OS Therapies Inc. reported a net operating loss of $3.876 million for the first quarter of 2025, compared to a net operating loss of $1.490 million in the same period of 2024. The increase in net loss was primarily attributed to expenses associated with the closure of the OST-HER2 Phase 2b osteosarcoma trial and costs related to initiating regulatory affairs activities for seeking Accelerated Approval from the US FDA for OST-HER2 in osteosarcoma. The net loss per share for the first quarter of 2025 was $0.18 on 21.249 million weighted average shares outstanding, compared to a loss of $0.25 per share on 5.991 million weighted average shares outstanding in the first quarter of 2024. In the first quarter of 2025, OS Therapies announced positive data from the Phase 2b clinical trial of OST-HER2 for preventing recurrent, fully resected lung metastatic osteosarcoma, a rare pediatric indication. The company also disclosed an agreement to acquire three clinical stage, eight preclinical stage assets, and all intellectual property related to the listeria cancer immunotherapy platform from Ayala Pharmaceuticals. The company remains on track to file a Biologics License Application $(BLA.AU)$ in the third quarter of 2025 for OST-HER2 aimed at preventing recurrent, fully resected, lung metastatic pediatric osteosarcoma. Additionally, OS Therapies has extended exclusivity protection for its commercial runway into 2040 with a new manufacturing patent and has secured research coverage from Wall Street analysts interested in the listeria immunotherapy platform.
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