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NEW YORK - OS Therapies (NYSE-A: OSTX), a biopharmaceutical company specializing in immunotherapy and Antibody Drug Conjugates (ADC), has announced the acquisition of listeria-based cancer immunotherapy assets from Ayala Pharmaceuticals, positioning itself as a global leader in this innovative treatment field. The company, currently valued at $28.4 million, has seen its stock trade near its 52-week low of $1.26, suggesting potential opportunity according to InvestingPro analysis. The company's lead asset, OST-HER2, aimed at preventing recurrence in lung metastatic osteosarcoma post-surgery, is anticipated to be a new commercial category in oncology upon expected approval by the end of 2025.
The transaction includes late-stage, mid-stage, and early-stage cancer immunotherapy candidates, expanding OS Therapies' clinical pipeline with three new candidates and adding eight pre-clinical candidates targeting over 30 cancer types. The newly acquired assets include OST-AXAL for HPV-associated cancers, OST-503 for Non-Small Cell Lung Cancer and Glioblastoma, and OST-PSA for Prostate Cancer.
Chief Medical & Scientific Officer Dr. Robert Petit expressed optimism about the platform's ability to generate potent immune responses against a range of cancers, potentially improving treatment outcomes for patients. The listeria-based platform delivers cancer targets directly to the immune system, fostering T cell responses to combat cancers and metastases.
OS Therapies' OST-HER2 has already demonstrated positive data in Phase 2b clinical trials and is preparing for a Biologics License Application (BLA) Accelerated Approval submission to the FDA in the third quarter of 2025. If approved, the company could receive a Priority Review Voucher, currently valued at $150 million.
The acquisition also enhances OS Therapies' intellectual property portfolio, with new manufacturing-based IP extending protection into 2040. This strategic move comes at a time when the global cancer immunotherapy market is projected to grow significantly, from $126 billion in 2023 to an estimated $296 billion by 2033, according to Nova One Advisor. While InvestingPro data shows the company is currently burning through cash, analysts maintain a strong buy consensus with price targets ranging from $6 to $20 per share. InvestingPro subscribers can access 10+ additional exclusive insights about OSTX's financial health and growth prospects.
OS Therapies continues to advance in the oncology field with its next-generation tunable ADC platform and proprietary technologies that allow the delivery of multiple payloads per linker, through its wholly-owned subsidiary OS Drug Candidates. With an EPS forecast of $4.73 for FY2025 and a "Fair" financial health score from InvestingPro, the company shows promise despite current market challenges.
The information in this article is based on a press release statement from OS Therapies.
In other recent news, OS Therapies Inc has been actively advancing its OST-HER2 program, a promising treatment for osteosarcoma. The company completed a Phase 2b clinical trial for OST-HER2, which met its primary endpoint and demonstrated a significant improvement in Event Free Survival rates. OS Therapies is now preparing to submit a Biologics Licensing Application (BLA) to the FDA in the second quarter of 2025, with hopes of receiving approval within six months. The company has secured substantial funding, including a $7.1 million financing round, to support these efforts and sustain operations into 2026.
In addition to its clinical progress, OS Therapies has established a new subsidiary, OS Drug Conjugates, to enhance its drug delivery platforms and explore joint ventures. Regulatory discussions are ongoing, with the company aiming for accelerated approval of OST-HER2, which could qualify for a Priority Review Voucher. Analysts from various firms have noted the potential impact of OS Therapies' advancements on cancer treatment. The company has also strategically acquired assets from Ayala, expanding its clinical portfolio and reducing anticipated cash milestones. As OS Therapies continues to engage with regulatory agencies, its developments are closely watched by the healthcare community and investors.
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