Neurologix, Inc. 10 KSB 12-31-2004
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-KSB
x |
ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934 |
For the
Fiscal Year Ended December 31, 2004
o |
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934 |
For the
transition period from ____ to ____
Commission
File Number 0-13347
NEUROLOGIX,
INC.
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DELAWARE |
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06-1582875 |
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(State
or other jurisdiction of |
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I.R.S.
Employer |
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Incorporation
or organization) |
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Identification
No.) |
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ONE
BRIDGE PLAZA, FORT LEE, NEW JERSEY |
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07024 |
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(Address
of principal executive offices) |
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(Zip
Code) |
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(201)
592-6451 |
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(Issuer’s
telephone number, including area code) |
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N/A |
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(Former
name, former address and former fiscal year, if
changed since last report) |
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Securities
registered pursuant to Section 12(b) of the Act: None
Securities
registered pursuant to Section 12(g) of the Act:
Common
Stock, par value $.001 per share
(Title of
Class)
Check
whether the issuer (1) filed all reports required to be filed by Section 13 or
15(d) of the Exchange Act during the past 12 months (or for such shorter period
that the Registrant was required to file such reports), and (2) has been subject
to such filing requirements for the past 90 days. Yes x No o
Check
here if there is no disclosure of delinquent filers in response to Item 405 of
Regulation S-B contained in this form, and no disclosure will be contained, to
the best of the Registrant’s knowledge, in definitive proxy or information
statements incorporated by reference in Part III of this 10-KSB or any amendment
to this Form 10-KSB. o
The
Registrant had no revenues during the year ended December 31, 2004.
The
aggregate market value of the Registrant’s voting and non-voting common equity
held by non-affiliates as of March 24, 2005 was approximately
$32,440,000.
State the
number of shares outstanding of each of the issuer’s classes of common equity,
as of the latest practicable date:
As of
March 25, 2005, there were outstanding 24,956,856 shares of the Registrant’s
Common Stock, $.001 par value.
DOCUMENTS
INCORPORATED BY REFERENCE
Certain
information required in Part III of this Annual Report on Form 10-KSB is
incorporated herein by reference to the registrant’s Proxy Statement for its
2005 Annual Meeting of Stockholders.
Transitional
Small Business Disclosure Format: Yes o No
x
PART
I
Item
1. Description of Business
BACKGROUND
INFORMATION
Arinco
Computer Systems Inc. (formerly known as Change Technology Partners, Inc. and
referred to herein as “Arinco”), the
predecessor to Neurologix, Inc. (collectively with its wholly-owned subsidiary,
the “Company” or
“Neurologix”), was
incorporated in New Mexico on March 31, 1978 for the principal purpose of
serving its subsidiary operations, which included the sale of telecommunications
equipment and services and the retail sales of computers. Arinco, which became
public in 1982, did not have any business operations from 1985 to March 2000. At
that time, an investor group acquired control of Arinco and commenced a new
consulting business strategy focusing on internet and e-services and digital
media solutions.
Thereafter,
until approximately July 2001, the Company provided a broad range of consulting
services, including e-services and technology strategy, online branding, web
architecture and design, systems integration, systems architecture and
outsourcing. However, the Company was not successful with its business strategy
and therefore, the Company’s Board of Directors (the “Board”) voted
to divest the Company of a majority of its then existing operations. On
September 30, 2002, the Board adopted a plan of liquidation and dissolution in
order to maximize stockholder value.
During
the period from December 2001 through June 30, 2003, Canned Interactive, which
designs and produces interactive media such as digital video discs (DVDs) and
web sites, primarily for entertainment, consumer goods, sports and technology
companies, was the Company’s sole source of operating revenues. On June 30,
2003, the Company sold all of the issued and outstanding shares of Canned
Interactive to a limited partnership of which Canned Interactive’s managing
director was the general partner. With the
sale of Canned Interactive, the Company ceased to have any continuing
operations.
On
February 10, 2004, the Company completed a merger (the “Merger”) of its
newly-formed, wholly-owned subsidiary with Neurologix Research, Inc. (formerly
known as “Neurologix, Inc.” and sometimes referred to herein as “NRI”). As a
result of the Merger, NRI became a wholly-owned subsidiary of the Company and
stockholders of NRI received an aggregate number of shares of Neurologix Common
Stock representing approximately 68% of the total number shares of the Company’s
Common Stock outstanding after the Merger. In addition, the Board and management
of the Company are now controlled by members of the board of directors and
management of NRI.
Accordingly,
the Merger has been accounted for as a reverse acquisition, with NRI being the
accounting parent and Neurologix being the accounting subsidiary. The
consolidated financial statements include the operations of Neurologix, the
accounting subsidiary, from the date of acquisition. Since the Merger was
accounted for as a reverse acquisition, the accompanying consolidated financial
statements reflect the historical financial statements of NRI, the accounting
acquiror, as adjusted for the effects of the exchange of shares on its equity
accounts, the inclusion of net liabilities of the accounting subsidiary as of
February 10, 2004 on their historical basis and the inclusion of the accounting
subsidiary’s results of operations from that date.
BUSINESS
OF THE COMPANY
The
Company is a development stage company, which through its wholly-owned
subsidiary, NRI, is engaged in the research and development of proprietary
treatments for disorders of the brain and central nervous system primarily
utilizing gene therapies. These treatments are designed as alternatives to
conventional surgical and pharmacological treatments. From the formation of NRI
in 1999 to 2002, NRI conducted its gene therapy research through sponsorship
agreements with Thomas Jefferson University, The Rockefeller University and the
University of Auckland. In October 2002, it established and staffed its own
laboratory facility to manufacture the gene therapy products required for its
pre-clinical trials and to continue the research and development of additional
gene therapy products.
NRI’s
scientific co-founders, Dr. Matthew J. During and Dr. Michael G. Kaplitt, have
collaborated for more than ten years in working with central nervous system
disorders. Their research spans from animal studies (for gene therapy in
Parkinson’s disease and epilepsy) to the currently open Phase I human clinical
trial for the treatment of Parkinson’s disease. They both remain as consultants
to NRI and serve on its Scientific Advisory Board (“SAB”).
Unless
the context otherwise requires, in describing the business herein, references to
the “Company” shall collectively refer to both Neurologix and NRI.
The
Company’s initial development efforts have been focused on gene therapy products
for treating Parkinson’s disease and, more recently, epilepsy. The Company’s
core gene therapy technology, which it refers to as NLX, is currently being
tested in a Phase I human clinical trial, sponsored by the Company, to treat
Parkinson’s disease. A Phase I clinical trial is designed to test the safety, as
opposed to efficacy, of a proposed treatment. The clinical trial is being
conducted by Dr. Kaplitt and Dr. During. As part of this clinical trial, twelve
patients with Parkinson’s disease will undergo surgical gene therapy at The New
York Presbyterian Hospital/Weill Medical College of Cornell University. The
first of these surgeries was performed in August 2003 and marked the first time
that gene therapy products have been used in a human to attempt to treat
Parkinson’s disease. As of March 22, 2005, the gene transfer surgery has been
performed on a total of 10 patients and, depending upon obtaining the informed
consent of qualified patients, the Company currently expects the remaining 2
gene transfer surgeries to be completed by the end of 2005. With guidance during
the approval process from the National Institutes of Health and the Food and
Drug Administration (“FDA”), Dr.
During and Dr. Kaplitt designed a clinical trial aimed at minimizing
complications to patients participating in the study. Subject
to the successful completion of the Phase I clinical trial, the Company expects
to proceed with a Phase II human clinical trial to determine the efficacy of NLX
in treating Parkinson’s disease.
In
October 2004, motivated by encouraging rodent studies, the Company entered into
an agreement with Universida Federal de Sao Paolo to commence a non-human
primate study for evaluating the toxicity and efficacy of using its NLX
technology in the brain for the treatment of epilepsy. The study is expected to
begin and be completed by the end of 2005. If this study is successfully
completed, the Company plans to
submit an Investigational New Drug application to the FDA in the fourth quarter
of 2005 for permission to begin a Phase I clinical trial in temporal lobe
epilepsy. The proposed clinical protocol was presented to the NIH Recombinant
DNA Advisory Committee on September 23, 2004 and reviewed
favorably.
Business
Strategy
The
Company’s objective is to develop and commercialize long-term, cost-effective
treatments for disorders of the brain and central nervous system. Key elements
of the Company’s strategy are:
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Focus
resources on development of NLX technology.
The Company intends to focus its research and development efforts on what
it believes are achievable technologies having practical applications.
Consequently, the Company expects to initially allocate the majority of
its resources and efforts to the development of its first-generation NLX
products for the treatment of Parkinson’s disease and
epilepsy. |
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Focus
on central nervous system disorders that are likely to be receptive to
gene therapy treatment.
To attempt to reduce the technical and commercial risks inherent in the
development of new gene therapies, the Company intends to pursue
treatments for neurological diseases for
which: |
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the
therapeutic gene function is reasonably well
understood; |
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animal
studies, which may include those studies involving non-human primates,
have indicated that gene therapy technology may be effective in treating
the disease; |
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partial
correction of the disease is expected to be
established; |
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clinical
testing can be conducted in a relatively small number of patients within a
reasonably short time period. |
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Establish
strategic relationships to facilitate research and manufacturing.
The
Company intends to seek to establish collaborative research and
manufacturing relationships with universities and companies involved in
the development of gene therapy and other technologies. The Company
believes that such relationships, if established, will make additional
resources available to Company for the manufacture of gene therapy
products and for the clinical trials involving these
products. |
Technology
Overview
Deoxyribonucleic
acid (“DNA”) is organized into segments called genes, with each gene
representing the information necessary to make one particular protein.
Occasionally, the DNA for one or more genes can be defective, resulting in the
absence or improper production of a functioning protein in the cell. This
improper expression can alter a cell’s normal function and can frequently result
in a disease. One goal of gene therapy is to treat these diseases by delivering
DNA containing the corrected gene into cells. Also, gene therapy can increase or
decrease the synthesis of gene products, or introduce new genes in a cell and
thus provide new or augmented functions to that cell. There are several
different ways of delivering genes to cells. Each of the methods of delivery
uses carriers, called “vectors,” to transport the genes into cells. Similar to
the relationship between a delivery truck and its cargo, the vector (the
“truck”) provides a mode of transport and the therapeutic agent (the “cargo”)
provides the disease remedy. These carriers can be either man-made components or
modified viruses. The use of viruses takes advantage of their natural ability to
introduce DNA into cells. Gene therapy takes advantage of this property by
replacing viral DNA with a payload consisting of a specific gene. Once the
vector inserts the gene into the cell, the gene acts as a blueprint directing
the cell to make the therapeutic protein.
For its
first-generation of products, the Company intends to exclusively utilize the
adeno-associated virus (“AAV”)
vector. In 1994, Dr. Michael Kaplitt and Dr. Matthew During demonstrated that
AAV could be a safe and effective vehicle for gene therapy in the brain. Since
that time, AAV has been used safely in a variety of clinical gene therapy trials
and, to the Company’s knowledge the virus has not been associated with any human
disease.
The
Company believes that the benefits of AAV vector gene therapy technology
include:
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Safety.
AAV vectors are based on a virus that, to the Company’s knowledge, has not
been associated with a human disease. |
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Efficiency
of Delivery. AAV
vectors are effective at delivering genes to cells. Once in the cell,
genes delivered by AAV vectors in animal models have produced effective
amounts of protein on a continuous basis, often for months or longer from
a single administration. |
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Ability
to Deliver Many Different Genes.
The vast majority of the coding part of genes (cDNA) fit into AAV vectors
and have been successfully delivered to a wide range of cell
types. |
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A
Simpler and Safer Option than Standard Surgery.
The Company intends to administer the AAV vector-based products in a
procedure that is simpler and safer than other established neurosurgical
procedures. |
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Stability.
Unlike some other viruses, AAV is stable under a wide range of conditions.
This allows AAV vectors to be handled like normal pharmaceutical products,
lending themselves to traditional shipping and storing
procedures. |
Product
Development
The
Company’s initial focus is to develop therapeutic products (i) to meet the needs
of patients suffering from Parkinson’s disease and (ii) the needs of patients
suffering from a type of epilepsy known as temporal lobe epilepsy or
“TLE”.
Parkinson’s
Disease
Parkinson’s
disease is a neurodegenerative disorder; it arises from the gradual death of
nerve cells. Parkinson’s disease is a progressive and debilitating disease that
affects the control of movement and is characterized by four principal
symptoms:
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bradykinesia
of the limbs and body evidenced by difficulty and slowness of movement,
and |
Physicians
and patients have long recognized that this disease, or treatment complications,
can cause a wide spectrum of other symptoms, including dementia, abnormal
speech, sleep disturbances, swallowing problems, sexual dysfunction, and
depression.
Rigidity,
tremor, and bradykinesia result, primarily, from a loss of dopamine in two
regions of the brain: the substantia nigra and striatum (caudate and putamen).
Dopamine is a chemical, or neurotransmitter, that is a chemical released from
nerve cells (neurons), which helps regulate the flow of impulses from the
substantia nigra to neurons in the caudate and putamen. Standard therapy for
Parkinson’s disease often involves use of levodopa, a drug which stimulates
production of dopamine. However, over extended periods of time levodopa often
declines in its effectiveness. In advanced stages of Parkinson’s disease, as the
disease becomes more and more debilitating, it becomes necessary and advisable
to accept a riskier and potentially more invasive medical procedure to treat the
disease. It is at this juncture that surgical procedures (deep brain
stimulators, lesioning, etc.) are commonly advised. The Company believes that
the glutamic acid decarboxylase (“GAD”), gene
can be used to selectively mimic normal physiology and alter the neural
circuitry affected in Parkinson’s disease. The Company’s technology inserts a
GAD gene into the AAV-based viral vector, introducing it directly into an area
of the brain know as the sub-thalmic nucleus. The GAD gene is responsible for
making gamma aminobutyric acid (GABA), which is released by nerve cells to
inhibit or dampen activity. The Company’s gene therapy is designed to reset the
overactive brain cells (e.g. reduce tremors, rigidity and slowness of movement)
to inhibit electrical activity and return brain network activity to more normal
levels without destroying brain tissue and without implanting a permanent
medical device.
According
to the National Parkinson Foundation, there are approximately 1.5 million
Parkinson’s patients in America, with approximately 60,000 new cases diagnosed
each year. While the peak onset of Parkinson’s disease is age 60 years,
Parkinson’s disease is not just a disease of middle or old age: 15% of
Parkinson’s disease patients are 50 years or less and 10% are 40 years or
less.
Epilepsy
Epilepsy,
a group of diseases associated with recurrent seizures, is caused by periodic
episodes of repetitive, abnormal electrochemical disturbance in the central
nervous system, beginning in the brain. Generalized seizures happen when massive
bursts of electrical energy sweep through the whole brain at once, causing loss
of consciousness, falls, convulsions or intense muscle spasms. Partial seizures
happen when the disturbance occurs in only one part of the brain, affecting the
physical or mental activity that area of the brain controls. Seizures may also
begin as partial or focal seizures and then generalize.
