OS Therapies Inc. (NYSE American: OSTX), a clinical-stage oncology company specializing in immunotherapies for osteosarcoma and other solid tumors, announced its upcoming participation in the Moody Capital Solutions 2026 Disruptive Growth & Life Sciences Conference, scheduled for September 9-10 in New York City. The company will engage with investors and strategic partners, with a particular focus on its OS Animal Health subsidiary. This conference arrives at a potentially transformative time for OS Therapies as it approaches several critical regulatory milestones for its lead asset, OST-HER2.
OST-HER2 is an investigational immunotherapy designed to treat fully resected pulmonary metastatic osteosarcoma, a rare and aggressive bone cancer primarily affecting children and young adults. The therapy leverages the immune-stimulatory properties of listeria bacteria to provoke a robust immune response against the HER2 protein, which is overexpressed in many tumors. By targeting three specific epitopes of the HER2 oncogene, OST-HER2 requires only one epitope to be present to trigger an immune attack, potentially broadening its applicability across patient populations.
The company has outlined a series of expected regulatory interactions and data readouts in the coming months. In September, OS Therapies anticipates interim three-year overall survival data from its ongoing clinical trials, alongside key meetings with the U.S. Food and Drug Administration (FDA) and U.K. regulatory authorities. These discussions could lead to potential decisions on Regenerative Medicine Advanced Therapy (RMAT) designation and Rolling Review status, which would expedite the development and review process. Looking ahead to the fourth quarter of 2026, the company targets final three-year data, a U.S. Pre-BLA meeting, and regulatory submissions in the U.S., U.K., and Europe.
In parallel, OS Animal Health is seeking alignment with the U.S. Department of Agriculture (USDA) to reinstate conditional approval for OST-HER2 in canine osteosarcoma. This veterinary application not only addresses a significant unmet need in dogs but also provides valuable data that could inform the human clinical program. The dual-track approach underscores OS Therapies' commitment to leveraging its listeria-based platform across species.
The company's participation in the Moody Capital Conference is expected to highlight these near-term catalysts to investors. With OST-HER2 having already received Orphan Drug Designation, Fast Track Designation, and Rare Pediatric Disease Designation from the FDA, as well as corresponding designations from the European Medicines Agency, the therapy's regulatory pathway is well-supported. The upcoming data and meetings could significantly impact the company's trajectory, making this a critical period for stakeholders.
For more information on OS Therapies, visit the company's website at www.ostherapies.com. To view the full press release, see https://ibn.fm/ERaOp.
