OS Therapies Inc

OSTX

Market cap $62.4M

New York, New York--(Newsfile Corp. - October 22, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today announced additional overall and event free survival data generated from the Company's 41-patient Phase 2b clinical trial of its off-the-shelf immunotherapeutic candidate OST-HER2 in recurrent, fully resected, pulmonary metastatic osteosarcoma (the "Phase 2b Osteosarcoma Trial"). The Company previously announced statistically significant positive final 2-year overall survival data from its Phase 2b Osteosarcoma Trial on October 10, 2025.

Final FDA Type C Meeting December 11, 2025 - biomarker data to be available October 10, 2025 FDA/Osteosarcoma Institute Workshop narrows focus for OST-HER2 overall survival, biomarker correlation & canine osteosarcoma data New York, New York--(Newsfile Corp. - October 17, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today announced that the United States Food & Drug Administration ("FDA") has granted a second Type C Meeting, following its successful End of Phase 2 Meeting. The primary purpose of the meeting is to gain alignment on the clinical efficacy data endpoints to support a Biologics Licensing Application ("BLA") under the Accelerated Approval Program ("Accelerated Approval") for OST-HER2 following a successful Phase 2b clinical trial in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma (the "Metastatic Osteosarcoma Program").

75% of OST-HER2 treated patients achieved 2-year overall survival compared with 40% in the historical control group (p < 0.0001) 100% of patients who achieved 12 month event free survival achieved 2 year overall survival New York, New York--(Newsfile Corp. - October 10, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today announced statistically significant positive final 2-year overall survival data from the Company's Phase 2b trial of off-the-shelf immunotherapy candidate OST-HER2 in the prevention or delay of recurrent, fully-resected, pulmonary metastatic osteosarcoma (the "Fully Resected Metastatic Osteosarcoma Trial"). 75% (27 out of 36 evaluable patients; 5 patients were lost to follow-up) of OST-HER2 treated patients achieved 2-year overall survival as measured from most recent pulmonary resection, compared with 40% of historical control patients1 (p < 0.0001) Subgroup analyses showed that 100% of patients who achieved 12-month Event Free Survival (EFS) achieved 2-year overall survival, whereas 59% of patients who did not achieve EFS achieved 2-year overall survival.

Overall survival recognized as key efficacy endpoint in osteosarcoma, where no standard of care exists Rapporteur highlights potential broader benefits of OST-HER2 in pulmonary and primary osteosarcoma settings, supported by translational canine data from the University of Pennsylvania New York, New York--(Newsfile Corp. - October 9, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today announced a positive regulatory update following an October 6, 2025 meeting with its European Medicines Agency (EMA) rapporteur, the Dutch Medicines Evaluation Board (MEB). During the meeting, OS Therapies and the Dutch Rapporteur aligned on key areas, including safety, non-clinical and chemistry, manufacturing, and controls (CMC) data in support of the Company's ongoing OST-HER2 Phase 2b clinical trial in the prevention or delay of recurrent, fully-resected, pulmonary metastatic osteosarcoma.

