to the persons receiving the
greatest number of votes, up to the number of directors then to be elected, sometimes referred to
as being elected by a plurality; the stockholders of neither CytRx nor Innovive are entitled to
cumulate votes in connection with the election of their respective directors.
Director Nominations
CytRxs bylaws provide that nominations of candidates for election to the board of directors
at a meeting of the stockholders may be made only by (i) a majority of the board of directors,
(ii) a nominating committee appointed by the board of directors, or (iii) by any stockholder
entitled to vote in such election. A nomination may be made by a stockholder only if written notice
of the nomination has been given to the Secretary of the corporation not less than the date
specified under Rule 14a8(a)(4) of the Securities Exchange Act of 1934, or the Exchange Act (or
any amendment or successor to such rule), as the deadline for submitting stockholder proposals for
any meeting of stockholders called for purposes of electing directors. The rule currently requires
that stockholder proposals be submitted no later than 120 days before the anniversary of the
mailing date of the previous years proxy statement. Each notice shall set forth:
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the name and address of the stockholder who intends to make the nomination and any
other stockholders known by the nominating stockholder to be supporting such nominee; |
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the number of shares of stock beneficially owned by each stockholder specified in
clause (1) and a representation that the stockholder is a holder of record or
beneficial owner of shares of the corporation entitled to vote at the meeting and
intends to appear in person or by proxy at the meeting to nominate the person or
persons specified in the notice; |
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the name, address and principal occupation or employment of the person or persons to
be nominated; |
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the number of shares of any class of the corporations stock beneficially owned by
each such person; |
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a description of all arrangements or understandings between the stockholder and each
nominee and any other person or persons (naming such person or persons) pursuant to
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such other information regarding each nominee proposed by the stockholder as would
be required to be disclosed pursuant to Regulation 13D under the 1934 Act, as amended
or included in a proxy statement filed pursuant to the proxy rules of the Securities
and Exchange Commission if the nominee had been nominated by the board of directors,
regardless of whether such person is subject to the provisions of any such rules or
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a representation signed by the nominee that he or she is a natural person of full
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the written consent of each nominee, signed by such nominee, to serve as a director
of the corporation if so elected. |
Any stockholder nomination for a director to be elected by the holders of a class or series of
stock of CytRx must be made by a stockholder of the same class or series.
Innovive does not have a written policy regarding the nomination of directors by stockholders.
Removal of Directors
CytRxs bylaws provide that any or all directors of the board of directors may be removed from
the board of directors only for cause, by action of either the stockholders or the board of
directors.
Innovives bylaws provide that any or all directors may be removed, with or without cause, by
the holders of a majority of shares then entitled to vote at a meeting for the election of
directors.
Filling Vacancies of the Board of Directors
Both CytRxs and Innovives bylaws provide that any vacancy on the board of directors may be
filled by the vote of a majority of the directors then in office, although less than a quorum, or
by the sole remaining director. A director selected to fill such vacancy shall serve until the end
of the term of the position filled or until his successor is elected and qualified or his earlier
death, resignation or removal.
Innovives bylaws also provide that upon resignation of one or more directors from the board
of directors, effective at a future date, a majority of the directors then in office, including
those who have so resigned, shall have the power to fill such vacancy or vacancies, the vote
thereon to take effect when such resignation or resignations shall become effective.
Calling Special Meetings of Stockholders
CytRxs bylaws provide that special meetings may be called by the directors or by any officer
instructed by the directors to call a meeting.
Innovives bylaws provide that special meetings of the stockholders may only be called by the
board of directors, the Chairman of the Board, the Chief Executive Office, the President or the
Secretary of the Corporation or any committee of the board of directors which has been designated
with the power to call a special meeting.
167
Submission of Stockholder Proposals
CytRxs bylaws provides that any stockholder entitled to vote in the election of directors may
propose any action or actions for consideration by the stockholders at any meeting of stockholders
only if written notice of such stockholders intent to propose such action or actions for
consideration by the stockholders has been given, either by personal delivery or by registered or
certified mail, to the Secretary of the corporation, by the date specified under Rule 14a-8(a)(4)
under the Exchange Act (or any amendment or successor to such rule) as the deadline for submitting
stockholder proposals. The Rule currently requires that stockholder proposals be submitted no later
than 120 days before the anniversary of the mailing date of the previous years proxy statement.
Each such notice shall set forth:
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the name and address of the stockholder who intends to make the proposal and any
other stockholders known by the proposing stockholder to be supporting such proposal; |
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a representation that the stockholder is a holder of record of stock of the
corporation entitled to vote at such meeting and intends to appear in person or by
proxy at the meeting to propose such action or actions for consideration by the
stockholders; and |
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such information regarding each action as would be required to be included in a
proxy statement filed with the Securities and Exchange Commission pursuant to the proxy
rules under the Exchange Act. |
Innovives certificate and Innovives bylaws do not provide procedures for the submission of
stockholder proposals.
Voting Rights
Both CytRxs and Innovives bylaws provide that each share of their respective common stock is
entitled to one vote. Any action, other than the election of directors or as otherwise required by
law, shall be authorized by a majority of the votes cast.
Quorum for Meeting of Stockholders
CytRxs bylaws and Innovives bylaws both provide that the holders of a majority of the
outstanding voting interests shall constitute a quorum at a meeting of stockholders for the
transaction of any business.
Notice of Stockholder Meetings
Both CytRxs and Innovives bylaws provide that written notice of all stockholders meetings
shall be given, stating the place, date, and hour of the meeting, and the purpose of the meeting,
as applicable. CytRxs bylaws provide that notice of any meeting shall be given, personally or by
mail, not less than 10 days nor more than 50 days before the date of the meeting, while Innovives
bylaws provide that notice of any meeting shall be given not less than 10 days nor more than 60
days before the date of the meeting.
Indemnification
Both CytRxs and Innovives certificate provide that the corporation shall indemnify and hold
harmless any and all of its directors or officers or former directors or officers to the fullest
extent from time to time permitted by the DGCL. The certificates further provide that such
indemnification shall not be deemed exclusive of any other rights to which those indemnified may be
entitled under any law, bylaws, agreement, vote of stockholders, or otherwise.
168
Both CytRxs and Innovives bylaws provide that the corporation shall indemnify, to the
fullest extent permitted by law, each person who was or is a party or threatened to be made a party
to any threatened, pending or completed action, suit or proceeding, whether civil, criminal,
administrative or investigative, by reason of the fact that he is or was one of its directors or
officers, or is or was serving at its request as a director, officer, employee or agent of another
enterprise, against expenses, judgments, fines and amounts paid in settlement by him in connection
with such action, suit or proceeding, if he acted in good faith and in a manner he reasonably
believed to be in or not opposed to the best interests of the corporation, and, with respect to a
criminal action, had no reasonable cause to believe his conduct was unlawful. Both bylaws also
provide that the corporation will advance litigation expenses upon its receipt of an undertaking by
the director or officer to repay such advances if it is ultimately determined that the director or
officer is not entitled to indemnification.
The DGCL generally permits, and Innovives bylaws specifically provide for, indemnification of
expenses, including attorneys fees, actually and reasonably incurred in defense or settlement of a
derivative or third-party action, provided the person seeking indemnification is determined to have
acted in good faith and in a manner reasonably believed to be in best interests of the corporation.
Such determination must be made, with respect to a person who is an officer or director at the
time of such determination, by a majority vote of the disinterested directors, by a committee of
such directors, by independent counsel or by the stockholders. Unless otherwise determined by the
court, however, no indemnification may be made in respect of any action or suit brought by or in
the right of the corporation in which such person is adjudged liable to the corporation. To the
extent a director, officer, employee or agent is successful in the defense of such an action, suite
or proceeding, the corporation is required by the DGCL to indemnify such person for reasonable
expenses incurred thereby.
Innovives bylaws further provide that it may, to the extent authorized by its board of
directors, grant rights to indemnification, and rights to advancement of expenses, to any of its
employees or agents.
Limitation on Liability
CytRxs bylaws and Innovives certificate provide that, pursuant to the DGCL, a director shall
not be liable for monetary damages for breach of the directors fiduciary duty of care to the
corporation or its stockholders, except for breaches of the directors duty of loyalty to the
corporation or its stockholders, for acts or omissions not in good faith or involving intentional
misconduct or knowing violations of law, for actions leading to improper personal benefit to the
director, and for payment of dividends or approval of stock repurchases or redemptions that are
unlawful under the DGCL.
Insurance
Under the DGCL, CytRx is permitted to, and Innovives bylaws provide specifically that the
corporation may, purchase indemnity insurance for the benefit of its officers, directors, employees
and agents whether or no the corporation would have the power to indemnify against the liability
covered by the policy.
Bylaw Amendments
CytRxs certificate and bylaws provide that the bylaws may be rescinded, altered, amended or
repealed, and new bylaws may be made by a majority vote of the stockholders or the board of
directors, except for any provision for the classification of directors for staggered terms, which
shall be set forth in an initial Bylaw or in a bylaw adopted by the stockholders entitled to vote,
unless provisions for such classification shall be set forth in CytRxs certificate.
Innovives bylaws provide that the bylaws may be rescinded, altered, amended or repealed, and
new bylaws may be made by a majority vote of the stockholders or the board of directors, provided
however that
169
changes regarding the provisions related to the power to call a special meeting of the
stockholders can only be amended if that section as amended would not conflict with the Innovives
certificate.
Derivative Suits
CytRxs certificate and CytRxs bylaws do not provide any specific policies or procedures
regarding stockholders derivative suits.
Innovives bylaws provide that any transaction questioned in any stockholders derivative suit
on the grounds of lack of authority, defective or irregular execution, adverse interest of
director, officer or stockholder, nondisclosure, miscomputation or the application of improper
principles or practices of accounting, may be ratified before or after judgment, by the board of
directors or by the stockholders in case less than a quorum of directors are qualified, and, if so
ratified, shall have the same force and effect as if the questioned transaction had been originally
duly authorized, and said ratification shall be binding upon Innovive and its stockholders, and
shall constitute a bar to any claim or execution of any judgment in respect of such questioned
transaction.
Agreements with Creditors
CytRxs certificate provides that whenever a compromise is proposed between CytRx and some or
all of its creditors or some or all of its stockholders, a Delaware court may, upon the application
of an appropriate party, order a meeting of all the creditors or stockholders, or any class of
either, as the case may be, to be summoned in such manner as the court directs. If a majority in
number representing three-fourths in value of the creditors or stockholders, or any class of
either, as the case may be, agree to any compromise and to any reorganization of this corporation
as a consequence of such compromise, the said compromise and the said reorganization shall, if
sanctioned by the court, be binding on all the creditors or class of creditors or stockholders, or
any class of either, as the case may be, and also on CytRx.
Innovives certificate and Innovives bylaws do not provide any specific policies or
procedures regarding such meetings.
OTHER MATTERS
Other Business at the Special Meeting
Management of Innovive is not aware of any matters to be presented for action at the special
meeting other than those set forth in this proxy statement/prospectus. However, should any other
business properly come before the special meeting, or any adjournment or postponement of the
meeting, the enclosed proxy confers upon the persons entitled to vote the shares represented by
such proxy discretionary authority to vote the same in respect of any such other business in
accordance with their best judgment in the interest of Innovive.
Multiple Stockholders Sharing One Address
In accordance with SEC Rule 14a-3(e)(1), one proxy statement/prospectus will be delivered to
two or more stockholders who share an address, unless Innovive has received contrary instructions
from one or more of the stockholders. Innovive will deliver promptly upon written or oral request
a separate copy of the proxy statement/prospectus to a stockholder at a shared address to which a
single copy of the proxy statement/prospectus was delivered. Requests for additional copies of the
proxy statement/prospectus should be directed by writing to Innovive Pharmaceuticals, Inc., 555
Madison Avenue, 25th Floor, New York, New York 10022, Attention: Corporate Secretary,
or by calling J. Gregory Jester, our Chief Financial Officer, at (212) 716-1814. In addition,
stockholders who share a single address but receive multiple copies of the proxy
170
statement/prospectus may request that in the future they receive a single copy by contacting
Innovive at the address and phone number set forth in the prior sentence.
LEGAL MATTERS
The validity of CytRx common stock to be issued in connection with the merger will be passed
upon for CytRx by TroyGould PC, Los Angeles, California. As of June 30, 2008, TroyGould PC owned
70,000 shares of CytRx common stock and warrants to purchase 7,146 shares of CytRx common stock, as
well as 23,491 shares of common stock of RXi.
EXPERTS
The CytRx financial statements and schedules as of December 31, 2007 and 2006 and for each of
the three years in the period ended December 31, 2007 and managements assessment of the
effectiveness of internal control over financial reporting as of December 31, 2007 included in this
prospectus and in the registration statement have been so included in reliance on the reports of BDO Seidman, LLP, an
independent registered public accounting firm, the report on the effectiveness of internal control
over financial reporting expresses an adverse opinion on the effectiveness of CytRxs internal
control over financial reporting as of December 31, 2007, appearing elsewhere herein and in the
registration statement, given on the authority of said firm as experts in auditing and accounting.
The Innovive financial statements as of December 31, 2007 and 2006,
for each of the years in the three-year period ended December 31, 2007 and for the period from
March 24, 2004 (inception) to December 31, 2007 have
been audited by J.H. Cohn LLP, an independent
registered public accounting firm, as set forth in their report
thereon included herein, which includes an explanatory paragraph
relating to our ability to continue as a going concern. Such
financial statements are included herein in reliance upon such report given on the authority of
such firm as experts in accounting and auditing.
INNOVIVE 2008 ANNUAL MEETING STOCKHOLDER PROPOSALS
We will hold a 2008 annual meeting of stockholders only if the merger is not completed as
contemplated by the merger agreement. If it is determined that the merger will not be completed as
contemplated by the merger agreement, we will provide notice of the date fixed for the annual
meeting, as well as the deadline for submitting stockholder proposals for such meeting and to have
stockholder proposals included in our proxy statement. Such date will be disclosed in a Quarterly
Report on Form 10-Q or Current Report on Form 8-K.
WHERE YOU CAN FIND MORE INFORMATION
CytRx has filed with the SEC a registration statement under the Securities Act that registers
the distribution to our stockholders of the shares of CytRx common stock to be issued in connection
with the merger. This proxy statement/prospectus is a part of that registration statement and
constitutes a prospectus of CytRx and a proxy statement of Innovive for its special meeting. The
registration statement, including the exhibits and schedules, contains additional relevant
information about CytRx and us. The rules and regulations of the SEC allow us to omit certain
information included in the registration statement from this proxy statement/prospectus.
You may read and copy this information at the Public Reference Room of the SEC at 100 F
Street, N.E., Room 1580, Washington, D.C. 20549. You may obtain information on the operation of
the SECs Public Reference Room by calling the SEC at 1-800-SEC-0330. The SEC also maintains an
Internet website that contains reports, proxy statements and other information about issuers, like
CytRx and us, who file electronically with the SEC. The address of
the site is http://www.sec.gov.
The reports and other information filed by us with the SEC are also available at our Internet
website. The address of the site is www.innovivepharma.com. We have included the web addresses of
the SEC and us as inactive textual
171
references only. Except as specifically incorporated by reference into this document,
information on those websites is not part of this proxy statement/prospectus.
172
APPENDIX A
AGREEMENT
AND PLAN OF MERGER
dated as of
June 6, 2008
among
INNOVIVE PHARMACEUTICALS, INC.,
CYTRX CORPORATION,
CYTRX MERGER SUBSIDIARY, INC.
and
STEVEN KELLY
(As the Stockholder Representative)
TABLE OF
CONTENTS
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§ ARTICLE I THE MERGER; CLOSING
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A-1
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Section 1.01
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The Merger
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A-1
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Section 1.02
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Effective Time
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A-1
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Section 1.03
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Effects of the Merger
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A-1
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Section 1.04
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Conversion of Shares
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A-1
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Section 1.05
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Dissenting Shares
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A-2
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Section 1.06
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Payment of Merger Consideration
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A-2
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Section 1.07
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Treatment of Company Stock Options
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A-4
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Section 1.08
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Treatment of Company Warrants
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A-4
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Section 1.09
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The Closing
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A-4
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ARTICLE II THE SURVIVING CORPORATION; DIRECTORS AND OFFICERS
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A-5
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Section 2.01
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Certificate of Incorporation
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A-5
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Section 2.02
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Bylaws
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A-5
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Section 2.03
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Directors and Officers
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A-5
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ARTICLE III EARNOUT MERGER CONSIDERATION
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A-5
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Section 3.01
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Net Sales; Determination of Earnout
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A-5
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Section 3.02
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Payment
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A-6
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Section 3.03
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Transfer of the Surviving Corporation
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A-7
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Section 3.04
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Earnout Rights Not Transferable
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A-7
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ARTICLE IV REPRESENTATIONS AND WARRANTIES OF CYTRX AND MERGER
SUBSIDIARY
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A-7
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Section 4.01
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Organization and Qualification
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A-7
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Section 4.02
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Capitalization
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A-7
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Section 4.03
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Authority; Non-Contravention; Approvals
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A-8
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Section 4.04
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Reports and Financial Statements
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A-9
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Section 4.05
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Proxy Statement/Prospectus
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A-9
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Section 4.06
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No Violation of Law
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A-9
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Section 4.07
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Material Contracts; Compliance with Contracts
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A-9
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Section 4.08
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Brokers and Finders
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A-10
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Section 4.09
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No Prior Activities of Merger Subsidiary
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A-10
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Section 4.10
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Litigation; Government Investigations
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A-10
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Section 4.11
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Taxes
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A-10
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ARTICLE V REPRESENTATIONS AND WARRANTIES OF THE COMPANY
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A-11
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Section 5.01
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Organization and Qualification
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A-11
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Section 5.02
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Capitalization
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A-11
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Section 5.03
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Authority; Non-Contravention; Approvals
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A-12
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Section 5.04
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Reports and Financial Statements
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A-13
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Section 5.05
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Sarbanes-Oxley Act; Internal Accounting Controls
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A-13
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Section 5.06
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Liabilities
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A-13
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Section 5.07
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Absence of Certain Changes or Events
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A-14
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Section 5.08
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Litigation; Government Investigations
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A-14
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Section 5.09
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Proxy Statement/Prospectus
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A-14
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A-i
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Page
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Section 5.10
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No Violation of Law
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A-14
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Section 5.11
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Material Contracts; Compliance with Contracts
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A-14
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Section 5.12
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Taxes
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A-15
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Section 5.13
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Employee Benefit Plans; ERISA; Employment Agreements.
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A-15
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Section 5.14
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Labor Controversies
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A-16
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Section 5.15
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Environmental Matters
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A-16
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Section 5.16
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Title to Assets
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A-16
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Section 5.17
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Company Stockholders Approval
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A-17
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Section 5.18
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Intellectual Property
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A-17
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Section 5.19
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Insurance
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A-19
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Section 5.20
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Certain Payments
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A-19
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Section 5.21
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Brokers and Finders
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A-19
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Section 5.22
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Opinion of Financial Advisor
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A-20
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ARTICLE VI COVENANTS
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A-20
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Section 6.01
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Conduct of Business by the Company Pending the Merger
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A-20
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Section 6.02
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Conduct of Business by CytRx Pending the Merger
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A-22
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Section 6.03
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Acquisition Proposals
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A-22
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Section 6.04
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Access to Information; Confidentiality
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A-24
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Section 6.05
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Notices of Certain Events
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A-25
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Section 6.06
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Merger Subsidiary
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A-25
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Section 6.07
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Meeting of the Companys Stockholders
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A-26
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Section 6.08
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Registration Statement
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A-26
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Section 6.09
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Public Announcements
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A-26
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Section 6.10
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Expenses and Fees
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A-27
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Section 6.11
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Agreement to Cooperate
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A-27
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Section 6.12
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Directors and Officers Indemnification
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A-27
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Section 6.13
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Loan and Security Agreement
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A-28
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Section 6.14
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Exemption From Liability Under Section 16(b)
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A-28
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Section 6.15
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Resignation of Officers
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A-28
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Section 6.16
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Office Lease
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A-28
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ARTICLE VII CONDITIONS TO THE MERGER
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A-29
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Section 7.01
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Conditions to the Obligations of Each Party
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A-29
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Section 7.02
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Conditions to Obligation of the Company to Effect the Merger
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A-29
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Section 7.03
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Conditions to Obligations of CytRx and Subsidiary to Effect the
Merger
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A-29
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ARTICLE VIII TERMINATION
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A-30
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Section 8.01
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Termination
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A-30
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Section 8.02
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Termination Fee
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A-31
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Section 8.03
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Effect of Termination
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A-31
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ARTICLE IX OFFSET
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A-32
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Section 9.01
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Survival
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A-32
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Section 9.02
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Offset
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A-32
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Section 9.03
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Offset Claims
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A-32
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A-ii
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Page
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Section 9.04
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Resolution of Conflicts
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A-33
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Section 9.05
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Stockholder Representative
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A-33
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ARTICLE X MISCELLANEOUS
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A-34
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Section 10.01
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Non-Survival of Representations and Warranties
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A-34
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Section 10.02
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Notices
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A-34
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Section 10.03
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Interpretation
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A-35
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Section 10.04
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Assignment; Governing Law; Forum
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A-36
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Section 10.05
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Counterparts
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A-36
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Section 10.06
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Amendments; No Waivers
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A-36
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Section 10.07
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Entire Agreement
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A-36
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Section 10.08
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Severability
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A-36
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Section 10.09
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Specific Performance
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A-36
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A-iii
AGREEMENT
AND PLAN OF MERGER
AGREEMENT AND PLAN OF MERGER (this Agreement)
entered into on June 6, 2008, by and among INNOVIVE
PHARMACEUTICALS, INC., a Delaware corporation (the
Company), CYTRX CORPORATION, a Delaware
corporation (CytRx), CYTRX MERGER SUBSIDIARY,
INC., a Delaware corporation (Merger
Subsidiary), and STEVEN KELLY, as the Stockholder
Representative (as defined in Section 9.05).
WHEREAS, the respective Boards of Directors of the Company,
CytRx and Merger Subsidiary have determined that this Agreement
and the transactions contemplated hereby, including the Merger
(as defined below), are advisable and in the best interests of
their respective stockholders, and have approved the merger of
Merger Subsidiary with and into the Company on the terms and
subject to the conditions set forth in this Agreement (the
Merger); and
WHEREAS, in connection with the Merger, the parties desire to
make certain representations, warranties, covenants and
agreements and prescribe certain conditions to the Merger, as
provided herein; and
WHEREAS, as an inducement to CytRx and Merger Subsidiary to
enter into this Agreement, certain stockholders of the Company
have concurrently herewith entered into a Support Agreement in
substantially the form attached hereto as Exhibit A,
pursuant to which, among other things, such stockholders have
agreed to vote the shares of Company Common Stock (as defined
below) owned by them in favor of the approval and adoption of
this Agreement and the approval of the Merger;
NOW, THEREFORE, in consideration of the foregoing and the
respective representations, warranties, covenants and agreements
set forth herein, the parties hereto agree as follows:
ARTICLE I
THE MERGER;
CLOSING
Section 1.01 The
Merger. Upon the terms and subject to the
conditions of this Agreement, at the Effective Time (as defined
in Section 1.02) Merger Subsidiary shall be merged with and
into the Company in accordance with the Delaware General
Corporation Law (the DGCL). Upon the Merger,
the separate existence of Merger Subsidiary shall cease and the
Company shall continue as the surviving corporation (the
Surviving Corporation) and shall continue its
existence under the DGCL. CytRx, in its capacity as the sole
stockholder of Merger Subsidiary, hereby approves of the Merger
and this Agreement.
Section 1.02 Effective
Time. Unless this Agreement is earlier
terminated pursuant to the terms hereof, the Merger shall become
effective at or following the Closing (as defined in
Section 1.09) upon the filing with the Secretary of State
of the State of Delaware (the Secretary of
State) of a certificate of merger in accordance with
the requirements of the DGCL (the Certificate of
Merger). When used in this Agreement, the term
Effective Time means the date and time at
which the Certificate of Merger is accepted by the Secretary of
State for filing, or such later time as shall be set forth in
the Certificate of Merger.
Section 1.03 Effects
of the Merger. The Merger shall have the
effects provided for in this Agreement and in Section 259
of the DGCL.
Section 1.04 Conversion
of Shares. At the Effective Time, by virtue
of the Merger and without any action on the part of the parties
or the holders of any of the following securities:
(a) each issued and outstanding share of capital stock of
Merger Subsidiary shall be converted into one validly issued,
fully paid and nonassessable share of common stock of the
Surviving Corporation;
(b) each issued and outstanding share of the common stock,
par value $0.001 per share, of the Company (Company
Common Stock) owned by the Company as treasury stock,
or owned by any wholly owned subsidiary of the Company or by
CytRx, Merger Subsidiary or any other subsidiary of CytRx, shall
automatically be cancelled and retired and shall cease to exist,
and no payment or consideration shall be made with respect
thereto; and
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(c) each issued and outstanding share of Company Common
Stock other than shares of Company Common Stock referred to in
paragraph (b) above and other than any Dissenting Shares
(as defined in Section 1.05) shall be converted into the
right to receive, as provided herein, an amount equal to the
quotient determined by dividing (i) the sum of
(1) $3,000,000, less the consideration, if any, paid or
payable upon the termination pursuant to Section 1.07 of
all outstanding Company Options (as defined in
Section 5.02) (the Initial Merger
Consideration) and (2) the Earnout Merger
Consideration (determined as provided in Section 3.01), if
any, by (ii) the fully diluted shares (as defined below) of
Company Common Stock immediately prior to the Effective Time
(such amount per fully diluted share of Company Common Stock,
the Merger Consideration). For purposes of
this Agreement, the term fully diluted shares
means the sum of (i) all issued and outstanding shares
(including any Dissenting Shares) of Company Common Stock and
(ii) all shares of Company Common Stock issuable upon the
exercise, in full, of all outstanding Company Warrants (as
defined in Section 5.02) that will remain outstanding
following the Effective Time as provided in Section 5.02.
At the Effective Time, all issued and outstanding shares of
Company Common Stock shall no longer be outstanding and shall
automatically be cancelled and retired and shall cease to exist,
and each holder of a certificate representing any such shares of
Company Common Stock shall cease to have any rights with respect
thereto, except the right to receive the Merger Consideration,
without interest. The holders of shares of Company Common Stock
immediately prior to the Effective Time are sometimes
collectively referred to herein as the Company
Stockholders.
Section 1.05 Dissenting
Shares.
(a) For purposes of this Agreement, Dissenting
Shares means shares of the Company Common Stock held
immediately prior to the Effective Time by a stockholder who did
not vote in favor of the Merger (or consent thereto in writing)
and with respect to which demand to the Company for purchase of
such shares is duly made and perfected in accordance with
Section 262 of the DGCL and not subsequently and
effectively withdrawn or forfeited. Notwithstanding the
provisions of Section 1.04(c) or any other provision of
this Agreement to the contrary, Dissenting Shares shall not be
converted into or be exchangeable for the right to receive the
Merger Consideration at or after the Effective Time, but shall
entitle the holder thereof to receive such consideration as may
be determined to be due to holders pursuant to the DGCL, unless
and until the holder of such Dissenting Shares withdraws his or
her demand for such appraisal in accordance with the DGCL or
becomes ineligible for such appraisal. If a holder of Dissenting
Shares shall withdraw his or her demand for such appraisal or
shall become ineligible for such appraisal (through failure to
perfect or otherwise), then, as of the Effective Time or the
occurrence of such event, whichever last occurs, such
holders Dissenting Shares shall automatically be converted
into and represent the right to receive the Merger
Consideration, without interest, as provided in
Section 1.04(c) and in accordance with the DGCL.
(b) The Company shall give CytRx (i) prompt notice of
any demands received by the Company for appraisal of shares of
Company Common Stock and (ii) the opportunity to
participate in and direct all negotiations and proceedings with
respect to any such demands. The Company shall not, without the
prior written consent of CytRx, make any payment with respect
to, or settle, offer to settle or otherwise negotiate, any such
demands.
Section 1.06 Payment
of Merger Consideration.
(a) The Initial Merger Consideration shall be payable in
fully paid and non-assessable shares of the common stock,
$0.001 par value per share, of CytRx (CytRx Common
Stock), which shall be valued for this purpose at
$0.94 per share (the Initial Merger Consideration
Price).
(b) Prior to the Effective Time, CytRx shall appoint an
agent reasonably satisfactory to the Company to act as agent
(the Disbursing Agent) for the payment of the
Initial Merger Consideration upon surrender of certificates
representing shares of Company Common Stock. At or prior to the
Effective Time, CytRx shall deposit or cause to be deposited
with the Disbursing Agent in trust for the benefit of the
Company Stockholders certificates representing shares of CytRx
Common Stock sufficient to pay the Initial Merger Consideration.
(c) The Earnout Merger Consideration, if any, shall be
payable as provided in Section 3.02. The provisions of this
Section 1.06 also shall apply to the payment of any Earnout
Merger Consideration.
(d) Promptly after the Effective Time, the Surviving
Corporation shall cause the Disbursing Agent to mail to each
individual, corporation, limited liability company, partnership,
association, joint venture, unincorporated
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organization, trust or any other entity, including a
governmental authority (each, a person), who
was a record holder as of the Effective Time of an outstanding
certificate or certificates which immediately prior to the
Effective Time represented shares of Company Common Stock (the
Certificates) or of uncertificated shares of
Company Common Stock in book-entry form (Book-Entry
Shares), and whose shares were converted into the
right to receive the Initial Merger Consideration pursuant to
Section 1.04(c), a form of letter of transmittal (which
shall specify that delivery shall be effected, and risk of loss
and title to the Certificates shall pass, only upon proper
delivery of the Certificates to the Disbursing Agent, and which
shall be in such form and shall have such other customary
provisions as CytRx may reasonably specify) and instructions for
use in effecting the surrender of the Certificates or Book-Entry
Shares in exchange for payment of the Initial Merger
Consideration. Upon surrender to the Disbursing Agent of a
Certificate, together with such letter of transmittal duly
executed and such other documents as may be reasonably required
by the Disbursing Agent, the holder of such Certificate or
Book-Entry Share shall be paid promptly in exchange therefor the
Initial Merger Consideration and such Certificate or Book-Entry
Share shall forthwith be canceled. If payment is to be made to a
person other than the person in whose name the Certificate or
Book-Entry Share surrendered is registered, it shall be a
condition of payment that the Certificate so surrendered be
properly endorsed or otherwise be in proper form for transfer
and that the person requesting such payment pay any transfer or
other taxes required by reason of the payment of the Initial
Merger Consideration to a person other than the registered
holder of the Certificate surrendered or establish to the
satisfaction of the Surviving Corporation that such tax has been
paid or is not applicable. Until surrendered in accordance with
the provisions of this Section 1.06, each Certificate or
Book-Entry Share (other than Certificates or Book-Entry Shares
representing shares of Company Common Stock owned by any
subsidiary of the Company, CytRx, Merger Subsidiary or any other
subsidiary of CytRx and shares of Company Common Stock held in
the treasury of the Company, which shall have been canceled as
provided in Section 1.04(b), and other than Certificates or
Book-Entry Shares representing Dissenting Shares) shall
represent for all purposes only the right to receive, as and
when payable hereunder, the Merger Consideration multiplied by
the number of shares of Company Common Stock evidenced by such
Certificate or the number of Book-Entry Shares, without any
interest thereon.
(e) From and after the Effective Time, there shall be no
registration of transfers of shares of Company Common Stock
which were outstanding immediately prior to the Effective Time
on the stock transfer books of the Surviving Corporation. From
and after the Effective Time, the holders of shares of Company
Common Stock outstanding immediately prior to the Effective Time
shall cease to have any rights with respect to such shares of
Company Common Stock except as otherwise provided in this
Agreement or by applicable law. All Merger Consideration paid
upon the surrender of Certificates in accordance with the terms
of this Article I shall be deemed to have been paid in full
satisfaction of all rights pertaining to the shares of Company
Common Stock previously represented by such Certificates. If,
after the Effective Time, Certificates are presented to the
Surviving Corporation for any reason, such Certificates shall be
cancelled and exchanged as provided in this Article I. At
the close of business on the day of the Effective Time, the
stock ledger of the Company shall be closed.
(f) If any Certificate shall have been lost, stolen or
destroyed, upon the making of an affidavit of that fact by the
person claiming such Certificate to be lost, stolen or destroyed
and, if reasonably required by the Surviving Corporation, the
posting by such person of a bond, in such reasonable amount as
CytRx may direct, as indemnity against any claim that may be
made against it with respect to such Certificate, the Disbursing
Agent will pay, in exchange for such lost, stolen or destroyed
Certificate, the Initial Merger Consideration to be paid in
respect of the shares of Company Common Stock formerly
represented by such Certificate, as contemplated by this
Article I.
(g) No certificate or scrip representing fractional shares
of CytRx Common Stock shall be issued as part of the Initial
Merger Consideration upon the surrender of the Certificates. In
lieu thereof, each Company Stockholder otherwise entitled to a
fraction of a share of CytRx Common Stock shall be entitled to
receive an amount of cash (without interest) determined by
multiplying the Initial Merger Consideration Price by the
fractional share interest to which such holder would otherwise
be entitled, less any applicable tax withholding. If a Company
Stockholder surrenders more than one Certificate, any fractions
of a share of CytRx Common Stock shall be aggregated for
purposes of determining whether such Company Stockholder is
entitled to a fraction of a share.
(h) At any time after six months after the Effective Time,
CytRx shall be entitled to require the Disbursing Agent to
deliver to it any Merger Consideration which had been deposited
by CytRx with the Disbursing Agent and not disbursed in exchange
for Certificates (including all interest and other income
received by the Disbursing Agent
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in respect of such Merger Consideration). Thereafter, holders of
shares of Company Common Stock shall look only to CytRx (subject
to the terms of this Agreement and abandoned property, escheat
and other similar laws) as general creditors thereof with
respect to any Merger Consideration that may be payable, without
interest, upon surrender of the Certificates held by them. If
any Certificates shall not have been surrendered prior to two
years after the Effective Time (or immediately prior to such
time on which any payment in respect thereof would otherwise
escheat or become the property of any governmental unit or
agency), the payment in respect of such Certificates shall, to
the extent permitted by applicable law, become the property of
CytRx, free and clear of all claims or interest of any person
previously entitled thereto. Notwithstanding the foregoing, none
of CytRx, the Company, the Surviving Corporation nor the
Disbursing Agent shall be liable to any holder of a share of
Company Common Stock for any Merger Consideration delivered in
respect of such share of Company Common Stock to a public
official pursuant to any abandoned property, escheat or other
similar law.
(i) CytRx, the Surviving Corporation and the Disbursing
Agent shall be entitled to deduct and withhold from the Merger
Consideration otherwise payable to a holder of shares of Company
Common Stock pursuant to this Agreement such amounts as may be
required to be deducted and withheld with respect to the making
of such payment under the Internal Revenue Code of 1986, as
amended, and the rules and regulations promulgated thereunder
(the Code), or under any provision of state,
local or foreign tax law. To the extent amounts are so withheld
and paid over to the appropriate taxing authority, the withheld
amounts shall be treated for all purposes of this Agreement as
having been paid to the person in respect of which such
deduction and withholding was made.
Section 1.07 Treatment
of Company Stock Options. At or prior to the
Closing, the administrator of the Company Stock Plans (as
defined below) shall have resolved under the Company Stock Plans
to determine that each unexercised Company Option (as defined in
Section 5.02) granted pursuant to the Company Stock Plans
shall terminate immediately prior to the Effective Time, with
any consideration due to the holders thereof being paid at such
time, and the Company will take all necessary and appropriate
action to effect the termination of all Company Options
(including, but not limited to, the giving of any notice
required under any agreement relating to Company Options). For
purposes of this Agreement, the term Company Stock
Plans means, collectively, the Companys 2004
Stock Option Plan, 2007 Stock Option Plan and each other stock
option, stock appreciation rights or other equity incentive plan
maintained or assumed by the Company at any time.
Section 1.08 Treatment
of Company Warrants. Effective immediately
prior to the Effective Time, all unexercised Company Warrants
(as defined in Section 5.02) shall, by their terms and
without any action of the Company, either (a) be canceled,
without any consideration to the holders thereof, and be of no
further force or effect or (b) remain outstanding in
accordance with the terms thereof and the holders thereof shall
thereafter have the right to purchase and receive (in lieu of
the shares of Company Common Stock) the Merger Consideration
payable with respect to or in exchange for the number of shares
of Company Common Stock purchasable immediately prior to the
Effective Time upon the exercise thereof. If and to the extent
Company Warrants outstanding at the Effective Time are
subsequently cancelled, or terminate, without being exercised in
full, all Merger Consideration otherwise payable with respect to
such cancelled or terminated Company Warrants shall thereupon
become the property of CytRx. The holders of Company Warrants
immediately prior to or at any time after the Effective Time are
sometimes collectively referred to herein as the
Company Warrant Holders. CytRx shall cause
the Surviving Corporation to comply with any provisions of
Company Warrants regarding the issuance of replacement warrants
in exchange for the surrender of Company Warrants that, by their
terms, remain outstanding following the Effective Time.
Section 1.09 The
Closing. The consummation of the transactions
contemplated by this Agreement (the Closing)
shall take place at the offices of TroyGould PC, 1801 Century
Park East,
16th Floor,
Los Angeles, California 90067, commencing at 9:00 A.M.,
local time, on the second business day following the
satisfaction or waiver of all conditions set forth in
Article VII or such other place and date as the parties may
mutually determine (the Closing Date). As
soon as practicable following the Closing, the Company and
Merger Subsidiary shall file with the Secretary of State the
duly executed Certificate of Merger and such other documents as
may be required by the DGCL, and the parties shall take all such
other and further actions as may be required by law to make the
Merger effective.
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ARTICLE II
THE
SURVIVING CORPORATION; DIRECTORS AND OFFICERS
Section 2.01 Certificate
of Incorporation. The Certificate of
Incorporation of Merger Subsidiary in effect at the Effective
Time shall be the certificate of incorporation of the Surviving
Corporation, except that the name of the Surviving Corporation
shall be changed to CytRx Oncology Corporation, unless and until
amended in accordance with applicable law and the terms of this
Agreement.
Section 2.02 Bylaws. The
Bylaws of Merger Subsidiary in effect at the Effective Time
shall be the bylaws of the Surviving Corporation, unless and
until amended in accordance with applicable law.
Section 2.03 Directors
and Officers. The directors of Merger
Subsidiary immediately prior to the Effective Time shall be the
directors of the Surviving Corporation as of the Effective Time.
The officers identified in the Certificate of Merger shall be
the officers of the Surviving Corporation as of the Effective
Time, subject to the right of the Board of Directors of the
Surviving Corporation to appoint or replace officers.
ARTICLE III
EARNOUT
MERGER CONSIDERATION
Section 3.01 Net
Sales; Determination of Earnout.
(a) For purposes of this Agreement, the following
capitalized terms shall have the meanings indicated:
(i) Company License Agreements
has the meaning set forth in Section 3.01(a) of the Company
Disclosure Schedule (as defined in Article V);
(ii) Earnout Merger Consideration
means the amounts set forth in the following table corresponding
to the Surviving Corporations achievement of Net Sales (as
defined below) indicated:
|
|
|
|
|
Net Sales
|
|
Earnout Merger Consideration
|
|
|
$ 2,000,000
|
|
$
|
2,000,000
|
|
$15,000,000
|
|
$
|
5,000,000
|
|
$30,000,000
|
|
$
|
5,000,000
|
|
$40,000,000
|
|
$
|
6,253,462
|
|
provided, that the final payment of the Earnout Merger
Consideration (i.e., $6,253,462 payment corresponding to
Net Sales of $40,000,000), shall be increased by the excess, if
any, of (1) the Estimated Net Liabilities (as defined in
Section 5.06(b)) of the Company as of the date of this
Agreement over (2) the actual Net Liabilities (as defined
in Section 5.06(b) but excluding up to $97,785 that may
become due and payable to Davos Chemical Corporation) of the
Company as of such date.
(iii) Earnout Period means the
period commencing upon the Effective Time and ending on the
earlier of (1) the end of the first calendar year in which
Net Sales equal or exceed $40,000,000 and (2) the
expiration of the last of the patents licensed under the Company
License Agreements;
(iv) Net Sales means the sum of
all net sales as defined in the Company License
Agreements;
(v) Market Price means, for any
date: (i) if the CytRx Common Stock is then listed or
quoted on a Trading Market (as defined below), the last sale
price of the CytRx Common Stock on such date (or the nearest
preceding Trading Day (as defined below) if such date is not a
Trading Day) on the Trading Market on which the Common Stock is
then listed or quoted for trading as reported by Bloomberg L.P.;
or (ii) if CytRx Common Stock is not then quoted for
trading on a Trading Market and if prices for CytRx Common Stock
are then reported in the Pink Sheets published by
Pink Sheets, LLC (or a similar organization or agency succeeding
to its functions of reporting prices), the most recent bid price
per share of CytRx Common Stock so reported; or (iii) in
all other cases, the fair market value of a share of CytRx
Common Stock as determined in good faith by the Board of
Directors of CytRx;
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(vi) Trading Day means a day on
which the principal Trading Market is open for business; and
(vii) Trading Market means the
following exchanges or markets on which the CytRx Common Stock
is listed or quoted for trading on the date in question: The
Nasdaq Capital Market; The Nasdaq Global Market; the Nasdaq
Global Select Market; the American Stock Exchange; the New York
Stock Exchange; or the OTC Bulletin Board.
(b) Subject to the achievement of Net Sales as set forth in
paragraph (a) above and to CytRxs offset rights under
Article IX, CytRx shall pay the related Earnout Merger
Consideration as provided in Section 3.02.
Section 3.02 Payment.
(a) If, in a calendar year during the Earnout Period, the
Surviving Corporation achieves Net Sales for such year in one or
more of the amounts specified in Section 3.01(a), CytRx
shall promptly, and in no event later than 90 days
following the end of such year, pay and deliver to the
Stockholder Representative, on behalf of the Company
Stockholders, and reserve on behalf of the Company Warrant
Holders the relevant Earnout Merger Consideration pursuant to
Section 3.01(a). For clarity, the Earnout Merger
Consideration shall be payable only with respect to the first
year during the Earnout Period in which Net Sales as specified
in Section 3.01(a) are achieved. For further clarity, the
Relevant Earnout Merger Consideration shall be payable with
respect to each level of Net Sales specified in
Section 3.01(a) first achieved during such year. By way of
example only, if, in the first calendar year during the Earnout
Period for which Net Sales were at least $2,000,000, the
Surviving Corporation achieves Net Sales of $17,000,000, the
Earnout Merger Consideration payable by CytRx would be
$7,000,000 (i.e., $2,000,000 + $5,000,000). In this
example, no further Earnout Merger Consideration would be
payable unless and until Net Sales for any calendar year equaled
or exceeded $30,000,000.
(b) Subject to the Equity Conditions (as defined below) and
share limitation described below, the Earnout Merger
Consideration, if any, shall be payable in shares of CytRx
Common Stock valued for this purpose at the average of the daily
Market Price during the ten-Trading Day period ending on the
second Trading Day prior to CytRxs payment of the Earnout
Consideration or, in CytRxs discretion, in cash, or by any
combination of shares of CytRx Common Stock and cash. For
purposes of this Agreement, the term Equity
Conditions means, at the time of payment of any
Earnout Merger Consideration, (i) CytRx Common Stock is
listed for trading on a Trading Market and all of the shares
issuable in payment of such Earnout Merger Consideration are
listed or quoted for trading on such Trading Market,
(ii) the shares of CytRx Common Stock comprising the
Earnout Merger Consideration are registered, if necessary, under
the Securities Act pursuant to an effective registration
statement or otherwise will be freely tradeable upon issuance
thereof, and (iii) there are sufficient authorized but
unissued and otherwise unreserved shares of CytRx Common Stock
for the issuance of all of the shares issuable in payment of
such Earnout Merger Consideration. Notwithstanding the foregoing
or any other provision of this Agreement, the maximum number of
shares of CytRx Common Stock issued in payment of the Merger
Consideration shall not exceed 18,145,013 (subject to adjustment
for reverse and forward stock splits, stock dividends, stock
combinations and like events with respect to CytRx Common
Stock), unless such issuance shall have been approved by the
requisite vote or consent of CytRx stockholders under applicable
Trading Market listing standards. In the event that the Equity
Conditions shall not have been satisfied, or if payment in
shares of CytRx Common Stock of any Earnout Merger Consideration
would cause such share limitation to be exceeded, CytRx shall,
to the extent necessary, instead pay such Earnout Merger
Consideration in cash.
(c) No certificate or scrip representing fractional shares
of CytRx Common Stock shall be issued as part of the Earnout
Merger Consideration. In lieu thereof, each Company Stockholder
otherwise entitled to a fraction of a share of CytRx Common
Stock shall be entitled to receive an amount of cash (without
interest) determined by multiplying the Market Price for
purposes of the payment of such Earnout Merger Consideration by
the fractional share interest to which such holder would
otherwise be entitled, less any applicable tax withholding. If a
Company Stockholder surrenders more than one Certificate, any
fractions of a share of CytRx Common Stock shall be aggregated
for purposes of determining whether such Company Stockholder is
entitled to a fraction of a share.
(d) CytRx shall afford the Stockholder Representative and
his advisers and representatives, upon request, reasonable
access to the books and records of the Surviving Corporation for
purposes relating to the determination of Net Sales, provided
that such access shall be limited to that portion of the books
and records that relate to the
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calculation of Net Sales and provided further that prior to
granting such access, the Stockholder Representative shall have
entered into a confidentiality agreement on terms and conditions
reasonably satisfactory to CytRx. If the Stockholder
Representative disputes any Net Sales determination by CytRx,
either party may make a demand for formal resolution in the
manner provided in Section 9.04.
Section 3.03 Transfer
of the Surviving Corporation. No sale or
transfer by CytRx of any beneficial ownership in the Surviving
Corporation shall relieve CytRx of its obligations with respect
to this Agreement, unless the purchaser of such interest shall
agree in writing to assume all of CytRxs obligations
hereunder and to be bound by all of the terms and conditions of
this Agreement (in which event, the term
CytRx shall thereafter include such
purchaser).
Section 3.04 Earnout
Rights Not Transferable. No person may sell,
exchange, transfer or otherwise dispose of his, her or its right
to receive the Earnout Merger Consideration, if any, other than
by operation of law. Any transfer or purported transfer in
violation of this Section 3.04 shall be null and voice
ab initio and shall not be recognized by CytRx.
ARTICLE IV
REPRESENTATIONS
AND WARRANTIES OF CYTRX AND MERGER SUBSIDIARY
CytRx and Merger Subsidiary, jointly and severally, represent
and warrant to the Company that, except as set forth in
(i) the CytRx SEC Reports (as defined in Section 4.04)
filed with the Securities and Exchange Commission (the
SEC) prior to the date hereof or
(ii) the disclosure schedule delivered to the Company by
CytRx concurrently herewith (the CytRx Disclosure
Schedule), which shall be arranged in sections
corresponding to the numbered sections of this Article IV,
it being agreed that disclosure of any item on the CytRx
Disclosure Schedule shall be deemed disclosure with respect to
all Sections of this Agreement if the relevance of such item is
reasonably apparent from the face of the CytRx Disclosure
Schedule:
Section 4.01 Organization
and Qualification. Each of CytRx and Merger
Subsidiary is a corporation duly organized, validly existing and
in good standing under the laws of the State of Delaware and has
the requisite corporate power and authority to own, lease and
operate its assets and properties and to carry on its business
as it is now being conducted. Each of CytRx and Merger
Subsidiary is duly qualified and licensed to transact business
and is in good standing (with respect to jurisdictions that
recognize such concept) in each jurisdiction in which the
properties owned, leased or operated by it or the nature of the
business conducted by it makes such qualification necessary,
except where the failure to be so qualified, licensed and in
good standing would not reasonably be expected to have a CytRx
Material Adverse Effect (as hereinafter defined). In this
Agreement, the term CytRx Material Adverse
Effect means any change, event, circumstance,
development or occurrence (other than an effect arising out of
or resulting from the entering into or the public announcement
or disclosure of this Agreement and the transactions
contemplated hereby) that, individually or in the aggregate,
(i) has a material adverse effect on the business,
financial condition or ongoing operations of CytRx or
(ii) has a material adverse effect on CytRxs ability
to consummate the Merger; provided, that no change, event,
circumstance, development or occurrence regarding the clinical
hold placed by the U.S. Food and Drug Administration on
Cytrxs Phase II clinical trial as described in the
CytRx SEC reports shall constitute or be considered a material
adverse effect. True, accurate and complete copies of
CytRxs Amended and Restated Certificate of Incorporation
and Bylaws and Merger Subsidiarys Certificate of
Incorporation and Bylaws, in each case, as in effect on the date
hereof, including all amendments thereto, have heretofore been
made available to the Company.
Section 4.02 Capitalization.
(a) The authorized capital stock of CytRx consists of
150,000,000 shares of CytRx Common Stock and
5,000,000 shares of preferred stock, par value $0.01 per
share (CytRx Preferred Stock). As of
May 30, 2008, (i) 90,770,453 shares of CytRx
Common Stock were issued and outstanding (exclusive of
633,816 shares held in treasury), all of which shares were
duly authorized, validly issued, fully paid, nonassessable and
free of preemptive rights, (ii) 15,000 shares of CytRx
Preferred Stock were designated as Series A Junior
Participation Preferred Stock, (iii) no shares of CytRx
Preferred Stock were issued and outstanding, and
(iv) 17,583,203 shares of CytRx Common Stock were
reserved for issuance upon exercise of outstanding stock options
and warrants (the CytRx Options and Warrants).
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(b) The shares of CytRx Common Stock to be issued pursuant
to the Merger, when issued and delivered in accordance with this
Agreement, will be duly authorized, validly issued, fully paid
and non-assessable and issued in compliance with federal and
state securities laws.
(c) Except for the CytRx Options and Warrants, there are no
outstanding subscriptions, options, calls, contracts,
commitments, understandings, restrictions, arrangements, rights
or warrants, including any right of conversion or exchange under
any outstanding security, instrument or other agreement and also
including any rights plan or other anti-takeover agreement,
obligating CytRx or any subsidiary of CytRx to issue, deliver or
sell, or cause to be issued, delivered or sold, additional
shares of the capital stock of CytRx or obligating CytRx or any
subsidiary of CytRx to grant, extend or enter into any such
agreement or commitment. There are no outstanding stock
appreciation rights or similar derivative securities or rights
of CytRx or any of its subsidiaries. There are no voting trusts,
irrevocable proxies or other agreements or understandings to
which CytRx or any subsidiary of CytRx is a party or is bound
with respect to the voting of any shares of CytRx Common Stock.
Section 4.03 Authority;
Non-Contravention; Approvals.
(a) Each of CytRx and Merger Subsidiary has the requisite
corporate power and authority to enter into this Agreement and
to perform its obligations hereunder and to consummate the
transactions contemplated hereby. The execution and delivery of
this Agreement and the consummation of the transactions
contemplated hereby have been duly authorized and approved by
the respective Boards of Directors of CytRx and Merger
Subsidiary. No other corporate proceedings on the part of CytRx
or Merger Subsidiary are necessary to authorize the execution,
delivery and performance of this Agreement or the consummation
by CytRx and Merger Subsidiary of the transactions contemplated
hereby. This Agreement has been duly executed and delivered by
each of CytRx and Merger Subsidiary, and, assuming the due
authorization, execution and delivery hereof by the Company,
constitutes a valid and legally binding agreement of each of
CytRx and Merger Subsidiary, enforceable against CytRx and
Merger Subsidiary in accordance with its terms, subject to
applicable bankruptcy, insolvency, reorganization, moratorium
and similar laws affecting creditors rights and remedies
generally, and subject, as to enforceability, to general
principles of equity, including principles of commercial
reasonableness, good faith and fair dealing (regardless of
whether enforcement is sought in a proceeding at law or in
equity).
(b) The respective Boards of Directors of CytRx and Merger
Subsidiary, at meetings duly called and held, have unanimously
approved this Agreement and the Merger. CytRx, in its capacity
as the sole stockholder of Merger Subsidiary, hereby approves of
this Agreement and the Merger.
(c) The execution, delivery and performance of this
Agreement by each of CytRx and Merger Subsidiary and the
consummation of the Merger and the transactions contemplated
hereby do not and will not violate, conflict with or result in a
breach of any provision of, or constitute a default (or an event
which, with notice or lapse of time or both, would constitute a
default) under, or result in the termination of, or accelerate
the performance required by, or result in a right of termination
or acceleration under, contractually require any offer to
purchase or any prepayment of any debt, or result in the
creation of any lien, security interest or encumbrance upon any
of the properties or assets of CytRx or any subsidiary (as
defined below) of CytRx under any of the terms, conditions or
provisions of (i) the respective Certificates of
Incorporation or the respective Bylaws of CytRx and Merger
Subsidiary, (ii) any statute, law, ordinance, rule,
regulation, judgment, decree, order, injunction, writ, permit or
license of any court or governmental authority applicable to
CytRx or any CytRx subsidiary or any of their respective
properties or assets, subject, in the case of consummation, to
obtaining (prior to the Effective Time) the CytRx Required
Statutory Approvals (as defined in Section 4.03(d)), or
(iii) any contract, agreement, commitment or understanding
(each, a contract) to which CytRx or any
CytRx subsidiary is now a party or by which CytRx or any CytRx
subsidiary or any of their respective properties or assets may
be bound or affected, other than, in the case of
clauses (ii) and (iii) of this paragraph (c), such
violations, conflicts, breaches, defaults, terminations,
accelerations, contractual requirements or creations of liens,
security interests or encumbrances that would not reasonably be
expected, individually or in the aggregate, to have a CytRx
Material Adverse Effect and would not prevent or materially
delay the consummation of the Merger. For purposes of this
Agreement, the term subsidiary means, with respect
to any person, any corporation or other entity of which such
person owns, directly or indirectly, more than 50% of the
capital stock or other equity interests generally entitled to
vote for the election of the board of directors or other
governing body of such corporation or other legal entity.
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(d) Except for (i) the filing with the Securities and
Exchange Commission (the SEC) of a
Registration Statement on
Form S-4
under the Securities Act by CytRx with respect to the Merger
(the Registration Statement) and applicable
filings pursuant to the Securities Exchange Act of 1934, as
amended (the Exchange Act), and (ii) the
filing of the Certificate of Merger with the Secretary of State
in connection with the Merger (collectively, the CytRx
Required Statutory Approvals), no declaration, filing
or registration with, or notice to, or authorization, consent or
approval of, any governmental or regulatory body or authority is
necessary for the execution and delivery of this Agreement by
CytRx or Merger Subsidiary or the consummation by CytRx or
Merger Subsidiary of the transactions contemplated hereby, other
than such declarations, filings, registrations, notices,
authorizations, consents or approvals which, if not made or
obtained, as the case may be, would not reasonably be expected,
individually or in the aggregate, to have a CytRx Material
Adverse Effect and would not prevent or materially delay the
consummation of the Merger.
Section 4.04 Reports
and Financial Statements.
(a) Since January 1, 2007, CytRx has filed with the
SEC all material forms, statements, reports and documents,
including all exhibits, post-effective amendments and
supplements thereto (the CytRx SEC Reports),
required to be filed by it under each of the Securities Act of
1933, as amended (the Securities Act), the
Exchange Act and the respective rules and regulations
thereunder, all of which, as amended if applicable, complied
when filed, or amended, in all material respects with all
applicable requirements of the appropriate act and the rules and
regulations thereunder. As of their respective dates, the CytRx
SEC Reports did not contain any untrue statement of a material
fact or omit to state a material fact required to be stated
therein or necessary to make the statements therein, in light of
the circumstances under which they were made, not misleading,
except to the extent corrected by a subsequent Company SEC
Report filed with the SEC prior to the date hereof.
