OS THERAPIES INCORPORATED Stock Price, News & Analysis

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

OS Therapies (NYSE-A: OSTX) has secured a presentation slot at the MIB Agents Factor Osteosarcoma Conference in Salt Lake City (June 26-28, 2025) to showcase data from their Phase 2b clinical trial of OST-HER2. The trial focuses on preventing recurrent, fully resected, lung metastatic osteosarcoma.

The company will present comparative data with a regulatorily compliant synthetic control group, which will be used for their upcoming FDA Biologics License Application (BLA). The company plans to submit the BLA in Q2 2025, with potential approval expected in Q4 2025.

OST-HER2 has received multiple regulatory designations including:

• Rare & Pediatric Disease Designation from FDA
• Fast Track and Orphan Drug Designations from both FDA and EMA

OS Therapies (NYSE-A: OSTX) has scheduled a Scientific Advice Meeting with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) in Q3 2025 to discuss the Innovative Licensing and Access Pathway for its OST-HER2 immunotherapy. This therapy aims to prevent metastases recurrence in osteosarcoma patients.

The company reported positive Phase 2b data in January 2025, showing statistically significant results in the primary endpoint of 12-month event-free survival. The meeting positions OS Therapies to potentially launch OST-HER2 in the UK market in 2025.

As a UK reference country approval could facilitate approvals in multiple nations including Australia, Canada, and several European countries. The treatment has already received Fast Track and Orphan Drug designations from the European Medicines Agency.