Tonix Pharmaceuticals Reports Q2 2024 Results and FDA Meeting Success

CHATHAM, N.J., Aug. 19, 2024 (GLOBE NEWSWIRE) – Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) has released its financial results for the second quarter ending June 30, 2024, alongside key operational highlights. The company is actively preparing for a New Drug Application (NDA) submission for its lead candidate, TNX-102 SL, which has received Fast Track designation from the U.S. Food and Drug Administration (FDA). This designation underscores the seriousness of fibromyalgia and the potential of TNX-102 SL to meet an unmet medical need, with hopes for FDA approval by 2025. At the recent American Society of Clinical Psychopharmacology meeting, Tonix presented promising data indicating that TNX-102 SL may improve depressive symptoms and other fibromyalgia-related issues. The company is also planning to initiate a Phase 2 clinical study for TNX-1300, aimed at treating cocaine intoxication in emergency settings, in the third quarter of 2024. Additionally, Tonix received Rare Pediatric Disease designation for TNX-2900, which is being developed for Prader-Willi Syndrome (PWS). Financially, Tonix reported $4.2 million in cash and cash equivalents as of June 30, 2024, a significant decrease from $24.9 million at the end of 2023. The company’s net cash used in operations was approximately $30.5 million for the first half of 2024, down from $56.3 million in the same period last year. Research and development expenses also saw a decline, totaling $9.7 million in Q2 2024 compared to $22.0 million in Q2 2023, reflecting a strategic focus on CNS disorders and ongoing product development.