OS Therapies Announces Brand Name 'Herlystic' Approved by World Health Organization for OST-HER2 (daznelimgene lisbac)

OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or the "Company"), the world leader in gene-edited, Listeria-based cancer immunotherapies, today announce that the World Health Organization has approved the proprietary name 'Herlystic' was approved by the World Health Organization (WHO) as the brand name for OST-HER2. The nonproprietary name daznelimgene lisbac for the ingredients in OST-HER2 was previously approved WHO.

With both the branded proprietary name and the nonproprietary name now approved by WHO, the Company is positioned to initiate regulatory submissions seeking early market access for OST-HER2 worldwide. The Company intends to initiate international regulatory submissions initially in the U.K. at the invitation of the Medicines and Healthcare products Regulatory Agency (MHRA), and immediately thereafter expand submissions to include the U.S. Food & FDA, the European Medicines Agency (EMA) and the Australian Therapeutic Goods Administration (TGA).

The Company accepted MHRA's request to become the lead international regulatory agency to coordinate early market access approval processes under, Project Orbis, the FDA's Oncology Center of Excellence (OCE) initiative started in May 2019 to provide a framework for concurrent submission and review of oncology products among international partners. Since 2021, 29 MHRA-led oncology products have been approved by the FDA under Project Orbis.

Mr. Romness continued "We appreciate MHRA taking the lead under Project Orbis, and the access they have given the Company to the U.K.'s Clinical Practice Research Datalink (CPRD ). While MHRA, EMA and TGA have aligned on the use of non-concurrent historical control to evaluate the efficacy of OST-HER2's pending Conditional Marketing Authorization Application (CMAA) submissions, we know the FDA approves Biologics License Applications (BLAs) under the Accelerated Approval Program using surrogate clinical endpoints , such as biomarkers, to make approval decisions. To this end, the Company is waiting for the 3-year OS data to be complete for its pending meeting with the Center for Drug Research Evaluation (CDER) to review the correlation between previously announced pharmacodynamic response biomarkers and overall survival as part of the Biomarker Qualification Program . The previously announced Type B Pre-BLA Meeting will occur once the full data package is complete, while BLA submission continues that was initiated in January 2026. The Company expects that it will have sufficient additional concurrent external historical control comparator data via the CPRD to further buttress its BLA package as part of its BLA filing. This is a very exciting period for OS Therapies."

OST-HER2 has received Orphan Drug Designation (ODD), Fast Track Designation (FTD) and Rare Pediatric Disease Designation (RPDD) from the FDA. OST-HER2 has received ODD, FTD and ATMP from the EMA. OST-HER2 has received ODD and ATMP from MHRA, who also recruited the Company into Project Orbis. Under the RPDD program, if the Company is granted a BLA in the United States, it will become eligible to receive a Priority Review Voucher (PRV) that it intends to sell.