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 during the event, with a particular focus on its subsidiary OS Animal Health. This engagement comes at a pivotal time as OS Therapies prepares for a series of regulatory interactions and data releases 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 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 multiple epitopes of HER2, the therapy aims to trigger an immune response even if only one of the epitopes is present, potentially addressing a broad patient population. OST-HER2 has already received Orphan Drug Designation (ODD), Fast Track Designation (FTD), and Rare Pediatric Disease Designation (RPDD) from the U.S. Food and Drug Administration (FDA), as well as ODD, FTD, and Advanced Therapy Medicinal Products (ATMP) classification from the European Medicines Agency.
The upcoming months are critical for OST-HER2. The company anticipates interim three-year overall survival data and key meetings with the FDA and U.K. regulatory authorities in September. These interactions are expected to inform potential decisions on Regenerative Medicine Advanced Therapy (RMAT) designation and Rolling Review, which could expedite the development and review process. Looking further ahead, OS Therapies targets 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. Successful outcomes could bring OST-HER2 closer to market approval, offering a new treatment option for patients with limited choices.
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 expands the company's pipeline but also provides valuable data that could support the human program. The conference participation allows OS Therapies to communicate these developments to potential investors and partners, highlighting the company's strategic progress and the potential value of its platform.
The significance of these milestones cannot be overstated. Osteosarcoma is the most common type of bone cancer, yet treatment options for metastatic disease remain limited, with poor survival rates. OST-HER2's mechanism of action offers a novel approach that could improve outcomes for patients who have exhausted standard therapies. The regulatory designations already granted underscore the potential of this therapy to address an unmet medical need. As the company moves closer to potential approvals, its engagement with the investment community at conferences like Moody Capital is crucial for securing the resources needed to advance development.
OS Therapies' presence at the Moody Capital Solutions conference reflects its proactive strategy to build momentum ahead of these critical milestones. Investors and stakeholders will be closely watching the data and regulatory decisions in the coming months, as they could significantly impact the company's trajectory and the landscape of osteosarcoma treatment. For more information about OS Therapies and its pipeline, visit the company's website at www.ostherapies.com. The full press release is available at https://ibn.fm/ERaOp.