The
Company believes that its technology can be applied to the treatment of epilepsy
with advantages over the currently available treatments. The Company’s proposed
treatment uses gene-transfer technology to deliver genes which restore the
chemical balance but only in the areas in which the disease process is
occurring.
According
to the Epilepsy Foundation (USA), epilepsy affects approximately 2.5 million
Americans of all ages and backgrounds, making it one of the most common
neurological diseases in this country. Approximately 181,000 new cases of
seizures and epilepsy occur each year, with 72% of epileptic Americans below age
65. Despite optimal medical (drug) treatment, as many as 50% of people with
epilepsy continue to have seizures and are potential candidates for surgery,
including gene therapy.
Patents
and Other Proprietary Rights
The
Company believes that its success depends upon its ability to develop and
protect proprietary products and technology. Accordingly, whenever practicable,
the Company applies for U.S. patents (and, in some instances, foreign patents as
well) covering those developments that it believes are innovative,
technologically significant and have commercial potential to its field of
operations. Presently, it holds the exclusive license to 4 issued U.S. patents,
4 pending U.S. patent applications and 5 pending foreign patent applications. In
addition, the Company owns 1 issued U.S. patent and 4 U.S. pending patent
applications covering gene therapy technologies and holds a non-exclusive
license to a U.S. patent covering delivery mechanisms for gene
therapy.
The
exclusive patent licenses were granted by Rockefeller University (“Rockefeller”)
and Thomas Jefferson University (“TJU”)
pursuant to research agreements which the Company had with these institutions.
The non-exclusive license is provided pursuant to an agreement the Company has
with Rockefeller University and Yale University. In each instance, Dr. Michael
Kaplitt and/or Dr. Matthew During are named as one of the co-inventors in the
patent.
In
accordance with TJU’s Intellectual Property Policy, an aggregate of 40% of all
income it receives from licensing transactions is paid to the inventors. Dr.
During has advised the Company that during 2004 and 2003 he received
approximately $17,000 and $22,000, respectively, from TJU as a result of
payments made by the Company to TJU under two exclusive license agreements. The
amounts received by Dr. During represent approximately 18% of the total payments
made by the Company to TJU during 2004 and 2003. Dr. During will also have a
similar interest in future royalties that may become payable under the agreement
with TJU.
In
accordance with Rockefeller’s Intellectual Property Policy, an aggregate of
one-third of all income it receives from licensing transactions is paid to the
inventors. Dr. Kaplitt has advised the Company that he received less than $2,000
in each of 2004 and 2003 from Rockefeller as a result of payments made by the
Company to Rockefeller under a non-exclusive license agreement. In December
2002, the Company issued to Rockefeller 368,761 shares of the Company’s Common
Stock in exchange for the cancellation of certain fees under its exclusive
patent license agreement with the Company. When, and if, Rockefeller sells these
shares, Dr. Kaplitt estimates that he will be entitled to approximately 25% of
the proceeds. Dr. Kaplitt will also have a similar interest in future royalties
that may become payable under the agreement with Rockefeller.
Currently,
the Company has an agreement with Cornell University for its Medical College
(“Cornell”) to
fund the ongoing Phase I clinical trial for the treatment of Parkinson’s disease
and the development of gene therapy approaches for neurodegenerative disorder,
including Parkinson’s disease, Huntington’s disease, Alzheimer’s disease and
epilepsy. Under this agreement, the Company has the right of first refusal to
obtain from Cornell, upon commercially reasonable terms, exclusive license
rights to any intellectual property developed in the course of the sponsored
research projects.
In
addition to patents, the Company relies on trade secrets, technical know-how and
continuing technological innovation to develop and maintain its competitive
position. The Company requires all of its employees and scientific consultants
to execute confidentiality and assignment of invention agreements. These
agreements typically provide that (i) all materials and confidential information
developed or made known to the individual during the course of the individual’s
relationship with the Company is to be kept confidential and not disclosed to
third parties except in specific circumstances and (ii) all inventions arising
out of the relationship with the Company shall be the Company’s exclusive
property. While the Company takes these and other measures to protect its trade
secrets, they do not assure against the unauthorized use and/or disclosure of
its confidential information.
Manufacturing
Pursuant
to an agreement, Auckland UniServices, Ltd (“AUL”) a New
Zealand based company, has manufactured and delivered to the Company in bulk
form all of the AAV that it requires to complete the pending Phase I clinical
trial. The Company’s laboratory purifies the AAV that it gets from AUL to the
final product form that is used in the trial.
Competition
The
Company is aware of other companies currently conducting clinical trials of gene
therapy products in humans to treat Parkinson’s disease or epilepsy, and
recognizes that it faces intense competition from pharmaceutical companies,
biotechnology companies, universities, governmental entities and other
healthcare providers developing alternative treatments for these diseases.
Alternative treatments include surgery, deep brain stimulator implants and the
use of pharmaceuticals. The Company may also face competition from companies and
institutions involved in developing gene therapy and cell therapy treatments for
other diseases, whose technologies may be adapted for the treatment of central
nervous system disorders. Some companies, such as Avigen, Inc. (“Avigen”), Cell
Genesys, Inc., and Targeted Genetics Corporation, have significant experience in
developing and using AAV vectors to deliver gene therapy products.
In August
2004, Avigen announced that the FDA authorized it to initiate a Phase I/II
clinical trial of gene therapy for the treatment of Parkinson’s disease using
AV201, an AAV vector containing the gene for AADC (aromatic amino acid
decarboxylase) which is delivered directly to the part of the brain that
requires dopamine to control movement. Avigen commenced such trial with its
first patient undergoing gene transfer surgery in December, 2004.
Many of
the Company’s competitors have significantly greater research and development,
marketing, manufacturing, financial and/or managerial resources than the Company
enjoys. Moreover, developments by others may render the Company’s products or
technologies noncompetitive or obsolete.
Government
Regulation
The
production and marketing of the Company’s proposed products and research and
development activities are subject to extensive regulation for safety, efficacy
and quality by numerous governmental authorities in the United States and
potentially other foreign countries. In the United States, the FDA regulates,
among other things, the testing, manufacturing, safety, efficacy, labeling,
storage, record keeping, advertising and promotional practices and import and
export of drugs and biological products.
In
addition, in the event that the Company seeks to commercialize a product
embodying technology covered by a patent that was exclusively licensed to the
Company by an educational or other non-profit institution in the United States,
the Company may be required to manufacture such product substantially in the
United States, if the technology resulted from federally funded
research.
Employees
As of
December 31, 2004, the Company had four full-time employees, including three
research scientists with doctoral degrees. These research scientists have
expertise in virology, protein chemistry and molecular biology. In addition to
its research staff, the Company’s executive Chairman and former President and
Chief Executive Officer, Dr. Martin J. Kaplitt (who is the father of Dr. Michael
G. Kaplitt, one of the Company’ scientific co-founders) is paid a management fee
and Mark S. Hoffman serves as the Company’s Secretary-Treasurer, without any
compensation.
The
Company’s employees are not subject to any collective bargaining agreements and
it regards its relations with its employees to be good.
Scientific
Advisory Board (“SAB”)
The
Company has assembled the SAB to advise the Company on the selection,
implementation and prioritization of its research programs. The SAB, which
currently consists of the following seven scientists, will hold its first annual
meeting in May 2005.
Paul
Greengard, Ph.D. Dr.
Greengard has been a member and chairman of the SAB since July 2003. Dr.
Greengard is the Vincent Astor Professor and Chairman of the Laboratory of
Molecular and Cellular Neuroscience at The Rockefeller University. Dr. Greengard
was awarded the 2000 Nobel Prize in Physiology or Medicine. Dr. Greengard
received a Ph.D. in biophysics from Johns Hopkins University. Prior to joining
The Rockefeller University in 1983, Dr. Greengard was the director of
biochemical research at the Geigy Research Laboratories and subsequently
Professor of Pharmacology and Professor of Psychiatry at the Yale University
School of Medicine. Dr. Greengard is an elected member of the U.S. National
Academy of Sciences and its Institute of Medicine and of the American Academy of
Arts and Sciences. He is also a foreign member of the Royal Swedish Academy of
Sciences and a member of the Norwegian Academy of Science and
Letters.
Andrew
J. Brooks, Ph.D. Dr.
Brooks has been a member of the SAB since January 2002. Dr. Brooks is currently
the Director of the Center for Functional Genomics in the Aab Institute for
Biomedical Science at the University of Rochester from which he also received
his Ph.D.
Matthew
J. During, M.D.,
D.Sc. Dr.
During, one of the Company’s scientific co-founders, has been a member of the
SAB since October 1999. Since June 2004, he has been the Research Lab Director
of the Department of Neurological Surgery at Cornell. He is also a Professor of
Molecular Medicine and Pathology at the University of Auckland in New Zealand
where he directs neuroscience and gene therapy programs. He served as Director
of the CNS Gene Therapy Center and Professor of Neurosurgery at Jefferson
Medical College from 1998 through 2002. From 1989 through 1998, Dr. During was a
faculty member at Yale University where he directed a translational neuroscience
program and headed Yale’s first gene therapy protocol. Dr. During is a graduate
of the University of Auckland School of Medicine and did further postgraduate
training at M.I.T. from 1985 to 1987, Harvard Medical School from 1986 to 1989
and Yale University from 1988 to 1989.
Michael
G. Kaplitt, M.D., Ph.D. Dr.
Kaplitt, one of the Company’s scientific co-founders, has been a member of the
SAB since October 1999. Dr. Kaplitt is Assistant Professor of Neurosurgery,
Director of Stereotactic and Functional Neurosurgery and Director of the
Laboratory of Molecular Neurosurgery at Weill Medical College of Cornell
University. He is also a Clinical Assistant Attending, Division of Neurosurgery,
Department of Surgery at Memorial-Sloan Kettering Cancer Center, and Adjunct
Faculty, Laboratory of Neurobiology and Behavior at The Rockefeller University.
Dr. Kaplitt graduated magna cum laude with a bachelor’s degree in molecular
biology from Princeton University. He received his M.D. from Cornell University
School of Medicine in 1995, where he completed his residency in Neurosurgery and
a Ph.D. in molecular neurobiology from The Rockefeller University. Dr. Michael
Kaplitt is the son of Dr. Martin Kaplitt.
Daniel
H. Lowenstein, M.D. Dr.
Lowenstein has been a member of the SAB since January 2005. Dr. Lowenstein is
Professor and Vice Chairman in the Department of Neurology at the University of
California, San Francisco (“UCSF”),
Director of the UCSF Epilepsy Center and Director of Physician-Scientist
Training Programs for the UCSF School of Medicine. He received his M.D. degree
from Harvard Medical School in 1983. Dr. Lowenstein established the UCSF
Epilepsy Research Laboratory, and was the Robert B. and Ellinor Aird Professor
of Neurology from 1998 to 2000. He then joined Harvard Medical School as the
Dean for Medical Education and Carl W. Walter Professor of Neurology for two and
a half years, and in 2003, moved back to UCSF in his current position. During
2004, he served as the President of the American Epilepsy Society. His interests
include the molecular and cellular changes in neural networks following seizure
activity and injury and the contribution of neurogenesis to seizure-induced
network reorganization in the adult central nervous system. He has received
several national awards for excellence in teaching and numerous academic honors
and awards, including the American Epilepsy Society’s 2001 Basic Research Award.
Among his numerous publications, he has authored approximately 80 papers in
peer-reviewed journals, 80 research abstracts and 43 review articles, editorials
and book chapters.
Andres
M. Lozano, M.D., Ph.D. Dr.
Lozano has been a member of the SAB since April 2001. He is currently Professor
of Neurosurgery and holds the Ronald Tasker Chair in Stereotactic and Functional
Neurosurgery at The University of Toronto. Dr. Lozano received his M.D. from the
University of Ottawa and a Ph.D. from McGill University. He completed a
residency in Neurosurgery at the Montreal Neurological Institute prior to
joining the staff at the University of Toronto. Dr. Lozano is currently the
President of the American Society for Stereotactic and Functional Neurosurgery
and the President-elect of the World Society for Stereotactic and Functional
Neurosurgery.
Eric
J. Nestler, M.D., Ph.D. Dr.
Nestler has been a member of the SAB since May 2004. Dr. Nestler’s research
focuses on ways in which the brain responds to repeated perturbations under
normal and pathological conditions, with a primary focus on drug addiction and
depression. He has authored or edited seven books, and published more than 300
articles and reviews and 267 abstracts relating to the field of
neuropsychopharmacology. Since 2000, he has been the Lou and Ellen McGinley
Distinguished Chair in Psychiatric Research and Professor and Chairman of the
Department of Psychiatry at the University of Texas Southwestern Medical Center.
From 1992 to 2000, he was Director of the Abraham Ribicoff Research Facilities
and of the Division of Molecular Psychiatry at Yale University. Dr. Nestler’s
awards and honors include the Pfizer Scholars Award (1987), Sloan Research
Fellowship (1987), McKnight Scholar Award (1989), Efron Award of the American
College of Neuropsychopharmacology (1994) and Pasarow Foundation Award for
Neuropsychiatric Research (1998).
Risk
Factors
The
following sets forth some of the business risks and challenges facing the
Company as it seeks to develop its business:
· The
Company is still in the development stage and has not generated any revenues.
From inception through December 31, 2004 it has incurred net losses of
$8,774,000 and negative cash flows from operating activities of $7,741,000.
Management believes that the Company will continue to incur net losses and cash
flow deficiencies from operating activities for the foreseeable future. Because
it may take years to develop, test and obtain regulatory approval for a
gene-based therapy product before it can be sold, the Company likely will
continue to incur significant losses for the foreseeable future. Accordingly, it
may never be profitable and, if it does become profitable, it may be unable to
sustain profitability.
· The
Company has not demonstrated that it can:
|
- |
discover
gene therapies that will be effective in treating Parkinson’s disease or
any other disease; |
|
- |
obtain
the regulatory approvals necessary to commercialize product candidates
that it may develop in the future; |
|
- |
manufacture,
or arrange for third-parties to manufacture, future product candidates in
a manner that will enable the company to be
profitable; |
|
- |
attract,
retain and manage a large, diverse staff of physicians and
researchers; |
|
- |
establish
many of the business functions necessary to operate, including sales,
marketing, administrative and financial functions, and establish
appropriate financial controls; |
|
- |
develop
relationships with third-party collaborators to assist in the marketing
and/or distribution of the technologies that the Company may
develop; |
|
- |
make,
use and sell future product candidates without infringing upon third party
intellectual property rights; |
|
- |
secure
meaningful intellectual property protection covering its future product
candidates; or |
|
- |
respond
effectively to competitive pressures. |
· If the
pending Phase I clinical trial for treatment of Parkinson’s disease is
unsuccessful, future operations and the potential for profitability will be
significantly adversely affected and the business may not succeed.
· Since the
Company’s existing resources will not be sufficient to enable it to obtain the
regulatory approvals necessary to commercialize its current or future product
candidates, it will need to raise additional funds through public or private
equity offerings, debt financings or additional corporate collaboration and
licensing arrangements. Availability of financing depends upon a number of
factors beyond the Company’s control, including market conditions and interest
rates. The Company does not know whether additional financing will be available
when needed or if available; will be on acceptable or favorable terms to it or
its stockholders.
