Opexa Strengthens Management Team with Hire of Cell Therapy Expert

April 27, 2022 08:30 AM Eastern Daylight Time

VP of Scientific Development will lead Opexas R&D; efforts in Tovaxin®

THE WOODLANDS, Texas--(April 27, 2022)--Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company developing Tovaxin, a personalized T-cell therapy for multiple sclerosis (MS), announced today the hiring of an experienced cell therapy immunologist to lead the Company's research and development efforts including the further development of Tovaxin. Donald Healey, Ph.D., joins Opexa having developed an international reputation in the area of cellular therapy in both the U.S. and the U.K.

Dr. Healey is the former Director of Immunology at Argos Therapeutics, a North Carolina based cell therapy company developing personalized immunotherapeutic cell therapy products for the treatment of cancer and infectious disease. His responsibilities at Argos from 2003 to 2010 included guiding and developing all aspects of dendritic cell technology from small scale laboratory work, through product and process development for cGMP manufacture, and preparation of non-clinical regulatory documentation for submission to the U.S. FDA. Previously from 2001 to 2003 he was Group Leader at ML Laboratories (formerly Cobra Therapeutics, Ltd.) in the United Kingdom where he managed all clinical and preclinical cell therapy development programs. He has been an invited lecturer in immunology at numerous universities, authored numerous publications and is listed on several patent applications. He was a member of the Council of the British Society for Immunology from 1996-1998 and held post-doctoral positions in the Department of Pathology, Cambridge University, UK, conducting studies on immunoregulation in animal models of autoimmunity, including Type I Diabetes and Multiple Sclerosis.

"I couldn't be more pleased with bringing Don on board at this stage of our development," stated Neil K. Warma, President and Chief Executive Officer of Opexa. "We were extremely vigilant in our search and focused on finding an individual with a very strong immunology background and an in depth understanding of cell therapy, specifically in the area of manufacturing. This was an important position to fill as we build our world-class management team. As Vice President of Scientific Development, Don will oversee our Research and Development function, working closely with the Clinical and Manufacturing teams. His immediate focus will be on preparing for future clinical studies with Tovaxin and continuing the analysis of the immunology data suporting Tovaxin's mechanism of action. The strengthening of our management team is proceeding on schedule and we continue to be selective and deliberate in building an organization to best meet the development needs of the business," added Mr. Warma.

About Opexa

Opexa Therapeutics, Inc. is dedicated to the development of patient-specific cellular therapies for the treatment of autoimmune diseases. The Company's leading therapy, Tovaxin, is a personalized cellular immunotherapy treatment that is in clinical development for multiple sclerosis (MS). Tovaxin is derived from T-cells isolated from peripheral blood, expanded ex vivo, and reintroduced into the patients via subcutaneous injections. This process triggers a potent immune response against specific subsets of autoreactive T-cells known to attack myelin and, thereby, reduces the risk of relapse over time.

Opexa completed its 150 patient Tovaxin for Early Relapsing Multiple Sclerosis (TERMS) Phase 2b clinical study in late 2008 which was one of the first clinical studies investigating an autologous T-cell therapy in MS patients. Data from this clinical study show evidence that Relapsing Remitting MS (RRMS) patients treated with Tovaxin saw overall clinical, MRI, and immunological benefits over the placebo group, including statistical significance for decrease in the Annualized Relapse Rate (ARR), improvement in disability score (EDSS), and improvement in quality of life measures (MSQLI), as well as an excellent safety profile with no serious adverse events related to Tovaxin treatment.

For more information visit the Opexa Therapeutics website at www.opexatherapeutics.com

Cautionary Statement Relating to Forward - Looking Information for the Purpose of "Safe Harbor" Provisions of the Private Securities Litigation Reform Act of 1995

This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements in this release do not constitute guarantees of future performance. Investors are cautioned that statements in this press release which are not strictly historical statements, including, without limitation, statements regarding current or future financial payments, returns, royalties, performance and position, management's strategy, plans and objectives for future operations, plans and objectives for product development, plans and objectives for present and future clinical trials and results of such trials, plans and objectives for regulatory approval, litigation, intellectual property, product development, manufacturing plans and performance, constitute forward-looking statements. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, without limitation, risks associated with: market conditions, our capital position, the success of third party development and commercialization efforts with respect to products covered by intellectual property rights transferred by the Company, the success of third party patent prosecution efforts with respect to such products, the ability of the Company to enter into and benefit from a partnering arrangement for the Company's product candidate, Tovaxin, on reasonably satisfactory terms (if at all), and our dependence (if partnered) on the resources and abilities of any partner for the further development of Tovaxin, our ability to compete with larger, better financed pharmaceutical and biotechnology companies, new approaches to the treatment of our targeted diseases, our expectation of incurring continued losses, our uncertainty of developing a marketable product, our ability to raise additional capital to continue our treatment development programs, the success of our clinical trials, our ability to develop and commercialize products, our ability to obtain required regulatory approvals, our compliance with all Food and Drug Administration regulations, our ability to obtain, maintain and protect intellectual property rights for our products, the risk of litigation regarding our intellectual property rights, our limited manufacturing capabilities, our dependence on third-party manufacturers and value added resellers, our ability to hire and retain skilled personnel, our volatile stock price, and other risks detailed in our filings with the Securities and Exchange Commission. We assume no obligation to update any forward-looking information contained in this press release or with respect to the announcements described herein.