THE WOODLANDS, Texas--(BUSINESS WIRE)--

Opexa Therapeutics, Inc. (NASDAQ:OPXA - News), a company developing Tovaxin, a novel T-cell therapy for multiple sclerosis (MS), today reported financial results for the quarter ended March 31, 2012 and provided an update on recent corporate developments.

Corporate development highlights include:

We are progressing favorably in the planning and preparations for a clinical trial in Secondary Progressive MS patients, commented Neil K. Warma, President and Chief Executive Officer of Opexa. The clinical trial protocol was submitted to the FDA for final review and we received no additional comments from them. This is a key milestone for us, providing us with the necessary regulatory positioning to advance with the trial preparations and discussions with potential trial sites. Operationally, we believe we remain on track to initiate the trial in the coming months as the team continues to work diligently to finalize preparations. In order to initiate the trial, we will need to secure additional financing, either through a potential partnership or additional capital raise, and this continues to be an important focus for us.

The meeting we recently held with clinical trial investigators at the annual American Academy of Neurology conference was well attended and included some of the most influential MS opinion leaders participating in the discussions related to our clinical trial design and enrollment criteria. We are anticipating strong enrollment once we are able to begin the trial, driven by the support of the clinicians and a strong desire from patients to participate. SPMS is understood to be a very serious medical condition coupled with the fact that patients have limited treatment options. We hope that Tovaxin can eventually develop into a treatment of choice, not only for SPMS but for all MS patients.

As of the end of the first quarter, our cash and cash equivalents totaled approximately $4.7million and our monthly burn rate for the quarter was approximately $810,000, inclusive of increased cash expenditures to support preparations for the initiation of the planned Phase IIb clinical study in North America.

First Quarter Financial Results

Opexa reported no commercial revenues in the three months ended March 31, 2012 or in the comparable prior-year period.

Research and development expenses were $1,490,097 for the three months ended March 31, 2012, compared with $685,161 for the three months ended March 31, 2011. The increase in expenses was primarily related to an increase in the procurement and use of laboratory reagents and supplies, and increases in professional service fees, employee personnel costs, facility costs and non-cash stock compensation expense.

General and administrative expenses for the three months ended March 31, 2012 were $816,196, compared with $592,058 for the three months ended March 31, 2011. The increase in expense is due to increases in business development activities, legal expenses, employee compensation expense and non-cash stock compensation expense.

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Opexa Therapeutics Reports First Quarter 2012 Financial Results and Provides Corporate Update

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