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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o
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934
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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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¨
Large accelerated
filer
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o
Accelerated
filer
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o
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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Page
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market conditions;
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our capital position;
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our ability to compete with larger, better financed pharmaceutical and biotechnology companies;
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new approaches to the treatment of our targeted diseases;
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our expectation of incurring continued losses;
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our uncertainty of developing a marketable product;
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our ability to raise additional capital to continue our development programs (including to undertake and complete any ongoing or further clinical studies for Tcelna or OPX-212);
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our ability to maintain compliance with NASDAQ listing standards;
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the success of our clinical trials (including the Phase IIb trial for Tcelna in SPMS which, depending upon results, may determine whether Merck Serono elects to exercise its Option to acquire an exclusive, worldwide (excluding Japan) license of our Tcelna program for the treatment of multiple sclerosis (MS);
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whether Merck Serono exercises its Option and, if so, whether we receive any development or commercialization milestone payments or royalties from Merck Serono pursuant to the Option;
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our dependence (if Merck Serono exercises its Option) on the resources and abilities of Merck Serono for the further development of Tcelna;
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the efficacy of Tcelna for any particular indication, such as for relapsing remitting MS or secondary progressive MS, and the efficacy of OPX-212 for neuromyelitis optica (NMO);
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our ability to develop and commercialize products;
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our ability to obtain required regulatory approvals;
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our compliance with all Food and Drug Administration regulations;
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our ability to obtain, maintain and protect intellectual property rights (including for Tcelna and OPX-212);
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the risk of litigation regarding our intellectual property rights or the rights of third parties;
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the success of third party development and commercialization efforts with respect to products covered by intellectual property rights that we may license or transfer;
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our limited manufacturing capabilities;
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our dependence on third-party manufacturers;
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our ability to hire and retain skilled personnel;
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our volatile stock price; and
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other risks detailed in our filings with the SEC.
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Item 1.
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Business.
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In the modified intent to treat patient population consisting of all patients who received at least one dose of study product and had at least one MRI scan at week 28 or later (n=142), the ARR for Tcelna-treated patients was 0.214 as compared to 0.339 for placebo-treated patients, which represented a 37% decrease in ARR for Tcelna 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), Tcelna demonstrated a 55% reduction in ARR as compared to placebo, an 88% reduction in whole brain atrophy and a statistically significant improvement in disability (EDSS) compared to placebo (p<0.045) at week 52 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, the results showed that patients, when treated with Tcelna, had a 56% to 73% reduction in ARR versus placebo for the various subsets and p values ranged from 0.009 to 0.06.
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Creating a detailed plan for potential Phase III development of Tcelna (the “Pre-Phase III Plan”), including documenting all of the activities necessary for laboratory facilities both in the U.S. and Europe to reach operational readiness by the end of December 2016. The Joint Steering Committee (“JSC”) established pursuant to the Merck Serono Agreement will be responsible for reviewing, approving and ultimately overseeing our completion of the Pre-Phase III Plan. In the event the JSC has not approved the Pre-Phase III Plan prior to the end of the period in the Merck Serono Agreement within which Merck Serono may exercise its option, such period will be extended for 60 days following approval of the Pre-Phase III Plan by the JSC.
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Providing Merck Serono with updates and analysis on a blinded basis, grouped in patient batches according to our analysis timetable, on the progress of our immune monitoring program being conducted in conjunction with our ongoing Abili-T clinical trial.
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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 efficacy 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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Item 1A.
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Risk
Factors.
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Tranche 2
: $1,000,000 in shares of common stock, at a per share purchase price of 90% of the 10-day volume weighted average price of the common stock for the 10 trading days (the “10-day VWAP”) immediately preceding the Tranche 2 milestone, which is the submission to the FDA of a preclinical study package to support the filing of an IND application for OPX-212, so long as such submission occurs on or before August 15, 2016 or any later date agreed to by the purchasers.
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Tranche 3
: $1,500,000 in shares of common stock, at a per share purchase price of 90% of the 10-day VWAP immediately preceding the Tranche 3 milestone, which is the acceptance of such IND by the FDA, so long as such acceptance occurs on or before the later of November 15, 2016 or three months following the Tranche 2 closing, or any later date agreed to by the purchasers.
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Tranche 4
: $1,000,000 in shares of common stock, at a per share purchase price of 90% of the 10-day VWAP immediately preceding the Tranche 4 milestone, which is the enrollment of the first patient in a Phase 1/2 clinical study of OPX-212 in patients with NMO, so long as such enrollment occurs on or before the later of February 28, 2017 or five months following the Tranche 3 closing, or any later date agreed to by the purchasers.
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Tranche 5
: $1,000,000 in shares of common stock, at per share purchase price of 90% of the 10-day VWAP immediately preceding the Tranche 5 milestone, which is the enrollment of patients representing at least 30% of the minimum targeted enrollment in such Phase 1/2 study, so long as such enrollment occurs on or before the later of June 30, 2017 or four months following the Tranche 4 closing, or any later date agreed to by the purchasers.
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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 2015 and beyond as well as for the clinical study of Tcelna and OPX-212;
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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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does not have sufficient resources or decides not to devote the necessary resources due to internal constraints such as limited cash or human resources;
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decides to pursue a competitive potential product;
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cannot obtain the necessary regulatory approvals;
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determines 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, epitope profiles, 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, retention and data collection during or after treatment (e.g., patients’ failure to return for follow-up visits or to complete the trial, detection of epitope profiles in subsequent visits, etc.); 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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licenses needed from third parties for manufacturing in order to conduct Phase III trials or to conduct commercial manufacturing, if applicable, are not obtained;
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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 sales and marketing strategies for the product and competition for such product;
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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 Tcelna;
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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 Tcelna, 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 (such as developments involving Merck Serono and the Option, including a decision by Merck Serono to exercise or not exercise the Option) 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;
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regulatory developments in the United States and in foreign countries; or
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dilutive effects of sales of shares of common stock by us or our shareholders, and sales of common stock acquired upon exercise or conversion by the holders of warrants, options or convertible notes.
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Item 1B.
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Unresolved
Staff Comments.
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Item 2.
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Item 3.
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Legal
Proceedings.
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Item 4.
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Mine
Safety Disclosures.
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Item 5.
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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, 2014
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||||||||
First Quarter
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$ | 17.60 | $ | 13.12 | ||||
Second Quarter
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15.44 | 10.08 | ||||||
Third Quarter
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13.68 | 6.80 | ||||||
Fourth Quarter
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8.56 | 5.60 |
Fiscal Year Ended December 31, 2015
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||||||||
First Quarter
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$ | 8.64 | $ | 4.24 | ||||
Second Quarter
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5.84 | 2.64 | ||||||
Third Quarter
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4.24 | 2.33 | ||||||
Fourth Quarter
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5.10 | 2.75 |
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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417,404 | $ | 18.04 | 60,810 | ||||||||
Equity Compensation Plans Not Approved by Stockholders
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— | — | — | |||||||||
Total
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417,404 | $ | 18.04 | 60,810 |
Item 6.
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Selected
Financial Data.
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Item 7.
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Management’s
Discussion and Analysis of Financial Condition and Results of Operations.
