Tonix Pharmaceuticals (NASDAQ: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, has appointed a new executive vice president of commercial operations, effective immediately. According to the announcement, the company named Thomas (Tom) Englese as its new executive, noting that he has more than two decades of commercial and operations experience in the biopharmaceutical industry. The company also noted that it is on track to submit an NDA for TNX-102 SL for fibromyalgia in October 2024.

“Tom brings extraordinary biopharmaceutical expertise as an industry leader with more than 20 years of commercial experience and a proven track record of launching and building commercial strategies and executing strategic growth planning,” said Tonix Pharmaceuticals CEO Seth Lederman, MD, in the press release. “We expect to submit the NDA for TNX-102 SL for fibromyalgia, a critical milestone for this program, in October of this year. Tom will be a valuable addition to Tonix as we advance the fibromyalgia program toward launch, and further build out our existing commercial and marketing capabilities.”

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About Tonix Pharmaceuticals Holding Corp.

Tonix is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and modernizing solutions for public-health challenges. Tonix’s development portfolio is focused on central nervous system (“CNS”) disorders, and its priority is to submit a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) in October 2024 for TNX-102 SL, a product candidate for which two statistically significant phase 3 studies have been completed for the management of fibromyalgia. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in phase 2 development designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (“CD40L” or “CD154”) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease, including TNX-2900 for Prader-Willi syndrome, and infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced the U.S. Department of Defense (“DoD”), Defense Threat Reduction Agency (“DTRA”) awarded it a contract for up to $34 million over five years in an Other Transaction Agreement (“OTA”) to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Maryland, instrumental in progressing this development. Tonix Medicines, the company’s commercial subsidiary, markets Zembrace(R) SymTouch(R) (sumatriptan injection) 3 mg and Tosymra(R) (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults. For more information about the company, please visit www.TonixPharma.com.

NOTE TO INVESTORS: The latest news and updates relating to TNXP are available in the company’s newsroom at https://ibn.fm/TNXP

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