Neurologix, Inc.
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-KSB
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the Fiscal Year Ended December 31, 2006
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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 |
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) |
(201) 592-6451
(Issuers telephone number, including area code)
N/A
(Former name, former address and former fiscal year,
if changed since last report)
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 is not required to file reports pursuant to Section 13 or 15(d) of
the Exchange Act. o
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 þ 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
Registrants 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
Indicate by checkmark whether the registrant is a shell company (as defined by Rule 126-2 of
the Exchange Act).
Yes o No þ
The Registrant had no revenues during the year ended December 31, 2006.
The aggregate market value of the Registrants voting and non-voting common equity held by
non-affiliates as of March 28, 2007 was approximately $18,580,047.
State the number of shares outstanding of each of the issuers classes of common equity, as of
the latest practicable date: As of March 28, 2007, there were
outstanding 26,542,924 shares of the
Registrants common stock, par value $0.001 per share.
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 registrants Proxy Statement for its 2007 Annual Meeting of
Stockholders.
Transitional Small Business Disclosure Format: Yes o No þ
TABLE OF CONTENTS
PART I
Item 1. Description of Business
INTRODUCTION
Neurologix, Inc. (the Company) is engaged in the research and development of
proprietary treatments for disorders of the brain and central nervous system, primarily utilizing
gene therapies. The Companys initial development efforts are focused on gene therapy for treating
Parkinsons disease and epilepsy. The Companys core technology, which it refers to as
NLX, is in the clinical development stages, having recently been tested in a Phase I
human clinical trial to treat Parkinsons disease. Recent highlights include:
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For the 12 months ended December 31, 2006, the Company reported a net loss of
approximately $7.0 million versus a net loss of $5.3 million for the 12 months
ended December 31, 2005. The increase in the net loss over fiscal year 2005 was
primarily due to increased expenditures for research and development and
administrative personnel. Management believes that the Companys current resources
will enable it to continue as a going concern through at least December 31, 2007.
The Companys existing resources, however, are not sufficient to enable it to
obtain the regulatory approvals necessary to commercialize its current or future
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. (See Risk Factors the Company Does Not Have
Sufficient Funds to Continue its Operations in the Long Run or to Commercialize its
Product Candidates below). |
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In October 2006, the Company announced that it had completed its Phase I
clinical trial of gene therapy for Parkinsons disease and presented its results
for the 12 treated subjects at the Annual Meeting of the Society of Neuroscience in
Atlanta. The results indicated that the treatment appears to be safe and
well-tolerated in patients with advanced Parkinsons disease, with no evidence of
adverse effects or immunologic reaction related to the study treatment. The trial
also yielded statistically significant clinical efficacy and neuro-imaging results.
(See Business of the Company-Parkinsons Disease below). |
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In September 2006 the Audit Committee of the Board of Directors of the Company
engaged BDO Seidman, LLP as the Companys independent registered public accounting
firm to replace J.H. Cohn LLP, the Companys former independent registered public
accounting firm. |
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In August 2006, the Company entered into a Sublicense Agreement with Diamyd
Therapeutics AB. Pursuant to the Sublicense Agreement, Diamyd granted to the
Company a non-exclusive worldwide license to certain patent rights and technical
information for the use of a gene version of glutamic acid decarboxylase (GAD) 65
in connection with its gene therapy treatment for Parkinsons disease. The Company
paid Diamyd an initial fee of $500,000 and will pay annual license maintenance
fees, certain milestone payments and royalty payments to Diamyd as provided for in
the Sublicense Agreement. (See Business of the Company-Patents and Other
Proprietary Rights below). |
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The Company strengthened and expanded its management in 2006. In January 2006,
Marc L. Panoff was appointed as the Chief Financial Officer and Treasurer of the
Company. In July 2006, Dr. Michael Sorell resigned as the President and Chief
Executive Officer and John E. Mordock, a director of the Company, was appointed as
the President and Chief Executive Officer. Also in July 2006, Dr. Christine V.
Sapan was appointed as Executive Vice President, Chief Development Officer of the
Company. |
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In May 2006, the Company issued and sold 342,857 shares of a newly created
series of preferred stock, par value $.10 per share (Series C Preferred
Stock), at a price of $35.00 per share, or a total price of approximately $12
million, to investors led by General Electric Pension Trust and DaimlerChrysler
Corporation Master Retirement Trust in a private placement transaction. Each share
of Series C Preferred Stock, including all dividends paid to date, is convertible
into 19.66 shares of Common Stock per share. The Series C Preferred Stock accrues
cumulative dividends at a rate of 9% per annum, payable in quarterly installments
in shares of Series C Preferred Stock. The transaction also involved the issuance
of warrants to purchase approximately 2.2 million shares of Common Stock at an
exercise price of $2.05 per share. |
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Effective May 2006, the Company entered into a Sponsored Research Agreement with
The Ohio State University Research Foundation (OSURF) which provides for
research covering the development of gene therapy approaches to neurodegenerative
disorders, including Parkinsons disease, epilepsy, Huntingtons disease,
Alzheimers disease as well as gene therapy approaches to pain, stroke,
neurovascular diseases and other research. The sponsored research is funded by the
Company and is conducted under the direction of Dr. Matthew During, one of the
Companys co-founders and a member of its Scientific Advisory Board
(SAB). The initial term of the agreement is 18 months, and may be
mutually extended for an additional 18-month period. |
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In April 2006, in connection with the Sponsored Research Agreement with OSURF,
the Company entered into a Facility Use Agreement as well as Visiting Scientist
Agreements with The Ohio State University (OSU), all of which allow three
of the Companys scientists to access and use OSUs laboratory facilities and
certain equipment to perform their research. The term of the Facility Use
Agreement is four years, subject to earlier termination under certain
circumstances. |
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HISTORY
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 referred to herein as 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, 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 Companys 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 Companys 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 Interactives 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 a wholly-owned
subsidiary with Neurologix Research, Inc. (formerly known as Neurologix, Inc. and sometimes
referred to herein as NRI). Following 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 Common Stock outstanding after
the Merger.
Effective December 31, 2005, the Company completed a short-form merger whereby its operating
subsidiary, NRI, was merged with and into the Company. Following the merger, NRI no longer exists
as a separate corporation. As the surviving corporation in the merger, the Company assumed all
rights and obligations of NRI. The short-form merger was completed for administrative purposes and
did not have any material impact on the Company or its operations or financial statements.
BUSINESS OF THE COMPANY
The Company is a development stage company 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.
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The Companys 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 Parkinsons disease and epilepsy) to the
current Phase I human clinical trial for the treatment of Parkinsons disease. They both remain as
consultants to the Company and serve on its SAB.
From 1999 to 2002, the Company conducted its gene therapy research through sponsorship
agreements with Thomas Jefferson University, the Rockefeller University (Rockefeller) and
the University of Auckland. From October 2002 to April 2006, the Company staffed its own
laboratory facilities at Columbia Universitys Audubon Biomedical Science and Technology Park
(Columbia) in New York City to manufacture the gene therapy products required for its
pre-clinical trials and to continue the research and development of additional gene therapy
products.
Currently, the Company conducts its gene therapy research through research agreements with
Cornell University for its Medical College (Cornell) in a laboratory directed by Dr.
Michael Kaplitt and one of the companys scientists; and OSURF in a laboratory directed by Dr.
During and three of the Companys scientists.
Business Strategy
The Companys objective is to develop and commercialize long-term, cost-effective treatments
for disorders of the brain and central nervous system. Key elements of the Companys strategy are:
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Focus resources on development of the Companys 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 Parkinsons
disease and epilepsy. |
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Focus on central nervous system disorders that are likely to be candidates for
gene therapy. 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 and
has a physiologic role; |
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neurosurgical approaches are already established and standard; |
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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; and |
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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, product development
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 the
Company for the manufacture of gene therapy products and for clinical trials
involving these products. The Company may enter into joint ventures or strategic
alliances with one or more pharmaceutical companies to develop or manufacture its
products. The Company believes that such companies have extensive resources and
knowledge to enable the Company to develop and commercialize its products. |
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Funding Operations. The Company must continue to seek additional funds through
public or private equity offerings, debt financings or corporate collaborations and
licensing arrangements, including joint ventures and strategic alliances. (See
Risk Factors-The Company Does not Have Sufficient Funds to Continue its Operations
in the Long Run or to Commercialize its Product Candidates, Managements
Discussion and Analysis or Plan of Operation-Plan of Operation and Managements
Discussion and Analysis or Plan of Operation-Liquidity and Capital Resources
below). |
The Companys initial focus is to develop therapeutic products to meet (i) the needs of
patients suffering from Parkinsons disease and (ii) the needs of patients suffering from a type of
epilepsy known as temporal lobe epilepsy or TLE.
Technology Overview
Deoxyribonucleic acid (DNA) is organized into segments called genes, with each gene
representing the region of DNA that determines the structure of a protein, as well as the timing
and location of such proteins production. 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 cells 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 into a cell and thus provide new or augmented functions to that cell.
There are several different ways of delivering genes into 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 utilize exclusively the AAV
vector. In 1994, Drs. Michael Kaplitt and Matthew During demonstrated that AAV could be a
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safe and effective vehicle for gene therapy in the brain. Since that time, the AAV vector has
been used safely in a variety of clinical gene therapy trials.
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 Companys 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 parts
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. |
Parkinsons Disease
General. Parkinsons disease is a neurodegenerative disorder; it arises from the
gradual death of nerve cells. Parkinsons disease is a progressive and debilitating disease that
affects the control of movement and is characterized by four principal symptoms:
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tremor of the limbs, |
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rigidity of the limbs, |
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bradykinesia of the limbs and body evidenced by difficulty and slowness of
movement, and |
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postural instability. |
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
neurotransmitter, 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
Parkinsons 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 Parkinsons disease, as the disease becomes more and more debilitating, it becomes
necessary to accept a riskier and potentially more invasive medical procedure to treat
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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 Parkinsons disease.
The Companys technology inserts a GAD gene into the AAV-based viral vector, and the packaged
vector is introduced directly into an area of the brain known as the subthalamic nucleus (STN).
The GAD gene is responsible for making gamma aminobutyric acid (GABA), which is released by nerve
cells to inhibit or dampen activity. The loss of dopamine leads to a change in the activity of
several brain structures which control movement. Central to this is the STN, which is overactive
and does not receive adequate GABA, as well as targets of the STN, which are also hyperactive and
also do not receive enough GABA. The goal of this therapy is to deliver GABA to the STN in order
to re-establish the normal neurochemical balance and activity among these key structures.
The Companys gene therapy is therefore designed to reset the overactive brain cells to
inhibit electrical activity and return brain network activity to more normal levels. This in turn
reduces symptoms of Parkinsons, including tremors, rigidity and slowness of movement. The therapy
is designed to be administered without destroying brain tissue and without implanting a permanent
medical device.
According to the National Parkinson Foundation, there are approximately 1.5 million
Parkinsons patients in America, with approximately 60,000 new cases diagnosed each year. While
the peak onset of Parkinsons disease is age 60 years, Parkinsons disease is not just a disease of
middle or old age: 15% of Parkinsons disease patients are 50 years or less and 10% are 40 years or
less.
Product Development and Operations. In 2006, the Company completed its Phase I human
clinical trial to treat Parkinsons disease for its core gene therapy technology, which it refers
to as NLX. A Phase I clinical trial is primarily designed to test the safety, as opposed to
efficacy, of a proposed treatment. The clinical trial was conducted by Dr. Michael Kaplitt and Dr.
During. As part of this clinical trial, twelve patients with Parkinsons disease underwent
surgical gene therapy at The New York Presbyterian Hospital/Weill Medical College of Cornell
University. All patients were evaluated both pre- and post-operatively with PET scans and with
graded neurological evaluations by Drs. Andrew Feigin and David Eidelberg of the North Shore
University Hospital. The Phase I trial was an open-label dose-escalation study with four patients
in each of three escalating dose cohorts. The third cohort of four patients received 10 times the
dose of the first cohort. The 12 patients who participated in the trial were diagnosed with severe
Parkinsons disease of at least five years duration and were no longer adequately responding to
current medical therapies.
The surgery entailed a stereotactic neurosurgical procedure performed under local anesthesia.
First, magnetic resonance imaging (MRI) was used to image the target STN region of the brain. The
STN was mapped by using microelectrodes to record the firing of single neurons as the electrode
slowly moved toward the STN. Once a signature firing pattern was obtained confirming that the
electrode was in the STN, the fine-wire electrode was removed, leaving only the microelectrode
sheath through which a hair-thin (165 microns) hollow tube was
inserted. Thirty five microliters
containing 3.5 billion particles of the AAV vector (and a correspondingly higher dose in subsequent
cohorts) containing GAD genes (cDNA), was then
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infused at 0.5 microliters/minute, together with 15 microliters of 25% mannitol. After the
100-minute infusion period, the delivery catheter was withdrawn and the incision was closed.
The first of the 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 Parkinsons disease. The gene
transfer surgeries were completed on all 12 patients by May 2005.
In October 2006, the Company announced that it had completed its Phase I clinical trial of
gene therapy for Parkinsons disease and presented its results for the 12 treated subjects at the
Annual Meeting of the Society of Neuroscience in Atlanta. The results indicated that the treatment
appears to be safe and well-tolerated in patients with advanced Parkinsons disease, with no
evidence of adverse effects or immunologic reaction related to the study treatment. The trial also
yielded statistically significant clinical efficacy and neuro-imaging results.
The Company plans to commence a Phase II clinical trial for Parkinsons in the second half of
2007. This trial will be a randomized, controlled study designed, among other things, to further
establish the effectiveness and the safety of the treatment. The trial will be conducted in
multiple medical centers and the treatment will be infused bi-laterally in trial subjects.
Commencement of such trial is subject, among other things, to concurrence by the Food and Drug
Administration (FDA), the Companys ability to manufacture product on a timely basis, the
availability of funding and the availability of the catheter gene delivery system being developed
by Medtronic International, Ltd. (Medtronic). (See Risk Factors-The Company Cannot
Ensure that it will be Able to Pursue Further Trials for its Product Candidates or the Timing of
any future Trials and Risk Factors-The Company is Subject to Stringent Regulation; FDA Approvals
below).
The Company, under its manufacturing and development agreement with Medtronic, is
co-developing a new catheter system with Medtronic to infuse the Companys gene therapy product
into the brain with respect to the treatment of Parkinsons disease. (See Manufacturing below).
The Company expects to have a workable system to use in its planned Phase II clinical study in the
second half of 2007. The use of such a catheter could facilitate the use of the Companys gene
therapy treatment by neurosurgeons and simplify the procedures for infusing the gene product into
the brain. Before the Company can market its products, Medtronic must obtain FDA approval of such
catheter. (See Risk Factors below).
Epilepsy
General. 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 controlled by that area of the brain. 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 Companys 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.
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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 180,000 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.
Product Development and Operations. The Companys development efforts have more
recently begun to also focus on epilepsy, which affects millions of patients in the United States
alone. 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 Companys approach is based on the use of the non-pathogenic AAV vector, delivered using
standard neurosurgical techniques. The study was completed in November 2005 and indicated no
untoward toxicity for primates. Other studies have demonstrated that Neuropeptide Y (rAAV-NPY), a
36-amino acid peptide which acts to dampen excessive excitatory activity and prevents seizures in
multiple models, had efficacy in preventing the development of spontaneous seizures that occur
after a prolonged episode of status epilepticus.
Clinical Trials. In December 2006, the Company submitted an Investigational New Drug
application to the FDA for permission to begin a Phase I clinical trial in temporal lobe epilepsy.
The proposed clinical protocol for this study was presented to the NIH Recombinant DNA Advisory
Committee on September 23, 2004 and reviewed favorably. Commencement of a Phase I trial is
subject, among other things, to concurrence by the FDA, the Companys ability to manufacture
product on a timely basis and the resolution of issues regarding technology transfer and
procurement of related intellectual property licenses. (See Risk Factors-The Companys Cannot
Ensure that it Can Pursue Subsequent Trials for its Product Candidates or the Timing of any such
Trials below).
Other Neurodegenerative and Metabolic Disorders
The Company has also undertaken efforts to develop gene therapy for the treatment of other
neurodegenerative and metabolic disorders, including Huntingtons disease. In November 2005, the
Company presented findings from preclinical studies which showed that the gene XIAP (X-linked
inhibitor of apoptosis) may prevent the progression of Huntingtons disease. Using cell culture
models of the disease, the Company showed that a truncated form of XIAP lacking the RING domain
(called dXIAP) may significantly reduce cell death caused by a mutated form of human Huntington
gene.
The Company further investigated the neuroprotective effects of dXIAP in a transgenic animal
model (HD mice) by injecting HD mice with AAV vectors encoding dXIAP into the striatum, an area of
the brain largely affected in Huntingtons patients. In the study, mice injected with this vector
experienced significant reversal of motor dysfunction to the level of normal mice, while there was
no improvement in HD mice treated with a control vector. dXIAP also appeared to prolong the
lifespan of the mice. Furthermore, no adverse effects due to dXIAP over-production were observed.
The Company is currently further developing technology based upon the dXIAP findings. A
patent application has been filed based upon certain of these findings. Using information obtained
from research conducted by the Companys scientists, an additional strategy is being
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pursued to develop a gene therapy system to protect neurons from death. The goal of this
strategy is to both optimize therapy and provide some element of control should there be
unanticipated or undesirable effects in human patients from too much activation of these pathways.
This research program was initially targeted to treat Huntingtons disease, since it is a
lethal, incurable disorder which can be identified in patients prior to their developing severe
symptoms. However, this program is not specific to Huntingtons disease, and the Company has
evidence that shows that this therapy may be effective in other diseases involving cell death, such
as Parkinsons disease. Therefore, success in the development of therapies to treat such diseases
could lead to more advanced therapies to follow the Companys current program in Parkinsons
disease, and may be useful in other disorders caused by the death of brain cells.
