UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
Form 10-K
(Mark One)
|
|
|
þ
|
|
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
|
|
|
|
|
For the fiscal year ended December 31, 2009 |
|
|
|
o
|
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
|
|
|
|
|
For
the transition period
from to |
COMMISSION FILE NO. 0-27264
VIA PHARMACEUTICALS, INC.
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
|
|
|
Delaware
|
|
33-0687976 |
(STATE OR OTHER JURISDICTION OF
INCORPORATION OR ORGANIZATION)
|
|
(I.R.S. EMPLOYER
IDENTIFICATION NO.) |
750 Battery Street, Suite 330
San Francisco, California 94111
(ADDRESS OF PRINCIPAL EXECUTIVE OFFICES, INCLUDING ZIP CODE)
REGISTRANTS TELEPHONE NUMBER, INCLUDING AREA CODE:
(415) 283-2200
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
(Title of Class)
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in
Rule 405 of the Securities Act. Yes o No þ
Indicate by check mark if the registrant is not required to file reports pursuant to
Section 13 or 15(d) of the Act. Yes o No þ
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period
that the registrant was required to submit and post such files). Yes o No o
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of
Regulation S-K is not contained herein, and will not be contained, to the best of registrants
knowledge, in definitive proxy or information statements incorporated by reference in Part III of
this Form 10-K or any amendment to this Form 10-K. o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act. (Check one):
|
|
|
|
|
|
|
Large accelerated filer o
|
|
Accelerated filer o
|
|
Non-accelerated filer o
|
|
Smaller reporting company þ |
|
|
(Do not check if a smaller reporting company)
|
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act). Yes o No þ
As of June 30, 2009, the aggregate market value of the registrants common stock held by
non-affiliates was approximately $4,804,977 based upon the closing sales price of the registrants
common stock on The NASDAQ Capital Market on such date.
The number of shares of the registrants Common Stock outstanding as of March 15, 2010 was
20,636,998.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the definitive Proxy Statement for the 2010 Annual Meeting of Stockholders, which
will be filed within 120 days after the end of the fiscal year, are incorporated by reference into
Part III hereof.
PART I
Forward-looking statements
This Annual Report on Form 10-K contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. These statements relate to future events or
to the Companys future financial performance and involve known and unknown risks, uncertainties
and other factors that may cause the Companys actual results, levels of activity, performance or
achievements to be materially different from any future results, levels of activity, performance or
achievements expressed or implied by these forward-looking statements. In some cases, you can
identify forward-looking statements by the use of words such as may, could, expect, intend,
plan, seek, anticipate, believe, estimate, predict, potential, continue or the
negative of these terms or other comparable terminology. You should not place undue reliance on
forward-looking statements since they involve known and unknown risks, uncertainties and other
factors which are, in some cases, beyond the Companys control and which could materially affect
actual results, levels of activity, performance or achievements. Factors that may cause actual
results to differ materially from current expectations include, but are not limited to:
|
|
|
the Companys ability to find a market maker to apply and be cleared by the Financial
Industry Regulatory Authority to quote the Companys common stock on the OTC Bulletin Board; |
|
|
|
ability and willingness of active market makers in our Companys common stock to trade
the Companys common stock on the Pink Sheets under a piggyback qualification; |
|
|
|
the Companys ability to borrow additional amounts under the new loan from Bay City
Capital, as described in Other Information in Part II, Item 9B and in Note 12 in the Notes
to the Financial Statements; |
|
|
|
the Companys ability to obtain necessary financing in the near term, including amounts
necessary to repay the previous loan from Bay City Capital following the April 1, 2010
maturity date; |
|
|
|
the Companys ability to control its operating expenses; |
|
|
|
the Companys ability to comply with covenants included in the loans with Bay City
Capital; |
|
|
|
the Companys ability to operate its business following the restructuring, as described
in Other Information in Part II, Item 9B and in Note 12 in the Notes to the Financial
Statements; |
|
|
|
the Companys ability to comply with its reporting obligations under the rules and
regulations promulgated by the Securities and Exchange Commission following the
restructuring; |
|
|
|
the Companys ability to timely recruit and enroll patients in any future clinical
trials; |
|
|
|
the Companys failure to obtain sufficient data from enrolled patients that can be used
to evaluate VIA-2291, thereby impairing the validity or statistical significance of its
clinical trials; |
|
|
|
the Companys ability to successfully complete its clinical trials of VIA-2291 on
expected timetables and the outcomes of such clinical trials; |
|
|
|
complexities in designing and implementing cardiometabolic clinical trials using
surrogate endpoints in Phase 1 and Phase 2 clinical trials which may differ from the
ultimate endpoints required for registration of a candidate drug; |
|
|
|
the results of the Companys FDG-PET clinical trial as well as any future clinical
trials; |
|
|
|
if the results of the ACS and CEA studies, upon further review and analysis, are revised,
interpreted differently by regulatory authorities or negated by later stage clinical trials; |
|
|
|
the Companys ability to obtain necessary FDA approvals; |
|
|
|
the Companys ability to successfully commercialize VIA-2291; |
1
|
|
|
the Companys ability to identify potential clinical candidates from the family of DGAT1
compounds licensed and move them into preclinical development; |
|
|
|
the Companys ability to obtain and protect its intellectual property related to its
product candidates; |
|
|
|
the Companys potential for future growth and the development of its product pipeline,
including the THR beta agonist candidate and the other compounds licensed from Roche; |
|
|
|
the Companys ability to obtain strategic opportunities to partner and collaborate with
large biotechnology or pharmaceutical companies to further develop VIA-2291; |
|
|
|
the Companys ability to form and maintain collaborative relationships to develop and
commercialize our product candidates; |
|
|
|
general economic and business conditions; and |
|
|
|
the other risks described under the heading Risk Factors in Part I, Item 1A below. |
All forward-looking statements attributable to the Company or persons acting on the Companys
behalf are expressly qualified in their entirety by the cautionary statements set forth above.
Forward-looking statements speak only as of the date they are made, and the Company undertakes no
obligation to update publicly any of these statements in light of new information or future events.
ITEM 1. BUSINESS
Corporate History and Description of Merger
On June 5, 2007, privately-held VIA Pharmaceuticals, Inc. completed a reverse merger
transaction (the Merger) with Corautus Genetics Inc. Until shortly before the Merger, Corautus
Genetics Inc. (Corautus) was primarily focused on the clinical development of gene therapy
products using a vascular growth factor gene. These activities were discontinued in November 2006.
Privately-held VIA Pharmaceuticals, Inc. was formed in Delaware and began operations in June 2004.
Unless otherwise specified, the Company, VIA, we, us, and our refers to the business of
the combined company after the Merger and the business of privately-held VIA Pharmaceuticals, Inc.
prior to the Merger. Unless specifically noted otherwise, Corautus Genetics Inc. or Corautus
refers to the business of Corautus Genetics Inc. prior to the Merger.
Business Overview
VIA is a biotechnology company focused on the development of compounds for the treatment of
cardiovascular and metabolic disease. Specifically, the Companys lead compound, VIA-2291, targets
an unmet medical need of reducing atherosclerotic plaque inflammation, which is an underlying cause
of atherosclerosis and its complications. Atherosclerosis is a common cardiovascular disease that
results from chronic inflammation and the build-up of plaque in arterial blood vessel walls. Plaque
consists of inflammatory cells, cholesterol and cellular debris. Atherosclerosis, depending on its
severity and the location of the artery it affects, may result in blockage in certain vessels and
can also cause a rupture of inflamed plaque tissue, leading to major adverse cardiovascular events
(MACE) such as heart attack and stroke. Heart attack and stroke are leading causes of death
worldwide.
In 2008, the Company expanded its drug development pipeline with preclinical compounds that
target additional underlying causes of cardiovascular and metabolic disease, including high
cholesterol, high triglycerides and insulin sensitization/diabetes. The Companys clinical
development strategy integrates several technologies to provide clinical proof-of-concept as early
as possible in the clinical development process. These technologies include the measurement of
biomarkers (specific biochemicals in the body with a particular molecular feature that makes them
useful for measuring the progress of a disease or the effects of treatment), medical imaging of the
coronary and carotid vessel walls to evaluate the plaque characteristics, and atherosclerotic
plaque bioassays (measurements of indicators of atherosclerotic plaque inflammation believed to
promote MACE). Once the Company has established proof-of-concept, the Company plans to consider
business collaborations with larger biotechnology or pharmaceutical companies for the late-stage
clinical development and commercialization of its compounds.
2
In March 2005, the Company entered into an exclusive license agreement (the Stanford
License) with Stanford University (Stanford) to use a comprehensive gene expression database and
analysis tool to identify novel, and prioritize known, molecular
targets for the treatment of vascular inflammation and to study the impact of candidate
therapeutic interventions on the molecular mechanisms underlying atherosclerosis (the Stanford
Platform). One of the Companys founders, Thomas Quertermous, M.D., who currently serves on the
advisory board to the Company, developed the Stanford Platform at Stanford during the course of a
four-year, $30.0 million research study (the Stanford Study). The Stanford Study initially
utilized human tissue samples made available from the Stanford heart transplant program to
characterize human plaque at the level of gene expression and identify the inflammatory genes and
pathways involved in the development of atherosclerosis and associated complications in humans. To
develop the Stanford Platform, the Stanford Study performed similar experiments on vascular tissue
samples from mice prone to developing atherosclerosis and identified genes and pathways associated
with the development of atherosclerosis that mice and humans have in common (the Overlap Genes).
The Stanford Platform allowed us to analyze the expression of the Overlap Genes following the
administration of candidate drugs to atherosclerotic-prone mice, and thus provided a useful tool
for studying the effects of therapeutic intervention in the development of cardiovascular disease.
This platform also gave us useful insight into the molecular pathways that we believe to be most
relevant to the cardiovascular disease process. In January 2009, the Company advised Stanford that
it was terminating its exclusive license agreement effective February 14, 2009.
In 2005, the Company identified 5-Lipoxygenase (5LO) as a key target of interest for
treating atherosclerosis. 5LO is a key enzyme in the biosynthesis of leukotrienes, which are
important mediators of inflammation and are involved in the development and progression of
atherosclerosis. In addition, cardiovascular-related literature has also identified 5LO as a key
target of interest for treating atherosclerosis and preventing heart attack and stroke. Following
such identification, the Company identified a number of late-stage 5LO inhibitors that had been in
clinical trials conducted by large biotechnology and pharmaceutical companies primarily for
non-cardiovascular indications, including ABT-761, a compound developed by Abbott Laboratories
(Abbott) for use in treatment of asthma. Abbott abandoned its ABT-761 clinical program in 1996
after the U.S. Food and Drug Administration (FDA) approved a similar Abbott compound for use in
asthma patients. Abbott made no further developments to ABT-761 from 1996 to 2005. In August 2005,
the Company entered into an exclusive, worldwide license agreement (the Abbott License) with
Abbott to develop and commercialize ABT-761 for any indication. The Company subsequently renamed
the compound VIA-2291.
VIA-2291 is a potent, selective and reversible inhibitor of 5LO that the Company is developing
as a once-daily, oral drug to treat inflammation in the blood vessel wall. In March 2006, the
Company filed an Investigational New Drug (IND) application with the FDA outlining the Companys
Phase 2 clinical program, which initially consisted of two trials for VIA-2291. Each of these
clinical trials was initiated during 2006 to study the safety and efficacy of VIA-2291 in patients
with existing cardiovascular disease. Using biomarkers of inflammation, medical imaging techniques
and bioassays of plaque, the Company is evaluating and determining VIA-2291s ability to reduce
vascular inflammation in atherosclerotic plaque. The Company enrolled 50 patients in a Phase 2
study of VIA-2291 at clinical sites in Italy for patients who had a carotid endarterectomy (CEA)
procedure. In addition, the Company enrolled 191 patients in a second Phase 2 study at 15 clinical
sites in the United States and Canada for patients with acute coronary syndrome (ACS) who
experienced a recent heart attack.
In October 2007, the Companys Data Safety Monitoring Board (DSMB) performed a review of
both safety and efficacy data related to the Companys CEA and ACS clinical trials to determine the
progress in the clinical program and the patient safety of VIA-2291. Based on this review, the DSMB
observed a continued acceptable safety profile and evidence of a consistent pharmacological effect
of VIA-2291 as would be predicted given its proposed mechanism of action. The DSMB recommended the
studies continue as planned.
Following the results of the DSMB review, the Company began enrolling patients in a third
Phase 2 clinical trial that utilized Positron Emission Tomography with fluorodeoxyglucose tracer
(FDG-PET) to measure the impact of VIA-2291 on reducing atherosclerotic plaque inflammation in
treated patients. The Company enrolled 52 patients following an acute coronary syndrome event, such
as heart attack or stroke, into the 24 week, randomized, double blind, placebo-controlled study,
which was run at five clinical sites in the United States and Canada. Endpoints in the study
included reduction in atherosclerotic plaque inflammation as measured by serial FDG-PET scans. The
last patient visit was reported in December 2009 and completion of data analysis and reporting of
clinical trial results are anticipated in the first half of 2010.
In December 2008, the Company entered into two research, development and commercialization
agreements with Hoffman-LaRoche Inc. and Hoffman-LaRoche Ltd. (collectively, Roche) to license,
on an exclusive, worldwide basis, two sets of compounds (the Roche Licenses). The first license
is for Roches thyroid hormone receptor (THR) beta agonist, a clinically ready candidate for the
control of cholesterol, triglyceride levels and potential in insulin sensitization/diabetes. The
second license is for multiple compounds from Roches preclinical diacylglycerol acyl transferease
1 (DGAT1) metabolic disorders program.
To further expand the Companys product candidate pipeline, the Company continues to engage in
discussions regarding the purchase or license of additional preclinical or clinical compounds that
the Company believes may be of interest in treating cardiovascular and metabolic disease.
3
Business Strategy
The Companys objective is to become a leading biotechnology company focused on discovering,
developing and commercializing novel drugs for the treatment of unmet medical needs of
cardiovascular and metabolic disease. The key elements of the Companys business strategy are as
follows:
|
|
|
Maximize the value of our lead product candidate, VIA-2291. The Company seeks to develop
VIA-2291 for the treatment of atherosclerotic plaque and secondary prevention of ACS in
patients who have experienced a recent heart attack. The Company is applying its clinical
development expertise to complete its clinical trials for VIA-2291. The Company anticipates
that the development of VIA-2291 may ultimately be expanded to include primary prevention of
ACS and stroke. The Company plans to pursue business collaborations with large biotechnology
or pharmaceutical companies to conduct additional clinical trials required for regulatory
approval. |
|
|
|
Pursue the clinical development of the THR beta agonist compound licensed from Roche.
The Company intends to pursue this clinically ready asset and is in the planning phases
for its clinical development. The Company anticipates filing an IND application, and
initiating Phase 1 clinical trials, during the next twelve months. |
|
|
|
Pursue the preclinical development of DGAT1 compounds licensed from Roche. The Company
intends to pursue the preclinical development of the DGAT1 compounds in order to identify a
potential lead candidate for further development in human clinical trials. |
|
|
|
Expand our portfolio of small molecule product candidates through acquisitions and
in-licensing. The Company intends to continue to license and develop preclinical and
clinical small molecule compounds for the treatment of cardiovascular and metabolic disease.
The Company believes this strategy will enable the Company to build a valuable drug
development pipeline. |
|
|
|
Maximize economic value for our product candidates under development. The Company
intends to maximize the value of its product candidates through independent development,
licensing and other partnership and collaboration opportunities with large biotechnology or
pharmaceutical companies. |
|
|
|
Enhance and protect our intellectual property portfolio. The Company plans to pursue,
license and acquire additional intellectual property protection as required to enhance and
protect its existing and future portfolio and to enable the Company to maximize the
commercial lifespan of its compounds and technology. |
Inflammation and Cardiovascular Disease
Inflammation is a normal response of the body to protect tissues from infection, injury or
disease. The inflammatory response begins with the production and release of chemical agents by
cells in the infected, injured or diseased tissue. These agents cause redness, swelling, pain, heat
and loss of function. Inflamed tissues generate additional signals that recruit white blood cells
to the site of inflammation. White blood cells destroy any infective or injurious agent, and remove
cellular debris from damaged tissue. This inflammatory response usually promotes healing but, if
uncontrolled, may become harmful.
The inflammatory response can be either acute or chronic. Acute inflammation lasts at most
only a few days. The treatment of acute inflammation, where therapy typically includes the
administration of aspirin and other non-steroidal anti-inflammatory drugs, provides relief of pain
and fever for patients. In contrast, chronic inflammation lasts weeks, months or even indefinitely
and results in tissue damage. In chronic inflammation, the inflammation becomes the problem rather
than the solution to infection, injury or disease. Chronically inflamed tissues continue to
generate signals that attract white blood cells from the bloodstream. When white blood cells
migrate from the bloodstream into the tissue they amplify the inflammatory response. This chronic
inflammatory response can break down healthy tissue in a misdirected attempt at repair and healing.
Evidence of the key role of chronic inflammation in diverse disease states, such as
atherosclerosis and arthritis, is mounting. For many of these diseases, the existing
anti-inflammatory treatments are incomplete and limited in use. As more physicians believe that
inflammation is a root cause of a wide range of chronic diseases, the Company believes that the
market will require safer and more effective anti-inflammatory treatments.
4
Atherosclerosis is the result of chronic inflammation and the build-up of plaque in arterial
blood vessel walls. Plaque consists of inflammatory cells, cholesterol and cellular debris.
Atherosclerosis, depending on its severity and the location of the artery it affects, may result in
blockage in certain vessels and can cause a rupture of inflamed plaque tissue, leading to MACE such
as heart attack and stroke. Heart attack and stroke are leading causes of death worldwide.
Atherosclerosis in the blood vessels of the heart is called coronary artery disease or heart
disease. It is the leading cause of death in the United States, claiming more lives each year than
all forms of cancer combined. Estimates from the American Heart Associations Heart Disease and
Stroke Statistics 2009 Update indicate that approximately 16.8 million Americans were diagnosed
with coronary heart disease in 2006. Approximately 1.7 million of these cases were patients with a
history of heart attacks and strokes and a high risk of MACE. When atherosclerosis becomes severe
enough to cause complications, physicians must treat the complications, which can include angina,
heart attack, abnormal heart rhythms, heart failure, kidney failure, stroke or obstructed
peripheral arteries. Many of the patients with established atherosclerosis are treated aggressively
for their associated risk factors, which include elevated triglyceride levels, high blood pressure,
smoking, diabetes, obesity and physical inactivity. In addition, most patients suffering from
atherosclerosis have concomitant high cholesterol, and as a result, the current treatment regime
focuses primarily on cholesterol reduction. Additionally, these patients are routinely treated with
anti-hypertensives to lower blood pressure and anti-platelet drugs to help prevent the formation of
blood clots. There are currently no medications available for physicians to directly treat the
underlying chronic inflammation of the blood vessel wall associated with atherosclerosis.
Carotid artery disease is the narrowing of the carotid arteries caused by the buildup of
plaque inside the blood vessels causing decreased blood flow to the brain and an increased risk of
stroke. VIA believes that VIA-2291 may also have utility in the treatment of inflammation in
carotid artery disease and may reduce the risk of stroke in patients.
Metabolic Syndrome
The American Heart Association currently estimates that more than 50 million Americans suffer
from metabolic syndrome and its incidence is high and growing worldwide. Metabolic syndrome is
generally considered a group of risk factors, including high blood pressure, insulin resistance or
diabetes (the body cant properly use insulin), unhealthy cholesterol levels, high triglycerides,
abdominal fat and a proinflammatory state, evidenced by elevated levels of C-reactive protein in
the blood. People with metabolic syndrome are at increased risk of atherosclerosis and its
complications, including heart attack and stroke. While the biological mechanisms of metabolic
syndrome are complex and not fully understood, risk factors considered in the diagnosis include
insulin resistance, diabetes, dyslipidemia, obesity (especially abdominal obesity) and unhealthy
lifestyle.
The Company believes that small molecule drugs targeting a number of these key risk factors
will be important in treating metabolic syndrome and reducing patient risk from cardiovascular and
metabolic disease, including heart attack, stroke and type 2 diabetes. The Company believes that
the compounds recently licensed from Roche described more fully below have the potential to be
important drugs for the treatment of cardiovascular and metabolic disease.
VIA-2291
The Companys lead product candidate is VIA-2291, a small molecule drug that targets
atherosclerotic plaque inflammation, a primary disease process in atherosclerosis. VIA-2291 is a
potent, selective and reversible inhibitor of 5LO, which is believed to be a key enzyme in the
biosynthesis of leukotrienes (important mediators of inflammation involved in the development and
progression of atherosclerosis). The Company is developing VIA-2291 as a once-daily, oral drug to
target atherosclerotic plaque inflammation. The goal of the VIA-2291 program is to treat
inflammation in atherosclerotic plaques of patients with existing disease, thus decreasing their
risk of MACE, including heart attack and stroke.
The potential market for VIA-2291 comprises the approximately 16.8 million patients in the
United States who are diagnosed annually with coronary artery disease, according to the American
Heart Association. The Companys initial focus within this patient population is the approximately
1.4 million patients who are discharged annually from the hospital after suffering from an episode
of ACS and who have a high risk of MACE.
The Company is undertaking the clinical development of VIA-2291 for the secondary prevention
of MACE in ACS patients. On March 30, 2006, the Company filed IND 72,381 for VIA-2291 under its
name with the FDA and in 2006, began two Phase 2 proof-of-concept studies of VIA-2291: the first
study focused on patients undergoing CEA surgical procedures, while the second focused on patients
with ACS who recently experienced heart attack and remain at an increased risk for MACE. Prior to
that, Abbott conducted a clinical development program for ABT-761 (now VIA-2291) under IND 48,839.
5
Abbott previously tested VIA-2291 in more than 1,100 patients in 29 clinical trials for the
treatment of asthma. During preclinical animal testing conducted by Abbott, and clinical trials of
ABT-761 (now VIA-2291), safety issues with regards to tumors in animals and higher incidence of
liver function abnormality in humans were identified. The liver function abnormalities were
demonstrated to be reversible with discontinuance of the drug in Abbotts trials. Lower doses of
the drug may reduce these safety concerns. In the ACS clinical trial, the Company did see generally
mild, reversible elevations of normal liver enzymes in the low dose VIA-2291 treated group, but no
elevations in the higher dose drug-treated groups.
The first Phase 2 clinical study of VIA-2291 enrolled 50 patients with significant stenosis of
the carotid artery who had a CEA after three months of treatment with VIA-2291 or placebo. A CEA is
a surgical procedure to remove plaque in the lining of the carotid artery to allow for normal blood
flow to the brain. This Phase 2 clinical study was designed to demonstrate efficacy and mechanism
of action of VIA-2291 in the vessel wall, and had the unique advantage of providing access to
atherosclerotic tissue removed in surgery for direct evaluation of VIA-2291s effect on
inflammation, through a panel of assays and histological examinations. The study also included
measures of leukotrienes and biomarkers of inflammation in blood serum that are indicative of
increased risk of MACE.
The second Phase 2 clinical study, which the Company conducted concurrently with the first
Phase 2 clinical study, enrolled 191 ACS patients who experienced a recent heart attack. Patients
were treated once daily with one of three dose levels of VIA-2291 or placebo. The study was
designed to establish dose and safety data in the ACS patient population, and included measures of
leukotrienes and biomarkers of inflammation, and medical imaging of the coronary vessel wall in a
sub-study of patients to evaluate plaque characteristics in patients in the VIA-2291 groups and
placebo groups.
VIA-2291 Clinical Trial Results
On November 9, 2008, the Company announced the results of its ACS and CEA Phase 2 clinical
trials at the American Heart Association (AHA) conference in New Orleans, Louisiana. In both the
ACS trial and the CEA trial, VIA-2291 effectively inhibited production of leukotrienes. The ACS
trial met its primary endpoint by demonstrating a significant change from baseline in Leukotriene
B4 (LTB4) production at all doses tested (p<0.001). The CEA trial missed its primary endpoint
of percentage reduction in macrophage inflammatory cells in plaque tissue, but met key secondary
endpoints including reduction of high sensitivity C-reactive protein (hs-CRP) (p<0.01).
VIA-2291 was generally well-tolerated in both trials.
The ACS Phase 2 study was designed to establish optimal dosing and safety data in 191 patients
with ACS who recently had a heart attack or unstable angina. Patients were treated once daily for
12 weeks with one of three dose levels of VIA-2291 or placebo. In order to further evaluate
VIA-2291s effect over a longer timeframe, a sub-study of patients in the ACS trial continued for
an additional 12 weeks of treatment at the same dose followed by a 64 slice multi-detector computed
tomography (MDCT) scan following up on the baseline MDCT scan that all patients received in the
ACS trial. The statistical outcomes for the ACS trial were validated by an independent academic
statistics group at Montreal Heart Institute.
The ACS trial demonstrated a statistically-significant, dose-dependent inhibition of ex vivo
stimulated LTB4 production at twelve weeks. LTB4 production was measured at trough, just before the
next dose of VIA-2291 was taken, indicating a sustained pharmacological effect of the drug between
doses. The secondary endpoint of change from baseline in urine Leukotriene E4 (LTE4) also showed
significant inhibition at all dose levels. A statistically-significant reduction in hs-CRP levels,
a measure of general inflammation in the treated patients, as compared to placebo, was also
observed in those patients treated for 24 weeks. Significant reductions in hs-CRP levels were not
observed in the ACS trial in patients treated for twelve weeks, possibly due in part to variability
in the level of hs-CRP at the baseline as a result of the recent heart attack or unstable angina.
The CEA Phase 2 study evaluated VIA-2291s effect on atherosclerotic plaque inflammation in
50 patients scheduled for CEA, a surgical procedure to remove plaque from the carotid artery to
increase blood flow to the brain and to reduce the risk of stroke in patients with significant
blockage in the artery. Patients in the CEA trial were treated for 12 weeks with either 100 mg of
VIA-2291 or placebo, and then underwent a CEA procedure. The CEA trial was designed to provide
direct evaluation of VIA-2291s effect on inflammation by analyzing plaque removed from the carotid
arteries of patients treated with VIA-2291 or placebo. The CEA trial also measured serum biomarkers
of inflammation to measure reduction in inflammation in treated patients.
While the results of the CEA trial did not demonstrate a reduction in macrophages in the
plaque tissue in carotid arteries of patients treated with VIA-2291, analysis of our data,
including a post-hoc analysis, did show a reduction in necrotic core thickness relative to plaque
thickness. Necrotic core is a region within plaque associated with a high risk of plaque rupture,
and preventing expansion, or reducing necrotic core thickness, may reduce the risk of heart attacks
in patients with cardiovascular disease. Furthermore, mRNA levels of Interleukin 6, or IL-6, a
pro-inflammatory cytokine, appeared to decrease in plaque tissue from patients treated with
VIA-2291. These findings may indicate anti-inflammatory activity of VIA-2291 in plaque tissue.
6
The CEA trial confirmed the findings of statistically significant inhibition in leukotriene
production observed in the ACS trial, as measured by stimulated levels of LTB4 in serum and levels
of LTE4 in urine. In the CEA trial, LTB4 production was highly inhibited at 12 weeks (p<0.001).
Leukotriene inhibition was seen early in both trials and was already highly significant after two
weeks of drug treatment, the first time it was assessed after starting the drug. In the CEA trial,
a statistically-significant reduction from baseline compared with placebo in hs-CRP was observed
over the twelve week treatment period.
VIA-2291 was generally well-tolerated in both trials. In the ACS trial, common
(>10 percent) adverse events (AEs) with no clear difference between placebo and VIA-2291
treated patients included angina, fatigue, musculoskeletal pain, and headache. Laboratory
abnormalities included generally mild, reversible three times upper limit of normal liver enzymes
in the low dose VIA-2291 treated group (10 percent) and placebo (2 percent), not seen in the higher
dose drug-treated groups. In the CEA study, common AEs (>7 percent) included fever, diarrhea and
cystitis that occurred somewhat more commonly in VIA-2291 treated patients. Common laboratory
abnormalities included mild reversible elevations of BUN and reversible decreases >1 gm/dL of
hemoglobin that were more frequent in VIA-2291 treated patients.
Safety of VIA-2291 was monitored throughout the trials by the independent DSMB which is
chaired by Sidney Goldstein, M.D., Division of Cardiovascular Medicine, Henry Ford Hospital, Wayne
State University. The DSMB conducted a preliminary review of the patient safety data from the
VIA-2291 ACS and CEA trials and found that the drug was well-tolerated at the doses tested and
supports further development of VIA-2291.
In addition to the CEA and ACS Phase 2 clinical trials, the Company conducted a third Phase 2
clinical trial involving VIA-2291 that utilizes FDG-PET to measure the impact of VIA-2291 on
reducing atherosclerotic plaque inflammation in treated patients. The Company enrolled 52 patients
following an acute coronary syndrome event, such as heart attack or stroke, into the 24 week,
randomized, double blind, placebo-controlled study. Endpoints in the study include reduction in
atherosclerotic plaque inflammation as measured by serial FDG-PET scans. The last patient visit was
reported in December 2009 and completion of the data analysis and reporting of clinical trial
results are anticipated in the first half of 2010.
In May 2009, the Company announced results of a sub-study of the ACS Phase 2 clinical trial of
VIA-2291 at the AHA Arteriosclerosis, Thrombosis and Vascular Biology Annual Conference 2009 in
Washington D.C. The purpose of the sub-study was to evaluate the effect of VIA-2291 25mg, 50mg and
100mg doses relative to placebo from baseline in patients dosed with VIA-2291 for 24 weeks. After
completion of the initial 12 weeks of dosing, more than 85 of the 191 total ACS patients continued
on to receive an additional 12 weeks of dosing on top of current standard medical care and received
a 64 slice MDCT scan at baseline and 24 weeks. Evaluable scans from patients treated with placebo
showed significantly more evidence of new plaque lesions from VIA-2291 treated patients. MDCT scans
of patients with low density plaques demonstrated statistically significant, lower plaque volumes
in combined VIA treated groups compared to placebo. Together these results suggest that VIA-2291
may reduce the progression of unstable coronary plaques that lead to heart attacks and stroke.
In June 2009, the Company announced that it held an end of Phase 2a meeting with the FDA. The
Company reviewed safety and biologic activity data from the VIA-2291 CEA and ACS trials with the
FDA and received guidance, including suggestions from the FDA on the Companys potential Phase 3
trial design.
The Company plans to pursue business collaborations with large biotechnology or pharmaceutical
companies to conduct additional clinical trials required for regulatory approval.
Abbott Exclusive License Agreement
In August 2005, the Company entered into an exclusive, worldwide license agreement with Abbott
for the development and commercialization of a patented compound and related technology, formerly
known as ABT-761 and subsequently renamed VIA-2291, claimed in U.S. Patent No. 5,288,751 and EU
Patent No. 667,855. In exchange for such license, the Company agreed to make certain payments to
Abbott related to: (i) the grant of the license, (ii) the transfer of the licensed technology,
(iii) the achievement of certain development milestones (i.e., the first dosing of a Phase 3
clinical trial patient, and regulatory approval to commence sale of a licensed product in United
States, Japan or specified European countries), and (iv) the achievement of certain worldwide sales
milestones. Abbott will be entitled to an aggregate of $19.0 million in payments if all development
milestones are achieved and $27.0 million in payments if all worldwide sales milestones are paid.
To date, the Company has paid Abbott $2.0 million for the grant of the license and $1.0 million for
the transfer of the licensed technology. However, to date, no development or worldwide sales
milestones have been achieved.
7
The Company is also required to pay Abbott a royalty (subject to certain step-down and offset
provisions) during the term of the agreement, ranging from 3% to 6.5% of aggregate worldwide annual
net sales. The Company may sublicense its rights under the agreement to third parties, and the
agreement continues on a jurisdiction-by-jurisdiction basis until there are no remaining royalty
payment obligations in such jurisdiction. Upon completing payment of all royalty obligations due
under the agreement, the Company will have a perpetual, irrevocable and fully-paid exclusive
license to commercialize VIA-2291 for any indication.
Stanford License Agreement
In January 2009, the Company notified Stanford that it was terminating the March 2005 Stanford
License to use the Stanford Platform effective February 14, 2009. The Stanford License required
certain royalty payments to Stanford related to the issuance and sublicense of the Stanford License
and payments corresponding to the achievement of certain development and regulatory milestones. The
royalty rate varied from 1% to 6% of net sales depending on the type of product sold and whether
the Company held an exclusive right to the Stanford License at the time of sale. The Company was
also required to make milestone payments to Stanford for each VIA licensed product that used the
Stanford License as the product reaches various development and regulatory milestones. The Company
does not believe that it owes any amounts under the terminated Stanford License.
Roche Licensed Assets
In December 2008, the Company entered into the Roche Licenses for two sets of compounds that
we believe represent novel potential drugs for treatment of cardiovascular and metabolic disease.
The first license is for Roches THR beta agonist, a clinically ready candidate for the control of
cholesterol, triglyceride levels and potential in insulin sensitization/diabetes. The second
license is for multiple compounds from Roches preclinical DGAT1 metabolic disorders program. Under
the terms of the agreements, the Company assumes control of all development and commercialization
of the compounds, and will own exclusive worldwide rights for all potential indications.
Roche will receive up to $22.8 million in upfront and milestone payments, the majority of
which is tied to the achievement of product development and regulatory milestones. In addition,
once products containing the compounds are approved for marketing, Roche will receive single-digit
royalties based on net sales, subject to certain reductions.
The Company must use commercially reasonable efforts to conduct clinical and commercial
development programs for products containing the compounds. Under the license for the THR beta
agonist, if the Company has not completed a Phase 1 clinical trial with respect to a lead product
containing this compound by January 5, 2012, then either the Company must commit to developing
another of Roches compounds or Roche may terminate the license for that compound.
If the Company determines that it is not reasonable to continue clinical trials or other
development of the compounds, it may elect to cease further development and Roche may terminate the
licenses. If the Company determines not to pursue the development or commercialization of the
compounds in the United States, Japan, the United Kingdom, Germany, France, Spain, or Italy, Roche
may terminate the licenses for such territories.
The Roche Licenses will expire, unless earlier terminated pursuant to other provisions of the
licenses, on the last to occur of (i) the expiration of the last valid claim of a licensed patent
covering the manufacture, use or sale of products containing the compounds, or (ii) ten years after
the first sale of a product containing the compounds.
The THR beta agonist is an orally administered, small-molecule beta-selective thyroid hormone
receptor agonist designed to specifically target receptors in the liver involved in metabolism and
cholesterol regulation, and avoid side effects associated with thyroid hormone receptor activation
outside the liver. Roche has completed preclinical studies of the THR beta agonist. These studies
demonstrated a rapid reduction of non-HDL cholesterol and the drug was shown to be synergistic with
statins in animal studies. The Company will investigate the possibility of using the THR beta
agonist in combination with statins for the treatment of hypercholesterolemia. In addition, in
animal studies insulin sensitization and glucose lowering were observed making this compound a
possible treatment of patients with type 2 diabetes in combination with other diabetes medications.
DGAT1 is an enzyme that catalyzes triglyceride synthesis and fat storage. Triglycerides are
the principal component of fat, which is the major repository for storage of metabolic energy in
the body. Overweight and obese individuals have significantly greater triglyceride levels, making
them more prone to diabetes and its associated metabolic complications. DGAT1 inhibitors are
believed to be an innovative class of compounds that modify lipid metabolism. In studies of obese
animals, DGAT1 inhibitors have been shown to
induce weight loss and improve insulin sensitization, glucose tolerance and lipid levels.
These observations suggest DGAT1 inhibitors may have the potential to treat obesity, diabetes and
dyslipidemia. The Company intends to identify potential clinical candidates from the compounds in
this program and determine which compounds may be moved into further preclinical development.
8
Patents and Intellectual Property
Protection of assets by means of patents and other instruments conferring proprietary rights
is an essential element of the Companys business strategy. The Company primarily relies on patent
law, trade secret law and contract law to protect its proprietary information and technology as
well as to establish and maintain market exclusivity. In regard to patents, the Company actively
seeks patent protection in the United States and other jurisdictions to protect technology,
inventions and improvements to inventions that are commercially important to the development of its
business.
In 2005, the Company exclusively licensed from Abbott various U.S. and European Union (EU)
composition of matter patents related to VIA-2291, including United States Patent No. 5,288,751
(collectively, the Abbott Patents). The Abbott Patents will expire in 2012 in the United States
and 2013 in the EU.
In February 2009, the Company was issued United States Patent No. 7,495,024 entitled
Phenylalkyl N-Hydroxyureas for Combating Atherosclerotic Plaque, covering the use of VIA-2291 for
the treatment of atherosclerosis. This patent will expire in August 2026, and is pending in other
major markets worldwide.
The United States Drug Price Competition and Patent Term Restoration Act of 1984, known as the
Hatch-Waxman Act, provides for the restoration of up to five years of patent term for a patent that
covers a new product or its use, to compensate for time lost from the effective life of the patent
due to the regulatory review process of the FDA. An application for patent term restoration is
subject to approval by the U.S. Patent and Trademark Office in conjunction with the FDA. If the
Companys clinical trials of VIA-2291 are successful, and the Company ultimately receives the FDAs
approval to market the drug prior to the expiration of the Abbott Patent in November 2012, the
Company intends to work with Abbott to seek an extension of the term of the Abbott Patent under the
Hatch-Waxman Act. The Hatch-Waxman Act also provides for up to five years of data exclusivity in
the United States for new chemical entities (NCE) such as VIA-2291 that have not yet been
commercially sold in the market.
Other jurisdictions have statutory provisions similar to those of the Hatch-Waxman Act that
afford both patent extensions and market exclusivity for drugs that have obtained market
authorizations, such as European Supplementary Protection Certificates that extend effective patent
life and European data exclusivity rules that create marketing exclusivity for certain time periods
following marketing authorization. European data exclusivity is longer than the equivalent NCE
marketing exclusivity in the United States, possibly as long as 11 years. The Company believes that
if it obtains marketing authorization for VIA-2291 in Europe or other jurisdictions with similar
statutory provisions, the Company may be eligible for patent term extension and marketing
exclusivity under these provisions and the Company intends to seek such privileges.
The Companys commercial success will depend in part on its ability to manufacture, use and
sell its product candidates and proposed product candidates without infringing on the patents or
other proprietary rights of third parties. The Company may not be aware of all patents or patent
applications that may impact its ability to make, use or sell any of its product candidates or
proposed product candidates. For example, U.S. patent applications do not publish until 18 months
from their effective filing date. Further, the Company may not be aware of published or granted
conflicting patent rights. Any conflicts resulting from patent applications and patents of others
could significantly affect the validity or enforceability of the Companys patents and limit the
Companys ability to obtain meaningful patent protection. If others obtain patents with competing
claims, the Company may be required to obtain licenses to these patents or to develop or obtain
alternative technology. The Company may not be able to obtain any licenses or other rights to
patents, technology or know-how necessary to conduct our business as described in this Annual
Report. Any failure to obtain such licenses or other rights could delay or prevent the Company from
developing or commercializing its product candidates and proposed product candidates, which could
materially affect the Companys business.
Litigation or patent interference proceedings may be necessary to enforce the Companys patent
or other proprietary rights, or to determine the scope and validity or enforceability of the
proprietary rights of others. The defense and prosecution of patent and intellectual property
claims are both costly and time consuming, even if the outcome is favorable to the Company. Any
adverse outcome could subject the Company to significant liabilities, require the Company to
license disputed rights from others or to cease selling the Companys future products.
9
Trademarks
The Company has not yet applied to register any of its trademarks with the USPTO. The Company
will take any and all actions that it deems necessary to protect the trademarks and/or service
marks that the Company uses or intends to use in connection with its business.
Clinical Trials
The Company enters into master services agreements with contract research organizations to
assist in the conduct of its clinical trials for development of products. The Company used i3
Research, a division of Ingenix Pharmaceutical Services, Inc., to conduct the VIA-2291 ACS and CEA
clinical trials. The Company used PharmaNet LLC to conduct the VIA-2291 FDG PET clinical trial.
Manufacturing
The Company enters into manufacturing agreements with third party contract manufacturing
organizations that comply with current Good Manufacturing Practice (cGMP) guidelines for bulk
drug substance and oral formulations of VIA-2291 and the Companys other product candidates needed
to support both ongoing and planned clinical trials, as well as commercial marketing of the product
following regulatory approval.
Sales and Marketing
The Company plans to consider business collaborations with large biotechnology or
pharmaceutical companies to commercialize approved products that it develops to target patients or
prescribing physicians in broad markets. The Company believes that collaborating with large
companies that have significant marketing and sales capabilities provides for optimal penetration
into broad markets, particularly into those areas that are highly competitive.
Competition
The Company faces intense competition in the development of compounds addressing
cardiovascular and metabolic disease particularly from biotechnology and pharmaceutical companies.
Certain of these companies may, using other approaches, identify and decide to pursue the discovery
and development of new drug targets or disease pathways that the Company has identified through its
research. Many of the Companys competitors, either alone or with collaborative partners, have
substantially greater financial resources and larger research and development operations than the
Company does. These competitors may discover, characterize or develop important genes, drug targets
or drug candidates with respect to treating atherosclerosis, inflammation or other targets to
address cardiovascular and metabolic diseases before the Company does or they may obtain regulatory
approvals of their drugs more rapidly than the Company does.
In addition, the Company believes that certain companies may have preclinical programs
underway targeting atherosclerotic-related inflammation. Many of these entities have substantially
greater resources, longer operating histories and greater marketing and financial resources than
the Company does. They may, therefore, succeed in commercializing products before the Company does
that compete on the basis of efficacy, safety and price.
The Company also faces competition from other biotechnology and pharmaceutical companies
focused on alternative treatments for cardiovascular and metabolic disease, such as anti-oxidants,
antibodies against oxidized LDL, compounds to raise HDL, and compounds addressing insulin
resistance. Any product that the Company successfully develops may compete with these other
approaches and may be rendered obsolete or noncompetitive.
