Business
Tonix Pharmaceuticals Reports First Quarter 2022 Financial Results and Operational Highlights
Fibromyalgia Phase 3 Trial of TNX-102 SL Enrollment Initiated; Results from Interim Analysis Expected First Quarter 2023 Long COVID IND Cleared for TNX-102
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"Fibromyalgia Phase 3 Trial of TNX-102 SL Enrollment Initiated; Results from Interim Analysis Expected First Quarter 2023 Long COVID IND Cleared for TNX-102 SL; Phase 2 Trial Expected to Initiate Second Quarter 2022 Three Additional CNS Programs Expected to Initiate Phase 2 Studies in 2022: TNX-1300 for Cocaine Intoxication, TNX-1900 for Chronic Migraine and TNX-102 SL for PTSD FDA Granted Orphan-Drug Designation for TNX-2900 for Treatment of Prader-Willi Syndrome Organ Transplantation Phase 1 Study of TNX-1500 Expected to Initiate Second Half 2022 Cash and Cash Equivalents Totaled Approximately $140 Million at March 31, 2022 CHATHAM, N.J., May 09, 2022 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced financial results for the first quarter ended March 31, 2022, and provided an overview of recent operational highlights. “Tonix is making meaningful strides developing our rich portfolio of high impact product candidates,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “By the end of this year, we expect to have five central nervous system (CNS) programs in the clinic, led by our most advanced program, TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for fibromyalgia, which is in mid-Phase 3 development. Enrollment has begun for TNX-102 SL in a registration-enabling-Phase 3 clinical trial. TNX-102 SL trials in Long COVID and PTSD are also expected to initiate enrollment in the second quarter of 2022.” Dr. Lederman continued, “Long COVID is a growing problem because it is a chronic condition experienced by approximately 30% of people who recover from COVID-19. There is no currently approved treatment for this condition. We recently reported data from a retrospective observational study of U.S. adults that shows that 35% of Long COVID sufferers who experience multi-site pain are turning to addictive opioids. We are excited to study TNX-102 SL for this condition, since TNX-102 SL is a centrally-acting, non-addictive analgesic which is intended for chronic use. We look forward to starting our Phase 2 study for Long COVID with multi-site pain imminently.” Gregory Sullivan, M.D., Chief Medical Officer of Tonix said, “We are excited by the opportunities ahead for our rich pipeline of CNS, rare disease, immunology and in...