This program is expected to remain in the pre-clinical phase for the current year, with the
goal of advancing towards an initial Phase I clinical trial within the next 3 years. The timing is
subject to change based upon the uncertainties of medical research, the potential need to license
key intellectual property and the need to obtain regulatory approval by appropriate agencies. (See
Risk Factors-The Company Cannot Ensure that it Can Pursue Subsequent Trials for its Product
Candidates or the Timing of any such Trials below).
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 commercially attractive to its field of
operations. At present, it holds the exclusive license to 4 issued U.S. patents, 8 pending U.S.
patent applications, 7 pending foreign patent applications and 1 issued foreign patent. In
addition, the Company owns 1 issued U.S. patent and 8 U.S. pending patent applications covering
gene therapy technologies and 2 non-exclusive licenses to U.S. patents covering delivery mechanisms
for gene therapy.
The exclusive patent licenses were granted by Rockefeller and Thomas Jefferson University
(TJU) pursuant to research agreements which the Company had with these institutions. The
non-exclusive licenses were granted pursuant to agreements the Company has with Rockefeller, Yale
University and Diamyd Therapeutics AB (Diamyd). Other than the patent license granted by Diamyd,
Dr. Michael Kaplitt and/or Dr. Matthew During are named as one of the co-inventors on each patent.
In accordance with TJUs 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 in each of 2006 and 2005 he received approximately $17,000 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 in each of 2006
and 2005. Dr. During will also have a similar interest in future royalties that may become payable
under the agreement with TJU.
In accordance with Rockefellers 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 2006 and 2005 from
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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 Common
Stock in exchange for the cancellation of certain fees under a separate, 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 in connection the development of gene
therapy approaches for neurodegenerative disorders, including Parkinsons disease, Huntingtons
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 August 2006, the Company entered into a Sublicense Agreement with Diamyd. Pursuant to the
Sublicense Agreement, Diamyd granted to the Company a non-exclusive worldwide license to certain
patent rights and technical information for the use of a gene version of GAD 65 in connection with
its gene therapy treatment for Parkinsons disease. The Company paid Diamyd an initial fee of
$500,000 and will pay annual license maintenance fees, certain milestone and royalty payments to
Diamyd as provided for in the Sublicense Agreement.
Effective May 2006, the Company entered into a Sponsored Research Agreement (Research
Agreement) with OSURF which provides for research covering the development of gene therapy
approaches to neurodegenerative disorders, including Parkinsons disease, epilepsy, Huntingtons
disease, Alzheimers disease, as well as gene therapy approaches to pain, stroke, neurovascular
diseases and other research. The Company has first right to negotiate with OSURF, on reasonably
commercial terms, for an exclusive, worldwide right and license for commercial products embodying
inventions conceived under the Research Agreement with the assistance of employees of OSURF.
In May 2005, the Company announced that it had entered into a license agreement with Keio
University in Tokyo, Japan to develop and commercialize therapeutics to treat brain and other CNS
disorders (excluding Amyotrophic Lateral Sclerosis) using the humanin gene. This license agreement
was terminated effective January 2006, because the gene could not be developed to function in the
manner intended for use in the Companys programs.
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 individuals
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 Companys exclusive property. While the Company takes these and other measures to
protect its trade secrets, they do not ensure against the unauthorized use and/or disclosure of its
confidential information.
The Companys intellectual property rights may be called into question or subject to
litigation. (See Risk Factors-The Companys Intellectual Property Rights may be Called into
Question or Subject to Litigation below).
12
Manufacturing
The Company, or third parties retained by it, will need to have available, or develop,
capabilities for the manufacture of components and delivery systems utilized in the Companys
products, including all necessary equipment and facilities. In order to receive approval by the
FDA and commercialize its product candidates, the Company must develop and implement manufacturing
processes and facilities that comply with governmental regulations, including the FDAs Good
Manufacturing Practices (GMP). As discussed below, the Company has, to date,
manufactured its own AAV and other components for its Phase I clinical trial for Parkinsons
disease. Nonetheless, the large scale manufacture and development of components and systems will
require both time and significant funding. (See Risk Factors below).
The Companys two most advanced product candidates, AAVGAD for Parkinsons disease, and AAVNPY
for Temporal Lobe Epilepsy, are biological products requiring manufacture in specialized
facilities. As the Companys development programs advance through the phases of clinical
development, the regulatory requirements for manufacture proportionately increase. The Company is
planning to continue manufacturing product consistent with current GMP as defined by the FDA and
commensurate with the clinical phase of development and commercial release. The Company does not
currently own such a facility and it is evaluating whether it will seek to establish such
capabilities on its own or it will contract with third parties for such manufacturing.
The Company is currently negotiating and expects to complete a Vector Production Agreement
with Cincinnati Childrens Hospital Medical Center (CCHMC) for the production of the
viral vectors to be used in the Companys planned Phase II clinical trial for Parkinsons disease
and Phase I clinical trial for epilepsy. The agreement will require CCHMC to produce such vectors
in accordance with current GMP clinical phase of development.
Pursuant to a research agreement, Auckland Uniservices, Ltd. the commercial research and
knowledge transfer company for the University of Auckland in New Zealand, (AUL) has
manufactured and delivered to the Company in bulk form all of the AAVGAD that the Company required
to complete the Phase I clinical trial procedures for Parkinsons disease. The Companys
laboratory purified the AAVGAD that it received from AUL to the final product form that was used in
the trial. On October 15, 2006 the research agreement between AUL and the Company expired and was
not renewed.
Under the Companys manufacturing and development agreement with Medtronic, dated April 27,
2005, the Company will develop a new catheter system for infusing gene therapies into the brain.
Medtronic engineers are working with the Companys scientists to develop this system for use in
planned later-phase gene therapy studies. Currently, there is no commercial product available for
infusion of gene therapeutics or any other type of biological agent into the brain, and all
clinical trials to date, including the Companys Phase I clinical trial for Parkinsons disease,
have utilized either experimental devices created specifically for the particular trial or have
used technologies which were not designed for use in the brain. The goal of this program is to
provide the Company with a proprietary technology to deliver its gene therapy agents which would
facilitate acceptance and use by the general community of practicing neurosurgeons. The Company
will make payments to Medtronic based upon Medtronics attainment of certain development
milestones. As of December 31, 2006, the Company had paid $638,000 to Medtronic for milestones
achieved under the manufacturing and development agreement.
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The Company does not have any experience in manufacturing products for commercial sale and, if
the Company is not successful in establishing its own manufacturing capabilities or engaging a
third-party to manufacture its products, no assurance can be provided that it will be able to reach
its planned objectives. Furthermore, manufacturing costs could exceed the Companys expectations
and become prohibitive. (See Risk Factors-The Company Does Not Have any Experience in
Manufacturing Products for Commercial Sale below).
Competition
The Company is aware of other companies currently conducting clinical trials of gene therapy
products in humans to treat Parkinsons 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 Genzyme
Corp. (Genzyme), Cell Genesys, Inc., and Targeted Genetics Corporation, have significant
experience in developing and using AAV vectors to deliver gene therapy products.
Ceregene, Inc., an affiliate company of Cell Genesys, Inc., announced on October 10, 2006 the
initial results of its Phase I Parkinsons disease gene therapy using AAV expressing the neurturin
gene (a nerve growth factor). Ceregene also announced that is was planning to conduct a Phase II
randomized controlled clinical trial once the Phase I trial was complete.
Genzyme purchased the AAV gene therapy assets of Avigen, Inc. (Avigen) in December
2005, including Avigens 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. 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 Parkinsons disease using AV201. Avigen
commenced such trial with its first patient undergoing gene transfer surgery in December, 2004 and
Genzyme has since taken over the control of the study.
In February, 2005, Amgen, Inc. (Amgen), a major biotechnology company, announced
that it had discontinued its clinical trials of infusion of a different growth factor into patients
with Parkinsons disease. The goal of this approach was to infuse a recombinant growth factor
called glial-derived neurotrophic factor (GDNF) into the brains of patients with Parkinsons
disease in an attempt to stop the loss of dopamine cells and to possibly promote growth. Amgen
announced that the decision to stop this program, which was in collaboration with Medtronic, was
based upon results of their Phase II trial which showed no evidence of efficacy compared with a
placebo group and some safety concerns.
Many of the Companys 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 Companys products or technologies noncompetitive or
obsolete.
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Government Regulation
All of the Companys potential products must receive regulatory approval before they can be
marketed. Human therapeutic products are subject to rigorous preclinical and clinical testing and
other pre-market approval procedures administered by the FDA and similar authorities in foreign
countries. In accordance with the Federal Food, Drug and Cosmetics Act, the FDA exercises
regulatory authority over, among other things, the development, testing, formulation, manufacture,
labeling, storage, record keeping, reporting, quality control, advertising, promotion, export and
sale of the Companys potential products. Similar requirements are imposed by foreign regulatory
agencies. In some cases, state regulations may also apply.
Gene therapy is a relatively new technology that has not been extensively tested or shown to
be effective in humans. The FDA reviews all product candidates for safety at each stage of clinical
testing. Safety standards must be met before the FDA permits clinical testing to proceed to the
next stage. Also, efficacy must be demonstrated before the FDA grants product approval. The
approval process, and ongoing compliance with applicable regulations after approval is
time-intensive and involves substantial risk and expenditure of financial and other resources.
(See Risk Factors- The Company is Subject to Stringent Regulation; FDA Approvals below)
Preclinical studies generally require studies in the laboratory or in animals to assess the
potential products safety and effectiveness. Preclinical studies include laboratory evaluation of
toxicity, pharmacokinetics, how the body processes and reacts to the drug, and pharmacodynamics,
whether the drug is actually having the expected effect on the body. Preclinical studies must be
conducted in accordance with the FDAs Good Laboratory Practice regulations and, before any
proposed clinical testing in humans can begin, the FDA must review the results of these preclinical
studies as part of an Investigational New Drug application.
If preclinical studies of a product candidate, including animal studies, demonstrate safety,
and laboratory test results are acceptable, then the potential product will undergo clinical trials
to test the therapeutic agent in humans. Human clinical trials are subject to numerous governmental
regulations that provide detailed procedural and administrative requirements designed to protect
the trial participants. Each institution that conducts human clinical trials has an Institutional
Review Board or Ethics Committee charged with evaluating each trial and any trial amendments to
ensure that the trial is ethical, subjects are protected and the trial meets the institutional
requirements. These evaluations include reviews of how the institution will communicate the risks
inherent in the clinical trial to potential participants, so that the subjects may give their
informed consent. Clinical trials must be conducted in accordance with the FDAs Good Clinical
Practices regulations and the protocols the company establishes to govern the trial objectives, the
parameters to be used for monitoring safety, the criteria for evaluating the efficacy of the
potential product and the rights of each trial participant with respect to safety. FDA regulations
require the Company to submit these protocols as part of the application. FDA review or approval of
the protocols, however, does not necessarily mean that the trial will successfully demonstrate
safety and/or efficacy of the potential product. (See Risk Factors- The Company is Subject to
Stringent Regulation; FDA Approvals below)
Institutions that receive NIH funding for gene therapy clinical trials must also comply with
the NIH Recombinant DNA Guidelines, and the clinical trials are subject to a review by the NIHs
Office of Biotechnology Activities Recombinant DNA Advisory Committee (RAC) RAC. The outcome of
this review can be either an approval to initiate the trial without a public
15
review or a requirement that the proposed trial be reviewed at a quarterly committee meeting.
A clinical trial will be publicly reviewed when at least three of the committee members or the
Director of the Office of Biotechnology Activities recommends a public review. The review by the
RAC may also delay or impede the Companys clinical trials. (See Risk Factors The Companys
Research Activities are Subject to Review by the RAC below)
Clinical trials are typically conducted in three phases often involving multiple clinical
trials in each phase. In Phase I, clinical trials generally involve a small number of subjects, who
may or may not be afflicted with the target disease, to determine the preliminary safety profile.
In Phase II, clinical trials are conducted with larger groups of subjects afflicted with the target
disease in order to establish preliminary effectiveness and optimal dosages and to obtain
additional evidence of safety. In Phase III, large-scale, multi-center, comparative clinical trials
are conducted with subjects afflicted with the target disease in order to provide enough data for
the statistical proof of efficacy and safety required by the FDA and other regulatory agencies for
market approval. The Company report its progress in each phase of clinical testing to the FDA,
which may require modification, suspension or termination of the clinical trial if it deems patient
risk too high. The length of the clinical trial period, the number of trials conducted and the
number of enrolled subjects per trial vary, depending on the Companys results and FDA requirements
for the particular clinical trial. Although the Company and other companies in its industry have
made progress in the field of gene therapy, it cannot predict what the FDA will require in any of
these areas to establish to its satisfaction the safety and effectiveness of the product candidate.
(See Risk Factors- The Company is Subject to Stringent Regulation; FDA Approvals below)
If the Company successfully completes clinical trials for a product candidate, it must obtain
FDA approval or similar approval required by foreign regulatory agencies, as well as the approval
of several other governmental and nongovernmental agencies, before it can market the product in the
United States or in foreign countries. Current FDA regulations relating to biologic therapeutics
require the Company to submit an acceptable Biologics License Application, or BLA, to the FDA and
receive approval before the FDA will permit commercial marketing. The BLA includes a description of
the Companys product development activities, the results of preclinical studies and clinical
trials and detailed manufacturing information. Unless the FDA gives expedited review status, this
stage of the review process generally takes at least one year. Should the FDA have concerns with
respect to the potential products safety and efficacy, it may request additional data, which could
delay product review or approval. The FDA may ultimately decide that the BLA does not satisfy its
criteria for approval and might require the Company to do any or all of the following:
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Because the FDA has not yet approved any gene therapy products, it is not clear what, if any,
unforeseen issues may arise during the approval process. While the Company expects this regulatory
structure to continue, it also expects the FDAs regulatory approach to product approval, and its
requirements with respect to product testing, to become more predictable as its scientific
knowledge and experience in the field of gene therapy increases. Adverse events in the
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field of gene therapy or other biotechnology-related fields, however, could result in greater
governmental regulation, stricter labeling requirements and potential regulatory delays in the
testing or approval of gene therapy products. (See Risk Factors- Events in the General Field of
Gene Therapy may Affect the Companys Ability to Develop its Products below.)
Once approved by the FDA, marketed products are subject to continual FDA review, which could
result in restrictions on marketing a product or in its withdrawal from the market, as well as
potential criminal penalties or sanctions. (See Once Approved by the FDA, the Companys Products
Would Be Subject to Continual FDA Review and The Company may Face Liability Due to its Use of
Hazardous Materials under Risk Factors below)
Employees
As of December 31, 2006, the Company had eight full-time employees, of which five are directly
involved in its research and development activities, including product development, manufacturing,
regulatory affairs and clinical affairs. Four of the Companys employees have Ph.D. degrees,
having expertise in virology, protein chemistry and molecular biology. The Companys employees are
not subject to any collective bargaining agreements and the Company regards its relations with its
employees to be good.
Scientific Advisory Board
The Company has assembled the Scientific Advisory Board (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, met one time in 2006.
Paul Greengard, Ph.D. Dr. Greengard has been a member and chairman of the SAB since July
2003. Dr. Greengard receives an annual fee of $25,000 for his participation in the SAB. 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 receives an annual fee of $12,000 for his participation in the SAB. Dr. Brooks is currently
the Director of the Bionomics Research and Technology Center (BRTC) at the Environmental and
Occupational Health Science Institute of the University of Medicine and Dentistry of New Jersey.
He is also the Associate Director of Technology Development at Rutgers Universitys Cell and DNA
Repository and an Associate Professor of Environmental Medicine and Genetics at UMDNJ. Dr. Brooks
is a molecular neuroscientist whose research focuses on deciphering the molecular mechanisms that
underlie memory and learning. These studies investigate gene-environment interactions in the
context of aging, neurodegenerative disease and neurotoxicant exposure. Previously, Dr. Brooks was
the Director of the Center for
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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 Companys scientific co-founders, has
been a member of the SAB since October 1999. Dr. During is currently Professor of Molecular
Virology, Immunology and Medical Genetics at Ohio State Medical School. 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. From June 2004 to February 2006 he was the Research Lab
Director of the Department of Neurological Surgery at Cornell. 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 Yales 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 Companys 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 bachelors 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 receives an annual fee of $12,000 for his participation in the SAB. 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 Societys 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. Dr.
Lozano receives an annual fee of $12,000 for his participation in the SAB. He is currently
Professor of Neurosurgery and holds the Ronald Tasker Chair in Stereotactic and
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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 receives an annual fee of $12,000 for his participation in the SAB. Dr. Nestlers 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. Nestlers
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, 2006, the Company has incurred net losses of approximately
$21.2 million and negative cash flows from operating activities of approximately $16.2 million.
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 and
cash flow deficiencies 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 Does not have Sufficient Funds to Continue its Operations in the Long Run or to
Commercialize its Product Candidates
The Companys existing resources are not sufficient to enable it to obtain the regulatory
approvals necessary to commercialize its current or future product candidates. The Company will
from time to time 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 Companys control, including market
conditions and interest rates. The Company does not know whether additional financing will be
available when needed, or, if available, whether any such financing will be on terms acceptable or
favorable to the Company.
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The Company has not Demonstrated that it Can Establish Many Necessary Business Functions
The Company has not demonstrated that it can:
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obtain the regulatory approvals necessary to commercialize product candidates
that it may develop in the future; |
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manufacture, or arrange for third-parties to manufacture, future product
candidates in a manner that will enable the company to be profitable; |
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attract, retain and manage a large, diverse staff of physicians and researchers; |
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establish sales, marketing, administrative and financial functions; |
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develop relationships with third-party collaborators to assist in the marketing
and/or distribution of the technologies that the Company may develop; |
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make, use and sell future product candidates without infringing upon third party
intellectual property rights; |
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secure meaningful intellectual property protection covering its future product
candidates; or |
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respond effectively to competitive pressures. |
The Company will need to establish or otherwise arrange for such functions in order to operate
in the long term.
