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Opexa Therapeutics Reports Third Quarter 2010 Financial Results

Opexa reported a net loss for the three months ended September 30, 2010 of $1.29 million, or ($0.07) per share, and a net loss for the nine months ended September 30, 2010 of $4.53 million, or ($0.27) per share. For the same three month and nine month period ending September 30, 2009, Opexa reported net income of $2.22 million, or $0.18 basic income per share and $0.14 diluted income per share, and a net loss of $0.28 million, or ($0.02) per share, respectively, relating to the gain on technology sale and initial technology transfer fee milestone recorded in the prior year quarter.   

Cash and cash equivalents were $4,733,445 as of September 30, 2010.

Further details can be found in the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2010.

About Opexa

Opexa Therapeutics, Inc. is dedicated to the development of patient-specific cellular therapies for the treatment of autoimmune diseases. The Company's leading therapy, Tovaxin®, is a personalized cellular immunotherapy treatment that is in clinical development for multiple sclerosis (MS). Tovaxin is derived from T-cells isolated from peripheral blood, expanded ex vivo, and reintroduced into the patients via subcutaneous injections. This process triggers a potent immune response against specific subsets of autoreactive T-cells known to attack myelin and, thereby, reduces the risk of relapse over time.

Opexa has completed a Phase 2b clinical study with Tovaxin in 150 patients with MS. Data from this clinical study show evidence that Relapsing Remitting MS (RRMS) patients treated with Tovaxin saw overall clinical and disability benefits over the placebo group, including a clinically relevant decrease in the Annualized Relapse Rate (ARR), and improvement in disability score (EDSS), as well as an excellent safety profile with no serious adverse events related to Tovaxin treatment.

For more information visit the Opexa Therapeutics website at www.opexatherapeutics.com .

The Opexa Therapeutics, Inc. is available at http://www.globenewswire.com/newsroom/prs/?pkgid=8296

Cautionary Statement Relating to Forward - Looking Information for the Purpose of "Safe Harbor" Provisions of the Private Securities Litigation Reform Act of 1995

This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words "expects," "believes," "anticipates," "estimates," "may," "could," "intends," and similar expressions are intended to identify forward-looking statements. The forward-looking statements in this release do not constitute guarantees of future performance. Investors are cautioned that statements in this press release which are not strictly historical statements, including, without limitation, statements regarding current or future financial payments, returns, royalties, performance and position, management's strategy, plans and objectives for future operations, plans and objectives for product development, plans and objectives for present and future clinical trials and results of such trials, plans and objectives for regulatory approval, litigation, intellectual property, product development, manufacturing plans and performance, constitute forward-looking statements. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, without limitation, risks associated with: market conditions, our capital position, the ability of the Company to enter into and benefit from a partnering arrangement for the Company's product candidate, Tovaxin, on reasonably satisfactory terms (if at all), and our dependence (if partnered) on the resources and abilities of any partner for the further development of Tovaxin, our ability to compete with larger, better financed pharmaceutical and biotechnology companies, new approaches to the treatment of our targeted diseases, our expectation of incurring continued losses, our uncertainty of developing a marketable product, our ability to raise additional capital to continue our treatment development programs, the success of our clinical trials, our ability to develop and commercialize products, our ability to obtain required regulatory approvals, our compliance with all Food and Drug Administration regulations, our ability to obtain, maintain and protect intellectual property rights (including for Tovaxin), the risk of litigation regarding our intellectual property rights, the success of third party development and commercialization efforts with respect to products covered by intellectual property rights transferred by the Company, our limited manufacturing capabilities, our dependence on third-party manufacturers, our ability to hire and retain skilled personnel, our volatile stock price, and other risks detailed in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date made. We assume no obligation or undertaking to update any forward-looking statements to reflect any changes in expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based. You should, however, review additional disclosures we make in the reports filed with the Securities and Exchange Commission.

         
Statements of Expenses Data:        
  Three Months Ended September 30, Nine Months Ended September 30,
  2010 2009 2010 2009
Research and development  $ 625,282  $ 490,273  $ 2,193,919  $ 1,653,755
General and administrative  626,697  665,649  1,706,546  1,473,639
Depreciation and amortization  37,647  52,055  136,022  163,139
Loss on disposal of assets  --  1,771  --  1,771
Operating loss  (1,289,626)  (1,209,748)  (4,036,487)  (3,292,304)
         
Interest income  815  131  1,395  1,625
Other income and expense, net  --  500,000  --  500,000
Gain on extinguishment of debt  --  --  --  --
Loss on derivative instruments  --  --  --  (366,774)
Gain on sale of technology  --  3,000,000    3,000,000
Interest expense  (2,004)  (69,901)  (499,200)  (122,529)
Net loss  $ (1,290,815)  $ 2,220,482  $ (4,534,292)  $ (279,982)
         
Basic loss per share  $ (0.07)  $ 0.18  $ (0.27)  $ (0.02)
Diluted loss per share  $ (0.07)  $ 0.14  $ (0.27)  $ (0.02)
         
Weighted average shares outstanding - Basic 18,421,600 12,354,942 16,601,503 12,282,619
Weighted average shares outstanding - Diluted 18,421,600 16,723,005 16,601,503 12,282,619
         
Selected Balance Sheet Data:        
  September 30, 2010 September 30, 2009    
Cash and cash equivalents  $ 4,733,445  $ 3,952,224    
Other current assets  45,691  647,880    
Fixed assets, net  813,888  1,001,621    
Total assets  5,593,024  5,601,725    
Total current liabilities  783,333  1,086,646    
Total long term liabilities   --  992,788    
Total stockholders' equity  4,809,691  3,522,291    
CONTACT:  Opexa Therapeutics, Inc.
          Neil K. Warma
          281.775.0600
          nwarma@opexatherapeutics.com

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