Unassociated Document
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-KSB
x
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ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
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For
the Fiscal Year Ended December 31,
2007
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o
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TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
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For
the transition period from ____ to
____
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Commission
File Number 0-13347
NEUROLOGIX,
INC.
DELAWARE
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06-1582875
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(State
or other jurisdiction of
Incorporation
or organization)
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I.R.S.
Employer
Identification
No.)
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ONE
BRIDGE PLAZA, FORT LEE, NEW JERSEY
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07024
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(Address
of principal executive offices)
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(Zip
Code)
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(201)
592-6451
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(Issuer’s
telephone number, including area
code)
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N/A
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(Former
name, former address and former fiscal year,
if
changed since last report)
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Securities
registered pursuant to Section 12(b) of the Act: None
Securities
registered pursuant to Section 12(g) of the Act:
Common
Stock, par value $0.001 per share
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(Title
of Class)
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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 x No o
Check
here if there is no disclosure of delinquent filers in response to Item 405 of
Regulation S-B contained in this form, and no disclosure will be contained, to
the best of the Registrant’s knowledge, in definitive proxy or information
statements incorporated by reference in Part III of this 10-KSB or any amendment
to this Form 10-KSB. o
Indicate
by checkmark whether the registrant is a shell company (as defined by Rule 126-2
of the Exchange Act). Yes o No x
The
Registrant had no revenues during the year ended December 31, 2007.
The
aggregate market value of the Registrant’s voting and non-voting common equity
held by non-affiliates as of March 14, 2008 was approximately
$12,076,021.
State the
number of shares outstanding of each of the issuer’s classes of common equity,
as of the latest practicable date: As of March 14, 2008, there were
outstanding 27,632,808 shares of the Registrant’s 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 registrant’s Proxy Statement for its
2008 Annual Meeting of Stockholders.
Transitional
Small Business Disclosure Format: Yes o No x
TABLE
OF CONTENTS
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Page
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PART
I
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2
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2
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27
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27
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27
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PART
II
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28
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28
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29
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37
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72
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72
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73
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PART
III
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73
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73
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73
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73
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73
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74
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74
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75
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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 Company’s initial development efforts are focused on
gene transfer for treating Parkinson’s disease and epilepsy. The
Company’s core technology, which it refers to as “NLX,” is in the
clinical development stages, having recently been tested in a Phase 1 clinical
trial to treat Parkinson’s disease. Currently, the Company plans to
conduct a Phase 2 clinical trial for Parkinson’s disease and a Phase 1 clinical
trial for epilepsy, subject to receipt of necessary regulatory
approvals. Recent highlights include:
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·
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For
the 12 months ended December 31, 2007, the Company reported a net loss of
approximately $6.8 million versus a net loss of $7.0 million for the 12
months ended December 31, 2006. Cash and cash equivalents were
$20.2 million at December 31, 2007.
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·
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On
January 24, 2008, the Company announced that it would be conducting an
additional pre-clinical study in primates prior to commencing its Phase 1
clinical trial for epilepsy, and has submitted to the U.S. Food and Drug
Administration (“FDA”) a
protocol design for this study. (See “BUSINESS OF THE COMPANY -
Epilepsy”).
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·
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On
December 13, 2007, the Company announced that the FDA had granted Fast
Track Designation for the Company’s gene transfer procedure for the
treatment of Parkinson’s disease. Although Fast Track
Designation will provide various means to expedite the development and
review of the gene transfer procedure for Parkinson’s disease, it does not
assure the approval of any of the Company’s study protocols or the
ultimate approval of any Biologics License Application (“BLA”) that may
be submitted by the Company to the FDA for marketing
approval.
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·
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On
December 4, 2007, the Company entered into employment agreements with John
E. Mordock, the Company’s President and Chief Executive Officer; and Marc
L. Panoff, the Company’s Chief Financial Officer, Treasurer and
Secretary. The agreements are for a period of two years and
provide compensation and certain severance benefits in the event of
certain terminations of employment. (See Item 10 – “Executive
Compensation”).
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·
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On
November 19, 2007, the Company issued and sold 428,571 shares of a newly
created series of preferred stock, the Series D Convertible Preferred
Stock, par value $0.10 per share (the “Series D
Stock”), at a price of $35.00 per share, for a total of $15
million, less applicable expenses, in a private placement
transaction. Each share of Series D Stock is convertible into
30.17 shares of common stock, par value $0.001 per share (the “Common Stock”),
of the Company. The Series D Stock accrues dividends at a rate
of 7% per annum, payable in semi-annual installments, which accrue,
cumulatively, until paid. The transaction also involved the issuance of
warrants to purchase approximately 3.2 million shares of Common Stock at
an exercise price of $1.39 per share. (See Note 9 to
Consolidated Financial Statements).
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·
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In
November 2007, the Company announced the publication of data from its
Phase 1 clinical trial for Parkinson’s disease, which demonstrated the
ability of the Company’s gene transfer treatment to quiet the abnormal
brain activity in treated patients. Details of the results were
published in the online edition of the Proceedings of the National
Academy of Sciences.
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·
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In
October 2007, the Company entered into a letter agreement with Dr. Matthew
During, one of the Company’s scientific co-founders, amending his
consulting agreement dated October 1, 1999, by extending the term of the
agreement through September 30,
2008.
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·
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In
June 2007, the Company announced the publication of positive results from
its Phase 1 clinical trial for Parkinson’s disease in the journal The
Lancet. The trial demonstrated a lack of adverse events
related to the gene transfer procedure and statistically significant
improvements from baseline in both clinical symptoms and abnormal brain
metabolism.
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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 the Company, 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 a public company 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 Company’s Board of Directors (the “Board”) voted to
divest the Company of a majority of its then existing operations. On
September 30, 2002, the Board adopted a plan of liquidation and dissolution in
order to maximize stockholder value.
During
the period from December 2001 through June 30, 2003, Canned Interactive, which
designs and produces interactive media such as digital video discs (DVDs) and
web sites, primarily for entertainment, consumer goods, sports and technology
companies, was the Company’s sole source of operating revenues. On
June 30, 2003, the Company sold all of the issued and outstanding shares of
Canned Interactive to a limited partnership of which Canned Interactive’s
managing director was the general partner. With the sale of Canned
Interactive, the Company ceased to have any continuing operations.
On
February 10, 2004, the Company completed a merger (the “Merger”) of 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 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 existed 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.
The
Company’s scientific co-founders, Dr. Matthew J. During and Dr. Michael G.
Kaplitt, have collaborated for more than ten years in working with central
nervous system disorders. Their research spans from animal studies
(for gene transfer in Parkinson’s disease, epilepsy and other disorders of the
central nervous system) to the completed Phase 1 clinical trial for the
treatment of Parkinson’s disease. They both remain as consultants to
the Company and serve on its Scientific Advisory Board (“SAB”).
From 1999
to 2002, the Company, through NRI, conducted its gene transfer research through
sponsorship agreements with Thomas Jefferson University (“TJU”), the
Rockefeller University (“Rockefeller”) and the
University of Auckland in New Zealand (“AUL”). From
October 2002 to April 2006, the Company staffed its own laboratory facilities at
Columbia University’s Audubon Biomedical Science and Technology Park (“Columbia”) in New
York City to manufacture the gene transfer products required for its
pre-clinical trials and to continue the research and development of additional
gene transfer products.
Currently,
the Company conducts basic and applied gene transfer research through research
agreements with Cornell University for its Medical College (“Cornell”) in a
laboratory directed by Dr. Michael G. Kaplitt and one of the company’s
scientists; and The Ohio State University Research Foundation, (“OSURF”) in a
laboratory directed by Dr. During and five of the Company’s
scientists.
Business
Strategy
The
Company’s objective is to develop and commercialize innovative therapeutic
treatments for disorders of the brain and central nervous system, primarily
using gene therapy. Key elements of the Company’s strategy
are:
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·
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Focus resources on development
of the Company’s NLX technology. The Company intends to
focus its research and development efforts on what it believes are
achievable technologies having practical
applications. Consequently, the Company expects to initially
allocate the majority of its resources and efforts to the development of
its first-generation NLX products for the treatment of Parkinson’s disease
and temporal lobe epilepsy (“TLE”).
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·
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Focus on central nervous
system disorders that are likely to be candidates for gene
transfer. 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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o
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the
therapeutic gene function is reasonably well understood and has a
physiologic role;
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o
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neurosurgical
approaches are already established and
standard;
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o
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animal
studies, which may include those studies involving non-human primates,
have indicated that gene transfer technology may be effective in treating
the disease;
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o
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partial
correction of the disease is expected to be clinically proven;
and
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o
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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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·
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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 transfer and other
technologies. The Company believes that such relationships, if
established, will make additional resources available to the Company for
the manufacture of gene transfer products and for clinical trials
involving these products. The Company may enter into joint
ventures or strategic alliances with one or more pharmaceutical companies
or other medical specialty companies to develop or manufacture its
products. The Company may seek such companies that have
extensive resources and knowledge to enable the Company to develop and
commercialize its products.
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·
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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”, See Item 6 -
“Management’s Discussion and Analysis or Plan of Operation - Plan of
Operation” and Item 6 - “Management’s Discussion and Analysis or Plan of
Operation - Liquidity and Capital
Resources”).
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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 protein’s 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 cell’s normal function and may result in a disease. One goal
of gene transfer is to treat these diseases by delivering DNA containing the
corrected gene into the affected cells. Also, gene transfer 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 transfer 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
adeno-associated virus (“AAV”)
vector. In 1994, Drs. Michael G. Kaplitt and Matthew During
demonstrated that AAV could be a safe and effective vehicle for gene transfer in
the brain. Since that time, the AAV vector has been used safely in a
variety of clinical gene transfer trials.
The
Company believes that the benefits of AAV vector gene transfer technology
include:
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·
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Safety. AAV
vectors are based on a virus that, to the Company’s knowledge, has not
been associated with a human
disease.
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·
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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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·
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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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·
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A Simpler and
Safer Option than Standard Surgery. The Company intends
to administer the AAV vector-based products in a procedure that is simpler
and safer than other established neurosurgical
procedures.
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Parkinson’s
Disease
General. Parkinson’s
disease is a neurodegenerative disorder; it arises from the gradual death of
nerve cells in the brain. Parkinson’s disease is a progressive and
debilitating disease that affects the control of bodily movement and is
characterized by four principal symptoms:
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·
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bradykinesia
of the limbs and body evidenced by difficulty and slowness of movement,
and
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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 Parkinson’s disease often involves use of levodopa, a drug which
stimulates production of dopamine. However, over extended periods of
time levodopa often declines in its effectiveness. In advanced stages
of Parkinson’s disease, as the disease becomes more and more debilitating, it
becomes necessary to accept a riskier and potentially more invasive medical
procedure to treat the disease. It is at this juncture that surgical
procedures, including deep brain stimulators and lesioning, which target an area
of the brain called the subthalamic nucleus (“STN”), are commonly
advised.
The
Company believes that the glutamic acid decarboxylase (“GAD”) gene can be
used to selectively mimic normal physiology and alter the neural circuitry
affected in Parkinson’s disease. The Company’s technology inserts a
GAD gene into an AAV-based viral vector, and this packaged vector is introduced
directly into the 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
Company’s gene transfer 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 Parkinson’s disease,
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
Parkinson’s disease patients in America, with approximately 60,000 new cases
diagnosed each year. While the peak onset of Parkinson’s disease is
age 60 years, Parkinson’s disease is not just a disease of middle or old age:
15% of Parkinson’s disease patients are less than 50 years of age.
Product Development and
Operations. In October 2006, the Company announced that it had
completed its Phase 1 clinical trial of gene transfer for Parkinson’s 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, which was infused unilaterally, appears to be safe and
well-tolerated in patients with advanced Parkinson’s 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. Such results were published in 2007 in two leading
peer-reviewed medical and scientific journals: The Lancet and Proceedings of the National Academy
of Sciences.
A Phase 1
clinical trial is primarily designed to test the safety, as opposed to the
efficacy, of a proposed treatment. The clinical trial was conducted
by Drs. Kaplitt and During. As part of this clinical trial, twelve
patients with Parkinson’s disease underwent surgical gene transfer 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 1 clinical 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 Parkinson’s disease of at least five years duration
and were no longer adequately responding to current medical
therapies.
The
Company plans to commence a Phase 2 clinical trial for Parkinson’s disease in
the first half of 2008. 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 bilaterally in trial
subjects. Commencement of such trial is subject, among other things,
to concurrence by the FDA. (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”, “RISK FACTORS - The Company is Subject to
Stringent Regulation; FDA Approvals” and “RISK FACTORS – The Company’s Research
Activities are Subject to Review by the RAC”).
On
December 3, 2007, the Company reviewed its Phase 2 protocol with the National
Institutes of Health’s Office of Biotechnology Activities Recombinant DNA
Advisory Committee (the “RAC”) in a public
forum. The Company does not believe it will encounter any significant
delay in initiating its Phase 2 clinical trial as a result of the
meeting. (See “RISK FACTORS – The Company’s Research Activities are
Subject to Review by the RAC”).
On
December 13, 2007, the Company announced that the FDA granted Fast Track
Designation for the Company’s treatment of Parkinson’s disease. Under
the FDA Modernization Act of 1997, Fast Track Designation may facilitate the
development and expedite the review of a drug candidate that is intended for the
treatment of a serious life-threatening condition and demonstrates the potential
to address an unmet medical need for such a condition. Fast Track Designation
will provide various means to expedite the development and review of the
Company’s gene transfer procedure for Parkinson’s disease, including the
facilitation of meetings and other correspondence with FDA reviewers,
consideration for priority review and the ability to submit portions of a BLA
early for review as part of a “rolling” submission. The receipt of Fast Track
Designation does not, however, assure the approval of any of the Company’s study
protocols or the ultimate approval of any BLA that may be submitted by the
Company to the FDA for marketing approval.
The
Company, under its manufacturing and development agreement with Medtronic, Inc.
(referred to herein as “Medtronic” as
distinguished from its a wholly-owned subsidiary Medtronic International, Ltd.,
referred to herein as “Medtronic
International”), has co-developed a new catheter system with Medtronic to
infuse the Company’s gene transfer product into the brain with respect to the
treatment of Parkinson’s disease. (See “BUSINESS OF THE COMPANY -
Manufacturing”). The Company expects to have a workable system to use
in its planned Phase 2 clinical trial. The FDA is currently reviewing
the use of this device for such clinical trial under the Company’s
investigational new drug application (“IND”). The
use of such a catheter would facilitate the use of the Company’s gene transfer
treatment by neurosurgeons and simplify the procedures for infusing the gene
product into the brain. In order for the Company to market its
products, Medtronic must obtain the FDA’s approval of such
catheter. (See “RISK FACTORS”).
The
Company is currently taking steps to move toward a pivotal trial for treatment
of Parkinson’s disease, and hopes to be in a position to file its protocol with
the FDA in 2010. The Company’s conduct of such a trial will require,
among other things, approval by the FDA and adequate funding. (See
“RISK FACTORS” and Item 6 - “Management’s Discussion and Analysis or Plan of
Operation”).
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 entire brain at once,
causing loss of consciousness, falls, convulsions or intense muscle
spasms. Partial or focal 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.
According
to the Epilepsy Foundation (USA) (the “EF”), epilepsy
affects approximately 2.7 million Americans of all ages and backgrounds, making
it one of the most common neurological diseases in this
country. Approximately 200,000 new cases of seizures and epilepsy
occur each year, with 79% 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 transfer.
Product Development and
Operations. The Company has intensified its development
efforts on epilepsy. Over the past several years, the Company has
completed multiple pre-clinical studies in rodents and two non-human primate
studies to evaluate the toxicity and efficacy of using its gene transfer
technology in the brain for the treatment of epilepsy. The Company’s
approach is based on the use of the non-pathogenic AAV vector, delivered using
standard neurosurgical techniques. 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 animal models,
had efficacy in preventing the development of spontaneous seizures that occur
after a prolonged episode of status epilepticus. The Company’s
proposed treatment uses gene transfer technology to deliver genes into the brain
which restore the chemical balance, but only in the areas in which the disease
process is occurring.
On
December 4, 2007, the Company announced the receipt of a grant from the Epilepsy
Research Foundation (“ERF”), a joint
venture of three non-profit epilepsy organizations -- the Epilepsy Therapy
Project (“ETP”), EF, and
Finding a Cure for Epilepsy and Seizures (“FACES”) -- formed to
identify and accelerate the development of promising epilepsy
research. The grant will help fund the Company’s Phase 1 clinical
trial of epilepsy.
In
December 2006, the Company submitted an IND to the FDA for permission to begin a
Phase 1 clinical trial in TLE. The proposed clinical protocol for
this study was presented to the RAC on September 23, 2004 and was reviewed
favorably.
In
January 2008, the Company announced that as a result of comments from, and
discussions with, the FDA, the Company has decided to conduct an additional
pre-clinical study in non-human primates. The study will be designed
to confirm the safety of the administration and use of the
rAAV-NPY. The Company has submitted to the FDA a protocol design for
this study. The Company is unable to estimate the total time or costs
involved in conducting its Phase 1 clinical trial until such time that it
receives guidance from the FDA with respect to the submitted protocol
design. In this regard, the commencement of a Phase 1 clinical trial
will be subject, among other things, to the successful completion of this
additional pre-clinical study, concurrence by the FDA and procurement of related
intellectual property licenses. (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”).
Until
successful completion of the additional pre-clinical study, the Company cannot
predict the timing for the conduct of additional trials or for a filing for the
FDA’s approval of the epilepsy product. The Company is undertaking
all reasonable efforts to advance the commencement of its Phase 1 clinical
trial.
The
Company expects to use a catheter system, substantially equivalent to the system
developed by Medtronic for the treatment of Parkinson’s disease, to infuse the
Company’s gene transfer product into the brain with respect to the treatment of
epilepsy. (See “BUSINESS OF THE COMPANY -
Manufacturing”). Similar to Parkinson’s disease, the FDA will need to
review the use of this device in a Phase 1 clinical trial under the Company’s
IND. As previously stated, in order for the Company to market its
products, Medtronic must obtain the FDA’s approval of such catheter. (See “RISK
FACTORS”).
