OS Therapies Inc. (NYSE American: OSTX) is set to present at the Moody Capital Solutions 2026 Disruptive Growth & Life Sciences Conference on Sept. 9-10 in New York City, where its animal health subsidiary will also participate. The appearance comes at a crucial juncture for the company, as it prepares for a wave of regulatory and clinical events that could shape the future of its lead investigational therapy, OST-HER2, for osteosarcoma.
The conference will provide a platform for OS Therapies to engage with investors and strategic partners, but the spotlight will be on the company's near-term milestones. In September, OS Therapies expects interim three-year overall survival data from its pivotal trial of OST-HER2 in patients with fully resected pulmonary metastatic osteosarcoma. Concurrently, the company is scheduled for key meetings with the U.S. Food and Drug Administration (FDA) and U.K. regulators, with potential decisions on Regenerative Medicine Advanced Therapy (RMAT) designation and Rolling Review. These regulatory pathways are designed to expedite the development and review of promising therapies for serious conditions.
The significance of these events cannot be overstated. Positive survival data and regulatory designations could accelerate the path to market for OST-HER2, addressing a high unmet medical need in osteosarcoma, a rare bone cancer primarily affecting children and young adults. The company is also targeting final three-year data, a U.S. Pre-BLA meeting, and regulatory submissions in the U.S., U.K., and Europe for the fourth quarter of 2026, indicating a tightly packed timeline toward potential approval.
Beyond human health, OS Therapies is also advancing OST-HER2 for canine osteosarcoma through its OS Animal Health division. The company is seeking alignment with the U.S. Department of Agriculture (USDA) to reinstate conditional approval for the therapy in dogs, which could open a significant veterinary market and provide additional value.
OST-HER2 is an immunotherapy based on a gene-edited, listeria-based platform that stimulates a potent immune response against the HER2 protein, which is overexpressed in many tumors. The therapy is designed to target three specific epitopes of HER2, requiring only one to be present to trigger an immune attack, potentially making it effective across a broad range of patients. OST-HER2 has already received Orphan Drug Designation, Fast Track Designation, and Rare Pediatric Disease Designation from the FDA, as well as similar designations from the European Medicines Agency, including Advanced Therapy Medicinal Product classification.
The company's participation in the Moody Capital conference is a strategic move to bolster investor confidence and forge partnerships as it navigates this critical period. With multiple regulatory and clinical catalysts on the horizon, OS Therapies is positioning itself as a leader in osteosarcoma treatment, and the outcomes of the coming months could have lasting implications for patients and shareholders alike.
For more information about OS Therapies, visit www.ostherapies.com.
