x
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934
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¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934
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Opexa Therapeutics, Inc.
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(Exact Name of Registrant as Specified in Its Charter)
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Texas
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76-0333165
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(State or Other Jurisdiction of
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(IRS Employer
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Incorporation or Organization)
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Identification No.)
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2635 Technology Forest Blvd., The Woodlands, Texas
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77381
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(Address of Principal Executive Offices)
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(Zip Code)
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Title of Each Class
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Name of Each Exchange on Which Registered
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Common Stock, $.01 par value per share
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The NASDAQ Stock Market LLC
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Series E Common Stock Purchase Warrants
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The NASDAQ Stock Market LLC
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¨
Large accelerated
filer
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¨
Accelerated
filer
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¨
Non-accelerated filer
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þ
Smaller reporting
company
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(Do not check if a smaller reporting
company)
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Business.
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In the modified intent to treat patient population (n=142), the annualized relapse rate (ARR) for Tovaxin-treated patients was 0.214 as compared to 0.339 for placebo-treated patients, which represented a 37% decrease in ARR for Tovaxin as compared to placebo in the general population;
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In a prospective group of patients with more active disease (ARR>1, n=50), Tovaxin demonstrated a 55% reduction in ARR as compared to placebo, and a 73% reduction in relapse rate was observed in Tovaxin patients in this population compared to placebo during the 24-week period following the administration of the full course of treatment; and
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In a retrospective analysis in patients naïve to previous disease modifying treatment (
i.e.,
patients who had not previously used any drugs other than steroids to treat their disease), the results showed that patients, when treated with Tovaxin, had a 64% reduction in ARR versus placebo (p=0.046, n=70).
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In Phase I, product candidates are typically introduced into healthy human subjects or into selected patient populations (
i.e.,
patients with a serious disease or condition under study, under physician supervision) to test for adverse reactions, dosage tolerance, absorption and distribution, metabolism, excretion and clinical pharmacology.
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Phase II involves studies in a limited population of patients with the disease or condition under study to (i) determine the efficacy of the product candidates for specific targeted indications and populations, (ii) determine optimal dosage and dosage tolerance and (iii) identify possible and common adverse effects and safety risks. (Phase II may divided into Phase IIa and Phase IIb studies to address these issues.) When a dose is chosen and a candidate product is found to have preliminary evidence of effectiveness, and to have an acceptable safety profile in Phase II evaluations, Phase III trials begin.
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Phase III trials are undertaken to develop additional safety and effectiveness information from an expanded patient population, generally at multiple study sites. This information obtained is used to develop a better understanding of the risks and benefits of the product candidate, and to determine appropriate labeling for use.
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Registration and listing;
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Regulatory submissions relating to changes in an NDA or BLA (such as the manufacturing process or labeling) and annual reports;
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Adverse event reporting;
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Compliance with advertising and promotion restrictions that relate to drugs and biologics; and
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Compliance with GMP and biological product standards (subject to FDA inspection of facilities to determine compliance).
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Risk Factors.
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our ability to establish, enforce and maintain strategic arrangements for research, development, clinical testing, manufacturing and marketing;
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the accuracy of the assumptions underlying our estimates for capital needs in 2011 and beyond as well as for any clinical study of Tovaxin;
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scientific progress in our research and development programs;
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the magnitude and scope of our research and development programs;
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our progress with preclinical development and clinical trials;
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the time and costs involved in obtaining regulatory approvals;
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the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims; and
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the number and type of product candidates that we pursue.
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do not have sufficient resources or decide not to devote the necessary resources due to internal constraints such as limited cash or human resources;
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decide to pursue a competitive potential product developed outside of the collaboration;
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cannot obtain the necessary regulatory approvals;
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determine that the market opportunity is not attractive; or
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cannot manufacture or obtain the necessary materials in sufficient quantities from multiple sources or at a reasonable cost.
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FDA or IRB objection to proposed protocols;
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discussions or disagreement with the FDA over the adequacy of trial design to potentially demonstrate effectiveness, and subsequent design modifications;
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unforeseen safety issues;
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determination of dosing issues and related adjustments;
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lack of effectiveness during clinical trials;
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slower than expected rates of patient recruitment;
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product quality problems (
e.g.
, sterility or purity);
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challenges to patient monitoring and data collection during or after treatment (for example, patients’ failure to return for follow-up visits); and
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failure of medical investigators to follow our clinical protocols.
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any third party upon whom we rely does not successfully carry out its contractual duties or regulatory obligations or meet expected deadlines;
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any such third party needs to be replaced; or
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the quality or accuracy of the data obtained by the third party is compromised due to its failure to adhere to clinical protocols or regulatory requirements or for other reasons.
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difficulties in integrating the development program for the acquired product candidate into our existing operations;
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diversion of financial and management resources from existing operations;
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risks of entering new potential markets or technologies;
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inability to generate sufficient funding to offset acquisition costs; and
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delays that may result from our having to perform unanticipated preclinical trials or other tests on the product candidate.
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demonstration of efficacy;
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relative convenience and ease of administration;
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the prevalence and severity of any adverse side effects;
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availability and cost of alternative treatments, including cheaper generic drugs;
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pricing and cost effectiveness, which may be subject to regulatory control;
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effectiveness of our or any of our partners’ sales and marketing strategies;
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the product labeling or product insert required by the FDA or regulatory authority in other countries; and
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the availability of adequate third-party insurance coverage or reimbursement.
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obtain and maintain patents to protect our product candidates such as Tovaxin;
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obtain and maintain any required or desirable licenses to use certain technologies of third parties, which may be protected by patents;
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protect our trade secrets and know-how;
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operate without infringing the intellectual property and proprietary rights of others;
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enforce the issued patents under which we hold rights; and
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develop additional proprietary technologies that are patentable.
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we or our licensor might not have been the first to make the inventions covered by pending patent applications or issued patents owned by, or licensed to, us;
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we or our licensor might not have been the first to file patent applications for these inventions;
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others may independently develop similar or alternative technologies or duplicate any of the technologies owned by, or licensed to, us;
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it is possible that none of the pending patent applications owned by, or licensed to, us will result in issued patents;
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any patents under which we hold rights may not provide us with a basis for commercially viable products, may not provide us with any competitive advantages or may be challenged by third parties as invalid, or unenforceable under U.S. or foreign laws; or
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any of the issued patents under which we hold rights may not be valid or enforceable or may be circumvented successfully in light of the continuing evolution of domestic and foreign patent laws.
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payment of actual damages, royalties, lost profits, potentially treble damages and attorneys’ fees, if we are found to have willfully infringed a third party’s patent rights;
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injunctive or other equitable relief that may effectively block our ability to further develop, commercialize and sell our products;
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we or our collaborators having to enter into license arrangements that may not be available on commercially acceptable terms if at all; or
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significant cost and expense, as well as distraction of our management from our business.
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the development status of any drug candidates, such as Tovaxin, including clinical study results and determinations by regulatory authorities with respect thereto;
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the initiation, termination, or reduction in the scope of any collaboration arrangements or any disputes or developments regarding such collaborations;
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announcements of technological innovations, new commercial products or other material events by our competitors or us;
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disputes or other developments concerning our proprietary rights;
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changes in, or failure to meet, securities analysts’ or investors’ expectations of our financial performance;
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additions or departures of key personnel;
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discussions of our business, products, financial performance, prospects or stock price by the financial and scientific press and online investor communities;
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public concern as to, and legislative action with respect to, the pricing and availability of prescription drugs or the safety of drugs and drug delivery techniques; or
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regulatory developments in the United States and in foreign countries.
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Unresolved Staff Comments.
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Properties.
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Legal Proceedings.
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RESERVED.
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Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
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Price Ranges
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||||||||
High
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Low
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|||||||
Fiscal Year Ended December 31, 2009
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||||||||
First Quarter
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$ | 0.70 | $ | 0.15 | ||||
Second Quarter
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0.75 | 0.31 | ||||||
Third Quarter
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6.93 | 0.36 | ||||||
Fourth Quarter
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3.77 | 1.61 | ||||||
Fiscal Year Ended December 31, 2010
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||||||||
First Quarter
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$ | 2.86 | $ | 1.82 | ||||
Second Quarter
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3.07 | 1.43 | ||||||
Third Quarter
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2.10 | 1.02 | ||||||
Fourth Quarter
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1.66 | 1.29 |
Plan Category
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Number of Securities
to be Issued Upon
Exercise of
Outstanding Options,
Warrants and Rights
(A)
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Weighted Average
Exercise Price of
Outstanding
Options, Warrants
and Rights
(B)
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Number of
Securities
Remaining
Available for
Future Issuance
Under Equity
Compensation
Plans (Excluding
Securities
Reflected in
Column A)
(C)
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|||||||||
Equity Compensation Plans Approved by Stockholders
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1,542,072 | $ | 2.15 | 3,010,808 | ||||||||
Equity Compensation Plans Not Approved by Stockholders
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— | — | — | |||||||||
Total
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1,542,072 | $ | 2.15 | 3,010,080 | ||||||||
Selected Financial Data.
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Management’s Discussion and Analysis of Financial Condition and Results of Operations.
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Quantitative and Qualitative Disclosures About Market Risk.
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Financial Statements and Supplementary Data.
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Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.
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Controls and Procedures.
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Other Information.
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Directors, Executive Officers and Corporate Governance.
