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| VIAP > SEC Filings for VIAP > Form 10-Q on 12-Aug-2009 | All Recent SEC Filings |
12-Aug-2009
Quarterly Report
The following discussion and analysis of the Company's financial condition
and results of operations should be read in conjunction with the Company's
financial statements and related notes appearing elsewhere in this Quarterly
Report on Form 10-Q. In addition to historical information, this discussion and
analysis contains forward-looking statements that involve risks, uncertainties
and assumptions. The Company's actual results may differ materially from those
anticipated in these forward-looking statements as a result of risks and
uncertainties that exist in our operations, development efforts and business
environment, including but not limited to those set forth under the Section
entitled "Risk Factors" in our Annual Report on Form 10-K for the year ended
December 31, 2008 and elsewhere in this Quarterly Report on Form 10-Q and in
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 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 inflammation in plaque, 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 II 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 II 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 plaque inflammation.
On November 9, 2008, the Company announced the results of its ACS and CEA
Phase II 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"). Enrollment of patients in the FDG-PET
Phase II clinical trial is ongoing and results are expected in the second half
of 2009.
On May 1, 2009, the Company announced results of a sub-study of the ACS Phase
II 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 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.
The Company recently expanded its drug development pipeline. In January 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 Roche's 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 Roche's preclinical diacylglycerol acyltransferease 1
metabolic disorders program.
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
Company's founders, Thomas Quertermous, M.D., who currently serves as chairman
of the VIA Scientific Advisory Board, 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 plaque
thereby leading to a reduction in MACE. In March 2006, the Company filed an
Investigational New Drug ("IND") application with the FDA outlining the
Company's Phase II 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-2291's
ability to reduce vascular inflammation in atherosclerotic plaque. The Company
enrolled 50 patients in a Phase II study of VIA-2291 at clinical sites in Italy
for patients who had a CEA procedure. In addition, the Company enrolled 191
patients in a second Phase II study at 15 clinical sites in the United States
and Canada for patients with ACS who experienced a recent heart attack. In order
to further evaluate VIA-2291's 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 MDCT scan following up on the baseline MDCT
scan that all patients received in the ACS trial.
In October 2007, the Company's Data Safety Monitoring Board ("DSMB")
performed a review of both safety and efficacy data related to the Company's 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 II clinical trial that utilizes FDG-PET, to measure
the impact of VIA-2291 on reducing vascular inflammation in treated patients.
The Company plans to enroll approximately 50 patients following an ACS event,
such as heart attack or stroke, into a 24 week, randomized, double blind,
placebo-controlled study. Endpoints in the study include reduction in plaque
inflammation as measured with FDG-PET, as well as assessment of standard
biomarker measurements of inflammation.
As described under Part I, Item 1 "Business - ACS and CEA Clinical Trial
Results," in the Company's Annual Report on Form 10-K for the year ended
December 31, 2008, on November 9, 2008, the Company announced the results of its
ACS and CEA Phase II clinical trials of its lead product candidate, VIA-2291, at
the AHA Conference. Enrollment of patients in the FDG-PET Phase II clinical
trial is ongoing and results are expected in the second half of 2009.
On May 1, 2009, the Company announced results of a sub-study of the ACS Phase
II 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 January 2007, the Company expanded its product pipeline with the
acquisition of certain patent applications, know-how and related assets
(including, compounds and quantities of physical materials and reagents) related
to a library of over 2,000 phosphodiesterase ("PDE") inhibitor small molecule
compounds (the "Neuro3D Compounds") from Neuro3D, S.A., a French corporation
("Neuro3D"). The Company has focused preclinical research and development
activities on identifying the compounds of highest interest for treatment of
atherosclerotic-related inflammation. While the Company's experts and advisors
believe that inhibitors of certain classes of PDEs, in particular PDE4, may be
novel targets for the treatment of inflammation related to atherosclerosis,
preclinical research has not identified a lead compound appropriate for further
development and all preclinical work on compounds has been terminated.
In March 2007, the Company entered into an Option and License Agreement with
Santen Pharmaceutical Co. Ltd., a Japanese pharmaceutical company ("Santen"),
pursuant to which the Company paid Santen a $25,000 option fee to acquire an
exclusive, twelve-month option to enter into a worldwide license agreement
related to certain patent rights, know-how and related compounds held by Santen
generally characterized as leukotriene A4 hydrolase inhibitors. During 2008, the
Company concluded that it would not exercise the option agreement and terminated
its relationship with Santen.
The Company recently 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. In January 2009, the Company licensed from Roche the
exclusive worldwide rights to two sets of compounds. The first license is for
Roche's 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 Roche's preclinical diacylglycerol acyltransferease 1 ("DGAT1") metabolic
disorders program. The Company's 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.
To further expand its product candidate pipeline, the Company continues to
engage in discussions regarding the purchase or license of additional
preclinical or clinical compounds that it believes may be of interest in
treating cardiovascular and metabolic diseases.