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Item 7A.
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Quantitative
and Qualitative Disclosures About Market Risk.
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Item 8.
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Financial
Statements and Supplementary Data.
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Item 9.
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Changes
in and Disagreements With Accountants on Accounting and Financial Disclosure.
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Item 9A.
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Controls
and Procedures.
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Item 9B.
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Other
Information.
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Item 10.
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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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53 |
President, Chief Executive Officer, Acting Chief Financial Officer and Director
|
|||
Don Healey, Ph.D.
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54 |
Chief Scientific Officer
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Donna R. Rill
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62 |
Chief Development Officer
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Name
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Age
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Position
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|||
Timothy C. Barabe
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62 |
Director
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|||
Hans-Peter Hartung, M.D.
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61 |
Director
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Gail J. Maderis
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58 |
Director
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Michael S. Richman
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54 |
Director
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Scott B. Seaman
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60 |
Director
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Neil K. Warma
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53 |
Director, President and Chief Executive Officer
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Item 11.
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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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Stock
Awards(1)
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Options
Awards(2)
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All Other
Compensation
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Total
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||||||||||||||||
Neil K. Warma
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2015
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$
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416,625
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$
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-
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$
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-
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$
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92,112
|
|
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$
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0
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$
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508,737
|
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|||||
President and Chief
Executive Officer
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2014
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|
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$
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406,464
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|
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$
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172,747
|
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$
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94,181
|
|
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$
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1,137,357
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|
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$
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0
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$
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1,810,749
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|
|||
Don Healey, Ph.D. (3)
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2015
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$
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266,240
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$
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-
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$
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-
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$
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46,056
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$
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0
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$
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312,296
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|||||||||||||||
Chief Scientific Officer
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||||||||||||||||||||||||||||
Karthik Radhakrishnan (4)
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2015
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$
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271,250
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|
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-
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$
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-
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$
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38,380
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|
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$
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0
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$
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309,630
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|||||||
Chief Financial Officer
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2014
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|
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$
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246,000
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|
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$
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71,033
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$
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30,319
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$
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232,417
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|
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$
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0
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$
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579,769
|
|
(1)
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Amounts in this column represent the aggregate grant date fair value of restricted stock awards computed in accordance with Financial Accounting Standards Board Accounting Standards Codification Topic 718 (“FASB ASC 718”). The fair value of restricted stock awards is based on the closing price of our common stock on the grant date, and we recognize the compensation expense over the vesting period.
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(2)
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Amounts in this column represent the aggregate grant date fair value of option awards computed in accordance with FASB ASC 718. Each officer was granted two options on February 28, 2014, and the fair value of each was calculated using the Black-Scholes option-pricing model. The first option is based upon the achievement of a future performance-based strategic milestone objective, and the grant date fair value is based upon the probable outcome of the performance conditions. The second option is time-based. See Note 13 to our financial statements included in our annual report on Form 10-K for assumptions underlying the valuation of equity awards.
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(3)
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Mr. Healey was appointed as an executive officer on October 26, 2015.
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(4)
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Mr. Radhakrishnan’s employment terminated on March 2, 2016 as part of a restructuring initiative and reduction-in-force which occurred on that date.
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Option Awards
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|||||||||||||
Name
|
Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable
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Number of
Securities
Underlying
Unexercised
Options (#)
Unexercisable
|
Option
Exercise
Price
|
Option
Expiration
Date
|
|||||||||
Neil K. Warma
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7,812 | — | $ | 32.32 |
06/16/18
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||||||||
4,687 | — | $ | 7.04 |
01/16/19
|
|||||||||
3,125 | — | $ | 65.60 |
11/30/19
|
|||||||||
2,343 | — | $ | 49.92 |
01/04/21
|
|||||||||
5,452 | — | $ | 30.40 |
01/06/22
|
|||||||||
11,919 | 77 | (1) | $ | 30.40 |
01/06/22
|
||||||||
5,452 | — | $ | 30.40 |
01/06/22
|
|||||||||
6,250 | — | $ | 15.04 |
11/08/23
|
|||||||||
17,294 | 22,237 | (2) | $ | 14.56 |
02/28/24
|
||||||||
— | 39,531 | (3) | $ | 14.56 |
02/28/24
|
||||||||
— | 15,000 | (2) | $ | 6.56 |
03/02/25
|
||||||||
Don Healey, Ph.D.
|
937 | — | $ | 72.00 |
04/30/20
|
||||||||
937 | — | $ | 49.92 |
01/04/21
|
|||||||||
1,308 | — | $ | 30.40 |
01/06/22
|
|||||||||
2,600 | 17 | (1) | $ | 30.40 |
01/06/22
|
||||||||
1,199 | — | $ | 30.40 |
01/06/22
|
|||||||||
2,084 | 416 | (4) | $ | 14.00 |
04/29/23
|
||||||||
3,533 | 4,545 | (2) | $ | 14.56 |
02/28/24
|
||||||||
— | 8,078 | (3) | $ | 14.56 |
02/28/24
|
||||||||
— | 7,500 | (2) | $ | 6.56 |
03/02/25
|
||||||||
Karthik Radhakrishnan (5)
|
14,323 | 1,302 | (4) | $ | 18.72 |
03/29/23
|
|||||||
3,533 | 4,545 | (2) | $ | 14.566 |
02/28/24
|
||||||||
— | 8,078 | (3) | $ | 14.56 |
02/28/24
|
||||||||
— | 6,250 | (2) | $ | 6.56 |
03/02/25
|
||||||||
(1)
|
The performance-based options began vesting quarterly over a three year-period upon achievement of certain key milestone events. On February 5, 2013, the second tranche of two-thirds of the performance option shares commenced three-year quarterly vesting upon achievement of the second key milestone, which was Opexa entering into a collaboration, partnership or other strategic arrangement involving rights in the United States for Tcelna.
|
(2)
|
25% of the shares vest on the one-year anniversary of the grant date, and the remaining 75% vesting quarterly over the remaining three years.
|
(3)
|
The performance-based options will vest, if at all, 100% in the event our ongoing Phase IIb Abili-T clinical trial for patients with SPMS meets it’s designated study endpoints.
|
(4)
|
The shares vest quarterly over a three-year period from the grant date.
|
(5)
|
As a result of his employment termination on March 2, 2016, vesting for any unvested stock options will accelerate by six additional months. In addition, Mr. Radhakrishnan will have a period of 12 months following his termination of employment within which to exercise any vested options, as opposed to the three months otherwise available for terminating employees.
|
Name
|
Fees Earned
or Paid
in Cash
|
Options
Awards
(3)(4)(5)
|
All Other Compensation
|
Total
|
||||||||||||
Timothy C. Barabe
|
$ | 15,000 | (1) | $ | 40,000 | $ | 0 | $ | 55,000 | |||||||
Hans-Peter Hartung, M.D.
