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. During the conference, OS Animal Health, a subsidiary, will also be present, and the company expects to engage with investors and strategic partners. This appearance comes at a pivotal time as the company approaches a series of regulatory and clinical milestones for its lead investigational therapy, OST-HER2.
OST-HER2 is 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 properties of listeria bacteria to target the HER2 protein, which is overexpressed in many tumors. Unlike traditional approaches, OST-HER2 is engineered to recognize three distinct epitopes of the HER2 oncogene—two mutated extracellular and one mutated intracellular—requiring only one to be present to trigger an immune response. This innovative mechanism has already earned the therapy Orphan Drug Designation, Fast Track Designation, and Rare Pediatric Disease Designation from the U.S. Food and Drug Administration, as well as similar designations from the European Medicines Agency.
The company has outlined a busy regulatory roadmap for the coming months. In September, it expects to release interim three-year overall survival data from its ongoing clinical trials. Concurrently, it anticipates key meetings with the FDA and regulatory bodies in the United Kingdom. These discussions could lead to decisions on Regenerative Medicine Advanced Therapy (RMAT) designation and Rolling Review, which would expedite the development and review process. Looking ahead to the fourth quarter of 2026, OS Therapies targets final three-year data, a U.S. Pre-BLA meeting, and regulatory submissions in the U.S., U.K., and Europe.
The significance of these milestones cannot be overstated. Osteosarcoma is the most common type of bone cancer, yet treatment options for metastatic forms remain limited, with poor survival rates. If OST-HER2 demonstrates efficacy, it could fill a critical unmet need. The potential for accelerated approval pathways, such as RMAT, underscores the therapy’s promise. Moreover, the company’s parallel efforts in veterinary medicine—seeking USDA alignment to reinstate conditional approval for OST-HER2 in canine osteosarcoma—highlight the translational potential of the platform, as dogs naturally develop this disease and can serve as a valuable model.
Investors and industry observers will be closely watching the upcoming data and regulatory interactions. Positive outcomes could accelerate OST-HER2’s path to market and solidify OS Therapies’ position as a leader in listeria-based cancer immunotherapies. The company’s participation in the Moody Capital Conference offers a platform to communicate these developments and engage with potential partners, which may be crucial for advancing its pipeline. As the company navigates this critical juncture, its success could have profound implications for patients and the oncology landscape.
For more information about OS Therapies, visit www.ostherapies.com. To view the full press release, see https://ibn.fm/ERaOp.