(b) The financial statements of CytRx included in the CytRx
SEC Reports (collectively, the CytRx Financial
Statements) were prepared in accordance with generally
accepted accounting principles (except, with respect to any
unaudited financial statements, as permitted by applicable SEC
rules or requirements) applied on a consistent basis (except as
may be indicated therein or in the notes thereto) and fairly
present in all material respects the financial position of CytRx
as of the dates thereof and the results of operations and
changes in financial position of CytRx for the periods then
ended (subject, in the case of any unaudited interim financial
statements, to normal year-end adjustments).
Section 4.05 Proxy
Statement/Prospectus. None of the information
to be supplied by CytRx or Merger Subsidiary for inclusion in
the Proxy Statement/Prospectus (as defined in
Section 5.03(d)) will, at the time of the mailing thereof
or any amendments or supplements thereto, or at the time of the
meeting of stockholders of the Company to be held in connection
with the transactions contemplated by this Agreement, contain
any untrue statement of a material fact or omit to state any
material fact required to be stated therein or necessary in
order to make the statements therein, in light of the
circumstances under which they are made, not misleading. The
Registration Statement will comply, as of its effective date, as
to form in all material respects with all applicable laws,
including the provisions of the Securities Act and the rules and
regulations promulgated thereunder, except that no
representation is made by CytRx with respect to information
supplied by the Company for inclusion therein.
Section 4.06 No
Violation of Law. Neither CytRx nor Merger
Subsidiary is in violation of or has been given written (or, to
the knowledge of CytRx and Merger Subsidiary, oral) notice of
any violation of any law, statute, order, rule, regulation,
ordinance or judgment of any governmental or regulatory body or
authority, except for violations which would not reasonably be
expected, individually or in the aggregate, to have a CytRx
Material Adverse Effect. Neither CytRx nor any CytRx subsidiary
is in violation of the terms of any permits, licenses,
franchises, variances, exemptions, orders and other governmental
authorizations, consents and approvals necessary to conduct
their businesses as presently conducted, except for delays in
filing reports or violations which would not reasonably be
expected, individually or in the aggregate, to have a CytRx
Material Adverse Effect.
Section 4.07 Material
Contracts; Compliance with Contracts. The
CytRx SEC Reports include a list of each contract to which CytRx
or any CytRx subsidiary is a party or by which CytRx or any
CytRx subsidiary or their respective assets are bound or
affected as of the date hereof which is required to be disclosed
in the CytRx SEC Reports (each, a CytRx Material
Contract). With respect to each CytRx Material
Contract (i) the CytRx Material Contract is legal, valid,
binding and enforceable and in full force and effect with
respect to CytRx or any CytRx
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subsidiary, subject to applicable bankruptcy, insolvency,
reorganization, moratorium and similar laws affecting
creditors rights and remedies generally, and subject, as
to enforceability, to general principles of equity, including
principles of commercial reasonableness, good faith and fair
dealing (regardless of whether enforcement is sought in a
proceeding at law or in equity) and (ii) neither CytRx nor
any CytRx subsidiary is in material breach or violation of or in
material default in the performance or observance of any term or
provision of, and, to the knowledge of CytRx, no event has
occurred which, with lapse of time or action by a third party,
would result in a default under, the Material Contract.
Section 4.08 Brokers
and Finders. CytRx has not entered into any
contract with any person that may result in the obligation of
CytRx to pay any investment banking fees, finders fees or
brokerage fees in connection with the transactions contemplated
hereby.
Section 4.09 No
Prior Activities of Merger Subsidiary. Except
for obligations incurred in connection with its incorporation or
organization and the negotiation, execution and consummation of
this Agreement and the transactions contemplated hereby, Merger
Subsidiary has neither incurred any obligation or liability nor
engaged in any business or activity of any type or kind
whatsoever or entered into any agreement or arrangement with any
person.
Section 4.10 Litigation;
Government Investigations. There are no
material claims, suits, actions, proceedings, arbitrations or
other actions pending or, to the knowledge of CytRx, threatened
against, relating to or affecting CytRx or any CytRx subsidiary,
before any court, governmental department, commission, agency,
instrumentality or authority, or any arbitrator. No material
investigation or review by any governmental or regulatory body
or authority is pending or, to the knowledge of CytRx,
threatened, nor has any governmental or regulatory body or
authority indicated an intention to conduct the same. Neither
CytRx nor any CytRx subsidiary is subject to any judgment,
decree, injunction, rule or order of any court, governmental
department, commission, agency, instrumentality or authority, or
any arbitrator, or any settlement agreement or stipulation,
which as of the date hereof prohibits the consummation of the
transactions contemplated hereby or would reasonably be
expected, individually or in the aggregate, to have a CytRx
Material Adverse Effect.
Section 4.11 Taxes.
(a) CytRx and each CytRx subsidiary has timely
(i) filed with the appropriate governmental authorities all
material Tax Returns (as defined in Section 5.12) required
to be filed by it, and such Tax Returns are true, correct and
complete in all material respects, and (ii) paid in full or
reserved in accordance with generally accepted accounting
principles on the CytRx Financial Statements all material Taxes
(as defined in Section 5.12) required to be paid. Neither
CytRx nor any CytRx subsidiary has requested an extension of
time within which to file a material Tax Return, which has not
been since filed, except that CytRx has requested an extension
of time within which to file its federal and California and
Massachusetts state income tax returns for 2007 and such Tax
Returns have not yet been filed. There are no liens for Taxes
upon any property or asset of CytRx or any CytRx subsidiary,
other than liens for Taxes not yet due and payable or Taxes
contested in good faith by appropriate proceedings or that are
otherwise not material and reserved against in accordance with
generally accepted accounting principles. No deficiency with
respect to Taxes has been proposed, asserted or assessed in
writing against CytRx or any CytRx subsidiary, which has not
been fully paid or adequately reserved or reflected in the CytRx
SEC Reports, and there are no material unresolved issues of law
or fact arising out of a written notice of a deficiency,
proposed deficiency or assessment from the Internal Revenue
Service or any other governmental taxing authority with respect
to Taxes of CytRx or any CytRx subsidiary. Neither CytRx nor any
CytRx subsidiary has agreed to an extension of time with respect
to a Tax deficiency, other than extensions which are no longer
in effect. Neither CytRx nor any CytRx subsidiary is a party to
any agreement providing for the allocation or sharing of Taxes
with any entity other than agreements the consequences of which
are fully and adequately reserved for in the CytRx Financial
Statements. Neither CytRx nor any CytRx subsidiary has been a
United States real property holding corporation within the
meaning of Code Section 897(c)(2) during the five-year
period ending on the date hereof.
(b) CytRx and each CytRx subsidiary has withheld or
collected and has paid over to the appropriate governmental
entities (or are properly holding for such payment) all Taxes
required to be collected or withheld, including with respect to
amounts paid or owed to any employee, independent contractor,
stockholder, or other third party.
A-10
ARTICLE V
REPRESENTATIONS AND WARRANTIES OF THE COMPANY
The Company represents and warrants to CytRx and Merger
Subsidiary that, except as set forth in (i) the Company SEC
Reports (as defined in Section 5.04) filed with the SEC
prior to the date hereof and (ii) the disclosure schedule
delivered to CytRx by the Company concurrently herewith (the
Company Disclosure Schedule), which shall be
arranged in sections corresponding to the numbered sections of
this Article V, it being agreed that disclosure of any item
on the Company Disclosure Schedule shall be deemed disclosure
with respect to all Sections of this Agreement if the relevance
of such item is reasonably apparent from the face of the Company
Disclosure Schedule:
Section 5.01 Organization
and Qualification. The Company is a
corporation duly organized, validly existing and in good
standing under the laws of the State of Delaware and has the
requisite corporate power and authority to own, lease and
operate its assets and properties and to carry on its business
as it is now being conducted. The Company is duly qualified and
licensed to transact business and is in good standing (with
respect to jurisdictions that recognize such concept) in each
jurisdiction in which the properties owned, leased or operated
by it or the nature of the business conducted by it makes such
qualification necessary, except where the failure to be so
organized, existing, qualified, licensed and in good standing
would not reasonably be expected to have a Company Material
Adverse Effect (as hereinafter defined). In this Agreement, the
term Company Material Adverse Effect means
any change, event, circumstance, development or occurrence
(other than an effect arising out of or resulting from the
entering into or the public announcement or disclosure of this
Agreement and the transactions contemplated hereby) that,
individually or in the aggregate, (i) has a material
adverse effect on the business, financial condition or ongoing
operations of the Company, or (ii) has a material adverse
effect on the Companys ability to consummate the Merger.
True, accurate and complete copies of the Companys
Certificate of Incorporation and Bylaws, in each case, as in
effect on the date hereof, including all amendments thereto,
have heretofore been made available to CytRx.
Section 5.02
Capitalization.
(a) The authorized capital stock of the Company consists of
75,000,000 shares of Company Common Stock and
10,000,000 shares of preferred stock, par value $0.001 per
share (Company Preferred Stock). As of
May 30, 2008, (i) 14,610,003 shares of Company
Common Stock were issued and outstanding, all of which shares
were duly authorized, validly issued, fully paid, nonassessable
and free of preemptive rights, (ii) no shares of Company
Preferred Stock were issued and outstanding,
(iii) 1,689,101 shares of Company Common Stock were
reserved for issuance upon exercise of outstanding stock options
(the Company Options), and
(iv) 3,559,309 shares of Company Common Stock were
reserved for issuance upon exercise of outstanding Warrants (the
Company Warrants). The outstanding shares of Company
Common Stock, the Company Options and the Company Warrants were
issued in compliance with all applicable securities laws. Since
May 30, 2008, except as permitted by this Agreement,
(i) no shares of capital stock of the Company have been
issued and (ii) no options, warrants or securities
convertible into, or commitments with respect to the issuance
of, shares of capital stock of the Company have been issued,
granted or made.
(b) Section 5.02(b) of the Company Disclosure Schedule
sets forth a complete and accurate list of all Company Stock
Plans and all holders of Company Options and Company Warrants,
indicating with respect to each Company Option and Company
Warrant, the number of shares of Company Common Stock subject to
such Company Option and Company Warrant, the exercise price, the
date of grant, and the expiration date thereof. The Company has
delivered or made available to CytRx accurate and complete
copies of all Company Stock Plans, the standard forms of stock
option agreement and warrant agreement evidencing Company
Options and Company Warrants, and any stock option agreements
and warrant agreements evidencing a Company Option or a Company
Warrant that deviates in any material manner from the
Companys standard forms of stock option agreement and
warrant agreement.
(c) Except for Company Options and Company Warrants, there
are no outstanding subscriptions, options, calls, contracts,
commitments, understandings, restrictions, arrangements, rights
or warrants, including any right of conversion or exchange under
any outstanding security, instrument or other agreement and also
including any rights plan or other anti-takeover agreement,
obligating the Company to issue, deliver or sell, or cause to be
issued, delivered or sold, additional shares of the capital
stock of the Company or obligating the Company to grant, extend
or enter into any such agreement or commitment. There are no
outstanding stock appreciation rights or similar
A-11
derivative securities or rights of the Company. There are no
voting trusts, irrevocable proxies or other agreements or
understandings to which the Company is a party or is bound with
respect to the voting of any shares of capital stock of the
Company.
(d) The Company has no subsidiaries.
Section 5.03
Authority; Non-Contravention; Approvals.
(a) The Company has the requisite corporate power and
authority to enter into this Agreement and, subject to the
Company Stockholders Approval (as defined in
Section 5.17), to perform its obligations hereunder and to
consummate the transactions contemplated hereby. The execution
and delivery of this Agreement and the consummation of the
transactions contemplated hereby have been duly authorized and
approved by the Board of Directors of the Company. No other
corporate proceedings on the part of the Company are necessary
to authorize the execution, delivery and performance of this
Agreement or, except for the Company Stockholders
Approval, the consummation by the Company of the transactions
contemplated hereby. This Agreement has been duly executed and
delivered by the Company, and, assuming with respect to this
Agreement the due authorization, execution and delivery hereof
by CytRx and Merger Subsidiary, constitutes a valid and legally
binding agreement of the Company, enforceable against the
Company in accordance with its terms, subject to applicable
bankruptcy, insolvency, reorganization, moratorium and similar
laws affecting creditors rights and remedies generally,
and subject, as to enforceability, to general principles of
equity, including principles of commercial reasonableness, good
faith and fair dealing (regardless of whether enforcement is
sought in a proceeding at law or in equity).
(b) The Company Board of Directors, at a meeting duly
called and held, has unanimously (i) approved and declared
advisable this Agreement and the Merger, and (ii) resolved
to recommend that stockholders of the Company adopt this
Agreement and approve the Merger.
(c) The execution, delivery and performance of this
Agreement by the Company and the consummation of the Merger and
the transactions contemplated hereby do not and will not
violate, conflict with or result in a breach of any provision
of, or constitute a default (or an event which, with notice or
lapse of time or both, would constitute a default) under, or
result in the termination of, or accelerate the performance
required by, or result in a right of termination or acceleration
under, contractually require any offer to purchase or any
prepayment of any debt, or result in the creation of any lien,
security interest or encumbrance upon any of the properties or
assets of the Company under any of the terms, conditions or
provisions of (i) the Certificate of Incorporation or the
Bylaws of the Company, (ii) any statute, law, ordinance,
rule, regulation, judgment, decree, order, injunction, writ,
permit or license of any court or governmental authority
applicable to the Company or any of its properties or assets,
subject, in the case of consummation, to obtaining (prior to the
Effective Time) the Company Required Statutory Approvals (as
defined in Section 5.03(d)) and the Company
Stockholders Approval, or (iii) any Contract to which
the Company is now a party or by which the Company or any of its
properties or assets may be bound or affected, other than, in
the case of clauses (ii) and (iii) of this paragraph
(b), such violations, conflicts, breaches, defaults,
terminations, accelerations, contractual requirements or
creations of liens, security interests or encumbrances that
would not reasonably be expected, individually or in the
aggregate, to have a Company Material Adverse Effect and would
not prevent or materially delay the consummation of the Merger.
(d) Except for (i) the filing with the SEC of the
Companys proxy statement relating to the Company
Stockholders Meeting (as defined in Section 6.07),
which also shall constitute the prospectus of CytRx with respect
to the shares of CytRx Common Stock to be issued as part of the
Merger Consideration (the Proxy
Statement/Prospectus), and other applicable filings
pursuant to the Exchange Act, and) the filing of the Certificate
of Merger with the Secretary of State in connection with the
Merger (collectively, the Company Required Statutory
Approvals), and no declaration, filing or registration
with, or notice to, or authorization, consent or approval of,
any governmental or regulatory body or authority is necessary
for the execution and delivery of this Agreement by the Company
or the consummation by the Company of the transactions
contemplated hereby, other than such declarations, filings,
registrations, notices, authorizations, consents or approvals
which, if not made or obtained, as the case may be, would not
reasonably be expected, individually or in the aggregate, to
have a Company Material Adverse Effect and would not prevent or
materially delay the consummation of the Merger.
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Section 5.04 Reports
and Financial Statements.
(a) Since January 1, 2007, the Company has filed with
the SEC all material forms, statements, reports and documents,
including all exhibits, post-effective amendments and
supplements thereto (the Company SEC Reports),
required to be filed by it under each of the Securities Act, the
Exchange Act and the respective rules and regulations
thereunder, all of which, as amended if applicable, complied
when filed, or amended, in all material respects with all
applicable requirements of the appropriate act and the rules and
regulations thereunder. As of their respective dates, the
Company SEC Reports filed did not contain any untrue statement
of a material fact or omit to state a material fact required to
be stated therein or necessary to make the statements therein,
in light of the circumstances under which they were made, not
misleading, except to the extent corrected by a subsequently
filed Company SEC Report filed with the SEC prior to the date
hereof.
(b) The financial statements of the Company included in the
Companys SEC Reports (collectively, the Company
Financial Statements) were prepared in accordance with
generally accepted accounting principles (except, with respect
to any unaudited financial statements, as permitted by
applicable SEC rules or requirements) applied on a consistent
basis (except as may be indicated therein or in the notes
thereto) and fairly present in all material respects the
financial position of the Company as of the dates thereof and
the results of operations and changes in financial position of
the Company for the periods then ended (subject in the case of
any unaudited interim financial statements, to normal year-end
adjustments).
Section 5.05
Sarbanes-Oxley Act; Internal Accounting
Controls. The Company is in material
compliance with all applicable provisions of the Sarbanes-Oxley
Act of 2002. The Company maintains a system of internal
accounting controls sufficient to provide reasonable assurance
that (i) transactions are executed in accordance with
managements general or specific authorizations,
(ii) access to assets is permitted only in accordance with
managements general or specific authorization, and
(iii) the recorded accountability for assets is compared
with the existing assets at reasonable intervals and appropriate
action is taken with respect to any differences. The
Companys certifying officers have evaluated the
effectiveness of its controls and procedures as of the date
(such date, the Evaluation Date) prior to the
filing date of the most recently filed periodic report under the
Exchange Act. The Company presented in its most recently filed
periodic report under the Exchange Act the conclusions of the
certifying officers about the effectiveness of the disclosure
controls and procedures based on their evaluations as of the
Evaluation Date. Since the Evaluation Date, there have been no
significant changes in the Companys internal controls or,
to the Companys knowledge, in other factors that could
adversely affect the Companys internal controls.
Section 5.06
Liabilities.
(a) The Company had at March 31, 2008, and has
incurred since that date and as of the date hereof, no
liabilities or obligations (whether absolute, accrued,
contingent or otherwise) of any nature, except
(a) liabilities, obligations or contingencies
(i) which are accrued or reserved against in the Company
Financial Statements or reflected in the notes thereto or
(ii) which were incurred after March 31, 2008 in the
ordinary course of business and consistent with past practices,
(b) liabilities, obligations or contingencies which
(i) would not reasonably be expected, individually or in
the aggregate, to have a Company Material Adverse Effect, or
(ii) have been discharged or paid in full prior to the date
hereof in the ordinary course of business, and
(c) liabilities, obligations and contingencies which are of
a nature not required to be reflected in the financial
statements of the Company prepared in accordance with generally
accepted accounting principles consistently applied.
(b) Section 5.06(b) of the Company Disclosure Schedule
sets forth the Companys best estimate of the Net
Liabilities (as defined below) of the Company as of the date of
this Agreement (the Estimated Net
Liabilities). For purposes of this Agreement, the term
Net Liabilities means Liabilities (as defined
below) less the sum of all cash and equivalents and deposits of
the Company. For purposes of this Agreement, the term
Liabilities means all direct and indirect
liabilities, indebtedness, obligations, commitments, claims,
deficiencies, expenses, deferred income, guaranties and
endorsements of any type, whether known, unknown, accrued,
absolute, contingent, matured or unmatured, of the sort which
would be reflected on a balance sheet of the Company prepared in
accordance with generally accepted accounting principles applied
on a basis consistent with the Company Financial Statements.
A-13
Section 5.07
Absence of Certain Changes or Events. Since
December 31, 2007, (a) except with respect to the
transactions contemplated by this Agreement, the Company has
carried on and operated its businesses in all material respects
in the ordinary course of business and (b) there have not
been any changes, events, circumstances, developments or
occurrences that would reasonably be expected to have a Company
Material Adverse Effect.
Section 5.08 Litigation;
Government Investigations. There are no
material claims, suits, actions, proceedings, arbitrations or
other actions pending or, to the knowledge of the Company,
threatened against, relating to or affecting the Company, before
any court, governmental department, commission, agency,
instrumentality or authority, or any arbitrator. No material
investigation or review by any governmental or regulatory body
or authority is pending or, to the knowledge of the Company,
threatened, nor has any governmental or regulatory body or
authority indicated an intention to conduct the same. The
Company is not subject to any judgment, decree, injunction, rule
or order of any court, governmental department, commission,
agency, instrumentality or authority, or any arbitrator, or any
settlement agreement or stipulation, which as of the date hereof
prohibits the consummation of the transactions contemplated
hereby or would reasonably be expected, individually or in the
aggregate, to have a Company Material Adverse Effect.
Section 5.09
Proxy Statement/Prospectus. None of the
information to be supplied by the Company or its stockholders
for inclusion in the Proxy Statement/Prospectus will, at the
time of the mailing thereof or any amendments or supplements
thereto, or at the time of the Company Stockholders
Meeting, contain any untrue statement of a material fact or omit
to state any material fact required to be stated therein or
necessary in order to make the statements therein, in light of
the circumstances under which they are made, not misleading. The
Proxy Statement/Prospectus will comply, as of its mailing
date, as to form in all material respects with all applicable
laws, including the provisions of the Exchange Act and the rules
and regulations promulgated thereunder, except that no
representation is made by the Company with respect to
information supplied by CytRx or Merger Subsidiary for inclusion
therein.
Section 5.10 No
Violation of Law. The Company is not in
violation of and has not been given written (or, to the
knowledge of the Company, oral) notice of any violation of any
law, statute, order, rule, regulation, ordinance or judgment of
any governmental or regulatory body or authority, except for
violations which would not reasonably be expected, individually
or in the aggregate, to have a Company Material Adverse Effect.
The Company is not in violation of the terms of any permits,
licenses, franchises, variances, exemptions, orders and other
governmental authorizations, consents and approvals necessary to
conduct their businesses as presently conducted, except for
delays in filing reports or violations which would not
reasonably be expected, individually or in the aggregate, to
have a Company Material Adverse Effect.
Section 5.11 Material
Contracts; Compliance with Contracts.
(a) The Company SEC Reports include a list of each
contract, agreement, license, arrangement or understanding to
which the Company is a party or by which the Company or its
assets are bound or affected as of the date hereof (each, a
Material Contract):
(i) which is required to be disclosed in the Company SEC
Reports;
(ii) pursuant to which payments are required or
acceleration of benefits is required upon a change of control of
the Company or similar event;
(iii) which is material to the Companys assets,
including the Company Intellectual Property and Company
Technology (as those terms are defined in Section 5.18), or
business and which requires the consent or waiver of a third
party prior to the Company consummating the transactions
contemplated hereby; or
(iv) which relates to (A) any acquisition by or from
the Company, or any grant by or to the Company, of any right,
title or interest in, under or to any Intellectual Property (as
defined in Section 5.18), including Intellectual Property
Licenses (as defined in Section 5.18), contracts,
agreements, arrangements or understandings or (B) any
covenant not to sue granted by the Company to any person or
granted by any person to the Company for the benefit of the
Company, with respect to any Intellectual Property, all of which
Intellectual
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Property in clauses (A) and (B) is material to the
Company, other than standardized nonexclusive licenses obtained
by the Company in the ordinary course of business.
(b) With respect to each Material Contract (i) the
Material Contract is legal, valid, binding and enforceable and
in full force and effect with respect to the Company, subject to
applicable bankruptcy, insolvency, reorganization, moratorium
and similar laws affecting creditors rights and remedies
generally, and subject, as to enforceability, to general
principles of equity, including principles of commercial
reasonableness, good faith and fair dealing (regardless of
whether enforcement is sought in a proceeding at law or in
equity) and (ii) the Company is not in material breach or
violation of or in material default in the performance or
observance of any term or provision of, and, to the knowledge of
the Company, no event has occurred which, with lapse of time or
action by a third party, would result in a default under, the
Material Contract.
Section 5.12 Taxes.
(a) The Company has timely (i) filed with the
appropriate governmental authorities all material Tax Returns
(as defined below) required to be filed by it, and such Tax
Returns are true, correct and complete in all material respects,
and (ii) paid in full or reserved in accordance with
generally accepted accounting principles on the Company
Financial Statements all material Taxes (as defined below)
required to be paid. The Company has not requested an extension
of time within which to file a material Tax Return, which has
not been since filed. There are no liens for Taxes upon any
property or asset of the Company, other than liens for Taxes not
yet due and payable or Taxes contested in good faith by
appropriate proceedings or that are otherwise not material and
reserved against in accordance with generally accepted
accounting principles. No deficiency with respect to Taxes has
been proposed, asserted or assessed in writing against the
Company, which has not been fully paid or adequately reserved or
reflected in the Company SEC Reports, and there are no material
unresolved issues of law or fact arising out of a written notice
of a deficiency, proposed deficiency or assessment from the
Internal Revenue Service or any other governmental taxing
authority with respect to Taxes of the Company. The Company has
not agreed to an extension of time with respect to a Tax
deficiency, other than extensions which are no longer in effect.
The Company is not a party to any agreement providing for the
allocation or sharing of Taxes with any entity other than
agreements the consequences of which are fully and adequately
reserved for in the Company Financial Statements. The Company
has not been a United States real property holding corporation
within the meaning of Code Section 897(c)(2) during the
five-year period ending on the date hereof.
(b) The Company has withheld or collected and has paid over
to the appropriate governmental entities (or are properly
holding for such payment) all Taxes required to be collected or
withheld, including with respect to amounts paid or owed to any
employee, independent contractor, stockholder, or other third
party.
(c) For purposes of this Agreement, Tax
(including, with correlative meaning, the terms
Taxes) means all federal, state, local and
foreign taxes, charges, fees, imposts, levies or other
assessments, including all net income, profits, franchise, gross
receipts, environmental, customs duty, capital stock,
communications services, severance, stamp, payroll, sales,
employment, unemployment, disability, social security,
occupation, use, property, withholding, excise, production,
value added, occupancy, capital, ad valorem, transfer,
inventory, license, customs duties, fees, assessments and
charges of any kind whatsoever and other taxes, duties or
assessments of any nature whatsoever, together with all
interest, penalties, fines and additions imposed with respect to
such amounts and any interest in respect of such penalties and
additions, and includes any liability for Taxes of another
person by contract, as a transferee or successor, under Treas.
Reg.
Section 1.1502-6
or analogous state, local or foreign law provision or otherwise,
and Tax Return means any return, report, claim for
refund, estimate, information return or statement or other
similar document (including attached schedules) relating to or
required to be filed with respect to any Tax, including, any
information return, claim for refund, amended return or
declaration of estimated Tax.
Section 5.13 Employee
Benefit Plans; ERISA; Employment Agreements.
(a) The Company SEC Reports set forth or refer to each
employee or director benefit plan, arrangement or agreement
(other than immaterial plans, arrangements or agreements),
including any (i) employment agreement or indemnification
agreement, as well as (ii) any employee welfare benefit
plan within the meaning of Section 3(1) of the Employee
Retirement Income Security Act of 1974, as amended
(ERISA), any employee pension benefit plan
within the meaning of Section 3(2) of ERISA (whether or not
such plan is subject to ERISA), or bonus, incentive,
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deferred compensation, vacation, stock purchase, stock option,
severance, employment, change of control or fringe benefit plan,
program or agreement (excluding any multi-employer plans as
defined in Section 3(37) of ERISA (a
Multi-employer Plan)) and any multiple
employer plan within the meaning of Section 413(c) of the
Code) that is sponsored, maintained or contributed to by the
Company or by any trade or business, whether or not
incorporated, all of which together with the Company would be
deemed a single employer within the meaning
of Section 4001 of ERISA, or with respect to which the
Company or any such trade or business has any liability (the
Company Plans).
(b) (i) There have been no prohibited transactions
within the meaning of Section 406 or 407 of ERISA or
Section 4975 of the Code with respect to any of the Company
Plans that could result in penalties, taxes or liabilities which
would reasonably be expected to have a Company Material Adverse
Effect, (ii) no Company Plan is subject to Title IV of
ERISA, (iii) each of the Company Plans has been operated
and administered in accordance with applicable laws during the
period of time covered by the applicable statute of limitations,
except for failures to comply which would not reasonably be
expected, individually or in the aggregate, to have a Company
Material Adverse Effect, (iv) each of the Company Plans
which is intended to be qualified within the
meaning of Section 401(a) of the Code has been the subject
of a favorable determination letter from the IRS or other IRS
letter to the same effect and such letter has not been revoked
by failure to satisfy any condition thereof or by a subsequent
amendment thereto or a failure to amend, except that it may be
necessary to make additional amendments retroactively to
maintain the qualified status of such Company
Plans, and the period for making any such necessary retroactive
amendments has not expired, (v) to the knowledge of the
Company, there are no pending or threatened claims involving any
of the Company Plans other than claims for benefits in the
ordinary course or claims which would not reasonably be
expected, individually or in the aggregate, to have a Company
Material Adverse Effect, (vi) no Company Plan provides
post-retirement medical benefits to employees or directors of
the Company beyond their retirement or other termination of
service, other than coverage mandated by applicable law,
(vii) all material contributions or other amounts payable
by the Company as of the date hereof with respect to each
Company Plan in respect of current or prior plan years have been
paid or accrued in accordance with generally accepted accounting
principles, (viii) with respect to each Multi-employer Plan
contributed to by the Company, to the knowledge of the Company,
as of the date hereof, the Company has not received any
notification that any such Multi-employer Plan is in
reorganization, has been terminated or is insolvent,
(ix) the Company has complied in all respects with the
Worker Adjustment and Retraining Notification Act, except for
failures which would not reasonably be expected, individually or
in the aggregate, to have a Company Material Adverse Effect, and
(x) no act, omission or transaction has occurred with
respect to any Company Plan that has resulted or could result in
any liability of the Company under Section 409, 502(c) or
502(l) of ERISA or Chapter 43 of Subtitle (A) of the
Code, except for liabilities which would not reasonably be
expected, individually or in the aggregate, to have a Company
Material Adverse Effect.
(c) Neither the execution and delivery of this Agreement
nor the consummation of the transactions contemplated hereby
will, or could reasonably be expected to, (i) result in any
material payment (including severance or excess
parachute payment (within the meaning of
Section 280G of the Code)) becoming due to any director or
employee of the Company under any Company Plan or any Material
Contract, (ii) materially increase any benefits otherwise
payable under any Company Plan or (iii) result in any
acceleration of the time of payment or vesting of any such
benefits.
(d) The Company is not a party to or bound by any
employment, consulting, termination, severance or similar
agreement with any individual officer, director or employee of
the Company or any agreement pursuant to which any such person
is entitled to receive any benefits from the Company upon the
occurrence of a change in control of the Company or similar
event.
Section 5.14 Labor
Controversies. [Intentionally Omitted]
Section 5.15
Environmental Matters. [Intentionally Omitted]
Section 5.16
Title to Assets. The Company has good title
to all its leasehold interests and other properties, as
reflected in the most recent balance sheet included in the
Company Financial Statements, except for properties and assets
that have been disposed of in the ordinary course of business
since the date of such balance sheet, free and clear of all
mortgages, liens, pledges, charges or encumbrances of any nature
whatsoever, except (i) liens for current
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Taxes, payments of which are not yet delinquent or are being
disputed in good faith by appropriate proceedings and
(ii) such imperfections in title and easements and
encumbrances, if any, as are not substantial in character,
amount or extent and do not materially detract from the value,
or interfere with the present use of the property subject
thereto or affected thereby, or otherwise impair the
Companys assets, business or operations. With respect to
real property leased by the Company, the Company is entitled to
and has exclusive possession of such leased properties, and the
leased properties are not subject to any other legally binding
lease, tenancy, license or easement of any kind that materially
interferes with the Companys use of the leased properties
as currently used. To the knowledge of the Company, all leases
under which the Company leases any real or personal property are
in good standing, valid and effective in accordance with their
respective terms, and, to the knowledge of the Company, there is
not, under any of such leases, any existing default or event
which with notice or lapse of time or both would become a
default other than failures to be in good standing, valid and
effective and defaults under such leases which would not
reasonably be expected, individually or in the aggregate, to
have a Company Material Adverse Effect.
Section 5.17 Company
Stockholders Approval. The only vote or
approval of the holders of any class or series of capital stock
of the Company required for approval of this Agreement or the
Merger is the affirmative vote of the holders of a majority of
the outstanding shares of Company Common Stock entitled to vote
thereon (the Company Stockholders
Approval). There are no bonds, debentures, notes or
other indebtedness of the Company having the right to vote (or
convertible into, or exchangeable for, securities having the
right to vote) on any matters on which stockholders of the
Company may vote.
Section 5.18 Intellectual
Property.
(a) As used in this Agreement, the following capitalized
terms have the meanings indicated below.
(i) Company Intellectual Property
means all Intellectual Property (as defined below) used in or
necessary for the conduct of the business of the Company, or
owned or held for use by the Company;
(ii) Company Technology means all
Technology (as defined below) used in or necessary for the
conduct of the business of the Company, or owned or held for use
by the Company;
(iii) Intellectual Property means
all intellectual property rights and related priority rights,
arising from or in respect of the following, whether protected,
created or arising under the laws of the United States or any
other jurisdiction or under any international convention,
including: (A) all patents and patent applications
worldwide, including all continuations, divisionals,
continuations-in-part
and provisionals and patents issuing thereon, and all reissues,
reexaminations, substitutions, renewals and extensions thereof
(collectively, Patents); (B) all trademarks,
service marks, trade names, trade dress, logos, corporate names
and other source or business identifiers, together with the
goodwill associated with any of the foregoing, and all
applications, registrations, renewals and extensions thereof
(collectively, Marks); (C) all Internet
domain names; (D) all copyrights, works of authorship and
moral rights, and all registrations, applications, renewals,
extensions and reversions thereof (collectively,
Copyrights); (E) all Registrations (as defined
below); and (F) all confidential and proprietary
information or non-public discoveries, concepts, ideas, research
and development, technology, know-how, formulae, inventions,
trade secrets, compositions, processes, techniques, technical
data and information, procedures, designs, drawings,
specifications, databases, customer lists, supplier lists,
pricing and cost information, and business and marketing plans
and proposals, in each case excluding any rights in respect of
any of the foregoing that comprise or are protected by Patents
(collectively, Trade Secrets);
(iv) Intellectual Property
License means (A) any grant by the Company to
another person of any license, sublicense, right, permission,
consent or non-assertion relating to or under any Company
Intellectual Property
and/or
Company Technology; and (B) any grant by another person to
the Company of any license, sublicense, right, permission,
consent or non-assertion relating to or under any Intellectual
Property
and/or
Technology, including the Company License Agreements;
(v) Registrations means any and
all applications, registrations, licenses, authorizations and
approvals submitted to the FDA or to an analogous regulatory
authority anywhere outside of the
U.S. (Ex-U.S. Authority), all
material correspondence submitted to or received from the FDA or
an Ex-U.S. Authority (including material minutes and
official contact reports relating to any communications with the
FDA or Ex-U.S. Authority) and all
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material supporting documentation and all clinical studies and
material tests relating to Company Intellectual Property, and
all material data contained in any of the foregoing, including
any of the following filed with the FDA or
Ex-U.S. Authority, including all analogous submissions
filed outside of the U.S.: (A) all INDs and NDAs filed with
the FDA; and (B) all marketing authorizations, regulatory
drug lists, adverse event files, complaint files and material
manufacturing records generated under or in connection with
Company Intellectual Property that are held or beneficially
owned by the Company, which are set forth in
Section 5.18(b) of the Company Disclosure Schedule, as well
as the information contained therein together with the
pertaining registration dossiers;
(vi) Software means any and all:
(A) computer programs, including any and all software
implementations of algorithms, models and methodologies, whether
in source code or object code; (B) databases and
compilations, including any and all data and collections of
data, whether machine readable or otherwise;
(C) descriptions, flow-charts and other work product used
to design, plan, organize and develop any of the foregoing, and
screens, user interfaces, report formats, firmware, development
tools, templates, menus, buttons and icons; and (D) all
documentation, including user manuals and other training
documentation, related to any of the foregoing; and
(vii) Technology means all
Software, information, designs, formulae, algorithms,
procedures, methods, techniques, ideas, know-how, research and
development, technical data, programs, subroutines, tools,
materials, specifications, processes, inventions (whether
patentable or unpatentable and whether or not reduced to
practice), apparatus, creations, improvements and other similar
materials, and all recordings, graphs, drawings, reports,
analyses, and other writings, and other embodiments of any of
the foregoing, in any form or media whether or not specifically
listed herein, and all related technology used in, incorporated
in, embodied in, displayed by or related to, or used in
connection with, any of the foregoing.
(b) Section 5.18(b) of the Company Disclosure
Schedules sets forth an accurate and complete list of the
following Company Intellectual Property: all issued Patents and
pending Patent applications; registered Marks; pending
applications for registration of Marks and material unregistered
Marks; registered Copyrights; Internet domain names owned or
filed by the Company or any of its subsidiaries; Registrations
owned by the Company or to which the Company has rights of use
or reference, in whole or in part. Section 5.18(b) of the
Company Disclosure Schedules also lists (i) the record
owner of each such item of Intellectual Property and
(ii) the jurisdictions in which each such item of
Intellectual Property has been issued or registered or in which
any such application for issuance or registration has been filed.
(c) The Company is the sole and exclusive owner of, or has
valid and continuing rights to use, sell, license and otherwise
commercially exploit, as the case may be, all Company
Intellectual Property, Company Technology and Intellectual
Property licensed to the Company under the Intellectual Property
Licenses as the same is used, sold, licensed and otherwise
commercially exploited by the Company in its business as
presently conducted or proposed to be conducted, free and clear
of all liens, claims, encumbrances and security interests. The
Company Intellectual Property, the Company Technology and the
Intellectual Property licensed to the Company under the
Intellectual Property Licenses include all of the Intellectual
Property and Technology necessary and sufficient to enable the
Company to conduct its business in the manner in which it is
currently being conducted or proposed to be conducted. The
Company owns no proprietary Software.
(d) The Company Intellectual Property, the Company
Technology, the development, manufacturing, licensing,
marketing, importation, offer for sale, sale or use of any
products and services in connection with the business as
presently conducted or proposed to be conducted, and the present
business practices, methods and operations of the Company do
not, to the knowledge of the Company, infringe, dilute,
constitute an unauthorized use or misappropriation of, or
violate any Intellectual Property, Technology or other right of
any person. To the knowledge of the Company, no person is
infringing, diluting, violating, misusing or misappropriating
any Company Intellectual Property or Company Technology, and no
claims of infringement, dilution, violation, misuse or
misappropriation of any Company Intellectual Property or Company
Technology have been made against any person by the Company.
(e) The Company has taken reasonable security measures to
protect the confidentiality and value of all Trade Secrets and
any other material non-public, proprietary information of the
Company (and any confidential information owned by a third
person to whom the Company has a confidentiality obligation)
which measures
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are reasonable in the industry in which the business operates.
Each Company employee, consultant and independent contractor
involved in the creation or development of any products,
services, Intellectual Property or Technology related to the
business of the Company has entered into a written
non-disclosure and invention assignment agreement with the
Company in a form provided to CytRx prior to the date hereof.
(f) As of the date hereof, the Company is not the subject
of any pending or, to the knowledge of the Company, threatened
legal proceedings that involve a claim by any person against the
Company of infringement, unauthorized use, misappropriation,
dilution or violation of any Intellectual Property, or that
challenges the ownership, use, validity or enforceability of any
Company Intellectual Property, Company Technology or
Intellectual Property licensed to the Company under any of the
Intellectual Property Licenses. The Company has not received
oral or written notice of any such threatened claim. The Company
Intellectual Property and the Company Technology, and all of the
Companys rights in and to the Company Intellectual
Property, the Company Technology and the Intellectual Property
licensed to the Company under the Intellectual Property
Licenses, to the knowledge of the Company, are valid and
enforceable.
(g) The consummation of the transactions contemplated
hereby will not result in the loss or impairment of the
Surviving Corporations right to own or use any of the
Company Intellectual Property, the Company Technology or any
Intellectual Property licensed to the Company under the
Intellectual Property Licenses. Neither this Agreement nor any
transaction contemplated by this Agreement will result in the
grant of any license or other rights with respect to any Company
Intellectual Property, Company Technology or Intellectual
Property licensed to the Company under the Intellectual Property
Licenses to any third person pursuant to any Contract to which
the Company is a party or by which any assets or properties of
the Company is bound.
(h) The data and information in all regulatory filings and
submissions by the Company to any regulatory agency, department,
bureau or other government entity (collectively,
Regulatory Filings) were and are accurate and
reliable for purposes of supporting approval of the Regulatory
Filings.
(i) The Company has, prior to the date hereof, provided to
CytRx copies of all of the Companys Regulatory Filings and
correspondence between the Company, its employees, agents or
representatives, on the one hand, and the U.S. Food and
Drug Administration or any other governmental or regulatory
bodies or authorities in any state, country, territory or group
of countries (including the European Union) (each of the
foregoing a Governmental Health Authority),
on the other hand.
(j) No clinical trial that the Company has applied for,
sought, proposed or commenced has been placed on clinical hold
by any Governmental Health Authority or any institutional review
board.
(k) No Governmental Health Authority has informed the
Company of any unresolved issues regarding any of Companys
product candidates.
Section 5.19 Insurance. Section 5.19
of the Company Disclosure Schedule sets forth each insurance
policy maintained by the Company and its subsidiaries as of the
date hereof and each general liability, umbrella and excess
liability policy currently maintained by the Company (each, an
Insurance Policy). Each Insurance Policy is
in full force and effect with respect to the period covered and
is valid, outstanding and enforceable, and all premiums or
installment payments of premiums, as applicable, due thereon
have been paid in full. No insurer under any Insurance Policy
has canceled or generally disclaimed liability under any such
policy or, to the knowledge of the Company, indicated any intent
to do so or not to renew any such policy. To the knowledge of
the Company, all material claims under the Insurance Policies
have been filed in a timely fashion.
Section 5.20 Certain
Payments. The Company has not, nor to the
knowledge of the Company, has any director, officer, agent or
employee of the Company, or any other person, directly or
indirectly, made any contribution, gift, bribe, rebate, payoff,
influence payment, kickback or other payment to any entity or
person, private or public, regardless of form, whether in money,
property or services, in material violation of any applicable
law.
Section 5.21 Brokers
and Finders. The Company has not entered into
any contract with any person that may result in the obligation
of the Company or the Surviving Corporation to pay any
investment banking fees, finders fees or brokerage fees in
connection with the transactions contemplated hereby, other than
fees payable to
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Chartered Capital Advisers, Inc. (the Company Financial
Advisor). A true, correct and complete copy of the fee
agreement with the Company Financial Advisor has been made
available to CytRx, and the Company has provided to CytRx a
true, correct and complete copy of any and all other engagement
or retention agreements with outside legal counsel, financial
advisors or other advisors, to which the Company is a party and
which are related to the transactions contemplated hereby.
Section 5.22 Opinion
of Financial Advisor. The Board of Directors
of the Company has received the signed opinion of Company
Financial Advisor, dated the date of this Agreement (the
Financial Advisor Opinion), to the effect
that, as of such date, and subject to customary assumptions and
qualifications set forth therein, the consideration to be
received by the Companys stockholders in the Merger is
fair to such stockholders from a financial point of view. A true
and complete copy of such Financial Advisor Opinion has been
furnished for informational purposes only to CytRx, and such
Financial Advisor Opinion has not been withdrawn, revoked or
modified.
ARTICLE VI
COVENANTS
Section 6.01 Conduct
of Business by the Company Pending the
Merger. Except as otherwise contemplated by
this Agreement or disclosed in the Company Disclosure Schedule,
after the date hereof and until the Effective Time or earlier
termination of this Agreement, unless CytRx shall otherwise
agree in writing (which agreement shall not be unreasonably
withheld or delayed), the Company shall:
(a) conduct its business in the ordinary course of business
consistent with past practice;
(b) consult with CytRx, in advance, regarding the conduct
and management of the Companys clinical trials and other
development activities;
(c) use its commercially reasonable efforts to mitigate or
compromise the Liabilities of the Company from time to time;
(d) not (i) amend or propose to amend its Certificate
of Incorporation or its Bylaws, (ii) split, combine,
subdivide or reclassify any shares of outstanding capital stock,
(iii) declare, set aside or pay any dividend or
distribution payable in cash, stock, property or otherwise, or
make any other distribution in respect of any shares of its
capital stock, or (iv) repurchase, redeem or otherwise
acquire, or modify or amend, any shares of its capital stock or
any other securities or any rights, warrants or options to
acquire any such shares or other securities;
(e) not issue, sell, pledge, grant or dispose of, or agree
to issue, sell, pledge, grant or dispose of, any additional
shares of, or any options, warrants or rights of any kind to
acquire any shares of, its capital stock of any class or any
debt or equity securities convertible into or exchangeable for
its capital stock, except that the Company may issue shares upon
the exercise of Company Warrants outstanding on the date hereof;
(f) not (i) incur or become contingently liable with
respect to any indebtedness for borrowed money,
(ii) redeem, purchase, acquire or offer to purchase or
acquire any shares of its capital stock or any options, warrants
or rights to acquire any of its capital stock or any security
convertible into or exchangeable for its capital stock,
(iii) make any acquisition of any capital stock, assets or
businesses of any other person other than expenditures for
current assets in the ordinary course of business consistent
with past practice and expenditures for fixed or capital assets
in the ordinary course of business consistent with past
practice, (iv) sell, pledge, dispose of or encumber any
assets or businesses that are material to the Company, except
(A) sales, leases, rentals and licenses in the ordinary
course of business consistent with past practice,
(B) pursuant to contracts that are in force at the date of
this Agreement and are disclosed in the Company Disclosure
Schedules hereto, (C) dispositions of obsolete or worthless
assets or, or (v) enter into any contract with respect to
any of the foregoing;
(g) use all reasonable efforts to preserve intact its
business organization and goodwill, keep available the services
of its present officers and key employees, and preserve the
goodwill and business relationships with
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customers and others having business relationships with them,
other than as expressly permitted by the terms of this Agreement;
(h) not enter into, amend, modify or renew any employment,
consulting, severance or similar contract with, pay any bonus or
grant any increase in salary, wage or other compensation or any
increase in any employee benefit to, any directors, officers or
employees of the Company, except in each such case (i) as
may be required by applicable law or (ii) to satisfy
obligations existing as of the date hereof pursuant to the terms
of contracts that are in effect on the date hereof;
(i) not enter into, establish, adopt, amend or modify any
pension, retirement, stock purchase, savings, profit sharing,
deferred compensation, consulting, bonus, group insurance or
other employee benefit, incentive or welfare plan, agreement,
program or arrangement, in respect of any directors, officers or
employees of the Company, except, in each such case (i) as
may be required by applicable law or pursuant to the terms of
this Agreement or (ii) to satisfy obligations existing as
of the date hereof pursuant to the terms of contracts that are
in effect on the date hereof;
(j) except to the extent required under existing employee
and director benefit plans, agreements or arrangements as in
effect on the date hereof or as expressly provided by this
Agreement, not accelerate the payment, right to payment or
vesting of any bonus, severance, profit sharing, retirement,
deferred compensation, stock option, insurance or other
compensation or benefits;
(k) not make capital expenditures or enter into any binding
commitment or contract to make capital expenditures, except
(i) capital expenditures which the Company or its
subsidiaries are currently committed to make, (ii) capital
expenditures consistent with the estimated amounts disclosed in
the Company SEC Reports, (iii) capital expenditures for
emergency repairs and other capital expenditures necessary in
light of circumstances not anticipated as of the date of this
Agreement which are necessary to avoid significant disruption to
the Companys business or operations consistent with past
practice (and, if reasonably practicable, after consultation
with CytRx), and (iv) repairs and maintenance in the
ordinary course of business;
(l) not make, change or revoke any material Tax election
unless required by law or make any agreement or settlement with
any taxing authority regarding any material amount of Taxes or
which would reasonably be expected to materially increase the
obligations of the Company or the Surviving Corporation to pay
Taxes in the future;
(m) not make any changes in financial or Tax accounting
methods, principles or practices (or change an annual accounting
period), except insofar as may be required by a change in
generally accepted accounting principles or applicable law;
(n) not adopt a plan or agreement of complete or partial
liquidation or dissolution;
(o) not pay, discharge or satisfy any material claims,
material liabilities or material obligations (absolute, accrued,
asserted or unasserted, contingent or otherwise), other than the
payment, discharge or satisfaction (A) of any such material
claims, material liabilities or material obligations in the
ordinary course of business consistent with past practice or
(B) of material claims, material liabilities or material
obligations reflected or reserved against in, or contemplated
by, the financial statements (or the notes thereto) contained in
the Company SEC Reports;
(p) not agree to the settlement of any claim, litigation,
investigation or other action that is material to the Company;
(q) not enter into any contract that restrains, limits or
impedes the ability of the Company or the Surviving Corporation
to compete with or conduct any business or line of business,
including geographic limitations on the activities of the
Company;
(r) not materially modify or amend, or terminate any
Material Contract, or waive, relinquish, release or terminate
any material right or material claim, or enter into any contract
that would have been a Material Contract if it had been in
existence at the time of the execution of this Agreement;
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(s) not incur transaction costs and expenses in connection
with this Agreement and the transactions contemplated hereby,
including, without limitation, legal, accounting and financial
advisory fees, including fees payable to the Company Financial
Advisor but excluding fees payable to Ropes & Gray LLP
(collectively, Transaction Costs), in excess
of $200,000 in the aggregate; and
(t) not agree to take any of the foregoing actions.
Section 6.02 Conduct
of Business by CytRx Pending the
Merger. Except as otherwise contemplated by
this Agreement or disclosed in the CytRx Disclosure Schedule,
after the date hereof and until the Effective Time or earlier
termination of this Agreement, unless the Company shall
otherwise agree in writing (which agreement shall not be
unreasonably withheld or delayed), CytRx shall:
(a) conducts its business in the ordinary course of
business consistent with past practice;
(b) not (i) amend or propose to amend its Amended and
Restated Certificate of Incorporation or its Bylaws,
(ii) split, combine, subdivide or reclassify any shares of
CytRx Common Stock or (iii) declare, set aside or pay any
dividend or distribution payable in cash, stock, property or
otherwise, or make any other distribution in respect of any
shares of CytRx Common Stock;
(c) use all reasonable efforts to preserve intact its
business organization and goodwill, keep available the services
of it present officers and key employees, and preserve the
goodwill and business relationships with customers and others
having business relationships with it, other than as expressly
permitted by the terms of this Agreement;
(d) not make any changes in financial or Tax accounting
methods, principles or practices (or change an annual accounting
period), except insofar as may be required by a change in
generally accepted accounting principles or applicable law;
(e) not adopt a plan or agreement of complete or partial
liquidation or dissolution; and
(f) not agree to take any of the foregoing actions.
Section 6.03 Acquisition
Proposals.
(a) After the date hereof and until the Effective Time or
earlier termination of this Agreement, the Company shall, and
shall cause its directors, officers and investment bankers,
attorneys, accountants, financial advisors and other advisors,
agents or representatives (collectively,
Representatives) to, (i) cease any
discussions or negotiations that may be ongoing as of the date
of this Agreement with any person with respect to an Acquisition
Transaction (as defined below), (ii) request the prompt
return or destruction of all confidential information relating
to the Company previously furnished to such person and
(iii) furnish CytRx with such information as it may request
with respect to any recent discussions or negotiations with any
person with regard to an Acquisition Proposal.
(b) After the date hereof and until the Effective Time or
earlier termination of this Agreement, the Company shall not,
and shall not permit any of its Representatives to, directly or
indirectly, (i) initiate, solicit, induce, negotiate,
encourage or provide non-public or confidential information to
facilitate any inquiry that constitutes, or may reasonably be
expected to lead to, a proposal or offer to acquire, in one or
any series of transactions with such person (other than CytRx
and Merger Subsidiary), any (A) license, sublicense or
similar arrangement by the Company involving any Intellectual
Property of the Company under any of the Company License
Agreements, (B) acquisition of assets of the Company equal
to 10% or more of the Companys consolidated assets or to
which 10% or more of the Companys revenues or earnings on
a consolidated basis is attributable, (C) acquisition of
10% or more of the outstanding Company Common Stock,
(D) tender offer or exchange offer that if consummated
would result in any person beneficially owning 10% or more of
the outstanding Company Common Stock or (E) merger,
consolidation, share exchange, business combination,
recapitalization, liquidation, dissolution or similar
transaction involving the Company; in each case, other than the
transactions contemplated by this Agreement (any such
transactions being referred to herein as an Acquisition
Transaction); or (ii) enter into, continue or
otherwise participate in any discussions or negotiations with
any third party regarding, or furnish to any person any
non-public information or data, or afford access to the
properties, books or records of the Company with respect to, any
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inquiries that constitute, or may reasonably be expected to lead
to, an Acquisition Transaction, or otherwise knowingly
facilitate any effort to attempt to make or implement any
Acquisition Transaction.
(c) Notwithstanding anything in this Agreement to the
contrary, (i) prior to receipt of the Company
Stockholders Approval, the Company may, in response to a
bona fide written offer or proposal with respect to a potential
or proposed Acquisition Transaction (Acquisition
Proposal) from a person or group (a Potential
Acquirer) that was not solicited, initiated, induced
or knowingly encouraged in violation of this Section 6.03
and which the Company Board of Directors determines, in good
faith and after consultation with the Company Financial Advisor
or other financial advisor and its outside legal counsel, is or
could reasonably be expected to result in a Superior Proposal
(as defined below), and only after the Company Board of
Directors determines, in good faith and after consultation with
the Company Financial Advisor or other financial advisor and its
outside legal counsel, that such action is necessary to comply
with its fiduciary duties to the Companys stockholders
under applicable law, (A) furnish (subject to the execution
of a confidentiality agreement not materially less favorable to
the Company than the Confidentiality Agreement, dated
April 2, 2008, between CytRx and the Company (the
Confidentiality Agreement)) confidential or
non-public information to, and negotiate with, such Potential
Acquirer and (B) subject to
Sections 6.03(d)-(e)
below, resolve to accept, or recommend, and, upon termination of
this Agreement in accordance with Section 8.01(e), enter
into agreements relating to, an Acquisition Proposal as to which
the Company Board of Directors has determined in good faith
constitutes a Superior Proposal and (ii) the Company Board
of Directors may take and disclose to the Companys
stockholders a position contemplated by
Rule 14d-9
or
Rule 14e-2
under the Exchange Act and otherwise make disclosures required
by applicable law. In addition, it is understood and agreed
that, for purposes of this Agreement (including
Article VIII), a factually accurate public statement by the
Company that describes the Companys receipt of an
Acquisition Proposal and the operation of this Agreement with
respect thereto shall not be deemed a withdrawal or modification
of, or proposal by the Company Board of Directors to withdraw or
modify, the Directors Recommendation (as defined in
Section 6.07), or an approval or recommendation or neutral
position with respect to such Acquisition Proposal. It is
understood and agreed that negotiations and other activities
conducted in accordance with this paragraph (c) and
Sections 6.03(d) and (e) hereof shall not constitute a
violation of paragraph (a) of this Section 6.03. The
Company agrees to provide to CytRx, to the extent the Company
shall not have done so previously, any information that it is
providing to any Potential Acquirer pursuant to this
Section 6.03 at substantially the same time as it provides
it to such other Potential Acquirer. Superior
Proposal means a proposal to acquire, directly or
indirectly, for consideration consisting of cash or securities,
all of the equity securities of the Company or all, or
substantially all, of the assets of the Company made by a third
party, and which is otherwise on terms and conditions which the
Company Board of Directors determines in good faith (after
consultation with its financial advisor and outside legal
counsel) to be more favorable to the Companys stockholders
from a financial point of view than the Merger and the other
transactions contemplated hereby, taking into account any offer
by CytRx to amend the terms of this Agreement pursuant to
Section 6.03(d) below.
(d) The Company shall promptly notify CytRx after receipt
of any Acquisition Proposal, indication of interest or request
for non-public information relating to the Company or its
subsidiaries in connection with an Acquisition Proposal or for
access to the properties, books or records of the Company by any
person or entity that informs the Board of Directors of the
Company that it is considering making, or has made, an
Acquisition Proposal. Such notice to CytRx shall be made orally
and in writing and shall indicate in reasonable detail the
identity of the offeror and the material terms and conditions of
such proposal, inquiry or contact. Thereafter, the Company shall
keep CytRx informed on a current basis of any material changes
in the status of any such Acquisition Proposal, including
whether any such Acquisition Proposal has been withdrawn or
rejected. The Company shall notify CytRx if the Company Board of
Directors shall resolve to accept, or recommend, a Superior
Proposal, in which event CytRx shall have the right, but not the
obligation, to offer to amend the terms of this Agreement at any
time during the four
business-day
period referred to in Section 8.01(e). The Company Board of
Directors will review any proposal by CytRx to amend the terms
of this Agreement in good faith in order to determine, in its
discretion in the exercise of its fiduciary duties, whether
CytRxs amended proposal upon acceptance by the Company
would result in such Superior Proposal ceasing to be a Superior
Proposal. If the Company Board of Directors so determines, it
will enter into an amended agreement with CytRx reflecting
CytRxs amended proposal. If the Company Board of Directors
continues to believe, in good faith and after consultation with
financial advisors and outside counsel, that such Superior
Proposal remains a Superior Proposal and therefore rejects
CytRxs amended proposal, the Company may,
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on termination of this Agreement in accordance with
Section 8.01(e), accept, approve, recommend or enter into
an agreement, understanding or arrangement in respect of such
Superior Proposal.
