OS Therapies Inc

OSTX

Market cap $72.4M

Conference call scheduled for Thursday, April 30, 2026, at 8:30 am ET to review new OST-HER2 immune pharmacodynamic biomarker response (seroconversion) data and review regulatory successes validating the OST-HER2 approach. Participants will include strategic advisors Dr. Craig Eagle and Dr. Bob Langer, and Osteosarcoma key opinion leader Dr. Peter Anderson from Cleveland Clinic.

Regulatory feedback recent from April 2026 EU EMA and Australian TGA meetings Remaining Q2-2026 regulatory meetings include two U.S. FDA meetings and one UK MHRA meeting, in addition to follow-up meetings with EU EMA and Australian TGA New York, New York--(Newsfile Corp. - April 27, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in gene-edited, listeria-based cancer immunotherapies, today announced that it will be hosting a conference call on Thursday April 30, 2026 at 8:30am ET to review the data that supported the recent Patent Cooperation Treaty (PCT) international application for a OST-HER2 pharmacodynamic biomarker 1 (the "OST-HER2 Immune Signature") as a surrogate clinical efficacy endpoint. The OST-HER2 Immune Signature is expected to be used to support early market access in the second half of 2026 in the U.S via a Biologics License Application ("BLA") under the Accelerated Approval Program 2 (Accelerated Approval), in addition to Europe, the UK and Australia via Conditional Marketing Authorisations 3 (CMAs).

New patent application covers treatment-emergent immune signature related to 'turning cold tumors hot' and the activation of targeted cytotoxic cellular immune responses Company to host conference call later in April 2026 to review new biomarker signature Biomarker signature meets pharmacodynamic/response criteria established by FDA's Biomarkers, EndpointS and other Tools (BEST) program for use as a surrogate clinical endpoint of 1-year event free survival and 2-year overall survival in OST-HER2's Phase 2b trial in the prevention of delay of recurrent, fully-resected, pulmonary metastatic osteosarcoma to support a BLA submission under FDA's Accelerated Approval Program New York, New York--(Newsfile Corp. - April 16, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in gene-edited, listeria-based cancer immunotherapies, today announced that it has filed a new patent application covering a unique immune signature in response to treatment with therapeutic candidates developed from the Company's proprietary Listeria monocytogenes platform ('Listeria') based on new biomarker data from the Company's Phase 2b trial of OST-HER2 in the prevention or delay of recurrent, fully-resected, pulmonary metastatic osteosarcoma. Filed claims include treatment with Listeria leading to the downregulation of genes associated with tumor and circulating tumor cell immune evasion in combination with the upregulation of genes associated with cytotoxic cellular immune activation leads to improved anti-tumor cellular immunity activation.

Co-founder of more than 40 biotechnology companies, including 16 IPOs and 19 successful acquisitions Scientific and medical titan focused on driving innovation for human health Will assist with listeria oncology pipeline prioritization, combinations with other oncology-focused biotechnologies and tADC candidate selection for further development New York, New York--(Newsfile Corp. - April 13, 2026) - OS Therapies, Inc.  (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in gene-edited, listeria-based cancer immunotherapies, announced today that Dr. Robert "Bob" S. Langer, co-founder of Moderna, was appointed to the Company's strategic advisory board.

NEW YORK--(BUSINESS WIRE)--Why: Rosen Law Firm, a global investor rights law firm, announces an investigation of potential securities claims on behalf of shareholders of OS Therapies Incorporated (NYSE American: OSTX) resulting from allegations that OS Therapies may have issued materially misleading business information to the investing public. So what: If you purchased OS Therapies securities you may be entitled to compensation without payment of any out of pocket fees or costs through a conti.

NEW YORK--(BUSINESS WIRE)--Why: Rosen Law Firm, a global investor rights law firm, announces an investigation of potential securities claims on behalf of shareholders of OS Therapies Incorporated (NYSE American: OSTX) resulting from allegations that OS Therapies may have issued materially misleading business information to the investing public. So what: If you purchased OS Therapies securities you may be entitled to compensation without payment of any out of pocket fees or costs through a conti.

Senior leadership roles at Guardant Health, Genentech and Pfizer Regulatory, clinical and commercial expertise in therapeutics and biomarkers Will assist with osteosarcoma regulatory advice and oncology pipeline prioritization New York, New York--(Newsfile Corp. - April 8, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in gene-edited, listeria-based cancer immunotherapies, today announced that Craig Eagle, MD, was appointed to the Company's newly-formed strategic advisory board. The Company's strategic advisory board is being formed to assist the Company in fine-tuning its osteosarcoma regulatory execution plan and to help develop a detailed pipeline development plan to prioritize the highest value opportunities beyond osteosarcoma.

Company expects approximately $2 million in non-dilutive VAT refunds from wholly owned U.K. subsidiary in 2Q-26 Company 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-26 Offering net proceeds, together with funds expected to be received via U.K. subsidiary, expected to provide cash runway into 2027 Company 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 American: OSTX) ("OS Therapies" or "the Company"), the world leader in gene-edited, listeria-based cancer immunotherapies, today announced it that it has completed a $5.25 million registered direct offering of common stock (or pre-funded warrants in lieu thereof) and warrants, with participation primarily from high-net-worth investors who have invested in several of the Company's prior financing rounds. Each investor was issued either shares of common stock at a purchase price of $1.40 per share or, in lieu thereof, pre-funded warrants at a purchase price of $1.399 per pre-funded warrant, together with one warrant to purchase one share of common stock at an exercise price of $1.40 per share for each share of common stock issued or issuable upon exercise of the pre-funded warrants.

December 2025 Type C Meeting confirmed immune biomarkers suitability to establish surrogate clinical efficacy that could support BLA under Accelerated Approval Pathway Pre-specified clinical outcomes data correlates with Immune biomarker signature Company 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/26 Company expects to initiate confirmatory Phase 3 trial in Australia in 3Q/26 Company 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/26 New York, New York--(Newsfile Corp. - March 31, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today announced that it has completed the submission on clinical and biomarker data from the Company's Phase 2b clinical trial of OST-HER2 in the prevention of delay of recurrent, fully resected, pulmonary metastatic osteosarcoma to the U.S. Food & Drug Administration in preparation for the Company's upcoming Pre-BLA Meeting, reported full-year 2025 financial results for the period ended December 31, 2025 and provided a business update. The Company expects the Pre-BLA Meeting to occur in May 2026.

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. & Europe New York, New York--(Newsfile Corp. - March 27, 2026) - OS Therapies, Inc. (NYSE American: 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.K. Medicines and Healthcare products Regulatory Agency (MHRA), the European Medicines Agency (EMA) and the Australian Therapeutic Goods Administration (TGA) to review the design of the proposed global confirmatory Phase 3 trial for OST-HER2 in metastatic osteosarcoma. Meetings with each of these four regulatory agencies are expected to occur in the second quarter of 2026, with trial enrollment expected to begin in the third quarter of 2026 initially in Australia.