If the Clinical Trials for Parkinsons Disease are Unsuccessful, it would Likely have a Material
Adverse Effect on the Companys Operations
The Company completed its Phase I human clinical trial for the treatment of Parkinsons
disease in 2006. The Company plans to pursue a Phase II clinical trial prior to conducting a
pivotal trial which could lead to commercialization of the product. However, the Company cannot
ensure that the trial can be completed successfully or that there will be no adverse effects or
immunologic reaction in the patients.
If the planned clinical trials for treatment of Parkinsons disease are unsuccessful, future
operations and the potential for profitability will be significantly adversely affected and the
business may not succeed. (See Business of the Company-Parkinsons Disease above).
The Company Cannot Ensure that it will be Able to Pursue Further Trials for its Product Candidates
or the Timing of any Future Trials
The Companys ability to conduct further trials for its product candidates depends upon a
number of factors beyond the Companys control, including, but not limited to, regulatory reviews
of trials, procurement of licenses from third parties and access to third party manufacturing
facilities. Accordingly, the Company is unable to assure that it will be able to pursue further
trials for any of its product candidates or the timing of any such trials. As described directly
below, the Companys ability to pursue further trials also depends upon the
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Companys ability to retain its current key physicians and researchers. Additionally, as
described above under The Company does not have Sufficient Funds to Continue its Operations in the
Long Run or To Commercialize its Product Candidates, the Company will be required to raise
additional capital from time to time in order to fund further trials.
The Companys Future Success Depends Upon Key Physicians and Researchers
The Companys 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 of Dr. During or Dr. Kaplitt were unable or unwilling to continue his present
relationship with the Company, it is likely that the Companys business, financial condition,
operating results and future prospects would be materially adversely affected. Dr. During and Dr.
Kaplitt are not employees of the Company and they devote their attention to other projects and
ventures in addition to the services that they render to the Company.
The Company is Subject to Stringent Regulation; FDA Approvals
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 the
completion of rigorous pre-clinical testing and clinical trials and an extensive regulatory
approval process implemented by the FDA. Satisfaction of regulatory requirements typically takes
several years, depends upon the type, complexity and novelty of the product and requires the
expenditure of substantial resources. The Company may encounter difficulties or unanticipated
costs in its efforts to secure necessary governmental approvals, which could delay or prevent the
marketing of its product candidates. 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. In addition,
the regulatory requirements governing gene therapy product candidates and commercialized products
are subject to change.
Additionally, before the Company is able to market its products, it must have access to an FDA
approved catheter system that has been tested and found compatible to infuse the Companys gene
therapy product into the brain. Currently the Company is expecting to use a catheter system
currently being developed by Medtronic. To date, such system has not received regulatory approval.
To the Companys knowledge, to date, neither the FDA nor any other regulatory agency has
approved a gene therapy product for sale in the United States.
The Companys Research Activities are Subject to Review by the RAC
As noted above, institutions that receive NIH funding for gene therapy clinical trials are
subject to a review by the RAC. The outcome of this review can be either an approval to initiate
the trial without a public review or a requirement that the proposed trial be reviewed at a
quarterly committee meeting. Should the RAC require a public hearing, the start of the trial must
be delayed until after the hearing date. Although the NIH guidelines do not have regulatory status,
the RAC review process can impede the initiation of the trial, even if the FDA has reviewed the
trial and approved its initiation. Additionally, before any clinical trial can be
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initiated at an NIH-funded site, the Institutional Biosafety Committee of that site must
perform a review of the proposed clinical trial and ensure there are no safety issues associated
with the trial.
The Company May Face Substantial Penalties if it Fails to Comply with Regulatory Requirements
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 Companys
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 risks similar to those associated
with FDA clearance.
The Company Will Need to Conduct Significant Additional Research and Testing Before Conducting
Clinical Trials Involving Future Product Candidates
Before the Company can conduct clinical trials involving future product candidates, the
Company will need to conduct substantial research and animal testing, referred to as preclinical
testing. 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, the Company must demonstrate that a particular future product candidate is safe and
effective. The Companys failure to adequately demonstrate the safety and efficacy of future
product candidates would prevent the FDA from approving such products. The Companys 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 Companys financial results, ability to raise capital
and the commercial prospects for future product candidates.
The Companys Future Success Depends Upon Acceptance of its Products by Health Care Administrators
and Providers
The Companys future success depends upon the acceptance of its products by health care
administrators and providers, patients and third-party payors (including, without limitation,
health insurance companies, Medicaid and Medicare). Market acceptance will depend on numerous
factors, many of which are outside the Companys 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 |
22
|
|
|
the availability of third-party reimbursement. |
Events in the General Field of Gene Therapy may Affect the Companys Ability to Develop its
Products
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
Companys 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.
Side Effects, Patient Discomfort, Defects or Unfavorable Publicity May Affect the Companys Ability
to Commercialize its Products
The Companys results for its Phase I trial for Parkinsons disease indicate that this
treatment appears to be safe and well-tolerated in advanced Parkinsons disease, with no evidence
of adverse effects or immunologic reaction related to the study treatment. However, the Company
cannot assure that it will not discover unanticipated side effects, patient discomfort or product
defects in connection with its trials for any other product candidates. Unanticipated side
effects, patient discomfort, or product defects discovered in connection with the Companys future
trials may significantly impact the Companys ability to commercialize its products or achieve
market acceptance. Commercialization could also be materially affected by unfavorable publicity
concerning any of the Companys future product candidates, or any other product incorporating
technology similar to that used by future product candidates.
The Company Does not have any Experience in Manufacturing Products for Commercial Sale
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 FDAs GMP. |
23
The Companys Ability to Manufacture Products Depends upon FDA Approval and Access to Third-Party
Manufacturing Facilities
The Company, or any third-party manufacturer that it contracts with to manufacture any future
product candidate, must receive FDA approval before producing clinical material or commercial
products. The Companys 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 Companys 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.
The Companys Intellectual Property Rights may be Called into Question or Subject to Litigation
Because of the complex and difficult legal and factual questions that relate to patent
positions in the Companys 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
Companys 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 partys
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 a particular technology.
The Company may be Subject to Product Liability Claims in Connection with its Clinical Trials
Clinical trials of future product candidates, and any subsequent sales of products employing
the Companys 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 in connection with its
completed Phase I clinical trial and planned Phase II clinical trial for Parkinsons disease, 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 would have
a material adverse effect on its business, financial condition, results of operations and future
prospects.
The Company may Face Liability Due to its Use of Hazardous Materials
The Companys 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,
24
handling and disposal of these materials, including, but not limited to, the Occupational
Safety and Health Act, the Environmental Protection Act, the Toxic Substances Control Act and the
Resource Conservation and Recovery Act. 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 Companys liability may exceed its total
assets. Compliance with environmental laws and regulations may be expensive and current or future
environmental regulations may impair the Companys research, development or production efforts.
Once Approved by the FDA, the Companys Products Would Remain Subject to Continual FDA Review
Once approved by the FDA, marketed products are subject to continual FDA review. Later
discovery of previously unknown problems or failure to comply with applicable regulatory
requirements may result in restrictions on marketing a product or in its withdrawal from the
market, as well as potential criminal penalties or sanctions. In addition, the FDA requires that
manufacturers of a product comply with current Good Manufacturing Practices requirements, both as a
condition to product approval and on a continuing basis. In complying with these requirements, the
Company expects to expend significant amounts of time, money and effort in production, record
keeping and quality control. All manufacturing facilities are subject to periodic inspections by
the FDA. If major problems are identified during these inspections that could impact patient
safety, the FDA could subject the Company to possible action, such as the suspension of product
manufacturing, product seizure, withdrawal of approval or other regulatory sanctions. The FDA could
also require the Company to recall a product.
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 (the Exchange Act) 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 Companys 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:
25
|
|
|
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 commence and complete all necessary
clinical trials for the commercialization of its product to treat Parkinsons
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 managements expectations is
found in the section entitled Risk Factors starting on page 19. 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 Companys
expectations.
26
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 approximately $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.
On November 3, 2006, the Company entered into a lease (the BPRA Lease) with Bridge
Plaza Realty Associates, LLC (BPRA) for an additional 703 square feet of office space at
One Bridge Plaza, Fort Lee, New Jersey 07024. The BPRA Lease will commence upon the completion of
build out work performed by BPRA and will expire three years thereafter. The BPRA Lease provides
for a base annual rent of approximately $21,000 or $2,000 per month through its term.
In addition, effective February 1, 2008 through March 2010, the BPRA Lease will include the
1,185 square feet of office space currently subleased from PCS, with such office space being leased
by the Company at a base annual rent of $36,000 or $3,000 per month through the term of the lease.
Effective April 2006, the Company terminated its lease of approximately 2,000 square feet of
laboratory space at Columbia in New York City.
In April 2006, the Company entered into a Facility Use Agreement (the Facility Use
Agreement) and Visiting Scientist Agreements with OSU, all of which allow three of the
Companys scientists to access and use OSUs laboratory facilities and certain equipment to perform
their research under the direction of Dr. Matthew During. The term of the Facility Use Agreement
is four years, subject to earlier termination under certain circumstances. The Company paid OSU an
initial amount of $23,000 representing prepaid rent for the first year of the Facility Use
Agreement. Unless sooner terminated the Company will pay an additional $70,000 over the remaining
three years of such agreement.
One of the Companys scientists conducts research at Cornell University in New York City under
the direction of Dr. Michael Kaplitt, as provided for by the Companys research agreement with
Cornell University.
Management believes that the properties the Company leases are adequately covered by
insurance.
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 2006.
27
PART II
Item 5. Market for Registrants Common Equity and Related Stockholder Matters
The Company had 565 stockholders of record as of December 31, 2006. The Company did not pay
cash dividends during the two year period ended December 31, 2006 and does not currently expect to
pay any cash dividends to stockholders in the foreseeable future.
The Common Stock is traded on the OTC Bulletin Board under the symbol NRGX.
The following table shows the high and low bid quotations as furnished by Bloomberg. 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 Common Stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
2005 |
|
|
High |
|
Low |
|
High |
|
Low |
First quarter |
|
$ |
2.05 |
|
|
$ |
1.60 |
|
|
$ |
2.40 |
|
|
$ |
1.50 |
|
Second quarter |
|
$ |
1.80 |
|
|
$ |
1.15 |
|
|
$ |
2.40 |
|
|
$ |
1.74 |
|
Third quarter |
|
$ |
1.65 |
|
|
$ |
1.10 |
|
|
$ |
2.05 |
|
|
$ |
1.50 |
|
Fourth quarter |
|
$ |
1.16 |
|
|
$ |
0.62 |
|
|
$ |
2.10 |
|
|
$ |
1.45 |
|
Company Equity Compensation Plans
The following table sets forth information as of December 31, 2006, with respect to
compensation plans (including individual compensation arrangements) under which equity securities
of the Company are authorized for issuance.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of securities |
|
|
Number of securities to |
|
Weighted-average |
|
remaining available |
|
|
be issued upon exercise |
|
exercise price of |
|
for future issuance |
|
|
of outstanding options, |
|
outstanding options, |
|
under equity |
Plan Category |
|
warrants and rights |
|
warrants and rights |
|
compensation plans |
|
2000 Stock Option Plan approved by stockholders |
|
|
2,946,815 |
|
|
$ |
1.49 |
|
|
|
713,185 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other equity compensation plans approved by stockholders |
|
|
69,014 |
|
|
$ |
1.56 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
3,015,829 |
|
|
$ |
1.50 |
|
|
|
713,185 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Item 6. Managements Discussion and Analysis or Plan of Operation
The following discussion should be read in conjunction with the audited financial statements
and accompanying notes of the Company for the fiscal year ended December 31, 2006. The Companys
fiscal year ends on the last day of December in each year. References to 2006 and 2005 shall mean
the Companys fiscal year ended on December 31st of such year. All amounts in this Item
6 are in thousands.
28
Business Overview
The Company is a development stage company that is engaged in the research and 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, the Company has not generated any operating revenues and has incurred annual net
losses. From inception through December 31, 2006, the Company had an accumulated deficit of
$23,786, and it expects to incur additional losses in the foreseeable future. The Company
recognized net losses of $7,046 for the year ended December 31, 2006, and $5,345 for the year ended
December 31, 2005. The increase in net loss is primarily due to increased expenditures related to
the progression of the Companys research and development programs in Parkinsons disease and
epilepsy and the expanded administrative infrastructure needed to support that progression.
Since its inception, the Company has financed its operations primarily through sales of its
equity and debt securities. From inception through December 31, 2006, the Company received
proceeds primarily from private sales of equity and debt securities and from the Merger of
approximately $24,831 in the aggregate. Although its costs of administration and public company
compliance have increased this year, the Company has devoted a significant portion of its capital
resources to the research and development of its products.
The Companys primary efforts are directed to develop therapeutic products (i) to meet the
needs of patients suffering from Parkinsons disease and (ii) the needs of patients suffering from
a type of human epilepsy known as temporal lobe epilepsy or TLE.
Parkinsons Disease
In October 2006, the Company announced that it had completed its Phase I clinical trial of
gene therapy for Parkinsons disease and presented its results for the 12 treated subjects at the
Annual Meeting of the Society of Neuroscience in Atlanta. The results indicated that the treatment
appears to be safe and well-tolerated in patients with advanced Parkinsons disease, with no
evidence of adverse effects or immunologic reaction related to the study treatment. The trial, in
which treatment was confined to only one side of the brain, also yielded statistically significant
clinical efficacy and neuro-imaging results.
The Company is planning to commence a Phase II clinical trial in the second half of 2007. The
trial will be a randomized, controlled study designed, among other things, to further establish the
effectiveness and the safety of the treatment. The trial will be conducted in multiple medical
centers and the treatment will be infused bi-laterally in trial subjects. Commencement of such
trial is subject, among other things, to concurrence by the FDA, the Companys ability to
manufacture product on a timely basis, the availability of funding and the availability of the
catheter system being developed by Medtronic. (For further information, see Plan of Operation
below).
Epilepsy
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
29
evaluating the toxicity and efficacy of using its NLX technology in the brain for the
treatment of epilepsy. The Companys approach is based on the use of the non-pathogenic AAV
vector, delivered using standard neurosurgical techniques. The study was completed in November
2005 and results were announced in December 2005. Results showed that Neuropeptide Y (NPY) gene
transfer reduces spontaneous seizures in an in vivo model of epilepsy and positively influences the
fundamental biological process which leads to a chronically epileptic state.
Other Therapies
The Company will also continue its efforts in developing therapies to treat other
neurodegenerative and metabolic disorders including Huntingtons disease under its research
agreements with Cornell and The Ohio State University. (See Business of the Company-Patents and
Other Proprietary Rights above).
Plan of Operation
As discussed above under Business OverviewParkinsons Disease, in October 2006, the Company
announced that it had completed its Phase I clinical trial of gene therapy for Parkinsons disease
and presented its results for the 12 treated subjects at the Annual Meeting of the Society of
Neuroscience in Atlanta. The results indicated that the treatment appears to be safe and
well-tolerated in patients with advanced Parkinsons disease, with no evidence of adverse effects
or immunologic reaction related to the study treatment. The trial, in which treatment was confined
to only one side of the brain, also yielded statistically significant clinical efficacy and
neuro-imaging results.
The Company currently plans to conduct a Phase II clinical study prior to conducting a pivotal
trial for its treatment of Parkinsons disease, commencing in the second half of 2007. The trial
will be a multi-center, randomized, controlled study with subjects being treated bi-laterally. The
trial will be designed, among other things, to further establish the effectiveness and safety of
the treatment. The scope and timing of such trials will largely depend upon FDA concurrence, the
ability to manufacture product on a timely basis, the availability of funding, the availability of
the catheter system being developed by Medtronic and other factors.
The Company will also take steps to move toward a pivotal trial for treatment of Parkinsons
disease, and hopes to be in a position to file its protocol with the FDA in 2009. The Company
presently estimates that the pivotal trial could be completed in 2011 and the estimated total costs
to reach that milestone are expected to be between $20,000 and $30,000.
The cost and timing for further trials and FDA approval are subject to numerous risks, as
further described under Risk Factors above.
The Company also intends to focus its efforts on advancing its product development for the
treatment of epilepsy. The Company expects to commence such trial in the second half of 2007. The
Company expects the cost of such trial to amount to approximately $1,000. The scope and timing of
such trial will, in large part, depend upon, FDA concurrence and the successful completion of
certain license arrangements.
The Company currently expects that, if the project progresses and certain other conditions are
met, it can file for FDA approval for its epilepsy product by 2012, and the
30
estimated total costs to reach that milestone are currently expected to be between $15,000 and
$25,000.
The Company has also recently undertaken efforts to develop gene therapy for the treatment of
other neurodegenerative and metabolic disorders, including Huntingtons disease, with a goal of
advancing towards an initial Phase I clinical trial within the next 3 years.
Over the next 12 months, in addition to its normal recurring expenditures, the Company expects
to spend approximately: $1,300 in Phase II clinical trial expenses with regard to its Parkinsons
treatment; $750 in Phase I clinical trial expenses with regard to its epilepsy product; $1,000 in
costs associated with operating as a publicly traded company, such as legal fees, accounting fees,
insurance premiums, stock market listing fees and investor and public relations fees; $850 in
research and licensing fees; and $300 in expenses in order to scale up its manufacturing
capabilities for the supply of product for a Parkinsons pivotal trial.
Results of Operations
Year Ended December 31, 2006 Compared to the Year Ended December 31, 2005
Revenues. The Company did not generate any operating revenues in 2006 and 2005.