· The
Company’s future success depends, to a significant degree, on the skills,
experience and efforts of its current key physicians and researchers, including
Dr. Matthew During and Dr. Michael Kaplitt. If either Dr. During or Dr. Kaplitt
were unable or unwilling to continue present relationships with the Company, it
is likely that its business, financial condition, operating results and future
prospects would be materially adversely affected.
· The
industry in which the Company competes is subject to stringent regulation by
certain regulatory authorities. The Company may not obtain regulatory approval
for any future product candidates it develops. To market a pharmaceutical
product in the United States requires rigorous preclinical testing and clinical
trials, which must be completed and an extensive regulatory approval process
implemented by the FDA. To the Company’s knowledge, to date, neither the FDA nor
any other regulatory agency has approved a gene therapy product for sale in the
United States. Satisfaction of regulatory requirements typically takes many
years, is dependent upon the type, complexity and novelty of the product and
requires the expenditure of substantial resources. The Company may encounter
delays or rejections in the regulatory approval process resulting from
additional governmental regulation or changes in policy during the period of
product development, clinical trials and FDA regulatory review.
· Failure
to comply with applicable FDA or other applicable regulatory requirements may
result in criminal prosecution, civil penalties, recall or seizure of products,
total or partial suspension of production or injunction, as well as other
regulatory action against the Company’s future product candidates or the Company
itself. Outside the United States, the ability to market a product is also
contingent upon receiving clearances from appropriate foreign regulatory
authorities. The non-U.S. regulatory approval process includes similar risks to
those associated with FDA clearance.
· The
Company will need to conduct significant additional research and animal testing,
referred to as preclinical testing, before clinical trials involving other
future product candidates can be conducted. It may take many years to complete
preclinical testing and clinical trials and failure could occur at any stage of
testing. Acceptable results in early testing or trials may not be repeated in
later tests. Whether any products in preclinical testing or early stage clinical
trials will receive approval is unknown. Before applications can be filed with
the FDA for product approval, it must be demonstrated that a particular future
product candidate is safe and effective. The Company’s failure to adequately
demonstrate the safety and efficacy of future product candidates would prevent
the FDA from approving them. The Company’s product development costs will
increase if it experiences delays in testing or regulatory approvals or if it
becomes necessary to perform more or larger clinical trials than planned. If the
delays are significant, they could negatively affect the Company’s financial
results, ability to raise capital and the commercial prospects for future
product candidates.
· The
Company’s future success depends upon health care administrators and providers,
patients and third-party payors’ (including, without limitation, health
insurance companies, Medicaid and Medicare) acceptance of its products. Market
acceptance will depend on numerous factors, many of which are outside the
Company’s control, including:
|
- |
the
safety and efficacy of future product candidates, as demonstrated in
clinical trials; |
|
- |
favorable
regulatory approval and product labeling; |
|
- |
the
frequency of product use; |
|
- |
the
availability, safety, efficacy and ease of use of alternative
therapies; |
|
- |
the
price of future product candidates relative to alternative therapies;
and |
|
- |
the
availability of third-party reimbursement. |
· Patient
complications that may occur in gene-based clinical trials conducted by the
Company and other companies and the resulting publicity surrounding them, as
well as any other serious adverse events in the field of gene therapy that may
occur in the future, may result in greater governmental regulation of future
product candidates and potential regulatory delays relating to the testing or
approval of them. Even with the requisite approval, the commercial success of
the Company’s product candidates will depend in part on public acceptance of the
use of gene therapies for the prevention or treatment of human disease. Public
attitudes may be influenced by claims that gene therapy is unsafe, and gene
therapy may not gain the acceptance of the public or the medical community.
Negative public reaction to gene therapy could result in greater governmental
regulation, stricter clinical trial oversight and commercial product labeling
requirements of gene therapies and could negatively affect demand for any
products the Company may develop.
· Unanticipated
side effects, patient discomfort, defects or unfavorable publicity concerning
any of the Company’s future product candidates, or any other product
incorporating technology similar to that used by future product candidates,
could have a material adverse effect on the Company’s ability to commercialize
its products or achieve market acceptance.
· The
Company does not have any experience in manufacturing products for commercial
sale and if the Company is not successful in engaging a third-party to
manufacture its products, no assurance can be provided that it will be able
to:
|
- |
develop
and implement large-scale manufacturing processes and purchase needed
equipment and machinery on favorable terms; |
|
- |
hire
and retain skilled personnel to oversee manufacturing
operations; |
|
- |
avoid
design and manufacturing defects; or |
|
- |
develop
and maintain a manufacturing facility in compliance with governmental
regulations, including the FDA’s good manufacturing
practices. |
· The
Company, or third-party manufacturers that it contracts with to manufacture any
future product candidate, must receive FDA approval before producing clinical
material or commercial products. The Company’s future product candidates may
compete with other products for access to third-party manufacturing facilities
and may be subject to delays in manufacture if third party manufacturers give
priority to products other than the Company’s future product candidates. The
Company may be unable to manufacture commercial-scale quantities of gene-based
therapy products, or any quantities at all. Failure to successfully manufacture
products in commercial-scale quantities, and on a timely basis, would prevent
the Company from achieving its business objectives.
· Because of the complex
and difficult legal and factual questions that relate to patent positions in the
Company’s industry, no assurance can be provided that its future product
candidates or technologies will not be found to infringe upon the intellectual
property or proprietary rights of others. Third parties may claim that future
product candidates or the Company’s technologies infringe on their patents,
copyrights, trademarks or other proprietary rights and demand that it cease
development or marketing of those products or technology or pay license fees.
The Company may not be able to avoid costly patent infringement litigation,
which will divert the attention of management and cash resources away from the
development of new products and the operation of its business. No assurance can
be provided that the Company would prevail in any such litigation. If the
Company is found to have infringed on a third party’s intellectual property
rights it may be liable for money damages, encounter significant delays in
bringing products to market or be precluded from manufacturing particular future
product candidates or using particular technology.
· Clinical trials of future
product candidates, and any subsequent sales of products employing the Company’s
technology, may involve injuries to persons using those products as a result of
mislabeling, misuse or product failure. Product liability insurance is
expensive. Although the Company has purchased product liability insurance to
cover claims made during the expected duration of the ongoing Phase I clinical
trials, there can be no assurance that this insurance will be available to the
Company in the future on satisfactory terms, if at all. A successful product
liability claim or series of claims brought against the Company in excess of any
insurance coverage that it may obtain in the future could have a material
adverse effect on its business, financial condition, results of operations and
future prospects.
· The Company’s research
and development processes may involve the use of hazardous materials, including
chemicals and radioactive and biological materials. The risk of accidental
contamination or discharge or any resultant injury from these materials cannot
be completely eliminated. Federal, state and local laws and regulations govern
the use, manufacture, storage, handling and disposal of these materials. The
Company could be subject to civil damages in the event of an improper or
unauthorized release of, or exposure of individuals to, such hazardous
materials. In addition, claimants may sue the Company for injury or
contamination that results from its use or the use by third parties of these
materials and the Company’s liability may exceed its total assets. Compliance
with environmental laws and regulations may be expensive and current or future
environmental regulations may impair the Company’s research, development or
production efforts.
FORWARD
LOOKING STATEMENTS
This
document includes certain statements of the Company that may constitute
“forward-looking statements” within the meaning of Section 27A of the Securities
Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934,
as amended, and which are made pursuant to the Private Securities Litigation
Reform Act of 1995. These forward-looking statements and other information
relating to the Company are based upon the beliefs of management and assumptions
made by and information currently available to the Company. Forward-looking
statements include statements concerning plans, objectives, goals, strategies,
future events, or performance, as well as underlying assumptions and statements
that are other than statements of historical fact. When used in this document,
the words “expects,” “anticipates,” “estimates,” “plans,” “intends,” “projects,”
“predicts,” “believes,” “may” or “should,” and similar expressions, are intended
to identify forward-looking statements. These statements reflect the current
view of the Company’s management with respect to future events and are subject
to numerous risks, uncertainties, and assumptions. Many factors could cause the
actual results, performance or achievements of the Company to be materially
different from any future results, performance, or achievements that may be
expressed or implied by such forward-looking statements, including, among other
things:
|
● |
the
inability of the Company to raise additional funds, when needed, through
public or private equity offerings, debt financings or additional
corporate collaboration and licensing
arrangements. |
|
● |
the
inability of the Company to successfully complete the Phase I clinical
trial for Parkinson’s disease. |
Other
factors and assumptions not identified above could also cause the actual results
to differ materially from those set forth in the forward-looking statements.
Additional information regarding factors which could cause results to differ
materially from management’s expectations is found in the section entitled “Risk
Factors” starting on page 9. Although the Company believes these assumptions are
reasonable, no assurance can be given that they will prove correct. Accordingly,
you should not rely upon forward-looking statements as a prediction of actual
results. Further, the Company undertakes no obligation to update forward-looking
statements after the date they are made or to conform the statements to actual
results or changes in the Company’s expectations.
Item
2. Description of Property
In August
2004, the Company subleased 1,185 square feet of space at One Bridge Plaza, Fort
Lee, New Jersey 07024 from Palisade Capital Securities, LLC (“PCS”), an
affiliated company, for use as its corporate offices. This sublease, which
expires on January 31, 2008, provides for a base annual rent of $35,000 or
$3,000 per month. The rent
that the Company pays to PCS is the same rental amount that PCS pays under its
master lease for this space.
The
Company leases approximately 2,000 square feet of laboratory space in New York
City pursuant to a lease, which provides for an annual rental payment of $48,000
and expires on August 31, 2005. In addition, one of the Company’s scientists
conducts research at Cornell under the direction of Dr. Michael Kaplitt, as
provided for by the Company’s research agreement with such
institution.
Item
3. Legal Proceedings
None.
Item
4. Submission of Matters to a Vote of Security
Holders
No
matters were submitted to a vote of security holders during the fourth quarter
of 2004.
PART
II
Item
5. Market for Registrant’s Common Equity and Related Stockholder
Matters
The
Company had 475 stockholders of record as of March 25, 2004. The Company did not
pay cash dividends during the two year period ended December 31, 2004 and will
not pay any cash dividends to stockholders in the foreseeable
future.
During
2004 and until the closing of the Merger on February 10, 2004, the Company’s
Common Stock, par value $.01 per share, was listed on the OTC Bulletin Board and
traded under the symbol “CTPI”. Pursuant to the Merger, the Company amended its
certificate of incorporation and changed the par value of its Common Stock from
$.01 to $.001 per share. From the date of the Merger through September 9, 2004,
the Company’s Common Stock traded on the OTC Bulletin Board under the symbol
“NLGX”.
On
September 10, 2004, pursuant to the written consent of stockholders owning
approximately 59% of the Company’s Common Stock, the Company amended and
restated its Certificate of Incorporation, as a result of which it effected a
reverse stock split of the shares of Common Stock at a ratio of 1 for 25 and
reduced the Company’s number of authorized shares of Common Stock from
750,000,000 to 60,000,000. Since that date, the Company’s Common Stock has
traded on the OTC Bulleting Board under the symbol “NRGX”.
The
following table shows the high and low bid quotations as
furnished by Bloomberg and adjusted to reflect the September 10, 2004 1 for 25
reverse stock split. The quotations shown reflect inter-dealer prices, without
retail mark-up, markdown or commission and may not necessarily represent actual
transactions.
High
and Low Bid Prices of the Company’s Common Stock |
|
2004 |
2003 |
|
High |
Low |
High |
Low |
First
quarter |
$2.88 |
$0.95 |
$0.45 |
$0.38 |
Second
quarter |
$2.18 |
$0.80 |
$1.50 |
$0.13 |
Third
quarter |
$1.25 |
$0.55 |
$1.85 |
$0.73 |
Fourth
quarter |
$2.00 |
$1.01 |
$1.48 |
$0.83 |
Company
Equity Compensation Plans
The
following table sets forth information as of
December 31, 2004, with respect to compensation plans (including individual
compensation arrangements) under which equity securities of the Company are
authorized for issuance.
Plan
Category |
Number
of securities to be issued upon exercise of outstanding options, warrants
and rights |
Weighted-average
exercise price of outstanding options, warrants and rights |
Number
of securities remaining available for future issuance under equity
compensation plans |
2000
Stock Option Plan approved by stockholders |
787,892 |
$1.47 |
2,108 |
Other
equity compensation plans approved by stockholders |
709,458 |
$0.23 |
- |
Stock
option grant to a former chief executive officer which grant was approved
by stockholders |
240,000 |
$0.75 |
- |
Stock
option grant to Dr. Michael Sorell, the current Chief Executive Officer,
which grant was not approved by stockholders (1) |
876,108 |
$0.75 |
- |
Total |
2,613,458 |
$0.83 |
2,108 |
(1) |
Dr.
Sorell was granted options to purchase 1,150,000 shares of Common Stock in
connection with his hiring in September 2004. Of such grant, options to
purchase 273,892 shares were granted under the Plan (and are intended to
qualify as incentive stock options under the Internal Revenue Code) and
options to purchase 876,108 shares of Common Stock were granted outside
the Plan but on terms identical to those provided for by the Plan. See
Note 8 to the consolidated financial
statements. |
The Board
has amended, subject to stockholder approval, the Company’s 2000 Stock Option
Plan to increase the number of shares available for issuance under the Plan by
500,000 shares. The above table does not reflect the 500,000 additional shares
proposed by such amendment.
Item
6. Management’s Discussion and Analysis or Plan of
Operation
(all amounts in this Item 6 are in
thousands)
The
following discussion should be read in conjunction with the audited financial
statements and accompanying notes of Neurologix for the fiscal year ended
December 31, 2004. The Company’s fiscal year ends on the last day of December in
each year. As used in this Item 6, references to 2004 and 2003 shall mean the
Company’s fiscal year ended on December 31st of such
year.
Plan
of Operation
The
Company is in the development stage and is involved in the development of
proprietary treatments for disorders of the brain and central nervous system
using gene therapy and other innovative therapies. These treatments are designed
as alternatives to conventional surgical and pharmacological treatments. To
date, it has not generated any operating revenues and has incurred total net
losses and aggregate negative cash flows from operating activities from
inception to December 31, 2004 of $8,774 and $7,741, respectively.
The
Company’s initial focus is to develop therapeutic products (i) to meet the needs
of patients suffering from Parkinson’s disease and (ii) the needs of patients
suffering from a type of human epilepsy known as temporal lobe epilepsy or
“TLE”. As of March 22, 2005, the gene transfer surgery has been performed on a
total of 10 patients for its Company sponsored Phase I clinical trial for
Parkinson’s disease and, depending upon obtaining the informed consent of
qualified patients, the Company currently expects the remaining 2 gene transfer
surgeries to be completed by the end of 2005.
In
October 2004, motivated by encouraging rodent studies, the Company entered into
an agreement with Universida Federal de Sao Paolo to commence a non-human
primate study for evaluating the toxicity and efficacy of using its NLX
technology in the brain for the treatment of epilepsy. The study is expected to
begin and be completed by the end of 2005. Subject to the successful completion
of this study, the Company plans to
submit an Investigational New Drug application to the FDA in the fourth quarter
of 2005 for permission to begin a Phase I clinical trial in temporal lobe
epilepsy. The proposed clinical protocol was presented to the NIH Recombinant
DNA Advisory Committee on September 23, 2004 and was reviewed
favorably.
