Tonix Pharmaceuticals to Participate in the 2025 BIO CEO & Investor Conference

Core Insights - Tonix Pharmaceuticals Holding Corp. is a biopharmaceutical company focused on pain management therapies and vaccines for public health challenges, with a significant emphasis on central nervous system (CNS) disorders [3] Group 1: Company Overview - Tonix Pharmaceuticals is advancing TNX-102 SL for fibromyalgia management, with a New Drug Application (NDA) submitted based on two statistically significant Phase 3 studies, and a PDUFA goal date of August 15, 2025, for marketing authorization [3] - The FDA has granted Fast Track designation to TNX-102 SL for fibromyalgia management [3] - The company is also developing TNX-102 SL for acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina [3] - Tonix's CNS portfolio includes TNX-1300, a biologic in Phase 2 development for cocaine intoxication, which has received FDA Breakthrough Therapy designation [3] - The immunology development portfolio includes TNX-1500, an Fc-modified humanized monoclonal antibody targeting CD40-ligand for organ transplant rejection and autoimmune diseases [3] - Tonix is developing a vaccine for mpox, TNX-801, and has a contract with the U.S. Department of Defense for up to $34 million over five years to develop TNX-4200, a broad-spectrum antiviral agent [3] Group 2: Market Presence - Tonix Medicines, the commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray) for acute migraine treatment in adults [3][7] - Zembrace and Tosymra are not intended for migraine prevention and are not approved for use in children under 18 years of age [8]