Research and Development Expenses. The following table summarizes the Companys research and
development expenses for fiscal years ended December 31, 2006 and 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
2005 |
|
$ Change |
License & Research Agreements |
|
$ |
847 |
|
|
$ |
499 |
|
|
$ |
348 |
|
Development and Manufacturing |
|
|
824 |
|
|
|
761 |
|
|
|
63 |
|
Compensation Expenses |
|
|
620 |
|
|
|
321 |
|
|
|
299 |
|
Medical and Scientific Consultants |
|
|
679 |
|
|
|
482 |
|
|
|
197 |
|
Clinical Trial Expenses |
|
|
132 |
|
|
|
361 |
|
|
|
(229 |
) |
Laboratory Supplies |
|
|
214 |
|
|
|
251 |
|
|
|
(37 |
) |
Other R&D Expenses |
|
|
265 |
|
|
|
160 |
|
|
|
105 |
|
|
|
|
Totals |
|
$ |
3,581 |
|
|
$ |
2,835 |
|
|
$ |
746 |
|
|
|
|
Research and development expenses increased by $746 in 2006 over the comparable expense
in 2005. The increase is, in part, due to the $500 initial fee paid to Diamyd Therapeutics AB for
the license of their patent rights and technical information of a gene version of GAD 65 (see
Business of the Company Patents and Other Proprietary Rights). The increase was also due to $321
in costs incurred in 2006 associated with the manufacturing of product to be used in the Companys
future clinical trials, $598 in increased costs for the compensation and travel of Company
scientists and scientific consultants and $107 in costs associated with the Sponsored Research
Agreement entered into with OSURF. These increases were offset by a reduction, from the prior
comparable period of $257 in charges related to the development and manufacturing agreement and the
stock purchase agreement entered into with Medtronic in April 2005 and $229 due to the winding down
of the treatment of patients as part of the Companys Phase I clinical trial for Parkinsons
disease. The Company also benefited from the elimination of $281 in costs, incurred in the year
ended December 31, 2005 under a research agreement with Auckland Uniservices, Ltd.
31
General and Administrative Expenses. General and administrative expenses increased by $1,217
to $3,904 in 2006 as compared to $2,687 in 2005. This increase was primarily due to a $1,296
increase in compensation expense in 2006, mainly related to (i) the $232 charge for the accelerated
vesting of and the extension of the exercise period for Michael Sorells stock options in
connection with his resignation, (ii) the $185 charge for severance payable to Dr. Sorell in
connection with his resignation, (iii) the cash and non-cash compensation charges of $334 for John
E. Mordock in connection with his hiring as the Companys President and CEO in July 2006, (iv) the
cash and non-cash compensation charges of $289 for Marc L. Panoff in connection with his hiring as
the Companys Chief Financial Officer and Treasurer and (v) non-cash compensation charges of $279
related to options granted to the Companys directors.
Other Income (Expense), Net. The Company had net other income of $439 in 2006 as compared to
net other income of $177 in 2005. This increase is a result of increased interest income earned on
funds received by the Company during the fiscal year ended December 31, 2006 from its private
placement of its Series C Preferred Stock.
Liquidity and Capital Resources
Cash and cash equivalents were $10,478 at December 31, 2006.
The Company is still in the development stage and has not generated any operating revenues as
of December 31, 2006. In addition, the Company will continue to incur net losses and cash flow
deficiencies from operating activities for the foreseeable future.
Based on its cash flow projections, the Company believes that the Companys current resources
will enable it to continue as a going concern through at least December 31, 2007. Although the
Company believes that its resources are sufficient to begin its planned Phase II clinical trial for
Parkinsons disease and complete a Phase I clinical trial for epilepsy, the Companys resources
are not sufficient to allow it to perform all of the clinical trials required for drug approval and
marketing, including a pivotal trial for Parkinsons disease. 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. (See Risk Factors above).
Net cash used in operating activities was $4,888 in fiscal year 2006 as compared to $3,619 in
fiscal year 2005. The $1,269 increase in net cash used in operations was primarily due to a larger
net loss of approximately $1,701 in fiscal 2006 over fiscal 2005. The increase in net cash used
was also due to adjustments to net income related to an increase in net operating assets in 2006 of
$318. This increase was offset by $750 in adjustments to net income for increased non-cash
expenses, such as stock-based compensation expense, depreciation expense and amortization expense.
The Company has net cash provided by investing activities of $2,512 during the fiscal year
ended December 31, 2006 versus net cash used in investing activities during the fiscal year ended
December 31, 2005, of $1,418. The $3,930 difference was primarily attributable to a decrease in
net purchases of marketable securities of $4,000.
Net cash provided by financing activities during the year ended December 31, 2006 was $11,599
as compared to $5,170 during the year ended December 31, 2005. During the year
32
ended December 31, 2006, the Company completed a private placement of its Series C Preferred
Stock to investors led by General Electric Pension Trust and Daimler Chrysler Corporation Master
Retirement Trust that yielded $11,612 in net proceeds. During the year ended December 31, 2005,
the Company completed a private placement of its Common Stock to a group of investors led by Merlin
Biomed Group that yielded $5,066 in net proceeds.
Critical Accounting Estimates and Policies
The Companys discussion and analysis and plan of operation is based upon its 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 (SEC). 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 ongoing 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, 2006, as outlined in the
accompanying notes to the financial statements, have been applied consistently for the year ended
December 31, 2006.
Carrying Value of Fixed and Intangible Assets
The Companys fixed assets and certain of its patents have been recorded at cost. The
Companys fixed assets are being amortized using accelerated methods and its patents 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 fair value
determined by the present value of the expected future cash flows associated with the use of the
asset. Adverse changes to the Companys 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 assets carrying value at that time.
Research and Development
Research and development expenses consist of costs incurred in identifying, developing and
testing product candidates. These expenses consist primarily of salaries and related expenses for
personnel, fees of the Companys scientific and research consultants and related costs, contracted
research fees and expenses, clinical studies and license agreement milestone and maintenance fees.
Research and development costs are expensed as incurred. Certain of these expenses, such as fees
to consultants, fees to collaborators for research activities and costs related to clinical trials,
are incurred over multiple reporting periods. Management assesses how
33
much of these multi-period costs should be charged to research and
development expense in each
reporting period.
Stock Based Compensation
Effective January 1, 2006, the Company adopted SFAS No. 123R, Accounting For Share-Based
Compensation. From that date forward, the Company records share-based compensation expense for all
stock options issued to all persons to the extent such options vest on January 1, 2006 or later.
That expense is determined under the fair value method using the Black-Scholes option pricing
model. The Company records that expense ratably over the period the stock options vest.
Prior to January 1, 2006, the Company applied Accounting Principles Board Opinion No. 25 (APB
No. 25), Accounting for Stock Issued to Employees and related interpretations for determining
compensation expense related to its stock option grants. Under that principle, the Company measured
compensation expense for stock options issued to its directors and employees using the intrinsic
value of the stock option at date of grant, which generally resulted in the Company recording no
compensation expense since the intrinsic value of those stock options was typically zero at the
date of grant due to the exercise price of those stock options being equal to the fair value of its
shares on the date of grant. Compensation expense for stock options issued to all other persons was
measured using the fair value of the stock option at the date of grant determined under the
Black-Scholes option pricing model, which generally resulted in the Company recording a
compensation expense.
The Black-Scholes option pricing model used to compute share-based compensation expense
requires extensive use of accounting judgment and financial estimates. Items requiring estimation
include the expected term option holders will retain their vested stock options before exercising
them, the estimated volatility of the Companys common stock price over the expected term of a
stock option, and the number of stock options that will be forfeited prior to the completion of
their vesting requirements. Application of alternative assumptions could result in significantly
different share-based compensation amounts being recorded in the Companys financial statements.
The Company implemented SFAS No. 123R using the modified prospective transition method. Under
this method, prior periods are not restated.
Recent Accounting Pronouncements
In September 2006, the FASB issued Statement of Financial Accounting Standards No. 157 (SFAS
157), Fair Value Measurements, which defines fair value, establishes guidelines for measuring
fair value and expands disclosures regarding fair value measurements. SFAS 157 does not require any
new fair value measurements but rather eliminates inconsistencies in guidance found in various
prior accounting pronouncements. SFAS 157 is effective for fiscal years beginning after November
15, 2007. Earlier adoption is permitted, provided the company has not yet issued financial
statements, including for interim periods, for that fiscal year. The Company is currently
evaluating the impact of SFAS 157, but does not expect the adoption of SFAS 157 to have a material
impact on its consolidated financial position, results of operations or cash flows.
34
In July 2006, the FASB issued FASB Interpretation No. 48 (FIN 48) Accounting for
Uncertainty in Income Taxes (an interpretation of FASB Statement No. 109) which is effective for
fiscal years beginning after December 15, 2006. The new guidance will be effective for the Company
on January 1, 2007. This interpretation was issued to clarify the accounting for uncertainty in the
amount of income taxes recognized in the financial statements by prescribing a recognition
threshold and measurement attribute for the financial statement recognition and measurement of a
tax position taken or expected to be taken in a tax return. The provisions of FIN 48 are effective
as of the beginning of 2007, with the cumulative effect of the change in accounting principle
recorded as an adjustment to retained earnings. The Company does not expect the adoption of FIN 48
to have a material impact on its consolidated financial position, results of operations or cash
flows.
35
Item 7. Financial Statements
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board of Directors and Stockholders
Neurologix, Inc.
Fort Lee, NJ
We have audited the accompanying consolidated balance sheet of Neurologix, Inc. and subsidiary (the
Company) (a development stage company) as of December 31, 2006, and the related consolidated
statements of operations, changes in stockholders equity and cash flows for the year then ended.
These consolidated financial statements are the responsibility of the Companys management. Our
responsibility is to express an opinion on these consolidated financial statements based on our
audit.
We conducted our audit in accordance with the standards of the Public Company Accounting Oversight
Board (United States). Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the consolidated financial statements are free of material
misstatement. The Company is not required to have, nor were we engaged to perform, an audit of its
internal control over financial reporting. Our audit included consideration of internal control
over financial reporting as a basis for designing audit procedures that are appropriate in the
circumstances, but not for the purpose of expressing an opinion on the effectiveness of the
Companys internal control over financial reporting. Accordingly, we express no such opinion. An
audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in
the financial statements, assessing the accounting principles used and significant estimates made
by management, as well as evaluating the overall presentation of the financial statements. We
believe that our audit provides a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present fairly, in all
material respects, the consolidated financial position of the Company at December 31, 2006, and the
results of its operations and its cash flows for the year then ended, in conformity with accounting
principles generally accepted in the United States of America.
As described in Note 2(k), in 2006 the Company adopted provisions of Statement of Financial
Accounting Standards No. 123(R), Share Based Payment, utilizing the modified prospective
transition method.
/s/ BDO Seidman, LLP
BDO Seidman, LLP
New York, New York
March 27, 2007
36
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board of Directors and Stockholders
Neurologix, Inc.
We have audited the accompanying consolidated statements of operations, changes in stockholders
equity (deficiency) and cash flows of Neurologix, Inc. and subsidiary (the Company) (a
development stage company) for the year ended December 31, 2005 and for the period from February
12, 1999 (inception) through December 31, 2005 as such
amounts relate to the period from February 12, 1999 (date of inception)
through December 31, 2006. These consolidated financial statements are the
responsibility of the Companys 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 consolidated 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
consolidated 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 consolidated results of operations and cash flows of the Company (a
development stage company) for the year ended December 31, 2005 and for the period from February
12, 1999 (inception) through December 31, 2005 as such
amounts relate to the period from February 12, 1999 (date of inception)
through December 31, 2006, in conformity with accounting principles generally
accepted in the United States of America.
The consolidated financial statements referred to above have been
prepared assuming that the Company will continue as a going concern.
As discussed in Note 1 to the consolidated financial statements in
the 2005 10-KSB, the
Company has incurred recurring losses from operations and has had
negative cash flows from its operating activities. These matters
raise substantial doubt about the Companys ability to continue
as a going concern. Managements plans concerning these matters
are also described in Note 1. The accompanying consolidated
financial statements do not include any adjustments that might result
from the outcome of this uncertainty.
/s/ J.H. Cohn LLP
Jericho, New York
March 24, 2006
37
NEUROLOGIX, INC. AND SUBSIDIARY
(A Development Stage Company)
CONSOLIDATED BALANCE SHEET
(Amounts in thousands, except share and per share amounts)
|
|
|
|
|
|
|
December 31, |
|
|
|
2006 |
|
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
10,478 |
|
Prepaid expenses and other current assets |
|
|
413 |
|
|
|
|
|
Total current assets |
|
|
10,891 |
|
Equipment, less accumulated depreciation of $329 |
|
|
169 |
|
Intangible assets, less accumulated amortization of $79 |
|
|
512 |
|
Other assets |
|
|
8 |
|
|
|
|
|
Total Assets |
|
$ |
11,580 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
729 |
|
|
|
|
|
Total liabilities |
|
|
729 |
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
Stockholders equity: |
|
|
|
|
Preferred stock; 5,000,000 shares authorized |
|
|
|
|
Series A Convertible, $.10 par value; 300,000 shares designated, 645 shares issued and
outstanding with an aggregate liquidation preference of $645 |
|
|
|
|
Series B $.10 par value; 4,000,000 shares designated, no shares issued and outstanding |
|
|
|
|
Series C Convertible, $.10 par value; 700,000 shares designated, 368,155 shares issued
and outstanding with an aggregate liquidation preference of $12,708,162 |
|
|
37 |
|
Common Stock: |
|
|
|
|
$.001 par value; 60,000,000 shares authorized, 26,542,924 issued and outstanding |
|
|
27 |
|
Additional paid-in capital |
|
|
34,573 |
|
Deficit accumulated during the development stage |
|
|
(23,786 |
) |
|
|
|
|
Total stockholders equity |
|
|
10,851 |
|
|
|
|
|
Total Liabilities and Stockholders Equity |
|
$ |
11,580 |
|
|
|
|
|
See accompanying notes to consolidated financial statements.
38
NEUROLOGIX, INC. AND SUBSIDIARY
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the period |
|
|
|
|
|
|
|
|
|
|
February 12, 1999 |
|
|
|
|
|
|
|
|
|
|
(inception) through |
|
|
Year Ended December 31, |
|
December 31, 2006 |
|
|
2006 |
|
2005 |
|
|
|
|
Revenues |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
3,581 |
|
|
|
2,835 |
|
|
|
11,399 |
|
General and administrative
expenses |
|
|
3,904 |
|
|
|
2,687 |
|
|
|
10,111 |
|
|
|
|
Loss from operations |
|
|
(7,485 |
) |
|
|
(5,522 |
) |
|
|
(21,510 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Dividend, interest and other
income |
|
|
441 |
|
|
|
181 |
|
|
|
756 |
|
Interest expense-related parties |
|
|
(2 |
) |
|
|
(4 |
) |
|
|
(411 |
) |
|
|
|
Other income, net |
|
|
439 |
|
|
|
177 |
|
|
|
345 |
|
|
|
|
Net loss |
|
$ |
(7,046 |
) |
|
$ |
(5,345 |
) |
|
$ |
(21,165 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Charge for accretion of beneficial
conversion rights |
|
|
(2,621 |
) |
|
|
|
|
|
|
|
|
Preferred stock dividends |
|
|
(708 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss applicable to common stock |
|
$ |
(10,375 |
) |
|
$ |
(5,345 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss applicable to common stock
per share, basic and diluted |
|
$ |
(0.39 |
) |
|
$ |
(0.21 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding, basic and diluted |
|
|
26,542,924 |
|
|
|
25,693,986 |
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
39
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, 2006)
(Amounts in thousands, except for share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
|
|
|
During the |
|
|
|
|
Series C Preferred Stock |
|
Common Stock |
|
Paid-in |
|
Unearned |
|
Development |
|
|
|
|
Shares |
|
Amount |
|
Shares |
|
Amount |
|
Capital |
|
Compensation |
|
Stage |
|
Total |
|
|
|
Sale of common stock to founders |
|
|
|
|
|
$ |
0 |
|
|
|
6,004,146 |
|
|
$ |
0 |
|
|
$ |
4 |
|
|
$ |
0 |
|
|
$ |
0 |
|
|
$ |
4 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(328 |
) |
|
|
(328 |
) |
|
|
|
Balance, December 31, 1999 |
|
|
|
|
|
|
0 |
|
|
|
6,004,146 |
|
|
|
0 |
|
|
|
4 |
|
|
|
0 |
|
|
|
(328 |
) |
|
|
(324 |
) |
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,055 |
) |
|
|
(1,055 |
) |
|
|
|
Balance, December 31, 2000 |
|
|
|
|
|
|
0 |
|
|
|
6,004,146 |
|
|
|
0 |
|
|
|
4 |
|
|
|
0 |
|
|
|
(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 |
|
|
|
|
|
|
0 |
|
|
|
6,263,637 |
|
|
|
0 |
|
|
|
37 |
|
|
|
0 |
|
|
|
(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
convertible preferred stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,613 |
|
|
|
|
|
|
|
|
|
|
|
2,613 |
|
Amortization of unearned compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
24 |
|
|
|
|
|
|
|
24 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,310 |
) |
|
|
(1,310 |
) |
|
|
|
Balance, December 31, 2002 |
|
|
|
|
|
|
0 |
|
|
|
6,599,272 |
|
|
|
0 |
|
|
|
3,227 |
|
|
|
(553 |
) |
|
|
(3,563 |
) |
|
|
(889 |
) |
Sale of Common Stock |
|
|
|
|
|
|
|
|
|
|
276,054 |
|
|
|
|
|
|
|
90 |
|
|
|
(89 |
) |
|
|
|
|
|
|
1 |
|
Amortization of unearned compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
164 |
|
|
|
|
|
|
|
164 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,274 |
) |
|
|
(2,274 |
) |
|
|
|
Balance, December 31, 2003 |
|
|
|
|
|
|
0 |
|
|
|
6,875,326 |
|
|
|
0 |
|
|
|
3,317 |
|
|
|
(478 |
) |
|
|
(5,837 |
) |
|
|
(2,998 |
) |
Conversion of note payable to Common
Stock at $2.17 per share |
|
|
|
|
|
|
|
|
|
|
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
preferred 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 |
|
|
|
|
|
|
0 |
|
|
|
22,521,404 |
|
|
|
22 |
|
|
|
12,124 |
|
|
|
(318 |
) |
|
|
(8,774 |
) |
|
|
3,054 |
|
Sale of Common Stock through private
placement at an average price of
$1.30 per share |
|
|
|
|
|
|
|
|
|
|
2,473,914 |
|
|
|
4 |
|
|
|
3,062 |
|
|
|
|
|
|
|
|
|
|
|
3,066 |
|
40
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
|
|
|
During the |
|
|
|
|
Series C Preferred Stock |
|
Common Stock |
|
Paid-in |
|
Unearned |
|
Development |
|
|
|
|
Shares |
|
Amount |
|
Shares |
|
Amount |
|
Capital |
|
Compensation |
|
Stage |
|
Total |
|
Sale of Common Stock at an average
price of $1.752 per share and
warrants to Medtronic |
|
|
|
|
|
|
|
|
|
|
1,141,552 |
|
|
|
1 |
|
|
|
2,794 |
|
|
|
|
|
|
|
|
|
|
|
2,795 |
|
Amortization of unearned compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
825 |
|
|
|
|
|
|
|
825 |
|
Stock options granted for services |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,305 |
|
|
|
(1,305 |
) |
|
|
|
|
|
|
|
|
Exercise of stock options |
|
|
|
|
|
|
|
|
|
|
406,054 |
|
|
|
|
|
|
|
127 |
|
|
|
|
|
|
|
|
|
|
|
127 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,345 |
) |
|
|
(5,345 |
) |
|
|
|
Balance, December 31, 2005 |
|
|
|
|
|
|
0 |
|
|
|
26,542,924 |
|
|
|
27 |
|
|
|
19,412 |
|
|
|
(798 |
) |
|
|
(14,119 |
) |
|
|
4,522 |
|
Sale of Preferred Stock through
private placement at an average
price of $35.00 per share |
|
|
342,857 |
|
|
|
34 |
|
|
|
|
|
|
|
|
|
|
|
11,578 |
|
|
|
|
|
|
|
|
|
|
|
11,612 |
|
Fair value of beneficial conversion
rights issued in connection with
issuance of Series C Preferred Stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,621 |
|
|
|
|
|
|
|
|
|
|
|
2,621 |
|
Preferred Dividend and accretion of
fair value of beneficial conversion
charge |
|
|
25,298 |
|
|
|
3 |
|
|
|
|
|
|
|
|
|
|
|
(3 |
) |
|
|
|
|
|
|
(2,621 |
) |
|
|
(2,621 |
) |
Employee share-based compensation
expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,193 |
|
|
|
|
|
|
|
|
|
|
|
1,193 |
|
Non-employee share-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
83 |
|
|
|
|
|
|
|
|
|
|
|
83 |
|
Reclassification of prior year
non-employee compensation to prepaid expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
487 |
|
|
|
|
|
|
|
487 |
|
Effects of adoption of SFAS 123R |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(311 |
) |
|
|
311 |
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(7,046 |
) |
|
|
(7,046 |
) |
|
|
|
Balance, December 31, 2006 |
|
|
368,155 |
|
|
$ |
37 |
|
|
|
26,542,924 |
|
|
$ |
27 |
|
|
$ |
34,573 |
|
|
$ |
|
|
|
$ |
(23,786 |
) |
|
$ |
10,851 |
|
|
|
|
See accompanying notes to consolidated financial statements.