Under the
Company’s research agreement with Cornell, the Company will continue to fund the
development of gene therapy approaches for neurodegenerative disorders,
including Parkinson’s disease, Huntington’s disease, Alzheimer’s disease and
epilepsy. In addition, the Company expects to hire a lab technician during the
second quarter of 2005 to assist the research scientists working at its lab
facility.
During
February and March 2005, the Company completed a private placement resulting in
net proceeds to the Company, after expenses, of approximately $3,086. Management
believes that the Company’s current resources will enable it to continue as a
going concern through at least December 31, 2005 and, if necessary, that it can
implement cost saving initiatives that can extend its operations after that
period. The Company’s existing resources will not be sufficient to support
further clinical trials beyond the pending Phase 1 clinical trial for the
treatment of Parkinson’s disease, the non-human primate study for epilepsy
and/or the commercial introduction of any of its product candidates.
Accordingly, it will continue to seek additional funds through public or private
equity offerings, debt financings or corporate collaboration and licensing
arrangements. The Company does not know whether additional financing will be
available when needed or if available, will be on acceptable or favorable terms
to it or its stockholders.
Results
of Operations
Year
Ended December 31, 2004 Compared to the Year Ended December 31,
2003
Revenues.
The
Company did not generate any operating revenues during the years ended December
31, 2004 and 2003.
Costs
and Expenses.
Research
and Development.
Research and development expenses increased by $89 during the year ended
December 31, 2004 to $1,359 from $1,270 during the same period in 2003. The
increase is primarily due to additional costs related to conducting the
Company’s research and other costs associated with running its lab, partially
offset by an aggregate decrease in amounts paid to its consultants and members
of the SAB.
General
and Administrative. General
and administrative expenses increased by $752 to $1,638 during the year ended
December 31, 2004, as compared to $886 during the comparable period in 2003.
Since the
Merger has been accounted for as a reverse acquisition (with NRI being the
accounting parent and Neurologix being the accounting subsidiary), the Company
had costs associated with being a public company of $629 in 2004 whereas it had
no such costs during 2003. Also
contributing to the higher expenses during this period was a collective increase
in other general and administrative expenses totaling $123.
Other
Income (Expense), Net. The
Company had net other income of $60 during the year ended December 31, 2004 as
compared to net other expense of $118 during the year ended December 31, 2003.
As a result of the financing made available to the Company from the Merger, it
was able to eliminate certain indebtedness and the related interest expense and
earn interest on its cash accounts and cash equivalents. In addition, during
2004 the Company recovered $52 in bad debts that had been written off in
2003.
Liquidity
and Capital Resources.
Cash and
cash equivalents were $1,122 and investments being held to maturity were $1,600
at December 31, 2004.
The
Company is still
in the development stage and has not generated any operating revenues as of
December 31, 2004. In addition, the Company will continue to incur net losses
and cash flow deficiencies from operating activities for the foreseeable
future.
During
February and March 2005, the Company completed a private placement resulting in
net proceeds to the Company, after expenses, of approximately $3,086. Management
believes that the Company’s current resources will enable it to continue as a
going concern through at least December 31, 2005 and, if necessary, that it can
implement cost saving initiatives that can extend its operations after that
period. The Company’s existing resources will not be sufficient to support
further clinical trials beyond the pending Phase 1 clinical trial for the
treatment of Parkinson’s disease, the non-human primate study for epilepsy
and/or the commercial introduction of any of its product candidates.
Accordingly, it will continue to seek additional funds through public or private
equity offerings, debt financings or corporate collaboration and licensing
arrangements. The
Company does not know whether additional financing will be available when needed
or, if available, will be on acceptable or favorable terms to it or its
stockholders.
Operating
activities used $2,836 of cash during the year ended December 31, 2004 as
compared to $1,772 during the same period in 2003.
Net cash
used in investing activities during the years ended December 31, 2004 and 2003,
was $1,796 and $195, respectively, primarily for the development of intangible
assets and the purchase of equipment. Net cash provided by financing activities
was $4,999 during the year ended December 31, 2004, principally from cash
acquired in the Merger ($5,413), partially offset by Merger related costs
($375). During the year ended December 31, 2003, financing activities provided
$1,086, primarily from the proceeds from a note payable.
Critical
Accounting Policies
The
Company’s discussion and analysis and plan of operation is based upon the
Company’s consolidated financial statements, which have been prepared in
accordance with accounting principles generally accepted in the United States of
America for consolidated financial statements filed with the Securities and
Exchange Commission. The preparation of these consolidated financial statements
requires the Company 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 on-going basis, the Company evaluates
its estimates, including those related to fixed assets, intangible assets,
stock-based compensation, income taxes and contingencies. The Company 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 from
these estimates under different assumptions or conditions.
The
accounting policies and estimates used as of December 31, 2004, as outlined in
the accompanying notes to the financial statements, have been applied
consistently for the year ended December 31, 2004.
Carrying
Value of Fixed and Intangible Assets
The
Company’s fixed assets and certain of its patents have been recorded at cost and
are being amortized on a straight-line basis over the estimated useful lives of
those assets. If the Company becomes aware of facts that indicate one or more of
those assets may be impaired, the Company assesses whether the carrying value of
such assets can be recovered through undiscounted future operating cash flows.
If the Company determines that an asset is impaired, the Company measures the
amount of such impairment by comparing the carrying value of the asset to the
present value of the expected future cash flows associated with the use of the
asset. Adverse changes to the Company’s estimates of the future cash flows to be
received from a particular long-lived asset could indicate that the asset is
impaired, and would require the Company to write-down the asset’s carrying value
at that time.
Valuation
of Deferred Tax Assets
The
Company regularly evaluates its ability to recover the reported amount of its
deferred income taxes considering several factors, including its estimate of the
likelihood that it will generate sufficient taxable income in future years in
which temporary differences reverse. Due to the uncertainties related to, among
other things, the extent and timing of future taxable income and the potential
changes in the ownership of the Company, which could subject its net operating
loss carryforwards to substantial annual limitations, the Company offset its net
deferred tax assets by an equivalent valuation allowance as of December 31,
2004.
Allowance
for Doubtful Accounts
The
Company has entered into settlement agreements with two individuals who had
defaulted in the payment of their promissory notes payable to the Company, which
notes were written off in 2003. Based upon management’s assessment of the
likelihood of future collection, the Company has established a valuation
allowance for the remaining amounts due under the settlement agreements totaling
$101 as of December 31, 2004.
New
Accounting Pronouncements
In
May 2003, the Financial Accounting Standards Board (“FASB”) issued
Statement of Financial Standards (“SFAS”) No.
150, “Accounting for Certain Financial Instruments with Characteristics of both
Liabilities and Equity.” This standard requires that certain financial
instruments embodying obligations to transfer assets or to issue equity
securities be classified as liabilities. It is effective for financial
instruments entered into or modified after May 31, 2003, and is otherwise
effective July 1, 2003. The adoption of this statement did not have a material
impact on the Company’s consolidated financial statements.
In
December 2004, the FASB issued SFAS No. 153, “Exchanges of Nonmonetary
Assets”. This
Statement addresses the measurement of exchanges of nonmonetary assets and is
effective for nonmonetary asset exchanges occurring in fiscal years beginning
after June 15, 2005. The adoption of SFAS No.
153 is not expected to have a material effect on the Company’s financial
position or results of operations.
In
December 2004, the FASB issued SFAS No. 123(R) - Share-Based Payment, which is a
revision of SFAS No. 123, “Accounting for Stock-Based Compensation”. SFAS No.
123(R) supersedes APB Opinion No. 25, “Accounting for Stock Issued to
Employees”, and amends SFAS No. 95, “Statement of Cash Flows”. Generally, the
approach in SFAS No. 123(R) is similar to the approach described in SFAS No.
123. However, SFAS No. 123(R) requires all share-based payments to employees,
including grants of employee stock options, to be recognized in the income
statement based on their fair values. Pro forma disclosure is no longer an
alternative. The new standard will be effective for the Company in the first
interim or annual reporting period beginning after December 15, 2005. The
Company is still evaluating the impact the adoption of this standard will have
on its financial statements.
SFAS No.
148, “Accounting for Stock-Based Compensation”, is an amendment to SFAS No. 123,
and provides alternative methods of transition for an entity that voluntarily
changes from the intrinsic value based method of accounting for stock-based
employee compensation prescribed in APB No. 25 to the fair value method
prescribed in SFAS No. 123. As permitted under SFAS No. 148, the Company has
continued to apply the accounting provisions of APB No. 25, and to provide the
annual pro forma disclosures of the effect of adopting the fair value method as
required by SFAS No. 123. SFAS No. 148 also requires pro forma disclosure to be
provided on a quarterly basis. The Company adopted the quarterly disclosure
requirement during the first quarter of 2003.
Item
7. Financial Statements
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board
of Directors and Stockholders
Neurologix,
Inc.
We have
audited the accompanying consolidated balance sheet of Neurologix, Inc. and
subsidiary (a development stage company) as of December 31, 2004, and the
related consolidated statements of operations, changes in stockholders’ equity
(deficiency) and cash flows for the years ended December 31, 2004 and 2003 and
for the period from February 12, 1999 (inception) through December 31, 2004.
These consolidated financial statements are the responsibility of the Company’s
management. Our responsibility is to express an opinion on these consolidated
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 consolidated financial statements referred to above present fairly,
in all material respects, the financial position of Neurologix, Inc. and
subsidiary (a development stage company) as of December 31, 2004, and their
results of operations and cash flows for the years ended December 31, 2004 and
2003 and for the period from February 12, 1999 (inception) through December 31,
2004, in conformity with accounting principles generally accepted in the United
States of America.
/s/ J.H.
Cohn LLP
Roseland,
New Jersey
March 16,
2005
NEUROLOGIX,
INC.
AND SUBSIDIARY
(A
Development Stage Company)
CONSOLIDATED
BALANCE SHEET
(Amounts
in thousands, except share and per share amounts) |
|
|
|
December
31, |
|
|
|
2004 |
|
ASSETS |
|
|
|
|
Current
assets: |
|
|
|
|
Cash
and cash equivalents |
|
$ |
1,122 |
|
Investments
held to maturity |
|
|
1,600 |
|
Prepaid
expenses and other current assets |
|
|
52 |
|
Total
current assets |
|
|
2,774 |
|
|
|
|
|
|
Equipment,
less accumulated depreciation of $182 |
|
|
177 |
|
Intangible
assets, less accumulated amortization of $67 |
|
|
385 |
|
Other
assets |
|
|
14 |
|
Total
Assets |
|
$ |
3,350 |
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY |
|
|
|
|
Current
liabilities: |
|
|
|
|
Accounts
payable and accrued expenses |
|
$ |
262 |
|
Current
portion of capital lease obligations |
|
|
21 |
|
Total
current liabilities |
|
|
283 |
|
|
|
|
|
|
Capital
lease obligations, net of current portion |
|
|
13 |
|
Total
Liabilities |
|
|
296 |
|
Commitments
and contingencies |
|
|
|
|
Stockholders’
equity: |
|
|
|
|
Preferred
stock: |
|
|
|
|
Series
A - $.06 per share cumulative, convertible 1-for-25 into Common Stock;
$.10 par value; 500,000 shares authorized, 645 shares issued and
outstanding with an
aggregate liquidation preference of $1 per share |
|
|
- |
|
Common
Stock:
$.001
par value; 60,000,000 shares authorized, 22,521,404 issued
and outstanding |
|
|
22 |
|
Additional
paid-in capital |
|
|
12,124 |
|
Unearned
compensation |
|
|
(318 |
) |
Deficit
accumulated during the development stage |
|
|
(8,774 |
) |
Total
stockholders’ equity |
|
|
3,054 |
|
Total
Liabilities and Stockholders’ Equity |
|
$ |
3,350 |
|
See
accompanying notes to consolidated financial statements.
NEUROLOGIX,
INC.
AND SUBSIDIARY
(A
Development Stage Company)
CONSOLIDATED
STATEMENTS OF OPERATIONS
(Amounts
in thousands, except share and per share amounts)
|
|
Year
Ended December 31, |
|
For
the period
February
12, 1999 (inception) through
December
31, 2004 |
|
|
|
2004 |
|
2003 |
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
$ |
1,359 |
|
$ |
1,270 |
|
$ |
4,983 |
|
General
and administrative expenses |
|
|
1,638 |
|
|
886 |
|
|
3,520 |
|
Loss
from operations |
|
|
(2,997 |
) |
|
(2,156 |
) |
|
(8,503 |
) |
|
|
|
|
|
|
|
|
|
|
|
Other
income (expense): |
|
|
|
|
|
|
|
|
|
|
Dividend
income, interest income and other income |
|
|
93 |
|
|
16 |
|
|
134 |
|
Interest
expense-related parties |
|
|
(33 |
) |
|
(134 |
) |
|
(405 |
) |
Other
income (expense), net |
|
|
60 |
|
|
(118 |
) |
|
(271 |
) |
Net
loss |
|
$ |
(2,937 |
) |
$ |
(2,274 |
) |
$ |
(8,774 |
) |
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted net loss per share |
|
$ |
(0.14 |
) |
$ |
(0.34 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average common shares outstanding, basic and diluted |
|
|
20,766,729 |
|
|
6,784,597 |
|
|
|
|
See
accompanying notes to consolidated financial
statements.
