Herlystic (diznalimgene lisbac) / OS Therapies - LARVOL DELTA

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

Commercial • Osteosarcoma

OS Therapies, Inc….announced that it has achieved incremental alignment with the U.S. Food & Drug Administration (FDA) in the Company’s pursuit of a Biologics License Application (BLA) for OST-HER2 in the prevention or delay of recurrence in fully-resected, pulmonary metastatic osteosarcoma (the “Metastatic Osteosarcoma Program“) (Newsfile) - "The Company aligned with the FDA on the use of the proposed adaptive design agreed upon with...MHRA and the European Medicines Agency...for the pending Phase 3 clinical trial that is expected to commence in the fourth quarter of 2026. The Company expects to hold its previously disclosed invited Type B Pre-BLA meeting with FDA in the fourth quarter of 2026 following the submission of the clinical section, inclusive of 3-year overall survival data, thereby completing the ongoing BLA filing that was initiated in January 2026...OS Therapies announced that it has accepted a request from MHRA to become the Company's representative to Project Orbis....OS Therapies is seeking to obtain a BLA under the Accelerated Approval Program in the U.S. and Conditional Marketing Authorization Applications (CMAAs) in Europe, the U.K. and Australia for OST-HER2 in metastatic osteosarcoma in the fourth quarter of 2026."

EMA filing • FDA event • FDA filing • Filing • MHRA filing • Osteosarcoma

OS Therapies Completes FDA Type C Statistical Methods Meeting and Provides Update on Global Regulatory Coordination for OST-HER2 Under Project Orbis (OS Therapies Press Release) - "Recent U.K. MHRA Scientific Advice Meeting (SAM) that resulted in full alignment to initiate confirmatory Phase 3 trial in U.K. with existing Phase 2 drug product paved the way Conditional Marketing Authorisation Application (CMAA) submission in the coming weeks and Phase 3 trial initiation in mid Q4/'26 following Phase 2b drug product requalification....Company continues to engage with U.S. FDA on the non-Orbis Accelerated Approval route after successful Type C Statistical Methods Meeting that resulted in alignment on amended Phase 3 study design as buildout of OST-400 natural history database expands to include U.K. national patient registry data and Company awaits FDA decisions on RMAT, Rolling Review and CNPV ahead of the pending Q4/'26 completion of its ongoing BLA filing initiated in Q1/'26."

FDA event • FDA filing • MHRA filing • New P3 trial • Project Orbis • Osteosarcoma

OS Therapies Achieves Statistically Significant Benefit for OST-HER2-Treated Patients in Interim 3-Year Overall Survival Analysis of Phase 2b Pulmonary Metastatic Osteosarcoma Trial (FinancialContent) - "The interim 3-year overall survival rate among OST-HER2 treated patients was 71.2%, compared with 45.8% of patients in the comparable combined historical control group (p = 0.002, 41 total enrolled patients, with visits for the two remaining patients who have not reached 3-years from enrollment scheduled for September 2026 and early October 2026, respectively, and 6 patients lost to follow-up)."

P2b data • Osteosarcoma

Expected Remaining Second Half 2026 Milestones (Newsfile) - "Interim 3-year Overall Survival data expected in early September 2026 ahead of MHRA Statistical Methods Scientific Advice Meeting for Conditional MAA submission acceptance criteria; Final 3-year Overall Survival data to be included in FDA BLA Accelerated Approval Program submission ahead of Type B Pre-BLA Meeting previously granted in Q2/26...Type C Statistical Methods Meeting with FDA in mid-September 2026; Statistical Methods SAM scheduled with MHRA in mid-September 2026; FDA Biomarker Qualification Program (BQP) Meeting...Submission of the Clinical Trial Notification (CTN) to MHRA in preparation for initiation of confirmatory Phase 3 Metastatic Osteosarcoma Program."