Daytime Emmy Awards participation - 2 nomination for 'Shelter Me: Cancer Pioneers' Comparative Oncology documentary that features clinicians, veterinarians and human & canine patients who participated in OST-HER2 clinical trials New York, New York--(Newsfile Corp. - October 7, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today announced its participation in upcoming October 2025 conferences and events. Cell and Gene Meeting on the Mesa What: Partnering and one-on-one meetingsWhen: October 6-8, 2025Where: Arizona Biltmore, Phoenix, AZWho: Paul Romness, Chairman & CEOHow: OS Therapies is now a member of the Alliance for Regenerative Medicine Roth Annual Healthcare Opportunities Conference What: Meeting participation and one-on-one meetingsWhen: October 9, 2025Where: Metropolitan Club, New York City, NYWho: Gerald Commissiong, Chief Business Officer FDA/The Osteosarcoma Institute (OSI) Workshop: Advancing Osteosarcoma Drug Development - Connecting Research and Regulatory Pathways for Improved Outcomes What: Meeting participation and availability for sideline discussionsWhen: October 10, 2025Where: Lincoln Square, Washington, DCWho: OS Therapies Management & Regulatory Team BIOFuture 2025 What: Spotlight Panel and one-on-one meetingsWhen: October 13-15, 2025Where: Cure, New York City, NYWho: Gerald Commissiong, Chief Business Officer 52nd Daytime Emmy Awards Shelter Me: Cancer Pioneers - Nominated for 2 Emmy's trailer here movie here What: Main awards presentation and select investor meetingsWhen: October 17, 2025Where: Pasadena Civic Auditorium, Pasadena, CAWho: Paul Romness, Chairman & CEO; Gerald Commissiong, Chief Business Officer; Nicola J.

Company updates sequence of OST-HER2 regulatory submissions, prioritizing UK MHRA conditional Marketing Authorisation Application (MAA) submission following positive August 2025 Scientific Advice Meeting feedback from UK MHRA In principle, UK MHRA accepts use of historical control arm to support conditional MAA UK MHRA conditional MAA and US FDA Biologics Licensing Application (BLA) submissions expected to be completed within 30 days of each other, between December 2025 and January 2026 Company to propose use of immune activation biomarker coupled with overall survival data as surrogate efficacy endpoint to support Accelerated Approval in Type C Meeting invited by FDA, following positive End of Phase 2 Meeting and follow-up interactions New York, New York--(Newsfile Corp. - September 30, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today provided a regulatory update on its plans for filing marketing authorizations in the United States (US) and United Kingdom (UK) for OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma based on a data generated from its completed Phase 2b clinical trial currently in the long term follow-up phase. The Company has updated its regulatory filing sequence to prioritize the UK Medicines and Healthcare products Regulatory Agency (MHRA) conditional Marketing Authorisation Application (MAA) final module submission to immediately precede its US FDA Biologics Licensing Application (BLA) final module submission under the Accelerated Approval Program (Accelerated Approval).

New York, New York--(Newsfile Corp. - September 19, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today announced that it has been invited to participate in the "Beyond the Cure: The Brave New World of Revolutionary Cancer Therapeutics" Spotlight Panel at BioFuture 2025 taking place at Cure in New York City on October 13, 2025 at 11:00am EDT. A virtual partnering option is offered October 21-23, 2025, including access to the event's recorded content.

Clinical data from Phase 1b prostate cancer trial to be released in Q4/25 Additionally, updated 2-year overall survival data from all 40 patients in the Phase 2b clinical trial of OST-HER2 in the prevention of delay of recurrent, fully resected, pulmonary metastatic osteosarcoma to be released on October 10, 2025 New York, New York--(Newsfile Corp. - September 12, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today announced that the last patient enrolled in its OST-504 (previously ADXS-504) Phase 1b clinical trial in subjects with biochemically recurrent prostate cancer previously treated with radical prostatectomy (RP) or radiation therapy (external beam or brachytherapy) who are not currently receiving androgen ablation therapy has completed their last patient visit (NCT05077098). A total of 7 patients enrolled in the study.

Dallas, Texas--(Newsfile Corp. - September 8, 2025) - OS Therapies Inc. (NYSE American: OSTX): Stonegate Capital Partners initiates their coverage on OS Therapies Inc. (NYSE American: OSTX). OS Therapies advanced meaningful clinical, regulatory, and financial milestones in 2Q25 as it moves closer to bringing OST-HER2 to patients with recurrent, fully resected, pulmonary metastatic osteosarcoma.

New York, New York--(Newsfile Corp. - September 3, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today announced that it will participate in the upcoming investor conferences: Cantor Global Healthcare Conference 2025 being held September 3-5, 2025 in New York City. Management will be available for meetings with institutional investors and brokers H.C.