The Companys competitors may obtain patent protection or other intellectual property rights
that could limit the Companys rights to use its technologies or databases, or commercialize its
products. In addition, the Company faces, and will continue to face, intense competition from other
companies for collaborative arrangements with biotechnology and pharmaceutical companies, for
establishing relationships with academic and research institutions and for licenses to proprietary
technology.
The Companys ability to compete successfully will depend, in part, on its ability to: (i)
develop proprietary products; (ii) develop and maintain products that reach the market first, and
are technologically superior to and more cost effective than other products on the market; (iii)
obtain patent or other proprietary protection for its products and technologies; (iv) attract and
retain scientific and product development personnel; (v) obtain required regulatory approvals; and
(vi) manufacture, market and sell products that the
Company develops. Developments by third parties may render our product candidates obsolete or
noncompetitive. These competitors, either alone or in collaboration, may succeed in developing
technologies or products that are more effective than those developed by the Company.
10
Governmental Regulation
The Company plans to develop prescription-only drugs for the foreseeable future. Prescription
drug products are subject to extensive pre- and post-market regulation by the FDA, including
regulations that govern the testing, manufacturing, safety, efficacy, labeling, storage, record
keeping, advertising and promotion of such products under the Federal Food Drug and Cosmetic Act
(FDCA) and its implementing regulations, and by comparable agencies and laws in foreign
jurisdictions. The European Union has vested centralized authority in the European Medicines
Evaluation Agency and Committee on Proprietary Medicinal Products to standardize review and
approval across EU member nations. Failure to comply with applicable FDA, EU or other requirements
may result in civil or criminal penalties, recall or seizure of products, partial or total
suspension of production or withdrawal of the product from the market.
FDA approval is required before any new unapproved drug or dosage form, including a new use of
a previously approved drug, can be marketed in the United States. All applications for FDA approval
must contain, among other things, information relating to pharmaceutical formulation, stability,
manufacturing, processing, packaging, labeling, and quality control.
New Drug Application
Approval by the FDA of a new drug application (NDA) is generally required before a drug may
be marketed in the United States. This process generally involves:
|
|
|
completion of preclinical laboratory and animal testing in compliance with the FDAs good
laboratory practice regulations; |
|
|
|
submission to the FDA of an IND for human clinical testing which must become effective
before human clinical trials may begin; |
|
|
|
performance of adequate and well-controlled human clinical trials to establish the safety
and efficacy of the proposed drug product for each intended use; |
|
|
|
satisfactory completion of an FDA pre-approval inspection of the facility or facilities
at which the product is produced to assess compliance with the FDAs current cGMP
guidelines; and |
|
|
|
submission to, and approval by, the FDA of an NDA. |
The preclinical and clinical testing and approval process requires substantial time, effort
and financial resources, and the Company cannot be certain that the FDA will grant any approvals
for its product candidates on a timely basis, if at all.
Preclinical tests include laboratory evaluation of product chemistry, formulation and
stability, as well as studies to evaluate toxicity in animals. The results of preclinical tests,
together with manufacturing information and analytical data, are submitted as part of an IND to the
FDA. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA,
within the 30-day time period, raises concerns or questions about the conduct of the clinical
trial, including concerns that human research subjects will be exposed to unreasonable health
risks. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the
clinical trial can begin. The Companys submission of an IND may not result in FDA authorization to
commence a clinical trial. A separate submission to an existing IND must also be made for each
successive clinical trial conducted during product development. Further, an independent
institutional review board (IRB) for each medical center proposing to conduct the clinical trial
must review and approve the plan for any clinical trial before it commences at that center and it
must monitor the study until completed. The FDA, the IRB, or the sponsor (i.e. VIA) may suspend a
clinical trial at any time on various grounds, including a finding that the subjects or patients
are being exposed to an unacceptable health risk. Clinical testing also must satisfy extensive GCP,
or Good Clinical Practice requirements, including regulations for informed consent.
The Company is also subject to various laws and regulations regarding laboratory practices and
the experimental use of animals in connection with its research. In these areas, as elsewhere, the
FDA has broad regulatory and enforcement powers, including the ability to levy fines and civil
penalties, suspend or delay issuance of approvals, seize or recall products, and withdraw
approvals, any one or more of which could have a material adverse effect on the Company.
11
For purposes of an NDA submission and approval, human clinical trials are typically conducted
in the following three sequential phases, which may overlap:
|
|
|
Phase 1: Studies are initially conducted in a limited population to test the product
candidate for safety, dose tolerance, absorption, metabolism, distribution and excretion in
healthy humans or, on occasion, in patients, such as cancer patients. |
|
|
|
Phase 2: Studies are generally conducted in a limited patient population to identify
possible adverse effects and safety risks, to evaluate the efficacy of the product for
specific targeted indications and to determine dose tolerance and optimal dosage. Multiple
Phase 2 clinical trials may be conducted by the sponsor to obtain information prior to
beginning larger and more expensive Phase 3 clinical trials. |
|
|
|
Phase 3: These are commonly referred to as pivotal studies. When Phase 2 evaluations
demonstrate that a dose range of the product may be effective and has an acceptable safety
profile, Phase 3 trials are undertaken in large patient populations to further evaluate
dosage, to provide substantial evidence of clinical efficacy and to further test for safety
in an expanded and diverse patient population at multiple, geographically-dispersed clinical
trial sites. |
|
|
|
Phase 4: In some cases, the FDA may condition approval of an NDA for a product candidate
on the sponsors agreement to conduct additional post-approval clinical trials to further
assess the drugs safety and effectiveness after NDA approval and commercialization. Such
post approval trials are typically referred to as Phase 4 studies. |
Clinical trials, including the adequate and well-controlled clinical investigations conducted
in Phase 3, are designed and conducted in a variety of ways. Phase 3 studies are often randomized,
placebo-controlled and double-blinded. A placebo-controlled trial is one in which one group of
patients, referred to as an arm of the trial, receives the drug being tested while another group
receives a placebo, which is a substance known not to have pharmacologic or therapeutic activity.
In a double-blind study, neither the researcher nor the patient knows which arm of the trial is
receiving the drug or the placebo. Randomized means that upon enrollment patients are placed into
one arm or the other at random by computer. Other controls also may be used by which the test drug
is evaluated against a comparator. For example, parallel control trials generally involve
studying a patient population that is not exposed to the study medication (i.e., is either on
placebo or standard treatment protocols). In such studies experimental subjects and control
subjects are assigned to groups upon admission to the study and remain in those groups for the
duration of the study. Not all studies are highly controlled. An open label study is one where
the researcher and the patient know that the patient is receiving the drug. A trial is said to be
pivotal if it is designed to meet statistical criteria with respect to pre-determined
endpoints, or clinical objectives, that the sponsor believes, based usually on its interactions
with the relevant regulatory authority, will be sufficient to demonstrate safety and effectiveness
meeting regulatory approval standards. In some cases, two pivotal clinical trials are necessary
for approval.
The results of product development, preclinical studies and clinical trials are submitted to
the FDA as part of an NDA. NDAs must also contain extensive manufacturing information. Once the
submission has been accepted for filing, by law the FDA has 180 days to review the application and
respond to the applicant. In 1992, under the Prescription Drug User Fee Act (PDUFA), the FDA
agreed to specific goals for improving the drug review time and created a two-tiered system of
review times Standard Review and Priority Review. Standard Review is applied to a drug that
offers at most, only minor improvement over existing marketed therapies. The 2002 amendments to
PDUFA set a goal that a Standard Review of an NDA be accomplished within ten months. A Priority
Review designation is given to drugs that offer major advances in treatment, or provide a treatment
where no adequate therapy exists. A Priority Review means that the time it takes the FDA to review
an NDA is reduced such that the goal for completing a Priority Review initial review cycle is six
months. The review process is often significantly extended by FDA requests for additional
information or clarification. The FDA may refer the application to an advisory committee for
review, evaluation and recommendation as to whether the application should be approved. The FDA is
not bound by the recommendation of an advisory committee, but it generally follows such
recommendations. The FDA may deny approval of an NDA if the applicable regulatory criteria are not
satisfied, or it may require additional clinical data and/or an additional pivotal Phase 3 clinical
trial. Even if such data are submitted, the FDA may ultimately decide that the NDA does not satisfy
the criteria for approval. Data from clinical trials are not always conclusive and the FDA may
interpret data differently than the Company does. Once issued, the FDA may withdraw product
approval if ongoing regulatory requirements are not met or if safety problems occur after the
product reaches the market. In addition, the FDA may require testing, including Phase 4 studies,
and surveillance programs to monitor the effect of approved products which have been
commercialized, and the FDA has the power to prevent or limit further marketing of a product based
on the results of these postmarketing programs. Drugs may be marketed only for the approved
indications and in accordance with the provisions of the approved label. Further, if there are any
modifications to the drug, including changes in indications, labeling, or manufacturing processes
or facilities, the Company may be required to submit and obtain FDA approval of a new or
supplemental NDA, which may require the Company to develop additional data or conduct additional
preclinical studies and clinical trials.
12
The FDA has expanded its expedited review process in recognition that certain severe or
life-threatening diseases and disorders have only limited treatment options. Fast track designation
expedites the development process, but places greater responsibility on a drug company during
Phase 4 clinical trials. The drug company may request fast track designation for one or more
indications at any time during the IND process, and the FDA must respond within 60 days. Fast track
designation allows the drug company to develop product candidates faster based on the ability to
request an accelerated approval of the NDA. For accelerated approval the clinical effectiveness is
based on a surrogate endpoint in a smaller number of patients. In addition, the drug company may
request priority review at the time of the NDA submission. If the FDA accepts the NDA submission as
a priority review, the time for review is reduced from one year to six months. The Company plans to
request fast track designation and/or priority review, as appropriate, for its product candidates.
PDUFA, which has been reauthorized twice and is likely to be reauthorized again before the
Companys submission of an NDA, requires the payment of user fees with the submission of NDAs.
These application fees are substantial ($1,405,500 in the FDAs Fiscal Year 2010) and will likely
increase in future years. If the Company obtains FDA approval for its product candidates, it could
obtain five years of Hatch-Waxman marketing exclusivity for product candidates containing no active
ingredient (including any ester or salt of the active ingredient) previously approved by the FDA.
Under this form of exclusivity, third parties would be precluded from submitting a drug application
which refers to the previously approved drug and for which the safety and effectiveness
investigations relied upon by the new applicant were not conducted by or for the applicant and for
which the applicant has not obtained a right of reference or use for a period of five years. This
form of exclusivity does not block acceptance and review of stand-alone NDAs supported entirely by
data developed by the applicant or to which the applicant has a right of reference.
The Company and its contract manufacturers are required to comply with applicable cGMP
guidelines. cGMP guidelines require among other things, quality control, and quality assurance as
well as the corresponding maintenance of records and documentation. The manufacturing facilities
for the Companys products must demonstrate that they meet GMP guidelines to the satisfaction of
the FDA pursuant to a pre-approval inspection before they can manufacture products. The Company and
its third-party manufacturers are also subject to periodic inspections of facilities by the FDA and
other authorities, including procedures and operations used in the testing and manufacture of its
products to assess its compliance with applicable regulations.
Failure to comply with statutory and regulatory requirements subjects a manufacturer to
possible legal or regulatory action, including warning letters, the seizure or recall of products,
injunctions, consent decrees placing significant restrictions on or suspending manufacturing
operations, and civil and criminal penalties. Adverse experiences with the product must be reported
to the FDA and could result in the imposition of market restriction through labeling changes or in
product removal. Product approvals may be withdrawn if compliance with regulatory requirements is
not maintained or if problems concerning safety or efficacy of the product occur following
approval.
Other Regulatory Requirements
Following approval of a drug candidate, the FDA imposes a number of complex regulations on
entities that advertise and promote pharmaceuticals, which include, among others, standards for
direct-to-consumer advertising, prohibitions on off-label promotion, and restrictions on
industry-sponsored scientific and educational activities, and promotional activities involving the
internet. The FDA has very broad enforcement authority under the FDCA, and failure to abide by
these regulations can result in penalties, including the issuance of a warning letter directing
entities to correct deviations from FDA standards, a requirement that future advertising and
promotional materials be pre-cleared by the FDA, and state and federal civil and criminal
investigations and prosecutions.
Any products the Company manufactures or distributes under FDA approvals are subject to
pervasive and continuing regulation by the FDA, including record-keeping requirements and reporting
of adverse experiences with the products. Safety issues uncovered by such reporting may result in
it having to recall approved products or FDA withdrawing its approval for such products, which
could have a material adverse effect on the Company. Failure to make such reports as required by
the FDA may result in fines and civil penalties, suspension of approvals, the seizure or recall of
products, and the withdrawal of approvals, any one or more of which could have a material adverse
effect on the Company.
Outside the United States, the Companys ability to market a product is contingent upon
receiving marketing authorization from the appropriate regulatory authorities. The requirements
governing marketing authorization, pricing and reimbursement vary widely from jurisdiction to
jurisdiction. At present, foreign marketing authorizations are applied for at a national level,
although within the EU registration procedures are available to companies wishing to market a
product in more than one EU member state. The regulatory authority generally will grant marketing
authorization if it is satisfied that the Company has presented it with adequate evidence of
safety, quality and efficacy.
13
Research and Development
The Companys research and development expenses were $6.1 million and $11.8 million in the
years ended December 31, 2009 and 2008, respectively. The Company continues to incur significant
research and development expenses as it finalizes its clinical programs related to its lead
compound VIA-2291, continues planning for clinical trials of its preclinical pipeline assets and
evaluates other potential preclinical or clinical compounds that the Company may consider acquiring
or licensing.
Employees
As of December 31, 2009, the Company had nineteen full-time employees, including nine in
research and development. Of these employees, four have Ph.D.s, one has an M.D. and six have
Masters degrees. For employee information following the restructuring, please see Other
Information in Part II, Item 9B below.
EXECUTIVE OFFICERS OF THE REGISTRANT
The executive officers of VIA Pharmaceuticals, Inc. as of March 15, 2010 are as follows:
|
|
|
|
|
|
|
Name |
|
Age |
|
Position |
Lawrence K. Cohen
|
|
|
56 |
|
|
Director, President and Chief Executive Officer |
James G. Stewart
|
|
|
57 |
|
|
Senior Vice President, Chief Financial Officer and Secretary |
Rebecca A. Taub
|
|
|
58 |
|
|
Senior Vice President, Research and Development |
Biographical information relating to each of our executive officers is set forth below.
Lawrence K. Cohen, Ph.D. has served as President, Chief Executive Officer and a director of
the Company since the consummation of the Merger on June 5, 2007, and prior to that time served as
President, Chief Executive Officer and a director of privately-held VIA Pharmaceuticals, Inc. since
its formation in 2004. Previously, he was the Chief Executive Officer of Zyomyx, Inc., a
privately-held biotechnology company focused on protein chip technologies. Dr. Cohen joined Zyomyx
in 1999 as Chief Operating Officer, where he was responsible for all internal activities, including
research and development, business development, financing and operations. Dr. Cohen received a
Ph.D. in Microbiology from the University of Illinois and completed his postdoctoral work in
Molecular Biology at the Dana-Farber Cancer Institute and the Department of Biological Chemistry at
Harvard Medical School.
James G. Stewart has served as Senior Vice President, Chief Financial Officer and Secretary of
the Company since the consummation of the Merger on June 5, 2007, and prior to that time served as
Senior Vice President, Chief Financial Officer and Secretary of privately-held VIA Pharmaceuticals,
Inc. since November 2006. From 1988, Mr. Stewart has held a number of senior financial and
operating roles with privately-held, venture backed companies in a number of industries, including
telecommunications, corporate ethics and governance, semiconductor equipment and wireless sensors.
From April 2005 to August 2006, Mr. Stewart served as Senior Vice President, Chief Financial
Officer at Advanced Cell Technology, a public biotechnology company focused on stem cell derived
products. From August 2004 to March 2005, Mr. Stewart served as Chief Financial Officer and
Executive Vice President Administrator at LRN, a private venture capital-backed company focused on
corporate governance matters. From April 2002 to July 2004, he served as Chief Financial Officer of
SS8 Networks, Inc., a private venture capital-backed telecommunications company. From March 2001 to
March 2002, Mr. Stewart served as Chief Financial Officer of Graviton, Inc., a private venture
capital-backed technology company. From February 1999 to March 2001, Mr. Stewart served as Chief
Financial Officer at Ventro Corporation, a public business-to-business marketplace company, where
he was responsible for raising significant capital in the companys initial public offering and
subsequent debt offering. From June 1995 to February 1999, Mr. Stewart served as Chief Financial
Officer of CN Biosciences, Inc., a public life sciences company where he was responsible for the
companys initial public offering and management of finance and other operating responsibilities
culminating in the successful sale of the business to Merck KgaA Darmstadt. Prior to CN
Biosciences, Mr. Stewart held key finance and operating responsibilities at two other companies
after leaving Ernst & Young (formerly Arthur Young & Co.) where he ultimately served as an audit
partner after 13 years with the firm. Mr. Stewart holds a B.A. from the University of Southern
California.
Rebecca Taub, M.D. has served as Senior Vice President, Research and Development of the
Company since January 14, 2008, and prior to that time served as Vice President of Research in
Metabolic Diseases of Roche Pharmaceuticals, a unit of Roche Holding Ltd. since 2004. While at
Roche Dr. Taub oversaw drug discovery programs in diabetes, dyslipidemia and obesity, including
target identification, lead optimization and advancement of preclinical candidates into clinical
development. From 2000 through 2003, Dr.
Taub worked at Bristol-Myers Squibb Co. and DuPont Pharmaceutical Company, which was acquired
by Bristol-Myers in 2001, in a variety of positions, including executive director of CNS and
obesity research. Before becoming a pharmaceutical executive, Dr. Taub served in a number of
academic medicine and biomedical research positions. She was a tenured professor of genetics and
medicine at the University of Pennsylvania School of Medicine from 1997 to 2001, and she remains an
adjunct professor. Earlier she was an assistant professor at the Joslin Diabetes Center of Harvard
Medical School, Harvard University and an associate investigator with the Howard Hughes Medical
Institute. She is the author of more than 120 research articles. Dr. Taub received her M.D. from
Yale University School of Medicine and B.A. from Yale College.
14
Advisors
The Company has established an advisory board to provide guidance and counsel on aspects of
its business. Members of the board provide input on product research and development strategy,
assist in targeting future pathways of interest, provide industry perspectives and background and
assist in education and publication plans.
The Companys advisors are as follows:
|
|
|
|
|
Name |
|
Specialty |
|
Employment/Current Positions |
|
|
|
|
|
Marcelo di Carli, MD
|
|
Atherosclerosis and cardiovascular
disease and imaging technologies
|
|
Associate Professor of
Radiology, and Chief of
Nuclear Medicine, Brigham
and Womens Hospital |
|
|
|
|
|
Robert Fenichel, MD, Ph.D.
|
|
Atherosclerosis and cardiovascular
disease and regulatory matters
|
|
Former Deputy Division
Director, Division of
CardioRenal Drug Products,
Food and Drug
Administration |
|
|
|
|
|
Peter Libby, MD
|
|
Atherosclerosis and cardiovascular
disease, including the role of
inflammation in the disease process
|
|
Mallinckrodt Professor of
Medicine, and Chief,
Cardiovascular Division,
Brigham and Womens
Hospital |
|
|
|
|
|
Marc Pfeffer, MD, Ph.D.
|
|
Pathophysiology and clinical management
of progressive cardiac dysfunction
following heart attack or hypertension
|
|
Dzau Professor of Medicine,
Harvard Medical School
Senior Physician, Brigham
and Womens Hospital in
Boston |
|
|
|
|
|
Thomas Quertermous, MD
|
|
Vascular pathophysiological, genetic and
molecular mechanisms of inflammation and
atherogenics
|
|
William G. Irwin Professor
of Cardiovascular Medicine
and Chief of Research,
Cardiovascular Medicine
Division, at Stanford
University School of
Medicine. |
|
|
|
|
|
Paul Ridker, MD
|
|
Atherosclerosis and cardiovascular
disease, including the role of
inflammation in the disease process and
the role of CRP
|
|
Eugene Braunwald Professor
of Medicine, Harvard
Medical School and
Director, Center for
Cardiovascular Disease
Prevention, Divisions of
Cardiovascular Diseases and
Preventive Medicine,
Brigham and Womens
Hospital |
|
|
|
|
|
Jean-Lucien Rouleau, MD
|
|
Atherosclerosis and cardiovascular disease
|
|
Dean, Faculty of Medicine,
University of Montreal |
|
|
|
|
|
Jean-Claude Tardif, MD
|
|
Atherosclerosis and cardiovascular disease
|
|
Associate Professor of
Medicine, University of
Montreal Director of
Research, Montreal Heart
Institute |
|
|
|
|
|
Renu Virmani, MD
|
|
Cardiovascular pathology
|
|
President and Medical
Director of CVPath
Institute, Inc. |
15
Corporate Information
Our principal executive office is located at 750 Battery Street, Suite 330, San Francisco, CA
94111, and our telephone number is (415) 283-2200. Our website address is:
www.viapharmaceuticals.com. The reference to our website address does not constitute incorporation
by reference of the information contained on the website, which should not be considered part of
this annual report on Form 10-K. You may view our financial information, including the information
contained in this annual report, and other reports we file with the Securities and Exchange
Commission (SEC), on the Internet, without charge as soon as reasonably practicable after we file
them with the SEC, in the SEC Filings page of the Investor Relations section of our website at
www.viapharmaceuticals.com. Alternatively, you may view or obtain reports filed with the SEC at the
SEC Public Reference Room at 100 F Street, N.E. in Washington, D.C. 20549, or at the SECs Internet
site at www.sec.gov. You may obtain information on the operation of the SEC Public Reference Room
by calling the SEC at 1-800-SEC-0330.
ITEM 1A. RISK FACTORS
Risks Related to the Companys Financial Results
The Company has experienced significant losses, expects losses in the future, has limited
resources and there is substantial doubt as to the Companys ability to continue as a going
concern.
The Company is a clinical-stage biotechnology company with a limited operating history and a
single product candidate in clinical trials, VIA-2291. The Company is not profitable and its
current operating business has incurred losses in each year since the inception of the Company in
2004. The Company currently does not have any products that have been approved for marketing, and
the Company will continue to incur significant research and development and general and
administrative expenses related to its operations. The Companys net loss for the years ended
December 31, 2009 and 2008 was approximately $21.0 million and $20.3 million, respectively. As of
December 31, 2009, the Company had an accumulated deficit of approximately $81.6 million. The
Company expects that it will continue to incur significant losses for the foreseeable future, and
the Company may never achieve or sustain profitability. If the Companys product candidates,
including VIA-2291, fail in clinical trials or do not gain regulatory approval, or if the Companys
future products do not achieve market acceptance, the Company may never become profitable. Even if
the Company achieves profitability in the future, it may not be able to sustain profitability in
subsequent periods.
Failure to obtain adequate financing in the near term will adversely affect the Companys
ability to operate as a going concern. The Companys ability to continue as a going concern is also
dependent upon its ability to control its operating expenses and its ability to achieve a level of
revenues adequate to support its capital and operating requirements.
The factors described in the auditors report and Note 1 and Note 12 in the Notes to the
Financial Statements may make it more difficult for the Company to obtain additional financing, and
there can be no assurance that the Company will be able to obtain such financing on favorable
terms, or at all. As a result of the Companys losses to date, expected losses in the future,
limited capital resources, including cash on hand, and accumulated deficit, the Companys
independent registered public accounting firm concluded that there is substantial doubt as to the
Companys ability to continue as a going concern, and accordingly, included an explanatory
paragraph describing conditions that raise substantial doubt about its ability to continue as a
going concern in their report on the Companys December 31, 2009 financial statements.
The Company will require substantial additional funding in the near term to continue operating its
business, which may not be available to the Company on acceptable terms, or at all, which could
force the Company to delay, scale back or eliminate some or all of its research and development
programs, or ultimately cease operations.
As of December 31, 2009, the Company had $2.2 million in cash. As described under
Managements Discussion and Analysis of Financial Condition and Results of Operations in Part II,
Item 7 below and in Note 6 in the Notes to the Financial Statements, in March 2009, the Company
entered into a loan (the March 2009 Loan) with its principal stockholder, Bay City Capital, and
one of Bay City Capitals affiliates (the Lenders) whereby the Lenders agreed to lend to the
Company in the aggregate up to $10.0 million, which loan is secured by all of the Companys assets,
including its intellectual property, and accrues interest at the rate of 15% per annum, which
increases to 18% per annum following an event of default. As of September 11, 2009, the Company had
drawn down the full amount from the debt facility. As described in Other Information in Part II,
Item 9B and in Note 12 in the Notes to the Financial Statements, the Company entered into another
loan (the March 2010 Loan) with the Lenders whereby the Lenders agreed to lend to the Company in
the aggregate up to $3.0 million, which loan is secured by all of the Companys assets, including
its intellectual property, and accrues interest at the rate of 15%
16
per annum, which increases to
18% per annum following an event of default. On March 29, 2010, the Company borrowed an initial
amount of $1,250,000. Management believes that the total amount of cash borrowed under the March
2010 Loan, if fully drawn, will enable the Company to meet its current obligations into the third
quarter of 2010. Management does not believe that existing cash resources will be sufficient
to enable the Company to meet its ongoing working capital requirements for the next twelve months
and the Company will need to raise substantial additional funding in the near term to meet its
working capital requirements and to continue its research, development and commercialization
activities. Current funds and additional funds raised will be required to:
|
|
|
fund the business operations of the Company, including general and administrative
expenses and the expenses surrounding the restructuring as described in Other Information
in Part II, Item 9B and in Note 12 in the Notes to the Financial Statements; |
|
|
|
fund clinical trials and seek regulatory approvals; |
|
|
|
pursue and implement strategic partnering transactions; |
|
|
|
pursue the development of additional product candidates; |
|
|
|
conduct and expand the Companys research and development activities; |
|
|
|
access manufacturing and commercialization capabilities, including seeking collaboration
and partnering opportunities; |
|
|
|
implement additional internal systems and infrastructure; and |
|
|
|
maintain, defend and expand the scope of the Companys intellectual property portfolio. |
The Companys future funding requirements will depend on many factors, including but not limited
to:
|
|
|
the terms and timing of any collaboration, licensing or other strategic arrangements into
which the Company may enter; |
|
|
|
the scope, cost, rate of progress, and results of the Companys current and future
clinical trials, preclinical studies and other discovery, research and development
activities; |
|
|
|
the costs associated with establishing manufacturing and commercialization capabilities; |
|
|
|
the costs of acquiring or investing in product candidates and technologies; |
|
|
|
the costs of filing, prosecuting, defending and enforcing any patent claims and other
intellectual property rights; |
|
|
|
the costs and timing of seeking and obtaining FDA and other regulatory approvals; |
|
|
|
the potential need to hire additional management and research, development and clinical
personnel; |
|
|
|
the effect of competing technological and market developments; and |
|
|
|
general and industry-specific economic conditions that may affect the Companys research
and development expenditures. |
Until the Company can establish profitable operations to finance its cash requirements, which
the Company may never do, the Company plans to finance future cash needs primarily through public
or private equity or debt financings, the establishment of credit or other funding facilities, or
entering into collaborative or other strategic arrangements with corporate sources or other sources
of financing. Global market and economic conditions have been, and continue to be, disrupted and
volatile. Concern about the stability of the markets has led many lenders and institutional
investors to reduce, and in some cases, cease to provide credit to businesses and consumers. The
Company does not know whether additional financing will be available in the near term when needed,
particularly in light of the current economic environment and adverse conditions in the financial
markets, or that, if available, financing will be obtained on terms favorable to the Company or its
stockholders. Since August 2007, other than through bridge loans from its largest stockholder, the
Company has been unsuccessful in securing additional financing and may not be able to do so in the
near term when needed. The delisting of the Companys common stock from the NASDAQ Capital Market
may further adversely affect our ability to obtain additional financing in the near term when
needed. Having insufficient funds may require the Company to delay, scale back, or eliminate some
or all of its research and development programs, including activities related to its clinical
trials, or to relinquish greater or all rights to product candidates at an earlier stage of
development or on less favorable terms than the Company would otherwise choose, or ultimately cease
operations.
17
The Company expects to be in default under the March 2009 Loan, which default could lead to a
foreclosure on the Companys assets.
All outstanding principal and accrued interest under the March 2009 Loan are due on April 1,
2010. The Company will not be able to repay the loan when it becomes due on April 1, 2010. When
the Company does not repay the loan at maturity, it will be in default under the March 2009 loan
agreement and the Lenders may terminate the March 2009 Loan, demand immediate payment of all
amounts borrowed by the Company and take possession of all collateral securing the March 2009 Loan,
which could cause the Company to cease operations. In addition, if the Company raises additional
funds through collaborative or other strategic arrangements, it may be required to relinquish
potentially valuable rights to its product candidates or grant licenses on terms that are not
favorable to the Company.
The Company may not be able to satisfy certain covenant restrictions, which could adversely affect
the Companys business, financial condition, results of operations and liquidity.
As described under Managements Discussion and Analysis of Financial Condition and Results of
Operations in Part II, Item 7 below and in Note 6 in the Notes to the Financial Statements, in
March 2009, the Company entered into a loan with the Lenders whereby the Lenders agreed to lend to
the Company in the aggregate up to $10.0 million, which loan is secured by all of the Companys
assets, including its intellectual property. As of September 11, 2009, the Company had drawn down
the full amount from the debt facility. As described in Other Information in Part II, Item 9B
and in Note 12 in the Notes to the Financial Statements, the Company entered into the March 2010
Loan with the Lenders whereby the Lenders agreed to lend to the Company in the aggregate up to $3.0
million, which loan is secured by all of the Companys assets, including its intellectual property.
On March 29, 2010, the Company borrowed an initial amount of $1,250,000. In connection with both
loans, the Company must also satisfy certain conditions and comply with covenants, including
covenants relating to the Companys ability to incur additional indebtedness, make future
acquisitions, consummate asset dispositions, grant liens and pledge assets, pay dividends or make
other distributions, incur capital expenditures and make restricted payments. These restrictions
may limit the Companys ability to pursue its business strategies and obtain additional funds. The
Companys ability to meet these financial covenants may be adversely affected by a deterioration in
business conditions or its results of operations, adverse regulatory developments, the economic
environment and adverse conditions in the financial markets or other events beyond the Companys
control. Failure to comply with these restrictions may result in the occurrence of an event of
default under the loan. Upon the occurrence of an event of default, the Lenders may terminate the
loan, demand immediate payment of all amounts borrowed by the Company and take possession of all
collateral securing the loan, which could adversely affect the Companys ability to repay its debt
securities and cause the Company to cease operations. In addition, the loans provide that, subject
to certain specified exemptions, the proceeds of any debt or equity offering or asset sale must be
used to reduce outstanding indebtedness under the loan or other specified indebtedness. This
restriction severely limits the Companys ability to use the proceeds of any debt or equity
offering or asset sale to operate or grow the Companys business. All outstanding principal and
accrued interest under the March 2009 Loan are due on April 1, 2010. The Company will not be able
to repay the loan when it becomes due on April 1, 2010.
Raising additional funds by issuing securities or through collaboration and other strategic
arrangements will likely cause dilution to existing stockholders, restrict operations or require
the Company to relinquish potentially valuable rights.
The Company may raise additional capital through private or public equity or debt financings,
the establishment of credit or other funding facilities, entering into collaborative or other
strategic arrangements with corporate sources or other sources of financing, which may include
partnerships for product development and commercialization, merger, sale of assets or other similar
transactions. If the Company raises additional capital by issuing equity securities, its existing
stockholders ownership will be diluted. Given the Companys current market capitalization and
financing needs, it is likely that any financing obtained will result in significant dilution to
existing stockholders. Any additional debt financing that the Company enters into may involve
covenants that restrict its operations. These restrictive covenants may include limitations on
additional borrowing, specific restrictions on the use of its assets as well as prohibitions on its
ability to create liens, pay dividends, redeem its stock or make investments. The Company may also
be required to pledge all or substantially all of its assets, including intellectual property
rights, as collateral to secure any debt obligations.
The March 2009 Loan is secured by all of the Companys assets, including its intellectual
property. In connection with this loan, the Company granted the Lenders warrants to purchase an
aggregate of 83,333,333 shares of common stock (Warrant Shares) at $0.12 per share. The Warrant
Shares vest based on the amount of borrowings under the loan and the passage of time. For each
$2.0 million borrowing, 8,333,333 Warrant Shares vest and are exercisable immediately on the date
of grant, and 8,333,333 vest and are exercisable 45 days thereafter as the Company meets certain
conditions provided for in the warrants, including that the Company did not complete a $20.0
million financing, as defined in the Loan Agreement, within 45 days of the borrowing. Based on the
$10.0
million of borrowings, 83,333,333 Warrant Shares are vested and are exercisable. The Warrant
Shares are exercisable at any time until 5:00 p.m. (Pacific Time) on March 12, 2014, upon the
surrender to the Company of the properly endorsed Warrant Shares, as specified in the warrants. To
the extent the Warrant Shares are exercised by the Lenders, existing stockholders ownership in the
Company will be significantly diluted.
18
As described in Other Information in Part II, Item 9B and in Note 12 in the Notes to the
Financial Statements, the March 2010 Loan is secured by all of the Companys assets, including its
intellectual property. In connection with this loan, the Company granted the Lenders warrants to
purchase an aggregate of 17,647,059 shares of common stock (2010 Warrant Shares) at $0.17 per
share. The 2010 Warrant Shares vest based on the amount of borrowings under the loan. Based on
the $1,250,000 of borrowings, 7,352,941 of the 2010 Warrant Shares are vested and are exercisable
as of March 29, 2010. The 2010 Warrant Shares are exercisable at any time until 5:00 p.m. (Pacific
Time) on March 26, 2015, upon the surrender to the Company of the properly endorsed 2010 Warrant
Shares, as specified in the warrants. To the extent the Warrant Shares are exercised by the
Lenders, existing stockholders ownership in the Company will be further diluted. In addition,
upon default of the March 2009 Loan the Lenders will have the right to declare the March 2010 Loan
due and payable upon sixty days notice.
Risks Related to the Companys Business
The Company is at an early stage of development. The Company has never generated and may never
generate revenues from commercial sales of its products and the Company may not have products to
market for several years, if ever.
Since its inception, the Company has dedicated substantially all its resources to the support
and conduct of research and development of compounds for clinical trials, and specifically, toward
the development of VIA-2291. Because none of the Companys current or potential products have been
finally approved by any regulatory authority, the Company currently has no products for commercial
sale and has not generated any revenues to date. The Company is considering its partnering
opportunities with large biotechnology or pharmaceutical companies in connection with its current
and future clinical trials and development activities. The Company does not expect to generate any
revenues until it successfully partners its current or future programs or until it receives final
regulatory approval and launches one of its products for sale.
The Company has conducted three Phase 2 clinical trials for VIA-2291: the CEA study, the ACS
study, and the FDG-PET study. Based on the data reported, and to be reported, from these three
studies, and subject to the receipt of substantial additional financing, the Company anticipates
initiating future clinical development activities with respect to VIA-2291 and is currently
evaluating various development alternatives, particularly strategic partnering opportunities. Such
clinical development activities may include one or more additional clinical trials designed to
further demonstrate that the drug can be safely administered following an acute coronary syndrome
event and link the mechanism of action of VIA-2291 to improved cardiac outcomes. The Company is
presently evaluating the design and strategy of additional clinical trials, which may take the form
of a Phase 2b trial, a Phase 3 registration trial or some combination thereof. Any future trials
will require regulatory approval and the failure to obtain such approval would have a material
adverse effect on the Companys business. Substantial additional investment in future clinical
trials will be required and will require significant time.
In December 2008, the Company entered into two license agreements with Roche to develop and
commercialize two sets of compounds (the Metabolic Compounds). The first license is for Roches
THR beta agonist, a clinically ready candidate for the control of cholesterol, triglyceride levels
and potential in insulin sensitization/diabetes. The second license is for multiple compounds from
Roches preclinical DGAT1 metabolic disorders program. If necessary financing is obtained either
through additional investment in the Company or through another vehicle, the Company intends to
enter into strategic arrangements to pursue preclinical and clinical development of the Metabolic
Compounds. There can be no assurance that the Company will be able to obtain such financing.
The Companys ability to generate product revenue will depend heavily on the successful
development and regulatory approval of VIA-2291, the Metabolic Compounds or any other product
candidates. The Company cannot guarantee that it will be successful in completing the remaining
Phase 2 trial or any subsequent clinical trials initiated for VIA-2291, or that it will be able to
obtain the necessary financing to initiate and/or complete clinical trials for VIA-2291, the
Metabolic Compounds or any other product candidates. The Company also cannot assure you that it
will be able to successfully negotiate a strategic collaboration with a large biotechnology or
pharmaceutical company with respect to VIA-2291 or otherwise finance the development of VIA-2291,
the Metabolic Compounds or any other product candidates. The Companys revenues, if any, will be
derived from products that the Company does not expect to be commercially available for several
years, if ever. The development of VIA-2291, the Metabolic Compounds or any other product
candidates may be discontinued at any stage of the clinical trial programs and the Company may
never generate revenue from any of its product candidates. Accordingly, there is no assurance
that the Company will ever generate revenues.
19
Clinical trials are expensive, difficult to design and implement, time-consuming and subject to
delay, particularly in the cardiovascular area due to the large number of patients who must be
enrolled and treated in clinical trials. As a result, there is a high risk that the Companys drug
development activities will not result in regulatory approval, or that such approval will be
delayed, thereby reducing the likelihood of successful commercialization of products.
Clinical trials are very expensive and difficult to design and implement. Conducting clinical
trials is a complex and uncertain process and involves screening, assessing, testing, treating and
monitoring patients at multiple sites, and coordinating with patients and clinical institutions.
This is especially true for trials related to the cardiovascular indications that the Company is
pursuing, in part because they require a large number of patients and because of the complexities
involved in using histology, measurement of biomarkers and medical imaging. The clinical trial
process is also time-consuming. For example, based on the clinical data reported from the CEA and
ACS Phase 2 clinical trials, as described under Business VIA-2291 Clinical Trial Results in
Part I, Item 1 above, and subject to the receipt of additional financing, the Company intends to
pursue strategic partnering opportunities with respect to future clinical development of VIA-2291.
Such clinical development activities may include one or more additional clinical trials designed to
further demonstrate that the drug can be safely administered following an acute coronary syndrome
event and link the mechanism of action of VIA-2291 to improved cardiac outcomes. The Company is
presently evaluating the design and strategy of additional clinical trials, which may take the form
of a Phase 2b trial, a Phase 3 registration trial or some combination thereof. The Company
currently expects that any additional trial would require the recruitment of a significant number
of patients, would require significant investment, and could require more than two years to
complete. The Company is unable to currently estimate the costs of additional trials, but industry
estimates for trials of cardiovascular drugs often exceed $200 million, and require in excess of
two years to complete. If the results of the additional clinical trials do not demonstrate a
statistically significant reduction of MACE, the Company would likely be required to conduct
additional clinical trials or narrow the labeling of its product based on results achieved, thereby
delaying or preventing the commercial launch of VIA-2291. In addition, subject to the receipt of
additional financing, the Company intends to pursue clinical development of the THR beta agonist
compound and preclinical development of the DGAT1 compounds licensed from Roche, each of which will
require significant spending and may require separate sources of funding. Until the Company can
generate a sufficient amount of revenue to finance its cash requirements, which the Company may
never do, it expects to finance future cash needs primarily through public or private equity
offerings, debt financings or strategic collaborations. Global market and economic conditions have
been, and continue to be, disrupted and volatile. Concern about the stability of the markets has
led many lenders and institutional investors to reduce, and in some cases, cease to provide credit
to businesses and consumers. To date the Company has been unsuccessful in securing additional
financing and may not be able to do so in the near term when needed, particularly in light of the
current economic environment, adverse conditions in the financial markets, and the Companys
inability to secure financing over the past two years other than through bridge financing from its
largest stockholder. Further, additional financing, if available, may not be obtained on terms
favorable to the Company or its stockholders.
The Companys DSMB reviewed safety data numerous times in connection with the CEA, ACS and
FDG-PET clinical trials and has recommended that studies continue as planned. Additional DSMB
reviews may be performed in connection with potential future clinical trials, and if the results of
the DSMB review are unfavorable, the Company may be required to modify or discontinue its clinical
trials of VIA-2291, thereby delaying or preventing completion of subsequent clinical trials, and
the commercial launch of VIA-2291.