|
$ | 15,000 | $ | 40,000 | $ | 0 | $ | 55,000 | ||||||||
Gail J. Maderis
|
$ | 15,000 | (1) | $ | 40,000 | $ | 0 | $ | 55,000 | |||||||
Michael S. Richman
|
$ | 15,000 | (1) | $ | 40,000 | $ | 0 | $ | 55,000 | |||||||
Scott B. Seaman
|
$ | 15,000 | (2) | $ | 40,000 | $ | 0 | $ | 55,000 |
(1)
|
In lieu of $15,000 cash, Messrs. Barabe and Richman and Ms. Maderis elected to receive 4,459 shares of restricted common stock, of which 852 shares vested on March 31, 2015, 1,053 shares vested on June 30, 2015, 1,200 shares vested on September 30, 2015, and 1,354 shares vested on December 31, 2015.
|
(2)
|
In lieu of $15,000 cash, Mr. Seaman elected to receive an option to purchase 4,463 shares of common stock on March 30, 2015 at an exercise price of $4.24 per share, with 25% vesting on each of March 31, 2015, June 30, 2015, September 30, 2015 and December 31, 2015.
|
(3)
|
Amount represents the aggregate grant date fair value of equity awards computed in accordance with FASB ASC 718. The fair value of time-based option awards is calculated using the Black-Scholes option-pricing model. See Note 11 to our financial statements included in our annual report on Form 10-K for assumptions underlying the valuation of equity awards.
|
(4)
|
The aggregate number of shares underlying outstanding option awards as of December 31, 2015 was: Mr. Barabe, 14,050 shares; Dr. Hartung, 14,856 shares; Ms. Maderis, 19,301 shares; Mr. Richman, 23,005 shares; and Mr. Seaman, 28,806 shares
|
(5)
|
As compensation for Board services, our non-employee directors were issued the following two options on March 30, 2015 to purchase shares of common stock at an exercise price of $4.24 per share, the market value on the date of grant: (i) an option, with a term of the earlier of ten years or upon a change of control of Opexa, to purchase 8,926 shares, with 50% vesting immediately upon grant and the remaining 50% vesting on December 31, 2015; and (ii) an option, with a term of ten years, to purchase 2,975 shares, with 50% vesting immediately upon grant and the remaining 50% vesting on March 30, 2016.
|
|
(i)
|
an option to purchase shares of our common stock having a Black-Scholes determined value of $30,000 on the date of grant and an exercise price equal to the fair market value of Opexa’s common stock on such date, with 50% vesting upon grant and the balance vesting on December 31 of that year;
|
|
(ii)
|
an option to purchase shares of our common stock having a Black-Scholes determined value of $10,000 on the date of grant and an exercise price equal to the fair market value of Opexa’s common stock on such date, with 50% vesting upon grant and the balance vesting generally one year from the date of grant; and
|
(iii)
|
$15,000 in cash, payable in equal quarterly installments in arrears, which, at the individual election of each director, may instead be paid in the form of a stock option or restricted shares of common stock, subject to quarterly vesting of such equity award.
|
Item 12.
|
Security
Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
|
Name and Address of Beneficial Owner
(1)
|
Number of
Shares Owned
|
Percentage of Class
|
||||||
Executive Officers and Directors:
|
||||||||
Scott B. Seaman
(2)
|
264,296 | (3) | 3.71 | % | ||||
Neil K. Warma
|
94,143 | (4) | 1.33 | % | ||||
Karthik Radhakrishnan
|
43,058 | (5) | * | |||||
Don Healey, Ph.D.
|
19,457 | (6) | * | |||||
Michael S. Richman
|
30,555 | (7) | * | |||||
Gail J. Maderis
|
26,851 | (8) | * | |||||
Timothy Barabe
|
24,509 | (9) | * | |||||
Hans-Peter Hartung, M.D.
|
14,856 | (10) | * | |||||
All directors and current executive officers as a group (8 persons)
|
498,696 | (11) | 6.84 | % |
(1)
|
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.
|
(2)
|
Scott B. Seaman is a principal of Chaswil, Ltd. (“Chaswil”), the investment manager of Alkek & Williams Ventures, Ltd. (“Ventures”). Chaswil holds voting power and investment power with respect to Company securities held by Ventures pursuant to a written agreement, and Mr. Seaman 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 Schedule 13D/A filed with the SEC on August 23, 2012, by Ventures, Chaswil, Mr. Seaman, Albert and Margaret Alkek Foundation (the “Foundation”), DLD Family Investments, LLC (“DLD Family”) and certain 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. Seaman, Charles Williams, Daniel Arnold, Joe Bailey 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. Ms. Williams is the principal of DLD Family and she may be deemed to exercise voting and investment power with respect to such shares held by DLD Family. Pursuant to the Foundation 13D, the Foundation, Ventures, Chaswil, Mr. Seaman and certain 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 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 certain other reporting persons named therein and (ii) that they have agreed to act together with certain other reporting persons named therein other than as described in the Foundation 13D. Each reporting person disclaims beneficial ownership with respect to all other shares of common stock other than those securities whereby the reporting person possesses sole voting power and sole dispositive power. The mailing address of the beneficial owner is 1100 Louisiana, Suite 5250, Houston, Texas 77002.
|
(3)
|
Consisting of: (i) 129,676 shares of common stock held by Ventures; (ii) 21,972 shares of common stock underlying Series I warrants held by Ventures; (iii) 2,868 shares of common stock underlying Series K warrants held by Ventures; (iv) 64,838 shares of common stock underlying Series M warrants held by Ventures; (v) 10,625 shares of common stock held by Mr. Seaman; and (vi) 5,510 shares of common stock underlying Series M warrants; (vii) 28,806 shares of common stock underlying currently exercisable stock options held by Mr. Seaman.
|
(4)
|
Consisting of: (i) 18,110 shares of common stock; (ii) 659 shares of common stock underlying Series I Warrants; (iii) 86 shares of common stock underlying Series K Warrants; (iv) 4,656 shares of common stock underlying Series M warrants; and (v) 70,632 shares of common stock underlying currently exercisable stock options.
|
(5)
|
Consisting of: (i) 15,582 shares of common stock; (ii) 6,250 shares of common stock underlying Series M warrants; and (iii) 21,226 shares of common stock underlying currently exercisable stock options. Mr. Radhakrishnan’s employment terminated on March 2, 2016 as part of a restructuring initiative and reduction-in-force which occurred on that date.
|
(6)
|
Consisting of: (i) 4,045 shares of common stock; and (ii) 15,412 shares of common stock underlying currently exercisable stock options.
|
(7)
|
Consisting of: (i) 6,520 shares of common stock; (ii) 1,030 shares of common stock underlying Series M warrants; and (iii) 23,005 shares of common stock underlying currently exercisable stock options.
|
(8)
|
Consisting of: (i) 6,520 shares of common stock; (ii) 1,030 shares of common stock underlying Series M warrants; and (iii) 19,301 shares of common stock underlying currently exercisable stock options.
|
(9)
|
Consisting of: (i) 8,459 shares of common stock; (ii) 2,000 shares of common stock underlying Series M warrants; and (iii) 14,050 shares of common stock underlying currently exercisable stock options.
|
(10)
|
Consisting of: 14,856 shares of common stock underlying currently exercisable stock options.
