OS Therapies (NYSE American: OSTX), a clinical-stage oncology company focused on osteosarcoma and other solid tumors, has 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 expects to engage with investors and strategic partners during the conference, with OS Animal Health also participating. This event comes at a critical juncture as OS Therapies prepares for a series of regulatory milestones that could shape the future of 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 that primarily affects children and young adults. The therapy leverages the immune-stimulatory effects of listeria bacteria to trigger a strong immune response targeting the HER2 protein, which is overexpressed in many tumors. Unlike traditional HER2-targeted therapies, OST-HER2 is engineered to target three specific epitopes of the HER2 oncogene, requiring only one to be present in a tumor or micro-metastasis to initiate an immune response.
The upcoming regulatory period could be transformative for the company. In September, OS Therapies expects interim three-year overall survival data from its clinical trials, along with 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, which would expedite the development and review of OST-HER2. Later in Q4 2026, the company plans to release final three-year data, hold a U.S. Pre-BLA meeting, and submit regulatory applications in the U.S., U.K., and Europe.
The implications of these milestones are significant for patients and the oncology community. Osteosarcoma is the most common type of bone cancer, with current treatment options largely limited to surgery and chemotherapy. For patients with pulmonary metastases, the prognosis remains poor, and new therapeutic approaches are desperately needed. If OST-HER2 demonstrates improved overall survival in its trials, it could offer a much-needed treatment option for this underserved patient population.
OS Therapies has already received several regulatory designations that underscore the potential of OST-HER2. The therapy has been granted 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) designation from the European Medicines Agency. These designations provide incentives such as market exclusivity and expedited review, which could accelerate the path to commercialization if the therapy proves successful.
In addition to its human health applications, OS Therapies is also exploring the use of OST-HER2 in veterinary medicine through OS Animal Health. The company is seeking alignment with the U.S. Department of Agriculture (USDA) on reinstating conditional approval for OST-HER2 in canine osteosarcoma, a naturally occurring disease in dogs that closely resembles the human condition. This dual-track approach could provide valuable data and potentially expand the therapy's market reach.
The Moody Capital Conference appearance provides OS Therapies with a platform to communicate its progress and strategic vision to potential investors and partners. As the company navigates this pivotal period, successful outcomes in regulatory meetings and clinical data releases could position OST-HER2 as a leading immunotherapy for osteosarcoma, ultimately improving outcomes for patients and creating value for stakeholders.
For more information about OS Therapies and its pipeline, visit OS Therapies.