NEUROLOGIX,
INC. AND SUBSIDIARY
(A
Development Stage Company)
CONSOLIDATED
STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(DEFICIENCY)
FOR
THE PERIOD FROM FEBRUARY 12, 1999 (INCEPTION) THROUGH DECEMBER 31,
2004
(In
thousands, except share amounts) |
|
|
|
|
|
|
|
|
|
|
|
Deficit |
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
Additional |
|
|
|
During
the |
|
|
|
|
|
Common
Stock |
|
Paid-in |
|
Unearned |
|
Development |
|
|
|
|
|
Shares |
|
Amount |
|
Capital |
|
Compensation |
|
Stage |
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sale
of Common Stock to founders |
|
|
6,004,146 |
|
$ |
0 |
|
$ |
4 |
|
|
- |
|
|
- |
|
$ |
4 |
|
Net
loss |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
(328 |
) |
|
(328 |
) |
Balance,
December 31, 1999 |
|
|
6,004,146 |
|
|
0 |
|
|
4 |
|
|
- |
|
|
(328 |
) |
|
(324 |
) |
Net
loss |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
(1,055 |
) |
|
(1,055 |
) |
Balance,
December 31, 2000 |
|
|
6,004,146 |
|
|
0 |
|
|
4 |
|
|
- |
|
|
(1,383 |
) |
|
(1,379 |
) |
Stock
options granted for services |
|
|
-
|
|
|
-
|
|
|
9 |
|
|
- |
|
|
- |
|
|
9 |
|
Common
Stock issued for intangible assets at $0.09 per share |
|
|
259,491 |
|
|
- |
|
|
24 |
|
|
- |
|
|
- |
|
|
24 |
|
Net
loss |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
(870 |
) |
|
(870 |
) |
Balance,
December 31, 2001 |
|
|
6,263,637 |
|
|
0 |
|
|
37 |
|
|
- |
|
|
(2,253 |
) |
|
(2,216 |
) |
Retirement
of founder shares |
|
|
(33,126 |
) |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
Common
Stock issued pursuant to license agreement at $1.56 per
share |
|
|
368,761 |
|
|
- |
|
|
577 |
|
|
(577 |
) |
|
- |
|
|
-
|
|
Private
placement of Series B preferred stock |
|
|
-
|
|
|
- |
|
|
2,613 |
|
|
-
|
|
|
- |
|
|
2,613 |
|
Amortization
of unearned compensation |
|
|
-
|
|
|
- |
|
|
- |
|
|
24 |
|
|
- |
|
|
24 |
|
Net
loss |
|
|
-
|
|
|
- |
|
|
- |
|
|
-
|
|
|
(1,310 |
) |
|
(1,310 |
) |
Balance,
December 31, 2002 |
|
|
6,599,272 |
|
|
0 |
|
|
3,227 |
|
|
(553 |
) |
|
(3,563 |
) |
|
(889 |
) |
Sale
of Common Stock |
|
|
276,054 |
|
|
0 |
|
|
90 |
|
|
(89 |
) |
|
- |
|
|
1 |
|
Amortization
of unearned compensation |
|
|
- |
|
|
- |
|
|
- |
|
|
164 |
|
|
- |
|
|
164 |
|
Net
loss |
|
|
- |
|
|
- |
|
|
- |
|
|
-
|
|
|
(2,274 |
) |
|
(2,274 |
) |
Balance,
December 31, 2003 |
|
|
6,875,326 |
|
|
0 |
|
|
3,317 |
|
|
(478 |
) |
|
(5,837 |
) |
|
(2,998 |
) |
Conversion
of note payable to Common Stock |
|
|
1,091,321 |
|
|
1 |
|
|
2,371 |
|
|
-
|
|
|
- |
|
|
2,372 |
|
Conversion
of mandatory redeemable preferred stock to Common Stock |
|
|
6,086,991 |
|
|
6 |
|
|
494 |
|
|
-
|
|
|
- |
|
|
500 |
|
Conversion
of Series B convertible stock to Common Stock |
|
|
1,354,746 |
|
|
1 |
|
|
(1 |
) |
|
-
|
|
|
- |
|
|
-
|
|
Effects
of reverse acquisition |
|
|
7,103,020 |
|
|
14 |
|
|
5,886 |
|
|
-
|
|
|
- |
|
|
5,900 |
|
Amortization
of unearned compensation |
|
|
-
|
|
|
- |
|
|
-
|
|
|
202 |
|
|
- |
|
|
202 |
|
Stock
options granted for services |
|
|
-
|
|
|
- |
|
|
42 |
|
|
(42 |
) |
|
- |
|
|
-
|
|
Exercise
of stock options |
|
|
10,000 |
|
|
- |
|
|
15 |
|
|
-
|
|
|
- |
|
|
15 |
|
Net
loss |
|
|
-
|
|
|
- |
|
|
-
|
|
|
-
|
|
|
(2,937 |
) |
|
(2,937 |
) |
Balance,
December 31, 2004 |
|
|
22,521,404 |
|
$ |
22 |
|
$ |
12,124 |
|
$ |
(318 |
) |
$ |
(8,774 |
) |
$ |
3,054 |
|
See
accompanying notes to consolidated financial statements.
NEUROLOGIX,
INC.
AND SUBSIDIARY
(A
Development Stage Company)
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(Amounts
in thousands) |
|
|
|
Year
Ended December 31, |
|
For
the period February 12, 1999 (inception) through |
|
|
|
2004 |
|
2003 |
|
December
31, 2004 |
|
Operating
activities: |
|
|
|
|
|
|
|
Net
loss |
|
$ |
(2,937 |
) |
$ |
(2,274 |
) |
$ |
(8,774 |
) |
Adjustments
to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
|
|
|
|
Depreciation |
|
|
83 |
|
|
56 |
|
|
190 |
|
Amortization |
|
|
26 |
|
|
19 |
|
|
69 |
|
Stock
options granted for services |
|
|
-
|
|
|
-
|
|
|
9 |
|
Impairment
of intangible assets |
|
|
-
|
|
|
51 |
|
|
51 |
|
Amortization
of unearned compensation |
|
|
202 |
|
|
164 |
|
|
390 |
|
Non-cash
interest expense |
|
|
18 |
|
|
120 |
|
|
376 |
|
Changes
in operating assets and liabilities |
|
|
|
|
|
|
|
|
|
|
Increase
in prepaid expenses and other current assets |
|
|
(42 |
) |
|
(210 |
) |
|
(252 |
) |
Increase
(decrease) in accounts payable and accrued expenses |
|
|
(186 |
) |
|
302 |
|
|
200 |
|
Net
cash used in operating activities |
|
|
(2,836 |
) |
|
(1,772 |
) |
|
(7,741 |
) |
Investing
activities: |
|
|
|
|
|
|
|
|
|
|
Security
deposits paid |
|
|
(7 |
) |
|
-
|
|
|
(7 |
) |
Purchases
of equipment |
|
|
(71 |
) |
|
(16 |
) |
|
(253 |
) |
Development
of intangible assets |
|
|
(118 |
) |
|
(179 |
) |
|
(480 |
) |
Purchases
of marketable securities |
|
|
(7,473 |
) |
|
-
|
|
|
(7,473 |
) |
Proceeds
from sale of marketable securities |
|
|
5,873 |
|
|
-
|
|
|
5,873 |
|
Net
cash used in investing activities |
|
|
(1,796 |
) |
|
(195 |
) |
|
(2,340 |
) |
Financing
activities: |
|
|
|
|
|
|
|
|
|
|
Proceeds
from note payable |
|
|
-
|
|
|
1,100
|
|
|
1,100 |
|
Borrowings
from related party |
|
|
-
|
|
|
-
|
|
|
2,000 |
|
Cash
acquired in Merger |
|
|
5,413 |
|
|
-
|
|
|
5,413 |
|
Merger-related
costs |
|
|
(375 |
) |
|
- |
|
|
(375 |
) |
Payments
of capital lease obligations |
|
|
(54 |
) |
|
(15 |
) |
|
(69 |
) |
Proceeds
from exercise of stock options |
|
|
15 |
|
|
1 |
|
|
20 |
|
Proceeds
from issuance of preferred stock |
|
|
-
|
|
|
-
|
|
|
3,114 |
|
Net
cash provided by financing activities |
|
|
4,999 |
|
|
1,086 |
|
|
11,203 |
|
Net
increase (decrease) in cash and cash equivalents |
|
|
367 |
|
|
(881 |
) |
|
1,122 |
|
Cash
and cash equivalents, beginning of period |
|
|
755 |
|
|
1,636 |
|
|
-
|
|
Cash
and cash equivalents, end of period |
|
$ |
1,122 |
|
$ |
755 |
|
$ |
1,122 |
|
Supplemental
disclosure of non-cash investing and financing activities: |
|
|
|
|
|
|
|
|
|
|
Issuance
of common stock to pay debt |
|
$ |
2,372 |
|
|
-
|
|
$ |
2,372 |
|
Reverse
acquisition - net liabilities assumed, excluding cash |
|
$ |
(214 |
) |
|
-
|
|
$ |
(214 |
) |
Mandatory
redeemable convertible preferred stock converted to Common
Stock |
|
$ |
500 |
|
|
-
|
|
$ |
500 |
|
Common
Stock issued to acquire intangible assets |
|
|
-
|
|
|
-
|
|
$ |
24 |
|
Acquisition
of equipment through capital leases |
|
$ |
65 |
|
$ |
41 |
|
$ |
106 |
|
See
accompanying notes to consolidated financial
statements. |
Neurologix,
Inc. and subsidiary
(A
Development Stage Company)
Notes
to Consolidated Financial Statements
(In
thousands, except for share and per share
amounts)
(1) |
Description
of Business and Basis of
Presentation |
Arinco Computer Systems Inc. (formerly known as Change Technology Partners, Inc.
and referred to herein as “Arinco”), the
predecessor to Neurologix, Inc. (collectively with its wholly-owned subsidiary,
the “Company” or
“Neurologix”), was
incorporated in New Mexico on March 31, 1978 for the principal purpose of
serving its subsidiary operations, which included the sale of telecommunications
equipment and services and the retail sales of computers. Arinco, which became
public in 1982, did not have any business operations from 1985 to March 2000. At
that time, an investor group acquired control of Arinco and commenced a new
consulting business strategy focusing on internet and e-services and digital
media solutions.
Thereafter,
until approximately July 2001, the Company provided a broad range of consulting
services, including e-services and technology strategy, online branding, web
architecture and design, systems integration, systems architecture and
outsourcing. However, the Company was not successful with its business strategy
and therefore, the Company’s Board of Directors (the “Board”) voted
to divest the Company of a majority of its then existing operations. On
September 30, 2002, the Board adopted a plan of liquidation and dissolution in
order to maximize stockholder value.
During
the period from December 2001 through June 30, 2003, Canned
Interactive, which designs and produces interactive media such as digital video
discs (DVDs) and web sites, primarily for entertainment, consumer goods, sports
and technology companies, was the Company’s sole source of operating revenues.
On June 30, 2003, the Company sold all of the issued and outstanding shares of
Canned Interactive to a limited partnership of which Canned Interactive’s
managing director is the general partner. With the sale of Canned Interactive,
the Company ceased to have any continuing operations.
On
February 10, 2004, the Company completed a merger (the “Merger”) of its
newly-formed, wholly-owned subsidiary with Neurologix Research, Inc. (formerly
known as “Neurologix, Inc.” and sometimes referred to herein as “NRI”). As a
result of the Merger, NRI became a wholly-owned subsidiary of the Company and
stockholders of NRI received an aggregate number of shares of Neurologix Common
Stock representing approximately 68% of the total number shares of the Company’s
Common Stock outstanding after the Merger. The shares of NRI common stock,
convertible preferred stock and Series B convertible preferred stock outstanding
at the effective time of the Merger were converted into an aggregate of
15,408,413 shares of the Company’s Common Stock and outstanding options to
purchase an aggregate of 257,000 shares of the NRI common stock were converted
into options to purchase an aggregate of 709,459 shares of the Company's Common
Stock. In addition, the Board and management of the Company are now controlled
by members of the board of directors and management of NRI prior to the
Merger.
Accordingly,
the Merger has been accounted for as a reverse acquisition, with NRI being the
accounting parent and Neurologix being the accounting subsidiary. The
consolidated financial statements include the operations of Neurologix, the
accounting subsidiary, from the date of acquisition. Since the Merger was
accounted for as a reverse acquisition, the accompanying consolidated financial
statements reflect the historical financial statements of NRI, the accounting
acquiror, as adjusted for the effects of the exchange of shares on its equity
accounts, the inclusion of net liabilities of the accounting subsidiary as of
February 10, 2004 on their historical basis and the inclusion of the accounting
subsidiary’s results of operations from that date.
Neurologix,
Inc. and subsidiary
(A
Development Stage Company)
Notes
to Consolidated Financial Statements
(In
thousands, except for share and per share amounts) -
(continued)
On
September 10, 2004, pursuant to the written consent of stockholders owning
approximately 59% of the Company’s Common Stock, the Company amended and
restated its Certificate of Incorporation, as a result of which it effected a
reverse stock split of the shares of Common Stock at a ratio of 1 for 25 and
reduced the Company’s number of authorized shares of Common Stock from
750,000,000 to 60,000,000. All information related to the Company’s Common
Stock, preferred stock, options and warrants to purchase the Company’s Common
Stock and earnings per share included in the accompanying consolidated financial
statements has been retroactively adjusted to give effect to the Company’s 1 for
25 reverse stock split, which became effective on September 10,
2004.
Currently,
the Company, which through its wholly-owned subsidiary, NRI, is engaged in the
research and development of proprietary treatments for disorders of the brain
and central nervous system primarily utilizing gene therapies. These treatments
are designed as alternatives to conventional surgical and pharmacological
treatments. The Company has not generated any operating revenues and
accordingly, it is a development stage company.
Unless
the context otherwise requires, references to the “Company” shall collectively
refer to both Neurologix and NRI.
The
accompanying consolidated financial statements have been prepared assuming that
the Company will continue as a going concern. The Company is in the development
stage and has not generated any revenues as of December 31, 2004. As a result,
the Company incurred net losses of $2,937, $2,274 and $8,774 and negative cash
flows from operating activities of $2,837, $1,772, and $7,742 for the years
ended December 31, 2004 and 2003 and for the period from February 12, 1999
(inception) to December 31, 2004, respectively. The Company expects that it will
continue to incur net losses and cash flow deficiencies from operating
activities for the foreseeable future.
During
February and March 2005, the Company completed a private placement resulting in
net proceeds to the Company, after expenses, of approximately $3,086. Management
believes that the Company’s current resources will enable it to continue as a
going concern through at least December 31, 2005 and, if necessary, that it can
implement cost saving initiatives that can extend its operations after that
period. The Company’s existing resources will not be sufficient to support
further clinical trials beyond the pending Phase 1 clinical trial for the
treatment of Parkinson’s disease, the non-human primate study for epilepsy
and/or the commercial introduction of any of its product candidates.
Accordingly, it will continue to seek additional funds through public or private
equity offerings, debt financings or corporate collaboration and licensing
arrangements. The Company does not know whether additional financing will be
available when needed or if available, will be on acceptable or favorable terms
to it or its stockholders.
(2) |
Summary
of significant accounting policies |
The
Company has not generated any revenues and, accordingly, is in the development
stage as defined in Statement of Financial Accounting Standards (“SFAS”) No. 7,
“Accounting and Reporting for Development Stage Enterprises.”
Neurologix,
Inc. and subsidiary
(A
Development Stage Company)
Notes
to Consolidated Financial Statements
(In
thousands, except for share and per share amounts) -
(continued)
|
(b) |
Principles
of Consolidation |
The
consolidated financial statements include the accounts of the Company and its
wholly-owned subsidiary, NRI. All significant intercompany transactions and
balances have been eliminated in consolidation.
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 the reported amounts of assets and
liabilities, the disclosure of contingent assets and liabilities at the date of
the financial statements and the reported amounts of revenues and expenses
during the reporting period. Actual results could differ from those estimates.
Significant estimates embedded in the consolidated financial statements for the
periods presented concern the allowances for doubtful amounts receivable under
settlement agreements, the estimates used in the fair value of purchased
intangible assets, and the estimated useful lives of purchased intangible
assets.
|
(d) |
Cash
and Cash Equivalents: |
The
Company considers all highly-liquid investments purchased with an original
maturity of three months or less to be cash equivalents. The Company is subject
to credit risk related to its cash equivalents and marketable securities. From
time to time, the Company places its cash and cash equivalents in money market
funds and United States Treasury bills with a maturity of three months or
less.
Investment
holdings consist of United States Treasury bills that bear interest ranging from
1.625% to 2.33% and mature through October 31, 2005. The Company categorizes and
accounts for its investment holdings as “Investments held to maturity.”