The conduct of the Companys clinical trial activities, including analysis of the FDG-PET
trial, as well as the commencement and completion of any future clinical trial activities, could be
delayed, prevented or otherwise negatively impacted by several factors, including:
|
|
|
lack of adequate funding to continue the clinical development of VIA-2291 or to commence
the preclinical and clinical development of the Metabolic Compounds, including the
incurrence of unforeseen costs due to enrollment delays, requirements to conduct additional
trials and studies and increased expenses associated with the services of the Companys
clinical research organizations (CROs) and other third parties; |
|
|
|
failure to enter into strategic partnering transactions or other strategic arrangements
for the continued research and development of compounds for clinical trials; |
|
|
|
delays in obtaining regulatory approvals to commence a clinical trial; |
20
|
|
|
delays in identifying and reaching agreement on acceptable terms with prospective CROs
and clinical trial sites; |
|
|
|
delays in obtaining institutional review board approval to conduct a clinical trial at a
prospective site; |
|
|
|
slower than expected rates of patient recruitment and enrollment for a variety of
reasons, including competition from other clinical trial programs for the treatment of
similar indications, the nature of the protocol, and the eligibility criteria for the trial; |
|
|
|
enrolled patients may not remain in or complete clinical trials at the rates we expect; |
|
|
|
failure to obtain sufficient data from enrolled patients that can be used to evaluate
VIA-2291, thereby impairing the validity or statistical significance of our clinical trials; |
|
|
|
lack of effectiveness during clinical trials; |
|
|
|
failure to achieve clinical trial endpoints; |
|
|
|
unforeseen safety issues; |
|
|
|
uncertain dosing issues; |
|
|
|
changes in regulatory requirements causing the Company to amend clinical trial protocols
or add new clinical trials to comply with these changes; |
|
|
|
unforeseen difficulties developing the advanced manufacturing techniques, including
adequate process controls, quality controls, and quality assurance testing, required to
scale up production of the Companys product candidates to commercial levels; |
|
|
|
inability to monitor patients adequately during or after treatment; |
|
|
|
conflicting or negating results, upon further analysis of the data from the clinical
trials; |
|
|
|
retaining participants who have enrolled in a clinical trial but may be prone to withdraw
due to the design of the trial, lack of efficacy or personal issues or who fail to return
for follow-up visits for a variety of reasons; and |
|
|
|
inability or unwillingness of medical investigators to follow the Companys clinical
trial protocols and follow good clinical practices. |
The Company will not know whether the analysis of the FDG-PET clinical trial will end on time
and whether any future clinical trials, if any, will begin on time, need to be restructured or be
completed on schedule, if at all. Significant delays in clinical trials will impede the Companys
ability to commercialize its product candidates and generate revenue, and could significantly
increase its development costs, all of which could have a material adverse effect on the Companys
business.
Failure to timely recruit and enroll patients for any future clinical trials may cause the
development of the Companys product candidates to be delayed.
The Company may encounter delays if it is unable to timely recruit and enroll enough patients
to complete any future clinical trials. Clinical trial patient levels depend on many factors,
including the eligibility criteria for the trial, assumptions regarding the baseline disease state
and the impact of standard medical care, the size of the patient population, the nature of the
protocol, the proximity of patients to clinical sites, and competition from other clinical trial
programs for the treatment of similar indications. For example, although patient enrollment was
completed, the Company experienced slower than expected patient enrollment in its completed CEA
clinical trial. Any delays in planned patient enrollment in the future may result in increased
costs, delay or prevent regulatory approval or harm the Companys ability to develop and
commercialize current or future product candidates, including in collaboration with biotechnology
or pharmaceutical companies.
21
The Companys Phase 2 clinical trials of VIA-2291 primarily target biomarkers, histology and
medical imaging as endpoints, and the results of any Phase 2 clinical trials may not be indicative
of success in future clinical trials that will target outcomes such as
heart attack and stroke. The results of previous clinical trials may not be predictive of future
results, and the Companys current and future clinical trials may not satisfy the requirements of
the FDA or other non-U.S. regulatory authorities.
The clinical data collected during the (i) prior clinical trials involving VIA-2291 (formerly
known as ABT-761) conducted by Abbott prior to the licensing of VIA-2291 from Abbott in August
2005, and (ii) the CEA, ACS, ACS MDCT sub-study and FDG-PET clinical trials for VIA-2291, do not
provide evidence of whether VIA-2291 will prove to be an effective treatment to reduce the rate of
MACE in the prospective treatment population. In order to prove or disprove the validity of the
Companys assumption about the efficacy of VIA-2291, at least one additional clinical trial will
need to be conducted which may include a Phase 2b or Phase 3 clinical trial and which may be 12 to
36 months in duration from the recruitment of the first patient, although this time may increase
due to unforeseen circumstances. Such additional clinical trials must ultimately demonstrate that
there is a statistically significant reduction in the number of MACE in patients treated with
VIA-2291 compared to patients taking a placebo. Until data from one or more of these outcome
clinical trials can be collected and analyzed, the Company will not know whether VIA-2291 shows
clinically significant benefits.
Results of the CEA and ACS clinical trials as described under Business VIA-2291 Clinical
Trial Results in Part I, Item 1 above are based on a very limited number of patients and may, upon
review and further analysis, be revised, interpreted differently by regulatory authorities or
negated by later stage clinical results. For instance, we believe the results of the CEA and ACS
clinical trials support further clinical development of VIA-2291 in larger outcome trials based on
the fact both trials achieved nearly every key endpoint, although the CEA trial missed its primary
endpoint. The results from preclinical testing and Phase 2 clinical trials often have not been
predictive of results obtained in later trials. A number of new drugs and therapeutics have shown
promising results in initial clinical trials, but later-stage trials may fail to establish
sufficient safety and efficacy data to obtain necessary regulatory approvals. Negative or
inconclusive results, or adverse medical events during a clinical trial, could cause the
termination of a clinical trial or require it to be repeated or a whole new clinical trial
conducted. Data obtained from preclinical and clinical studies are subject to varying
interpretations, which may delay, limit or prevent regulatory approval.
The Companys Phase 2 FDG-PET clinical trial utilizes new, innovative imaging technology that does
not represent a widely accepted and validated clinical trial methodology for measuring
inflammation in atherosclerosis. The results of this clinical trial may not be predictive of
future results and may not be consistent with the results of the CEA and ACS clinical trials, the
ACS MDCT sub-study or future clinical trials.
FDG-PET is a new, innovative imaging technology that does not represent a widely accepted and
validated clinical trial methodology for measuring atherosclerotic plaque inflammation. The last
patient in the FDG-PET Phase 2 clinical trial was reported in December 2009 and completion of data
analysis and reporting of clinical trial results are anticipated in the first half of 2010. If the
results from this clinical trial are unfavorable, the Company may be delayed or prevented from
completing subsequent clinical trials related to VIA-2291 or from commercially launching VIA-2291.
In addition, the results of this clinical trial may not be predictive of future results and may not
be consistent with results from the CEA or ACS clinical trials or the ACS MDCT sub-study, which may
delay or prevent regulatory approval of VIA-2291, may harm the Companys ability to develop and
commercialize VIA-2291, and may negatively impact the Companys ability to raise additional capital
in the future.
The Companys clinical trials could be delayed, suspended or stopped.
The Company will not know whether future clinical trials, if any, will begin on time or
whether it will complete any of its ongoing clinical trials on schedule or at all. Product
development costs to the Company and potential future collaborators or strategic partners will
increase if the Company has delays in testing or approvals, or if the Company needs to perform more
or larger clinical trials than planned. Significant delays, suspension or termination of clinical
trials would adversely affect the Companys financial results and the commercial prospects for the
Companys products, and would delay or prevent the Company from achieving profitable operations.
The Company relies on third parties to conduct its clinical trials. If these third parties do not
successfully carry out their contractual duties or meet expected deadlines, the Company may be
unable to obtain, or may experience delays in obtaining, regulatory approval, or may not be
successful in commercializing the Companys planned and future products.
The Company enters into master service agreements with third-party CROs and relied primarily
on CROs to oversee its Phase 2 clinical trials for VIA-2291, and depends on independent clinical
investigators, medical institutions and contract laboratories to conduct its clinical trials.
Similarly, the Company intends to rely on CROs to oversee any additional clinical trials for
VIA-2291 and will depend on independent clinical investigators, medical institutions and contract
laboratories to conduct these clinical trials, whether in the form of a Phase 2b trial, a Phase 3
registration trial or some combination thereof. The
22
Company
remains responsible, however, for ensuring that each of its clinical trials is conducted in accordance with the
general investigational plan and protocols for the trial. Moreover, the FDA requires the Company to
comply with standards, commonly referred to as Good Clinical Practices, for conducting, recording
and reporting the results of clinical trials to assure that data and reported results are credible
and accurate and that the rights, integrity and confidentiality of trial participants are
protected. The Companys reliance on third parties that it does not control does not relieve it of
these responsibilities and requirements. If the Companys CROs or independent investigators fail to
devote sufficient time and resources to the Companys drug development programs, if they are unable
or unwilling to follow the Companys clinical protocols, or if their performance is substandard,
our clinical trials may not meet regulatory requirements. If our clinical trials do not meet
regulatory requirements or if these third parties need to be replaced, our clinical trials may be
extended, delayed, suspended or terminated. If any of these events occurs, the clinical development
costs for the Companys product candidates would be expected to rise and the Company may not be
able to obtain regulatory approval or commercialize its product candidates.
The Company will need to provide additional information to the FDA regarding preclinical and
clinical safety issues raised during prior trials of VIA-2291 that could result in delays in
future FDA approvals.
During preclinical animal testing and clinical trials of ABT-761 (now VIA-2291) conducted by
Abbott, safety issues with regards to tumors in animals and higher incidence of liver function
abnormality in clinical trials in humans were identified. The liver function abnormalities were
demonstrated to be reversible with discontinuance of the drug in Abbotts trials. The FDA requested
that the Company provide additional materials and information regarding the incidence of tumors in
animals. As described under Business VIA-2291 in Part I, Item 1 above, lower doses of the drug
may reduce these safety concerns. In the ACS clinical trial, the Company did see generally mild,
reversible elevations of normal liver enzymes in the low dose VIA-2291 treated group, but no
elevations in the higher dose drug-treated groups. Safety issues could delay the FDAs approval of
any Phase 2b and/or Phase 3 clinical trial, which could have a material adverse effect on the
Companys business.
VIA-2291 is the Companys only product candidate currently in clinical trials. The Companys
efforts to identify, develop and commercialize new product candidates beyond VIA-2291 will be at
an early stage and will be subject to a high risk of failure.
The Companys product candidates are in various stages of development and are prone to the
risks of failure inherent in drug development. The Company will need to complete significant
additional clinical trials before it can demonstrate that its product candidates are safe and
effective to the satisfaction of the FDA and other non-U.S. regulatory authorities. Clinical trials
are expensive and uncertain processes that take years to complete. Failure can occur at any stage
of the process, and successful early clinical trials do not ensure that later clinical trials will
be successful. Current and future preclinical products have increased risk as there is no assurance
that products will be identified that will qualify for, and be successful in, clinical trials.
Furthermore, the Company may expend significant resources on research or target compounds that
ultimately do not qualify for, or are not successful in, clinical trials. For example, in December
2008 the Company entered into two license agreements with Roche to develop and commercialize the
Metabolic Compounds for up to $22.8 million in upfront and milestone payments with potential
royalty payments in the future. If necessary financing is obtained, the Company intends to pursue
preclinical and clinical development of these compounds. There can be no assurance that the
Company will successfully develop and commercialize products containing these compounds. Product
candidates may fail to show desired efficacy and safety traits despite having progressed through
initial clinical trials. A number of companies in the biotechnology and pharmaceutical industries
have suffered significant setbacks in advanced clinical trials where costs of clinical trials are
significant, even after obtaining promising results in earlier trials. In addition, a clinical
trial may prove successful with respect to a secondary endpoint, but fail to demonstrate clinically
significant benefits with respect to a primary endpoint. Failure to satisfy a primary endpoint in a
Phase 2b and/or Phase 3 clinical trial would generally mean that a product candidate would not
receive regulatory approval without a subsequent successful Phase 2b and/or Phase 3 clinical trial
which the Company may not be able to fund, and may be unable to complete.
If the Company is unable to form and maintain the collaborative relationships that its business
strategy requires, its product development programs will suffer, and the Company may not be able
to develop or commercialize its product candidates and may ultimately have to cease operations.
A key element of the Companys business strategy with regard to the development and
commercialization of VIA-2291 includes collaboration with third parties, particularly leading
biotechnology and pharmaceutical companies. If necessary financing is obtained, the Company plans
to pursue partnering opportunities with biotechnology and pharmaceutical companies to conduct
additional clinical trials required for regulatory approval of VIA-2291. Subject to the receipt of
additional financing, the Company expects to consider further collaborations for the development
and commercialization of its product candidates in the future. The timing and terms of any
collaboration will depend on the evaluation by prospective collaborators of the Companys clinical
trial results and other aspects of the safety and efficacy profiles of its product candidates. If
the Company is
23
unable
to reach agreements with suitable collaborators for any product candidate, it would be forced to fund the entire development and
commercialization of such product candidate, and the Company currently does not have the resources
to do so. Even if the Company is able to reach an agreement with a suitable collaborator, the
Company may be forced to fund a significant portion of the development and commercialization
expenses, and the Company currently does not have the resources to do so. Additionally, if
resource constraints require the Company to enter into a collaboration early in the development of
a product candidate, the Company may be forced to accept a more limited share of any revenues such
product may eventually generate. The Company faces significant competition in seeking appropriate
collaborators. Moreover, these collaboration arrangements are complex and time-consuming to
negotiate and document. The Company may not be successful in its efforts to establish
collaborations or other alternative arrangements for any product candidate, may be unable to raise
required capital to fund clinical trials, and therefore, may be unable to continue operations.
Even if the Company receives regulatory approval to market VIA-2291 and its other product
candidates, such products may not gain the market acceptance among physicians, patients,
healthcare payors and the medical community.
Any products, including VIA-2291, that the Company may develop may not gain market acceptance
among physicians, patients, healthcare payors and the medical community even if they ultimately
receive regulatory approval. If these products do not achieve an adequate level of acceptance, the
Company, or future collaborators, may not be able to generate material product revenues and the
Company may not become profitable. The degree of market acceptance of any of the Companys product
candidates, if approved for commercial sale, will depend on a number of factors, including:
|
|
|
demonstration of efficacy and safety in clinical trials; |
|
|
|
the prevalence and severity of any side effects; |
|
|
|
the introduction and availability of generic substitutes for any of the Companys
products, potentially at lower prices (which, in turn, will depend on the strength of the
Companys intellectual property protection for such products); |
|
|
|
potential or perceived advantages over alternative treatments; |
|
|
|
the timing of market entry relative to competitive treatments; |
|
|
|
the ability to offer the Companys product candidates for sale at competitive prices; |
|
|
|
relative convenience and ease of administration; |
|
|
|
the strength of marketing and distribution support; |
|
|
|
sufficient third party coverage or reimbursement; and |
|
|
|
the product labeling or product insert (including any warnings) required by the FDA or
regulatory authorities in other countries. |
The Company will rely on third parties to manufacture and supply its product candidates.
The Company does not own or operate manufacturing facilities for clinical or commercial
production of product candidates. The Company will not have any experience in drug formulation or
manufacturing, and it will lack the resources and the capability to manufacture any of the
Companys product candidates on a clinical or commercial scale. The Company expects to depend on
third-party contract manufacturers for the foreseeable future. Any performance failure on the part
of the Companys contract manufacturers could delay clinical development, regulatory approval or
commercialization of the Companys current or future product candidates, depriving the Company of
potential product revenue and resulting in additional losses.
The manufacture of pharmaceutical products requires significant expertise and capital
investment, including the development of advanced manufacturing techniques and process controls.
Manufacturers of pharmaceutical products often encounter difficulties in production, particularly
in scaling up initial production. These problems include difficulties with production costs and
yields, quality control (including stability of the product candidate and quality assurance
testing), shortages of qualified personnel, as well as compliance with strictly enforced federal,
state and foreign regulations. If the Companys third-party contract manufacturers were to
encounter any of these difficulties or otherwise fail to comply with their obligations to the
Company or under applicable regulations, the Companys ability to provide product candidates to
patients in its clinical trials would be jeopardized. Any delay or interruption in
the supply of clinical trial supplies could delay the completion of the Companys clinical
trials, increase the costs associated with maintaining its clinical trial program and, depending
upon the period of delay, require the Company to commence new trials at significant additional
expense or terminate the trials completely.
24
The Company may be subject to costly claims related to its clinical trials and may not be able to
obtain adequate insurance.
Because the Company currently conducts clinical trials in humans, it faces the risk that the
use of its current or future product candidates will result in adverse side effects. During
preclinical animal testing and clinical trials of ABT-761 (now VIA-2291) conducted by Abbott,
safety issues with regard to tumors in animals and higher incidence of liver function abnormality
in clinical trials in humans were identified. The liver function abnormalities were demonstrated to
be reversible with discontinuance of the drug in Abbotts trials. As described under Business
VIA-2291 in Part I, Item 1 above, lower doses of the drug may reduce these safety concerns.
Although the Company currently has, and intends to maintain, clinical trial liability insurance for
up to $10.0 million, such insurance may be insufficient to cover any such adverse events. The
Company does not know whether it will be able to continue to obtain clinical trial coverage on
acceptable terms, or at all. The Company may not have sufficient resources to pay for any
liabilities resulting from a claim excluded from, or beyond the limit of, its insurance coverage.
There is also a risk that third parties, which the Company has agreed to indemnify, could incur
liability. Any litigation arising from the Companys clinical trials, even if the Company is
ultimately successful in its defense, would consume substantial amounts of its financial and
managerial resources and may create adverse publicity, which may result in significant damages and
may adversely impact the Companys ability to raise required capital or continue operations.
The Company may be subject to costly claims related to Corautus former clinical trials of
Vascular Endothelial Growth Factor 2.
Prior to November 1, 2006, Corautus was the sponsor of a Phase 2b clinical trial to study the
efficacy of VEGF-2 for the treatment of severe cardiovascular disease, known as the GENASIS trial.
In addition, Corautus supported initial clinical trials studying the efficacy of VEGF-2 for the
treatment of peripheral artery disease and diabetic neuropathy. On April 10, 2006, Corautus
announced the termination of enrollment in the GENASIS trial.
The Company has and intends to maintain, clinical trial liability insurance for up to
$10.0 million. Insurance may not adequately cover any such claims and if not, such claims may have
a material adverse effect on the Companys business, financial condition and results of operations.
Such insurance may be insufficient to cover any claims unrelated to the GENASIS trial. The Company
does not know whether it will be able to continue to obtain clinical trial coverage on acceptable
terms, or at all. The Company may not have sufficient resources to pay for any liabilities
resulting from a claim excluded from, or beyond the limit of, its insurance coverage. There is also
a risk that third parties, which the Company has agreed to indemnify, could incur liability, and
the Company may be required to reimburse such third parties for such liability if required pursuant
to these indemnification arrangements.
For example, on July 17, 2007, the Company received a letter requesting indemnification from
the Company of approximately $1.3 million of legal costs incurred by Tailored Risk Assurance
Company, Ltd. in defending Caritas St. Elizabeths Medical Center of Boston, Inc. (CSEMC) and
several physician co-defendants in the matter of Susan Darke, Individually, and as Executrix of the
Estate of Roger J. Darke v. Caritas St. Elizabeths Medical Center of Boston, Inc., et al. (Suffolk
Superior Court, Boston, Massachusetts). Vascular Genetics Inc. (VGI), the Companys wholly-owned
subsidiary, was also a defendant in the litigation, but was dismissed from the litigation in March
2007 after entering into a settlement agreement with the plaintiffs. The letter alleged that the
Company, as a successor to Corautus Genetics Inc., was required to indemnify CSEMC pursuant to a
License Agreement, dated October 31, 1997, between CSEMC and VGI. In August 2008, the parties
reached a settlement. The Companys insurance carrier covered the entire settlement payment. The
Company, VGI and the insurance carrier obtained a release of liabilities in connection with the
settlement.
Any cost required to be paid out by the Company or any litigation arising from these
terminated clinical trials, even if the Company is ultimately successful in its defense, would
consume substantial amounts of its financial and managerial resources and may create adverse
publicity, which may result in significant damages and may adversely impact the Companys ability
to raise required capital or adversely affect the Companys business, financial condition or
results of operations.
25
If the Company is unable to retain its management, research, development, clinical teams and
scientific advisors or to attract additional qualified personnel, the Companys product operations
and development efforts may be seriously jeopardized.
As described in Other Information in Part II, Item 9B and in Note 12 in the Notes to the
Financial Statements, the Companys current financial constraints has caused and may further cause
the loss of the services of principal members of our management and research, development and
clinical teams which could negatively impact our ability to operate, obtain necessary financing, or
pursue strategic partnering opportunities. The employment agreement for Dr. Lawrence K. Cohen, the
Companys Chief Executive Officer, provides that his employment is terminable at will at any time
with or without cause or notice by either the Company or Dr. Cohen. The employment agreement for
Dr. Rebecca Taub, the Companys Sr. Vice President, Research & Development, is terminable at will
at any time with or without cause or notice by either the Company or Dr. Taub. Competition among
biotechnology companies for qualified employees is intense, and the ability to retain and attract
qualified individuals is critical to the Companys success. The Company may be unable to attract
and retain key personnel on acceptable terms, if at all. The Company does not maintain key person
life insurance on any of its officers, employees or consultants.
The Company has relationships with consultants and scientific advisors who will continue to
assist the Company in formulating and executing its research, development, regulatory and clinical
strategies. The Companys consulting agreements typically have provisions for hourly billing,
non-disclosure of confidential information, and the assignment to the Company of any inventions
developed within the scope of services to the Company. The consulting and scientific advisory
agreements are typically terminable by either party on 30 days or shorter notice. These consultants
and scientific advisors are not the Companys employees and may have commitments to, or consulting
or advisory contracts with, other entities that may limit their availability to the Company. The
Company will have only limited control over the activities of these consultants and scientific
advisors and can generally expect these individuals to devote only limited time to the Companys
activities. The Company relies heavily on these consultants to perform critical functions in key
areas of its operations. The Company also relies on these consultants to evaluate potential
compounds and products, which may be important in developing a long-term product pipeline for the
Company. Consultants also assist the Company in preparing and submitting regulatory filings. The
Companys scientific advisors provide scientific and technical guidance on cardiovascular drug
discovery and development. The loss of service of any or all of these consultants may further
impact our ability to operate or obtain additional financing needed in the near term. Failure of
any of these persons to devote sufficient time and resources to the Companys programs could harm
its business. In addition, these advisors may have arrangements with other companies to assist
those companies in developing technologies that may compete with the Companys products.
If the Companys competitors develop and market products that are more effective than the
Companys product candidates or others it may develop, or obtain regulatory and marketing approval
for similar products before the Company does, the Companys commercial opportunity may be reduced
or eliminated.
The development and commercialization of new pharmaceutical products that target
cardiovascular and metabolic disease is competitive, and the Company will face competition from
numerous sources, including major biotechnology and pharmaceutical companies worldwide. Many of the
Companys competitors have substantially greater financial and technical resources, and
development, production and marketing capabilities than the Company does. In addition, many of
these companies have more experience than the Company in preclinical testing, clinical trials and
manufacturing of compounds, as well as in obtaining FDA and foreign regulatory approvals. The
Company will also compete with academic institutions, governmental agencies and private
organizations that are conducting research in the same fields. Competition among these entities to
recruit and retain highly qualified scientific, technical and professional personnel and
consultants is also intense. As a result, there is a risk that one of the competitors of the
Company will develop a more effective product for the same indication for which the Company is
developing a product or, alternatively, bring a similar product to market before the Company can do
so. Failure of the Company to successfully compete will adversely impact the ability to raise
additional capital and continue operations.
The Company may be subject to damages resulting from claims that the Company or its employees,
have wrongfully used or disclosed alleged trade secrets of its employees former employers.
Many of the Companys employees were previously employed at biotechnology or pharmaceutical
companies, including the Companys competitors or potential competitors. Although the Company has
not received any claim to date, it may be subject to claims that these employees or the Company
have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of
such employees former employers. Litigation may be necessary to defend against these claims. If
the Company fails in defending such claims, in addition to paying monetary damages, the Company may
lose valuable intellectual property rights or personnel or may be unsuccessful in identifying,
developing or commercializing current or future products.
26
Risks Related to the Companys Intellectual Property
The Companys failure to protect adequately or to enforce its intellectual property rights or
secure rights to third party patents could materially harm its proprietary position in the
marketplace or prevent the commercialization of its products.
The Companys success will depend in large part on its ability to obtain and maintain
protection in the United States and other countries for the intellectual property covering or
incorporated into its technologies and products. The patents and patent applications in the
Companys existing patent portfolio are either owned by the Company or licensed to the Company. The
Companys ability to protect its product candidates from unauthorized use or infringement by third
parties depends substantially on its ability to obtain and maintain valid and enforceable patents.
Due to evolving legal standards relating to the patentability, validity and enforceability of
patents covering pharmaceutical inventions and the scope of claims made under these patents, the
Companys ability to obtain and enforce patents is uncertain and involves complex legal and factual
questions for which important legal principles are unresolved.
The Company may not be able to obtain patent rights on products, treatment methods or
manufacturing processes that it may develop or to which the Company may obtain license or other
rights. Even if the Company does obtain patents, rights under any issued patents may not provide it
with sufficient protection for the Companys product candidates or provide sufficient protection to
afford the Company a commercial advantage against its competitors or their competitive products or
processes. It is possible that no patents will be issued from any pending or future patent
applications owned by the Company or licensed to the Company. Others may challenge, seek to
invalidate, infringe or circumvent any patents the Company owns or licenses. Alternatively, the
Company may in the future be required to initiate litigation against third parties to enforce its
intellectual property rights. The cost of this litigation could be substantial and the Companys
efforts could be unsuccessful. Changes in patent laws or in interpretations of patent laws in the
United States and other countries may diminish the value of the Companys intellectual property or
narrow the scope of the Companys patent protection.
The Companys patents also may not afford protection against competitors with similar
technology. The Company may not have identified all patents, published applications or published
literature that affect its business either by blocking the Companys ability to commercialize its
product candidates, by preventing the patentability of its products or by covering the same or
similar technologies that may affect the Companys ability to market or license its product
candidates. For example, patent applications filed with the United States Patent and Trademark
Office (USPTO) are maintained in confidence for up to 18 months after their filing. In some
cases, however, patent applications filed with the USPTO remain confidential for the entire time
prior to issuance as a U.S. patent. Patent applications filed in countries outside the United
States are not typically published until at least 18 months from their first filing date.
Similarly, publication of discoveries in the scientific or patent literature often lags behind
actual discoveries. Therefore, the Company or its licensors might not have been the first to
invent, or the first to file, patent applications on the Companys product candidates or for their
use. The laws of some foreign jurisdictions do not protect intellectual property rights to the same
extent as in the United States and many companies have encountered significant difficulties in
protecting and defending these rights in foreign jurisdictions. If the Company encounters such
difficulties in protecting or is otherwise precluded from effectively protecting its intellectual
property rights in either the United States or foreign jurisdictions, the Companys business
prospects could be substantially harmed.
Because VIA-2291 is exclusively licensed from Abbott and the Metabolic Compounds are exclusively
licensed from Roche, any dispute with Abbott or Roche, respectively, may materially harm the
Companys ability to develop and commercialize VIA-2291 or the Metabolic Compounds, as applicable.
In August 2005, the Company licensed exclusive worldwide rights to its product candidate,
VIA-2291, from Abbott (the Abbott License) and in 2008, Company entered into two license
agreements (the Roche Licenses) with Roche to develop and commercialize the Metabolic Compounds.
The Company does not have, nor has the Company ever had, any material disputes with Abbott or Roche
regarding the Abbott License or the Roche Licenses. However, if there is any future dispute between
the Company and Abbott regarding the parties rights under the Abbott License agreement, the
Companys ability to develop and commercialize VIA-2291 may be materially harmed. Any uncured,
material breach under the Abbott License could result in the Companys loss of exclusive rights to
VIA-2291 and may lead to a complete termination of the Abbott License and force the Company to
cease product development efforts for VIA-2291. Similarly, if there is any future dispute between
the Company and Roche regarding the parties rights under the Roche License agreements, the
Companys ability to develop and commercialize the Metabolic Compounds may be materially harmed.
Any uncured, material breach under the Roche License agreements could result in the Companys loss
of exclusive rights to Metabolic Compounds and may lead to a complete termination of the Roche
License agreements and force the Company to cease product development efforts for the Metabolic
Compounds.
27
If Abbott or Roche elect to maintain or enforce proprietary rights under the Abbott License or the
Roche Licenses, respectively, the Company will depend on Abbott or Roche, as applicable, for the
maintenance and enforcement of certain intellectual
property rights and will have limited control, if any, over the amount or timing of resources that
Abbott or Roche devote on the Companys behalf.
The Company depends on Abbott to protect certain proprietary rights covering VIA-2291 and
Roche to protect certain proprietary rights covering THR beta agonist (the VIA Rights) pursuant
to the terms of the Abbott License and the Roche Licenses, respectively. Abbott and Roche are
responsible for maintaining certain issued patents and prosecuting certain patent applications.
Abbott and Roche are also responsible for seeking to obtain all available extensions or
restorations of the VIA Rights. Although the Company has limited, if any, control over the amount
or timing of resources that Abbott or Roche devote or the priority they place on maintaining these
certain patent rights to the Companys advantage, the Company expects Abbott and Roche to comply
with its respective obligations pursuant to the Abbott License and the Roche Licenses and devote
resources accordingly. However, if Abbott or Roche decide to no longer maintain any of the patents
licensed under the Abbott License or the Roche Licenses, they are required to afford the Company
the opportunity to do so at the Companys expense. If Abbott or Roche elect not to maintain any of
these certain licensed patents and if the Company does not assume the maintenance of these certain
licensed patents in sufficient time to make required payments or filings with the appropriate
governmental agencies, the Company risks losing the benefit of all or some of the VIA Rights.
While the Company currently intends to take actions reasonably necessary to enforce its patent
rights, such enforcement depends, in part, on Abbott and Roche, respectively, to protect the VIA
Rights. Abbott and Roche each have the first right to bring and pursue a third-party infringement
action related to the VIA Rights. The Company has the right to cooperate with Abbott and Roche in
third-party infringement suits involving the VIA Rights. If Abbott or Roche decline to prosecute a
claim, the Company will have the right but not the obligation to bring suit and/or pursue any such
infringement action as it determines, in its discretion, to be appropriate.
Abbott, Roche, and the Company may also be notified of alleged infringement and be sued for
infringement of third-party patents or other proprietary rights related to the VIA Rights. Abbott
has the right but not the obligation to defend and control the defense of an alleged third-party
patent infringement claim or suit asserting that VIA-2291 infringes third-party patent rights
directed to the composition of matter or the use of VIA-2291 in the treatment and/or prevention of
diseases in humans, if Abbott is made a party to such suit. If Abbott so elects, the Company may
have limited, if any, control or involvement over the defense of these claims, and Abbott and the
Company could be subject to injunctions and temporary or permanent exclusionary orders in the
United States or other countries. The Company has the sole responsibility to defend and control the
defense of all other claims of infringement by a third party. If Abbott elects not to defend a
claim it has the first right to defend against, or if the claim is one that the Company has the
responsibility to defend against, Abbott is required to reasonably assist the Company in its
defense. Roche has the right but not the obligation to defend and control the defense of an alleged
third-party patent infringement claim or suit against the Metabolic Compounds in which the Company
has indemnification rights under the Roche Licenses. The Company has limited, if any, control over
the amount or timing of resources, if any, that Abbott or Roche devote, or the priority Abbott or
Roche place on the defense of such third-party claims of infringement.
If the Company fails to comply with its obligations and meet certain milestones related to its
intellectual property licenses with third parties, the Company could lose license rights that are
important to its business.
The Companys commercial success depends on not infringing the patents and proprietary rights
of other parties and not breaching any collaboration, license or other agreements that the Company
has entered into with regard to its technologies and product candidates. For example, the Company
entered into a license agreement with Abbott pursuant to which the Company is required to use
commercially reasonable efforts, at its own expense, to (a) initiate and complete the clinical
development of VIA-2291, (b) obtain all required regulatory approvals in major markets, and
(c) obtain and carry out subsequent worldwide marketing, distribution and sale of VIA-2291 in such
major markets. Prior to the first commercial sale of VIA-2291, the Company is required to furnish
Abbott with an annual written report summarizing the progress of its efforts to implement the
preclinical/clinical development plan.
In December 2008, the Company entered into the Roche Licenses to develop and commercialize the
Metabolic Compounds. The Company must use commercially reasonable efforts to conduct preclinical,
clinical and commercial development programs for products containing the Metabolic Compounds. If
the Company has not completed a Phase I clinical trial with respect to a lead product containing
the THR beta agonist compound by January 5, 2012, the Company either must commit to developing
another of Roches compounds or Roche may terminate the license for that compound. If the Company
determines that it is not reasonable to continue clinical trials or other development of the
compounds, it may elect to cease further development and Roche may terminate the licenses. If the
Company determines not to pursue the development or commercialization of the compounds in the
United States, Japan, the United Kingdom, Germany, France, Spain or Italy, Roche may terminate the
licenses solely for such territories.
28
Third parties may own or control intellectual property that the Company may infringe.
If a third party asserts that the Company infringes such third partys patents, copyrights,
trademarks, trade secrets or other proprietary rights, the Company could face a number of issues
that could seriously harm the Companys competitive position, including:
|
|
|
infringement and other intellectual property claims, which would be costly and
time-consuming to litigate, whether or not the claims have merit, and which could delay the
regulatory approval process and divert managements attention from the Companys business; |
|
|
|
substantial damages for past infringement, which the Company may have to pay if a court
determines that the Company has infringed a third partys patents, copyrights, trademarks,
trade secrets or other proprietary rights; |
|
|
|
a court prohibiting the Company from selling or licensing its technologies or future
products unless such third party licenses its patents, copyrights, trademarks, trade secrets
or other proprietary rights to the Company, which it is not required to do; and |
|
|
|
if a license is available from a third party, the requirement that the Company pay
substantial royalties or grant cross licenses to its patents, copyrights, trademarks, trade
secrets or other proprietary rights. |
The Companys commercial success will depend in part on its ability to manufacture, use, sell and
offer to sell its products without infringing patents or other proprietary rights of others.
The Company may not be aware of all patents or patent applications that potentially impact its
ability to manufacture (or have manufactured by a third party), use or sell any of its product
candidates or proposed product candidates. For example, patent applications are filed with the
USPTO but not published until 18 months after their effective filing date. Further, the Company may
not be aware of published or granted conflicting patent rights. Any conflicts resulting from other
patent applications and patents of third parties could significantly reduce the coverage of the
Companys patents and limit the Companys ability to obtain meaningful patent protection. If others
obtain patents with conflicting claims, the Company may be required to obtain licenses to these
patents or to develop or obtain alternative technology. The Company may not be able to obtain any
licenses or other rights to patents, technology or know-how necessary to conduct the Companys
business. Any failure to obtain such licenses or other rights could delay or prevent the Company
from developing or commercializing its product candidates and proposed product candidates, which
could materially affect the Companys business.
Additionally, litigation or patent interference proceedings may be necessary to enforce any of
the Companys patents or other proprietary rights, or to determine the scope and validity or
enforceability of the proprietary rights of others. The defense and prosecution of patent and
intellectual property claims are both costly and time consuming, even if the outcome is favorable
to the Company. Any adverse outcome could subject the Company to significant liabilities, require
the Company to license disputed rights from others, or require the Company to cease selling its
future products.
Risks Related to the Companys Industry
The Companys product candidates are subject to extensive regulation, which can be costly and
time-consuming, cause unanticipated delays or prevent the receipt of the required approvals to
commercialize such product candidates.
The Company is subject to extensive and rigorous government regulation in the United States
and foreign countries. The research, testing, manufacturing, labeling, approval, sale, marketing
and distribution of drug products are subject to extensive regulation by the FDA and other
regulatory authorities in foreign jurisdictions, which regulations differ from jurisdiction to
jurisdiction. The Company will not be permitted to market its product candidates in the United
States until it receives approval of an NDA from the FDA, or in any foreign jurisdiction until the
Company receives the requisite approval from the applicable regulatory authorities in such
jurisdiction. The Company has not submitted an NDA or received marketing approval for VIA-2291 or
any of its other product candidates in the United States or any foreign jurisdiction. Obtaining
approval of an NDA is a lengthy, expensive and uncertain process. The FDA also has substantial
discretion in the drug approval process, including the ability to delay, limit, condition or deny
approval of a product candidate for many reasons. For example:
|
|
|
the FDA may not deem a product candidate safe and effective; |
|
|
|
the FDA may not find the data from preclinical studies and clinical trials sufficient to
support approval; |
29
|
|
|
the FDA may not approve of the Companys third-party manufacturers processes and
facilities; |
|
|
|
the FDA may change its approval policies or adopt new regulations; or |
|
|
|
the FDA may condition approval on additional clinical studies, including post-approval
clinical studies. |
These requirements vary widely from jurisdiction to jurisdiction and make it difficult to
estimate when the Companys product candidates will be commercially available, if at all. If the
Company is delayed or fails to obtain required approvals for its product candidates, the Companys
operations and financial condition would be damaged.
The process of obtaining these approvals is expensive, often takes many years, and can vary
substantially based upon the type, complexity and novelty of the products involved. Approval
policies or regulatory requirements may change in the future and may require the Company to
resubmit its clinical trial protocols to institutional review boards for re-examination, which may
impact the costs, timing or successful completion of a clinical trial. In addition, although
members of the Companys management have drug development and regulatory experience, as a company,
it has not previously filed the applications necessary to gain regulatory approvals for any
product. This lack of experience may impede the Companys ability to obtain regulatory approval in
a timely manner, if at all, for its product candidates for which development and commercialization
is the Companys responsibility. The Company will not be able to commercialize its product
candidates in the United States until it obtains FDA approval and in other jurisdictions until it
obtains approval by comparable governmental authorities. Any delay in obtaining, or inability to
obtain, these approvals would prevent the Company from commercializing its product candidates and
the Companys ability to generate revenue will be delayed.
Even if any of the Companys product candidates receives regulatory approval, it may still face
future development and regulatory difficulties.
Even if U.S. regulatory approval is obtained, the FDA may still impose significant
restrictions on a products indicated uses or marketing or impose ongoing requirements for
potentially costly post-approval studies. The Companys product candidates will also be subject to
ongoing FDA requirements governing the labeling, packaging, storage, advertising, promotion,
recordkeeping and submission of safety and other post-marketing information. In addition,
manufacturers of drug products and their facilities are subject to continual review and periodic
inspections by the FDA and other regulatory authorities for compliance with current good
manufacturing practices. If the Company or a regulatory agency discovers problems with a product,
such as adverse events of unanticipated severity or frequency, or problems with the facility where
the product is manufactured, a regulatory agency may impose restrictions on that product, the
manufacturer or the Company, including requiring withdrawal of the product from the market or
suspension of manufacturing. If the Company or the manufacturing facilities for the Companys
product candidates fail to comply with applicable regulatory requirements, a regulatory agency may:
|
|
|
issue warning letters or untitled letters; |
|
|
|
impose civil or criminal penalties; |
|
|
|
suspend regulatory approval; |
|
|
|
suspend any ongoing clinical trials; |
|
|
|
refuse to approve pending applications or supplements to approved applications filed by
the Company or its collaborators; |
|
|
|
impose restrictions on operations, including costly new manufacturing requirements; or |
|
|
|
seize or detain products or require a product recall. |
The FDA and other regulatory agencies actively enforce regulations prohibiting the promotion
of a drug for a use that has not been cleared or approved by the FDA. Use of a drug outside its
cleared or approved indications is known as off-label use. Physicians may use the Companys
products for off-label uses, as the FDA does not restrict or regulate a physicians choice of
treatment within the practice of medicine. However, if the FDA or another regulatory agency
determines that the Companys promotional materials or training constitutes promotion of an
off-label use; it could request that the Company modify its training or promotional materials or
subject the Company to regulatory enforcement actions, including the issuance of a warning
letter, injunction, seizure, civil fine and criminal penalties.
30
In order to market any products outside of the United States, the Company and its
collaborators must establish and comply with numerous and varying regulatory requirements of other
countries regarding safety and efficacy. Approval procedures vary among jurisdictions and can
involve additional product testing and additional administrative review periods. The time required
to obtain approval in other jurisdictions might differ from that required to obtain FDA approval.
The regulatory approval process in other jurisdictions may include all of the risks detailed above
regarding FDA approval in the United States. Regulatory approval in one jurisdiction does not
ensure regulatory approval in another, but a failure or delay in obtaining regulatory approval in
one jurisdiction may negatively impact the regulatory process in others. Failure to obtain
regulatory approval in other jurisdictions or any delay or setback in obtaining such approval could
have the same adverse effects described above regarding FDA approval in the United States,
including the risk that product candidates may not be approved for all indications requested, which
could limit the uses of product candidates and adversely impact potential royalties and product
sales, and that such approval may be subject to limitations on the indicated uses for which the
product may be marketed or require costly, post-approval follow-up studies.
If the Company or any of its manufacturers or other partners fails to comply with applicable
foreign regulatory requirements, the Company and such other parties may be subject to fines,
suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating
restrictions and criminal prosecution.
Legislative or regulatory reform of the healthcare system may affect the Companys ability to sell
its products profitably.
In both the United States and certain foreign jurisdictions, there have been a number of
legislative and regulatory changes to the healthcare system in ways that could impact upon the
Companys ability to sell its products profitably. In recent years, new legislation has been
enacted in the United States at the federal and state levels that effects major changes in the
healthcare system, either nationally or at the state level. These new laws include a prescription
drug benefit for Medicare beneficiaries and certain changes in Medicare reimbursement. Given the
recent enactment of these laws, it is still too early to determine their impact on the
biotechnology and pharmaceutical industries and the Companys business. Further, federal and state
proposals are likely. More recently, administrative proposals are pending and others have become
effective that would change the method for calculating the reimbursement of certain drugs. The
adoption of these proposals and pending proposals may affect the Companys ability to raise
capital, obtain additional collaborators or profitably market its products. Such proposals may
reduce the Companys revenues, increase its expenses or limit the markets for its products. In
particular, the Company expects to experience pricing pressures in connection with the sale of its
products due to the trend toward managed health care, the increasing influence of health
maintenance organizations and additional legislative proposals.
Risks Related to the Securities Market and Ownership of the Companys Common Stock
Our common stock has been delisted from the NASDAQ Capital Market and is not listed on any other
national securities exchange. It will likely be more difficult for stockholders and investors to
sell our common stock or to obtain accurate quotations of the share price of our common stock.