Through June 30, 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 June 30, 2009, the Company's accumulated
deficit was approximately $69.3 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 Company's 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. The
Company raised $11.1 million through a merger (the "Merger") with Corautus
Genetics Inc. ("Corautus") that was consummated on June 5, 2007, to cover
existing obligations and provide operating cash flows. On June 29, 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 of June 30, 2009, the Company had $2.9 million in cash on hand. As
more fully described in Note 6 to the Unaudited Condensed Financial Statements,
in March 2009, the Company entered into a loan 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. On March 12, 2009, the Company
borrowed an initial amount of $2.0 million, and 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. Subject to the Lenders' approval, the Company may
borrow in the aggregate up to an additional $4.0 million at subsequent closings
pursuant to the terms of the loan. The Company secured the loan with all of its
assets, including the Company's intellectual property. Management believes that,
under normal continuing operations, the total amount of cash available under
this loan, if borrowed, will enable the Company to meet its current operating
cash requirements through the third quarter of 2009. The Company's ability to
draw the remaining $4.0 million of available future borrowings is at the
discretion of the Lenders. 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 this loan, which are due September 14, 2009, 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. The unaudited condensed 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 entity be unable to continue as a going concern.
The Company cannot guarantee to its stockholders that the Company's 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 loan are due on
September 14, 2009, subject to certain repayment acceleration provisions,
including, without limitation, upon completion of a financing with gross
proceeds in excess of $20.0 million. The Company will need to be able to repay
the loan when it becomes due, extend the terms of the loan or find alternative
financing arrangements acceptable to the Company. There is no guarantee that the
Company will be able to do so. 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
consists of all of our assets, including our intellectual property rights.
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
Since inception, the Company is focused on the development of compounds for
the treatment of cardiovascular and metabolic disease. The Company has one
compound, VIA-2291, in completed ACS and CEA Phase II clinical trials in North
America and Europe, and ongoing in the FDG-PET Phase II clinical trial in North
America. The Company recently reported results from a sub-study of its ACS Phase
II clinical trial in May of 2009.
Research and development ("R&D") expense represented 47% and 60% of total
operating expense for the three months ended June 30, 2009 and 2008,
respectively, 49% and 57% for the six months ended June 30, 2009 and 2008,
respectively, and 57% for the period from June 14, 2004 (date of inception) to
June 30, 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;
• 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 Company's clinical trials;
• depreciation and equipment; and
• allocated costs of facilities and infrastructure.
The following reflects the breakdown of the Company's research and development expenses generated internally versus externally for the three and six months ended June 30, 2009 and 2008, and for the period from inception (June 14, 2004) through June 30, 2009:
Period from
June 14, 2004
Three Months Ended Six Months Ended (date of inception) to
June 30, 2009 June 30, 2008 June 30, 2009 June 30, 2008 June 30, 2009
Externally generated R&D expense $ 817,598 $ 1,890,096 $ 2,253,473 $ 4,109,573 $ 27,319,449
Internally generated R&D expense 690,455 1,229,931 1,389,336 2,328,616 11,174,323
Total $ 1,508,053 $ 3,120,027 $ 3,642,809 $ 6,438,189 $ 38,493,772
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Externally generated research and development expenses consist primarily of the following:
Period from
June 14, 2004
Three Months Ended Six Months Ended (date of inception) to
June 30, 2009 June 30, 2008 June 30, 2009 June 30, 2008 June 30, 2009
In-licensing expenses $ - $ 6,250 $ 400,000 $ 12,500 $ 5,270,000
CRO and investigator expenses 157,512 1,165,357 688,266 2,621,647 10,347,490
Consulting expenses 435,075 392,868 704,204 705,467 6,002,742
Other 225,011 325,621 461,003 769,959 5,699,217
Total $ 817,598 $ 1,890,096 $ 2,253,473 $ 4,109,573 $ 27,319,449
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Internally generated research and development expenses consist primarily of the following:
Period from
June 14, 2004
Three Months Ended Six Months Ended (date of inception) to
June 30, 2009 June 30, 2008 June 30, 2009 June 30, 2008 June 30, 2009
Payroll and payroll related expenses $ 438,439 $ 821,233 $ 921,015 $ 1,591,113 $ 7,734,969
Stock-based compensation 115,703 134,206 216,814 248,239 1,036,647
Travel and entertainment expenses 66,231 99,698 105,016 208,583 1,090,386
Other 70,082 174,794 146,491 280,681 1,312,321
Total $ 690,455 $ 1,229,931 $ 1,389,336 $ 2,328,616 $ 11,174,323
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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, these areas are combined and have not yet matured to the point where they are separate and distinct projects. The Company does not separately allocate the intellectual property, scientists and other resources dedicated to these efforts to individual projects as we are conducting our research on an integrated basis. . . .
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