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Company expects approximately $2 million in non-dilutive VAT refunds from wholly owned U.K. subsidiary in 2Q-26Company expects to receive approximately $2 million in non-dilutive R&D tax credits repayable to the company in cash from its U.K. subsidiary in 2H-26Offering net proceeds, together with funds expected to be received via U.K. subsidiary, expected to provide cash runway into 2027Company expects to receive approvals in the U.S., U.K. and Europe for OST-HER2 in the prevention of delay of recurrent, fully resected, pulmonary metastatic osteosarcoma in the second half of 2026 New York, New York--(Newsfile Corp. - April 2, 2026) - OS Therapies, Inc. (NYSE:OSTX) ("OS Therapies" or "the Co

December 2025 Type C Meeting confirmed immune biomarkers suitability to establish surrogate clinical efficacy that could support BLA under Accelerated Approval PathwayPre-specified clinical outcomes data correlates with Immune biomarker signatureCompany positioned to review completed Phase 2b clinical & biomarker data and confirmatory Phase 3 trial protocol with U.S. FDA, EMA and U.K. MHRA in 2Q/26Company expects to initiate confirmatory Phase 3 trial in Australia in 3Q/26Company anticipates receiving a BLA under Accelerated Approval Program in the U.S. and Conditional Marketing Authorizations in Europe and in the U.K. in 2H/26New York, New York--(Newsfile Corp. - March 31, 2026) - OS Therap

Meetings with all four regulatory agencies scheduled to occur in the second quarter of 2026, with expected Phase 3 commencement in the third quarter of 2026 initially in Australia Commencing the Phase 3 confirmatory study is a pre-requisite to being granted a Biologics License Application (BLA) under the Accelerated Approval Program in the U.S. and Conditional Marketing Authorisations (CMAs) in the U.K. & EuropeNew York, New York--(Newsfile Corp. - March 27, 2026) - OS Therapies, Inc. (NYSE:OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today announced that it has been granted meetings with the U.S. Food & Drug Administration (FDA), the U.

ATMP benefits include access to the Conditional Marketing Authorisation accelerated market access pathway in Europe, significantly reduced user fees for small and medium-sized enterprises (SMEs), tailored regulatory assessment via Committee for Advanced Therapies (CAT) and increased pricing power New York, New York--(Newsfile Corp. - March 25, 2026) - OS Therapies, Inc. (NYSE:OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today announced that the European Medicines Agency's (EMA) Committee for Advanced Therapies (CAT) granted OST-HER2 Advanced Therapy Medicinal Product designation (ATMP) for the treatment of pulmonary recurrence in resec

FDA's elevated meeting status signals transition from biomarker data discussions to Accelerated Approval discussionsOS Therapies on track to complete clinical data submission by the end of Q1 2026New York, New York--(Newsfile Corp. - March 9, 2026) - OS Therapies Inc. (NYSE:OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today provided an update regarding ongoing conversations with the United States Food & Drug Administration (FDA) with regards to its ongoing Biologics License Application (BLA) submission under the Accelerated Approval Program (Accelerated Approval) for OST-HER2 in the prevention or delay of recurrent, fully resected, pulmo

Additional forthcoming biomarker data from human trial expected to further characterize immune pathway activation and its relationship to clinical outcomesU.S., U.K. and European osteosarcoma key opinion leaders assembling to review clinical & biomarker trial data, and comment on proposed confirmatory trial designAyala Pharmaceuticals announces dissolution following liquidation of assetsNew York, New York--(Newsfile Corp. - February 17, 2026) - OS Therapies Inc. (NYSE:OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today provided a global regulatory update for OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metas

New York, New York--(Newsfile Corp. - February 4, 2026) - OS Therapies Inc. (NYSE:OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, is honored to celebrate the passage of the Mikaela Naylon Give Kids A Chance Act. Mikaela, like so many other children, courageously battled pediatric cancer - specifically Osteosarcoma. Her legacy through this legislation will accelerate critical opportunities for research and therapeutic access for other children and teens currently living with pediatric cancers. Innovation is urgent and direly needed as pediatric cancers remain the leading disease-based cause of pediatric death in the United States. OS T

Request for FDA Rolling Review submitted to FDA on January 30, 2026Non-Clinical and CMC BLA modules submitted to FDAAt FDA's request, Type D Meeting expected in March 2026 to review Comparative Oncology biomarker data from patients treated in OST-HER2 Phase 2b human clinical trial and OST-HER2 trial in spontaneous osteosarcoma in caninesFinal BLA clinical module expected to be submitted to FDA by end of March 2026 after Type D Meeting Regenerative Medicine Advanced Therapy (RMAT) designation requests update submitted to FDA with recent biomarker dataCompany remains on track to be eligible to receive Priority Review Voucher under Rare Pediatric Disease Designation (RPDD) with approval anticip