On December 29, 2009, the Company received written notice from the listing qualifications
staff of the NASDAQ Stock Market informing the Company that trading of the Companys common stock
would be suspended from the NASDAQ Capital Market prior to the open of business on January 4, 2010
and that NASDAQ would initiate procedures to delist the Companys common stock. The Company had
notified NASDAQ on December 23, 2009 that the Company would be unable to comply with NASDAQ listing
rule 5550(b), which requires a minimum stockholders equity requirement of $2.5 million, and NASDAQ
listing rule 5605, which requires, among other things, that the Companys board of directors be
comprised of at least a majority of independent directors and that the Companys audit committee be
comprised of at least three independent directors. The Companys common stock is currently traded
on the Pink Sheets, a real-time inter-dealer electronic quotation and trading system in the
over-the-counter securities market.
The trading of our common stock on the Pink Sheets entails certain risks. Stocks trading on
the over-the-counter market are typically less liquid than stocks that trade on a national
securities exchange such as the NASDAQ Capital Market. Liquidity may be impaired not only in the
number of shares that are bought and sold, but also through delays in the timing of transactions,
and coverage by security analysts and the news media, if any, of the Company. Trading on the
over-the-counter market may also negatively impact the market price of our common stock, the number
of institutional and other investors that will consider investing in our common stock, the
availability of information concerning the trading prices and volume of our common stock, and the
number of broker-dealers willing to execute trades in shares of our common stock. In addition, the
trading of our common stock on the Pink Sheets may materially and adversely affect our access to
the capital markets, and the limited liquidity and reduced price of our common stock could
materially and adversely affect our ability to raise capital through alternative financing sources
on favorable terms or at all.
Trading of securities on an over-the-counter securities market is often more sporadic than the
trading of securities listed on a national exchange. The decreased liquidity of securities traded
on the Pink Sheets may make it more difficult for holders of the Companys common stock to sell
their securities. There can be no assurance that we will be able to re-list our common stock on a
national securities exchange in the future or that our common stock will continue to be traded on
the Pink Sheets or any trading market.
31
The Companys operating results and stock price may fluctuate significantly.
The Companys results of operations may be expected to be subject to quarterly fluctuations.
The Companys level of revenues, if any, and results of operations at any given time, will be based
primarily on the following factors:
|
|
|
the Companys ability to obtain additional financing and the terms of such financing; |
|
|
|
the Companys ability to operate its business following the restructuring, as described
in Other Information in Part II, Item 9B and in Note 12 in the Notes to the Financial
Statements; |
|
|
|
the status of development of VIA-2291, the Metabolic Compounds, and any other product
candidates; |
|
|
|
whether or not the Company enters into development and license agreements with strategic
partners that provide for payments to the Company, and the timing and accounting treatment
of payments to the Company, if any, under those agreements; |
|
|
|
whether or not the Company achieves specified development or commercialization milestones
under any agreement that the Company enters into with collaborators and the timely payment
by commercial collaborators of any amounts payable to the Company; |
|
|
|
the addition or termination of research programs or funding support; |
|
|
|
the timing of milestone and other payments that the Company may be required to make to
others; and |
|
|
|
variations in the level of expenses related to the Companys product candidates or
potential product candidates during any given period. |
These factors may cause the price of the Companys stock to fluctuate substantially.
Additionally, global market and economic conditions have been, and continue to be, disrupted and
volatile. The Company believes that quarterly comparisons of its financial results are not
necessarily meaningful and should not be relied upon as an indication of the Companys future
performance.
The Companys stock price could decline significantly based on the results and timing of its
clinical trials.
The Company may not be successful in completing the analysis of the FDG-PET clinical trial or
commencing or completing further clinical trials to demonstrate the efficacy of VIA-2291 on the
currently projected timetable, if at all. The Company anticipates results from the FDG-PET Phase 2
clinical trial in the first half of 2010. Biotechnology and pharmaceutical company stock prices
have declined significantly when clinical trial results were unfavorable or perceived negatively,
or when clinical trials were delayed or otherwise did not meet expectations. Failure to initiate or
delays in the Companys clinical trials of any of its product candidates or unfavorable results or
negative perceptions regarding the results of any such clinical trials, could cause the Companys
stock price to decline significantly.
Bay City Capital, the Companys principal stockholder, has significant influence over the
Company, and the interests of the Companys other stockholders may conflict with the interests of
Bay City Capital.
Bay City Capital, the Companys principal stockholder, currently claims beneficial ownership
of approximately 90% of the Companys common stock and holds a security interest in all of the
Companys assets, including its intellectual property, as a Lender under the March 2009 Loan and
March 2010 Loan. As a result, Bay City Capital, as a stockholder and a secured lender, is able to
exert significant influence over the Companys management and affairs, including any financing
transactions, and matters requiring stockholder approval, including the election of directors, any
merger, consolidation or sale of all or substantially all of the Companys assets, and any other
significant corporate transaction. The interests of Bay City Capital, may not always coincide with
the interests of the Company or its other stockholders. For example, Bay City Capital could delay
or prevent a change of control of the Company even if such a change of control would benefit the
Companys other stockholders. The significant concentration of stock ownership may
adversely affect the trading price of the Companys common stock due to investors perception
that conflicts of interest may exist or arise.
32
A significant portion of the Companys outstanding common stock may be sold into the market in the
future. Substantial sales of the Companys common stock, or the perception that such sales are
likely to occur, could cause the price of the Companys common stock to decline.
In August 2007 and December 2007, the Company also filed Form S-8 registration statements
covering the resale of the shares of common stock underlying options granted to the Companys
employees, directors and consultants pursuant to stock incentive plans and shares of common stock
that it may issue in the future under these plans. In March 2008 and 2009, the Company filed
Form S-8 registration statements covering the issuance of up to 500,000 additional shares of common
stock, respectively, that the Company may issue in the future to employees, directors and
consultants pursuant to the VIA Pharmaceuticals, Inc. 2007 Incentive Award Plan. In March 2009, the
Company issued to the Lenders warrants to purchase an aggregate of 83,333,333 shares of common
stock of the Company at $0.12 per share. In accordance with the terms of the warrant, the Company
entered into a registration rights agreement with the Lenders and certain stockholders of the
Company, pursuant to which the Company has granted certain demand, shelf and piggyback
registration rights to register their shares (including shares underlying the warrants) with the
SEC so that such shares become freely tradeable without restriction under the Securities Act of
1933, as amended. As described in Other Information in Part II, Item 9B and in Note 12 in the
Notes to the Financial Statements, in March 2010, the Company issued to the Lenders warrants to
purchase an aggregate of 17,647,059 shares of common stock of the Company at $0.17 per share (of
which 7,352,941 are vested as of March 29, 2010). In accordance with the terms of the warrant, the
Company amended the registration rights agreement to include the shares underlying these warrants
as well. Once registered, shares of the Companys common stock generally can be freely sold in the
public market upon issuance. Sales of a large number of these shares in the public market, or the
perception that such sales are likely to occur, could cause the price of the Companys common stock
to decline and could make it more difficult for the Company to raise additional financing due to
the additional overhang represented by these registered and to-be registered shares of common
stock.
Our change of control agreements with our named executive officers may require us to pay severance
benefits to any of those persons who are terminated in connection with a change of control of the
Company.
All of our named executive officers are parties to change of control agreements providing for
the payment of severance benefits and acceleration of vesting stock options in the event of a
termination of employment in connection with a change of control of the Company. Accelerated
vesting of options could result in dilution to our existing stockholders and harm the market price
of our common stock. The payment of these severance benefits could harm our financial condition and
results. In addition, these potential severance payments under these agreements may discourage or
prevent third parties from seeking a business combination with the Company.
As a smaller reporting company, the Company has not been subject to the full requirements of
Section 404 of the Sarbanes-Oxley Act of 2002. If the Company is unable to favorably assess the
effectiveness of its internal controls over financial reporting, or if, beginning the year ending
December 31, 2010, the Companys independent registered public accounting firm is unable to
provide an unqualified attestation report on the Companys assessment, the price of the Companys
common stock could be adversely affected.
Pursuant to Section 404 of SOX, the Companys management is required to report on the
effectiveness of its internal control over financial reporting as of December 31, 2009 in this
Annual Report on Form 10-K for the fiscal year ending December 31, 2009, and the Companys
independent auditor will be required to attest to the effectiveness of the Companys internal
control over financial reporting, as of June 15, 2010, in its Annual Report on Form 10-K for the
fiscal year ending December 31, 2010. As a smaller reporting company, the Company has not been
subject to the full requirements of Section 404 of SOX. During 2007, the Company installed systems
of internal accounting and administrative controls it believes are needed to comply with
Section 404 of SOX. Testing of systems installed was performed to enable management to report on
the effectiveness of the controls as of December 31, 2009. While management did not identify any
material weaknesses in the Companys internal control over financial reporting, there can be no
assurance that the systems will be deemed effective when the Companys independent auditor reviews
the systems during 2010, and tests transactions. In addition, any updates to the Companys finance
and accounting systems, procedures and controls, which may be required as a result of the Companys
ongoing analysis of its internal controls, or results of testing by the Company or its independent
auditor, may require significant time and expense. If the Company fails to have effective internal
control over financial reporting, is unable to complete any necessary modifications to its internal
control reporting, or if the Companys independent registered public accounting firm is unable to
provide the Company with an unqualified report as to the effectiveness of its internal control over
financial reporting, investors could lose confidence in the accuracy and completeness of the
Companys financial reports
and in the reliability of the Companys internal control over financial reporting, which could
lead to a substantial price decline in the Companys common stock.
33
The stock price of the Companys common stock is likely to be volatile and you may lose all, or a
substantial portion, of your investment.
The trading price of the Companys common stock has been and is likely to continue to be
volatile and could be subject to wide fluctuations in price in response to various factors, many of
which are beyond the Companys control including, among others, lack of trading volume in the
Companys stock, concentration of stock ownership by Bay City Capital, the Companys ability to
pursue preclinical and clinical development of the Metabolic Compounds, market perception of the
results of the Companys clinical trials, the Companys ability to control its operating expenses,
the Companys ability to recruit and enroll patients in potential future clinical trials for
VIA-2291, the Companys ability to acquire new compounds for the pipeline, and in particular, the
Companys ability to obtain necessary financing in the near term and successfully enter into
collaborative or strategic arrangements in the long-term. In addition, global market and economic
conditions have been, and continue to be, disrupted and volatile. Continued concerns about the
systemic impact of potential long-term and wide-spread recession, energy costs, geopolitical
issues, the availability and cost of credit, and the global housing and mortgage markets have
contributed to increased market volatility and diminished expectations for western and emerging
economies. The stock market in general, and the market for biotechnology and development-stage
pharmaceutical companies in particular, have experienced extreme price and volume fluctuations that
have often been unrelated or disproportionate to the operating performance of those companies.
These broad market and industry factors have seriously harmed and may continue to harm the market
price of the Companys common stock, regardless of the Companys actual operating performance. In
addition, in the past, following periods of volatility in the overall market and the market price
of a companys securities, securities class action litigation has often been instituted against
these companies. This litigation, if instituted against the Company, could result in substantial
costs and a diversion of managements attention and resources.
The Company has never paid cash dividends on its common stock, and the Company does not anticipate
that it will pay any cash dividends on its common stock in the foreseeable future.
The Company has never declared or paid cash dividends on its common stock. In addition, the payment
of cash dividends is restricted by the covenants in the Companys loan from the Lenders. The
Company does not anticipate that it will pay any cash dividends on its common stock in the
foreseeable future. The Company intends to retain all available funds and any future earnings to
fund the development and growth of its business. Any future determination to pay dividends will be
at the discretion of the Companys board of directors and will depend on the Companys financial
condition, results of operations, capital requirements, restrictions contained in current or future
financing instruments and such other factors as the Companys board of directors deems relevant. As
a result, capital appreciation, if any, of the Companys common stock will be your sole source of
gain for the foreseeable future.
ITEM 2. PROPERTIES
The Company leases its principal executive offices in San Francisco, California, which consist
of approximately 8,180 square feet. This lease expires on May 31, 2013. The Company also leases
approximately 4,979 square feet in Princeton, New Jersey, where its Senior Vice President, Research
and Development, is located. This lease expires on April 2, 2012. The Company believes that its
current facilities are adequate for its needs for the foreseeable future.
ITEM 3. LEGAL PROCEEDINGS
The Company is currently not a party to any material legal proceedings.
PART II
ITEM 5. MARKET FOR REGISTRANTS COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF
EQUITY SECURITIES
Market Information
Our common stock is currently traded on the Pink Sheets, a real-time inter-dealer electronic
quotation and trading system in the over-the-counter securities market, under the symbol VIAP.
Prior to January 4, 2010, our common stock was traded on The NASDAQ Capital Market under the same
ticker symbol. Effective January 4, 2010, trading in our common stock on The NASDAQ
Capital Market was suspended and NASDAQ has initiated procedures to delist our common stock.
As of March 15, 2010, there were approximately 115 registered holders of record of common stock.
34
The following table shows the high and low sales prices for our common stock on The NASDAQ
Capital Market during the fiscal year ended 2008 and 2009, respectively:
|
|
|
|
|
|
|
|
|
|
|
High |
|
|
Low |
|
FISCAL YEAR ENDED December 31, 2008: |
|
|
|
|
|
|
|
|
First Quarter |
|
$ |
3.20 |
|
|
$ |
2.11 |
|
Second Quarter |
|
$ |
3.20 |
|
|
$ |
1.90 |
|
Third Quarter |
|
$ |
2.23 |
|
|
$ |
0.67 |
|
Fourth Quarter |
|
$ |
1.60 |
|
|
$ |
0.11 |
|
FISCAL YEAR ENDED December 31, 2009: |
|
|
|
|
|
|
|
|
First Quarter |
|
$ |
0.25 |
|
|
$ |
0.08 |
|
Second Quarter |
|
$ |
0.84 |
|
|
$ |
0.15 |
|
Third Quarter |
|
$ |
0.74 |
|
|
$ |
0.21 |
|
Fourth Quarter |
|
$ |
0.60 |
|
|
$ |
0.20 |
|
Dividend Policy
We have never paid any cash dividends on our common stock to date. We currently anticipate
that we will retain all future earnings, if any, to fund the development and growth of our business
and do not anticipate paying any cash dividends for at least the next five years, if ever.
ITEM 6. SELECTED FINANCIAL DATA
The information set forth below should be read in conjunction with Item 7. Managements
Discussion and Analysis of Financial Condition and Results of Operations and our financial
statements and related notes included elsewhere in this report. On June 5, 2007, Corautus completed
the Merger with privately-held VIA Pharmaceuticals, Inc. pursuant to which Resurgens Merger Corp.,
a wholly-owned subsidiary of Corautus, merged with and into privately-held VIA Pharmaceuticals,
Inc., with privately-held VIA Pharmaceuticals, Inc. continuing as the surviving corporation and as
a wholly-owned subsidiary of Corautus. Immediately following the effectiveness of the Merger,
privately-held VIA Pharmaceuticals, Inc. then merged with and into Corautus, pursuant to which
Corautus continued as the surviving corporation. For accounting purposes, privately-held VIA
Pharmaceuticals, Inc. was considered to be the acquiring company in the Merger, and the Merger was
accounted for as a reverse acquisition of assets under the purchase method of accounting for
business combinations in accordance with accounting principles generally accepted in the United
States of America (GAAP). In connection with the Merger, the name of the business was changed
from Corautus Genetics Inc. to VIA Pharmaceuticals, Inc. and retroactively restated its
authorized, issued and outstanding shares of common and preferred stock to reflect a 1 to 15
reverse common stock split. The financial data included in this report reflect the historical
results of privately-held VIA Pharmaceuticals, Inc. prior to the Merger and that of the combined
company following the Merger. The historical results are not necessarily indicative of results to
be expected in any future period.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 14, 2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Date of |
|
|
|
Years Ended December 31, |
|
|
Inception) to |
|
(In whole dollars) |
|
2009 |
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
|
2005 |
|
|
Dec 31, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Loss from continuing operations |
|
|
(20,978,324 |
) |
|
|
(20,274,828 |
) |
|
|
(21,835,382 |
) |
|
|
(8,626,887 |
) |
|
|
(8,804,220 |
) |
|
|
(81,604,565 |
) |
Loss from continuing
operations per common share |
|
|
(1.05 |
) |
|
|
(1.03 |
) |
|
|
(2.24 |
) |
|
|
(19.81 |
) |
|
|
(21.63 |
) |
|
|
|
|
Total assets |
|
|
2,556,094 |
|
|
|
5,000,803 |
|
|
|
24,484,941 |
|
|
|
3,726,420 |
|
|
|
686,856 |
|
|
|
|
|
Long-term obligations |
|
|
37,450 |
|
|
|
30,637 |
|
|
|
3,980 |
|
|
|
6,827 |
|
|
|
4,946 |
|
|
|
|
|
Cash dividends declared per
common share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
35
ITEM 7. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion of our financial condition contains certain statements that are not
strictly historical and are forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995 and involve a high degree of risk and uncertainty. Our
actual results may differ materially from those projected in the forward-looking statements due to
risks and uncertainties that exist in our operations, development efforts and business environment,
including those set forth under the Section entitled Risk Factors in Item 1A, and other documents
we file with the Securities and Exchange Commission. All forward-looking statements included in
this report are based on information available to us as of the date hereof, and, unless required by
law, we assume no obligation to update any such forward-looking statement.
Management Overview
VIA Pharmaceuticals, Inc., incorporated in Delaware in June 2004 and headquartered in San
Francisco, California, is a development stage biotechnology company focused on the development of
compounds for the treatment of cardiovascular and metabolic disease. The Company is building a
pipeline of small molecule drugs that target the underlying causes of cardiovascular and metabolic
disease, including atherosclerotic plaque inflammation, high cholesterol, high triglycerides and
insulin sensitization/diabetes.
During 2005, the Company in-licensed a small molecule compound, VIA-2291, which targets an
unmet medical need of reducing atherosclerotic plaque inflammation, an underlying cause of
atherosclerosis and its complications, including heart attack and stroke. Atherosclerosis,
depending on its severity and the location of the artery it affects, may result in major adverse
cardiovascular events (MACE), such as heart attack and stroke. During 2006, the Company initiated
two Phase 2 clinical trials of VIA-2291 in patients undergoing a carotid endarterectomy (CEA),
and in patients at risk for acute coronary syndrome (ACS). During 2007, the Company initiated a
third Phase 2 clinical trial where ACS patients undergo Positron Emission Tomography with
flurodeoxyglucose tracer (FDG-PET), a non-invasive imaging technique to measure the effect of
treatment of VIA-2291 on atherosclerotic plaque inflammation.
On November 9, 2008, the Company announced the results of its ACS and CEA Phase 2 clinical
trials of its lead product candidate, VIA-2291, at the American Heart Association (AHA) 2008
Scientific Sessions conference in New Orleans, Louisiana (the AHA Conference). The Company
completed enrollment of 52 patients in the FDG-PET Phase 2 clinical trial in May 2009, and results
of the trial are expected in the first half of 2010.
On May 1, 2009, the Company announced results of a sub-study of the ACS Phase 2 clinical trial
of VIA-2291 at the AHA Arteriosclerosis, Thrombosis and Vascular Biology Annual Conference 2009 in
Washington D.C. The Company found that in 64 slice multi-detector computed tomography (MDCT)
scans of patients with low density plaques demonstrated statistically significant, lower plaque
volumes in combined VIA-2291 treated groups compared to placebo. Together these results suggest
that VIA-2291 may reduce the progression of unstable coronary plaques that lead to heart attacks
and stroke.
On May 14, 2009, the Company announced it had completed patient enrollment in the FDG-PET
Phase 2 clinical trial. On December 3, 2009, the Company announced the last patient clinical
visit. The Company expects to report results in the first half of 2010.
In 2008, the Company expanded its drug development pipeline with preclinical compounds that
target additional underlying causes of cardiovascular and metabolic disease, including high
cholesterol, high triglycerides and insulin sensitization/diabetes. The Companys clinical
development strategy integrates several technologies to provide clinical proof-of-concept as early
as possible in the clinical development process. These technologies include the measurement of
biomarkers (specific biochemicals in the body with a particular molecular feature that makes them
useful for measuring the progress of a disease or the effects of treatment), medical imaging of the
coronary and carotid vessel walls to evaluate the plaque characteristics, and atherosclerotic
plaque bioassays (measurements of indicators of atherosclerotic plaque inflammation believed to
promote MACE). Once the Company has established proof-of-concept, the Company plans to consider
business collaborations with larger biotechnology or pharmaceutical companies for the late-stage
clinical development and commercialization of its compounds.
36
Background
In March 2005, the Company entered into an exclusive license agreement (the Stanford
License) with Leland Stanford Junior University (Stanford) to use a comprehensive gene
expression database and analysis tool to identify novel, and prioritize known, molecular targets
for the treatment of vascular inflammation and to study the impact of candidate therapeutic
interventions on the molecular mechanisms underlying atherosclerosis (the Stanford Platform). One
of the Companys founders, Thomas Quertermous, M.D., developed the Stanford Platform at Stanford
during the course of a four-year, $30.0 million research study (the Stanford Study). The Stanford
Study initially utilized human tissue samples made available from the Stanford heart transplant
program to characterize human plaque at the level of gene expression and identify the inflammatory
genes and pathways involved in the development of atherosclerosis and associated complications in
humans. To develop the Stanford Platform, the Stanford Study performed similar experiments on
vascular tissue samples from mice prone to developing atherosclerosis and identified genes and
pathways associated with the development of atherosclerosis that mice and humans have in common
(the Overlap Genes). The Stanford Platform allowed us to analyze the expression of the Overlap
Genes following the administration of candidate drugs to atherosclerotic-prone mice, and thus
provided a useful tool for studying the effects of therapeutic intervention in the development of
cardiovascular disease. This platform also gave us useful insight into the molecular pathways that
we believe to be most relevant to the cardiovascular disease process. In January 2009, the Company
advised Stanford that it was terminating its exclusive license agreement effective February 14,
2009.
VIA-2291
In 2005, the Company identified 5-Lipoxygenase (5LO) as a key target of interest for
treating atherosclerosis. 5LO is a key enzyme in the biosynthesis of leukotrienes, which are
important mediators of inflammation and are involved in the development and progression of
atherosclerosis. In addition, cardiovascular-related literature has also identified 5LO as a key
target of interest for treating atherosclerosis and preventing heart attack and stroke. Following
such identification, the Company identified a number of late-stage 5LO inhibitors that had been in
clinical trials conducted by large biotechnology and pharmaceutical companies primarily for
non-cardiovascular indications, including ABT-761, a compound developed by Abbott Laboratories
(Abbott) for use in treatment of asthma. Abbott abandoned its ABT-761 clinical program in 1996
after the U.S. Food and Drug Administration (FDA) approved a similar Abbott compound for use in
asthma patients. Abbott made no further developments to ABT-761 from 1996 to 2005. In August 2005,
the Company entered into an exclusive, worldwide license agreement (the Abbott License) with
Abbott to develop and commercialize ABT-761 for any indication. The Company subsequently renamed
the compound VIA-2291.
VIA-2291 is a potent, selective and reversible inhibitor of 5LO that the Company is developing
as a once-daily, oral drug to treat inflammation in the blood vessel wall. In March 2006, the
Company filed an Investigational New Drug (IND) application with the FDA outlining the Companys
Phase 2 clinical program, which initially consisted of two trials for VIA-2291. Each of these
clinical trials was initiated during 2006 to study the safety and efficacy of VIA-2291 in patients
with existing cardiovascular disease. Using biomarkers of inflammation, medical imaging techniques
and bioassays of plaque, the Company is evaluating and determining VIA-2291s ability to reduce
vascular inflammation in atherosclerotic plaque. The Company enrolled 50 patients in a Phase 2
study of VIA-2291 at clinical sites in Italy for patients who had a carotid endarterectomy (CEA)
procedure. In addition, the Company enrolled 191 patients in a second Phase 2 study at 15 clinical
sites in the United States and Canada for patients with acute coronary syndrome (ACS) who
experienced a recent heart attack.
In October 2007, the Companys Data Safety Monitoring Board (DSMB) performed a review of
both safety and efficacy data related to the Companys CEA and ACS clinical trials to determine the
progress in the clinical program and the patient safety of VIA-2291. Based on this review, the DSMB
observed a continued acceptable safety profile and evidence of a consistent pharmacological effect
of VIA-2291 as would be predicted given its proposed mechanism of action. The DSMB recommended the
studies continue as planned.
Following the results of the DSMB review, the Company began enrolling patients in a third
Phase 2 clinical trial that utilized Positron Emission Tomography with fluorodeoxyglucose tracer
(FDG-PET) to measure the impact of VIA-2291 on reducing atherosclerotic plaque inflammation in
treated patients. The Company enrolled 52 patients following an acute coronary syndrome event, such
as heart attack or stroke, into the 24 week, randomized, double blind, placebo-controlled study,
which was run at five clinical sites in the United States and Canada. Endpoints in the study
included reduction in atherosclerotic plaque inflammation as measured by serial FDG-PET scans. The
last patient visit was reported in December 2009 and completion of data analysis and reporting of
clinical trial results are anticipated in the first half of 2010.
As more fully described under Part I, Item 1 Business VIA-2291 Clinical Trial Results, on
November 9, 2008, the Company announced the results of its ACS and CEA Phase 2 clinical trials at
the AHA conference in New Orleans, Louisiana. In both the ACS trial and the CEA trial, VIA-2291
effectively inhibited production of leukotrienes. The ACS trial met its primary endpoint by
demonstrating a significant change from baseline in Leukotriene B4 (LTB4) production at all
doses tested (p<0.001). The CEA trial missed its primary endpoint of percentage reduction in
macrophage inflammatory cells in plaque tissue, but met key secondary endpoints including reduction
of high sensitivity C-reactive protein (hs-CRP) (p<0.01). VIA-2291 was generally
well-tolerated in both trials.
37
In May 2009, the Company announced results of a sub-study of the ACS Phase 2 clinical trial of
VIA-2291 at the AHA Arteriosclerosis, Thrombosis and Vascular Biology Annual Conference 2009 in
Washington D.C. The purpose of the sub-study was to evaluate the effect of VIA-2291 25mg, 50mg and
100mg doses relative to placebo from baseline in patients dosed with VIA-2291 for 24 weeks. After
completion of the initial 12 weeks of dosing, more than 85 of the 191 total ACS patients continued
on to receive an additional 12 weeks of dosing on top of current standard medical care and received
a 64 slice MDCT scan at baseline and 24 weeks. Evaluable scans from patients treated with placebo
showed significantly more evidence of new plaque lesions from VIA-2291 treated patients. MDCT scans
of patients with low density plaques demonstrated statistically significant, lower plaque volumes
in combined VIA-2291 treated groups compared to placebo. Together these results suggest that
VIA-2291 may reduce the progression of unstable coronary plaques that lead to heart attacks and
stroke.
In June 2009, the Company announced that it held an end of Phase 2a meeting with the FDA. The
Company reviewed safety and biologic activity data from the VIA-2291 CEA and ACS trials with the
FDA and received guidance, including suggestions from the FDA on the Companys potential Phase 3
trial design.
The Company completed enrollment and last patient clinical visit in the FDG-PET Phase 2
clinical trial and results are expected to be reported in the first half of 2010.
The Company plans to consider business collaborations with large biotechnology or
pharmaceutical companies to conduct additional clinical trials required for regulatory approval.
Roche Licensed Assets
In December 2008, the Company entered into two exclusive, worldwide Research, Development and
Commercialization agreements with Roche for two sets of compounds that we believe represent novel
potential drugs for treatment of cardiovascular and metabolic disease. The first license is for
Roches THR beta agonist, a clinically ready candidate for the control of cholesterol, triglyceride
levels and potential in insulin sensitization/diabetes. The second license is for multiple
compounds from Roches preclinical DGAT1 metabolic disorders program. Under the terms of the
agreements, the Company assumes control of all development and commercialization of the compounds,
and will own exclusive worldwide rights for all potential indications.
Roche will receive up to $22.8 million in upfront and milestone payments, the majority of
which is tied to the achievement of product development and regulatory milestones. In addition,
once products containing the compounds are approved for marketing, Roche will receive single-digit
royalties based on net sales, subject to certain reductions.
The Company must use commercially reasonable efforts to conduct clinical and commercial
development programs for products containing the compounds. Under the license for the THR beta
agonist, if the Company has not completed a Phase 1 clinical trial with respect to a lead product
containing this compound within three years, then either the Company must commit to developing
another of Roches compounds or Roche may terminate the license for that compound.
If the Company determines that it is not reasonable to continue clinical trials or other
development of the compounds, it may elect to cease further development and Roche may terminate the
licenses. If the Company determines not to pursue the development or commercialization of the
compounds in the United States, Japan, the United Kingdom, Germany, France, Spain, or Italy, Roche
may terminate the licenses for such territories.
The Roche license will expire, unless earlier terminated pursuant to other provisions of the
licenses, on the last to occur of (i) the expiration of the last valid claim of a licensed patent
covering the manufacture, use or sale of products containing the compounds, or (ii) ten years after
the first sale of a product containing the compounds.
The THR beta agonist is an orally administered, small-molecule beta-selective thyroid hormone
receptor agonist designed to specifically target receptors in the liver involved in metabolism and
cholesterol regulation, and avoid side effects associated with thyroid hormone receptor activation
outside the liver. Roche has completed preclinical studies of the THR beta agonist. These studies
demonstrated a rapid reduction of non-HDL cholesterol and the drug was shown to be synergistic with
statins in animal studies. The
Company will investigate the possibility of using the THR beta agonist in combination with
statins for the treatment of hypercholesterolemia. In addition, in animal studies insulin
sensitization and glucose lowering were observed making this compound a possible treatment of
patients with type 2 diabetes in combination with other diabetes medications.
38
DGAT1 is an enzyme that catalyzes triglyceride synthesis and fat storage. Triglycerides are
the principal component of fat, which is the major repository for storage of metabolic energy in
the body. Overweight and obese individuals have significantly greater triglyceride levels, making
them more prone to diabetes and its associated metabolic complications. DGAT1 inhibitors are
believed to be an innovative class of compounds that modify lipid metabolism. In studies of obese
animals, DGAT1 inhibitors have been shown to induce weight loss and improve insulin sensitization,
glucose tolerance and lipid levels. These observations suggest DGAT1 inhibitors may have the
potential to treat obesity, diabetes and dyslipidemia. The Company intends to identify potential
clinical candidates from the compounds in this program and determine which compounds may be moved
into further preclinical development.
Going Concern
To further expand the Companys product candidate pipeline, the Company continues to engage in
discussions regarding the purchase or license of additional preclinical or clinical compounds that
the Company believes may be of interest in treating cardiovascular and metabolic disease.
Through December 31, 2009, the Company has been primarily engaged in developing initial
procedures and product technology, recruiting personnel, screening and in-licensing of target
compounds, clinical trial activity, and raising capital. The Company is organized and operates as
one operating segment.
The Company has incurred losses since inception as it has devoted substantially all of its
resources to research and development, including early-stage clinical trials. As of December 31,
2009, the Companys accumulated deficit was approximately $81.6 million. The Company expects to
incur substantial and increasing losses for the next several years as it continues to expend
substantial resources seeking to successfully research, develop, manufacture, obtain regulatory
approval for, and commercialize its product candidates.
The Company has not generated any revenues to date, and does not expect to generate any
revenues from licensing, achievement of milestones or product sales until it is able to
commercialize product candidates or execute a collaboration agreement. The Company cannot estimate
the actual amounts necessary to successfully complete the successful development and
commercialization of its product candidates or whether, or when, it may achieve profitability.
Until the Company can establish profitable operations to finance its cash requirements, the
Companys ability to meet its obligations in the ordinary course of business is dependent upon its
ability to raise substantial additional capital through public or private equity or debt
financings, the establishment of credit or other funding facilities, collaborative or other
strategic arrangements with corporate sources or other sources of financing, the availability of
which cannot be assured. On June 5, 2007, the Company raised $11.1 million through the Merger with
Corautus to cover existing obligations and provide operating cash flows. In July 2007, the Company
entered into a securities purchase agreement that provided for issuance of 10,288,065 shares of
common stock for approximately $25.0 million in gross proceeds. As more fully described in Note 6
in the notes to the financial statements, in March 2009, the Company entered into a Note and
Warrant Purchase Agreement (the Loan Agreement) with its principal stockholder and one of its
affiliates (the Lenders) whereby the Lenders agreed to lend to the Company in the aggregate up to
$10.0 million (the March 2009 Loan). The Company secured the March 2009 Loan with all of its
assets, including the Companys intellectual property. On March 12, 2009, the Company borrowed the
initial $2.0 million available under the Loan Agreement. Subsequently, the Company made $2.0
million borrowings under the Loan Agreement on May 19, 2009, June 29, 2009, August 14, 2009, and
the Company borrowed the final $2.0 million available under the Loan Agreement on September 11,
2009. According to the terms of the original Loan Agreement, the debt was due to the Lenders on
September 14, 2009. The parties agreed to extend the repayment terms and, as more fully described
in Note 12 in the notes to the financial statements, on February 26, 2010, the Lenders agreed to
modify the Loan Agreement to further extend the repayment terms to April 1, 2010. The Lenders did
not modify the interest rate or offer any concessions in the amended Loan Agreement. The Company
had $2.2 million in cash at December 31, 2009. As more fully described in Other Information in
Part II, Item 9B and in Note 12 in the Notes to the Financial Statements, in March 2010, the
Company entered into a Note and Warrant Purchase Agreement (the 2010 Loan Agreement) with the
Lenders whereby the Lenders agreed to lend to the Company in the aggregate up to $3.0 million (the
March 2010 Loan). The Company secured the March 2010 Loan with all of its assets, including the
Companys intellectual property. On March 29, 2010, the Company borrowed an initial $1.25 million
available under the 2010 Loan Agreement. Management believes that the total amount of cash
borrowed under the March 2010 loan, if fully drawn, will enable the Company to meet its current
obligations into the third quarter of 2010. Management does not believe
that existing cash resources will be sufficient to enable the Company to meet its ongoing
working capital requirements for the next twelve months and the Company will need to raise
substantial additional funding in the near term to repay amounts owed under the loan, which are due
April 1, 2010, and to meet its ongoing working capital requirements. As a result, there are
substantial doubts that the Company will be able to continue as a going concern and, therefore, may
be unable to realize its assets and discharge its liabilities in the normal course of business. The
financial statements do not include any adjustments relating to the recoverability and
classification of recorded asset amounts or to amounts and classifications of liabilities that may
be necessary should the Company be unable to continue as a going concern.
39
The Company cannot guarantee to its stockholders that the Companys efforts to raise
additional private or public funding will be successful. If adequate funds are not available in the
near term, the Company may be required to:
|
|
|
terminate or delay clinical trials or studies of VIA-2291; |
|
|
|
|
terminate or delay the preclinical development of one or more of its other preclinical
candidates; |
|
|
|
|
curtail its licensing activities that are designed to identify molecular targets and
small molecules for treating cardiovascular disease; |
|
|
|
|
relinquish rights to product candidates, development programs, or discovery development
programs that it may otherwise seek to develop or commercialize on its own; and |
|
|
|
|
delay, reduce the scope of, or eliminate one or more of its research and development
programs, or ultimately cease operations. |
All outstanding principal and accrued interest under the March 2009 Loan are due on April 1,
2010. The Company will not be able to repay the March 2009 Loan when it becomes due on April 1,
2010. When the Company does not repay the March 2009 Loan at maturity, it will be in default under
the March 2009 loan agreement and the Lenders may terminate the March 2009 Loan, demand immediate
payment of all amounts borrowed by the Company and take possession of all collateral securing the
March 2009 Loan, including our intellectual property rights, which could cause the Company to cease
operations.
Revenue
The Company has not generated any revenue to date and does not expect to generate any revenue
from licensing, achievement of milestones or product sales until the Company is able to
commercialize product candidates or execute a collaboration arrangement.
Research and Development Expenses
The Company is focused on the development of compounds for the treatment of cardiovascular and
metabolic disease. The Company completed the ACS and CEA Phase 2 clinical trials for VIA-2291, and
has completed enrollment and the last patient visit in the ongoing FDG-PET Phase 2 clinical trial
for VIA-2291. In November 2008, the Company announced the results of its ACS and CEA Phase 2
clinical trials at the AHA Conference, and the Company reported results from an MDCT sub-study of
its ACS Phase 2 clinical trial in May of 2009. In June 2009, the Company announced that it held an
end of Phase 2a meeting with the FDA. The Company reviewed safety and biologic activity data from
the VIA-2291 CEA and ACS trials with the FDA and received guidance, including suggestions from the
FDA on the Companys potential Phase 3 trial design. In December 2009, the Company announced its
last patient visit and expects to report the results of the FDG-PET Phase 2 clinical trial in the
first half of 2010. In addition to the VIA-2291 compound, the Companys pipeline consists of the
THR beta agonist, a clinically ready candidate for the control of cholesterol, triglyceride levels
and potential in insulin sensitization/diabetes, and DGAT1, a set of preclinical compounds for the
treatment of metabolic disorders and dyslipidemia.
Research and development (R&D) expense represented 46% and 58% of total operating expense
for the years ended December 31, 2009 and 2008, respectively, and 56% for the period from June 14,
2004 (date of inception) to December 31, 2009. The Company expenses research and development costs
as incurred. Research and development expenses are those incurred in identifying, in-licensing,
researching, developing and testing product candidates. These expenses primarily consist of the
following:
|
|
|
compensation of personnel associated with research and development activities, including
consultants, investigators, and contract research organizations (CROs); |
|
|
|
|
in-licensing fees; |
40
|
|
|
laboratory supplies and materials; |
|
|
|
|
costs associated with the manufacture of product candidates for preclinical testing and
clinical studies; |
|
|
|
|
preclinical costs, including toxicology and carcinogenicity studies; |
|
|
|
|
fees paid to professional service providers for independent monitoring and analysis of the
Companys clinical trials; |
|
|
|
|
depreciation and equipment; and |
|
|
|
|
allocated costs of facilities and infrastructure. |
The following reflects the breakdown of the Companys research and development expenses
generated internally versus externally for the years ended December 31, 2009 and 2008, and for the
period from June 14, 2004 (date of inception) to December 31, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
|
|
|
|
|
|
June 14, 2004 |
|
|
|
Years Ended |
|
|
(Date of Inception)to |
|
|
|
December 31, |
|
|
December 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
Externally generated research and development expense |
|
$ |
3,639,215 |
|
|
$ |
7,906,799 |
|
|
$ |
28,705,191 |
|
Internally generated research and development expense |
|
|
2,416,000 |
|
|
|
3,897,254 |
|
|
|
12,200,987 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
6,055,215 |
|
|
$ |
11,804,053 |
|
|
$ |
40,906,178 |
|
|
|
|
|
|
|
|
|
|
|
Externally generated research and development expenses consist primarily of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
|
|
|
|
|
|
June 14, 2004 |
|
|
|
Years Ended |
|
|
(Date of Inception) to |
|
|
|
December 31, |
|
|
December 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
Externally generated research and development expense |
|
|
|
|
|
|
|
|
|
|
|
|
In-licensing expenses |
|
$ |
400,000 |
|
|
$ |
25,000 |
|
|
$ |
5,270,000 |
|
CRO and investigator expenses |
|
|
1,090,115 |
|
|
|
4,841,760 |
|
|
|
10,749,339 |
|
Consulting expenses |
|
|
1,120,131 |
|
|
|
1,239,447 |
|
|
|
6,418,669 |
|
Other |
|
|
1,028,969 |
|
|
|
1,800,592 |
|
|
|
6,267,183 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
3,639,215 |
|
|
$ |
7,906,799 |
|
|
$ |
28,705,191 |
|
|
|
|
|
|
|
|
|
|
|
Internally generated research and development expenses consist primarily of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
|
|
|
|
|
|
June 14, 2004 |
|
|
|
Years Ended |
|
|
(Date of Inception) to |
|
|
|
December 31, |
|
|
December 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
Internally generated research and development expense |
|
|
|
|
|
|
|
|
|
|
|
|
Personnel and related expenses |
|
$ |
1,693,205 |
|
|
$ |
2,771,734 |
|
|
$ |
8,507,159 |
|
Stock-based compensation expense |
|
|
275,961 |
|
|
|
320,624 |
|
|
|
1,095,794 |
|
Travel and entertainment expense |
|
|
170,249 |
|
|
|
320,616 |
|
|
|
1,155,619 |
|
Other |
|
|
276,585 |
|
|
|
484,280 |
|
|
|
1,442,415 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
2,416,000 |
|
|
$ |
3,897,254 |
|
|
$ |
12,200,987 |
|
|
|
|
|
|
|
|
|
|
|
The Company does not presently segregate total research and development expenses by individual
project because our research is focused on atherosclerosis and cardiometabolic disease as a unitary
field of study. Although the Company has a mix of preclinical and clinical research and
development, personnel working on the programs are combined, financial expenditures are combined,
and reporting has not matured to the point where they are separate and distinct projects. The
Company cannot reliably allocate the personnel costs, consulting costs, and other resources
dedicated to these efforts to individual projects, as we are conducting our research on an
integrated basis.
41
Assuming the Company is able to raise additional financing, it is expected that there will be
significant research and development expenses for the foreseeable future. Clinical trial activity
in the CEA and ACS Phase 2 clinical trials and related expenses have decreased as a result of
completing the studies, and expenses for the ongoing FDG-PET trial have decreased and will continue
to decrease as the last patient visit was reported in December 2009. The Company began the
development of its preclinical metabolic assets in 2009 and the Company expects expenses to
increase substantially over the next several years. The ultimate level and timing of research and
development spending is difficult to predict due to the uncertainty inherent in the timing of
raising additional financing, the timing and extent of progress in our research programs, and
initiation and progress of clinical trials. In addition, the results from the Companys preclinical
and clinical research and development activities, as well as the results of trials of similar
therapeutics under development by others, will influence the number, size and duration of planned
and unplanned trials. As the Companys research efforts mature, we will continue to review the
direction of our research based on an assessment of the value of possible future compounds emerging
from these efforts. Based on this continuing review, the Company expects to establish discrete
research programs and evaluate the cost and potential for cash inflows from commercializing
products, partnering with others in the biotechnology or pharmaceutical industry, or licensing the
technologies associated with these programs to third parties.