(e) Except as expressly permitted by Section 6.03(c)
or this Section 6.03(e), neither the Company Board of
Directors, nor any committee thereof, shall (i)(A) withdraw or
modify, or propose publicly to withdraw or modify, in a manner
adverse to CytRx, the Directors Recommendation or the
approval or declaration of advisability by such Board of this
Agreement and the Merger or (B) approve or recommend, or
propose publicly to approve or recommend, the adoption of any
Acquisition Proposal (any action described in this
clause (i) being referred to as a Company Adverse
Recommendation Change), or (ii) cause, authorize
or permit the Company to enter into any letter of intent,
memorandum of understanding, agreement in principal, acquisition
agreement, merger agreement, option agreement, joint venture
agreement, partnership agreement, or any similar agreement, with
respect to any Acquisition Proposal (other than a
confidentiality agreement permitted by Section 6.03(c))
(each, a Company Acquisition Agreement).
Notwithstanding the foregoing, (x) the Company Board of
Directors may withdraw or modify the Directors
Recommendation, or recommend an Acquisition Proposal, if the
Company Board of Directors determines in good faith, based on
those matters as it deems appropriate after consulting with the
Company Financial Advisor or other financial advisor and its
outside legal counsel, that taking such action is necessary to
comply with its fiduciary duties under applicable law, and
(y) if the Company Board of Directors receives an
Acquisition Proposal that such Board determines in good faith
constitutes a Superior Proposal, then the Company or its
subsidiaries may terminate this Agreement pursuant to
Section 8.01(e) and concurrently enter into a Company
Acquisition Agreement with respect to such Superior Proposal;
provided, that, with respect to any termination pursuant to
clause (y), the Company shall have complied in all material
respects with its obligations under this Section 6.03 since
the date of this Agreement and the Company pays CytRx the
Termination Fee pursuant to Section 8.02 hereof concurrent
with (and as a condition of) such termination.
(f) After the date hereof and until the Effective Time or
earlier termination of this Agreement, CytRx shall promptly
notify the Company after receipt of any proposal or offer to
acquire all or any substantial part of the business, properties
or capital stock of CytRx, whether by merger, purchase of
assets, tender offer or otherwise, whether for cash, securities
or any other consideration or combination thereof and shall
indicate in reasonable detail the identity of the offeror or
person and the material terms and conditions of such proposal or
offer and the financing arrangements, if any, relating thereto.
Section 6.04 Access
to Information; Confidentiality.
(a) Subject to applicable law relating to the exchange of
information, the parties shall afford to each other and the
others accountants, counsel, financial advisors, sources
of financing and other representatives reasonable access during
normal business hours with reasonable notice throughout the
period from the date hereof until the Effective Time to all of
their respective properties, books, contracts and records
(including, but not limited to, Tax Returns) and, during such
period, shall furnish promptly (i) a copy of each report,
schedule and other document filed or received by any of them
pursuant to the requirements of federal or state securities laws
or filed by any of them with the SEC in connection with the
transactions contemplated by this Agreement, and (ii) such
other information concerning its businesses, properties and
personnel as any party shall reasonably request, and will use
reasonable efforts to obtain the reasonable cooperation of its
officers, employees, counsel, accountants, consultants and
financial advisors in connection with the review of such other
information by the parties and their respective representatives.
(b) All nonpublic information provided to, or obtained by,
a party regarding another party in connection with the
transactions contemplated hereby shall be Proprietary
Information. Notwithstanding the foregoing, the term
Proprietary Information shall not include information that
(i) is or becomes within the public domain through no act
of the receiving party in breach of this Section 6.04,
(ii) was in the possession of the receiving party prior to
its disclosure or transfer hereunder, (iii) is
independently developed by the receiving party, or (iv) is
received from another source without any restriction on use or
disclosure through no act of the receiving party in breach of
this Section 6.04.
(c) Except as specifically provided herein, each party
agrees that it shall not disclose any Proprietary Information to
any third party nor use any Proprietary Information of another
party for any purpose other than as may be necessary in
connection with the transactions contemplated hereby. The
parties shall each protect all
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Proprietary Information with the same degree of care as it
applies to protect its own proprietary information. As used
herein, the term third party shall be broadly
interpreted to include any corporation, company, partnership or
individual.
(d) Notwithstanding the foregoing, a party may disclose
such Proprietary Information to its directors, officers,
employees, consultants, agents and representatives who need to
know such Proprietary Information in connection with the
transactions contemplated hereby (it being understood that such
directors, officers, consultants, agents and representatives
shall be informed by the receiving party of the confidential
nature of such Proprietary Information and will agree to be
bound by the terms of this Section 6.04), provided, that,
the receiving party agrees to be responsible for any breach of
this Section 6.04 by such persons.
(e) The parties agree that all communications with the
other parties and all requests for information related thereto
will be submitted only to persons specifically designated in
writing by the parties.
(f) In the event a party is legally requested or required
to disclose Proprietary Information of the other party, the
receiving party shall promptly notify the disclosing party of
such request or requirement so that the disclosing party may
seek an appropriate protective order or waive the provisions of
this Section 6.04. In the event that such protection or
other remedy is not obtained or that the disclosing party waives
compliance, the receiving party agrees to furnish only that
portion of the Proprietary Information which it is advised by
counsel is legally required. Notwithstanding anything to the
contrary in this Agreement, a disclosing party shall not be
required to provide any information to any other party which it
reasonably believes it may not provide to another party by
reason of applicable law, rules or regulations, which
constitutes information protected by attorney/client privilege,
or which the disclosing party or any subsidiary is required to
keep confidential by reason of Contract, agreement or
understanding with third parties.
Section 6.05 Notices
of Certain Events.
(a) The Company and CytRx shall as promptly as reasonably
practicable after executive officers acquire knowledge thereof,
notify the other of: (i) any notice or other communication
from any person alleging that the consent of such person (or
another person) is or may be required in connection with the
transactions contemplated by this Agreement which consent
relates to a Material Contract or the failure of which to obtain
could materially delay consummation of the Merger; (ii) any
notice or other communication from any governmental or
regulatory agency or authority in connection with the
transactions contemplated by this Agreement; and (iii) any
actions, suits, claims, investigations or proceedings commenced
or, to its knowledge, threatened, relating to or involving or
otherwise affecting the Company or CytRx, as the case may be
that, if pending on the date of this Agreement, would have been
required to have been disclosed pursuant to Sections 6.08,
6.09 or 6.11 or which relate to the consummation of the
transactions contemplated by this Agreement.
(b) Subject to the provisions of Section 6.03, each of
the Company and CytRx agrees to give prompt notice to the other
of, and to use its reasonable best efforts to remedy,
(i) the occurrence or failure to occur of any event which
occurrence or failure to occur would reasonably be expected to
cause any of its representations or warranties in this Agreement
to be untrue or inaccurate at the Effective Time unless such
occurrence or failure to occur would not reasonably be expected
to have a Company Material Adverse Effect or a CytRx Material
Adverse Effect, as the case may be, and (ii) any failure on
its part to comply with or satisfy any covenant, condition or
agreement to be complied with or satisfied by it hereunder
unless such failure would not reasonably be expected to have a
Company Material Adverse Effect or a CytRx Material Adverse
Effect, as the case may be; provided, however, that the delivery
of any notice pursuant to this Section 6.05(b) shall not
limit or otherwise affect the representations, warranties,
covenants or agreements of the parties, the remedies available
hereunder to the party receiving such notice or the conditions
to such partys obligation to consummate the Merger.
Section 6.06 Merger
Subsidiary. CytRx will take all action
necessary to cause Merger Subsidiary to perform its obligations
under this Agreement and to consummate the Merger on the terms
and conditions set forth in this Agreement. Until the Effective
Time, Merger Subsidiary will not carry on any business or
conduct any operations other than the execution of this
Agreement, the performance of its obligations hereunder and
matters ancillary hereto.
A-25
Section 6.07 Meeting
of the Companys Stockholders. The
Company shall as promptly as practicable after the date of this
Agreement take all action necessary in accordance with the DGCL
and its Certificate of Incorporation and Bylaws to establish a
record date for, duly call, give notice of, and convene a
meeting of the Companys stockholders (the Company
Stockholders Meeting) for the purpose of
obtaining the Company Stockholders Approval and will use
its reasonable best efforts (including postponing or adjourning
the Company Stockholders Meeting to obtain a quorum or to
solicit additional proxies and, at CytRxs request,
retaining a proxy solicitation firm to assist in soliciting
proxies) to obtain the Company Stockholders Approval;
provided, however, that the Company shall be relieved of its
obligations with respect to the Company Stockholders
Meeting if the Company Board of Directors terminates this
Agreement pursuant to Section 8.01(e) and pays CytRx the
Termination Fee pursuant to Section 8.02 concurrent with
(and as a condition of) such termination. Subject to
Sections 6.03(c) and (e), the Company Board of Directors
shall recommend that the Companys stockholders vote to
approve this Agreement, and the Proxy Statement/Prospectus shall
contain the unqualified recommendation of the Company Board of
Directors that its stockholders vote in favor of the adoption of
this Agreement and the approval of the transactions contemplated
hereby (the Directors Recommendation).
Section 6.08 Registration
Statement.
(a) As promptly as practicable after execution of this
Agreement, CytRx shall prepare and file with the SEC the
Registration Statement containing the Proxy Statement/Prospectus
and thereafter shall use its reasonable best efforts to have the
Registration Statement declared effective under the Securities
Act as promptly as practicable after such filing. The Proxy
Statement/Prospectus shall, subject to Section 6.07,
include the Directors Recommendation. CytRx, Merger
Subsidiary and the Company shall cooperate with each other in
the preparation of the Registration Statement, and CytRx shall
promptly notify the Company of the receipt of any comments of
the SEC with respect to the Registration Statement and of any
requests by the SEC for any amendment or supplement thereto or
for additional information and shall provide to the Company
promptly copies of all correspondence between CytRx or its
representatives and the SEC. CytRx shall give the Company and
its counsel the opportunity to review the Registration Statement
within a reasonable period of time prior to its being filed with
the SEC and to review all amendments and supplements to the
Registration Statement and all responses to requests for
additional information and replies to comments within a
reasonable period of time prior to their being filed with, or
sent to, the SEC. Each of the Company, CytRx and Merger
Subsidiary agrees to use its reasonable best efforts, after
consultation with the other parties hereto, to respond promptly
to all such comments of and requests by the SEC. As promptly as
practicable after the SEC has cleared the Registration
Statement, the Company shall mail the Proxy Statement/Prospectus
to the stockholders of the Company. Prior to the date of
approval of the Merger by the Companys stockholders, the
Company shall correct promptly any information provided by it to
be used specifically in the Registration Statement that shall
have become false or misleading in any material respect, and
CytRx shall take all steps necessary to file with the SEC and
have cleared by the SEC any amendment or supplement to the
Registration Statement so as to correct the same and to cause
the Proxy Statement/Prospectus as so corrected to be
disseminated to the stockholders of the Company, in each case to
the extent required by applicable law.
(b) The Company shall cooperate with CytRx in connection
with investor meetings and customary road show
presentations of CytRx. As part of such meetings and
presentations, the Company understands and agrees that CytRx may
provide information with respect to the Companys clinical
trials, product candidates and other assets and business,
subject to customary confidentiality agreements.
Section 6.09 Public
Announcements. In connection with the
execution and delivery of this Agreement, Cytx and the Company
shall issue press releases in substantially the forms attached
hereto as Exhibit C (the Signing
Releases). CytRx, in its discretion, shall be entitled
to convene an investor conference call in conjunction with the
issuance of the Signing Releases. Except for the Signing
Releases and such conference call, no party shall issue or cause
the publication of any press release or other public
announcement (to the extent not previously issued or made in
accordance with this Agreement) with respect to this Agreement,
the Merger or the other transactions contemplated hereby without
the prior consent of the other parties (which consent shall not
be unreasonably withheld or delayed), except as may be required
by law, including applicable SEC requirements, applicable
fiduciary duties or by any applicable listing agreement with The
Nasdaq Capital Market (in which case such party shall not issue
or cause the publication of such press release or other public
statement without prior consultation with the other party).
A-26
Section 6.10 Expenses
and Fees. Each of the parties shall bear and
pay all costs and expenses incurred by it in connection with
this Agreement and the transactions contemplated hereby. Subject
to the limitation set forth in Section 6.01(r), within
30 days following the Closing Date, CytRx shall pay or
cause to be paid any unpaid Transaction Costs.
Section 6.11 Agreement
to Cooperate.
(a) Subject to the terms and conditions of this Agreement,
including Section 6.03 and this Section 6.11, each of
the parties hereto shall use its reasonable best efforts to
take, or cause to be taken, all actions and to do, or cause to
be done, all things necessary, proper or advisable under
applicable law and regulations to consummate and make effective
the transactions contemplated by this Agreement, including using
its reasonable best efforts to obtain all necessary or
appropriate waivers, consents or approvals of third parties
required in order to preserve material contractual relationships
of CytRx and the Company and their respective subsidiaries and
to effect all necessary registrations, filings and submissions.
In addition, subject to the terms and conditions herein provided
and subject to the fiduciary duties of the respective Boards of
Directors of the Company and CytRx, none of the parties hereto
shall knowingly take or cause to be taken any action that would
reasonably be expected to materially delay or prevent
consummation of the Merger.
(b) CytRx shall use its reasonable efforts to ensure that
the Equity Conditions cited in Section 3.02(b) are met
prior to the issuance of any shares of CytRx Common Stock that
comprise the Earnout Merger Consideration and to obtain any
necessary permits and approvals under all applicable state
securities laws required to permit the distribution of the
shares of CytRx Common Stock that comprise the Earnout Merger
Consideration. This Section 6.11(b) shall survive the
Effective Time and shall not terminate until the expiration of
the Earnout Period and the payment of all Earnout Merger
Consideration pursuant to Section 3.02.
Section 6.12 Directors
and Officers Indemnification.
(a) After the Effective Time, CytRx shall cause the
Surviving Corporation to, to the fullest extent permitted under
applicable law, indemnify, defend and hold harmless, each
individual who at the Effective Time is, or at any time prior to
the Effective Time was, a director, officer, employee or agent
of the Company or any of its subsidiaries (each, together with
such persons heirs, executors or administrators, an
Indemnified Party and collectively, the
Indemnified Parties) against any costs or
expenses (including attorneys fees), judgments, fines,
losses, claims, damages, liabilities and amounts paid in
settlement in connection with any actual or threatened claim,
action, suit, proceeding or investigation, whether civil,
criminal, administrative or investigative (collectively,
Costs and Expenses), arising out of, relating
to or in connection with any action or omission occurring or
alleged to occur prior to the Effective Time (including acts or
omissions in connection with such persons serving as an officer,
director or other fiduciary in any entity if such service was at
the request or for the benefit of the Company or any of its
affiliates). In the event of any actual or threatened claim,
action, suit, proceeding or investigation (whether arising
before or after the Effective Time) subject to this
Section 6.12, (i) CytRx and the Surviving Corporation
shall pay the reasonable fees and expenses of counsel selected
by the Indemnified Parties, which counsel shall be reasonably
satisfactory to CytRx, the Surviving Corporation and the
Stockholder Representative, promptly after statements therefor
are received and shall pay all other reasonable expenses in
advance of the final disposition of such action, (ii) CytRx
and the Surviving Corporation will cooperate and use all
reasonable efforts to assist in the defense of any such matter,
and (iii) to the extent any determination is required to be
made with respect to whether an Indemnified Partys conduct
complies with the standards set forth under the DGCL and
CytRxs or the Surviving Corporations respective
certificate or articles of incorporation or bylaws, such
determination shall be made by independent legal counsel
acceptable to CytRx or the Surviving Corporation, as the case
may be, and the Indemnified Party; provided, however, that
neither CytRx nor the Surviving Corporation shall be liable for
any settlement effected without its written consent (which
consent shall not be unreasonably withheld or delayed); and,
provided, further, that if CytRx or the Surviving Corporation
advances or pays any amount to any person under this paragraph
(b) and if it shall thereafter be finally determined by a
court of competent jurisdiction that such person was not
entitled to be indemnified hereunder for all or any portion of
such amount, to the extent required by law, such person shall
repay such amount or such portion thereof, as the case may be,
to CytRx or the Surviving Corporation, as the case may be. The
Indemnified Parties as a group may not retain more than one law
firm to
A-27
represent them with respect to each matter, except to the extent
that under applicable standards of professional conduct such
counsel would have a conflict representing such Indemnified
Party or Indemnified Parties.
(b) In the event the Surviving Corporation or CytRx or any
of their successors or assigns (i) consolidates with or
merges into any other person and shall not be the continuing or
surviving corporation or entity of such consolidation or merger,
or (ii) transfers all or substantially all of its
properties and assets to any person, then and in each such case,
proper provisions shall be made so that the successors and
assigns of the Surviving Corporation or CytRx shall assume the
obligations of the Surviving Corporation or CytRx, as the case
may be, set forth in this Section 6.12.
(c) For a period of three years commencing immediately
after the Effective Time, CytRx shall cause to be maintained, or
shall cause the Surviving Corporation to maintain, in effect the
current policies of directors and officers liability
insurance maintained by the Company and its subsidiaries
(provided that CytRx may substitute therefor policies, including
a tail policy, of at least the same coverage and amounts
containing terms and conditions that are no less advantageous to
the Indemnified Parties, and which coverages and amounts shall
be no less than the coverages and amounts provided at that time
for CytRxs directors and officers) with respect to matters
arising on or before the Effective Time; provided, however,
that, if the aggregate annual premiums for such insurance shall
exceed 125% of the current aggregate annual premium, then CytRx
shall provide or cause to be provided a policy for the
applicable individuals with the best coverage as shall then be
available at an annual premium of not more than 125% of the
current aggregate annual premium.
(d) To the maximum extent permitted by applicable law,
CytRx and the Surviving Corporation shall pay all reasonable
expenses, including reasonable attorneys fees, that may be
incurred by any Indemnified Party in enforcing the indemnity and
other obligations provided in this Section 6.12. The rights
of each Indemnified Party hereunder shall be in addition to, and
not in limitation of, any other rights such Indemnified Party
may have under the charter or bylaws of the Company, any
indemnification agreement, under the DGCL or otherwise. The
provisions of this Section 6.12 shall survive the
consummation of the Merger and expressly are intended to benefit
each of the Indemnified Parties.
Section 6.13 Loan
and Security Agreement. Concurrently with the
execution and delivery of this Agreement, CytRx and the Company
shall enter into the Loan and Security Agreement in
substantially the form attached hereto as Exhibit B
(the Loan and Security Agreement), and
thereafter shall comply with their respective obligations in
accordance with the terms thereof.
Section 6.14 Exemption From
Liability Under Section 16(b). CytRx and
the Company shall cause their respective Boards of Directors and
the Board of Directors of the Surviving Corporation to adopt
prior to the Effective Time such resolutions as may be required
to, and shall otherwise use reasonable efforts to, exempt the
transactions contemplated by this Agreement from the provisions
of Section 16(b) of the Exchange Act to the maximum extent
permitted by law. The Company shall use reasonable efforts to
provide the information to CytRx required in connection with the
adoption of such resolutions to exempt the transactions
contemplated by this Agreement from the provisions of
Section 16(b) of the Exchange Act to the maximum extent
permitted by law.
Section 6.15 Resignation
of Officers. CytRx and Merger Sub hereby
agree that the resignation of the Company officers required by
Section 7.03(c) will not have any effect on any severance
provision in any applicable employment, change in control or
similar agreement or under the Companys Employee Retention
Program adopted in February 2008, in each of which case the
officers resignation will not be deemed to be a voluntary
resignation but rather a termination of employment by the
Company.
Section 6.16 Office
Lease. Immediately after the execution of
this Agreement, CytRx shall use its commercially reasonable
efforts to remove Steven Kelly as a guarantor of the lease for
the Companys offices located at 555 Madison Avenue,
25th Floor,
New York, New York 10022, to be effective at the Effective Time.
If such removal is not effective at the Effective Time, CytRx
and the Surviving Corporation shall (a) at the Effective
Time, enter into a written agreement satisfactory to the Company
and Mr. Kelly to indemnify, defend and hold harmless
Mr. Kelly under such lease guarantee and (b) use their
commercially reasonable efforts to have such removal effective
as soon as possible after the Effective Time.
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ARTICLE VII
CONDITIONS TO THE MERGER
Section 7.01 Conditions
to the Obligations of Each Party. The
obligations of the parties to consummate the Merger are subject
to the fulfillment at or prior to the Effective Time of the
following conditions:
(a) this Agreement and the Merger shall have been adopted
by the requisite vote of the stockholders of the Company in
accordance with the DGCL;
(b) none of the parties hereto shall be subject to any law,
order, injunction, judgment or ruling enacted, promulgated,
issued, entered, amended or enforced by any governmental
authority of competent jurisdiction that prohibits the
consummation of the Merger or makes the consummation of the
Merger illegal;
(c) the Registration Statement shall be effective under the
Securities Act, and no stop order suspending the effectiveness
of the Registration Statement shall have been issued by the SEC
and no proceeding for that purpose shall have been initiated by
the SEC and not concluded or withdrawn;
(d) the issuance of the shares of CytRx Common Stock to be
issued as the Initial Merger Consideration shall be exempt from
registration, or shall have been appropriately registered or
qualified, under applicable state securities laws;
(e) the shares of CytRx Common Stock to be issued as part
of the Initial Merger Consideration shall have been approved for
listing on The Nasdaq Capital Market, effective upon notice of
issuance; and
(f) there shall not be pending any action, suit or other
proceeding (i) seeking to restrain or prohibit the
consummation of the Merger or seeking to obtain from CytRx or
Merger Subsidiary in connection with the Merger any damages that
are material in relation to CytRx, or seeking to obtain from the
Company any damages that are material in relation to the
Company, (ii) seeking the sale, divestiture or disposition
of any material assets or businesses of the Company, or
(iii) otherwise seeking to limit the freedom of action of
CytRx with respect to the material assets or businesses of the
Company or of the Surviving Corporation.
Section 7.02 Conditions
to Obligation of the Company to Effect the
Merger. Unless waived by the Company, the
obligation of the Company to consummate the Merger shall be
subject to the fulfillment at or prior to the Effective Time of
the following additional conditions:
(a) (i) the representations and warranties of CytRx
and Merger Subsidiary set forth in
Sections 4.03(a) (c) (Authority;
Non-Contravention) shall be true and correct in all respects as
of the date hereof and as of the Effective Time as if made on
and as of the Effective Time (or, if given as of a specific
date, at and as of such date) and (ii) the other
representations and warranties of CytRx and Merger Subsidiary
contained in this Agreement, disregarding all qualifications and
exceptions contained therein relating to materiality or CytRx
Material Adverse Effect, shall be true and correct in all
respects as of the date hereof and as of the Effective Time as
if made on and as of the Effective Time (or, if given as of a
specific date, at and as of such date), except in the case of
this clause (ii) (x) for changes expressly permitted by
this Agreement or (y) where the failure to be true and
correct would not reasonably be expected to have a CytRx
Material Adverse Effect. The Company shall have received a
certificate of the chief executive officer or the chief
financial officer of the CytRx to that effect; and
(b) each of CytRx and Merger Subsidiary shall have
performed in all material respects all obligations required to
be performed by it under this Agreement on or prior to the
Effective Time, and the Company shall have received a
certificate of the chief executive officer or the chief
financial officer of CytRx to that effect.
Section 7.03 Conditions
to Obligations of CytRx and Subsidiary to Effect the
Merger. Unless waived by CytRx and Merger
Subsidiary, the obligations of CytRx and Merger Subsidiary to
consummate the Merger shall be subject to the fulfillment at or
prior to the Effective Time of the following additional
conditions:
(a) (i) the representations and warranties of the
Company set forth in Sections 5.02 (Capitalization),
5.03(a) (c) (Authority; Non-Contravention) and 5.22
(Opinion of Financial Advisor) shall be true and correct in all
respects as of the date hereof and as of the Effective Time as
if made on and as of the Effective Time (or, if given as of a
specific date, at and as of such date) and (ii) the other
representations and warranties of
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the Company contained in this Agreement, disregarding all
qualifications and exceptions contained therein relating to
materiality or Company Material Adverse Effect, shall be true
and correct in all respects as of the date hereof and as of the
Effective Time as if made on and as of the Effective Time (or,
if given as of a specific date, at and as of such date), except
in the case of this clause (ii) (x) for changes expressly
permitted by this Agreement or (y) where the failure to be
true and correct would not reasonably be expected to have a
Company Material Adverse Effect. CytRx shall have received a
certificate of the chief executive officer or the chief
financial officer of the Company to that effect;
(b) the Company shall have performed in all material
respects all obligations required to be performed by it under
this Agreement on or prior to the Effective Time, and CytRx
shall have received a certificate of the chief executive officer
or the chief financial officer of the Company to that effect;
(c) CytRx shall have received the resignations, effective
as of the Effective Time, of each member of the Companys
Board of Directors and of each officer of the Company; and
(d) Dissenting Shares, if any, shall constitute less than
5% of the issued and outstanding shares of Company Common Stock.
ARTICLE VIII
TERMINATION
Section 8.01 Termination. This
Agreement may be terminated and the Merger may be abandoned at
any time prior to the Effective Time (notwithstanding any
approval of this Agreement by the stockholders of the Company):
(a) by mutual written consent of the Company and CytRx duly
authorized by each of their respective Boards of Directors;
(b) by either the Company or CytRx, if the Merger has not
been consummated by September 30, 2008 (the
Outside Date); provided, however, that the
right to terminate this Agreement under this
Section 8.01(b) shall not be available to (i) CytRx,
if the failure of CytRx or Merger Subsidiary to fulfill any of
its material obligations under this Agreement caused the failure
of the Closing to occur on or before such date, or (ii) the
Company, if the failure of the Company to fulfill any of its
material obligations under this Agreement caused the failure of
the Closing to occur on or before such date, or (ii) CytRx
or the Company, if the failure of the Closing to occur on or
before such date is due solely to the failure of the condition
set forth in Section 7.01(c) notwithstanding the
performance by CytRx of its obligations under Section 6.08;
(c) by either the Company or CytRx, if (x) there has
been a breach by the other of any representation or warranty
contained in this Agreement which would reasonably be expected
to have a Company Material Adverse Effect or a CytRx Material
Adverse Effect, as the case may be, and which breach is not
curable or, if curable, the breaching party shall not be using
on a continuous basis its reasonable best efforts to cure in all
material respects such breach after written notice of such
breach by the terminating party or such breach has not been
cured within twenty business days after written notice of such
breach by the terminating party, or (y) there has been a
breach of any of the covenants or agreements set forth in this
Agreement on the part of the other party, which would reasonably
be expected to have a CytRx Material Adverse Effect or a Company
Material Adverse Effect, as the case may be, and which breach is
not curable or, if curable, the breaching party shall not be
using on a continuous basis its reasonable best efforts to cure
such breach after written notice of such breach by the
terminating party or such breach has not been cured within
twenty business days after written notice of such breach by the
terminating party;
(d) by either the Company or CytRx after ten days following
the entry of any final and non-appealable judgment, injunction,
order or decree by a court or governmental agency or authority
of competent jurisdiction restraining or prohibiting the
consummation of the Merger;
(e) by the Company if, prior to receipt of the Company
Stockholders Approval, the Company receives a Superior
Proposal, resolves to accept such Superior Proposal, complies
with its Termination Fee payment
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obligations under Section 8.02 hereof and gives CytRx at
least four business days prior written notice of its
intention to terminate pursuant to this provision; provided,
however, that such termination shall not be effective until such
time as the payment required by Section 8.02 shall have
been received by CytRx;
(f) by CytRx, if the Board of Directors of the Company
shall have failed to recommend, or shall have withdrawn,
modified or amended in a manner adverse to CytRx in any material
respect the Directors Recommendation, or shall have
resolved to do any of the foregoing, or shall have recommended
another Acquisition Proposal or if the Board of Directors of the
Company shall have resolved to accept a Superior Proposal or
shall have recommended to the stockholders of the Company that
they tender their shares in a tender or an exchange offer
commenced by a third party (excluding any affiliate of CytRx or
any group of which any affiliate of CytRx is a member) or any
other circumstance in which a Company Adverse Recommendation
Change shall have occurred; or
(g) by CytRx, if the Company shall have received an
Acquisition Proposal from any person and the Company Board of
Directors took a neutral position or made no recommendation with
respect to such Acquisition Proposal and did not publicly
reaffirm the Directors Recommendation in favor of the
Merger and the transactions contemplated hereby after a
reasonable amount of time (and in no event more than five
business days following such receipt) has elapsed for the
Company Board of Directors to review and make a recommendation
with respect to such Acquisition Proposal; or
(h) by CytRx or the Company if the stockholders of the
Company fail to approve the Merger at the Company
Stockholders Meeting (including any adjournment or
postponement thereof).
Section 8.02 Termination
Fee. The Company shall pay to CytRx a
termination fee in an amount in cash equal to $1,500,000 (the
Termination Fee) in the event that
(i) the Company terminates this Agreement pursuant to
Section 8.01(e); (ii) CytRx terminates this Agreement
pursuant to Sections 8.01(f) or (g); (iii) CytRx
terminates this Agreement pursuant to Section 8.01(c),
provided that such termination is as a result of the
Companys breach of Section 6.03; or (iv) CytRx
or the Company terminates this Agreement pursuant to
Section 8.01(h), provided, in the case of this clause (iv),
that (A) after the date hereof and prior to the Company
Stockholders Meeting, an Acquisition Proposal has been
publicly announced and not withdrawn or abandoned at the time of
termination, and (B) within one year after such
termination, the Company enters into a definitive agreement with
respect to or consummates such Acquisition Proposal. Payment of
the Termination Fee under this Section 8.02 shall be paid
by wire transfer of
same-day
funds to an account designated by CytRx, in the event of payment
pursuant to clause (i) above on the date of termination of
this Agreement, in the event of payment pursuant to
clauses (ii) or (iii) above within three business days
following the date of termination of this Agreement, and in the
event of payment pursuant to clause (iv) above, on the date
of the execution and delivery by the Company of the definitive
agreement regarding such Acquisition Proposal. CytRx
acknowledges and agrees that, notwithstanding anything to the
contrary in this Agreement or any document or instrument
delivered in connection herewith, the rights set forth in
clause (iii) of this Section 8.02 shall be the sole
and exclusive remedy of CytRx, Merger Subsidiary and their
respective affiliates against the Company or its Subsidiaries or
any of their respective affiliates with respect to the
Companys breach of Section 6.03 of this Agreement
(excluding any willful breach of such provisions).
Section 8.03 Effect
of Termination. In the event of termination
of this Agreement by either CytRx or the Company pursuant to the
provisions of Section 8.01, written notice thereof shall be
given to the other party or parties, specifying the provision
hereof pursuant to which such termination is made, and this
Agreement shall forthwith become void and there shall be no
liability or further obligation on the part of the Company,
CytRx, Merger Subsidiary or their respective officers or
directors (except as set forth in the first sentence of
Section 5.21, Section 6.04(b) (d) and
(f), Section 6.10, Section 8.02 and this
Section 8.03, and Article X, all of which shall
survive the termination). Nothing in this Section 8.03
shall relieve any party from liability for fraud or any willful
breach of this Agreement.
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ARTICLE IX
OFFSET
Section 9.01 Survival. The
parties agree that, regardless of any investigation made by or
on behalf of CytRx and Merger Subsidiary, the representations,
warranties, covenants and agreements of the Company contained in
this Agreement shall survive the execution and delivery of this
Agreement and the Closing until the last day of the statute of
limitations period for any third-party claim relating thereto.
Section 9.02 Offset.
(a) Subject to paragraph (b) below, CytRx shall be
entitled to offset against the Earnout Merger Consideration, if
any, (i) the amount, if any, by which the actual Net
Liabilities of the Company as of the date of this Agreement
(excluding up to $97,785 that may become due and payable to
Davos Chemical Corporation) exceed the Estimated Net
Liabilities, (ii) any and all Losses (as defined below)
incurred by CytRx, Merger Subsidiary or the Surviving
Corporation (collectively, Indemnitees) by
reason of any inaccuracy in or breach of any of the
Companys representations, warranties, covenants or
agreements contained in this Agreement, and any
misrepresentation contained in the Company Disclosure Schedule
or in any written agreement or certificate entered into or
executed in connection herewith and furnished to CytRx or Merger
Subsidiary by or on behalf of the Company in connection with the
transactions contemplated by this Agreement and (iii) the
amount, if any, by which the actual deposits returned to or
recovered by CytRx or the Surviving Corporation is less than the
deposits reflected on Section 5.06(b) of the Company
Disclosure Schedule. For purposes of this Agreement, the term
Losses means any and all deficiencies,
judgments, settlements, demands, claims, suits, actions or
causes of action, assessments, liabilities, losses, damages
(whether direct, indirect, incidental or consequential),
interest, taxes, fines, penalties, costs, expenses (including
reasonable legal, accounting and other costs and expenses of
professionals) incurred in connection with investigating,
defending, settling or satisfying any and all demands, claims,
actions, causes of action, suits, proceedings, assessments,
judgments or appeals; provided, however, that Losses shall not
include any amounts for which Indemnitees are actually
reimbursed under any insurance policy.
(b) Indemnitees shall have no right of offset under
paragraph (a)(ii) above unless the cumulative aggregate Losses
exceed $50,000, in which event Indemnitees shall have a right of
offset for all Losses (including the first $50,000).
Section 9.03 Offset
Claims.
(a) In the event Indemnitees determine to offset against
the Earnout Merger Consideration, if any, any amounts pursuant
to Section 9.02, CytRx shall a deliver notice (each, an
Offset Notice) to the Stockholder
Representative setting forth in reasonable detail a description
of such amounts, whether the basis for such offset is clause
(i), (ii) or (iii) of Section 9.02(a) and, with
respect to any Losses claimed under clause 9(ii) of
Section 9.02(a), the nature of the inaccuracy in or breach
of representation, warranty, covenant or agreement of the
Company to which such Losses relate. Upon delivery of an Offset
Notice, CytRx shall, subject to paragraph (b) below and to
Section 9.04, be entitled and authorized to withhold from
the Earnout Merger Consideration, if any, as and when the
Earnout Merger Consideration would otherwise be payable
hereunder, the amounts set forth in the Offset Notice.
(b) Within 30 days after the delivery of an Offset
Notice to the Stockholder Representative, the Stockholder
Representative may notify (the Response
Notice) CytRx either that the Stockholder
Representative agrees to the offset against the Earnout Merger
Consideration of amounts as set forth in the Offset Notice or
disputes all, or any portion of, the amounts claimed in the
Offset Notice. If no Response Notice has been delivered to CytRx
before the expiration of such
30-day
period, the Stockholder Representative shall be deemed to have
agreed, on behalf of the Company Stockholders, that all of the
amounts set forth in the Offset Notice may be offset pursuant to
this Article IX, and CytRx may thereafter offset against
the Earnout Merger Consideration, if any, and retain, as and
when the Earnout Merger Consideration would otherwise be payable
hereunder, such amounts. If the Response Notice is delivered to
CytRx before the expiration of such thirty
30-day
period and disputes a portion, but not all, of the claimed
amounts, then the Stockholder Representative shall be deemed to
have agreed, on behalf of the Company Stockholders, that such
undisputed amounts may likewise be offset pursuant to this
Article IX.
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Section 9.04 Resolution
of Conflicts. If the Stockholder
Representative shall have timely delivered a Response Notice to
CytRx disputing any amounts claimed in any Offset Notice, the
Stockholder Representative and CytRx will attempt in good faith
to agree upon the rights of the respective parties with respect
to the disputes amounts. If the parties fail to reach such an
agreement, either the Stockholder Representative or CytRx may
make a written demand upon the other for formal resolution of
the dispute and specifying the scope of the dispute. As soon as
practicable, and in any event within 60 days, after such
written notification, the parties and their respective
representatives shall meet for one day with an impartial
mediator, mutually agreed upon by the Stockholder Representative
and CytRx for purposes of reaching an agreement on a dispute
resolution alternative other than litigation. If an alternative
method of dispute resolution is not agreed upon as a result of
the one-day
mediation, the parties may thereafter exercise any and all
available rights and remedies. With respect to the
one-day of
mediation and any other mediation that may result from this
Section 9.04, the parties shall cooperate with one another
in selecting a mediator and in scheduling mediation proceedings,
and shall act in good faith in such mediation. CytRx initially
shall bear the costs of mediation, but shall be entitled to an
offset against the Earnout Merger Consideration, if any, of all
or a portion of such costs as determined in such mediation or
any ensuing litigation.
Section 9.05 Stockholder
Representative.
(a) If the Company Stockholders Approval is obtained
as contemplated in this Agreement, then, as part thereof,
immediately and automatically upon the Effective Time, and
without any further action on the part of the Company
Stockholders, each Company Stockholder shall be deemed to have
consented to the appointment of Steven Kelly, as his, her or its
representative and attorney-in-fact (the Stockholder
Representative) for and on behalf of each such Company
Stockholder, and the taking by the Stockholder Representative of
any and all actions and the making of any decisions required or
permitted to be taken by such Company Stockholder under this
Agreement, including the exercise of the power to (i) agree
to, negotiate, enter into settlements and compromises of, and
comply with orders of courts and awards of arbitrators with
respect to, the determination of the Liabilities of the Company
as of the date of this Agreement, Net Sales and Losses;
(ii) resolve any disputes with respect to the Liabilities
of the Company as of the date of this Agreement, Net Sales and
Losses; and (iii) take all actions necessary in the
judgment of the Stockholder Representative for the
accomplishment of the foregoing and all of the other terms,
conditions and limitations of this Agreement. Accordingly, the
Stockholder Representative shall have all necessary authority
and power to act on behalf of the Company Stockholders with
respect to this Agreement and the disposition, settlement or
other handling of all claims, rights or obligations arising from
and taken pursuant to this Agreement, including matters
contemplated by, but not specifically addressed in, this
Section 9.05. The Company Stockholders will be bound by all
actions taken by the Stockholder Representative in connection
with this Agreement, and CytRx shall be entitled to rely on any
action or decision of the Stockholder Representative as being
the decision, act, consent or instruction of each and every
Company Stockholder. Subject to Section 9.05(e) below,
CytRx is hereby relieved from any liability to any person for
any acts done by it in accordance with such decision, act,
consent or instruction of the Stockholder Representative. The
Stockholder Representative shall have no liability with respect
to any action taken or suffered by him in reliance upon any
notice, direction, instruction, consent, statement or other
document believed by him to be genuine and to have been signed
by the proper person (and shall have no responsibility to
determine the authenticity thereof), nor for any other action or
inaction, except his own willful misconduct or gross negligence.
In all questions arising under this Agreement, the Stockholder
Representative may rely on the advice of counsel, and the
Stockholder Representative will not be liable to any person for
anything done, omitted to be done or suffered in good faith by
the Stockholder Representative based on such advice. The
Stockholder Representative will not be required to take any
action involving any expense to the Stockholder Representative
unless the payment of such expense is made or provided for in a
manner satisfactory to him. The reasonable legal fees and other
expenses, if any, incurred by the Stockholder Representative in
performance of his duties hereunder, not to exceed $20,000 in
the aggregate, shall be advanced by CytRx. CytRx shall
compensate the Stockholder Representative at the rate of $250
per hour, not to exceed $10,000 in the aggregate, for the
performance of his duties hereunder. All such legal fees and
expenses and compensation of the Stockholder Representative,
including any such legal fees and expenses in excess of $20,000,
shall be paid or reimbursed to CytRx or the Stockholder
Representative, as the case may be, from the Earnout Merger
Consideration, if any, before any payment thereof to the Company
Stockholders.
A-33
(b) This appointment of agency and this power of attorney
is coupled with an interest and shall be irrevocable and is not
terminable by any Company Stockholder or by operation of law,
whether by the death or incapacity of any Company Stockholder or
the occurrence of any other event, and any action taken by the
Stockholder Representative shall be as valid as if such death,
incapacity or other event had not occurred, regardless of
whether or not the Stockholder Representative shall have
received any notice thereof.
(c) The Stockholder Representative shall establish and
maintain a register of the Company Stockholders and the Company
Warrant Holders for purposes of payment and distribution of the
Earnout Merger Consideration, if any. CytRx shall be entitled to
rely conclusively on such register for purposes of determining
the persons to whom the Earnout Merger Consideration, if any,
shall be payable hereunder.
(d) The Stockholder Representative may resign as such at
any time by giving 30 days prior notice to CytRx.
Such resignation shall take effect upon the appointment of a
successor Stockholder Representative as provided below. As a
condition to the Stockholder Representatives resignation,
the Stockholder Representative shall appoint a successor
Stockholder Representative. If a successor Stockholder
Representative has not been appointed within such
30-day
period, CytRx may petition any court of competent jurisdiction
or may interplead the Stockholder Representative in a proceeding
for the appointment of a successor Stockholder Representative.
All fees, including, but not limited to, extraordinary fees
associated with the filing of interpleader and expenses
associated therewith, shall be advanced by CytRx and shall be
offset by CytRx against the Earnout Merger Consideration, if any.
(e) Notwithstanding anything herein to the contrary, CytRx
shall indemnify and hold harmless the Stockholder Representative
from and against any and all loss, liability, cost, damage and
expense, including, without limitation, reasonable
attorneys fees, which the Stockholder Representative may
suffer or incur by reason of any action, claim or proceeding
brought against the Stockholder Representative, in his capacity
as such (but not in any other capacity), arising out of or
relating in any way to this Agreement, any transaction to which
this Agreement relates or the performance of the Stockholder
Representatives duties pursuant thereto unless such
action, claim or proceeding is the result of the willful
misconduct or gross negligence of the Stockholder Representative.
ARTICLE X
MISCELLANEOUS
Section 10.01 Non-Survival
of Representations and Warranties. Except as
otherwise provided in this Agreement, no representations,
warranties or agreements in this Agreement or in any instrument
delivered pursuant to this Agreement shall survive the Effective
Time, and after the Effective Time neither the Company, CytRx,
Merger Subsidiary nor their respective officers or directors
shall have any further obligation with respect thereto;
provided, however, that this Section 10.01 shall not limit
any covenant or agreement of the parties hereto which by its
express terms contemplates performance, in whole or in part,
after the Effective Time.
Section 10.02 Notices. All
notices and other communications hereunder shall be in writing
and shall be deemed given if delivered personally, mailed by
registered or certified mail (return receipt requested), sent
via facsimile or sent by a nationally recognized overnight
courier (providing proof of delivery) to the parties at the
following addresses (or at such other address for a party as
shall be specified by like notice):
If to the Company:
Innovive Pharmaceuticals, Inc.
555 Madison Avenue,
25th
Floor
New York, New York 10022
Attention: Steve Kelly
Facsimile:
(212) 716-1811
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with a copy to:
Wyrick Robbins Yates & Ponton LLP
4101 Lake Boone Trail, Suite 300
Raleigh, North Carolina 27607
Attention: W. David Mannheim, Esq.
and
Alexander M. Donaldson, Esq.
Facsimile:
(919) 781-4815
If to CytRx or Merger Subsidiary:
CytRx Corporation
11726 San Vicente Blvd., Suite 650
Los Angeles, California 90049
Attention: Steven A. Kriegsman
Facsimile:
(310) 826-6139
with a copy to:
TroyGould PC
1801 Century Park East,
16th
Floor
Los Angeles, California 90067
Attention: Sanford J. Hillsberg, Esq. and Dale E.
Short, Esq.
Facsimile:
(310) 201-4746
If to the Stockholder Representative and prior to the Effective
Time:
Steven Kelly
c/o Innovive
Pharmaceuticals, Inc.
555 Madison Avenue,
25th
Floor
New York, New York 10022
Facsimile:
(212) 716-1811
If to Stockholder Representative and after the Effective Time:
Steven Kelly
83 Mercer St. #3
New York, New York 10012
(917) 607-6015
Section 10.03 Interpretation.
(a) The headings contained in this Agreement are for
reference purposes only and shall not affect in any way the
meaning or interpretation of this Agreement. In this Agreement,
unless a contrary intention appears, (i) the words
herein, hereof and
hereunder and other words of similar import
refer to this Agreement as a whole and not to any particular
Article, Section or other subdivision,
(ii) knowledge shall mean actual
knowledge as of the date hereof of the executive officers of the
Company or CytRx, as the case may be, after reasonable inquiry
of any person directly reporting to any such executive officer,
(iii) including shall mean
including, without limitation, and
includes shall mean includes,
without limitation, and (iv) reference to any
Article or Section means such Article or Section hereof. No
provision of this Agreement shall be interpreted or construed
against any party hereto solely because such party or its legal
representative drafted such provision. For purposes of
determining whether any fact or circumstance involves a material
adverse effect on the ongoing operations of a party, any special
transaction charges incurred by such party as a result of the
consummation of transactions contemplated by this Agreement
shall not be considered.
(b) The parties hereto have participated jointly in the
negotiation and drafting of this Agreement and, in the event an
ambiguity or question of intent or interpretation arises, this
Agreement shall be construed as jointly drafted by the parties
hereto and no presumption or burden of proof shall arise
favoring or disfavoring any party by virtue of the authorship of
any provision of this Agreement.
A-35
Section 10.04 Assignment;
Governing Law; Forum. This Agreement
(including the documents and instruments referred to herein)
shall not be assigned by operation of law or otherwise except
that Merger Subsidiary may assign its obligations under this
Agreement to any other wholly-owned subsidiary of CytRx subject
to the terms of this Agreement, in which case such assignee
shall become the Merger Subsidiary for all
purposes of this Agreement. THIS AGREEMENT, AND ANY DISPUTES
ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE
PARTIES RELATIONSHIP TO EACH OTHER, SHALL BE GOVERNED BY,
AND CONSTRUED IN ACCORDANCE WITH, THE INTERNAL LAWS OF THE STATE
OF DELAWARE, REGARDLESS OF THE LAWS THAT MIGHT OTHERWISE GOVERN
UNDER APPLICABLE PRINCIPLES OF CONFLICTS OF LAW THEREOF. The
parties hereby (a) submit to the jurisdiction of any
federal or state court sitting in the State of Delaware,
(b) agree not to object to venue in such courts or to claim
that such forum is inconvenient and (c) agree that notice
or the service of process in any proceeding shall be properly
served or delivered if delivered in the manner contemplated by
Section 10.02 of this Agreement.
Section 10.05 Counterparts. This
Agreement may be executed in two or more counterparts, each of
which shall be deemed to be an original, but all of which shall
constitute one and the same agreement.
Section 10.06 Amendments;
No Waivers.
(a) Any provision of this Agreement may be amended or
waived prior to the Effective Time if, and only if, such
amendment or waiver is in writing and signed, in the case of an
amendment, by the Company, CytRx and Merger Subsidiary or, in
the case of a waiver, by the party against whom the waiver is to
be effective; provided that any waiver or amendment shall be
effective against a party only if the board of directors of such
party approves such waiver or amendment.
(b) No failure or delay by any party in exercising any
right, power or privilege hereunder shall operate as a waiver
thereof nor shall any single or partial exercise thereof
preclude any other or further exercise thereof or the exercise
of any other right, power or privilege. The rights and remedies
herein provided shall be cumulative and not exclusive of any
rights or remedies provided by law.
Section 10.07 Entire
Agreement. This Agreement and the
Confidentiality Agreement constitute the entire agreement
between the parties with respect to the subject matter hereof
and supersede all prior agreements, understandings and
negotiations, both written and oral, between the parties with
respect to the subject matter of this Agreement. No
representation, inducement, promise, understanding, condition or
warranty not set forth herein has been made or relied upon by
any party hereto. Neither this Agreement nor any provision
hereof is intended to confer upon any person other than the
parties hereto any rights or remedies hereunder except for the
provisions of Section 6.12, which are intended for the
benefit of the Companys officers, directors, employees and
agents, the provisions of Articles I, II and III,
which are intended for the benefit of the Company Stockholders
and the Company Warrant Holders, and Section 6.16, which
are intended for the benefit of Steven Kelly, the Companys
President and Chief Executive Officer.
Section 10.08 Severability. If
any term or other provision of this Agreement is invalid,
illegal or unenforceable, all other provisions of this Agreement
shall remain in full force and effect so long as the economic or
legal substance of the transactions contemplated hereby is not
affected in any manner materially adverse to any party.
Section 10.09 Specific
Performance. The parties hereto agree that
irreparable damage would occur in the event any of the
provisions of this Agreement were not to be performed in
accordance with the terms hereof and that the parties shall be
entitled to specific performance of the terms hereof in addition
to any other remedies at law or in equity.
[Signature
Page Follows]
A-36
IN WITNESS WHEREOF, the parties hereto have caused this
Agreement to be duly executed by their respective authorized
officers as of the day and year first above written.
INNOVIVE PHARMACEUTICALS, INC.
Name: Steven Kelly
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Title:
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President and Chief Executive Officer
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CYTRX CORPORATION
Name: Steven A. Kriegsman
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Title:
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President and Chief Executive Officer
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CYTRX MERGER SUBSIDIARY, INC.
Name: Steven A. Kriegsman
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Title:
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President and Chief Executive Officer
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STEVEN KELLY
A-37
APPENDIX B
SUPPORT
AGREEMENT
THIS SUPPORT AGREEMENT (this Agreement) is
made and entered into as of June 6, 2008, by and among
CytRx Corporation, a Delaware corporation
(CytRx), CytRx Merger Subsidiary, Inc., a
Delaware corporation and wholly owned subsidiary of CytRx
(Merger Subsidiary),
and
(Stockholder).
WHEREAS, concurrently with the execution of this Agreement,
CytRx, Merger Subsidiary and Innovive Pharmaceuticals, Inc., a
Delaware corporation (the Company), are
entering into an Agreement and Plan of Merger (as it may be
amended, the Merger Agreement), providing for
the merger of Merger Subsidiary with and into the Company (the
Merger), pursuant to which the Company will
become a wholly owned subsidiary of CytRx;
WHEREAS, as of the date hereof, Stockholder is the record and
beneficial owner
of shares
of common stock, par value $0.001 per share, of the Company
(such shares, together with any other shares of Company common
stock acquired by Stockholder after the date hereof, being
collectively referred to herein as the
Shares); and
WHEREAS, as a condition to their willingness to enter into the
Merger Agreement, CytRx and Merger Subsidiary have required that
Stockholder enter into this Agreement and, in order to induce
CytRx and Merger Subsidiary to enter into the Merger Agreement,
Stockholder is willing to enter into this Agreement.
NOW, THEREFORE, in consideration of the foregoing and the mutual
covenants and agreements contained herein, the parties hereto,
intending to be legally bound hereby, agree as follows:
1. Agreements of Stockholder.
(a) Voting; Refrain From Certain Proxy
Solicitations. From the date hereof until any
termination of this Agreement in accordance with its terms, at
any meeting of the shareholders of the Company however called
(or any action by written consent in lieu of a meeting) and any
adjournment thereof, Stockholder shall vote the Shares (or cause
them to be voted) or (as appropriate) execute written consents
in respect thereof, (i) in favor of the adoption of the
Merger Agreement and the approval of the transactions
contemplated thereby, (ii) against any action or agreement
(including, without limitation, any amendment of any agreement)
that would result in a breach of any representation, warranty,
covenant, agreement or other obligation of the Company under the
Merger Agreement, (iii) against any Acquisition Proposal
and (iv) against any agreement (including, without
limitation, any amendment of any agreement), amendment of the
Companys charter documents or other action that is
intended or could reasonably be expected to prevent, impede,
interfere with, delay, postpone or discourage the consummation
of the Merger. Any such vote shall be cast (or consent shall be
given) by Stockholder in accordance with such procedures
relating thereto so as to ensure that it is duly counted,
including for purposes of determining that a quorum is present
and for purposes of recording the results of such vote (or
consent). Stockholder further covenants and agrees that he shall
not solicit proxies or participate in a solicitation with
respect to an Acquisition Proposal.
(b) Irrevocable
Proxy. Concurrently with the execution of
this Agreement, Stockholder agrees to deliver to CytRx a proxy
in the form attached hereto as Annex A (the
Proxy), which shall be irrevocable to the
extent provided therein.
(c) Restriction on Transfer; Other
Restrictions. From the date hereof until any
termination of this Agreement in accordance with its terms,
Stockholder shall not directly or indirectly (i) sell,
transfer (including by operation of law), give, pledge,
encumber, assign or otherwise dispose of, or enter into any
contract, option or other arrangement or understanding with
respect to the sale, transfer, gift, pledge, encumbrance,
assignment or other disposition of, any of the Shares (or any
right, title or interest thereto or therein), (ii) deposit
any of the Shares into a voting trust or grant any proxies or
enter into a voting agreement, power of attorney or voting trust
with respect to any of the Shares, (iii) take any action
that would make any representation or warranty of Stockholder
set forth in this Agreement untrue or incorrect in any material
respect or have the effect of preventing, disabling or delaying
Stockholder from performing any of his obligations under this
Agreement or (iv) agree (whether or not in writing) to take
any of the actions referred to in the foregoing clauses of this
Section 1(c). Notwithstanding the foregoing, Stockholder
(a) may transfer any of the
B-1
Shares, or execute an assignment with respect to the Shares, if
such transfer or assignment is made to a family member or a
controlled affiliate of the Stockholder or is made to a trust or
similar vehicle in connection with estate planning purposes;
provided that, in each case, the transferee, trustee, proxy
holder, or beneficiary of the Shares resulting from such
transfer or assignment executes a joinder agreement, reasonably
acceptable to CytRx and Merger Subsidiary, whereby such
transferee, proxy holder or beneficiary would become a party to
this Agreement and become subject to all of the rights and
obligations hereunder, or (b) with the prior written
consent of CytRx and Merger Subsidairy (which consent may be
withheld in their sole discretion), may transfer any of the
Shares, or execute an assignment with respect to the Shares,
other than as contemplated in clause (a).
2. Representation and Warranties of CytRx and
Merger Subsidiary. CytRx and Merger
Subsidiary jointly and severally represent and warrant to
Stockholder as follows:
(a) Due Authorization. This
Agreement has been authorized by all necessary corporate action
on the part of each of CytRx and Merger Subsidiary and has been
duly executed by a duly authorized officer of each of CytRx and
Merger Subsidiary.
(b) Validity; No Conflict. This
Agreement constitutes the legal, valid and binding obligation of
each of CytRx and Merger Subsidiary, enforceable against each of
them in accordance with its terms, except as such enforceability
may be limited by bankruptcy, insolvency, moratorium or other
similar laws affecting or relating to creditors rights
generally and by general principles of equity. Neither the
execution of this Agreement by CytRx and Merger Subsidiary nor
the consummation of the transactions contemplated hereby will
result in a breach or violation of the terms of any agreement by
which CytRx or any CytRx subsidiary is bound or of any decree,
judgment, order, law or regulation now in effect of any court or
other governmental body applicable to CytRx or any CytRx
subsidiary.
3. Representations and Warranties of
Stockholder. Stockholder hereby represents
and warrants to CytRx and Merger Subsidiary as follows:
(a) Validity; Consents and Approvals; No
Conflict. This Agreement constitutes the
legal, valid and binding obligation of Stockholder, enforceable
against Stockholder in accordance with its terms, except as such
enforceability may be limited by bankruptcy, insolvency,
moratorium or other similar laws affecting or relating to
creditors rights generally and by general principles of
equity. No consents or approvals of, or filings, declarations or
registrations with, any governmental agency are necessary for
the performance by Stockholder of its obligations under this
Agreement, other than such other consents, approvals, filings,
declarations or registrations that, if not obtained, made or
given, would not, individually or in the aggregate, reasonably
be expected to prevent or materially delay the performance by
Stockholder of any of his obligations under this Agreement.
