OS Therapies Inc

OSTX

Market cap $82M

Confirmatory Phase 3 trial to commence prior to BLA grant under Accelerated Approval Program in the U.S. and Conditional MAA in the U.K., Europe and Australia Patent pending pharmacodynamic response biomarker accepted as surrogate clinical efficacy endpoint TGA and MHRA agree to allow utilization of remaining Phase 2b drug product for initiation of confirmatory Phase 3 FDA and EMA fully align with Company on Chemistry, Manufacturing and Controls (CMC) Market access process initiated with UK NICE and EU JCA New York, New York and Rockville, Maryland--(Newsfile Corp. - June 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 it achieved alignment on the design of its pending Phase 3 study of OST-HER2 in the prevention or delay of recurrence in fully resected, pulmonary metastatic osteosarcoma with the U.S. Food & Drug Administration (FDA) and the U.K. Medicines and Healthcare products Regulatory Agency (MHRA). A confirmatory Phase 3 study is required to have commenced prior to the grant of a Biologics License Application (BLA) under the Accelerated Approval Program in the U.S. and Conditional Marketing Authorisation Applications (CMAAs) in the U.K., Europe and Australia.

OS Therapies Incorporated (NYSE:OSTX) shares are up during Tuesday's premarket session as the company recently announced that its Phase 2b trial of OST-HER2 achieved statistically significant overall survival results at the 2.5-year mark.

75% 2.5-year overall survival for OST-HER2 vs. 47% pooled historical control (p = 0.003), with no new patient deaths reported since the 2-year overall survival data (75% vs.

The Company confirms that it will release 2.5 year overall survival data from Phase 2b clinical trial OST-HER2 in the prevention or delay of recurrence in fully-resected pulmonary metastatic osteosarcoma during the 2026 American Society of Clinical Oncologists (ASCO) Annual Meeting being held from May 28, 2026 to June 2, 2026. New York, New York and Rockville, Maryland--(Newsfile Corp. - May 29, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in gene-edited, listeria-based cancer immunotherapies, today announced the publication of four articles related to OST-HER2 and/or Osteosarcoma in Drug Discovery World.

ASCO 2026: 2.5-Year Overall Survival Data Jefferies Healthcare Conference: Partnering & Investor meetings BIO International Convention: Panel Participation MIB Agents Factor Osteosarcoma Conference: Data Presentation New York, New York and Rockville, Maryland--(Newsfile Corp. - May 26, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in gene-edited, listeria-based cancer immunotherapies, announced that it will attend upcoming medical, financial and scientific conferences: American Society of Clinical Oncologists 2026 Where: Chicago, ILWhen: May 29, 2026 to June 2, 2026What: 2.5-year overall survival data announcement Jefferies Global Healthcare Conference 2026 Where: New York, NYWhen: June 2, 2026 to June 4, 2026What: Partnering meetings and select investor meetings BIO International Convention 2026 Where: San Diego, CAWhen: June 22, 2026 to June 25, 2026What: Partnering meetings and panel participation - "ADCs: How can we make bringing ADCs to market a faster, simpler, and more collaborative process?" MIB Agents: Factor Osteosarcoma Conference 2026 Where: Columbus, OHWhen: June 25, 2026 to June 27, 2026What: Data Presentation About OS Therapies OS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for Osteosarcoma (OS) and other solid tumors.

$5.5 million financing that closed on April 2, 2026 together with $5.7 million in capital raised in Q1-2026, expected to provide Company with cash runway into 2027 $4.5 million of accrued VAT refunds and R&D refundable tax credits from UK subsidiary begin maturing, including $1.9 million VAT cash refund expected in June 2026 Successful EMA and Australia TGA (ATGA) meetings aligned around use of existing biomarker and pending release of 3-year overall survival data to support Conditional Marketing Authorisations (CMAs) for OST-HER2 in prevention or delay of recurrence in fully-resected, pulmonary metastatic osteosarcoma ("Metastatic Osteosarcoma") 2.5-year overall survival data expected to be released during ASCO 2026 EMA and ATGA have aligned on key design aspects of confirmatory Phase 3 Metastatic Osteosarcoma protocol required to have commenced prior to grant of CMAs or FDA BLA, including alignment on 3-year overall survival as a primary clinical efficacy endpoint Upcoming U.S. FDA Type C meeting and U.K. MHRA SAM meeting to align with EMA & ATGA prior to Australia Clinical Trial Notification submission for Phase 3, including alignment on 3-year overall survival as a primary clinical efficacy endpoint. U.S. FDA ("FDA") Pre-BLA meeting to confirm alignment on surrogate and primary clinical efficacy endpoints with EMA/ATGA, including alignment on 3-year overall survival as a primary clinical efficacy endpoint, and seek decisions on rolling review acceptance and RMAT designation following the EMA and U.K. MHRA granting ATMP designation (EMA/MHRA RMAT equivalent) for OST-HER2 in Metastatic Osteosarcoma OS Animal Health S-1 filing for proposed 'Go-Public' transaction and receipt of SEC comments New York, New York and Rockville, Maryland--(Newsfile Corp. - May 18, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in gene-edited, listeria-based cancer immunotherapies, reported first quarter 2026 financial results and provided a business update centered on the Company's lead program for OST-HER2 in the prevention or delay of recurrence in fully-resected, pulmonary metastatic osteosarcoma ("Metastatic Osteosarcoma").

New York, New York and Rockville, Maryland--(Newsfile Corp. - May 15, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in gene-edited, listeria-based cancer immunotherapies, announced that it will announce first quarter 2026 financials and provide a business update on the morning of Monday May 18, 2026. About OS Therapies OS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for Osteosarcoma (OS) and other solid tumors.

Appointment strengthens medical, regulatory, and commercial leadership as Company prepares to complete early market access regulatory filings in the U.S., U.K, Europe and Australia in anticipation of OST-HER2 approval decisions expected by year-end 2026 Upcoming FDA Pre-BLA meeting will focus on the use of recent seroconversion biomarker data as a key surrogate clinical efficacy endpoint to support a BLA for OST-HER2 under the Accelerated Approval Program Commercialization and reimbursement preparations well underway for the U.S., U.K., and Europe in parallel with ongoing partnership discussions New York, New York and Rockville, Maryland--(Newsfile Corp. - May 14, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in gene-edited, listeria-based cancer immunotherapies, announced Dr. Craig Eagle's appointment as Chief Medical Advisor. His appointment strengthens the Company's medical, regulatory, and commercial leadership team in preparation for potential early market access decisions from regulators at the U.S. Food & Drug Administration (FDA), U.K. Medicines and Healthcare products Regulatory Agency (MHRA), European Medicines Agency (EMA) and Australian Therapeutic Good Administrations (ATGA) for OST-HER2 in the prevention or delay of recurrence in fully-resected, pulmonary metastatic osteosarcoma (the "Metastatic Osteosarcoma Program").

Dallas, Texas--(Newsfile Corp. - May 12, 2026) - OS Therapies Inc. (NYSE American: OSTX): Stonegate Capital Partners updates their coverage on OS Therapies Inc. (NYSE American: OSTX). OS Therapies advanced materially through late-stage regulatory and commercialization preparation as OST-HER2 moved from Phase 2bsupported planning toward a more defined global approval pathway in recurrent, fully resected, pulmonary metastatic osteosarcoma.

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.