OS THERAPIES INCORPORATED Stock Price, News & Analysis

OS Therapies (NYSE-A: OSTX) has submitted a request for Regenerative Medicine Advanced Therapy (RMAT) Designation to the FDA for OST-HER2, targeting the prevention of metastases in recurrent, fully-resected, lung metastatic pediatric osteosarcoma. If granted, OST-HER2 would be the first listeria investigational medicinal product with RMAT designation. The therapy already holds Rare Pediatric Disease, Orphan Drug, and Fast Track Designations. If OST-HER2 receives conditional BLA via Accelerated Review before September 2026, the company could receive a Priority Review Voucher worth potentially $155 million based on recent sales. OS Therapies expects FDA feedback by mid-June 2025 and plans to request an End of Phase 2 meeting to begin BLA submission in Q3 2025. The company is also pursuing European and UK market access through EMA PRIME Designation and CMA applications.

OS Therapies (NYSE-A: OSTX) reported Q1 2025 financial results and provided key business updates. The company reported a net loss of $3.876 million ($0.18 per share) compared to $1.490 million ($0.25 per share) in Q1 2024. Key highlights include:

The company announced positive data from its OST-HER2 Phase 2b clinical trial for preventing recurrent, fully resected, lung metastatic pediatric osteosarcoma. OS Therapies expects FDA feedback by mid-June 2025 regarding statistical analysis methods for pending Accelerated Approval.

Notable achievements include acquiring the listeria immunotherapy platform from Ayala Pharmaceuticals, adding three clinical stage and eight preclinical assets. A new manufacturing patent extends exclusivity protection until 2040. The company remains on track for Q3 2025 BLA filing for OST-HER2 and has sufficient funds to operate into mid-2026.

OS Therapies (NYSE-A: OSTX) has announced the formation of OS Animal Health, a subsidiary focused on commercializing OST-HER2 for canine osteosarcoma treatment. The market opportunity for OST-HER2 in canine osteosarcoma exceeds $150 million. The subsidiary will operate independently with separate funding to target the veterinary market. Recent data shows OST-HER2's effectiveness in preventing amputation and controlling metastatic osteosarcoma. The company plans to submit for USDA conditional approval in H2 2025, while the parent company targets FDA Accelerated Approval for pediatric osteosarcoma in Q3 2025. Osteosarcoma affects over 40,000 dogs annually in the U.S., representing 86% of the $1.57 billion veterinary oncology market. A new patent protects OST-HER2's commercial manufacturing process until 2040, and revenue generation is expected to begin in 2025.

OS Therapies (NYSE-A: OSTX) has secured US Patent #12,230,738, protecting its proprietary commercial manufacturing methods for listeria monocytogenes (Lm) cancer immunotherapy platform until 2040. The patent covers their lead asset OST-HER2 for pediatric osteosarcoma, along with several other clinical and pre-clinical candidates. The company expects potential FDA approval for OST-HER2 by end of 2025, which could bring a Priority Review Voucher worth $150 million. The osteosarcoma treatment market was valued at $1.2 billion in 2022, with OST-HER2's market opportunity estimated at $500 million for lung metastases prevention. The patent protection extends to multiple pipeline assets including Phase 3 OST-AXIL (HPV), Phase 2 OST-503 (NSCLC & GBM), Phase 1 OST-504 (Prostate cancer), and 8 pre-clinical immunotherapy candidates.

The Emmy Award-winning series "Shelter Me" has released a trailer for its latest documentary "The Cancer Pioneers," set to stream on PBS starting May 15, 2025. The film explores groundbreaking cancer research through comparative oncology, where dogs with cancer receive innovative immunotherapy treatments that are helping develop life-saving therapies for humans. The documentary features leading scientists and veterinarians from prestigious institutions including the National Institutes of Health, National Cancer Institute, and several major universities. Created by Steven Latham, the film showcases how veterinary oncology is advancing treatment for osteosarcoma patients while highlighting the crucial bond between humans and animals in medical research.

OS Therapies (NYSE: OSTX) announced positive data for their OST-HER2 treatment in canine osteosarcoma, showing promising results for potential human applications. The study demonstrated that combining OST-HER2 with palliative radiation in dogs with unresected osteosarcoma led to tumor arrest and extended survival of over 500 days in 5 out of 15 dogs.

A new publication in Molecular Therapy revealed that OST-HER2 induces strong immune responses from the first dose, correlating with metastasis prevention and long-term survival in dogs with resected osteosarcoma. The treatment was well-tolerated in both studies, suggesting potential for progression-free survival of primary osteosarcoma and prevention of metastatic disease.

The company plans to submit data to USDA for conditional approval of their new manufacturing process, aiming to begin sales in 2025, with full approval targeted for 2026. OS Therapies is pursuing Accelerated Approval for OST-HER2 in human osteosarcoma by year-end 2025.

OS Therapies (NYSE-A: OSTX) has completed the acquisition of Advaxis Immunotherapies' listeria-based cancer immunotherapy assets from Ayala Pharmaceuticals, positioning itself as the world leader in this field. The acquisition includes:

- Three clinical-stage cancer immunotherapy candidates:

• OST-AXAL for HPV-associated cancers
• OST-503 for Non-Small Cell Lung Cancer & Glioblastoma
• OST-PSA for Prostate Cancer

Additionally, 8 pre-clinical immunotherapy candidates were acquired, targeting 30+ cancers. The company's lead asset, OST-HER2, targets approval by year-end 2025 for preventing recurrence in fully-resected, lung metastatic osteosarcoma. New manufacturing-based IP protects the platform until 2040. The global cancer immunotherapy market is valued at $126 billion (2023) and projected to exceed $296 billion by 2033.

OS Therapies (NYSE-A: OSTX) has submitted a request for a formal meeting with the FDA's CBER to discuss endpoints for Breakthrough Therapy Designation and Accelerated Approval of OST-HER2, their immunotherapy candidate for preventing recurrence in fully resected, lung metastatic osteosarcoma.

The company reported positive Phase 2b clinical trial results from a 21-site study of 39 patients, showing statistically significant improvement in 12-month event-free survival compared to historical control (33% vs. 20%, p=0.0158). Following FDA feedback, OS Therapies designed OST-400, a retrospective study collecting over 200 patient records from US, UK, and French oncology centers.

The FDA meeting is expected in Q2 2025, with potential Accelerated Approval by year-end 2025. OST-HER2 has received Rare Pediatric Disease Designation, making it eligible for a Priority Review Voucher if approved before September 30, 2026. The company has sufficient cash to operate into mid-2026.

OS Therapies (NYSE-A: OSTX) has announced an upcoming Analyst Day event at the New York Stock Exchange on April 7, 2025 at 10am ET. The clinical-stage biopharmaceutical company will present key developments in their immunotherapy and Antibody Drug Conjugate programs.

The event will spotlight three main areas:

• The OST-HER2 program for human recurrent lung metastatic osteosarcoma, targeting Accelerated Approval in late 2025
• Canine osteosarcoma treatments seeking conditional approval in H2 2025
• OST-HER2 applications in breast cancer and other solid tumors

Additionally, the company will discuss their pipeline acquisitions from Ayala Pharmaceuticals and their tunable drug conjugates (tDC) & antibody drug conjugates (tADC) platform. The event will be held at 18 Broad St, New York, with attendees requested to arrive at 9:30am ET for security clearance.