|
(11)
|
Consisting of: 188,049 shares of common stock; (ii) 104,650 shares of common stock underlying warrants; and (iii) 205,996 shares of common stock underlying stock options. Includes only current directors and executive officers serving in such capacity on the date of this report.
|
Item 13.
|
Certain
Relationships and Related Transactions, and Director Independence.
|
Director
|
Independent
|
Audit
Committee
|
Compensation
Committee
|
Nominating and
Corporate
Governance
Committee
|
||||||||||||
Timothy C. Barabe
|
X | X | X | |||||||||||||
Hans-Peter Hartung
|
X | |||||||||||||||
Gail J. Maderis
|
X | X | X | X | ||||||||||||
Michael S. Richman
|
X | X | X | |||||||||||||
Scott B. Seaman
|
X | X | X |
Item 14.
|
Principal
Accountant Fees and Services.
|
Years Ended
December 31,
|
||||||||
2015
|
2014
|
|||||||
Audit fees
(1)(2) (3)
|
$ | 65,000 | $ | 75,000 | ||||
Tax fees
|
— | — | ||||||
All other fees
(4)
|
31,500 | 16,500 | ||||||
$ | 96,500 | $ | 91,500 |
(1)
|
Audit fees include professional services rendered for (i) the audit of our annual financial statements for the fiscal years ended December 31, 2015 and 2014, and (ii) the reviews of the financial statements included in our quarterly reports on Form 10-Q for such years.
|
(2)
|
Audit fees paid in 2015 include $20,000 for the 2014 fiscal year audit.
|
(3)
|
Audit fees paid in 2014 include $30,000 for the 2013 fiscal year audit.
|
(4)
|
We have not engaged MaloneBailey, LLP for any consulting services. “All other fees” reflect payments to provide consent for financing activities such as registration statements on Forms S-1, S-3 and S-8 filings.
|
Item 15.
|
Exhibits
and Financial Statement Schedules.
|
(a)
|
1. Financial Statements
|
Audited Financial Statements for years ended December 31, 2015 and December 31, 2014
|
|
|
2.
|
Financial Statement Schedules
|
|
3.
|
List of Exhibits
|
OPEXA THERAPEUTICS, INC.
|
|||
|
By:
|
/s/ Neil K. Warma | |
Neil K. Warma | |||
Date: March 15, 2016
|
|||
Signature
|
Title
|
Date
|
||
/s/
Neil K. Warma
|
President, Chief Executive Officer, Acting Chief Financial Officer and Director
(Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer)
|
March 15, 2016
|
||
Neil K. Warma
|
||||
/s/
Timothy Barabe
|
Director
|
March 15, 2016
|
||
Timothy Barabe
|
||||
/s/
Hans-Peter Hartung
|
Director
|
March 15, 2016
|
||
Hans-Peter Hartung
|
/s/
Gail J. Maderis
|
Director
|
March 15, 2016
|
||
Gail J. Maderis
|
||||
/s/
Michael S. Richman
|
Director
|
March 15, 2016
|
||
Michael S. Richman
|
||||
/s/
Scott B. Seaman
|
Director
|
March 15, 2016
|
||
Scott B. Seaman
|
December 31,
2015
|
December 31,
2014
|
|||||||
Assets
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$ | 12,583,764 | $ | 9,906,373 | ||||
Other current assets
|
995,067 | 758,943 | ||||||
Total current assets
|
13,578,831 | 10,665,316 | ||||||
Property & equipment, net of accumulated depreciation of $2,443,600 and $2,099,389, respectively
|
837,867 | 1,098,104 | ||||||
Other long term assets
|
— | 38,939 | ||||||
Total assets
|
$ | 14,416,698 | $ | 11,802,359 | ||||
Liabilities and Stockholders’ Equity
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$ | 739,850 | $ | 702,494 | ||||
Accrued expenses
|
1,008,077 | 1,049,513 | ||||||
Deferred revenue
|
2,905,165 | 1,230,746 | ||||||
Notes payable – Insurance
|
148,344 | 149,671 | ||||||
Total current liabilities
|
4,801,436 | 3,132,424 | ||||||
Long term liability:
|
||||||||
Deferred revenue
|
— | 1,230,748 | ||||||
Total liabilities
|
$ | 4,801,436 | $ | 4,363,172 | ||||
Stockholders’ equity:
|
||||||||
Preferred stock, no par value, 10,000,000 shares authorized, none issued and outstanding
|
— | — | ||||||
Common stock, $0.01 par value, 150,000,000 shares authorized, 6,982,909 and 3,529,344 shares issued and outstanding
|
69,829 | 35,293 | ||||||
Additional paid in capital
|
162,884,919 | 148,724,102 | ||||||
Accumulated deficit
|
(153,339,486 | ) | (141,320,208 | ) | ||||
Total stockholders’ equity
|
9,615,262 | 7,439,187 | ||||||
Total liabilities and stockholders’ equity
|
$ | 14,416,698 | $ | 11,802,359 |
2015
|
2014
|
|||||||
Revenue:
|
||||||||
Option revenue
|
$ | 2,556,329 | $ | 1,271,895 | ||||
Research and development
|
10,039,496 | 12,118,629 | ||||||
General and administrative
|
4,258,147 | 3,833,370 | ||||||
Depreciation and amortization
|
351,403 | 387,779 | ||||||
Loss on disposal of fixed assets
|
1,167 | — | ||||||
Operating loss
|
(12,093,884 | ) | (15,067,883 | ) | ||||
Interest income, net
|
5,911 | 13,473 | ||||||
Other income and expense, net
|
68,695 | 2,147 | ||||||
Net loss
|
$ | (12,019,278 | ) | $ | (15,052,263 | ) | ||
Basic and diluted loss per share
|
$ | (2.05 | ) | $ | (4.33 | ) | ||
Weighted average shares outstanding
|
5,854,438 | 3,477,628 |
Common Stock
|
Additional Paid in
|
Accumulated
|
||||||||||||||||||
Shares
|
Par
|
Capital
|
Deficit
|
Total
|
||||||||||||||||
Balances at December 31, 2013
|
3,443,257 | $ | 34,433 | $ | 146,810,786 | $ | (126,267,945 | ) | $ | 20,577,274 | ||||||||||
Shares issued for service
|
21,285 | 212 | 305,891 | — | 306,103 | |||||||||||||||
Shares sold for cash
|
64,802 | 648 | 647,527 | — | 648,175 | |||||||||||||||
Option expense
|
— | — | 959,898 | — | 959,898 | |||||||||||||||
Net loss
|
— | — | — | (15,052,263 | ) | (15,052,263 | ) | |||||||||||||
Balances at December 31, 2014
|
3,529,344 | $ | 35,293 | $ | 148,724,102 | $ | (141,320,208 | ) | $ | 7,439,187 | ||||||||||
Shares issued for services
|
13,379 | 134 | 78,079 | — | 78,213 | |||||||||||||||
Cancellation of fractional shares
|
(1,365 | ) | (13 | ) | (5,015 | ) | — | (5,028 | ) | |||||||||||
Shares sold for cash
|
3,440,448 | 34,404 | 13,247,631 | — | 13,282,035 | |||||||||||||||
Exercise of warrants
|
1,103 | 11 | 4,399 | — | 4,410 | |||||||||||||||
Option expense
|
— | — | 835,723 | — | 835,723 | |||||||||||||||
Net loss
|
— | — | — | (12,019,278 | ) | (12,019,278 | ) | |||||||||||||
Balances at December 31, 2015
|
6,982,909 | $ | 69,829 | $ | 162,884,919 | $ | (153,339,486 | ) | $ | 9,615,262 |
2015
|
2014
|
|||||||
Cash flows from operating activities
|
||||||||
Net loss
|
$ | (12,019,278 | ) | $ | (15,052,263 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities
|
||||||||
Shares issued for services
|
78,213 | 306,103 | ||||||
Depreciation
|
351,403 | 387,779 | ||||||
Option expense
|
835,723 | 959,898 | ||||||
Loss on disposal of equipment
|
1,167 | — | ||||||
Changes in:
|
||||||||
Other current assets
|
(87,780 | ) | 513,304 | |||||
Accounts payable
|
37,356 | 6,339 | ||||||
Accrued expenses
|
(191,107 | ) | (183,477 | ) | ||||
Deferred revenue
|
443,671 | 138,727 | ||||||
Other long-term assets
|
38,939 | (1,271,895 | ) | |||||
Net cash used in operating activities
|
(10,511,693 | ) | (14,195,485 | ) | ||||
Cash flows from investing activities
|
||||||||
Purchase of property & equipment
|
(92,333 | ) | (190,859 | ) | ||||
Net cash used in investing activities
|
(92,333 | ) | (190,859 | ) | ||||
Cash flows from financing activities
|
||||||||
Common stock and warrants sold for cash, net of offering costs
|
13,282,035 | 648,175 | ||||||
Cash generated from exercise of warrants
|
4,410 | — | ||||||
Repurchase of fractional shares
|
(5,028 | ) | — | |||||
Net cash provided by financing activities
|
13,281,417 | 648,175 | ||||||
Net change in cash and cash equivalents
|
2,677,391 | (13,738,169 | ) | |||||
Cash and cash equivalents at beginning of period
|
9,906,373 | 23,644,542 | ||||||
Cash and cash equivalents at end of period
|
$ | 12,583,764 | $ | 9,906,373 | ||||
Cash paid for:
|
||||||||
Income tax
|
$ | — | $ | — | ||||
Interest
|
$ | 2,315 | $ | 1,983 | ||||
●
|
Opexa will create a detailed Pre-Phase III Plan (including a GANTT chart containing key tasks, decision points, timing, budget and milestones) documenting all of the activities necessary for laboratory facilities both in the U.S. and Europe to reach operational readiness by the end of December 2016 (e.g., review and identification of a preferred contract manufacturing organization in Europe; set-up, identification and qualification of third parties for raw materials; validation of laboratory facilities in the U.S. and Europe; and a hiring plan for key personnel). For Europe, the Pre-Phase III Plan would address the creation of a dedicated lab to support a Phase III trial, and for the U.S., the Pre-Phase III Plan would address the expansion of existing capabilities and infrastructure for a Phase III trial. The Joint Steering Committee (“JSC”) established pursuant to the Merck Serono Agreement will be responsible for reviewing, approving and ultimately overseeing Opexa’s completion of the Pre-Phase III Plan, which approval may not be unreasonably withheld or delayed. The JSC will meet at least quarterly to advise and make specific recommendations with respect to the Pre-Phase III Plan. In the event the JSC has not approved the Pre-Phase III Plan prior to the end of the Option Period (as defined in the Merck Serono Agreement), the Option Period will be extended for 60 days following approval of the Pre-Phase III Plan by the JSC.
|
●
|
Opexa will provide Merck Serono updates and analysis on a blinded basis, grouped in patient batches according to Opexa’s analysis timetable, on the progress of Opexa’s immune monitoring program (the “Program”) being conducted in conjunction with Opexa’s ongoing Abili-T clinical trial, with such updates and analysis to be shared with Merck Serono within 30 days of Opexa’s initial assessment of such information. Opexa will inform Merck Serono of any existing or future external bioinformatics vendor used by Opexa for the Program, and Merck Serono will have the right, at its expense, to review current and future data storage and integrity measures for the on-going Abili-T clinical trial.
|
Description
|
2015
|
2014
|
||||||
Custom reagents
|
$ | 496,269 | $ | - | ||||
Deferred offering costs
|
28,876 | 259,989 | ||||||
Prepaid expenses
|
469,922 | 498,954 | ||||||
Total Other Current Assets
|
$ | 995,067 | $ | 758,943 |
Description
|
Life
|
2015
|
2014
|
|||||||
Computer equipment
|
3 years
|
$ | 193,596 | $ | 168,209 | |||||
Office furniture and equipment
|
5-7 years
|
247,679 | 247,679 | |||||||
Software
|
3 years
|
125,412 | 116,022 | |||||||
Laboratory equipment
|
7 years
|
1,120,693 | 1,100,559 | |||||||
Leasehold improvements
|
5 years
|
683,295 | 675,672 | |||||||
Manufacturing equipment
|
7 years
|
910,792 | 889,352 | |||||||
Subtotal
|
3,281,467 | 3,197,493 | ||||||||
Less: accumulated depreciation
|
(2,443,600 | ) | (2,099,389 | ) | ||||||
Property and equipment, net
|
$ | 837,867 | $ | 1,098,104 |
Deferred tax asset resulting from:
|
December 31, 2015
|
December 31, 2014
|
||||||
Net Operating Loss
|
$ | 24,806,175 | $ | 24,531,026 | ||||
Research and development tax credits
|
2,593,792 | 1,778,030 | ||||||
Capitalized research and development costs
|
11,900,122 | 8,803,914 | ||||||
Subtotal
|
39,300,089 | 35,112,970 | ||||||
Less valuation allowance
|
(39,300,089 | ) | (35,112,970 | ) | ||||
Net deferred tax asset
|
$ | - | $ | - |
Year
|
Amount
|
|||
2016 | $ | 200,000 | ||
2017 | 200,000 | |||
2018 | 201,250 | |||
2019 | 206,250 | |||
2020 | 157,500 | |||
Total future minimum lease payments
|
$ | 965,000 |
●
|
On February 28, 2014, 13,700 shares of restricted common stock with an aggregate fair value of $199,503 were issued to certain members of Opexa’s management and certain members of the board of directors. Opexa recognized stock based compensation expense of $31,090 and $168,412 related to these shares for the year ended December 31, 2015 and 2014 respectively. The restricted shares issued to management vested in full on the earlier of the first anniversary of the grant date or termination of employment without cause following a change of control. The restricted shares issued to members of the board of directors vested in four quarterly increments beginning on March 31, 2014.
|
●
|
On March 19, 2014, 750 shares of restricted common stock with an aggregate fair value of $12,000 were issued to a certain member of Opexa’s board of directors. Opexa recognized stock based compensation expense of $2,123 and $9,877 related to these shares for the year ended December 31, 2015 and 2014 respectively. The restricted shares vested in three quarterly increments beginning on June 30, 2014.