Investments held to maturity are
recorded at their amortized cost. This categorization is based upon the
Company’s positive intent and ability to hold these securities to maturity.
Interest from such securities is reported in dividend, interest income and other
income.
Equipment
is stated at cost less accumulated depreciation. The Company records
depreciation using accelerated methods over an estimated useful life of five
years.
Intangible
assets consist of patents and patent rights obtained under licensing agreements
and are amortized on a straight-line basis over the estimated useful lives which
range from five to 15 years. Neurologix estimates amortization expenses related
to intangible assets owned as of December 31, 2004 to be approximately $26 per
year for the next five years.
Neurologix,
Inc. and subsidiary
(A
Development Stage Company)
Notes
to Consolidated Financial Statements
(In
thousands, except for share and per share amounts) -
(continued)
|
(h) |
Impairment
of Long-Lived Assets: |
The
Company periodically assesses the recoverability of the carrying amounts of
long-lived assets, including intangible assets. A loss is recognized when
expected undiscounted future cash flows are less than the carrying amount of the
asset. The impairment loss is the amount by which the carrying amount of the
asset exceeds its fair value.
The
Company complies with SFAS No. 109, “Accounting for Income Taxes,” which
requires an asset and liability approach to financial accounting and reporting
for income taxes. Deferred income tax assets and liabilities are computed for
temporary differences between the financial statement and tax bases of assets
and liabilities that will result in future taxable or deductible amounts, based
on enacted tax laws and rates applicable to the periods in which the differences
are expected to affect taxable income. Valuation allowances are established,
when necessary, to reduce deferred tax assets to the amount expected to be
realized.
|
(j) |
Stock-Based
Compensation: |
Statement
of Financial Accounting Standards No. 123, “Accounting for Stock-Based
Compensation” (“SFAS
123”),
provides for the use of a fair value based method of accounting for employee
stock compensation. However, SFAS 123 also allows an entity to continue to
measure compensation cost for stock options granted to employees using the
intrinsic value method of accounting prescribed by Accounting Principles Board
Opinion No. 25, “Accounting for Stock Issued to Employees” (“APB
25”), which
only requires charges to compensation expense for the excess, if any, of the
fair value of the underlying stock at the date a stock option is granted (or at
an appropriate subsequent measurement date) over the amount the employee must
pay to acquire the stock, if such amounts differ materially from the historical
amounts. The Company has elected to continue to account for employee stock
options using the intrinsic value method under APB 25. By making that election,
the Company is required by SFAS 123 and SFAS 148, “Accounting for Stock-Based
Compensation -- Transition and Disclosure” to provide pro forma disclosures of
net income (loss) and earnings (loss) per share as if a fair value based method
of accounting had been applied. The Company has used the Black-Scholes option
pricing model, as permitted by SFAS 123, to estimate the fair value of options
granted to employees for such pro forma disclosures, as follows:
|
|
Year
Ended
December
31, |
|
|
|
2004 |
|
2003 |
|
Net
loss - as reported |
|
$ |
(2,937 |
) |
$ |
(2,274 |
) |
Deduct
total stock-based employee compensation expense determined under fair
value-based method for all awards |
|
|
243 |
|
|
-
|
|
Net
loss - pro forma |
|
$ |
(3,180 |
) |
$ |
(2,274 |
) |
Basic/diluted
loss per share - as reported |
|
$ |
(0.14 |
) |
$ |
(0.34 |
) |
Basic/diluted
loss per share - pro forma |
|
$ |
(0.15 |
) |
$ |
(0.34 |
) |
Neurologix,
Inc. and subsidiary
(A
Development Stage Company)
Notes
to Consolidated Financial Statements
(In
thousands, except for share and per share amounts) -
(continued)
The
following are the weighted-average assumptions used with the Black-Scholes
pricing model:
|
2004 |
Expected
option term (years) |
5 |
Risk-free
interest rate (%) |
3.15%
- 3.79% |
Expected
volatility (%) |
115%
- 152% |
Dividend
yield (%) |
0% |
There
were no options granted during the year ended December 31, 2003.
In
accordance with SFAS 123, all other issuances of Common Stock, stock options or
other equity instruments issued to employees and non-employees as consideration
for goods or services received by the Company are accounted for based on the
fair value of the consideration received or the fair value of the equity
instrument, whichever is more readily measurable. Such fair value is measured at
an appropriate date pursuant to the guidance in EITF Issue No. 96-18 and
capitalized or expensed as appropriate.
As a
result of amendments to SFAS 123, the Company will be required to expense the
fair value of employee stock options over the vesting period in the first
interim or annual reporting period beginning after December 15, 2005.
|
(k) |
Basic
and Diluted Net Loss Per Common
Share |
Basic net
loss per common share excludes the effect of potentially dilutive securities and
is computed by dividing net income or loss available to Common Stockholders by
the weighted average number of common shares outstanding for the period. Diluted
net income or loss per share is adjusted for the effect of convertible
securities, warrants and other potentially dilutive financial instruments only
in the periods in which such effect would have been dilutive.
The
following securities were not included in the computation of diluted net loss
per share because to do so would have had an anti-dilutive effect for the
periods presented:
|
December
31, |
|
2004 |
2003 |
Stock
options |
2,613,458 |
1,288,888 |
Warrants |
828,000 |
1,034,250 |
Series
A Convertible Preferred Stock |
645 |
645 |
(3) |
Capital
lease obligations: |
During
2004 and 2003, the Company acquired equipment with capitalized costs of $65 and
$41, respectively, pursuant to capital lease obligations. Since such equipment
was acquired in non-cash transactions, they are not reflected in the
accompanying consolidated statements of cash flows for the years ended December
31, 2004 and 2003.
Future
minimum payments under capital leases in each of the years subsequent to
December 31, 2004
are as follows:
Neurologix,
Inc. and subsidiary
(A
Development Stage Company)
Notes
to Consolidated Financial Statements
(In
thousands, except for share and per share amounts) -
(continued)
Description |
|
Amount |
|
Year
ended December 31, 2005 |
|
$ |
24 |
|
Year
ended December 31, 2006 |
|
|
14 |
|
Total
minimum lease payments |
|
|
38 |
|
Less
amount representing interest |
|
|
4 |
|
|
|
|
|
|
Present
value of net minimum lease payments |
|
|
34 |
|
Less
current portion |
|
|
21 |
|
Long-term
portion |
|
$ |
13 |
|
(4) |
Related
Party Transactions: |
Since the
Merger, Refac, which is 90% owned by Palisade Concentrated Equity Partnership,
L.P., a private equity partnership managed by Palisade Capital Management, LLC
(“PCM”), has
provided consulting services to the Company at a basic monthly retainer of $5
subject to a quarterly adjustment to reflect the services rendered during such
quarter. Either party has the right to terminate this agreement at any time
without any prior notice. Under this arrangement, the Company paid $95 with
respect to services rendered during 2004.
Pursuant
to the Merger Agreement, the Company paid Palisade Capital Securities, LLC
(“PCS”), $200
for investment banking services rendered in connection with the Merger. PCS is
an affiliate of Palisade Private Partnership, LP, a private equity partnership
managed by PCM, which is the beneficial owner of approximately 27% of the
Company’s outstanding Common Stock.
Effective
with the closing of the Merger, the Company relocated its corporate offices to
One Bridge Plaza, Fort Lee, New Jersey 07024, where NRI had its headquarters
since its founding in 1999. The Company used these premises on a month-to-month
basis under a verbal agreement with PCS that did not require the payment of
rent. On August 10, 2004, the Company entered into a sublease with PCS for the
lease of space at One Bridge Plaza, Fort Lee, New Jersey through January 31,
2008 at a base annual rent of approximately $35. The rent that the Company pays
to PCS is the same rental amount that PCS pays under its master lease for this
space.
Additionally,
the Company
maintains brokerage accounts with PCS for the Company’s marketable securities
for which it pays customary brokerage fees.
In April
2001, the Company loaned two consultants an aggregate of $500. The full recourse
promissory notes, with initial principal amounts of $350 (the “$350
Note”) and
$150 (the “$150
Note”)
(collectively the “Notes”),
respectively, accrue interest at 7.25% per annum, with an increase to 12% per
annum for a late payment as provided for in the Notes. Payments are due in
various installments of principal plus accrued interest commencing on April 25,
2002 and continuing annually thereafter through April 25, 2006. In April 2002,
the Company received the first such installment under the $350 Note, totaling
$61. During the second quarter of 2003, the Company received installment
payments on the $350 Note totaling $36, which amount was less than the $86 due
in that period. As a result of the underpayment and management’s assessment of
the likelihood of future collection, the Company established a valuation
allowance for the remaining principal amount of the Notes totaling $473 as of
December 31, 2003.
Neurologix,
Inc. and subsidiary
(A
Development Stage Company)
Notes
to Consolidated Financial Statements
(In
thousands, except for share and per share amounts) -
(continued)
In June
2004, the Company entered into a settlement agreement with the maker of the $350
Note, which, as subsequently amended, provides for payments totaling $115
through December 2005. As of December 31, 2004 the Company received a total of
$50 under this settlement agreement. In December 2004, the Company entered into
a settlement agreement with the maker of the $150 Note, which provides for
payments totaling $38 through July 2009. As of December 31, 2004, the Company
received a total of $2 under this settlement agreement. Both settlement
agreements provide that in the event of a default which is not timely cured, the
Company may pursue all of its rights under each of the Notes giving credit to
any payments received pursuant to the settlement agreements. The Company has
included these recoveries in other income in 2004.
At
December 31, 2004, the Company has net operating loss carryforwards
(“NOLs”) of
approximately $9,103 which, if not used, expire through 2024. The deferred tax
asset for the Company’s NOLs approximated $3,636. The Company has a deferred tax
asset from research and development credits of approximately $426, which, if not
used, will also expire through 2024. Due to the significant doubt related to the
Company’s ability to utilize its deferred tax assets, a valuation allowance for
the full amount of the deferred tax assets of $4,062 has been established at
December 31, 2004. There are no other significant permanent or temporary
differences.
The
Company had also offset the potential benefits of $2,518, $1,400, and $880 from
NOLs by equivalent valuation allowances as of December 31, 2003, 2002, and 2001,
respectively. As a result of the increases in the valuation allowance of $1,457,
$1,118, and $4,062 during the years ended December 31, 2004, and 2003 and for
the period from February 12, 1999 (inception) to December 31, 2004,
respectively, there are no income tax benefits reflected in the accompanying
consolidated statements of operations to offset pre-tax losses.
The tax
effects of temporary differences that give rise to a significant portion of the
net deferred income tax assets are as follows:
|
|
December
31, |
|
|
|
2004 |
|
2003 |
|
Net
deferred income tax assets: |
|
|
|
|
|
|
|
Net
operating losses |
|
$ |
3,636 |
|
$ |
2,518 |
|
Research
& development credit |
|
|
426 |
|
|
87 |
|
Total
net deferred income tax assets |
|
|
4,062 |
|
|
2,605 |
|
Valuation
allowance |
|
|
4,062 |
|
|
2,605 |
|
Total
net deferred income tax assets |
|
|
- |
|
|
- |
|
Neurologix,
Inc. and subsidiary
(A
Development Stage Company)
Notes
to Consolidated Financial Statements
(In
thousands, except for share and per share amounts) -
(continued)
The
provision (benefit) for income taxes differed from the amounts computed by
applying the statutory federal income tax rate of 34% to pretax losses as a
result of the following:
|
|
2004 |
|
2003 |
|
|
|
$ |
|
% |
|
$ |
|
% |
|
Expected
tax benefit |
|
|
(999 |
) |
|
(34.00 |
%) |
|
(774 |
) |
|
(34.00 |
%) |
State
income taxes |
|
|
(176 |
) |
|
(6.00 |
%) |
|
(136 |
) |
|
(6.00 |
%) |
Non-deductible
expenses |
|
|
7 |
|
|
0.23 |
% |
|
20 |
|
|
0.88 |
% |
Prior
year under-accrual |
|
|
- |
|
|
- |
|
|
(228 |
) |
|
(10.00 |
%) |
Valuation
allowance |
|
|
1,168 |
|
|
39.77 |
% |
|
1,118 |
|
|
49.12 |
% |
Tax
Expense |
|
|
- |
|
|
0.00 |
% |
|
- |
|
|
0.00 |
% |
(7) |
Employment
Agreement with Dr. Michael Sorell |
Effective
September 21, 2004, the Board entered into an employment agreement with Michael
Sorell, M.D. to serve as the President and Chief Executive Officer of the
Company and NRI for an initial term of employment of 18 months, which will
automatically be extended for an additional 18 months absent notice to the
contrary from either party. Dr. Sorell receives an annual base salary of $150,
which is subject to automatic increase (to between $175 and $200) upon the
achievement of specified performance objectives of the Company. In addition to
cash compensation, Dr. Sorell’s employment agreement also provides for the grant
of options as described in Note 8.
During
2000, the Company approved a stock option plan (the “Plan”) which
provides for the granting of stock options and restricted stock to employees,
independent contractors, consultants, directors and other individuals. A maximum
of 800,000 shares of Common Stock were originally approved for issuance under
the Plan by the Board. The Board has amended, subject to stockholder approval,
the Plan to increase the number of shares available for issuance under the Plan
by 500,000 shares. Not including the 500,000 share increase approved by the
Board, as of December 31, 2004, there are 2,108 shares available for issuance
under the Plan.
Base
Stock Option Grant -
In
connection with Dr. Sorell’s employment, the Company entered into a Stock Option
Agreement with him pursuant to which it granted Dr. Sorell options to
purchase up to 1,150,000 shares of Common Stock at an exercise price of $0.75
per share. These options include a base grant and an incentive grant. The base
grant consists of an option to purchase 250,000 shares of Common Stock, which
vested with respect to 25,000 shares on the date of grant. The remaining 225,000
shares vest as follows: 100,000 shares on March 31, 2005, 100,000 shares on
December 31, 2005 and 25,000 shares on March 31, 2006.
Incentive
Stock Option Grant - The
incentive grant consists of an option to purchase up to 900,000 shares
of the Company’s Common Stock at an exercise price of $0.75 per share
(the “Incentive
Grant”).
This grant is subject to the Company’s ability to close one or more financings
and/or corporate partner contributions (in the form of up-front payments or
payments based on milestones which, in the judgment of the Board, are likely to
be realized within eighteen months following such agreement) with gross proceeds
totaling $5,000 (collectively referred to herein as the “Financing”) on or
before June 30, 2005 at a weighted average per share price of at least
$1.30. If the weighted average per share price is at least $1.30 per
share but less than $2.65 (without taking into account the value of warrants, if
any, included in the Financing), then, upon the final closing of the Financing,
one percent (1%) of the shares of Company Common Stock underlying the Incentive
Grant shall lapse for each $0.03 decrement of price below $2.65 per share.
Through March 4, 2005, the Company has raised gross proceeds before expenses of
approximately $3,166 at $1.30 per share.