41
NEUROLOGIX, INC. AND SUBSIDIARY
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Amounts in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the period February |
|
|
|
|
|
|
|
|
|
|
12, 1999 (inception) |
|
|
Year Ended December 31, |
|
through |
|
|
2006 |
|
2005 |
|
December 31, 2006 |
|
|
|
Operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(7,046 |
) |
|
$ |
(5,345 |
) |
|
$ |
(21,165 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation |
|
|
67 |
|
|
|
78 |
|
|
|
335 |
|
Amortization |
|
|
118 |
|
|
|
32 |
|
|
|
219 |
|
Stock options granted for services |
|
|
|
|
|
|
|
|
|
|
9 |
|
Impairment of intangible assets |
|
|
|
|
|
|
97 |
|
|
|
148 |
|
Amortization of non-employee share-based compensation |
|
|
83 |
|
|
|
825 |
|
|
|
1,297 |
|
Share-based employee compensation expense |
|
|
1,193 |
|
|
|
|
|
|
|
1,193 |
|
Non-cash interest expense |
|
|
|
|
|
|
2 |
|
|
|
378 |
|
Changes in operating assets and liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
Decrease in prepaid expenses and other current assets |
|
|
851 |
|
|
|
71 |
|
|
|
670 |
|
Increase (decrease) in accounts payable and accrued expenses |
|
|
(154 |
) |
|
|
621 |
|
|
|
668 |
|
|
|
|
Net cash used in operating activities |
|
|
(4,888 |
) |
|
|
(3,619 |
) |
|
|
(16,248 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Security deposits paid |
|
|
|
|
|
|
|
|
|
|
(7 |
) |
Purchases of equipment |
|
|
(92 |
) |
|
|
(45 |
) |
|
|
(390 |
) |
Additions to intangible assets |
|
|
(196 |
) |
|
|
(173 |
) |
|
|
(849 |
) |
Purchases of marketable securities |
|
|
(5,000 |
) |
|
|
(5,200 |
) |
|
|
(12,673 |
) |
Proceeds from maturities of marketable securities |
|
|
7,800 |
|
|
|
4,000 |
|
|
|
12,673 |
|
|
|
|
Net cash provided by (used in) investing activities |
|
|
2,512 |
|
|
|
(1,418 |
) |
|
|
(1,246 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from note payable |
|
|
|
|
|
|
|
|
|
|
1,100 |
|
Borrowings from related party |
|
|
|
|
|
|
|
|
|
|
2,000 |
|
Cash acquired in Merger |
|
|
|
|
|
|
|
|
|
|
5,413 |
|
Merger-related costs |
|
|
|
|
|
|
|
|
|
|
(375 |
) |
Payments of capital lease obligations |
|
|
(13 |
) |
|
|
(23 |
) |
|
|
(99 |
) |
Proceeds from exercise of stock options |
|
|
|
|
|
|
127 |
|
|
|
142 |
|
Proceeds from issuance of common stock and warrants |
|
|
|
|
|
|
5,066 |
|
|
|
5,066 |
|
Proceeds from issuance of preferred stock |
|
|
11,612 |
|
|
|
|
|
|
|
14,725 |
|
|
|
|
Net cash provided by financing activities |
|
|
11,599 |
|
|
|
5,170 |
|
|
|
27,972 |
|
|
|
|
Net increase in cash and cash equivalents |
|
|
9,223 |
|
|
|
133 |
|
|
|
10,478 |
|
Cash and cash equivalents, beginning of period |
|
|
1,255 |
|
|
|
1,122 |
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of period |
|
$ |
10,478 |
|
|
$ |
1,255 |
|
|
$ |
10,478 |
|
|
|
|
Supplemental disclosure of non-cash investing and financing
activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Dividends on Series C Preferred Stock paid in preferred shares |
|
$ |
614 |
|
|
|
|
|
|
$ |
614 |
|
Accrued dividends on Series C Preferred Stock |
|
$ |
94 |
|
|
|
|
|
|
$ |
94 |
|
42
NEUROLOGIX, INC. AND SUBSIDIARY
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Amounts in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the period February |
|
|
|
|
|
|
|
|
|
|
12, 1999 (inception) |
|
|
Year Ended December 31, |
|
through |
|
|
2006 |
|
2005 |
|
December 31, 2006 |
|
|
|
Accretion of fair value of beneficial conversion on preferred stock |
|
$ |
2,621 |
|
|
|
|
|
|
$ |
2,621 |
|
Issuance of Common Stock to pay debt |
|
|
|
|
|
|
|
|
|
$ |
2,372 |
|
Reverse
acquisition net liabilities assumed, excluding cash |
|
|
|
|
|
|
|
|
|
$ |
(214 |
) |
Mandatory redeemable convertible preferred stock converted to
Common Stock |
|
|
|
|
|
|
|
|
|
$ |
500 |
|
Common Stock issued to acquire intangible assets |
|
|
|
|
|
|
|
|
|
$ |
24 |
|
Stock options granted for services |
|
|
|
|
|
$ |
1,305 |
|
|
$ |
1,424 |
|
Deferred research and development cost resulting from Medtronic
Stock Purchase |
|
|
|
|
|
$ |
795 |
|
|
$ |
795 |
|
Acquisition of equipment through capital leases |
|
|
|
|
|
|
|
|
|
$ |
106 |
|
See accompanying notes to consolidated financial statements.
43
Neurologix, Inc. and Subsidiary
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except for share and per share amounts)
(1) |
|
Description of Business |
Neurologix, Inc. (Neurologix or the Company), 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 developmental stage company.
The Company incurred net losses of $7,046, $5,345 and $21,165 and negative cash flows from
operating activities of $4,888, $3,619 and $16,248 for the years ended December 31, 2006 and 2005
and for the period from February 12, 1999 (inception) to December 31, 2006, respectively. The
Company expects that it will continue to incur net losses and cash flow deficiencies from operating
activities for the foreseeable future.
On May 10, 2006, the Company completed a private placement of a new series of preferred stock,
resulting in net proceeds to the Company, after expenses, of $11,612. As of December 31, 2006, the
Company had cash and cash equivalents of $10,478. Management believes that, as a result of this
offering, the Companys current resources will enable it to continue as a going concern through at
least December 31, 2007. Although the Company believes that its resources are sufficient to
initiate a Phase II trial for Parkinsons disease and to complete a Phase I clinical trial for
epilepsy, the Companys resources are not sufficient to allow it to perform all of the clinical
trials required for drug approval and marketing. Accordingly, it will, from time to time, 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 and basis of presentation |
(a) Basis of Presentation:
On February 10, 2004, the Company completed a merger (the Merger) of its newly-formed,
wholly-owned subsidiary with Neurologix Research Inc. (NRI). Following 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
Common Stock outstanding after the Merger. The shares of NRI common stock, convertible preferred
stock and Series B convertible preferred stock out-standing at the effective time of the Merger
were converted into an aggregate of 15,408,413 shares of 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 Common Stock. In addition, the Board and management of
the Company were then controlled by members of the board of directors and management of NRI prior
to the Merger.
44
Neurologix, Inc. and Subsidiary
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except for share and per share amounts)
Accordingly, the Merger had 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
financial statements reflect the historical financial statements of NRI, the accounting acquirer,
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 subsidiarys results of operations from that date.
On September 10, 2004, pursuant to the written consent of stockholders owning approximately
59% of 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 Companys number of authorized shares of Common Stock from 750,000,000 to 60,000,000.
All information related to Common Stock, preferred stock, options and warrants to purchase Common
Stock and loss per share included in the accompanying consolidated financial statements has been
retroactively adjusted to give effect to the Companys 1 for 25 reverse stock split, which became
effective on September 10, 2004.
Effective December 31, 2005, the Company completed a short-form merger whereby its operating
subsidiary, NRI, was merged with and into the Company. Following the merger, NRI no longer exists
as a separate corporation. As the surviving corporation in the merger, the Company assumed all
rights and obligations of NRI. The short form merger was completed for administrative purposes and
did not have any material impact on the Company or its operations or financial statements.
Certain prior period amounts have been reclassified to conform to the current period
presentation.
(b) Development Stage:
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.
(c) Principles of Consolidation:
The consolidated financial statements include the accounts of the Company and its former
wholly owned subsidiary, NRI. All significant intercompany transactions and balances have been
eliminated in consolidation.
(d) Use of Estimates:
The preparation of financial statements in conformity with accounting principles generally
accepted in the United States of America requires management to make estimates and
45
Neurologix, Inc. and Subsidiary
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except for share and per share amounts)
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 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.
(e) Cash and Cash Equivalents:
The Company considers all highly liquid investments purchased with an original maturity when
purchased 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.
(f) Equipment:
Equipment is stated at cost less accumulated depreciation. The Company records depreciation
of property and equipment using accelerated methods over an estimated useful life of between three
and seven years.
(g) Intangible Assets:
Intangible assets consist of patents and patent rights developed internally and obtained under
licensing agreements and are amortized on a straight-line basis over the estimated useful lives
which range from 15 to 20 years. Neurologix estimates amortization expenses related to intangible
assets owned as of December 31, 2006 to be approximately $60 per year for the next five years.
(h) Impairment of Long-Lived Assets:
The Company follows SFAS No. 144, Accounting for the Impairment or Disposal of Long-Lived
Assets, which requires impairment losses to be recorded on long-lived assets with definitive lives
when indicators of impairment are present and the undiscounted cash flows estimated to be generated
by those assets are less than the assets carrying amount. In the evaluation of the fair value and
future benefits of long-lived assets, the Company performs an analysis of the anticipated
undiscounted future net cash flows of the related long-lived assets. If the carrying value of the
related asset exceeds the undiscounted cash flows, the carrying value is reduced to its fair value.
Various factors including future sales growth and profit margins are included in this analysis.
The Company recognized losses of $71 and $97 associated with abandoned patents that were written-off
in 2006 and 2005, respectively.
46
Neurologix, Inc. and Subsidiary
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except for share and per share amounts)
(i) Income Taxes:
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) Research and Development:
Research and development expenses consist of costs incurred in identifying, developing and
testing product candidates. These expenses consist primarily of salaries and related expenses for
personnel, fees of the Companys scientific and research consultants and related costs, contracted
research fees and expenses, clinical studies and license agreement milestone and maintenance fees.
Research and development costs are expensed as incurred. Up front license fees are expensed when
paid, and milestone fees are expensed upon the attainment of such milestone. Certain other
expenses, such as fees to consultants, fees to collaborators for research activities and costs
related to clinical trials, are incurred over multiple reporting periods. Management assesses how
much of these multi-period costs should be charged to research and development expense in each
reporting period.
(k) Stock-Based Compensation:
At December 31, 2006, the Company had one active share-based employee compensation plan. Stock
option awards granted from this plan are granted at the fair market value on the date of grant, and
vest over a period determined at the time the options are granted, ranging from one to five years,
and generally have a maximum term of ten years. Certain options provide for accelerated vesting if
there is a change in control (as defined in the plans). When options are exercised, new shares of
the Companys common stock (the Common Stock) are issued.
At the Companys Annual Meeting of Stockholders held on May 9, 2006, the Companys 2000 Stock
Option Plan was amended to increase the number of shares that may be issued pursuant thereto from
1,300,000 to 3,800,000 shares.
Prior to January 1, 2006, the Company accounted for share-based employee compensation,
including employee stock options, using the intrinsic value method prescribed in Accounting
Principles Board Opinion No. 25, Accounting for Stock Issued to Employees and related
Interpretations (APB Opinion No. 25). Under APB Opinion No. 25, no compensation cost was
recognized for stock options granted with an exercise price equal to or greater than the market
price and disclosure was made regarding the pro forma effect on net earnings assuming compensation
cost had been recognized using a fair-value method in accordance with Statement of Financial
Accounting Standards No. 123, Accounting for Stock-Based Compensation (SFAS No. 123).
47
Neurologix, Inc. and Subsidiary
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except for share and per share amounts)
Effective January 1, 2006, the Company adopted Statement of Financial Accounting Standards No.
123R Share-based Payment (SFAS No. 123R) for employee stock options and other share based
compensation using the modified prospective method. No share-based employee compensation cost had
been reflected in net loss prior to the adoption of SFAS No. 123R. Results for prior periods have
not been restated.
Under SFAS 123R, compensation expense is recognized for awards that are granted, modified or
cancelled on or after January 1, 2006 as well as for the portion of awards previously granted that
had not vested as of January 1, 2006. Compensation expense for these previously granted awards is
being recognized over the remaining service period using the compensation cost calculated based on
the same estimate of grant-date fair value previously reported for pro-forma disclosure purposes
under FAS 123R. As of December 31, 2006, total unrecognized compensation cost related to stock
option awards was approximately $438 and the related weighted-average period over which it is
expected to be recognized is approximately 1.38 years.
During 2006, the Company recognized employee total stock-based compensation expense of $1,193,
or $0.04 per share, of which $134 was classified as research and development expense and $1,059 was
classified as general and administrative expense.
A summary of option activity as of December 31, 2006 and changes during the year then ended is
presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
Shares |
|
Weighted- |
|
Average |
|
|
|
|
Subject to |
|
Average |
|
Remaining |
|
Aggregate |
|
|
Option |
|
Exercise |
|
Contractual |
|
Intrinsic |
Options |
|
(000) |
|
Price |
|
Term (years) |
|
Value |
Outstanding at
January 1, 2006 |
|
|
2,225 |
|
|
$ |
1.25 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
1,155 |
|
|
|
1.53 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited or expired |
|
|
(364 |
) |
|
|
(0.09 |
) |
|
|
|
|
|
|
|
|
Outstanding at
December 31, 2006 |
|
|
3,016 |
|
|
$ |
1.50 |
|
|
|
7.15 |
|
|
$ |
0 |
|
Exercisable at
December 31, 2006 |
|
|
2,234 |
|
|
$ |
1.47 |
|
|
|
6.40 |
|
|
$ |
0 |
|
The weighted-average grant-date fair value of options granted during the year ended December
31, 2006 and 2005, respectively was $1.15 and $1.51 and were estimated using the Black Scholes
option valuation model.
The fair value of each stock option award is estimated under SFAS No. 123R and was estimated
under SFAS No. 123 on the date of the grant using the Black-Scholes option pricing model based on
the assumptions noted in the following table. Expected volatility is based on historical
volatility of the Common Stock.