Activation of immune blood biomarkers from interferon gamma pathway distinguished long term survivors (>=2 years) from short-term survivors (<1year)Pre-specified pathway analysis strategy developed as a result of immune biomarker pathway data generated from 118-patient canine metastatic osteosarcoma study published in February 2025 demonstrates translational power of Comparative Oncology to identify surrogate markers of clinical efficacyNew York, New York--(Newsfile Corp. - January 15, 2026) - OS Therapies Inc. (NYSE:OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today announced positive biomarker data from its Phase 2b clinical trial of O

OS Animal Health (OSAH), a wholly-owned subsidiary of OS Therapies (OSTX), targeting Initial Public Offering (IPO) on NYSE American or Nasdaq Capital Markets national stock exchange in the first half of 2026 (1H/2026)OSTX shareholders expected to receive one (1) share of OSAH for every ten (10) shares of OSTX owned as of the expected to-be-determined 1H/2026 record dateOSAH to focus primarily on the re-establishment of USDA conditional approval and commercialization of immunotherapy OST-HER2 for canine osteosarcoma and other HER2 positive cancers in animalsOST-HER2 featured in 2025 2x Emmy-nominated and Anthem Award-winning documentary 'Shelter Me: Cancer Pioneers' streaming on PBSOSTX reite

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Lake Street initiated coverage of OS Therapies with a rating of Buy and set a new price target of $19.00

USA News Group News CommentaryIssued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, June 26, 2025 /PRNewswire/ -- USA News Group News Commentary – With analysts forecasting the global oncology drug market to surpass US$900 billion by 2034, investor interest in cancer-focused biotechs is rapidly intensifying. ResearchAndMarkets and Vision Research Reports both point to strong double-digit growth, citing surging demand for next-gen diagnostics and immunotherapies. Yet even as market potential grows, the U.S. public health sector is facing potential setbacks. Budget proposals suggest National Cancer Institute (NCI) funding could be slashed by up to 40%, while Bloomberg highlights concerns 

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

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December 2025 Type C Meeting confirmed immune biomarkers suitability to establish surrogate clinical efficacy that could support BLA under Accelerated Approval PathwayPre-specified clinical outcomes data correlates with Immune biomarker signatureCompany positioned to review completed Phase 2b clinical & biomarker data and confirmatory Phase 3 trial protocol with U.S. FDA, EMA and U.K. MHRA in 2Q/26Company expects to initiate confirmatory Phase 3 trial in Australia in 3Q/26Company anticipates receiving a BLA under Accelerated Approval Program in the U.S. and Conditional Marketing Authorizations in Europe and in the U.K. in 2H/26New York, New York--(Newsfile Corp. - March 31, 2026) - OS Therap

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 survivalNew York, New York--(Newsfile Corp. - October 10, 2025) - OS Therapies Inc. (NYSE: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 "Fu

New York, New York--(Newsfile Corp. - August 14, 2025) - OS Therapies Inc. (NYSE:OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today announced that it will report second quarter 2025 financial results ended June 30, 2025 and provide a business update on the morning of Tuesday, August 19, 2025.About OS TherapiesOS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for Osteosarcoma (OS) and other solid tumors. OST-HER2, the Company's lead asset, is an immunotherapy leveraging the immune-stimulatory effects of Listeria bacteria to initia

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

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, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company advancing immunotherapies and targeted drug conjugates for cancer treatment, announced the formation of subsidiary OS Drug Conjugates (OSDC). The formation of OSDC coincides with formal strategic options initiatives to create value from the Company's leading-edge, patented silicone dioxide-based, pH sensitive tunable antibody drug conjugates (tADC) & other tunable drug conjugates (tDC) platforms. The Company has initiated discussions with clinical-stage ADC therapeutics companies in the U.S., China and other jurisdictions to form joint ventures (JVs) pairing those companies' clinical-stage assets with certain assets f

ORLANDO, FL / ACCESSWIRE / August 9, 2024 / RedChip Companies will air interviews with OS Therapies Inc. (NYSE:OSTX) and Can-Fite BioPharma Ltd. (NYSE:CANF) on the RedChip Small Stocks, Big Money™ show, a sponsored program on Bloomberg TV, this Saturday, August 10, at 7 p.m. Eastern Time (ET). Bloomberg TV is available in an estimated 73 million homes across the U.S.Access the interviews in their entirety at:OS Therapies: https://www.redchip.com/assets/access/ostx_accessCan-Fite: https://www.redchip.com/assets/access/canf_accessIn an exclusive interview, Paul Romness, Chairman and CEO of OS Therapies, appears on the RedChip Small Stocks Big Money™ show on Bloomberg TV to provide a corporate