Neurologix,
Inc. and subsidiary
(A
Development Stage Company)
Notes
to Consolidated Financial Statements
(In
thousands, except for share and per share amounts) -
(continued)
That
portion of the Incentive Grant that has not lapsed will vest on June 30, 2005
with one-third (⅓) becoming exercisable on that date and the balance ratably
over the subsequent twenty-four (24) month period. In the event that Dr. Sorell
ceases to be an officer and director of the Company, then the option shall
immediately terminate as to any shares that have not previously become
exercisable as of the date of such termination. The options have a maximum
ten-year term and are subject to accelerated vesting in the event that Dr.
Sorell’s employment is terminated by the Company without cause, due to his death
or disability or upon a change in control. If the Financing is not completed by
June 30, 2005, the entire Incentive Grant shall lapse. Of the total options
granted to Dr. Sorell, 273,892 were granted pursuant to the Plan in order to
qualify as incentive stock options and the remaining 876,108 options were not
granted under a shareholder-approved plan but are governed by terms identical to
the provisions of the Plan.
The
following table summarizes the
Company’s option activity for the years ended December 31, 2004 and
2003:
|
|
Number
of Shares |
|
Weighted
Average Exercise Price |
|
January
1, 2003 |
|
|
709,459 |
|
$ |
0.25 |
|
Granted |
|
|
-
|
|
|
- |
|
Exercised |
|
|
-
|
|
|
- |
|
Forfeited/Cancelled |
|
|
-
|
|
|
- |
|
January
1, 2004 |
|
|
709,459 |
|
$ |
0.25 |
|
Additional
options resulting from the reverse acquisition |
|
|
581,377 |
|
|
2.00 |
|
Granted |
|
|
1,370,000 |
* |
|
0.85 |
|
Exercised |
|
|
(10,000 |
) |
|
1.50 |
|
Forfeited/Cancelled |
|
|
(37,377 |
) |
|
7.65 |
|
December
31, 2004 |
|
|
2,613,459 |
|
$ |
0.83 |
|
|
* |
Includes
the Incentive Grant of an option to Dr. Sorell to purchase up to 900,000
shares that will vest should the Company achieve certain financing goals
as provided for under the terms of his
employment. |
Neurologix,
Inc. and subsidiary
(A
Development Stage Company)
Notes
to Consolidated Financial Statements
(In
thousands, except for share and per share amounts) -
(continued)
|
Options
Outstanding |
|
Options
Exercisable |
Exercise
Prices |
Outstanding
at
December
31, 2004 |
Weighted
Average
Contractual
Life Remaining |
Weighted
Average
Exercise
Price |
|
Number
Exercisable |
Weighted
Average
Exercise
Price |
|
|
|
|
|
|
|
$0.08 |
345,067 |
1.95
|
0.08 |
|
345,067 |
$0.08 |
0.09 |
295,378 |
1.95
|
0.09 |
|
295,378 |
0.09 |
0.75 |
1,630,000* |
7.41 |
0.75 |
|
480,000 |
0.75 |
1.00 |
60,000 |
4.59 |
1.00 |
|
20,000 |
1.00 |
1.38 |
28,000 |
6.85
|
1.38 |
|
28,000 |
1.38 |
1.50 |
120,000 |
9.23
|
1.50 |
|
33,333 |
1.50 |
1.55 |
30,000 |
4.33
|
1.55 |
|
10,000 |
1.55 |
1.56 |
69,014 |
2.54
|
1.56 |
|
69,014 |
1.56 |
12.50 |
36,000 |
5.59
|
12.50 |
|
36,000 |
12.50 |
Total |
2,613,459 |
|
$0.83 |
|
1,316,792 |
$0.83 |
|
* |
Includes
the Incentive Grant of an option to Dr. Sorell to purchase up to 900,000
shares that will vest should the Company achieve certain financing goals
as provided for under the terms of his employment.
|
(9) |
Pro
forma Financial Information: |
As
described in Note 1 above, the Merger was completed on February 10, 2004. The
following unaudited pro forma information summarizes the combined results of
Neurologix and NRI as if the Merger had occurred at the beginning of
2003:
|
|
Year
ended
December
31, |
|
|
|
2004 |
|
2003 |
|
Net
loss |
|
$ |
(3,256 |
) |
$ |
(4,602 |
) |
|
|
|
|
|
|
|
|
Basic
and diluted net loss per share |
|
$ |
(0.14 |
) |
$ |
(0.21 |
) |
|
|
|
|
|
|
|
|
Weighted
average common shares outstanding, basic and diluted |
|
|
22,518,297 |
|
|
22,445,547 |
|
(10) |
Accounts
Payable and Accrued Expenses |
Accounts
payable and accrued expenses consist of the following:
Neurologix,
Inc. and subsidiary
(A
Development Stage Company)
Notes
to Consolidated Financial Statements
(In
thousands, except for share and per share amounts) -
(continued)
|
|
December
31, |
|
|
|
2004 |
|
Accounts
payable |
|
$ |
43 |
|
Accounting
and auditing fees |
|
|
57 |
|
Consulting
fees |
|
|
91 |
|
Insurance
financing |
|
|
24 |
|
Other |
|
|
47 |
|
|
|
$ |
262 |
|
(11) |
Commitments
and Contingencies: |
License
Agreements:
In
September 1999 and April 2001, the Company entered into two license agreements
with Rockefeller University (“Rockefeller”)
whereby Rockefeller granted to the Company the sole and exclusive right and
license, under the ownership rights of the university, to certain patent rights
and technical information. Pursuant to the agreements, the Company paid the
university annual maintenance fees of $25 per agreement as well as benchmark
payments and royalties, as defined. The licenses shall continue for the lives of
the patents covered in the agreements. In December 2002, the license agreements
were modified under a new license agreement. In connection with the new
agreement, the Company issued shares to Rockefeller in exchange for the
cancellation of annual maintenance fees. The shares issued to Rockefeller were
converted into 368,761 shares of the Company’s Common Stock in connection with
the Merger. The Common Stock was valued at approximately $577 and was initially
charged to unearned compensation with an offsetting credit to additional paid-in
capital. The unearned compensation is being amortized to research and licensing
expense over four years, the estimated benefit period.
In 2002,
the Company entered into two license agreements with Thomas Jefferson University
(“TJU”)
whereby TJU granted to the Company the sole and exclusive right and license to
certain patent rights and technical information. In conjunction with the
agreements, the Company paid the university an initial fee of $100 and $50,
respectively for each agreement. In addition, the Company is committed to pay
annual maintenance fees of $75 and $20, respectively, as well as benchmark
payments and royalties, as defined. The maintenance fees can be applied to
royalty and benchmark fees incurred in the calendar year of payment only. The
licenses will continue for the lives of the patents covered in the agreements,
which expire through October 2021. The Company has the right to terminate the
agreements at any time upon 90 days written notice to the
university.
In August
2002, the Company entered into a license agreement with Rockefeller and Yale
University whereby the universities granted to the Company a nonexclusive
license to certain patent rights and technical information. An initial fee of
$20 was paid to each of the two universities pursuant to the agreement. In
addition, the Company is committed to pay an annual maintenance fee of $5 per
year to each university. Pursuant to the agreement, the Company must make
payments upon reaching certain milestones, as defined. The Company has the right
to terminate the agreement at any time upon 90 days written notice to the
universities.
Neurologix,
Inc. and subsidiary
(A
Development Stage Company)
Notes
to Consolidated Financial Statements
(In
thousands, except for share and per share amounts) -
(continued)
Research
Agreements:
In
December 2001, the Company entered into a research agreement with University
Health (University of Toronto). University Health granted to the Company the
sole and exclusive right and license to certain patent rights and technical
information for a period of three years. In conjunction with the agreement, the
Company paid University Health $50 per year in quarterly installments. The
Company did not renew the agreement with University Health and made the last
required payment in June 2004.
In June
2002, the Company entered into an Option and Research Support Agreement with
Rockefeller, which provide for two semi-annual payments of $50 each. The Company
terminated this agreement in May 2004.
On July
2, 2003, the Company entered into a Clinical Study Agreement (the “Clinical
Study Agreement”) with
Cornell University for its Medical College (“Cornell”) to
sponsor the Company’s Phase 1 clinical trial for the treatment of Parkinson’s
disease. Under this agreement, the Company pays Cornell $36 when a patient
commences treatment and $23 annually for the services of a nurse to assist in
the clinical study.
On
September 24, 2004, the parties amended the Clinical Study Agreement to provide
for research covering the development of gene therapy approaches to
neurodegenerative disorders, including Parkinson’s disease, Huntington’s
disease, Alzheimer’s disease and epilepsy (the “Scientific
Studies”). This
sponsored research is funded by the Company and is being conducted in Cornell’s
Laboratory of Molecular Neurosurgery under the direction of Dr. Michael G.
Kaplitt, one of the Company’s scientific co-founders. The term of this amendment
to the Clinical Study Agreement commenced on September 1, 2004 and extends
through August 31, 2007, with possible one year extensions by mutual written
agreement of both parties. The Company is required to pay Cornell $135 per year
for the duration of the Scientific Studies and Cornell has agreed that the
Company has a 60 day exclusive right and option to negotiate with it an
exclusive, worldwide right and license to make, have made, use and sell
commercial products embodying any inventions conceived or first reduced to
practice by in the course of this work.
Consulting
and Employment Agreements:
The
Company has consulting agreements with seven scientists who comprise the
Company’s Scientific Advisory Board (the “SAB”). These
agreements provide that the scientists are engaged by the Company to provide
advice and consulting services in scientific research on human gene therapy in
the brain and central nervous system and to assist the Company in seeking
financing and meeting with prospective investors.
Dr.
Michael G. Kaplitt and Dr. Matthew J. During, the two scientific co-founders of
the Company are members of the SAB and have consulting agreements with the
Company. At Dr. Kaplitt’s request, dated April 30, 2003, his compensation was
waived and it will continue to be waived through the end of the Phase I clinical
trial. Dr. During’s agreement, as amended, provides for payments of $175 per
annum through 2007.
In May
2003, NRI
entered into a stock purchase agreement to sell shares of its Common Stock at a
purchase price of $.01 per share to an individual. At the time of such
agreement, the fair value per share of Common Stock based on an estimate of the
fair market value of common equity in NRI on a minority interest basis, as of
April 28, 2003, was deemed to be $0.90 per share. The reduced purchase price was
provided to the individual as an inducement for the individual to serve as the
Chairman of the SAB. Accordingly, the fair value of the shares of approximately
$89, based on the difference between the purchase price of $0.01 per share and
the fair value per share of $0.90, is being recognized as an advisory board fee
over the service period of three years. In connection therewith, on July
1, 2003, the Company entered
into a consulting agreement with the individual to serve
as the Chairman of the SAB for a three-year term. Pursuant to the terms of the
agreement, the individual receives compensation of $25 annually, payable in
quarterly installments through June 30, 2006. The
shares issued to the Chairman of the SAB were converted into 276,054 shares of
the Company’s Common Stock in connection with the Merger.
Neurologix,
Inc. and subsidiary
(A
Development Stage Company)
Notes
to Consolidated Financial Statements
(In
thousands, except for share and per share
amounts)
The
agreements with the remaining four SAB members each provide for payments
aggregating $12 per annum for a duration of three years from the date of each
respective agreement, and are automatically renewed from year to year unless
terminated for cause or upon 30 days written notice to the other party prior to
an annual anniversary date. All of the consulting agreements with the SAB
members are subject to confidentiality, proprietary information and invention
agreements. Any discoveries and intellectual property obtained through these
agreements related to the research covered under the agreements are the property
of the Company.
See Note
7 for details on the Employment Agreement of Dr. Michael Sorell, who joined the
Company on September 21, 2004 as its President and Chief Executive
Officer.
Operating
Lease Agreements:
In August
2003, the Company entered into a lease agreement for laboratory facilities,
which expired on August 31, 2004 and provided for annual rent of $44. In August
2004, the Company renewed the lease agreement for an additional year at an
annual rent of $48. Rent expense under the leases aggregated $45 for the year
ended December 31, 2004.
In
August, 2004, the Company entered into a sublease with PCS for space at One
Bridge Plaza, Fort Lee, New Jersey at a base annual rent of $35 or $3 per month
through January 31, 2008. The Company is using this space as its corporate
offices. Rent expense under the lease was approximately $13 during the year
ended December 31, 2004. The rent that the Company pays to PCS is the same
rental amount that PCS pays under its master lease for this space.
From February
4 through March 3, 2005, pursuant to a Stock Purchase Agreement, as amended, the
Company sold and issued 2,435,452 shares of Common Stock to investors led by
Merlin Biomed Group (the “Purchasers”), for
an aggregate purchase price of $3,166, or $1.30 per share, resulting in net
proceeds after expenses of approximately $3,086 (the “Private
Placement”). The
Purchasers also received five-year warrants to purchase a total of 608,855
shares of Common Stock at an exercise price of $1.625 per share. The warrants
are callable beginning in August 2007 if the share price of the Company’s Common
Stock exceeds $3.25 per share for any ten consecutive trading day period
and certain other conditions are met. Proceeds will be used for general
corporate purposes, including clinical trials and research and development. The
purchase price represented a small premium to the market price at the time the
Company and Merlin Biomed Group commenced discussions regarding the transaction
in early December.
Item
8. Changes in and Disagreements with Accountants on Accounting and
Financial Disclosure
KPMG LLP
(“KPMG”) served
as the independent public accountants for the Company during the fiscal year
ended December 31, 2002. On February 20, 2004, following the Merger, the Audit
Committee engaged the accounting firm of J.H. Cohn LLP (“J.H.
Cohn”), the
Independent Regististered Public Accounting Firm for NRI prior to the
Merger, to replace KPMG. KPMG did not resign or decline to stand for
re-election, but was dismissed on February 23, 2004 as part of the change of
control to allow the appointment of J.H. Cohn as the Company’s Independent
Registered Public Accounting Firm upon recommendation of the Board following the
Merger.
KPMG’s
opinions regarding the financial statements of the Company for the two fiscal
years ended December 31, 2002 and 2001 did not contain an adverse opinion or
disclaimer of opinion and were not qualified or modified as to uncertainty,
audit scope or accounting principles; except that the audit report, dated March
27, 2003, of KPMG for the audit of the consolidated financial statements as of
December 31, 2001 and 2002 and for the two years ended December 31, 2002
contained two explanatory paragraphs. The first explanatory paragraph referred
to the Company’s change in its method of accounting for goodwill and other
intangible assets, in 2002, as discussed in Note 2 to the consolidated financial
statements for the year ended December 31, 2002. The second explanatory
paragraph referred to the uncertainty as to the Company’s ability to continue as
a going concern in light of a plan of liquidation and dissolution that it had
adopted. The Company’s plans with regard to these matters are also described in
Note 1 to the consolidated financial statements for the year ended December 31,
2002 The consolidated financial statements do not include any adjustments that
might arise from the outcome of this uncertainty.
The
Company is not aware of any disagreements with KPMG during the two fiscal years
ended December 31, 2002 and 2001 and the subsequent interim period up to the
date of dismissal on any matter of accounting principles or practices, financial
statement disclosure or auditing scope or procedure which disagreements if not
resolved to their satisfaction would have caused KPMG to make reference in
connection with their opinion to the subject matter of the disagreement.