48
Neurologix, Inc. and Subsidiary
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except for share and per share amounts)
See Note 7 for additional information about the
Companys stock compensation plans. The risk-free rate is based on the five year U.S. Treasury
security rate.
The expected term represents the period that stock-based awards are expected to be outstanding
based on the simplified method provided in Staff Accounting Bulletin No. 107 (SAB 107) which
averages an awards weighted average vesting period and expected term for plain vanilla share
options. Under SAB 107, options are considered to be plain vanilla if they have the following
basic characteristics: granted at-the-money; exerciseability is conditioned upon service through
the vesting date; termination of service prior to vesting results in forfeiture; limited exercise
period following termination of service; and options are non-transferable and non-hedgeable.
The following are the assumptions used with the Black-Scholes option
pricing model in determining stock-based compensation under SFAS No.
123R in 2006 and the proforma disclosures below required as a result
of the use of the intrinsic value method under APB 25 in 2005:
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
2006 |
|
2005 |
Expected option term |
|
5 to 6.5 years |
|
5 |
Risk-free interest rate |
|
4.07% - 5.10% |
|
4.33% |
Expected volatility |
|
86.5% - 90.3% |
|
98.3% - 116.1% |
Dividend yield |
|
0% |
|
0% |
The following table illustrates the pro-forma effect on net loss and net loss applicable to
common stock per share as if the Company had applied the fair value recognition provisions of SFAS
No. 123 to all outstanding stock option awards in 2005 prior to the Companys
adoption of SFAS No. 123R:
|
|
|
|
|
|
|
Year Ended |
|
|
December 31, |
|
|
2005 |
Net loss applicable to common stock, as reported |
|
$ |
(5,345 |
) |
Add: Total stock-based employee compensation expense
included in reported net loss |
|
|
388 |
|
Deduct: Total stock-based employee compensation expense
determined under fair value based method |
|
|
517 |
|
|
|
|
|
Pro-forma net loss applicable to common stock |
|
$ |
(5,474 |
) |
|
|
|
|
Net loss applicable to common stock per share: |
|
|
|
|
Basic and diluted as reported |
|
$ |
(0.21 |
) |
|
|
|
|
Basic and diluted pro-forma |
|
$ |
(0.21 |
) |
|
|
|
|
(l) Basic and Diluted Net Loss Per Common Share:
Basic net loss per common share excludes the effects of potentially dilutive securities and is
computed by dividing net loss applicable to Common Stockholders by the weighted average number of
common shares outstanding for the period. Diluted net income or loss per common share is adjusted
for the effects of convertible securities, options, warrants and other potentially dilutive
financial instruments only in the periods in which such effects would have been dilutive.
49
Neurologix, Inc. and Subsidiary
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except for share and per share amounts)
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:
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
2006 |
|
2005 |
Stock options |
|
|
3,015,829 |
|
|
|
2,225,220 |
|
Warrants |
|
|
3,131,585 |
|
|
|
906,867 |
|
Common Stock issuable upon conversion of Series
A Convertible Preferred Stock |
|
|
645 |
|
|
|
645 |
|
Common Stock issuable upon conversion of Series
C Convertible Preferred Stock |
|
|
7,238,995 |
|
|
|
|
|
(m) New Accounting Pronouncements
In September 2006, the FASB issued Statement of Financial Accounting Standards No. 157 (SFAS
157), Fair Value Measurements, which defines fair
value, establishes guidelines for measuring
fair value and expands disclosures regarding fair value measurements. SFAS 157 does not require any
new fair value measurements but rather eliminates inconsistencies in guidance found in various
prior accounting pronouncements. SFAS 157 is effective for fiscal years beginning after November
15, 2007. Earlier adoption is permitted, provided the company has not yet issued financial
statements, including for interim periods, for that fiscal year. The Company is currently
evaluating the impact of SFAS 157, but does not expect the adoption of SFAS 157 to have a material
impact on its consolidated financial position, results of operations or cash flows.
In July 2006, the FASB issued FASB Interpretation No. 48 (FIN 48) Accounting for
Uncertainty in Income Taxes (an interpretation of FASB Statement No. 109) which is effective for
fiscal years beginning after December 15, 2006. The new guidance will be effective for the Company
on January 1, 2007. This interpretation was issued to clarify the accounting for uncertainty in the
amount of income taxes recognized in the financial statements by prescribing a recognition
threshold and measurement attribute for the financial statement recognition and measurement of a
tax position taken or expected to be taken in a tax return. The provisions of FIN 48 are effective
as of the beginning of 2007, with the cumulative effect of the change in accounting principle
recorded as an adjustment to retained earnings. The Company does not expect the adoption of FIN 48
to have a material impact on its consolidated financial position, results of operations or cash
flows.
(3) |
|
Related Party Transactions: |
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. In accordance with Rockefellers Intellectual Property Policy, an
aggregate of one-third of all income it receives from licensing transactions is paid to
50
Neurologix, Inc. and Subsidiary
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except for share and per share amounts)
the inventors. Dr. Michael G. Kaplitt (Michael Kaplitt), one of the Companys scientific
co-founders and the son of Dr. Martin J. Kaplitt (Martin Kaplitt), the Companys former Executive
Chairman and the current Chairman of the Board of Directors, has advised the Company that he
received less than $2 in each of 2006 and 2005 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 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, Michael Kaplitt estimates that he will be entitled to approximately 25% of the
proceeds. Michael Kaplitt will also have a similar interest in future royalties that may become
payable under the agreement with Rockefeller.
Between February 2004 and July 2005, Refac, which is approximately 90% owned by Palisade
Concentrated Equity Partnership, L.P., a private equity partnership managed by Palisade Capital
Management, LLC (PCM), 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. Under
this arrangement, the Company paid $0 and $43 with respect to services rendered during 2006 and
2005, respectively. PCM is the beneficial owner of approximately 20% of the Companys outstanding
Common Stock.
The Company is party to an Amended and Restated Consulting Agreement, dated April 25, 2005,
with Dr. Michael G. Kaplitt (Michael Kaplitt Consulting Agreement), one of the Companys
scientific co-founders and the son of Dr. Martin J. Kaplitt, the Companys Chairman of the Board
and former Executive Chairman. Pursuant to the terms of this agreement, Dr. Kaplitt provides advice
and consulting services on an exclusive basis in scientific research on human gene therapy in the
nervous system and serve as a member of the Companys Scientific Advisory Board. Dr. Kaplitt was
paid an annual retainer of $100 in equal quarterly installment payments from October 2005
through September 2006. Effective October 1, 2006 Dr. Kaplitts annual retainer was increased to
$175 payable in equal quarterly installment payments, which installment payments commenced in
January 2007. The Company paid Dr. Kaplitt approximately
$119 and $25 in retainer fees in
2006 and 2005 respectively thereunder.
Under the Michael Kaplitt Consulting Agreement, the Company granted Dr. Kaplitt non-qualified
stock options to purchase 160,000 shares of Common Stock at an exercise price of $2.05 per share on
April 25, 2005. Twenty percent of the options became exercisable on the date of the grant and the
balance vested on December 31, 2005. The fair value of the
options of $208 at the measurement date, determined by using
the Black-Scholes pricing model, is being amortized to expense over the five-year term of the
Michael Kaplitt Agreement. The amount charged to operations for the years ended December 31, 2006
and 2005 were $43 and $31, respectively.
Dr. Matthew During, a founder of the Company and a member of its Scientific Advisory Board,
has advised the Company that in each of 2005 and 2006 he received
approximately $17 from Thomas
Jefferson University (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 in each of
51
Neurologix, Inc. and Subsidiary
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except for share and per share amounts)
2005 and 2006. Dr. During will also have a similar interest in future royalties that may
become payable under the agreement with TJU. Dr. During and the Company entered into a consulting
agreement in October 1999 which was subsequently amended. The consulting agreement provides for
payments to Dr. During of $175 per year through September 2007.
The Company is party to a sublease, dated August 10, 2004, for the Companys space at One
Bridge Plaza, Fort Lee, New Jersey at a base annual rent of approximately $35, which lease expires
on January 31, 2008. The rent that the Company pays to PCS is the same rental amount that PCS pays
under its master lease for this space.
In April 2005, the Company entered into an agreement pursuant to which PCM provided
administrative support services at a rate of $3 per month. Under the terms of the agreement,
either party had the right to terminate at any time upon 30 days prior notice. The administrative
services agreement was terminated in November 2005.
Effective July 17, 2006, Dr. Michael Sorell resigned as the Companys President and Chief
Executive Officer. In connection with such resignation, the Company and Dr. Sorell entered into a
Separation Agreement. Pursuant to this agreement, the Company will pay Dr. Sorell severance of
$185, payable in equal semi-monthly installments through September 30, 2007. The agreement also
provides for the immediate vesting of Dr. Sorells stock options. See Note 6 for the accounting
treatment of Dr. Sorells separation. Such options will terminate upon the later of (i) the 15th
day following the date on which Dr. Sorell ceases to be a director of the Company or (ii) December
31st of the calendar year during which Dr. Sorell ceases to be a director of the Company. Dr.
Sorell is currently a Class I director of the Company, but is not standing for re-election at the
2007 Annual Meeting of Stockholders.
Effective February 23, 2007, the Company entered into a consulting agreement with Martin J.
Kaplitt, M.D., the Chairman of the Companys Board of Directors. Under the terms of this agreement,
Dr. Martin Kaplitt will provide medical and scientific consulting and advisory services to the
Company for a one year period, unless sooner terminated pursuant to its terms. Dr. Martin Kaplitt
will receive annual compensation of $85. Effective as of this date, Dr. Martin Kaplitt no
longer serves the Executive Chairman of the Company, but will continue to serve as Chairman of the
Companys Board of Directors.
Additionally, the Company maintains a brokerage account with PCS for certain of the Companys
marketable securities for which it pays customary brokerage fees.
In April 2001, two consultants borrowed an aggregate of $500 from the Company in exchange for
two full recourse promissory notes, accruing interest and were due on April 25, 2006 (the Notes).
In December 2003, after both consultants were continually delinquent in their payments, the
Company established a full valuation allowance for the remaining principal amount of the Notes
totaling $473. By December 2004, the Company entered into settlement agreements with both
consultants which provide for payments totaling $153 to be made through
52
Neurologix, Inc. and Subsidiary
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except for share and per share amounts)
July 2009. As of December 31, 2006, the Company recovered a total of $133 under these
settlement agreements. The Company has charged all recoveries received through December 31, 2006
to other income in its consolidated statement of operations.
At December 31, 2006, the Company has net operating loss carryforwards (NOLs) of
approximately $20,056 which, if not used, expire through 2026. The deferred tax asset for the
Companys NOLs approximated $8,010. The Company has a deferred tax asset from research and
development credits of approximately $855 at December 31, 2006, which, if not used, will also
expire through 2026. The Company records a valuation allowance against deferred tax assets to the
extent that it is more likely than not that some portion, or all of, the deferred tax assets will
not be realized. Due to the significant doubt related to the Companys ability to utilize its
deferred tax assets, a valuation allowance for the full amount of the deferred tax assets of $8,865
has been established at December 31, 2006. There are no other significant permanent or temporary
differences.
The Company had also offset the potential benefit of $2,006 from NOLs by equivalent valuation
allowances as of December 31, 2005. As a result of the increases in the valuation allowance of
$2,253, $2,550 and $8,865 during the years ended December 31, 2006 and 2005 and for the period from
February 12, 1999 (inception) to December 31, 2006, 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, |
|
|
2006 |
|
2005 |
|
|
|
Net deferred income tax assets: |
|
|
|
|
|
|
|
|
Net operating losses |
|
$ |
8,010 |
|
|
$ |
6,004 |
|
Research & development credit |
|
|
855 |
|
|
|
608 |
|
|
|
|
Total net deferred income tax assets |
|
|
8,865 |
|
|
|
6,612 |
|
Valuation allowance |
|
|
(8,865 |
) |
|
|
(6,612 |
) |
|
|
|
Total net deferred income tax assets |
|
$ |
|
|
|
$ |
|
|
|
|
|
(6) |
|
Agreements with Dr. Michael Sorell |
Effective September 21, 2004, the Board entered into an employment agreement with Dr. Michael
Sorell to serve as the President and Chief Executive Officer of the Company for an initial term of
employment of 18 months, which was automatically extended for an additional 18 months on March 21,
2006. Dr. Sorell received an initial annual base salary of $150, which was increased to $182
effective March 15, 2005 as a result of achieving specified performance objectives of the Company.
Upon achieving further performance objectives, Dr. Sorells salary
53
Neurologix, Inc. and Subsidiary
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except for share and per share amounts)
was increased to $200 effective April 27, 2005. In addition to cash compensation, Dr.
Sorells employment agreement also provided for the grant of options as described in Note 7.
Effective July 17, 2006, Dr. Michael Sorell resigned as the President and Chief Executive
Officer. In connection with such resignation, the Company and Dr. Sorell entered into a Separation
Agreement. This agreement provided for such resignation effective July 17, 2006. Dr. Sorell will
continue as a director of the Company, without further compensation. Dr. Sorell is not expected to
stand for re-election at the 2007 Annual Meeting of Stockholders.
The Company will pay Dr. Sorell severance of $185, payable in equal semi-monthly installments
through September 30, 2007. The Company recognized this amount as compensation expense in July
2006.
In connection with the agreement, the Company modified the vesting terms for options
representing 149,397 shares of common stock to allow for immediate vesting. The Company also
modified the expiration terms for options representing 638,418 shares of common stock to allow for
an extended period to exercise all vested stock options. Such options will terminate upon the
later of (i) the 15th day following the date on which Dr. Sorell ceases to be a director of the
Company or (ii) December 31st of the calendar year during which Dr. Sorell ceases to be a director
of the Company. The Company recognized a non-cash compensation charge of $232 in 2006 as a result
of the accelerated vesting of and the extension of the exercise period for Dr. Sorells stock
options.
(7) |
|
Stock Options and Warrants: |
2000 Stock Option Plan
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 Plan was amended twice by the Board and the
Companys stockholders to increase the number of shares available for issuance by 3,000,000 shares.
As of December 31, 2006, the Company had 713,185 shares available for issuance under the plan.
On November 9, 2005, the Board approved that all non-vested options held by any of the
Companys consultants would be accelerated to vest as of December 31, 2005. There were 220,500 of
non-vested options which vested as of December 31, 2005. No other terms or conditions of the
options held by the consultants were modified. The acceleration of these options was approved to
eliminate the unnecessary variation effect on the statement of operations and the expense
associated with the accounting for such options to the extent that they remained as un-vested.
54
Neurologix, Inc. and Subsidiary
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except for share and per share amounts)
Dr. Sorell Options
Base Stock Option Grant The Company is party to a Stock Option Agreement with Dr. Sorell,
dated September 21, 2004, 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, the fair market value on
the date of the grant. These options included a base grant and an incentive grant. The base grant
consisted of an option to purchase 250,000 shares of Common Stock vesting as follows 25,000
immediately upon issuance, 100,000 shares on March 31, 2005, 100,000 shares on December 31, 2005
and 25,000 shares on March 31, 2006.
Performance Incentive Stock Option Grant The incentive grant originally consisted of options
to purchase up to 900,000 shares of Common Stock at an exercise price of $0.75 per share (the
Incentive Grant). The ultimate number of shares issued under the Incentive Grant was 537,815 on
April 27, 2005 and was determined by reference to the amount of gross proceeds raised in equity
financings by the Company on or before December 31, 2005, taking into account the price per share
paid for Common Stock issued in such financings. Since the issuance of the options was conditioned
on Dr. Sorell raising the proceeds, the grant date of April 27, 2005 was considered the date the
options were actually granted, at which time the closing stock price was $2.05. Through December
31, 2005, the Company raised gross proceeds of approximately $5,216 at an average price of $1.44
per share.
The options covered by the Incentive Grant were issued at an exercise price of $0.75 per
share. Since the fair value, determined by the quoted market price of the underlying shares on the
measurement date in April 2005 exceeded the exercise price, the difference or intrinsic value was
amortized as compensation expense over the vesting period of the options through December 31, 2005.
Beginning January 1, 2006 through Dr. Sorells termination date (see Note 6), compensation expense
was recognized at fair value for all unvested options previously granted in accordance with SFAS
No. 123R. The expense recognized for 2006 through July 17, 2006 and for the year ended December
31, 2005 was $154 and $388, respectively.
On July 17, 2006, Dr. Sorell resigned as the Companys President and Chief Executive Officer
(see Note 6). In connection with such resignation, the Company and Dr. Sorell entered into a
Separation Agreement. The agreement provided for the immediate vesting of Dr. Sorells stock
options. Such options will terminate upon the later of (i) the 15th day following the date on
which Dr. Sorell ceases to be a director of the Company or (ii) December 31st of the calendar year
during which Dr. Sorell ceases to be a director of the Company. Dr. Sorell is not expected to
stand for re-election as a director at the 2007 Annual Meeting of Stockholders. The Company
recognized an additional non-cash compensation charge of $232 in 2006 as a result of the
accelerated vesting of and the extension of the exercise period for Dr. Sorells stock options.
