OS Therapies Inc. (NYSE American: OSTX), a clinical-stage oncology company specializing in immunotherapies for osteosarcoma and other solid tumors, announced its 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 subsidiary OS Animal Health. This appearance comes at a pivotal time as OS Therapies prepares for a series of regulatory and clinical milestones that could significantly impact the future of its lead asset, OST-HER2.
The company expects to receive interim three-year overall survival data from its ongoing trial of OST-HER2 in patients with fully resected pulmonary metastatic osteosarcoma. Concurrently, key meetings with the U.S. Food and Drug Administration (FDA) and U.K. regulatory authorities are slated for September. These discussions may lead to decisions on Regenerative Medicine Advanced Therapy (RMAT) designation and Rolling Review, which could expedite the therapy's development and review process. Looking ahead, OS Therapies targets the release of final three-year data, a pre-BLA meeting with the FDA, and regulatory submissions in the U.S., U.K., and Europe during the fourth quarter of 2026.
OST-HER2 is an investigational immunotherapy that leverages the immune-stimulatory properties of listeria bacteria to trigger a robust immune response against the HER2 protein. The therapy is designed to target two mutated extracellular epitopes and one mutated intracellular epitope of the HER2 oncogene, requiring only one of these epitopes to be present in a tumor or micro-metastasis to initiate the desired immune response. This mechanism has earned OST-HER2 Orphan Drug Designation (ODD), Fast Track Designation (FTD), and Rare Pediatric Disease Designation (RPDD) from the FDA, as well as ODD, FTD, and Advanced Therapy Medicinal Products (ATMP) classification from the European Medicines Agency.
In addition to its human oncology pipeline, OS Therapies is 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 OST-HER2 in dogs, which would expand the therapy's reach into veterinary medicine.
The upcoming regulatory activities are critical for OS Therapies as it seeks to bring OST-HER2 to market, addressing a significant unmet need in osteosarcoma, a rare bone cancer primarily affecting children and young adults. The outcome of these meetings and data releases will likely influence the company's strategic direction and its ability to secure partnerships and funding. As OS Therapies navigates this complex regulatory landscape, the investor community will be closely monitoring progress, making the Moody Capital conference a key venue for the company to articulate its vision and milestones.
For more information about OS Therapies, visit www.ostherapies.com.