Neither the execution and delivery of this Agreement by
Stockholder, nor the performance by Stockholder of his
obligations hereunder, will result in a breach or violation of
the terms of any agreement by which Stockholder is bound or of
any decree, judgment, order, law or regulation now in effect of
any court or other governmental body applicable to Stockholder.
(b) Ownership of Shares. Except as
specifically described on Annex B, Stockholder
(i) is the record and beneficial owner of all of the Shares
and (ii) owns all of the Shares free and clear of any
proxy, voting restriction, adverse claim or other Lien (other
than proxies and restrictions in favor of CytRx and Merger
Subsidiary pursuant to this Agreement and except for such
transfer restrictions of general applicability as may be
provided under the Securities Act and the blue sky
laws of the various states of the United States). Without
limiting the foregoing, except for certain proxies and
restrictions provided for in clause (ii) above, Stockholder
has sole voting power and sole power of disposition with respect
to all of the Shares, with no restrictions on Stockholders
rights of voting or disposition pertaining thereto and no Person
other than Stockholder has any right to direct or approve the
voting or disposition of any of the Shares. As of the date
hereof, Stockholder does not own, beneficially or of record, any
securities of the Company other
than shares
of common stock which constitute the Shares.
4. Termination. This
Agreement and the Proxy shall terminate on the first to occur of
(a) the termination of the Merger Agreement in accordance
with its terms and (b) the Effective Time. Notwithstanding
the foregoing,
B-2
(i) nothing herein shall relieve any party from liability
for breach of this Agreement and (ii) the provisions of
this Section 4 and Section 5 of this Agreement shall
survive any termination of this Agreement.
5. Miscellaneous.
(a) Action in Stockholder Capacity
Only. The parties acknowledge that this
Agreement is entered into by Stockholder in his capacity as
owner of the Shares and that nothing in this Agreement shall in
any way restrict or limit any director or officer of the Company
from taking any action in his capacity as a director or officer
of the Company that is necessary for him to comply with his
fiduciary duties as a director or officer of the Company,
including, without limitation, participating in his capacity as
a director of the Company in any discussions or negotiations in
accordance with Section 6.03 of the Merger Agreement.
(b) Expenses. Except as otherwise
expressly provided in this Agreement, all costs and expenses
incurred in connection with the transactions contemplated by
this Agreement shall be paid by the party incurring such costs
and expenses.
(c) Additional Shares. Until any
termination of this Agreement in accordance with its terms,
Stockholder shall promptly notify CytRx of the number of shares
of Company common stock, if any, as to which Stockholder
acquires record or beneficial ownership after the date hereof.
Any shares of Company common stock as to which Stockholder
acquires record or beneficial ownership after the date hereof
and prior to termination of this Agreement shall be
Shares for purposes of this Agreement. Without
limiting the foregoing, in the event of any stock split, stock
dividend or other change in the capital structure of the Company
affecting the Company common stock, the number of shares
constituting Shares shall be adjusted appropriately
and this Agreement and the obligations hereunder shall attach to
any additional shares of Company common stock or other voting
securities of the Company issued to Stockholder in connection
therewith.
(d) Definition of Beneficial
Ownership. For purposes of this
Agreement, beneficial ownership with respect to (or
to own beneficially) any securities shall mean
having beneficial ownership of such securities (as
determined pursuant to
Rule 13d-3
under the Exchange Act), including pursuant to any agreement,
arrangement or understanding, whether or not in writing.
(e) Further Assurances. From time
to time, at the request of CytRx and without further
consideration, Stockholder shall execute and deliver such
additional documents and take all such further action as may be
reasonably required to consummate and make effective, in the
most expeditious manner practicable, the transactions
contemplated by this Agreement.
(f) Entire Agreement; No Third Party
Beneficiaries. This Agreement constitutes the
entire agreement, and supersedes all prior agreements and
understandings, both written and oral, among the parties, or any
of them, with respect to the subject matter hereof. This
Agreement is not intended to and shall not confer upon any
Person other than the parties hereto any rights hereunder.
(g) Assignment; Binding
Effect. Neither this Agreement nor any of the
rights, interests or obligations hereunder shall be assigned by
any of the parties hereto without the prior written consent of
the other parties, except that (i) Merger Subsidiary may
assign its rights and interests hereunder to CytRx or to any
wholly owned subsidiary of CytRx if such assignment would not
cause a delay in the consummation of any of the transactions
contemplated by the Merger Agreement and (ii) the rights,
interests and obligations of Stockholder hereunder shall be
binding upon Stockholders heirs, trustees, executors and
other representatives in the event of Stockholders death
or incapacity. Subject to the preceding sentence, this Agreement
shall be binding upon and shall inure to the benefit of the
parties hereto and their respective successors and permitted
assigns. Any purported assignment not permitted under this
Section shall be null and void.
(h) Amendments. This Agreement may
not be amended or supplemented, except by a written agreement
executed by the parties hereto.
(i) Severability. If any term or
other provision of this Agreement is determined by a court of
competent jurisdiction to be invalid, illegal or incapable of
being enforced by any rule of law or public policy, all other
terms, provisions and conditions of this Agreement shall
nevertheless remain in full force and effect. Upon such
determination that any term or other provision is invalid,
illegal or incapable of being enforced, the parties hereto
B-3
shall negotiate in good faith to modify this Agreement so as to
effect the original intent of the parties as closely as possible
to the fullest extent permitted by applicable law in an
acceptable manner to the end that the transactions contemplated
hereby are fulfilled to the extent possible.
(j) Counterparts. This Agreement
may be executed in two or more separate counterparts, each of
which shall be deemed to be an original but all of which taken
together shall constitute one and the same agreement. This
Agreement shall become effective when each party hereto shall
have received counterparts hereof signed by the other parties
hereto.
(k) Descriptive Headings. Headings
of Sections and subsections of this Agreement are for
convenience of the parties only, and shall be given no
substantive or interpretive effect whatsoever.
(l) Notices. All notices, requests
and other communications to any party hereunder shall be in
writing (including facsimile transmission) and shall be given,
If to CytRx or Merger Subsidiary, to:
CytRx Corporation
11726 San Vicente Boulevard, Suite 650
Los Angeles, California 90049
Attention: Steven A. Kriegsman
Facsimile:
(310) 826-6139
with a copy (which shall not constitute notice) to:
TroyGould PC
1801 Century Park East,
16th
Floor
Los Angeles, California 90067
Attention: Sanford J. Hillsberg, Esq. and Dale E.
Short, Esq.
Facsimile:
(310) 201-4746
If to Stockholder, to:
Facsimile:
with a copy (which shall not constitute notice) to:
Attention:
Facsimile:
or such other address or facsimile number as such party may
hereafter specify for the purpose by notice to the other parties
hereto. All such notices, requests and other communications
shall be deemed received on the date of receipt by the recipient
thereof if received prior to 5 P.M. in the place of receipt
and such day is a business day in the place of receipt.
Otherwise, any such notice, request or communication shall be
deemed not to have been received until the next succeeding
business day in the place of receipt.
(m) Governing Law; Enforcement;
Jurisdiction. This Agreement shall be
governed by, and construed in accordance with, the laws of the
State of Delaware, applicable to contracts executed in and to be
performed entirely
B-4
within that State. All actions and proceedings arising out of or
relating to this Agreement shall be heard and determined in any
federal or state court sitting in the State of Delaware, and the
parties hereto hereby irrevocably submit to the exclusive
jurisdiction of such courts in any such action or proceeding and
irrevocably waive the defense of an inconvenient forum to the
maintenance of any such action or proceeding. The parties hereto
agree that a final judgment in any such action or proceeding
shall be conclusive and may be enforced in other jurisdictions
by suit on the judgment or in any other manner provided by
applicable law.
(n) Specific Performance; Injunctive
Relief. The parties agree that irreparable
damage would occur in the event that any of the provisions of
this Agreement were not performed in accordance with their
specific terms or were otherwise breached. It is accordingly
agreed that the parties shall be entitled to an injunction or
injunctions to prevent breaches of this Agreement and to enforce
specifically the terms and provisions of this Agreement in any
federal or state court sitting in the State of Delaware, this
being in addition to any other remedy to which they are entitled
at law or in equity.
(o) Definitions. Capitalized terms
not otherwise defined herein shall have the meanings ascribed
thereto in the Merger Agreement.
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]
B-5
IN WITNESS WHEREOF, the parties hereto have duly executed and
delivered this Agreement as of the date and year first written
above.
CYTRX CORPORATION
Name: Steven A. Kriegsman
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Title:
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President and Chief Executive Officer
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CYTRX MERGER SUBSIDIARY, INC.
Name: Steven A. Kriegsman
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Title:
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President and Chief Executive Officer
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Name:
THE UNDERSIGNED, SPOUSE OF THE SHAREHOLDER, HEREBY EXPRESSLY
APPROVES AND AGREES TO BE BOUND BY THE PROVISIONS OF THIS
AGREEMENT, AND HEREBY AGREES NOT TO DEVISE OR BEQUEATH WHATEVER
COMMUNITY PROPERTY INTEREST OR QUASI-COMMUNITY PROPERTY INTEREST
THE UNDERSIGNED MAY HAVE IN THE SHARES IN CONTRAVENTION OF
THE TERMS OF THIS AGREEMENT.
(spouse
of
)
B-6
ANNEX A
IRREVOCABLE
PROXY
The undersigned Stockholder of Innovive Pharmaceuticals, Inc., a
Delaware corporation (the Company), hereby
irrevocably appoints and constitutes the members of the Board of
Directors of CytRx Corporation, a Delaware corporation
(CytRx), and each of them (the
Proxyholders), the proxies of the
undersigned, with full power of substitution and resubstitution,
to the full extent of the undersigneds rights with respect
to the shares of common stock of the Company beneficially owned
by the undersigned as of the date here, together with any other
shares of common stock of the Company acquired by Stockholder
after the date hereof and prior to the date this proxy
terminates (collectively, the Shares), to
vote the Shares for the following limited, and for no other,
purposes:
1. In favor of adoption of the Agreement and Plan of
Merger, dated as of June 6, 2008, by and among CytRx, CytRx
Merger Subsidiary, Inc., a Delaware corporation and wholly owned
subsidiary of CytRx (Merger Subsidiary), and
the Company, as the same may be amended from time to time, and
approval of the transactions contemplated by the Merger
Agreement; and
2. Against (A) any action or agreement (including,
without limitation, any amendment of any agreement) that would
result in a breach of any representation, warranty, covenant,
agreement or other obligation of the Company under the Merger
Agreement, (B) any Acquisition Proposal (as such term is
defined in the Merger Agreement) and (C) any agreement
(including, without limitation, any amendment of any agreement),
amendment of the Companys charter documents or other
action that is intended or could reasonably be expected to
prevent, impede, interfere with, delay, postpone or discourage
the consummation of the Merger.
The Proxyholders may not exercise this proxy on any other
matter. The undersigned Stockholder may vote the Shares on all
such other matters.
The proxies named above are empowered at any time prior to
termination of this proxy to exercise all voting rights
(including the power to execute and deliver written consents
with respect to the Shares) of the undersigned at every annual,
special or adjourned meeting of Company shareholders, and in
every written consent in lieu of such meeting, or otherwise.
The proxy granted by the Stockholder to the Proxyholders is
hereby granted as of the date hereof in connection with the
obligations of the Stockholder set forth in the Support
Agreement, dated as of June 6, 2008, among CytRx, Merger
Subsidiary and the Stockholder (the Support
Agreement), and is irrevocable and coupled with an
interest in such obligations and in the interests in the Company
to be purchased and sold pursuant to the Merger Agreement. This
proxy will automatically terminate upon the termination of the
Support Agreement in accordance with its terms.
Upon the execution hereof, all prior proxies given by the
undersigned with respect to the Shares, and any and all other
shares or securities issued or issuable in respect thereof on or
after the date hereof, are hereby revoked and no subsequent
proxies will be given until such time as this proxy shall be
terminated in accordance with its terms.
Any obligation of the undersigned hereunder shall be binding
upon the successors and assigns of the undersigned. The
undersigned hereby authorizes the Proxyholders to file this
proxy and any substitution or revocation of substitution with
the Secretary of the Company and with any Inspector of Elections
at any meeting of Stockholders of the Company.
This proxy is irrevocable and shall survive the incapacity or
death of the undersigned.
[
]
Dated: June 6, 2008
THE UNDERSIGNED, SPOUSE OF THE SHAREHOLDER, HEREBY EXPRESSLY
APPROVES AND AGREES TO BE BOUND BY THE PROVISIONS OF THIS PROXY,
AND HEREBY AGREES NOT TO DEVISE OR BEQUEATH WHATEVER COMMUNITY
PROPERTY INTEREST OR QUASI-COMMUNITY PROPERTY INTEREST THE
UNDERSIGNED MAY HAVE IN THE SHARES IN CONTRAVENTION OF THE
TERMS OF THIS PROXY.
(spouse
of
)
A-1
ANNEX B
OWNERSHIP
OF SHARES
B-1
APPENDIX C
Chartered Capital
Advisers, Inc.
590 Madison Avenue
. 21st
Floor
New York, New York
10022
(212) 327-0200
.
(212) 327-0225
Fax
June 6, 2008
Board of Directors
Innovive Pharmaceuticals, Inc.
555 Madison Avenue,
25th
Floor
New York, New York 10022
Dear Members of the Board of Directors:
We understand that the board of directors (the
Board) of Innovive Pharmaceuticals, Inc.
(IVPH or the Company) is evaluating a
proposed merger (the Proposed Merger) by and among
IVPH and a newly created, wholly owned merger subsidiary of
CytRx Corporation (CytRx). The Board has engaged
Chartered Capital Advisers, Inc. (CCA) to analyze
and, if appropriate, render an opinion to the Board regarding
the fairness of the Proposed Merger, from a financial point of
view, to the shareholders of IVPH.
Under the terms of the Proposed Merger, Merger
Consideration1
would be allocated on a pro rata basis among the fully diluted
shares of IVPH that are outstanding as of the effective date of
the Proposed Merger. Merger Consideration would be comprised of
the sum of Initial Merger Consideration and Earnout Merger
Consideration. Initial Merger Consideration would amount to
$3,000,000. Earnout Merger Consideration would be based on net
sales, as defined under the Company License Agreements,
generated during the Earnout Period, calculated as follows:
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Net Sales
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Earnout Merger Consideration
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$ 2,000,000
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$2,000,000
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$15,000,000
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Additional $5,000,000
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$30,000,000
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Additional $5,000,000
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$40,000,000
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Additional $6,253,462 plus the excess of Estimated Net
Liabilities over actual Net Liabilities, subject to certain
potential adjustments
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Earnout Merger Consideration would be payable only with respect
to the first year during the Earnout Period in which target Net
Sales are achieved; target Net Sales previously met and achieved
again during subsequent years would not be considered in
determining Earnout Merger Consideration. Notwithstanding the
foregoing, the maximum number of shares of CytRx common stock
issued as payment of Initial Merger Consideration and Earnout
Merger Consideration cannot exceed 18,145,013 shares
(subject to adjustment for reverse and forward splits, stock
dividends, stock combinations, and similar events affecting
CytRx common stock), unless such issuance is approved by the
requisite vote or consent of CytRx stockholders. The Earnout
period terminates upon the earlier of: (1) the end of the
first calendar year in which Net Sales equal or exceed
$40,000,000; or (2) the expiration of the last of the
patents licensed to IVPH under the Company License Agreements.
The Initial Merger Consideration is payable in CytRx common
stock valued based on the daily average volume-weighted closing
price of CytRx common stock during the ten trading days
preceding the signing of the Merger Agreement. Payment of the
Initial Merger Consideration would be made by an independent
Disbursing Agent upon receiving certificates representing shares
of the Companys common stock. Earnout Merger Consideration
would be payable promptly, and under no circumstances paid later
than 90 days following the end of the year in which it was
earned. Earnout
1 Terms
not defined herein are consistent with the definitions contained
in the Agreement and Plan of Merger (the Merger
Agreement) dated as of June 6, 2008 among Innovive
Pharmaceuticals, Inc., CytRx Corporation, CytRx Merger
Subsidiary, Inc., and Steven Kelly (as the Stockholder
Representative), and documents relating thereto.
C-1
Merger Consideration would be payable, at the discretion of
CytRx, in cash
and/or CytRx
common stock. The value attributed to CytRx common stock in
paying Earnout Merger Consideration would be the average of the
daily Market Price of CytRx common stock during the ten-Trading
Day period ending the second Trading Day prior to the payment of
the Earnout Consideration. All of the Companys options are
out of the money, and would be terminated; therefore, they would
not participate in the Initial Merger Consideration or the
Earnout Merger Consideration. The vast majority of the
outstanding warrants to purchase the Companys common stock
would remain outstanding and become exercisable for the
consideration they would have received if they had been
exercised prior to the effective date of the Proposed Merger,
and thus the holders thereof may participate in the Initial
Merger Consideration and Earnout Merger Consideration.
CCA is customarily engaged in the valuation of securities and
other financial advisory work in connection with mergers and
acquisitions, recapitalizations, private placements, financial
restructuring, shareholder transactions, financial reporting,
estate and gift taxes, litigation, and for other purposes.
In connection with rendering our opinions we have, among other
things:
(i) Reviewed the Merger Agreement and various documents
relating thereto;
(ii) Conferred with Management, its legal advisors, and the
management of CytRx;
(iii) Reviewed various documents and other information
prepared by or in connection with the Company including, but not
limited to documents filed with the Securities and Exchange
Commission, historical financial statements, a balance sheet as
of May 31, 2008, financial projections, a summary of
financing contacts, an investor presentation dated as of May
2008, technical documentation, and the Company Website;
(iv) Reviewed various documents and other information
prepared by or in connection with CytRx including, but not
limited to documents filed with the Securities and Exchange
Commission, historical financial statements, analyst reports,
and the CytRx Website;
(v) Analyzed the historical financial performance and
financial condition of IVPH and CytRx;
(vi) Analyzed the IVPH financial projections prepared by
Management;
(vii) Analyzed the historical stock prices of IVPH and
CytRx;
(viii) Considered the Companys current
capitalization, financial condition, and risks relating thereto;
(ix) Evaluated the proposed consideration to IVPH equity
holders reflected in the Proposed Merger, taking into
consideration various valuation benchmarks including:
a. Net book value;
b. Current and historical market price of IVPH common stock;
c. Premiums paid in mergers deemed to be relevant to IVPH;
d. Discounted cash flow analysis;
e. Capitalization multiples of guideline public
companies; and
f. Capitalization multiples paid in acquisitions deemed to
be relevant to IVPH;
(x) Considered the historical experience of Management and
the investment bankers that it retained to pursue capital
infusions and other potential transactions;
(xi) Considered the potential perception of the Company and
its investment prospects from the vantage point of investors
capable of committing the amount of capital required by the
Company, and the amount of dilution that may result from a
potential capital infusion;
(xii) Considered the current financing environment for
financing development-stage companies similar to IVPH;
(xiii) Considered the process employed by Management to
negotiate the Proposed Merger;
C-2
(xiv) Considered the risks of rejecting the Proposed Merger
in order to seek an enhanced transaction with CytRx or an
improved transaction with an alternative investor or
acquirer; and
(xv) Considered such other information, financial studies,
and analyses as we deemed relevant, and performed such analyses,
studies, and investigations as we deemed appropriate.
Chartered Capital Advisers has assumed and relied upon, without
independent verification, the accuracy and completeness of the
information reviewed by us that was obtained from Management,
CytRx, and from public sources that are routinely used in our
profession. We have assumed that: (i) the representations
of Management and its advisors have been made in good faith, and
that they reflect the best currently available Management
judgments as to the matters covered; and (ii) that the
distributions of Initial Merger Consideration and Earnout Merger
Consideration would be made on a timely basis in accordance with
the provisions of the Merger Agreement.
Our opinion is necessarily based upon economic, market, and
other conditions as in effect on, and the information made
available to us as of, the date hereof. CCA disclaims any
undertaking or obligation to advise any person of any change in
any fact or matter affecting our opinion which may come up or be
brought to our attention after the date hereof. Notwithstanding
and without limiting the foregoing, in the event that there is
any change of fact or matter affecting our opinion after the
date hereof and prior to the consummation of the Proposed
Merger, CCA reserves the right to change, modify, or withdraw
this letter.
Our opinion is limited to the fairness of the Proposed Merger,
taken as a whole, as of the date hereof, from a financial point
of view, to the shareholders of IVPH. No other party, such as
the creditors, employees, option holders, or warrant holders of
IVPH, or the management, board of directors, or equity holders
or creditors of CytRx, may rely upon this opinion. This opinion
should not be construed as a valuation opinion, credit rating,
solvency opinion, an analysis of the Companys credit
worthiness, or otherwise as tax advice, accounting advice, or
investment advice. This opinion should not be construed as
creating any fiduciary duty on CCAs part to any party. We
are not expressing any opinion as to the fair market value or
investment merits of IVPH or CytRx common stock, or the total
Merger Consideration to be received by IVPH shareholders if the
Proposed Merger is consummated. We make no representations
regarding the business decision by the Board to agree to the
Proposed Merger, the capacity of CytRx to fulfill its
obligations under the Proposed Merger, the current or future
value or marketability of CytRx common stock, or the fairness of
the Proposed Merger to any party other than the IVPH
shareholders. This letter is not intended to substitute for the
Boards exercise of its own business judgment in reviewing
the Proposed Merger. We have not been engaged to negotiate the
Proposed Merger or to determine whether the terms could be
enhanced, or to determine whether a transaction could be
consummated with an alternative merger partner or source of
financing.
It is understood that this opinion is for the information of the
Board and its advisors in connection with the Proposed Merger,
and may not be used for any other purpose without our prior
written consent, except that the Company may review, summarize,
or otherwise reference the existence of this opinion in
documents pertaining to the Proposed Merger, provided that any
such summary or reference language shall be subject to the prior
approval of CCA. This opinion is not a recommendation as to how
the Board or IVPH shareholders should vote or act with respect
to any matters pertaining to the Proposed Merger, or whether to
proceed with the Proposed Merger, or any related transaction,
nor does it indicate that the proposed consideration is the best
possible attainable under any circumstances. The decision as to
whether to proceed with the Proposed Merger or any related
transaction may depend on an assessment of factors unrelated to
the financial analyses on which our opinion is based.
Based upon and subject to the foregoing considerations, it is
our opinion that, as of the date hereof the Proposed Merger is
fair, from a financial point of view, to the shareholders of
IVPH.
C-3
The foregoing opinion is to be used solely for the information
and assistance of the Board. Accordingly, it is understood that
no person other than the Board and its advisors and shareholders
shall be allowed to use or rely upon this opinion.
Yours truly,
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CHARTERED CAPITAL ADVISERS, INC.
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Ronald G. Quintero, CPA, CFA, ABV, CDBV
Managing Director
C-4
APPENDIX D
TITLE 8
Corporations
CHAPTER 1. GENERAL CORPORATION LAW
Subchapter IX. Merger, Consolidation or Conversion
§ 262. Appraisal rights.
(a) Any stockholder of a corporation of this State who
holds shares of stock on the date of the making of a demand
pursuant to subsection (d) of this section with respect to
such shares, who continuously holds such shares through the
effective date of the merger or consolidation, who has otherwise
complied with subsection (d) of this section and who has
neither voted in favor of the merger or consolidation nor
consented thereto in writing pursuant to § 228 of this
title shall be entitled to an appraisal by the Court of Chancery
of the fair value of the stockholders shares of stock
under the circumstances described in subsections (b) and
(c) of this section. As used in this section, the word
stockholder means a holder of record of stock in a
stock corporation and also a member of record of a nonstock
corporation; the words stock and share
mean and include what is ordinarily meant by those words and
also membership or membership interest of a member of a nonstock
corporation; and the words depository receipt mean a
receipt or other instrument issued by a depository representing
an interest in one or more shares, or fractions thereof, solely
of stock of a corporation, which stock is deposited with the
depository.
(b) Appraisal rights shall be available for the shares of
any class or series of stock of a constituent corporation in a
merger or consolidation to be effected pursuant to
§ 251 (other than a merger effected pursuant to
§ 251(g) of this title), § 252,
§ 254, § 257, § 258,
§ 263 or § 264 of this title:
(1) Provided, however, that no appraisal rights under this
section shall be available for the shares of any class or series
of stock, which stock, or depository receipts in respect
thereof, at the record date fixed to determine the stockholders
entitled to receive notice of and to vote at the meeting of
stockholders to act upon the agreement of merger or
consolidation, were either (i) listed on a national
securities exchange or (ii) held of record by more than
2,000 holders; and further provided that no appraisal rights
shall be available for any shares of stock of the constituent
corporation surviving a merger if the merger did not require for
its approval the vote of the stockholders of the surviving
corporation as provided in subsection (f) of
§ 251 of this title.
(2) Notwithstanding paragraph (1) of this subsection,
appraisal rights under this section shall be available for the
shares of any class or series of stock of a constituent
corporation if the holders thereof are required by the terms of
an agreement of merger or consolidation pursuant to
§§ 251, 252, 254, 257, 258, 263 and 264 of this
title to accept for such stock anything except:
a. Shares of stock of the corporation surviving or
resulting from such merger or consolidation, or depository
receipts in respect thereof;
b. Shares of stock of any other corporation, or depository
receipts in respect thereof, which shares of stock (or
depository receipts in respect thereof) or depository receipts
at the effective date of the merger or consolidation will be
either listed on a national securities exchange or held of
record by more than 2,000 holders;
c. Cash in lieu of fractional shares or fractional
depository receipts described in the foregoing subparagraphs a.
and b. of this paragraph; or
d. Any combination of the shares of stock, depository
receipts and cash in lieu of fractional shares or fractional
depository receipts described in the foregoing subparagraphs a.,
b. and c. of this paragraph.
D-1
(3) In the event all of the stock of a subsidiary Delaware
corporation party to a merger effected under § 253 of
this title is not owned by the parent corporation immediately
prior to the merger, appraisal rights shall be available for the
shares of the subsidiary Delaware corporation.
(c) Any corporation may provide in its certificate of
incorporation that appraisal rights under this section shall be
available for the shares of any class or series of its stock as
a result of an amendment to its certificate of incorporation,
any merger or consolidation in which the corporation is a
constituent corporation or the sale of all or substantially all
of the assets of the corporation. If the certificate of
incorporation contains such a provision, the procedures of this
section, including those set forth in subsections (d) and
(e) of this section, shall apply as nearly as is
practicable.
(d) Appraisal rights shall be perfected as follows:
(1) If a proposed merger or consolidation for which
appraisal rights are provided under this section is to be
submitted for approval at a meeting of stockholders, the
corporation, not less than 20 days prior to the meeting,
shall notify each of its stockholders who was such on the record
date for such meeting with respect to shares for which appraisal
rights are available pursuant to subsection (b) or
(c) hereof that appraisal rights are available for any or
all of the shares of the constituent corporations, and shall
include in such notice a copy of this section. Each stockholder
electing to demand the appraisal of such stockholders
shares shall deliver to the corporation, before the taking of
the vote on the merger or consolidation, a written demand for
appraisal of such stockholders shares. Such demand will be
sufficient if it reasonably informs the corporation of the
identity of the stockholder and that the stockholder intends
thereby to demand the appraisal of such stockholders
shares. A proxy or vote against the merger or consolidation
shall not constitute such a demand. A stockholder electing to
take such action must do so by a separate written demand as
herein provided. Within 10 days after the effective date of
such merger or consolidation, the surviving or resulting
corporation shall notify each stockholder of each constituent
corporation who has complied with this subsection and has not
voted in favor of or consented to the merger or consolidation of
the date that the merger or consolidation has become
effective; or
(2) If the merger or consolidation was approved pursuant to
§ 228 or § 253 of this title, then either a
constituent corporation before the effective date of the merger
or consolidation or the surviving or resulting corporation
within 10 days thereafter shall notify each of the holders
of any class or series of stock of such constituent corporation
who are entitled to appraisal rights of the approval of the
merger or consolidation and that appraisal rights are available
for any or all shares of such class or series of stock of such
constituent corporation, and shall include in such notice a copy
of this section. Such notice may, and, if given on or after the
effective date of the merger or consolidation, shall, also
notify such stockholders of the effective date of the merger or
consolidation. Any stockholder entitled to appraisal rights may,
within 20 days after the date of mailing of such notice,
demand in writing from the surviving or resulting corporation
the appraisal of such holders shares. Such demand will be
sufficient if it reasonably informs the corporation of the
identity of the stockholder and that the stockholder intends
thereby to demand the appraisal of such holders shares. If
such notice did not notify stockholders of the effective date of
the merger or consolidation, either (i) each such
constituent corporation shall send a second notice before the
effective date of the merger or consolidation notifying each of
the holders of any class or series of stock of such constituent
corporation that are entitled to appraisal rights of the
effective date of the merger or consolidation or (ii) the
surviving or resulting corporation shall send such a second
notice to all such holders on or within 10 days after such
effective date; provided, however, that if such second notice is
sent more than 20 days following the sending of the first
notice, such second notice need only be sent to each stockholder
who is entitled to appraisal rights and who has demanded
appraisal of such holders shares in accordance with this
subsection. An affidavit of the secretary or assistant secretary
or of the transfer agent of the corporation that is required to
give either notice that such notice has been given shall, in the
absence of fraud, be prima facie evidence of the facts stated
therein. For purposes of determining the stockholders entitled
to receive either notice, each constituent corporation may fix,
in advance, a record date that shall be not more than
10 days prior to the date the notice is given, provided,
that if the notice is given on or after the effective date of
the merger or consolidation, the record date shall be such
effective date. If no record date is fixed and the notice is
given prior to the effective date, the record date shall be the
close of business on the day next preceding the day on which the
notice is given.
D-2
(e) Within 120 days after the effective date of the
merger or consolidation, the surviving or resulting corporation
or any stockholder who has complied with subsections (a)
and (d) of this section hereof and who is otherwise
entitled to appraisal rights, may commence an appraisal
proceeding by filing a petition in the Court of Chancery
demanding a determination of the value of the stock of all such
stockholders. Notwithstanding the foregoing, at any time within
60 days after the effective date of the merger or
consolidation, any stockholder who has not commenced an
appraisal proceeding or joined that proceeding as a named party
shall have the right to withdraw such stockholders demand
for appraisal and to accept the terms offered upon the merger or
consolidation. Within 120 days after the effective date of
the merger or consolidation, any stockholder who has complied
with the requirements of subsections (a) and (d) of
this section hereof, upon written request, shall be entitled to
receive from the corporation surviving the merger or resulting
from the consolidation a statement setting forth the aggregate
number of shares not voted in favor of the merger or
consolidation and with respect to which demands for appraisal
have been received and the aggregate number of holders of such
shares. Such written statement shall be mailed to the
stockholder within 10 days after such stockholders
written request for such a statement is received by the
surviving or resulting corporation or within 10 days after
expiration of the period for delivery of demands for appraisal
under subsection (d) of this section hereof, whichever is
later. Notwithstanding subsection (a) of this section, a
person who is the beneficial owner of shares of such stock held
either in a voting trust or by a nominee on behalf of such
person may, in such persons own name, file a petition or
request from the corporation the statement described in this
subsection.
(f) Upon the filing of any such petition by a stockholder,
service of a copy thereof shall be made upon the surviving or
resulting corporation, which shall within 20 days after
such service file in the office of the Register in Chancery in
which the petition was filed a duly verified list containing the
names and addresses of all stockholders who have demanded
payment for their shares and with whom agreements as to the
value of their shares have not been reached by the surviving or
resulting corporation. If the petition shall be filed by the
surviving or resulting corporation, the petition shall be
accompanied by such a duly verified list. The Register in
Chancery, if so ordered by the Court, shall give notice of the
time and place fixed for the hearing of such petition by
registered or certified mail to the surviving or resulting
corporation and to the stockholders shown on the list at the
addresses therein stated. Such notice shall also be given by 1
or more publications at least 1 week before the day of the
hearing, in a newspaper of general circulation published in the
City of Wilmington, Delaware or such publication as the Court
deems advisable. The forms of the notices by mail and by
publication shall be approved by the Court, and the costs
thereof shall be borne by the surviving or resulting corporation.
(g) At the hearing on such petition, the Court shall
determine the stockholders who have complied with this section
and who have become entitled to appraisal rights. The Court may
require the stockholders who have demanded an appraisal for
their shares and who hold stock represented by certificates to
submit their certificates of stock to the Register in Chancery
for notation thereon of the pendency of the appraisal
proceedings; and if any stockholder fails to comply with such
direction, the Court may dismiss the proceedings as to such
stockholder.
(h) After the Court determines the stockholders entitled to
an appraisal, the appraisal proceeding shall be conducted in
accordance with the rules of the Court of Chancery, including
any rules specifically governing appraisal proceedings. Through
such proceeding the Court shall determine the fair value of the
shares exclusive of any element of value arising from the
accomplishment or expectation of the merger or consolidation,
together with interest, if any, to be paid upon the amount
determined to be the fair value. In determining such fair value,
the Court shall take into account all relevant factors. Unless
the Court in its discretion determines otherwise for good cause
shown, interest from the effective date of the merger through
the date of payment of the judgment shall be compounded
quarterly and shall accrue at 5% over the Federal Reserve
discount rate (including any surcharge) as established from time
to time during the period between the effective date of the
merger and the date of payment of the judgment. Upon application
by the surviving or resulting corporation or by any stockholder
entitled to participate in the appraisal proceeding, the Court
may, in its discretion, proceed to trial upon the appraisal
prior to the final determination of the stockholders entitled to
an appraisal. Any stockholder whose name appears on the list
filed by the surviving or resulting corporation pursuant to
subsection (f) of this section and who has submitted such
D-3
stockholders certificates of stock to the Register in
Chancery, if such is required, may participate fully in all
proceedings until it is finally determined that such stockholder
is not entitled to appraisal rights under this section.
(i) The Court shall direct the payment of the fair value of
the shares, together with interest, if any, by the surviving or
resulting corporation to the stockholders entitled thereto.
Payment shall be so made to each such stockholder, in the case
of holders of uncertificated stock forthwith, and the case of
holders of shares represented by certificates upon the surrender
to the corporation of the certificates representing such stock.
The Courts decree may be enforced as other decrees in the
Court of Chancery may be enforced, whether such surviving or
resulting corporation be a corporation of this State or of any
state.
(j) The costs of the proceeding may be determined by the
Court and taxed upon the parties as the Court deems equitable in
the circumstances. Upon application of a stockholder, the Court
may order all or a portion of the expenses incurred by any
stockholder in connection with the appraisal proceeding,
including, without limitation, reasonable attorneys fees
and the fees and expenses of experts, to be charged pro rata
against the value of all the shares entitled to an appraisal.
(k) From and after the effective date of the merger or
consolidation, no stockholder who has demanded appraisal rights
as provided in subsection (d) of this section shall be
entitled to vote such stock for any purpose or to receive
payment of dividends or other distributions on the stock (except
dividends or other distributions payable to stockholders of
record at a date which is prior to the effective date of the
merger or consolidation); provided, however, that if no petition
for an appraisal shall be filed within the time provided in
subsection (e) of this section, or if such stockholder
shall deliver to the surviving or resulting corporation a
written withdrawal of such stockholders demand for an
appraisal and an acceptance of the merger or consolidation,
either within 60 days after the effective date of the
merger or consolidation as provided in subsection (e) of
this section or thereafter with the written approval of the
corporation, then the right of such stockholder to an appraisal
shall cease. Notwithstanding the foregoing, no appraisal
proceeding in the Court of Chancery shall be dismissed as to any
stockholder without the approval of the Court, and such approval
may be conditioned upon such terms as the Court deems just;
provided, however that this provision shall not affect the right
of any stockholder who has not commenced an appraisal proceeding
or joined that proceeding as a named party to withdraw such
stockholders demand for appraisal and to accept the terms
offered upon the merger or consolidation within 60 days
after the effective date of the merger or consolidation, as set
forth in subsection (e) of this section.
(l) The shares of the surviving or resulting corporation to
which the shares of such objecting stockholders would have been
converted had they assented to the merger or consolidation shall
have the status of authorized and unissued shares of the
surviving or resulting corporation. (8 Del. C. 1953,
§ 262; 56 Del. Laws, c. 50; 56 Del. Laws, c. 186,
§ 24; 57 Del. Laws, c. 148,
§§ 27-29;
59 Del. Laws, c. 106, § 12; 60 Del. Laws, c. 371,
§§ 3-12; 63 Del. Laws, c. 25, § 14; 63
Del. Laws, c. 152, §§ 1, 2; 64 Del. Laws, c. 112,
§§ 46-54;
66 Del. Laws, c. 136,
§§ 30-32;
66 Del. Laws, c. 352, § 9; 67 Del. Laws, c. 376,
§§ 19, 20; 68 Del. Laws, c. 337,
§§ 3, 4; 69 Del. Laws, c. 61, § 10; 69
Del. Laws, c. 262, §§ 1-9; 70 Del. Laws, c. 79,
§ 16; 70 Del. Laws, c. 186, § 1; 70 Del.
Laws, c. 299, §§ 2, 3; 70 Del. Laws, c. 349,
§ 22; 71 Del. Laws, c. 120, § 15; 71 Del.
Laws, c. 339,
§§ 49-52;
73 Del. Laws, c. 82, § 21; 76 Del. Laws, c. 145,
§§ 11-16.)
D-4
APPENDIX E
CYTRX
FINANCIAL STATEMENTS
AND FINANCIAL STATEMENT SCHEDULE
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Audited Consolidated Financial Statements
December 31, 2007, 2006 and 2005:
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Reports of Independent Registered Public Accounting Firm
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E-2
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Consolidated Balance Sheets
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E-5
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Consolidated Statements of Operations
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E-6
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Consolidated Statements of Stockholders Equity
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E-7
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Consolidated Statements of Cash Flows
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E-8
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Notes to Consolidated Financial Statements
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E-9
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Financial Statement Schedule Schedule II
Valuation and Qualifying Accounts
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E-29
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Unaudited Financial Statements March 31, 2008:
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Condensed Consolidated Balance Sheets
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E-30
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Condensed Consolidated Statements of Operations
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E-31
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Condensed Consolidated Statements of Cash Flows
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E-32
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Notes to Condensed Consolidated Financial Statements
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E-33
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E-1
REPORT OF
INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Board of Directors and Stockholders
CytRx Corporation
Los Angeles, California
We have audited the accompanying consolidated balance sheets of
CytRx Corporation (the Company) as of
December 31, 2007 and 2006 and the related consolidated
statements of operations, stockholders equity, and cash
flows for each of the three years in the period ended
December 31, 2007. We have also audited the schedule listed
in the accompanying index under Item 15a(2). These
financial statements and schedule are the responsibility of the
Companys management. Our responsibility is to express an
opinion on these financial statements and schedule based on our
audits.
We conducted our audits in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are
free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in
the financial statements, assessing the accounting principles
used and significant estimates made by management, as well as
evaluating the overall financial statement presentation. We
believe that our audits provide a reasonable basis for our
opinion.
In our opinion, the consolidated financial statements referred
to above present fairly, in all material respects, the financial
position of CytRx Corporation at December 31, 2007 and
2006, and the results of its operations and its cash flows for
each of the three years in the period ended December 31,
2007, in conformity with accounting principles generally
accepted in the United States of America. Also, in our opinion,
the schedule presents fairly, in all material respects, the
information set forth therein.
As more fully described in Note 2 to the consolidated
financial statements, effective January 1, 2006, the
Company adopted Statement of Financial Accounting Standard
(SFAS) No. 123 (revised 2004), Share-based
Payment.
We also have audited, in accordance with the standards of the
Public Company Accounting Oversight Board (United States), the
Companys internal control over financial reporting as of
December 31, 2007, based on criteria established in
Internal Control Integrated Framework issued
by the Committee of Sponsoring Organizations of the Treadway
Commission (COSO) and our report dated April 1, 2008,
expressed an adverse opinion on the effectiveness of the
Companys internal control over financial reporting due to
material weaknesses.
BDO Seidman, LLP
Los Angeles, California
April 1, 2008
E-2
REPORT OF
INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Board of Directors and Stockholders
CytRx Corporation
Los Angeles, California
We have audited CytRx Corporations (the
Company) internal control over financial reporting
as of December 31, 2007, based on criteria established in
Internal Control Integrated Framework issued
by the Committee of Sponsoring Organizations of the Treadway
Commission (the COSO criteria). CytRx
Corporations management is responsible for maintaining
effective internal control over financial reporting and for its
assessment of the effectiveness of internal control over
financial reporting, included in the accompanying,
Item 9A, Managements Report on Internal Control
Over Financial Reporting. Our responsibility is to express
an opinion on the Companys internal control over financial
reporting based on our audit.
We conducted our audit in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether effective internal control
over financial reporting was maintained in all material
respects. Our audit included obtaining an understanding of
internal control over financial reporting, assessing the risk
that a material weakness exists, and testing and evaluating the
design and operating effectiveness of internal control based on
the assessed risk. Our audit also included performing such other
procedures as we considered necessary in the circumstances. We
believe that our audit provides a reasonable basis for our
opinion.
A companys internal control over financial reporting is a
process designed to provide reasonable assurance regarding the
reliability of financial reporting and the preparation of
financial statements for external purposes in accordance with
generally accepted accounting principles in the United States of
America. A companys internal control over financial
reporting includes those policies and procedures that
(1) pertain to the maintenance of records that, in
reasonable detail, accurately and fairly reflect the
transactions and dispositions of the assets of the company;
(2) provide reasonable assurance that transactions are
recorded as necessary to permit preparation of financial
statements in accordance with generally accepted accounting
principles, and that receipts and expenditures of the company
are being made only in accordance with authorizations of
management and directors of the company; and (3) provide
reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use, or disposition of the
companys assets that could have a material effect on the
financial statements.
Because of its inherent limitations, internal control over
financial reporting may not prevent or detect misstatements.
Also, projections of any evaluation of effectiveness to future
periods are subject to the risk that controls may become
inadequate because of changes in conditions, or that the degree
of compliance with the policies or procedures may deteriorate.
A material weakness is a deficiency, or a combination of
deficiencies, in internal control over financial reporting, such
that there is a reasonable possibility that a material
misstatement of the companys annual or interim financial
statements will not be prevented or detected on a timely basis.
The following material weaknesses have been identified and
included in managements assessment. As of
December 31, 2007, the Company did not maintain effective
controls over its annual financial reporting process. We noted
during our substantive audit procedures that certain schedules
provided by management contained errors indicating that the
schedules had not been reviewed, or reviewed in sufficient
detail, to identify and correct the errors prior to the
schedules being provided for audit. We noted errors in schedules
relating to accrued liabilities, stock compensation, research
and development expenses and related revenue recognition. In
addition, we noted that there were lapses in the maintenance of
the Companys books and records. Material weaknesses in
financial reporting impacts the Companys ability to report
financial information in conformity with generally accepted
accounting principles in the United States of America, which
could affect all significant financial statement accounts. These
material weaknesses were considered in determining the nature,
timing and extent of audit tests applied in our audit of the
2007 consolidated financial statements, and this report does not
affect our report dated April 1, 2008 on those consolidated
financial statements.
E-3
In our opinion, CytRx Corporation did not maintain, in all
material respects, effective internal control over financial
reporting as of December 31, 2007, based on the COSO
criteria. We do not express an opinion or any other form of
assurance on managements statements referring to any
corrective actions taken by the Company after the date of
managements assessment.
We also have audited, in accordance with the standards of the
Public Company Accounting Oversight Board (United States), the
consolidated balance sheets of CytRx Corporation as of
December 31, 2007 and 2006, and the related consolidated
statements of operations, stockholders equity, and cash
flows for each of the three years in the period ended
December 31, 2007 and our report dated April 1, 2008
expressed an unqualified opinion thereon.
BDO Seidman, LLP
Los Angeles, California
April 1, 2008
E-4
CYTRX
CORPORATION
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
ASSETS
|
Current assets:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
50,498,261
|
|
|
$
|
30,381,393
|
|
Short-term investments, at amortized cost
|
|
|
9,951,548
|
|
|
|
|
|
Accounts receivable
|
|
|
101,217
|
|
|
|
105,930
|
|
Prepaid expenses and other current assets
|
|
|
930,596
|
|
|
|
233,323
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
61,481,622
|
|
|
|
30,720,646
|
|
Equipment and furnishings, net
|
|
|
1,573,290
|
|
|
|
252,719
|
|
Molecular library, net
|
|
|
193,946
|
|
|
|
283,460
|
|
Goodwill
|
|
|
183,780
|
|
|
|
183,780
|
|
Other assets
|
|
|
713,398
|
|
|
|
195,835
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
64,146,036
|
|
|
$
|
31,636,440
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY
|
Current liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
1,946,215
|
|
|
$
|
955,156
|
|
Accrued expenses and other current liabilities
|
|
|
3,700,866
|
|
|
|
2,722,478
|
|
Deferred revenue, current portion
|
|
|
8,399,167
|
|
|
|
6,733,350
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
14,046,248
|
|
|
|
10,410,984
|
|
Deferred revenue, non-current portion
|
|
|
7,167,381
|
|
|
|
16,075,117
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
21,213,629
|
|
|
|
26,486,101
|
|
|
|
|
|
|
|
|
|
|
Minority interest
|
|
|
2,708,368
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitment and contingencies
|
|
|
|
|
|
|
|
|
Stockholders equity:
|
|
|
|
|
|
|
|
|
Preferred Stock, $.01 par value, 5,000,000 shares
authorized, including 5,000 shares of Series A Junior
Participating Preferred Stock; no shares issued and outstanding
|
|
|
|
|
|
|
|
|
Common stock, $.001 par value, 150,000,000 shares
authorized; 90,397,867 and 70,788,586 shares issued and
outstanding at December 31, 2007 and 2006, respectively
|
|
|
90,398
|
|
|
|
70,789
|
|
Additional paid-in capital
|
|
|
203,905,691
|
|
|
|
146,961,657
|
|
Treasury stock, at cost (633,816 shares held, at
December 31, 2007 and 2006, respectively)
|
|
|
(2,279,238
|
)
|
|
|
(2,279,238
|
)
|
Accumulated deficit
|
|
|
(161,492,812
|
)
|
|
|
(139,602,869
|
)
|
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
40,224,039
|
|
|
|
5,150,339
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity
|
|
$
|
64,146,036
|
|
|
$
|
31,636,440
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these
consolidated financial statements.
E-5
CYTRX
CORPORATION
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
Service revenue
|
|
$
|
7,241,920
|
|
|
$
|
1,858,772
|
|
|
$
|
82,860
|
|
Licensing revenue
|
|
|
101,000
|
|
|
|
101,000
|
|
|
|
101,500
|
|
Grant revenue
|
|
|
116,118
|
|
|
|
105,930
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,459,038
|
|
|
|
2,065,702
|
|
|
|
184,360
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development (includes an aggregate of
462,112 shares of RXi common stock valued at $2,310,560
issued in exchange for licensing rights in the second quarter of
2007)
|
|
|
18,823,802
|
|
|
|
9,781,007
|
|
|
|
9,087,270
|
|
General and administrative
|
|
|
14,822,142
|
|
|
|
9,657,257
|
|
|
|
6,424,106
|
|
Depreciation and amortization
|
|
|
272,229
|
|
|
|
227,704
|
|
|
|
217,095
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
33,918,173
|
|
|
|
19,665,968
|
|
|
|
15,728,471
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before other income
|
|
|
(26,459,135
|
)
|
|
|
(17,600,266
|
)
|
|
|
(15,544,111
|
)
|
Other income:
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and dividend income
|
|
|
2,663,542
|
|
|
|
996,647
|
|
|
|
206,195
|
|
Gain on lease termination
|
|
|
|
|
|
|
|
|
|
|
163,604
|
|
Other income (expense), net
|
|
|
1,496,979
|
|
|
|
(3,205
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(22,298,614
|
)
|
|
|
(16,606,824
|
)
|
|
|
(15,174,312
|
)
|
Minority interest in losses of subsidiary
|
|
|
448,671
|
|
|
|
|
|
|
|
81,452
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss before provision for income taxes
|
|
|
(21,849,943
|
)
|
|
|
(16,606,824
|
)
|
|
|
(15,092,860
|
)
|
Provision for income taxes
|
|
|
(40,000
|
)
|
|
|
(145,000
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(21,889,943
|
)
|
|
|
(16,751,824
|
)
|
|
|
(15,092,860
|
)
|
Deemed dividend for anti-dilution adjustments made to
outstanding common stock warrants
|
|
|
|
|
|
|
(488,429
|
)
|
|
|
(1,075,568
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss applicable to common stockholders
|
|
$
|
(21,889,943
|
)
|
|
$
|
(17,240,253
|
)
|
|
$
|
(16,168,428
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share
|
|
$
|
(0.26
|
)
|
|
$
|
(0.25
|
)
|
|
$
|
(0.28
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted weighted average shares outstanding
|
|
|
84,006,728
|
|
|
|
68,105,626
|
|
|
|
56,852,402
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these
consolidated financial statements.
E-6
CYTRX
CORPORATION
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock
|
|
|
Paid-In
|
|
|
Accumulated
|
|
|
Treasury
|
|
|
|
|
|
|
Shares Issued
|
|
|
Amount
|
|
|
Capital
|
|
|
Deficit
|
|
|
Stock
|
|
|
Total
|
|
|
Balance at December 31, 2004
|
|
|
40,189,688
|
|
|
$
|
40,190
|
|
|
$
|
110,028,327
|
|
|
$
|
(106,194,187
|
)
|
|
$
|
(2,279,238
|
)
|
|
$
|
1,595,092
|
|
Common stock and warrants issued in connection with private
placements
|
|
|
18,084,494
|
|
|
|
18,084
|
|
|
|
19,572,362
|
|
|
|
|
|
|
|
|
|
|
|
19,590,446
|
|
Issuance of stock options/warrants:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For services and licenses
|
|
|
|
|
|
|
|
|
|
|
586,471
|
|
|
|
|
|
|
|
|
|
|
|
586,471
|
|
For minority interest
|
|
|
|
|
|
|
|
|
|
|
273,000
|
|
|
|
|
|
|
|
|
|
|
|
273,000
|
|
Options and warrants exercised
|
|
|
1,009,778
|
|
|
|
1,010
|
|
|
|
255,203
|
|
|
|
|
|
|
|
|
|
|
|
256,213
|
|
Deemed dividend
|
|
|
|
|
|
|
|
|
|
|
1,075,569
|
|
|
|
(1,075,569
|
)
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(15,092,860
|
)
|
|
|
|
|
|
|
(15,092,860
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2005
|
|
|
59,283,960
|
|
|
|
59,284
|
|
|
|
131,790,932
|
|
|
|
(122,362,616
|
)
|
|
|
(2,279,238
|
)
|
|
|
7,208,362
|
|
Common stock and warrants issued in connection with private
placements
|
|
|
10,650,795
|
|
|
|
10,651
|
|
|
|
12,393,709
|
|
|
|
|
|
|
|
|
|
|
|
12,404,360
|
|
Issuance of stock options/warrants for services and licenses
|
|
|
149,928
|
|
|
|
150
|
|
|
|
1,930,098
|
|
|
|
|
|
|
|
|
|
|
|
1,930,248
|
|
Options and warrants exercised
|
|
|
703,903
|
|
|
|
704
|
|
|
|
358,489
|
|
|
|
|
|
|
|
|
|
|
|
359,193
|
|
Deemed dividend
|
|
|
|
|
|
|
|
|
|
|
488,429
|
|
|
|
(488,429
|
)
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(16,751,824
|
)
|
|
|
|
|
|
|
(16,751,824
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006
|
|
|
70,788,586
|
|
|
|
70,789
|
|
|
|
146,961,657
|
|
|
|
(139,602,869
|
)
|
|
|
(2,279,238
|
)
|
|
|
5,150,339
|
|
Common stock and warrants issued in connection with private
placements
|
|
|
8,615,000
|
|
|
|
8,615
|
|
|
|
34,239,442
|
|
|
|
|
|
|
|
|
|
|
|
34,248,057
|
|
Issuance of stock options/warrants for services and licenses
|
|
|
|
|
|
|
|
|
|
|
2,402,035
|
|
|
|
|
|
|
|
|
|
|
|
2,402,035
|
|
Options and warrants exercised
|
|
|
10,994,281
|
|
|
|
10,994
|
|
|
|
18,778,180
|
|
|
|
|
|
|
|
|
|
|
|
18,789,174
|
|
Issuance of stock options by subsidiary
|
|
|
|
|
|
|
|
|
|
|
1,524,377
|
|
|
|
|
|
|
|
|
|
|
|
1,524,377
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(21,889,943
|
)
|
|
|
|
|
|
|
(21,889,943
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007
|
|
|
90,397,867
|
|
|
$
|
90,398
|
|
|
$
|
203,905,691
|
|
|
$
|
(161,492,812
|
)
|
|
$
|
(2,279,238
|
)
|
|
$
|
40,224,039
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these
consolidated financial statements.
E-7
CYTRX
CORPORATION
CONSOLIDATED
STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(21,889,943
|
)
|
|
$
|
(16,751,824
|
)
|
|
$
|
(15,092,860
|
)
|
Adjustments to reconcile net loss to net cash provided by (used
in) operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
272,229
|
|
|
|
227,704
|
|
|
|
217,095
|
|
Non-cash earned on short-term investments
|
|
|
(172,055
|
)
|
|
|
|
|
|
|
|
|
Loss on retirement of equipment
|
|
|
|
|
|
|
2,864
|
|
|
|
|
|
Minority interest in losses of subsidiary
|
|
|
(448,671
|
)
|
|
|
|
|
|
|
(81,452
|
)
|
Gain on lease termination
|
|
|
|
|
|
|
|
|
|
|
(163,604
|
)
|
Stock option and warrant expense
|
|
|
3,511,541
|
|
|
|
1,284,032
|
|
|
|
366,753
|
|
Common stock issued for services
|
|
|
3,089,639
|
|
|
|
262,500
|
|
|
|
|
|
Non-cash stock compensation related to research and development
|
|
|
|
|
|
|
411,530
|
|
|
|
219,718
|
|
Changes in assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
4,713
|
|
|
|
66,930
|
|
|
|
(172,860
|
)
|
Prepaid expenses and other current assets
|
|
|
(1,214,836
|
)
|
|
|
100,295
|
|
|
|
596,935
|
|
Accounts payable
|
|
|
757,086
|
|
|
|
139,530
|
|
|
|
(845,477
|
)
|
Deferred revenue
|
|
|
(7,241,919
|
)
|
|
|
22,533,467
|
|
|
|
|
|
Accrued expenses and other current liabilities
|
|
|
978,388
|
|
|
|
1,082,557
|
|
|
|
456,637
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total adjustments
|
|
|
(463,885
|
)
|
|
|
26,111,409
|
|
|
|
593,745
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) operating activities
|
|
|
(22,353,828
|
)
|
|
|
9,359,585
|
|
|
|
(14,499,115
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of short-term investments
|
|
|
(9,779,493
|
)
|
|
|
|
|
|
|
|
|
Redemption of short-term investments
|
|
|
|
|
|
|
|
|
|
|
1,011,814
|
|
Purchases of equipment and furnishings
|
|
|
(1,269,313
|
)
|
|
|
(41,133
|
)
|
|
|
(47,563
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities
|
|
|
(11,048,806
|
)
|
|
|
(41,133
|
)
|
|
|
964,251
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net proceeds from exercise of stock options and warrants
|
|
|
18,789,173
|
|
|
|
359,191
|
|
|
|
256,213
|
|
Net proceeds from issuances of common stock
|
|
|
34,248,058
|
|
|
|
12,404,360
|
|
|
|
19,590,446
|
|
Capital contributions from minority interest
|
|
|
482,271
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
53,519,502
|
|
|
|
12,763,551
|
|
|
|
19,846,659
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents
|
|
|
20,116,868
|
|
|
|
22,082,003
|
|
|
|
6,311,795
|
|
Cash and cash equivalents at beginning of year
|
|
|
30,381,393
|
|
|
|
8,299,390
|
|
|
|
1,987,595
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of year
|
|
$
|
50,498,261
|
|
|
$
|
30,381,393
|
|
|
$
|
8,299,390
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash received during the years for interest received
|
|
$
|
2,491,487
|
|
|
$
|
996,647
|
|
|
$
|
206,195
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid during the years for income taxes
|
|
$
|
183,461
|
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosures of non-cash investing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair market value of options and warrants provided for goods and
services
|
|
$
|
|
|
|
$
|
705,794
|
|
|
$
|
586,471
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair market value of common stock exchanged for minority
interest in subsidiary
|
|
$
|
|
|
|
$
|
|
|
|
$
|
273,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquisition of property and equipment through accrued liabilities
|
|
$
|
233,974
|
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash
financing activities:
During 2007, the Company allocated $289,254 of additional paid
in capital arising from subsidiary common stock options issued
to minority interest.