The Company believes that it is not possible at this time to provide a meaningful estimate of
the total cost to complete our ongoing projects and to bring any proposed products to market. The
potential use of compounds targeting atherosclerotic plaque inflammation as a therapy is an
emerging area. Costs to complete current or future development programs could vary substantially
depending upon the projects selected for development, the number of clinical trials required and
the number of patients needed for each study. It is possible that the completion of these studies
could be delayed for a variety of reasons, including difficulties in enrolling patients, incomplete
or inconsistent data from the preclinical or clinical trials, difficulties evaluating the trial
results and delays in manufacturing. Any delay in completion of a trial would increase the cost of
that trial, which would harm our results of operations. Due to these uncertainties, the Company
cannot reasonably estimate the size, nature or timing of the costs to complete, or the amount or
timing of the net cash inflows from our current activities. Until the Company obtains further
relevant preclinical and clinical data, and progresses further through the FDA regulatory process,
the Company will not be able to estimate our future expenses related to these programs or when, if
ever, and to what extent we will receive cash inflows from resulting products.
General and Administrative
General and administrative expense consists primarily of personnel costs, including salaries,
incentive and other compensation, travel and entertainment expenses, for personnel in executive,
finance, accounting, business development, information technology and human resource functions.
Other costs include facility costs not otherwise included in research and development expense,
professional fees for legal and accounting services, and public company expenses, including
investor relations, transfer agent fees and printing expenses.
Interest Income, Interest Expense and Other Expenses
Interest income consists of interest earned on cash and cash equivalents. Interest expense
consists primarily of interest due on secured notes payable and on capital leases, and amortization
of discount on notes payable affiliate. Other expenses consist of net realized and unrealized
gains and losses associated with foreign currency transactions, and unrealized gains and losses
associated with the warrant obligation.
Results of Operations
Comparison of the years ended December 31, 2009 and 2008
The following table summarizes the Companys results of operations with respect to the items
set forth in such table for the years ended December 31, 2009 and 2008 together with the change in
such items in dollars and as a percentage:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Years Ended |
|
|
|
|
|
|
|
|
|
December 31, |
|
|
December 31, |
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
$ Change |
|
|
% Change |
|
Revenue |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
Research and development expense |
|
|
6,055,215 |
|
|
|
11,804,053 |
|
|
|
(5,748,838 |
) |
|
|
(49 |
)% |
General and administrative expense |
|
|
7,198,320 |
|
|
|
8,657,166 |
|
|
|
(1,458,846 |
) |
|
|
(17 |
)% |
Interest income |
|
|
|
|
|
|
189,656 |
|
|
|
(189,656 |
) |
|
|
|
|
Interest expense |
|
|
7,733,390 |
|
|
|
6,029 |
|
|
|
7,727,361 |
|
|
|
|
|
Other income |
|
|
8,601 |
|
|
|
2,764 |
|
|
|
5,837 |
|
|
|
211 |
% |
42
Revenue. The Company did not generate any revenue in the year ended December 31, 2009 and
2008, respectively, and does not expect to generate any revenue from licensing, achievement of
milestones or product sales until the Company is able to commercialize product candidates or
execute a collaboration arrangement.
Research and Development Expense. Research and development expense decreased 49%, or
approximately $5.7 million, from $11.8 million in the year ended December 31, 2008 to $6.1 million
in the year ended December 31, 2009. Clinical trial and preclinical related CRO and investigator
clinical trial related expenses decreased by approximately $3.8 million from $4.8 million in the
year ended December 31, 2008 to $1.0 million in the year ended December 31, 2009. The ACS Phase 2
clinical trial was completed in 2008, resulting in a $2.5 million decrease in CRO and investigator
expenses. The CEA Phase 2 clinical trial was also completed in 2008 resulting in a $800,000
decrease in CRO and investigator expenses. FDG-PET CRO and investigator expenses decreased $500,000
as last patient visit occurred in 2009. Lab data analysis and other R&D expenses decreased
$700,000 from $1.8 million in the year ended December 31, 2008 to $1.1 million in the year ended
December 31, 2009 primarily due to an $800,000 decrease in ACS expenses, a $300,000 decrease in CEA
expenses from the completion of the ACS and CEA Phase 2 clinical trials in 2008, and a $100,000
decrease in FDG-PET expenses due to the completion of patient clinical visits in late 2009; net of
an increase of $100,000 in expenses associated with the DNA isolation and genotyping study
associated with the development of VIA-2291, and net of an increase of $400,000 in drug development
expenses for one of the Roche compounds. Employee related expenses including salary, benefits,
stock-based compensation, travel and entertainment expense, information technology and facilities
expenses, decreased $1.5 million from $3.9 million in the year ended December 31, 2008 to $2.4
million in the year ended December 31, 2009 primarily due to personnel turnover and pay
adjustments. In-licensing expenses increased $400,000 from $0 in the year ended December 31, 2008
to $400,000 in the year ended December 31, 2009 due to the in-licensing of two Roche compounds in
the year ended December 31, 2009. Consulting expenses decreased $100,000 from $1.2 million in the
year ended December 31, 2008 to $1.1 million in the year ended December 31, 2009.
General and Administrative Expense. General and administrative expense decreased 17%, or
approximately $1.5 million, from $8.7 million in the year ended December 31, 2008 to $7.2 million
in the year ended December 31, 2009 which reflects the Companys efforts to reduce operating
expenses. Employee related expenses, including salary and benefits, stock-based compensation and
travel and entertainment expenses decreased $300,000 from $4.3 million in the year ended December
31, 2008 to $4.0 million in the year ended December 31, 2009, primarily due to a decrease in
travel, while salary, benefits and stock-based compensation expenses did not change significantly
in the year ended December 31, 2009 from expenses incurred in the year ended December 31, 2008.
Corporate and facilities general and administrative expenses decreased $900,000 from $3.6 million
in the year ended December 31, 2008 to $2.7 million in the year ended December 31, 2009 primarily
due to a $300,000 decrease in audit and legal expense, and a $600,000 decrease in investor
relations and other public company expenses. Consulting expenses decreased $300,000 from $800,000
in the year ended December 31, 2008 to $500,000 in the year ended December 31, 2009 due primarily
to the timing of business development consulting services.
Interest Income. Interest income decreased approximately $200,000, from approximately
$200,000 in the year ended December 31, 2008 to $0 in the year ended December 31, 2009. The Company
did not have sufficient excess cash reserves to justify the expected cost of investments in the
year ended December 31, 2009.
Interest Expense. Interest expense increased $7,727,000 from $6,000 in the year ended
December 31, 2008 to $7,733,000 in the year ended December 31, 2009. The $7,733,000 in interest
expense in the year ended December 31, 2009 consisted of $789,000 interest on the note payable
affiliate and $6,944,000 in interest expense incurred in the amortization of the discount on the
$10.0 million notes payable affiliate.
Other Income. Other income increased $6,000 from $3,000 in the year ended December 31, 2008
to $9,000 in the year ended December 31, 2009. Unrealized losses on foreign exchange transactions
increased $28,000 from unrealized gains of $24,000 in the year ended December 31, 2008 to $4,000 in
unrealized losses in the year ended December 31, 2009; realized gains on foreign exchange
transactions increased $30,000 from realized losses of $17,000 in the year ended December 31, 2008
to realized gains of $13,000 in the year ended December 31, 2009. The foreign exchange transactions
were incurred primarily in connection with the CEA Phase 2 clinical trial. Losses on the disposal
of fixed assets decreased $4,000 from $4,000 in the year ended December 31, 2008 to approximately
$0 in the year ended December 31, 2009.
Income Tax Expense. There is no income tax provision (benefit) for federal or state income
taxes as the Company has incurred operating losses since inception and a full valuation allowance
has also been in place since inception.
43
Liquidity and Capital Resources
The Company does not have commercial products from which to generate cash resources. As a
result, from June 14, 2004 (date of inception) to December 31, 2009, the Company has financed its
operations primarily through a series of issuances of secured convertible notes, the generation of
interest income on the borrowed funds, the Merger with Corautus, a private placement through a
public equities transaction, and debt. The Company expects to incur substantial and increasing
losses for the next several years as it continues to expend substantial resources seeking to
successfully research, develop, manufacture, obtain regulatory approval for, and commercialize its
product candidates.
The Companys ability to meet its obligations in the ordinary course of business is dependent
upon its ability to raise substantial additional financing through public or private equity or debt
financings, collaborative or other strategic arrangements with corporate sources or other sources
of financing, until it is able to establish profitable operations. The Company received
approximately $11.1 million in cash through the Merger with Corautus that was consummated on June
5, 2007, and the Company issued 10,288,065 shares of common stock for $25.0 million in gross
proceeds in the private placement equity financing which closed in July and August of 2007.
In March 2009, the Company entered into the Loan Agreement with the Lenders whereby the
Lenders agreed to lend to the Company in the aggregate up to $10.0 million as more fully described
in Note 6 in the notes to the financial statements. The Company secured the March 2009 Loan with
all of its assets, including the Companys intellectual property. On March 12, 2009, the Company
borrowed an initial amount of $2.0 million. During the three months ended June 30, 2009, the
Company borrowed $2.0 million on May 19, 2009, and another $2.0 million on June 29, 2009. During
the three months ended September 30, 2009, the Company borrowed $2.0 million on August 14, 2009,
and a final $2.0 million on September 11, 2009. According to the terms of the original Loan
Agreement, the debt was due to the Lenders on September 14, 2009. The parties agreed to extend the
repayments terms and, as more fully described in Note 12 in the notes to the financial statements,
on February 26, 2010, the Lenders agreed to modify the Loan Agreement to further extend the
repayment terms to April 1, 2010. The Lenders did not modify the interest rate or offer any
concessions in the amended Loan Agreement. The Company will not be able to repay the loan when it
becomes due on April 1, 2010. When the Company does not repay the loan at maturity, it will be in
default under the March 2009 loan agreement and the Lenders may terminate the March 2009 Loan,
demand immediate payment of all amounts borrowed by the Company and take possession of all
collateral securing the March 2009 Loan, which could cause the Company to cease operations.
Management believes that the $2.2 million of cash on hand at December 31, 2009 is sufficient
for the Company, under normal continuing operations, to meet its current operating cash
requirements through the end of March 2010. As more fully described in Other Information in Part
II, Item 9B and in Note 12 in the Notes to the Financial Statements, in March 2010, the Company
entered into the 2010 Loan Agreement with the Lenders whereby the Lenders agreed to lend to the
Company in the aggregate up to $3.0 million. The Company secured the March 2010 Loan with all of
its assets, including the Companys intellectual property. On March 29, 2010, the Company borrowed
an initial $1.25 million available under the 2010 Loan Agreement. Management believes that the
total amount of cash borrowed under the March 2010 Loan, if fully drawn, will enable the Company to
meet its current obligations into the third quarter of 2010. Management does not believe that
existing cash resources will be sufficient to enable the Company to meet its ongoing working
capital requirements for the next twelve months and the Company will need to raise substantial
additional funding in the near term to repay amounts owed under the March 2009 Loan, which are due
April 1, 2010, and to meet its working capital requirements. As a result, there are substantial
doubts that the Company will be able to continue as a going concern and, therefore, may be unable
to realize its assets and discharge its liabilities in the normal course of business. Management is
continuously exploring financing alternatives, including raising additional capital through private
or public equity or debt financings, the establishment of credit or other funding facilities,
entering into collaborative or other strategic arrangements with corporate sources or other sources
of financing, which may include partnerships for product development and commercialization, merger,
sale of assets or other similar transactions.
Global market and economic conditions have been, and continue to be, disrupted and volatile.
The Company cannot provide assurance that additional financing will be available in the near term
when needed, particularly in light of the current economic environment and adverse conditions in
the financial markets, or that, if available, financing will be obtained on terms favorable to the
Company or to the Companys stockholders. Having insufficient funds may require the Company to
delay, scale back, or eliminate some or all research and development programs, including clinical
trial activities, or to relinquish greater or all rights to product candidates at an earlier stage
of development or on less favorable terms than the Company would otherwise choose. Failure to
obtain adequate financing in the near term will adversely affect the Companys ability to operate
as a going concern and may require the Company to cease operations. If the Company raises
additional capital by issuing equity securities, its
44
existing
stockholders ownership will be
diluted. In addition, to the extent the vested warrants granted to the Lenders to purchase an
aggregate of 83,333,333
shares of common stock at an exercise price of $0.12 per share or the warrants granted to the
Lenders to purchase an aggregate of 17,647,059 shares (of which 7,352,941 are vested as of March
29, 2010) at an exercise price of $0.17 per share, are exercised by the Lenders, existing
stockholders ownership in the Company will be significantly diluted. Any new debt financing the
Company enters into may involve covenants that restrict its operations. The loans with the Lenders
include restrictive covenants relating to the Companys ability to incur additional indebtedness,
make future acquisitions, consummate asset dispositions, grant liens and pledge assets, pay
dividends or make other distributions, incur capital expenditures and make restricted payments. The
Company may also be required to pledge all or substantially all of its assets, including
intellectual property rights, as collateral to secure any debt obligations. The Companys
obligations under the loans are secured by all of the Companys assets, including its intellectual
property and any additional pledge of its assets would require the consent of the Lenders. In
addition, if the Company raises additional funds through collaborative or other strategic
arrangements, the Company may be required to relinquish potentially valuable rights to its product
candidates or grant licenses on terms that are not favorable to the Company.
Prior to the Merger and the private placement, the Company issued secured convertible notes
for a total of $24.4 million from June 14, 2004 (date of inception) to December 31, 2009 to finance
its operations. All of the $24.4 million in secured convertible notes have been converted to equity
as of December 31, 2007. No convertible notes were issued in the years ended December 31, 2009 and
2008.
The Companys cash on hand decreased $1.9 million from $4.1 million at December 31, 2008 to
$2.2 million at December 31, 2009. In the year ended December 31, 2009, the Company received $10.0
million in cash inflows and disbursed $11.9 million in cash outflows resulting in the $1.9 million
decrease in cash. Cash inflows consisted of the $10.0 million in proceeds from borrowings on the
affiliate loan arrangement and $2,000 from employee stock option exercises. Cash outflows consisted
of $4.0 million in payments for payroll and related expenses, $2.9 million in payments for research
and development related expenses, $1.6 million in payments to consultants for consulting services,
$1.2 million in payments for legal services, $1.0 million in payments for corporate expenses,
including audit fees, board fees, and public company expenses, and $1.2 million in payments for
travel reimbursement, facilities and other office related expenses.
The Company used $11.9 million and $18.9 million in net cash from operations in the years
ended December 31, 2009 and 2008, respectively, and $65.5 million for the period from June 14, 2004
(date of inception) to December 31, 2009. The $7.0 million decrease in the net cash used in
operations was comprised of an $703,000 increase in net loss from $20.3 million in the year ended
December 31, 2008 to $21.0 million in the year ended December 31, 2009, a $65,000 decrease in the
change in net assets, a $50,000 decrease in the change in net liabilities, a $6.9 million increase
in the change in amortization of the discount on notes payable, a $789,000 increase in the change
in interest payable to affiliate, and a decrease of $36,000 in stock-based compensation expense.
The $703,000 increase in net loss was the result of a decrease of $5.7 million in research and
development expenses and a $1.5 million decrease in general and administrative expenses, offset by
a decrease of $190,000 in interest income and a $7.7 million increase in interest expense. For the
period from June 14, 2004 (date of inception) to December 31, 2009, the Company used $65.5 million
of net cash in operating activities which was comprised of inception-to-date net losses of $81.6
million, net of $11.5 million non-cash expenses, including $4.0 million inception-to-date
stock-based compensation expense, $600,000 in depreciation and deferred rent expenses, $6.9 million
in interest expense from the amortization of the discount on notes payable, and net of $4.6 million
net increase in the change in net assets and liabilities. The Company cannot be certain if, when or
to what extent it will receive cash inflows from the commercialization of its product candidates.
The Company expects its clinical, research and development expenses to be substantial and to
increase over the next few years as it continues the advancement of its product development
programs.
The Company used $16,000 and $141,000 in net cash from investing activities in the years ended
December 31, 2009 and 2008, respectively, and obtained $10.1 million cash from investing activities
for the period from June 14, 2004 (date of inception) to December 31, 2009. The Company used
$16,000 and $141,000 in cash for capital expenditures in the years ended December 31, 2009 and
2008, respectively. From June 14, 2004 (date of inception) to December 31, 2009, the Company
received $11.1 million in cash from the Merger with Corautus, net of an additional $350,000 in
capitalized Merger costs and $664,000 in capital expenditures.
The Company received $10.0 million in cash from financing activities through a loan
arrangement with its principal stockholder in the year ended December 31, 2009. There were no debt
financings in the year ended December 31, 2008, and there were no equity financings in the years
ending December 31, 2009 and 2008. The Company received $2,000 in cash from employee exercises of
stock options in the years ended December 31, 2009 and 2008. The Company used $0 and $2,000 of cash
from financing activities in capital equipment lease payments in the years ended December 31, 2009
and 2008, respectively. From June 14, 2004 (date of inception) to December 31, 2009, the Company
received $57.6 million in net cash provided by financing activities, including $10.0 million in new
notes payable borrowings from the principal stockholder in the year ended December 31, 2009, $24.4
million of cash received through the issuance of secured convertible debt, $23.1 million of net
cash received through the equity financing completed in 2007, and $100,000 of cash received from
employee and consultant exercises of stock options.
45
Contractual Obligation and Commitments
The following table describes the Companys contractual obligations and commitments as of
December 31, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period |
|
|
|
|
|
|
|
Less Than |
|
|
|
|
|
|
|
|
|
|
After |
|
|
|
Total |
|
|
1 Year |
|
|
1-3 Years |
|
|
4-5 Years |
|
|
5 Years |
|
Operating lease obligations (1) |
|
$ |
1,385,584 |
|
|
$ |
437,597 |
|
|
$ |
808,245 |
|
|
$ |
139,742 |
|
|
$ |
|
|
Notes and related interest payable affiliate (2) |
|
|
10,789,041 |
|
|
|
10,789,041 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Uncertain tax positions (3) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing agreements (4) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
12,174,625 |
|
|
$ |
11,226,638 |
|
|
$ |
808,245 |
|
|
$ |
139,742 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Operating lease obligations reflect contractual commitments for the
Companys office facilities for its headquarters in San Francisco,
California and its clinical operations location in Princeton, New
Jersey. In January 2008, the Company expanded and extended both leases
to ensure adequate facilities for current activities. The
San Francisco headquarters lease has been extended through May 31,
2013 and has been expanded to a total of 8,180 square feet. The lease
amendment resulted in an increase of approximately $1.5 million in
future rent. The lease amendment to the Princeton, New Jersey facility
extends the lease through April 2, 2012 and has been expanded to a
total of 4,979 square feet. The lease amendment resulted in an
increase of approximately $330,000 in future rent. |
|
(2) |
|
As more fully described in Note 6 in the notes to the financial
statements, in March 2009, the Company entered into the Loan Agreement
with the Lenders whereby the Lenders agreed to lend to the Company in
the aggregate up to $10.0 million, pursuant to the terms of the Notes
delivered under the Loan Agreement. On March 12, 2009, the Company
borrowed an initial amount of $2.0 million. During the three months
ended June 30, 2009, the Company borrowed $2.0 million on May 19,
2009, and another $2.0 million on June 29, 2009. During the three
months ended September 30, 2009, the Company borrowed $2.0 million on
August 14, 2009, and a final $2.0 million on September 11, 2009. The
Notes are secured by a first priority lien on all of the assets of the
Company, including the Companys intellectual property. Amounts
borrowed under the Notes accrue interest at the rate of 15% per annum,
which increases to 18% per annum following an event of default. As of
December 31, 2009, the Company accrued $789,041 in interest payable -
affiliate for unpaid interest expenses. Unless earlier paid in
accordance with the terms of the Notes, all unpaid principal and
accrued interest shall become fully due and payable on the earlier to
occur of (i) April 1, 2010, as more fully discussed in Note 12 in the
notes to the financial statements, (ii) the closing of a Financing,
and (iii) the closing of a transaction in which the Company sells,
conveys, licenses or otherwise disposes of a majority of its assets or
is acquired by way of a merger, consolidation, reorganization or other
transaction or series of transactions pursuant to which stockholders
of the Company prior to such acquisition own less than 50% of the
voting interests in the surviving or resulting entity. |
|
(3) |
|
The Company adopted new accounting guidance for the accounting for
uncertainty in income tax positions on the first day of its 2007
fiscal year. The amount of unrecognized tax benefits at December 31,
2009 was $584,710. This amount has been excluded from the contractual
obligations table because a reasonably reliable estimate of the timing
of future tax settlements cannot be determined. |
|
(4) |
|
Under certain licensing agreements, Roche may receive up to $22.4
million in milestone payments, the majority of which would be tied to
the achievement of product development and regulatory milestones. In
addition, once products containing the compounds are approved for
marketing, Roche will receive single-digit royalties based on net
sales, subject to certain reductions. |
Off-Balance Sheet Arrangements
The Company has not engaged in any off-balance sheet activities.
Critical Accounting Policies
The Companys discussion and analysis of its financial condition and results of operations are
based on its financial statements, which have been prepared in accordance with GAAP. The
preparation of these financial statements requires the Company to make estimates and judgments that
affect the reported amounts of assets and liabilities and the disclosure of contingent assets and
liabilities at the date of the financial statements and the reported amounts of revenue and
expenses during the reporting periods. Note 2 in the Notes to the Financial Statements includes a
summary of the Companys significant
46
accounting
policies and methods used in the preparation of the Companys financial statements. On an ongoing basis, the Companys
management evaluates its estimates and judgments, including those related to accrued expenses and
the fair value of its common stock. The Companys management bases its estimates on historical
experience, known trends and events, and various other factors that it believes to be reasonable
under the circumstances, which form its basis for managements 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 Companys management believes the following accounting policies and estimates are most
critical to aid in understanding and evaluating the Companys reported financial results.
A critical accounting policy is defined as one that is both material to the presentation of
our financial statements and requires management to make difficult, subjective or complex judgments
that could have a material effect on our financial condition and results of operations.
Specifically, critical accounting estimates have the following attributes: (i) we are required to
make assumptions about matters that are uncertain at the time of the estimate; and (ii) different
estimates we could reasonably have used, or changes in the estimate that are reasonably likely to
occur, would have a material effect on our financial condition or results of operations.
Estimates and assumptions about future events and their effects cannot be determined with
certainty. We base our estimates on historical experience, facts available to date, and on various
other assumptions believed to be applicable and reasonable under the circumstances. These estimates
may change as new events occur, as additional information is obtained and as our operating
environment changes. These changes have historically been minor and have been included in the
financial statements as soon as they became known. The estimates are subject to variability in the
future due to external economic factors as well as the timing and cost of future events. Based on a
critical assessment of our accounting policies and the underlying judgments and uncertainties
affecting the application of those policies, management believes that our financial statements are
fairly stated in accordance with GAAP, and present a meaningful presentation of our financial
condition and results of operations. We believe the following critical accounting policies reflect
our more significant estimates and assumptions used in the preparation of our financial statements.
Research and Development Accruals
As part of the process of preparing its financial statements, the Company is required to
estimate expenses that the Company believes it has incurred, but has not yet been billed for. This
process involves identifying services and activities that have been performed by third party
vendors on the Companys behalf and estimating the level to which they have been performed and the
associated cost incurred for such service as of each balance sheet date in its financial
statements. Examples of expenses for which the Company accrues include professional services, such
as those provided by certain CROs and investigators in conjunction with clinical trials, and fees
owed to contract manufacturers in conjunction with the manufacture of clinical trial materials. The
Company makes these estimates based upon progress of activities related to contractual obligations
and also information received from vendors.
A substantial portion of our preclinical studies and all of the Companys clinical trials have
been performed by third-party CROs and other vendors. For preclinical studies, the significant
factors used in estimating accruals include the percentage of work completed to date and contract
milestones achieved. For clinical trial expenses, the significant factors used in estimating
accruals include the number of patients enrolled, duration of enrollment and percentage of work
completed to date.
The Company monitors patient enrollment levels and related activities to the extent possible
through internal reviews, correspondence and status meetings with CROs, and review of contractual
terms. The Companys estimates are dependent on the timeliness and accuracy of data provided by our
CROs and other vendors. If we have incomplete or inaccurate data, we may either underestimate or
overestimate activity levels associated with various studies or trials at a given point in time. In
this event, we could record adjustments to research and development expenses in future periods when
the actual activity level become known. No material adjustments to preclinical study and clinical
trial expenses have been recognized to date.
Incentive Award Accruals
The Company accrues for liabilities under discretionary employee and executive incentive award
plans. These estimated liabilities are based upon progress against corporate objectives approved
by the Board of Directors, compensation levels of eligible individuals, and target bonus percentage
level of employees. The Board of Directors and the Compensation Committee of the Board of
Directors review and evaluate the performance against these objectives and ultimately determine
what discretionary payments are made. Included in accrued liabilities at December 31, 2009 and
December 31, 2008, we have accrued $1,308,043 and $727,539, respectively, for liabilities
associated with these employee and executive incentive award plans. As described in Note 12 to the
financial statements, on March 26, 2010, the Companys Board of Directors approved a
restructuring of the Company to reduce its workforce and operating
costs effective March 31, 2010. The impact of the restructuring included reversal
of $531,000 of incentive award accruals recorded as of December 31, 2009 related to
terminated employees, which will be reflected in the quarter ended March 31, 2010.
47
Stock-based Compensation
On January 1, 2006, the Company adopted new accounting guidance for accounting for stock-based
compensation. Under the fair value recognition provisions of this accounting guidance, stock-based
compensation cost is measured at the grant date based on the fair value of the award and is
recognized as expense on a straight-line basis over the requisite service period, which is the
vesting period. The Company elected the modified-prospective method, under which prior periods are
not revised for comparative purposes. The valuation provisions of the accounting guidance apply to
new grants and to grants that were outstanding as of the effective date and are subsequently
modified. Estimated compensation for grants that were outstanding as of the effective date of this
new guidance are now being recognized over the remaining service period using the compensation cost
estimated for the required pro forma disclosures.
The Company uses the Black-Scholes option pricing model to estimate the fair value of
stock-based awards. The determination of the fair value of stock-based awards on the date of grant
using an option-pricing model is affected by the value of the Companys stock price as well as
assumptions regarding a number of complex and subjective variables. These variables include
expected stock price volatility over the term of the awards, actual and projected employee stock
option exercise behaviors, risk-free interest rate and expected dividends.
Prior to June 5, 2007, the Company was a privately-held company and its common stock was not
publicly traded. The fair value of stock options granted from January 2006 through June 5, 2007
(date of completion of the Merger with Corautus), and related stock-based compensation expense,
were determined based upon quoted stock prices of Corautus, the exchange ratio of shares in the
Merger, and a private company 10% discount for grants prior to March 31, 2007, as this represented
the best estimate of market value to use in measuring compensation. Subsequent to the Merger, the
Company, now publicly held, uses the closing stock price of the Companys common stock on the date
the options are granted to determine the fair market value of each option. The Company revalues
each non-employee option quarterly based on the closing stock price of the Companys common stock
on the last day of the quarter. The Company also revalues options when there is a change in
employment status.
The Company estimates the expected term of options granted by taking the average of the
vesting term and the contractual term of the option. As of December 31, 2009, the Company estimates
common stock price volatility using a hybrid approach consisting of the weighted-average of actual
historical volatility using a look back period of approximately two years, representing the period
of time the Companys stock has been publicly traded, blended with an average of selected peer
group volatility for approximately six years, consistent with the expected life from grant date.
The volatility for the Company and the selected peer group was approximately 130% and 104%,
respectively, as of December 31, 2009, and the blended volatility rate was approximately 114% as of
December 31, 2009. The Company will continue to incrementally increase the look back period of the
Companys common stock and percent of actual historical volatility until historical data meets or
exceeds the estimated term of the options. Prior to the year ended December 31, 2009, the Company
used peer group calculated volatility as the Company is a development stage company with limited
stock price history from which to forecast stock price volatility. The risk-free interest rates
used in the valuation model are based on U.S. Treasury issues with remaining terms similar to the
expected term on the options. The Company does not anticipate paying any dividends in the
foreseeable future and therefore used an expected dividend yield of zero.
The Company calculated an annualized forfeiture rate of 2.82% and 4.0% using historical data
for the years ended December 31, 2009 and 2008, respectively. This rate was used to exclude future
forfeitures in the calculation of stock-based compensation expense as of December 31, 2009 and
2008, respectively.
The assumptions used to value option and restricted stock award grants for the years ended
December 31, 2009 and 2008 are as follows:
|
|
|
|
|
|
|
|
|
|
|
Years Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
Expected life from grant date |
|
|
6.08 7.96 |
|
|
|
2.75 6.25 |
|
Expected volatility |
|
|
105% 114 |
% |
|
|
79% 82 |
% |
Risk free interest rate |
|
|
2.89% 3.07 |
% |
|
|
1.52% 3.49 |
% |
Dividend yield |
|
|
|
|
|
|
|
|
48
The following table summarizes stock-based compensation expense related to stock options and
warrants for the years ended December 31, 2009 and 2008 and for the period from June 14, 2004 (date
of inception) to December 31, 2009, which was included in the statements of operations in the
following captions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
|
|
|
|
|
|
June 14, 2004 |
|
|
|
Years Ended |
|
|
(Date of Inception)to |
|
|
|
December 31, |
|
|
December 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
Research and development expense |
|
$ |
260,226 |
|
|
$ |
319,990 |
|
|
$ |
1,079,426 |
|
General and administrative expense |
|
|
941,540 |
|
|
|
979,061 |
|
|
|
2,804,862 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
1,201,766 |
|
|
$ |
1,299,051 |
|
|
$ |
3,884,288 |
|
|
|
|
|
|
|
|
|
|
|
If all of the remaining non-vested and outstanding stock option awards that have been granted
became vested, we would recognize approximately $1.7 million in compensation expense over a
weighted average remaining period of 1.6 years. However, no compensation expense will be recognized
for any stock option awards that do not vest.
The following table summarizes stock-based compensation expense related to employee restricted
stock awards for the years ended December 31, 2009 and 2008 and for the period from June 14, 2004
(date of inception) to December 31, 2009, which was included in the statements of operations in the
following captions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
|
|
|
|
|
|
June 14, 2004 |
|
|
|
Years Ended |
|
|
(Date of Inception) to |
|
|
|
December 31, |
|
|
December 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
Research and development expense |
|
$ |
15,734 |
|
|
$ |
634 |
|
|
$ |
16,368 |
|
General and administrative expense |
|
|
47,655 |
|
|
|
1,893 |
|
|
|
49,548 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
63,389 |
|
|
$ |
2,527 |
|
|
$ |
65,916 |
|
|
|
|
|
|
|
|
|
|
|
If all of the remaining non-vested restricted stock awards that have been granted became
vested, we would recognize approximately $61,000 in compensation expense over a weighted average
remaining period of 1.0 years. However, no compensation expense will be recognized for any stock
option awards that do not vest.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
See Item 15. Exhibits and Financial Statement Schedules.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
None.
ITEM 9A(T). CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
The Company maintains a set of disclosure controls and procedures designed to ensure that
information required to be disclosed by the Company in reports that it files or submits under the
Securities Exchange Act of 1934, as amended (the Exchange Act), is recorded, processed,
summarized and reported within the time periods specified in SEC rules and forms. As of the end of
the period covered by this Annual Report on Form 10-K, an evaluation was carried out under the
supervision and with the participation of the Companys management, including its Chief Executive
Officer and Chief Financial Officer, of the effectiveness of its disclosure controls and
procedures. Based on that evaluation, the Companys Chief Executive Officer and Chief Financial
Officer concluded that the Companys disclosure controls and procedures, as of the end of the
period covered by this Annual Report on Form 10-K, were effective at the reasonable assurance level
to ensure that information required to be disclosed by the Company in reports that it files or
submits under the Exchange Act is recorded, processed, summarized and reported within the time
periods specified in SEC rules and forms and is accumulated and communicated to the Companys
management, including the Chief Executive Officer and Chief Financial Officer, as appropriate to
allow timely decisions regarding required disclosure.
49
Managements Annual Report on Internal Control Over Financial Reporting
Internal control over financial reporting refers to the process designed by, or under the
supervision of, the Companys Chief Executive Officer and Chief Financial Officer, and effected by
the Companys board of directors, management and other personnel, to
provide reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with generally accepted
accounting principles, and includes those policies and procedures that:
|
1. |
|
Pertain to the maintenance of records that in reasonable detail accurately and fairly
reflect the transactions and dispositions of the assets of the Company; |
|
|
2. |
|
Provide reasonable assurance that transactions are recorded as necessary to permit
preparation of financial statements in accordance with generally accepted accounting principles,
and that receipts and expenditures of the Company are being made only in accordance with
authorizations of management and directors of the Company; and |
|
|
3. |
|
Provide reasonable assurance regarding prevention or timely detection of unauthorized
acquisition, use or disposition of the Companys assets that could have a material effect on the
financial statements. |
Internal control over financial reporting cannot provide absolute assurance of achieving
financial reporting objectives because of its inherent limitations. Internal control over financial
reporting is a process that involves human diligence and compliance and is subject to lapses in
judgment and breakdowns resulting from human failures. Internal control over financial reporting
also can be circumvented by collusion or improper management override. Because of such limitations,
there is a risk that material misstatements may not be prevented or detected on a timely basis by
internal control over financial reporting. However, these inherent limitations are known features
of the financial reporting process. Therefore, it is possible to design into the process safeguards
to reduce, though not eliminate, this risk. Management is responsible for establishing and
maintaining adequate internal control over financial reporting for the Company.
Management conducted an evaluation of the effectiveness of the Companys internal control over
financial reporting based on the framework set forth in the report entitled Internal Control
Integrated Framework published by the Committee of Sponsoring Organizations of the Treadway
Commission. Based on this evaluation, management has concluded that the Companys internal control
over financial reporting was effective as of December 31, 2009.
This Annual Report does not include an attestation report of the Companys registered public
accounting firm regarding internal control over financial reporting. Managements report was not
subject to attestation by the Companys registered public accounting firm pursuant to temporary
rules of the SEC that permit the Company to provide only managements report in this Annual Report.
Changes in Internal Control Over Financial Reporting
There have not been any changes in the Companys internal control over financial reporting
that occurred during the Companys last fiscal quarter that has materially affected, or is
reasonably likely to materially affect, internal control over financial reporting.
ITEM 9B. OTHER INFORMATION
On March 26, 2010, the Company entered into a Note and Warrant Purchase Agreement (the 2010
Loan Agreement) with the Lenders whereby the Lenders agreed to lend to the Company in the
aggregate up to $3,000,000, pursuant to the terms of promissory notes (collectively, the 2010
Notes) delivered under the 2010 Loan Agreement (the 2010 Loan Transaction). On March 29, 2010,
the Company borrowed an initial amount of $1,250,000. Subject to the Lenders approval, the
Company may borrow in the aggregate up to an additional $1,750,000 at subsequent closings pursuant
to the terms of the 2010 Loan Agreement and 2010 Notes.
The 2010 Notes are secured by a lien on all of the assets of the Company. Amounts borrowed
under the 2010 Notes accrue interest at the rate of fifteen percent (15%) per annum, which
increases to eighteen percent (18%) per annum following an event of default. Unless earlier paid in
accordance with the terms of the 2010 Notes, all unpaid principal and accrued interest shall become
fully due and payable on the earlier to occur of (i) December 31, 2010, (ii) the closing of a debt,
equity or combined debt/equity financing resulting in gross proceeds or available credit to the
Company of not less than $20,000,000, and (iii) the closing of a transaction in which the Company
sells, conveys, licenses or otherwise disposes of a majority of its assets or is acquired by way of
a merger, consolidation, reorganization or other transaction or series of transactions pursuant to
which stockholders of the Company prior to such acquisition own less than 50% of the voting
interests in the surviving or resulting entity.
50
Pursuant to the 2010 Loan Agreement, the Company issued to the Lenders warrants (the 2010
Warrants) to purchase an aggregate of 17,647,059 shares (the 2010 Warrant Shares) of
common stock at $0.17 per share. The number of 2010 Warrant Shares
is equal to the $3,000,000 maximum aggregate principal amount that may be borrowed under the
2010 Loan Agreement, divided by the $0.17 per share exercise price of the 2010 Warrants. The 2010
Warrant Shares vest based on the amount of borrowings under the 2010 Notes. Based on the $1,250,000
borrowing at the initial closing, 7,352,941 of the 2010 Warrant Shares vested immediately on the
date of grant. At each subsequent closing, the 2010 Warrants will vest with respect to the
additional amount borrowed by the Company. The 2010 Warrant Shares, to the extent they are vested
and exercisable, are exercisable at any time until March 26, 2015.
On March 26, 2010 the Companys Board of Directors approved a restructuring of the Company to
reduce its workforce and operating costs effective March 31, 2010. The reduction in workforce
decreased total employees by approximately 63% to a total of six employees, and increased the focus
of future operating expense on research and development activities. This decision resulted in
recording a charge to operating expenses of approximately $69,000 in March 2010. This charge
includes cash costs of restructuring, principally related to severance and related medical costs
for terminated employees, of approximately $413,000, and non-cash charges of approximately $187,000
related to the fair value of excess facilities at the Companys corporate headquarters, offset by
approximately $531,000 related to the reversal of previously recorded incentive award accruals
recorded as of December 31, 2009. In addition to this restructuring charge, the Company will pay
terminated employees approximately $183,000 for amounts accrued for unused vacation and sick pay.
The total estimated cash cost of the restructuring costs, and amounts to be paid for accrued
vacation and sick pay, is approximately $596,000. The Company expects that restructuring decisions
will reduce operating costs for 2010 by approximately $1,320,000, with approximately $88,000 of
this amount being non-cash related to excess facility costs at the Companys corporate
headquarters. The personnel-related restructuring charges that the Company expects to incur are
subject to a number of assumptions and actual results may differ. The Company may also incur other
material charges not currently contemplated due to the events that may occur as a result of, or
associated with, the restructuring plan.
In connection with the restructuring and reduction in workforce, the employment of James G.
Stewart, Senior Vice President, Chief Financial Officer and Secretary, will terminate effective
March 31, 2010. Among the positions also affected by the reduction in workforce is the Senior Vice
President of Business Development.
In connection with the 2010 Loan Transaction and the 2010 Warrants, on March 26, 2010, the
Company also amended the Second Amended and Restated Registration Rights Agreement (the
Registration Rights Agreement) with the Lenders and certain stockholders of the Company (the
Lenders and certain stockholders collectively, the Stockholders), to include the 2010 Warrants
Shares in the Registration Rights Agreement, pursuant to which the Company has granted certain
demand, shelf and piggyback registration rights to such Stockholders to register their shares of
common stock with the SEC so that such shares become freely tradeable without restriction under the
Securities Act.
The Lenders beneficially owned in the aggregate approximately 90% of the Companys common
stock immediately prior to the 2010 Loan Transaction. Fred B. Craves, Ph.D., a member of the
Companys Board of Directors, is the founder, chairman, and a manager of Bay City Capital LLC, the
beneficial owner of the shares held by the Investors. Dr. Craves also owns 22.0588% of the
membership interests in Bay City Capital LLC. Douglass Given, the chairman of the Companys Board
of Directors is an investment partner of Bay City Capital LLC.
The 2010 Loan Transaction was approved by the Companys Board of Directors on March 26, 2010
following the recommendation of a special committee of the Companys Board of Directors.
The 2010 Loan Agreement, the 2010 Notes, the 2010 Warrants and the amendment to the
Registration Rights Agreement (collectively, the Filed Agreements) have been filed as exhibits to
this Form 10-K to provide investors and security holders with information regarding their terms.
They are not intended to provide any other factual information about the Company. The
representations, warranties, and covenants contained in the Filed Agreements were made only for
purpose of the Filed Agreements and as of specific dates, were solely for the benefit of the
parties to the Filed Agreements, and may be subject to limitations agreed upon by the contracting
parties, including being qualified by confidential disclosures exchanged between the parties in
connection with the execution of the Filed Agreements. The representations and warranties may have
been made for the purposes of allocating contractual risk between the parties to the Filed
Agreements instead of establishing these matters as facts, and may be subject to standards of
materiality applicable to the contracting parties that differ from those applicable to investors.
Investors and security holders (other than the Lenders who are a party to the Filed Agreements) are
not third-party beneficiaries under the Filed Agreements and should not rely on the
representations, warranties and covenants or any descriptions thereof as characterizations of the
actual state of facts or condition of the Company. Moreover, information concerning the subject
matter of the representations and warranties may change after the date of the Filed Agreements,
which subsequent information may or may not be fully reflected in the Companys public disclosures.
51
The 2010 Warrants issued to the Lenders were offered and issued pursuant to a private
placement in reliance upon the exemption from registration pursuant to Rule 506 under the
Securities Act. Each Lender represented to the Company that it is an accredited investor as
defined in Rule 501(a) of Regulation D and that such Lender is acquiring the securities for
investment purposes for such Lenders own account and not with a view toward distribution of the
securities. The Company advised the Lenders that the 2010 Warrants and the securities underlying
the 2010 Warrants have not been registered under the Securities Act and may not be sold unless they
are registered under the Securities Act or sold pursuant to a valid exemption from registration
under the Securities Act. The 2010 Warrants issued to the Lenders contain legends that the 2010
Warrants have not been registered under the Securities Act and states the restrictions on transfer
and resale as described above. Additionally, the Company did not engage in any general
solicitation or advertisement in connection with the issuance of the 2010 Warrants.
PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The information required by this item with respect to directors is incorporated herein by
reference to the information regarding directors included in our proxy statement for our 2010
Annual Meeting of Stockholders. The information required by this item with respect to our executive
officers is set forth in Part I, Item 1 of this report under the caption Executive Officers of the
Registrant. Information required by Item 405 of Regulation S-K will be set forth under the caption
Section 16(a) Beneficial Ownership Reporting Compliance in our proxy statement for our 2010
Annual Meeting of Stockholders and is incorporated herein by reference.