|
●
|
In the third quarter of 2014, Opexa settled sales of 64,801 shares of common stock generating gross and net proceeds including amortization of deferred financing costs of $674,126 and $648,175, respectively, which were issued pursuant to the ATM facility.
|
●
|
In the fourth quarter of 2014, Opexa issued 6,833 shares of restricted stock with an aggregate fair market value of $50,000 in partial consideration for the performance of services rendered by a consultant pursuant to a consulting agreement dated October 21, 2014.
|
●
|
In February 2015, Opexa recognized stock-based compensation expense of $33,213 related to vested shares of restricted common stock issued, on February 28, 2014, to certain members of Opexa’s management and non-employee directors.
|
●
|
On March 31, 2015, 2,557 shares of restricted common stock with an aggregate fair value of $11,250 were issued to certain non-employee directors for service on Opexa’s Board. Opexa recognized stock-based compensation of $11,250 related to these shares. The shares vested immediately upon grant.
|
●
|
On April 9, 2015, Opexa issued 3,137,305 shares of common stock and Series M warrants to purchase a like number of shares upon the closing of a rights offering. Opexa raised $13,804,140 in gross proceeds, before expenses, through subscriptions for 3,137,305 units at a price of $4.40 per unit. Net proceeds were $12,095,210 after deduction of related fees and expenses, including dealer-manager fees, totaling $ 1,708,930.
|
●
|
In June 2015, Opexa issued 953 shares of common stock and received gross proceeds of $3,810 upon the exercise of Series M warrants to purchase 953 shares of common stock.
|
●
|
On June 30, 2015, 3,160 shares of restricted common stock with an aggregate fair value of $11,250 were issued to certain non-employee directors for service on Opexa’s Board. Opexa recognized stock-based compensation of $11,250 related to these shares. The shares vested immediately upon grant.
|
●
|
July 2015, Opexa issued 150 shares of common stock and received gross proceeds of $600 upon the exercise of Series M warrants to purchase 150 shares of common stock.
|
●
|
At Opexa’s annual meeting on August 28, 2015, shareholders approved an amendment to the Company’s Restated Certificate of Formation to increase the number of authorized shares of common stock from 100 million to 150 million, and the amendment was effect as of September 9, 2015.
|
●
|
On September 1, 2015, Opexa sold 113,636 shares of common stock for $4.40 per share and issued Series N warrants to purchase a like number of shares for gross and net proceeds of $499,999 upon the closing of tranche one of a private placement. Opexa also agreed to sell and the purchasers agreed to purchase an additional aggregate of $4.5 million of common stock in four additional tranches upon Opexa’s achievement of certain milestones to further the clinical development of OPX-212, Opexa’s autologous T-cell immunotherapy being developed for the treatment of neuromyelitis optica.
|
●
|
On September 28, 2015, Opexa effected the 1:8 Reverse Stock Split. An aggregate of 1,365 shares of common stock were identified as fractional shares, and cash in the amount of $5,028 was paid in lieu of these fractional shares. Unless otherwise noted, impacted amounts included in the consolidated financial statements and notes thereto have been retroactively adjusted for the stock splits as if such stock splits occurred on the first day of the first period presented. Impacted amounts include shares of common stock issued and outstanding, shares underlying warrants and stock options, shares reserved, exercise prices of warrants and options, and loss per share. There was no impact on the amount of preferred or common stock authorized resulting from the 1:8 Reverse Stock Split.
|
●
|
On September 30, 2015, 3,600 shares of restricted common stock with an aggregate fair value of $11,250 were issued to certain non-employee directors for service on Opexa’s Board. Opexa recognized stock-based compensation of $11,250 related to these shares. The shares vested immediately upon grant.
|
●
|
On September 30, 2015 Opexa sold an aggregate of 75,000 shares of common stock under the ATM facility for gross and net proceed of $240,143 and $232,934, respectively. These sales settled and shares were issued in October 2015.
|
●
|
In November 2015, Opexa sold an aggregate of 114,507 shares of common stock under the ATM facility for gross and net proceed of $483,634 and $469,116, respectively. These sales settled and shares were issued in December 2015.
|
●
|
On December 31, 2015, 4,062 shares of restricted common stock with an aggregate fair value of $11,250 were issued to certain non-employee directors for service on Opexa’s Board. Opexa recognized stock-based compensation of $11,250 related to these shares. The shares vested immediately upon grant.
|
Number of Shares
|
Weighted Avg. Exercise Price
|
Weighted Average Remaining Contract Term
(# years)
|
Intrinsic Value
|
|||||||||||||
Outstanding at December 31, 2013
|
145,233
|
$
|
34.39
|
|||||||||||||
Granted
|
175,417
|
14.27
|
||||||||||||||
Exercised
|
-
|
-
|
||||||||||||||
Forfeited and canceled
|
(17,816
|
)
|
23.86
|
|||||||||||||
Outstanding at December 31, 2014
|
302,834
|
$
|
23.34
|
8.0
|
$
|
-
|
||||||||||
Exercisable at December 31, 2014
|
120,485
|
$
|
36.52
|
6.4
|
$
|
-
|
||||||||||
Granted
|
135,430
|
5.22
|
||||||||||||||
Exercised
|
-
|
-
|
||||||||||||||
Forfeited and canceled
|
(20,860
|
)
|
13.35
|
|||||||||||||
Outstanding at December 31, 2015
|
417,404
|
$
|
18.04
|
7.7
|
$
|
-
|
||||||||||
Exercisable at December 31, 2015
|
231,071
|
$
|
23.58
|
7.0
|
$
|
-
|
Number of Shares
|
Weighted Avg. Exercise Price
|
Weighted Average Remaining Contract Term
(# years)
|
Intrinsic Value
|
|||||||||||||
Outstanding at January 1, 2014
|
383,603
|
$
|
32.96
|
2.46
|
-
|
|||||||||||
Granted
|
-
|
-
|
-
|
-
|
||||||||||||
Exercised
|
-
|
-
|
-
|
-
|
||||||||||||
Forfeited and canceled
|
(2,789)
|
80.00
|
-
|
-
|
||||||||||||
Outstanding at December 31, 2014
|
380,814
|
29.92
|
2.21
|
-
|
||||||||||||
Exercisable at December 31, 2014
|
380,814
|
29.92
|
2.21
|
-
|
||||||||||||
Outstanding at January 1, 2015
|
380,814
|
$
|
29.92
|
2.21
|
-
|
|||||||||||
Granted
|
3,311,128
|
4.16
|
-
|
-
|
||||||||||||
Exercised
|
(1,103)
|
4.00
|
-
|
-
|
||||||||||||
Forfeited and canceled
|
(27,885)
|
74.96
|
-
|
-
|
||||||||||||
Outstanding at December 31, 2015
|
3,662,954
|
6.30
|
2.17
|
-
|
||||||||||||
Exercisable at December 31, 2015
|
3,662,954
|
6.30
|
2.17
|
-
|
Exhibit No.
|
Description
|
|
3.1
|
Restated Certificate of Formation of Opexa Therapeutics, Inc. (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on July 26, 2012).
|
|
3.2
|
Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock of Opexa Therapeutics, Inc. (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed on July 26, 2012).
