Tonix Pharmaceuticals Reports $130M Net Loss and $10.1M Revenue for Fiscal Year 2024

Tonix Pharmaceuticals Holding Corp. reported a net loss of $130.0 million for the fiscal year ended December 31, 2024, compared to a net loss of $116.7 million in 2023. Revenue, generated from the sale of Zembrace SymTouch and Tosymra, reached $10.1 million in 2024, up from $7.8 million in 2023. The increase in net loss was primarily due to a $58.9 million asset impairment charge related to property, equipment, goodwill, and intangible assets, partially offset by a decrease in research and development expenses. Research and development expenses decreased by 54% to $40.0 million in 2024, primarily due to fewer clinical trials and a reduction in workforce.

Significant changes compared to the previous fiscal year include the $58.9 million asset impairment charge and the decrease in research and development expenses. The company also noted a 15% increase in selling, general, and administrative expenses to $40.1 million, primarily due to increased financial reporting, sales and marketing, and professional fees. The company attributed the impairment charges to delays in building out the sales team for its commercialized products, as resources were prioritized towards advancing TNX-102 SL through the FDA approval process.

In October 2024, Tonix submitted a New Drug Application (NDA) to the FDA for TNX-102 SL for the management of fibromyalgia, with a PDUFA goal date of August 15, 2025. The company is preparing for a commercial launch in the fourth quarter of 2025, contingent on FDA approval. Other key operational developments include the submission of a Phase 2 ready investigator-initiated IND for TNX-102 SL for acute stress reaction, and the initiation of a Phase 2 clinical trial for TNX-1300 for cocaine intoxication. Topline results from a Phase 1 study of TNX-1500 were reported in the first quarter of 2025.

Tonix also highlighted preclinical progress on TNX-801, a potential mpox and smallpox vaccine, including positive data presented at the DoD’s MHSRS conference and the World Vaccine Congress. The company announced a sponsored research agreement with the Kenya Medical Research Institute to conduct a Phase 1 clinical study of TNX-801 in Kenya. Furthermore, Tonix announced a collaboration with Bilthoven Biologicals to advance TNX-801. The company also reported on preclinical progress for TNX-1800, a COVID-19 vaccine candidate selected by the NIH’s Project NextGen for inclusion in clinical trials. The company's employee headcount was 81 as of March 17, 2025, with 45 employees dedicated to research and development.

Tonix's outlook is contingent upon the successful development, regulatory approval, and commercialization of its product candidates, particularly TNX-102 SL. The company anticipates continued operating losses for the foreseeable future and acknowledges the substantial doubt about its ability to continue as a going concern. The company's financial condition and results of operations are expected to fluctuate due to various factors, including the progress of its research and development efforts and the timing and outcome of regulatory submissions. The company's ability to continue operations depends on securing additional funding.