OS Therapies Provides OST-HER2 Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma Program Update Following FDA End of Phase 2 Meeting

About this update from Os Therapies Incorporated

[{"type":"list","items":[{"val":[{"type":"text","content":"Company on track to begin submission of a rolling Biologics Licensing Application (BLA) request for OST-HER2 to U.S. Food & Drug Administration in September 2025 ","length":165,"tagName":"p","attribs":{}}]}],"tagName":"ul","bulletedList":true,"length":165,"olType":false},{"type":"text","content":"New York, New York--(Newsfile Corp. - September 2, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today provided stakeholders with a detailed update regarding the Company's OST-HER2 recurrent, fully resected, pulmonary metastatic osteosarcoma program (the "Metastatic Osteosarcoma Program") following a highly productive End of Phase 2 Meeting with the US Food & Drug Administration ("FDA"). The Company remains on track to begin rolling submission of a Biologics Licensing Application ("BLA") request to FDA for the Metastatic Osteosarcoma Program in September 2025.","length":750,"tagName":"p"},{"type":"text","content":"Key Metastatic Osteosarcoma Program updates following FDA End of Phase 2 Meeting","length":80,"tagName":"p"},{"type":"text","content":"FDA and the Company achieved alignment in a number of areas crucial for a successful BLA:","length":89,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"No significant safety concerns with OST-HER2 in the targeted indication were identified based on the excellent safety profile from clinical data to date","length":152,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Non-clinical related matters were agreed to with minimal follow-up required","length":75,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Chemistry, Manufacturing, and Controls ("CMC")-related matters were agreed to, with clear guidance on final steps needed to support a BLA approval. The Company expected the feedback it received from FDA, based on prior feedback from the OST-AXAL (previously ADXS-AXAL) program. In February 2025, the Company began generating the necessary data and expects to have it ready for submission to FDA as part of the rolling BLA submission in Q4/25, ahead of an expected pre-BLA meeting","length":489,"tagName":"p","attribs":{}}]}],...

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