Other Neurodegenerative and Metabolic
Disorders
The
Company has also undertaken efforts to develop gene transfer for the treatment
of other neurodegenerative and metabolic disorders, including Huntington’s
disease, depression and metabolic syndrome or genetically-based
obesity. In November 2005, the Company presented findings from
pre-clinical studies which showed that the gene XIAP (X-linked inhibitor of
apoptosis) may prevent the progression of Huntington’s 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 Huntington’s
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 overproduction
were observed.
The
Company is currently further researching 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 Company’s scientists, an additional strategy is being pursued to develop a
gene transfer 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 Huntington’s 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 Huntington’s disease, and the Company has evidence that shows that
this therapy may be effective in other diseases involving cell death, such as
Parkinson’s disease. Therefore, success in the development of
therapies to treat such diseases could lead to more advanced therapies to follow
the Company’s current program in Parkinson’s 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 such program towards a Phase 1 clinical trial within
the next several years. The timing is subject to change based upon
the uncertainties of medical research, the need to license key intellectual
property, available resources and the need to obtain regulatory approval by
appropriate agencies. (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”).
The
Company is also continuing its research and development of gene transfer for the
treatment of the previously mentioned disorders relating to depression and
genetically-based obesity. Since the Company’s primary focus remains
the development of its products for the treatment of Parkinson’s disease and
epilepsy, the Company expects that these other treatment candidates will remain
in pre-clinical phases for the next several years.
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 license to 6 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, 8 U.S. pending patent applications and 7 foreign
patent applications. All of the above patents cover gene transfer
technologies and delivery mechanisms for gene transfer.
The
exclusive patent licenses were granted by Rockefeller and 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 G. Kaplitt, Dr. Matthew
During and/or the Company’s employees are named as inventors on each
patent.
All of
such licenses granted to the Company cover patent rights and technical
information relating to its gene transfer products and its NLX
technology. Under the licenses granted by Rockefeller, TJU and the
Rockefeller-Yale Agreement (as defined below), Drs. Michael G. Kaplitt and
During, the Company’s founders, are entitled to receive, and have received,
certain amounts out of the payments made by the Company to Rockefeller, TJU and
Yale University pursuant to such licenses. (See Note 3 to
Consolidated Financial Statements).
In August
2002, the Company entered into a license agreement with Rockefeller and Yale
University (the “Rockefeller-Yale
Agreement”) whereby the universities granted to the Company a
nonexclusive license to certain patent rights and technical
information. An initial fee of $20,000 was paid to each of the two
universities pursuant to the agreement, and the Company pays an annual
maintenance fee of $5,000 per year to each university. In addition,
the Company must make additional payments upon reaching certain
milestones. The Company has the right to terminate the agreement at
any time upon 90 days written notice. (See Note 10 to Consolidated
Financial Statements).
On July
2, 2003, the Company entered into a Clinical Study Agreement (the “Clinical Study
Agreement”) with Cornell to sponsor the Company’s Phase 1 clinical trial
for the treatment of Parkinson’s disease. Under this agreement, the
Company paid Cornell $36,000 when each patient commenced treatment and $23,000
annually for the services of a nurse to assist in the clinical
trial. The Company fulfilled its obligation under this portion of the
agreement in May 2006 when the last patient to participate in the clinical trial
completed its one-year follow-up. On September 24, 2004, the parties
amended the Clinical Study Agreement to provide for research covering the
development of gene transfer approaches to neurodegenerative disorders,
including Parkinson’s disease, Huntington’s disease, Alzheimer’s disease and
epilepsy (the “Scientific
Studies”). On March 2, 2007, the parties entered into
Amendment No. 2 to the Clinical Study Agreement to further revise and extend the
agreement until August 31, 2008. This period may be extended for
additional one (1) year terms by mutual written agreement of both
parties. This sponsored research is funded by the Company and is
being conducted in Cornell's Laboratory of Molecular Neurosurgery under the
direction of Dr. Michael G. Kaplitt. The Company is required to pay
Cornell $200,000 per year for the duration of the Scientific Studies. (See Note
10 to Consolidated Financial Statements).
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
transfer treatment for Parkinson’s 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 transfer
approaches to neurodegenerative disorders, including Parkinson's disease,
epilepsy, Huntington's disease, Alzheimer's disease, as well as gene transfer
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 if there
is involvement from employees of OSURF. The term of the Research
Agreement expired in November 2007, but the Company and OSURF have agreed to
extend the term of the Research Agreement for a period of one year for an annual
amount of $166,666 (See Note 10 to Consolidated Financial
Statements).
In
addition to patents, the Company relies on trade secrets, technical know-how and
continuing technological innovation to develop and maintain its competitive
position. The Company requires all of its employees and scientific
consultants to execute confidentiality and assignment of invention
agreements. These agreements typically provide that (i) all materials
and confidential information developed or made known to the individual during
the course of the individual’s relationship with the Company are to be kept
confidential and not disclosed to third parties except in specific circumstances
and (ii) all inventions arising out of the relationship with the Company shall
be the Company’s exclusive property. While the Company takes these
and other measures to protect its trade secrets, they do not ensure against the
unauthorized use and/or disclosure of its confidential information.
The
Company’s intellectual property rights may be called into question or subject to
litigation. (See “RISK FACTORS - The Company’s Intellectual Property
Rights may be Called into Question or Subject to Litigation”).
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 Company’s 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 FDA’s Good Manufacturing Practices (“GMP”). As
discussed below, the Company manufactured its own AAV and other components for
its Phase 1 clinical trial for Parkinson’s disease and contracted and oversaw a
third party manufacturer for the production of its planned Phase 2 clinical
trial for Parkinson’s disease and its planned Phase 1 clinical trial for
epilepsy. Both products have been reviewed by the Company and the
third party manufacturer and subsequently were submitted to the FDA for
review. The large scale manufacture and development of components and
systems will require both time and significant funding. (See “RISK
FACTORS”).
The
Company’s two most advanced product candidates, AAVGAD for Parkinson’s disease,
and AAVNPY for TLE, are biological products requiring manufacture in specialized
facilities. As the Company’s development programs advance through the
phases of clinical development, the regulatory requirements for manufacture
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 any such facilities, and it is evaluating whether it will
seek to establish such capabilities on its own or will contract with third
parties for such manufacturing.
Pursuant
to a research agreement, Auckland Uniservices, Ltd., the commercial research and
knowledge transfer company for AUL, manufactured and delivered to the Company in
bulk form all of the AAVGAD that the Company required to complete the Phase 1
clinical trial procedures for Parkinson’s disease. The Company’s
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 Company’s manufacturing and development agreement with Medtronic, dated
April 27, 2005, the Company’s scientists, along with Medtronic’s engineers,
developed a novel catheter system for infusing gene therapies into the
brain. The Company plans to use this system in its Phase 2 clinical
trial for Parkinson’s disease and in follow-on clinical studies, and expects to
use a substantially equivalent catheter system with respect to the Phase 1
clinical trial for the treatment of epilepsy. The FDA is currently
reviewing the use of this device in the Company’s Phase 2 clinical trial for
Parkinson’s disease under the Company’s IND. In order for the Company
to market its products, Medtronic must obtain the FDA’s approval of such
catheter.
The
Company contracted with Cincinnati Children’s Hospital Medical Center (“CCHMC”) for the
production of the viral vectors to be used in the Company’s planned Phase 2
clinical trial for Parkinson’s disease and Phase 1 clinical trial for
epilepsy. Such production for both clinical trials was completed in
2007. The agreement required CCHMC to produce such vectors in
accordance with current GMP for the corresponding clinical phase of
development. The products have been released by CCHMC and the
Company, and the products have been filed with the FDA in connection with the
Company’s submitted clinical protocols.
Currently,
there is no commercial product available for infusion of gene therapeutics or
other biological agents into the brain, and all clinical trials to date,
including the Company’s Phase 1 clinical trial for Parkinson’s 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 transfer agents which would
facilitate acceptance and use by the general community of practicing
neurosurgeons. The Company has made and will make payments to
Medtronic based upon Medtronic’s attainment of certain development
milestones. As of December 31, 2007, the Company had paid $638,000 to
Medtronic for milestones achieved under the manufacturing and development
agreement.
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
Company’s expectations and become prohibitive. (See “RISK FACTORS -
The Company Does Not Have any Experience in Manufacturing Products for
Commercial Sale”).
Competition
The
Company is aware of other companies currently conducting clinical trials of gene
transfer products in humans to treat Parkinson’s disease, and recognizes that it
faces intense competition from pharmaceutical companies, biotechnology
companies, universities, governmental entities and other healthcare providers
developing alternative treatments for Parkinson’s disease and
epilepsy. 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 transfer 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 (“Targeted Genetics”),
have significant experience in developing and using AAV vectors to deliver gene
transfer products.
Ceregene,
Inc. (“Ceregene”), an
affiliate company of Cell Genesys, Inc., announced in November 2007 that it had
completed enrollment for its Phase 2 randomized controlled clinical trial for
Parkinson’s disease using AAV expressing the neurturin gene (a nerve growth
factor). In June 2007, Ceregene announced that it had entered into a partnership
with Genzyme for the development and commercialization of its Parkinson’s
indication. Under this partnership, Genzyme will gain all marketing
rights outside of the U.S. and Canada to Ceregene’s Parkinson’s
indication.
Genzyme
also purchased the AAV gene transfer assets of Avigen, Inc. (“Avigen”) in December
2005, including Avigen’s 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 had authorized it to initiate a Phase 1/2 clinical
trial of gene transfer for the treatment of Parkinson’s 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. This study is separate and distinct from
Ceregene’s study discussed above.
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 Parkinson’s
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 Parkinson’s disease in an attempt to stop the loss of
dopamine cells and possibly to promote growth. Amgen announced that
the decision to stop this program, which was in collaboration with Medtronic,
was based upon results of their Phase 2 clinical trial which showed no evidence
of efficacy compared with a placebo group and raised some safety
concerns.
Many of
the Company’s competitors have significantly greater research and development,
marketing, manufacturing, financial and/or managerial resources than the Company
enjoys. Moreover, developments by others may render the Company’s
products or technologies noncompetitive or obsolete.
Government
Regulation
All of
the Company’s potential products must receive regulatory approval before they
can be marketed. Human therapeutic products are subject to rigorous pre-clinical
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 Company’s potential products. Similar
requirements are imposed by foreign regulatory agencies. In some cases, state
regulations may also apply.
Gene
transfer 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”).
Pre-clinical
studies generally require studies in the laboratory or in animals to assess the
potential product’s safety and effectiveness. Pre-clinical studies include
laboratory evaluation of toxicity; pharmacokinetics, or how the body processes
and reacts to the drug; and pharmacodynamics, or whether the drug is actually
having the expected effect on the body. Pre-clinical studies must be conducted
in accordance with the FDA’s Good Laboratory Practice regulations and, before
any proposed clinical testing in humans can begin, the FDA must review the
results of these pre-clinical studies as part of an IND.
If
pre-clinical studies of a product candidate, including animal studies,
demonstrate safety, and laboratory test results are acceptable, then the
potential product may 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 FDA’s Good Clinical Practices regulations and
the protocols established by the Company 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 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”).
Institutions
that receive National Institutes of Health (“NIH”) funding for
gene transfer clinical trials must also comply with the NIH Recombinant DNA
Guidelines, and the 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. 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 Company's clinical
trials. (See “RISK FACTORS – The Company's Research Activities are
Subject to Review by the RAC”). On December 3, 2007, the Company reviewed
its Parkinson’s disease Phase 2 protocol with the RAC in a public
forum. The Company does not believe it will encounter a significant
delay in initiating its Phase 2 clinical trial as a result of the
meeting.
Clinical
trials are typically conducted in three phases and may involve multiple studies
in each phase. In Phase 1, 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 2, 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 3, 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 reports 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 Company’s results and the FDA’s requirements
for the particular clinical trial. Although the Company and other companies in
its industry have made progress in the field of gene transfer, 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”).
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 BLA to the FDA to receive the FDA’s approval
before the Company may commence commercial marketing. The BLA includes a
description of the Company’s product development activities, the results of
pre-clinical studies and clinical trials and detailed manufacturing information.
Unless the FDA gives expedited review status (which the Company has been
granted by the FDA with regards to Parkinson’s disease), this stage of the
review process generally takes at least one year. Should the FDA have concerns
with regard to the potential product’s 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:
|
·
|
modify
the scope of its desired product
claims;
|
|
·
|
add
warnings or other safety-related information;
and/or
|
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·
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perform
additional testing.
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Because
the FDA has not yet approved any gene transfer products, it is not clear what,
if any, unforeseen issues may arise during the approval process. The Company
expects the FDA’s 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 transfer increases. Adverse
events in the field of gene transfer 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
transfer products. (See “RISK FACTORS - Events in the General
Field of Gene Transfer may Affect the Company’s Ability to Develop its
Products”).
Once
approved by the FDA, marketed products are subject to continual review by the
FDA, 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 “RISK FACTORS - Once Approved by the FDA, the Company's
Products Would Remain Subject to Continual FDA Review” and “RISK FACTORS - The
Company May Face Liability Due to its Use of Hazardous Materials”).
For the
fiscal year ended December 31, 2007, the Company’s research and development
expenses were approximately $4.2 million, in the aggregate. This
represents a $639,000 increase in comparable research and development expenses
from fiscal year 2006. The Company expects research and development
expenses to increase in the current fiscal year, as the Company expects to
commence the Phase 2 clinical trial for Parkinson’s disease. (See Item 6 –
“Results of Operations”).
Employees
As of
December 31, 2007, the Company had eleven full-time employees, of which seven
are directly involved in its research and development activities, including
product development, manufacturing, regulatory affairs and clinical
affairs. Four of the Company’s employees have Ph.D. degrees, with
expertise in virology, protein chemistry and molecular biology. The
Company’s 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 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
2007.
Paul Greengard,
Ph.D. Dr. Greengard has been a member and the 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 Rockefeller. 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 Rockefeller 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 (“UMDNJ”). He
is also the Associate Director of Technology Development at Rutgers University’s
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
Functional Genomics in the Aab Institute for Biomedical Science at the
University of Rochester from which he also received his Ph.D.
Matthew J. During, M.D.,
D.Sc. Dr. During, one of the Company’s scientific co-founders,
has been a member of the SAB since October 1999. 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 AUL where he directs neuroscience and gene transfer
programs. From June 2004 to February 2006 he was the Research Lab
Director of the Department of Neurological Surgery at Cornell
University. He served as Director of the CNS Gene Therapy Center and
Professor of Neurosurgery at Jefferson Medical College from 1998 through
2002. From 1989 through 1998, Dr. During was a faculty member at Yale
University where he directed a translational neuroscience program and headed
Yale’s first gene transfer protocol. Dr. During is a graduate of the
AUL School of Medicine and did further postgraduate training at M.I.T. from 1985
to 1987, Harvard Medical School from 1986 to 1989 and Yale University from 1988
to 1989.
Michael G. Kaplitt, M.D.,
Ph.D. Dr. Kaplitt, one of the Company’s scientific
co-founders, has been a member of the SAB since October 1999. Dr.
Kaplitt is the Victor and Tara Menezes Clinical Scholar, Associate Professor and
Vice-Chairman for Research, Department of Neurological Surgery 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 Rockefeller. Dr. Kaplitt graduated magna cum laude with a
bachelor’s degree in molecular biology from Princeton University. He
received his M.D. from Cornell University School of Medicine in 1995, where he
completed his residency in Neurosurgery, and a Ph.D. in molecular neurobiology
from Rockefeller. 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 research interests have included the molecular
and cellular changes in neural networks following seizure activity and injury,
and the clinical problem of status epilepticus. More recently, he has
turned his attention to the genetics of epilepsy, and he is leading the
“Epilepsy Phenome/Genome Project,” a large, national study aimed at identifying
the genes responsible for the more common forms of epilepsy. Dr. Lowenstein has
received several national awards for excellence in teaching and numerous
academic honors and awards, including the American Epilepsy Society’s 2001 Basic
Research Award. Among his numerous publications, he has authored
approximately 80 papers in peer-reviewed journals, 80 research abstracts and 43
review articles, editorials and book chapters.
Andres M. Lozano, M.D.,
Ph.D. Dr. Lozano has been a member of the SAB since April
2001. Dr. Lozano receives an annual fee of $25,000 for his
participation in the SAB. He is currently Professor of Neurosurgery
and holds the Ronald Tasker Chair in Stereotactic and Functional Neurosurgery at
The University of Toronto. Dr. Lozano received his M.D. from the
University of Ottawa and a Ph.D. from McGill University. He completed
a residency in Neurosurgery at the Montreal Neurological Institute prior to
joining the staff at the University of Toronto. Dr. Lozano is the
Past President of the American Society for Stereotactic and Functional
Neurosurgery and the current President 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. Nestler’s research focuses on ways in
which the brain responds to repeated perturbations under normal and pathological
conditions, with a primary focus on drug addiction and depression. He
has authored or edited seven books, and published more than 300 articles and
reviews and 267 abstracts relating to the field of
neuropsychopharmacology. Since 2000, he has been the Lou and Ellen
McGinley Distinguished Chair in Psychiatric Research and Professor and Chairman
of the Department of Psychiatry at the University of Texas Southwestern Medical
Center. From 1992 to 2000, he was Director of the Abraham Ribicoff
Research Facilities and of the Division of Molecular Psychiatry at Yale
University. Dr. Nestler’s awards and honors include the Pfizer
Scholars Award (1987), Sloan Research Fellowship (1987), McKnight Scholar Award
(1989), Efron Award of the American College of Neuropsychopharmacology (1994)
and Pasarow Foundation Award for Neuropsychiatric Research (1998). He is a member of the
Institute of Medicine (elected 1998) and a fellow of the American Academy of
Arts and Sciences (elected 2005).
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, 2007, the Company has incurred net losses of
approximately $28.0 million and negative cash flows from operating activities of
approximately $21.6 million. Because it takes 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
Company’s 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 Company’s control, including market conditions and interest
rates. The Company does not know whether additional financing will be
available when needed, or, if available, whether any such financing will be on
terms acceptable or favorable to the Company.
The
Company Has Not Demonstrated that it Can Establish Many Necessary Business
Functions.