FDA event • New P3 trial • P2b data • Regulatory • Osteosarcoma

Concurrent with this announcement, the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has granted a new Scientific Advice Meeting (SAM) to review the statistical methods that will be used to support the Company's pending Conditional Marketing Authorisation Application (CMAA) submission... (Newsfile) - "...including whether the Company can finalize its U.K. CMAA submission leveraging 2.5-year overall survival....This meeting is expected to occur in September 2026."

Non-US regulatory • Osteosarcoma

OS Therapies…Provides Business and Regulatory Updates (Newsfile) - "Expected Remaining Second Half 2026 Milestones: Receipt of at least $3 million in cash from VAT refund by OST U.K.; Formal submission for at least $4.2 million in reimbursable R&D Tax Credit by OST U.K.; Acceptance of OS Animal Health regulatory submission by USDA followed by meeting; Complete submission of BLA request to FDA; Complete submission of CMAA requests to MHRA, EMA and TGA."

Commercial • Filing • Regulatory • Osteosarcoma

OS Therapies…Provides Business and Regulatory Updates (Newsfile) - "Expected Remaining Second Half 2026 Milestones: FDA decisions on Regenerative Medicine; Advanced Therapy (RMAT), Breakthrough Therapy Designation and Commissioner's National Priority Review Voucher (CNPV); Initiation of confirmatory Phase 3 trial in the U.K. FDA decision on BLA request under Accelerated Approval Program; EMA decision on CMAA request; MHRA decision on MAA request; TGA decision on MAA request."

Approval • FDA event • New P3 trial • Osteosarcoma

OS Therapies Granted U.S. FDA Type C Statistical Methods Meeting to Review 2.5-Year Overall Survival Data for OST-HER2 in the Prevention or Delay of Recurrence in Fully Resected, Pulmonary Metastatic Osteosarcoma (Newsfile) - "The Company expects the FDA Type C Statistical Methods Meeting to occur in mid-September 2026 with members from division within the Center for Biologics Evaluation and Research (CBER), in parallel with the pending Biomarker Data Review Meeting being scheduled with members of the Center for Drug Evaluation and Research's (CDER) Biomarker Qualification Program (BQP). CBER is ultimately responsible for granting regulatory approval for gene-edited products such as OST-HER2. The Company expects to announce interim 3-year overall survival data in early September 2026."

FDA event • P2b data • Osteosarcoma

OS Therapies Receives Rare Pediatric Disease Designation (RDD) in Osteosarcoma for OST-HER2 (Listeria monocytogenes) (PRNewswire) - "OS Therapies...announced the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RDD) for OST-HER2 (OST31-164) for the treatment of Osteosarcoma."

FDA event • Oncology • Osteosarcoma • Sarcoma • Solid Tumor

OS Therapies Accepts New FDA Meeting Request to Review Biomarker Data as Part of BEST Program (Newsfile) - "This meeting is in addition to the forthcoming Type B Statistical Methods Meeting being scheduled with FDA's Center for Biologics Evaluation and Research (CBER) to review the 2.5-year overall survival data alongside the OST-HER2 Biomarker data...CBER is the regulatory agency that will make the regulatory approval decision on OST-HER2...Alignment between CBER and CDER on the use of the OST-HER2 Biomarker Data is an important step in preparation for formal evaluation of the pending final 3-year overall survival data that will be included in the Company's Biologics License Application (BLA) submission under the Accelerated Approval Program expected in early Fall 2026...The Company expects to announce interim 3-year overall survival data in the summer of 2026.....Company is seeking to obtain a BLA under the Accelerated Approval Program for OST-HER2 in osteosarcoma by year-end 2026 in the U.S..."