The information required by this item regarding our audit committee members and our audit
committee financial expert is incorporated herein by reference from the information provided under
the heading Meetings and Committees of the Board of Directors The Audit Committee in our proxy
statement for our 2010 Annual Meeting of Stockholders.
The information required by this item with respect to our code of business conduct and ethics
is incorporated herein by reference to the information included in our proxy statement for our 2010
Annual Meeting of Stockholders.
The information required by this item regarding material changes to the procedures by which
our stockholders may recommend nominees to our board of directors is incorporated herein by
reference from the information provided under the heading Meetings and Committees of the Board of
Directors The Nominating and Governance Committee in our proxy statement for our 2010 Annual
Meeting of Stockholders.
ITEM 11. EXECUTIVE COMPENSATION
The information required by this item is incorporated herein by reference to the information
regarding executive compensation included in our proxy statement for our 2010 Annual Meeting of
Stockholders.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER
MATTERS
The information required by this item is incorporated herein by reference to the information
regarding security ownership of certain beneficial owners and management and related stockholder
matters included in our proxy statement for our 2010 Annual Meeting of Stockholders.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
The information required by this item is incorporated herein by reference to the information
regarding certain relationships and related transactions, and director independence included in our
proxy statement for our 2010 Annual Meeting of Stockholders.
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
The information required under this item is incorporated herein by reference to the
information regarding principal accountant fees and services included in our proxy statement for
our 2010 Annual Meeting of Stockholders.
52
PART IV
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
1. Financial Statements and Financial Statement Schedules
The Companys Financial Statements included in Item 8 include:
2. Financial Statement Schedules
All other schedules not listed above have been omitted, because they are not applicable or not
required, or because the required information is included in the financial statements or notes
thereto.
3. Exhibits required to be filed by Item 601 of Regulation S-K.
|
|
|
Exhibit |
|
|
Number |
|
Description |
2.1
|
|
Agreement and Plan of Merger and Reorganization, dated February 7, 2007, as amended, by and among
Corautus Genetics Inc., Resurgens Merger Corp., and VIA Pharmaceuticals, Inc. (filed as Exhibit 2.1 to
the Form 8-K filed on February 8, 2007 and incorporated herein by reference) |
|
|
|
3.1
|
|
Restated Certificate of Incorporation (filed as Exhibit 3.1 to the Form 10-K filed on March 22, 2005
and incorporated herein by reference) |
|
|
|
3.2
|
|
Certificate of Amendment to the Restated Certificate of Incorporation (filed as Exhibit 3.1 to the
Form 10-KSB filed on March 30, 2000 and incorporated herein by reference) |
|
|
|
3.3
|
|
Certificate of Amendment to the Restated Certificate of Incorporation (filed as Exhibit 3.3 to the
Form 10-K filed on March 28, 2003 and incorporated herein by reference) |
|
|
|
3.4
|
|
Certificate of Amendment to the Restated Certificate of Incorporation (filed as Exhibit 3.4 to the
Form 10-K filed on March 28, 2003 and incorporated herein by reference) |
|
|
|
3.5
|
|
Certificate of Amendment to the Restated Certificate of Incorporation (filed as Exhibit 3.5 to the
Form 10-K filed on March 28, 2003 and incorporated herein by reference) |
|
|
|
3.6
|
|
Amended and Restated Certificate of Designation of Preferences and Rights of Series C Preferred Stock
(filed as Annex H to the Form S-4/A filed on December 19, 2002 and incorporated herein by reference) |
|
|
|
3.7
|
|
Certificate of Amendment to the Restated Certificate of Incorporation (Increase in Authorized Shares)
(filed as Exhibit 3.7 to the Form 10-Q filed on August 14, 2007 and incorporated herein by reference) |
|
|
|
3.8
|
|
Certificate of Amendment to the Restated Certificate of Incorporation (Reverse Stock Split) (filed as
Exhibit 3.8 to the Form 10-Q filed on August 14, 2007 and incorporated herein by reference) |
|
|
|
3.9
|
|
Certificate of Amendment to the Restated Certificate of Incorporation (Name Change) (filed as Exhibit
3.9 to the Form 10-Q filed on August 14, 2007 and incorporated herein by reference) |
53
|
|
|
Exhibit |
|
|
Number |
|
Description |
3.10
|
|
Fourth Amended and Restated Bylaws (filed as Exhibit 3.1 to the Form 8-K filed on April 17, 2008 and
incorporated herein by reference) |
|
|
|
4.1
|
|
Warrant issued to Trout Partners LLC, dated July 31, 2007 (filed as Exhibit 99.1 to the Form 8-K filed
on August 6, 2007 and incorporated herein by reference) |
|
|
|
4.2
|
|
Warrant issued to Redington, Inc., dated March 1, 2008 (filed as Exhibit 4.2 to the Form 10-K filed on
March 28, 2008 and incorporated herein by reference) |
|
|
|
4.3
|
|
Warrant to Purchase Common Stock of VIA Pharmaceuticals, Inc. issued to Bay City Capital Fund IV Fund,
L.P., dated March 12, 2009 (filed as Exhibit 4.1 to the Form 8-K filed on March 12, 2009 and
incorporated herein by reference) |
|
|
|
4.4
|
|
Warrant to Purchase Common Stock of VIA Pharmaceuticals, Inc. issued to Bay City Capital Fund IV
Co-Investment Fund, L.P., dated March 12, 2009 (filed as Exhibit 4.2 to the Form 8-K filed on March
12, 2009 and incorporated herein by reference) |
|
|
|
4.5
|
|
Warrant to Purchase Common Stock of VIA Pharmaceuticals, Inc. issued to Bay City Capital Fund IV Fund,
L.P., dated March 26, 2010 |
|
|
|
4.6
|
|
Warrant to Purchase Common Stock of VIA Pharmaceuticals, Inc. issued to Bay City Capital Fund IV
Co-Investment Fund, L.P., dated March 26, 2010 |
|
|
|
4.7
|
|
Second Amended and Restated Registration Rights Agreement, dated as of March 12, 2009, by and among
VIA Pharmaceuticals, Inc. and the parties named therein (filed as Exhibit 4.3 to the Form 8-K filed on
March 12, 2009 and incorporated herein by reference) |
|
|
|
4.8
|
|
Amendment No. 1 to the Second Amended and Restated Registration Rights Agreement, dated as of March
26, 2010, by and among VIA Pharmaceuticals, Inc. and the parties named therein |
|
|
|
10.1
|
|
Note and Warrant Purchase Agreement, dated as of March 12, 2009 by and among VIA Pharmaceuticals,
Inc., Bay City Capital Fund IV, L.P. and Bay City Capital Fund IV Co-Investment Fund, L.P. (filed as
Exhibit 10.1 to the Form 8-K filed on March 12, 2009 and incorporated herein by reference) |
|
|
|
10.2
|
|
Note and Warrant Purchase Agreement, dated as of March 26, 2010 by and among VIA Pharmaceuticals,
Inc., Bay City Capital Fund IV, L.P. and Bay City Capital Fund IV Co-Investment Fund, L.P. |
|
|
|
10.3
|
|
Promissory Note, dated as of March 12, 2009, by VIA Pharmaceuticals, Inc. and payable to Bay City
Capital Fund IV, L.P. (filed as Exhibit 10.2 to the Form 8-K filed on March 12, 2009 and incorporated
herein by reference) |
|
|
|
10.4
|
|
Promissory Note, dated as of March 12, 2009, by VIA Pharmaceuticals, Inc. and payable to Bay City
Capital Fund IV Co-Investment Fund, L.P. (filed as Exhibit 10.3 to the Form 8-K filed on March 12,
2009 and incorporated herein by reference) |
|
|
|
10.5
|
|
First Amendment to Promissory Note, dated as of September 11, 2009, by VIA Pharmaceuticals, Inc. and
Bay City Capital Fund IV, L.P. (filed as Exhibit 10.1 to the Form 8-K filed on September 11, 2009 and
incorporated herein by reference) |
|
|
|
10.6
|
|
First Amendment to Promissory Note, dated as of September 11, 2009, by VIA Pharmaceuticals, Inc. and
Bay City Capital Fund IV Co-Investment Fund, L.P. (filed as Exhibit 10.2 to the Form 8-K filed on
September 11, 2009 and incorporated herein by reference) |
|
|
|
10.7
|
|
Second Amendment to Promissory Note, dated as of September 11, 2009, by VIA Pharmaceuticals, Inc. and
Bay City Capital Fund IV, L.P. (filed as Exhibit 10.1 to the Form 8-K filed on October 30, 2009 and
incorporated herein by reference) |
|
|
|
10.8
|
|
Second Amendment to Promissory Note, dated as of September 11, 2009, by VIA Pharmaceuticals, Inc. and
Bay City Capital Fund IV Co-Investment Fund, L.P. (filed as Exhibit 10.2 to the Form 8-K filed on
October 30, 2009 and incorporated herein by reference) |
|
|
|
10.9
|
|
Third Amendment to Promissory Note, dated as of September 11, 2009, by VIA Pharmaceuticals, Inc. and
Bay City Capital Fund IV, L.P. (filed as Exhibit 10.1 to the Form 8-K filed on December 22, 2009 and
incorporated herein by reference) |
54
|
|
|
Exhibit |
|
|
Number |
|
Description |
10.10
|
|
Third Amendment to Promissory Note, dated as of September 11, 2009, by VIA Pharmaceuticals, Inc. and
Bay City Capital Fund IV Co-Investment Fund, L.P. (filed as Exhibit 10.2 to the Form 8-K filed on
December 22, 2009 and incorporated herein by reference) |
|
|
|
10.11
|
|
Promissory Note, dated as of March 26, 2010, by VIA Pharmaceuticals, Inc. and payable to Bay City
Capital Fund IV, L.P. |
|
|
|
10.12
|
|
Promissory Note, dated as of March 26, 2010, by VIA Pharmaceuticals, Inc. and payable to Bay City
Capital Fund IV Co-Investment Fund, L.P. |
|
|
|
10.13
|
|
Form of Securities Purchase Agreement, dated June 29, 2007, by and among VIA Pharmaceuticals, Inc. and
the Investors named therein (filed as Exhibit 10.1 to the Form 8-K filed on July 3, 2007 and
incorporated herein by reference) |
|
|
|
10.14
|
|
Exclusive License Agreement, effective August 10, 2005, between VIA Pharmaceuticals, Inc. and Abbott
Laboratories (filed as Exhibit 10.4 to the Form 10-Q filed on August 14, 2007 and incorporated herein
by reference) |
|
|
|
10.15
|
|
Research, Development and Commercialization Agreement, dated as of December 18, 2008, by and between
Hoffmann-La Roche Inc., F. Hoffmann-La Roche Ltd and VIA Pharmaceuticals, Inc. (filed as Exhibit 10.1
to the Form 8-K filed on December 23, 2008 and incorporated herein by reference) |
|
|
|
10.16
|
|
Research, Development and Commercialization Agreement, dated as of December 18, 2008, by and between
Hoffmann-La Roche Inc., F. Hoffmann-La Roche Ltd and VIA Pharmaceuticals, Inc. (filed as Exhibit 10.2
to the Form 8-K filed on December 23, 2008 and incorporated herein by reference) |
|
|
|
10.17
|
|
Employment Agreement, dated as of August 10, 2004, by and between VIA Pharmaceuticals, Inc. and
Lawrence K. Cohen (filed as Exhibit 10.2 to the Form 8-K filed on June 11, 2007 and incorporated
herein by reference) |
|
|
|
10.18
|
|
Amendment to Employment Agreement, dated as of June 4, 2007, by and between VIA Pharmaceuticals, Inc.
and Lawrence K. Cohen (filed as Exhibit 10.3 to the Form 8-K filed on June 11, 2007 and incorporated
herein by reference) |
|
|
|
10.19
|
|
Letter Agreement, dated as of October 3, 2006, between VIA Pharmaceuticals, Inc. and James G. Stewart
(filed as Exhibit 10.6 to the Form 8-K filed on June 11, 2007 and incorporated herein by reference) |
|
|
|
10.20
|
|
Amendment to Letter Agreement, dated as of June 4, 2007, by and between VIA Pharmaceuticals, Inc. and
James G. Stewart (filed as Exhibit 10.7 to the Form 8-K filed on June 11, 2007 and incorporated herein
by reference) |
|
|
|
10.21
|
|
Letter Agreement, dated as of December 21, 2007, between VIA Pharmaceuticals, Inc. and Rebecca Taub
(filed as Exhibit 10.15 to the Form 10-K filed on March 28, 2008 and incorporated herein by reference) |
|
|
|
10.22
|
|
Consulting Agreement, dated as of January 29, 2009, by and between VIA Pharmaceuticals, Inc. and
Adeoye Olukotun (filed as Exhibit 10.1 to the Form 8-K filed on February 3, 2009 and incorporated
herein by reference) |
|
|
|
10.23
|
|
VIA Pharmaceuticals, Inc. 2004 Stock Plan (filed as Exhibit 10.8 to the Form 8-K filed on June 11,
2007 and incorporated herein by reference) |
|
|
|
10.24
|
|
VIA Pharmaceuticals, Inc. standard form of stock option agreement (filed as Exhibit 10.9 to the Form
8-K filed on June 11, 2007 and incorporated herein by reference) |
|
|
|
10.25
|
|
VIA Pharmaceuticals, Inc. early exercise form of stock option agreement (filed as Exhibit 10.10 to the
Form 8-K filed on June 11, 2007 and incorporated herein by reference) |
|
|
|
10.26
|
|
Standard Director Form of Option Agreement (filed as Exhibit 10.18 to the Form 10-Q filed on August
14, 2007 and incorporated herein by reference) |
|
|
|
10.27
|
|
Conversion Agreement, dated as of May 11, 2007, between Corautus Genetics Inc. and Boston Scientific
Corporation (filed as Exhibit 10.19 to the Form 10-Q filed on August 14, 2007 and incorporated herein
by reference) |
|
|
|
10.28
|
|
Change in Control Agreement by and between VIA Pharmaceuticals, Inc and Lawrence K. Cohen, Ph.D.,
dated December 21, 2007 (filed as Exhibit 10.1 to the Form 8-K/A filed on December 21, 2007 and
incorporated herein by reference) |
|
|
|
10.29
|
|
Change in Control Agreement by and between VIA Pharmaceuticals, Inc and James G. Stewart, dated
December 21, 2007 (filed as Exhibit 10.2 to the Form 8-K/A filed on December 21, 2007 and incorporated
herein by reference) |
55
|
|
|
Exhibit |
|
|
Number |
|
Description |
10.30
|
|
Change in Control Agreement by and between VIA Pharmaceuticals, Inc and Rebecca Taub, M.D., dated
January 14, 2008 (filed as Exhibit 10.25 to the Form 10-K filed on March 28, 2008 and incorporated
herein by reference) |
|
|
|
10.31
|
|
VIA Pharmaceuticals, Inc. Form of Stock Option Agreement (filed as Exhibit 10.1 to the Form 8-K filed
on December 19, 2007 and incorporated herein by reference) |
|
|
|
10.32
|
|
VIA Pharmaceuticals, Inc. 2007 Incentive Award Plan (filed as Exhibit A to the Definitive Proxy
Statement filed on November 5, 2007 and incorporated herein by reference) |
|
|
|
10.33
|
|
Office Lease, dated October 13, 2005, between VIA Pharmaceuticals, Inc. and James P. Edmondson, as
amended by Lease Amendment No. One, dated January 15, 2008 (filed as Exhibit 10.28 to the Form 10-K
filed on March 28, 2008 and incorporated herein by reference) |
|
|
|
10.34
|
|
Lease, dated July 24, 2006, between VIA Pharmaceuticals, Inc. and 100 & RW CRA LLC, as amended by
First Extension and Modification of Lease, dated January 15, 2008 (filed as Exhibit 10.29 to the
Form 10-K filed on March 28, 2008 and incorporated herein by reference) |
|
|
|
21.1
|
|
Subsidiaries of VIA Pharmaceuticals, Inc. |
|
|
|
23.1
|
|
Consent of Independent Registered Public Accounting Firm |
|
|
|
31.1
|
|
Principal Executive Officers Certifications Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
31.2
|
|
Principal Financial Officers Certifications Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
32.1
|
|
Certification Pursuant to 18 U.S.C. § 1350 (Section 906 of Sarbanes-Oxley Act of 2002). |
|
|
|
32.2
|
|
Certification Pursuant to 18 U.S.C. § 1350 (Section 906 of Sarbanes-Oxley Act of 2002). |
56
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
|
|
|
|
|
|
VIA PHARMACEUTICALS, INC.
|
|
|
By: |
/s/ James G. Stewart
|
|
|
|
James G. Stewart |
|
|
|
Senior Vice President, Chief Financial Officer |
|
Date: March 31, 2010
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been
signed below by the following persons, on behalf of the registrant in the capacities indicated.
|
|
|
|
|
Signatures |
|
Titles |
|
Date |
|
|
|
|
|
|
|
President, Chief Executive Officer and
|
|
March 31, 2010 |
Lawrence K. Cohen
|
|
Director |
|
|
|
|
|
|
|
|
|
Senior Vice President, Chief Financial
|
|
March 31, 2010 |
James G. Stewart
|
|
Officer and Secretary |
|
|
|
|
|
|
|
/s/ Douglass B. Given
Douglass B. Given
|
|
Chairman of the Board of Directors
|
|
March 31, 2010 |
|
|
|
|
|
/s/ Mark N.K. Bagnall
Mark N.K. Bagnall
|
|
Director
|
|
March 31, 2010 |
|
|
|
|
|
/s/ Fred B. Craves
Fred B. Craves
|
|
Director
|
|
March 31, 2010 |
|
|
|
|
|
/s/ David T. Howard
David T. Howard
|
|
Director
|
|
March 31, 2010 |
|
|
|
|
|
/s/ John R. Larson
John R. Larson
|
|
Director
|
|
March 31, 2010 |
57
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders of
VIA Pharmaceuticals, Inc.
San Francisco, CA
We have audited the accompanying balance sheets of VIA Pharmaceuticals, Inc. (a development
stage company) (the Company), as of December 31, 2009 and 2008, and the related statements of
operations, stockholders equity (deficit), and cash flows for each of the two years in the period
ended December 31, 2009, and for the period from June 14, 2004 (date of inception) to December 31,
2009. These financial statements are the responsibility of the Companys management. Our
responsibility is to express an opinion on these financial statements based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting
Oversight Board (United States). Those standards require that we plan and perform the audit to
obtain reasonable assurance about whether the financial statements are free of material
misstatement. The Company is not required to have, nor were we engaged to perform, an audit of its
internal control over financial reporting. Our audits included consideration of internal control
over financial reporting as a basis for designing audit procedures that are appropriate in the
circumstances, but not for the purpose of expressing an opinion on the effectiveness of the
Companys internal control over financial reporting. Accordingly, we express no such opinion. An
audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in
the financial statements, assessing the accounting principles used and significant estimates made
by management, as well as evaluating the overall financial statement presentation. We believe that
our audits provide a reasonable basis for our opinion.
In our opinion, such financial statements present fairly, in all material respects, the
financial position of the Company as of December 31, 2009 and 2008, and the results of its
operations and its cash flows for each of the two years in the period ended December 31, 2009, and
for the period from June 14, 2004 (date of inception) to December 31, 2009, in conformity with
accounting principles generally accepted in the United States of America.
The accompanying financial statements have been prepared assuming that the Company will
continue as a going concern. The Company is a development stage enterprise engaged in the research
and development of cardiovascular disease. As discussed in Note 1 to the financial statements, the
deficiency in working capital at December 31, 2009 and Companys operating losses since inception
raise substantial doubt about its ability to continue as a going concern. Managements plans
concerning these matters are also discussed in Note 1 to the financial statements. The financial
statements do not include any adjustments that might result from the outcome of this uncertainty.
/s/ Deloitte & Touche LLP
San Francisco, California
March 30, 2010
F-1
VIA PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
2,189,742 |
|
|
$ |
4,064,545 |
|
Prepaid expenses and other current assets |
|
|
155,361 |
|
|
|
604,080 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
2,345,103 |
|
|
|
4,668,625 |
|
Property and equipment-net |
|
|
170,617 |
|
|
|
291,804 |
|
Other non-current assets |
|
|
40,374 |
|
|
|
40,374 |
|
|
|
|
|
|
|
|
Total |
|
$ |
2,556,094 |
|
|
$ |
5,000,803 |
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS EQUITY (DEFICIT) |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
705,887 |
|
|
$ |
753,824 |
|
Accrued expenses and other liabilities |
|
|
2,226,720 |
|
|
|
2,652,458 |
|
Interest payable affiliate |
|
|
789,041 |
|
|
|
|
|
Notes payable affiliate net of discount of $4,374 |
|
|
9,995,626 |
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
13,717,274 |
|
|
|
3,406,282 |
|
Deferred rent |
|
|
37,450 |
|
|
|
30,637 |
|
|
|
|
|
|
|
|
Total liabilities |
|
|
13,754,724 |
|
|
|
3,436,919 |
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
Shareholders equity (deficit): |
|
|
|
|
|
|
|
|
Common stock, $0.001 par value-200,000,000 shares
authorized at December 31, 2009 and December 31,
2008, respectively; 20,646,374 and 20,592,718 shares
issued and outstanding at December 31, 2009 and
December 31, 2008, respectively |
|
|
20,646 |
|
|
|
20,593 |
|
Preferred stock Series A, $0.001 par
value-5,000,000 shares authorized at December 31,
2009 and December 31, 2008, respectively; 0 shares
issued and outstanding at December 31, 2009 and
December 31, 2008, respectively |
|
|
|
|
|
|
|
|
Convertible preferred stock Series C, $0.001 par
value-17,000 shares authorized at December 31, 2009
and December 31, 2008, respectively; 2,000 shares
issued and outstanding at December 31, 2009 and
December 31, 2008, respectively; liquidation
preference of $2,000,000 |
|
|
2 |
|
|
|
2 |
|
Additional paid-in capital |
|
|
70,385,287 |
|
|
|
62,169,530 |
|
Deficit accumulated in the development stage |
|
|
(81,604,565 |
) |
|
|
(60,626,241 |
) |
|
|
|
|
|
|
|
Total shareholders equity (deficit) |
|
|
(11,198,630 |
) |
|
|
1,563,884 |
|
|
|
|
|
|
|
|
Total |
|
$ |
2,556,094 |
|
|
$ |
5,000,803 |
|
|
|
|
|
|
|
|
See accompanying notes
F-2
VIA PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
|
|
|
|
|
|
June 14, 2004 |
|
|
|
|
|
|
|
|
|
|
|
(Date of |
|
|
|
Years Ended |
|
|
Inception) to |
|
|
|
December 31, |
|
|
December 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
Revenue |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
6,055,215 |
|
|
|
11,804,053 |
|
|
|
40,906,178 |
|
General and administration |
|
|
7,198,320 |
|
|
|
8,657,166 |
|
|
|
29,046,053 |
|
Merger transaction costs |
|
|
|
|
|
|
|
|
|
|
3,824,090 |
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
13,253,535 |
|
|
|
20,461,219 |
|
|
|
73,776,321 |
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(13,253,535 |
) |
|
|
(20,461,219 |
) |
|
|
(73,776,321 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
|
|
|
|
189,656 |
|
|
|
914,628 |
|
Interest expense |
|
|
(7,733,390 |
) |
|
|
(6,029 |
) |
|
|
(8,738,483 |
) |
Other income (expense)-net |
|
|
8,601 |
|
|
|
2,764 |
|
|
|
(4,389 |
) |
|
|
|
|
|
|
|
|
|
|
Total other income (expense) |
|
|
(7,724,789 |
) |
|
|
186,391 |
|
|
|
(7,828,244 |
) |
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
$ |
(20,978,324 |
) |
|
$ |
(20,274,828 |
) |
|
$ |
(81,604,565 |
) |
|
|
|
|
|
|
|
|
|
|
Loss per share of common stock-basic and diluted |
|
$ |
(1.05 |
) |
|
$ |
(1.03 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding-basic and diluted |
|
|
19,939,848 |
|
|
|
19,606,526 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes
F-3
VIA PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
STATEMENTS OF STOCKHOLDERS EQUITY (DEFICIT)
For the Period June 14, 2004 (Date of Inception) To December 31, 2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit |
|
|
|
|
|
|
|
|
|
|
|
|
Preferred |
|
|
Preferred |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
Series A |
|
|
Series C |
|
|
Common Stock |
|
|
Treasury Stock |
|
|
Additional |
|
|
Deferred |
|
|
in the |
|
|
Other |
|
|
Total |
|
|
Total |
|
|
|
Shares |
|
|
|
|
|
|
Shares |
|
|
|
|
|
|
Shares |
|
|
|
|
|
|
Shares |
|
|
|
|
|
|
Paid-in |
|
|
Stock |
|
|
Development |
|
|
Comprehensive |
|
|
Stockholders |
|
|
Comprehensive |
|
|
|
Issued |
|
|
Amount |
|
|
Issued |
|
|
Amount |
|
|
Issued |
|
|
Amount |
|
|
Issued |
|
|
Amount |
|
|
Capital |
|
|
Compensation |
|
|
Stage |
|
|
Income |
|
|
Equity (Deficit) |
|
|
Income (Loss) |
|
BALANCE June 14, 2004 (date of inception) |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Issuance of common stock net of issuance costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
371,721 |
|
|
|
1,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,000 |
|
|
|
|
|
Stock-based compensation net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,360 |
|
|
|
(4,675 |
) |
|
|
|
|
|
|
|
|
|
|
1,685 |
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,084,924 |
) |
|
|
|
|
|
|
(1,084,924 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BALANCE December 31, 2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
371,721 |
|
|
|
1,000 |
|
|
|
|
|
|
|
|
|
|
|
6,360 |
|
|
|
(4,675 |
) |
|
|
(1,084,924 |
) |
|
|
|
|
|
|
(1,082,239 |
) |
|
|
|
|
Issuance of common stock net of issuance costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
37,172 |
|
|
|
100 |
|
|
|
|
|
|
|
|
|
|
|
900 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,000 |
|
|
|
|
|
Exercise of common stock options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,965 |
|
|
|
30 |
|
|
|
|
|
|
|
|
|
|
|
266 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
296 |
|
|
|
|
|
Stock-based compensation net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,124 |
|
|
|
4,568 |
|
|
|
|
|
|
|
|
|
|
|
5,692 |
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(8,804,220 |
) |
|
|
|
|
|
|
(8,804,220 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BALANCE December 31, 2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
419,858 |
|
|
|
1,130 |
|
|
|
|
|
|
|
|
|
|
|
8,650 |
|
|
|
(107 |
) |
|
|
(9,889,144 |
) |
|
|
|
|
|
|
(9,879,471 |
) |
|
|
|
|
Exercise of common stock options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25,181 |
|
|
|
67 |
|
|
|
|
|
|
|
|
|
|
|
1,360 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,427 |
|
|
|
|
|
Issuance of series A preferred stock |
|
|
3,234,900 |
|
|
|
8,703 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,174,797 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,183,500 |
|
|
|
|
|
Stock-based compensation net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
107 |
|
|
|
|
|
|
|
|
|
|
|
107 |
|
|
|
|
|
Stock based compensation stock options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
434,837 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
434,837 |
|
|
|
|
|
Unrealized gain from foreign currency hedges |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,582 |
|
|
|
12,582 |
|
|
|
12,582 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(8,626,887 |
) |
|
|
|
|
|
|
(8,626,887 |
) |
|
|
(8,626,887 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(8,614,305 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BALANCE December 31, 2006 |
|
|
3,234,900 |
|
|
$ |
8,703 |
|
|
|
|
|
|
$ |
|
|
|
|
445,039 |
|
|
$ |
1,197 |
|
|
|
|
|
|
$ |
|
|
|
$ |
12,619,644 |
|
|
$ |
|
|
|
$ |
(18,516,031 |
) |
|
$ |
12,582 |
|
|
$ |
(5,873,905 |
) |
|
|
|
|
Issuance of common stock net of issuance costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,288,065 |
|
|
|
10,288 |
|
|
|
|
|
|
|
|
|
|
|
23,130,072 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
23,140,360 |
|
|
|
|
|
Exercise of common stock options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
317,369 |
|
|
|
854 |
|
|
|
|
|
|
|
|
|
|
|
41,469 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
42,323 |
|
|
|
|
|
Repurchase and retirement of common stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(42,283 |
) |
|
|
(95 |
) |
|
|
|
|
|
|
|
|
|
|
(5,654 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,749 |
) |
|
|
|
|
Issuance of series A preferred stock |
|
|
3,540,435 |
|
|
|
9,524 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,324,698 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,334,222 |
|
|
|
|
|
Merger |
|
|
(6,775,335 |
) |
|
|
(18,227 |
) |
|
|
2,000 |
|
|
|
2 |
|
|
|
8,699,067 |
|
|
|
7,463 |
|
|
|
(2,014 |
) |
|
|
(10,276 |
) |
|
|
10,818,077 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,797,039 |
|
|
|
|
|
Stock-based compensation warrants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
21,954 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
21,954 |
|
|
|
|
|
Stock based compensation stock options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
926,574 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
926,574 |
|
|
|
|
|
Unrealized gain from foreign currency hedges |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,302 |
|
|
|
4,302 |
|
|
|
4,302 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(21,835,382 |
) |
|
|
|
|
|
|
(21,835,382 |
) |
|
|
(21,835,382 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(21,831,080 |
) |
BALANCE December 31, 2007 |
|
|
|
|
|
$ |
|
|
|
|
2,000 |
|
|
$ |
2 |
|
|
|
19,707,257 |
|
|
$ |
19,707 |
|
|
|
(2,014 |
) |
|
$ |
(10,276 |
) |
|
$ |
60,876,834 |
|
|
$ |
|
|
|
$ |
(40,351,413 |
) |
|
$ |
16,884 |
|
|
$ |
20,551,738 |
|
|
|
|
|
Exercise of common stock options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
32,711 |
|
|
|
33 |
|
|
|
|
|
|
|
|
|
|
|
2,247 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,280 |
|
|
|
|
|
Repurchase and retirement of treasury stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,014 |
|
|
|
10,276 |
|
|
|
(10,276 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of restricted common stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
852,750 |
|
|
|
853 |
|
|
|
|
|
|
|
|
|
|
|
1674 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,527 |
|
|
|
|
|
Stock-based compensation warrants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
47,525 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
47,525 |
|
|
|
|
|
Stock based compensation stock options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,251,526 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,251,526 |
|
|
|
|
|
Unrealized gain from foreign currency hedges |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(16,884 |
) |
|
|
(16,884 |
) |
|
|
(16,884 |
) |
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(20,274,828 |
) |
|
|
|
|
|
|
(20,274,828 |
) |
|
|
(20,274,828 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(20,291,712 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BALANCE December 31, 2008 |
|
|
|
|
|
$ |
|
|
|
|
2,000 |
|
|
$ |
2 |
|
|
|
20,592,718 |
|
|
$ |
20,593 |
|
|
|
|
|
|
$ |
|
|
|
$ |
62,169,530 |
|
|
$ |
|
|
|
$ |
(60,626,241 |
) |
|
$ |
|
|
|
$ |
1,563,884 |
|
|
|
|
|
Exercise of common stock options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
57,615 |
|
|
|
57 |
|
|
|
|
|
|
|
|
|
|
|
1,875 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,932 |
|
|
|
|
|
Retirement of restricted common stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,959 |
) |
|
|
(4 |
) |
|
|
|
|
|
|
|
|
|
|
4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation restricted stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
63,389 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
63,389 |
|
|
|
|
|
Stock based compensation stock options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,201,766 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,201,766 |
|
|
|
|
|
Issuance of warrants affiliate |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,948,723 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,948,723 |
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(20,978,324 |
) |
|
|
|
|
|
|
(20,978,324 |
) |
|
|
(20,978,324 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(20,978,324 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BALANCE December 31, 2009 |
|
|
|
|
|
$ |
|
|
|
|
2,000 |
|
|
$ |
2 |
|
|
|
20,646,374 |
|
|
$ |
20,646 |
|
|
|
|
|
|
$ |
|
|
|
$ |
70,385,287 |
|
|
$ |
|
|
|
$ |
(81,604,565 |
) |
|
$ |
|
|
|
$ |
(11,198,630 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes
F-4
VIA PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
|
|
|
|
|
|
June 14, 2004 |
|
|
|
|
|
|
|
|
|
|
|
(Date of |
|
|
|
Years Ended |
|
|
Inception) to |
|
|
|
December 31, |
|
|
December 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(20,978,324 |
) |
|
$ |
(20,274,828 |
) |
|
$ |
(81,604,565 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
136,360 |
|
|
|
205,919 |
|
|
|
529,873 |
|
Amortization of discount on notes payable affiliate |
|
|
6,944,349 |
|
|
|
|
|
|
|
6,944,349 |
|
Disposal of property and equipment |
|
|
450 |
|
|
|
4,163 |
|
|
|
4,613 |
|
Change in unrealized gain on foreign currency hedge |
|
|
|
|
|
|
(16,884 |
) |
|
|
|
|
Stock compensation expense |
|
|
1,265,155 |
|
|
|
1,301,578 |
|
|
|
3,957,582 |
|
Deferred rent |
|
|
6,813 |
|
|
|
26,657 |
|
|
|
37,450 |
|
Changes in assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Prepaid expenses and other assets |
|
|
448,719 |
|
|
|
383,978 |
|
|
|
(220,735 |
) |
Accounts payable |
|
|
(47,937 |
) |
|
|
1,617 |
|
|
|
702,398 |
|
Accrued expenses and other liabilities |
|
|
(425,738 |
) |
|
|
(525,995 |
) |
|
|
2,326,721 |
|
Interest payable affiliate |
|
|
789,041 |
|
|
|
|
|
|
|
1,781,763 |
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(11,861,112 |
) |
|
|
(18,893,795 |
) |
|
|
(65,540,551 |
) |
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of property and equipment |
|
|
(16,155 |
) |
|
|
(140,653 |
) |
|
|
(664,175 |
) |
Sale of property and equipment |
|
|
532 |
|
|
|
|
|
|
|
532 |
|
Cash provided in the Merger |
|
|
|
|
|
|
|
|
|
|
11,147,160 |
|
Capitalized merger transaction costs |
|
|
|
|
|
|
|
|
|
|
(350,069 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities |
|
|
(15,623 |
) |
|
|
(140,653 |
) |
|
|
10,133,448 |
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from convertible promissory notes affiliate |
|
|
|
|
|
|
|
|
|
|
24,425,000 |
|
Proceeds from notes payable affiliate |
|
|
10,000,000 |
|
|
|
|
|
|
|
10,000,000 |
|
Capital lease payments |
|
|
|
|
|
|
(2,051 |
) |
|
|
(11,973 |
) |
Issuance of common stock |
|
|
|
|
|
|
|
|
|
|
23,141,360 |
|
Exercise of stock options for the issuance of common stock |
|
|
1,932 |
|
|
|
2,280 |
|
|
|
48,258 |
|
Repurchase and retirement of common stock |
|
|
|
|
|
|
|
|
|
|
(5,800 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
10,001,932 |
|
|
|
229 |
|
|
|
57,596,845 |
|
|
|
|
|
|
|
|
|
|
|
Increase (decrease) in cash and cash equivalents |
|
|
(1,874,803 |
) |
|
|
(19,034,219 |
) |
|
|
2,189,742 |
|
Cash and cash equivalents-beginning of period |
|
|
4,064,545 |
|
|
|
23,098,764 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents-end of period |
|
$ |
2,189,742 |
|
|
$ |
4,064,545 |
|
|
$ |
2,189,742 |
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of noncash activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of warrant and related discount on notes payable affiliate |
|
$ |
6,948,723 |
|
|
$ |
|
|
|
$ |
6,948,723 |
|
|
|
|
|
|
|
|
|
|
|
Interest on convertible debt converted to notes payable affiliate |
|
$ |
|
|
|
$ |
|
|
|
$ |
992,722 |
|
|
|
|
|
|
|
|
|
|
|
Conversion of notes to preferred stock Series A affiliate |
|
$ |
|
|
|
$ |
|
|
|
$ |
25,517,722 |
|
|
|
|
|
|
|
|
|
|
|
Accrued compensation converted to notes payable |
|
$ |
|
|
|
$ |
|
|
|
$ |
100,000 |
|
|
|
|
|
|
|
|
|
|
|
Equipment acquired under capital lease |
|
$ |
|
|
|
$ |
(11,973 |
) |
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
Stock issuance for license acquisition |
|
$ |
|
|
|
$ |
|
|
|
$ |
1,000 |
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest paid |
|
$ |
|
|
|
$ |
6,028 |
|
|
$ |
7,856 |
|
|
|
|
|
|
|
|
|
|
|
Taxes paid (refunded) |
|
$ |
(2,834 |
) |
|
$ |
3,470 |
|
|
$ |
36,615 |
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes
F-5
VIA PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO THE FINANCIAL STATEMENTS
1. ORGANIZATION
Overview VIA Pharmaceuticals, Inc. (VIA, the Company, we, our, or us),
incorporated in Delaware in June 2004 and headquartered in San Francisco, California, is a
development stage biotechnology company focused on the development of compounds for the treatment
of cardiovascular and metabolic disease. The Company is building a pipeline of small molecule drugs
that target the underlying causes of cardiovascular and metabolic disease, including vascular
inflammation, high cholesterol, high triglycerides and insulin sensitization/diabetes. During 2005,
the Company in-licensed a small molecule compound, VIA-2291, which targets an unmet medical need of
reducing atherosclerotic plaque inflammation, an underlying cause of atherosclerosis and its
complications, including heart attack and stroke. Atherosclerosis, depending on its severity and
the location of the artery it affects, may result in major adverse cardiovascular events (MACE),
such as heart attack and stroke. During 2006, the Company initiated two Phase 2 clinical trials of
VIA-2291 in patients undergoing a carotid endarterectomy (CEA), and in patients at risk for acute
coronary syndrome (ACS). During 2007, the Company initiated a third Phase 2 clinical trial where
ACS patients undergo Positron Emission Tomography with flurodeoxyglucose tracer (FDG-PET), a
non-invasive imaging technique to measure the effect of treatment of VIA-2291 on vascular
inflammation. Effective during the first quarter of 2009, the Company licensed from Hoffman-LaRoche
Inc. and Hoffmann-LaRoche Ltd. (collectively Roche) the exclusive worldwide rights to two sets of
compounds. The first license is for Roches thyroid hormone receptor beta agonist, a clinically
ready candidate for the control of cholesterol, triglyceride levels and potential in insulin
sensitization/diabetes. The second license is for multiple compounds from Roches preclinical
diacylglycerol acyl transferease 1 metabolic disorders program.
Through December 31, 2009, the Company has been primarily engaged in developing initial
procedures and product technology, recruiting personnel, screening and in-licensing of target
compounds, clinical trial activity, and raising capital. To fund operations, VIA has been raising
cash through debt, a merger and equity financings. The Company is organized and operates as one
operating segment.
On March 21, 2006, the Company formed VIA Pharma UK Limited, a private corporation, in the
United Kingdom to enable clinical trial activities in Europe. VIA Pharma UK Limited did not engage
in operations from June 14, 2004 (date of inception) to December 31, 2009. The Company has a
wholly-owned subsidiary Vascular Genetics Inc. (VGI) that was involved in Corautus clinical
trials. VGI has not been active since the Corautus clinical trials ceased in 2006.
Merger On June 5, 2007, Corautus completed a merger (the Merger) with privately-held VIA
Pharmaceuticals, Inc. pursuant to the Agreement and Plan of Merger and Reorganization (the Merger
Agreement), dated February 7, 2007, by and among Corautus, Resurgens Merger Corp., a Delaware
corporation and a wholly owned subsidiary of Corautus (Resurgens), and privately-held VIA
Pharmaceuticals, Inc. Pursuant to the Merger Agreement, Resurgens merged with and into
privately-held VIA Pharmaceuticals, Inc., which continued as the surviving company as a
wholly-owned subsidiary of Corautus. Immediately following the effectiveness of the Merger on June
5, 2007, privately-held VIA Pharmaceuticals, Inc. merged (the Parent-Subsidiary Merger) with and
into Corautus, pursuant to which Corautus continued as the surviving corporation. Immediately
following the Parent- Subsidiary Merger, Corautus changed its corporate name from Corautus
Genetics Inc. to VIA Pharmaceuticals,Inc. Unless otherwise specified, as used throughout these
financial statements, the Company, we, us, and our refers to the business of the combined
company after the merger (the Merger) with Corautus Genetics Inc. (Corautus) on June 5, 2007
and the business of privately-held VIA Pharmaceuticals, Inc. prior to the Merger. Unless
specifically noted otherwise, as used throughout these financial statements, Corautus Genetics
Inc. or Corautus refers to the business of Corautus prior to the Merger.
Going Concern From inception, the Company has incurred expenses in research and development
activities without generating any revenues to offset those expenses and the Company does not expect
to generate revenues in the near future. The Company has incurred losses and negative cash flow
from operating activities from inception, and as of December 31, 2009, the Company had an
accumulated net deficit of approximately $81.6 million. Until the Company can establish profitable
operations to finance its cash requirements, the Companys ability to meet its obligations in the
ordinary course of business is dependent upon its ability to raise substantial additional capital
through public or private equity or debt financings, the establishment of credit or other funding
facilities, collaborative or other strategic arrangements with corporate sources or other sources
of financing, the availability of which cannot be assured. On June 5, 2007, the Company raised
$11.1 million through the Merger with Corautus to cover existing obligations and provide operating
cash flows. In July 2007, the Company entered into a
F-6
securities purchase agreement that
provided for issuance of 10,288,065 shares of common stock for approximately $25.0 million
in gross proceeds. As more
fully described in Note 6 in the notes to the financial statements, in March 2009, the Company
entered into a Note and Warrant Purchase Agreement (the Loan Agreement) with its
principal stockholder and one of its affiliates (the Lenders) whereby the Lenders agreed to lend to the
Company in the aggregate up to $10.0 million. The Company secured the loan with all of its assets,
including the Companys intellectual property. On March 12, 2009, the Company borrowed the initial
$2.0 million available under the Loan Agreement. Subsequently, the Company made $2.0 million
borrowings under the Loan Agreement on May 19, 2009, June 29, 2009, August 14, 2009, and the
Company borrowed the final $2.0 million available under the Loan Agreement on September 11, 2009.