On
February 20, 2004, the Company engaged J.H. Cohn LLP as its Independent
Registered Public Accounting Firm to perform the Company’s audit for 2003. In
accordance with Item 304 (a) (3) of regulation S-B and in connection with the
Company’s filing of its Current Report on Form 8-K, dated February 27, 2004,
KPMG was provided with a copy of this disclosure.
Item
8A. Controls and Procedures
(a)
Disclosure Controls and Procedures. The Company’s Chief Executive Officer and
Secretary and Treasurer (as the Company’s principal financial officer) have
evaluated the effectiveness of the Company’s disclosure controls and procedures
(as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Securities
Exchange Act of 1934, as amended (the “Exchange
Act”)) as of
the end of the period covered by this report. Based on such evaluation, the
Company’s Chief Executive Officer and Secretary and Treasurer have concluded
that, as of the end of such period, the Company’s disclosure controls and
procedures are effective.
(b)
Internal Control Over Financial Reporting. There have not been any changes in
the Company’s internal control over financial reporting (as such term is defined
in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the fourth
quarter to which this report relates that have materially affected, or are
reasonably likely to materially affect, the Company’s internal control over
financial reporting.
Item
8B. Other Information
None
PART
III
Item
9. Directors, Executive Officers, Promoters and Control Persons;
Compliance with Section 16(a) of the Exchange Act
Under the
by-laws of the Company, the Board is divided into three classes: Class 1
directors, Class 2 directors and Class 3 directors. The members of one of the
three classes of directors are elected each year for a three-year term or until
their successors have been elected and qualified, or until the earliest of their
death, resignation or retirement. The Board is currently comprised of seven
directors.
There are
no family relationships between any of the directors or executive officers of
the Registrant nor were there any special arrangements or understandings
regarding the selection of any director or executive officer.
Executive
Officers
The
executive officers of the Company are as follows:
Name |
Age |
Served
in Such Position or
Office
Continually Since |
Present
Position with the Company (1) |
Martin
J. Kaplitt, M.D. |
66 |
2004 |
Executive
Chairman of the Board (2) |
Michael
Sorell, M.D. |
57 |
2004 |
President,
Chief Executive Officer and Director (3) |
Mark
S. Hoffman |
44 |
2004 |
Secretary,
Treasurer and Director (4) |
___________
NOTES:
(1) |
Each
executive officer’s term of office is until the next organizational
meeting of the Board (traditionally held immediately after the Annual
Meeting of Stockholders of the Company) and until the election and
qualification of his or her successor. However, the Board has the
discretion to replace officers at any time. Dr. Sorell is a Class I
Director with a term expiring at the 2007 Annual Meeting of Stockholders.
Mr. Hoffman and Dr. Kaplitt are Class II Directors with terms expiring at
the 2005 Annual Meeting of Stockholders. |
(2) |
Dr.
Martin Kaplitt became the Chairman of the Board and President of the
Company on February 10, 2004 as a result of the Merger and has been a
director and president of NRI since August 1999. On September 21, 2004, he
relinquished the position of President of both the Company and NRI when
the Company hired Michael Sorell, M.D. as its Chief Executive Officer and
President. Dr. Kaplitt has been associated with North Shore University
Hospital for over 30 years and has held a variety of positions there,
including: Chief of Thoracic and Cardiovascular Surgery from 1971 to 1978,
Associate Attending in Cardiovascular Surgery from 1978 to 2001 and
Adjunct Associate Attending in Surgery from 2001 to present. He was also a
clinical associate professor of surgery at Cornell University Medical
College. Dr. Kaplitt attended Cornell University and the State University
of New York, Downstate Medical Center. Dr. Kaplitt is a fellow of the
American College of Surgeons and the American College of
Cardiology. |
(3) |
Dr.
Sorell
became the President, Chief Executive Officer and a director of the
Company on September 21, 2004. Dr. Sorell has been managing member of MS
Capital Advisors LLC, an investment banking and advisory firm based in
Washington, CT since 1996. From 1986 to 1992 and from 1994 to 1996, Dr.
Sorell was with Morgan Stanley & Co. in various capacities including
biotechnology and pharmaceuticals analyst and lastly as emerging growth
strategist and executive director. From 1992 to 1994, Dr. Sorell was a
partner in a joint venture with Essex Investment Management, a
Boston-based investment management firm. Previously, Dr. Sorell was a
director of clinical research at Schering-Plough Corporation. As a
physician, Dr. Sorell specialized in pediatric oncology, and was a member
of the attending staff at Memorial Sloan-Kettering Cancer Center in New
York City where he was among the founders of its Bone Marrow Transplant
Unit. Dr. Sorell received his medical degree from the Albert Einstein
College of Medicine, Bronx, NY, and studied at the Visiting Professionals
Program at the New York University Graduate School of Business with a
major in finance. He is also a director of SCOLR, Inc. and Applied
Neurosolutions, Inc. |
(4) |
Mr.
Hoffman became a director of the Company and its Secretary and Treasurer
on February 10, 2004 as a result of the Merger. He has been a director,
the secretary and the treasurer of the Company’s wholly-owned subsidiary,
Neurologix Research, Inc., since November 1999. He is a Managing Director
of Palisade Capital Management, LLC (“PCM”),
an affiliate of Palisade Private Partnership, LP (“PPP”),
which he joined upon its formation in 1995. PCM is a registered investment
adviser based in Fort Lee, New Jersey specializing in small capitalization
equities and convertible securities as well as private equity and acts as
investment manager to PPP and to two other private equity partnerships. In
addition to the Company, he is currently a director of OptiCare Health
Systems, Inc. and Refac, both of which are controlled by
PCM. |
The
additional information required by this item will be included in the Company’s
definitive Proxy Statement in connection with the 2005 Annual Meeting of
Stockholders and is hereby incorporated herein by reference.
Item
10. Executive Compensation
The
information required by this item will be included in the Company’s definitive
Proxy Statement in connection with the 2005 Annual Meeting of Stockholders and
is hereby incorporated herein by reference.
Item
11. Security Ownership of Certain Beneficial Owners and Management
and Related Stockholders Matters
The
information required by this item will be included in the Company’s definitive
Proxy Statement in connection with the 2005 Annual Meeting of Stockholders and
is hereby incorporated herein by reference.
Item
12. Certain Relationships and Related
Transactions
The
information required by this item will be included in the Company’s definitive
Proxy Statement in connection with the 2005 Annual Meeting of Stockholders and
is hereby incorporated herein by reference.
Item
13. Exhibits
See the
Exhibit Index attached hereto for a list of the exhibits filed or incorporated
by reference as a part of this report.
Item
14. Principal Accountant Fees and Services
The
information required by this item will be included in the Company’s definitive
Proxy Statement in connection with the 2005 Annual Meeting of Stockholders and
is hereby incorporated herein by reference.
Signatures
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of
1934, the Registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
|
Neurologix,
Inc. |
|
|
|
|
Dated:
March 30, 2005 |
By:
/s/
Michael Sorell |
|
Michael
Sorell, President and CEO |
Pursuant
to the requirements of the Securities Exchange Act of 1934, this report has been
signed below by the following persons on behalf of the Company and in the
capacities and on the dates indicated.
Dated:
March 30, 2005 |
/s/
Michael Sorell |
|
Michael
Sorell, President and CEO |
|
(Principal
Executive Officer) |
|
|
Dated:
March 30, 2005 |
/s/
Mark S. Hoffman |
|
Mark
S. Hoffman, Secretary, Treasurer and Director |
|
(Principal
Financial Officer) |
|
|
Dated:
March 30, 2005 |
/s/
Martin J. Kaplitt |
|
Martin
J. Kaplitt, Executive Chairman |
|
|
Dated:
March 30, 2005 |
/s/
Clark A. Johnson |
|
Clark
A. Johnson, Director |
|
|
Dated:
March 30, 2005 |
/s/
Craig J. Nickels |
|
Craig
J. Nickels, Director |
|
|
Dated:
March 30, 2005 |
/s/
Austin M. Long, III |
|
Austin
M. Long, III, Director |
|
|
Dated:
March 30, 2005 |
/s/
Jeffrey B. Reich |
|
Jeffrey
B. Reich, Director |
EXHIBIT
INDEX
3.1 |
Certificate
of Incorporation of Change Technology Partners, Inc. (filed as an exhibit
to the Registrant’s Quarterly Report on Form 10-Q for the fiscal quarter
ended September 30, 2000 and incorporated herein by
reference). |
3.2 |
By-laws
of the Registrant (filed as an exhibit to the Registrant’s Quarterly
Report on Form 10-Q for the fiscal quarter ended September 30, 2000 and
incorporated herein by reference). |
3.3 |
Certificate
of Amendment of the Certificate of Incorporation of Neurologix, Inc.
(formerly Change Technology Partners, Inc.), dated February 10, 2004
(filed as an exhibit to the Registrant’s Annual Report on Form 10-K dated
April 9, 2004 and incorporated herein by
reference). |
3.4 |
Amended
and Restated By-laws of Neurologix, Inc. (filed as an exhibit to the
Registrant’s Annual Report on Form 10-K dated April 9, 2004 and
incorporated herein by reference). |
3.5 |
Restated
Certificate of Incorporation of Neurologix, Inc. (filed as an exhibit to
the Registrant’s Report on Form 8-K, dated September 13, 2004 and
incorporated herein by reference). |
4.2 |
Registration
Rights Agreement by and among Arinco Computer Systems Inc., Pangea
Internet Advisors LLC and the persons party to the Securities Purchase
Agreement, dated as of March 28, 2000 (filed as an exhibit to the
Registrant’s Report on Form 8-K dated March 28, 2000 and incorporated
herein by reference). |
10.1 |
Warrants
for William Avery, Cary S. Fitchey, The Roberts Family Revocable Trust
U/D/T dated as of December 15, 1997, David M. Roberts and Gail M. Simpson,
Trustees, Roberts Children Irrevocable Trust U/D/T dated October 21, 1996,
Stephen H. Roberts, Trustee and Turtle Holdings LLC (filed as an exhibit
to the Registrant’s Report on Form 8-K dated March 28, 2000 and
incorporated herein by reference). |
10.2 |
Consulting
Agreement as of October 1, 1999 by and between Dr. Matthew During and
Neurologix Research, Inc. (filed as an exhibit to the Registrant’s Report
on Form 10-K, dated April 9, 2004 and incorporated herein by
reference). |
10.3 |
Consulting
Agreement as of October 1, 1999 by and between Dr. Michael Kaplitt and
Neurologix Research, Inc. (filed as an exhibit to the Registrant’s Report
on Form 10-K, dated April 9, 2004 and incorporated herein by
reference). |
10.4 |
Exclusive
License Agreement between Thomas Jefferson University and Neurologix,
Research Inc., effective as of June 1, 2002. (filed as an exhibit to the
Registrant’s Report on Form 10-K, dated April 9, 2004 and incorporated
herein by reference). |
10.5 |
Exclusive
License Agreement between Thomas Jefferson University and Neurologix
Research, Inc., effective as of August 1, 2002. (filed as an exhibit to
the Registrant’s Report on Form 10-K, dated April 9, 2004 and incorporated
herein by reference). |
10.6 |
Non-Exclusive
License Agreement by and between Yale University, The Rockefeller
University and Neurologix Research, Inc., dated as of August 28, 2002.
(filed as an exhibit to the Registrant’s Report on Form 10-K, dated April
9, 2004 and incorporated herein by
reference). |
10.7 |
License
Agreement made as of November 1, 2002 by and between The Rockefeller
University and Neurologix Research, Inc. (filed as an exhibit to the
Regisrant’s Report on Form 10-K, dated April 9, 2004 and incorporated
herein by reference). |
10.8 |
Clinical
Study Agreement between Cornell University and Neurologix Research, Inc.
entered into as of July 2, 2003. (filed as an exhibit to the Registrant’s
Report on Form 10-K, dated April 9, 2004 and incorporated herein by
reference). |
10.9 |
Clinical
Study Agreement, dated as of July, 2003 between North Shore University
Hospital and Neurologix Research, Inc. (filed as an exhibit to the
Registrant’s Report on Form 10-K, dated April 9, 2004 and incorporated
herein by reference). |
10.10 |
Amendment,
dated October 8, 2003 to Consulting Agreement, dated October 1, 1999,
between Dr. Matthew During and Neurologix Research, Inc. (filed as an
exhibit to the Registrant’s Report on Form 10-K, dated April 9, 2004 and
incorporated herein by reference). |
10.11 |
Amendment,
dated October 8, 2003, to Consulting Agreement, dated October 1, 1999,
between Dr. Michael Kaplitt and Neurologix Research, Inc. (filed as an
exhibit to the Registrant’s Report on Form 10-K, dated April 9, 2004 and
incorporated herein by reference). |
10.12 |
Amendment
No. 1 to Clinical Study Agreement, between Cornell University and
Neurologix Research, Inc., dated September 24, 2004 (filed as an exhibit
to the Registrant’s Report on Form 8-K, dated September 30, 2004 and
incorporated herein by reference). |
10.13 |
Stock
Purchase Agreement, dated as of February 4, 2005, by and among Neurologix,
Inc, Merlin Biomed Long Term Appreciation Fund LP and Merlin Biomed
Offshore Master Fund LP. (filed as an exhibit to the Registrant’s Report
on Form 8-K, dated February 10, 2005 and incorporated herein by
reference). |
10.14 |
Registration
Rights Agreement, dated as of February 4, 2005, by and among Neurologix,
Inc, Merlin Biomed Long Term Appreciation Fund LP and Merlin Biomed
Offshore Master Fund LP. (filed as an exhibit to the Registrant’s Report
on Form 8-K, dated February 10, 2005 and incorporated herein by
reference). |
10.15 |
Amendment
No. 1 to the Stock Purchase Agreement, dated as of February 9, 2005, by
and between Neurologix, Inc. and Copper Spire Fund Portfolio. (filed as an
exhibit to the Registrant’s Report on Form 8-K, dated February 10, 2005
and incorporated herein by reference). |
10.14 |
Form
of Amendment to the Stock Purchase Agreement dated as of February 4, 2005,
by and among Neurologix, Inc, Merlin Biomed Long Term Appreciation Fund LP
and Merlin Biomed Offshore Master Fund LP. (filed as an exhibit to the
Registrant’s Report on Form 8-K, dated February 25, 2005 and incorporated
herein by reference). |
10.15 |
Employment
Agreement, dated as of September 21, 2004, between Michael Sorell, M.D.
and Neurologix, Inc. (filed as an exhibit to the Registrant’s Report on
Form 8-K, dated March 18, 2005 and incorporated herein by
reference). |
16.1 |
Letter
regarding change in certifying accountant (filed as an exhibit to the
Registrant’s Report on Form 8-K dated February 27, 2004 and incorporated
herein by reference). |
22.1 |
Definitive
Information Statement on Schedule 14C filed by the Company with the
Securities and Exchange Commission on August 9, 2004, which is
incorporated herein by reference. |
31.1 |
Rule
13a-15(e)/15d-15(e) Certification of Principal Executive Officer.
** |
31.2 |
Rule
13a-15(e)/15d-15(e) Certification of Principal Financial Officer.
** |
32.1 |
Section
1350 Certification, Chief Executive Officer and secretary and treasurer
(as chief financial officer). ** |
__________
** Filed
herewith