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Opexa Therapeutics Reports Year End 2013 Financial Results And Provides Corporate Update

Opexa Therapeutics, Inc. (NASDAQ: OPXA), a biotechnology company developing a novel T-cell immunotherapy for multiple sclerosis (MS), today reported financial results for the year ended December 31, 2013, and provided an overview of recent corporate developments.

2013 and recent highlights include:
  • Clinical
    • As of February 27, 2014, enrolled over 80% of the total number of patients expected to be enrolled in the Phase IIb “Abili-T” clinical study of Tcelna ® (imilecleucel-T) in patients with Secondary Progressive Multiple Sclerosis (SPMS). The Abili-T clinical trial is a randomized, double-blind, placebo-controlled study designed to enroll 180 patients at approximately 35 leading clinical sites in the U.S. and Canada; and
    • Furthered the accumulation of comprehensive patient data to support Opexa’s Immune Monitoring Program which is being conducted in conjunction with the Abili-T trial. The goals of this Program are to identify potential novel biomarkers that could distinguish responders, to strengthen our intellectual property protection, and to broaden our understanding of the mechanism of action of Tcelna and the pathophysiology of SPMS patients.
  • Financial/Operational
    • Reported cash and cash equivalents of $23,644,542 as of December 31, 2013;
    • Closed two underwritten public offerings of an aggregate of 17,638,000 shares of common stock during the second half of 2013 for aggregate gross proceeds of approximately $27.4 million, or net proceeds of approximately $24.8 million after deducting underwriting discounts and commissions and offering expenses;
    • Eliminated debt on Opexa’s consolidated balance sheet through the conversion into common stock of the July 2012 convertible secured promissory notes in an aggregate principal amount of $4.1 million, and unencumbered all of our intellectual property and physical assets previously pledged as collateral;
    • Strengthened the team with the addition of several talented individuals dedicated to furthering the Company’s development initiatives, including enhancing the manufacturing and delivery of Tcelna;
    • Secured an option and license agreement with Merck Serono which, if exercised by Merck Serono, has the potential to bring in up to $220 million in milestone payments plus 8-15% royalties;
    • Secured the 50 th patent for the T-cell immunotherapy platform (U.S. and international jurisdictions, collectively); and
    • Laid the foundation to explore potential disease indications beyond MS that could be addressed through use of our T-cell platform.

“2013 was a strong year for Opexa as we executed on several critical strategic goals for the company. We secured a partnering agreement with Merck Serono, a large pharmaceutical company with a deep understanding of Multiple Sclerosis, advanced on the landmark Abili-T study in Secondary Progressive MS patients and ended the year in a strong financial position,” commented Neil K. Warma, President and Chief Executive Officer of Opexa. “In 2014, we look forward to completing enrollment in the Abili-T study, which is expected to occur in the second quarter of this year, and exploring other potential disease areas through the utilization of our Precision Immunotherapy TM platform.”

“The focus of the Company remains fixed on the execution of the Phase IIb study in Secondary Progressive MS patients. Currently, the treatment options for these patients are very limited, so the importance of bringing a safe and effective therapy to market is heightened. If we are successful with the development of Tcelna in the ongoing SPMS trial and Merck Serono exercises its option, Merck Serono would bear the expense of subsequent clinical development of Tcelna in MS. In addition, we believe Opexa would be solidly positioned with the potential to receive milestone payments in excess of $200 million as well as royalty payments ranging from 8-15% on product sales in the event Merck Serono is successful in its development efforts.”

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