The
Company has not demonstrated that it can:
|
·
|
obtain
the regulatory approvals necessary to commercialize product candidates
that it may develop in the future;
|
|
·
|
manufacture,
or arrange for third parties to manufacture, future product candidates in
a manner that will enable the company to be
profitable;
|
|
·
|
attract,
retain and manage a large, diverse staff of physicians and
researchers;
|
|
·
|
establish
sales, marketing, administrative and financial
functions;
|
|
·
|
develop
relationships with third-party collaborators to assist in the marketing
and/or distribution of the technologies that the Company may
develop;
|
|
·
|
make,
use and sell future product candidates without infringing upon third party
intellectual property rights;
|
|
·
|
secure
meaningful intellectual property protection covering its future product
candidates; or
|
|
·
|
respond effectively to
competitive pressures.
|
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 Parkinson’s Disease are Unsuccessful, it Would Likely
Have a Material Adverse Effect on the Company’s Operations.
The
Company completed its Phase 1 clinical trial for the treatment of Parkinson’s
disease in 2006. The Company plans to pursue a Phase 2 clinical trial
prior to conducting a pivotal trial which could lead to commercialization of the
product. However, the Company cannot ensure that the Phase 2 clinical trial can
be completed successfully or that there will be no adverse effects or
immunologic reactions in the patients.
If the
planned clinical trials for treatment of Parkinson’s 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 - Parkinson’s Disease”).
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
Company’s ability to conduct further trials for its product candidates depends
upon a number of factors beyond the Company’s 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. The Company has experienced delays in the
commencement of its Phase 2 clinical trials for Parkinson’s disease and its
Phase 1 clinical trials for epilepsy. (See “BUSINESS OF THE COMPANY -
Parkinson’s Disease” and “BUSINESS OF THE COMPANY - Epilepsy”). As
described directly below, the Company’s ability to pursue further trials also
depends upon the Company’s ability to retain its current key physicians and
researchers. 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
Company’s Future Success Depends Upon Key Physicians and
Researchers.
The
Company’s future success depends, to a significant degree, on the skills,
experience and efforts of its current key physicians and researchers, including
Dr. Matthew During and Dr. Michael Kaplitt. If either of Dr. During
or Dr. Kaplitt were unable or unwilling to continue his present relationship
with the Company, it is likely that the Company's 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 that 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 transfer 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
Company’s gene transfer product into the brain. Currently the Company
plans to use a catheter system that was developed by Medtronic in collaboration
with the Company. To date, such system has not received regulatory
approval.
To the
Company’s knowledge, to date, neither the FDA nor any other regulatory agency
has approved a gene transfer product for sale in the United States.
The
Company's Research Activities are Subject to Review by the RAC.
As noted
above, institutions that receive NIH funding for gene transfer 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. Before any gene transfer
clinical trial can be initiated, the Institutional Biosafety Committee of each
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 Company’s future product candidates or the Company
itself. Outside the United States, the ability to market a product is
also contingent upon receiving clearances from appropriate foreign regulatory
authorities. The non-U.S. regulatory approval process includes risks
similar to those associated with the FDA’s 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 pre-clinical testing. It may take many years to complete
pre-clinical 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 pre-clinical 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 Company’s failure to adequately
demonstrate the safety and efficacy of future product candidates would prevent
the FDA from approving such products. The Company’s product
development costs will increase if it experiences delays in testing or
regulatory approvals or if it becomes necessary to perform more or larger
clinical trials than planned. If the delays are significant, they
could negatively affect the Company’s financial results, ability to raise
capital and the commercial prospects for future product candidates.
The
Company’s Future Success Depends Upon Acceptance of its Products by Health Care
Administrators and Providers.
The
Company’s 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 Company’s control, including:
|
·
|
the
safety and efficacy of future product candidates, as demonstrated in
clinical trials;
|
|
·
|
favorable
regulatory approval and product
labeling;
|
|
·
|
the
frequency of product use;
|
|
·
|
the
availability, safety, efficacy and ease of use of alternative
therapies;
|
|
·
|
the
price of future product candidates relative to alternative therapies;
and
|
|
·
|
the
availability of third-party
reimbursement.
|
Events
in the General Field of Gene Transfer May Affect the Company’s 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 (“SAE”) in the field of
gene transfer that may occur in the future, may result in greater governmental
regulation of future product candidates and potential regulatory delays relating
to the testing or approval of them. Even with the requisite approval,
the commercial success of the Company’s product candidates will depend in part
on public acceptance of the use of gene therapy for the prevention or treatment
of human disease. Public attitudes may be influenced by claims that
gene transfer is unsafe, and gene transfer may not gain the acceptance of the
public or the medical community. Negative public reaction to gene
transfer 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.
In July
2007, Targeted Genetics announced that the FDA had placed its gene transfer
program for the treatment of inflammatory arthritis on hold due to the
uncertainty of the cause of an SAE that occurred in one subject enrolled in the
study. In November 2007, the FDA removed the hold on the study, after
reviewing the safety data related to the SAE. The Company believes
this SAE and the related clinical hold, in general, effected the progress in the
area of gene transfer and specifically resulted in new testing requirements for
enrolled subjects’ safety.
Side
Effects, Patient Discomfort, Defects or Unfavorable Publicity May Affect the
Company’s Ability to Commercialize its Products.
The
Company’s results for its Phase 1 clinical trial for Parkinson’s disease
indicate that this treatment appears to be safe and well-tolerated in advanced
Parkinson’s 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 Company’s future trials may
significantly impact the Company’s ability to commercialize its products or
achieve market acceptance. Commercialization could also be materially
affected by unfavorable publicity concerning any of the Company’s future product
candidates, or any other product incorporating technology similar to that used
by future product candidates.
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 FDA’s
GMP.
|
The
Company’s 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 the FDA’s approval before producing
clinical material or commercial products. The Company’s future
product candidates may compete with other products for access to third-party
manufacturing facilities and may be subject to delays in manufacture if third
party manufacturers give priority to products other than the Company’s future
product candidates. The Company may be unable to manufacture
commercial-scale quantities of gene-based therapy products or any quantities at
all. Failure to successfully manufacture products in commercial-scale
quantities, and on a timely basis, would prevent the Company from achieving its
business objectives.
The
Company’s 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 Company’s industry, no assurance can be provided that its
future product candidates or technologies will not be found to infringe upon the
intellectual property or proprietary rights of others. Third parties
may claim that future product candidates or the Company’s technologies infringe
on their patents, copyrights, trademarks or other proprietary rights and demand
that it cease development or marketing of those products or technologies or pay
license fees. The Company may not be able to avoid costly patent
infringement litigation, which will divert the attention of management and cash
resources away from the development of new products and the operation of its
business. No assurance can be provided that the Company would prevail
in any such litigation. If the Company is found to have infringed on
a third party’s intellectual property rights, it may be liable for money
damages, encounter significant delays in bringing products to market or be
precluded from manufacturing particular future product candidates or using 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 Company’s technology, may involve injuries to persons using those
products as a result of mislabeling, misuse or product
failure. Product liability insurance is
expensive. Although the Company has purchased product liability
insurance to cover claims made in connection with its completed Phase 1 clinical
trial, its planned Phase 2 clinical trial for Parkinson’s disease and its
planned Phase 1 clinical trial for epilepsy, 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
Company’s research and development processes may involve the use of hazardous
materials, including chemicals and radioactive and biological
materials. The risk of accidental contamination or discharge or any
resultant injury from these materials cannot be completely
eliminated. Federal, state and local laws and regulations govern the
use, manufacture, storage, handling and disposal of these materials, 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 Company’s liability may exceed its total
assets. Compliance with environmental laws and regulations may be
expensive and current or future environmental regulations may impair the
Company’s research, development or production efforts.
Once
Approved by the FDA, the Company's 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 GMP 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,” “should,” “potential,” “continue” and
similar expressions, are intended to identify forward-looking
statements. These statements reflect the current view of the
Company’s management with respect to future events and are subject to numerous
risks, uncertainties, and assumptions. Many factors could cause the
actual results, performance or achievements of the Company to be materially
different from any future results, performance, or achievements that may be
expressed or implied by such forward-looking statements, including, among other
things:
|
·
|
the
inability of the Company to raise additional funds, when needed, through
public or private equity offerings, debt financings or additional
corporate collaboration and licensing
arrangements.
|
|
·
|
the
inability of the Company to successfully commence and complete all
necessary clinical trials for the commercialization of its product to
treat Parkinson’s disease.
|
Other
factors and assumptions not identified above could also cause the actual results
to differ materially from those set forth in the forward-looking
statements. Additional information regarding factors which could
cause results to differ materially from management’s expectations is found in
the section entitled “RISK FACTORS” starting on page 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 Company’s
expectations.
Item 2. Description of Property
In August
2004, the Company subleased 1,185 square feet of space at One Bridge Plaza, Fort
Lee, New Jersey 07024 (the “Sublease”) from
Palisade Capital Securities, LLC (“PCS”), an affiliated
company, for use as its corporate offices. The Sublease provided for a base
annual rent of approximately $36,000 or $3,000 per month. The
Sublease expired on January 31, 2008.
Effective
April 13, 2007, 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, which expires in March 2010, provides
for a base annual rent of approximately $21,000 or $2,000 per month through its
term.
Effective
February 1, 2008, the BPRA Lease was amended to include the office space leased
under the Sublease at a base annual rent of $36,000 or $3,000 per month through
the term of the BPRA Lease. The total annual rent for the Company’s
leased office space under the amended BPRA Lease is approximately $57,000 or
approximately $5,000 per month.
In April
2006, the Company entered into a Facility Use Agreement (the “Facility Use
Agreement”) and Visiting Scientist Agreements with The Ohio State
University (“OSU”), all of which
allow the Company’s scientists to access and use OSU’s 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 Facility Use Agreement
will automatically terminate upon the termination of the Research Agreement with
OSURF. As of December 31, 2007, the Company has paid OSU an amount of
$46,000 representing rent for the first two years of the Facility Use
Agreement. Unless sooner terminated, the Company will pay an
additional $47,000 over the remaining two years of such agreement. (See Note 10 to
Consolidated Financial Statements)
One of
the Company’s scientists conducts research at Cornell University in New York
City under the direction of Dr. Michael G. Kaplitt, as provided for by the
Company’s research agreement with Cornell.
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 2007.
PART II
Item 5. Market for Registrant’s Common Equity and Related
Stockholder Matters
The
Company is prohibited from declaring, paying or setting aside any distribution
or dividend for the shares of Common Stock, unless all accrued and unpaid
dividends have been paid in full on all outstanding shares of Series C
Convertible Preferred Stock, par value $0.10 per share (the “Series C Stock”), and
the Series D Stock.
The
Company had 542 stockholders of record as of December 31, 2007. The
Company did not pay cash dividends during the two-year period ended December 31,
2007 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
|
|
Fiscal
Year 2007
|
|
Fiscal
Year 2006
|
|
|
High
|
|
Low
|
|
High
|
|
Low
|
First
quarter
|
|
$
|
0.74 |
|
|
$
|
0.56 |
|
|
$
|
2.05 |
|
|
$
|
1.60 |
|
Second
quarter
|
|
$
|
1.95 |
|
|
$
|
0.60 |
|
|
$
|
1.80 |
|
|
$
|
1.15 |
|
Third
quarter
|
|
$
|
1.52 |
|
|
$
|
1.03 |
|
|
$
|
1.65 |
|
|
$
|
1.10 |
|
Fourth
quarter
|
|
$
|
1.19 |
|
|
$
|
0.91 |
|
|
$
|
1.16 |
|
|
$
|
0.62 |
|
Company
Equity Compensation Plans
The
following table sets forth information as of December 31, 2007, with respect to
compensation plans (including individual compensation arrangements) under which
equity securities of the Company are authorized for issuance.
Plan
Category
|
|
Number
of securities to be issued upon exercise of outstanding
options
|
|
Weighted-average
exercise price of outstanding options
|
|
Number
of securities remaining available for future issuance under equity
compensation plans
|
|
2000
Stock Option Plan approved by stockholders
|
|
|
2,857,333 |
|
|
|
1.62 |
|
|
|
14,852 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock
option grants to directors of the Corporation which grants were not
approved by stockholders
|
|
|
20,000 |
|
|
$
|
0.72 |
|
|
|
- |
|
Total
|
|
|
2,877,333 |
|
|
$
|
1.61 |
|
|
|
14,852 |
|
Item 6. Management’s 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, 2007. The Company’s fiscal year ends on the last day of
December in each year. References to 2007 and 2006 shall mean the
Company’s fiscal year ended on December 31st of such
year. All amounts in this Item 6 are in thousands.
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 transfer 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, 2007, the Company had an
accumulated deficit of $36,156, and it expects to incur additional losses in the
foreseeable future. The Company recognized net losses of $6,817 for
the year ended December 31, 2007, and $7,046 for the year ended December 31,
2006.
Since its
inception, the Company has financed its operations primarily through sales of
its equity and debt securities. From inception through December 31,
2007, the Company received proceeds primarily from private sales of equity and
debt securities and from the Merger of approximately $39,599 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
Company’s primary efforts are directed to develop therapeutic products (i) to
meet the needs of patients suffering from Parkinson’s disease and (ii) the needs
of patients suffering from a type of human epilepsy known as TLE.
Plan
of Operation
Parkinson’s
Disease
In
October 2006, the Company announced that it had completed its Phase 1 clinical
trial of gene transfer for Parkinson’s 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 Parkinson’s 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. These results along with additional
efficacy data were peer-reviewed and published in the June 23, 2007 issue of the
journal The Lancet and
the online edition of the Proceedings of the National Academy
of Sciences in November 2007.
The
Company plans to commence a Phase 2 clinical trial for Parkinson's disease in
the first half of 2008. 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 bilaterally in trial
subjects. Commencement of such trial is subject, among other things,
to concurrence by the FDA.
On
December 13, 2007, the Company announced that the FDA granted Fast Track
Designation for the Company’s Parkinson’s treatment. The receipt of
Fast Track Designation does not, however, assure the approval of any of the
Company’s study protocols or the ultimate approval of any BLA that may be
submitted by the Company to the FDA for marketing approval. (See “BUSINESS OF
THE COMPANY - Parkinson’s Disease”).
On
December 3, 2007, the Company reviewed its Parkinson’s disease Phase 2 protocol
with the RAC in a public forum. The Company does not believe it will
encounter a significant delay in initiating its Phase 2 clinical trial as a
result of the meeting. (See “RISK FACTORS – The Company’s Research Activities
are Subject to Review by the RAC”).
Since the
date of the Merger, the Company has accounted for the direct costs associated
with its Parkinson’s project, including research fees, license fees and
pre-clinical and clinical study costs. For the years ended December
31, 2007 and 2006, the Company has incurred $808 and $415 of these costs,
respectively. The costs in both years mainly relate to the
manufacturing of products to be used in the Company’s planned clinical
trials.
The
Company will also take steps to move toward a pivotal trial for treatment of
Parkinson's disease, and hopes to be in a position to file its protocol with the
FDA in 2010. Currently, the Company estimates that the pivotal trial
could be completed in 2012 and the estimated total costs to reach that milestone
are expected to be in excess of $20,000.
Epilepsy
In
December 2006, the Company submitted an IND to the FDA for permission to begin a
Phase 1 clinical trial in TLE. The proposed clinical protocol for
this study was presented to the RAC on September 23, 2004 and reviewed
favorably.
In
January 2008, the Company announced that as a result of comments from, and
discussions with, the FDA, the Company has decided to conduct an additional
pre-clinical study in non-human primates. The study will be designed
to confirm the safety of the administration and use of the
rAAV-NPY. The Company has submitted to the FDA a protocol design for
this study. The Company is unable to estimate the total time or costs
involved in conducting its Phase 1 clinical trial until such time that it
receives guidance from the FDA for the submitted protocol design. In
this regard, the commencement of a Phase 1 clinical trial will be subject, among
other things, to the successful completion of this additional pre-clinical
study, concurrence by the FDA, and procurement of related intellectual property
licenses. (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”).
Since the
date of the Merger, the Company has accounted for the direct costs associated
with its epilepsy project, including research fees, license fees and
pre-clinical and clinical study costs. For the years ended December
31, 2007 and 2006, the Company has incurred $454 and $54 of these costs,
respectively. The increase is primarily due to costs of manufacturing
products in 2007 for the Company’s planned Phase 1 clinical trial.
Until
successful completion of the additional pre-clinical study, the Company cannot
predict the timing or costs for the conduct of additional trials or for a filing
for the FDA’s approval of the epilepsy product. The Company is
undertaking all reasonable efforts to advance the commencement of its Phase 1
clinical trial.
Other
Therapies
The
Company will also continue its efforts in developing therapies to treat other
neurodegenerative and metabolic disorders including Huntington’s disease,
depression and genetically-based obesity under its research agreements with
Cornell and OSU. (See “BUSINESS OF THE COMPANY - Patents and Other
Proprietary Rights”). The cost and timing for further clinical and
pre-clinical trials and the FDA’s approval are subject to numerous risks, as
further described under “RISK FACTORS”.
2008
Expenditures
Over the
next 12 months, in addition to its normal recurring expenditures, the Company
expects to spend approximately: $3,500 in Phase 2 clinical trial expenses with
regard to its Parkinson’s treatment; $1,000 in costs associated with operating
as a publicly traded company, such as legal fees, accounting fees, insurance
premiums, investor and public relations fees; $1,000 in research and licensing
fees; $750 in pre-clinical study expenses with regard to its epilepsy product;
and $700 in expenses in order to scale up its manufacturing capabilities for the
supply of product for a Parkinson’s pivotal trial.
Results
of Operations
Year
Ended December 31, 2007 Compared to the Year Ended December 31,
2006
Revenues. The
Company did not generate any operating revenues in 2007 and 2006.