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Name
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Age
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Position
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|||
Neil K. Warma
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48 |
President, Chief Executive Officer, Acting Chief Financial Officer and Director
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Jaye L. Thompson
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45 |
Senior Vice President of Clinical Development and Regulatory Affairs
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Donna R. Rill
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57 |
Senior Vice President of Operations
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Name
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Age
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Position
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David Hung
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53 |
Director
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David E. Jorden
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48 |
Director
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Michael S. Richman
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50 |
Director
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Scott B. Seaman
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55 |
Director
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Neil K. Warma
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48 |
Director, President, Chief Executive Officer and Acting Chief Financial Officer
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Executive Compensation.
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Name and Principal Position
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Year
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Salary
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Bonus
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Options
Awards
(1)
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All Other
Compensation
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Total
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|||||||||||||||
Neil K. Warma
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2010
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$ | 362,083 | $ | 50,000 | — | — | $ | 412,083 | ||||||||||||
President, Chief Executive Officer, Acting Chief Financial Officer and Director
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2009
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$ | 312,083 | $ | 142,500 | $ | 235,117 | — | $ | 689,700 | |||||||||||
Donna R. Rill
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2010
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$ | 208,000 | $ | 25,000 | — | — | $ | 233,000 | ||||||||||||
Senior Vice President of Operations
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2009
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$ | 197,963 | — | $ | 113,870 | (2) | — | $ | 311.833 | |||||||||||
Jaye L. Thompson
(3)
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2010
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$ | 200,000 | $ | 25,000 | — | — | $ | 225,000 | ||||||||||||
Senior Vice President of Clinical Development and Regulatory Affairs
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2009
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$ | 23,590 | — | $ | 101,440 | — | $ | 125,030 |
(1)
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Amounts in this column represent the aggregate grant date fair value of awards computed in accordance with Financial Accounting Standards Board Accounting Standards Codification Topic 718. See Note 9 to our financial statements included in this annual report on Form 10-K for assumptions underlying the valuation of equity awards.
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(2)
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Includes Ms. Rill’s accrued salary increase from 2008 totaling $8,396 that was exchanged in February 2009 for a fully vested stock option to purchase 8,396 shares of Opexa common stock at an exercise price of $0.47 per share, the market value on the date of grant.
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(3)
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Dr. Thompson joined Opexa as an executive officer in November 2009.
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No stock options were granted to our Named Executive Officers during the fiscal year ended December 31, 2010.
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Option Awards
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Option
Exercise
Price
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Option
Expiration
Date
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|||||||||||
Name
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Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable
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Number of
Securities
Underlying
Unexercised
Options (#)
Unexercisable
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|||||||||||
Neil K. Warma
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216,667 | 33,333 | (1) | $ | 1.01 |
06/16/18
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150,000 | — | $ | 0.22 |
01/16/19
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33,333 | 66,667 | (1) | $ | 2.05 |
11/30/19
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Donna R. Rill
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6,000 | — | $ | 7.00 |
12/05/15
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23,380 | — | $ | 5.00 |
04/20/16
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32,000 | — | $ | 5.47 |
06/18/17
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3,000 | — | $ | 1.09 |
05/06/18
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27,500 | 5,500 | (1) | $ | 1.17 |
06/26/18
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40,000 | — | $ | 0.22 |
01/16/19
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8,396 | — | $ | 0.47 |
02/06/19
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16,667 | 33,333 | (1) | $ | 2.05 |
11/30/19
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Jaye L. Thompson
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16,667 | 33,333 | (1) | $ | 2.05 |
11/30/19
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(1)
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The shares vest quarterly over a three-year period from the grant date.
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Name
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Fees Earned
or Paid
in Cash
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Options
Awards
(2) (3)(4)
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Total
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|||||||||
David Hung
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— | $ | 39,667 | $ | 39,667 | |||||||
David E. Jorden
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$ | 60,000 | (1) | $ | 39,667 | $ | 99,667 | |||||
Michael S. Richman
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— | $ | 39,667 | $ | 39,667 | |||||||
Scott B. Seaman
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— | $ | 39,667 | $ | 39,667 |
(1)
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Compensation for services as chair of the Audit Committee.
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(2)
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Amounts in this column represent the aggregate grant date fair value of awards computed in accordance with Financial Accounting Standards Board Accounting Standards Codification Topic 718. See Note 9 to our financial statements included in this annual report on Form 10-K for assumptions underlying the valuation of equity awards.
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(3)
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As compensation for Board services, each non-employee director was issued the following two options on April 30, 2010 to purchase shares of our common stock at an exercise price of $2.25 per share, the market value on the date of grant: (i) an option to purchase 10,000 shares, with 50% vesting immediately upon grant and the remaining 50% vesting on April 30, 2011; and (ii) an option to purchase 7,889 shares in lieu of cash compensation for services, with 50% vesting on June 30, 2010 and the remaining 50% vesting on December 31, 2010.
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(4)
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As of December 31, 2010, our non-employee directors held options to purchase the following aggregate number of shares of our common stock: Dr. Hung, 78,889 shares; Mr. Jorden, 60,769 shares; Mr. Richman, 121,539 shares; and Mr. Seaman, 129,039 shares.
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Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
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Name and Address of Beneficial Owner
(1)
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Number of Shares
Owned
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Percentage of
Class
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||||||
Beneficial Owners of more than 5%:
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Albert and Margaret Alkek Foundation
(2)
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2,341,130 | (3) | 9.79 | % | ||||
Charles E. Sheedy
(4)
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1,658,159 | (5) | 7.01 | % | ||||
Visium Balanced Master Fund Ltd.
(6)
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1,522,000 | (7) | 6.56 | % | ||||
LBI Group, Inc.
(8)
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1,461,754 | (9) | 6.15 | % | ||||
Alkek & Williams Ventures Ltd.
(10)
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1,427,323 | (11) | 6.05 | % | ||||
DLD Family Investments, LLC
(12)
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1,263,374 | (13) | 5.39 | % | ||||
Officers and Directors:
|
||||||||
Scott B. Seaman
(10)
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1,630,090 | (14) | 6.87 | % | ||||
David E. Jorden
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1,564,886 | (15) | 6.61 | % | ||||
Neil K. Warma
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477,003 | (16) | 2.04 | % | ||||
Donna R. Rill
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167,553 | (17) | * | |||||
Michael S. Richman
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116,539 | (18) | * | |||||
David Hung
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91,462 | (19) | * | |||||
Jaye L. Thompson
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27,230 | (20) | * | |||||
All directors and executive officers as a group (7 persons)**
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4,074,762 | (21) | 16.13 | % | ||||
*
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Less than 1%
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**
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Includes only current directors and officers serving in such capacity as of the date of the table.
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(1)
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Unless otherwise indicated in the footnotes, the mailing address of the beneficial owner is c/o Opexa Therapeutics, Inc., 2635 Technology Forest Boulevard, The Woodlands, Texas 77381.
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(2)
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This information is based on the Schedule 13D/A filed with the SEC on December 16, 2009, by Albert and Margaret Alkek Foundation (the “Foundation”), Alkek & Williams Ventures, Ltd. (“Ventures”), Scott Seaman, DLD Family Investments, LLC (“DLD Family”), and the other reporting persons named therein (the “Foundation 13D”) and other information available to us. The Foundation acts through an investment committee of its board of directors, which includes Mr. Daniel Arnold, Mr. Joe Bailey, Mr. Scott Seaman and Ms. Randa Duncan Williams. Mr. Seaman is the executive director of the Foundation and chairman of the investment committee. The investment committee has sole voting and investment power over all of the shares of common stock beneficially owned by the Foundation. However, pursuant to the Foundation 13D, neither the executive director nor any member of the investment committee may act individually to vote or sell shares of common stock held by the Foundation; therefore, the Foundation has concluded that no individual committee member is deemed to beneficially own, within the meaning of Rule 13d-3 of the Exchange Act, any shares of common stock held by the Foundation solely by virtue of the fact that he or she is a member of the investment committee. Additionally, pursuant to the Foundation 13D, the Foundation has concluded that because Mr. Seaman, in his capacity as executive director or chairman of the investment committee, cannot act in such capacity to vote or sell shares of common stock held by the Foundation without the approval of the investment committee, he is not deemed to beneficially own, within the meaning of Rule 13d-3 of the Exchange Act, any shares of common stock held by the Foundation by virtue of his position as executive director or chairman of the investment committee. The mailing address of the beneficial owner is 1100 Louisiana, Suite 5250, Houston, Texas 77002.