FDA approval • FDA event • FDA filing • P2 data • Osteosarcoma

OS Therapies, Inc…provided regulatory update on the Company's interactions with the U.S. Food and Drug Administration (FDA) in its pursuit of a Biologics License Application (BLA) under the Accelerated Approval Program (Accelerated Approval) for OST-HER2 in the prevention or delay of recurrence in fully resected, pulmonary metastatic osteosarcoma (Yahoo Finance) - "OS Therapies has requested a Type B Meeting to review the Company's 2.5-year overall survival data and to confirm alignment that 3-year overall survival data is an approvable clinical efficacy endpoint. The Company recently aligned with the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency on 3-year overall survival as the proposed approvable clinical endpoint to support Conditional Marketing Authorisations. The Company has also submitted its pharmacodynamic response biomarker data to the FDA's Biomarkers, Endpoints, and other Tools (BEST) program for evaluation as a surrogate clinical efficacy data...OS Therapies intends to review with FDA the potential inclusion of concurrent natural history control database OST-400..."

FDA event • Osteosarcoma

OS Therapies Achieves Statistically Significant 2.5-Year Overall Survival in Phase 2b Trial of OST-HER2 in Fully Resected Pulmonary Metastatic Osteosarcoma (Newsfile) - "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. 60%, p = 0.034)...No new patient deaths were reported between the 2 and 2.5-year timepoints in the OST-HER2 treated group. OST-HER2 data is supported by a unique, patent pending pharmacodynamic immune response biomarker signature (Antigen Presentation, NK Cell Activation, T Cell Activation, etc.) that was developed as a surrogate clinical efficacy endpoint. The Company intends to present detailed data results during the MIB Agents Factor 2026 Osteosarcoma Conference being held June 25-27, 2026 in Columbus, OH....'With 3-year survival data on the horizon in early Q4-2026 to support our FDA, EMA, MHRA and TGA filings for early market access, we anticipate receiving authorizations in late Q4-2026.'"

Approval • P2b data • Osteosarcoma

OS Therapies, Inc…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). (Newsfile) - "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. The Phase 3 study has received substantial support from international KOLs as part of regulatory meetings and is expected to commence late in the third quarter in Australia making the Company eligible for regulatory decisions in the fourth quarter...'MHRA and TGA are allowing us to initiate the Phase 3 trial with the same drug product used in the Phase 2b trial, positioning the Phase 3 trial to open in the third quarter of 2026.'"

FDA event • New P3 trial • Osteosarcoma

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… (Newsfile)

P2b data • Osteosarcoma

Upcoming 2nd Quarter Milestones (FinancialContent) - "FDA Pre-BLA Type B meeting to gain alignment on surrogate clinical efficacy endpoints based on most up-to-date Phase 2b clinical, biomarker and CMC, following the December 2025 alignment achieved non-clinical and safety data; Regenerative Medicine Advanced Therapy designation ('RMAT' - FDA equivalent to EMA ATMP designation) decision to be based upon preliminary evidence of efficacy supported by clinical and biomarker data metrics aligned upon; FDA rolling review decision based upon pre-BLA meeting outcome; FDA Type C meeting to gain alignment on the design of the confirmatory Phase 3 study; Submission of the Accelerated Approval BLA request to FDA."

FDA event • FDA filing • New P3 trial • Osteosarcoma

Upcoming 2nd Quarter Milestones (FinancialContent) - "The Company is seeking to obtain a BLA under the Accelerated Approval Program for OST-HER2 in osteosarcoma in the second half of 2026, in addition to CMAs in...the U.K. and Australia....MHRA meeting to gain alignment on the design of the confirmatory Phase 3 study Submission of CMA request to MHRA; MHRA rolling review decision based on Phase 3 confirmatory study design alignment; Submission of CMA request to Australia in conjunction with Clinical Trial Notification (CTN) request for confirmatory Phase 3 study."

Approval • MHRA approval • New P3 trial • Osteosarcoma

OS Therapies Announces EMA Initiates Rolling Review of Conditional Marketing Authorization Application for OST-HER2 in the Prevention or Delay of Recurrence in Fully Resected Pulmonary Metastatic Osteosarcoma (FinancialContent) - "OS Therapies and EMA have agreed that 3-year overall survival data will serve as the basis to complete evaluation of the CMA request. The Company's recently submitted clinical efficacy data includes 2-year overall survival data, with EMA requesting updated 2.5-year overall survival data that will be available by the middle of the second quarter of 2026, and 3-year overall survival data that will become available early in the fourth quarter of 2026, which will complete the CMA submission. The Company anticipates a potential CMA decision by EMA in the fourth quarter of 2026."