According to the terms of the original Loan Agreement, the debt was due to the Lenders on September
14, 2009. The parties agreed to extend the repayment terms and, as more fully described in Note 12
in the notes to the financial statements, on February 26, 2010, the Lenders agreed to modify the
Loan Agreement to further extend the repayment terms to April 1, 2010. The Lenders did not modify
the interest rate or offer any concessions in the amended Loan Agreements. The Company had $2.2
million in cash at December 31, 2009 which management believes is sufficient for the Company, under
normal continuing operations, to meet its current operating cash requirements through March 2010.
As more fully described in Note 12 in the notes to the financial statements, in March 2010, the
Company entered into a Note and Warrant Purchase Agreement (the 2010 Loan Agreement) with the
Lenders whereby the Lenders agreed to lend to the Company in the aggregate up to $3.0 million (the
March 2010 Loan). The Company secured the March 2010 Loan with all of its assets, including the
Companys intellectual property. On March 29, 2010, the Company borrowed an initial $1.25 million
available under the 2010 Loan Agreement. Management does not believe that existing cash
resources will be sufficient to enable the Company to meet its ongoing working capital requirements
for the next twelve months and the Company will need to raise substantial additional funding in the
near term to repay amounts owed under the March 2009 loan, which are due April 1, 2010, and to meet
its ongoing working capital requirements. As a result, there are substantial doubts that the
Company will be able to continue as a going concern and, therefore, may be unable to realize its
assets and discharge its liabilities in the normal course of business. The financial statements do
not include any adjustments relating to the recoverability and classification of recorded asset
amounts or to amounts and classifications of liabilities that may be necessary should the Company
be unable to continue as a going concern.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Use of Estimates The preparation of financial statements in conformity with GAAP requires
management to make judgments, assumptions and estimates that affect the amounts reported in our
financial statements and accompanying notes. Actual results could differ materially from those
estimates.
Cash and Cash Equivalents Cash equivalents are included with cash and consist of short term,
highly liquid investments with original maturities of three months or less.
Property and Equipment Property and equipment are stated at cost, less accumulated
depreciation. Depreciation is calculated using the straight-line method over the estimated useful
lives of the assets, ranging from three to five years. Computers, lab and office equipment have
estimated useful lives of three years; office furniture and equipment have estimated useful lives
of five years; and leasehold improvements are amortized using the straight-line method over the
shorter of the useful lives or the lease term.
Long-Lived Assets Long-lived assets include property and equipment and certain purchased
licensed patent rights that are included in other assets in the balance sheet. The Company reviews
long-lived assets, including property and equipment, for impairment annually or whenever events or
changes in circumstances indicate that the carrying amount of the assets may not be recoverable. In
December 2008, the Company wrote-off $21,000 in certain unamortized purchased licensed patent
rights in anticipation of terminating the related purchase contract in 2009. Through December 31,
2009, there have been no other such impairments.
Incentive Award Accruals The Company accrues for liabilities under discretionary employee
and executive incentive award plans. These estimated liabilities are based upon progress against
corporate objectives approved by the Board of Directors, compensation levels of eligible
individuals, and target bonus percentage level of employees. The Board of Directors and the
Compensation Committee of the Board of Directors review and evaluate the performance against these
objectives and ultimately determine what discretionary payments are made. Included in accrued
liabilities at December 31, 2009 and December 31, 2008, we have accrued $1,308,043 and $727,539,
respectively, for liabilities associated with these employee and
executive incentive award plans. As described in Note 12 to the financial statements, on
March 26, 2010, the Companys Board of Directors approved a restructuring of the Company to
reduce its workforce and operating costs effective March 31, 2010. The impact of the
restructuring included reversal of $531,000 of incentive award accruals recorded as of
December 31, 2009 related to terminated employees, which will be reflected in the quarter ended
March 31, 2010.
F-7
Research and Development Expenses Research and development (R&D) expenses are charged to
operations as incurred in accordance with accounting guidance for the accounting for research and
development costs. R&D expenses include salaries, contractor and consultant fees; external clinical
trial expenses performed by contract research organizations (CROs) and contracted investigators,
licensing fees and facility allocations. In addition, the Company funds R&D at third-party research
institutions under agreements that are generally cancelable at the Companys option. Research costs
typically consist of applied research, preclinical and toxicology work. Pharmaceutical
manufacturing development costs consist of product formulation, chemical analysis and the transfer
and scale-up of manufacturing at our contract manufacturers. Clinical costs include the costs of
Phase 2 clinical trials. These costs, along with the manufacturing scale-up costs, are a
significant component of R&D expenses.
The Company accrues costs for clinical trial activities performed by CROs and other third
parties based upon the estimated amount of work completed on each study as provided by the vendors.
These estimates may or may not match the actual services performed by the organizations as
determined by patient enrollment levels and related activities. The Company monitors patient
enrollment levels and related activities using available information; however, if the Company
underestimates activity levels associated with various studies at a given point in time, the
Company could record significant R&D expenses in future periods when the actual activity level
becomes known. The Company charges all such costs to R&D expenses.
Fair Value of Financial and Derivative Instruments The Company values its financial
instruments in accordance with new accounting guidance on fair value measurements which, for
certain financial assets and liabilities, requires that assets and liabilities carried at fair
value be classified and disclosed in one of the following three categories:
|
|
|
Level 1 Quoted prices in active markets for identical assets or liabilities. |
|
|
|
|
Level 2 Inputs other than quoted prices included in Level 1, such as quoted prices for
similar assets and liabilities in active markets; quoted prices for identical or similar
assets and liabilities in markets that are not active; or other inputs that are observable
or can be corroborated by observable market data. |
|
|
|
|
Level 3 Unobservable inputs that are supported by little or no market activity and that
are significant to the fair value of the assets or liabilities. This includes certain
pricing models, discounted cash flow methodologies and similar techniques that use
significant unobservable inputs. |
In March 2009, the Company entered into a $10.0 million Loan Agreement with its principal
stockholder and one of its affiliates, as more fully described in Note 6 in the notes to the
financial statements. At the date of each borrowing under the Loan Agreement, the Company valued
and reported the freestanding warrants issued in connection with the financing of notes payable to
affiliates as paid-in-capital in the Stockholders Equity (Deficit) section of the Companys
balance sheets in accordance with the following accounting guidance:
|
|
|
Derivative financial instruments indexed to and potentially settled in a Companys own
stock; |
|
|
|
|
Accounting for derivative instruments and hedging activities; and |
|
|
|
|
Accounting for convertible debt and debt issued with stock purchase warrants. |
The Company made separate $2.0 million borrowings under the $10.0 million Loan Agreement on
March 12, 2009, May 19, 2009, June 29, 2009, August 14, 2009, and a final borrowing on September
11, 2009, with warrants vesting at the time of each draw as described more fully in Note 6 in the
notes to the financial statements. The Company estimated the fair value of the warrants issued on
the date of each draw using the Black-Scholes pricing model methodology. This methodology requires
significant judgments in the estimation of fair value based on certain assumptions, including the
market value and the estimated volatility of the Companys common stock, a risk-free interest rate
applicable to the facts and circumstances of the transaction, and the estimated life of the
warrant. The freestanding warrant is classified within Level 3 of the fair value hierarchy.
Changes in Level 3 Recurring Fair Value Measurements The following is a rollforward of
balance sheet amounts as of December 31, 2009 (including the change in fair value when applicable),
for financial instruments classified as Level 3. When a determination is made to classify a
financial instrument within Level 3, the determination is based upon the significance of the
unobservable parameters to the overall fair value measurement. However, Level 3 financial
instruments typically include, in addition to the unobservable components, observable components
(that is, components that are actively quoted and can be validated to external
sources). Accordingly, the gains and losses in the table below include changes in fair value
(when applicable) due in part to observable factors that are part of the methodology.
F-8
|
|
|
|
|
|
|
As of |
|
|
|
December 31, |
|
|
|
2009 |
|
Fair value December 31, 2008 |
|
$ |
|
|
Warrants (1) |
|
|
6,948,723 |
|
Change in unrealized gains related to financial instruments at December 31, 2009 (2) |
|
|
|
|
|
|
|
|
Fair value December 31, 2009 |
|
$ |
6,948,723 |
|
|
|
|
|
Total unrealized gains (losses) (2) |
|
$ |
|
|
|
|
|
|
|
|
|
(1) |
|
The Warrants are included in additional paid in capital in the Stockholders Equity section
of the Balance Sheet. |
|
(2) |
|
The Warrants are not revalued at the reporting date and do not result in gains and losses. |
Income Taxes The Company accounts for income taxes using an asset and liability approach.
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, and operating loss and tax credit carryforwards measured by applying currently
enacted tax laws. A valuation allowance is provided to reduce net deferred tax assets to an amount
that is more likely than not to be realized. The amount of the valuation allowance is based on the
Companys best estimate of the recoverability of its deferred tax assets. On January 1, 2007, the
Company adopted new accounting guidance for the accounting for uncertainty in income tax positions.
This guidance seeks to reduce the diversity in practice associated with certain aspects of
measurement and recognition in accounting for income taxes and provide guidance on de-recognition,
classification, interest and penalties, and accounting in interim periods and requires expanded
disclosure with respect to the uncertainty in income taxes. The accounting guidance requires that
the Company recognize in its financial statements the impact of a tax position if that position is
more likely than not to be sustained on audit, based on the technical merits of the position.
Segment Reporting Accounting guidance on disclosures about segments of an enterprise and
related information requires the use of a management approach in identifying segments of an
enterprise. Management has determined that the Company operates in one business segment -
scientific research and development activities.
Earnings (Loss) Per Share of Common Stock Basic earnings (loss) per share of common stock is
computed by dividing net income (loss) by the weighted-average number of common shares outstanding
for the period. Diluted earnings (loss) per share of common stock is computed by dividing net
income (loss) by the weighted-average number of shares of common stock and potentially dilutive
shares of common stock equivalents outstanding during the period.
The following table presents the calculation of basic and diluted net loss per common share
for the years ended December 31, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
Years Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
Net loss |
|
$ |
(20,978,324 |
) |
|
$ |
(20,274,828 |
) |
|
|
|
|
|
|
|
Basic and diluted net loss per share: |
|
|
|
|
|
|
|
|
Weighted-average shares of common stock outstanding |
|
|
20,634,380 |
|
|
|
19,754,046 |
|
Less: Weighted-average shares of common stock subject to repurchase |
|
|
(694,532 |
) |
|
|
(147,520 |
) |
|
|
|
|
|
|
|
Weighted-average shares used in computing basic net loss per share |
|
|
19,939,848 |
|
|
|
19,606,526 |
|
Dilutive effect of common share equivalents |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares used in computing diluted net loss per share |
|
|
19,939,848 |
|
|
|
19,606,526 |
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
(1.05 |
) |
|
$ |
(1.03 |
) |
|
|
|
|
|
|
|
F-9
Diluted earnings (loss) per share of common stock reflects the potential dilution that could
occur if options or warrants to purchase shares of common stock were exercised, or shares of
preferred stock were converted into shares of common stock. The following table details potentially
dilutive shares of common stock equivalents that have been excluded from diluted net loss per share
for the years ended December 31, 2009 and 2008 because their inclusion would be anti-dilutive:
|
|
|
|
|
|
|
|
|
|
|
Years Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
Common stock equivalents (in shares): |
|
|
|
|
|
|
|
|
Shares of common stock subject to outstanding options |
|
|
2,740,686 |
|
|
|
2,807,927 |
|
Shares of common stock subject to outstanding warrants |
|
|
83,403,348 |
|
|
|
207,479 |
|
Shares of common stock subject to conversion from series C preferred stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total shares of common stock equivalents |
|
|
86,144,034 |
|
|
|
3,015,406 |
|
|
|
|
|
|
|
|
As described in Note 7 in the notes to the financial statements, the number of shares of
common stock into which Series C Preferred Stock will be converted will not be known until the date
of conversion because the conversion factor is based on fair value of the Companys common stock on
the date the Series C Preferred Stock becomes convertible, June 13, 2010. Accordingly, we have not
included any Series C Preferred Stock in the table above.
Comprehensive Income (Loss) Comprehensive income (loss) generally represents all changes in
stockholders equity except those resulting from investments or contributions by stockholders.
Amounts reported in other comprehensive income (loss) include derivative financial instruments
designated and effective as hedges of underlying foreign currency denominated transactions.
The following table presents the calculation of total comprehensive income (loss) for the
years ended December 31, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
Years Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
Net loss |
|
$ |
(20,978,324 |
) |
|
$ |
(20,274,828 |
) |
Change in unrealized gain on foreign currency cash flow hedges |
|
|
|
|
|
|
(16,884 |
) |
|
|
|
|
|
|
|
Total comprehensive loss |
|
$ |
(20,978,324 |
) |
|
$ |
(20,291,712 |
) |
|
|
|
|
|
|
|
Derivative Instruments From time to time, the Company uses derivatives to manage its market
exposure to fluctuations in foreign currencies. The Company records these derivatives on the
balance sheet at fair value in accordance with accounting guidance for derivatives. To receive
hedge accounting treatment, all hedging relationships are formally documented at the inception of
the hedge and the hedges must be highly effective in offsetting changes to future cash flows on
hedged transactions. For derivative instruments that are designated and qualify as a cash flow
hedge (i.e., hedging the exposure to variability in expected future cash flows that is attributable
to a particular risk), the effective portion of the gain or loss on the derivative instrument is
reported as a component of other comprehensive income (loss) and in the Companys statement of
operations in the same period or periods during which the hedged transaction affects earnings. The
gain or loss on the derivative instruments in excess of the cumulative change in the present value
of future cash flows of the hedged transaction, if any, is recognized in the Companys statement of
operations during the period of change. The Company does not use derivative instruments for
speculative purposes.
As of December 31, 2009, the Company does not have any outstanding forward foreign exchange
contracts. All foreign currency purchased under forward foreign exchange contracts has been
expended in the purchase of clinical trial services and, as a result, the Company does not have any
outstanding unrealized gains or losses on forward foreign exchange contracts and also does not have
any related accumulated other comprehensive income on the Companys December 31, 2009 and 2008
Balance Sheets.
The Company recorded net realized losses of $0 and net realized gains of $30,662 for the years
ended December 31, 2009 and 2008, respectively, and a net realized loss of $24,604 for the period
from June 14, 2004 (date of inception) to December 31, 2009 on foreign exchange transactions that
were consummated using foreign currency obtained in hedge transactions. The net gains and losses
are included in other income (expense) in the statement of operations. Of the $30,662 in net
realized losses for the year ended December 31, 2008, $12,577 were losses on forward foreign
exchange contracts. We have incurred cumulative net losses on forward foreign exchange contracts of
$9,148 for the period June 14, 2004 (date of inception) to December 31, 2009. Net unrealized gains
remaining in accumulated other comprehensive income (loss) were $0 at December 31, 2009 and 2008,
respectively. The intrinsic value of the Companys cash flow hedge contracts outstanding was $0 at
December 31, 2009 and 2008.
Recently Adopted Accounting Pronouncements In June 2009, the Financial Accounting Standards
Board (FASB) issued the FASB accounting standards codification and the hierarchy of generally
accepted accounting principles. The primary purpose of this new accounting guidance is to improve
clarity and use of existing standards by grouping authoritative literature under common topics. The
new guidance does not change or alter existing GAAP. The new guidance is effective for annual and
interim periods ending after
September 15, 2009. The Company effectively adopted the new guidance on July 1, 2009 and
determined it did not have a material impact on the Companys financial statements.
F-10
In June 2009, the FASB issued new accounting guidance on accounting for the consolidation of
variable interest entities. The guidance amends certain previously existing guidance for
determining whether an entity is a variable interest entity, requires an enterprise to perform an
analysis to determine whether an enterprises variable interest or interests give it a controlling
financial interest in a variable interest entity, and requires ongoing reassessments of whether an
enterprise is the primary beneficiary of a variable interest entity. An identified primary
beneficiary of a variable interest entity is an enterprise that has both the power to direct the
activities of significant impact on a variable interest entity and the obligation to absorb losses
or receive benefits from the variable interest entity that could potentially be significant to the
variable interest entity. The new guidance is effective for annual and interim reporting periods
beginning after November 15, 2009. The Company has not yet adopted the new guidance and does not
expect that the new guidance will have any impact on the Companys financial statements.
In June 2009, the FASB issued new guidance on accounting for transfers of financial assets.
The new guidance removes the concept of a qualifying special-purpose entity and removes a certain
exception from applying previous FASB interpretations on the consolidation of variable interest
entities to qualifying special-purpose entities. The new guidance is effective for annual and
interim reporting periods beginning after November 15, 2009. The Company has not yet adopted the
new guidance and does not expect that the new guidance will have any impact on the Companys
financial statements.
In May 2009, the FASB issued new accounting guidance for subsequent events. The new guidance
sets forth the period after the balance sheet date during which management will evaluate
transactions for potential recognition or disclosure in the financial statements, and the
circumstances under which management should recognize transactions or events occurring after the
balance sheet date in the financial statements, and the requisite disclosures. The new guidance is
effective for annual and interim financial periods ending after June 15, 2009. The Company
effectively adopted the new guidance on April 1, 2009 and determined it did not have a material
impact on the Companys financial statements or disclosures in the financial statements.
In April 2009, the FASB issued new accounting guidance for determining fair value when the
volume and level of activity for the asset or liability have significantly decreased and
identifying transactions that are not orderly. The new guidance provides clarification for prior
accounting guidance regarding the measurement of fair values of assets and liabilities when the
market activity has significantly decreased and in identifying transactions that are not orderly.
The new guidance is effective for interim reporting periods ending after June 15, 2009. The Company
effectively adopted the new guidance on April 1, 2009 and determined it did not have an impact on
the Companys financial results.
In April 2009, the FASB issued new accounting guidance for interim disclosures about fair
value of financial instruments which amends prior guidance for disclosures about fair value of
financial instruments and interim financial reporting. The new guidance requires disclosures about
the fair value of financial instruments during interim reporting periods. The new disclosure
requirements are effective for interim reporting periods ending after June 15, 2009. The Company
effectively adopted the new guidance on April 1, 2009 and determined it did not have a material
impact on the Companys financial statements.
In June 2008, the FASB issued new accounting guidance for determining whether an instrument or
embedded feature is indexed to an entitys own stock. The new guidance provides a two-step approach
to use in determining whether an equity-linked financial instrument, or embedded feature, is
indexed to an entitys own stock for purposes of determining whether the instrument or embedded
feature meets the definition of derivative instrument for accounting purposes. The new guidance is
effective for financial statements issued for fiscal years beginning after December 15, 2008, and
interim periods within those fiscal years. The Company effectively adopted the new guidance on
January 1, 2009 and determined it did not have a material impact on the Companys financial
statements.
In March 2008, the FASB issued new accounting guidance for disclosures about derivative
instruments and hedging activities. The new guidance requires additional disclosures about the
objectives of the derivative instruments and hedging activities, the method of accounting for such
instruments, and a tabular disclosure of the effects of such instruments and related hedged items
on the Companys financial statements. The new guidance is effective for the Company beginning
January 1, 2009. The Company effectively adopted the new guidance on January 1, 2009 and determined
it did not have a material impact on the Companys financial statements.
In December 2007, the FASB issued new accounting guidance for accounting for collaborative
agreements. The new guidance defines collaborative arrangements and establishes reporting
requirements, financial statement presentation and disclosure of collaborative arrangements, which
includes arrangements entered into regarding development and commercialization of products. It
requires certain transactions between collaborators to be recorded in the income statement on
either a gross or net basis when certain characteristics exist in the collaborative relationship.
The new guidance is effective for fiscal years beginning after December 15,
2008. The Company effectively adopted the new guidance on January 1, 2009 and determined it
did not have a material impact on the Companys financial statements.
F-11
Subsequent Events On February 26, 2010, as more fully described in Note 12 in the notes to
the financial statements, the Lenders agreed to modify the Loan Agreement to extend the repayment
terms of the $10.0 million borrowings to April 1, 2010. The Lenders did not modify the interest
rate or offer any concessions in the amended Loan Agreement. On March 26, 2010, as more fully
described in Note 12 in the notes to the financial statements, the Company entered into the 2010
Loan Agreement with the Lenders whereby the Lenders agreed to lend to the Company in the aggregate
up to $3.0 million. The Company secured the March 2010 Loan with all of its assets, including the
Companys intellectual property. On March 29, 2010, the Company borrowed an initial $1.25 million
available under the 2010 Loan Agreement. Additionally, on March 26, 2010 and as more fully
described in Note 12 in the notes to the financial statements, the Companys Board of Directors
approved a restructuring of the Company to reduce its workforce and operating costs effective March
31, 2010. The reduction in workforce decreased total employees by approximately 63% to a total of
six employees, and increased the focus of future operating expense on research and development
activities. There were no other events or transactions occurring during this subsequent event
reporting period which require recognition or disclosure in the Companys financial statements.
3. STOCK-BASED COMPENSATION
On January 1, 2006, the Company adopted new accounting guidance for accounting for stock-based
compensation. Under the fair value recognition provisions of this accounting guidance, stock-based
compensation cost is measured at the grant date based on the fair value of the award and is
recognized as expense on a straight-line basis over the requisite service period, which is the
vesting period. The Company elected the modified-prospective method, under which prior periods are
not revised for comparative purposes. The valuation provisions of the accounting guidance apply to
new grants and to grants that were outstanding as of the effective date and are subsequently
modified. Estimated compensation for grants that were outstanding as of the effective date of this
new guidance are now being recognized over the remaining service period using the compensation cost
estimated for the required pro forma disclosures.
The Company uses the Black-Scholes option pricing model to estimate the fair value of
stock-based awards. The determination of the fair value of stock-based awards on the date of grant
using an option-pricing model is affected by the value of the Companys stock price as well as
assumptions regarding a number of complex and subjective variables. These variables include
expected stock price volatility over the term of the awards, actual and projected employee stock
option exercise behaviors, risk-free interest rate and expected dividends.
Prior to June 5, 2007, the Company was a privately-held company and its common stock was not
publicly traded. The fair value of stock options granted from January 2006 through June 5, 2007
(date of completion of the Merger with Corautus), and related stock-based compensation expense,
were determined based upon quoted stock prices of Corautus, the exchange ratio of shares in the
Merger, and a private company 10% discount for grants prior to March 31, 2007, as this represented
the best estimate of market value to use in measuring compensation. Subsequent to the Merger, the
Company, now publicly held, uses the closing stock price of the Companys common stock on the date
the options are granted to determine the fair market value of each option. The Company revalues
each non-employee option quarterly based on the closing stock price of the Companys common stock
on the last day of the quarter. The Company also revalues options when there is a change in
employment status.
The Company estimates the expected term of options granted by taking the average of the
vesting term and the contractual term of the option. As of December 31, 2009, the Company estimates
common stock price volatility using a hybrid approach consisting of the weighted-average of actual
historical volatility using a look back period of approximately two years, representing the period
of time the Companys stock has been publicly traded, blended with an average of selected peer
group volatility for approximately six years, consistent with the expected life from grant date.
The volatility for the Company and the selected peer group was approximately 130% and 104%,
respectively, as of December 31, 2009, and the blended volatility rate was approximately 114% as of
December 31, 2009. The Company will continue to incrementally increase the look back period of the
Companys common stock and percent of actual historical volatility until historical data meets or
exceeds the estimated term of the options. Prior to the year ended December 31, 2009, the Company
used peer group calculated volatility as the Company is a development stage company with limited
stock price history from which to forecast stock price volatility. The risk-free interest rates
used in the valuation model are based on U.S. Treasury issues with remaining terms similar to the
expected term on the options. The Company does not anticipate paying any dividends in the
foreseeable future and therefore used an expected dividend yield of zero.
F-12
The Company calculated an annualized forfeiture rate of 2.82% and 4.0% using historical data
for the years ended December 31, 2009 and 2008, respectively. This rate was used to exclude future
forfeitures in the calculation of stock-based compensation expense as of December 31, 2009 and
2008, respectively.
The assumptions used to value option and restricted stock award grants for the years ended
December 31, 2009 and 2008 are as follows:
|
|
|
|
|
|
|
|
|
|
|
Years Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
Expected life from grant date |
|
|
6.08 7.96 |
|
|
|
2.75 6.25 |
|
Expected volatility |
|
|
105% 114 |
% |
|
|
79% 82 |
% |
Risk free interest rate |
|
|
2.89% 3.07 |
% |
|
|
1.52% 3.49 |
% |
Dividend yield |
|
|
|
|
|
|
|
|
The following table summarizes stock-based compensation expense related to stock options and
warrants for the years ended December 31, 2009 and 2008 and for the period from June 14, 2004 (date
of inception) to December 31, 2009, which was included in the statements of operations in the
following captions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
|
|
|
|
|
|
June 14, 2004 |
|
|
|
Years Ended |
|
|
(Date of Inception) to |
|
|
|
December 31, |
|
|
December 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
Research and development expense |
|
$ |
260,226 |
|
|
$ |
319,990 |
|
|
$ |
1,079,426 |
|
General and administrative expense |
|
|
941,540 |
|
|
|
979,061 |
|
|
|
2,804,862 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
1,201,766 |
|
|
$ |
1,299,051 |
|
|
$ |
3,884,288 |
|
|
|
|
|
|
|
|
|
|
|
If all of the remaining non-vested and outstanding stock option awards that have been granted
became vested, we would recognize approximately $1.7 million in compensation expense over a
weighted average remaining period of 1.6 years. However, no compensation expense will be recognized
for any stock option awards that do not vest.
The following table summarizes stock-based compensation expense related to employee restricted
stock awards for the years ended December 31, 2009 and 2008 and for the period from June 14, 2004
(date of inception) to December 31, 2009, which was included in the statements of operations in the
following captions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
|
|
|
|
|
|
June 14, 2004 |
|
|
|
Years Ended |
|
|
(Date of Inception) to |
|
|
|
December 31, |
|
|
December 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
Research and development expense |
|
$ |
15,734 |
|
|
$ |
634 |
|
|
$ |
16,368 |
|
General and administrative expense |
|
|
47,655 |
|
|
|
1,893 |
|
|
|
49,548 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
63,389 |
|
|
$ |
2,527 |
|
|
$ |
65,916 |
|
|
|
|
|
|
|
|
|
|
|
If all of the remaining non-vested restricted stock awards that have been granted became
vested, we would recognize approximately $61,000 in compensation expense over a weighted average
remaining period of 1.0 years. However, no compensation expense will be recognized for any stock
option awards that do not vest.
4. RESEARCH AND DEVELOPMENT
The Companys research and development expenses include expenses related to Phase 2 clinical
development of the Companys lead compound VIA-2291, regulatory activities, and preclinical
development costs for additional assets in the Companys product pipeline. R&D expenses include
salaries, contractor and consultant fees, external clinical trial expenses performed by CROs and
contracted investigators, licensing fees and facility allocations. In addition, the Company funds
R&D at third-party research institutions under agreements that are generally cancelable at the
Companys option. Research costs typically consist of applied research, preclinical and toxicology
work. Pharmaceutical manufacturing development costs consist of product formulation, chemical
analysis and the transfer and scale-up of manufacturing at our contract manufacturers. Clinical
costs include the costs of Phase 2 clinical trials. These costs, along with the manufacturing
scale-up costs, are a significant component of research and development expenses.
F-13
The following reflects the breakdown of the Companys research and development expenses
generated internally versus externally for the years ended December 31, 2009 and 2008, and for the
period from June 14, 2004 (date of inception) to December 31, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
|
|
|
|
|
|
June 14, 2004 |
|
|
|
Years Ended |
|
|
(Date of Inception) to |
|
|
|
December 31, |
|
|
December 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
Externally generated research and development expense |
|
$ |
3,639,215 |
|
|
$ |
7,906,799 |
|
|
$ |
28,705,191 |
|
Internally generated research and development expense |
|
|
2,416,000 |
|
|
|
3,897,254 |
|
|
|
12,200,987 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
6,055,215 |
|
|
$ |
11,804,053 |
|
|
$ |
40,906,178 |
|
|
|
|
|
|
|
|
|
|
|
Externally generated research and development expenses consist primarily of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
|
|
|
|
|
|
June 14, 2004 |
|
|
|
Years Ended |
|
|
(Date of Inception) to |
|
|
|
December 31, |
|
|
December 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
Externally generated research and development expense |
|
|
|
|
|
|
|
|
|
|
|
|
In-licensing expenses |
|
$ |
400,000 |
|
|
$ |
25,000 |
|
|
$ |
5,270,000 |
|
CRO and investigator expenses |
|
|
1,090,115 |
|
|
|
4,841,760 |
|
|
|
10,749,339 |
|
Consulting expenses |
|
|
1,120,131 |
|
|
|
1,239,447 |
|
|
|
6,418,669 |
|
Other |
|
|
1,028,969 |
|
|
|
1,800,592 |
|
|
|
6,267,183 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
3,639,215 |
|
|
$ |
7,906,799 |
|
|
$ |
28,705,191 |
|
|
|
|
|
|
|
|
|
|
|
Internally generated research and development expenses consist primarily of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
|
|
|
|
|
|
June 14, 2004 |
|
|
|
Years Ended |
|
|
(Date of Inception) to |
|
|
|
December 31, |
|
|
December 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
Internally generated research and development expense |
|
|
|
|
|
|
|
|
|
|
|
|
Personnel and related expenses |
|
$ |
1,693,205 |
|
|
$ |
2,771,734 |
|
|
$ |
8,507,159 |
|
Stock-based compensation expense |
|
|
275,961 |
|
|
|
320,624 |
|
|
|
1,095,794 |
|
Travel and entertainment expense |
|
|
170,249 |
|
|
|
320,616 |
|
|
|
1,155,619 |
|
Other |
|
|
276,585 |
|
|
|
484,280 |
|
|
|
1,442,415 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
2,416,000 |
|
|
$ |
3,897,254 |
|
|
$ |
12,200,987 |
|
|
|
|
|
|
|
|
|
|
|
5. PROPERTY AND EQUIPMENT
Property and equipment net, at December 31, 2009 and 2008 consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
Years Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
Property and equipment at cost: |
|
|
|
|
|
|
|
|
Computer equipment and software |
|
$ |
308,467 |
|
|
$ |
321,217 |
|
Furniture and fixtures |
|
|
113,363 |
|
|
|
108,869 |
|
Office equipment |
|
|
38,282 |
|
|
|
38,282 |
|
Leasehold Improvements |
|
|
129,740 |
|
|
|
129,740 |
|
|
|
|
|
|
|
|
Total property and equipment at cost |
|
|
589,852 |
|
|
|
598,108 |
|
Less: accumulated depreciation |
|
|
(419,235 |
) |
|
|
(306,304 |
) |
|
|
|
|
|
|
|
Total |
|
$ |
170,617 |
|
|
$ |
291,804 |
|
|
|
|
|
|
|
|
F-14
Depreciation expense on property and equipment was $136,360 and $183,602 in the years ended
December 31, 2009 and 2008, respectively, and $503,873 for the period from June 14, 2004 (date of
inception) to December 31, 2009, and was included in the statements of operations as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
|
|
|
|
|
|
June 14, 2004 |
|
|
|
Years Ended |
|
|
(Date of Inception) to |
|
|
|
December 31, |
|
|
December 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
Research and development expense |
|
$ |
22,292 |
|
|
$ |
58,761 |
|
|
$ |
131,928 |
|
General and administrative expense |
|
|
114,068 |
|
|
|
124,841 |
|
|
|
371,945 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
136,360 |
|
|
$ |
183,602 |
|
|
$ |
503,873 |
|
|
|
|
|
|
|
|
|
|
|
6. NOTES PAYABLE AFFILIATES
In March 2009, the Company entered into the Loan Agreement whereby the Lenders agreed to lend
to the Company in the aggregate up to $10.0 million, pursuant to the terms of promissory notes
(collectively the Notes) delivered under the Loan Agreement.
On March 12, 2009, the Company borrowed an initial amount of $2.0 million under the Loan
Agreement. During the three months ended June 30, 2009, the Company borrowed $2. 0 million on May
19, 2009, and another $2.0 million on June 29, 2009. During the three months ended September 30,
2009, the Company borrowed $2.0 million on August 14, 2009, and borrowed the final $2.0 million on
September 11, 2009. The Notes are secured by a first priority lien on all of the assets of the
Company, including the Companys intellectual property. Amounts borrowed under the Notes accrue
interest at the rate of 15% per annum, which increases to 18% per annum following an event of
default. Unless earlier paid in accordance with the terms of the Notes, all unpaid principal and
accrued interest shall become fully due and payable on the earlier to occur of (i) April 1, 2010,
as amended on February 26, 2010, (ii) the closing of a debt, equity or combined debt/equity
financing resulting in gross proceeds or available credit to the Company of not less than $20.0
million (a Financing), and (iii) the closing of a transaction in which the Company sells,
conveys, licenses or otherwise disposes of a majority of its assets or is acquired by way of a
merger, consolidation, reorganization or other transaction or series of transactions pursuant to
which stockholders of the Company prior to such acquisition own less than 50% of the voting
interests in the surviving or resulting entity. On September 11, 2009, the Lenders agreed to extend
the repayment terms from September 14, 2009 to October 31, 2009; on October 30, 2009, the Lenders
agreed to further extend the repayment terms from October 31, 2009 to December 31, 2009; on
December 22, 2009, the Lenders agreed to again further extend the repayment terms from December 31,
2009 to February 28, 2010; and on February 26, 2010, the Lenders agreed to further extend the
repayment terms from February 28, 2010 to April 1, 2010. There were no other significant changes to
any of the terms and conditions of the original Notes in the September 11, 2009, October 30, 2009,
December 22, 2009 or February 26, 2010 amendments and the Lenders did not give any loan
concessions. As a result of the three loan amendments in 2009, total interest expense on the note
and the note discount amortization increased $404,941 from anticipated interest expense based on
the original due dates of the notes of $7,328,449 to actual interest after the loan amendments of
$7,733,390 in the year ended December 31, 2009. The February 26, 2010 loan amendment modifying the
repayment terms to April 1, 2010 did not have any impact on the reported interest expense at
December 31, 2009 as the amendment occurred after December 31, 2009.
Pursuant to the terms of the Loan Agreement, the Company issued to the Lenders warrants (the
Warrants) to purchase an aggregate of up to 83,333,333 shares (the Warrant Shares) of common
stock at $0.12 per share, which will become fully exercisable to the extent that the entire $10.0
million is drawn, as more fully described below. The number of Warrant Shares is equal to the $10.0
million maximum aggregate principal amount that may be borrowed under the Loan Agreement, divided
by the $0.12 per share exercise price of the Warrants. The Warrant Shares vest based on the amount
of borrowings under the Notes and based on the passage of time. For each $2.0 million borrowing,
8,333,333 Warrant Shares vest and are exercisable immediately on the date of grant, and 8,333,333
vest and are exercisable 45 days thereafter as the Company meets certain conditions provided for in
the Warrant, including that the Company did not complete a $20.0 million financing, as defined in
the Loan Agreement, within 45 days of the borrowing. Based on the aggregate $10.0 million of
borrowings at December 31, 2009, all 83,333,333 Warrant Shares are vested and are exercisable at
December 31, 2009. The Warrant Shares, to the extent they are vested and exercisable, are
exercisable at any time until March 12, 2014.
On March 12, 2009, the fair value of the note and of the 16,666,666 Warrant Shares related to
the $2.0 million borrowed under the Loan Agreement was $2.0 million and approximately $1.6 million,
respectively. This resulted in the Company allocating the relative fair value of approximately $1.1
million of the $2.0 million in proceeds to the note and approximately $900,000 to the Warrant. The
Company has recorded the $900,000 freestanding Warrant as permanent equity under accounting
guidance for accounting for derivative financial instruments indexed to, and potentially settled
in, a companys own stock, and
F-15
accounting
guidance for determining whether an instrument (or embedded feature) is indexed to an entitys own stock.
The $900,000 discount on the note payable affiliate is netted against the $2.0 million note and
is being amortized to interest expense using the interest method from March 12, 2009 through
February 28, 2010, the maturity date of the note payable as amended on December 22, 2009. The loan
repayment date was further extended to April 1, 2010. The amortization period used to compute
interest expense on the amortization of the note discount was not extended to April 1, 2010 as the
February 26, 2010 amendment occurred after December 31, 2009. In the year ended December 31, 2009,
the Company reported $1,142,474 in interest expense, consisting of $900,008 from the amortization
of the discount and $242,466 of 15% interest expense on the debt, which is included in the
statement of operations for the year ended December 31, 2009. At December 31, 2009, the balance of
notes payable affiliate net of discount was $1,999,964 and the unamortized discount was $36.
The Company estimated the fair value of the Warrant of approximately $1.6 million at March 12,
2009 using the Black-Scholes pricing model methodology with assumptions outlined below. The
assumptions used to value the Warrant at March 12, 2009 (date of inception) are:
|
|
|
|
|
|
|
March 12, 2009 |
|
Expected life from grant date in years |
|
|
5.0 |
|
Expected volatility |
|
|
116.79 |
% |
Risk free interest rate |
|
|
2.10 |
% |
Dividend yield |
|
|
|
|
On May 19, 2009, the Company borrowed an additional $2.0 million under the Loan Agreement and
the fair value of the note and of the 16,666,666 Warrant Shares related was $2.0 million and
approximately $6.6 million, respectively. This resulted in the Company allocating the relative fair
value of approximately $500,000 of the $2.0 million in proceeds to the note and approximately $1.5
million to the Warrant. The Company has recorded the $1.5 million freestanding Warrant as permanent
equity under accounting guidance for accounting for derivative financial instruments indexed to,
and potentially settled in, a companys own stock, and accounting guidance for determining whether
an instrument (or embedded feature) is indexed to an entitys own stock. The $1.5 million discount
on the note payable affiliate is netted against the $2.0 million note and is being amortized to
interest expense using the interest method from May 19, 2009 through February 28, 2010, the
maturity date of the note payable as amended on December 22, 2009. On February 26, 2010, the loan
repayment date was further extended to April 1, 2010. The amortization period used to compute
interest expense on the amortization of the note discount was not extended to April 1, 2010 as the
February 26, 2010 amendment occurred after December 31, 2009. In the year ended December 31, 2009,
the Company reported $1,719,371 in interest expense, consisting of $1,532,796 from the amortization
of the discount and $186,575 of 15% interest expense on the debt, which is included in the
statement of operations for the year ended December 31, 2009. At December 31, 2009, the balance of
notes payable affiliate net of discount was $1,999,904 and the unamortized discount was $96.
The Company estimated the fair value of the Warrant of approximately $1.5 million at May 19,
2009 using the Black-Scholes pricing model methodology with assumptions outlined below. The
assumptions used to value the Warrant at May 19, 2009 (date of inception) are:
|
|
|
|
|
|
|
May 19, 2009 |
|
Expected life from grant date in years |
|
|
4.81 |
|
Expected volatility |
|
|
108.63 |
% |
Risk free interest rate |
|
|
2.05 |
% |
Dividend yield |
|
|
|
|
On June 29, 2009, the Company borrowed an additional $2.0 million under the Loan Agreement and
the fair value of the note and of the 16,666,666 Warrant Shares related was $2.0 million and
approximately $8.7 million, respectively. This resulted in the Company allocating the relative fair
value of approximately $400,000 of the $2.0 million in proceeds to the note and approximately $1.6
million to the Warrant. The Company has recorded the $1.6 million freestanding Warrant as permanent
equity under accounting guidance for accounting for derivative financial instruments indexed to,
and potentially settled in, a companys own stock, and accounting guidance for determining whether
an instrument (or embedded feature) is indexed to an entitys own stock. The $1.6 million discount
on the note payable affiliate is netted against the $2.0 million note and is being amortized to
interest expense using the interest method from June 29, 2009 through February 28, 2010, the
maturity date of the note payable as amended on December 22, 2009. On February 26, 2010, the loan
repayment date was further extended to April 1, 2010. The amortization period used to compute
interest expense on the amortization of the note discount was not extended to April 1, 2010 as the
February 26, 2010 amendment occurred after December 31, 2009. In the year ended December 31, 2009,
the Company reported $1,778,655 in interest expense, consisting of $1,625,778 from the
amortization of the discount and $152,877 of 15% interest expense on the debt, which is
included in the statement of operations for the year ended December 31, 2009. At December 31, 2009,
the balance of notes payable affiliate net of discount was $1,999,843 and the unamortized
discount was $157.