In connection with the Companys adjustments to terms of
certain outstanding warrants on January 20, 2005 and
March 2, 2006, the Company recorded deemed dividends of
$1,075,568 and $488,429, respectively, which were recorded as
charges to retained earnings with corresponding credits to
additional paid-in capital.
The accompanying notes are an integral part of these
consolidated financial statements.
E-8
CYTRX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS
CytRx Corporation (CytRx or the Company)
is clinical-stage biopharmaceutical company engaged in
developing human therapeutic products based primarily upon our
small-molecule molecular chaperone amplification technology.
Molecular chaperone proteins occur normally in human cells and
are key components of the bodys defenses against
potentially toxic mis-folded cellular proteins. Since damaged
toxic proteins called aggregates are thought to play a role in
many diseases, the Company believes that amplification of
molecular chaperone proteins could have therapeutic efficacy for
a broad range of indications. Currently, the Company is using
its chaperone amplification technology to develop treatments for
neurodegenerative disorders and diabetic complications. CytRx
currently owns approximately 49% of RXi Pharmaceuticals
Corporation, or RXi, which was founded in April 2006 by the
Company and four researchers in the field of RNAi, including
Dr. Craig Mello, recipient of the 2006 Nobel Prize for
Medicine for his co-discovery of RNAi. At December 31,
2007, CytRx owned approximately 85% of RXi, and on
March 11, 2007, CytRx paid approximately 36% of its shares
of RXi common stock as a dividend to CytRx stockholders. RNAi is
a naturally occurring mechanism for the regulation of gene
expression that has the potential to selectively inhibit the
activity of any human gene. RXi is focused solely on developing
and commercializing therapeutic products based upon RNAi
technologies for the treatment of human diseases, including
neurodegenerative diseases, cancer, type 2 diabetes and obesity.
At December 31, 2007, the Company had cash, cash
equivalents and short-term investments of $60.4 million,
including $11.7 million held by RXi. Management believes
that CytRxs current resources will be sufficient to
support its currently planned level of operations into the
second half of 2009. This estimate is based, in part, upon the
Companys currently projected expenditures for 2008 of
approximately $29.2 million, including approximately
$5.1 million for its clinical program for arimoclomol for
ALS and related studies, approximately $6.4 million for its
planned Phase II clinical trial of arimoclomol in stroke
patients and Phase II clinical trial of iroxanadine for
diabetic ulcers, approximately $9.2 million for equipping
and operating its research laboratory in San Diego,
California, and approximately $8.5 million for other
general and administrative expenses. Management believes that
RXis current resources will be sufficient to support its
currently planned level of operations into the second quarter of
2009. Projected expenditures for CytRx and RXi are based upon
numerous assumptions and subject to many uncertainties, and the
Companys actual expenditures may be significantly
different from these projections. The Company will be required
to obtain additional funding in order to execute its long-term
business plans, although it does not currently have commitments
from any third parties to provide it with capital. The Company
cannot assure that additional funding will be available on
favorable terms, or at all. If the Company fails to obtain
additional funding when needed, it may not be able to execute
its business plans and its business may suffer, which would have
a material adverse effect on its financial position, results of
operations and cash flows.
|
|
2.
|
Summary
of Significant Accounting Policies
|
Basis of Presentation and Principles of
Consolidation The consolidated financial
statements include the accounts of CytRx together with those of
its wholly-owned and majority-owned subsidiaries. The accounts
of CytRx Laboratories, less the minority interest, are included
through June 30, 2005, when the Company purchased the
outstanding 5% interest in CytRx Laboratories (see
Note 11) and CytRx Laboratories became wholly owned by
the Company. RXi began its operations in 2007, and had no
operations during 2006.
Revenue Recognition Biopharmaceutical
revenues consist of license fees from strategic alliances with
pharmaceutical companies as well as service and grant revenues.
Service revenues consist of contract research and laboratory
consulting. Grant revenues consist of government and private
grants.
Monies received for license fees are deferred and recognized
ratably over the performance period in accordance with Staff
Accounting Bulletin (SAB) No. 104, Revenue
Recognition. Milestone payments will be recognized upon
achievement of the milestone as long as the milestone is deemed
substantive and we have no other performance obligations related
to the milestone and collectability is reasonably assured, which
is generally
E-9
CYTRX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
upon receipt, or recognized upon termination of the agreement
and all related obligations. Deferred revenue represents amounts
received prior to revenue recognition.
Revenues from contract research, government grants, and
consulting fees are recognized over the respective contract
periods as the services are performed, provided there is
persuasive evidence or an arrangement, the fee is fixed or
determinable and collection of the related receivable is
reasonably assured. Once all conditions of the grant are met and
no contingencies remain outstanding, the revenue is recognized
as grant fee revenue and an earned but unbilled revenue
receivable is recorded.
In August 2006, the Company received approximately
$24.3 million in proceeds from the privately-funded ALS
Charitable Remainder Trust (ALSCRT) in exchange for
the commitment to continue research and development of
arimoclomol and other potential treatments for ALS and a one
percent royalty in the worldwide sales of arimoclomol. Under the
arrangement, the Company retains the rights to any products or
intellectual property funded by the arrangement and the proceeds
of the transaction are non-refundable. Further, the ALSCRT has
no obligation to provide any further funding to the Company. The
Company has concluded that due to the research and development
components of the transaction that it is properly accounted for
under Statement of Financial Accounting Standards No. 68,
Research and Development Arrangements. Accordingly, the
Company has recorded the value received under the arrangement as
deferred service revenue and will recognize service revenue
using the proportional performance method of revenue
recognition, meaning that service revenue is recognized on a
dollar-for-dollar basis for each dollar of expense incurred for
the research and development of arimoclomol and other potential
ALS treatments. The Company believes that this method best
approximates the efforts expended related to the services
provided. The Company adjusts its estimates of expense incurred
for this research and development on a quarterly basis. For the
years ended December 31, 2007 and 2006, the Company
recognized approximately $7.2 and $1.8 million,
respectively, of service revenue related to this transaction.
Any significant change in ALS related research and development
expense in any particular quarterly or annual period will result
in a change in the recognition of revenue for that period and
consequently affect the comparability or revenue from period to
period.
The amount of deferred revenue, current portion is
the amount of deferred revenue that is expected to be recognized
in the next twelve months and is subject to fluctuation based
upon managements estimates. Managements estimates
include an evaluation of what pre-clinical and clinical trials
are necessary, the timing of when trials will be performed and
the estimated clinical trial expenses. These estimates are
subject to changes and could have a significant effect on the
amount and timing of when the deferred revenues are recognized.
Other Income In June 2007, the Company
recognized $1.5 million of income arising from a fee
received pursuant to a
change-in-control
provision included in the purchase agreement for its 1998 sale
of its animal pharmaceutical unit. Management concluded that the
fee did not represent revenue generated from the Companys
normal course of its business, and accordingly the Company
recorded this fee as other income.
Cash Equivalents The Company considers all
highly liquid debt instruments with an original maturity of
90 days or less to be cash equivalents. Cash equivalents
consist primarily of amounts invested in money market accounts.
Fair Value of Financial Instruments The
carrying amounts reported in the balance sheet for cash and cash
equivalents approximate their fair values.
Short-term Investments RXi has purchased zero
coupon U.S Treasury Bills at a discount. These securities mature
within the next twelve months. They are classified as
held-to-maturity and under Statement of Financial Accounting
Standards No. 115, Investments in Debt Securities,
are measure at amortized cost since RXi has the intent and
ability to hold these securities to maturity. The interest
income has been amortized at the effective interest rate.
E-10
CYTRX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Equipment and Furnishings Equipment and
Furnishings are stated at cost and depreciated using the
straight-line method based on the estimated useful lives
(generally three to five years for equipment and furniture) of
the related assets. Whenever there is a triggering event that
might suggest an impairment, management evaluates the
realizability of recorded long-lived assets to determine whether
their carrying values have been impaired. The Company records
impairment losses on long-lived assets used in operations when
events and circumstances indicate that the assets might be
impaired and the non-discounted cash flows estimated to be
generated by those assets are less than the carrying amount of
those assets. Any impairment loss is measured by comparing the
fair value of the asset to its carrying amount.
Molecular Library The Molecular Library, a
collection of chemical compounds that the Company believes may
be developed into drug candidates, are stated at cost and
depreciated over five years; the estimated useful life of the
molecular library, which is less than the remaining life of the
related patents. The molecular library is presently used as a
tool in the Companys drug discovery program. On an annual
basis, or whenever there is a triggering event that might
suggest an impairment, management evaluates the realizability of
the molecular library to determine whether its carrying value
has been impaired. The Company records impairment losses on
long-lived assets used in operations when events and
circumstances indicate that the assets might be impaired and the
non-discounted cash flows estimated to be generated by those
assets are less than the carrying amount of those assets. Any
impairment loss is measured by comparing the fair value of the
asset to its carrying amount.
Impairment of Long-Lived Assets The Company
reviews long-lived assets, including finite lived intangible
assets, for impairment on an annual basis, as of
December 31, or on an interim basis if an event occurs that
might reduce the fair value of such assets below their carrying
values. An impairment loss would be recognized based on the
difference between the carrying value of the asset and its
estimated fair value, which would be determined based on either
discounted future cash flows or other appropriate fair value
methods.
Patents and Patent Application Costs Although
the Company believes that its patents and underlying technology
have continuing value, the amount of future benefits to be
derived from the patents is uncertain. Patent costs are
therefore expensed as incurred.
Basic and Diluted Loss per Common Share Basic
and diluted loss per common share are computed based on the
weighted average number of common shares outstanding. Common
share equivalents (which consist of options and warrants) are
excluded from the computation of diluted loss per share since
the effect would be antidilutive. Common share equivalents which
could potentially dilute basic earnings per share in the future,
and which were excluded from the computation of diluted loss per
share, totaled approximately 17.1 million shares,
30.2 million shares and 24.7 million shares at
December 31, 2007, 2006 and 2005, respectively. In
connection with the Companys adjustment to the exercise
terms of certain outstanding warrants to purchase common stock
on March 2, 2006 and January 20, 2005, the Company
recorded deemed dividends of $488,000 and $1.1 million,
respectively. These deemed dividends are reflected as an
adjustment to net loss for the first quarter of 2006 and the
year ended 2005 to arrive at net loss applicable to common
stockholders on the consolidated statement of operations and for
purposes of calculating basic and diluted earnings per shares.
Shares Reserved for Future Issuance As of
December 31, 2007, the Company has reserved approximately
2.2 million of its authorized but unissued shares of common
stock for future issuance pursuant to its employee stock option
plans issued to consultants and investors.
Stock-based Compensation Prior to
January 1, 2006, the Company accounted for its stock based
compensation plans under the recognition and measurement
provisions of Accounting Principles Board No. 25,
Accounting for Stock Issued to Employees (APB 25),
and related interpretations for all awards granted to employees.
Under APB 25, when the exercise price of options granted to
employees under these plans equals the market price of the
common stock on the date of grant, no compensation expense is
recorded. When the exercise price of options granted to
employees under these plans is less than the market price of the
common stock on the date of grant, compensation expense is
recognized over the vesting period.
E-11
CYTRX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The Companys share-based employee compensation plans are
described in Note 12. On January 1, 2006, the Company
adopted SFAS 123(R), Accounting for Stock-based
Compensation (Revised 2004) (123(R)), which
requires the measurement and recognition of compensation expense
for all share-based payment awards made to employees,
non-employee directors, and consultants, including employee
stock options. SFAS 123(R) supersedes the Companys
previous accounting under APB 25 and SFAS 123, for periods
beginning in fiscal 2006. In March 2005, the Securities and
Exchange Commission issued SAB 107 relating to
SFAS 123(R). The Company has applied the provisions of
SAB 107 in its adoption of SFAS 123(R).
The Company adopted SFAS 123(R) using the modified
prospective transition method, which requires the application of
the accounting standard as of January 1, 2006, the first
day of the Companys fiscal year 2006. The following table
illustrates the pro forma effect on net loss and net loss per
share assuming the Company had applied the fair value
recognition provisions of SFAS 123 to options granted under
the Companys stock option plans for the year ending
December 31, 2005. For purposes of this presentation, the
value of the options is estimated using a Black Scholes
option-pricing model and recognized as an expense on a
straight-line basis over the options vesting periods.
Numbers presented are in thousands with the exception of per
share data.
|
|
|
|
|
|
|
Year Ended
|
|
|
|
December 31, 2005
|
|
|
Net loss applicable to common stockholders
|
|
$
|
(16,168
|
)
|
Total stock-based employee compensation expense determined under
fair-value based method for all awards
|
|
|
(1,388
|
)
|
|
|
|
|
|
Pro forma net loss
|
|
$
|
(17,556
|
)
|
|
|
|
|
|
Loss per share, as reported (basic and diluted)
|
|
$
|
(0.28
|
)
|
Loss per share, pro forma (basic and diluted)
|
|
$
|
(0.31
|
)
|
The Companys Statement of Operations as of and for the
years ended December 31, 2006 and 2007 reflects the impact
of SFAS 123(R). In accordance with the modified prospective
transition method, the Companys Statements of Operations
for prior periods have not been restated to reflect, and do not
include, the impact of SFAS 123(R). Share-based
compensation expense recognized under SFAS 123(R) for the
years ended December 31, 2007 and 2006 was
$2.7 million and $1.2 million, respectively. As of
December 31, 2007, there was $3.4 million of
unrecognized compensation cost related to unvested employee
stock options that is expected to be recognized as a component
of the Companys operating expenses through 2009.
Compensation costs will be adjusted for future changes in
estimated forfeitures.
For stock options paid in consideration of services rendered by
non-employees, the Company recognizes compensation expense in
accordance with the requirements of SFAS No. 123(R)
and
EITF 96-18,
as amended, and Emerging Issues Task Force Issue
No. 96-18,
Accounting for Equity Instruments that are Issued to Other
Than Employees for Acquiring, or in Conjunction with Selling,
Goods or Services. Under SFAS No. 123(R), the
compensation associated with stock options paid to non-employees
is generally recognized in the period during which services are
rendered by such non-employees. Since its adoption of
SFAS 123(R), there been no change to its equity plans or
modifications of its outstanding stock-based awards.
Deferred compensation for non-employee option grants that do not
vest immediately upon grant are recorded as an expense over the
vesting period of the underlying stock options. At the end of
each financial reporting period prior to vesting, the value of
these options, as calculated using the Black Scholes option
pricing model, will be
re-measured
using the fair value of the Companys common stock and
deferred compensation and the non-cash compensation recognized
during the period will be adjusted accordingly. Since the fair
market value of options granted to non-employees is subject to
change in the future, the amount of the future compensation
expense is subject to adjustment until the stock options are
fully vested. The Company recognized $1.5 million of stock
based compensation expense related to non-employee stock options
in 2007.
E-12
CYTRX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Research and Development Expenses Research
and development expenses consist of costs incurred for direct
and overhead-related research expenses and are expensed as
incurred. Costs to acquire technologies, including licenses,
that are utilized in research and development and that have no
alternative future use are expensed when incurred. Technology
developed for use in its products is expensed as incurred until
technological feasibility has been established.
Income Taxes Income taxes are accounted for
using an asset and liability approach that requires the
recognition of deferred tax assets and liabilities for the
expected future tax consequences of events that have been
recognized in the Companys financial statements or tax
returns. A valuation allowance is established to reduce deferred
tax assets if all, or some portion, of such assets will more
than likely not be realized.
Concentrations of Credit Risk Financial
instruments that potentially subject the Company to significant
concentrations of credit risk consist principally of cash, cash
equivalents and short-term investments. The Company maintains
cash and cash equivalents in large well-capitalized financial
institutions and the Companys investment policy disallows
investment in any debt securities rated less than
investment-grade by national ratings services. The
Company has not experienced any losses on its deposits of cash
and cash equivalent or its short-term investments.
Use of Estimates The preparation of the
financial statements in conformity with accounting principles
generally accepted in the United States of America requires
management to make estimates and assumptions that affect the
amounts reported in the financial statements and accompanying
notes. Significant estimates include the accrual for research
and development expenses, the basis for the classification of
current deferred revenue and the estimate of expense arising
from the common stock options granted to employees and
non-employees. Actual results could materially differ from those
estimates.
Reclassifications Certain prior year balances
have been reclassified to conform with the 2007 presentation,
with no change in net loss for prior periods presented.
Other comprehensive income/(loss) The Company
follows the provisions of Statement of Financial Accounting
Standards (SFAS) No. 130, Reporting
Comprehensive Income, which requires separate
representation of certain transactions, which are recorded
directly as components of shareholders equity. The Company
has no components of other comprehensive income (loss) and
accordingly comprehensive loss is the same as net loss reported.
|
|
3.
|
Recent
Accounting Pronouncements
|
In July 2006, the Financial Accounting Standards Board
(FASB) issued Interpretation No. 48,
Accounting for Uncertainty in Income Taxes, an
interpretation of FASB Statement No. 109
(FIN No. 48), to create a single model to
address accounting for uncertainty in tax positions.
FIN No. 48 clarifies the accounting for income taxes
by prescribing a minimum recognition threshold in which a tax
position be reached before financial statement recognition.
FIN No. 48 also provides guidance on derecognition,
measurement, classification, interest and penalties, accounting
in interim periods, disclosure and transition.
FIN No. 48 is effective for fiscal years beginning
after December 15, 2006. The Company adopted
FIN No. 48 as of January 1, 2007, as required.
The adoption of FIN No. 48 did not have an impact on
the Companys financial position and results of operations.
In September 2006, the FASB issued Statement of Financial
Accounting Standards (SFAS) No. 157, Fair
Value Measurements (SFAS No. 157).
SFAS No. 157 defines fair value, establishes a
framework for measuring fair value in accordance with generally
accepted accounting principles, and expands disclosures about
fair value measurements. SFAS No. 157 does not expand
the use of fair value in any new circumstances. In February
2008, the FASB issued Staff Position
No. FAS 157-1,
which amended SFAS No. 157 to exclude
SFAS No. 13, Accounting for Leases, and other
accounting pronouncements that address fair value measurements
for purposes of lease classification or measurement under
Statement 13. However, this scope exception does not apply to
assets acquired and liabilities assumed in a business
combination. Also in February 2008, the FASB issued Staff
Position
E-13
CYTRX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
No. FAS 157-2,
which delayed the effective date of SFAS No. 157 for
non-financial assets and liabilities, except those items
recognized at fair value on an annual or more frequently
recurring basis to fiscal years beginning after
November 15, 2008 and interim periods within those fiscal
years. The Company does not expect SFAS No. 157 will
have a significant impact on the Companys consolidated
financial statements.
In February 2007, the FASB issued SFAS No. 159,
Fair Value Option for Financial Assets and Financial
Liabilities (SFAS No. 159).
SFAS No. 159 permits entities to choose to measure
many financial assets and financial liabilities at fair value.
Unrealized gains and losses on items for which the fair value
option has been elected are reported in earnings.
SFAS No. 159 is effective for fiscal years beginning
after November 15, 2007. The Company does not expect
SFAS No. 159 will have a significant impact on the
Companys consolidated financial statements.
In June 2007, the FASB ratified the consensus on Emerging Issues
Task Force (EITF) Issue
No. 06-11,
Accounting for Income Tax Benefits of Dividends on
Share-Based Payment Awards
(EITF 06-11).
EITF 06-11
requires companies to recognize the income tax benefit realized
from dividends or dividend equivalents that are charged to
retained earnings and paid to employees for non-vested
equity-classified employee share-based payment awards as an
increase to additional paid-in capital.
EITF 06-11
is effective for fiscal years beginning after September 15,
2007. The adoption is not expected to have a significant impact
on the Companys consolidated financial statements.
In June 2007, the FASB ratified the consensus reached on EITF
Issue
No. 07-3,
Accounting for Nonrefundable Advance Payments for Goods or
Services Received for Use in Future Research and Development
Activities
(EITF 07-3),
which requires that nonrefundable advance payments for goods or
services that will be used or rendered for future research and
development activities be deferred and amortized over the period
that the goods are delivered or the related services are
performed, subject to an assessment of recoverability.
EITF 07-3
will be effective for fiscal years beginning after
December 15, 2007. The Company does not expect that the
adoption of
EITF 07-3
will have an impact on the Companys consolidated financial
statements.
In December 2007, the FASB issued SFAS No. 160,
Noncontrolling Interests in Consolidated Financial Statements
(SFAS No. 160) and a revision to
SFAS No. 141, Business Combinations
(SFAS No. 141R).
SFAS No. 160 modifies the accounting for
noncontrolling interest in a subsidiary and the deconsolidation
of a subsidiary. SFAS No. 141R establishes the
measurements in a business combination of the identifiable
assets acquired, the liabilities assumed and any noncontrolling
interest in the acquiree. Both of these related statements are
effective for fiscal years beginning after December 15,
2008. The Company has not determined the impact that the
adoption of these two statements will have on the consolidated
financial statements.
In December 2007, the SEC issued Staff Accounting
Bulletin 110 (SAB 110), which expresses
the views of the Staff regarding use of a simplified
method, as discussed in SAB 107, in developing an estimate
of expected term of plain vanilla share options in
accordance with Statement of Financial Accounting Standards
No. 123. SAB 110 will allow, under certain
circumstances, the use of the simplified method beyond
December 31, 2007 when a Company is unable to rely on the
historical exercise data. The Company does not anticipate the
adoption of SAB 110 having a material impact on our
financial statements.
At December 31, 2007 and 2006, the accounts receivable
balance of $101,217 and $105,930, respectively, primarily
related annual licensing fees due to the Company. Due to the
certainty of the collectability of the account receivable, no
allowance was recorded.
E-14
CYTRX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
At December 31, 2007 and 2006, the Company had
approximately $713,000 and $196,000, respectively, of
non-current other assets, which consist primarily of security
deposits on contracts for research and development and leases
for its facilities.
|
|
6.
|
Equipment,
Furnishing and Molecular Library, net
|
Equipment, furnishings and molecular library, net, at
December 31, 2007 and 2006 consist of the following
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
2006
|
|
|
Equipment and furnishings
|
|
$
|
1,965
|
|
|
$
|
502
|
|
Less accumulated depreciation
|
|
|
(392
|
)
|
|
|
(249
|
)
|
|
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
|
1,573
|
|
|
|
253
|
|
|
|
|
|
|
|
|
|
|
Molecular library
|
|
$
|
447
|
|
|
$
|
447
|
|
Less accumulated amortization
|
|
|
(253
|
)
|
|
|
(164
|
)
|
|
|
|
|
|
|
|
|
|
Molecular library, net
|
|
$
|
194
|
|
|
$
|
283
|
|
|
|
|
|
|
|
|
|
|
The molecular library was purchased in 2004 and placed in
service by the Company in March 2005. The molecular library is
being amortized over 60 months, which is less than the
estimated effective life of the patents. The Company will incur
related amortization of approximately $89,000 in 2008, $89,000
in 2009 and $16,000 in 2010.
Depreciation and amortization expense for the years ended
December 31, 2007, 2006 and 2005 were $272,000, $228,000,
and $217,000, respectively.
|
|
7.
|
Accrued
Expenses and Other Current Liabilities
|
Accrued expenses and other current liabilities at
December 31, 2007 and 2006 are summarized below (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
2006
|
|
|
Professional fees
|
|
$
|
907
|
|
|
$
|
900
|
|
Research and development costs
|
|
|
873
|
|
|
|
1,013
|
|
Wages, bonuses and employee benefits
|
|
|
1,255
|
|
|
|
404
|
|
Income taxes
|
|
|
30
|
|
|
|
145
|
|
Other
|
|
|
636
|
|
|
|
260
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
3,701
|
|
|
$
|
2,722
|
|
|
|
|
|
|
|
|
|
|
|
|
8.
|
Termination
of the Atlanta Facility Lease
|
Subsequent Subsequent to the Companys merger with Global
Genomics in 2002, it recorded a loss of $563,000 associated with
the closure of the Atlanta headquarters and its relocation to
Los Angeles. This loss represented the total remaining lease
obligations and estimated operating costs through the remainder
of the lease term, less estimated sublease rental income and
deferred rent at the time. In August 2005, the Company entered
into a lease termination agreement pursuant to which it was
released from all future obligations on the lease in exchange
for a one-time $110,000 payment and the forfeiture of a $49,000
security deposit. As a result of this agreement the Company
realized $164,000 in other income in 2005.
E-15
CYTRX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
9.
|
Commitments
and Contingencies
|
The Company acquires assets still in development and enters into
research and development arrangements with third parties that
often require milestone and royalty payments to the third party
contingent upon the occurrence of certain future events linked
to the success of the asset in development. Milestone payments
may be required, contingent upon the successful achievement of
an important point in the development life-cycle of the
pharmaceutical product (e.g., approval of the product for
marketing by a regulatory agency). If required by the
arrangement, CytRx may have to make royalty payments based upon
a percentage of the sales of the pharmaceutical product in the
event that regulatory approval for marketing is obtained.
Because of the contingent nature of these payments, they are not
included in the table of contractual obligations.
These arrangements may be material individually, and in the
unlikely event that milestones for multiple products covered by
these arrangements were reached in the same period, the
aggregate charge to expense could be material to the results of
operations in any one period. In addition, these arrangements
often give CytRx the discretion to unilaterally terminate
development of the product, which would allow CytRx to avoid
making the contingent payments; however, CytRx is unlikely to
cease development if the compound successfully achieves clinical
testing objectives.
As a result of RXis separation from CytRx in March 2008
(see discussion in the Our Separation from RXi
Pharmaceuticals Corporation section on page 8), each
of CytRx and RXi will be responsible for their respective future
contractual obligations, therefore, they are shown separately
below.
CytRxs current contractual obligations that will require
future cash payments are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-Cancelable
|
|
|
Cancelable
|
|
|
|
|
|
|
Operating
|
|
|
Employment
|
|
|
|
|
|
Research and
|
|
|
License
|
|
|
|
|
|
|
|
|
|
Leases(1)
|
|
|
Agreements(2)
|
|
|
Subtotal
|
|
|
Development(3)
|
|
|
Agreements(4)
|
|
|
Subtotal
|
|
|
Total
|
|
|
|
(In thousands)
|
|
|
|
|
|
2008
|
|
$
|
446
|
|
|
$
|
900
|
|
|
$
|
1,346
|
|
|
$
|
4,035
|
|
|
$
|
|
|
|
$
|
4,035
|
|
|
$
|
5,381
|
|
2009
|
|
|
236
|
|
|
|
650
|
|
|
|
886
|
|
|
|
3,279
|
|
|
|
|
|
|
|
3,279
|
|
|
|
4,165
|
|
2010
|
|
|
145
|
|
|
|
|
|
|
|
145
|
|
|
|
3,045
|
|
|
|
|
|
|
|
3,045
|
|
|
|
3,190
|
|
2011
|
|
|
11
|
|
|
|
|
|
|
|
11
|
|
|
|
2,188
|
|
|
|
|
|
|
|
2,188
|
|
|
|
2,199
|
|
2012 and thereafter
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
681
|
|
|
|
|
|
|
|
681
|
|
|
|
681
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
838
|
|
|
$
|
1,550
|
|
|
$
|
2,388
|
|
|
$
|
13,228
|
|
|
$
|
|
|
|
$
|
13,228
|
|
|
$
|
15,616
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RXis current contractual obligations that will require
future cash payments are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-Cancelable
|
|
|
Cancelable
|
|
|
|
|
|
|
Operating
|
|
|
Employment
|
|
|
|
|
|
Research and
|
|
|
License
|
|
|
|
|
|
|
|
|
|
Leases(1)
|
|
|
Agreements(2)
|
|
|
Subtotal
|
|
|
Development(3)
|
|
|
Agreements(4)
|
|
|
Subtotal
|
|
|
Total
|
|
|
|
(In thousands)
|
|
|
|
|
|
2008
|
|
$
|
180
|
|
|
$
|
942
|
|
|
$
|
1,122
|
|
|
$
|
|
|
|
$
|
716
|
|
|
$
|
716
|
|
|
$
|
1,838
|
|
2009
|
|
|
105
|
|
|
|
448
|
|
|
|
553
|
|
|
|
|
|
|
|
666
|
|
|
|
666
|
|
|
|
1,219
|
|
2010
|
|
|
|
|
|
|
290
|
|
|
|
290
|
|
|
|
|
|
|
|
616
|
|
|
|
616
|
|
|
|
906
|
|
2011
|
|
|
|
|
|
|
105
|
|
|
|
105
|
|
|
|
|
|
|
|
816
|
|
|
|
816
|
|
|
|
921
|
|
2012
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,126
|
|
|
|
1,126
|
|
|
|
1,126
|
|
2013 and thereafter
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,325
|
|
|
|
10,325
|
|
|
|
10,325
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
285
|
|
|
$
|
1,785
|
|
|
$
|
2,070
|
|
|
$
|
|
|
|
$
|
14,265
|
|
|
$
|
14,265
|
|
|
$
|
16,335
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
E-16
CYTRX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
|
(1) |
|
Operating leases are primarily facility lease related
obligations, as well as equipment and software lease obligations
with third party vendors. |
|
(2) |
|
Employment agreement obligations include management contracts,
as well as scientific advisory board member compensation
agreements. Certain agreements, which have been revised from
time to time, provide for minimum salary levels, adjusted
annually at the discretion of the Companys Compensation
Committee, as well as for minimum bonuses that are payable. |
|
(3) |
|
Research and development obligations relate primarily to
clinical trials. Most of these purchase obligations are
cancelable. |
|
(4) |
|
License agreements generally relate to RXis obligations
with UMMS associated with RNAi and, for future periods,
represent minimum annual royalty payment obligations. Not
included in the table are milestone payment amounts that may be
required under RXis license agreements, due to their
contingent nature. RXi has determined that a hypothetical
product candidate attaining all possible product milestones
would have aggregate potential milestone payments of
$36 million. This hypothetical product analysis was
undertaken since RXi has not yet named a lead product candidate.
RXi determined what would be a like product candidate based on
its current research and ran an analysis of the milestone
payments due under its current licenses for this hypothetical
product. As a part of this analysis, due to the fact that
certain of its licenses are for technologies that are mutually
exclusive, if any two licenses are mutually exclusive and only
one would be applicable to any single product, RXi selected the
milestone payments that would result in higher fees to include
in its analysis. |
The Company applies the disclosure provisions of FASB
Interpretation No. (FIN) 45, Guarantors
Accounting and Disclosure Requirements for Guarantees, Including
Indirect Guarantees of Indebtedness of Others
(FIN 45), to its agreements that contain
guarantee or indemnification clauses. The Company provides
(i) indemnifications of varying scope and size to certain
investors and other parties for certain losses suffered or
incurred by the indemnified party in connection with various
types of third-party claims; and (ii) indemnifications of
varying scope and size to officers and directors against third
party claims arising from the services they provide to us. These
indemnifications and guarantees give rise only to the disclosure
provisions of FIN 45. To date, the Company has not incurred
material costs as a result of these obligations and does not
expect to incur material costs in the future; further, the
Company maintains insurance to cover certain losses arising from
these indemnifications. Accordingly, the Company has not accrued
any liabilities in its consolidated financial statements related
to these indemnifications or guarantees.
|
|
10.
|
Private
Placements of Common Stock
|
On April 19, 2007, the Company completed a
$37.0 million private equity financing in which we issued
8.6 million shares of its common stock at $4.30 per share.
Net of investment banking commissions, legal, accounting and
other expenses related to the transaction, the Company received
approximately $34.2 million of proceeds.
On March 2, 2006, the Company completed a
$13.4 million private equity financing in which it issued
10,650,795 shares of its common stock and warrants to
purchase an additional 5,325,397 shares of its common stock
at an exercise price of $1.54 per share. Net of investment
banking commissions which included 745,556 warrants to purchase
CytRx common stock at $1.54 per share, legal, accounting and
other expenses related to the transaction, the Company received
approximately $12.4 million of proceeds.
In connection with the financing, the Company adjusted the price
and number of underlying shares of warrants to purchase
approximately 2.8 million shares that had been issued in
prior equity financings in May and September 2003. The
adjustment was made as a result of anti-dilution provisions in
those warrants that were triggered by the Companys
issuance of common stock in that financing at a price below the
closing market price on the date of the transaction. The Company
accounted for the anti-dilution adjustments as deemed dividends
analogous with the guidance in Emerging Issues Task Force Issues
(EITF)
No. 98-5,
Accounting for Convertible Securities with Beneficial
Conversion Features
E-17
CYTRX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
or Contingently Adjustable Conversion Ratios, and
EITF 00-27,
Application of
98-5 to
Certain Convertible Instruments, recorded an approximate
$488,000 charge to retained earnings and a corresponding credit
to additional paid-in capital.
In January 2005, the Company entered into a Stock Purchase
Agreement with a group of institutional and other investors (the
January 2005 Investors). The January 2005 Investors
purchased, for an aggregate purchase price of
$21.3 million, 17,334,494 shares of the Companys
common stock and warrants to purchase an additional
8,667,247 shares of the Companys common stock, at
$2.00 per share, expiring in 2010. After consideration of
offering expenses, net proceeds to the Company were
approximately $19.4 million. The shares and the shares
underlying the warrants issued to the January 2005 Investors
were subsequently registered. In addition, the Company issued
approximately $158,000 worth of common stock in February 2005.
In connection with the March 2006 and January 2005 private
equity financings, the Company entered into a registration
rights agreement with the purchasers of its stock and warrants,
which provides among other things, for cash penalties in the
event that the Company were unable to initially register, or
maintain the effective registration of the securities. The
Company initially evaluated the penalty provisions in light of
EITF 00-19,
Accounting for Derivative Financial Instruments Indexed To,
and Potentially Settled In a Companys Own Stock, and
determined that the maximum penalty does not exceed the
difference between the fair value of a registered share of CytRx
common stock and unregistered share of CytRx common stock on the
date of the transaction. The Company then evaluated the
provisions of FASB Staff Position
No. EITF 00-19-2,
Accounting for Registration Payment Arrangements, which
specifies that the contingent obligation to make future payments
or otherwise transfer consideration under a registration payment
arrangement should be separately recognized and measured in
accordance with FASB Statement No. 5, Accounting for
Contingencies, pursuant to which a contingent obligation
must be accrued only if it is more likely than not to occur. In
managements estimation, the contingent payments related to
the registration payment arrangement are not likely to occur,
and thus no amount need be accrued. The Company has elected to
reflect early adoption of
FSP 00-19-2
in its 2006 financial statements, and the adoption did not have
an effect on its financial statements.
In connection with the Companys private equity financing
that was consummated on January 20, 2005, the Company
adjusted the price and number of underlying shares of warrants
to purchase approximately 2.8 million shares that had been
issued in prior equity financings in May and September 2003. The
adjustment was made as a result of anti-dilution provisions in
those warrants that were triggered by the Companys
issuance of common stock in that financing at a price below the
closing market price on the date of the transaction. Consistent
with EITF
No. 98-5
and
EITF 00-27
the Company accounted for the anti-dilution adjustments as a
deemed dividend, which was recorded as an approximate
$1.1 million charge to retained earnings and a
corresponding credit to additional paid-in capital.
|
|
11.
|
Investment
in CytRx Laboratories
|
On June 30, 2005, the Company issued 650,000 shares of
its common stock to Dr. Michael Czech as part of a
transaction in which the Company purchased Dr. Czechs
5% interest in CytRx Laboratories. As a result of this purchase,
CytRx Laboratories became a wholly-owned subsidiary of CytRx.
CytRx Laboratories was subsequently merged with and into the
Company on September 30, 2005. The purchase of
Dr. Czechs interest in CytRx Laboratories was
consummated pursuant to the terms of the Stockholders Agreement
dated September 17, 2003, by and among CytRx, CytRx
Laboratories and Dr. Czech. Of the shares of CytRx common
stock issued to Dr. Czech 300,000 option shares were
unrestricted and in exchange for his 5% interest in CytRx
Laboratories. For financial statement purposes, that stock was
valued at $0.91 per share, the then fair value of the common
stock. The non-cash transaction was accounted for using purchase
accounting and the difference between the market value of the
300,000 unrestricted shares issued to Dr. Czech and the
fair value of the minority interest at June 30, 2005, of
$184,000 was recorded as goodwill for financial statement
purposes.
E-18
CYTRX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
12.
|
Stock
Options and Warrants
|
CytRx
Options
As of December 31, 2007, an aggregate of
10,000,000 shares of common stock were reserved for
issuance under the Companys 2000 Stock Option Incentive
Plan, as amended, including 5,999,300 shares subject to
outstanding stock options and 2,192,000 shares available
for future grant. Additionally, the Company has two other plans,
the 1994 Stock Option Plan and the 1998 Long Term Incentive
Plan, which include 9,167 and 100,041 shares subject to
outstanding stock options. As the terms of the plans provide
that no options may be issued after 10 years, no options
are available under the 1994 Plan. Under the 1998 Long Term
Incentive Plan, 29,517 shares are available for future
grant. Options granted under these plans generally vest and
become exercisable as to 33% of the option grants on each
anniversary of the grant date until fully vested. The options
will expire, unless previously exercised, not later than ten
years from the grant date.
The Company adopted the provisions of SFAS No. 123(R),
Share-Based Payment (SFAS 123(R)), which
requires the measurement and recognition of compensation expense
for all stock-based awards made to employees and non-employee
directors.
The fair value of stock options at the date of grant was
estimated based on the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
Weighted average risk free interest rate
|
|
|
4.41
|
%
|
|
|
4.91
|
%
|
|
|
4.10
|
%
|
Dividend yields
|
|
|
0
|
%
|
|
|
0
|
%
|
|
|
0
|
%
|
Weighted average volatility
|
|
|
108
|
%
|
|
|
112
|
%
|
|
|
109
|
%
|
Expected lives (years)
|
|
|
6
|
|
|
|
6
|
|
|
|
8
|
|
The Companys computation of expected volatility is based
on the historical daily volatility of its publicly traded stock.
For option grants issued during the year ended December 31,
2007 and 2006, the Company used a calculated volatility for each
grant. The Companys computation of expected life were
estimated using the simplified method provided for under Staff
Accounting Bulletin 107 (SAB 107), which
averages the contractual term of the Companys options of
ten years with the average vesting term of three years for an
average of six years. In December 2007, Staff Accounting
Bulletin 110 (SAB 110) was released which
permits the continued use of the simplified method when a
Company is unable to relay on the historical exercise data.
Since the Company is still in its relatively early stages, it
will continue with the simplified method. The dividend yield
assumption of zero is based upon the fact the Company has never
paid cash dividends and presently has no intention of paying
cash dividends. The risk-free interest rate used for each grant
is equal to the U.S. Treasury rates in effect at the time
of the grant for instruments with a similar expected life. Based
on historical experience, for the years ended December 31,
2007 and 2006, the Company has estimated an annualized
forfeiture rate of 10% and 10%, respectively, for options
granted to its employees and 1% for each period for options
granted to senior management and directors. Compensation costs
will be adjusted for future changes in estimated forfeitures.
The Company will record additional expense if the actual
forfeitures are lower than estimated and will record a recovery
of prior expense if the actual forfeiture rates are higher than
estimated. No amounts relating to employee stock-based
compensation have been capitalized. Under provisions of
SFAS 123(R), the Company recorded $1.7 million and
$1.2 million of employee stock-based compensation for the
years ended December 31, 2007 and 2006, respectively.
E-19
CYTRX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
At December 31, 2007, there remained approximately
$3.4 million of unrecognized compensation expense related
to unvested employee stock options to be recognized as expense
over a weighted-average period of 6 years. Presented below
is the Companys stock option activity:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average
|
|
|
|
Stock Options
|
|
|
Exercise Price
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
Outstanding beginning of year
|
|
|
4,500,208
|
|
|
|
4,097,542
|
|
|
|
3,026,042
|
|
|
$
|
1.66
|
|
|
$
|
1.70
|
|
|
$
|
2.02
|
|
Granted
|
|
|
1,685,500
|
|
|
|
783,500
|
|
|
|
1,124,500
|
|
|
|
4.02
|
|
|
|
1.36
|
|
|
|
.83
|
|
Exercised
|
|
|
(1,030,933
|
)
|
|
|
(82,500
|
)
|
|
|
(15,000
|
)
|
|
|
1.76
|
|
|
|
.97
|
|
|
|
1.00
|
|
Forfeited
|
|
|
(222,503
|
)
|
|
|
(296,667
|
)
|
|
|
(38,000
|
)
|
|
|
1.24
|
|
|
|
1.59
|
|
|
|
1.52
|
|
Expired
|
|
|
|
|
|
|
(1,667
|
)
|
|
|
|
|
|
|
|
|
|
|
1.00
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding end of year
|
|
|
4,932,273
|
|
|
|
4,500,208
|
|
|
|
4,097,542
|
|
|
|
2.46
|
|
|
|
1.66
|
|
|
|
1.70
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at end of year
|
|
|
3,210,320
|
|
|
|
3,316,994
|
|
|
|
2,360,989
|
|
|
$
|
1.93
|
|
|
$
|
1.84
|
|
|
$
|
1.98
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average fair value of stock options granted during the
year:
|
|
$
|
3.34
|
|
|
$
|
1.16
|
|
|
$
|
.72
|
|
|
|
|
|
|
|
|
|
|
|
|
|
A summary of the activity for unvested employee stock options as
of December 31, and changes during the year is presented
below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average
|
|
|
|
|
|
|
Grant Date Fair
|
|
|
|
Stock Options
|
|
|
Value per Share
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
Nonvested at January 1,
|
|
|
1,183,214
|
|
|
|
1,736,553
|
|
|
|
1,574,162
|
|
|
$
|
.99
|
|
|
$
|
1.16
|
|
|
$
|
1.77
|
|
Granted
|
|
|
1,685,500
|
|
|
|
783,500
|
|
|
|
1,124,500
|
|
|
|
3.34
|
|
|
|
1.16
|
|
|
|
0.72
|
|
Vested
|
|
|
(924,259
|
)
|
|
|
(1,040,172
|
)
|
|
|
(924,109
|
)
|
|
|
1.67
|
|
|
|
1.29
|
|
|
|
1.65
|
|
Pre-vested forfeitures
|
|
|
(222,503
|
)
|
|
|
(296,667
|
)
|
|
|
(38,000
|
)
|
|
|
1.06
|
|
|
|
1.39
|
|
|
|
1.34
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nonvested at December 31,
|
|
|
1,721,952
|
|
|
|
1,183,214
|
|
|
|
1,736,553
|
|
|
$
|
2.92
|
|
|
$
|
.99
|
|
|
$
|
1.16
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table summarizes significant ranges of outstanding
stock options under the three plans at December 31, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Remaining
|
|
|
Weighted
|
|
|
Number of
|
|
|
Weighted
|
|
|
Weighted
|
|
Range of
|
|
Number of
|
|
|
Contractual Life
|
|
|
Average
|
|
|
Options
|
|
|
Average
|
|
|
Average
|
|
Exercise Prices
|
|
Options
|
|
|
(Years)
|
|
|
Exercise Price
|
|
|
Exercisable
|
|
|
Contractual Life
|
|
|
Exercise Price
|
|
|
$0.25 1.00
|
|
|
814,774
|
|
|
|
6.76
|
|
|
$
|
0.81
|
|
|
|
699,440
|
|
|
|
6.76
|
|
|
$
|
0.81
|
|
$1.01 2.00
|
|
|
1,269,500
|
|
|
|
7.16
|
|
|
|
1.48
|
|
|
|
1,041,222
|
|
|
|
7.16
|
|
|
|
1.49
|
|
$2.01 3.00
|
|
|
1,162,499
|
|
|
|
5.51
|
|
|
|
2.45
|
|
|
|
1,162,499
|
|
|
|
5.51
|
|
|
|
2.45
|
|
$3.01 4.00
|
|
|
700,500
|
|
|
|
9.74
|
|
|
|
3.45
|
|
|
|
137,539
|
|
|
|
9.74
|
|
|
|
3.34
|
|
$4.01 4.65
|
|
|
985,000
|
|
|
|
9.35
|
|
|
|
4.42
|
|
|
|
169,621
|
|
|
|
9.35
|
|
|
|
4.45
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,932,273
|
|
|
|
7.51
|
|
|
$
|
2.46
|
|
|
|
3,210,321
|
|
|
|
7.51
|
|
|
$
|
1.93
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The aggregate intrinsic value of outstanding options as of
December 31, 2007, was $3,836,556 of which $3,273,003 is
related to exercisable options. The aggregate intrinsic value
was calculated based on the positive difference between the
closing fair market value of the Companys common stock on
December 31, 2007 ($2.84) and the exercise price of the
underlying options.
E-20
CYTRX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
For stock options paid in consideration of services rendered by
non-employees, the Company recognizes compensation expense in
accordance with the requirements of SFAS No. 123(R),
Emerging Issues Task Force Issue
No. 96-18
(EITF 96-18),
Accounting for Equity Instruments that are Issued to other
than Employees for Acquiring, or in Conjunction with Selling
Goods or Services and
EITF 00-18,
Accounting Recognition for Certain Transactions involving
Equity Instruments Granted to Other Than Employees, as
amended.
Non-employee option grants that do not vest immediately upon
grant are recorded as an expense over the performance period. At
the end of each financial reporting period prior to performance,
the value of these options, as calculated using the
Black-Scholes option pricing model, will be determined, and
compensation expense recognized during the period will be
adjusted accordingly. Since the fair market value of options
granted to non-employees is subject to change in the future, the
amount of the future compensation expense is subject to
adjustment until the common stock options are fully vested.
The Company recorded approximately $0.4 million,
$1.3 million and $0.6 million of non-cash charges
related to the issuance of stock options to certain consultants
in exchange for services during 2007, 2006 and 2005,
respectively. In January 2007, the Companys RNAi
operations (RXi Pharmaceuticals Corporation) began operating on
a stand-alone basis (see Our Separation from RXi
Pharmaceuticals Corporation on page 8 for further
details). Except for approximately $0.2 million in 2006,
the non-cash charges for services incurred during 2006 and 2005
relate primarily to the RXi operations and are discussed more
fully in the RXi Options section that follows on
page F-17.
At December 31, 2007, there was no change in the number of
non-employee options outstanding from the prior year. There
remained 1,067,000 options granted.
The fair value of stock options at the date of grant was
estimated based on the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
2006
|
|
|
Weighted average risk free interest rate
|
|
|
|
|
|
|
4.31
|
%
|
Dividend yields
|
|
|
|
|
|
|
0
|
%
|
Weighted average volatility
|
|
|
|
|
|
|
108
|
%
|
Expected lives (years)
|
|
|
|
|
|
|
6
|
|
A summary of the activity for nonvested stock options as of
December 31, and changes during the years are presented
below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock Options
|
|
|
Weighted Average Grant Date Fair Value per Share
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
Nonvested at January 1,
|
|
|
916,663
|
|
|
|
1,030,831
|
|
|
$
|
1.44
|
|
|
$
|
1.53
|
|
Granted
|
|
|
|
|
|
|
250,000
|
|
|
|
|
|
|
|
.95
|
|
Vested
|
|
|
(104,163
|
)
|
|
|
(364,168
|
)
|
|
|
1.63
|
|
|
|
1.35
|
|
Pre-vested forfeitures
|
|
|
(562,500
|
)
|
|
|
|
|
|
|
1.63
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nonvested at December 31,
|
|
|
250,000
|
|
|
|
916,663
|
|
|
$
|
1.00
|
|
|
$
|
1.44
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
E-21
CYTRX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
CytRx
Warrants
A summary of the Companys warrant activity and related
information for the years ended December 31 are shown below.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average
|
|
|
|
Warrants
|
|
|
Exercise Price
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
Outstanding beginning of year
|
|
|
23,360,165
|
|
|
|
18,508,949
|
|
|
|
9,735,416
|
|
|
$
|
1.83
|
|
|
$
|
1.94
|
|
|
$
|
1.64
|
|
Granted
|
|
|
|
|
|
|
6,112,870
|
|
|
|
10,267,887
|
|
|
|
|
|
|
|
1.54
|
|
|
|
1.96
|
|
Exercised
|
|
|
(10,233,650
|
)
|
|
|
(1,261,654
|
)
|
|
|
(1,294,354
|
)
|
|
|
1.77
|
|
|
|
1.16
|
|
|
|
0.55
|
|
Forfeited
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expired
|
|
|
(95,000
|
)
|
|
|
|
|
|
|
(200,000
|
)
|
|
|
2.25
|
|
|
|
|
|
|
|
1.00
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding end of year
|
|
|
13,031,515
|
|
|
|
23,360,165
|
|
|
|
18,508,949
|
|
|
|
1.87
|
|
|
|
1.83
|
|
|
|
1.94
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at end of year
|
|
|
13,031,515
|
|
|
|
23,360,165
|
|
|
|
18,508,949
|
|
|
$
|
1.87
|
|
|
$
|
1.83
|
|
|
$
|
1.94
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average fair value of warrants granted during the year:
|
|
$
|
|
|
|
$
|
1.54
|
|
|
$
|
2.00
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table summarizes additional information concerning
warrants outstanding and exercisable at December 31, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants Outstanding
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average
|
|
|
|
|
|
Warrants
|
|
|
|
|
|
|
|
|
|
Remaining
|
|
|
Weighted
|
|
|
Number of
|
|
|
Exercisable
|
|
|
|
Number of
|
|
|
Contractual Life
|
|
|
Average
|
|
|
Shares
|
|
|
Weighted Average
|
|
Range of Exercise Prices
|
|
Shares
|
|
|
(Years)
|
|
|
Exercise Price
|
|
|
Exercisable
|
|
|
Exercise Price
|
|
|
$0.20 1.26
|
|
|
482,001
|
|
|
|
1.68
|
|
|
$
|
.20
|
|
|
|
482,001
|
|
|
$
|
.20
|
|
$1.54 1.84
|
|
|
4,183,844
|
|
|
|
5.35
|
|
|
|
1.59
|
|
|
|
4,183,844
|
|
|
|
1.59
|
|
$1.85 2.36
|
|
|
7,056,917
|
|
|
|
4.98
|
|
|
|
2.00
|
|
|
|
7,056,917
|
|
|
|
2.00
|
|
$2.37 2.67
|
|
|
1,308,753
|
|
|
|
5.04
|
|
|
|
2.67
|
|
|
|
1,308,753
|
|
|
|
2.67
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,031,515
|
|
|
|
4.98
|
|
|
$
|
1.87
|
|
|
|
13,031,515
|
|
|
$
|
1.87
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RXi
Options
As of December 31, 2007, an aggregate of 2.75 million
shares of common stock were reserved for issuance under the RXi
Pharmaceuticals Corporation 2007 Incentive Plan, including
approximately 1,340,000 shares subject to outstanding
common stock options granted under this plan and approximately
1,410,000 shares available for future grants. The
administrator of the plan determines the times which an option
may become exercisable. Vesting periods of options granted to
date include vesting upon grant to vesting at the end of a
five-year period. The options will expire, unless previously
exercised, not later than ten years from the grant date.
E-22
CYTRX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
RXi issued options to purchase approximately
1,340,000 shares of its common stock during 2007. The fair
value of the common stock options granted in the year listed in
the table below was estimated using the Black-Scholes
option-pricing model, based on the following assumptions:
|
|
|
|
|
|
|
2007
|
|
|
Weighted average risk free interest rate
|
|
|
4.50
|
%
|
Weighted average volatility
|
|
|
108.7
|
%
|
Expected lives (years)
|
|
|
6
|
|
Expected dividend yield
|
|
|
0
|
%
|
The fair value of RXis common stock and RXis
expected common stock price volatility assumption is based upon
a valuation conducted by Sanli Pastore & Hill, an
independent third party valuation firm engaged by the RXis
Board of Directors, which determined the RXi corporate valuation
and analyzed the volatility of a basket of comparable companies.
The expected life assumptions were based upon the simplified
method provided for under SAB 107, which averages the
contractual term of RXis options of ten years with the
average vesting term of three years for an average of six years.
The dividend yield assumption of zero is based upon the fact
that RXi has never paid cash dividends and presently has no
intention of paying cash dividends. The risk-free interest rate
used for each grant was also based upon prevailing short-term
interest rates. Based on CytRxs historical experience, RXi
has estimated an annualized forfeiture rate of 4.0% for options
granted to its employees, 2.1% for options granted senior
management and no forfeiture rate for the directors. RXi will
record additional expense if the actual forfeitures are lower
than estimated and will record a recovery of prior expense if
the actual forfeiture rates are higher than estimated. Under
provisions of SFAS 123(R), RXi recorded $1.0 million
of employee stock-based compensation for the year ended
December 31, 2007. No amounts relating to employee
stock-based compensation have been capitalized. As of
December 31, 2007, there was $2.1 million of
unrecognized compensation cost related to outstanding options
that is expected to be recognized as a component of RXis
operating expenses through 2011. Compensation costs will be
adjusted for future changes in estimated forfeitures.
At December 31, 2007, the unrecognized compensation expense
related to unvested common stock options granted to employees
and non-employee directors is expected to be recognized as
expense over a weighted-average period of 1.8 years.
Presented below is RXis common stock activity:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average
|
|
|
|
Stock Options
|
|
|
Exercise Price
|
|
|
|
2007
|
|
|
2007
|
|
|
Outstanding beginning of year
|
|
|
|
|
|
$
|
|
|
Granted
|
|
|
1,139,375
|
|
|
|
5.00
|
|
Exercised
|
|
|
(66,044
|
)
|
|
|
5.00
|
|
Forfeited
|
|
|
(92,465
|
)
|
|
|
5.00
|
|
|
|
|
|
|
|
|
|
|
Outstanding end of year
|
|
|
980,866
|
|
|
|
5.00
|
|
|
|
|
|
|
|
|
|
|
Exercisable at end of year
|
|
|
274,129
|
|
|
$
|
5.00
|
|
|
|
|
|
|
|
|
|
|
E-23
CYTRX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
A summary of the activity for nonvested stock options as of
December 31, and changes during the year is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average
|
|
|
|
|
|
|
Grant Date Fair
|
|
|
|
Stock Options
|
|
|
Value per Share
|
|
|
|
2007
|
|
|
2007
|
|
|
Nonvested at January 1,
|
|
|
|
|
|
$
|
|
|
Granted
|
|
|
1,139,375
|
|
|
|
3.51
|
|
Vested
|
|
|
(274,129
|
)
|
|
|
3.45
|
|
Pre-vested forfeitures
|
|
|
(92,465
|
)
|
|
|
3.57
|
|
|
|
|
|
|
|
|
|
|
Nonvested at December 31,
|
|
|
772,781
|
|
|
$
|
3.51
|
|
|
|
|
|
|
|
|
|
|
The following table summarizes significant ranges of outstanding
stock options at December 31, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
|
|
|
|
|
Average
|
|
Weighted
|
|
|
|
Weighted
|
|
Weighted
|
|
|
|
|
Remaining
|
|
Average
|
|
Number of
|
|
Average
|
|
Average
|
|
|
Number of
|
|
Contractual
|
|
Exercise
|
|
Options
|
|
Contractual
|
|
Exercise
|
Range of Exercise Prices
|
|
Options
|
|
Life (Years)
|
|
Price
|
|
Exercisable
|
|
Life
|
|
Price
|
|
$5.00
|
|
|
980,866
|
|
|
|
9.46
|
|
|
$
|
5.00
|
|
|
|
274,129
|
|
|
|
9.46
|
|
|
$
|
5.00
|
|
The aggregate intrinsic value of outstanding options as of
December 31, 2007 is negligible. The aggregate intrinsic
value is calculated based on the positive difference between the
closing fair market value of RXis common stock on
December 31, 2007 and the exercise price of the underlying
options.