Research and Development
Expenses. The following table summarizes the Company’s
research and development expenses for fiscal years ended December 31, 2007 and
2006 (certain prior period amounts have been reclassified to conform to current
period presentation):
|
|
2007
|
|
2006
|
|
$
Change
|
Clinical
Trial Expenses
|
|
$
|
1,125 |
|
|
$
|
415 |
|
|
$
|
710 |
|
Compensation
Expenses
|
|
|
963 |
|
|
|
620 |
|
|
|
343 |
|
Research,
Development and Licensing Fees
|
|
|
834 |
|
|
|
1,388 |
|
|
|
(554 |
) |
Medical
and Scientific Consultants
|
|
|
618 |
|
|
|
679 |
|
|
|
(61 |
) |
Laboratory
Supplies
|
|
|
249 |
|
|
|
214 |
|
|
|
35 |
|
Other
R&D Expenses
|
|
|
431 |
|
|
|
265 |
|
|
|
166 |
|
Totals
|
|
$
|
4,220 |
|
|
$
|
3,581 |
|
|
$
|
639 |
|
Research
and development expenses increased by $639 in 2007 over the comparable expense
in 2006. The increase is, in part, due to a $710 rise in costs associated with
preparation for the commencement of the Company’s planned future clinical trials
for Parkinson’s disease and epilepsy, which included $518 in costs for study
product manufacturing and $195 in costs incurred by the clinical research
organization administering the trial. The increase was also due to
$343 in higher compensation expenses, as a result of an increase in the number
of the Company’s scientists in the full year 2007 over 2006, and $92 in costs
associated with process development for large scale manufacturing of the
Company’s products. These increases were offset by a reduction, from
the prior comparable period, of the $500 initial fee paid to Diamyd in 2006 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”).
General and Administrative
Expenses. General and administrative expenses decreased by
$819 to $3,085 in 2007 as compared to $3,904 in 2006. This decrease
was primarily due to a $497 decrease in compensation expense in 2007, mainly
related to the $232 charge for the accelerated vesting of and the extension of
the exercise period for Michael Sorell’s stock options in connection with his
resignation as the Company’s President and Chief Executive Officer in 2006, and
the $230 non-cash compensation charge in 2006 in connection with the hiring of
John E. Mordock, the Company’s President and Chief Executive
Officer. The decrease was also due to a $376 reduction in
professional fees in 2007, including $170 in lower consulting fees and $205 in
lower corporate legal fees.
Other Income (Expense),
Net. The Company had net other income of $488 in 2007 as
compared to net other income of $439 in 2006. This increase is a result of
increased interest income earned on funds received by the Company during the
fiscal year ended December 31, 2007 from its private placement of the Series D
Stock.
Liquidity
and Capital Resources
Cash and
cash equivalents were $20,157 at December 31, 2007.
The
Company is still in the development stage and has not generated any operating
revenues as of December 31, 2007. 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 Company’s current
resources will enable it to continue as a going concern through at least June
30, 2009. The Company’s existing 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 Parkinson’s
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”).
Net cash
used in operating activities was $5,401 in fiscal year 2007 as compared to
$4,888 in fiscal year 2006. The $513 increase in net cash used in
operations was primarily due to $513 in adjustments to net loss for decreased
non-cash expenses, such as stock-based compensation expense, depreciation
expense and amortization expense.
The
Company had net cash used in investing activities of $281 during the fiscal year
ended December 31, 2007 versus net cash provided by investing activities during
the fiscal year ended December 31, 2006, of $2,512. The $2,793
difference was primarily attributable to a decrease in net proceeds from
maturities of marketable securities of $2,800.
Net cash
provided by financing activities during the year ended December 31, 2007 was
$15,361 as compared to $11,599 during the year ended December 31,
2006. During the year ended December 31, 2007, the Company completed
a private placement of its Series D Stock that yielded $14,770 in net
proceeds. Also in 2007, the Company received proceeds from the
exercise of stock options of $591. During the year ended December 31,
2006, the Company completed a private placement of its Series C Stock that
yielded $11,612 in net proceeds.
Critical
Accounting Estimates and Policies
The
Company’s 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 (the “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, 2007, as outlined in
the accompanying notes to the financial statements, have been applied
consistently for the year ended December 31, 2007. The Company
believes the following critical accounting policies affect the significant
estimates and judgments used in the preparation of its consolidated financial
statements.
Carrying
Value of Fixed and Intangible Assets
The
Company’s fixed assets and certain of its patents have been recorded at
cost. The Company’s 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 Company’s estimates
of the future cash flows to be received from a particular long-lived asset could
indicate that the asset is impaired, and would require the Company to write-down
the asset’s carrying value at that time.
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 Company’s 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 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 that 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 Company’s 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 Company’s financial statements.
The
Company implemented SFAS No. 123R using the modified prospective
transition method. Under this method, prior periods are not
restated.
For
equity awards to non-employees, the Company also applies the Black-Scholes
method to determine the fair value of such investments in accordance with SFAS
No. 123R and Emerging Issues Task Force Issue 96-18, “Accounting for Equity
Instruments That Are Issued to Other Than Employees for Acquiring, or in
Conjunction with Selling, Goods, or Services.” The options granted to
non-employees are re-measured as they vest and the resulting value is recognized
as an expense against our net loss over the period during which the services are
received.
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. In February 2008, the FASB issued FSP 157-2 “Partial Deferral
of the Effective Date of Statement 157” (“FSP
157-2”). FSP 157-2 delays the effective date of SFAS 157, for
all nonfinancial assets and nonfinancial liabilities, except those that are
recognized or disclosed at fair value in the financial statements on a recurring
basis (at least annually) to fiscal years beginning after November 15,
2008. 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
February 2007, FASB issued SFAS No. 159, “The Fair Value Option for Financial
Assets and Financial Liabilities” (“SFAS 159”), including
an amendment to FASB No. 115. SFAS 159 provides entities with the irrevocable
option to measure eligible financial assets, financial liabilities and firm
commitments at fair value, on an instrument-by-instrument basis, that are
otherwise not permitted to be accounted for at fair value under other accounting
standards. The election, called the fair value option, will enable entities to
achieve an offset accounting effect for changes in fair value of certain related
assets and liabilities without having to apply complex hedge accounting
provisions. SFAS 159 is effective as of the beginning of a company’s first
fiscal year that begins after November 15, 2007. The Company is currently
evaluating the impact of SFAS 159, but does not expect the adoption of SFAS 159
to have a material impact on its consolidated financial position, results of
operations or cash flows.
In June
2007, the EITF reached a consensus on EITF Issue No. 07-3, “Accounting for
Nonrefundable Advance Payments for Goods or Services Received to Be Used in
Future Research and Development Activities” (“EITF 07-3”). EITF No.
07-3 requires that nonrefundable advance payments for goods or services that
will be used or rendered for future research and development activities be
deferred and amortized over the period that the goods are delivered or the
related services are performed, subject to an assessment of recoverability. The
provisions of EITF 07-3 will be effective for financial statements issued for
fiscal years beginning after December 15, 2008, and interim periods within those
fiscal years. Early application is prohibited. The provisions of this EITF are
applicable for new contracts entered into on or after the effective date. The
Company is currently assessing the potential impact, if any, the adoption of
EITF 07-3 may have on its consolidated financial position, results of operations
and cash flows.
In
December 2007, the FASB issued Statement No. 141 (revised 2007) (“SFAS 141R”),
“Business Combinations,” and Statement No. 160, “Noncontrolling Interests in
Consolidated Financial Statements” (“SFAS
160”). SFAS No. 141R requires an acquirer to measure the
identifiable assets acquired, the liabilities assumed and any noncontrolling
interest in the acquiree at their fair values on the acquisition date, with
goodwill being the excess value over the net identifiable assets acquired. This
standard also requires the fair value measurement of certain other assets and
liabilities related to the acquisition such as contingencies. SFAS 141R (revised
2007) applies prospectively to business combinations and is effective for fiscal
years beginning on or after December 15, 2008. The provisions of SFAS 141R will
impact the Company if it is party to a business combination after the
pronouncement has been adopted.
SFAS 160
requires that a noncontrolling interest in a subsidiary be reported as equity in
the consolidated financial statements. Consolidated net income should include
the net income for both the parent and the noncontrolling interest with
disclosure of both amounts on the consolidated statement of income. The
calculation of earnings per share will continue to be based on income amounts
attributable to the parent. The presentation provisions of SFAS 160 are to be
applied retrospectively, and SFAS 160 is effective for fiscal years beginning on
or after December 15, 2008. The Company is currently evaluating the impact of
SFAS 160, but does not expect the adoption of SFAS 160 to have a material impact
on its consolidated financial position, results of operations or cash
flows.
In
December 2007, the FASB ratified EITF Issue No. 07-1, “Accounting for
Collaborative Arrangements” (“EITF 07-1”). EITF
07-1 defines collaborative arrangements and establishes reporting requirements
for transactions between participants in a collaborative arrangement and between
participants in the arrangement and third parties. EITF 07-1 also establishes
the appropriate income statement presentation and classification for joint
operating activities and payments between participants, as well as the
sufficiency of the disclosures related to these arrangements. EITF 07-1 is
effective for fiscal years beginning after December 15, 2007. EITF 07-1 shall be
applied using a modified version of retrospective transition for those
arrangements in place at the effective date. An entity should report the effects
of applying EITF 07-1 as a change in accounting principle through retrospective
application to all prior periods presented for all arrangements existing as of
the effective date, unless it is impracticable to apply the effects of the
change retrospectively. The Company is currently assessing the potential impact,
if any, the adoption of EITF 07-1 may have on its consolidated financial
position, results of operations and cash flows.
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, 2007, and the related consolidated
statements of operations, changes in stockholders’ equity (deficit) and cash
flows for each of the two years in the period ended December 31, 2007, and for
the period from February 12, 1999 (inception) to December 31,
2007. These consolidated financial statements are the responsibility
of the Company’s management. Our responsibility is to express an
opinion on these consolidated financial statements based on our audits. We did
not audit the consolidated statements of operations, shareholders’ deficit and
cash flows for the period from February 12, 1999 (inception) to December 31,
2005, which reflect expenses of approximately $14.0 million, other expense, net
of $0.1 million, cash used in operating activities of $11.4 million, cash used
in investing activities of approximately $3.8 million and cash provided by
financing activities of $16.4 million. Those financial statements
were audited by another auditor whose report has been furnished to us, and our
opinion, insofar as it relates to the amounts included for such period, is based
solely on the report of the other auditor.
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. 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 Company’s 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 financial statement presentation. We believe that our audits
and the report of the other auditor provide a reasonable basis for our
opinion.
In our
opinion, based on our audits and the report of the other auditor, the
consolidated financial statements referred to above present fairly, in all
material respects, the financial position of the Company at December 31, 2007
and the results of its operations and its cash flows for each of the two years
in the period ended December 31, 2007, and for the period from February 12, 1999
(inception) to December 31, 2007, in conformity with accounting principles
generally accepted in the United States of America.
/s/ BDO
Seidman, LLP
BDO
Seidman, LLP
New York,
New York
March 24,
2008
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 period from February 12, 1999 (date of
inception) through December 31, 2005 as such amounts relate to the period from
February 12, 1999 (date of inception) through December 31,
2007. These consolidated financial statements are the responsibility
of the Company’s management. Our responsibility is to express an
opinion on these consolidated financial statements based on our
audits.
We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require
that we plan and perform the audit to obtain reasonable assurance about whether
the 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 period from February 12,
1999 (date of inception) through December 31, 2005 as such amounts relate to the
period from February 12, 1999 (date of inception) through December 31, 2007, 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 Form 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 Company’s ability to continue as a going
concern. Management’s plans concerning these matters are also
described in Note 1 in the 2005 Form 10-KSB. 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
NEUROLOGIX,
INC. AND SUBSIDIARY
(A
Development Stage Company)
CONSOLIDATED
BALANCE SHEET
(Amounts
in thousands, except share and per share amounts)
|
|
December
31,
2007
|
|
|
|
|
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash
and cash equivalents
|
|
$ |
20,157 |
|
Prepaid
expenses and other current assets
|
|
|
418 |
|
Total
current assets
|
|
|
20,575 |
|
Equipment,
less accumulated depreciation of $437
|
|
|
231 |
|
Intangible
assets, less accumulated amortization of $127
|
|
|
623 |
|
Other
assets
|
|
|
5 |
|
Total
Assets
|
|
$ |
21,434 |
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable and accrued expenses
|
|
$ |
1,265 |
|
Total
liabilities
|
|
|
1,265 |
|
|
|
|
|
|
Commitments
and contingencies
|
|
|
|
|
Stockholders’
equity:
|
|
|
|
|
Preferred stock; 5,000,000
shares authorized
|
|
|
|
|
Series A – Convertible, $0.10 par
value; 650 shares designated, 645 shares issued and outstanding with an
aggregate liquidation preference of $1
|
|
|
- |
|
Series C – Convertible, $0.10 par
value; 700,000 shares designated, 295,115 shares issued and outstanding
with an aggregate liquidation preference of $6,529
|
|
|
30 |
|
Series D – Convertible, $0.10 par
value; 792,100 shares designated, 597,149 shares issued and outstanding
with an aggregate liquidation preference of $22,673
|
|
|
60 |
|
Common Stock:
|
|
|
|
|
$0.001 par value; 100,000,000
shares authorized, 27,632,808 issued and outstanding
|
|
|
28 |
|
Additional paid-in
capital
|
|
|
56,207 |
|
Deficit
accumulated during the development stage
|
|
|
(36,156 |
) |
Total
stockholders’ equity
|
|
|
20,169 |
|
Total
Liabilities and Stockholders’ Equity
|
|
$ |
21,434 |
|
See
accompanying notes to consolidated financial statements.
NEUROLOGIX,
INC. AND SUBSIDIARY
(A
Development Stage Company)
CONSOLIDATED
STATEMENTS OF OPERATIONS
(Amounts
in thousands, except share and per share amounts)
|
|
|
|
Year
Ended December 31,
|
|
For
the period
February
12, 1999
(inception)
through
December
31, 2007
|
|
|
2007
|
|
2006
|
|
|
Revenues
|
|
$
|
- |
|
|
$
|
- |
|
|
$
|
- |
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
4,220 |
|
|
|
3,581 |
|
|
|
15,619 |
|
General
and administrative expenses
|
|
|
3,085 |
|
|
|
3,904 |
|
|
|
13,196 |
|
Loss
from operations
|
|
|
(7,305 |
) |
|
|
(7,485 |
) |
|
|
(28,815 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividend,
interest and other income
|
|
|
488 |
|
|
|
441 |
|
|
|
1,244 |
|
Interest
expense-related parties
|
|
|
- |
|
|
|
(2 |
) |
|
|
(411 |
) |
Other
income, net
|
|
|
488 |
|
|
|
439 |
|
|
|
833 |
|
Net
loss
|
|
|
(6,817 |
) |
|
|
(7,046 |
) |
|
$
|
(27,982 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred
stock dividends
|
|
|
(1,395 |
) |
|
|
(708 |
) |
|
|
|
|
Charge
for accretion of beneficial conversion feature
|
|
|
(2,130 |
) |
|
|
(2,621 |
) |
|
|
|
|
Charge
for contingent beneficial conversion feature related to Series C Preferred
Stock
|
|
|
(627 |
) |
|
|
- |
|
|
|
|
|
Charges
for induced conversion of Series C Preferred Stock
|
|
|
(2,796 |
) |
|
|
- |
|
|
|
|
|
Net
loss applicable to common stock
|
|
$
|
(13,765 |
) |
|
$
|
(10,375 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss applicable to common stock per share, basic and
diluted
|
|
$
|
(0.51 |
) |
|
$
|
(0.39 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average common shares outstanding, basic and diluted
|
|
|
26,764,087 |
|
|
|
26,542,924 |
|
|
|
|
|
See
accompanying notes to consolidated financial statements.
NEUROLOGIX,
INC. AND SUBSIDIARY
(A
Development Stage Company)
CONSOLIDATED
STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIENCY)
FOR
THE PERIOD FROM FEBRUARY 12, 1999 (INCEPTION) THROUGH DECEMBER 31,
2007
(Amounts
in thousands, except for share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
Series
D
|
|
Series
C
|
|
|
|
|
Additional
|
|
|
|
|
During
the
|
|
|
|
|
|
Preferred
Stock
|
|
Preferred
Stock
|
|
Common
Stock
|
|
Paid-in
|
|
Unearned
|
|
Development
|
|
|
|
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Capital
|
|
Compensation
|
|
Stage
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sale
of common stock to founders
|
|
|
- |
|
|
$
|
0 |
|
|
|
- |
|
|
$
|
0 |
|
|
|
6,004,146 |
|
|
$
|
0 |
|
|
$
|
4 |
|
|
$
|
0 |
|
|
$
|
0 |
|
|
$
|
4 |
|
Net
loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(328 |
) |
|
|
(328 |
) |
Balance,
December 31, 1999
|
|
|
- |
|
|
|
0 |
|
|
|
- |
|
|
|
0 |
|
|
|
6,004,146 |
|
|
|
0 |
|
|
|
4 |
|
|
|
0 |
|
|
|
(328 |
) |
|
|
(324 |
) |
Net
loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,055 |
) |
|
|
(1,055 |
) |
Balance,
December 31, 2000
|
|
|
- |
|
|
|
0 |
|
|
|
- |
|
|
|
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 |
|
|
|
- |
|
|
|
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 |
|
|
|
- |
|
|
|
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 |
|
|
|
- |
|
|
|
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 |
|
|
|
- |
|
|
|
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 |
|
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 |
|
|
|
- |
|
|
|
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
|
|
|
- |
|
|
|
0 |
|
|
|
368,155 |
|
|
$
|
37 |
|
|
|
26,542,924 |
|
|
$
|
27 |
|
|
$
|
34,573 |
|
|
$
|
- |
|
|
$
|
(23,786 |
) |
|
$
|
10,851 |
|
Sale
of Series D Preferred Stock through private placement at an average price
of $35.00 per share
|
|
|
428,571 |
|
|
|
43 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
14,727 |
|
|
|
- |
|
|
|
- |
|
|
|
14,770 |
|
Fair
value of beneficial conversion rights issued in connection with the
issuance of Series D Preferred Stock
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
2,130 |
|
|
|
- |
|
|
|
- |
|
|
|
2,130 |
|
Preferred
Dividend and accretion of fair value of beneficial conversion
charge
|
|
|
5,108 |
|
|
|
1 |
|
|
|
68,801 |
|
|
|
7 |
|
|
|
- |
|
|
|
- |
|
|
|
(8 |
) |
|
|
- |
|
|
|
(2,130 |
) |
|
|
(2,130 |
) |
Contingent
beneficial conversion feature related to Series C Preferred
Stock
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
627 |
|
|
|
- |
|
|
|
(627 |
) |
|
|
- |
|
Induced
conversion of preferred stock in connection with the issuance of Series D
Preferred Stock
|
|
|
163,470 |
|
|
|
16 |
|
|
|
(230,184 |
) |
|
|
(23 |
) |
|
|
- |
|
|
|
- |
|
|
|
(347 |
) |
|
|
- |
|
|
|
354 |
|
|
|
- |
|
Issuance
of Series C Preferred Stock in connection with induced conversion of
preferred stock
|
|
|
- |
|
|
|
- |
|
|
|
93,940 |
|
|
|
9 |
|
|
|
- |
|
|
|
- |
|
|
|
2,949 |
|
|
|
- |
|
|
|
(2,958 |
) |
|
|
- |
|
Issuance
of Common Stock in connection with issuance of Series D Preferred
Stock
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
192,017 |
|
|
|
- |
|
|
|
192 |
|
|
|
- |
|
|
|
(192 |
) |
|
|
- |
|
Employee
share-based compensation expense
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
702 |
|
|
|
- |
|
|
|
- |
|
|
|
702 |
|
Non-employee
share-based compensation
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
72 |
|
|
|
- |
|
|
|
- |
|
|
|
72 |
|
Conversion
of Series C Preferred Stock to Common Stock
|
|
|
- |
|
|
|
- |
|
|
|
(5,597 |
) |
|
|
- |
|
|
|
110,052 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Exercise
of stock options
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
787,815 |
|
|
|
1 |
|
|
|
590 |
|
|
|
- |
|
|
|
- |
|
|
|
591 |
|
Net
loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(6,817 |
) |
|
|
(6,817 |
) |
Balance,
December 31, 2007
|
|
|
597,149 |
|
|
$
|
60 |
|
|
|
295,115 |
|
|
$
|
30 |
|
|
|
27,632,808 |
|
|
$
|
28 |
|
|
$
|
56,207 |
|
|
$
|
- |
|
|
$
|
(36,156 |
) |
|
$
|
20,169 |
|
See
accompanying notes to consolidated financial statements.
