OS Therapies Incorporated ( (OSTX) ) has released its Q2 earnings. Here is a breakdown of the information OS Therapies Incorporated presented to its investors.
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OS Therapies Incorporated is a clinical-stage biotechnology company specializing in cancer immunotherapy and antibody drug conjugates, primarily focusing on treatments for osteosarcoma and other solid tumors. The company leverages the immune-stimulatory effects of Listeria bacteria in its lead asset, OST-HER2, which targets the HER2 protein.
In its second quarter 2025 earnings report, OS Therapies announced significant progress in its clinical and regulatory efforts, particularly with its OST-HER2 program. The company reported statistically significant results in its Phase 2b trial for preventing or delaying recurrent pulmonary metastatic osteosarcoma. Additionally, OS Therapies secured a commercial partnership with Eversana, positioning OST-HER2 for a potential U.S. launch in the first half of 2026.
Key financial and strategic highlights include a $4.2 million capital raise, extending the company’s cash runway into mid-2026, and the inclusion of its stock in the Russell Microcap indexes. The company also reported a net operating loss of $4.537 million for the quarter, attributed to increased regulatory activities. Furthermore, OS Therapies expanded its pipeline by acquiring a listeria cancer immunotherapy platform and formed a subsidiary to explore OST-HER2 applications in canine osteosarcoma.
Looking ahead, OS Therapies is preparing for an End of Phase 2 Meeting with the FDA, with plans to initiate a Biologics Licensing Application submission for OST-HER2 by late Q3 2025. The company anticipates potential regulatory approvals in the U.S. and U.K. by the end of 2025, which could significantly advance its market presence and financial performance.