OS THERAPIES INCORPORATED Stock Price, News & Analysis

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.

OS Therapies (NYSE-A: OSTX) reported its full-year 2024 financial results and business updates. The company completed the treatment phase of its Phase 2b clinical trial for OST-HER2 in osteosarcoma and successfully executed a $6 million IPO, along with a $6 million private placement.

Key financial metrics show a net operating loss of $10.886 million in 2024, compared to $7.916 million in 2023, with a net loss per share of $0.88 on 12.377 million weighted average shares outstanding. The increased loss was primarily attributed to IPO expenses.

The company expects to present full data from the OST-HER2 Phase 2b osteosarcoma trial in June 2025, with plans to begin a rolling BLA submission thereafter. OS Therapies aims to secure regulatory approval by year-end 2025, which would trigger a Priority Review Voucher (PRV). The company projects its current cash position will sustain operations into 2026.

OS Therapies (NYSE-A: OSTX) provided a regulatory update for its OST-HER2 immunotherapy candidate targeting osteosarcoma. The company outlined its regulatory timeline for 2025-2026, including planned interactions with FDA, MHRA, and EMA.

Key milestones include:

• FDA: Q1/25 regulatory communication, Q2/25 End of Phase 2 Meeting, Q3/25 rolling BLA submission, Q4/25 Conditional BLA
• MHRA: Scientific Advice Meetings and Conditional Marketing Authorization application in Q4/25
• EMA: Scientific Advice Meetings and Conditional Marketing Authorization application in Q1/26

The company has strengthened its regulatory infrastructure and confirmed sufficient cash through 2026. Additionally, OSTX reported progress in identifying biomarkers from its canine osteosarcoma program, which may predict treatment response in humans given the 96% genetic homology between human and canine osteosarcoma.

OS Therapies (NYSE-A: OSTX) announced its immunotherapy treatment OST-HER2 will be featured in the documentary 'Shelter Me: The Cancer Pioneers', focusing on canine comparative oncology. The film explores the similarities between cancer treatments in dogs and humans, particularly for rare cancers.

OST-HER2 is an experimental immunotherapy for osteosarcoma that uses a bioengineered form of Listeria monocytogenes bacteria targeting HER2-expressing cancer cells. The documentary highlights the 96% genetic similarity between human and canine osteosarcoma, underlining the importance of comparative oncology research.

The film will premiere at AMC Century City in Los Angeles on April 3, 2025, followed by streaming availability on PBS platforms in May. The documentary features scientists from various institutions including the National Cancer Institute, University of Pennsylvania, University of Illinois, University of Wisconsin, and Colorado State University.

OS Therapies (NYSE-A: OSTX), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, has announced its participation in The Jones Healthcare and Technology Innovation Conference. The event will take place on April 8-9, 2025 at the Venetian Resort in Las Vegas.

CEO Paul Romness and CBO Gerald Commissiong will be available for meetings with registered investors during the conference. The event, hosted by JonesTrading Institutional Services, , aims to connect leading healthcare and technology companies with institutional investors and opinion leaders.

The conference will feature:

• Expert-led panels
• Corporate presentations
• Fireside chats
• One-on-one meetings