Non-employee option grants that do not vest immediately upon
grant are recorded as an expense over the vesting period of the
underlying stock options. At the end of each financial reporting
period prior to vesting, the value of these options, as
calculated using the Black-Scholes option pricing model, will be
re-measured using the fair value of RXis common stock and
the non-cash compensation recognized during the period will be
adjusted accordingly. Since the fair market value of options
granted to non-employees is subject to change in the future, the
amount of the future compensation expense will include fair
value re-measurements until the stock options are fully vested.
RXi used an independent third-party valuation firm to estimate
the fair market value of RXis common stock and used the
common stock fair market value as an input into the calculation
of fair value of the common stock options granted using the
Black-Scholes option-pricing model. Under provisions of
SFAS 123(R),
EITF 96-18,
RXi recorded approximately $1.0 million of stock based
compensation expense related to non-employee stock options for
the year ended December 31, 2007 in respect of RXi.
The fair value of non-employee stock options at the date of
grant was estimated based on the following assumptions:
|
|
|
|
|
|
|
2007
|
|
|
Weighted average risk free interest rate
|
|
|
4.39
|
%
|
Dividend yields
|
|
|
0
|
%
|
Weighted average volatility
|
|
|
109.4
|
%
|
Expected lives (years)
|
|
|
6
|
|
The fair value of RXis common stock and RXis
expected common stock price volatility assumption is based upon
Sanli Pastore & Hill, Inc.s valuation that
determined the RXi corporate valuation and analyzed the
volatility of a basket of comparable companies. The expected
life assumptions were based upon the simplified method provided
for under SAB 107, which averages the contractual term of
RXis options of ten years with the average vesting term
for an average of six years. The dividend yield assumption of
zero is based upon the fact that RXi has never paid cash
dividends and presently has no intention of paying cash
dividends. The risk-free interest rate used for each grant was
also based upon prevailing short-term interest rates.
E-24
CYTRX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
At December 31, 2007, there remained approximately $489,000
of unrecognized compensation expense related to unvested common
stock options granted to non-employees is expected to be
recognized as expense over a weighted-average period of
1.8 years. Presented below is RXis common stock
activity:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average
|
|
|
|
Stock Options
|
|
|
Exercise Price
|
|
|
|
2007
|
|
|
2007
|
|
|
Outstanding beginning of year
|
|
|
|
|
|
$
|
|
|
Granted
|
|
|
357,318
|
|
|
|
5.00
|
|
Exercised
|
|
|
|
|
|
|
|
|
Forfeited
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding end of year
|
|
|
357,318
|
|
|
|
5.00
|
|
|
|
|
|
|
|
|
|
|
Exercisable at end of year
|
|
|
221,883
|
|
|
$
|
5.00
|
|
|
|
|
|
|
|
|
|
|
|
|
13.
|
Stockholder
Protection Rights Plan
|
Effective April 16, 1997, the Companys board of
directors declared a distribution of one right
(Rights) for each outstanding share of the
Companys common stock to stockholders of record at the
close of business on May 15, 1997 and for each share of
common stock issued by the Company thereafter and prior to a
Flip-in Date (as defined below). Each Right entitles the
registered holder to purchase from the Company one-ten
thousandth
(1/10,000th)
of a share of Series A Junior Participating Preferred
Stock, at an exercise price of $30. The Rights are generally not
exercisable until 10 business days after an announcement by the
Company that a person or group of affiliated persons (an
Acquiring Person) has acquired beneficial ownership
of 15% or more of the Companys then outstanding shares of
common stock (a Flip-in Date).
In the event the Rights become exercisable as a result of the
acquisition of shares, each Right will enable the owner, other
than the Acquiring Person, to purchase at the Rights
then-current exercise price a number of shares of common stock
with a market value equal to twice the exercise price. In
addition, unless the Acquiring Person owns more than 50% of the
outstanding shares of common stock, the Board of Directors may
elect to exchange all outstanding Rights (other than those owned
by such Acquiring Person) at an exchange ratio of one share of
common stock per Right. All Rights that are owned by any person
on or after the date such person becomes an Acquiring Person
will be null and void.
The Rights have been distributed to protect the Companys
stockholders from coercive or abusive takeover tactics and to
give the Board of Directors more negotiating leverage in dealing
with prospective acquirors. The Company recently extended the
stockholder rights plan through April 2017.
At December 31, 2007, the Company had United States federal
and state net operating loss carryforwards of $109 million
and $52 million, respectively, available to offset against
future taxable income, which expire in 2010 through 2027. As a
result of a change in-control that occurred in the CytRx
shareholder base in July 2002, approximately $45 million in
federal net operating loss carryforwards became limited in their
availability to $0.7 million annually. Management currently
believes that the remaining $64 million in federal net
operating loss carryforwards, and the $52 million in state
net operating loss carryforwards, are unrestricted. However,
management is reviewing its recent equity transactions to
determine if they may have resulted in any further restrictions
on the Companys net operating loss carryforwards.
Additionally, due to the
change-in-control,
approximately $6.3 million of research and development tax
credits will not be available for utilization and were written
off. As of December 31, 2007, CytRx also had research and
development and orphan drug credits for federal and state
purposes of approximately $3 million and $2 million,
respectively, available for offset against future income taxes,
which expire in 2008 through 2027. Based on an assessment of all
available evidence including, but not limited to,
E-25
CYTRX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
the Companys limited operating history in its core
business and lack of profitability, uncertainties of the
commercial viability of its technology, the impact of government
regulation and healthcare reform initiatives, and other risks
normally associated with biotechnology companies, the Company
has concluded that it is more likely than not that these net
operating loss carryforwards and credits will not be realized
and, as a result, a 100% deferred tax valuation allowance has
been recorded against these assets.
Deferred income taxes reflect the net effect of temporary
differences between the financial reporting carrying amounts of
assets and liabilities and income tax carrying amounts of assets
and liabilities. The components of the Companys deferred
tax assets and liabilities, all of which are long-term, are as
follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
Deferred tax assets:
|
|
|
|
|
|
|
|
|
Net operating loss carryforwards
|
|
$
|
39,919
|
|
|
$
|
30,892
|
|
Tax credit carryforwards
|
|
|
3,114
|
|
|
|
2,391
|
|
Equipment, furnishings and other
|
|
|
4,124
|
|
|
|
1,547
|
|
Deferred revenue
|
|
|
6,200
|
|
|
|
9,085
|
|
|
|
|
|
|
|
|
|
|
Total deferred tax assets
|
|
|
53,357
|
|
|
|
43,915
|
|
Deferred tax liabilities
|
|
|
(111
|
)
|
|
|
(85
|
)
|
|
|
|
|
|
|
|
|
|
Net deferred tax assets
|
|
|
53,246
|
|
|
|
43,830
|
|
Valuation allowance
|
|
|
(53,246
|
)
|
|
|
(43,830
|
)
|
|
|
|
|
|
|
|
|
|
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
For all years presented, the Company did not recognize any
deferred tax assets or liabilities. The net change in valuation
allowance for the years ended December 31, 2007 and 2006
were increases of $9,416,000 and $34,000, respectively.
The provision for income taxes differs from the provision
computed by applying the Federal statutory rate to net loss
before income taxes as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
Federal benefit at statutory rate
|
|
$
|
(7,781
|
)
|
|
$
|
(5,646
|
)
|
|
$
|
(5,128
|
)
|
State income taxes, net of Federal taxes
|
|
|
(908
|
)
|
|
|
(968
|
)
|
|
|
(603
|
)
|
Permanent differences
|
|
|
65
|
|
|
|
143
|
|
|
|
736
|
|
Provision related to change in valuation allowance
|
|
|
9,416
|
|
|
|
34
|
|
|
|
5,308
|
|
Net change in research and development tax credits
|
|
|
(1,125
|
)
|
|
|
5,059
|
|
|
|
|
|
Change in state tax rates
|
|
|
|
|
|
|
2,160
|
|
|
|
|
|
Other, net
|
|
|
373
|
|
|
|
(637
|
)
|
|
|
(313
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
40
|
|
|
$
|
145
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
E-26
CYTRX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
15.
|
Quarterly
Financial Data (unaudited)
|
Summarized quarterly financial data for 2007 and 2006 is as
follows (in thousands, except per share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quarters Ended
|
|
|
|
March 31
|
|
|
June 30
|
|
|
September 30
|
|
|
December 31
|
|
|
|
(In thousands, except per share data)
|
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
$
|
1,563
|
|
|
$
|
2,371
|
|
|
$
|
2,046
|
|
|
$
|
1,479
|
|
Net loss
|
|
|
(4,546
|
)
|
|
|
(6,285
|
)
|
|
|
(4,597
|
)
|
|
|
(6,462
|
)
|
Deemed dividend for anti-dilution adjustments made to
outstanding common stock warrants
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss applicable to common stockholders
|
|
$
|
(4,546
|
)
|
|
$
|
(6,285
|
)
|
|
$
|
(4,597
|
)
|
|
$
|
(6,462
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share applicable to common stock
|
|
$
|
(0.06
|
)
|
|
$
|
(0.07
|
)
|
|
$
|
(0.05
|
)
|
|
$
|
(0.07
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
$
|
61
|
|
|
$
|
|
|
|
$
|
776
|
|
|
$
|
1,229
|
|
Net loss
|
|
|
(4,166
|
)
|
|
|
(5,465
|
)
|
|
|
(2,972
|
)
|
|
|
(4,148
|
)
|
Deemed dividend for anti-dilution adjustments made to
outstanding common stock warrants
|
|
|
(488
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss applicable to common stockholders
|
|
$
|
(4,654
|
)
|
|
$
|
(5,465
|
)
|
|
$
|
(2,972
|
)
|
|
$
|
(4,148
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share applicable to common stock
|
|
$
|
(0.07
|
)
|
|
$
|
(0.08
|
)
|
|
$
|
(0.04
|
)
|
|
$
|
(0.06
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quarterly and year to date loss per share amounts are computed
independently of each other. Therefore, the sum of the per share
amounts for the quarters may not agree to the per share amounts
for the year.
Our Statements of Operations as of and for the years ended
December 31, 2007 and 2006 reflect the impact of
SFAS 123(R). In accordance with the modified prospective
transition method, our results of operations for prior periods
have not been restated to reflect the impact of
SFAS 123(R). Share-based compensation expense recognized
under SFAS 123(R) for the years ended December 31,
2007 and 2006 were $2.7 and $1.2 million, respectively.
In connection with the Companys adjustment to the exercise
terms of certain outstanding warrants to purchase common stock
on March 2, 2006 and January 20, 2005, the Company
recorded deemed dividends of $488,000 and $1.1 million,
respectively. These deemed dividends are reflected as an
adjustment to net loss for the first quarter of 2006 and the
year ended 2005 to arrive at net loss applicable to common
stockholders on the consolidated statements of operations and
for purposes of calculating basic and diluted earnings per
shares.
Fourth
Quarter Adjustment
During the fourth quarter of 2007, the Company recorded
adjustments for: (i) additional compensation expense of
$236,000 related to previously granted non-employee stock
options, (ii) additional compensation expense of $350,000
related to stock options previously granted to Directors and
(iii) additional general and administrative expense of
$192,000 related to legal fees rendered during the third
quarter. Management concluded the effect of these adjustments
was not material to any previously reported quarterly period.
E-27
CYTRX
CORPORATION
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
On February 14, 2008, the Companys board of directors
declared a dividend, payable to its stockholders as of
March 6, 2008, the record date, of one share of the common
stock of RXi Pharmaceuticals Corporation for each approximately
20.05 shares of our common stock held by such stockholders.
The dividend was paid on March 11, 2008. The RXi shares
distributed by the Company to its stockholders constituted
approximately 36% of the currently outstanding RXi shares, and
as a result, the Company currently owns approximately 49% of the
outstanding shares of RXi common stock. As a result, the
Companys financial statements will no longer consolidate
the financial condition and results of operation of RXi, but
instead will account for its ongoing investment in RXi based on
the equity method of accounting.
As of March 25, 2007, the Company has received
approximately $1.0 million in connection with the exercise
of warrants and options since December 31, 2007. The
exercise price of the warrants and options ranged from $.20 to
$2.00.
E-28
CYTRX
CORPORATION
SCHEDULE II
VALUATION AND QUALIFYING ACCOUNTS
For the
Years Ended December 31, 2007, 2006 and 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additions
|
|
|
|
|
|
|
|
|
|
Balance at
|
|
|
Charged to
|
|
|
Charged to
|
|
|
|
|
|
|
|
|
|
Beginning of
|
|
|
Costs and
|
|
|
Other
|
|
|
|
|
|
Balance at
|
|
Description
|
|
Year
|
|
|
Expenses
|
|
|
Accounts
|
|
|
Deductions
|
|
|
End of Year
|
|
|
Reserve Deducted in the Balance Sheet from the Asset to Which it
Applies:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance for Deferred Tax Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, 2007
|
|
$
|
43,830,000
|
|
|
$
|
|
|
|
$
|
9,416,000
|
|
|
$
|
|
|
|
$
|
53,246,000
|
|
Year ended December 31, 2006
|
|
|
43,796,000
|
|
|
|
|
|
|
|
34,000
|
|
|
|
|
|
|
|
43,830,000
|
|
Year ended December 31, 2005
|
|
|
38,488,000
|
|
|
|
|
|
|
|
5,308,000
|
|
|
|
|
|
|
|
43,796,000
|
|
E-29
CYTRX
CORPORATION
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
(Unaudited)
|
|
|
|
|
|
ASSETS
|
Current assets:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
43,538,946
|
|
|
$
|
50,498,261
|
|
Short-term investments, at amortized cost
|
|
|
|
|
|
|
9,951,548
|
|
Accounts receivable
|
|
|
|
|
|
|
101,217
|
|
Prepaid expense and other current assets
|
|
|
1,101,651
|
|
|
|
930,596
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
44,640,597
|
|
|
|
61,481,622
|
|
Equipment and furnishings, net
|
|
|
1,349,548
|
|
|
|
1,573,290
|
|
Molecular library, net
|
|
|
182,017
|
|
|
|
193,946
|
|
Investment in unconsolidated subsidiary
|
|
|
3,536,614
|
|
|
|
|
|
Goodwill
|
|
|
183,780
|
|
|
|
183,780
|
|
Other assets
|
|
|
647,055
|
|
|
|
713,398
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
50,539,611
|
|
|
$
|
64,146,036
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY
|
Current liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
721,093
|
|
|
$
|
1,946,215
|
|
Accrued expenses and other current liabilities
|
|
|
2,699,777
|
|
|
|
3,700,866
|
|
Income taxes payable
|
|
|
342,000
|
|
|
|
|
|
Deferred revenue, current portion
|
|
|
8,207,492
|
|
|
|
8,399,167
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
11,970,362
|
|
|
|
14,046,248
|
|
Deferred revenue, non-current portion
|
|
|
5,177,967
|
|
|
|
7,167,381
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
17,148,329
|
|
|
|
21,213,629
|
|
|
|
|
|
|
|
|
|
|
Minority interest
|
|
|
|
|
|
|
2,708,368
|
|
|
|
|
|
|
|
|
|
|
Commitments and Contingencies
|
|
|
|
|
|
|
|
|
Stockholders equity:
|
|
|
|
|
|
|
|
|
Preferred Stock, $.01 par value, 5,000,000 shares
authorized, including 15,000 shares of Series A Junior
Participating Preferred Stock; no shares issued and outstanding
|
|
|
|
|
|
|
|
|
Common stock, $.001 par value, 150,000,000 shares
authorized; 91,374,269 and 90,397,867 shares issued at
March 31, 2008 and December 31, 2007, respectively
|
|
|
91,374
|
|
|
|
90,398
|
|
Additional paid-in capital
|
|
|
206,089,009
|
|
|
|
203,905,691
|
|
Treasury stock, at cost (633,816 shares held at
March 31, 2008 and December 31, 2007, respectively)
|
|
|
(2,279,238
|
)
|
|
|
(2,279,238
|
)
|
Accumulated deficit
|
|
|
(170,509,863
|
)
|
|
|
(161,492,812
|
)
|
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
33,391,282
|
|
|
|
40,224,039
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity
|
|
$
|
50,539,611
|
|
|
$
|
64,146,036
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed
consolidated financial statements.
E-30
CYTRX
CORPORATION
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
|
March 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
(Unaudited)
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
Service revenue
|
|
$
|
2,181,088
|
|
|
$
|
1,446,993
|
|
Grant revenue
|
|
|
|
|
|
|
116,070
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,181,088
|
|
|
|
1,563,063
|
|
|
|
|
|
|
|
|
|
|
Expenses:
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
3,191,713
|
|
|
|
4,008,374
|
|
General and administrative
|
|
|
4,473,149
|
|
|
|
2,485,085
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,664,862
|
|
|
|
6,493,459
|
|
|
|
|
|
|
|
|
|
|
Loss before other income
|
|
|
(5,483,774
|
)
|
|
|
(4,930,396
|
)
|
Other income:
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
524,271
|
|
|
|
382,614
|
|
Other income, net
|
|
|
218,229
|
|
|
|
|
|
Equity in loss of unconsolidated subsidiary
|
|
|
(378,898
|
)
|
|
|
|
|
Minority interest in losses of subsidiary
|
|
|
88,374
|
|
|
|
2,000
|
|
|
|
|
|
|
|
|
|
|
Net loss before income taxes
|
|
|
(5,031,798
|
)
|
|
|
(4,545,782
|
)
|
Provision for income taxes
|
|
|
(342,000
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(5,373,798
|
)
|
|
|
(4,545,782
|
)
|
Deemed dividend for anti-dilution adjustment made to stock
warrants
|
|
|
(756,954
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss applicable to common stockholders
|
|
$
|
(6,130,752
|
)
|
|
$
|
(4,545,782
|
)
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share
|
|
$
|
(0.07
|
)
|
|
$
|
(0.06
|
)
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding
|
|
|
90,280,449
|
|
|
|
73,273,746
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed
consolidated financial statements.
E-31
CYTRX
CORPORATION
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
(Unaudited)
|
|
|
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(5,373,798
|
)
|
|
$
|
(4,545,782
|
)
|
Adjustments to reconcile net loss to net used in operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
133,052
|
|
|
|
71,353
|
|
Equity in loss of unconsolidated subsidiary
|
|
|
378,898
|
|
|
|
|
|
Minority interest in losses of subsidiary
|
|
|
(88,374
|
)
|
|
|
(2,000
|
)
|
RXi common stock transferred for services
|
|
|
244,860
|
|
|
|
|
|
Non-cash earned on short-term investments
|
|
|
(48,452
|
)
|
|
|
|
|
Non-cash gain on transfer of RXi common stock
|
|
|
(226,579
|
)
|
|
|
|
|
Common stock, stock options and warrants issued for services
|
|
|
|
|
|
|
975,545
|
|
Expense related to employee stock options
|
|
|
555,093
|
|
|
|
148,812
|
|
Net change in operating assets and liabilities
|
|
|
(2,898,342
|
)
|
|
|
(1,741,723
|
)
|
|
|
|
|
|
|
|
|
|
Total adjustments
|
|
|
(1,949,844
|
)
|
|
|
(548,013
|
)
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(7,323,642
|
)
|
|
|
(5,093,795
|
)
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
Purchases of equipment and furnishings
|
|
|
(223,203
|
)
|
|
|
(2,501
|
)
|
Deconsolidation of subsidiary, RXi Pharmaceutical Corporation
|
|
|
(10,359,278
|
)
|
|
|
|
|
Proceeds from sale of short-term investments
|
|
|
10,000,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities
|
|
|
(582,481
|
)
|
|
|
(2,501
|
)
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
Proceeds from exercise of stock options and warrants
|
|
|
946,808
|
|
|
|
11,064,892
|
|
Net proceeds from issuances of common stock in subsidiary
|
|
|
|
|
|
|
2,000
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
946,808
|
|
|
|
11,066,892
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents
|
|
|
(6,959,315
|
)
|
|
|
5,970,596
|
|
Cash and cash equivalents at beginning of period
|
|
|
50,498,261
|
|
|
|
30,381,393
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period
|
|
$
|
43,538,946
|
|
|
$
|
36,351,989
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information:
|
|
|
|
|
|
|
|
|
Cash received during the period as interest income
|
|
$
|
524,271
|
|
|
$
|
382,614
|
|
|
|
|
|
|
|
|
|
|
Supplemental
schedule of non-cash investing and financing
activities:
As the result of the stock dividend on March 6, 2008, the
Company deconsolidated its previously majority-owned subsidiary.
As part of the transaction, the Company deconsolidated
$3.7 million of total assets and $4.6 million of total
liabilities.
In connection with the Companys adjustment to the terms of
certain outstanding warrants on March 6, 2008, the Company
recorded a deemed dividend of approximately $757,000 in the
three months ended March 31, 2008. The deemed dividend was
recorded as a charge to accumulated deficit and a corresponding
credit to additional paid-in capital.
The accompanying notes are an integral part of these condensed
consolidated financial statements.
E-32
CYTRX
CORPORATION
March 31, 2008
(Unaudited)
|
|
1.
|
Description
of Company and Basis of Presdentation
|
CytRx CytRx Corporation (CytRx, the
Company, we, us or
our) is a clinical-stage biopharmaceutical company
engaged in developing human therapeutic products based primarily
upon its small-molecule molecular chaperone amplification
technology. Molecular chaperone proteins occur normally in human
cells and are key components of the bodys defenses against
potentially toxic mis-folded cellular proteins. Since these
toxic proteins called aggregates are thought to play a role in
many diseases, the Company believes that amplification of
molecular chaperone proteins could have therapeutic efficacy for
a broad range of indications. Currently, the Company is using
its chaperone amplification technology to discover and develop
potential treatments for a number of indications, including
neurodegenerative disorders and diabetic complications.
Through February 2008, the Company owned a majority of the
outstanding shares of common stock of RXi Pharmaceuticals
Corporation, or RXi, which was founded in April 2006 by the
Company and four researchers in the field of RNAi, including
Dr. Craig Mello, recipient of the 2006 Nobel Prize for
Medicine for his co-discovery of RNAi. RNAi is a naturally
occurring mechanism for the regulation of gene expression that
has the potential to selectively inhibit the activity of any
human gene. RXi is focused solely on developing and
commercializing therapeutic products based upon RNAi
technologies for the treatment of human diseases, including
neurodegenerative diseases, cancer, type 2 diabetes and obesity.
While RXi was majority-owned, the Companys consolidated
financial statements reflected 100% of the assets and
liabilities and results of operations of RXi, with the interests
of the minority shareholders of RXi recorded as minority
interests. In March 2008, the Company distributed to its
stockholders approximately 36% of RXis outstanding shares,
which reduced CytRxs ownership to less than 50% of RXi. As
a result of the reduced ownership, CytRx began to account for
its investment in RXi using the equity method, under which CytRx
records only its pro-rata share of the financial results of RXi
against its historical basis investment in RXi. The investment
in RXi is shown as investment in unconsolidated
subsidiary on the consolidated balance sheet and the
related earnings are shown as equity in loss of
unconsolidated subsidiary on the consolidated statements
of operations. Because only a portion of RXis financial
results for March 2008 were recorded by CytRx under the equity
method, the Companys results of operations for the first
quarter of 2008 are not directly comparable to results of
operations for the same period in 2007. The future results of
operations of the Company also will not be directly comparable
to corresponding periods in prior years during which our
financial statements reflected the consolidation of RXi.
To date, the Company has relied primarily upon sales of its
equity securities and upon proceeds received upon the exercise
of options and warrants and, to a much lesser extent, upon
payments from its strategic partners and licensees, to generate
funds needed to finance its business and operations. See
Note 6 Liquidity and Capital Resources.
In August 2006, the Company received approximately
$24.3 million in proceeds from the privately-funded ALS
Charitable Remainder Trust (ALSCRT) in exchange for
the commitment to continue research and development of
arimoclomol and other potential treatments for ALS and a one
percent royalty in the worldwide sales of arimoclomol. Under the
arrangement, the Company retains the rights to any developments
funded by the arrangement and the proceeds of the transaction
are non-refundable. Further, the ALS Charitable Remainder Trust
has no obligation to provide any further funding to the Company.
Management has concluded that due to the research and
development components of the transaction that it is properly
accounted for under SFAS No. 68, Research and
Development Arrangements
(SFAS No. 68). Accordingly, the
Company has recorded the value received under the arrangement as
deferred revenue and will recognize service revenue using the
proportional performance method of revenue recognition, meaning
that service revenue is recognized on a dollar-for-dollar basis
for each dollar of expense incurred for the research and
development of arimoclomol and other potential ALS treatments.
E-33
CYTRX
CORPORATION
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The accompanying condensed consolidated financial statements at
March 31, 2008 and for the three-month periods ended
March 31, 2008 and 2007 are unaudited, but include all
adjustments, consisting of normal recurring entries, which
management believes to be necessary for a fair presentation of
the periods presented. Interim results are not necessarily
indicative of results for a full year. Balance sheet amounts as
of December 31, 2007 have been derived from the
Companys audited financial statements as of that date.
The consolidated financial statements included herein have been
prepared by the Company pursuant to the rules and regulations of
the Securities and Exchange Commission (SEC).
Certain information and footnote disclosures normally included
in financial statements prepared in accordance with accounting
principles generally accepted in the United States of America
have been condensed or omitted pursuant to such rules and
regulations. The financial statements should be read in
conjunction with the Companys audited consolidated
financial statements in its
Form 10-K
for the year ended December 31, 2007. The Companys
operating results will fluctuate for the foreseeable future.
Therefore, period-to-period comparisons should not be relied
upon as predictive of the results in future periods.
|
|
2.
|
Recent
Accounting Pronouncements
|
In September 2006, the FASB issued Statement of Financial
Accounting Standards (SFAS) No. 157, Fair
Value Measurements (SFAS No. 157).
SFAS No. 157 defines fair value, establishes a
framework for measuring fair value in accordance with generally
accepted accounting principles, and expands disclosures about
fair value measurements. SFAS No. 157 does not expand
the use of fair value in any new circumstances. In February
2008, the FASB issued Staff Position
No. FAS 157-1,
which amended SFAS No. 157 to exclude
SFAS No. 13, Accounting for Leases, and other
accounting pronouncements that address fair value measurements
for purposes of lease classification or measurement under
Statement 13. However, this scope exception does not apply to
assets acquired and liabilities assumed in a business
combination. Also in February 2008, the FASB issued Staff
Position
No. FAS 157-2,
which delayed the effective date of SFAS No. 157 for
non-financial assets and liabilities, except those items
recognized at fair value on an annual or more frequently
recurring basis to fiscal years beginning after
November 15, 2008 and interim periods within those fiscal
years. The Company adopted SFAS No. 157 with no
material impact on the Companys consolidated financial
statements.
In February 2007, the FASB issued SFAS No. 159,
Fair Value Option for Financial Assets and Financial
Liabilities (SFAS No. 159).
SFAS No. 159 permits entities to choose to measure
many financial assets and financial liabilities at fair value.
Unrealized gains and losses on items for which the fair value
option has been elected are reported in earnings.
SFAS No. 159 is effective for fiscal years beginning
after November 15, 2007. The Company adopted
SFAS No. 159 with no material impact on the
Companys consolidated financial statements.
In June 2007, the FASB ratified the consensus on Emerging Issues
Task Force (EITF) Issue
No. 06-11,
Accounting for Income Tax Benefits of Dividends on
Share-Based Payment Awards
(EITF 06-11).
EITF 06-11
requires companies to recognize the income tax benefit realized
from dividends or dividend equivalents that are charged to
retained earnings and paid to employees for non-vested
equity-classified employee share-based payment awards as an
increase to additional paid-in capital.
EITF 06-11
is effective for fiscal years beginning after September 15,
2007. The Company adopted
EITF 06-11
with no material impact on the Companys consolidated
financial statements.
In June 2007, the FASB ratified the consensus reached on EITF
Issue
No. 07-3,
Accounting for Nonrefundable Advance Payments for Goods or
Services Received for Use in Future Research and Development
Activities
(EITF 07-3),
which requires that nonrefundable advance payments for goods or
services that will be used or rendered for future research and
development activities be deferred and amortized over the period
that the goods are delivered or the related services are
performed, subject to an assessment of recoverability.
EITF 07-3
will be effective for fiscal years beginning after
December 15, 2007. The Company adopted
EITF 07-3
with no material impact on the Companys consolidated
financial statements.
E-34
CYTRX
CORPORATION
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
In December 2007, the FASB issued SFAS No. 160,
Noncontrolling Interests in Consolidated Financial Statements
(SFAS No. 160) and a revision to
SFAS No. 141, Business Combinations
(SFAS No. 141R).
SFAS No. 160 modifies the accounting for
noncontrolling interest in a subsidiary and the deconsolidation
of a subsidiary. SFAS No. 141R establishes the
measurements in a business combination of the identifiable
assets acquired, the liabilities assumed and any noncontrolling
interest in the acquiree. Both of these related statements are
effective for fiscal years beginning after December 15,
2008. The Company has not determined the impact that the
adoption of these two statements will have on the consolidated
financial statements.
In December 2007, the SEC issued Staff Accounting
Bulletin 110 (SAB 110), which expresses
the views of the Staff regarding use of a simplified
method, as discussed in SAB 107, in developing an estimate
of expected term of plain vanilla share options in
accordance with Statement of Financial Accounting Standards
No. 123. SAB 110 will allow, under certain
circumstances, the use of the simplified method beyond
December 31, 2007 when a Company is unable to rely on the
historical exercise data. The Company adopted SAB 110 with
no material impact on its financial statements.
|
|
3.
|
Short-term
Invesstments
|
RXi had zero coupon U.S Treasury Bills that were purchased at a
discount and matured within twelve months. They were classified
as held-to-maturity and under Statement of Financial Accounting
Standards No. 115, Investments in Debt Securities,
were measured at amortized cost since RXi had the intent and
ability to hold these securities to maturity. The interest
income had been amortized at the effective interest rate.
|
|
4.
|
Basic and
Diluted Loss Per Common Share
|
Basic and diluted loss per common share are computed based on
the weighted average number of common shares outstanding. Common
share equivalents (which consist of options and warrants) are
excluded from the computation of diluted loss per share since
the effect would be antidilutive. Common share equivalents which
could potentially dilute basic earnings per share in the future,
and which were excluded from the computation of diluted loss per
share, totaled approximately 16.2 million and
22.7 million shares at March 31, 2008 and 2007,
respectively.
In connection with the Companys adjustment to the exercise
terms of certain outstanding warrants to purchase common stock
on March 11, 2008, the Company recorded a deemed dividend
of approximately $757,000. The deemed dividend is reflected as
an adjustment to net loss for the first quarter of 2008, to
arrive at net loss applicable to common stockholders on the
Condensed Consolidated Statement of Operations and for purposes
of calculating basic and diluted loss per share.
|
|
5.
|
Stock
Based Compensation
|
CytRx
Corporation
The Company has a stock option plan, the 2000 Stock Option
Incentive Plan, under which, as of March 31, 2008, an
aggregate of 10,000,000 shares of common stock were
reserved for issuance, including approximately
5,889,756 shares subject to outstanding stock options and
approximately 2,257,032 million shares available for future
grant. Additionally, the Company has two other plans, the 1994
Stock Option Plan and the 1998 Long Term Incentive Plan, which
include 9,167 and 100,041 shares subject to outstanding
stock options. As the terms of the plans provide that no options
may be issued after 10 years, no options are available
under the 1994 Plan. Under the 1998 Long Term Incentive Plan,
29,517 shares are available for future grant. Options
granted under these plans generally vest and become exercisable
as to 33% of the option grants on each anniversary of the grant
date until fully vested. The options expire, unless previously
exercised, not later than ten years from the grant date.
The Companys stock-based employee compensation plans are
described in Note 12 to its financial statements contained
in its Annual Report on
Form 10-K
filed for the year ended December 31, 2007.
E-35
CYTRX
CORPORATION
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The Company adopted the provisions of SFAS No. 123(R),
Share-Based Payment (SFAS 123(R)), which
requires the measurement and recognition of compensation expense
for all stock-based awards made to employees and non-employee
directors.
For stock options paid in consideration of services rendered by
non-employees, the Company recognizes compensation expense in
accordance with the requirements of SFAS No. 123(R),
Emerging Issues Task Force Issue
No. 96-18
(EITF 96-18),
Accounting for Equity Instruments that are Issued to other
than Employees for Acquiring, or in Conjunction with Selling
Goods or Services and
EITF 00-18,
Accounting Recognition for Certain Transactions involving
Equity Instruments Granted to Other Than Employees, as
amended.
Non-employee option grants that do not vest immediately upon
grant are recorded as an expense over the performance period. At
the end of each financial reporting period prior to performance,
the value of these options, as calculated using the
Black-Scholes option pricing model, will be determined, and
compensation expense recognized or recovered during the period
will be adjusted accordingly. Since the fair market value of
options granted to non-employees is subject to change in the
future, the amount of the future compensation expense is subject
to adjustment until the common stock options are fully vested.
The following table sets forth the total stock-based
compensation expense (recovery) resulting from stock options
included in the Companys unaudited interim consolidated
statements of operations:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
Research and development employee
|
|
$
|
171,000
|
|
|
$
|
37,000
|
|
General and administrative employee
|
|
|
291,000
|
|
|
|
112,000
|
|
|
|
|
|
|
|
|
|
|
Total employee stock-based compensation
|
|
$
|
462,000
|
|
|
$
|
149,000
|
|
|
|
|
|
|
|
|
|
|
Research and development non-employee
|
|
$
|
(422,000
|
)
|
|
$
|
695,000
|
|
General and administrative non-employee
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total non-employee stock-based compensation
|
|
$
|
(422,000
|
)
|
|
$
|
695,000
|
|
|
|
|
|
|
|
|
|
|
During the first three months of 2008, the Company issued stock
options to purchase 86,000 shares of its common stock. The
fair value of the stock options granted in the three-month
period listed in the table below was estimated using the
Black-Scholes option-pricing model, based on the following
assumptions:
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
|
2008
|
|
2007
|
|
Risk-free interest rate
|
|
2.84%
|
|
4.41%-4.89%
|
Expected volatility
|
|
93.8%-96.2%
|
|
116.8%
|
Expected lives (years)
|
|
6
|
|
6
|
Expected dividend yield
|
|
0.00%
|
|
0.00%
|
The Companys computation of expected volatility is based
on the historical daily volatility of its publicly traded stock.
For option grants issued during the three-month periods ended
March 31, 2008 and 2007, the Company used a calculated
volatility for each grant. The Companys computation of
expected life were estimated using the simplified method
provided for under Staff Accounting Bulletin 107,
Share-Based Payment (SAB 107), which
averages the contractual term of the Companys options of
ten years with the average vesting term of three years for an
average of six years. The dividend yield assumption of zero is
based upon the fact the Company has never paid cash dividends
and presently has no intention of paying cash dividends. The
risk-free interest rate used for each grant is equal to the
U.S. Treasury rates in effect at the time of the grant for
instruments with a similar expected life. Based on historical
experience, for the three-month periods ended March 31,
2008 and 2007, the Company has estimated an annualized
forfeiture rate of 10% and 5%, respectively, for options granted
to its employees and 1% for
E-36
CYTRX
CORPORATION
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
each period for options granted to senior management and
directors. Compensation costs will be adjusted for future
changes in estimated forfeitures. The Company will record
additional expense if the actual forfeitures are lower than
estimated and will record a recovery of prior expense if the
actual forfeiture rates are higher than estimated. No amounts
relating to employee stock-based compensation have been
capitalized.
At March 31, 2008, there remained approximately
$3.6 million of unrecognized compensation expense related
to unvested stock options granted to employees, directors,
scientific advisory board members and consultants, to be
recognized as expense over a weighted-average period of
1.55 years. Presented below is the Companys stock
option activity:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, 2008
|
|
|
|
Number of Options
|
|
|
Number of Options
|
|
|
Total Number
|
|
|
Weighted Average
|
|
|
|
(Employees)
|
|
|
(Non-Employees)
|
|
|
of Options
|
|
|
Exercise Price
|
|
|
Outstanding at January 1, 2008
|
|
|
4,594,000
|
|
|
|
1,397,000
|
|
|
|
5,991,000
|
|
|
$
|
2.29
|
|
Granted
|
|
|
86,000
|
|
|
|
|
|
|
|
86,000
|
|
|
$
|
1.93
|
|
Exercised
|
|
|
(25,000
|
)
|
|
|
|
|
|
|
(25,000
|
)
|
|
$
|
0.83
|
|
Forfeited
|
|
|
(162,000
|
)
|
|
|
|
|
|
|
(162,000
|
)
|
|
$
|
2.92
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at March 31, 2008
|
|
|
4,493,000
|
|
|
|
1,397,000
|
|
|
|
5,890,000
|
|
|
$
|
2.27
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable at March 31, 2008
|
|
|
2,944,000
|
|
|
|
1,147,000
|
|
|
|
4,091,000
|
|
|
$
|
1.89
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
A summary of the activity for non-vested stock options as of
March 31, 2008 is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average
|
|
|
|
Number of Options
|
|
|
Number of Options
|
|
|
Total Number of
|
|
|
Grant Date Fair
|
|
|
|
(Employees)
|
|
|
(Non-Employees)
|
|
|
Options
|
|
|
Value per Share
|
|
|
Non-vested at January 1, 2008
|
|
|
1,734,000
|
|
|
|
250,000
|
|
|
|
1,984,000
|
|
|
$
|
2.91
|
|
Granted
|
|
|
86,000
|
|
|
|
|
|
|
|
86,000
|
|
|
$
|
1.50
|
|
Forfeited
|
|
|
(162,000
|
)
|
|
|
|
|
|
|
(162,000
|
)
|
|
$
|
2.46
|
|
Vested
|
|
|
(84,000
|
)
|
|
|
|
|
|
|
(84,000
|
)
|
|
$
|
2.74
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-vested at March 31, 2008
|
|
|
1,574,000
|
|
|
|
250,000
|
|
|
|
1,824,000
|
|
|
$
|
2.92
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table summarizes significant ranges of outstanding
stock options under the Companys plans at March 31,
2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Remaining
|
|
|
Weighted
|
|
|
|
|
|
Weighted
|
|
|
Weighted
|
|
|
|
|
|
|
Contractual
|
|
|
Average
|
|
|
Number of
|
|
|
Average
|
|
|
Average
|
|
|
|
Number of
|
|
|
Life
|
|
|
Exercise
|
|
|
Options
|
|
|
Contractual
|
|
|
Exercise
|
|
Range of Exercise Prices
|
|
Options
|
|
|
(Years)
|
|
|
Price
|
|
|
Exercisable
|
|
|
Life
|
|
|
Price
|
|
|
$0.71 1.00
|
|
|
790,000
|
|
|
|
6.49
|
|
|
$
|
0.81
|
|
|
|
730,000
|
|
|
|
6.49
|
|
|
$
|
0.81
|
|
$1.01 2.00
|
|
|
2,362,000
|
|
|
|
6.97
|
|
|
$
|
1.48
|
|
|
|
1,863,000
|
|
|
|
6.97
|
|
|
$
|
1.52
|
|
$2.01 3.00
|
|
|
1,130,000
|
|
|
|
5.32
|
|
|
$
|
2.46
|
|
|
|
1,112,000
|
|
|
|
5.32
|
|
|
$
|
2.46
|
|
$3.01 4.00
|
|
|
623,000
|
|
|
|
9.47
|
|
|
$
|
3.42
|
|
|
|
150,000
|
|
|
|
9.47
|
|
|
$
|
3.34
|
|
$4.01 4.65
|
|
|
985,000
|
|
|
|
9.10
|
|
|
$
|
4.42
|
|
|
|
236,000
|
|
|
|
9.10
|
|
|
$
|
4.45
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,890,000
|
|
|
|
7.21
|
|
|
$
|
2.27
|
|
|
|
4,091,000
|
|
|
|
7.19
|
|
|
$
|
1.89
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The aggregate intrinsic value of outstanding options as of
March 31, 2008 was approximately $300,000, of which
approximately $270,000 was related to exercisable options. The
aggregate intrinsic value was calculated based on the positive
difference between the closing fair market value of the
Companys common stock on March 31, 2008 ($1.15) and
the exercise price of the underlying options. The intrinsic
value of options exercised
E-37
CYTRX
CORPORATION
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
was $8,000 for the three-month period ended March 31, 2008,
and the intrinsic value of options that vested was approximately
$11,000 for the same period.
RXi
Pharmaceuticals
RXi RXi has its own stock option plan named the RXi
Pharmaceuticals Corporation 2007 Incentive Plan. They account
for stock option expense in the same manner as CytRx, which is
described above.
The following table sets forth the total stock-based
compensation expense for January and February 2008, resulting
from stock options, that is included in the Companys
unaudited condensed consolidated statements of operations:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
Research and development employee
|
|
$
|
28,000
|
|
|
$
|
|
|
General and administrative employee
|
|
|
369,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total employee stock-based compensation
|
|
$
|
397,000
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
Research and development non-employee
|
|
$
|
121,000
|
|
|
$
|
|
|
General and administrative non-employee
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total non-employee stock-based compensation
|
|
$
|
121,000
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6.
|
Liquidity
and Capital Resources
|
At March 31, 2008, the Company had cash and cash
equivalents of $43.5 million. Management believes that the
Company has adequate financial resources to support its
currently planned level of operations into the second half of
2009, based, in part, upon projected expenditures for the
remainder of 2008 and the first three months of 2009 of
$31.0 million, including $6.2 million for the
Companys planned clinical program for arimoclomol for ALS
and related studies, $6.3 million for its other ongoing and
planned clinical programs, including a planned Phase II
clinical trial of arimoclomol in stroke patients and a planned
Phase II clinical trial of iroxanadine for diabetic ulcers,
$9.9 million for the operations of the Companys
research laboratory in San Diego and $8.6 million for
other general and administrative expenses. Managements
projected expenditures assume the prompt resumption of the
Companys Phase II clinical program for arimoclomol
for ALS, which has been placed on clinical hold by the
U.S. Food and Drug Administration, or FDA. If the Company
is required to conduct additional toxicology or human studies
prior to or in parallel with the resumption of that clinical
trial, alter the design of that trial, including by potentially
reducing the dosage of arimoclomol, or is prohibited by the FDA
from resuming the current planned clinical trial or initiating
any other clinical trial of arimoclomol for the treatment of ALS
or stroke recovery at the desired dose, or at all, due to safety
concerns, then the Companys actual expenditures will vary,
perhaps significantly from managements current
projections. The Company will be required to obtain additional
funding in order to execute its long-term business plans,
although it does not currently have commitments from any third
parties to provide it with capital. The Company cannot assure
that additional funding will be available on favorable terms, or
at all. If the Company fails to obtain additional funding when
needed, it may not be able to execute its business plans and its
business may suffer, which would have a material adverse effect
on its financial position, results of operations and cash flows.
On March 11, 2008, the Company paid a dividend to its
stockholders of approximately 36% of the outstanding shares of
RXi common stock. In connection with that distribution, the
Company adjusted the price of warrants to purchase approximately
10.6 million shares that had been issued in prior equity
financings in October 2004, January
E-38
CYTRX
CORPORATION
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
2005 and March 2006. The adjustment was made as a result of
anti-dilution provisions in those warrants that were triggered
by the Companys distribution of a portion of its assets to
its stockholders. The Company accounted for the anti-dilution
adjustments as deemed dividends analogous with the guidance in
Emerging Issues Task Force Issue (EITF)
No. 98-5,
Accounting for Convertible Securities with Beneficial
Conversion Features or Contingently Adjustable Conversion
Ratios, and
EITF 00-27,
Application of
98-5 to
Certain Convertible Instruments, and recorded an approximate
$757,000 charge to accumulated deficit and a corresponding
credit to additional paid-in capital.
On April 19, 2007, the Company completed a
$37.0 million private equity financing in which it issued
approximately 8.6 million shares of its common stock at a
price of $4.30 per share. Net of investment banking commissions,
legal, accounting and other expenses related to the transaction,
the Company received proceeds of approximately
$34.2 million. On April 30, 2007, the Company
contributed $15.0 million, net of reimbursed expenses
estimated at $2.0 million paid by RXi to the Company, in
exchange for equity in RXi, to satisfy the initial funding
requirements under its agreements with the University of
Massachusetts Medical School (UMMS). In September
2007, the actual reimbursed expenses paid by RXi to the Company
were finally determined to be approximately $3.0 million,
and on September 25, 2007, RXi issued to CytRx additional
equity as reimbursement of the excess expenses. Following those
transactions, CytRx owned approximately 85% of the outstanding
capital stock of RXi, of which approximately 36% was paid as a
dividend to CytRx stockholders on March 11, 2008.
In connection with the April 2007 private equity financing, the
Company adjusted the price and number of underlying shares of
warrants to purchase approximately 1.4 million shares that
had been issued in prior equity financings in May and September
2003. The adjustment was made as a result of anti-dilution
provisions in those warrants that were triggered by the
Companys issuance of common stock in the April 2007
financing at a price below the closing market price on the date
of the transaction. For the reasons described above, the Company
accounted for the anti-dilution adjustments as deemed dividends.
Because the fair value of the outstanding warrants decreased as
a result of the anti-dilution adjustment, no deemed dividend was
recorded, and thus the Company did not record a charge to
retained earnings or a corresponding credit to additional
paid-in capital.
In connection with the April 2007 private equity financing, the
Company entered into a registration rights agreement with the
purchasers of its common stock and warrants. That agreement
provides, among other things, for cash penalties, up to a
maximum of 16% (approximately $5.9 million) of the purchase
price paid for the securities in the event that the Company
failed to initially register or maintain the effective
registration of the securities until the sooner of two years or
the date on which the securities could be sold pursuant to
Rule 144 of the Securities Act of 1933, as amended. The
Company has evaluated the penalty provisions of the April 2007
registration rights agreement in light of FASB Staff Position
No. EITF 00-19-2,
Accounting for Registration Payment Arrangements, which
specifies that the contingent obligation to make future payments
or otherwise transfer consideration under a registration payment
arrangement should be separately recognized and measured in
accordance with FASB Statement No. 5, Accounting for
Contingencies, pursuant to which a contingent obligation
must be accrued only if it is reasonably estimable and probable.
In managements estimation, the contingent payments related
to the registration payment arrangement are not probable to
occur, and thus no amount need be accrued.
During the three-month period ended March 31, 2008, the
Company issued 1.0 million shares of its common stock, and
received $0.9 million, upon the exercise of stock options
and warrants. During the three-month period ended March 31,
2007, the Company issued 6.9 million shares of its common
stock, and received $11.1 million, upon the exercise of
stock options and warrants.
Through February 2008, the Company owned approximately 85% of
the outstanding shares of common stock of RXi. While RXi was
majority-owned, the Companys consolidated financial
statements reflected 100% of the assets and liabilities and
results of operations of RXi, with the interests of the minority
shareholders of RXi recorded as minority interests.
In March 2008, the Company distributed to its stockholders
approximately 36% of RXis
E-39
CYTRX
CORPORATION
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
outstanding shares, which reduced CytRxs ownership to less
than 50% of RXi. As a result, CytRx began to account for its
investment in RXi using the equity method, under which CytRx
records only its pro-rata share of the financial results of RXi
against its historical basis investment in RXi. Because only a
portion of RXis financial results for March 2008 were
recorded by CytRx under the equity method, the Companys
results of operations for the first quarter of 2008 are not
directly comparable to results of operations for the same period
in 2007. The future results of operations of the Company also
will not be directly comparable to corresponding periods in
prior years during which our financial statements reflected the
consolidation of RXi.
The Company offset $88,000 of minority interest in losses of RXi
against its net loss for the months of January and February
2008, and $2,000 of minority interest in losses of RXi against
its net loss for the three-month period ended March 31,
2007.
|
|
9.
|
Equity
Investment of RXi
|
In the first quarter of 2008, the Company distributed
approximately 4.5 million shares of RXi common stock to its
stockholders representing approximately 36% of RXis
outstanding shares, which reduced CytRxs ownership to
approximately 49% of RXi. Management determined that the
distribution of the RXi common stock to stockholders of CytRx
represented a partial spin-off of RXi and accounted for the
distribution of the RXi common shares at cost. As a result of
its reduced ownership in RXi, CytRx began to account for its
investment in RXi using the equity method, under which CytRx
records only its pro-rata share of the financial results of RXi
against its historical basis investment in RXi. The following
table presents summarized financial information for RXi for the
three months ended March 31, 2008:
|
|
|
|
|
|
|
Three Month
|
|
|
|
Period Ended
|
|
|
|
March 31, 2008
|
|
|
|
(In thousands)
|
|
|
Income Statement Data
|
|
|
|
|
Sales
|
|
$
|
|
|
Gross profit
|
|
|
|
|
Loss from continuing operations
|
|
|
(2,713
|
)
|
Loss
|
|
|
(2,646
|
)
|
|
|
|
|
|
|
|
March 31, 2008
|
|
|
|
(In thousands)
|
|
|
Balance Sheet Data
|
|
|
|
|
Current assets
|
|
$
|
10,179
|
|
Noncurrent assets
|
|
|
401
|
|
Current liabilities
|
|
|
1,774
|
|
Stockholders equity
|
|
|
8,806
|
|
At March 31, 2008, the fair value of CytRxs ownership
of 6,268,881 shares of RXis common stock was
$59,554,000 based on the closing price of RXis common
stock on that date.
On March 11, 2008, the Company distributed to our
stockholders approximately 4.5 million shares of RXi common
stock. We will recognize approximately a $32.9 million gain
for income tax purposes on the distribution of shares of RXi
common stock, which is the amount equal to the excess of the
fair market value of the stock distributed over our basis. The
gain will be included in determining whether we have current
year earnings and profits subject to taxation. Based upon our
anticipated loss from operations for 2008 and currently
available loss carryforwards, we expect to pay no regular income
taxes in connection with the distribution, however, we have
recorded a tax provision of $342,000 related to the estimated
Alternative Minimum Tax resulting from this gain.
E-40
APPENDIX F
INDEX TO
INNOVIVE FINANCIAL STATEMENTS
|
|
|
|
|
|
|
Page
|
|
Audited Financial Statements:
|
|
|
|
|
|
|
|
F-2
|
|
|
|
|
F-3
|
|
|
|
|
F-4
|
|
|
|
|
F-5
|
|
|
|
|
F-6
|
|
|
|
|
F-7
|
|
Unaudited Financial Statements:
|
|
|
|
|
|
|
|
F-22
|
|
|
|
|
F-23
|
|
|
|
|
F-24
|
|
|
|
|
F-25
|
|
|
|
|
F-26
|
|
F-1
Report of
Independent Registered Public Accounting Firm
The Board of Directors and Stockholders
Innovive Pharmaceuticals, Inc.
We have audited the accompanying balance sheets of Innovive
Pharmaceuticals, Inc. (A Development Stage Company) as of
December 31, 2007 and 2006, and the related statements of
operations, changes in shareholders equity (deficiency)
and cash flows for the years ended December 31, 2007, 2006
and 2005, and the period from March 24, 2004 (inception) to
December 31, 2007. These financial statements are the
responsibility of the Companys management. Our
responsibility is to express an opinion on these financial
statements based on our audits.
We conducted our audits in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are
free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in
the financial statements. An audit also includes assessing the
accounting principles used and significant estimates made by
management, as well as evaluating the overall financial
statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In our opinion, the financial statements referred to above
present fairly, in all material respects, the financial position
of Innovive Pharmaceuticals, Inc. as of December 31, 2007
and 2006, and its results of operations and cash flows for the
years ended December 31, 2007, 2006 and 2005, and the
period from March 24, 2004 (inception) to December 31,
2007, in conformity with accounting principles generally
accepted in the United States of America.
The accompanying financial statements have been prepared
assuming that the Company will continue as a going concern. As
discussed in Note 1 to the financial statements, the
Company has incurred net losses and negative net cash flows from
operating activities from its inception through
December 31, 2007 and has an accumulated deficit and
negative working capital as of December 31, 2007. These
matters raise substantial doubt about the Companys ability
to continue as a going concern. Managements plans
regarding these matters are also described in Note 1. The
accompanying financial statements do not include any adjustments
that might result from the outcome of this uncertainty.
