Blueprint
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM 8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act Of
1934
Date of
Report (Date of earliest event reported): November 13,
2018
Palatin Technologies, Inc.
(Exact
name of registrant as specified in its charter)
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Delaware
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001-15543
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95-4078884
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(State
or other jurisdiction
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(Commission
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(IRS
employer
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of
incorporation)
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File
Number)
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identification
number)
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4B Cedar Brook Drive, Cranbury, NJ
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08512
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(Address
of principal executive offices)
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(Zip
Code)
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Registrant's
telephone number, including area code: (609) 495-2200
Check
the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant
under any of the following provisions (see General Instruction A.2.
below):
[ ]
Written communications pursuant to Rule 425 under the Securities
Act (17 CFR 230.425)
[ ]
Soliciting material pursuant to Rule 14a-12 under the Exchange Act
(17 CFR 240.14a-12)
[ ]
Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
[ ]
Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))
Emerging
growth company ☐
If an
emerging growth company, indicate by checkmark if the registrant
has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided
pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial
Condition.
On
November 13, 2018, we issued a press release including results for
our first quarter ended September 30, 2018 and announcing a
teleconference and webcast to be held November 13, 2018 at 11:00
a.m. Eastern time, which will include a discussion on results of
operations in greater detail and an update on corporate
developments. We have attached a copy of the press release as an
exhibit to this report.
The
information in this Item 2.02 and the corresponding information in
the attached Exhibit 99.1 shall not be deemed to be
“filed” for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended, or otherwise subject to the
liabilities of that section. The information contained in this Item
2.02 and the corresponding information in the attached Exhibit 99.1
shall not be incorporated into any registration statement or other
document filed with the Securities and Exchange Commission by the
company, whether made before or after the date hereof, regardless
of any general incorporation language in such filing, except as
shall be expressly set forth by specific reference in such
filing.
Item 7.01. Regulation FD Disclosure.
AMAG
Pharmaceuticals, Inc. (“AMAG”), Palatin Technologies,
Inc.’s (“Palatin”) exclusive North American
licensee of Vyleesi™ (bremelanotide), has been in discussions
with the U.S. Food and Drug Administration (the “FDA”)
regarding its review of the New Drug Application
(“NDA”) submission for Vyleesi. The FDA has requested
that additional data be generated from a small Phase 1 study with
premenopausal volunteers assessing 24-hour ambulatory blood
pressure with short term daily use of Vyleesi. As part of its
ongoing review, the FDA has indicated that these data are required
to help characterize the impact of frequent dosing, including to
help inform the Vyleesi label. Palatin and AMAG believes that this
study can be conducted and data submitted prior to March 23, 2019,
the currently scheduled Prescription Drug User Fee Act
(“PDUFA”) date. The FDA will assess the need for an
Advisory Committee meeting after receipt and review of the
requested data, and has informed AMAG that the previously
communicated January 2019 Advisory Committee meeting will not take
place. Although AMAG’s discussions to date with the FDA are
preliminary, and AMAG will continue to have further discussions
with the FDA on this matter, AMAG believes that this submission of
additional data could cause a delay of the potential approval of
Vyleesi by three to six months.
This
report contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, Section 21E of the
Securities Exchange Act of 1934 and as that term is defined in the
Private Securities Litigation Reform Act of 1995. Any statements
contained herein or therein which do not describe historical facts,
including, among others, expectations as to the FDA’s
requests;beliefs that the additional study can be conducted and
data submitted prior to the PDUFA date; the impact on the timeline
of the potential approval of Vyleesi; and expectations as to
further discussions with the FDA are forward-looking statements
which involve risks and uncertainties that could cause actual
results to differ materially from those discussed in such
forward-looking statements.
Such
risks and uncertainties include, among others, the risk that the
FDA will require additional or more comprehensive study data, or
issue a complete response letter, which could cause a further delay
or challenges to the approval of the Vyleesi NDA, or which could
result in unanticipated restrictions or warnings on the product
label, if approved, and the risk that the costs associated with
such efforts will be higher than anticipated, as well as those
risks identified in Palatin’s filings with the U.S.
Securities and Exchange Commission (the “Commission”),
including its Annual Report on Form 10-K for the year ended June
30, 2018 and subsequent filings with the Commission, including its
Quarterly Report on Form 10-Q for the quarter ended September 30,
2018, which are available at the Commission’s website at
www.sec.gov. Any such risks and uncertainties could materially and
adversely affect Palatin’s results of operations, its
profitability and its cash flows, which would, in turn, have a
significant and adverse impact on Palatin’s stock price.
Palatin cautions you not to place undue reliance on any
forward-looking statements, which speak only as of the date they
are made. Palatin disclaims any obligation to publicly update or
revise any such statements to reflect any change in expectations or
in events, conditions or circumstances on which any such statements
may be based, or that may affect the likelihood that actual results
will differ from those set forth in the forward-looking
statements.
Item 9.01 Financial Statements and Exhibits.
(d)
Exhibits:
Press Release dated
November 13, 2018
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.
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PALATIN
TECHNOLOGIES, INC.
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Date:
November 13, 2018
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By:
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/s/
Stephen T. Wills
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Stephen
T. Wills, CPA, MST
Executive
Vice President, Chief Financial Officer and Chief Operating
Officer
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EXHIBIT INDEX
Press Release dated
November 13, 2018