Opexa Reports Financial Results and Updates on Tovaxin® Study

THE WOODLANDS, Texas -- Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company involved in the development and commercialization of cell therapies, has reported financial results for the first quarter of 2008 and provided an update on its Tovaxin IIb clinical trial.

Recent Highlights
- Completed a public equity financing with gross proceeds of $7.6 million in February
- Completed dosing in the Tovaxin IIb clinical trial with topline results expected in September 2008
- Recommendation received from the Data Safety Monitoring Board (DSMB) from its review of the mid-study descriptive analysis to continue the study as scheduled
- Positive results of Phase I/II studies of Tovaxin for multiple sclerosis (MS), with a greater than 90% reduction in annualized relapse rate in subjects as compared to their average prior two years was presented by the principal investigator, Brian Loftus, M.D. at the American Academy of Neurology annual meeting in April.

David McWilliams, CEO of Opexa, commented, “The Phase IIb trial continues to be executed according to our plan and the level of dropouts has remained low. To date only 150 patient visits remain of the approximately 2,500 total visits comprising the trial. We look forward to reporting topline results on our primary endpoints in September. McWilliams continued, “We are also encouraged by the strong interest in the open label extension study for Tovaxin offered to all participants completing the Phase IIb study. Over 90% of patients who have completed the one-year TERMS study to date have elected to enroll in the extension study.”

First Quarter Financial Results
Opexa reported no revenues for the three months ended March 31, 2008 or in the comparable prior-year period.

Research and development expenses were approximately $2.4 million in the first quarter of 2008, compared with approximately $3.2 million in the first quarter of 2007. The decrease was primarily related to the initial enrollment and start-up costs of the Phase IIb clinical trial for Tovaxin in 2007 and a reduction in stock compensation expense. Research and development expenses are expected to increase as the company continues to invest in the development of it's technology.

General and administrative expenses were approximately $0.7 million in the first quarter of 2008, compared with approximately $0.8 million in the first quarter of 2007. The decline is primarily due to a decrease in stock compensation expense, professional service fees and overhead expenses. Opexa expects future general and administrative expenses to be higher as it prepares for commercialization of its products.

Opexa reported a net loss for the first quarter of 2008 of approximately $3.1 million or $0.37 per share, compared with a net loss for the first quarter of 2007 of approximately $4.0 million or $0.59 per share. The decrease in net loss primarily was due to the initial enrollment and start-up costs of the Phase IIb trial for Tovaxin in 2007 and a reduction in stock-based compensation expense.

The Company had cash and cash equivalents of approximately $6.3 million as of March 31, 2008, compared with approximately $2.6 million as of December 31, 2007. The March 31, 2008 quarter-end cash balance included gross proceeds of approximately $7.6 million raised from the February 19, 2008 public offering.

About Opexa Therapeutics
Opexa Therapeutics develops and commercializes cell therapies to treat autoimmune diseases such as MS, rheumatoid arthritis, and diabetes. The Company is focused on autologous cellular therapy applications of its proprietary T-cell and stem cell therapies. The Company is in preclinical development for diabetes mellitus. For more information, visit the Opexa Therapeutics' Web site.