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NEW YORK - OS Therapies Inc. (NYSE-A: OSTX), a biotechnology firm specializing in cancer immunotherapies with a current market capitalization of $45.8 million, has requested the U.S. Food and Drug Administration (FDA) grant Regenerative Medicine Advanced Therapy (RMAT) Designation for its drug OST-HER2. According to InvestingPro data, the company’s stock has declined 62% year-to-date, though analysts maintain optimistic price targets ranging from $6 to $20. This drug is aimed at preventing metastases in pediatric osteosarcoma patients who have undergone complete lung metastasis resection.
The RMAT designation is significant as it could expedite the drug’s review process and enhance interactions with the FDA, potentially speeding up market access. OST-HER2 has already secured Rare Pediatric Disease, Orphan Drug, and Fast Track designations from the FDA.
If the FDA awards a conditional Biologics License Application (BLA) for OST-HER2 via an Accelerated Review before September 30, 2026, OS Therapies could be eligible for a Priority Review Voucher (PRV). The company plans to sell this voucher immediately, which could be lucrative given the recent sale of a PRV in May 2025 for $155 million. This potential cash injection would be significant for the company, which reported negative free cash flow of $10.08 million in the last twelve months. InvestingPro analysis reveals several additional financial metrics and insights available to subscribers.
The company is awaiting feedback from the FDA following a Type D meeting concerning the statistical analysis plan for OST-HER2. This feedback, expected by mid-June 2025, will inform the company’s request for an End of Phase 2 meeting, which could lead to a rolling BLA submission in the third quarter of 2025.
OS Therapies is also engaging with regulatory authorities in Europe and the United Kingdom, seeking EMA PRIME Designation and Conditional Market Access applications, respectively.
Beyond OST-HER2, OS Therapies is preparing for the late-stage clinical development of other pipeline candidates, indicating a broader growth strategy across multiple therapeutic areas. Despite maintaining a good financial health score according to InvestingPro, the company faces near-term profitability challenges, with analysts not expecting positive earnings this fiscal year.
OST-HER2 leverages the immune-stimulating effects of Listeria bacteria to target the HER2 protein, which is overexpressed in certain cancers. The drug has shown a statistically significant benefit in a Phase 2b clinical trial for osteosarcoma, and the company anticipates submitting a BLA to the FDA in 2025.
The company also highlighted its tunable Antibody Drug Conjugate platform, which features customizable antibody-linker-payload candidates, as part of its future growth plans.
This report is based on a press release statement from OS Therapies Inc. and does not endorse the company’s claims. The information presented is intended to provide an objective overview of the company’s announcement regarding its regulatory filings and future prospects.
In other recent news, OS Therapies has made significant strides in its efforts to develop cancer immunotherapies. The company secured a key patent extending protection for its Listeria monocytogenes (Lm) cancer immunotherapy platform until 2040, covering several assets, including OST-HER2, which targets pediatric osteosarcoma. This development comes as the FDA reviews OST-HER2 for potential Breakthrough Therapy Designation and Accelerated Approval, with a response expected by mid-June 2025. Additionally, OS Therapies acquired listeria-based cancer immunotherapy assets from Ayala Pharmaceuticals, enhancing its clinical pipeline with new candidates targeting various cancer types.
The company’s shareholders recently approved a significant stock issuance, potentially increasing its financial flexibility. This approval was part of a proposal to issue shares upon conversion of preferred stock and exercise of warrants, collectively exceeding 20% of its outstanding common stock. Furthermore, OS Therapies postponed a Special Meeting of Stockholders due to a lack of quorum, rescheduling it for April 9, 2025. OS Therapies continues to advance its oncology initiatives, with OST-HER2 also gaining attention in the upcoming PBS movie "Shelter Me: The Cancer Pioneers," highlighting its role in both human and canine osteosarcoma.
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