Roseland, New Jersey
March 28, 2008
F-2
Innovive
Pharmaceuticals, Inc
(A Development Stage Company)
Balance Sheets
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
ASSETS
|
Current assets:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
2,670,470
|
|
|
$
|
978,704
|
|
Short-term investments
|
|
|
|
|
|
|
1,566,458
|
|
Restricted cash
|
|
|
275,000
|
|
|
|
1,472,622
|
|
Other current assets
|
|
|
147,119
|
|
|
|
144,519
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
3,092,589
|
|
|
|
4,162,303
|
|
Equipment, net
|
|
|
42,021
|
|
|
|
19,900
|
|
Other assets
|
|
|
105,969
|
|
|
|
105,969
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
3,240,579
|
|
|
$
|
4,288,172
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS EQUITY (DEFICIENCY)
|
Current liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
1,962,378
|
|
|
$
|
1,937,409
|
|
Accrued expenses
|
|
|
3,352,664
|
|
|
|
894,759
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
5,315,042
|
|
|
|
2,832,168
|
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies
|
|
|
|
|
|
|
|
|
Shareholders equity (deficiency):
|
|
|
|
|
|
|
|
|
Preferred stock; $0.001 par value: 10,000,000 shares
authorized, none issued and outstanding
|
|
|
|
|
|
|
|
|
Common stock; $0.001 par value: 75,000,000 and
25,000,000 shares authorized at December 31, 2007 and
December 31, 2006, respectively; 14,610,003 and
9,147,068 shares issued and outstanding at
December 31, 2007 and December 31, 2006, respectively
|
|
|
14,610
|
|
|
|
9,147
|
|
Additional paid-in capital
|
|
|
39,648,271
|
|
|
|
24,999,329
|
|
Deficit accumulated in the development stage
|
|
|
(41,737,344
|
)
|
|
|
(23,552,472
|
)
|
|
|
|
|
|
|
|
|
|
Total shareholders equity (deficiency)
|
|
|
(2,074,463
|
)
|
|
|
1,456,004
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and shareholders equity (deficiency)
|
|
$
|
3,240,579
|
|
|
$
|
4,288,172
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to the financial statements
F-3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from
|
|
|
|
|
|
|
|
|
|
|
|
|
March 24, 2004
|
|
|
|
|
|
|
|
|
|
|
|
|
(Inception) to
|
|
|
|
Year Ended December 31,
|
|
|
December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
2007
|
|
|
Operating Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$
|
14,274,457
|
|
|
$
|
12,236,862
|
|
|
$
|
3,628,390
|
|
|
$
|
30,308,300
|
|
General and administrative
|
|
|
4,153,951
|
|
|
|
3,419,749
|
|
|
|
1,656,193
|
|
|
|
9,429,859
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
18,428,408
|
|
|
|
15,656,611
|
|
|
|
5,284,583
|
|
|
|
39,738,159
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(18,428,408
|
)
|
|
|
(15,656,611
|
)
|
|
|
(5,284,583
|
)
|
|
|
(39,738,159
|
)
|
Interest income
|
|
|
286,387
|
|
|
|
155,877
|
|
|
|
16,217
|
|
|
|
458,481
|
|
Interest expense
|
|
|
|
|
|
|
1,189,493
|
|
|
|
410,573
|
|
|
|
1,605,850
|
|
Other expense
|
|
|
42,851
|
|
|
|
|
|
|
|
|
|
|
|
42,851
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(18,184,872
|
)
|
|
|
(16,690,227
|
)
|
|
|
(5,678,939
|
)
|
|
|
(40,928,379
|
)
|
Imputed preferred stock dividends
|
|
|
|
|
|
|
808,965
|
|
|
|
|
|
|
|
808,965
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss applicable to common shares
|
|
$
|
(18,184,872
|
)
|
|
$
|
(17,499,192
|
)
|
|
$
|
(5,678,939
|
)
|
|
$
|
(41,737,344
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share basic and diluted
|
|
$
|
(1.41
|
)
|
|
$
|
(2.74
|
)
|
|
$
|
(1.83
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding basic and
diluted
|
|
|
12,902,475
|
|
|
|
6,391,802
|
|
|
|
3,107,338
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to the financial statements
F-4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deflcit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock
|
|
|
Additional
|
|
|
|
|
|
in the
|
|
|
|
|
|
|
Common Stock
|
|
|
Preferred Stock
|
|
|
Subscription
|
|
|
Paid-In
|
|
|
Deferred
|
|
|
Development
|
|
|
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Shares
|
|
|
Amount
|
|
|
Receivable
|
|
|
Capital
|
|
|
Compensation
|
|
|
Stage
|
|
|
Total
|
|
|
Issuance of common stock to founders and officer at $.001 per
share
|
|
|
3,002,100
|
|
|
$
|
3,002
|
|
|
|
|
|
|
$
|
|
|
|
$
|
(3,002
|
)
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(374,341
|
)
|
|
|
(374,341
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance December 31, 2004
|
|
|
3,002,100
|
|
|
|
3,002
|
|
|
|
|
|
|
|
|
|
|
|
(3,002
|
)
|
|
|
|
|
|
|
|
|
|
|
(374,341
|
)
|
|
|
(374,341
|
)
|
Issuance of common stock to officers at $.001 per share
|
|
|
157,900
|
|
|
|
158
|
|
|
|
|
|
|
|
|
|
|
|
(158
|
)
|
|
|
173,690
|
|
|
|
(173,690
|
)
|
|
|
|
|
|
|
|
|
Payments received for stock subscriptions
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,160
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,160
|
|
Stock-based employee compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
38,598
|
|
|
|
|
|
|
|
38,598
|
|
Shares issued in connection with license agreement at $3.96 per
share
|
|
|
200,000
|
|
|
|
200
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
791,600
|
|
|
|
|
|
|
|
|
|
|
|
791,800
|
|
Shares issued in connection with license agreement held in escrow
|
|
|
200,000
|
|
|
|
200
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
200
|
|
Stock-based non-employee compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
85,671
|
|
|
|
|
|
|
|
|
|
|
|
85,671
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,678,939
|
)
|
|
|
(5,678,939
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance December 31, 2005
|
|
|
3,560,000
|
|
|
|
3,560
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,050,961
|
|
|
|
(135,092
|
)
|
|
|
(6,053,280
|
)
|
|
|
(5,133,851
|
)
|
Reclassification of employee stock-based compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(135,092
|
)
|
|
|
135,092
|
|
|
|
|
|
|
|
|
|
Stock-based employee compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
456,699
|
|
|
|
|
|
|
|
|
|
|
|
456,699
|
|
Stock-based non-employee compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
406,589
|
|
|
|
|
|
|
|
|
|
|
|
406,589
|
|
Charge for shares released from escrow in connection with
License Agreement
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
792,000
|
|
|
|
|
|
|
|
|
|
|
|
792,000
|
|
Preferred stock issued at $3.96 per share, net of expenses
|
|
|
|
|
|
|
|
|
|
|
3,414,464
|
|
|
|
12,501,135
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,501,135
|
|
Conversion of note payable related party debt
(including accrued interest) to Series A convertible
preferred stock at $3.96 per share
|
|
|
|
|
|
|
|
|
|
|
1,376,518
|
|
|
|
5,451,011
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,451,011
|
|
Conversion of note payable senior convertible notes
(including accrued interest) to Series A convertible
preferred stock at $2.97 per share
|
|
|
|
|
|
|
|
|
|
|
796,086
|
|
|
|
2,364,415
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,364,415
|
|
Beneficial conversion feature attributable to senior convertible
notes (including accrued interest)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
788,086
|
|
|
|
|
|
|
|
|
|
|
|
788,086
|
|
Imputed dividends from beneficial conversion feature
attributable to preferred stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
808,965
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(808,965
|
)
|
|
|
|
|
Reclassification of warrant liability upon conversion of senior
convertible notes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
520,147
|
|
|
|
|
|
|
|
|
|
|
|
520,147
|
|
Conversion of Series A convertible preferred stock to
common stock upon effectiveness of registration statement
|
|
|
5,587,068
|
|
|
|
5,587
|
|
|
|
(5,587,068
|
)
|
|
|
(21,125,526
|
)
|
|
|
|
|
|
|
21,119,939
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(16,690,227
|
)
|
|
|
(16,690,227
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance December 31, 2006
|
|
|
9,147,068
|
|
|
|
9,147
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
24,999,329
|
|
|
|
|
|
|
|
(23,552,472
|
)
|
|
|
1,456,004
|
|
Stock-based employee compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
790,411
|
|
|
|
|
|
|
|
|
|
|
|
790,411
|
|
Stock-based non-employee compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(8,052
|
)
|
|
|
|
|
|
|
|
|
|
|
(8,052
|
)
|
Forfeiture of restriced stock
|
|
|
(31,580
|
)
|
|
|
(32
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
32
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from Private Placement of common stock units at $2.73,
net
|
|
|
5,494,515
|
|
|
|
5,495
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,866,551
|
|
|
|
|
|
|
|
|
|
|
|
13,872,046
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(18,184,872
|
)
|
|
|
(18,184,872
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance December 31, 2007
|
|
|
14,610,003
|
|
|
$
|
14,610
|
|
|
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
39,648,271
|
|
|
$
|
|
|
|
$
|
(41,737,344
|
)
|
|
$
|
(2,074,463
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to the financial statements
F-5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from
|
|
|
|
|
|
|
|
|
|
|
|
|
March 24,2004
|
|
|
|
|
|
|
|
|
|
|
|
|
(Inception) to
|
|
|
|
Year Ended December 31,
|
|
|
December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
2007
|
|
|
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(18,184,872
|
)
|
|
$
|
(16,690,227
|
)
|
|
$
|
(5,678,939
|
)
|
|
$
|
(40,928,379
|
)
|
Adjustments to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses paid by related party on behalf of the Company
|
|
|
|
|
|
|
|
|
|
|
20,000
|
|
|
|
120,000
|
|
Non-cash interest expense
|
|
|
|
|
|
|
937,072
|
|
|
|
|
|
|
|
937,072
|
|
Depreciation and amortization
|
|
|
9,136
|
|
|
|
143,675
|
|
|
|
7,853
|
|
|
|
161,651
|
|
Write-off of fixed assets
|
|
|
|
|
|
|
36,418
|
|
|
|
|
|
|
|
36,418
|
|
Stock-based compensation non-employees
|
|
|
(8,052
|
)
|
|
|
406,589
|
|
|
|
85,671
|
|
|
|
484,208
|
|
Stock-based compensation employees
|
|
|
790,411
|
|
|
|
456,699
|
|
|
|
38,598
|
|
|
|
1,285,708
|
|
Stock issued in connection with license agreement
|
|
|
|
|
|
|
792,000
|
|
|
|
792,000
|
|
|
|
1,584,000
|
|
Amortization of debt discount
|
|
|
|
|
|
|
127,619
|
|
|
|
127,619
|
|
|
|
255,238
|
|
Amortization of debt issuance costs
|
|
|
|
|
|
|
178,626
|
|
|
|
178,726
|
|
|
|
357,352
|
|
Change in fair value of warrant liability
|
|
|
|
|
|
|
(53,823
|
)
|
|
|
(19,445
|
)
|
|
|
(73,268
|
)
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted cash
|
|
|
1,197,622
|
|
|
|
(1,472,622
|
)
|
|
|
|
|
|
|
(275,000
|
)
|
Other current assets
|
|
|
(2,600
|
)
|
|
|
(260,157
|
)
|
|
|
(14,564
|
)
|
|
|
(277,321
|
)
|
Other assets
|
|
|
|
|
|
|
|
|
|
|
(105,969
|
)
|
|
|
(105,969
|
)
|
Accounts payable and accrued expenses
|
|
|
2,482,874
|
|
|
|
1,770,801
|
|
|
|
1,182,863
|
|
|
|
5,486,717
|
|
Accrued interest
|
|
|
|
|
|
|
|
|
|
|
123,673
|
|
|
|
129,457
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(13,715,481
|
)
|
|
|
(13,627,330
|
)
|
|
|
(3,261,914
|
)
|
|
|
(30,822,116
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of office equipment
|
|
|
(31,257
|
)
|
|
|
(2,237
|
)
|
|
|
(66,517
|
)
|
|
|
(109,886
|
)
|
Sales of short-term investments
|
|
|
1,566,458
|
|
|
|
|
|
|
|
|
|
|
|
1,566,458
|
|
Purchases of short-term investments
|
|
|
|
|
|
|
(1,566,458
|
)
|
|
|
|
|
|
|
(1,566,458
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities
|
|
|
1,535,201
|
|
|
|
(1,568,695
|
)
|
|
|
(66,517
|
)
|
|
|
(109,886
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from private placement
|
|
|
13,872,046
|
|
|
|
|
|
|
|
|
|
|
|
13,872,046
|
|
Proceeds from note payable to related party
|
|
|
|
|
|
|
3,540,000
|
|
|
|
1,377,000
|
|
|
|
5,167,000
|
|
Proceeds from senior convertible notes
|
|
|
|
|
|
|
|
|
|
|
2,249,984
|
|
|
|
2,249,984
|
|
Proceeds from Series A preferred financing
|
|
|
|
|
|
|
12,501,135
|
|
|
|
|
|
|
|
12,501,135
|
|
Proceeds from subscription receivable
|
|
|
|
|
|
|
|
|
|
|
3,160
|
|
|
|
3,160
|
|
Payments for debt issuance costs
|
|
|
|
|
|
|
|
|
|
|
(190,853
|
)
|
|
|
(190,853
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activites
|
|
|
13,872,046
|
|
|
|
16,041,135
|
|
|
|
3,439,291
|
|
|
|
33,602,472
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents
|
|
|
1,691,766
|
|
|
|
845,110
|
|
|
|
110,860
|
|
|
|
2,670,470
|
|
Cash and cash equivalents at beginning of period
|
|
|
978,704
|
|
|
|
133,594
|
|
|
|
22,734
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period
|
|
$
|
2,670,470
|
|
|
$
|
978,704
|
|
|
$
|
133,594
|
|
|
$
|
2,670,470
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental Schedule of Non-Cash Investing and Financing
Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Value of common stock issued to officers valued at $1.10 per
share
|
|
$
|
|
|
|
$
|
|
|
|
$
|
173,690
|
|
|
$
|
173,690
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Value of warrant liability allocated to senior convertible notes
|
|
$
|
|
|
|
$
|
|
|
|
$
|
360,798
|
|
|
$
|
360,798
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Value of warrants allocated to senior convertible notes
|
|
$
|
|
|
|
$
|
|
|
|
$
|
255,238
|
|
|
$
|
255,238
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Value of warrants issued to placement agent in connection with
senior convertible notes
|
|
$
|
|
|
|
$
|
|
|
|
$
|
166,499
|
|
|
$
|
166,499
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of note payable related party debt to
Series A convertible preferred stock
|
|
$
|
|
|
|
$
|
5,451,011
|
|
|
$
|
|
|
|
$
|
5,451,011
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of senior convertible notes to Series A
convertible preferred stock
|
|
$
|
|
|
|
$
|
2,364,415
|
|
|
$
|
|
|
|
$
|
2,364,415
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Value of beneficial conversion feature in connection with
convertible preferred stock
|
|
$
|
|
|
|
$
|
808,965
|
|
|
$
|
|
|
|
$
|
808,965
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Value of warrant liability allocated to consultant
|
|
$
|
|
|
|
$
|
|
|
|
$
|
159,347
|
|
|
$
|
159,347
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Value of stock option liability allocated to consultant
|
|
$
|
|
|
|
$
|
|
|
|
$
|
183,575
|
|
|
$
|
183,575
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reclassification of warrant liability to additional paid-in
capital
|
|
$
|
|
|
|
$
|
520,147
|
|
|
$
|
|
|
|
$
|
520,147
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Beneficial conversion feature attributable to senior convertible
notes (including accrued interest)
|
|
$
|
|
|
|
$
|
788,086
|
|
|
$
|
|
|
|
$
|
788,086
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of Series A convertible preferred stock to
common stock upon effectiveness of registration statement
|
|
$
|
|
|
|
$
|
21,125,526
|
|
|
$
|
|
|
|
$
|
21,125,526
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to the financial statements
F-6
Innovive
Pharmaceuticals, Inc.
(A Development Stage Company)
|
|
(1)
|
Summary
of Significant Accounting Policies
|
Innovive Pharmaceuticals, Inc. (Innovive or the
Company) was incorporated in the State of Delaware
on March 24, 2004. Innovive is a specialty pharmaceutical
company focused on the acquisition, development and
commercialization of innovative pharmaceutical products. The
Companys current licensed compounds target the treatment
of cancer, conditions stemming from the abnormal regulation of
cell growth and other immunological diseases.
|
|
(b)
|
Basis
of presentation
|
Since incorporation, the Companys activities have been
related primarily to acquiring and developing its pharmaceutical
compound portfolio and raising capital to support those
activities. The Companys research and development
activities include formulation, testing and manufacturing of its
licensed products and designing and executing clinical studies
for these products. The Company has not generated any revenues
since inception. Accordingly, the Company is considered to be in
the development stage.
The Companys financial statements have been prepared on a
going concern basis, which contemplates the realization of
assets and the settlement of liabilities and commitments in the
normal course of business. For the year ended December 31,
2007, the Company incurred a net loss of $18,184,872 and
negative net cash flows from operating activities of
$13,715,481. It had a net loss and negative cash flows from
operating activities from inception through December 31,
2007 of $40,928,379 and $30,822,116, respectively, and
shareholders deficiency as of December 31, 2007 of
$2,074,463. Management believes that the Company will continue
to incur losses for the foreseeable future and needs to
immediately raise additional equity or debt financing or to
immediately generate revenue from the licensing of its products
or by entering into strategic alliances to be able to sustain
its operations until it can achieve profitability and positive
cash flows, if ever. Management has been and will continue to
seek additional debt
and/or
equity financing for the Company, but it cannot assure that such
financing will be available on acceptable terms. These matters
raise substantial doubt about the Companys ability to
continue as a going concern. The accompanying financial
statements do not include any adjustments that might result from
the outcome of this uncertainty.
The preparation of financial statements in conformity with
accounting principles generally accepted in the United States of
America requires management to make estimates and use
assumptions that affect certain reported amounts of assets and
liabilities and disclosure of contingent liabilities at the date
of the financial statements and the reported amounts of expenses
during the reporting period. These estimates are often based on
judgments, probabilities and assumptions that management
believes are reasonable but that are inherently uncertain and
unpredictable. As a result, actual results could differ from
those estimates.
|
|
(d)
|
Stock-based
Compensation
|
In December 2004, the Financial Accounting Standards Board
(FASB) issued Statement of Financial Accounting
Standards No. 123 (revised 2004)
(SFAS 123R), Share-Based Payment,
revising Statement of Financial Accounting Standards
No. 123 Accounting for Stock Based Compensation
(SFAS 123) requiring that the fair value of all
share-based payments to employees be recognized in the financial
statements over the service period. The Company adopted
SFAS 123R effective January 1, 2006. Prior to
January 1, 2006 the Company had only granted options to
non-employees and accounted for those grants in accordance with
SFAS 123 and Emerging Issues Task Force Issue
No. 96-18,
Accounting for Equity Instruments That Are Issued to Other
Than Employees for Acquiring, or in conjunction with Selling,
Goods or Services. The Company has two stock-based
compensation
F-7
Innovive
Pharmaceuticals, Inc.
Notes to Financial Statements (Continued)
plans for employees, directors and consultants. Stock-based
compensation consists of stock options and restricted stock. All
stock options are granted at exercise prices equal to or above
the fair market value of the Companys common stock at the
dates of grant. Generally, stock options granted to employees
and directors fully vest ratably over the three years from the
grant date and have a term of 10 years. The Company
recognizes stock-based compensation over the requisite service
period of the individual grants, which generally equals the
vesting period. The Company reclassified the amounts in deferred
compensation related to the restricted stock granted to two
officers upon the adoption of SFAS 123R, but did not have
to restate its prior period financial statements.
|
|
(e)
|
Cash
and Cash Equivalents
|
Cash equivalents consist of short-term, highly-liquid
investments including money market securities with maturities of
less than three months when purchased.
|
|
(f)
|
Equipment
and Leasehold Improvements
|
Equipment and leasehold improvements are recorded at cost.
Depreciation is recorded on a straight-line basis over the
estimated useful lives of the related assets (5 years for
office and computer equipment). Leasehold improvements are
amortized on a straight-line basis over the shorter of their
useful lives or the terms of the respective leases. Maintenance
and repairs are charged to operations as incurred; renewals and
betterments are capitalized.
|
|
(g)
|
Research
and Development
|
Research and development expenses consist primarily of costs
associated with determining feasibility, licensing and
pre-clinical and clinical testing of the Companys licensed
pharmaceutical candidates. These costs primarily include fees
paid to consultants and outside service providers for drug
manufacture and development and other expenses. The Company
expenses research and development costs as they are incurred.
License fees and pre-approved milestone payments due under each
research and development arrangement that are paid prior to
regulatory approval are expensed when the license is entered
into or the milestone is achieved if the payment is contingent
upon reaching the milestone. If a product receives regulatory
approval, the Company will record any subsequent milestone
payments as intangible assets.
Income taxes are accounted for using an asset and liability
approach in which deferred tax assets and liabilities are
recognized for the differences between the financial statement
and tax basis of assets and liabilities using enacted tax rates
in effect for the years in which the differences are expected to
reverse. A valuation allowance is provided for the portion of
deferred tax assets when, based on available evidence, it is
more-likely-than-not that a portion of the deferred
tax assets will not be realized. Deferred tax assets and
liabilities are measured using enacted tax rates and laws.
Effective January 1, 2007, the Company adopted the
provisions of the Financial Accounting Standards Board
(FASB) Interpretation No. 48, Accounting
for Uncertainty in Income Taxes an interpretation of
FASB Statement No. 109 (FIN 48).
There were no unrecognized tax benefits as of January 1,
2007 and as of December 31, 2007. FIN 48 prescribes a
recognition threshold and a measurement attribute for the
financial statement recognition and measurement of tax positions
taken or expected to be taken in a tax return. For those
benefits to be recognized, a tax position must be
more-likely-than-not to be sustained upon examination by taxing
authorities. The Company recognizes accrued interest and
penalties related to unrecognized tax benefits as income tax
expense. No amounts were accrued for the payment of interest and
penalties at January 1, 2007. There was no change to this
balance at December 31, 2007. Management is currently
unaware of any issues under review that could result in
significant payments, accruals or material deviations from its
position. The adoption of the
F-8
Innovive
Pharmaceuticals, Inc.
Notes to Financial Statements (Continued)
provisions of FIN 48 did not have a material impact on the
Companys financial position, results of operations and
cash flows.
In the ordinary course of business there is inherent uncertainty
in quantifying income tax positions. The Company assesses income
tax positions and records tax benefits for all years subject to
examination based upon managements evaluation of the
facts, circumstances and information available at the reporting
dates. For those tax positions with a greater than 50%
likelihood of being realized, we record the benefit. For those
income tax positions where it is more-likely-than-not that a tax
benefit will not be sustained, no tax benefit is recognized in
the financial statements. When applicable, associated interest
and penalties are recognized as a component of interest expense.
|
|
(i)
|
Accounting
for Warrants Issued with Convertible Debt and Preferred
Stock
|
The Company accounts for the value of warrants and the intrinsic
value of beneficial conversion rights arising from the issuance
of convertible debt instruments with non-detachable conversion
rights that are in-the-money at the commitment date pursuant to
the consensuses for Emerging Issues Task Force
(EITF) Issue
No. 98-5,
EITF Issue
No. 00-19
and EITF Issue
No. 00-27.
Such values are determined by first allocating an appropriate
portion of the proceeds received from the debt instruments to
the warrants or any other detachable instruments included in the
exchange. The fair value of the warrants is then allocated to
warrant liability and to debt discount, which is subsequently
charged to interest expense over the term of the debt
instruments. The warrant liability is adjusted to its fair value
at the end of each reporting period. The intrinsic value of the
beneficial conversion rights at the commitment date may also be
recorded as additional paid-in capital and debt discount as of
that date or, if the terms of the debt instrument are
contingently adjustable, may only be recorded if a triggering
event occurs and the contingency is resolved. Since the warrants
associated with the Companys senior convertible notes were
initially exercisable into an indeterminable number of common
shares, the Company determined that, under the guidance in EITF
Issue
No. 00-19,
the Company could not conclude that it had sufficient authorized
and unissued shares to net-share settle any warrants or options
issued to non-employees. Therefore, as of December 31,
2005, the Company had classified the fair value of all vested
warrants and options issued to non-employees as a liability.
On June 29, 2006, in connection with the private placement
of Series A convertible preferred stock, the senior
convertible notes were converted into 796,086 shares of
Series A convertible preferred stock and an additional
140,883 warrants were issued in association with such senior
convertible notes. Accordingly, since the financial instrument
which prevented the Company from concluding whether it had
sufficient authorized and unissued shares to net-share settle
any warrants and options to non-employees was no longer
outstanding, the fair value of the liability for all vested
warrants and options issued to non-employees of $520,147 as of
that date was reclassified from warrant liability to additional
paid-in capital within the balance sheet at that time.
Furthermore, on June 29, 2006, in connection with the
private placement of Series A convertible preferred stock,
the contingent beneficial conversion feature on the senior
convertible notes totaling $788,086 (including accrued interest)
was charged to interest expense on the statement of operations
for the year ended December 31, 2006 and is included in
additional paid-in capital within the balance sheet as of
December 31, 2006.
|
|
(j)
|
Earnings
(Loss) Per Share
|
Basic earnings (loss) per common share equals
net income (loss) applicable to common shares divided by the
weighted average common shares outstanding during each period.
Diluted earnings per common share equals net income
applicable to common shares divided by the sum of weighted
average common shares outstanding during the period, adjusted
for the effects of potentially dilutive securities. In periods
where a loss is recorded, no effect is given to potentially
dilutive securities, since the effect would be antidilutive. As
of December 31, 2007, there were 4,733,410 warrants and
stock options outstanding which are potentially dilutive.
Furthermore, due to the lack of a required dividend and the full
voting rights associated with the Series A convertible
preferred shares sold on June 29, 2006, the Companys
weighted-average outstanding share amounts for the year ended
December 31, 2006 include the effect of
F-9
Innovive
Pharmaceuticals, Inc.
Notes to Financial Statements (Continued)
5,587,068 shares of Series A convertible preferred
stock that were issued and outstanding until their conversion
into common stock on August 10, 2006.
|
|
(k)
|
New
Accounting Pronouncements
|
In September 2006, the FASB issued SFAS No. 157
(SFAS 157), Fair Value
Measurements, which defines fair value, establishes a
framework for measuring fair value in GAAP and expands
disclosure about fair value measurements. SFAS 157 is
effective for fiscal years beginning after November 15,
2007. Although the Company will continue to evaluate the
application of SFAS 157, the Company does not currently
believe that the adoption of SFAS 157 will have a material
effect on its consolidated financial statements.
In February 2007, the FASB issued SFAS No. 159
(SFAS 159), The Fair Value Option for
Financial Assets and Financial Liabilities, providing
companies with an option to report selected financial assets and
liabilities at fair value. The objective of SFAS 159 is to
reduce both complexity in accounting for financial instruments
and the volatility in earnings caused by measuring related
assets and liabilities differently. Generally accepted
accounting principles have required different measurement
attributes for different assets and liabilities that can create
artificial volatility in earnings. SFAS 159 helps to
mitigate this type of accounting-induced volatility by enabling
companies to report related assets and liabilities at fair
value, which would likely reduce the need for companies to
comply with detailed rules for hedge accounting. SFAS 159
also establishes presentation and disclosure requirements
designed to facilitate comparisons between companies that choose
different measurement attributes for similar types of assets and
liabilities. The statement requires companies to provide
additional information that will help investors and other users
of financial statements to more easily understand the effect of
a companys choice to use fair value on its earnings. It
also requires entities to display the fair value of those assets
and liabilities for which they have chosen to use fair value on
the face of the balance sheet. SFAS 159 is effective for
fiscal years beginning after November 15, 2007. Although
the Company will continue to evaluate the application of
SFAS 159, the Company does not currently believe that the
adoption of SFAS 159 will have a material effect on its
consolidated financial statements.
In June 2007, the Emerging Issues Task Force (EITF)
reached a consensus on EITF Issue
No. 07-3
(EITF 07-3),
Accounting for Advance Payments for Goods or Services to
be Received for Use in Future Research and Development
Activities.
EITF 07-3
provides clarification surrounding the accounting for
nonrefundable research and development advance payments, whereby
such payments should be recorded as an asset when the advance
payment is made and recognized as an expense when the research
and development activities are performed.
EITF 07-3
is effective for interim and annual reporting periods beginning
after December 15, 2007. Although the Company will continue
to evaluate the application of
EITF 07-3,
the Company does not currently believe that the adoption of
EITF 07-3
will have a material effect on its consolidated financial
statements.
In December 2007, the Emerging Issues Task Force
(EITF) issued EITF Issue
No. 07-1
(EITF 07-1)
Accounting for Collaborative Arrangements.
EITF 07-1
affects entities that participate in collaborative arrangements
for the development and commercialization of intellectual
property. The EITF affirmed the tentative conclusions reached on
(1) what constitutes a collaborative arrangement,
(2) how the parties should present costs and revenues in
their respective income statements, (3) how the parties
should present cost-sharing payments, profit-sharing payments,
or both in their respective income statements, and
(4) disclosure in the annual financial statements of the
partners.
EITF 07-1
should be applied as a change in accounting principle through
retrospective application to all periods presented for
collaborative arrangements existing as of the date of adoption.
EITF 07-1
is effective for financial statements issued for fiscal years
beginning after December 15, 2008. The Company is currently
evaluating the impact that adopting
EITF 07-1
will have on its consolidated financial statements.
F-10
Innovive
Pharmaceuticals, Inc.
Notes to Financial Statements (Continued)
2007
Agreements
Tamibarotene
On September 10, 2007, the Company entered into a license
agreement with TMRC, Co., Ltd. (TMRC) for the
license of patent rights held by TMRC for the European
development and commercialization of tamibarotene, a novel
synthetic retinoid. The license granted to the Company is
exclusive, applies to all products that may be subject to the
licensed intellectual property and may be used in the treatment
of acute promyelocytic leukemia and human hematological
malignancies, including multiple myeloma, myelodysplastic
syndrome, chronic myelocytic leukemia, acute myelocytic leukemia
and solid tumors other than hepatocellular carcinoma. The
Company may sublicense the intellectual property in Europe at
its sole discretion.
The Company must pay TMRC a license issue fee of
¥80,000,000, of which ¥18,000,000 was due and paid
within 30 days of executing the agreement. The Company must
pay the remaining ¥62,000,000 (approximately $552,000 as of
December 31, 2007) upon the earlier of a funding event
or March 31, 2008. In addition, the Company is required to
pay ¥60,000,000 (approximately $535,000 as of
December 31, 2007) upon the earlier of June 30,
2008 or the achievement of one-half of the patients enrolled in
its tamibarotene STAR clinical study. The license issue fee and
the non-contingent milestones were all recorded as research and
development expense, at prevailing currency rates at the time of
the agreement, for the year ended December 31, 2007. The
non-contingent milestones are included in accrued expenses as of
December 31, 2007 and have been remeasured based on
prevailing currency rates as of December 31, 2007. Under
the license agreement, the Company must pay TMRC royalties based
on net sales and make additional payments to TMRC in the
aggregate of approximately ¥420,000,000 (approximately
$3.7 million as of December 31, 2007) upon
meeting various clinical and regulatory milestones.
All payments due under this agreement, as well as the
Companys previous agreement for the North American rights
to tamibarotene with TMRC (see below), are required to be made
in Japanese Yen. The ultimate United States dollar amount paid
under these agreements will depend on the foreign currency
exchange rates at the time of payment. The Company does not
currently employ any hedging strategies related to these
payments.
2006
Agreements
INNO-206
On August 18, 2006, the Company entered into a license
agreement with KTB Tumorforschungs GmbH (KTB) for
the license of patent rights held by KTB for the worldwide
development and commercialization of DOXO-EMCH, a novel
doxorubicin prodrug, or INNO-206. The license granted to
Innovive is exclusive and worldwide, applies to all products
that may be subject to the licensed intellectual property and
may be used in all fields of use. Innovive may sublicense the
intellectual property in its sole discretion. KTB granted the
Company an option to include within the license any technology
that is claimed or disclosed in the licensed patents and patent
applications for use in the field of oncology. Innovive also has
the right of first refusal on any license that KTB wishes to
make to a third party regarding any technology that is claimed
or disclosed in the licensed patents and patent applications for
use in the field of oncology.
The Company paid KTB a license issue fee of $500,000 on
execution of the agreement that was recorded as research and
development expense for the year ended December 31, 2006.
Under the license agreement, Innovive must make payments to KTB
in the aggregate of up to $7,500,000 upon meeting various
clinical and regulatory milestones up to and including the
products second final marketing approval. The Company also
agreed to pay:
|
|
|
|
|
commercially reasonable royalties based on a percentage of net
sales;
|
|
|
|
a percentage of non-royalty sub-licensing income; and
|
|
|
|
milestones of $1,000,000 for each additional final marketing
approval should the Company pursue them.
|
F-11
Innovive
Pharmaceuticals, Inc.
Notes to Financial Statements (Continued)
In the event that the Company must pay a third party in order to
exercise its rights to the intellectual property under the
agreement, it will deduct a percentage of those payments from
the royalties due KTB, up to an agreed upon cap.
Under the agreement, the Company must use commercially
reasonable efforts to conduct the research and development
activities it determines are necessary to obtain regulatory
approval to market the product in those countries that it
determines are commercially feasible. Under the agreement, KTB
will use its commercially reasonable efforts to provide Innovive
with access to suppliers of the active pharmaceutical ingredient
of the product on the same terms and conditions as may be
provided to KTB by those suppliers.
The license agreement expires on a
product-by-product
basis upon expiration of the subject patent rights. Innovive has
the right to terminate the agreement on 30 days notice,
provided it pays a cash penalty to KTB. KTB may terminate the
agreement if the Company is in breach and the breach is not
cured within a required amount of time or if the Company fails
to use diligent and commercially reasonable efforts to meet
various clinical milestones.
Tamibarotene
On December 8, 2006, the Company entered into a license
agreement with TMRC to acquire exclusive North American
rights to develop and commercialize tamibarotene, a novel
synthetic retinoid for the treatment of acute promyelocytic
leukemia (APL), a type of acute myeloid leukemia.
The Company paid TMRC a license issue fee of ¥10,000,000
(approximately $85,000) on execution of the agreement that was
recorded as research and development expense for the year ended
December 31, 2006. Under the license agreement, Innovive
must pay TMRC royalties based on net sales and make payments to
TMRC in the aggregate of up to ¥490,000,000 (approximately
$4.4 million as of December 31, 2007) upon
meeting various clinical, regulatory and sales milestones up to
and including the first commercial sale of the product for the
treatment of APL. Additional milestones are required for
additional approvals in different indications if the Company
chooses to further develop the product. Under the terms of the
agreement, Innovive acquired the exclusive North American
license from TMRC to develop and commercialize tamibarotene for
treatment of APL, with an option to include within the license
the use of tamibarotene in other fields in oncology including
multiple myeloma, myelodysplastic syndrome and solid tumors.
2005
Agreements
INNO-105
In March 2005, the Company entered into an agreement to acquire
the rights to an exclusive, world-wide, royalty-bearing
sublicense to develop and commercialize technology for the
treatment of cancer, conditions stemming from the abnormal
regulation of cell growth and other immunological diseases.
Based on the results of a Phase I clinical trial, the Company
discontinued the development of INNO-105 on September 29,
2006 and has no remaining financial obligations related to the
development of this product.
INNO-305
On December 15, 2005, the Company entered into an exclusive
worldwide royalty-bearing license agreement with the
Sloan-Kettering Institute for Cancer Research (SKI),
including the right to grant sub-licenses, for the intellectual
property relating to INNO-305 for all diseases, disorders
and/or
conditions, including but not limited to, oncology. The license
agreement expires on a
country-by-country
basis upon expiration of the subject patent rights.
In consideration for the grant of the license to INNO-305, in
December 2005 the Company paid an initial license fee of
$200,000 which was charged to research and development expense
and agreed to make additional
F-12
Innovive
Pharmaceuticals, Inc.
Notes to Financial Statements (Continued)
payments in the aggregate amount of up to $3,600,000 upon the
achievement of clinical and regulatory milestones through the
products first approval. The Company also agreed to pay:
|
|
|
|
|
commercially reasonable royalties based on a percentage of net
sales;
|
|
|
|
an annual license maintenance fee in any year which a milestone
is not paid beginning on the first anniversary of the agreement
and ending on the first commercial sale of INNO-305;
|
|
|
|
annual minimum payments for sales of INNO-305 for specified
indications;
|
|
|
|
a percentage of non-royalty sub-licensing income; and
|
|
|
|
milestones of $750,000 for each additional final marketing
approval should the Company pursue them.
|
INNO-406
On December 28, 2005, the Company entered into an exclusive
worldwide (with the exception of Japan) royalty-bearing license
agreement with Nippon Shinyaku, including the right to grant
sub-licenses, for the intellectual property relating to INNO-406
in any field. The Nippon Shinyaku license agreement expires on a
country-by-country
basis upon expiration of the subject patent rights.
In consideration for the grant of the license to INNO-406, in
December 2005 the Company paid Nippon Shinyaku an initial
license fee of $600,000 which was charged to research and
development expense, and agreed to make additional payments in
the aggregate amount of up to $13,350,000 (including $5,000,000
upon U.S. approval) upon the achievement of clinical and
regulatory milestones up to and including final marketing
approvals in the U.S. and Europe. The Company also issued
to Nippon Shinyaku 400,000 shares of common stock, of which
200,000 vested immediately. The vested shares were valued at
$792,000 and charged to research and development expense as a
part of the license fee. The remaining 200,000 shares were
held in escrow until the IND for INNO-406 was accepted for
review by the FDA. The IND was accepted for review by the FDA in
June 2006 and the remaining 200,000 shares with a value of
$792,000 were released from escrow and charged to research and
development expense. In addition, the Company paid a
finders fee of $100,000 and issued a warrant to purchase
54,967 shares of common stock with an exercise price of
$2.97 per share. The warrants were valued at $171,675 and
charged to research and development expense as part of the
license fee. The warrant is immediately exercisable and expires
in February 2013. The warrants were issued in February 2006.
The Company also agreed to pay the following:
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|
|
commercially reasonable royalties based on a percentage of net
sales, dependent on reaching certain revenue thresholds;
|
|
|
|
annual minimum payments if sales of INNO-406 do not meet
specified levels; and
|
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|
|
a percentage of non-royalty sub-licensing income.
|
Each of the Companys license agreements requires it to
make periodic payments, which in the Companys current
financial condition may be difficult. If the Company fails to
comply with its obligations in the intellectual property
licenses, the Company could lose its license rights.
F-13
Innovive
Pharmaceuticals, Inc.
Notes to Financial Statements (Continued)
|
|
(3)
|
Restricted
Cash and Short-term Investments
|
Short-term investments at December 31, 2006 consisted of
certificates of deposits with various maturities through August
2007, all of which matured or were liquidated as of
December 31, 2007.
Restricted cash consisted of:
|
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|
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|
|
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
Escrow collateralizing manufacturing activities
|
|
$
|
|
|
|
$
|
1,197,622
|
|
Compensating balance for letter of credit
|
|
|
275,000
|
|
|
|
275,000
|
|
|
|
|
|
|
|
|
|
|
Total restricted cash
|
|
$
|
275,000
|
|
|
$
|
1,472,622
|
|
|
|
|
|
|
|
|
|
|
The major categories of the Companys equipment and
leasehold improvements are as follows:
|
|
|
|
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|
|
|
|
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|
December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
Computer equipment
|
|
$
|
40,570
|
|
|
$
|
9,313
|
|
Office equipment
|
|
|
19,038
|
|
|
|
19,038
|
|
|
|
|
|
|
|
|
|
|
|
|
|
59,608
|
|
|
|
28,351
|
|
Less: accumulated depreciation
|
|
|
17,587
|
|
|
|
8,451
|
|
|
|
|
|
|
|
|
|
|
Net equipment
|
|
$
|
42,021
|
|
|
$
|
19,900
|
|
|
|
|
|
|
|
|
|
|
Depreciation expense was $9,136, $13,732 and $7,853 for the
years ended December 31, 2007, 2006 and 2005, respectively,
and $31,709 for the period from March 24, 2004 (inception)
to December 31, 2007.
Accrued expenses as of December 31, 2007 and
December 31, 2006 consist of the following:
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|
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|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
Accrued compensation
|
|
$
|
91,270
|
|
|
$
|
248,413
|
|
Accrued research and development costs
|
|
|
3,131,144
|
|
|
|
646,346
|
|
Other accrued expenses
|
|
|
130,250
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total accrued expenses
|
|
$
|
3,352,664
|
|
|
$
|
894,759
|
|
|
|
|
|
|
|
|
|
|
Accrued research and development costs as of December 31,
2007 include $1,086,711 related to non-contingent milestone
payments related to the Companys agreement with TMRC for
the license of European rights to tamibarotene (See Note 2).
|
|
(6)
|
Private
Placements/Financings
|
2007
On April 24, 2007, the Company raised gross proceeds of
$15,000,000 ($13,872,046 net of offering expenses) through
the private placement to 103 accredited investors of units
consisting of an aggregate of 5,494,515 shares of its
common stock and warrants to purchase an aggregate of
2,747,287 shares of its common stock. The Company sold
units to investors at a price per unit equal to $2.73. Each unit
consisted of one share of Company common stock and a warrant to
purchase one-half of a share of Company common stock. The
warrants issued to the investors have an exercise price of $3.75
per share and are immediately exercisable. All of the warrants
issued were outstanding at December 31, 2007 and will
expire on April 24, 2012.
F-14
Innovive
Pharmaceuticals, Inc.
Notes to Financial Statements (Continued)
The Company engaged Paramount BioCapital, Inc.
(PBI), a related party, as exclusive placement agent
for the Company for the offering. For its services, the Company
paid PBI a cash commission of $868,612 and issued a warrant to
PBI to purchase 274,726 shares of Company common stock with
an exercise price of $3.75 per share. The warrant issued to PBI
is exercisable immediately and will expire on April 24,
2012. One of the Companys directors is an employee of PBI
and one is an employee of an affiliate of PBI.
As part of the offering, the Company and the investors entered
into a price protection agreement. In the event that the Company
issued shares of its common stock at a price per share less than
$2.73 at any time within 180 days after April 24,
2007, then each investor would have had the right to receive a
number of additional shares of common stock equal to
(i) the aggregate purchase price per unit paid by the
investor in the offering, divided by the subsequent share
purchase price, (ii) less the number of shares of common
stock purchased by the investor in the offering. Each investor
would have to pay to the Company the par value for each
additional share received. This right expired on
October 21, 2007 and no additional shares were issued.
Pursuant to the terms of the subscription agreements between the
Company and the investors, the Company was required to file a
registration statement with the SEC by May 24, 2007 to
register for resale the shares of common stock purchased by the
investors and the shares of common stock underlying the investor
warrants and the PBI warrant. The Company filed the registration
statement with the SEC on May 24, 2007 and it was declared
effective on August 9, 2007.
2006
On June 29, 2006, Innovive raised gross proceeds of
$13,521,277 ($12,501,135 net of offering expenses) through
the private placement (Private Placement) of
3,414,464 shares of its $.001 par value Series A
convertible preferred stock at a sale price of $3.96 per share.
The Series A convertible preferred stock had no required
dividend. Each share of Series A convertible preferred
stock was convertible into one share of common stock. Innovive
was required to file a registration statement for the common
shares underlying the Series A convertible preferred shares
with the SEC no later than August 28, 2006. Such
registration statement was filed with the SEC on August 7,
2006 and declared effective on August 10, 2006. Upon the
effectiveness of such registration statement with the SEC, all
shares of Series A convertible preferred stock
automatically converted into common shares. In connection with
the Private Placement, a total of 341,446 warrants to purchase
common shares with an exercise price of $4.36 per share and an
expiration date of June 29, 2013 were issued to the
designees of the co-placement agents of the Private Placement,
resulting in an imputed preferred stock dividend. The Company
valued the warrants at fair value using a Black-Scholes
option-pricing model resulting in an imputed dividend payable of
$808,965 that was recorded as an increase in deficit accumulated
in the development stage with a corresponding increase to
preferred stock and as an addition to net loss for the purpose
of determining net loss per common share.
2005
On June 28, 2005, the Company issued 5% senior
convertible notes in the aggregate principal amount of
$2,249,984 (the Notes) of which $48,357 in principal
amount was issued to a related party. Upon the closing of an
equity financing transaction from which the Company received
proceeds of at least $5,000,000, the Notes, plus all accrued
interest, would automatically convert into the same securities
issued in the equity financing transaction at a conversion price
equal to 75% of the per share price of the securities sold. In
addition, each note holder would received warrants to purchase a
number shares of the Companys common stock equal to 15% of
the principal amount of the Notes purchased divided by the
lowest price paid for securities in the equity financing
transaction of at least $5,000,000. Each warrant issued as a
result of the equity financing transaction would be exercisable
at a price per share equal to 110% of the price per share of the
securities in the equity financing and would be exercisable for
a period of seven years. As a result of the Private Placement,
the Notes with an aggregate amount of principal and accrued
interest of $2,364,415 were automatically converted into
796,086 shares of Series A convertible preferred stock
at a conversion price of $2.97 per share, all of which converted
to shares of common stock on August 10, 2006
F-15
Innovive
Pharmaceuticals, Inc.
Notes to Financial Statements (Continued)
upon the effectiveness of the registration statement filed with
the SEC. In addition, the purchasers of the Notes received
85,227 warrants to purchase shares of common stock at an
exercise price of $4.36 per share. Accordingly, the total debt
converted was reclassified from notes payable to preferred stock
within the balance sheet. Furthermore, as a result of the
Private Placement the contingency was resolved and the
contingent beneficial conversion feature totaling $788,086 for
the Notes including accrued interest was charged to interest
expense and included in additional paid-in capital at that time.
Other
In June 2004, the Company entered into an open-ended future
advance promissory note agreement whereby Paramount Biocapital
Investments LLC or one or more of its affiliates
(Paramount), agreed to advance funds for obligations
arising out of the operations of the Companys business.
Paramount is solely owned by a significant stockholder of the
Company. Additionally, in April 2006, the Company entered into
an open-ended future advance promissory note agreement whereby
an entity related to the sole shareholder of Paramount agreed to
advance funds in a similar manner. Each individual future
advance promissory note accrued interest at a fixed rate equal
to 5% per annum and was payable upon the earlier of two years
from the date of issuance of the note or the date on which the
Company entered into certain specified financing transactions.
During the year ended December 31, 2006, the Company
borrowed an aggregate principal amount of $3,540,000 under these
future advance promissory notes. Interest expense pursuant to
the future advance promissory note agreements totaled $90,958
and $67,269 for the years ended December 31, 2006 and 2005,
respectively, $5,784 for the period from March 24, 2004
(inception) to December 31, 2004 and $164,011 for the
period from March 24, 2004 (inception) to December 31,
2006.
On June 29, 2006, in connection with the private placement
of Series A convertible preferred shares, the aggregate
amount of principal and accrued interest under the future
advance promissory note due to Paramount totaling $4,073,390
automatically converted into 1,028,634 shares of
Series A convertible preferred stock at fair value.
Additionally, the aggregate amount of principal and accrued
interest under the future advance promissory note due to the
entity related to the sole shareholder of Paramount totaling
$1,377,621 automatically converted into 347,884 shares of
Series A convertible preferred stock at fair value.
Accordingly, the total debt converted was reclassified from
notes payable to preferred stock.
There was no current or deferred income tax provision for the
years ended December 31, 2007, 2006, 2005 or for the period
from March 24, 2004 (inception) to December 31, 2004.
The components of the Companys deferred tax assets as of
December 31, 2007 and 2006 are as follows:
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
2006
|
|
|
Net operating loss carryforwards
|
|
$
|
14,640,000
|
|
|
$
|
7,941,000
|
|
License fees
|
|
|
568,000
|
|
|
|
591,000
|
|
Research and development tax credit carryforwards
|
|
|
1,625,000
|
|
|
|
824,000
|
|
Accrued research and development expenses
|
|
|
119,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Totals
|
|
|
16,952,000
|
|
|
|
9,356,000
|
|
Less: valuation allowance
|
|
|
(16,952,000
|
)
|
|
|
(9,356,000
|
)
|
|
|
|
|
|
|
|
|
|
Net deferred tax asset
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
F-16
Innovive
Pharmaceuticals, Inc.
Notes to Financial Statements (Continued)
A reconciliation of the statutory federal income tax rate and
the effective tax rate are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
Federal statutory tax rate
|
|
|
34
|
%
|
|
|
34
|
%
|
|
|
34
|
%
|
State income taxes, net of federal effect
|
|
|
5
|
%
|
|
|
5
|
%
|
|
|
5
|
%
|
Research and development tax credits
|
|
|
6
|
%
|
|
|
10
|
%
|
|
|
|
|
Change in valuation allowance
|
|
|
(42
|
)%
|
|
|
(50
|
)%
|
|
|
(39
|
)%
|
Other
|
|
|
(3
|
)%
|
|
|
1
|
%
|
|
|
0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effective income tax rate
|
|
|
0
|
%
|
|
|
0
|
%
|
|
|
0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At December 31, 2007, the Company, based on a completed
section 382 analysis, had available federal and state net
operating loss carryforwards of approximately $37,586,000 which
expire in the years 2024 through 2027. In addition, the Company
has federal research and development tax credit carryforwards of
approximately $1,625,000.
The Company adopted the provisions of Financial Standards
Accounting Board Interpretation No. 48 Accounting for
Uncertainty in Income Tax (FIN 48) an
interpretation of FASB Statement No. 109
(SFAS 109) on January 1, 2007. As a result
of the implementation of FIN 48, the Company recorded no
adjustment for the unrecognized income tax benefits. At the
adoption date of FIN 48, January 1, 2007 and also at
December 31, 2007, the Company had no unrecognized tax
benefits.
The Companys ability to utilize its NOLs may be limited if
it undergoes an ownership change, as defined in
section 382, as a result of subsequent changes in the
ownership of outstanding stock. An ownership change would occur
if, among other things, the stockholders, or group of
stockholders, who own or have owned, directly or indirectly, 5%
or more of the value of the outstanding stock, (or are otherwise
treated as 5% stockholders under section 382 and the
regulations promulgated there under), increase their aggregate
percentage ownership of the Companys outstanding stock by
more than 50 percentage points over the lowest percentage
of the Companys outstanding stock owned by these
stockholders at any time during the testing period, which is
generally the three-year period preceding the potential
ownership change. In the event of an ownership change,
section 382 imposes an annual limitation on the amount of
post-ownership change taxable income a corporation may offset
with pre-ownership change NOLs. Based on the 382 analysis
completed, there were no such limitations as of
December 31, 2007.
Given the Companys history of incurring operating losses,
management believes that it is unlikely that any of the deferred
tax assets will be recoverable. As a result, a valuation
allowance equal to the gross deferred tax assets was
established. The valuation allowance increased by $7,596,000,
$7,064,000 and $2,143,000 in 2007, 2006 and 2005, respectively.
|
|
(8)
|
Shareholders
Equity (Deficiency)/Stock-Based Compensation
|
In March 2004, Innovive established the 2004 Stock Option Plan
(the Plan), which provides for the granting of up to
925,000 options to officers, directors, employees and
consultants for the purchase of common stock through March 2014.
The options will have a maximum term of ten years, vest over a
period to be determined by the Companys Board of Directors
and have an exercise price at or above fair market value.
In May 2007, Innovive established the 2007 Stock Plan, which
provides for the granting of equity awards, including stock
options, stock awards and restricted stock, to officers,
directors, employees and consultants for the purchase of up to
an aggregate of 1,500,000 shares of common stock through
April 2017. The Companys Board of Directors or a Board
designated committee will determine the type of awards and their
terms within the parameters of the 2007 Stock Plan.
F-17
Innovive
Pharmaceuticals, Inc.
Notes to Financial Statements (Continued)
The Company adopted Statement of Financial Accounting Standards
No. 123 (revised 2004), Share-Based Payment
(SFAS 123(R)), effective January 1, 2006.
SFAS 123(R) requires the recognition of the fair value of
stock-based compensation in net income or loss. Stock-based
compensation consists of the value of stock options and
restricted stock issued to employees and non-employees. Stock
options have been granted at exercise prices equal to or above
the fair market value of the Companys stock at the dates
of grant. Generally, stock options granted to employees and
directors vest ratably over the three years from the grant date
and have a term of 10 years. The restricted stock vests
ratably over the three years from the grant date. No restricted
stock has been granted since 2005. The Company recognizes the
value of the options and restricted stock as stock-based
compensation expense over the requisite service period of the
individual grants, which generally equals the vesting period.
The Company recognized stock-based compensation expense of
$782,359, $863,288, $85,671 for 2007, 2006 and 2005,
respectively. For the Companys stock-based compensation
plan, the fair value of each grant was estimated at the date of
grant using the Black-Scholes option-pricing model.
Black-Scholes utilizes assumptions related to volatility, the
risk-free interest rate, the dividend yield (which is assumed to
be zero, as the Company had not paid and does not intend to pay
any cash dividends) and employee exercise behavior. Expected
volatilities utilized in the model are based on historical
volatilities of a peer group of several early stage specialty
pharmaceutical companies. The risk-free interest rate is derived
from the U.S. Treasury yield curve in effect in the period
of grant. The expected life is based on managements
expectations. The Companys calculation of stock-based
compensation also incorporates exercise and forfeiture
assumptions based on an analysis of historical data. The
following summarizes the Black-Scholes assumptions the Company
used for its options all of which were granted in 2007, 2006 and
2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
Average expected term (years)
|
|
|
7.0
|
|
|
|
7.0
|
|
|
|
7.0
|
|
Weighted average risk-free interest rate
|
|
|
4.81
|
%
|
|
|
4.89
|
%
|
|
|
3.84
|
%
|
Dividend yield
|
|
|
0
|
%
|
|
|
0
|
%
|
|
|
0
|
%
|
Volatility
|
|
|
95.5
|
%
|
|
|
69.8%-97.8
|
%
|
|
|
80.3
|
%
|
Weighted average grant date fair value
|
|
$
|
2.58
|
|
|
|
$2.93
|
|
|
$
|
3.53
|
|
There were no awards exercised during the years ended
December 31, 2007, 2006 and 2005. The total remaining
unrecognized compensation cost related to unvested awards
amounted to $1,592,489 at December 31, 2007 and is expected
to be recognized over the next three years. The weighted average
remaining requisite service period of the unvested awards was
20 months.
F-18
Innovive
Pharmaceuticals, Inc.
Notes to Financial Statements (Continued)
Stock
Option Plan
A summary of the status of the Companys stock options
granted as of December 31, 2007 and changes during the year
then ended is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
Average
|
|
|
|
|
|
|
|
|
|
Average
|
|
|
Remaining
|
|
|
Aggregate
|
|
|
|
Number of
|
|
|
Exercise
|
|
|
Contractual
|
|
|
Intrisic
|
|
|
|
Option Awards
|
|
|
Price
|
|
|
Life
|
|
|
Value
|
|
|
Balance December 31, 2004
|
|
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
Grants
|
|
|
94,800
|
|
|
|
1.10
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance December 31, 2005
|
|
|
94,800
|
|
|
|
1.10
|
|
|
|
|
|
|
|
|
|
Grants
|
|
|
644,801
|
|
|
|
3.98
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance December 31, 2006
|
|
|
739,601
|
|
|
|
3.61
|
|
|
|
|
|
|
|
|
|
Grants
|
|
|
674,500
|
|
|
|
4.08
|
|
|
|
|
|
|
|
|
|
Forfeitures
|
|
|
(240,000
|
)
|
|
|
3.72
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance December 31, 2007
|
|
|
1,174,101
|
|
|
$
|
3.86
|
|
|
|
8.96
|
|
|
$
|
18,960
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available for grant (2,425,000 authorized)
|
|
|
1,250,899
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exerciseable at December 31, 2007
|
|
|
408,934
|
|
|
$
|
3.31
|
|
|
|
8.38
|
|
|
$
|
18,960
|
|
There were no options granted prior to 2005.
Restricted
Stock
In May 2005, the Company granted 157,900 shares of
restricted common stock to two executives for subscriptions
receivable totaling $158, or $0.001 per share. The shares vest
equally over a three-year period and were valued at $1.10 per
share or a total value of $173,690. The Company is amortizing
the fair value of these awards over their three-year vesting
period.
A summary of the status of the Companys nonvested
restricted stock awards as of December 31, 2007 and changes
during the year ended December 31, 2007 is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
Average
|
|
|
|
|
|
|
Grant Date
|
|
|
|
Shares
|
|
|
Fair Value
|
|
|
Nonvested at December 31, 2006
|
|
|
105,266
|
|
|
$
|
1.10
|
|
Vested
|
|
|
(52,633
|
)
|
|
|
1.10
|
|
Forfeited
|
|
|
(31,580
|
)
|
|
|
1.10
|
|
|
|
|
|
|
|
|
|
|
Nonvested at December 31, 2007
|
|
|
21,053
|
|
|
$
|
1.10
|
|
|
|
|
|
|
|
|
|
|
There were no restricted stock awards granted prior to 2005.
Consultant
Options
In 2005, the Company issued options to a consultant to purchase
94,800 shares of common stock at an exercise price of $1.10
per share. The grant date fair value of these options was
determined to be $334,727.
In 2006, the Company issued options to purchase an aggregate of
97,500 shares of common stock to its Scientific Advisory
Board members and certain consultants. These options were
granted at a weighted average exercise price of $4.00. The fair
value of these options was determined to be $292,575.
F-19
Innovive
Pharmaceuticals, Inc.
Notes to Financial Statements (Continued)
Warrants
In connection with the June 2005 senior convertible note
financing, a total of 55,656 warrants at an exercise price of
$4.36 were issued to the designees of the placement agent, PBI
of the Notes financing. PBI is solely owned by a significant
shareholder of the Company. These warrants have a cashless
exercise feature and expire in June 2012. As of
December 31, 2007, none of these placement warrants had
been exercised. In addition, the purchasers of the Notes
received 85,227 warrants to purchase shares of common stock at
an exercise price of $4.36 per share.
In February 2006, 54,967 warrants were issued to a consultant
with an exercise price of $2.97 and will expire in February
2013. As a result of adjusting the liabilities related to these
warrants to fair value in accordance with EITF
No. 00-19,
the Company reduced expenses charged to the statement of
operations in the amounts of $12,328 for the year ended
December 31, 2006. As of December 31, 2007, none of
these warrants had been exercised.
On June 29, 2006, in connection with the Private Placement,
341,446 warrants at an exercise price of $4.36 were issued to
the co-placement agents of the private placement, of which
200,795 warrants were issued to designees of PBI. These warrants
have a cashless exercise feature and expire in June 2013. As of
December 31, 2007, none of these placement warrants had
been exercised.
On April 24, 2007, in connection with the private placement
of common shares the Company issued 2,747,287 warrants at an
exercise price of $3.75 per share. The warrants are immediately
exercisable and will expire on April 24, 2012. As of
December 31, 2007, none of these warrants had been
exercised. In addition, the Company issued 274,726 warrants to
its placement agent, PBI with an exercise price of $3.75. The
warrants are immediately exercisable and will expire on
April 24, 2012.
