Opexa Therapeutics reports lower net loss of $1.4M for first-quarter 2010

May 14 2010

Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company developing Tovaxin®, a novel T-cell therapy for multiple sclerosis (MS), today reported financial results for the quarter ended March 31, 2010 and provided an update on its corporate developments.

“The first several months of 2010 have been productive and we are progressing well with our development activities”

Recent highlights include:

• Strengthening of the Tovaxin patent estate through issuance of key patents;
• Presenting Tovaxin data at the 62^nd annual American Academy of Neurology (AAN) conference, indicating a possible link between Tovaxin's potential mechanism of action and relevant clinical outcomes in MS patients based on new immunological data analysis; and
• Strengthening of the management team through the hiring of an experienced cell therapy immunologist as V.P. of Scientific Development to lead R&D efforts of Tovaxin development.

"The first several months of 2010 have been productive and we are progressing well with our development activities," commented Neil K. Warma, President and Chief Executive Officer of Opexa. "We have been focused on strengthening our management team and patent estate and supporting the Tovaxin data analysis and I am pleased with our progress in all of these areas. The presentation of the TERMS immunology data was well received at AAN and with the issuance of certain key patents, we believe we have strengthened the value of the Tovaxin franchise. The hiring of Don Healey as VP of Scientific Development has also provided us with additional expertise as we prepare for planned FDA meetings later this year and for further clinical development of Tovaxin. Operationally over the next several months, we will be completing additional manufacturing support and optimization studies in preparation for the planned FDA discussions and will be continuing to further clarify Tovaxin's mechanism of action. The planning for the next clinical study has progressed and protocol synopses have been prepared. Input from the FDA will guide the timing and final design of the trial, together with feedback generated from discussions with potential partners," added Mr. Warma.

"As of the end of the first quarter, March 31, 2010, our cash and cash equivalents totaled approximately $7.1 million and our monthly burn rate for the quarter was approximately $350,000. At the current burn rate, we should have sufficient capital beyond 2010," commented Mr. Warma.

First Quarter Financial Results

Opexa reported no revenues in the three months ended March 31, 2010 or in the comparable prior-year period.

Research and development expenses were $783,534 for the three months ended March 31, 2010, compared with $737,778 for the three months ended March 31, 2009. The increase in expenses was primarily related to a slight increase in personnel and the initiation of key experiments, and was partially offset by a decrease in stock compensation expense.

General and administrative expenses for the three months ended March 31, 2010 were $484,425 compared with $396,315 for the three months ended March 31, 2009. The increase in expense is due to an increase in professional service fees and partially offset by a decrease in stock compensation expense.

Opexa reported a net loss for the three months ended March 31, 2010 of $1,422,495, or ($0.09) per share, compared with a net loss for the three months ended March 31, 2009 of $1,636,969, or ($0.13) per share.

Cash and cash equivalents and investments in marketable securities were $7,092,036 as of March 31, 2010 compared to $403,943 as of March 31, 2009.

Further details can be found in the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2010.

SOURCE Opexa Therapeutics, Inc.