Business
OS Therapies Reports Second Quarter 2025 Financial Results and Provides Business Update
U.S. FDA ("FDA") confirms OST-HER2 meets biological definition of Regenerative Medicine Advanced Therapy (RMAT) FDA issues OST-HER2 BLA number in preparation for Accelerated Approval submission following End of Phase 2 MeetingFDA End of Phase 2 Meeting scheduled for August 27, 2025 to review Phase 2b clinical trial in the prevention or delay of recurrent, pulmonary metastatic osteosarcomaStatistically significant 12-month Event Free Survival and interim 2-year Overall Survival and strong safety
About this update from Os Therapies Incorporated
[{"type":"list","items":[{"val":[{"type":"text","content":"U.S. FDA ("FDA") confirms OST-HER2 meets biological definition of Regenerative Medicine Advanced Therapy (RMAT)","length":121,"tagName":"p"}]},{"val":[{"type":"text","content":"FDA issues OST-HER2 BLA number in preparation for Accelerated Approval submission following End of Phase 2 Meeting","length":114,"tagName":"p"}]},{"val":[{"type":"text","content":"FDA End of Phase 2 Meeting scheduled for August 27, 2025 to review Phase 2b clinical trial in the prevention or delay of recurrent, pulmonary metastatic osteosarcoma","length":165,"tagName":"p"}]},{"val":[{"type":"text","content":"Statistically significant 12-month Event Free Survival and interim 2-year Overall Survival and strong safety data in Phase 2b trial drives global accelerated/conditional approval pathways","length":187,"tagName":"p"}]},{"val":[{"type":"text","content":"Commercial partnership with Eversana positions OST-HER2 for possible U.S. launch in first half of 2026","length":102,"tagName":"p"}]},{"val":[{"type":"text","content":"$4.2 million capital raise, closed July 11, 2025 via warrant exercise inducement and exchange offering, extends cash runway into mid-2026","length":137,"tagName":"p"}]},{"val":[{"type":"text","content":"NYSE American-listed OSTX included in the Russell Microcap, Russell Microcap Value and Russell Microcap Growth indexes","length":118,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":944,"olType":false},{"type":"text","content":"New York, New York--(Newsfile Corp. - August 19, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today reported second quarter 2025 financial results ended June 30, 2025 and provided a business update.","length":345,"tagName":"p"},{"type":"text","content":""The Company gained significant momentum in the second quarter as we began to make meaningful clinical and regulatory progress on our path towards bringing the first new treatment for osteosarcoma to market in the United States in the last 40 years," said Paul Romness, MPH, Chairman & CEO of OS Therapies. "Now midway through the third quarter, we have updated interim 2-year overall survival data readout that shows a statistically significant benefit f...