EMA approval • EMA filing • P2b data • Osteosarcoma

OS Therapies…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 (the 'OST-HER2 Immune Signature') as a surrogate clinical efficacy endpoint (Yahoo Finance)

Biomarker • Solid Tumor

OS Therapies Files New Patent Application Covering Biomarkers of the Immune Response to Listeria Monocytogenes (Newsfile) - "The Company will host a conference call later in April 2026 to review OST-HER2 Phase 2b's new treatment response biomarker signature data showing correlation with clinical outcomes, and its regulatory implications in upcoming Q2-2026 meetings and regulatory submissions with the U.S. Food & Drug Administration (FDA), the European Medicines Agency (EMA), the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) and the Australian Therapeutic Goods Administration (TGA). The Company will complete the first complete OST-HER2 regulatory market access filing in the world to the EMA, at its request, on April 30, 2026."

EMA filing • P2b data • Patent • Osteosarcoma

OS Therapies Granted Meetings with U.S. FDA, U.K. MHRA, EMA and Australian Therapeutic Goods Administration to Review Global Confirmatory Phase 3 Trial for OST-HER2 in Metastatic Osteosarcoma (Yahoo Finance) - "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...The Company is seeking to receive a BLA in the U.S. and CMAs in the U.K. & in Europe in the second half of 2026. The Company remains on track to deliver to FDA the clinical and biomarker data it requested in preparation for the Company's upcoming Type B Pre-BLA Meeting by the end of the first quarter of 2026. The company has also commenced preparatory market access activities in Europe, including the Health Technology Assessment (HTA) process...The Company is seeking to obtain a BLA under the Accelerated Approval Program for OST-HER2 in osteosarcoma in the second half of 2026."

EMA approval • FDA approval • FDA event • MHRA approval • New P3 trial • Osteosarcoma

OS Therapies Completes Submission of Biomarker & Clinical Data for U.S. FDA Pre-BLA Meeting... (Newsfile) - "The Company expects the Pre-BLA Meeting to occur in May 2026....The Company is seeking to obtain a BLA under the Accelerated Approval Program for OST-HER2 in osteosarcoma in the second half of 2026."

FDA approval • FDA filing • Osteosarcoma

OS Therapies, Inc…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 resected osteosarcoma in the European Union (EU) at CAT's 18-20th March 2026 meeting. (OS Therapies Press Release) - "The Company is finalizing the preparation of a CMA submission to EMA for OST-HER2 in the prevention or delay of recurrent, fully-resected, pulmonary metastatic osteosarcoma....The Company is seeking to obtain a BLA under the Accelerated Approval Program for OST-HER2 in osteosarcoma in the second half of 2026."

European regulatory • FDA approval • Osteosarcoma

OS Therapies...Reports Full Year 2025 Financial Results and Provides Business Update (Newsfile) - "'Now that the data is with FDA, we are focused on completing our pending Marketing Authorization Application requests to U.K.'s Medicines and Healthcare products Regulatory Agency and the European Medicines Agency in April 2026 with the expectation that we will receive approval decisions in each of these three jurisdictions in the second half of 2026.'"

EMA approval • EMA filing • MHRA approval • MHRA filing • Osteosarcoma

OS Therapies Announces FDA OST-HER2 Type D Meeting Elevated to Type B Pre-BLA Meeting (FinancialContent) - "FDA elevated OS Therapies' Type D Biomarker Meeting to a Type B pre-BLA Meeting, expected to occur shortly after the Company completes submission of its clinical data package to the agency, targeted for the end of the first quarter of 2026....FDA's elevated meeting status signals transition from biomarker data discussions to Accelerated Approval discussions."

FDA event • Osteosarcoma