Option
Activity
The following table summarizes the Companys option activity for the years ended December 31,
2006 and 2005:
55
Neurologix, Inc. and Subsidiary
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except for share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
Number of Shares |
|
Exercise Price |
January 1, 2005 |
|
|
2,613,459 |
|
|
|
0.83 |
|
Granted |
|
|
620,000 |
|
|
|
1.93 |
|
Exercised |
|
|
(406,054 |
) |
|
|
0.76 |
|
Forfeited/Cancelled |
|
|
(602,185 |
) |
|
|
0.75 |
|
|
|
|
|
|
|
|
|
|
January 1, 2006 |
|
|
2,225,220 |
|
|
|
1.25 |
|
Granted |
|
|
1,155,000 |
|
|
|
1.53 |
|
Forfeited/Cancelled |
|
|
(364,391 |
) |
|
|
0.09 |
|
|
|
|
|
|
|
|
|
|
December 31, 2006 |
|
|
3,015,829 |
|
|
|
1.50 |
|
|
|
|
|
|
|
|
|
|
Employee stock options are granted at a price equal to the fair market value of the
Companys stock on the date of the grant. The weighted average grant-date fair value of options
granted during 2006 and 2005 was $1.15 and $1.51, respectively and were estimated using the Black
Scholes option valuation model. The total intrinsic value of options exercised during 2006 and 2005
was approximately $0 and $697, respectively. The total intrinsic value of options outstanding and
options exercisable at December 31, 2006 was $0 because all outstanding options were out of the
money as of December 31, 2006.
As of December 31, 2006, there was approximately $438 of total unrecognized compensation
expense related to non-vested share-based compensation arrangements, which is expected to be
recognized over a weighted average period of 1.38 years.
As of December 31, 2006, there were 2,234,159 outstanding stock options that had vested with a
weighted average exercise price of $1.47, a weighted average remaining contractual term of 6.4
years and an aggregate intrinsic value of $0.
Warrants
In connection with sale of the Series C Preferred Stock, the Company issued warrants to
purchase approximately 2,224,719 shares of Common Stock at an exercise price of $2.05 per share
that expire on May 10, 2013. The Company initially computed the fair value of the warrants, or
$3,136 using the Black-Scholes option pricing model and then used the relative fair value method to
allocate the proceeds from the offering to the warrants and the Series C Preferred Stock. As a
result of that allocation, the value of the common shares issuable upon the conversion of the
Series C Preferred Stock as of the date of issuance (the amount for which the shares could have
been sold) exceeded the proceeds from the offering allocable to the Series C Preferred Stock by
$2,621. This amount represented the value of beneficial conversion rights which was immediately
accreted. The related charge is reflected in the accompanying consolidated statements of
operations for the year ended December 31, 2006 as an increase in the net loss for the purposes of
determining the net loss applicable to common stock in 2006. The warrants are exercisable anytime
within their terms. No such warrants were exercised in the fiscal
years ended December 31, 2006 and 2005.
56
Neurologix, Inc. and Subsidiary
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except for share and per share amounts)
During the period from February 4, 2005 to April 4, 2005, in connection with the sale of
shares of Common Stock to investors led by Merlin Biomed Group (see Note 9), the Company issued
five-year warrants to purchase a total of 618,479 shares of Common Stock at an exercise price of
$1.625 per share. Beginning in August 2007, if the share price of Common Stock exceeds $3.25 per
share for any ten consecutive trading day period and certain other conditions are met, the Company
may call any or all of the unexercised warrants by purchasing the warrants at a price of $0.01
each. No such warrants were exercised in the fiscal years ended
December 31, 2006 and 2005.
On April 27, 2005, in connection with the sale of shares of Common Stock to Medtronic
International, Ltd. (see Note 9) the Company issued five-year warrants to purchase a total of
285,388 shares of Common Stock at an exercise price of $2.19 per share. As a result of the
transaction, the Company recognized approximately $795 in deferred research and development cost,
an amount that is being expensed over the 24 month term of the agreement on a straight-line basis.
The deferred research and development cost represents the market value of the Common Stock and the
fair value of the warrant, or $2,800 (which was determined using the Black-Scholes pricing model)
issued by the Company on the effective date of the agreement. Beginning in August 2007, if the
share price of Common Stock exceeds $4.38 per share for any ten consecutive trading day period and
certain other conditions are met, the Company may call any or all of the unexercised warrants by
purchasing the warrants at a price of $0.01 each. No such warrants were exercised in the fiscal
years ended December 31, 2006 and 2005.
The following summarizes warrant activity for the years ended December 31, 2006 and 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
Warrants |
|
Exercise Price |
|
|
|
January 1, 2005 |
|
|
828,000 |
|
|
$ |
10.05 |
|
Granted |
|
|
903,867 |
|
|
|
1.80 |
|
Forfeited/Cancelled |
|
|
(825,000 |
) |
|
|
10.00 |
|
|
|
|
|
|
|
|
|
|
January 1, 2006 |
|
|
906,867 |
|
|
|
1.88 |
|
Granted |
|
|
2,224,719 |
|
|
|
2.05 |
|
|
|
|
|
|
|
|
|
|
December 31, 2006 |
|
|
3,131,586 |
|
|
|
2.00 |
|
|
|
|
|
|
|
|
|
|
The weighted-average remaining contractual life of warrants outstanding was 5.44 years at
December 31, 2006. The exercise prices for the warrants outstanding at December 31, 2006 ranged
from $1.625 to $25.00.
(8) |
|
Accounts Payable and Accrued Expenses |
Accounts payable and accrued expenses consist of the following:
57
Neurologix, Inc. and Subsidiary
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except for share and per share amounts)
|
|
|
|
|
|
|
December 31, |
|
|
|
2006 |
|
Accounts payable |
|
$ |
282 |
|
Severance |
|
|
141 |
|
Accounting and auditing fees |
|
|
93 |
|
Consulting fees |
|
|
65 |
|
Research fees |
|
|
56 |
|
Legal fees |
|
|
41 |
|
Other |
|
|
51 |
|
|
|
|
|
|
|
$ |
729 |
|
|
|
|
|
On May 10, 2006, the Company issued and sold 342,857 shares of a newly created series of
preferred stock, par value $.10 per share (the Series C Preferred Stock), at a price of $35.00
per share, or a total of approximately $12,000, to General Electric Pension Trust, DaimlerChrysler
Corporation Master Retirement Trust and certain funds managed by ProMed Management, LLC in a
private placement transaction, resulting in net proceeds after expenses of approximately $11,612.
The shares of Series C Preferred Stock, including all dividends paid to date, are currently
convertible into 19.66 shares of Common Stock per share, or 7,238,995 shares of Common Stock in the
aggregate. The Series C Preferred Stock is not redeemable by the Company. Upon a liquidation
event (such as a liquidation, a merger or a sale of substantially all of the Companys assets), the
holders of Series C Stock will be entitled to receive a per share amount equal to the greater of:
(i) $35 plus unpaid dividends or (ii) the amount payable upon conversion to Common Stock.
The Series C Preferred Stock will accrue cumulative dividends at a rate of 9% per annum,
payable in quarterly installments in shares of Series C Preferred Stock. As of December 31, 2006,
the Company paid dividends by issuing approximately 25,298 shares of Series C Preferred Stock with
a fair value of $614. As of December 31, 2006, the Company accrued dividends of Series C Preferred
Stock with a fair value of $94.
The Series C Preferred Stock will automatically be converted into shares of Common Stock upon
the first public offering of the Companys securities that results in gross proceeds of at least
$50,000,000 or upon the written consent of holders of at least 70% of the outstanding shares of
Series C Preferred Stock.
Each share of Series C Preferred Stock will be entitled to a number of votes per share equal
to the number of shares of underlying Common Stock. As long as the Series C Preferred Stock
comprises at least 5% of the Companys outstanding securities, the Company may not create any new
class of stock that is pari passu with or senior to the Series C Preferred Stock without the
consent of the holders of at least 70% of the Series C Preferred Stock.
The Series C Preferred Stocks conversion rate will be adjusted if the Company issues Common
Stock (or convertible securities) at a price per share that is less than $1.55. There is no
58
Neurologix, Inc. and Subsidiary
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except for share and per share amounts)
termination date for this anti-dilution protection. The Series C Preferred Stock is also
subject to customary adjustment for stock splits and reverse splits, and corporate transactions
such as mergers and reorganizations.
In connection with the sale of the Series C Preferred Stock, the Company also issued warrants
to purchase approximately 2,224,719 shares of Common Stock at an exercise price of $2.05 per share
that expire on May 10, 2013. The Company initially computed the fair value of the warrants using
the Black-Scholes option pricing model and then used the relative fair value method to allocate the
proceeds from the offering to the warrants and the Series C Preferred Stock. As a result of that
allocation, the value of the common shares issuable upon the conversion of the Series C Preferred
Stock as of the date of issuance (the amount for which the shares could have been sold) exceeded
the proceeds from the offering allocable to the Series C Preferred Stock by $2,621. This amount
represented the value of beneficial conversion rights which was immediately accreted. The related
charge is reflected in the accompanying consolidated statements of operations for the year ended
December 31, 2006 as an increase in the net loss for the purposes of determining the net loss
applicable to common stock in 2006.
The purchasers of the Series C Preferred Stock, among other things, have certain demand and
piggyback registration rights with respect to the Common Stock underlying the Series C Preferred
Stock and warrants.
During the period from February 4, 2005 to April 4, 2005, pursuant to a Stock Purchase
Agreement, as amended, the Company sold and issued 2,473,914 shares of Common Stock to investors
led by Merlin Biomed Group (the Purchasers), for an aggregate purchase price of $3,216, or $1.30
per share, resulting in net proceeds after expenses of approximately $3,066. The Purchasers also
received five-year warrants to purchase a total of 618,479 shares of Common Stock at an exercise
price of $1.625 per share. Beginning in August 2007, if the share price of Common Stock exceeds
$3.25 per share for any ten consecutive trading day period and certain other conditions are met,
the Company may call any or all of the unexercised warrants by purchasing the warrants at a price
of $0.01 each.
On April 27, 2005, Medtronic International, Ltd. (a wholly-owned subsidiary of Medtronic, Inc.
(Medtronic) and referred to herein as Medtronic International), in conjunction with a
development and manufacturing agreement between the Company and Medtronic (the Development
Agreement), increased its equity investment in the Company by $2,000 through the purchase of
1,141,522 shares of Common Stock at a price of $1.752 per share, plus a warrant to purchase 285,388
shares of Common Stock at an exercise price of $2.19 per share. As a result of the transaction,
the Company recognized approximately $795 in deferred research and development cost, an amount that
is being expensed over the 24 month term of the agreement on a straight-line basis. The deferred
research and development cost represents the market value of the Common Stock and the fair value of
the warrant (which was determined using the Black-Scholes pricing model) issued by the Company on
the effective date of the agreement, which totaled approximately $2,800, less the aggregate price
Medtronic paid for the Common Stock. The amounts charged to operations in 2006 and 2005 were
approximately $398 and $265. The Company has the option to call the warrant following the
thirtieth month after the
59
Neurologix, Inc. and Subsidiary
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except for share and per share amounts)
date of issuance, provided that at such time there is a shelf registration statement effective
for at least six months covering the shares of Common Stock underlying the warrant. If the holder
does not exercise the warrant once the call option requirements have been met, the Company may
redeem the Warrant at a price of $0.01 per share. Medtronic International is the beneficial owner
of approximately 6.0% of the outstanding Common Stock as of December 31, 2006. See Note 10 for a
discussion of the Development Agreement.
(10) |
|
Commitments and Contingencies: |
License Agreements:
The Company entered into a Sublicense Agreement (the Sublicense Agreement), effective as of
August 4, 2006, with Diamyd Therapeutics AB, a subsidiary of Diamyd Medical, AB (Diamyd), a
company organized under the laws of Sweden. Pursuant to the Sublicense Agreement, Diamyd granted
to the Company a non-exclusive worldwide license to certain patent rights and technical information
for the use of a gene version of glutamic acid decarboxylase (GAD) 65 in connection with the gene
therapy treatment of Parkinsons disease as conducted by the Company during its Phase I clinical
trial. Diamyd is the exclusive licensee of such patent rights owned by the Regents of the
University of California, Los Angeles, which has approved the Sublicense Agreement. Pursuant to
the Sublicense Agreement, the Company paid Diamyd an initial fee of $500, an amount that was
expensed as research and development expense on the effective date of the Sublicense Agreement.
Additionally, the Company will pay annual license maintenance fees of $75 beginning on January 1,
2008 through the term of the agreement and will make certain milestone and royalty payments to
Diamyd as provided for in the Sublicense Agreement. The Sublicense Agreement is terminable at any
time by the Company upon 90 days notice.
The Company entered into a License Agreement (the KEIO License Agreement), effective as of
April 1, 2005, with KEIO University (KEIO), whereby KEIO granted to the Company the sole and
exclusive right and license to certain patent rights and technical information throughout the world
with the exception of Japan. Pursuant to the KEIO License Agreement, the Company paid KEIO an up
front payment of $75. The KEIO License Agreement was terminated effective January 2006, because
KEIO was unable to deliver its patented technology in accordance with agreement specifications.
Pursuant to the Rockefeller 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 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
60
Neurologix, Inc. and Subsidiary
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except for share and per share amounts)
licensing expense over four years, the estimated benefit period. The amount charged to
operations for each of the years ended December 31, 2006 and 2005 was $144.
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 are currently set to expire through October
2021. The Company has the right to terminate the agreements at any time upon 90 days written
notice to the university. The Company expenses maintenance fees when the services are rendered.
The amount charged to operations in connection with the TJU agreements for each of the years ended
December 31, 2006 and December 31, 2005 was $95.
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. The Company expenses maintenance fees
when the services are rendered. The amount charged to operations in connection with Rockefeller
and Yale agreement for each of the years ended December 31, 2006 and December 31, 2005 was $10.
Research Agreements:
The following table summarizes the Companys research and development expenses for fiscal
years ended December 31, 2006 and 2005:
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
License & Research Agreements |
|
$ |
847 |
|
|
$ |
499 |
|
Development and Manufacturing |
|
|
824 |
|
|
|
761 |
|
Compensation Expenses |
|
|
620 |
|
|
|
321 |
|
Medical and Scientific Consultants |
|
|
679 |
|
|
|
482 |
|
Clinical Trial Expenses |
|
|
132 |
|
|
|
361 |
|
Laboratory Supplies |
|
|
214 |
|
|
|
251 |
|
Other R&D Expenses |
|
|
265 |
|
|
|
160 |
|
|
|
|
|
|
|
|
Total |
|
$ |
3,581 |
|
|
$ |
2,835 |
|
|
|
|
|
|
|
|
On April 15, 2005, the Company entered into a Research Agreement with Auckland
Uniservices, Ltd. whereby Auckland Uniservices will perform certain research activities for a fee
61
Neurologix, Inc. and Subsidiary
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except for share and per share amounts)
of $282 to be paid in three equal installments of $94 over an 18-month period with the first
payment made on April 30, 2005. The research activities to be performed will include, but are not
necessarily restricted to, gene therapy research studies on Parkinsons disease. In addition, the
research may include work on gene delivery systems, new viral and non-viral vectors, animal models
of neurological and metabolic diseases and pre-clinical gene therapy studies on epilepsy and other
neurological disorders. The Company made payments of $94 and $188 in 2006 and 2005, respectively.
In October 2006, the term of the Research Agreement expired and was not renewed.
On April 27, 2005, the Company entered into the Development Agreement with Medtronic (see Note
9). The Development Agreement provides that the Company will use its experience in technology
relating to biologics for the treatment of Parkinsons disease and temporal lobe epilepsy and
Medtronic will use its experience in delivery systems for biologic and pharmaceutical compositions
to collaborate on a project through which Medtronic will develop a system for delivering biologics
(the Product). The Development Agreement will be in place for two years and will renew
automatically for successive one-year periods thereafter, unless either party gives the other at
least sixty days prior written notice of its intent not to renew. Under the Development
Agreement, the Company is required to pay development costs of $850 to Medtronic over the course of
the project based upon development milestones. As of December 31, 2006, the Company had paid $638
to Medtronic for milestones achieved, consisting of a $213 up front fee paid upon signing the
Development Agreement, the amount of which is being expensed over the 24 month term of the
agreement. In 2006, the Company paid $425 for milestones achieved
during 2005.
Following regulatory approval and commercialization of the Product, Medtronic will pay certain
commissions to Neurologix with respect to sales of the Product. Furthermore, the Company has
granted to Medtronic a right of first offer to negotiate, in good faith, for the right to
distribute or commercialize certain gene therapy products developed by the Company for Parkinsons
disease or temporal lobe epilepsy.
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 Companys
Phase I clinical trial for the treatment of Parkinsons disease. Under this agreement, the Company
paid Cornell $36 when each patient commenced treatment and $23 annually for the services of a nurse
to assist in the clinical study. The Company fulfilled its obligation under this portion of the
agreement in May 2006 when the last patient to participate in the clinical study completed its
one-year follow-up. The amounts charged to operations in connection with the Clinical Study
Agreement for the years ended December 31, 2006 and 2005 were $12 and $167, respectively.
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 Parkinsons disease, Huntingtons disease, Alzheimers disease and epilepsy (the
Scientific Studies). This sponsored research is funded by the Company and is being conducted in
Cornells Laboratory of Molecular Neurosurgery under the direction of Dr. Michael G. Kaplitt, one
of the Companys scientific co-founders. The term of this amendment to the Clinical Study
62
Neurologix, Inc. and Subsidiary
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except for share and per share amounts)
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 sixty (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. The amounts
charged to operations in connection with the sponsored research for the years ended December 31,
2006 and 2005 were $135 and $113, respectively.
On March 2, 2007, the parties entered into Amendment No. 2 to the Clinical Study Agreement to
revise the scope of work to be performed. Pursuant to the terms of the amended agreement, the
Company must make an additional payment of $64, in two equal installments, the first on or about
the effective date of the agreement and the second on July 31, 2007.
In July 2003, the Company entered into a Clinical Study Agreement with North Shore University
Hospital to monitor, evaluate and conduct neurological reviews of the participants of the Companys
Parkinsons disease Phase I clinical study before and for one year following the patients
treatment. The agreement required the Company to make payments of $29 per satisfactorily completed
patient, up to a maximum of $344. The amounts charged to operations in connection with the North
Shore agreement for the years ended December 31, 2006 and 2005 were $37 and $115, respectively
Consulting and Employment Agreements:
On April 25, 2005 the Company entered into the Kaplitt Agreement with Dr. Michael G. Kaplitt,
one of Neurologixs scientific co-founders. The Company and Dr. Kaplitt had previously been
parties to a Consulting Agreement, dated October 1, 1999, as amended on October 8, 2003. Pursuant
to the terms of the Kaplitt Agreement, Dr. Kaplitt will continue to provide advice and consulting
services on an exclusive basis in scientific research on human gene therapy in the nervous system.