NEUROLOGIX,
INC. AND SUBSIDIARY
(A
Development Stage Company)
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(Amounts
in thousands)
|
|
|
Year
Ended December 31,
|
|
For
the period February 12, 1999 (inception) through
December
31, 2007
|
2007
|
|
2006
|
Operating
activities:
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
(6,817 |
) |
|
$
|
(7,046 |
) |
|
$
|
(27,982 |
) |
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
108 |
|
|
|
67 |
|
|
|
443 |
|
Amortization
|
|
|
48 |
|
|
|
118 |
|
|
|
267 |
|
Gain
on redemption of investment
|
|
|
(62 |
) |
|
|
- |
|
|
|
(62 |
) |
Stock
options granted for services
|
|
|
- |
|
|
|
- |
|
|
|
9 |
|
Impairment
of intangible assets
|
|
|
17 |
|
|
|
- |
|
|
|
165 |
|
Amortization
of non-employee share-based compensation
|
|
|
135 |
|
|
|
83 |
|
|
|
1,432 |
|
Share-based
employee compensation expense
|
|
|
702 |
|
|
|
1,193 |
|
|
|
1,895 |
|
Non-cash
interest expense
|
|
|
- |
|
|
|
- |
|
|
|
378 |
|
Changes
in operating assets and liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
(Increase)
decrease in prepaid expenses and other current assets
|
|
|
(68 |
) |
|
|
851 |
|
|
|
602 |
|
Increase
(decrease) in accounts payable and accrued expenses
|
|
|
536 |
|
|
|
(154 |
) |
|
|
1,204 |
|
Net
cash used in operating activities
|
|
|
(5,401 |
) |
|
|
(4,888 |
) |
|
|
(21,649 |
) |
Investing
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Security
deposits paid
|
|
|
- |
|
|
|
- |
|
|
|
(7 |
) |
Purchases
of equipment
|
|
|
(170 |
) |
|
|
(92 |
) |
|
|
(560 |
) |
Additions
to intangible assets
|
|
|
(176 |
) |
|
|
(196 |
) |
|
|
(1,025 |
) |
Proceeds
from redemption of investment
|
|
|
65 |
|
|
|
- |
|
|
|
65 |
|
Purchases
of marketable securities
|
|
|
- |
|
|
|
(5,000 |
) |
|
|
(12,673 |
) |
Proceeds
from maturities of marketable securities
|
|
|
- |
|
|
|
7,800 |
|
|
|
12,673 |
|
Net
cash (used in) provided by investing activities
|
|
|
(281 |
) |
|
|
2,512 |
|
|
|
(1,527 |
) |
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 |
) |
|
|
(99 |
) |
Proceeds
from exercise of stock options
|
|
|
591 |
|
|
|
- |
|
|
|
733 |
|
Proceeds
from issuance of common stock and warrants
|
|
|
- |
|
|
|
- |
|
|
|
5,066 |
|
Proceeds
from issuance of preferred stock
|
|
|
14,770 |
|
|
|
11,612 |
|
|
|
29,495 |
|
Net
cash provided by financing activities
|
|
|
15,361 |
|
|
|
11,599 |
|
|
|
43,333
|
|
Net
increase in cash and cash equivalents
|
|
|
9,679 |
|
|
|
9,223 |
|
|
|
20,157 |
|
Cash
and cash equivalents, beginning of period
|
|
|
10,478 |
|
|
|
1,255 |
|
|
|
- |
|
Cash
and cash equivalents, end of period
|
|
$
|
20,157 |
|
|
$
|
10,478 |
|
|
$
|
20,157 |
|
NEUROLOGIX,
INC. AND SUBSIDIARY
(A
Development Stage Company)
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(Amounts
in thousands)
|
|
|
Year
Ended December 31,
|
|
For
the period February 12, 1999 (inception) through December 31,
2007
|
|
|
2007
|
|
2006
|
|
Supplemental
disclosure of non-cash investing and financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends
on Series C Preferred Stock paid in preferred shares
|
|
$
|
1,197 |
|
|
$
|
614 |
|
|
$
|
1,811 |
|
Accrued
dividends on Preferred Stock
|
|
$
|
198 |
|
|
$
|
94 |
|
|
$
|
292 |
|
Accretion
of fair value of beneficial conversion on preferred stock
|
|
$
|
2,130 |
|
|
$
|
2,621 |
|
|
$
|
4,751 |
|
Accretion
of contingent beneficial conversion related on Series C Preferred
Stock
|
|
$
|
627 |
|
|
|
- |
|
|
$
|
627 |
|
Induced
conversion of preferred stock in connection with issuance of
Series D Preferred Stock
|
|
$
|
2,796 |
|
|
|
- |
|
|
$
|
2,796 |
|
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
|
|
|
- |
|
|
|
|
|
|
$
|
1,424 |
|
Deferred
research and development cost resulting from Medtronic Stock
Purchase
|
|
|
- |
|
|
|
|
|
|
$
|
795 |
|
Acquisition
of equipment through capital leases
|
|
|
- |
|
|
|
- |
|
|
$
|
106 |
|
See
accompanying notes to consolidated financial statements.
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 $6,817, $7,046 and $27,982 and negative cash
flows from operating activities of $5,401, $4,888 and $21,649 for the years
ended December 31, 2007 and 2006 and for the period from February 12, 1999
(inception) to December 31, 2007, respectively. The Company expects
that it will continue to incur net losses and cash flow deficiencies from
operating activities for the foreseeable future.
On
November 19, 2007, the Company completed a private placement of its newly
created series of preferred stock, the Series D Convertible Preferred Stock, par
value $0.10 per share (the “Series D Stock”),
resulting in net proceeds to the Company, after expenses, of $14,770 (See Note
9). As of December 31, 2007, the Company had cash and cash equivalents of
$20,157. Management believes that, as a result of this offering, the
Company’s current resources will enable it to continue as a going concern
through at least June 30, 2009. The Company’s existing resources,
however, 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 the merger (the “Merger”) of its
newly-formed, wholly-owned subsidiary NRI. Following the Merger, NRI
became a wholly-owned subsidiary of the Company and stockholders of NRI received
an aggregate number of shares of the Company’s common stock, par value $0.001
per share (the “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
outstanding 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.
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 was 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
subsidiary’s results of operations from that date.
On
September 10, 2004, the Company amended and restated its Certificate of
Incorporation, as a result of which it effected a reverse stock split of the
shares of Common Stock at a ratio of 1 for 25 and reduced the Company’s number
of authorized shares of Common Stock from 750,000,000 to
60,000,000. All information related to 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 Company’s 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.
On May 9,
2007, at the Company’s Annual Meeting of Stockholders, the Company’s Certificate
of Incorporation was restated to: (i) increase the number of authorized shares
of Common Stock from 60,000,000 to 100,000,000, (ii) increase the total number
of authorized shares of capital stock from 65,000,000 to 105,000,000, (iii)
delete the designation of Series B Preferred Stock and (iv) decrease the number
of authorized shares of Series A Preferred Stock from 300,000 to
650.
(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.
Neurologix,
Inc. and Subsidiary
(A
Development Stage Company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts
in thousands, except for share and per share amounts)
(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 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
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 their
estimated useful lives, which range from 15 to 20 years. Neurologix
estimates amortization expenses related to intangible assets owned as of
December 31, 2007 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 asset’s 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 $17 and $0 associated with abandoned patent applications that were
written-off in 2007 and 2006, respectively.
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 reduct deferred tax assets to the
amount expected to be realized.
In June 2006, the FASB issued FASB
Interpretation No. 48 (“FIN
48”) “Accounting for
Uncertainty in Income Taxes (an interpretation of FASB Statement No. 109”) which
became effective in 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. For those benefits to be
recognized, a tax position must be more likely than not to be sustained upon
examination by the taxing authorities. The amount recognized is
measured as the largest amount of benefit that is greater than 50 percent likely
of being realized upon ultimate settlement. The provisions of FIN 48
were adopted by the Company on January 1, 2007 and had no effect on the
Company's financial statements upon adoption, as the Company did not have any
unrecognized tax benefits. The Company also evaluated its tax positions as of
December 31, 2007 and reached the same conclusion.
(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 Company’s 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.
Neurologix,
Inc. and Subsidiary
(A
Development Stage Company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts
in thousands, except for share and per share amounts)
(k) Stock-Based
Compensation:
At
December 31, 2007, 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) or if there is a
termination of employment event for specified reasons set forth in certain
employment agreements. When options are exercised, new shares of Common Stock
are issued.
At the
Company’s Annual Meeting of Stockholders held on May 9, 2006, the Company’s 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 SFAS No. 123, “Accounting for Stock-Based Compensation” (“SFAS No.
123”).
Effective
January 1, 2006, the Company adopted SFAS 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 SFAS 123.
The
amount of compensation expense recognized under SFAS No. 123R during the years
ended December 31, 2007 and 2006 was comprised of the following (in
thousands):
|
|
Fiscal
Year Ended December 31,
|
|
|
2007
|
|
2006
|
Research
and development
|
|
$
|
219 |
|
|
$
|
134 |
|
General
and administrative
|
|
|
483 |
|
|
|
1,059 |
|
Share-based
compensation expense
|
|
$
|
702 |
|
|
$
|
1,193 |
|
Net
share-based compensation expenses per basic and diluted common
share
|
|
$
|
(0.03 |
) |
|
$
|
(0.04 |
) |
Neurologix,
Inc. and Subsidiary
(A
Development Stage Company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts
in thousands, except for share and per share amounts)
A summary
of option activity as of December 31, 2007 and changes during the year then
ended is presented below:
|
|
Shares
Subject to Option (000)
|
|
Weighted-
Average Exercise Price
|
|
Weighted-Average
Remaining Contractual Term (years)
|
|
Aggregate
Intrinsic Value
|
Outstanding
at December 31, 2005
|
|
|
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 |
|
|
|
|
|
Granted
|
|
|
718 |
|
|
|
1.15 |
|
|
|
|
|
Exercised
|
|
|
(788 |
) |
|
|
0.75 |
|
|
|
|
|
Forfeited
or expired
|
|
|
(69 |
) |
|
|
1.56 |
|
|
|
|
|
Outstanding
at December 31, 2007
|
|
|
2,877 |
|
|
$
|
1.61 |
|
|
6.95
|
|
$
0
|
Exercisable
at December 31, 2007
|
|
|
1,970 |
|
|
$
|
1.74 |
|
|
6.07
|
|
$
0
|
The fair
value of each stock option award is estimated under SFAS No. 123R 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. See Note 7 for additional
information about the Company’s stock compensation plans. The
risk-free rate is based on the five-year U.S. Treasury security
rate.
The
expected option 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 award's 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"; exercisability 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.
In
December 2007, the Securities and Exchange Commission (the “SEC”) issued Staff
Accounting Bulletin No. 110, or SAB 110. SAB 110 was effective January 1, 2008
and expresses the views of the Staff of the SEC regarding extending the use of
the simplified method, as discussed in SAB No. 107, in developing an estimate of
the expected term of "plain vanilla" share options in accordance with SFAS No.
123R.
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 are the assumptions used with the Black-Scholes option pricing model
in determining stock-based compensation under SFAS No. 123R in 2007 and
2006:
|
|
|
|
|
|
|
|
Expected
option term
|
|
5
to 6 years
|
|
5
to 6.5 years
|
Risk-free
interest rate
|
|
4.63%
|
|
4.07%
- 5.10%
|
Expected
volatility
|
|
89.2%
|
|
86.5%
- 90.3%
|
Dividend
yield
|
|
0%
|
|
0%
|
For
equity awards to non-employees, the Company also applies the Black-Scholes
method to determine the fair value of such awards in accordance with SFAS No.
123R and Emerging Issues Task Force Issue 96-18, “Accounting for Equity
Instruments That Are Issued to Other Than Employees for Acquiring, or in
Conjunction with Selling, Goods, or Services.” The options granted to
non-employees are re-measured as they vest and the resulting value is recognized
as an expense against our net loss over the period during which the services are
received.
(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.
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,
|
|
|
|
2007
|
|
|
2006
|
|
Stock
options
|
|
|
2,877,333 |
|
|
|
3,015,829 |
|
Warrants
|
|
|
6,364,334 |
|
|
|
3,131,585 |
|
Common
Stock issuable upon conversion of Series A Convertible Preferred
Stock
|
|
|
645 |
|
|
|
645 |
|
Common
Stock issuable upon conversion of Series C Convertible Preferred
Stock
|
|
|
6,336,827 |
|
|
|
7,238,995 |
|
Common
Stock issuable upon conversion of Series D Convertible Preferred
Stock
|
|
|
18,017,418 |
|
|
|
- |
|
(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. In February 2008, the FASB issued FSP 157-2 “Partial Deferral
of the Effective Date of Statement 157” (“FSP
157-2”). FSP 157-2 delays the effective date of SFAS 157, for
all nonfinancial assets and nonfinancial liabilities, except those that are
recognized or disclosed at fair value in the financial statements on a recurring
basis (at least annually) to fiscal years beginning after November 15,
2008. 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.
Neurologix,
Inc. and Subsidiary
(A
Development Stage Company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts
in thousands, except for share and per share amounts)
In
February 2007, FASB issued SFAS No. 159, “The Fair Value Option for Financial
Assets and Financial Liabilities” (“SFAS 159”), including
an amendment to FASB No. 115. SFAS 159 provides entities with the irrevocable
option to measure eligible financial assets, financial liabilities and firm
commitments at fair value, on an instrument-by-instrument basis, that are
otherwise not permitted to be accounted for at fair value under other accounting
standards. The election, called the fair value option, will enable entities to
achieve an offset accounting effect for changes in fair value of certain related
assets and liabilities without having to apply complex hedge accounting
provisions. SFAS 159 is effective as of the beginning of a company’s first
fiscal year that begins after November 15, 2007. The Company is currently
evaluating the impact of SFAS 159, but does not expect the adoption of SFAS 159
to have a material impact on its consolidated financial position, results of
operations or cash flows.
In June
2007, the EITF reached a consensus on EITF Issue No. 07-3, “Accounting for
Nonrefundable Advance Payments for Goods or Services Received to Be Used in
Future Research and Development Activities” (“EITF 07-3”). EITF No.
07-3 requires that nonrefundable advance payments for goods or services that
will be used or rendered for future research and development activities be
deferred and amortized over the period that the goods are delivered or the
related services are performed, subject to an assessment of recoverability. The
provisions of EITF 07-3 will be effective for financial statements issued for
fiscal years beginning after December 15, 2008, and interim periods within those
fiscal years. Early application is prohibited. The provisions of this EITF are
applicable for new contracts entered into on or after the effective date. The
Company is currently assessing the potential impact, if any, the adoption of
EITF 07-3 may have on its consolidated financial position, results of operations
and cash flows.
In December 2007, the FASB
issued Statement No. 141 (revised 2007) (“SFAS 141R”),
“Business Combinations,” and Statement No. 160, “Noncontrolling Interests in
Consolidated Financial Statements” (“SFAS
160”). SFAS No. 141R requires an acquirer to measure the
identifiable assets acquired, the liabilities assumed and any noncontrolling
interest in the acquiree at their fair values on the acquisition date, with
goodwill being the excess value over the net identifiable assets acquired. This
standard also requires the fair value measurement of certain other assets and
liabilities related to the acquisition such as contingencies. SFAS 141R (revised
2007) applies prospectively to business combinations and is effective for fiscal
years beginning on or after December 15, 2008. The provisions of SFAS 141R will
impact the Company if it is party to a business combination after the
pronouncement has been adopted.
SFAS 160
requires that a noncontrolling interest in a subsidiary be reported as equity in
the consolidated financial statements. Consolidated net income should include
the net income for both the parent and the noncontrolling interest with
disclosure of both amounts on the consolidated statement of income. The
calculation of earnings per share will continue to be based on income amounts
attributable to the parent. The presentation provisions of SFAS 160 are to be
applied retrospectively, and SFAS 160 is effective for fiscal years beginning on
or after December 15, 2008. The Company is currently evaluating the impact of
SFAS 160, but does not expect the adoption of SFAS 160 to have a material impact
on its consolidated financial position, results of operations or cash
flows.