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(3)
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Consisting of: (i) 1,432,965 shares of common stock; (ii) 250,000 shares of common stock underlying the April 2006 warrants; (iii) 250,000 shares of common stock underlying the Series E warrants; (iv) 158,165 shares of common stock underlying the Series F warrants; and (v) 250,000 shares of common stock underlying the Series G warrants. Pursuant to the Foundation 13D, the Foundation and other reporting persons named therein may be deemed to constitute a group for purposes of Section 13(d) or Section 13(g) of the Exchange Act. However, the Foundation, Ventures, Chaswil, Ltd. and Mr. Seaman expressly disclaim (i) that, for purposes of Section 13(d) or Section 13(g) of the Exchange Act, they are a member of a group with respect to securities of Opexa held by DLD Family, Mr. Arnold, Mr. Bailey or Ms. Williams and (ii) that they have agreed to act together with DLD Family, Mr. Arnold, Mr. Bailey or Ms. Williams as a group other than as described in the Foundation 13D. Therefore, this does not include the following securities: (i) 804,593 shares of common stock held by DLD Family; (ii) 110,000 shares of common stock underlying the April 2006 warrants held by DLD Family; (iii) 100,000 shares of common stock underlying Series E warrants held by DLD Family; (iv) 68,781 shares of common stock underlying Series F warrants held by DLD Family; (v) 100,000 shares of common stock underlying Series G warrants held by DLD Family; (vi) 80,000 shares of common stock underlying Series H warrants held by DLD Family; (vii) 26,667 shares of common stock held by Mr. Arnold; (viii) 10,000 shares of common stock underlying the April 2006 warrants held by Mr. Arnold; (ix) 5,000 shares of common stock underlying the April 2006 warrants held by Mr. Bailey; (x) 50,000 shares of common stock held by Mr. Bailey; (xi) 840,814 shares of common stock held by Ventures; (xii) 125,000 shares of common stock underlying the April 2006 warrants held by Ventures; (xiii) 200,000 shares of common stock underlying Series E warrants held by Ventures; (xiv) 61,509 shares of common stock underlying Series F warrants held by Ventures; (xv) 200,000 shares of common stock underlying Series G warrants held by Ventures; (xvi) 43,655 shares of common stock held by Mr. Seaman; (xvii) 7,500 shares of common stock underlying the April 2006 warrants held by Mr. Seaman; (xviii) 10,000 shares of common stock underlying Series E warrants held by Mr. Seaman; (xix) 17,573 shares of common stock underlying Series F warrants held by Mr. Seaman; and (xx) 124,039 shares of common stock underlying currently exercisable stock options held by Mr. Seaman.
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(4)
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Charles E. Sheedy exercises sole voting and dispositive power over all of the shares of common stock beneficially owned. The information in this footnote is primarily based on information reported on the Schedule 13G/A filed with the SEC on February 11, 2011 by Charles E. Sheedy and other information available to us. The mailing address of the beneficial owner is 909 Fannin Street, Suite 2907, Houston, Texas 77010.
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(5)
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Consisting of: (i) 998,423 shares of common stock; (ii) 50,000 shares of common stock underlying the April 2006 warrants; (iii) 150,000 shares of common stock underlying Series E warrants; (iv) 353,736 shares of common stock underlying Series F warrants; (v) 50,000 shares of common stock underlying the Series G warrants; and (vi) 56,000 shares of common stock underlying Series H warrants.
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(6)
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This information is based on the Schedule 13G filed with the SEC on February 18, 2011, by Visium Balanced Master Fund, Ltd. (“Visium”), Visium Asset Management, LP (“VAM”), JG Asset, LLC (“JGA”), and Jacob Gottlieb (the “Visium 13G”) and other information available to us. Pursuant to the Visium 13G, (i) as investment manager to the pooled investment funds, VAM may be deemed to beneficially own the shares beneficially owned by the funds, (ii) as general partner to VAM, JGA may be deemed to beneficially own the shares beneficially owned by VAM, and (iii) as managing member of JGA, Mr. Gottlieb may be deemed the beneficial owner of the shares beneficially owned by JGA, and he has sole voting and dispositive power over the shares. VAM, JGA and Mr. Gottlieb disclaim beneficial ownership of the securities, except to the extent of his or its pecuniary interest therein. The mailing address of the beneficial owner is 950 Third Avenue, New York, NY 10022.
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(7)
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Includes 192,000 shares of common stock underlying Series H warrants held by Visium.
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(8)
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Lehman Brothers Holdings Inc. exercises sole voting and dispositive power over all of the shares of common stock beneficially owned by LBI Group Inc. The information in this footnote is primarily based on information reported on the Schedule 13G filed with the SEC on August 19, 2008 by LBI Group Inc. The mailing address of the beneficial owner is 399 Park Avenue, New York, New York 10022.
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(9)
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Consisting of: (i) 675,675 shares of common stock and (ii) 786,079 shares of common stock underlying Series F warrants.
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(10)
|
Chaswil, Ltd. is the investment manager of Ventures and holds voting power and investment power with respect to Company securities held by Ventures pursuant to a written agreement. Scott B. Seaman is a principal of Chaswil, Ltd. and has shared voting power and shared investment power over all of the shares of common stock beneficially owned by Ventures. The information in this footnote is primarily based on the Foundation 13D and other information provided to us. The mailing address of the beneficial owner is 1100 Louisiana, Suite 5250, Houston, Texas 77002.
|
(11)
|
Consisting of: (i) 840,814 shares of common stock; (ii) 125,000 shares of common stock underlying the April 2006 warrants; (iii) 200,000 shares of common stock underlying Series E warrants; (iv) 61,509 shares of common stock underlying Series F warrants; and (v) 200,000 shares of common stock underlying Series G warrants.
|
(12)
|
Randa Duncan Williams is the principal of DLD Family and she may be deemed to exercise voting and investment power with respect to such shares. The information in this footnote is primarily based on the Foundation 13D and other information provided to us. The mailing address of the beneficial owner is P.O. Box 4735, Houston, Texas 77210-4735.
|
(13)
|
Consisting of: (i) 804,593 shares of common stock; (ii) 110,000 shares of common stock underlying the April 2006 warrants; (iii) 100,000 shares of common stock underlying Series E warrants; (iv) 68,781 shares of common stock underlying Series F warrants; (v) 100,000 shares of common stock underlying Series G warrants; and (vi) 80,000 shares of common stock underlying Series H warrants.
|
(14)
|
Consisting of: (i) 840,814 shares of common stock held by Ventures; (ii) 125,000 shares of common stock underlying the April 2006 warrants held by Ventures; (iii) 200,000 shares of common stock underlying Series E warrants held by Ventures; (iv) 61,509 shares of common stock underlying Series F Warrants held by Ventures; (v) 200,000 shares of common stock underlying Series G warrants held by Ventures; (vi) 124,039 shares underlying currently exercisable stock options held by Mr. Seaman; (vii) 7,500 shares of common stock underlying the April 2006 warrants held by Mr. Seaman; (viii) 10,000 shares of common stock underlying Series E warrants held by Mr. Seaman; (ix) 17,573 shares of common stock underlying Series F warrants held by Mr. Seaman; and (x) 43,655 shares of common stock held by Mr. Seaman. (See footnotes 10 and 11 for additional discussion of the information set forth in clauses (i) through (v) of the preceding sentence.) Pursuant to the Foundation 13D, this does not include the following shares which Mr. Seaman has determined he does not have beneficial ownership of or has disclaimed beneficial ownership: (i) 1,432,965 shares of common stock held by the Foundation; (ii) 250,000 shares of common stock underlying the April 2006 warrants held by the Foundation; (iii) 250,000 shares of common stock underlying Series E warrants held by the Foundation; (iv) 158,165 shares of common stock underlying Series F warrants held by the Foundation; and (v) 250,000 shares of common stock underlying Series G warrants held by the Foundation. (See footnotes 2 and 3 for additional discussion of the information set forth in clauses (i) through (v) of the preceding sentence.) The mailing address of the beneficial owner is 1100 Louisiana, Suite 5250, Houston, Texas 77002.
|
(15)
|
Consisting of: (i) 890,000 shares of common stock (ii) 60,000 shares of common stock underlying the April 2006 warrants; (iii) 145,000 shares of common stock underlying Series E warrants; (iv) 314,117 shares of common stock underlying Series F warrants; (v) 100,000 shares of common stock underlying the Series G Warrants; and (vii) 55,769 shares of common stock underlying currently exercisable stock options.
|
(16)
|
Consisting of: (i) 32,234 shares of common stock; (ii) 3,515 shares of common stock underlying Series F warrants; (iii) 10,000 shares of common stock underlying Series G Warrants; and (iv) 431,254 shares of common stock underlying currently exercisable stock options.
|
(17)
|
Consisting of: (i) 1,610 shares of common stock and (ii) 165,943 shares of common stock underlying currently exercisable stock options.
|
(18)
|
Consisting of 116,539 shares of common stock underlying currently exercisable stock options.
|
(19)
|
Consisting of: (i) 17,573 shares of common stock underlying Series F warrants and (ii) 73,889 shares of common stock underlying currently exercisable stock options.
|
(20)
|
Consisting of: (i) 4,313 shares of common stock and (ii) 22,917 shares of common stock underlying currently exercisable stock options.