|
|
3.3
|
Certificate of Amendment of the Restated Certificate of Formation of Opexa Therapeutics, Inc. (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on December 14, 2012).
|
|
3.4
|
Certificate of Amendment to the Restated Certificate of Formation of Opexa Therapeutics, Inc., effective as of September 9, 2015 (incorporated by reference to Exhibit 3.1 to the Company’s Quarterly Report on Form 10-Q filed on November 10, 2015).
|
|
3.5
|
Certificate of Amendment to the Restated Certificate of Formation of Opexa Therapeutics, Inc., effective as of September 28, 2015 (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on September 28, 2015).
|
|
3.6
|
Amended and Restated By-laws, as amended (incorporated by reference to Exhibit 3.3 to the Company’s Annual Report on form 10-K filed on March 8, 2011).
|
|
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
|
Form of Securities Purchase Agreement dated as of December 9, 2009 by and between Opexa Therapeutics, Inc. and each investor signatory thereto for Unit offering of Common Stock and Series A Warrants (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed December 10, 2009).
|
|
4.3
|
Form of Common Stock Purchase Warrant for Series A Warrants (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed December 10, 2009).
|
|
4.4
|
Form of Series H Warrant issued 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).
|
|
4.5
|
Form of Series I Warrant issued on July 25, 2012 (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on July 26, 2012).
|
|
4.6
|
Form of Series J Warrant issued on January 23, 2013 (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on January 23, 2013).
|
|
4.7
|
Form of Series K Warrant issued on January 30, 2013 (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on January 30, 2013).
|
|
4.8
|
Form of Series L Warrant issued on February 11, 2013 (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on February 7, 2013).
|
|
4.9
|
Form of Securities Purchase Agreement, dated as of February 7, 2013, by and between Opexa Therapeutics, Inc. and each investor signatory thereto (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on February 7, 2013).
|
|
4.10
|
Form of Series M Warrant issued on April 9, 2015 (incorporated by reference to Exhibit 4.11 to the Company’s Registration Statement on Form S-1, as amended (File No. 333-201731), originally filed on January 28, 2015).
|
4.11
|
Warrant Agreement, dated February 25, 2015, by and between Opexa Therapeutics, Inc. and Continental Stock Transfer & Trust Company (incorporated by reference to Exhibit 4.2 to the Company’s Quarterly Report on Form 10-Q filed on May 12, 2015).
|
|
4.12
|
Subscription Agent Agreement, dated February 25, 2015, by and between Opexa Therapeutics, Inc. and Continental Stock Transfer & Trust Company (incorporated by reference to Exhibit 4.3 to the Company’s Quarterly Report on Form 10-Q filed on May 12, 2015).
|
|
4.13*
|
Amended and Restated Series N Warrants issued on March 14, 2016.
|
|
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+
|
Opexa Therapeutics, Inc. 2010 Stock Incentive Plan, as amended and restated (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on November 12, 2013).
|
|
10.4+
|
Form of award agreement for awards to be made under the Opexa Therapeutics, Inc. 2010 Stock Incentive Plan (incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10-Q filed August 14, 2014).
|
|
10.5+
|
Employment Agreement dated June 16, 2008 by and between Opexa Therapeutics, Inc. 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).
|
|
10.6+
|
Amended and Restated Employment Agreement entered into on April 21, 2010 by and between Opexa Therapeutics, Inc. and Donna R. Rill (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed April 27, 2010).
|
|
10.7+
|
Offer Letter, effective March 29, 2013, by and between Opexa Therapeutics, Inc. and Karthik Radhakrishnan (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on April 1, 2013).
|
|
10.8
|
License Agreement dated September 5, 2001 by and between Opexa Therapeutics, Inc. 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).
|
|
10.9
|
Lease dated August 19, 2005 by and between Opexa Therapeutics, Inc. 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, File No. 000-25513).
|
|
10.10
|
License Agreement dated January 13, 2006 by and between Opexa Therapeutics, Inc. 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).
|
|
10.11
|
Sales Agreement, dated September 6, 2012, by and between Opexa Therapeutics, Inc. and Brinson Patrick Securities Corporation (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on September 7, 2012).
|
|
10.12
|
First Amendment to Sales Agreement, dated March 5, 2014, by and among Opexa Therapeutics, Inc., Meyers Associates, L.P. (doing business as Brinson Patrick, a division of Meyers Associates, L.P.) and Brinson Patrick Securities Corporation (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed March 5, 2014).
|
|
10.13
|
$15.0 million Purchase Agreement, dated as of November 2, 2012, by and between Opexa Therapeutics, Inc. and Lincoln Park Capital Fund, LLC (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on November 5, 2012).
|
|
10.14
|
$1.5 million Purchase Agreement, dated as of November 5, 2012, by and between Opexa Therapeutics, Inc. and Lincoln Park Capital Fund, LLC (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed on November 5, 2012).
|
10.15
|
Registration Rights Agreement, dated as of November 2, 2012, by and between Opexa Therapeutics, Inc. and Lincoln Park Capital Fund, LLC (incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K filed November 5, 2012).
|
|
10.16#
|
Option and License Agreement, dated February 4, 2013, by and between Ares Trading SA, a wholly owned subsidiary of Merck Serono S.A., and Opexa Therapeutics, Inc. (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on February 5, 2013).
|
|
10.17
|
First Amendment of Option and License Agreement, dated March 9, 2015, by and between Opexa Therapeutics, Inc. and Ares Trading S.A. (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on March 9, 2015).
|
|
10.18
|
First Amendment to Lease Agreement, dated May 11, 2015, by and between Opexa Therapeutics, Inc. and Dirk D. Laukien (incorporated by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q filed on May 12, 2015).
|
|
10.19
|
Form of restricted stock agreement for awards to be made under the Opexa Therapeutics, Inc. 2010 Stock Incentive Plan (incorporated by reference to Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q filed on May 12, 2015).
|
|
10.20
|
Stock Purchase Agreement by and between Opexa Therapeutics, Inc. and the purchasers party thereto, dated September 1, 2015 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on September 1, 2015).
|
|
10.21*
|
Amendment to Stock Purchase Agreement by and between Opexa Therapeutics, Inc. and the purchasers party thereto, dated March 14, 2016.
|
|
10.22+*
|
Offer Letter, dated March 2, 2010, by and between Opexa Therapeutics, Inc. and Don Healey.
|
|
21.1
|
List of Subsidiaries (incorporated by reference to Exhibit 21.1 to the Company’s Annual Report on Form 10-K filed on March 29, 2013).
|
|
23.1*
|
Consent of Independent Registered Public Accounting Firm MaloneBailey, LLP.
|
|
31.1*
|
Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
31.2*
|
Certification of Acting Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
32.1*
|
Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
32.2*
|
Certification of Acting Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
101*
|
Financial statements from the Annual Report on Form 10-K of the Company as of and for the period ended December 31, 2015, formatted in Extensible Business Reporting Language (XBRL): (i) Consolidated Balance Sheets; (ii) Consolidated Statements of Operations; (iii) Consolidated Statements of Changes in Stockholders’ Equity; (iv) Consolidated Statements of Cash Flows; and (v) Notes to Consolidated Financial Statements.
