OS Therapies Preps for FDA Meeting as It Eyes Accelerated Approval for Rare Bone Cancer Treatment

OS Therapies (NYSE:OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today provided a clinical and global regulatory update on its currently active clinical-stage oncology programs. The Company announced that the End of Phase 2 Meeting granted by the US Food & Drug Administration ("FDA") to review the clinical data from its OST-HER2 recurrent, pulmonary metastatic osteosarcoma program is scheduled for August 27, 2025, during which the Company expects to seek alignment with FDA to begin a rolling review Biologics Licensing Application ("BLA") submission to FDA under its Accelerated Approval Program ("Accelerated Approval").

Further, the Company announced that it has a confirmed a Scientific Advice Meeting ("SAM") with a European Medicines Agency ("EMA") rapporteur with respect to the OST-HER2 osteosarcoma program. This milestone is a critical step in the EMA's Centralized Procedure, providing a single Marketing Authorization valid across all European Member States. The Company also announced that it intends to pursue a Conditional Marketing Authorization ("CMA") in the United Kingdom via the Medicines and Health products Regulatory Agency's ("MHRA") Innovative Licensing and Access Pathway ("ILAP") in the event of a successful previously disclosed July 31st, 2025 UK SAM Meeting. Biolacuna has been appointed by OS Therapies as advisors for all global regulatory affairs efforts.

In addition, the Company reported that all patients enrolled in the Phase 1 clinical study of OST-504 (previously ADXS-504) have completed treatment, with updated clinical data expected to be reported in the second half of 2025.