|
(21)
|
Consisting of: (a) the following held by Mr. Seaman or for which Mr. Seaman may be deemed to have voting and investment power: (i) 840,814 shares of common stock held by Ventures; (ii) 125,000 shares of common stock underlying the April 2006 warrants held by Ventures; (iii) 200,000 shares of common stock underlying Series E warrants held by Ventures; (iv) 61,509 shares of common stock underlying Series F warrants held by Ventures; (v) 200,000 shares of common stock underlying Series G warrants held by Ventures; (vi) 124,039 shares of common stock underlying currently exercisable stock options held by Mr. Seaman; (vii) 7,500 shares of common stock underlying the April 2006 warrants held by Mr. Seaman; (viii) 10,000 shares of common stock underlying Series E warrants held by Mr. Seaman; (ix) 17,573 shares of common stock underlying Series F warrants held by Mr. Seaman; and (x) 43,655 shares of common stock held by Mr. Seaman; (b) the following held by Mr. Jorden: (i) 890,000 shares of common stock; (ii) 60,000 shares of common stock underlying the April 2006 warrants; (iii) 145,000 shares of common stock underlying Series E warrants; (iv) 314,117 shares of common stock underlying Series F warrants; (v) 100,000 shares underlying Series G warrants; and (vi) 55,769 shares of common stock underlying currently exercisable stock options; (c) the following held by Mr. Warma: (i) 32,234 shares of common stock; (ii) 3,515 shares of common stock underlying Series F warrants; (iii) 10,000 shares of common stock underlying Series G warrants; and (iv) 431,254 shares of common stock underlying currently exercisable stock options; (d) 1,610 shares of common stock and 165,943 shares of common stock underlying currently exercisable stock options held by Ms. Rill; (e) 116,539 shares of common stock underlying currently exercisable stock options held by Mr. Richman; (f) the following held by Dr. Hung: (i) 17,573 shares of common stock underlying Series F warrants; and (ii) 73,889 shares of common stock underlying currently exercisable stock options; and (g) 4,313 shares of common stock and 22,917 shares of common stock underlying currently exercisable stock options held by Dr. Thompson.
|
Certain Relationships and Related Transactions, and Director Independence.
|
Director
|
Independent
|
Audit
Committee
|
Compensation
Committee
|
Nominating and
Corporate
Governance
Committee
|
||||||||||||
David Hung
|
X | X | X | |||||||||||||
David E. Jorden
|
X | X | X | |||||||||||||
Michael S. Richman
|
X | X | X | |||||||||||||
Scott B. Seaman
|
X | X | X | X |
Principal Accountant Fees and Services.
|
Years Ended
December 31,
|
||||||||
2010
|
2009
|
|||||||
Audit fees
(1)
|
$ | 74,185 | $ | 75,375 | ||||
Tax fees
(2)
|
10,410 | — | ||||||
All other fees
(3)
|
7,340 | 7,125 | ||||||
$ | 91,935 | $ | 82,500 | |||||
|
(1)
|
Audit fees include professional services rendered for (i) the audit of our annual financial statements for the fiscal years ended December 31, 2009 and 2010, (ii) the reviews of the financial statements included in our quarterly reports on Form 10-Q for such years and (iii) the issuance of consents and other matters relating to registration statements filed by us.
|
|
(2)
|
Tax fees include professional services relating to preparation of the annual tax return.
|
|
(3)
|
Other fees include professional services for review of various filings and issuance of consents.
|
Exhibits and Financial Statement Schedules.
|
(a)
|
1. Financial Statements
|
Audited Financial Statements for years ended December 31, 2010 and 2009 and the period from January 22, 2003 (Inception) through December 31, 2010
|
|
Report of Independent Registered Public Accounting Firm
|
F-1
|
Balance Sheets as of December 31, 2010 and 2009
|
F-2
|
Statements of Expenses for the Years Ended December 31, 2010 and 2009 and the period from January 22, 2003 (Inception) through December 31, 2010
|
F-3
|
Statement of Changes in Stockholders Equity from January 22, 2003 (Inception) through December 31, 2010
|
F-4
|
Statements of Cash Flows for the years ended December 31, 2010 and 2009 and the period from January 22, 2003 (Inception) through December 31, 2010
|
F-6
|
Notes to Financial Statements
|
F-7
|
|
2.
|
Financial Statement Schedules
|
|
3.
|
List of Exhibits
|
Exhibit No.
|
Description
|
|
2.1
|
Stock Purchase Agreement by and among Sportan United Industries, Inc., Jason G. Otteson, PharmaFrontiers Corp., Warren C. Lau and other PharmaFrontiers stockholders, dated May 5, 2004 (incorporated by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K filed June 4, 2004, File No. 000-25513).
|
|
2.2
|
Agreement and Plan of Reorganization by and among PharmaFrontiers Corp., Pharma Acquisition Corp and Opexa Pharmaceuticals, Inc. dated October 7, 2004 (incorporated by reference to Exhibit 2.1 to the Company’s Current Report on 8-K filed October 8, 2004, File No. 000-25513).
|
|
3.1
|
Articles of Amendment and Restatement of the Articles of Incorporation (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on June 19, 2006).
|
|
3.2
|
Articles of Amendment to the Amended and Restated Articles of Incorporation (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on November 13, 2009).
|
|
3.3*
|
Amended and Restated By-laws, as amended.
|
|
4.1
|
Form of Common Stock Certificate (incorporated by reference to Exhibit 4.7 to the Company’s Registration Statement on Form S-3 filed on November 13, 2009, File No. 333-163108).
|
|
4.2
|
Purchase Agreement dated April 11, 2006 by and among the Company and the Investors named therein for April 2006 common stock and warrant offering (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed April 18, 2006).
|
|
4.3
|
Form of Warrant issued in connection with April 2006 offering (incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K filed April 18, 2006).
|
|
4.4
|
Registration Rights Agreement dated April 11, 2006 by and among the Company and the Investors named therein for April 2006 offering common stock and warrants (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed April 18, 2006).
|
|
4.5
|
Form of Series E Warrant (incorporated by reference to Exhibit 4.2 to the Company’s Registration Statement on Form SB-2 (Amendment No. 1) filed December 20, 2007, File No. 333-147167).
|
|
Exhibit No. |
Description
|
|
4.6
|
Warrant Agent Agreement by and between the Company and Continental Stock Transfer & Trust Company dated February 13, 2008 for the Series E Warrants (incorporated by reference to Exhibit 4.3 to the Company’s Current Report on Form 8-K filed February 14, 2008).
|
|
4.7
|
Form of Underwriters’ Warrant Agreement by and between the Company and each underwriter party thereto for the Series E Warrants (incorporated by reference to Exhibit 4.4 to the Company’s Current Report on Form 8-K filed February 14, 2008).
|
|
4.8
|
Form of Underwriters’ Warrant to Acquire Warrants Agreement by and between the Company and each underwriter party thereto for the Series E Warrants (incorporated by reference to Exhibit 4.5 to the Company’s Current Report on Form 8-K filed February 14, 2008).
|
|
4.9
|
Unit Purchase Agreement dated August 8, 2008 by and among the Company and the Investors named therein in connection with Unit offering of common stock and Series F Warrants (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed August 12, 2008).
|
|
4.10
|
Form of Series F Warrant issued in connection with August 8, 2008 financing (incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K filed August 12, 2008).
|
|
4.11
|
Registration Rights Agreement dated August 8, 2008 between the Company and the Investors named therein in connection with common stock and Series F Warrants (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed August 12, 2008).
|
|
4.12
|
Unit Purchase Agreement dated April 14, 2009 by and among the Company and the Investors party thereto for the 10% Convertible Notes and Series G Warrants (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed April 16, 2009).
|
|
4.13
|
Form of Series G Warrant issued by the Company on April 14, 2009 (incorporated by reference to Exhibit 10.4 of the Company’s Current Report on Form 8-K filed April 16, 2009).
|
|
4.14
|
Placement Agent Agreement dated December 9, 2009 by and between the Company and Rodman & Renshaw, LLC for Unit offering of Common Stock and Series A and Series B Warrants (incorporated by reference to Exhibit 1.1 to the Company’s Current Report on Form 8-K filed December 10, 2009).
|
|
4.15
|
Form of Securities Purchase Agreement dated as of December 9, 2009 by and between the Company and each investor signatory thereto for Unit offering of Common Stock and Series A and Series B Warrants (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed December 10, 2009).
|
|
4.16
|
Form of Common Stock Purchase Warrant for Series A and Series B Warrants (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed December 10, 2009).
|
|
4.17
|
Form of Series H Warrant issued by the Company on February 11, 2011 (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed February 8, 2011).
|
|
10.1+
|
Opexa Therapeutics, Inc. June 2004 Compensatory Stock Option Plan (incorporated by reference to Exhibit B to the Company’s Definitive Information Statement on Schedule 14C filed on June 29, 2004, File No. 000-25513).
|
|
10.2+
|
Certificate of Amendments to the Opexa Therapeutics, Inc. June 2004 Compensatory Stock Option Plan (incorporated by reference to Exhibit 10.15 of the Company’s Annual Report on Form 10-K filed March 5, 2010).
|
10.3+
|
Employment Agreement dated June 16, 2008 by and between the Company and Neil K. Warma (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on June 18, 2008).
|
|
10.4+
|
Employment Agreement dated April 14, 2009 between the Company and Donna R. Rill (incorporated by reference to Exhibit 10.6 of the Company’s Current Report on Form 8-K filed April 16, 2009).
|
|
10.5+
|
Amended and Restated Employment Agreement entered into on April 21, 2010 by and between the Company and Donna R. Rill (incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 8-K filed April 27, 2010).
|
|
10.6+
|
Employment Agreement dated November 16, 2009 by and between the Company and Jaye L. Thompson.
|
|
10.7
|
License Agreement dated September 5, 2001 by and between the Company and Baylor College of Medicine (incorporated by reference to Exhibit 10.14 to the Company’s Annual Report on Form 10-KSB filed April 15, 2005, File No. 000-25513).
|
Exhibit No. |
Description
|
|
10.8
|
Lease dated August 19, 2005 by and between the Company and Dirk D. Laukien (incorporated by reference to Exhibit 10.13 to the Company’s Annual Report on Form 10-KSB filed March 31, 2006).