|
|
*
|
Filed herewith
|
+
|
Management contract or compensatory plan or arrangement.
|
#
|
Confidential treatment was granted with respect to certain portions of this exhibit. Omitted portions have been filed separately with the Securities and Exchange Commission.
|
N-3 | March 14, 2016 |
●
|
Purchase Entirely for Own Account
. The Warrant and the securities to be received by the Warrantholder pursuant to the Warrant (the “
Securities
”) is being/will be acquired for the Warrantholder’s own account, not as nominee or agent, and not with a view to the resale or distribution of any part thereof in violation of the Securities Act, and the Warrantholder has no present intention of selling, granting any participation in, or otherwise distributing the same in violation of the Securities Act without prejudice, however, to the Warrantholder’s right at all times to sell or otherwise dispose of all or any part of the Securities in compliance with applicable federal and state securities laws.
|
●
|
Investment Experience
. The Warrantholder acknowledges that it can bear the economic risk and complete loss of its investment in the Securities and has such knowledge and experience in financial or business matters that it is capable of evaluating the merits and risks of an investment in the Securities.
|
●
|
Disclosure of Information
. The Warrantholder has had an opportunity to receive all information related to the Company requested by it and to ask questions of and receive answers from the Company regarding the Company, its business and the terms and conditions of the Securities.
|
●
|
Restricted Securities
. The Warrantholder understands that the Securities are characterized as “
restricted securities
” under the U.S. federal securities laws inasmuch as they are being acquired from the Company in a transaction not involving a public offering and that under such laws and applicable regulations such securities may be resold without registration under the Securities Act only in certain limited circumstances. The Warrantholder represents that it is familiar with Rule 144, as presently in effect, and understands the resale limitations imposed thereby and by the Securities Act. The Warrantholder acknowledges that the Securities have not been registered under the Securities Act or registration or qualified under any applicable blue sky laws in reliance, in part, on the representations and warranties herein.
|
●
|
Legends
. The Warrantholder understands that certificates evidencing the Securities may bear the following or any similar legend:
|
●
|
If required by the authorities of any state in connection with the issuance or sale of the Securities, the legend required by such state authority.
|
●
|
Accredited Investor
. The Warrantholder is an accredited investor as defined in Rule 501(a) of Regulation D, as amended, under the Securities Act.
|
●
|
No General Advertisement
. The Warrantholder did not learn of the investment in the Securities as a result of any public solicitation or advertisement, article, notice or other communication regarding the Securities published in any newspaper, magazine or similar media or broadcast over television, radio or internet or presented at any seminar or other general advertisement.
|
●
|
Brokers and Finders
. No person or entity will have any valid right, interest or claim against or upon the Company or the Warrantholder for any commission, fee or other compensation pursuant to any agreement, arrangement or understanding entered into by or on behalf of the Warrantholder.
|
N-4 | March 14, 2016 |
●
|
Purchase Entirely for Own Account
. The Warrant and the securities to be received by the Warrantholder pursuant to the Warrant (the “
Securities
”) is being/will be acquired for the Warrantholder’s own account, not as nominee or agent, and not with a view to the resale or distribution of any part thereof in violation of the Securities Act, and the Warrantholder has no present intention of selling, granting any participation in, or otherwise distributing the same in violation of the Securities Act without prejudice, however, to the Warrantholder’s right at all times to sell or otherwise dispose of all or any part of the Securities in compliance with applicable federal and state securities laws.
|
●
|
Investment Experience
. The Warrantholder acknowledges that it can bear the economic risk and complete loss of its investment in the Securities and has such knowledge and experience in financial or business matters that it is capable of evaluating the merits and risks of an investment in the Securities.
|
●
|
Disclosure of Information
. The Warrantholder has had an opportunity to receive all information related to the Company requested by it and to ask questions of and receive answers from the Company regarding the Company, its business and the terms and conditions of the Securities.
|
●
|
Restricted Securities
. The Warrantholder understands that the Securities are characterized as “
restricted securities
” under the U.S. federal securities laws inasmuch as they are being acquired from the Company in a transaction not involving a public offering and that under such laws and applicable regulations such securities may be resold without registration under the Securities Act only in certain limited circumstances. The Warrantholder represents that it is familiar with Rule 144, as presently in effect, and understands the resale limitations imposed thereby and by the Securities Act. The Warrantholder acknowledges that the Securities have not been registered under the Securities Act or registration or qualified under any applicable blue sky laws in reliance, in part, on the representations and warranties herein.
|
●
|
Legends
. The Warrantholder understands that certificates evidencing the Securities may bear the following or any similar legend:
|
●
|
If required by the authorities of any state in connection with the issuance or sale of the Securities, the legend required by such state authority.
|
●
|
Accredited Investor
. The Warrantholder is an accredited investor as defined in Rule 501(a) of Regulation D, as amended, under the Securities Act.
|
●
|
No General Advertisement
. The Warrantholder did not learn of the investment in the Securities as a result of any public solicitation or advertisement, article, notice or other communication regarding the Securities published in any newspaper, magazine or similar media or broadcast over television, radio or internet or presented at any seminar or other general advertisement.
|
●
|
Brokers and Finders
. No person or entity will have any valid right, interest or claim against or upon the Company or the Warrantholder for any commission, fee or other compensation pursuant to any agreement, arrangement or understanding entered into by or on behalf of the Warrantholder.
|
Dated as of: March 4, 2010
|
Signature:
|
/s/ Don Healey | |
Don Healey | |||
(a)
|
Prior Inventions
. Except as set forth in part (b) below, the following is a complete list of all Prior Inventions (as defined in Section 8 of the Proprietary Information and Inventions Agreement to which this Exhibit is attached) relevant to the present business of Opexa:
|
(b)
|
Confidential Prior Inventions
. Due to a prior confidentiality agreement, I cannot complete the disclosure with respect to the inventions or improvements generally listed below, the proprietary rights and duty of confidentiality with respect to which I owe to the following party(ies):
|
Invention or Improvement
|
Party(ies)
|
Relationship
|
|||
1. | |||||
2. | |||||
3. | |||||
4. | |||||
5. | |||||
EMPLOYEE
|
OPEXA THERAPEUTICS, INC.
|
|
/s/ Don Healey
|
/s/ Neil K. Warma
|
|
Signature | Signature | |
March 4, 2010
|
March 2, 2010
|
|
Date | Date | |
Don Healey
|
Neil K. Warma
|
|
Print Name | Print Name | |
President and CEO | ||
Title
|
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 15, 2016
|
By:
|
/s/ Neil K. Warma | |
Neil K. Warma
|
|||
President and Chief Executive Officer
|
|||
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 15, 2016
|
By:
|
/s/ Neil K. Warma | |
Neil K. Warma
|
|||
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 15, 2016
|
By:
|
/s/ Neil K. Warma | |
Neil K. Warma
|
|||
President and Chief Executive Officer
(Principal Executive 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.
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Date: March 15, 2016
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By:
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/s/ Neil K. Warma | |
Neil K. Warma
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Neil K. Warma
Acting Chief Financial Officer
(Principal Financial and Accounting Officer)
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