Lixte Biotechnology Reports $3.6 Million Net Loss for 2024, Seeks Additional Funding

Lixte Biotechnology Holdings, Inc. reported a net loss of $3.6 million for the year ended December 31, 2024, compared to a net loss of $5.1 million in 2023. The company has not yet generated any revenue from operations and continues to rely on equity financing to fund its operations. The company's accumulated deficit increased from $48.5 million at the end of 2023 to $52.1 million at the end of 2024. Research and development costs decreased by 19.1% to $726,232 in 2024, while general and administrative costs decreased by 32.1% to $2,846,557.

Significant changes in 2024 included a decrease in research and development costs, primarily due to a reduction in preclinical research, and a decrease in general and administrative costs, mainly attributed to lower stock-based compensation, patent and licensing fees, and officer salaries. The company also amended its collaboration agreement with the Spanish Sarcoma Group (GEIS), relieving itself of a $3.1 million financial obligation for the randomized Phase 2 portion of a clinical trial. Additionally, the company added the Robert H. Lurie Comprehensive Cancer Center as a second site for a clinical trial combining LB-100 with GSK's dostarlimab.

Key operational developments included the completion of the Phase 1b portion of a clinical trial with GEIS in advanced soft tissue sarcoma, with data on toxicity and preliminary efficacy expected by the end of December 2025. The company also initiated a Phase 1b clinical trial with the Netherlands Cancer Institute, combining LB-100 with atezolizumab for microsatellite stable metastatic colon cancer; however, this trial was temporarily paused due to two serious adverse events. Furthermore, the company terminated its clinical research support agreement with City of Hope National Medical Center due to slow patient accrual. As of March 14, 2025, Lixte had two officer/employees and one consultant.

The company's patent portfolio includes patents covering LB-100, its prodrugs and analogs, and combination therapies with checkpoint inhibitors and other compounds. As of March 10, 2025, Lixte held patents in several countries, including the United States, Mexico, Australia, Japan, China, Hong Kong, Canada, and those granted by the European Patent Office. The company's long-term objective is to secure strategic partnerships or licensing agreements with pharmaceutical companies.

The company's independent registered public accounting firm expressed substantial doubt about its ability to continue as a going concern due to its lack of recurring revenue and negative operating cash flows. Lixte estimates that its existing cash resources will fund operations through approximately September 30, 2025, but additional capital will be needed to complete development and obtain regulatory approval for LB-100. The company is exploring various strategies to secure additional funding and is appealing a Nasdaq delisting notice related to minimum stockholder equity requirements.