|
|
10.9
|
License Agreement dated January 13, 2006 by and between the Company and Shanghai Institute for Biological Services (incorporated by reference to Exhibit 10.23 to the Company’s Registration Statement on Form SB-2 (Amendment No. 1) filed February 9, 2006, File No. 333-126687).
|
|
10.10
|
Second Amended and Restated License Agreement dated July 31, 2007 by and between the Company and the University of Chicago (incorporated by reference to Exhibit 10.1 of the Company’s Report on Form 8-K filed August 3, 2007).
|
|
10.11++
|
Asset Purchase Agreement by and between the Company and Novartis Institutes for Biomedical Research, Inc. dated August 6, 2009 (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed August 7, 2009).
|
|
10.12+
|
Opexa Therapeutics, Inc. 2010 Stock Incentive Plan (incorporated by reference to Appendix A to the Company’s Schedule 14A definitive proxy statement filed September 14, 2010).
|
|
10.13+
|
Form of award agreement for awards to be made under the Opexa Therapeutics, Inc. 2010 Stock Incentive Plan (incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K filed October 22, 2010).
|
|
10.14
|
Continuous Offering Program Agreement dated May 14, 2010 by and between the Company and Rodman & Renshaw, LLC (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed on May 17, 2010) (subsequently terminated February 7, 2011 as disclosed in the Company’s Current Report on Form 8-K filed on February 7, 2011).
|
|
23.1*
|
Consent of Independent Registered Public Accounting Firm MaloneBailey, LLP, dated March 8, 2011 to the incorporation by reference of their report dated March 8, 2011, in the Company’s Registration Statements on Form S-8 and S-3.
|
|
31.1*
|
Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
32.1*
|
Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
*
|
Filed herewith
|
+
|
Management contract or compensatory plan or arrangement.
|
++
|
Confidential treatment has been requested as to certain portions of this Exhibit pursuant to Rule 406 promulgated under the Securities Act. Such portions have been omitted and filed separately with the SEC.
|
OPEXA THERAPEUTICS, INC.
|
|||
By:
|
/s/ NEIL K. WARMA | ||
Neil K. Warma
|
|||
President, Chief Executive Officer and
Acting Chief Financial Officer
|
|||
Date: March 8, 2011
|
Signature
|
Title
|
Date
|
||
/S/ NEIL K. WARMA
|
President and Chief Executive Officer
|
March 8, 2011
|
||
Neil K. Warma
|
(Principal Executive Officer)
Acting Chief Financial Officer
(Principal Financial and Accounting Officer)
Director
|
|||
/S/ DAVID HUNG
|
Director
|
March 8, 2011
|
||
David Hung
|
||||
/S/ DAVID E. JORDEN
|
Director
|
March 8, 2011
|
||
David E. Jorden
|
||||
/S/ MICHAEL S. RICHMAN
|
Director
|
March 8, 2011
|
||
Michael S. Richman
|
||||
/S/ SCOTT B. SEAMAN
|
Director
|
March 8, 2011
|
||
Scott B. Seaman
|
December 31,
2010
|
December 31,
2009
|
|||||||
Assets
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$ | 3,812,535 | $ | 8,181,582 | ||||
Other current assets
|
85,525 | 187,306 | ||||||
Total current assets
|
3,898,060 | 8,368,888 | ||||||
Property & equipment, net of accumulated depreciation of $1,109,558 and $1,029,241,
respectively
|
815,958 | 949,910 | ||||||
Total assets
|
$ | 4,714,018 | $ | 9,318,798 | ||||
Liabilities and Stockholders' Equity
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$ | 358,837 | $ | 593,011 | ||||
Accounts payable—related parties
|
15,000 | 32,591 | ||||||
Accrued expenses
|
335,861 | 141,065 | ||||||
Current maturity of loan payable
|
35,607 | 67,307 | ||||||
Total current liabilities
|
745,305 | 833,974 | ||||||
Long term liabilities:
|
||||||||
Convertible promissory notes, net of discount of $0 and $314,749
|
— | 987,251 | ||||||
Loan payable
|
— | 35,625 | ||||||
Accrued interest
|
— | 86,800 | ||||||
Total liabilities
|
745,305 | 1,943,650 | ||||||
Commitments and contingencies
|
— | — | ||||||
Stockholders’ equity:
|
||||||||
Preferred stock, no par value, 10,000,000 shares authorized, none issued and outstanding
|
— | — | ||||||
Common stock, $0.01 par value, 100,000,000 shares authorized, 18,466,924 and 15,476,222 shares issued and outstanding
|
184,670 | 154,762 | ||||||
Additional paid in capital
|
98,496,382 | 96,463,658 | ||||||
Deficit accumulated during the development stage
|
(94,712,339 | ) | (89,243,272 | ) | ||||
Total stockholders’ equity
|
3,968,713 | 7,375,148 | ||||||
Total liabilities and stockholders’ equity
|
$ | 4,714,018 | $ | 9,318,798 | ||||
2010
|
2009
|
Inception
through
2010
|
||||||||||
Research and development
|
$ | 2,584,734 | $ | 2,107,833 | $ | 66,838,837 | ||||||
General and administrative
|
2,216,043 | 2,020,572 | 25,202,806 | |||||||||
Depreciation
|
168,843 | 214,851 | 1,136,229 | |||||||||
Loss on disposal of fixed assets
|
459 | 1,771 | 500,562 | |||||||||
Operating loss
|
(4,970,079 | ) | (4,345,027 | ) | (93,678,434 | ) | ||||||
Interest income
|
1,660 | 1,764 | 1,357,485 | |||||||||
Other income and expense, net
|
— | 554,242 | 661,146 | |||||||||
Gain on extinguishment of debt
|
— | — | 1,612,440 | |||||||||
Gain (loss) on derivative instruments
|
— | (366,774 | ) | 1,388,848 | ||||||||
Gain on sale of technology
|
— | 3,000,000 | 3,000,000 | |||||||||
Interest expense
|
(500,648 | ) | (278,127 | ) | (9,053,824 | ) | ||||||
Net loss
|
$ | (5,469,067 | ) | $ | (1,433,922 | ) | $ | (94,712,339 | ) | |||
Basic and diluted loss per share
|
$ | (0.32 | ) | $ | (0.11 | ) | ||||||
Weighted average shares outstanding
|
17,071,691 | 12,556,056 |
Common Stock
|
Additional
Paid in
Capital
|
Accumulated
Deficit
|
Total
|
|||||||||||||||||
Shares
|
Par
|
|||||||||||||||||||
Shares issued for cash
|
525,000 | $ | 262,500 | $ | (261,500 | ) | $ | — | $ | 1,000 | ||||||||||
Shares repurchased and cancelled
|
(170,625 | ) | (85,313 | ) | 84,988 | — | (325 | ) | ||||||||||||
Discount related to:
|
||||||||||||||||||||
beneficial conversion feature
|
— | — | 28,180 | — | 28,180 | |||||||||||||||
warrants attached to debt
|
— | — | 28,180 | — | 28,180 | |||||||||||||||
Net loss
|
— | — | — | (126,003 | ) | (126,003 | ) | |||||||||||||
Balances at December 31, 2003
|
354,375 | 177,187 | (120,152 | ) | (126,003 | ) | (68,968 | ) | ||||||||||||
Shares issued for:
|
||||||||||||||||||||
cash
|
2,250 | 1,125 | 7,875 | — | 9,000 | |||||||||||||||
services
|
206,500 | 103,250 | 745,750 | — | 849,000 | |||||||||||||||
license
|
24,269 | 12,135 | 414,940 | — | 427,075 | |||||||||||||||
reverse merger with Sportan
|
99,740 | 49,870 | (197,603 | ) | — | (147,733 | ) | |||||||||||||
acquisition of Opexa
|
250,000 | 125,000 | 23,625,000 | — | 23,750,000 | |||||||||||||||
additional shares attached to convertible debt
|
16,100 | 8,050 | 280,316 | — | 288,366 | |||||||||||||||
conversion of convertible notes
|
60,750 | 30,375 | 217,995 | — | 248,370 | |||||||||||||||
Shares cancelled
|
(8,000 | ) | (4,000 | ) | 4,000 | — | — | |||||||||||||
Discount related to:
|
||||||||||||||||||||
beneficial conversion feature
|
— | — | 855,849 | — | 855,849 | |||||||||||||||
warrants attached to debt
|
— | — | 1,848,502 | — | 1,848,502 | |||||||||||||||
Option expense
|
— | — | 123,333 | — | 123,333 | |||||||||||||||
Net loss
|
— | — | — | (31,411,736 | ) | (31,411,736 | ) | |||||||||||||
Balances at December 31, 2004
|
1,005,984 | 502,992 | 27,805,805 | (31,537,739 | ) | (3,228,942 | ) | |||||||||||||
Shares issued for:
|
||||||||||||||||||||
cash, net of offering costs
|
389,451 | 194,725 | 5,151,492 | — | 5,346,217 | |||||||||||||||
convertible debt
|
611,026 | 305,513 | 7,343,933 | — | 7,649,446 | |||||||||||||||
debt
|
2,300 | 1,150 | 159,850 | — | 161,000 | |||||||||||||||
license
|
29,194 | 14,597 | 1,853,787 | — | 1,868,384 | |||||||||||||||
services
|
24,000 | 12,000 | 1,000,400 | — | 1,012,400 | |||||||||||||||
Discount related to:
|
||||||||||||||||||||
beneficial conversion feature
|
— | — | 831,944 | — | 831,944 | |||||||||||||||
warrants attached to debt
|
