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Opexa Therapeutics Reports Third Quarter 2013 Financial Results And Provides Corporate Update

Opexa Therapeutics, Inc. (NASDAQ: OPXA), a biotechnology company developing Tcelna ®, a novel T-cell immunotherapy for the treatment of multiple sclerosis (MS), today reported financial results for the third quarter ended September 30, 2013 and provided an overview of the Company’s recent corporate developments.

Recent highlights include:
  • Clinical
    • As of November 6, 2013, enrolled 100 patients 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 33 leading clinical sites in the U.S. and Canada.
    • Furthered the accumulation of comprehensive patient data to support Opexa’s Immune Monitoring Program initiative in conjunction with the Abili-T trial, including the potential identification of biomarkers for SPMS and further understanding of the immunopathology of SPMS.
  • Financial
    • Reported cash and cash equivalents of $20,172,485 as of September 30, 2013.
    • Closed an underwritten public offering of 12 million shares of common stock in August 2013 and sold an additional 900,000 shares of common stock in September 2013 through the exercise of an over-allotment option granted to the underwriter of the public offering, with aggregate gross proceeds of $19.4 million, or net proceeds of approximately $17.4 million after deducting underwriting discounts and commissions and estimated offering expenses.
    • Eliminated debt on Opexa’s consolidated balance sheet through the conversion into common stock of the remaining July 2012 convertible secured promissory notes in an aggregate principal amount of $3.185 million.
    • Terminated the remaining $500,000 deposit control agreement in connection with conversion of the July 2012 convertible secured promissory notes, resulting in the funds being reported as cash and cash equivalents on the consolidated balance sheet instead of as restricted cash.
  • Operational
    • 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.

“We recently reached a major milestone by enrolling the 100 th patient into the Abili-T study," commented Neil K. Warma, Opexa’s President and Chief Executive Officer. "With the recent addition of three new clinical trial sites in the U.S., we now have 33 centers across North America participating in the Abili-T study,” added Mr. Warma. “We expect to complete enrollment of 180 patients in early 2014 and release the top-line results of the study in the middle of 2016.”

“On the financial front, we focused our efforts this quarter on strengthening and cleaning up our balance sheet,” commented Karthik Radhakrishnan, Opexa’s Chief Financial Officer. “Following the receipt of net proceeds of approximately $17.4 million through our August 2013 public offering and the subsequent exercise of the underwriters’ over-allotment option, we ended the quarter with over $20 million of cash and cash equivalents. In addition, we eliminated the remaining $3.185 million principal amount of the July 2012 convertible secured promissory notes through the conversion of principal and accrued interest into shares of our common stock,” added Mr. Radhakrishnan.

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