Dr. Kaplitt will also continue to serve as a member of the Companys Scientific Advisory Board. Dr.
Kaplitt was being paid an initial annual retainer of $100 in equal monthly installment payments,
which installment payments commenced in October 2005. In October 2006, Dr. Kaplitts annual
retainer was increased to $175. The Company paid Dr. Kaplitt approximately $119 and $25 in retainer
fees in 2006 and 2005 thereunder. In connection with the execution of the Kaplitt Agreement, the
Company granted Dr. Kaplitt nonqualified stock options to purchase 160,000 shares of Common Stock.
On June 20, 2005, the Company executed a Consulting Agreement (Hertzog Agreement) with David
B. Hertzog. The Hertzog Agreement became effective as of May 16, 2005. The Hertzog Agreement
provided that Mr. Hertzog provide to the Company on a part-time basis independent consulting
services with respect to legal and financial regulatory matters. The initial term of the Hertzog
Agreement was one year and provided that Mr. Hertzog receive compensation of $100. On May 16,
2006, the parties renewed the agreement with a term of one year and provided that Mr. Hertzog
receive annual compensation of $108, payable in equal monthly installments. The Hertzog Agreement
was terminated effective September 30, 2006
63
Neurologix, Inc. and Subsidiary
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except for share and per share amounts)
because the Companys management team had been put in place and Mr. Hertzogs services were no
longer needed. The Company paid Mr. Hertzog $78 and $67 in retainer fees in 2006 and 2005. In
connection with the Hertzog Agreement, on June 20, 2005, the Company granted Mr. Hertzog
non-qualified stock options to acquire up to 250,000 shares of Common Stock.
The Company has consulting agreements with seven scientists who comprise the Companys
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. Dr. Kaplitts
agreement is discussed above, and Dr. Durings agreement, as amended, provides for payments of $175
per annum through September 2007.
In May 2003, the Company 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 Neurologix 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. The shares issued to the Chairman
of the SAB were converted into 276,054 shares of Common Stock in connection with the Merger.
The agreements with the remaining four SAB members provide for payments aggregating $12 per
annum for three of the members and $25 per annum for one of the members 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.
Operating Lease Agreements:
In August 2004, the Company entered into a lease agreement for
laboratory facilities, which expired on August 31, 2005 and provided
for annual rent of $48. In August 2005, the Company renewed the lease
agreement for an additional year to an annual rent of $53. Effective
April 2006 the Company terminated the lease agreement with no future
obligations.
In August, 2004, the Company entered into a sublease with PCS, a related party, 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 $35 during the years ended December 31, 2006 and
64
Neurologix, Inc. and Subsidiary
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except for share and per share amounts)
2005. The rent that the Company pays to PCS is the same rental amount that PCS pays under its
master lease for this space.
In August 2005, the Company entered into a lease agreement for laboratory facilities at
Columbia Universitys Audubon Biomedical Science and Technology Park, which provided for annual
rent of $53. Effective April 2006, the Company terminated this lease and has no future obligations
under such lease.
In April 2006, the Company entered into a Facility Use Agreement and Visiting Scientist
Agreements with the Ohio State University (OSU), all of which allow three of the Companys
scientists to access and use OSUs laboratory facilities and certain equipment to perform their
research under the direction of Dr. Matthew During. The term of the Facility Use Agreement is four
years, subject to earlier termination under certain circumstances. The Company paid OSU an initial
amount of $23, representing prepaid rent for the first year of such Agreement. Unless sooner
terminated, the Company will pay an additional $70 over the remaining three years of such
Agreement.
On November 3, 2006, the Company entered into a lease with Bridge Plaza Realty Associates, LLC
(BPRA) for an additional 703 square feet of office space at One Bridge Plaza, Fort Lee, New
Jersey 07024 (the BPRA Lease). This lease is expected to commence in April 2007 upon the
completion of build out work performed by BPRA and will expire three years thereafter. The lease
provides for a base annual rent of approximately $21 or $2 per month for the term of the lease.
In connection with the BPRA Lease, effective February 1, 2008 the Company will rent from BPRA
the 1,185 square feet of office space it currently rents from PCS. This lease pro-vides for a base
annual rent of $36 or $3 per month through the term of the lease, which expires in March 2010.
The
Company incurred total rent expense associated with operating leases
and subleases of $87 and $71 for the years ended December 31, 2006
and 2005, respectively.
At December 31, 2006, approximate future lease payments under the Companys operating leases
and subleases are as follows:
|
|
|
|
|
Year Ending December 31, |
|
|
|
|
2007 |
|
$ |
73 |
|
2008 |
|
|
80 |
|
2009 |
|
|
81 |
|
2010 |
|
|
17 |
|
2011 |
|
|
|
|
Thereafter |
|
|
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$ |
251 |
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65
Item 8. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
None
Item 8A. Controls and Procedures
(a) Disclosure Controls and Procedures. The Companys management with the participation of
the Companys President and Chief Executive Officer and Chief Financial Officer have evaluated the
effectiveness of the Companys disclosure controls and procedures (as such term is defined in Rules
13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the annual period covered by this
report. Based on such evaluation, the Companys President and Chief Executive Officer and Chief
Financial Officer have concluded that, as of the end of such period, the Companys disclosure
controls and procedures are effective in recording, processing, summarizing and reporting, on a
timely basis, information required to be disclosed by the Company in the reports that it files or
submits under the Exchange Act.
(b) Internal Control Over Financial Reporting. There have not been any changes in the
Companys 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 of 2006 that materially affected, or
are reasonably likely to materially affect, the Companys 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 nine 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:
66
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Served in |
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Such Position |
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or Office |
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Continually |
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Name |
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Age |
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Since |
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Present Position with the Company (1) |
John E. Mordock
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62 |
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July 2006
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President, Chief Executive Officer and
Director (2) |
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Marc L. Panoff
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36 |
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January 2006
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Chief Financial Officer and Treasurer (3) |
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Christine V. Sapan
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59 |
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July 2006
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Executive Vice President, Chief Development
Officer(4) |
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NOTES: |
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(1) |
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Each executive officers 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. |
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(2) |
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Mr. Mordock was appointed as the President and Chief Executive Officer of the Company on July
17, 2006. Mr. Mordock has been a director of the Company since November 14, 2005, when he was
elected as a Class III Directors to fill a newly created position on the Board. Mr. Mordock
is a Partner of Red Bird Capital, LLC, a position that he has held since 2001. From 1996 to
2001, Mr. Mordock was President and Chief Executive Officer and a director of Teleflex
Instruments & Surgical Services. Mr. Mordock was also President, Chief Operating Officer and
a director of Cabot Medical Corporation from 1981 to 1996. Mr. Mordock holds a B.S. and an
MBA from La Salle University and an E.P.S.M. from the Graduate School of Business at Stanford
University |
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(3) |
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Mr. Panoff was appointed as the Chief Financial Officer and Treasurer on January 23, 2006.
Mr. Panoff was the Chief Financial Officer at Nephros, Inc., a publicly traded medical device
company, from July 2004 to January 2006. From August 2001 to July 2004, Mr. Panoff was the
Vice President, Finance, at Walker Digital Companies, a privately held research and
development company. He also served as Corporate Controller at Medicis Pharmaceutical
Corporation, a publicly traded specialty pharmaceutical company, for over seven years. Mr.
Panoff received his Bachelor of Science in Business Administration from Washington University
in St. Louis and his Masters in Business Administration from Arizona State University. He is
also a Certified Public Accountant in the state of New York. |
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(4) |
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Dr. Sapan was appointed as the Executive Vice President, Chief Development Officer of the
Company effective July 10, 2006. Dr. Sapan was previously employed for 18 years at Nabi
Biopharmaceuticals, a vertically integrated biopharmaceutical company that focuses on serious
unmet medical needs including infectious diseases, most recently serving as Vice President,
Project Management from 2001 to 2005. Dr. Sapan has a Ph.D in Experimental Pathology and an
M.S. in Human Physiology from the University of North Carolina. |
The additional information required by this item will be included in the Companys
definitive Proxy Statement in connection with the 2007 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 Companys definitive Proxy
Statement in connection with the 2007 Annual Meeting of Stockholders and is hereby incorporated
herein by reference.
67
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 Companys definitive Proxy
Statement in connection with the 2007 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 Companys definitive Proxy
Statement in connection with the 2007 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 Companys definitive Proxy
Statement in connection with the 2007 Annual Meeting of Stockholders and is hereby incorporated
herein by reference.
68
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.
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NEUROLOGIX, INC. |
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Dated: March 30, 2007 |
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/s/ John E. Mordock |
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John E. Mordock
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President and Chief Executive Officer |
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/s/ Marc L. Panoff
Marc L. Panoff,
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Chief Financial Officer, Secretary and Treasurer |
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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.
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Dated: March 30, 2007 |
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/s/ Cornelius E. Golding
Cornelius E. Golding, Director
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Dated: March 30, 2007 |
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/s/ Martin J. Kaplitt
Martin J. Kaplitt, Director
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Dated: March 30, 2007 |
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/s/ Clark A. Johnson
Clark A. Johnson, Director
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Dated: March 30, 2007 |
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/s/ John E. Mordock
John E. Mordock, Director
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Dated: March 30, 2007 |
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/s/ Craig J. Nickels
Craig J. Nickels, Director
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Dated: March 30, 2007 |
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/s/ Austin M. Long, III
Austin M. Long, III, Director
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Dated: March 30, 2007 |
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/s/ Jeffrey B. Reich
Jeffrey B. Reich, Director
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Dated: March 30, 2007 |
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/s/ Elliott Singer
Elliott Singer, Director
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Dated: March 30, 2007 |
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/s/ Michael Sorell
Michael Sorell, Director
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69
EXHIBIT INDEX
|
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Exhibit |
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No. |
|
Exhibit |
3.1
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Restated Certificate of Incorporation of Neurologix, Inc. (filed as an
exhibit to the Registrants Report on Form 8-K, dated September 13, 2004 and
incorporated herein by reference). |
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3.2
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Amended and Restated Bylaws of Neurologix, Inc. (filed as an exhibit to the
Registrants Annual Report on Form 10-K dated April 9, 2004 and incorporated
herein by reference). |
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3.3
|
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Certificate of Designations, Preferences and Rights of Series C Convertible
Preferred Stock of Neurologix, Inc. (filed as an exhibit to the
Registrants Current Report on Form 10-K dated May 11, 2006 and incorporated
herein by reference). |
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4.1
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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
Registrants Report on Form 8 K dated March 28, 2000 and incorporated herein
by reference). |
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4.2
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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 Registrants
Report on Form 8-K, dated February 10, 2005 and incorporated herein by
reference). |
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4.3
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Registration Rights Agreement, dated as of April 27, 2005, by and among
Neurologix, Inc. and Medtronic International, Ltd. (filed as an exhibit to
the Registrants Current Report on Form 8-K, dated May 2, 2005, and
incorporated herein by reference). |
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10.1
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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 Registrants Report on Form 8-K dated March 28, 2000 and
incorporated herein by reference). |
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10.2
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Consulting Agreement as of October 1, 1999 by and between Dr. Matthew During
and Neurologix, Inc. (filed as an exhibit to the Registrants Report on Form
10-K, dated April 9, 2004 and incorporated herein by reference). |
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10.3
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Exclusive License Agreement between Thomas Jefferson University and
Neurologix Inc., effective as of June 1, 2002 (filed as an exhibit to the
Registrants Report on Form 10-K, dated April 9, 2004 and incorporated herein
by reference). |
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10.4
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Exclusive License Agreement between Thomas Jefferson University and
Neurologix, Inc., effective as of August 1, 2002 (filed as an exhibit to the
Registrants Report on Form 10-K, dated April 9, 2004 and incorporated herein
by reference). |
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10.5
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Non-Exclusive License Agreement by and between Yale University, The
Rockefeller University and Neurologix, Inc., dated as of August 28, 2002
(filed as an exhibit to the Registrants Report on Form 10-K, dated April 9,
2004 and incorporated herein by reference). |
70
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Exhibit |
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No. |
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Exhibit |
10.6
|
|
License Agreement made as of November 1, 2002 by and between The Rockefeller
University and Neurologix, Inc. (filed as an exhibit to the Registrants
Report on Form 10-K, dated April 9, 2004 and incorporated herein by
reference). |
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10.7
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Clinical Study Agreement between Cornell University and Neurologix, Inc.
entered into as of July 2, 2003 (filed as an exhibit to the Registrants
Report on Form 10-K, dated April 9, 2004 and incorporated herein by
reference). |
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10.8
|
|
Clinical Study Agreement, dated as of July, 2003 between North Shore
University Hospital and Neurologix, Inc. (filed as an exhibit to the
Registrants Report on Form 10-K, dated April 9, 2004 and incorporated herein
by reference). |
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10.9
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Amendment, dated October 8, 2003 to Consulting Agreement, dated October 1,
1999, between Dr. Matthew During and Neurologix, Inc. (filed as an exhibit to
the Registrants Report on Form 10-K, dated April 9, 2004 and incorporated
herein by reference). |
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10.10
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Amendment No. 1 to Clinical Study Agreement, between Cornell University and
Neurologix, Inc., dated September 24, 2004 (filed as an exhibit to the
Registrants Report on Form 8-K, dated September 30, 2004 and incorporated
herein by reference). |
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10.11
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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 Registrants
Report on Form 8-K, dated February 10, 2005 and incorporated herein by
reference). |
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10.12
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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 Registrants Report on Form 8-K, dated February 10, 2005
and incorporated herein by reference). |
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10.13
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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
Registrants Report on Form 8-K, dated February 25, 2005 and incorporated
herein by reference). |
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10.14
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Clinical Study Agreement, dated October 20, 2004, between Universidade
Federal de Sao Paolo and Neurologix, Inc. (filed as an exhibit to the
Registrants Amendment No. 1 to Annual Report on Form 10-KSB, dated September
28, 2005). |
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10.15
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Sub Lease, dated August 10, 2004, between Neurologix, Inc. and Palisade
Capital Securities L.L.C. (filed as an exhibit to the Registrants Amendment
No. 1 to Annual Report on Form 10-KSB, dated
September 28, 2005). |
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10.16
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Amended and Restated Consulting Agreement by and between Michael G. Kaplitt
and Neurologix Research, Inc., dated April 25, 2005 (filed as an exhibit to
the Registrants Current Report on Form 8-K, dated April 29, 2005, and
incorporated herein by reference). |
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10.17
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Stock Purchase Agreement, dated as of April 27, 2005, by and among
Neurologix, Inc. and Medtronic International, Ltd. (filed as an exhibit to
the Registrants Current Report on Form 8-K, dated May 2, 2005, and
incorporated herein by reference). |
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10.18
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Warrant Certificate (filed as an exhibit to the Registrants Current Report
on Form 8-K, dated May 2, 2005, and incorporated herein by reference). |
71
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Exhibit |
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|
No. |
|
Exhibit |
10.19
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Development and Manufacturing Agreement by and among Neurologix, Inc. and
Medtronic, Inc., dated as of April 27, 2005 (filed as an exhibit to the
Registrants Quarterly Report on Form 10-QSB for the three months ended March
31, 2005 and incorporated herein by reference). |
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|
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10.20
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|
Sublicense Agreement, dated July 27, 2006, between Neurologix, Inc. and
Diamyd Therapeutics AB (filed as an exhibit to the Registrants Current
Report on Form 8-K dated August 7, 2006 and incorporated herein by
reference). |
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10.21
|
|
Separation Agreement, dated as of July 17, 2006, between Neurologix, Inc. and
Michael Sorell. (filed as an exhibit to the Registrants Current Report on
Form 8-K dated July 20, 2006 and incorporated herein by reference). |
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10.22
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Subscription Agreement, dated as of May 10, 2006, by and between Neurologix,
Inc., General Electric Pension Trust, the DaimlerChrysler Corporation Master
Retirement Trust, ProMed Partners, LP, ProMed Partners II, LP, ProMed
Offshore Fund Ltd., ProMed Offshore Fund II, Ltd., Paul Scharfer and David B.
Musket. (filed as an exhibit to the Registrants Current Report on Form 8-K
dated May 11, 2006 and incorporated herein by reference). |
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|
|
10.23
|
|
Form of Warrant Certificate (filed as an exhibit to the Registrants Current
Report on Form 8-K dated May 11, 2006 and incorporated herein by reference). |
|
|
|
10.24
|
|
Consulting Agreement, dated February 23, 2007, between Neurologix, Inc. and
Dr. Martin J. Kaplitt. (filed as an exhibit to the Registrants Current
Report on Form 8-K dated February 26, 2007 and incorporated herein by
reference). |
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|
|
10.25
|
|
Amendment No. 19 to Stock Purchase Agreement, dated as of March 27, 2007, by
and among Neurologix, Inc, Merlin Biomed Long Term Appreciation Fund LP and
Merlin Biomed Offshore Master Fund LP.** |
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23.1
|
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Consent of BDO Seidman LLP,
Independent Registered Public Accounting Firm.** |
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23.2
|
|
Consent of J.H. Cohn LLP, Former Independent Registered Public Accounting
Firm.** |
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31.1
|
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Rule 13a-15(e)/15d-15(e) Certification of Principal Executive Officer.** |
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31.2
|
|
Rule 13a-15(e)/15d-15(e) Certification of Chief Financial Officer/Treasurer.** |
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32.1
|
|
Section 1350 Certification, Chief Executive Officer and Chief Financial
Officer/Treasurer.** |
72