OS Therapies secures patent for cancer immunotherapy tech

NEW YORK - OS Therapies (OSTX), a clinical-stage biopharmaceutical company with a current market capitalization of approximately $51 million, announced the issuance of a key patent extending protection for its listeria monocytogenes (Lm) cancer immunotherapy platform until 2040. This patent safeguards the company’s proprietary commercial manufacturing methods and its comprehensive pipeline, including the lead asset OST-HER2, aimed at treating pediatric osteosarcoma. The patent also encompasses OST-AXIL for HPV, OST-503 for NSCLC & GBM, OST-504 for prostate cancer, and eight pre-clinical immunotherapy candidates.

Paul Romness, CEO of OS Therapies, highlighted the significance of the patent, stating it revitalizes the company’s pipeline by ensuring exclusive development rights in the cancer immunotherapy field. Romness underscored the potential FDA approval of OST-HER2 for osteosarcoma, which could secure a Priority Review Voucher (PRV) worth at least $150 million. This non-dilutive capital would facilitate the expansion of OST-HER2’s application to additional cancers. According to InvestingPro data, analysts maintain a strong bullish stance on the company, with price targets ranging from $6 to $20 per share, significantly above the current trading price of $2.34.

OST-HER2 has garnered Rare Pediatric Disease Designation from the US FDA. If the drug gains a conditional Biologics License Application (BLA) via Accelerated Review by September 30, 2026, it will qualify for a PRV, which the company plans to sell immediately. The most recent PRV sale was valued at $150 million in February 2025.

The market for osteosarcoma treatments was estimated at $1.2 billion in 2022, with a significant portion of patients developing lung metastasis post-chemotherapy. OS Therapies believes the market opportunity for OST-HER2 in preventing lung metastases exceeds $500 million. The company’s stock has shown strong momentum, gaining over 15% in the past week, though InvestingPro analysis indicates the stock may be currently overvalued. Subscribers to InvestingPro can access 8 additional key insights about OS Therapies’ financial health and growth prospects.

Additionally, OST-HER2’s role in both human and canine osteosarcoma will be featured in the upcoming PBS movie "Shelter Me: The Cancer Pioneers," airing live and streaming on May 15, 2025.

OS Therapies is advancing in the oncology field with its next-generation Antibody Drug Conjugate (ADC) and tunable ADC (tADC) platforms, leveraging proprietary technologies for improved payload delivery.

The company’s progress is based on a press release statement, which also includes forward-looking statements subject to risks and uncertainties that could affect the actual results, including the FDA approval process for OST-HER2 and the potential sale of a PRV. While the company maintains a healthy current ratio of 1.2 and holds more cash than debt on its balance sheet, InvestingPro data shows it is not yet profitable, with a net loss of $10.89 million in the last twelve months.

In other recent news, OS Therapies has made significant strides with its OST-HER2 drug, aimed at treating lung metastatic osteosarcoma. The FDA has agreed to review a surrogate endpoint for potential Breakthrough Therapy Designation and Accelerated Approval, with a response expected by mid-June 2025. Additionally, OS Therapies has expanded its cancer immunotherapy portfolio by acquiring assets from Ayala Pharmaceuticals, including several candidates in various stages of development. The company’s shareholders have also approved a significant stock issuance, enhancing financial flexibility for future endeavors. OS Therapies has postponed a Special Meeting of Stockholders due to a lack of quorum, rescheduling it for April 9, 2025. The company is actively engaging with regulatory agencies in the US, UK, and Europe to advance OST-HER2’s approval process. OS Therapies is preparing for an End of Phase 2 Meeting with the FDA and aims for a Biologics License Application submission by late 2025. The company’s efforts align with the US government’s priority to address deadly childhood cancers, and it has enough funding to continue operations into 2026.

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