Opexa Therapeutics, Inc., a biopharmaceutical company, develops patient-specific cellular therapies for the treatment of autoimmune diseases. Its lead product candidate, Tovaxin, is a personalized T-cell therapeutic vaccine for the treatment of multiple sclerosis. Tovaxin is derived from T-cells isolated from peripheral blood, expanded ex vivo, and reintroduced into the patients via subcutaneous injections. The company was formerly known as PharmaFrontiers Corp. and changed its name to Opexa Therapeutics, Inc. in June 2006. Opexa Therapeutics was founded in 2003 and is based in The Woodlands, Texas.
Shs Outstand 18.47M Shs Float 14.85M Market Cap 25.49M Income -5.69M Sales 0
January 10-13, 2011: 29th Annual J.P. Morgan Healthcare Conference At the Westin St. Francis in San Francisco, CA.
* Manufacturing/Process Development: o Implementation of key process improvements and optimization of manufacturing process advanced as planned; o Documentation to support FDA Regulatory review is nearing completion; * Clinical Development: o Clinical Study Protocols continue to be developed and finalized for discussions with FDA; * Operations: o Opexa was awarded $244,000 in a grant under the Qualifying Therapeutic Discovery Project (QTDP) Program to advance the development of its lead product, Tovaxin®, for MS. The QTDP grant program provides support for innovative projects that are determined by the U.S. Department of Health and Human Services to have reasonable potential to result in a new therapy, reduce health care costs, or significantly advance the goal of curing diseases.
"During the third quarter of 2010, we remained focused on positioning the Company for further clinical studies with Tovaxin. There was and remains a significant amount of work and preparation required to be able to again treat patients under a clinical trial setting, but I am pleased with the substantial progress that has been made by everyone at Opexa to this end," commented Neil K. Warma, President and Chief Executive Officer of Opexa. "We are actively preparing for meetings with the FDA which we reasonably expect to take place toward the end of the year and are finalizing the documents and reports that will support these important discussions."
"The optimization of the manufacturing process to a commercial state has been advancing very well and I am equally as pleased with the progress we have made on the clinical and regulatory path. Based on strong input from our Scientific Advisory Board, we are now finalizing the clinical trial protocols that will be presented to the FDA. We continue to have active dialogue with potential partners regarding the further clinical development of Tovaxin," added Mr. Warma.
"As of the end of the third quarter, September 30, 2010, our cash and cash equivalents totaled approximately $4.7 million and our monthly burn rate for the year through the third quarter was approximately $380,000. We are maintaining tight control over our cash spend while still being able to actively advance our varied operational priorities. Our team remains lean but highly productive and focused on timely execution. At the current burn rate, we believe that while we have sufficient capital to support our operations, at current levels, through 2011, we will need to raise additional capital to support our operations." commented Mr. Warma.
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