Neurologix,
Inc. and Subsidiary
(A
Development Stage Company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts
in thousands, except for share and per share amounts)
In
December 2007, the FASB ratified EITF Issue No. 07-1, “Accounting for
Collaborative Arrangements” (“EITF 07-1”). EITF
07-1 defines collaborative arrangements and establishes reporting requirements
for transactions between participants in a collaborative arrangement and between
participants in the arrangement and third parties. EITF 07-1 also establishes
the appropriate income statement presentation and classification for joint
operating activities and payments between participants, as well as the
sufficiency of the disclosures related to these arrangements. EITF 07-1 is
effective for fiscal years beginning after December 15, 2007. EITF 07-1 shall be
applied using a modified version of retrospective transition for those
arrangements in place at the effective date. An entity should report the effects
of applying EITF 07-1 as a change in accounting principle through
retrospective application to all prior periods presented for all arrangements
existing as of the effective date, unless it is impracticable to apply the
effects of the change retrospectively. The Company is currently assessing the
potential impact, if any, the adoption of EITF 07-1 may have on its consolidated
financial position, results of operations and cash flows.
(3) Related
Party Transactions:
The
Company is party to an Amended and Restated Consulting Agreement, dated April
25, 2005, with Dr. Michael G. Kaplitt (“Michael Kaplitt”),
one of the Company’s scientific co-founders and the son of Dr. Martin J. Kaplitt
(“Martin
Kaplitt”), the Company’s Chairman of the Board. Pursuant to
the terms of this agreement, Michael Kaplitt provides advice and consulting
services on an exclusive basis in scientific research on human gene transfer in
the nervous system and serves as a member of the Company’s Scientific Advisory
Board (the “SAB”). Michael
Kaplitt was paid an annual retainer of $100 in equal quarterly installment
payments from October 2005 through September 2006. Effective October
1, 2006, Michael Kaplitt’s annual retainer was increased to $175 payable in
equal quarterly installment payments, which installment payments commenced in
January 2007. The Company paid Michael Kaplitt approximately $119 and
$175 in retainer fees in 2006 and 2007 respectively,
thereunder. Under this agreement, the Company granted Michael 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. Michael Kaplitt
is also the neurosurgeon who performed the surgical procedures on the twelve
patients required by the protocol for the Company’s sponsored Phase 1 clinical
trial for the treatment of Parkinson’s disease.
Neurologix,
Inc. and Subsidiary
(A
Development Stage Company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts
in thousands, except for share and per share amounts)
In
accordance with The Rockefeller University’s (“Rockefeller”)
Intellectual Property Policy, an aggregate of one-third of all income that it
receives from licensing transactions is paid to the
inventors. Michael Kaplitt has advised the Company that he received
less than $2 in each of 2007 and 2006 from Rockefeller as a result of payments
made by the Company to Rockefeller under a non-exclusive license
agreement. (See Note 10). 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. Rockefeller sold these shares in 2007, and Michael
Kaplitt received approximately $75 from the proceeds of the
sale. Michael Kaplitt estimates that he will be entitled to
receive approximately one-third of the proceeds of future royalties or other
amounts that may become payable by the Company to Rockefeller under the
Company’s license agreements with Rockefeller and the Rockefeller-Yale Agreement
(as defined below). (See Note 10).
Dr.
Matthew During, a founder of the Company and a member of its SAB, has advised
the Company that in each of 2006 and 2007 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
2006 and 2007. Dr. During will also have a similar interest in future
royalties or other amounts that may become payable under the agreement with
TJU.
Dr.
During has also advised the Company that in each of 2006 and 2007, he received
less than $2 from Yale University (“Yale”) as a result of
payments made by the Company to Yale under a non-exclusive license
agreement. The amounts received by Dr. During represent approximately
25% of the total payments made by the Company to Yale in each of 2006 and
2007. Dr. During will also have a similar interest in future
royalties or other amounts that may become payable under the agreement with
Yale.
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 2008. (See Note
10).
In August
2004, the Company subleased office space at One Bridge Plaza, Fort Lee, New
Jersey from Palisade Capital Securities, LLC (“PCS”), an affiliated
company, for use as its corporate offices for a base annual rent of
approximately $36 or $3 per month, and such lease expired on January 31,
2008.
Effective
July 17, 2006, Dr. Michael Sorell (“Dr. Sorell”) resigned
as the Company’s 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 paid Dr. Sorell
severance of $185 payable in equal semi-monthly installments through September
30, 2007. The agreement also provided for the immediate vesting of
Dr. Sorell’s stock options. Such options, to the extent not
exercised, terminated on December 31, 2007.
Effective
February 23, 2007, the Company entered into a consulting agreement with Martin
Kaplitt. Under the terms of this agreement, Martin Kaplitt provided
medical and scientific consulting and advisory services to the Company for a one
year period, and received compensation at an annual rate of
$85. Martin Kaplitt’s consulting agreement was extended for an
additional one-year term, effective January 1, 2008, at an annual rate of
$110. Effective February 23, 2007, Martin Kaplitt no longer served as
the Executive Chairman of the Company, but continues to serve as Chairman of the
Company’s Board of Directors.
Neurologix,
Inc. and Subsidiary
(A
Development Stage Company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts
in thousands, except for share and per share amounts)
On
November 19, 2007, the Company issued and sold 142,857 shares of Series D Stock
at a price of $35.00 per share, or a total of approximately $5,000 to General
Electric Pension Trust (“GEPT”), as part of a
private placement transaction. As part of this transaction, GEPT also
exchanged 230,184 shares of the Company’s Series C Convertible Preferred Stock,
par value $0.10 per share (the “Series C Stock”),
representing all of such shares of Series C Stock then owned by GEPT, for (i)
93,940 newly issued shares of Series C Stock and (ii) 163,470 shares of Series D
Stock (See Note 9). At the time of the transaction, GEPT was a beneficial owner
of more than five percent of the Company’s voting securities.
(4) Notes
Receivable
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, the Company established a full valuation allowance for the
remaining principal amount of the Notes totaling $473, after both consultants
were continually delinquent in their payments. By December 2004, the
Company entered into settlement agreements with both consultants which provide
for payments totaling $153 to be made through July 2009. As of
December 31, 2007, the Company recovered a total of $133 under these settlement
agreements and wrote off the remaining $20 from its balance
sheet. The Company has recorded all recoveries received through
December 31, 2007 to other income in its consolidated statement of
operations.
(5) Income
Taxes:
Deferred
income taxes reflect the net tax effects of temporary differences between the
carrying amounts of assets and liabilities for financial reporting purposes and
the amounts used for income tax purposes. Significant components of
the Company’s deferred tax assets as of December 31 are as follows:
|
|
December
31,
|
|
|
2007
|
|
2006
|
Net
deferred income tax assets:
|
|
|
|
|
|
|
Net
operating losses
|
|
$
|
10,525 |
|
|
$
|
8,010 |
|
Research
& development credit
|
|
|
1,152 |
|
|
|
855 |
|
Depreciable
assets
|
|
|
56 |
|
|
|
0 |
|
Equity
based compensation
|
|
|
1,027 |
|
|
|
0 |
|
Total
net deferred income tax assets
|
|
|
12,760 |
|
|
|
8,865 |
|
Valuation
allowance
|
|
|
(12,760 |
) |
|
|
(8,865 |
) |
Total
net deferred income tax assets
|
|
$
|
- |
|
|
$
|
- |
|
Neurologix,
Inc. and Subsidiary
(A
Development Stage Company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts
in thousands, except for share and per share amounts)
At
December 31, 2007, the Company has net operating loss carryforwards (“NOLs”)
of approximately $26,352 which, if not used, expire through
2027. The Company has a deferred tax asset from research and
development credits of approximately $1,152 at December 31, 2007, which, if not
used, will also expire through 2027. The utilization of these NOLs
may be subject to limitations based on past and future changes in ownership of
the Company pursuant to Internal Revenue Code Section 382. The
Company has determined that an ownership change had occurred as of November 19,
2007, although it does not believe that the changes in ownership to date will
restrict its ability to use its losses and credits within the carryforward
period. 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 Company’s ability to utilize its deferred tax
assets, a valuation allowance for the full amount of the deferred tax assets of
$12,760 has been established at December 31, 2007. There are no other
significant permanent or temporary differences.
As a
result of the increases in the valuation allowance of $3,895, $2,253 and $12,760
during the years ended December 31, 2007 and 2006 and for the period from
February 12, 1999 (inception) to December 31, 2007, respectively, there are no
income tax benefits reflected in the accompanying consolidated statements of
operations to offset pre tax losses.
The
provisions of FIN 48 were adopted by the Company on January 1, 2007 and had no
effect on the Company's financial position, cash flows or results of operations
upon adoption, as the Company did not have any unrecognized tax benefits. The
Company also evaluated its tax positions as of December 31, 2007 and reached the
same conclusion. The Company does
not currently expect any significant changes to unrecognized tax benefits during
the fiscal year ended December 31, 2008. The Company’s practice is to
recognize interest and/or penalties related to income tax matters in income tax
expense. As of January 1, 2007 and December 31, 2007, the Company had no accrued
interest or penalties.
In
certain cases, the Company’s uncertain tax positions are related to tax years
that remain subject to examination by the relevant tax
authorities. The Company files U.S. and state income tax returns in
jurisdictions with varying statutes of limitations. The 2004 through
2007 tax years generally remain subject to examination by federal and most state
tax authorities.
(6) Agreements
with Dr. Michael Sorell
Effective
September 21, 2004, the Board entered into an employment agreement with Dr.
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. Sorell’s
salary was increased to $200 effective April 27, 2005. In addition to
cash compensation, Dr. Sorell’s employment agreement also provided for the grant
of options as described in Note 7.
Effective
July 17, 2006, Dr. 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 continued as a
director of the Company, without further compensation, through May
2007.
The
Company paid Dr. Sorell severance of $185, in equal semi-monthly installments
through September 30, 2007. The Company recognized this amount as
compensation expense in July 2006.
Neurologix,
Inc. and Subsidiary
(A
Development Stage Company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts
in thousands, except for share and per share amounts)
In
connection with the Separation 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, to the extent not
exercised, terminated on December 31, 2007. 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. Sorell’s 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 Company’s stockholders to increase the number of shares available for
issuance by 3,000,000 shares. As of December 31, 2007, the Company
had 14,852 shares available for issuance under the plan.
On
November 9, 2005, the Board decided that all non-vested options held by any of
the Company’s 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 unvested. The fair value of these
options is being amortized to expense over the term of the respective consulting
agreements. The amount charged to operations for the years ended
December 31, 2007 and 2006 were $63 and $325, respectively.
Dr.
Sorell’s Options
Base Stock Option Grant – The
Company was 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.
Neurologix,
Inc. and Subsidiary
(A
Development Stage Company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts
in thousands, except for share and per share amounts)
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. Sorell’s 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 was $154.
On July
17, 2006, Dr. Sorell resigned as the Company’s President and Chief Executive
Officer. In connection with such resignation, the Company and Dr.
Sorell entered into a Separation Agreement (See Note 6).
Option
Activity
The
following table summarizes the Company’s option activity for the years ended
December 31, 2007 and 2006:
|
|
Number
of Shares
|
|
|
Weighted
Average Exercise Price
|
January
1, 2006
|
|
|
2,225,220 |
|
|
$
|
1.25 |
|
Granted
|
|
|
1,155,000 |
|
|
|
1.53 |
|
Forfeited/Cancelled
|
|
|
(364,391 |
) |
|
|
0.09 |
|
January
1, 2007
|
|
|
3,015,829 |
|
|
|
1.50 |
|
Granted
|
|
|
718,333 |
|
|
|
1.15 |
|
Exercised
|
|
|
(787,815 |
) |
|
|
0.75 |
|
Forfeited/Cancelled
|
|
|
(69,014 |
) |
|
|
1.56 |
|
December
31, 2007
|
|
|
2,877,333 |
|
|
$
|
1.61 |
|
Employee
stock options are granted at a price equal to the fair market value of the
Company’s stock on the date of the grant. The weighted average grant-date fair
value of options granted during 2007 and 2006 was $0.86 and $1.15, respectively
and were estimated using the Black Scholes option valuation model. The total
intrinsic value of options exercised during 2007 was $393. There were no options
exercised during 2006. The total intrinsic value of options
outstanding and options exercisable at December 31, 2007 and 2006 was $0 because
all outstanding options were out of the money as of December 31, 2007 and
2006.
As of
December 31, 2007, there was approximately $326 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 year.
Neurologix,
Inc. and Subsidiary
(A
Development Stage Company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts
in thousands, except for share and per share amounts)
As of
December 31, 2007, there were 1,970,102 outstanding stock options that had
vested with a weighted average exercise price of $1.74 and a weighted average
remaining contractual term of 6.1 years.
Warrants
On
November 19, 2007, in connection with the sale of the Series D Stock, the
Company issued warrants to purchase approximately 3,232,758 shares of Common
Stock at an exercise price of $1.39 per share that expire on November 19, 2014
(See Note 9). If such warrants are not exercised by November 19, 2014
they will terminate. The Company initially computed the fair value of the
warrants, or $2,482, 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 D Stock. As a result of that allocation, the
value of the common shares issuable upon the conversion of the Series D 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 D Stock by
$2,130. 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, 2007 as an increase in the net loss for the purposes of
determining the net loss applicable to common stock in 2007. The warrants are
exercisable at any time within their terms. No such warrants were
exercised in the year ended December 31, 2007.
On May
10, 2006, in connection with the sale of the Series C Stock, the Company issued
warrants (the “Series
C Warrants”) to purchase approximately 2,224,718 shares of Common Stock
at an exercise price of $2.05 per share that expire on May 10, 2013 (See Note
9). 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 Stock. As a result of that allocation, the value of the
common shares issuable upon the conversion of the Series C 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 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 years ended December 31, 2007 and 2006. As a result
of the sale of the Series D Stock, the exercise price of the Series C Warrants
was adjusted to $1.81 per share.
In
connection with the sale of shares of Common Stock to investors led by Merlin
Biomed Group, the Company, during the period from February 4, 2005 to April 4,
2005, issued five-year warrants to purchase a total of 618,470 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. The Common Stock has not exceeded $3.25, and
therefore the Company has not been entitled to exercise its call
right. No such warrants were exercised in the fiscal years ended
December 31, 2007 and 2006.
Neurologix,
Inc. and Subsidiary
(A
Development Stage Company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts
in thousands, except for share and per share amounts)
In
connection with the sale of shares of Common Stock to Medtronic International,
Ltd. (“Medtronic
International”) (See Note 9) the Company, on April 27, 2005, issued
five-year warrants to purchase a total of 285,388 shares of Common Stock at an
exercise price of $2.19 per share. 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, beginning in August 2007, 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, 2007 and 2006.
The
following summarizes warrant activity for the years ended December 31, 2007 and
2006:
|
|
Warrants
|
|
|
Weighted
Average Exercise Price
|
January
1, 2006
|
|
|
906,858 |
|
|
$
|
1.88 |
|
Granted
|
|
|
2,224,718 |
|
|
|
1.81 |
|
January
1, 2007
|
|
|
3,131,576 |
|
|
|
1.83 |
|
Granted
|
|
|
3,232,758 |
|
|
|
1.39 |
|
December
31, 2007
|
|
|
6,364,334 |
|
|
$
|
1.61 |
|
The
weighted-average remaining contractual life of warrants outstanding was 5.4
years at December 31, 2007 and 2006, respectively. The exercise
prices for the warrants outstanding at December 31, 2007 ranged from $1.39 to
$25.00.
(8) Accounts
Payable and Accrued Expenses
Accounts
payable and accrued expenses consist of the following:
|
|
December 31,
|
|
|
2007
|
Accounts
payable
|
|
$
|
487 |
|
Compensation
|
|
|
208 |
|
Clinical
trial fees
|
|
|
174 |
|
Accounting
and auditing fees
|
|
|
144 |
|
Consulting
fees
|
|
|
121 |
|
Research
fees
|
|
|
98 |
|
Other
|
|
|
33 |
|
|
|
$
|
1,265 |
|
Neurologix,
Inc. and Subsidiary
(A
Development Stage Company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts
in thousands, except for share and per share amounts)
(9) Private
Placements
Series
D Convertible Preferred Stock
On
November 19, 2007 the Company issued and sold 428,571 shares of Series D Stock,
at a price of $35.00 per share, or a total of $15,000, to GEPT and Corriente
Master Fund, L.P. (collectively, the “Series D Investors”)
in a private placement transaction, resulting in net proceeds after expenses of
approximately $14,770. Each share of Series D Stock is currently
convertible into 30.17 shares of Common Stock per share. The Series D
Stock is not redeemable by the Company.
The
Company also entered into a Registration Rights Agreement (the “Registration Rights
Agreement”), dated as of November 19, 2007, by and among the Company, the
Series D Investors and the holders (the “Series C Investors”)
of the Series C Stock, which provides, collectively to the Series D Investors
and the Series C Investors, certain registration rights for the shares of Common
Stock underlying the securities of the Company owned by them.
As part
of this transaction, each share of Series C Stock, held by a Series C Investor
who purchased at least the same dollar amount of Series D Stock as its initial
purchase of Series C Stock, was automatically converted, effective as of the
Closing Date, into 0.710172 shares of Series D Stock and 0.408109 additional
shares of Series C Stock. As a result, an aggregate of 230,184 shares
of Series C Stock was converted into 163,470 shares of Series D Stock and 93,940
shares of newly issued Series C Stock. Because the Company redeemed
certain investors’ convertible preferred stock for other securities, the
Company, in accordance with EITF D-42 “The Effect on the
Calculation of Earnings per Share for the Redemption or Induced Conversion of
Preferred Stock,” calculated the excess of (1) the fair value of all
securities and other consideration transferred to the participating Series C
Investors over (2) the fair value of securities issuable pursuant to the
original Series C Stock conversion terms. This excess, or $2,604, was
used to calculate net loss applicable to common stock for the year ended
December 31, 2007.
Additionally,
the Company issued 192,017 shares of Common Stock to the Series C Investors that
did not participate in the Series D Stock financing, in exchange for their
consent to the issuance of the Series D Stock and to certain amendments to the
Series C Stock Subscription Agreement and the Series C Certificate of
Designation. The fair value of such issuance, $192, was used to
calculate net loss applicable to common stock for the year ended December 31,
2007.
Upon a
liquidation event (such as a liquidation, merger or sale of substantially all of
the Company’s assets), the holders of the Series D Stock, on a pari passu basis
with the holders of the Company’s Series A Preferred Stock, will have a
liquidation preference prior and in preference to the holders of the Series C
Stock and Common Stock or any other class or series of capital stock ranking
junior to the Series D Stock, and will be entitled to receive a per share amount
equal to the greater of: (i) $35 plus all accrued and unpaid
dividends thereon or (ii) the amount payable upon conversion of the Series D
Stock into shares of Common Stock.