F-16
The Company estimated the fair value of the Warrant of approximately $1.6 million at June 29,
2009 using the Black-Scholes pricing model methodology with assumptions outlined below. The
assumptions used to value the Warrant at June 29, 2009 (date of inception) are:
|
|
|
|
|
|
|
June 29, 2009 |
|
Expected life from grant date in years |
|
|
4.7 |
|
Expected volatility |
|
|
112.03 |
% |
Risk free interest rate |
|
|
2.40 |
% |
Dividend yield |
|
|
|
|
On August 14, 2009, the Company borrowed an additional $2.0 million under the Loan Agreement
and the fair value of the note and of the 16,666,666 Warrant Shares related was $2.0 million and
approximately $4.4 million, respectively. This resulted in the Company allocating the relative fair
value of approximately $600,000 of the $2.0 million in proceeds to the note and approximately $1.4
million to the Warrant. The Company has recorded the $1.4 million freestanding Warrant as permanent
equity under accounting guidance for accounting for derivative financial instruments indexed to,
and potentially settled in, a companys own stock, and accounting guidance for determining whether
an instrument (or embedded feature) is indexed to an entitys own stock. The $1.4 million discount
on the note payable affiliate is netted against the $2.0 million note and is being amortized to
interest expense using the interest method from August 14, 2009 through February 28, 2010, the
maturity date of the note payable as amended on December 22, 2009. On February 26, 2010, the loan
repayment date was further extended to April 1, 2010. The amortization period used to compute
interest expense on the amortization of the note discount was not extended to April 1, 2010 as the
February 26, 2010 amendment occurred after December 31, 2009. In the year ended December 31, 2009,
the Company reported $1,487,780 in interest expense, consisting of $1,372,712 from the amortization
of the discount and $115,068 of 15% interest expense on the debt, which is included in the
statement of operations for the year ended December 31, 2009. At December 31, 2009, the balance of
notes payable affiliate net of discount was $1,999,671 and the unamortized discount was $329.
The Company estimated the fair value of the Warrant of approximately $1.4 million at August
14, 2009 using the Black-Scholes pricing model methodology with assumptions outlined below. The
assumptions used to value the Warrant at August 14, 2009 (date of inception) are:
|
|
|
|
|
|
|
August 14, 2009 |
|
Expected life from grant date in years |
|
|
4.58 |
|
Expected volatility |
|
|
115.22 |
% |
Risk free interest rate |
|
|
2.32 |
% |
Dividend yield |
|
|
|
|
On September 11, 2009, the Company borrowed the final $2.0 million under the Loan Agreement
and the fair value of the note and of the 16,666,666 Warrant Shares related was $2.0 million and
approximately $6.3 million, respectively. This resulted in the Company allocating the relative fair
value of approximately $500,000 of the $2.0 million in proceeds to the note and approximately $1.5
million to the Warrant. The Company has recorded the $1.5 million freestanding Warrant as permanent
equity under accounting guidance for accounting for derivative financial instruments indexed to,
and potentially settled in, a companys own stock, and accounting guidance for determining whether
an instrument (or embedded feature) is indexed to an entitys own stock. The $1.5 million discount
on the note payable affiliate is netted against the $2.0 million note and is being amortized to
interest expense using the interest method from September 11, 2009 through February 28, 2010, the
maturity date of the note payable as amended on December 22, 2009. On February 26, 2010, the loan
repayment date was further extended to April 1, 2010. The amortization period used to compute
interest expense on the amortization of the note discount was not extended to April 1, 2010 as the
February 26, 2010 amendment occurred after December 31, 2009. In the year ended December 31, 2009,
the Company reported $1,605,110 in interest expense, consisting of $1,513,055 from the amortization
of the discount and $92,055 of 15% interest expense on the debt, which is included in the statement
of operations for the year ended December 31, 2009. At December 31, 2009, the balance of notes
payable affiliate net of discount was $1,996,244 and the unamortized discount was $3,756.
F-17
The Company estimated the fair value of the Warrant of approximately $1.5 million at September
11, 2009 using the Black-Scholes pricing model methodology with assumptions outlined below. The
assumptions used to value the Warrant at September 11, 2009 (date of inception) are:
|
|
|
|
|
|
|
September 11, 2009 |
|
Expected life from grant date in years |
|
|
4.50 |
|
Expected volatility |
|
|
115.41 |
% |
Risk free interest rate |
|
|
2.07 |
% |
Dividend yield |
|
|
|
|
In the year ended December 31, 2009, the Company reported a total of $7,733,390 in interest
expense on the Notes, consisting of $6,944,349 from the amortization of the discount and $789,041
of 15% interest expense on the debt, which is included in the statement of operations for the year
ended December 31, 2009. At December 31, 2009 the aggregate balance of the notes payable
affiliate net of discount was $9,995,626 and the aggregate unamortized discount was $4,374. At
December 31, 2009, the Company has accrued interest of $789,041 which is included in the Balance
Sheet.
7. EQUITY
On June 5, 2007, in connection with the Merger, the Certificate of Incorporation of Corautus
became the Certificate of Incorporation of the Company, and the Company further amended and
restated its Certificate of Incorporation to increase the number of authorized shares of common
stock from 100,000,000 shares to 200,000,000 shares. The Certificate of Incorporation of the
Company provides that the total number of authorized shares of preferred stock of the Company is
5,000,000 shares. Significant components of the Companys stock are as follows:
Common Stock The Companys authorized common stock was 200,000,000 shares at December 31,
2009 and 2008. Common stockholders are entitled to dividends if and when declared by the Board of
Directors, subject to preferred stockholder dividend rights.
At December 31, 2009 and 2008, the Company had reserved the following shares of common stock
for issuance:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
2007 Incentive Award Plan outstanding and available to grant |
|
|
3,328,398 |
|
|
|
2,882,054 |
|
Shares of common stock subject to outstanding warrants |
|
|
83,403,348 |
|
|
|
207,479 |
|
Shares of common stock subject to conversion from series C preferred stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total shares of common stock equivalents |
|
|
86,731,746 |
|
|
|
3,089,533 |
|
|
|
|
|
|
|
|
Preferred Stock The Companys authorized Series A Preferred Stock was 5,000,000 shares at
December 31, 2009 and 2008. There were no issued and outstanding shares of Series A Preferred Stock
at December 31, 2009 and 2008.
The Companys authorized Series C Preferred Stock was 17,000 shares at December 31, 2009 and
2008. There were 2,000 shares of Series C Preferred Stock issued and outstanding at December 31,
2009 and 2008. The Series C Preferred Stock is not entitled to receive dividends, has a liquidation
preference amount of one thousand dollars ($1,000.00) per share, and has no voting rights, except
as to the issuance of additional Series C Preferred Stock. Each share of Series C Preferred Stock
becomes convertible into common stock on June 13, 2010. The Series C Preferred Stock is convertible
into common stock in an amount equal to (a) the quotient of (i) the liquidation preference
(adjusted for recapitalizations), divided by (ii) one hundred and ten percent (110%) of the per
share fair market value (as defined in the Amended and Restated Certificate of Designation of
Preferences and Rights of Series C Preferred Stock of the Company) of the Companys common stock
multiplied by (b) the number of shares of converted Series C Preferred Stock.
2002 Stock Option Plans In November 2002, the Corautus Board of Directors adopted the 2002
Stock Plan, which was approved by Corautus stockholders in February 2003 and was amended by
Corautus stockholder approval in May 2004. Under the 2002 Stock Plan, the Board of Directors or a
committee of the Board of Directors has the authority to grant options and rights to purchase
common stock to officers, key employees, consultants and certain advisors to the Company. Options
granted under the 2002 Stock Plan may be either incentive stock options or non-qualified stock
options, as determined by the Board of Directors or a committee. The 2002 Stock Plan, as amended in
May 2004, reserved an additional 233,333 shares for issuance under the 2002 Stock Plan plus (a) any
shares of common stock which have been reserved but not issued under the 1999 Stock Plan, the 1995
Stock Plan and the 1995 Directors Option Plan as of the date of stockholder approval of the 2002
Stock Plan, (b) any shares of common stock returned to the 1999 Stock Plan, the 1995 Stock Plan and
the 1995 Directors Option Plan as a
F-18
result
of the termination of options or repurchase of shares of common stock issued under those plans and (c) an annual increase on
the first day of each year by the lesser of (i) 20,000 shares, (ii) the number of shares equal to
two percent of the total outstanding common shares or (iii) a lesser amount determined by the Board
of Directors. Generally, options are granted with vesting periods from one to two years and expire
ten years from date of grant or three months after termination of employment or service, if sooner.
Under the 2002 Stock Plan, the Company had 0 shares available for future grant as of December 31,
2007. In December 2007, the Company incorporated the outstanding options and shares available for
grant into the 2007 Incentive Award Plan.
2004 Stock Option Plans In 2004, the Companys Board of Directors adopted the 2004 Stock
Plan. Under the 2004 Stock Plan, up to 427,479 shares of the Companys common stock, in the form of
both incentive and non-qualified stock options, may be granted to eligible employees, directors,
and consultants. In September 2006, the Companys Board of Directors authorized an increase of
743,442 shares to the 2004 Stock Plan for a total of 1,170,921 authorized shares available for
grant from the 2004 Stock Plan. The 2004 Stock Plan provides that grants of incentive stock options
will be made at no less than the estimated fair value of the Companys common stock, as determined
by the Board of Directors at the date of grant. If, at the time the Company grants an option, the
holder owns more than ten percent of the total combined voting power of all the classes of stock of
the Company, the option price shall be at least 110% of the fair value. Vesting and exercise
provisions are determined by the Board of Directors at the time of grant. Option vesting ranges
from immediate and full vesting to five year vesting (twenty percent of the shares one year after
the options vesting commencement date and the remainder vesting ratably each month). Options
granted under the 2004 Stock Plan have a maximum term of ten years. Options can only be exercised
upon vesting, unless the option specifies that the shares can be early exercised. The Company
retains the right to repurchase exercised and unvested shares. Under the 2004 Stock Plan, the
Company had 0 shares available for future grant as of December 31, 2007. In December of 2007, the
Company incorporated the outstanding options and shares available for grant into the 2007 Incentive
Award Plan.
2007 Incentive Award Plan In December 2007, the Companys Board of Directors adopted the
2007 Incentive Award Plan. The Company combined the 2002 and 2004 Stock Plan into the 2007
Incentive Award Plan, and added 2.0 million shares available for grant in the form of both
incentive and non-qualified stock options which may be granted to eligible employees, directors,
and consultants. Only employees are entitled to receive grants of incentive stock options. The 2007
Incentive Award Plan provides that grants of incentive stock options will be made at no less than
the estimated fair market value of the Companys common stock on the date of grant. If, at the time
the Company grants an option, the holder owns more than ten percent of the total combined voting
power of all the classes of stock of the Company, the option price shall be at least 110% of the
fair value. Vesting and exercise provisions are determined by the Board of Directors at the time of
grant. Option vesting ranges from immediate and full vesting to five year vesting (twenty percent
of the shares one year after the options vesting commencement date and the remainder vesting
ratably each month). Options granted under the 2007 Incentive Award Plan have a maximum term of ten
years. Options can only be exercised upon vesting, unless the option specifies that the shares can
be early exercised. The Company retains the right to repurchase exercised and unvested shares.
Under the 2007 Incentive Award Plan, the Company had 587,712 and 74,127 shares available for future
grant at December 31, 2009 and 2008, respectively. Under the 2007 Incentive Award Plan, there is an
annual evergreen provision which provides that the plan shares are increased by the lesser of
500,000 shares or 3% of total common shares outstanding at the Companys year-end. Effective
January 1, 2009 and 2008, the Company added an additional 500,000 shares to the plan pursuant to
this provision of the plan.
A summary of stock option award activity from December 31, 2007 to December 31, 2009 follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
Average |
|
|
|
Option Shares |
|
|
Exercise |
|
Stock Option Awards |
|
Outstanding |
|
|
Price |
|
2007 Incentive Award Plan Options Outstanding December 31, 2007 |
|
|
2,642,110 |
|
|
$ |
7.02 |
|
Granted |
|
|
332,750 |
|
|
$ |
2.42 |
|
Exercised |
|
|
(32,711 |
) |
|
$ |
0.07 |
|
Canceled |
|
|
(134,222 |
) |
|
$ |
2.72 |
|
|
|
|
|
|
|
|
2007 Incentive Award Plan Options Outstanding December 31, 2008 |
|
|
2,807,927 |
|
|
$ |
6.77 |
|
Granted |
|
|
11,000 |
|
|
$ |
0.18 |
|
Exercised |
|
|
(57,615 |
) |
|
$ |
0.03 |
|
Canceled |
|
|
(20,626 |
) |
|
$ |
3.79 |
|
|
|
|
|
|
|
|
2007 Incentive Award Plan Options Outstanding December 31, 2009 |
|
|
2,740,686 |
|
|
$ |
6.90 |
|
|
|
|
|
|
|
|
F-19
As of December 31, 2009, a total of 229,955 shares of stock options were early exercised
before the shares were vested pursuant to provisions of the share grants under the 2007 Incentive
Award Plan, of which 28,078 shares remain unvested and subject to repurchase by the Company in the
event of employee termination.
The following table summarizes information concerning outstanding and exercisable options
outstanding at December 31, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding |
|
|
Options Vested or Expected to Vest |
|
|
Options Exercisable |
|
|
|
|
|
|
|
Average |
|
|
Weighted |
|
|
Number |
|
|
Average |
|
|
Weighted |
|
|
|
|
|
|
Weighted |
|
Range of |
|
Number of |
|
|
Remaining |
|
|
Average |
|
|
Exercisable or |
|
|
Remaining |
|
|
Average |
|
|
|
|
|
|
Average |
|
Exercise |
|
Options |
|
|
Contractual |
|
|
Exercise |
|
|
Expected to |
|
|
Contractual |
|
|
Exercise |
|
|
Number |
|
|
Exercise |
|
Prices |
|
Outstanding |
|
|
Life (Years) |
|
|
Price |
|
|
Vest |
|
|
Life (Years) |
|
|
Price |
|
|
Exercisable |
|
|
Price |
|
$0.03 |
|
|
183,565 |
|
|
|
5.41 |
|
|
$ |
0.03 |
|
|
|
183,565 |
|
|
|
5.41 |
|
|
$ |
0.03 |
|
|
|
183,565 |
|
|
$ |
0.03 |
|
$0.14 |
|
|
87,718 |
|
|
|
6.82 |
|
|
$ |
0.14 |
|
|
|
87,675 |
|
|
|
6.82 |
|
|
$ |
0.14 |
|
|
|
86,176 |
|
|
$ |
0.14 |
|
$0.15 |
|
|
50,000 |
|
|
|
8.96 |
|
|
$ |
0.15 |
|
|
|
50,000 |
|
|
|
8.96 |
|
|
$ |
0.15 |
|
|
|
50,000 |
|
|
$ |
0.15 |
|
$0.18 |
|
|
11,000 |
|
|
|
9.29 |
|
|
$ |
0.18 |
|
|
|
10,690 |
|
|
|
9.29 |
|
|
$ |
0.18 |
|
|
|
|
|
|
$ |
0.18 |
|
$1.70 |
|
|
750 |
|
|
|
8.61 |
|
|
$ |
1.70 |
|
|
|
736 |
|
|
|
8.61 |
|
|
$ |
1.70 |
|
|
|
265 |
|
|
$ |
1.70 |
|
$2.19 |
|
|
35,000 |
|
|
|
8.46 |
|
|
$ |
2.19 |
|
|
|
34,404 |
|
|
|
8.46 |
|
|
$ |
2.19 |
|
|
|
13,854 |
|
|
$ |
2.19 |
|
$2.38 |
|
|
1,383,025 |
|
|
|
7.96 |
|
|
$ |
2.38 |
|
|
|
1,364,662 |
|
|
|
7.96 |
|
|
$ |
2.38 |
|
|
|
731,844 |
|
|
$ |
2.38 |
|
$2.90 |
|
|
235,000 |
|
|
|
8.04 |
|
|
$ |
2.90 |
|
|
|
231,548 |
|
|
|
8.04 |
|
|
$ |
2.90 |
|
|
|
112,604 |
|
|
$ |
2.90 |
|
$3.10 |
|
|
12,000 |
|
|
|
8.23 |
|
|
$ |
3.10 |
|
|
|
11,810 |
|
|
|
8.23 |
|
|
$ |
3.10 |
|
|
|
5,270 |
|
|
$ |
3.10 |
|
$3.48 |
|
|
389,375 |
|
|
|
7.59 |
|
|
$ |
3.48 |
|
|
|
384,800 |
|
|
|
7.59 |
|
|
$ |
3.48 |
|
|
|
227,131 |
|
|
$ |
3.48 |
|
$5.10 |
|
|
22,300 |
|
|
|
7.43 |
|
|
$ |
5.10 |
|
|
|
22,300 |
|
|
|
7.43 |
|
|
$ |
5.10 |
|
|
|
22,300 |
|
|
$ |
5.10 |
|
$5.55 |
|
|
18,586 |
|
|
|
7.42 |
|
|
$ |
5.55 |
|
|
|
18,586 |
|
|
|
7.42 |
|
|
$ |
5.55 |
|
|
|
18,586 |
|
|
$ |
5.55 |
|
$11.25$1023.75 |
|
|
312,367 |
|
|
|
4.90 |
|
|
$ |
42.36 |
|
|
|
312,367 |
|
|
|
4.90 |
|
|
$ |
42.36 |
|
|
|
312,367 |
|
|
$ |
42.36 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,740,686 |
|
|
|
7.38 |
|
|
$ |
6.90 |
|
|
|
2,713,143 |
|
|
|
7.38 |
|
|
$ |
6.95 |
|
|
|
1,763,962 |
|
|
$ |
9.29 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The weighted-average fair value of options granted was $0.15 and $1.35 per share in the years
ended December 31, 2009 and 2008, respectively. The total intrinsic value of stock options
exercised was $11,865 and $33,921 for the years ended December 31, 2009 and 2008, respectively.
See also Note 8 for stock options with Related Parties.
Restricted Stock In December 2008, under the provisions of the 2007 Incentive Award Plan,
the Company granted employees restricted stock awards for 852,750 shares of the Companys common
stock with a weighted-average fair value of $0.15 per share that vest monthly over a two year
period, with acceleration of vesting in the event of a defined partnering transaction related to
the development of VIA-2291. The Company recognized $63,389 and $2,527 in stock-based compensation
expense in the years ended December 31, 2009 and 2008, respectively, and $65,916 in stock-based
compensation expense in the period from June 14, 2004 (date of inception) to December 31, 2009. As
the restricted stock awards vest through 2010, the Company will recognize the related stock-based
compensation expense over the vesting period. If all of the outstanding restricted stock awards at
December 31, 2009 fully vest, the Company will recognize $61,000 in the year ended December 31,
2010. However, no compensation expense will be recognized for stock awards that do not vest.
Restricted stock awards are shares of common stock which are forfeited if the employee leaves the
Company prior to vesting. These stock awards offer employees the opportunity to earn shares of our
stock over time. In contrast, stock options give the employee the right to purchase stock at a set
price.
A summary of restricted stock activity from December 31, 2007 to December 31, 2009 follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
Grant Date |
|
Restricted Stock Awards |
|
Shares |
|
|
Fair Value |
|
Unvested at December 31, 2007 |
|
|
|
|
|
|
|
|
Granted |
|
|
852,750 |
|
|
$ |
0.15 |
|
Vested |
|
|
|
|
|
|
|
|
Forfeited |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unvested at December 31, 2008 |
|
|
852,750 |
|
|
$ |
0.15 |
|
Granted |
|
|
|
|
|
|
|
|
Vested |
|
|
(424,916 |
) |
|
$ |
0.15 |
|
Forfeited |
|
|
(3,959 |
) |
|
$ |
0.15 |
|
|
|
|
|
|
|
|
|
Unvested at December 31, 2009 |
|
|
423,875 |
|
|
$ |
0.15 |
|
|
|
|
|
|
|
|
|
F-20
Warrants Affiliates Pursuant to the terms of the Loan Agreement as more fully discussed in
Note 6 in the notes to the financial statements, the Company issued to the Lenders Warrants to
purchase an aggregate of up to 83,333,333 shares of common stock at
$0.12 per share, which will become fully exercisable to the extent that the entire $10.0
million is drawn. The number of Warrant Shares is equal to the $10.0 million maximum aggregate
principal amount that may be borrowed under the Loan Agreement, divided by the $0.12 per share
exercise price of the Warrants, which is fixed on the date of the Loan Agreement. The Warrant
Shares vest based on the amount of borrowings under the Notes and based on the passage of time. For
each $2.0 million borrowing, 8,333,333 Warrant Shares vested and are exercisable immediately on the
date of grant, and 8,333,333 vested and are exercisable 45 days thereafter as the Company had met
certain conditions provided for in the Warrant, including that the Company did not complete a $20.0
million financing, as defined in the Loan Agreement, within 45 days of the borrowing. At each
subsequent closing, the Warrants will vest with respect to additional shares in proportion to the
additional amount borrowed by the Company at the same coverage ratio as the initial closing and at
the same vesting schedule, such that one-half of such additional shares will vest on the date of
the subsequent closing and the remaining one-half of such shares will vest 45 days after such
closing if certain conditions are met as provided for in the Warrants. The Warrant Shares, to the
extent they are vested and exercisable, are exercisable at any time until March 12, 2014. Based on
the $10.0 million of borrowings, all 83,333,333 Warrant Shares are vested and are exercisable on
December 31, 2009.
As described more fully in Note 6 in the notes to the financial statements, at December 31,
2009, the Company computed the fair value of the 83,333,333 Warrant Shares related to the aggregate
$10.0 million of borrowings under the Loan Agreement utilizing the Black-Scholes pricing model. In
accordance with the provisions of derivative financial instruments indexed to and potentially
settled in a Companys own stock, accounting for derivative instruments and hedging activities, and
accounting for convertible debt and debt issued with stock purchase warrants, the relative fair
value assigned to the Warrants of approximately $6.9 million was recorded as permanent equity in
additional paid-in capital in the Stockholders Equity (Deficit) section of the Balance Sheet
Warrants Other The Company assumed obligations for certain warrants issued by Corautus in
connection with previous financings and consulting engagements. As of December 31, 2009,
outstanding warrants to purchase approximately 16,429 shares of common stock at exercise prices of
$10.05-$67.50 will expire at various dates through February 2013.
In July 2007 the Company granted warrants to its investor relations firm to purchase 18,586
shares of the Companys common stock at a fixed purchase price of $3.95 per share. The warrants
began vesting 30 days after the issuance date and vested over a twelve month contracted service
period. The warrant expires July 31, 2017. The warrants were expensed as stock-based compensation
expense over the vesting period in the statements of operations resulting in expense of $0 and
$8,670 in the years ended December 31, 2009 and 2008, respectively. The Company revalues
non-employee warrants quarterly based on the closing stock price of the Companys common stock on
the last day of the quarter, and does a final valuation on the last option vesting date based on
the closing stock price of the Companys common stock on the last vesting date.
In December 2007, the Company granted warrants to a management consultant to purchase 10,000
shares of the Companys common stock at a fixed purchase price of $2.38 per share. The warrants are
expensed as stock-based compensation expense over the vesting period in the statements of
operations. The warrants were fully expensed in 2007.
In March 2008, the Company granted warrants to a financial communications and investor
relations firm to purchase 125,000 shares of the Companys common stock at a fixed purchase price
of $3.00 per share. As of March 1, 2008, 25,000 shares immediately vested, 50,000 will vest
immediately upon attaining a Share Price Goal (as defined in the warrant) of $5.00, 25,000 shares
will vest immediately upon attaining a Share Price Goal of $7.50, and 25,000 shares will vest
immediately upon attaining a Share Price Goal of $10.00. The contractual service period and vesting
period within which to attain the performance vesting ended December 31, 2008 and June 30, 2009,
respectively. The 100,000 performance based warrants expired unvested on June 30, 2009. The
remaining vested 25,000 shares expire August 31, 2013. Using the Black-Scholes pricing model, the
Company valued the warrants at fair values ranging from $0.01 to $1.52 per share or an aggregate of
$38,855 using an expected life ranging from 2.75 to 3.25 years, a risk-free interest rate ranging
from 2.0% to 2.48%, volatility ranging from 79% to 81%, and the fair market value stock price on
the last option measurement dates ranging from $0.18 to $3.00 per share. The warrants are expensed
as stock-based compensation expense over the service period in the statements of operations
resulting in expense of $0 and $38,855 in the years ended December 31, 2009 and 2008, respectively.
The Company revalues non-employee warrants quarterly based on the closing stock price of the
Companys common stock on the last day of the quarter, and does a final valuation on the last
option vesting date based on the closing stock price of the Companys common stock on the last
vesting date.
F-21
8. RELATED PARTIES
As more fully described in Note 6 in the notes to the financial statements, in March 2009, the
Company entered into the Loan Agreement with its principal stockholder and one of its affiliates,
as the Lenders, whereby the Lenders agreed to lend to the Company in the aggregate up to $10.0
million.
The Company terminated its licensing agreement with Leland Stanford Junior University
(Stanford) effective February 2009. The Companys founding Chief Scientific Officer (Founder)
was an affiliate of Stanford and is a stockholder of the Company. The Company paid consulting fees
to the Founder of $7,500 and $121,612 in the years ended December 31, 2009 and 2008, respectively.
While the Company did not issue any stock options in year ended December 31, 2009, the Company did
issue 10,000 and 42,300 stock options to the Founder in the years ended December 31, 2008 and 2007,
respectively. Using the Black-Scholes pricing model, the Company valued the 10,000 option shares
granted in 2008 at a fair value of $0.0973 per share or $973 using an expected life of 5.0 years, a
1.5% risk free interest rate, an 81% volatility rate, and the grant date fair market value of $0.15
per share. The options were fully vested at the grant date, December 17, 2008, and expire December
17, 2018. The Company expensed the options as stock-based compensation expense over the vesting
period in the statements of operations, resulting in expense of $0 and 973 in the years ended
December 31, 2009 and 2008, respectively. Using the Black-Scholes pricing model, the Company valued
the 42,300 option shares granted in 2007 as of December 31, 2009 at fair values ranging from
$0.1315 per share to $0.1441 per share or an aggregate of $5,814 using an expected life ranging
from 7.59 to 7.96 years, a 3.07% risk free interest rate, a 114% volatility rate, and the fair
market value stock price at December 31, 2009 of $0.20 per share. The options become fully vested
in the period from August 2, 2011 through December 17, 2011 and expire in the period from August 2,
2017 through December 17, 2017. The Company expensed the options as stock-based compensation
expense over the vesting period in the statements of operations, resulting in expense of $2,706 and
($3,067) in the years ended December 31, 2009 and 2008, respectively. The Company revalues
non-employee options quarterly based on the closing stock price of the Companys common stock on
the last day of the quarter, and does a final valuation on the last option vesting date based on
the closing stock price of the Companys common stock on the last vesting date.
During 2006, the Company used the services of an employee of the Companys primary investor to
act as Chief Financial Officer (CFO) and granted 18,586 stock option shares to the acting CFO as
compensation for services rendered. The options were fully vested on March 8, 2008, and expire
September 8, 2016. The Company expensed the option as stock-based compensation expense over the
vesting period in the statements of operations resulting in expense of $0 and $12,297 in the years
ended December 31, 2009 and 2008, respectively. The Company revalues non-employee options
quarterly based on the closing stock price of the Companys common stock on the last day of the
quarter, and does a final valuation on the last option vesting date based on the closing stock
price of the Companys common stock on the last vesting date.
The Companys Chief Development Officer (Officer) from inception through December 2009 is
also an employee of the Companys primary investor. The Company paid the Officer compensation of
$60,000 and $280,000 in the years ended December 31, 2009 and 2008, respectively. The Company did
not grant any options to the Officer in fiscal years ended December 31, 2009 and 2008. However,
the Company granted 26,921, 35,685, and 15,611 shares of stock options to the CDO in 2007, 2006,
and 2005, respectively. The options granted in 2005 became fully vested in the period from June 1,
2005 through June 1, 2006 and expire on June 29, 2015. The Company expensed the options as
stock-based compensation expense over the vesting period in the statements of operations resulting
in no expense in the years ended December 31, 2009 and 2008, respectively, as the options were
fully vested in 2006. The options granted in 2006 became fully vested in the period from November
29, 2006 through November 29, 2007 and expire on November 29, 2016. The Company expensed the
options as stock-based compensation expense over the vesting period in the statements of operations
resulting in no expense in the years ended December 31, 2009 and 2008, respectively, as the options
were fully vested in 2007. Using the Black-Scholes pricing model, the Company valued the 2007
options at fair values ranging from $2.43 to $5.78 per share or an aggregate fair value of $95,284
using an expected life of from 5.27 to 6.02 years, a 4.20% to 4.639% risk-free interest rate, a 67%
to 77% volatility rate and the fair market value stock prices of the Companys common stock on the
grant dates ranging from $3.48 to $5.89 per share. The options become fully vested in the period
from November 29, 2007 through August 2, 2011 and expire in the period from January 23, 2017
through August 2, 2017. The Company expensed the options as stock-based compensation expense over
the vesting period in the statements of operations resulting in expense of $11,195 and $10,789 in
the years ended December 31, 2009 and 2008, respectively.
Effective July 1, 2009, the Company sub-leased property in the Companys office facilities in
its headquarters in San Francisco, California on a month-to-month basis to an affiliate of the
Companys primary investor for $279 per month. The Company received $1,674 for rent for the
period from July 1, 2009 through December 31, 2009, which were included as a reduction to rent
expenses in the statement of operations for the year ended December 31 2009.
F-22
9. COMMITMENTS
Operating Leases The Company leases its office facilities for various terms under long-term,
non-cancelable operating lease agreements. The leases expire at various dates through 2013. The
Company recognizes rent expense on a straight-line basis over the lease period, and accrues for
rent expense incurred but not paid. Rent expense was $434,556 and $392,955 for the years ended
December 31, 2009 and 2008, respectively, and $1,435,084 for the period from June 14, 2004 (date of
inception) to December 31, 2009, and was included in the statements of operations as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
|
|
|
|
|
|
June 14, 2004 |
|
|
|
Years Ended |
|
|
(Date of Inception) to |
|
|
|
December 31, |
|
|
December 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
Research and development expense |
|
$ |
121,986 |
|
|
$ |
154,329 |
|
|
$ |
517,724 |
|
General and administrative expense |
|
|
312,570 |
|
|
|
238,626 |
|
|
|
917,360 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
434,556 |
|
|
$ |
392,955 |
|
|
$ |
1,435,084 |
|
|
|
|
|
|
|
|
|
|
|
Future minimum lease payments under non-cancelable operating leases, including lease
commitments entered into subsequent to December 31, 2009 are as follows:
|
|
|
|
|
|
|
Amount |
|
2010 |
|
$ |
437,597 |
|
2011 |
|
|
445,777 |
|
2012 |
|
|
362,468 |
|
2013 |
|
|
139,742 |
|
|
|
|
|
Total minimum lease payments |
|
$ |
1,385,584 |
|
|
|
|
|
Operating lease obligations reflect contractual commitments for the Companys office
facilities for its headquarters in San Francisco, California and its clinical operations location
in Princeton, New Jersey. In January 2008, the Company expanded and extended both leases to ensure
adequate facilities for current activities. The San Francisco headquarter lease has been extended
through May 2013 and has been expanded to a total of 8,180 square feet. The lease amendment
resulted in an increase of approximately $1.5 million in future rent. The lease amendment to the
Princeton, New Jersey facility extends the lease through April 2, 2012 and has been expanded to a
total of 4,979 square feet. The lease amendment resulted in an increase of approximately $330,000
in future rent.
Capital Leases In September 2005, the Company acquired office equipment under a capital
lease agreement. As of December 31, 2009 and 2008, the Company has no future minimum lease payment
obligations as the Company has made all contractual payments under the lease and physically
returned the equipment to the lessor in the year ended December 31, 2008.
10. INCOME TAXES
There is no income tax provision (benefit) for federal or state income taxes as the Company
has incurred operating losses since inception. Deferred income taxes reflect the net tax effects of
net operating loss and tax credit carryovers and temporary differences between the carrying amounts
of assets and liabilities for financial reporting purposes and the amounts used for income tax
purposes.
The following table reconciles the amount of income taxes computed at the federal statutory
rate of 34% for all periods presented, to the amount reflected in the Companys statement of
operations for the years ended December 31, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
Year Ended |
|
|
Year Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
Tax provision (benefit) at federal statutory income tax rate |
|
|
(34 |
)% |
|
|
(34 |
)% |
State income taxes, net of federal income tax effect |
|
|
(6 |
) |
|
|
1 |
|
Adjustments of deferred tax assets |
|
|
|
|
|
|
37 |
|
Other |
|
|
1 |
|
|
|
1 |
|
Valuation allowance |
|
|
39 |
|
|
|
(5 |
) |
|
|
|
|
|
|
|
Income tax expense (benefit) |
|
|
0 |
% |
|
|
0 |
% |
|
|
|
|
|
|
|
F-23
The tax effect of temporary differences related to various assets, liabilities and
carryforwards that give rise to deferred tax assets and liabilities at December 31, 2009 and 2008
are comprised of the following:
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
Deferred tax assets and liabilities: |
|
|
|
|
|
|
|
|
Net operating loss carryforwards |
|
$ |
6,214,313 |
|
|
$ |
1,456,856 |
|
Tax credit carryforwards |
|
|
115,393 |
|
|
|
46,056 |
|
Property and equipment and intangibles |
|
|
10,953,858 |
|
|
|
8,002,996 |
|
Other |
|
|
1,638,641 |
|
|
|
1,144,899 |
|
|
|
|
|
|
|
|
|
|
|
18,922,205 |
|
|
|
10,650,807 |
|
Less valuation allowance |
|
|
(18,922,205 |
) |
|
|
(10,650,807 |
) |
|
|
|
|
|
|
|
Net deferred tax assets and liabilities |
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
The net valuation allowance increased by $8,271,398 during the period ended December 31, 2009,
principally related to increased net operating loss carryforwards.
The Company has federal net operating loss carryforwards of approximately $15,640,849 as of
December 31, 2009 that expire beginning in 2026. The Company has California state net operating
loss carryforwards of approximately $13,011,708 as of December 31, 2009 that expire beginning 2016.
The Company has New Jersey state net operating loss carryforwards of approximately $13,556,117 as
of December 31, 2009 that expire beginning 2013. The Company also has federal, California state,
and New Jersey state research and development tax credits of approximately $278,168, $263,842, and
$188,878, respectively. Federal research credits will expire beginning 2026, California state
credits can be carried forward indefinitely, and New Jersey state credits will expire beginning in
the year 2022.
Utilization of the net operating loss and tax credit carryforwards were subject to a
substantial annual limitation due to the ownership change limitations provided by the Internal
Revenue Code of 1986, as amended, and similar state provisions. The Company experienced a change of
control which resulted in a substantial reduction to the previously reported net operating losses
at December 31, 2008. As of December 31, 2009, the net operating loss carryforwards continue to be
fully reserved and any reduction in such amounts as a result of this study would also reduce the
related valuation allowances resulting in no net impact to the financial results of the Company.
On January 1, 2007, the Company adopted new accounting guidance for the accounting for
uncertainty in income tax positions. This guidance seeks to reduce the diversity in practice
associated with certain aspects of measurement and recognition in accounting for income taxes and
provide guidance on de-recognition, classification, interest and penalties, and accounting in
interim periods and requires expanded disclosure with respect to the uncertainty in income taxes.
The accounting guidance requires that the Company recognize in its financial statements the impact
of a tax position if that position is more likely than not to be sustained on audit, based on the
technical merits of the position. The Company recognized no liabilities for unrecognized income
tax benefits and, upon adoption of the new guidance, the Company recognized no material adjustment
for the cumulative effect of adoption. At December 31, 2009, the Company had unrecognized tax
benefits of $584,710, all of which would not currently affect the Companys effective tax rate if
recognized due to the Companys deferred tax assets being fully offset by a valuation allowance.
A reconciliation of the beginning and ending amount of unrecognized tax benefits is as
follows:
|
|
|
|
|
|
|
Amount |
|
Balance at January 1, 2008 |
|
$ |
139,711 |
|
Additions based on tax positions related to current year |
|
|
83,208 |
|
Additions for tax positions of prior year |
|
|
474,484 |
|
Reductions for tax positions of current year |
|
|
|
|
Reductions for tax positions of prior year |
|
|
(423,273 |
) |
Settlements |
|
|
|
|
|
|
|
|
Balance at December 31, 2008 |
|
$ |
274,130 |
|
Additions based on tax positions related to current year |
|
|
310,580 |
|
Additions for tax positions of prior year |
|
|
|
|
Reductions for tax positions of current year |
|
|
|
|
Reductions for tax positions of prior year |
|
|
|
|
Settlements |
|
|
|
|
|
|
|
|
Balance at December 31, 2009 |
|
$ |
584,710 |
|
|
|
|
|
F-24
The Company would classify interest and penalties related to uncertain tax positions in income
tax expense, if applicable. There was no interest expense or penalties related to unrecognized tax
benefits recorded through December 31, 2009. The tax years 2004 through 2009 remain open to
examination by one or more major taxing jurisdictions to which the Company is subject.
The Company does not anticipate that total unrecognized net tax benefits will significantly
change prior to the end of 2010.
11. EMPLOYEE BENEFIT PLANS
The Company established a defined contribution plan qualified under Section 401(k) of the
Internal Revenue Code. Employees of the Company are eligible to participate in the Companys 401(k)
plan. Employees participating in the plan are permitted to contribute up to the maximum amount
allowable by law. Company contributions are discretionary and only safe-harbor contributions were
made in 2009 and 2008. The Company made safe-harbor contributions to certain plan participants in
the aggregate amount of $94,529 and $40,825 in the years ended December 31, 2009 and 2008,
respectively, and $149,654 for the period from June 14, 2004 (date of inception) to December 31,
2009.
12. SUBSEQUENT EVENTS
On February 26, 2010, the Lenders agreed to modify the Loan Agreement, as more fully described
in Note 6 in the notes to the financial statements, to extend the repayment terms of the
$10.0 million borrowings to April 1, 2010. The Lenders did not modify the interest rate or offer
any concessions in the amended Loan Agreement.
In March 2010, the Company entered into an additional Note and Warrant Purchase Agreement (the
2010 Loan Agreement) with the Lenders whereby the Lenders agreed to lend to the Company in the
aggregate up to $3,000,000, pursuant to the terms of promissory notes (collectively, the 2010
Notes) delivered under the 2010 Loan Agreement (the 2010 Loan Transaction). On March 29, 2010,
the Company borrowed an initial amount of $1,250,000. Subject to the Lenders approval, the
Company may borrow in the aggregate up to an additional $1,750,000 at subsequent closings pursuant
to the terms of the 2010 Loan Agreement and 2010 Notes. The 2010 Notes are secured by a lien on all
of the assets of the Company. Amounts borrowed under the 2010 Notes accrue interest at the rate of
15% per annum, which increases to 18% per annum following an event of default. Unless earlier paid
in accordance with the terms of the 2010 Notes, all unpaid principal and accrued interest shall
become fully due and payable on the earlier to occur of (i) December 31, 2010, (ii) the closing of
a debt, equity or combined debt/equity financing resulting in gross proceeds or available credit to
the Company of not less than $20,000,000, and (iii) the closing of a transaction in which the
Company sells, conveys, licenses or otherwise disposes of a majority of its assets or is acquired
by way of a merger, consolidation, reorganization or other transaction or series of transactions
pursuant to which stockholders of the Company prior to such acquisition own less than 50% of the
voting interests in the surviving or resulting entity. Pursuant to the 2010 Loan Agreement, the
Company issued to the Lenders warrants (the 2010 Warrants) to purchase an aggregate of
17,647,059 shares (the 2010 Warrant Shares) of common stock at $.17 per share. The number of 2010
Warrant Shares is equal to the $3,000,000 maximum aggregate principal amount that may be borrowed
under the 2010 Loan Agreement, divided by the $0.17 per share exercise price of the 2010 Warrants.
The 2010 Warrant Shares vest based on the amount of borrowings under the 2010 Notes. Based on the
$1,250,000 borrowing at the initial closing, 7,352,941 of the 2010 Warrant Shares vested
immediately on the date of grant. At each subsequent closing, the 2010 Warrants will vest with
respect to the additional amount borrowed by the Company. The 2010 Warrant Shares, to the extent
they are vested and exercisable, are exercisable at any time until March 26, 2015.
On March 26, 2010 the Companys Board of Directors approved a restructuring of the Company to
reduce its workforce and operating costs effective March 31, 2010. The reduction in workforce
decreased total employees by approximately 63% to a total of six employees, and increased the focus
of future operating expense on research and development activities. This decision resulted in
recording a charge to operating expenses of approximately $69,000 in March 2010. This charge
includes cash costs of restructuring, principally related to severance and related medical costs
for terminated employees, of approximately $413,000, and non-cash charges of approximately $187,000
related to the fair value of excess facilities at the Companys corporate headquarters, offset by
approximately $531,000 related to the reversal of previously recorded incentive award accruals
recorded as of December 31, 2009. In addition to this restructuring charge, the Company will pay
terminated employees approximately $183,000 for amounts accrued for unused vacation and sick pay.
The total estimated cash cost of the restructuring costs, and amounts to be paid for accrued
vacation and sick pay, is approximately $596,000.
F-25
13. SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First |
|
|
Second |
|
|
Third |
|
|
Fourth |
|
|
|
Quarter |
|
|
Quarter |
|
|
Quarter |
|
|
Quarter |
|
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net service revenues |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Gross profit |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss before extraordinary items
and cumulative effect of any
accounting change |
|
|
(4,302,138 |
) |
|
|
(4,391,189 |
) |
|
|
(8,038,046 |
) |
|
|
(4,246,951 |
) |
Net loss per share Basic and diluted |
|
|
(0.22 |
) |
|
|
(0.22 |
) |
|
|
(0.40 |
) |
|
|
(0.21 |
) |
Net loss |
|
|
(4,302,138 |
) |
|
|
(4,391,189 |
) |
|
|
(8,038,046 |
) |
|
|
(4,246,951 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net service revenues |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Gross profit |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss before extraordinary items
and cumulative effect of any
accounting change |
|
|
(5,909,224 |
) |
|
|
(5,171,023 |
) |
|
|
(4,967,272 |
) |
|
|
(4,227,309 |
) |
Net loss per share Basic and diluted |
|
|
(0.30 |
) |
|
|
(0.27 |
) |
|
|
(0.25 |
) |
|
|
(0.21 |
) |
Net loss |
|
|
(5,909,224 |
) |
|
|
(5,171,023 |
) |
|
|
(4,967,272 |
) |
|
|
(4,227,309 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
F-26