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NEW YORK - OS Therapies (NYSE-A:OSTX), a clinical-stage biotech company with a market capitalization of $54.6 million, announced Monday that its immunotherapy candidate OST-HER2 demonstrated statistically significant improvement in one-year event-free survival for patients with fully resected, lung metastatic osteosarcoma. The stock has shown strong momentum recently, gaining over 8% in the past week, though it remains down 57% over the past six months. According to InvestingPro data, analysts have set price targets ranging from $6 to $20, suggesting significant upside potential despite current market challenges.
According to data presented at the MIB Factor Osteosarcoma Conference on June 28, 35% of patients treated with OST-HER2 achieved one-year event-free survival compared to 20% in a historical control group (p=0.0194).
The Phase 2b clinical trial involved 40 patients. Thirteen patients experienced severe adverse events during the trial, with seven cases classified as treatment-associated. All treatment-associated adverse events were grade 3, with no grade 4 or 5 events reported. No patients discontinued the study due to adverse events. While the company is not yet profitable, with negative EBITDA of $11.18 million in the last twelve months, InvestingPro analysis reveals 8 additional key insights about the company’s financial health and growth prospects.
"The updated OST-HER2 data showed event-free survival data statistically significantly favoring OST-HER2 treated patients when compared with the leading peer-reviewed publications on historical outcomes," said Dr. Robert Petit, Chief Medical & Scientific Officer of OS Therapies, according to the press release.
The company also provided regulatory updates, noting it has submitted responses to the FDA following a recent Type D Meeting and is awaiting response to its End of Phase 2 meeting request. OS Therapies is working to establish appropriate external control comparators to support a potential Biologics Licensing Application under the FDA’s Accelerated Approval Program.
OST-HER2 has received Rare Pediatric Disease Designation, Fast Track, and Orphan Drug designations from regulatory authorities. If approved before September 30, 2026, the company would become eligible to receive a Priority Review Voucher.
The immunotherapy uses a HER2-bioengineered form of the bacterium Listeria monocytogenes to trigger immune responses against HER2-expressing cancer cells. OS Therapies anticipates submitting a Biologics Licensing Application to the FDA for OST-HER2 in osteosarcoma in 2025. The company’s next earnings report is scheduled for August 14, 2025, which investors will closely watch for updates on the regulatory progress and financial position.
In other recent news, OS Therapies Inc. has announced several significant developments concerning its OST-HER2 treatment for pediatric lung metastatic osteosarcoma. The company received positive feedback from the U.S. Food and Drug Administration (FDA) regarding its Phase 2b trial, which could support a future Biologics Licensing Application through the Accelerated Approval Program. Additionally, OS Therapies has partnered with EVERSANA to facilitate the U.S. commercialization of OST-HER2, leveraging EVERSANA’s expertise in oncology to increase awareness and access among healthcare providers. The company has also secured a patent extending protection for its Listeria-based immunotherapy platform until 2040, which includes OST-HER2 and other pipeline candidates. OS Therapies is seeking Regenerative Medicine Advanced Therapy (RMAT) Designation from the FDA, potentially expediting the review process for OST-HER2. If OST-HER2 receives a conditional Biologics License Application via Accelerated Review before September 30, 2026, it could be eligible for a Priority Review Voucher, which the company plans to sell. The treatment has already shown statistically significant benefits in a Phase 2b clinical trial, and OS Therapies anticipates submitting a Biologics Licensing Application to the FDA in 2025. The market opportunity for OST-HER2 is estimated to exceed $500 million, within a broader osteosarcoma treatment market valued at $1.2 billion in 2022.
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