Feedback from Type D FDA Meeting expected by mid-June 2025 to confirm statistical analysis methods to support pending Accelerated Approval, Regenerative Medicine Advanced Therapy & Breakthrough Therapy designation requests Completed Phase 2b trial data analysis using methods agreed to by FDA to be presented at MIB Factor on June 28, 2025 Company remains on track for Q3 2025 BLA filing for OST-HER2 in the prevention of recurrent, fully resected, lung metastatic pediatric osteosarcoma OS Therapies Inc. (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today reported first quarter 2025 financial res

Official trailer is now live at https://youtu.be/pFaockwrROM The official trailer for "Shelter Me: The Cancer Pioneers" has just dropped, giving audiences a moving first look at the groundbreaking new documentary that follows the emotional and inspiring journey of dogs helping to pioneer cancer treatments that are saving human lives. The movie will stream through the PBS app and on PBS.org starting on Thursday, May 15. The newest film in the Emmy Award-winning "Shelter Me" series, ‘The Cancer Pioneers' brings viewers inside cutting-edge clinical trials where dogs with cancer are being treated with breakthrough immunotherapies, which are leading to treatments that are now extending and sav

Yet to be published data from clinical study combining OST-HER2 with palliative radiation in dogs with unresected, primary osteosarcoma shows clinical and radiographic arrest of the primary tumor, delayed pulmonary metastases and prolonged overall survival of greater than 500 days in 5 out of 15 dogs. Data from new publication in the journal "Molecular Therapy" show OST-HER2 induces strong innate and cytotoxic immune responses beginning at the 1st dose of 3 dose regimen, that correlate with prevention of metastasis and long-term survival in dogs with resected primary osteosarcoma. Data from the same study show that short-term survivors have defective immune responses to OST-HER2 that i

Company now listeria-based cancer immunotherapy world leader Expands clinical pipeline with 3 new cancer immunotherapy candidates 8 pre-clinical immunotherapy candidates targeting 30+ cancers added OS Therapies (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced that it has completed the acquisition of the listeria-based cancer immunotherapy assets of Advaxis Immunotherapies from Ayala Pharmaceuticals. The Company is now positioned as the world leader in listeria-based cancer immunotherapies, poised to become a new commercial category of immunotherapy in oncology upon approval of

OS Therapies (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced that the Company will be hosting an Analyst Day at the New York Stock Exchange in Lower Manhattan that will start at 10am on Monday, April 7, 2025. The Company intends to focus the Analyst Day discussion on: OST-HER2 program for human recurrent, fully resected lung metastatic osteosarcoma that is being positioned for Accelerated Approval in late 2025 OST-HER2 program for canine osteosarcoma that is being positioned for conditional approval in the second half of 2025, and plans for full approval OST-HER2 data in brea

Full data from OST-HER2 Phase 2b osteosarcoma trial, including synthetic control arm data being developed at the request of FDA to support a Breakthrough Therapy Designation request, to be presented at MIB Factor in June 2025 Rolling BLA submission expected to begin thereafter in order to gain regulatory approval by year-end 2025, triggering issuance of a Priority Review Voucher (PRV) OS Therapies Inc. (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today reported full-year 2024 financial results ended December 31, 2024 and provided a business update. "2024 was a transformative year for OS Thera

Dialogue open with FDA in preparation for End of Phase 2 Meeting request New canine elite responder biomarkers added to human biomarker strategy OS Therapies (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today provided a regulatory update for its OST-HER2 listeria monocytogenes (Lm) immunotherapeutic cancer biologic drug candidate in the prevention or delay of fully-resected, recurrent, lung metastatic osteosarcoma. "We are making rapid progress in putting together an appropriate data package to achieve accelerated approval for OST-HER2 given the feedback we've received to date from the FDA

OS Therapies (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced that Paul Romness, CEO, and Gerald Commissiong, CBO will be accepting meetings with registered investors at The Jones Healthcare and Technology Innovation Conference. The conference is being held on April 8-9, 2025 at the Venetian Resort in Las Vegas. The Company's participation aligns with its prioritization of advancements in healthcare and technology while connecting with other investors. Event: Jones Healthcare and Technology Innovation Conference Date: April 8-9, 2025 The conference is hosted by JonesTrading Instit

OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company advancing immunotherapies and targeted drug conjugates for cancer treatment, today announced that it has been awarded a presentation slot at the MIB Agents Factor Osteosarcoma Conference to be held June 26-28, 2025 in Salt Lake City, Utah. Key data will be presented from the Company's Phase 2b clinical trial of OST-HER2 in the prevention of recurrent, fully resected, lung metastatic osteosarcoma. This data will be compared with a newly created regulatorily compliant synthetic control group comprised of case matched controls that will be used for the Company's US Food & Drug Administration (FDA) OST-HER2 Biologics Lice

OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company advancing immunotherapies and targeted drug conjugates for cancer treatment, today announced that it has scheduled a Scientific Advice Meeting (SAM) in the third quarter of 2025 to discuss the Innovative Licensing and Access Pathway (ILAP) with the United Kingdom's (UK) Medicines and Healthcare products Regulatory Agency (MHRA) for OST-HER2, its immunotherapy candidate for the prevention of recurrence of metastases in osteosarcoma. The Company released positive Phase 2b data in January 2025 that demonstrates statistically significant results in the primary endpoint of the study, 12-month event free survival (EFS). The

Consolidates ownership of listeria monocytogenes-based immunotherapy IP Eliminates milestone payments and reduces future royalty obligations relating to OST-HER2 for osteosarcoma and other HER2-related indications Capital allocation focus remains on regulatory approval, priority review voucher (PRV) issuance and commercialization of OST-HER2 in osteosarcoma Previously disclosed $7.1M funding for OS therapies priced at $4.00/share provides cash runway into 2026 & precludes raises below $12.00 for 6 months Karim Galzahr appointed to OS Therapies Board of Directors OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company advancing immunotherapies and targeted d

Concurrently, the Company accepted the resignations of Dr. Colin Goddard and Mr. Joacim Borg OS Therapies (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate biopharmaceutical company, today announced the appointments of Avril McKean Dieser, MA, JD and Olivier R. Jarry, MS, MBA as independent members of the Company's Board of Directors. Collectively, Ms. McKean Dieser and Mr. Jarry bring over 50 years of biopharmaceutical executive decision-making experience to the Company, with a specific focus in commercializing biologic products. "OS Therapies is thrilled to welcome Ms. McKean Dieser and Mr. Jarry to our Board of Directors," sa

OS Therapies (NYSE:OSTX) ("OS Therapies" or "the Company"), an ADC and Immunotherapy research and clinical-stage biopharmaceutical company, today announced that it has appointed Borys Shor, PhD to its Antibody Drug Conjugate (ADC) Advisory Board. In his role, Dr. Shor will assist the Company in the selection of antibody and payloads to be developed using the Company's tunable ADC platform leveraging its proprietary pH-sensitive SiLinker™ silicone linker technology. Dr. Shor has 20 years of experience in leading oncology discovery programs and external R&D partnerships at large pharma (Pfizer, Wyeth) and biotech companies, with specific focus on preclinical discovery and development of sma