— | — | 1,433,108 | — | 1,433,108 | |||||||||||||||
Option expense
|
— | — | 2,487,741 | — | 2,487,741 | |||||||||||||||
Warrant expense
|
— | — | 2,373,888 | — | 2,373,888 | |||||||||||||||
Transition of warrants from equity instruments to liability instruments
|
— | — | (10,658,496 | ) | — | (10,658,496 | ) | |||||||||||||
Net loss
|
— | — | — | (14,856,724 | ) | (14,856,724 | ) | |||||||||||||
Balances at December 31, 2005
|
2,061,955 | 1,030,977 | 39,783,452 | (46,394,463 | ) | (5,580,034 | ) |
Common Stock
|
Additional
Paid in
Capital
|
Accumulated
Deficit
|
Total
|
|||||||||||||||||
Shares
|
Par
|
|||||||||||||||||||
Shares issued for:
|
||||||||||||||||||||
cash, net of offering costs
|
4,600,000 | 2,300,000 | 18,853,519 | — | 21,153,519 | |||||||||||||||
debt
|
34,829 | 17,374 | 162,626 | — | 180,000 | |||||||||||||||
Option expense
|
— | — | 2,749,617 | — | 2,749,617 | |||||||||||||||
Warrant expense
|
— | — | 1,568,966 | — | 1,568,966 | |||||||||||||||
Net loss
|
— | — | — | (12,649,170 | ) | (12,649,170 | ) | |||||||||||||
Balances at December 31, 2006
|
6,696,784 | 3,348,351 | 63,118,180 | (59,043,633 | ) | 7,422,898 | ||||||||||||||
Cumulative change in derivative liability
|
— | — | 10,658,496 | (4,001,820 | ) | 6,656,676 | ||||||||||||||
Option expense
|
— | — | 1,876,103 | — | 1,876,103 | |||||||||||||||
Warrant expense
|
— | — | 845,275 | — | 845,275 | |||||||||||||||
Net loss
|
— | — | — | (14,667,367 | ) | (14,667,367 | ) | |||||||||||||
Balances at December 31, 2007
|
6,696,784 | 3,348,351 | 76,498,054 | (77,712,820 | ) | 2,133,585 | ||||||||||||||
Shares issued for:
|
||||||||||||||||||||
cash, net of offering costs
|
5,503,874 | 2,751,937 | 5,899,642 | — | 8,651,579 | |||||||||||||||
services
|
45,200 | 22,600 | 26,365 | — | 48,965 | |||||||||||||||
Issuance of warrants for cash
|
— | — | 603,850 | — | 603,850 | |||||||||||||||
Option expense
|
— | — | 1,901,570 | — | 1,901,570 | |||||||||||||||
Net loss
|
— | — | — | (11,852,152 | ) | (11,852,152 | ) | |||||||||||||
Balances at December 31, 2008
|
12,245,858 | 6,122,888 | 84,929,481 | (89,564,972 | ) | 1,487,397 | ||||||||||||||
Cumulative effect of change in accounting principle
|
(1,976,457 | ) | 1,755,622 | (220,835 | ) | |||||||||||||||
Par value adjustment
|
— | (6,329,888 | ) | 6,329,888 | — | — | ||||||||||||||
Reduction in derivative liability
|
— | — | 587,609 | — | 587,609 | |||||||||||||||
Discount on convertible notes
|
— | — | 439,493 | — | 439,493 | |||||||||||||||
Discount on warrants
|
— | — | 37,453 | — | 37,453 | |||||||||||||||
Shares issued for:
|
||||||||||||||||||||
cash, net of offering costs
|
2,550,000 | 25,500 | 4,663,665 | — | 4,689,165 | |||||||||||||||
exercise of options
|
60,400 | 26,280 | 37,324 | 63,604 | ||||||||||||||||
exercise of warrants
|
619,964 | 309,982 | 764,953 | — | 1,074,935 | |||||||||||||||
Option expense
|
— | — | 650,249 | — | 650,249 | |||||||||||||||
Net loss
|
— | — | — | (1,433,922 | ) | (1,433,922 | ) | |||||||||||||
Balances at December 31, 2009
|
15,476,222 | 154,762 | 96,463,658 | (89,243,272 | ) | 7,375,148 | ||||||||||||||
Shares issued for:
|
||||||||||||||||||||
conversion of convertible notes
|
2,760,181 | 27,602 | 1,352,489 | — | 1,380,091 | |||||||||||||||
exercise of options
|
141,520 | 1,416 | 108,225 | 109,641 | ||||||||||||||||
exercise of warrants
|
34,001 | 340 | (340 | ) | — | — | ||||||||||||||
services
|
55,000 | 550 | 63,800 | — | 64,350 | |||||||||||||||
Option expense
|
— | — | 508,550 | — | 508,550 | |||||||||||||||
Net loss
|
— | — | — | (5,469,067 | ) | (5,469,067 | ) | |||||||||||||
Balances at December 31, 2010
|
18,466,924 | $ | 184,670 | $ | 98,496,382 | $ | (94,712,339 | ) | $ | 3,968,713 | ||||||||||
2010
|
2009
|
Inception
through
2010
|
||||||||||
Cash flows from operating activities
|
||||||||||||
Net loss
|
$ | (5,469,067 | ) | $ | (1,433,922 | ) | $ | (94,712,339 | ) | |||
Adjustments to reconcile net loss to net cash used in operating activities
|
||||||||||||
Stock payable for acquired research and development
|
— | — | 112,440 | |||||||||
Stock issued for acquired research and development
|
— | — | 26,286,589 | |||||||||
Stock issued for services
|
64,350 | — | 1,974,715 | |||||||||
Stock issued for debt in excess of principal
|
— | — | 109,070 | |||||||||
Amortization of discount on notes payable due to warrants and beneficial conversion feature
|
314,749 | 124,744 | 6,752,698 | |||||||||
Gain on extinguishment of debt
|
— | — | (1,612,440 | ) | ||||||||
Depreciation
|
168,843 | 214,851 | 1,136,229 | |||||||||
Amortization of debt financing costs
|
108,117 | 50,351 | 524,378 | |||||||||
Option and warrant expense
|
508,550 | 650,249 | 15,085,293 | |||||||||
Loss (gain) on derivative instruments
|
— | 366,774 | (1,388,848 | ) | ||||||||
Loss on disposal of fixed assets
|
459 | 1,771 | 500,562 | |||||||||
Changes in:
|
||||||||||||
Accounts receivable
|
(26,245 | ) | — | (26,245 | ) | |||||||
Prepaid and other expenses
|
19,909 | 7,516 | (475,953 | ) | ||||||||
Accounts payable – third parties and related parties
|
(251,765 | ) | (19,360 | ) | (76,213 | ) | ||||||
Accrued expenses
|
186,087 | 28,593 | 287,297 | |||||||||
Net cash used in operating activities
|
(4,376,013 | ) | (8,433 | ) | (45,522,767 | ) | ||||||
Cash flows from investing activities
|
||||||||||||
Purchase of property & equipment
|
(35,350 | ) | — | (1,374,861 | ) | |||||||
Net cash used in investing activities
|
(35,350 | ) | — | (1,374,861 | ) | |||||||
Cash flows from financing activities
|
||||||||||||
Common stock and warrants sold for cash, net of offering costs
|
— | 4,689,165 | 40,454,331 | |||||||||
Common stock repurchased and canceled
|
— | — | (325 | ) | ||||||||
Proceeds from exercise of warrants and options
|
109,641 | 1,138,947 | 1,248,588 | |||||||||
Proceeds from debt
|
— | 1,180,985 | 9,283,184 | |||||||||
Repayments on loan payable
|
(67,325 | ) | (62,269 | ) | (275,615 | ) | ||||||
Net cash provided by financing activities
|
42,316 | 6,946,828 | 50,710,163 | |||||||||
Net change in cash and cash equivalents
|
(4,369,047 | ) | 6,938,395 | 3,812,535 | ||||||||
Cash and cash equivalents at beginning of period
|
8,181,582 | 1,243,187 | — | |||||||||
Cash and cash equivalents at end of period
|
$ | 3,812,535 | $ | 8,181,582 | $ | 3,812,535 | ||||||
Cash paid for:
|
||||||||||||
Income tax
|
$ | — | $ | — | $ | — | ||||||
Interest
|
86,491 | 16,232 | 150,028 | |||||||||
|
||||||||||||
NON-CASH TRANSACTIONS
|
||||||||||||
Issuance of common stock to Sportan shareholders
|
— | — | 147,733 | |||||||||
Issuance of common stock for accrued interest
|
78,091 | — | 603,604 | |||||||||
Issuance of warrants to placement agent
|
— | 37,453 | 37,453 | |||||||||
Conversion of notes payable to common stock
|
1,302,000 | — | 7,709,980 | |||||||||
Conversion of accrued liabilities to common stock
|
— | — | 197,176 | |||||||||
Conversion of accounts payable to note payable
|
— | — | 93,364 | |||||||||
Discount on convertible notes relating to:
|
||||||||||||
Warrants
|
— | 349,947 | 3,659,737 | |||||||||
Beneficial conversion feature
|
— | 89,546 | 1,805,519 | |||||||||
Stock attached to notes
|
— | — | 1,287,440 | |||||||||
Fair value of derivative instrument
|
— | (1,976,457 | ) | 4,680,220 | ||||||||
Derivative reclassified to equity
|
— | 587,609 | 587,609 |
Description
|
Life
|
2010
|
2009
|
|||||||
Computer equipment
|
3 years
|
$ | 117,789 | $ | 123,155 | |||||
Office furniture and equipment
|
5-7 years
|
246,117 | 317,657 | |||||||
Software
|
3 years
|
80,480 | 87,929 | |||||||
Laboratory equipment
|
7 years
|
990,961 | 984,809 | |||||||
Leasehold improvements
|
10 years
|
465,601 | 465,601 | |||||||
Manufacturing equipment
|
3 years
|
24,568 | — | |||||||
Subtotal
|
1,925,516 | 1,979,151 | ||||||||
Less: accumulated depreciation
|
(1,109,558 | ) | (1,029,241 | ) | ||||||
Property and equipment, net
|
$ | 815,958 | $ | 949,910 | ||||||
|
●
|
525,000 shares of common stock were sold for $1,000.
