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NEW YORK and CHICAGO - OS Therapies Inc. (NYSE-A: OSTX), a biotechnology firm specializing in cancer immunotherapy and antibody drug conjugates with a current market capitalization of $55.63 million, announced a partnership with EVERSANA, a provider of global commercial services to the life sciences industry, to facilitate the U.S. commercialization of OST-HER2. According to InvestingPro data, the company maintains a GREAT financial health score despite being in its pre-revenue phase. This novel immunotherapy is designed for the treatment of recurrent, fully resected, pediatric lung metastatic osteosarcoma.
OST-HER2 is a Listeria monocytogenes-based immunotherapy and represents the first potential new treatment for pediatric osteosarcoma in over four decades. With analyst price targets ranging from $6 to $20, significantly above the current trading price of $1.98, market expectations for this breakthrough therapy appear optimistic. InvestingPro subscribers can access additional insights and 6 more ProTips about OS Therapies’ market position and growth potential. Osteosarcoma is a rare and aggressive bone cancer that predominantly affects children and adolescents, often spreading to the lungs. The therapy has been granted Orphan, Fast Track, and Rare Pediatric Disease Designations by the U.S. Food and Drug Administration (FDA). A Biologics License Application (BLA) rolling submission is expected to commence in the third quarter of 2025, with potential approval by the end of the same year.
Paul Romness, CEO of OS Therapies, emphasized the benefits of collaborating with EVERSANA, highlighting the company’s ability to access necessary infrastructure and expertise without significant capital expenditure. EVERSANA’s integrated commercialization operations and oncology experience are expected to enable the efficient and cost-effective distribution of OST-HER2.
EVERSANA will deploy its EVERSANA ONCOLOGY Commercialization model to increase awareness and access to OST-HER2 among healthcare providers. The model encompasses market access, medical affairs, field deployment, patient services, and stakeholder engagement, aiming to accelerate the delivery of OST-HER2 to patients.
Jim Lang, CEO of EVERSANA, expressed the company’s commitment to advancing cancer treatments and the intention to utilize their commercialization operation and oncology expertise to bring OST-HER2 to the market.
OS Therapies has recently been granted U.S. Patent #12,239,738, which secures commercial manufacturing exclusivity for OST-HER2 and its broader Listeria-based immunotherapy platform through 2040.
The company’s lead asset, OST-HER2, has shown positive data in a Phase 2b clinical trial for recurrent lung metastatic osteosarcoma, demonstrating a statistically significant benefit in the 12-month event-free survival primary endpoint. This progress has contributed to the stock’s strong recent performance, with a 24.53% return over the past week. While current financials show an EBITDA of -$11.18 million, reflecting the company’s development stage, InvestingPro analysis indicates strong potential for value creation as the company approaches key milestones. If approved, OS Therapies may receive a Priority Review Voucher from the FDA. OST-HER2 has also completed a Phase 1 clinical study in breast cancer patients and has shown preclinical efficacy in various models of breast cancer.
OS Therapies is also advancing its tunable Antibody Drug Conjugate (tADC) platform, which features customizable antibody-linker-payload candidates.
This announcement is based on a press release statement and contains forward-looking statements subject to risks and uncertainties, including the approval of OST-HER2 by the FDA.
In other recent news, OS Therapies Inc. has been actively advancing its cancer immunotherapy initiatives. The company has requested the FDA grant Regenerative Medicine Advanced Therapy (RMAT) Designation for its drug OST-HER2, which aims to prevent metastases in pediatric osteosarcoma patients. This follows the issuance of a key patent that extends protection for its listeria monocytogenes cancer immunotherapy platform until 2040. Additionally, OS Therapies has secured shareholder approval for a significant stock issuance, aimed at increasing financial flexibility.
The FDA has agreed to review a surrogate endpoint for OST-HER2, which could lead to Breakthrough Therapy Designation and Accelerated Approval. In a strategic move, OS Therapies acquired listeria-based cancer immunotherapy assets from Ayala Pharmaceuticals, expanding its clinical pipeline with several new candidates. The company is also seeking EMA PRIME Designation and Conditional Market Access in Europe and the UK. OST-HER2 has shown statistically significant benefits in Phase 2b clinical trials and is preparing for a Biologics License Application (BLA) submission in 2025. These developments position OS Therapies as a prominent player in the oncology sector.
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