The
Series D Stock accrues dividends at a rate of 7% per annum, payable in
semi-annual installments, which accrue, cumulatively, until paid. As
of December 31, 2007, the Company accrued dividends of Series D Stock with a
fair value of $179. The Company disclosed this aggregate amount of
arrearages in cumulative dividends on the face of the statement of operations
below the net loss line, and such amount was used to calculate net loss
applicable to common stock and common stock per share.
Neurologix,
Inc. and Subsidiary
(A
Development Stage Company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts
in thousands, except for share and per share amounts)
The
Series D Investors shall vote together with all other classes and series of
capital stock of the Company as a single class on all actions to be taken by the
Company’s stockholders, except that, as long as the Series D Stock comprises at
least 5% of the Company’s outstanding capital stock, the approval of the holders
in interest of 70% of the Series D Stock is required to (i) create any new class
of capital stock that is senior to, or on parity with, the Series D Stock, (ii)
amend the Company’s Certificate of Incorporation, including the Series D
Certificate, in any manner that adversely affects the Series D Stock and (iii)
purchase or redeem any of the Company’s capital stock or pay dividends
thereon. Each share of Series D Stock will be entitled to a number of
votes per share equal to the number of shares of Common Stock underlying such
share of Series D Stock.
The
Series D Stock’s conversion rate will be adjusted if the Company issues Common
Stock (or convertible securities) at a price per share below
$1.16. There is no termination date for this anti-dilution
protection. The Series D 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 D Stock, the Company also issued warrants
to purchase approximately 3,232,758 shares of Common Stock at an exercise price
of $1.39 per share that expire on November 19, 2014 (See Note 7).
Series
C Convertible Preferred Stock
On May
10, 2006, the Company issued and sold 342,857 shares of Series C Stock, at a
price of $35.00 per share, or a total of approximately $12,000, to GEPT,
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 Stock, including all dividends paid to date, are currently convertible
into approximately 21.4724 shares of Common Stock per share. The
Series C 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 Company's assets), the holders of Series C Stock will have a
liquidation preference prior and in preference to the holders of Common Stock or
any other class or series of capital stock ranking junior to the Series C Stock,
and 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.
Neurologix,
Inc. and Subsidiary
(A
Development Stage Company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts
in thousands, except for share and per share amounts)
Through
November 19, 2007, the Series C Stock accrued paid-in-kind cumulative dividends
at a rate of 9% per annum, payable in quarterly installments in shares of Series
C Stock (“PIK Dividends”). Effective November 19, 2007, certain terms
of the Series C Stock were amended as part of the issuance of Series D Stock,
including the payment of a 9% semi-annual cash dividend in lieu of the PIK
Dividends, and the inclusion of a provision that allows the Company to pay
accrued and unpaid dividends in either cash or shares of Common Stock upon
conversion of the Series C Stock. As of December 31, 2007, the Company paid
dividends by issuing approximately 90,858 shares of Series C Stock with a fair
value of $1,811. As of December 31, 2007, the Company accrued cash
dividends of Series C Stock with a fair value of $113.
Each
share of Series C 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 Stock comprises at least 5% of the Company's outstanding securities,
the Company may not create any new class of stock that is pari passu with or
senior to the Series C Stock and junior to the Series D Stock without the
consent of the holders of at least 70% of the Series C Stock.
As a
result of the issuance of Series D Stock, in accordance with the contingent
anti-dilution terms of the original Series C Stock’s Certificate of Designation,
the Series C Stock’s conversion rate was adjusted from 19.6629 to 21.4724 shares
of Common Stock per share. This anti-dilution adjustment resulted in
a contingent beneficial conversion charge of $627, which was used to calculate
net loss applicable to common stock for the year ended December 31,
2007.
The
Series C Preferred Stock’s conversion rate will be further adjusted if the
Company issues Common Stock (or convertible securities) at a price per share
that is less than $1.63. There is no termination date for this
anti-dilution protection. The Series C 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 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 (See Note 7).
In
accordance with the contingent anti-dilution terms of the Series C Warrants, the
exercise price of the warrants originally issued to the Series C Investors was
adjusted from $2.05 to $1.81 per share.
The
holders of both the Series C Stock and the Series D Stock, among other things,
have certain demand and piggyback registration rights with respect to the Common
Stock underlying the Series C Stock, the Series D Stock and warrants issued to
the Series C Investors and the Series D Investors.
Neurologix,
Inc. and Subsidiary
(A
Development Stage Company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts
in thousands, except for share and per share amounts)
Medtronic’s
Stock
On April
27, 2005, Medtronic International, in conjunction with a development and
manufacturing agreement between the Company and Medtronic, Inc. (“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 was expensed over the 24 month term of the agreement on a
straight-line basis. The deferred research and development cost
represented 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 2007 and 2006 were
approximately $132 and $398. The Company has the option to call the
warrant following the thirtieth month after the 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. (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
(“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 transfer treatment of Parkinson’s disease as conducted
by the Company during its Phase 1 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 began paying 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.
In
September 1999 and April 2001, the Company entered into two license agreements
with Rockefeller whereby Rockefeller granted to the Company the sole and
exclusive right and license, under the ownership rights of the university, to
certain patent rights and technical information. Pursuant to the
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, such license agreements
were replaced and incorporated as part of a new license agreement, also covering
an additional patent. 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 was being
amortized to research and licensing expense over four years, the estimated
benefit period. The amount charged to operations for each of the
years ended December 31, 2007 and 2006 was $0 and $132.
Neurologix,
Inc. and Subsidiary
(A
Development Stage Company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts
in thousands, except for share and per share amounts)
In 2002,
the Company entered into two license agreements with 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 TJU 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 through the term of the agreement,
as well as benchmark payments and royalties. 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 in October
2021. The Company has the right to terminate the agreements at any
time upon 90 days written notice to TJU. 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, 2007 and December 31, 2006 was $95. (See Note 3).
In August
2002, the Company entered into a license agreement with Rockefeller and Yale
(the “Rockefeller-Yale
Agreement”) 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. The Company has the right to
terminate the agreement at any time upon 90 days written notice. The
Company expenses maintenance fees when the services are rendered. The
amount charged to operations in connection with the Rockefeller-Yale Agreement
for each of the years ended December 31, 2007 and December 31, 2006 was
$10.
Research
Agreements:
Effective
May, 2006, the Company entered into a Sponsored Research Agreement (“Research
Agreement”) with The Ohio State University Research Foundation (“OSURF”) which
provides for research covering the development of gene transfer approaches to
neurodegenerative disorders, including Parkinson's disease, epilepsy,
Huntington's disease, Alzheimer's disease, as well as gene transfer approaches
to pain, stroke, neurovascular diseases and other research. The
Research Agreement required the Company to pay $250 over the initial 18 month
term, which expired in November 2007. The Company and OSURF have
agreed to extend the term of the Research Agreement for a period of one
additional year. The amounts charged to operations in connection with
the sponsored research for the years ended December 31, 2007 and 2006 were $167
and $104.
On April
15, 2005, the Company entered into a research agreement (the “Auckland Agreement”)
with Auckland Uniservices, Ltd. (“Auckland”) whereby
Auckland performed certain research activities for a fee 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 included gene transfer research
studies on Parkinson’s disease. In addition, the research included
work on gene delivery systems, new viral and non-viral vectors, animal models of
neurological and metabolic diseases and pre-clinical gene transfer studies on
epilepsy and other neurological disorders. In October 2006, the term
of the Auckland Agreement expired and was not renewed. The Company
made payments of $0 and $94 in 2007 and 2006, respectively.
Neurologix,
Inc. and Subsidiary
(A
Development Stage Company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts
in thousands, except for share and per share amounts)
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
Parkinson’s disease and temporal lobe epilepsy (“TLE”) 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, 2007, the Company had
paid $638 to Medtronic for milestones achieved, consisting of a $213 up front
fee paid upon signing of the Development Agreement, the amount of which has been
expensed over the 24 month term of the agreement. In 2007, the
Company expensed and accrued $213 for milestones achieved. Following regulatory
approval and commercialization of the Product, Medtronic will pay certain
commissions to the Company 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 transfer
products developed by the Company for Parkinson’s disease or TLE.
On July
2, 2003, the Company entered into a Clinical Study Agreement (the “Clinical Study
Agreement”) with Cornell University for its Medical College (“Cornell”) to sponsor
the Company’s Phase 1 clinical trial for the treatment of Parkinson’s
disease. Under this agreement, the Company 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, 2007 and 2006 were $0
and $12, respectively.
On
September 24, 2004, the parties amended the Clinical Study Agreement to provide
for research covering the development of gene transfer approaches to
neurodegenerative disorders, including Parkinson’s disease, Huntington’s
disease, Alzheimer’s disease and epilepsy (the “Scientific
Studies”). On March 2, 2007, the parties entered into
Amendment No. 2 to the Clinical Study Agreement to further revise and expand the
scope of the work to be performed. This sponsored research is funded
by the Company and is being conducted in Cornell’s Laboratory of Molecular
Neurosurgery under the direction of Michael Kaplitt, one of the Company’s
scientific co-founders. These amendments to the Clinical Study
Agreement extend the period of performance of the Scientific Studies through
August 31, 2008. This period may be extended for additional one-year
terms by mutual written agreement of both parties. The Company is
required to pay Cornell $200 per year for the duration of the Scientific
Studies. 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, 2007 and 2006 were $172 and
$135, respectively.
Neurologix,
Inc. and Subsidiary
(A
Development Stage Company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts
in thousands, except for share and per share amounts)
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 Company’s Parkinson’s disease Phase 1 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,
2007 and 2006 were $0 and $37, respectively. Such clinical study
agreement expired in 2006 when the last of the Company’s Phase 1 Parkinson’s
disease clinical trial participants was evaluated.
Consulting
and Employment Agreements:
Effective
July 17, 2006, the Company hired John E. Mordock to serve as its President and
Chief Executive Officer under a letter agreement dated as of July 17,
2006. Mr. Mordock was initially paid an annual base salary of $200,
which was increased to $250 effective January 1, 2007.
On
December 4, 2007, the Company entered into an employment agreement with Mr.
Mordock, which superseded his letter agreement. The employment
agreement provides that Mr. Mordock shall be employed by the Company for a
period of two years, shall initially receive an annual base salary of at least
$250 and shall be eligible to receive an annual bonus in the discretion of the
Board. During the period of his employment, Mr. Mordock will be
reimbursed for temporary housing and automobile expenses related to his
employment. If Mr. Mordock’s employment is terminated by the Company
without “Cause” or by Mr. Mordock for “Good Reason” (including a “Change in
Control”), as those terms are defined in his employment agreement, he shall be
entitled to a cash payment equal to the lesser of (i) one year of base salary or
(ii) the base salary payable for the remaining term of the employment
agreement. In addition, all of his options shall immediately vest and
be exercisable for up to one year following the date of any such
termination. As of December 31, 2007, total unrecognized compensation
cost related to Mr. Mordock’s stock option awards was approximately
$43.
Effective
July 10, 2006, Dr. Christine V. Sapan was appointed as Executive Vice President,
Chief Development Officer of the Company under a letter agreement dated June 23,
2006. Dr. Sapan’s base annual salary was $225 and she is eligible to
receive a discretionary annual bonus, with a target bonus of 40% of her annual
base salary. In the event of her relocation, Dr. Sapan will be
reimbursed by the Company for all reasonable moving expenses in connection with
such relocation. During the first six months of employment, Dr. Sapan
was reimbursed for temporary housing and automobile expenses. If Dr.
Sapan’s employment is terminated by the Company without “Cause” (as defined in
her letter agreement), or by Dr. Sapan as a result of a demotion of her position
or diminution in her duties or a “Change of Control” (as defined in the 2000
Stock Option Plan), she will be entitled to receive a payment of twelve months’
base salary. All of her options shall immediately vest and be
exercisable for up to one year following the date of any such
termination. As of December 31, 2007, total unrecognized compensation
cost related to Dr. Sapan’s stock option awards was approximately
$81.
Neurologix,
Inc. and Subsidiary
(A
Development Stage Company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts
in thousands, except for share and per share amounts)
On
January 23, 2006, the Company hired Marc L. Panoff as its Chief Financial
Officer and Treasurer under a letter agreement dated as of December 15,
2005. Mr. Panoff was also appointed as the Company’s Secretary on May
9, 2006. Mr. Panoff initially received an annual base salary of $165,
which was increased to $185 effective January 1, 2007.
On
December 4, 2007, the Company entered into an employment agreement with Mr.
Panoff, which superseded his letter agreement. The employment
agreement provides that Mr. Panoff shall be employed by the Company for a period
of two years, shall initially receive an annual base salary of at least $185 and
shall be eligible to receive an annual bonus in the discretion of the
Board. If Mr. Panoff’s employment is terminated by the Company
without “Cause” or by Mr. Panoff for “Good Reason” (including a “Change in
Control”), as those terms are defined in his employment agreement, he shall be
entitled to a cash payment equal to the lesser of (i) one year of base salary or
(ii) the base salary payable for the remaining term of the employment
agreement. In addition, all of his options shall immediately vest and
be exercisable for up to one year following the date of any such
termination. As of December 31, 2007, total unrecognized compensation
cost related to Mr. Panoff’s stock option awards was approximately
$53.
Effective
October 1, 2007, the Company extended, for a period of one year, the term of its
consulting agreement with Dr. Matthew J. During, one of the Company’s scientific
founders. Pursuant to the consulting agreement, dated as of October 1, 1999, as
amended, Dr. During provides advice and consulting services to the Company on an
exclusive basis in scientific research on human gene transfer in the central
nervous system. The consulting agreement also provides for Dr. During to assist
the Company in its fund raising efforts and to serve as a member of the
Company’s SAB. Dr. During’s agreement, as amended, provides for
payments of $175 per annum. The Company paid Dr. During $175 in
retainer fees in both 2007 and 2006.
The
Company is party to an Amended and Restated Consulting Agreement, dated April
25, 2005, with Michael Kaplitt, one of the Company’s scientific co-founders and
the son of Martin Kaplitt, the Company’s Chairman of the
Board. Pursuant to the terms of this agreement, Michael Kaplitt
provides advice and consulting services on an exclusive basis in scientific
research on human gene transfer in the nervous system and serves as a member of
the Company’s SAB. Michael Kaplitt was paid an annual retainer of
$100 in equal quarterly installment payments from October 2005 through September
2006. Effective October 1, 2006, Michael Kaplitt’s annual retainer
was increased to $175 payable in equal quarterly installment payments, which
installment payments commenced in January 2007. The Company paid
Michael Kaplitt approximately $119 and $175 in retainer fees in 2006 and 2007,
respectively, thereunder. Under this agreement, the Company granted
Michael 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. Michael Kaplitt is also the neurosurgeon who performed the
surgical procedures on the twelve patients required by the protocol for the
Company’s sponsored Phase 1 clinical trial for the treatment of Parkinson’s
disease.
Neurologix,
Inc. and Subsidiary
(A
Development Stage Company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts
in thousands, except for share and per share amounts)
Effective
February 23, 2007, the Company entered into a consulting agreement with Martin
Kaplitt. Under the terms of this agreement, Martin Kaplitt provided
medical and scientific consulting and advisory services to the Company for a
one-year period, and received compensation at an annual rate of
$85. Martin Kaplitt’s consulting agreement was extended for an
additional one-year term, effective January 1, 2008, at an annual rate of
$110. Effective February 23, 2007, Martin Kaplitt no longer served as
the Executive Chairman of the Company, but continues to serve as Chairman of the
Company’s Board of Directors.
On June 20, 2005, the Company executed a Consulting
Agreement (the “
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 additional 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 because the Company’s management team had been put in place
and Mr. Hertzog’s services were no longer needed. The Company paid Mr. Hertzog
$0 and $78 in retainer fees in 2007 and 2006, respectively. In
connection with the Hertzog Agreement, the Company granted Mr. Hertzog
non-qualified stock options to acquire up to 250,000 shares of Common Stock at
an exercise price of $1.83 per share.
The
Company has consulting agreements with five scientists who, in addition to
Michael Kaplitt and Dr. During, comprise the Company’s SAB. These
agreements provide that the scientists are engaged by the Company to provide
advice and consulting services in scientific research on human gene transfer in
the brain and central nervous system and to assist the Company in seeking
financing and meeting with prospective investors.
In May
2003, the Company entered into a stock purchase agreement to sell shares of its
Common Stock at a purchase price of $0.01 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, was 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, with automatic one year
renewals, until terminated by either party pursuant to the terms of the
agreement. 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.
Neurologix,
Inc. and Subsidiary
(A
Development Stage Company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts
in thousands, except for share and per share amounts)
Operating
Lease Agreements:
In August
2004, the Company entered into a lease agreement for laboratory facilities at
Columbia University in New York City, 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 at an annual rent of
$53. Effective April 2006, the Company terminated the lease agreement
with no further lease obligations.
In August
2004, the Company subleased office space at One Bridge Plaza, Fort Lee, New
Jersey (the “Sublease”) from PCS,
an affiliated company, for use as its corporate offices (See Note
3).
Effective
April 13, 2007, the Company entered into a lease (the “BPRA Lease”) with
Bridge Plaza Realty Associates, LLC (“BPRA”) for additional
office space at One Bridge Plaza, Fort Lee, New Jersey. The BPRA
Lease, which expires in March 2010, provides for a base annual rent of
approximately $21 through its term.
Effective
February 1, 2008, the BPRA Lease was amended to include the office space leased
under the Sublease at a base annual rent of $36 through the term of the BPRA
Lease. The total annual rent for the Company’s leased office space
under the amended BPRA Lease is approximately $57.
In April
2006, the Company entered into a Facility Use Agreement (the “Facility Use
Agreement”) and Visiting Scientist Agreements with The Ohio State
University (“OSU”), all of which
allow three of the Company’s scientists to access and use OSU’s 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 Facility Use Agreement will automatically
terminate upon the termination of the Research Agreement with
OSURF. As of December 31, 2007, the Company has paid OSU an amount of
$46 representing rent for the first two years of the Facility Use
Agreement. Unless sooner terminated, the Company will pay an
additional $47 over the remaining two years of such agreement.