|
|
●
|
170,625 shares were reacquired for $325 and canceled.
|
|
●
|
Additional contributions to capital of $56,360 resulted from the discounted value to notes payable due to warrants and beneficial conversion features attached to convertible notes was issued in 2003.
|
|
●
|
2,250 shares of common stock were sold for $9,000.
|
|
●
|
206,500 shares of common stock valued at their then fair value of $849,000 were issued to employees and consultants for their services.
|
|
●
|
24,269 shares of common stock valued at their then fair value of $427,075 were issued to the University of Chicago per the terms of a license agreement. See Note 11 for details.
|
|
●
|
99,740 shares of common stock were issued for net liabilities of $147,733 pursuant to the 2004 reorganization.
|
|
●
|
250,000 shares of common stock valued at their then fair value of $23,750,000 were issued to Opexa Pharmaceuticals, Inc. stockholders.
|
|
●
|
16,100 shares of common stock with a relative fair value of $288,366 were issued to noteholders as their additional shares for their subscription investment.
|
|
●
|
60,750 shares of common stock were issued to noteholders for the conversion of $248,370 of principal and interest from convertible notes.
|
|
●
|
8,000 shares of common stock were cancelled pursuant to the terms of an employment separation agreement.
|
|
●
|
Additional contributions to capital of $2,704,351 resulted from the discounted value to notes payable from warrants and beneficial conversion features attached to convertible notes.
|
|
●
|
Employee stock option compensation expense was $123,333 for 2004.
|
|
●
|
389,451 shares of common stock with warrants to purchase 1,070,993 shares were sold for $5,841,769. The relative fair value of the common stock was $1,103,714 and the relative fair value of the warrants was $4,738,055. Offering costs of $495,552 related to shares issued were charged to additional paid in capital.
|
|
●
|
45,168 shares of common stock with a relative fair value of $999,074 were issued to noteholders as their additional shares for their subscription investment.
|
|
●
|
565,858 shares of common stock were issued to noteholders for the conversion of $6,124,859 of principal and $525,513 interest from convertible notes.
|
|
●
|
2,300 shares of common stock valued at their fair value of $161,000 were issued to noteholders for the conversion of $51,930 of principal and interest from the notes.
|
|
●
|
29,194 shares of common stock were issued to the University of Chicago per the terms of a license agreement. These shares were recorded at $1,868,384. See Note 11 for details.
|
|
●
|
24,000 shares of common stock valued at their fair value of $1,012,400 were issued to consultants for their services.
|
|
●
|
Additional contributions to capital of $2,265,052 relating to the discounted value to notes payable from warrants, beneficial conversion features attached to convertible notes.
|
|
●
|
Employee stock option compensation expense was $2,487,741 for 2005.
|
|
●
|
Non-employee stock option compensation expense was $2,373,888 for 2005.
|
|
●
|
Transition of warrants from equity instruments to liability instruments in the amount of $10,658,496 was recorded.
|
|
●
|
In March 2006, 34,829 shares of common stock were issued to settle an outstanding accounts payable in the amount of $180,000.
|
|
●
|
In April 2006, Opexa sold 4,600,000 shares of its common stock and warrants to purchase 2,300,000 shares of Opexa’s common stock for $23 million. Opexa paid $1,846,481 for the commissions and fees related to this offering and granted to its brokers warrants to purchase 213,720 shares of common stock at an exercise price of $5.00 per share. These warrants are not callable and have a cashless exercise option.
|
|
●
|
Employee stock option compensation expense was $2,749,617 for 2006.
|
|
●
|
Non-employee stock option compensation expense was $1,568,966 for 2006.
|
|
●
|
Employee stock option compensation expense was $1,876,103 for 2007.
|
|
●
|
Non-employee stock option compensation expense was $845,275 for 2007.
|
|
●
|
In February 2008, Opexa sold 3,500,000 shares of common stock and 4,025,000 Series E warrants in a public offering for approximately $7.6 million. Opexa paid approximately $1.2 million for the underwriter discounts, commissions and other expenses related to this offering and granted to the underwriter warrants to purchase 350,000 shares of common stock at a price of $2.40 per share and an option to acquire 350,000 Series E warrants at a price of $0.18 per Series E warrant.
|
|
●
|
In August, Opexa sold 2,003,874 shares of common stock and Series F warrants to purchase 2,003,874 shares of common stock in a private offering to certain institutional and accredited investors for approximately $3.0 million. Opexa paid approximately $100,000 in expenses related to this offering.
|
|
●
|
45,200 shares of restricted common stock valued at $48,965 were issued to Board members as compensation for their Board services.
|
|
●
|
Employee stock option compensation expense was $1,467,364 for 2008.
|
|
●
|
Non-employee stock option compensation expense was $434,207 for 2008.
|
|
●
|
In December 2009, Opexa sold 2,550,000 shares of its common stock and warrants to purchase 1,275,000 shares of Opexa’s common stock for $5.1 million. Opexa paid $310,500 for the commissions related to this offering and granted broker warrants to purchase 89,250 shares of common stock at an exercise price of $2.50 per share. These warrants are not callable and have a cashless exercise option.
|
|
●
|
60,400 shares of common stock were issued in connection with the exercise of stock options.
|
|
●
|
48,200 shares of common stock were issued in connection with the exercise of Series E warrants.
|
|
●
|
472,968 shares of common stock were issued in connection with the exercise of Series F warrants
|
|
●
|
98,796 shares of common stock were issued in connection with the exercise of broker warrants.
|
|
●
|
In June 2010, 2,760,181 shares of common stock were issued to noteholders for the conversion of $1,302,000 of principal and $78,091 of accrued interest from the 10% Convertible Promissory Notes.
|
|
●
|
141,520 shares of common stock were issued in connection with the exercise of stock options.
|
|
●
|
34,001 shares of common stock were issued in connection with the cashless exercise of broker warrants.
|
|
●
|
55,000 shares of common stock valued at their fair value of $64,350 were issued to a consultant in exchange for services.
|
Options
|
Weighted
Average
Exercise
Price
|
Warrants
|
Weighted
Average
Exercise
Price
|
|||||||||||||
Outstanding at December 31, 2006
|
762,970 | $ | 11.48 | 3,670,361 | $ | 19.51 | ||||||||||
Year ended December 31, 2007:
|
||||||||||||||||
Granted
|
293,900 | 5.28 | — | — | ||||||||||||
Forfeited and canceled
|
(17,345 | ) | 7.74 | — | — | |||||||||||
Outstanding at December 31, 2007
|
1,039,525 | $ | 9.79 | 3,670,361 | $ | 19.51 | ||||||||||
Year ended December 31, 2008:
|
||||||||||||||||
Granted
|
640,400 | 1.10 | 6,728,874 | 1.96 | ||||||||||||
Forfeited and canceled
|
(126,578 | ) | 6.53 | — | — | |||||||||||
Outstanding at December 31, 2008
|
1,553,347 | $ | 6.47 | 10,399,235 | $ | 8.15 | ||||||||||
Year ended December 31, 2009:
|
||||||||||||||||
Granted
|
773,339 | 0.96 | 3,204,620 | 1.67 | ||||||||||||
Exercised
|
(60,774 | ) | 1.05 | (718,764 | ) | 1.66 | ||||||||||
Forfeited and canceled
|
(342,536 | ) | 10.56 | (208,330 | ) | 5.00 | ||||||||||
Outstanding at December 31, 2009
|
1,923,376 | $ | 3.70 | 12,676,761 | $ | 6.93 | ||||||||||
Year ended December 31, 2010:
|
||||||||||||||||
Granted
|
152,556 | 2.08 | 7,867 | 2.00 | ||||||||||||
Exercised
|
(141,146 | ) | 0.77 | (68,411 | ) | 2.10 | ||||||||||
Forfeited and canceled
|
(392,714 | ) | 9.11 | (1,156,633 | ) | 29.40 | ||||||||||
Outstanding at December 31, 2010
|
1,542,072 | $ | 2.15 | 11,459,584 | $ | 2.75 | ||||||||||
Range of Exercise
Prices
|
Weighted Average
Remaining Contractual
Life (years)
|
Number of Options
Outstanding
|
Number of Options
Exercisable
|
|||
$ 0.22 to 4.99
|
6.50
|
1,236,132
|
982,966
|
|||
5.00 to 9.80
|
0.87
|
305,940
|
305,940
|
|||
$ 0.22 to 9.80
|
7.37
|
1,542,072
|
1,288,906
|
|||
Range of Exercise
Prices
|
Weighted Average
Remaining Contractual
Life (years)
|
Number of Warrants
Outstanding
|
Number of Warrants
Exercisable
|
|||
$ 0.18 to 4.99
|
1.78
|
9,154,194
|
9,154,194
|
|||
5.00 to 6.50
|
0.06
|
2,305,390
|
2,305,390
|
|||
$ 0.18 to 6.50
|
1.84
|
11,459,584
|
11,459,584
|
|||
Exhibit No.
