OS Therapies Inc. (NYSE American: OSTX), a clinical-stage oncology company specializing in immunotherapies for 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 will also showcase its subsidiary, OS Animal Health, at the event, providing an opportunity to engage with investors and strategic partners during a pivotal period for its lead asset, OST-HER2.
The conference comes at a time when OS Therapies is preparing for a series of regulatory and clinical milestones that could shape the future of OST-HER2, an investigational therapy designed for patients with fully resected pulmonary metastatic osteosarcoma. The company expects to announce interim three-year overall survival data in September, alongside key meetings with the U.S. Food and Drug Administration (FDA) and regulatory authorities in the United Kingdom. These discussions are anticipated to address potential pathways for accelerated approval, including Regenerative Medicine Advanced Therapy (RMAT) designation and Rolling Review. Looking ahead to the fourth quarter of 2026, OS Therapies targets final three-year data, a pre-BLA meeting with the FDA, 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, a move that could expand the therapy's reach beyond human applications. The company's focus on both human and veterinary oncology underscores its commitment to addressing osteosarcoma across species.
OST-HER2 leverages a novel mechanism of action, utilizing gene-edited, listeria-based immunotherapy to stimulate a robust immune response against the HER2 protein. The therapy targets three distinct epitopes—two extracellular and one intracellular—of the HER2 oncogene, requiring only one to be present in a tumor or micro-metastasis to trigger the desired immune effect. This design aims to enhance the precision and efficacy of the treatment.
The regulatory landscape for OST-HER2 is already robust, with the therapy having received 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. These designations reflect the unmet medical need in osteosarcoma, a rare and aggressive bone cancer primarily affecting children and young adults.
The upcoming data and regulatory interactions are critical for OS Therapies as it seeks to bring OST-HER2 to market. Positive outcomes could position the company to address a significant gap in treatment options for osteosarcoma patients, who currently face limited therapeutic choices after surgical resection. The potential reinstatement of conditional approval for canine osteosarcoma also highlights the broader applicability of the therapy, which could generate additional revenue streams and validate the platform's efficacy.
Investors and industry observers will be closely monitoring the September announcements, as they could provide key insights into the therapy's efficacy and the regulatory path forward. The Moody Capital Conference offers OS Therapies a platform to articulate its strategy and milestones to a targeted audience of investors and potential collaborators.
For more information about OS Therapies and its pipeline, visit the company's website at www.ostherapies.com.