One of
the Company’s scientists conducts research at Cornell University in New York
City under the direction of Michael Kaplitt, as provided for by the Company’s
research agreement with Cornell.
The
Company incurred total rent expense associated with operating leases and
subleases of $79 and $74 for the years ended December 31, 2007 and 2006,
respectively.
Neurologix,
Inc. and Subsidiary
(A
Development Stage Company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts
in thousands, except for share and per share amounts)
At
December 31, 2007, approximate future lease payments under the Company’s
operating leases and subleases are as follows:
Year
Ending December 31,
|
|
|
|
2008
|
|
$
|
80 |
|
2009
|
|
|
81 |
|
2010
|
|
|
17 |
|
2011
and thereafter
|
|
|
- |
|
|
|
$
|
178 |
|
Item 8. Changes in and Disagreements with Accountants on
Accounting and Financial Disclosure
None.
Item
8A(T). Controls and Procedures
Disclosure Controls and
Procedures.
The
Company maintains disclosure controls and procedures as required under Rule
13a-15(e) and Rule 15d-15(e) promulgated under the Exchange Act, that are
designed to ensure that information required to be disclosed in the Company’s
Exchange Act reports is recorded, processed, summarized and reported within the
time periods specified in the SEC’s rules and forms, and that such information
is accumulated and communicated to the Company’s management, including its Chief
Executive Officer and Chief Financial Officer, as appropriate, to allow timely
decisions regarding required disclosure.
As of
December 31, 2007, the Company’s management carried out an evaluation, under the
supervision and with the participation of the Company’s Chief Executive Officer
and Chief Financial Officer, of the effectiveness of its disclosure controls and
procedures. Based on the foregoing, its Chief Executive Officer and Chief
Financial Officer concluded that the Company’s disclosure controls and
procedures were effective as of December 31, 2007.
Management’s Annual Report on
Internal Control Over Financial Reporting.
The
Company’s management is responsible for establishing and maintaining adequate
internal control over financial reporting. The Company’s internal control over
financial reporting is a process designed to provide reasonable assurance
regarding the reliability of financial reporting and the preparation of the
Company’s financial statements for external purposes in accordance with
generally accepted accounting principles. Internal control over financial
reporting is defined in Rules 13a-15(f) and 15d-15(f) promulgated under the
Exchange Act.
As of
December 31, 2007, the Company’s management assessed the effectiveness of the
Company’s internal control over financial reporting based on criteria for
effective internal control over financial reporting established in “Internal
Control — Integrated Framework,” issued by the Committee of Sponsoring
Organization of the Treadway Commission (“COSO”). Based on this
assessment, management has determined that the Company’s internal control over
financial reporting, as of December 31, 2007, is effective.
Because
of its inherent limitations, internal control over financial reporting may not
prevent or detect misstatements under all potential conditions. Therefore,
effective internal control over financial reporting provides only reasonable,
and not absolute, assurance that a restatement of our financial statements would
be prevented or detected.
Changes
in Internal Control Over Financial Reporting
There
were no changes in the Company’s internal control over financial reporting that
occurred during the period covered by this report that have materially affected,
or are reasonably likely to materially affect, the Company’s internal control
over financial reporting.
This
annual report does not include an attestation report of the Company's registered
public accounting firm regarding internal control over financial reporting.
Management's report was not subject to attestation by the Company's registered
public accounting firm pursuant to temporary rules of the SEC that permit the
Company to provide only management's report in this annual report.
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 I
directors, Class II directors and Class III 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.
The
information required by this item will be included in the Company’s definitive
Proxy Statement in connection with the 2008 Annual Meeting of Stockholders and
is hereby incorporated herein by reference.
Item
10. Executive Compensation
The
information required by this item will be included in the Company’s definitive
Proxy Statement in connection with the 2008 Annual Meeting of Stockholders and
is hereby incorporated herein by reference.
Item
11. Security Ownership of Certain Beneficial Owners and Management
and Related Stockholders Matters
The
information required by this item will be included in the Company’s definitive
Proxy Statement in connection with the 2008 Annual Meeting of Stockholders and
is hereby incorporated herein by reference.
Item
12. Certain Relationships and Related Transactions
The
information required by this item will be included in the Company’s definitive
Proxy Statement in connection with the 2008 Annual Meeting of Stockholders and
is hereby incorporated herein by reference.
See the
Exhibit Index attached hereto for a list of the exhibits filed or incorporated
by reference as a part of this report.
Item
14. Principal Accountant Fees and Services
The
information required by this item will be included in the Company’s definitive
Proxy Statement in connection with the 2008 Annual Meeting of Stockholders and
is hereby incorporated herein by reference.
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of
1934, the Registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
|
NEUROLOGIX,
INC.
|
|
|
|
|
|
|
/s/ John E.
Mordock
|
|
|
John
E. Mordock
|
|
|
President
and Chief Executive Officer
|
|
|
|
|
|
|
|
|
|
|
/s/ Marc L.
Panoff
|
|
|
Marc
L. Panoff,
|
|
|
Chief
Financial Officer, Secretary and Treasurer
|
|
|
|
|
|
In
accordance with the Exchange Act, this Report has been signed by the following
persons on behalf of the registrant and in the capacities and on the dates
indicated:
Dated:
March 24, 2008
|
/s/
Cornelius E. Golding
|
|
Cornelius
E. Golding, Director
|
|
|
|
/s/
William J. Gedale
|
|
William
J. Gedale, Director
|
|
|
|
/s/
Martin J. Kaplitt
|
|
Martin
J. Kaplitt, Director
|
|
|
|
/s/
Clark A. Johnson
|
|
Clark
A. Johnson, Director
|
|
|
|
/s/
John E. Mordock
|
|
John
E. Mordock, Director
|
|
|
|
/s/
Craig J. Nickels
|
|
Craig
J. Nickels, Director
|
|
|
|
/s/
Austin M. Long, III
|
|
Austin
M. Long, III, Director
|
|
|
|
/s/
Jeffrey B. Reich
|
|
Jeffrey
B. Reich, Director
|
|
|
|
/s/
Elliott Singer
|
|
Elliott
Singer, Director
|
|
|
EXHIBIT
INDEX
Exhibit
No.
|
Exhibit
|
3.1
|
Restated
Certificate of Incorporation of Neurologix, Inc. (filed as
Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, dated
September 13, 2004, and incorporated herein by
reference).
|
3.2
|
Amended
and Restated by-laws of Neurologix, Inc. (filed as Exhibit 3.4
to the Registrant’s Annual Report on Form 10-K, dated April 9, 2004, and
incorporated herein by reference).
|
4.1
|
Certificate
of Designations, Preferences and Rights of Series C Convertible Preferred
Stock of Neurologix, Inc. (filed as Exhibit 3.1 to the
Registrant’s Current Report on Form 8-K, dated May 11, 2006, and
incorporated herein by reference).
|
4.2
|
Certificate
of Designations, Preferences and Rights of Series C Convertible Preferred
Stock of Neurologix, Inc. (filed as Exhibit 3.1 to the
Registrant’s Current Report on Form 8-K, dated November 21, 2007, and
incorporated herein by reference).
|
4.3
|
Certificate
of Designations, Preferences and Rights of Series D Convertible Preferred
Stock of Neurologix, Inc. (filed as Exhibit 3.2 to the
Registrant’s Current Report on Form 8-K, dated November 21, 2007, and
incorporated herein by reference).
|
4.4
|
Registration
Rights Agreement, dated as of March 28, 2000, by and among Arinco Computer
Systems Inc., Pangea Internet Advisors LLC and the persons party to the
Securities Purchase Agreement (filed as Exhibit 10.2 to the Registrant’s
Current Report on Form 8-K, dated April 4, 2000, and incorporated herein
by reference).
|
4.5
|
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 Exhibit 10.3 to the Registrant’s Current
Report on Form 8-K, dated February 10, 2005, and incorporated herein by
reference).
|
4.6
|
Registration
Rights Agreement, dated as of April 27, 2005, by and among
Neurologix, Inc. and Medtronic International, Ltd. (filed as Exhibit 10.3
to the Registrant’s Current Report on Form 8-K, dated May 2,
2005, and incorporated herein by reference).
|
4.7
|
Registration
Rights Agreement, dated as of November 19, 2007, by and among Neurologix,
Inc., General Electric Pension Trust, the DaimlerChrysler Corporation
Master Retirement Trust, certain funds managed by ProMed Asset Management
LLC and Corriente Master Fund, L.P. (filed as Exhibit 10.2 to the
Registrant’s Current Report on Form 8-K, dated November 21, 2007, and
incorporated herein by reference).
|
10.1
|
Consulting
Agreement, dated as of October 1, 1999, by and between Dr. Matthew During
and Neurologix, Inc. (filed as Exhibit 10.29 to the Registrant’s Annual
Report on Form 10-K, dated April 9, 2004, and incorporated herein by
reference).
|
10.2
|
Exclusive
License Agreement, effective as of June 1, 2002, by and between Thomas
Jefferson University and Neurologix Inc. (filed as Exhibit 10.31 to the
Registrant’s Annual Report on Form 10-K, dated April 9, 2004, and
incorporated herein by reference).
|
10.3
|
Exclusive
License Agreement, effective as of August 1, 2002, by and between Thomas
Jefferson University and Neurologix, Inc. (filed as Exhibit 10.32 to the
Registrant’s Annual Report on Form 10-K, dated April 9, 2004, and
incorporated herein by reference).
|
10.4
|
Non-Exclusive
License Agreement, dated as of August 28, 2002, by and between Yale
University, The Rockefeller University and Neurologix, Inc. (filed as
Exhibit 10.33 to the Registrant’s Annual Report on Form 10-K, dated April
9, 2004, and incorporated herein by reference).
|
10.5
|
License
Agreement, dated as of November 1, 2002, by and between The Rockefeller
University and Neurologix, Inc. (filed as Exhibit 10.34 to the
Registrant’s Annual Report on Form 10-K, dated April 9, 2004, and
incorporated herein by reference).
|
10.6
|
Clinical
Study Agreement, dated as of July 2, 2003, by and between Cornell
University and Neurologix, Inc. (filed as Exhibit 10.35 to the
Registrant’s Annual Report on Form 10-K, dated April 9, 2004, and
incorporated herein by reference).
|
10.7
|
Clinical
Study Agreement, dated August 1, 2003, by and between North Shore
University Hospital and Neurologix, Inc. (filed as Exhibit 10.36 to the
Registrant’s Annual Report on Form 10-K, dated April 9, 2004, and
incorporated herein by reference).
|
10.8
|
Amendment,
dated as of October 8, 2003, to that certain Consulting Agreement, dated
October 1, 1999, by and between Dr. Matthew During and Neurologix, Inc.
(filed as Exhibit 10.37 to the Registrant’s Annual Report on Form 10-K,
dated April 9, 2004, and incorporated herein by
reference).
|
10.9
|
Sub
Lease, dated August 10, 2004, by and between Neurologix, Inc. and Palisade
Capital Securities L.L.C. (filed as Exhibit 10.19 to the Registrant’s
Amendment No. 1 to the Annual Report on Form 10-KSB, dated
September 28, 2005, and incorporated herein by
reference).
|
10.10
|
Amendment
No. 1 to Clinical Study Agreement, dated September 24, 2004, by and
between Cornell University for its Medical College and Neurologix, Inc.
(filed as Exhibit 99.1 to the Registrant’s Report on Form 8-K, dated
September 30, 2004, and incorporated herein by
reference).
|
10.11
|
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 Exhibit 10.1 to the Registrant’s Current
Report on Form 8-K, dated February 10, 2005, and incorporated herein by
reference).
|
10.12
|
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 Exhibit 10.1 to the
Registrant’s Current Report on Form 8-K, dated February 25, 2005, and
incorporated herein by reference).
|
10.13
|
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
Exhibit 10.4 to the Registrant’s Current Report on Form 8-K, dated
February 10, 2005, and incorporated herein by
reference).
|
10.14
|
Form
of Warrant Certificate to purchase shares of common stock of Neurologix,
Inc. (filed as Exhibit 10.2 to the Registrant’s Current Report on Form
8-K, dated February 10, 2005, and incorporated herein by
reference).
|
10.15
|
Amended
and Restated Consulting Agreement, dated April 25, 2005, by and between
Michael G. Kaplitt and Neurologix Research, Inc. (filed as Exhibit 10.1 to
the Registrant’s Current Report on Form 8-K, dated April 29, 2005, and
incorporated herein by reference).
|
10.16
|
Stock
Purchase Agreement, dated as of April 27, 2005, by and among Neurologix,
Inc. and Medtronic International, Ltd. (filed as Exhibit 10.1 to the
Registrant’s Current Report on Form 8-K, dated May 2, 2005, and
incorporated herein by reference).
|
10.17
|
Warrant
Certificate to purchase shares of common stock of Neurologix, Inc. (filed
as Exhibit 10.2 to the Registrant’s Current Report on Form 8-K, dated
May 2, 2005, and incorporated herein by reference).
|
10.18
|
Development
and Manufacturing Agreement, dated as of April 27, 2005, by and among
Neurologix, Inc. and Medtronic, Inc. (filed as Exhibit 10.8 to the
Registrant’s Quarterly Report on Form 10-QSB, dated May 13, 2005, and
incorporated herein by reference).
|
10.19
|
Master
Sponsored Research Agreement, dated as of May 10, 2006, by and between The
Ohio State University Research Foundation and Neurologix,
Inc.**
|
10.20
|
Stock
and Warrant 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 Exhibit 10.1 to the
Registrant’s Current Report on Form 8-K, dated May 11, 2006, and
incorporated herein by reference).
|
10.21
|
Form
of Warrant Certificate to purchase shares of common stock of Neurologix,
Inc. (filed as Exhibit 10.2 to the Registrant’s Current Report on
Form 8-K, dated May 11, 2006, and incorporated herein by
reference).
|
10.22
|
Letter
Agreement, dated June 23, 2006, by and between Christine V. Sapan and
Neurologix, Inc.**
|
10.23
|
Separation
Agreement, dated as of July 17, 2006, by and between Neurologix, Inc. and
Michael Sorell (filed as Exhibit 10.1 to the Registrant’s Current Report
on Form 8-K, dated July 20, 2006, and incorporated herein by
reference).
|
10.24
|
Sublicense
Agreement, dated July 27, 2006, by and between Neurologix, Inc.
and Diamyd Therapeutics AB (filed as Exhibit 10.1 to the
Registrant’s Current Report on Form 8-K, dated August 7, 2006, and
incorporated herein by reference).
|
10.25
|
Consulting
Agreement, dated February 23, 2007, by and between Neurologix, Inc. and
Dr. Martin J. Kaplitt (filed as Exhibit 99.1 to the Registrant’s Current
Report on Form 8-K, dated February 26, 2007, and incorporated herein
by reference).
|
10.26
|
Amendment
No. 2 to Clinical Study Agreement, dated March 2, 2007, by and between
Cornell University and Neurologix, Inc. (filed as Exhibit 10.1 to the
Registrant’s Current Report on Form 8-K, dated March 7, 2007, and
incorporated herein by reference).
|
10.27
|
Amendment
No. 1 to Stock Purchase Agreement, dated as of March 29, 2007, by and
among Neurologix, Inc., Merlin Biomed Long Term Appreciation Fund LP, and
Merlin Biomed Offshore Master Fund LP (filed as Exhibit 10.25 to the
Registrant’s Annual Report on Form 10-KSB, dated April 2, 2007, and
incorporated herein by reference).
|
10.28
|
Amendment
to Consulting Agreement, dated October 1, 2007, by and between Matthew
During and Neurologix, Inc. (filed as Exhibit 10.1 to the Registrant’s
Current Report on Form 8-K, dated October 5, 2007, and incorporated herein
by reference).
|
10.29
|
Stock
Purchase Letter Agreement, dated November 8, 2007, by and between
Neurologix, Inc. and General Electric Pension Trust (filed as Exhibit 10.4
to the Registrant’s Current Report on Form 8-K, dated November 21, 2007,
and incorporated herein by reference).
|
10.30
|
Stock
Purchase Letter Agreement, dated November 8, 2007, by and between
Neurologix, Inc. and DaimlerChrysler Corporation Master Retirement Trust
(filed as Exhibit 10.5 to the Registrant’s Current Report on Form 8-K,
dated November 21, 2007, and incorporated herein by
reference).
|
10.31
|
Stock
Purchase Letter Agreement, dated November 8, 2007, by and between
Neurologix, Inc. and ProMed Partners LP (filed as Exhibit 10.6 to the
Registrant’s Current Report on Form 8-K, dated November 21, 2007, and
incorporated herein by reference).
|
10.32
|
Stock
and Warrant Subscription Agreement, dated as of November 19, 2007, by and
between Neurologix, Inc., General Electric Pension Trust, Corriente Master
Fund, L.P., Martin J. Kaplitt, and Palisade Private Holdings LLC (filed as
Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, dated
November 21, 2007, and incorporated herein by
reference).
|
10.33
|
Form
of Warrant Certificate to purchase shares of common stock of Neurologix,
Inc. (filed as Exhibit 10.3 to the Registrant’s Current Report on Form
8-K, dated November 21, 2007, and incorporated herein by
reference).
|
10.34
|
Employment
Agreement, dated as of December 4, 2007, by and between John E. Mordock
and Neurologix, Inc. (filed as Exhibit 10.1 to the Registrant’s Current
Report on Form 8-K, dated December 4, 2007, and incorporated herein by
reference).
|
10.35
|
Employment
Agreement, dated as of December 4, 2007, by and between Marc Panoff and
Neurologix, Inc. (filed as Exhibit 10.2 to the Registrant’s Current Report
on Form 8-K, dated December 4, 2007, and incorporated herein by
reference).
|
23.1
|
Consent
of BDO Seidman LLP, Independent Registered Public Accounting
Firm.**
|
23.2
|
Consent
of J.H. Cohn LLP, Former Independent Registered Public Accounting
Firm.**
|
31.1
|
Rule
13a-15(e)/15d-15(e) Certification of Principal Executive Officer.
**
|
31.2
|
Rule
13a-15(e)/15d-15(e) Certification of Chief Financial
Officer/Treasurer.**
|
32.1
|
Section
1350 Certification, Chief Executive Officer and Chief Financial
Officer/Treasurer.**
|
** Filed
herewith