|
Description
|
|
2.1
|
Stock Purchase Agreement by and among Sportan United Industries, Inc., Jason G. Otteson, PharmaFrontiers Corp., Warren C. Lau and other PharmaFrontiers stockholders, dated May 5, 2004 (incorporated by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K filed June 4, 2004, File No. 000-25513).
|
|
2.2
|
Agreement and Plan of Reorganization by and among PharmaFrontiers Corp., Pharma Acquisition Corp and Opexa Pharmaceuticals, Inc. dated October 7, 2004 (incorporated by reference to Exhibit 2.1 to the Company’s Current Report on 8-K filed October 8, 2004, File No. 000-25513).
|
|
3.1
|
Articles of Amendment and Restatement of the Articles of Incorporation (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on June 19, 2006).
|
|
3.2
|
Articles of Amendment to the Amended and Restated Articles of Incorporation (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on November 13, 2009).
|
|
3.3*
|
Amended and Restated By-laws, as amended.
|
|
4.1
|
Form of Common Stock Certificate (incorporated by reference to Exhibit 4.7 to the Company’s Registration Statement on Form S-3 filed on November 13, 2009, File No. 333-163108).
|
|
4.2
|
Purchase Agreement dated April 11, 2006 by and among the Company and the Investors named therein for April 2006 common stock and warrant offering (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed April 18, 2006).
|
|
4.3
|
Form of Warrant issued in connection with April 2006 offering (incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K filed April 18, 2006).
|
|
4.4
|
Registration Rights Agreement dated April 11, 2006 by and among the Company and the Investors named therein for April 2006 offering common stock and warrants (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed April 18, 2006).
|
|
4.5
|
Form of Series E Warrant (incorporated by reference to Exhibit 4.2 to the Company’s Registration Statement on Form SB-2 (Amendment No. 1) filed December 20, 2007, File No. 333-147167).
|
4.6
|
Warrant Agent Agreement by and between the Company and Continental Stock Transfer & Trust Company dated February 13, 2008 for the Series E Warrants (incorporated by reference to Exhibit 4.3 to the Company’s Current Report on Form 8-K filed February 14, 2008).
|
|
4.7
|
Form of Underwriters’ Warrant Agreement by and between the Company and each underwriter party thereto for the Series E Warrants (incorporated by reference to Exhibit 4.4 to the Company’s Current Report on Form 8-K filed February 14, 2008).
|
|
4.8
|
Form of Underwriters’ Warrant to Acquire Warrants Agreement by and between the Company and each underwriter party thereto for the Series E Warrants (incorporated by reference to Exhibit 4.5 to the Company’s Current Report on Form 8-K filed February 14, 2008).
|
|
4.9
|
Unit Purchase Agreement dated August 8, 2008 by and among the Company and the Investors named therein in connection with Unit offering of common stock and Series F Warrants (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed August 12, 2008).
|
|
4.10
|
Form of Series F Warrant issued in connection with August 8, 2008 financing (incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K filed August 12, 2008).
|
|
4.11
|
Registration Rights Agreement dated August 8, 2008 between the Company and the Investors named therein in connection with common stock and Series F Warrants (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed August 12, 2008).
|
|
4.12
|
Unit Purchase Agreement dated April 14, 2009 by and among the Company and the Investors party thereto for the 10% Convertible Notes and Series G Warrants (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed April 16, 2009).
|
|
4.13
|
Form of Series G Warrant issued by the Company on April 14, 2009 (incorporated by reference to Exhibit 10.4 of the Company’s Current Report on Form 8-K filed April 16, 2009).
|
Exhibit No.
|
Description
|
|
4.14
|
Placement Agent Agreement dated December 9, 2009 by and between the Company and Rodman & Renshaw, LLC for Unit offering of Common Stock and Series A and Series B Warrants (incorporated by reference to Exhibit 1.1 to the Company’s Current Report on Form 8-K filed December 10, 2009).
|
|
4.15
|
Form of Securities Purchase Agreement dated as of December 9, 2009 by and between the Company and each investor signatory thereto for Unit offering of Common Stock and Series A and Series B Warrants (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed December 10, 2009).
|
|
4.16
|
Form of Common Stock Purchase Warrant for Series A and Series B Warrants (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed December 10, 2009).
|
|
4.17
|
Form of Series H Warrant issued by the Company on February 11, 2011 (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed February 8, 2011).
|
|
10.1+
|
Opexa Therapeutics, Inc. June 2004 Compensatory Stock Option Plan (incorporated by reference to Exhibit B to the Company’s Definitive Information Statement on Schedule 14C filed on June 29, 2004, File No. 000-25513).
|
|
10.2+
|
Certificate of Amendments to the Opexa Therapeutics, Inc. June 2004 Compensatory Stock Option Plan (incorporated by reference to Exhibit 10.15 of the Company’s Annual Report on Form 10-K filed March 5, 2010).
|
10.3+
|
Employment Agreement dated June 16, 2008 by and between the Company and Neil K. Warma (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on June 18, 2008).
|
|
10.4+
|
Employment Agreement dated April 14, 2009 between the Company and Donna R. Rill (incorporated by reference to Exhibit 10.6 of the Company’s Current Report on Form 8-K filed April 16, 2009).
|
|
10.5+
|
Amended and Restated Employment Agreement entered into on April 21, 2010 by and between the Company and Donna R. Rill (incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 8-K filed April 27, 2010).
|
|
10.6+
|
Employment Agreement dated November 16, 2009 by and between the Company and Jaye L. Thompson.
|
|
10.7
|
License Agreement dated September 5, 2001 by and between the Company and Baylor College of Medicine (incorporated by reference to Exhibit 10.14 to the Company’s Annual Report on Form 10-KSB filed April 15, 2005, File No. 000-25513).
|
10.8
|
Lease dated August 19, 2005 by and between the Company and Dirk D. Laukien (incorporated by reference to Exhibit 10.13 to the Company’s Annual Report on Form 10-KSB filed March 31, 2006).
|
|
10.9
|
License Agreement dated January 13, 2006 by and between the Company and Shanghai Institute for Biological Services (incorporated by reference to Exhibit 10.23 to the Company’s Registration Statement on Form SB-2 (Amendment No. 1) filed February 9, 2006, File No. 333-126687).
|
|
10.10
|
Second Amended and Restated License Agreement dated July 31, 2007 by and between the Company and the University of Chicago (incorporated by reference to Exhibit 10.1 of the Company’s Report on Form 8-K filed August 3, 2007).
|
|
10.11++
|
Asset Purchase Agreement by and between the Company and Novartis Institutes for Biomedical Research, Inc. dated August 6, 2009 (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed August 7, 2009).
|
|
10.12+
|
Opexa Therapeutics, Inc. 2010 Stock Incentive Plan (incorporated by reference to Appendix A to the Company’s Schedule 14A definitive proxy statement filed September 14, 2010).
|
|
10.13+
|
Form of award agreement for awards to be made under the Opexa Therapeutics, Inc. 2010 Stock Incentive Plan (incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K filed October 22, 2010).
|
|
10.14
|
Continuous Offering Program Agreement dated May 14, 2010 by and between the Company and Rodman & Renshaw, LLC (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed on May 17, 2010) (subsequently terminated February 7, 2011 as disclosed in the Company’s Current Report on Form 8-K filed on February 7, 2011).
|
Exhibit No.
|
Description
|
|
23.1*
|
Consent of Independent Registered Public Accounting Firm MaloneBailey, LLP, dated March 8, 2011 to the incorporation by reference of their report dated March 8, 2011, in the Company’s Registration Statements on Form S-8 and S-3.
|
|
31.1*
|
Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
32.1*
|
Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
*
|
Filed herewith
|
+
|
Management contract or compensatory plan or arrangement.
|
++
|
Confidential treatment has been requested as to certain portions of this Exhibit pursuant to Rule 406 promulgated under the Securities Act. Such portions have been omitted and filed separately with the SEC.
|
/s/ MaloneBailey, LLP
|
MaloneBailey, LLP
|
www.malone-bailey.com
|
Houston, Texas
|
March 8, 2011
|
1.
|
I have reviewed this Annual Report on Form 10-K of Opexa Therapeutics, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
|
a.
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
|
b.
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, 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;
|
|
c.
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
|
d.
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s fourth fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
|
a.
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
|
b.
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date: March 8, 2011
|
By:
|
/s/ Neil K. Warma
|
|
Neil K. Warma
President, Chief Executive Officer and
Acting Chief Financial Officer
|
1.
|
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
2.
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
Date: March 8, 2011
|
By:
|
/s/ Neil K. Warma
|
|
Neil K. Warma
President and Chief Executive Officer
(Principal Executive Officer)
Acting Chief Financial Officer
(Principal Financial and Accounting Officer)
|