Opexa Therapeutics aims to complete planned experiments, develop clinical study protocols

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 June 30, 2010 and provided an update on its corporate developments.

“Having put in place a world class management team in the first few months of this year, we have been leveraging this expertise to further advance the Tovaxin program in both the clinical development and manufacturing functions”

Recent highlights include:

• Implementation of process improvements and optimization of manufacturing process to support late stage clinical trials and regulatory requirements;
• Preparation for clinical studies and positioning for future FDA interactions;
• Enlisting the support of worldwide thought leaders in MS, neurology, and immunology for newly reconstituted SAB.

"Having put in place a world class management team in the first few months of this year, we have been leveraging this expertise to further advance the Tovaxin program in both the clinical development and manufacturing functions," commented Neil K. Warma, President and Chief Executive Officer of Opexa. "Additionally we have recently formed a new and very experienced Scientific Advisory Board to support the team and assist with the development efforts. The group is comprised of some of the most renowned MS leaders in North America and Europe and we are thrilled that they have agreed to work with us to advance Tovaxin. Our focus in 2010 has remained true to our plan to optimize the manufacturing process and develop the clinical plans to support late stage development of Tovaxin in MS. Over the remainder of the year, we aim to complete planned experiments for process improvements and develop clinical study protocols in advance of meeting with the FDA. Discussions with potential partners are also continuing."

"As of the end of the second quarter, June 30, 2010, our cash and cash equivalents totaled approximately $6 million and our monthly burn rate for the quarter was approximately $380,000. We continue to remain diligent in the utilization of cash resources and despite the planned increase in clinical and manufacturing activities this quarter, I am pleased with the returns we are seeing with relatively limited expenditures. At the current burn rate, we have sufficient capital beyond 2010," commented Mr. Warma.

Second Quarter Financial Results

Opexa reported no revenues in the three months ended June 30, 2010 or in the comparable prior-year period.

Research and development expenses were $785,103 and $1,568,637 for the three and six months ended June 30, 2010, respectively, compared with $425,701 and $1,163,482 for the three and six months ended June 30, 2009, respectively. The increase in expenses was primarily related to an 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 and six months ended June 30, 2010 were $595,424 and $1,079,849, respectively, compared with $411,675 and $807,990 for the three and six months ended June 30, 2009, respectively. The increase in expense is due to an increase in professional service fees, and was partially offset by a decrease in stock compensation expense.

Opexa reported a net loss for the three months ended June 30, 2010 of $1.82 million, or ($0.12) per share, and a net loss for the six months ended June 30, 2010 of $3.24 million, or ($0.21) per share. For the same three and six month period ending June 30, 2009, Opexa reported a net loss of $0.9 million, or ($0.07) per share, and $2.5 million, or ($0.20) per share, respectively.

Cash and cash equivalents were $5,874,614 as of June 30, 2010 compared to $827,004 as of June 30, 2009.

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