OS Therapies Unveils Q3 2025 Results and Upcoming Regulatory Steps

OS Therapies Inc. (NYSE American: OSTX), a leader in listeria-based cancer immunotherapies, announced its third quarter 2025 financial results and provided a comprehensive business update. The report highlights significant upcoming regulatory meetings and developments concerning its lead product, OST-HER2, designed to prevent or delay recurrent pulmonary metastatic osteosarcoma.

The company has scheduled a Type C meeting with the U.S. Food and Drug Administration (FDA) for December 11, 2025. This meeting follows an End of Phase 2 meeting held on August 27, 2025, aimed at discussing key items related to the Phase 2b clinical trial for OST-HER2. OS Therapies anticipates submitting a Biologics Licensing Application (BLA) in January 2026, following the insights gained from these regulatory discussions.

Paul Romness, Chairman and CEO, emphasized the importance of the upcoming period, stating, “The next six to twelve months will be transformative for OS Therapies.” He noted that the company aims to align its regulatory strategy with the FDA’s draft guidance issued on August 18, 2025, regarding overall survival assessments in oncology clinical trials.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has also been engaged, with a pre-Marketing Authorization Application (MAA) meeting scheduled for December 8, 2025. This meeting is crucial as it will facilitate the company’s efforts to submit a UK MAA concurrently with the BLA.

In a strategic move, OS Therapies has executed a $7.8 million warrant exercise, which provides capital to cover regulatory-related expenses and extends the company’s financial runway through late 2026. The delay in product launch until early 2027 is not expected to significantly impact the company’s revenue projections for 2026.

OS Therapies remains eligible for a Priority Review Voucher (PRV) based on its Rare Pediatric Disease Designation for osteosarcoma, contingent on successful approval by September 30, 2026. This voucher could be sold, potentially generating additional revenue.

Dr. Robert Petit, Chief Medical and Scientific Officer, expressed optimism about OST-HER2’s potential, stating, “The data we are generating with OST-HER2 in osteosarcoma are giving us hope that we can reduce and delay recurrence, significantly improving mortality rates and quality of life for primarily teen and young adult patients.” The company expects biomarker data to guide its post-market clinical development program following the FDA and MHRA meetings.

The third quarter of 2025 brought notable corporate milestones, including:

– A successful End of Phase 2 meeting with the FDA, which included informal discussions to prepare for the upcoming Type C meeting.
– Positive feedback from the UK MHRA during a Scientific Advice Meeting.
– Completion of the last patient visit in the Phase 1b clinical trial for OST-504, which targets castration-resistant prostate cancer.
– The replacement of an equity line of credit with an At-The-Market (ATM) agreement for funding.

As for financial performance, OS Therapies recorded a net operating loss of $6.879 million for the third quarter of 2025, an increase from $2.875 million during the same period in 2024. The net loss per share was $0.21, compared to $0.18 in the prior year, primarily due to pre-commercial and regulatory expenses related to the OST-HER2 program.

OS Therapies is focused on developing treatments for osteosarcoma and other solid tumors, leveraging its unique listeria-based immunotherapy platform. The company has also received conditional approval from the U.S. Department of Agriculture for OST-HER2 in treating canines with osteosarcoma.

Looking ahead, OS Therapies is committed to advancing its pipeline, including a next-generation antibody-drug conjugate platform. The company is on track to submit its BLA and MAA in early 2026, with significant implications for future revenue generation from product sales in the U.S., UK, and EU markets.

For more information about OS Therapies, visit their official website at www.ostherapies.com.