Tonix Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results and Operational Highlights

Core Insights - Tonix Pharmaceuticals is preparing for the potential launch of TNX-102 SL for fibromyalgia management, with a PDUFA goal date set for August 15, 2025, marking the first new drug for this condition in over 15 years [1][2][5] - The company reported a cash position of approximately $98.8 million as of December 31, 2024, which is expected to fund operations through the anticipated launch of TNX-102 SL [1][20] - Positive topline results from a Phase 1 study of TNX-1500, an anti-CD40L monoclonal antibody, were announced, supporting its advancement to a Phase 2 trial [1][13][8] Financial Highlights - For the fourth quarter of 2024, net product revenue was approximately $2.6 million, a decrease from $3.8 million in the same period in 2023 [22] - Research and development expenses for the fourth quarter of 2024 were approximately $8.3 million, down from $17.1 million in the previous year, attributed to fewer clinical trials [23] - The net loss available to common stockholders for the fourth quarter of 2024 was $22.1 million, compared to a net loss of $27.3 million in the same quarter of 2023 [25] Product Development and Pipeline - TNX-102 SL is a sublingual formulation of cyclobenzaprine designed for the management of fibromyalgia, showing statistically significant pain reduction in Phase 3 studies [5][9] - TNX-1500 is being developed for the prevention of kidney transplant rejection and treatment of autoimmune diseases, with a favorable safety profile demonstrated in Phase 1 trials [8][13] - TNX-801, a potential vaccine for mpox and smallpox, has shown promising results in non-human primates and is advancing towards clinical testing [11][30] Corporate Developments - The company is now debt-free following the repayment of a mortgage in February 2025 [19] - Tonix has expanded its leadership team with key appointments to enhance its commercial and technical capabilities [18] - The company received a contract from the U.S. Department of Defense for the development of broad-spectrum antiviral drugs, with potential funding of up to $34 million over five years [1][30]