At December 31, 2007, there were warrants outstanding for
the purchase of a total of 3,559,309 shares.
|
|
(9)
|
Other
Related Party Transactions and Balances
|
In May 2005, the Company engaged PBI as placement agent to
assist in its June 2005 private placement offering of senior
convertible promissory notes on a best efforts
basis. Lindsay A. Rosenwald, M.D. is chairman and chief
executive officer of PBI and its affiliates. Dr. Rosenwald
and trusts for the benefit of Dr. Rosenwald owned an
aggregate of 18.9% of the Companys outstanding common
stock as of December 31, 2007. The Company paid PBI, cash
commissions of $141,410 for its services. The Company also
reimbursed PBI for $27,977 of expenses (including legal fees)
incurred in connection with the offering.
In addition, PBI received a warrant to purchase a number shares
of the Companys common stock equal to 10% of the principal
amount of the Notes purchased divided by the lowest price paid
for securities in an equity financing transaction from which the
Company receives proceeds of at least $5,000,000 prior to the
maturity of the Notes. The warrants are exercisable at a price
per share equal to 110% of the related price per share set forth
above of the securities in the qualifying equity financing
transaction and are exercisable for a period of seven years. As
a result of the Private Placement, 55,656 warrants to purchase
common shares were issued to the placement agent of the senior
convertible notes at an exercise price of $4.36 per share.
Prior to October 2006, the Company paid $600 per month to PBI
for administrative services.
As of December 31, 2007, two directors of the Company were
also full-time employees of either PBI or its affiliates. In
addition, prior to October 2006, the Companys Treasurer
was also a full-time employee of PBI.
|
|
(10)
|
Commitments
and Contingencies
|
Operating
leases
The Company has various operating leases including the lease of
its office space and copiers. In March 2005, the Company signed
an agreement to lease office space. The lease commenced
April 1, 2005 and expires August 30, 2012. Rent
expense for the years ended December 31, 2007, 2006 and
2005 was $209,988, $209,988 and $157,491,
F-20
Innovive
Pharmaceuticals, Inc.
Notes to Financial Statements (Continued)
respectively. The Companys President and Chief Executive
Office has guaranteed the lease payments under the office space
lease.
Future minimum lease payments under all operating leases are as
follows:
|
|
|
|
|
Year Ended December 31,
|
|
Amount
|
|
|
2008
|
|
|
218,328
|
|
2009
|
|
|
209,988
|
|
2010
|
|
|
218,277
|
|
2011
|
|
|
221,040
|
|
2012
|
|
|
147,360
|
|
Thereafter
|
|
|
|
|
Employment
Agreements
The Company has employment agreements with its key executives.
The current terms of these agreements expire at various dates,
subject to certain renewal provisions.
Letters
of Credit
As of December 31, 2007, the Company had a $250,000 letter
of credit in support of a customs bond.
|
|
(11)
|
Quarterly
Data (Unaudited)
|
A summary of the quarterly results of operations is a follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Month Period Ended
|
|
|
|
Mar. 31
|
|
|
Jun. 30
|
|
|
Sep. 30
|
|
|
Dec. 31
|
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$
|
2,727,152
|
|
|
$
|
4,190,380
|
|
|
$
|
5,175,303
|
|
|
$
|
2,181,622
|
|
General and administrative
|
|
|
963,375
|
|
|
|
1,201,270
|
|
|
|
1,322,053
|
|
|
|
667,253
|
|
Net loss
|
|
|
(3,635,531
|
)
|
|
|
(5,329,031
|
)
|
|
|
(6,400,914
|
)
|
|
|
(2,819,396
|
)
|
Net loss applicable to common shares
|
|
|
(3,635,531
|
)
|
|
|
(5,329,031
|
)
|
|
|
(6,400,914
|
)
|
|
|
(2,819,396
|
)
|
Loss per common share basic and diluted
|
|
$
|
(0.40
|
)
|
|
$
|
(0.41
|
)
|
|
$
|
(0.44
|
)
|
|
$
|
(0.19
|
)
|
2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$
|
1,170,251
|
|
|
$
|
3,277,509
|
|
|
$
|
3,995,438
|
|
|
$
|
3,793,664
|
|
General and administrative
|
|
|
471,658
|
|
|
|
611,067
|
|
|
|
985,023
|
|
|
|
1,352,001
|
|
Net loss
|
|
|
(1,818,045
|
)
|
|
|
(4,891,889
|
)
|
|
|
(4,891,034
|
)
|
|
|
(5,089,259
|
)
|
Net loss applicable to common shares
|
|
|
(1,818,045
|
)
|
|
|
(5,700,854
|
)
|
|
|
(4,891,034
|
)
|
|
|
(5,089,259
|
)
|
Loss per common share basic and diluted
|
|
$
|
(0.51
|
)
|
|
$
|
(1.55
|
)
|
|
$
|
(0.53
|
)
|
|
$
|
(0.55
|
)
|
F-21
Innovive
Pharmaceuticals, Inc.
(A Development Stage Company)
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
(Unaudited)
|
|
|
(Note 1)
|
|
|
ASSETS
|
Current assets:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
301,962
|
|
|
$
|
2,670,470
|
|
Restricted cash
|
|
|
275,000
|
|
|
|
275,000
|
|
Other current assets
|
|
|
225,492
|
|
|
|
147,119
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
802,454
|
|
|
|
3,092,589
|
|
Equipment, net
|
|
|
39,078
|
|
|
|
42,021
|
|
Other assets
|
|
|
105,969
|
|
|
|
105,969
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
947,501
|
|
|
$
|
3,240,579
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS DEFICIENCY
|
Current liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
1,815,782
|
|
|
$
|
1,962,378
|
|
Accrued expenses
|
|
|
2,657,900
|
|
|
|
3,352,664
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
4,473,682
|
|
|
|
5,315,042
|
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies
|
|
|
|
|
|
|
|
|
Shareholders deficiency:
|
|
|
|
|
|
|
|
|
Preferred stock; $0.001 par value: 10,000,000 shares
authorized, none issued and outstanding
|
|
|
|
|
|
|
|
|
Common stock; $0.001 par value: 75,000,000 shares
authorized at March 31, 2008 and December 31, 2007;
14,610,003 shares issued and outstanding at March 31, 2008
and December 31, 2007
|
|
|
14,610
|
|
|
|
14,610
|
|
Additional paid-in capital
|
|
|
39,772,696
|
|
|
|
39,648,271
|
|
Deficit accumulated in the development stage
|
|
|
(43,313,487
|
)
|
|
|
(41,737,344
|
)
|
|
|
|
|
|
|
|
|
|
Total shareholders deficiency
|
|
|
(3,526,181
|
)
|
|
|
(2,074,463
|
)
|
|
|
|
|
|
|
|
|
|
Total liabilities and shareholders deficiency
|
|
$
|
947,501
|
|
|
$
|
3,240,579
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to the financial statements
F-22
Innovive
Pharmaceuticals, Inc.
(A Development Stage Company)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from
|
|
|
|
|
|
|
|
|
|
March 24, 2004
|
|
|
|
Three Months Ended March 31,
|
|
|
(Inception) to
|
|
|
|
2008
|
|
|
2007
|
|
|
March 31, 2008
|
|
|
Operating Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$
|
731,611
|
|
|
$
|
2,727,152
|
|
|
$
|
31,039,911
|
|
General and administrative
|
|
|
685,642
|
|
|
|
963,375
|
|
|
|
10,115,501
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
1,417,253
|
|
|
|
3,690,527
|
|
|
|
41,155,412
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(1,417,253
|
)
|
|
|
(3,690,527
|
)
|
|
|
(41,155,412
|
)
|
Interest income
|
|
|
17,771
|
|
|
|
54,996
|
|
|
|
476,252
|
|
Interest expense
|
|
|
|
|
|
|
|
|
|
|
1,605,850
|
|
Other expense
|
|
|
176,661
|
|
|
|
|
|
|
|
219,512
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(1,576,143
|
)
|
|
|
(3,635,531
|
)
|
|
|
(42,504,522
|
)
|
Imputed preferred stock dividends
|
|
|
|
|
|
|
|
|
|
|
808,965
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss applicable to common shares
|
|
$
|
(1,576,143
|
)
|
|
$
|
(3,635,531
|
)
|
|
$
|
(43,313,487
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share basic and diluted
|
|
$
|
(0.11
|
)
|
|
$
|
(0.40
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding - basic and diluted
|
|
|
14,610,003
|
|
|
|
9,147,068
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to the financial statements
F-23
Innovive
Pharmaceuticals, Inc.
(A Development Stage Company)
Three Months Ended March 31, 2008
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional
|
|
|
Accumulated in
|
|
|
|
|
|
|
Common Stock
|
|
|
Paid-In
|
|
|
the Development
|
|
|
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Stage
|
|
|
Total
|
|
|
Balance December 31, 2007
|
|
|
14,610,003
|
|
|
$
|
14,610
|
|
|
$
|
39,648,271
|
|
|
$
|
(41,737,344
|
)
|
|
$
|
(2,074,463
|
)
|
Stock-based employee compensation
|
|
|
|
|
|
|
|
|
|
|
133,665
|
|
|
|
|
|
|
|
133,665
|
|
Stock-based non-employee compensation
|
|
|
|
|
|
|
|
|
|
|
(9,240
|
)
|
|
|
|
|
|
|
(9,240
|
)
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,576,143
|
)
|
|
|
(1,576,143
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance March 31, 2008
|
|
|
14,610,003
|
|
|
$
|
14,610
|
|
|
$
|
39,772,696
|
|
|
$
|
(43,313,487
|
)
|
|
$
|
(3,526,181
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to the condensed financial statements
F-24
Innovive
Pharmaceuticals, Inc.
(A Development Stage Company)
Condensed Statements of Cash Flows
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from
|
|
|
|
Three Months Ended
|
|
|
March 24, 2004
|
|
|
|
March 31,
|
|
|
(Inception) to
|
|
|
|
2008
|
|
|
2007
|
|
|
March 31, 2008
|
|
|
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(1,576,143
|
)
|
|
$
|
(3,635,531
|
)
|
|
$
|
(42,504,522
|
)
|
Adjustments to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses paid by related party on behalf of the Company
|
|
|
|
|
|
|
|
|
|
|
120,000
|
|
Non-cash interest expense
|
|
|
|
|
|
|
|
|
|
|
937,072
|
|
Depreciation and amortization
|
|
|
2,943
|
|
|
|
1,348
|
|
|
|
164,594
|
|
Write-off of fixed assets
|
|
|
|
|
|
|
|
|
|
|
36,418
|
|
Stock-based compensation non-employees
|
|
|
(9,240
|
)
|
|
|
43,328
|
|
|
|
474,968
|
|
Stock-based compensation employees
|
|
|
133,665
|
|
|
|
240,936
|
|
|
|
1,419,373
|
|
Stock issued in connection with license agreement
|
|
|
|
|
|
|
|
|
|
|
1,584,000
|
|
Amortization of debt discount
|
|
|
|
|
|
|
|
|
|
|
255,238
|
|
Amortization of debt issuance costs
|
|
|
|
|
|
|
|
|
|
|
357,352
|
|
Change in fair value of warrant liability
|
|
|
|
|
|
|
|
|
|
|
(73,268
|
)
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted cash
|
|
|
|
|
|
|
323,200
|
|
|
|
(275,000
|
)
|
Other current assets
|
|
|
(78,373
|
)
|
|
|
34,178
|
|
|
|
(355,694
|
)
|
Other assets
|
|
|
|
|
|
|
|
|
|
|
(105,969
|
)
|
Accounts payable and accrued expenses
|
|
|
(841,360
|
)
|
|
|
636,321
|
|
|
|
4,645,357
|
|
Accrued interest
|
|
|
|
|
|
|
|
|
|
|
129,457
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(2,368,508
|
)
|
|
|
(2,356,220
|
)
|
|
|
(33,190,624
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of office equipment
|
|
|
|
|
|
|
|
|
|
|
(109,886
|
)
|
Sales of short-term investments
|
|
|
|
|
|
|
1,841,458
|
|
|
|
1,566,458
|
|
Purchases of short-term investments
|
|
|
|
|
|
|
|
|
|
|
(1,566,458
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities
|
|
|
|
|
|
|
1,841,458
|
|
|
|
(109,886
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from private placement, net
|
|
|
|
|
|
|
|
|
|
|
13,872,046
|
|
Proceeds from note payable to related party
|
|
|
|
|
|
|
|
|
|
|
5,167,000
|
|
Proceeds from senior convertible notes
|
|
|
|
|
|
|
|
|
|
|
2,249,984
|
|
Proceeds from Series A preferred financing
|
|
|
|
|
|
|
|
|
|
|
12,501,135
|
|
Proceeds from subscription receivable
|
|
|
|
|
|
|
|
|
|
|
3,160
|
|
Payments for debt issuance costs
|
|
|
|
|
|
|
|
|
|
|
(190,853
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activites
|
|
|
|
|
|
|
|
|
|
|
33,602,472
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents
|
|
|
(2,368,508
|
)
|
|
|
(514,762
|
)
|
|
|
301,962
|
|
Cash and cash equivalents at beginning of period
|
|
|
2,670,470
|
|
|
|
978,704
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period
|
|
$
|
301,962
|
|
|
$
|
463,942
|
|
|
$
|
301,962
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental Schedule of Non-Cash Investing and Financing
Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Value of common stock issued to officers valued at $1.10 per
share
|
|
$
|
|
|
|
$
|
|
|
|
$
|
173,690
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Value of warrant liability allocated to senior convertible notes
|
|
$
|
|
|
|
$
|
|
|
|
$
|
360,798
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Value of warrants allocated to senior convertible notes
|
|
$
|
|
|
|
$
|
|
|
|
$
|
255,238
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Value of warrants issued to placement agent in connection with
senior convertible notes
|
|
$
|
|
|
|
$
|
|
|
|
$
|
166,499
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of note payable related party debt to
Series A convertible preferred stock
|
|
$
|
|
|
|
$
|
|
|
|
$
|
5,451,011
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of senior convertible notes to Series A
convertible preferred stock
|
|
$
|
|
|
|
$
|
|
|
|
$
|
2,364,415
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Value of beneficial conversion feature in connection with
convertible preferred stock
|
|
$
|
|
|
|
$
|
|
|
|
$
|
808,965
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Value of warrant liability allocated to consultant
|
|
$
|
|
|
|
$
|
|
|
|
$
|
159,347
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Value of stock option liability allocated to consultant
|
|
$
|
|
|
|
$
|
|
|
|
$
|
183,575
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reclassification of warrant liability to additional paid-in
capital
|
|
$
|
|
|
|
$
|
|
|
|
$
|
520,147
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Beneficial conversion feature attributable to senior convertible
notes (including accrued interest)
|
|
$
|
|
|
|
$
|
|
|
|
$
|
788,086
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of Series A convertible preferred stock to
common stock upon effectiveness of registration statement
|
|
$
|
|
|
|
$
|
|
|
|
$
|
21,125,526
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to the condensed financial statements
F-25
Innovive
Pharmaceuticals, Inc.
(A Development Stage Company)
(Unaudited)
|
|
(1)
|
Summary
of Significant Accounting Policies:
|
Basis
of presentation:
Since incorporation on March 24, 2004, the Companys
activities have been related primarily to acquiring its
pharmaceutical compound portfolio, raising capital, establishing
office facilities and recruiting personnel as well as research
and development activities, including formulation, testing and
manufacturing of its licensed products and designing and
executing clinical studies for these products. The Company has
not generated any revenues since inception. Accordingly, the
Company is considered to be in the development stage.
The accompanying unaudited condensed financial statements of the
Company have been prepared in accordance with accounting
principles generally accepted in the United States of America
and the rules and regulations of the Securities and Exchange
Commission (SEC) for interim financial information.
Accordingly, the financial statements do not include all
information and notes required by accounting principles
generally accepted in the United States of America for complete
annual financial statements. In the opinion of management, the
accompanying unaudited condensed financial statements reflect
all adjustments, consisting of only normal recurring
adjustments, considered necessary for a fair presentation.
Interim operating results are not necessarily indicative of
results that may be expected for the year ending
December 31, 2008 or for any subsequent period. These
unaudited condensed financial statements should be read in
conjunction with the Companys audited financial statements
as of and for the year ended December 31, 2007 included in
its 2007
Form 10-K
filed with the SEC on March 31, 2008.
The Companys financial statements have been prepared on a
going concern basis, which contemplates the realization of
assets and the settlement of liabilities and commitments in the
normal course of business. As of March 31, 2008, the
Company had cash and cash equivalents of only $301,962 and a
working capital deficit of $3,671,228 and needs an immediate
infusion of cash to continue its operations. For the three
months ended March 31, 2008, the Company incurred a net
loss of $1,576,143 and had negative cash flows from operating
activities of $2,368,508. The Company had an accumulated deficit
from March 24, 2004 (inception) through March 31, 2008
of $43,313,487. Management believes that the Company will
continue to incur losses for the foreseeable future. The Company
has an immediate need for additional capital to be able to
continue its operations. The Company currently does not have
sufficient funds to satisfy its current obligations or finance
its current operations. The continued development and potential
commercialization of its product candidates and all other
aspects of its operations are and will continue to be contingent
on raising sufficient capital to continue to pursue pre-clinical
and clinical trials and, thereafter, the successful testing and
commercialization of each compound. Without additional capital,
the Company will not be able to pursue development of its
product candidates. The Company is currently exploring several
alternatives including licensing opportunities, the sale to or
merger into another company, the sale of one or more of its
product candidates and debt and equity financing. If the Company
is unable to secure additional capital on reasonable terms or
unable to generate sufficient sources of capital through
collaborative arrangements, it will not have the ability to
continue as a going concern. These matters raise substantial
doubt about the Companys ability to continue as a going
concern. The accompanying financial statements do not include
any adjustments that might result from the outcome of this
uncertainty.
Use of
estimates:
The preparation of financial statements in conformity with
accounting principles generally accepted in the United States of
America requires management to make estimates and assumptions
that affect certain reported amounts and disclosures.
Accordingly, actual results could differ from those estimates.
F-26
Innovive
Pharmaceuticals, Inc.
(A Development Stage Company)
Notes to Condensed Financial
Statements (Continued)
Loss
per common share:
Basic net loss per common share equals net loss applicable to
common shares divided by the weighted average common shares
outstanding during each period. Diluted loss per common share
equals net loss applicable to common shares divided by the sum
of weighted average common shares outstanding during the period,
adjusted for the effects of potentially dilutive securities. The
Companys basic and diluted per share amounts are the same
since the Company had losses in each period presented. As of
March 31, 2008 and 2007, there were a total of 4,893,910
and 1,336,897 options and warrants outstanding, respectively,
which were potentially dilutive.
Cash
and cash equivalents:
The Company considers highly-liquid investments with original
maturities of three months or less when purchased to be cash
equivalents.
Recent
Accounting Pronouncements:
In December 2007, the Financial Accounting Standards Board
issued Statement of Financial Accounting Standard
(SFAS) No. 141(R)
(SFAS 141(R)), Business Combinations (revised),
replacing SFAS No. 141 (SFAS 141)
Business Combinations. This new statement requires additional
assets and assumed liabilities to be measured at fair value when
acquired in a business combination as compared to SFAS 141.
SFAS 141(R) also requires liabilities related to contingent
consideration to be re-measured to fair value each reporting
period, acquisition-related costs to be expensed and not
capitalized and acquired in-process research and development to
be capitalized as an indefinite lived intangible asset until
completion of project or abandonment of project.
SFAS 141(R) requires prospective application for business
combinations consummated in fiscal years beginning on or after
December 15, 2008. This statement does not allow for early
adoption. The Company is currently evaluating the impact of the
adoption of this statement on its financial statements.
Restricted cash represents a compensating balance securing a
standby letter of credit for a customs bond.
Accrued expenses as of March 31, 2008 and December 31,
2007 consist of the following:
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
Accrued compensation
|
|
$
|
80,500
|
|
|
$
|
91,270
|
|
Accrued research and development costs
|
|
|
2,482,775
|
|
|
|
3,131,144
|
|
Other accrued expenses
|
|
|
94,625
|
|
|
|
130,250
|
|
|
|
|
|
|
|
|
|
|
Total accrued expenses
|
|
$
|
2,657,900
|
|
|
$
|
3,352,664
|
|
|
|
|
|
|
|
|
|
|
Accrued research and development costs as of March 31, 2008
include $1,228,707 of non-contingent milestone payments related
to its agreement with TMRC Co. Ltd. for the license of European
rights to tamibarotene.
|
|
(3)
|
Stock-Based
Compensation
|
The Company recognized stock-based compensation expense for the
three months ended March 31, 2008 and 2007 in the amount of
$124,425 and $284,264, respectively. The total number of shares
of common stock issuable upon the exercise of stock options
granted during the three months ended March 31, 2008 was
275,000 with a weighted average exercise price $0.45 per share.
Stock options granted during the three months ended
March 31,
F-27
Innovive
Pharmaceuticals, Inc.
(A Development Stage Company)
Notes to Condensed Financial
Statements (Continued)
2007 totaled 60,000 with a weighted average exercise price of
$3.83 per share. For the Companys stock-based compensation
plan, the fair value of each grant was estimated at the date of
grant using the Black-Scholes option-pricing model.
Black-Scholes utilizes assumptions related to volatility, the
risk-free interest rate, the dividend yield (which is assumed to
be zero, as the Company had not paid and does not intend to pay
any cash dividends) and employee exercise behavior. Expected
volatilities utilized in the model are based on historical
volatilities of a peer group of several specialty pharmaceutical
companies. The risk-free interest rate is derived from the
U.S. Treasury yield curve in effect in the period of grant.
The expected life is based on managements expectations.
The Companys calculation of stock-based compensation also
incorporates exercise and forfeiture assumptions based on an
analysis of historical data. The stock-based compensation for
the awards issued in the three months ended March 31, 2008
was determined using the following assumptions and calculated
average fair values:
|
|
|
|
|
|
|
Three Months Ended
|
|
|
|
March 31, 2008
|
|
|
Average expected term (years)
|
|
|
7.0
|
|
Weighted average risk-free interest rate
|
|
|
3.14
|
%
|
Dividend yield
|
|
|
0
|
%
|
Volatility
|
|
|
101.90
|
%
|
Weighted average grant date fair value
|
|
$
|
0.38
|
|
As of March 31, 2008, the aggregate intrinsic value of
awards outstanding and exercisable was $0, because the exercise
price of all outstanding and exercisable options was greater
than the Companys stock price quoted on the
Over-the-Counter Bulletin Board. There were no awards
exercised in the three months ended March 31, 2008. The
total remaining unrecognized compensation cost related to
unvested awards amounted to $1,440,714 at
March 31, 2008 and is expected to be recognized over
three years. The weighted average remaining requisite service
period of the unvested awards was 15 months.
F-28
PART
II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 20. Indemnification of Directors and Officers.
Section 102(b)(7) of the Delaware General Corporation Law authorizes a corporation in its
certificate of incorporation to eliminate or limit personal liability of directors of the
corporation for violations of the directors fiduciary duty of care. However, directors remain
liable for breaches of duties of loyalty, failing to act in good faith, engaging in intentional
misconduct, knowingly violating a law, paying a dividend or approving a stock repurchase which was
illegal under Delaware General Corporation Law Section 174 or obtaining an improper personal
benefit. In addition, equitable remedies for breach of fiduciary duty of care, such as injunction
or recession, are available.
CytRx Corporations restated certificate of incorporation eliminates the personal liability of
the members of CytRx Corporations board of directors to the fullest extent permitted by law.
Specifically, Article Eleven of CytRx Corporations amended and restated certificate of
incorporation provides as follows:
A director of the corporation shall not be personally liable to the corporation or
its stockholders for monetary damages for breach of fiduciary duty as a director,
except for liability (i) for any breach of the directors duty of loyalty to the
corporation or its stockholders, (ii) for acts or omissions not in good faith or
which involve intentional misconduct or a knowing violation of law, (iii) under
Section 174 of the Delaware General Corporation Law, or (iv) for any transaction
from which the director derived any improper personal benefit. If the Delaware
General Corporation Law is amended after approval by the stockholders of this
Article to authorize corporate action further eliminating or limiting the personal
liability of directors, then the liability of a director of the corporation shall be
eliminated or limited to the fullest extent permitted by the Delaware General
Corporation Law as so amended.
Any repeal or modification of the foregoing paragraph by the stockholders of the corporation
shall not adversely affect any right or protection of a director of the corporation existing at the
time of such repeal or modification.
In addition, CytRx Corporations restated certificate of incorporation and restated bylaws
provide for indemnification of CytRx Corporations officers and directors to the fullest extent
permitted by law. In particular, Article Nine of CytRx Corporations restated certificate of
incorporation provides as follows:
The corporation shall, to the fullest extent permitted by Section 145 of the General
Corporation Law of the State of Delaware, as the same may be amended and
supplemented, indemnify any and all persons whom it shall have power to indemnify
under said section from and against any and all of the expenses, liabilities or
other matters referred to in or covered by said section, and the indemnification
provided for herein shall not be deemed exclusive of any other rights to which those
indemnified may be entitled under any bylaw, agreement, vote of stockholders or
disinterested directors or otherwise, both as to action in his official capacity and
as to action in another capacity while holding such office, and shall continue as to
a person who has ceased to be a director, officer, employee or agent and shall inure
to the benefit of the heirs, executors and administrators of such a person.
Section 145 of the Delaware General Corporation Law empowers a corporation to indemnify any
person who was or is party or is threatened to be made a party to any threatened, pending or
completed action, suit or proceeding, whether civil, criminal, administrative or investigative, by
reason of the fact that he is or was a director, officer or agent of the corporation or another
enterprise if serving at the request of the
II-1
corporation. Depending on the character of the proceeding, a corporation may indemnify against
expenses (including attorneys fees), judgments, fines and amounts paid in settlement actually and
reasonably incurred in connection with such action, suit or proceeding if the person indemnified
acted in good faith in respect to any criminal action or proceeding, had no reasonable cause to
believe his conduct was unlawful. In the case of an action by or in the right of the corporation,
no indemnification may be made with respect to any claim, issue or matter as to which such person
shall have been adjudged to be liable to the corporation unless and only to the extent that the
Court of Chancery or the court in which such action or suit was brought shall determine that
despite the adjudication of liability such person is fairly and reasonably entitled to indemnity
for such expenses which the court shall deem proper. Section 145 further provides that to the
extent a director, officer, employee or agent of a corporation has been successful in the defense
of any action, suit or proceeding referred to above or in the defense of any claim, issue or matter
therein, he shall be indemnified against expenses (including attorneys fees) actually and
reasonably incurred by him in connection therewith. CytRx Corporations bylaws permit it to
purchase insurance on behalf of such person against any liability asserted against him and incurred
by him in any such capacity, or arising out of his status as such, whether or not CytRx Corporation
would have the power to indemnify him against such liability under the foregoing provision of the
bylaws.
CytRx Corporation holds an insurance policy covering directors and officers under which the
insurer agrees to pay, with some exclusions, for any claim made against CytRx Corporations
directors and officers for a wrongful act that they may become legally obligated to pay or for
which CytRx Corporation is required to indemnify CytRx Corporations directors or officers.
Insofar as indemnification for liabilities arising under the Securities Act of 1933, as
amended, or the Securities Act, may be permitted for directors, officers and controlling persons of
the Company under the above provisions, or otherwise, the Commission has advised CytRx Corporation
that, in its opinion, such indemnification is against public policy as expressed in the Securities
Act and is, therefore, unenforceable. In the event that a claim for indemnification against such
liabilities (other than the payment by the Company of expenses incurred or paid by a director,
officer or controlling person of the Company in the successful defense of any action, suit or
proceeding) is asserted by such director, officer or controlling person in connection with the
securities being registered, the Company will, unless in the opinion of its counsel the matter has
been settled by controlling precedent, submit to a court of appropriate jurisdiction the question
whether such indemnification by it is against public policy as expressed in the Securities Act and
will be governed by the final adjudication of such issue.
Item 21. Exhibits and Financial Schedules.
(a) Exhibits. The following is a list of Exhibits to this Registration Statement.
|
|
|
|
|
Exhibit |
|
|
|
|
Number |
|
Description |
|
Footnote |
2.1
|
|
Agreement and Plan of Merger, dated as of June 6, 2008, by and
among Innovive Pharmaceuticals, Inc., CytRx Corporation, CytRx
Merger Subsidiary, Inc. and Steven Kelly, as stockholder
representative (included in Part I as Appendix A to the proxy
statement/prospectus included in this Registration Statement) |
|
|
|
|
|
|
|
3.1
|
|
Restated Certificate of Incorporation of CytRx Corporation
(filed as Exhibit 3.1 to CytRx Corporations Annual Report on
Form 10-K filed on April 1, 2008) and incorporated herein by
reference) |
|
|
|
|
|
|
|
3.2
|
|
Certificate of Amendment to Restated Certificate of
Incorporation of CytRx Corporation |
|
(y) |
|
|
|
|
|
3.3
|
|
Restated By-Laws of CytRx Corporation, as amended (filed as
Exhibit 3.2 to CytRx Corporations Annual Report on Form 10-K
filed on April 1, 2008 and incorporated herein by reference) |
|
|
II-2
|
|
|
|
|
Exhibit |
|
|
|
|
Number |
|
Description |
|
Footnote |
4.1
|
|
Shareholder Protection Rights Agreement, dated April 16, 1997,
between CytRx Corporation and American Stock Transfer & Trust
Company, as Rights Agent
|
|
(a) |
|
|
|
|
|
4.2
|
|
Amendment No. 1 to Shareholder Protection Rights Agreement
(incorporated by reference to CytRx Corporations Annual Report
on Form 10-K filed on March 27, 2001)
|
|
(e) |
|
|
|
|
|
4.3
|
|
Amendment No. 2 to Shareholder Protection Rights Agreement
(incorporated by reference to CytRx Corporations Annual Report
on Form 10-K filed on April 2, 2007)
|
|
(s) |
|
|
|
|
|
5.1
|
|
Opinion of TroyGould PC |
|
(y) |
|
|
|
|
|
10.1*
|
|
CytRx Corporation 1994 Stock Option Plan, as amended and restated
|
|
(b) |
|
|
|
|
|
10.2*
|
|
CytRx Corporation 1995 Stock Option Plan
|
|
(r) |
|
|
|
|
|
10.3*
|
|
CytRx Corporation 1998 Long-Term Incentive Plan
|
|
(d) |
|
|
|
|
|
10.4*
|
|
CytRx Corporation 2000 Long-Term Incentive Plan
|
|
(e) |
|
|
|
|
|
10.5*
|
|
Amendment No. 1 to 2000 Long-Term Incentive Plan
|
|
(g) |
|
|
|
|
|
10.6*
|
|
Amendment No. 2 to 2000 Long-Term Incentive Plan
|
|
(g) |
|
|
|
|
|
10.7*
|
|
Amendment No. 3 to 2000 Long-Term Incentive Plan
|
|
(j) |
|
|
|
|
|
10.8*
|
|
Amendment No. 4 to 2000 Long-Term Incentive Plan
|
|
(j) |
|
|
|
|
|
10.9
|
|
License Agreement dated December 7, 2001 by and between CytRx
Corporation and Vical Incorporated
|
|
(f) |
|
|
|
|
|
10.10
|
|
Agreement between CytRx Corporation and Dr. Robert Hunter
regarding SynthRx, Inc dated October 20, 2003
|
|
(j) |
|
|
|
|
|
10.11
|
|
Office Lease between The Kriegsman Group and Douglas Emmett,
dated April 13, 2000
|
|
(j) |
|
|
|
|
|
10.12
|
|
First Amendment to Office Lease dated October 14, 2005, by and
between CytRx Corporation and Douglas Emmett 1993, LLC
|
|
(o) |
|
|
|
|
|
10.13
|
|
Second Amendment to Office Lease between CytRx Corporation and
Douglas Emmett 1993 LLC, dated June 19, 2008
|
|
(x) |
|
|
|
|
|
10.14
|
|
Assignment to CytRx Corporation effective July 1, 2003 of Office
Lease between The Kriegsman Group and Douglas Emmett, dated
April 13, 2000
|
|
(j) |
|
|
|
|
|
10.15
|
|
Asset Sale and Purchase Agreement dated October 4, 2004, by and
among CytRx Corporation, Biorex Research & Development, RT and
BRX Research and Development Company Ltd
|
|
(l) |
|
|
|
|
|
10.16*
|
|
Amended and Restated Employment Agreement dated May 17, 2005
between CytRx Corporation and Steven A. Kriegsman
|
|
(n) |
|
|
|
|
|
10.17*
|
|
Second Amended and Restated Employment Agreement dated June 16,
2006 between CytRx Corporation and Dr. Jack Barber
|
|
(q) |
|
|
|
|
|
10.18*
|
|
Second Amended and Restated Employment Agreement dated June 16,
2006 between CytRx Corporation and Benjamin S. Levin
|
|
(q) |
II-3
|
|
|
|
|
Exhibit |
|
|
|
|
Number |
|
Description |
|
Footnote |
10.19
|
|
Royalty Agreement dated August 28, 2006 between CytRx
Corporation and Kenneth Council, as Trustee of the ALS
Charitable Remainder Trust
|
|
(r) |
|
|
|
|
|
10.20
|
|
Contribution Agreement, dated as of January 8, 2007, between
CytRx Corporation and RXi Pharmaceuticals Corporation
|
|
(t) |
|
|
|
|
|
10.21
|
|
Reimbursement Agreement, dated January 8, 2007, between CytRx
Corporation and RXi Pharmaceuticals Corporation
|
|
(t) |
|
|
|
|
|
10.22
|
|
Voting agreement, dated as of January 10, 2007, between CytRx
Corporation and the University of Massachusetts
|
|
(t) |
|
|
|
|
|
10.23
|
|
Master Agreement for Clinical Trials Management Services, dated
February 5, 2007, between CytRx Corporation and Pharmaceutical
Research Associates
|
|
(t) |
|
|
|
|
|
10.24
|
|
Stockholders agreement, dated February 23, 2007, among CytRx
Corporation, RXi Pharmaceuticals Corporation, Craig C. Mello,
Ph.D., Tariq Rana, Ph.D., Gregory J. Hannon, Ph.D., and Michael
P. Czech, Ph.D.
|
|
(t) |
|
|
|
|
|
10.25
|
|
Form of Purchase Agreement, dated as of April 17, 2007, by and
between CytRx Corporation and each of the selling stockholders
named therein
|
|
(u) |
|
|
|
|
|
10.26
|
|
Contribution Agreement, dated as of April 30, 2007, between
CytRx Corporation and RXi Pharmaceuticals Corporation
|
|
(t) |
|
|
|
|
|
10.27*
|
|
Employment Agreement dated April 30, 2007, between CytRx
Corporation and Shi Chung Ng, Ph.D.
|
|
(v) |
|
|
|
|
|
10.28*
|
|
Lease dated July 20, 2007, between CytRx Corporation and
BMR-3030 Bunker Hill Street LLC
|
|
(v) |
|
|
|
|
|
10.29*
|
|
Employment Agreement dated September 11, 2007, between CytRx
Corporation and Mitchell K. Fogelman
|
|
(w) |
|
|
|
|
|
10.30*
|
|
Employment Letter dated October 26, 2007, between CytRx
Corporation and John Y. Caloz
|
|
(w) |
|
|
|
|
|
23.1
|
|
Consent of TroyGould PC (included in Exhibit 5.1 to this
Registration Statement) |
|
(y) |
|
|
|
|
|
23.2
|
|
Consent of BDO Seidman LLP |
|
|
|
|
|
|
|
23.3
|
|
Consent of J.H. Cohn LLP |
|
|
|
|
|
|
|
24.1
|
|
Powers of Attorney |
|
(y) |
|
|
|
|
|
99.1
|
|
Form of Proxy Card for Special Meeting of Stockholders of
Innovive Pharmaceuticals, Inc. |
|
(y) |
|
|
|
|
|
99.2
|
|
Consent of Chartered Capital Advisors, Inc. |
|
|
|
|
|
* |
|
Indicates a management contract or compensatory plan or arrangement. |
|
|
|
Confidential treatment has been requested or granted for certain portions which have been
blanked out in the copy of the exhibit filed with the Securities and Exchange Commission. The
omitted information has been filed separately with the Securities and Exchange Commission. |
|
(a) |
|
Incorporated by reference to the Registrants Current Report on Form 8-K filed on April 17,
1997 |
|
(b) |
|
Incorporated by reference to the Registrants Quarterly Report on Form 10-Q filed on November
13, 1997 |
II-4
|
|
|
(c) |
|
Incorporated by reference to the Registrants Registration Statement on Form S-8 (File No.
33-93818) filed on June 22, 1995 |
|
(d) |
|
Incorporated by reference to the Registrants Proxy Statement filed on April 30, 1998 |
|
(e) |
|
Incorporated by reference to the Registrants Annual Report on Form 10-K filed on March 27,
2001 |
|
(f) |
|
Incorporated by reference to the Registrants Current Report on Form 8-K filed on December 21, 2001 |
|
(g) |
|
Incorporated by reference to the Registrants Proxy Statement filed June 10, 2002 |
|
(h) |
|
Incorporated by reference to the Registrants 10-Q filed on May 15, 2003 |
|
(i) |
|
Incorporated by reference to the Registrants 8-K filed on May 30, 2003 |
|
(j) |
|
Incorporated by reference to the Registrants 10-K filed on May 14, 2004 |
|
(k) |
|
Incorporated by reference to the Registrants 10-Q filed on August 16, 2004 |
|
(l) |
|
Incorporated by reference to the Registrants 8-K filed on October 5, 2004 |
|
(m) |
|
Incorporated by reference to the Registrants 8-K filed on January 21, 2005 |
|
(n) |
|
Incorporated by reference to the Registrants 10-Q filed on August 15, 2005 |
|
(o) |
|
Incorporated by reference to the Registrants 8-K filed on October 20, 2005 |
|
(p) |
|
Incorporated by reference to the Registrants 8-K filed on March 3, 2006 |
|
(q) |
|
Incorporated by reference to the Registrants 10-Q filed on August 3, 2006 |
|
(r) |
|
Incorporated by reference to the Registrants 10-Q filed on November 13, 2006 |
|
(s) |
|
Incorporated by reference to the Registrants 10-K filed on April 2, 2007 |
|
(t) |
|
Incorporated by reference to the Registrants 10-Q filed on May 10, 2007 |
|
(u) |
|
Incorporated by reference to the Registrants Current Report on Form 8-K filed on April 18,
2007 |
|
(v) |
|
Incorporated by reference to the Registrants 10-Q filed on August 9, 2007 |
|
(w) |
|
Incorporated by reference to the Registrants 10-Q filed on November 14, 2007 |
|
(x) |
|
Incorporated by reference to Registrants 8-K filed on June 24, 2008 |
|
(y) |
|
Previously filed |
(b) Financial Statement schedules.
The following financial statement schedule of CytRx Corporation is set forth in Part I on page
E-28 of Appendix E to the proxy statement/prospectus included in this registration statement:
Schedule II Valuation and Qualifying Accounts for the years ended December 31, 2007, 2006
and 2005
II-5
All other schedules are omitted because they are not required, not applicable, or the
information is provided in the financial statements or notes thereto.
(c) Reports, opinions or approvals. The opinion of Chartered Capital Advisers, Inc. is
included in Part I as Appendix C to the proxy statement/prospectus included in this registration
statement.
Item 22. Undertakings
The undersigned Registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made, a post-effective
amendment to this registration statement: (i) to include any prospectus required by Section
10(a)(3) of the Securities Act of 1933, as amended (the Securities Act); (ii) to reflect in the
prospectus any facts or events arising after the effective date of the registration statement (or
the most recent post-effective amendment thereof) which, individually or in the aggregate,
represent a fundamental change in the information set forth in the registration statement
(notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the
total dollar value of securities offered would not exceed that which was registered) and any
deviation from the low or high end of the estimated maximum offering range may be reflected in the
form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the
changes in volume and price represent no more than a 20% change in the maximum aggregate offering
price set forth in the Calculation of Registration Fee table in the effective registration
statement); and (iii) to include any material information with respect to the plan of distribution
not previously disclosed in the registration statement or any material change to such information
in the registration statement.
(2) That, for the purpose of determining any liability under the Securities Act, each such
post-effective amendment will be deemed to be a new registration statement relating to the
securities offered therein, and the offering of such securities at that time will be deemed to be
the initial bonafide offering thereof.
(3) To remove from registration by means of a post-effective amendment any of the securities
being registered which remain unsold at the termination of the offering.
(4) That, for purposes of determining any liability under the Securities Act, each filing of
the Registrants annual report pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of
1934, as amended (and, where applicable, each filing of an employee benefit plans annual report
pursuant to Section 15(d) of the Securities Exchange Act of 1934, as amended) that is incorporated
by reference in this registration statement will be deemed to be a new registration statement
relating to the securities offered therein, and the offering of such securities at that time will
be deemed to be the initial bonafide offering thereof.
(5) That prior to any public reoffering of the securities registered hereunder through use of
a prospectus which is a part of this registration statement, by any person or party who is deemed
to be an underwriter within the meaning of Rule 145(c), the Registrant undertakes that such
reoffering prospectus will contain the information called for by the applicable registration form
with respect to reofferings by persons who may be deemed underwriters, in addition to the
information called for by the other items of the applicable form.
(6) That every prospectus (i) that is filed pursuant to paragraph (5) above, or (ii) that
purports to meet the requirements of Section 10(a)(3) of the Securities Act and is used in
connection with an offering of securities subject to Rule 415, will be filed as a part of an
amendment to this registration statement and will not be used until such amendment has become
effective, and that for the purposes of determining any liability under the Securities Act, each
such post-effective amendment will be deemed to be a new registration statement relating to the
securities offered therein, and the offering of such securities at that time will be deemed to be
the initial bonafide offering thereof.
II-6
(7) To respond to requests for information that is incorporated by reference into the
prospectus pursuant to Items 4, 10(b), 11 or 13 of this form, within one business day of receipt of
such request, and to send the incorporated documents by first class mail or other equally prompt
means. This includes information contained in documents filed subsequent to the effective date of
the registration statement through the date of responding to the request.
(8) To supply by means of a post-effective amendment all information concerning a transaction,
and the company being acquired involved therein, that was not the subject of and included in this
registration statement when it became effective.
(9) Insofar as indemnification for liabilities arising under the Securities Act may be
permitted to directors, officers and controlling persons of the registrant pursuant to the
foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the
Securities and Exchange Commission such indemnification is against public policy as expressed in
the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification
against such liabilities (other than the payment by the registrant of expenses incurred or paid by
a director, officer or controlling person of the registrant in the successful defense of any
action, suit or proceeding) is asserted by such director, officer, or controlling person in
connection with the securities being registered, the registrant will, unless in the opinion of its
counsel the matter has been settled by controlling precedent, submit to a court of appropriate
jurisdiction the question whether such indemnification by it is against public policy as expressed
in the Securities Act and will be governed by the final adjudication of such issue.
II-7
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the registrant has duly caused
this pre-effective Amendment No. 1 to registration statement to be signed on its behalf by the undersigned, thereunto duly
authorized in the City of Los Angeles, State of California, on
August 6, 2008.
|
|
|
|
|
|
CYTRX CORPORATION
|
|
|
By: |
/s/ STEVEN A. KRIEGSMAN
|
|
|
|
Steven A. Kriegsman |
|
|
|
President and Chief Executive Officer |
|
|
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes
and appoints Steven A. Kriegsman his true and lawful attorney-in-fact and agent, with full power of
substitution, for him in any and all capacities, to sign this registration statement and any
amendments hereto, and to file the same, with exhibits thereto, and other documents in connection
therewith, with the Securities and Exchange Commission, granting unto said attorney-in-fact and
agent full power and authority to do and perform each and every act and thing requisite and
necessary to be done in and about the premises, as he might do or could do in person, hereby
ratifying and confirming all that said attorney-in-fact and agent, or his substitute or
substitutes, may do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, this registration statement has
been signed by the following persons in the capacities and on the dates indicated.
|
|
|
|
|
Signature |
|
Title |
|
Date |
|
|
|
|
|
/s/ STEVEN A. KRIEGSMAN
Steven A. Kriegsman
|
|
President and Chief Executive
Officer and Director
|
|
August 6, 2008 |
|
|
|
|
|
/s/ MITCHELL K. FOGELMAN
Mitchell K. Fogelman
|
|
Chief Financial Officer and
Treasurer (principal financial
and accounting officer)
|
|
August 6, 2008 |
|
|
|
|
|
*
Louis J. Ignarro, Ph.D.
|
|
Director
|
|
August 6, 2008 |
|
|
|
|
|
|
|
Director
|
|
August 6, 2008 |
|
|
|
|
|
*
Joseph Rubinfeld, Ph.D.
|
|
Director
|
|
August 6, 2008 |
|
|
|
|
|
|
|
Director
|
|
August 6, 2008 |
|
|
|
|
|
|
|
Director
|
|
August 6, 2008 |
|
|
|
|
|
|
*By: |
/s/ STEVEN A. KRIEGSMAN
Steven A. Kriegsman
Attorney-in-Fact
|
|
|
|
|
II-8
EXHIBIT INDEX
|
|
|
|
|
Exhibit |
|
|
|
|
Number |
|
Description |
|
Footnote |
2.1
|
|
Agreement and Plan of Merger, dated as of June 6, 2008, by and
among Innovive Pharmaceuticals, Inc., CytRx Corporation, CytRx
Merger Subsidiary, Inc. and Steven Kelly, as stockholder
representative (included in Part I as Appendix A to the proxy
statement/prospectus included in this Registration Statement) |
|
|
|
|
|
|
|
3.1
|
|
Restated Certificate of Incorporation of CytRx Corporation
(filed as Exhibit 3.1 to CytRx Corporations Annual Report on
Form 10-K filed on April 1, 2008) and incorporated herein by
reference) |
|
|
|
|
|
|
|
3.2
|
|
Certificate of Amendment to Restated Certificate of
Incorporation of CytRx Corporation |
|
(y) |
|
|
|
|
|
3.3
|
|
Restated By-Laws of CytRx Corporation, as amended (filed as
Exhibit 3.2 to CytRx Corporations Annual Report on Form 10-K
filed on April 1, 2008 and incorporated herein by reference) |
|
|
|
|
|
|
|
4.1
|
|
Shareholder Protection Rights Agreement, dated April 16, 1997,
between CytRx Corporation and American Stock Transfer & Trust
Company, as Rights Agent
|
|
(a) |
|
|
|
|
|
4.2
|
|
Amendment No. 1 to Shareholder Protection Rights Agreement
(incorporated by reference to CytRx Corporations Annual Report
on Form 10-K filed on March 27, 2001)
|
|
(e) |
|
|
|
|
|
4.3
|
|
Amendment No. 2 to Shareholder Protection Rights Agreement
(incorporated by reference to CytRx Corporations Annual Report
on Form 10-K filed on April 2, 2007)
|
|
(s) |
|
|
|
|
|
5.1
|
|
Opinion of TroyGould PC |
|
|
|
|
|
|
|
10.1*
|
|
CytRx Corporation 1994 Stock Option Plan, as amended and restated
|
|
(b) |
|
|
|
|
|
10.2*
|
|
CytRx Corporation 1995 Stock Option Plan
|
|
(r) |
|
|
|
|
|
10.3*
|
|
CytRx Corporation 1998 Long-Term Incentive Plan
|
|
(d) |
|
|
|
|
|
10.4*
|
|
CytRx Corporation 2000 Long-Term Incentive Plan
|
|
(e) |
|
|
|
|
|
10.5*
|
|
Amendment No. 1 to 2000 Long-Term Incentive Plan
|
|
(g) |
|
|
|
|
|
10.6*
|
|
Amendment No. 2 to 2000 Long-Term Incentive Plan
|
|
(g) |
|
|
|
|
|
10.7*
|
|
Amendment No. 3 to 2000 Long-Term Incentive Plan
|
|
(j) |
|
|
|
|
|
10.8*
|
|
Amendment No. 4 to 2000 Long-Term Incentive Plan
|
|
(j) |
|
|
|
|
|
10.9
|
|
License Agreement dated December 7, 2001 by and between CytRx
Corporation and Vical Incorporated
|
|
(f) |
|
|
|
|
|
10.10
|
|
Agreement between CytRx Corporation and Dr. Robert Hunter
regarding SynthRx, Inc dated October 20, 2003
|
|
(j) |
|
|
|
|
|
10.11
|
|
Office Lease between The Kriegsman Group and Douglas Emmett,
dated April 13, 2000
|
|
(j) |
|
|
|
|
|
10.12
|
|
First Amendment to Office Lease dated October 14, 2005, by and
between CytRx Corporation and Douglas Emmett 1993, LLC
|
|
(o) |
|
|
|
|
|
Exhibit |
|
|
|
|
Number |
|
Description |
|
Footnote |
10.13
|
|
Second Amendment to Office Lease between CytRx Corporation and
Douglas Emmett 1993 LLC, dated June 19, 2008
|
|
(x) |
|
|
|
|
|
10.14
|
|
Assignment to CytRx Corporation effective July 1, 2003 of Office
Lease between The Kriegsman Group and Douglas Emmett, dated
April 13, 2000
|
|
(j) |
|
|
|
|
|
10.15
|
|
Asset Sale and Purchase Agreement dated October 4, 2004, by and
among CytRx Corporation, Biorex Research & Development, RT and
BRX Research and Development Company Ltd
|
|
(l) |
|
|
|
|
|
10.16*
|
|
Amended and Restated Employment Agreement dated May 17, 2005
between CytRx Corporation and Steven A. Kriegsman
|
|
(n) |
|
|
|
|
|
10.17*
|
|
Second Amended and Restated Employment Agreement dated June 16,
2006 between CytRx Corporation and Dr. Jack Barber
|
|
(q) |
|
|
|
|
|
10.18*
|
|
Second Amended and Restated Employment Agreement dated June 16,
2006 between CytRx Corporation and Benjamin S. Levin
|
|
(q) |
|
|
|
|
|
10.19
|
|
Royalty Agreement dated August 28, 2006 between CytRx
Corporation and Kenneth Council, as Trustee of the ALS
Charitable Remainder Trust
|
|
(r) |
|
|
|
|
|
10.20
|
|
Contribution Agreement, dated as of January 8, 2007, between
CytRx Corporation and RXi Pharmaceuticals Corporation
|
|
(t) |
|
|
|
|
|
10.21
|
|
Reimbursement Agreement, dated January 8, 2007, between CytRx
Corporation and RXi Pharmaceuticals Corporation
|
|
(t) |
|
|
|
|
|
10.22
|
|
Voting agreement, dated as of January 10, 2007, between CytRx
Corporation and the University of Massachusetts
|
|
(t) |
|
|
|
|
|
10.23
|
|
Master Agreement for Clinical Trials Management Services, dated
February 5, 2007, between CytRx Corporation and Pharmaceutical
Research Associates
|
|
(t) |
|
|
|
|
|
10.24
|
|
Stockholders agreement, dated February 23, 2007, among CytRx
Corporation, RXi Pharmaceuticals Corporation, Craig C. Mello,
Ph.D., Tariq Rana, Ph.D., Gregory J. Hannon, Ph.D., and Michael
P. Czech, Ph.D.
|
|
(t) |
|
|
|
|
|
10.25
|
|
Form of Purchase Agreement, dated as of April 17, 2007, by and
between CytRx Corporation and each of the selling stockholders
named therein
|
|
(u) |
|
|
|
|
|
10.26
|
|
Contribution Agreement, dated as of April 30, 2007, between
CytRx Corporation and RXi Pharmaceuticals Corporation
|
|
(t) |
|
|
|
|
|
10.27*
|
|
Employment Agreement dated April 30, 2007, between CytRx
Corporation and Shi Chung Ng, Ph.D.
|
|
(v) |
|
|
|
|
|
10.28*
|
|
Lease dated July 20, 2007, between CytRx Corporation and
BMR-3030 Bunker Hill Street LLC
|
|
(v) |
|
|
|
|
|
10.29*
|
|
Employment Agreement dated September 11, 2007, between CytRx
Corporation and Mitchell K. Fogelman
|
|
(w) |
|
|
|
|
|
10.30*
|
|
Employment Letter dated October 26, 2007, between CytRx
Corporation and John Y. Caloz
|
|
(w) |
|
|
|
|
|
23.1
|
|
Consent of TroyGould PC (included in Exhibit 5.1 to this
Registration Statement) |
|
(y) |
|
|
|
|
|
23.2
|
|
Consent of BDO Seidman LLP |
|
|
|
|
|
|
|
Exhibit |
|
|
|
|
Number |
|
Description |
|
Footnote |
23.3
|
|
Consent of J.H. Cohn LLP |
|
|
|
|
|
|
|
24.1
|
|
Powers of Attorney |
|
(y) |
|
|
|
|
|
99.1
|
|
Form of Proxy Card for Special Meeting of Stockholders of
Innovive Pharmaceuticals, Inc. |
|
(y) |
|
|
|
|
|
99.2
|
|
Consent of Chartered Capital Advisors, Inc. |
|
|
|
|
|
* |
|
Indicates a management contract or compensatory plan or arrangement. |
|
|
|
Confidential treatment has been requested or granted for certain portions which have been
blanked out in the copy of the exhibit filed with the Securities and Exchange Commission. The
omitted information has been filed separately with the Securities and Exchange Commission. |
|
(a) |
|
Incorporated by reference to the Registrants Current Report on Form 8-K filed on April 17,
1997 |
|
(b) |
|
Incorporated by reference to the Registrants Quarterly Report on Form 10-Q filed on November
13, 1997 |
|
(c) |
|
Incorporated by reference to the Registrants Registration Statement on Form S-8 (File No. 33-93818) filed on June 22, 1995 |
|
(d) |
|
Incorporated by reference to the Registrants Proxy Statement filed on April 30, 1998 |
|
(e) |
|
Incorporated by reference to the Registrants Annual Report on Form 10-K filed on March 27,
2001 |
|
(f) |
|
Incorporated by reference to the Registrants Current Report on Form 8-K filed on December 21, 2001 |
|
(g) |
|
Incorporated by reference to the Registrants Proxy Statement filed June 10, 2002 |
|
(h) |
|
Incorporated by reference to the Registrants 10-Q filed on May 15, 2003 |
|
(i) |
|
Incorporated by reference to the Registrants 8-K filed on May 30, 2003 |
|
(j) |
|
Incorporated by reference to the Registrants 10-K filed on May 14, 2004 |
|
(k) |
|
Incorporated by reference to the Registrants 10-Q filed on August 16, 2004 |
|
(l) |
|
Incorporated by reference to the Registrants 8-K filed on October 5, 2004 |
|
(m) |
|
Incorporated by reference to the Registrants 8-K filed on January 21, 2005 |
|
(n) |
|
Incorporated by reference to the Registrants 10-Q filed on August 15, 2005 |
|
(o) |
|
Incorporated by reference to the Registrants 8-K filed on October 20, 2005 |
|
(p) |
|
Incorporated by reference to the Registrants 8-K filed on March 3, 2006 |
|
(q) |
|
Incorporated by reference to the Registrants 10-Q filed on August 3, 2006 |
|
(r) |
|
Incorporated by reference to the Registrants 10-Q filed on November 13, 2006 |
|
(s) |
|
Incorporated by reference to the Registrants 10-K filed on April 2, 2007 |
|
|
|
(t) |
|
Incorporated by reference to the Registrants 10-Q filed on May 10, 2007 |
|
(u) |
|
Incorporated by reference to the Registrants Current Report on Form 8-K filed on April 18,
2007 |
|
(v) |
|
Incorporated by reference to the Registrants 10-Q filed on August 9, 2007 |
|
(w) |
|
Incorporated by reference to the Registrants 10-Q filed on November 14, 2007 |
|
(x) |
|
Incorporated by reference to Registrants 8-K filed on June 24, 2008 |
|
(y) |
|
Previously filed |