Tonix Pharmaceuticals Reports Second Quarter 2024 Financial Results and Operational Highlights

Core Insights - Tonix Pharmaceuticals is on track to submit a New Drug Application (NDA) for TNX-102 SL for fibromyalgia in the second half of 2024, having completed successful pre-NDA meetings with the FDA [1][4] - The FDA has granted Fast Track designation for TNX-102 SL, indicating its potential to address an unmet medical need in treating fibromyalgia [2][4] - The company has received a contract from the U.S. Department of Defense for up to $34 million over five years to develop a broad-spectrum antiviral drug [1][12] Product Development Highlights - TNX-102 SL is a centrally-acting, non-opioid analgesic intended for the management of fibromyalgia, with a once-daily administration at bedtime [3] - The company is also advancing TNX-4200, a broad-spectrum antiviral program, supported by the DoD contract [2][12] - TNX-801, a vaccine in development for mpox, has shown positive preclinical efficacy, providing immune protection against lethal challenges [14] Financial Overview - As of June 30, 2024, Tonix had $4.2 million in cash and cash equivalents, down from $24.9 million at the end of 2023 [19] - Net product revenue for the second quarter of 2024 was approximately $2.2 million, with a cost of sales of about $3.4 million [20] - The net loss available to common stockholders for the second quarter of 2024 was $78.8 million, compared to a net loss of $28.4 million for the same period in 2023 [23] Market Strategy and Research - Tonix is collaborating with EVERSANA to assess the U.S. market opportunity for TNX-102 SL, indicating a high level of physician interest in the product [5] - The company plans to conduct a Phase 2 trial for TNX-102 SL to treat Acute Stress Disorder, supported by a $3 million contract from the DoD [5][6] - TNX-1300, a biologic for cocaine intoxication, is expected to enter Phase 2 clinical studies in the third quarter of 2024 [6] Pipeline and Future Prospects - The company has a diverse pipeline including TNX-1500 for organ transplant rejection and autoimmune disorders, and TNX-2900 for Prader-Willi syndrome [9][10] - Tonix's immunology and infectious disease portfolios are being developed to address significant health challenges, with ongoing studies and collaborations [10][12] - The company aims to leverage its infrastructure to expedite the launch of TNX-102 SL pending FDA approval, expected in 2025 [24]