Lovaxin B (diznalimgene lisbac) / OS Therapies - LARVOL DELTA

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, 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 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

The Company [OS Therapies Inc] announced that it has been informed that Ayala Pharmaceuticals, Inc. ('Ayala') has informed its shareholders that Ayala is dissolving. (Newsfile) - "The Company acquired all listeria-based clinical, pre-clinical and intellectual property assets from Ayala in April 2025, issuing to Ayala the equivalent of 4.8 million shares of OS Therapies common stock that became eligible for trading on October 9, 2025."

Commercial • Osteosarcoma

The Company [OS Therapies Inc] disclosed that it is assembling a meeting of U.S., U.K. and European osteosarcoma key opinion leaders to review the clinical and biomarker data from the Human Metastatic Osteosarcoma Program and provide input on proposed confirmatory trial designs for the Company's confirmatory clinical development program. (Newsfile) - "The Company is seeking a BLA under the Accelerated Approval Program ('Accelerated Approval') in the U.S. and conditional MAAs in the U.K. and Europe, which all require confirmatory studies to be initiated prior to approval. The Company anticipates initiating the confirmatory trial in the third quarter of 2026 with the opening of a single site that allows it to meet the Accelerated Approval statutory requirement, with broader site activation expected following regulatory approval."

New trial • Osteosarcoma

OS Therapies Provides Global Regulatory Update for OST-HER2 in Recurrent, Fully Resected, Pulmonary Metstatic Osteosarcoma (Newsfile) - "Following the submission of the Non-Clinical and Chemistry, Manufacturing & Controls (CMC) modules of its Biologics License Application (BLA) to U.S. Food & Drug Administration (FDA) at the end of January 2026, the Company anticipates releasing additional biomarker data from its Human Metastatic Osteosarcoma Program in the first quarter of 2026...The Company expects to complete conditional Marketing Authorisation Application (MAA) submissions to both the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) by the end of the first quarter of 2026. The Company remains on track to submit the Clinical BLA module to the FDA following an anticipated Type D meeting expected to occur in March 2026."

Clinical data • EMA filing • FDA filing • MHRA filing • Osteosarcoma

OS Therapies Initiates US FDA BLA Filing for OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma (OS Therapies Press Release) - "Request for FDA Rolling Review submitted to FDA on January 30, 2026; Non-Clinical and CMC BLA modules submitted to FDA; At 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 canines; Final 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 data; Company remains on track to be eligible to receive Priority Review Voucher under Rare Pediatric Disease Designation (RPDD) with approval anticipated by September 30, 2026."

FDA event • FDA filing • Osteosarcoma

OS Therapies Announces Positive Biomarker Data from Phase 2b Clinical Trial of OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma (FinancialContent) - "Activation of immune blood biomarkers in the interferon gamma pathway was predictive of overall survival, distinguishing long term survivors (>=2 years) from short-term survivors (<1year)."

P2b data • Osteosarcoma

OS Therapies Enters into Warrant Inducement Agreements (Yahoo Finance) - "The gross proceeds raised provide the Company runway into 2027, and the Company expects to use the net proceeds to support regulatory filings and commercial preparation activities related for OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma in the U.S., UK and European Union (the 'Human Metastatic Osteosarcoma Program'), to provide funding for the Company's wholly owned subsidiary OS Animal Health's proposed spinoff transaction preparations, and general corporate purposes."

Financing • Osteosarcoma

OS Therapies Provides First Half 2026 Corporate Outlook (Newsfile) - "UK and EU Marketing Authorisation Application (MAA) submissions for conditional approval expected by end of February 2026 and March 2026, respectively...Company expects to participate in multiple H1 2026 meetings with U.S. FDA, U.K. MHRA and Europe's EMA as part of processes to gain regulatory approvals...The Company expects to release biomarker data from its Phase 2b human clinical trial of OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma during the week of the J.P. Morgan Healthcare Conference 2026....the Company anticipates the potential to receive regulatory approval for OST-HER2 in the U.K. in Q2 2026, in the United States in Q3 2026 and in Europe by the end of Q4 2026."

Approval • Filing • P2b data • Osteosarcoma

OS Therapies Announces Successful Type C Meeting with US FDA Regarding Phase 2b Clinical Trial of OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma (Newsfile) - "FDA suggested a confirmatory study design to include additional osteosarcoma disease settings such as prevention of recurrence following primary tumor resection, where a randomized controlled study may be feasible and that the confirmatory study would have to be underway prior to granting a BLA...FDA requested follow-up meeting once the forthcoming pre-specified immune activation biomarker analysis is available...The Company expects to complete the proposed pre-specified immune activation biomarker analysis in the forthcoming weeks, with data expected to be made public during the week of the JP Morgan Healthcare Conference in January 2026. The Company reiterates that it intends to submit BLA for Accelerated Approval by the end of January 2026."

FDA event • FDA filing • P2b data • Osteosarcoma

OS Therapies Announces Successful pre-Marketing Authorisation Application Meeting with UK MHRA Regarding the Phase 2b Clinical Trial of OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma (Newsfile) - "Biomarker data advanced as key pre-specified surrogate clinical efficacy endpoint, with pending analysis awaiting alignment with US FDA on biomarker statistical analysis plan to be discussed at upcoming December 11, 2025 FDA Type C Meeting...The Company achieved full alignment with its pre-meeting objectives related to non-clinical, CMC (chemistry, manufacturing, and controls) and post-market authorization confirmatory study design....The Company reiterated that it expects to submit a conditional MAA for the Metastatic Osteosarcoma Program to MHRA by the end of January 2026."

FDA event • MHRA filing • Osteosarcoma

OS Therapies Inc….announced the United States Food & Drug Administration (FDA) granted the Company waiver of the application fee for BLA 125867 for OST-HER2. - "Additionally, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use ('CHMP') granted Union Marketing Authorisation eligibility for OST-HERs in the prevention or delay of recurrent, fully-resected, pulmonary metastatic osteosarcoma (the 'Metastatic Osteosarcoma Program'). EMA CHMP requested an accelerated Marketing Authorisation Application ('MAA') submission for the Metastatic Osteosarcoma Program by February 28, 2026....the Company has completed pre-meeting submissions to the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) for its pre-MAA meeting on December 8, 2025 and its Type C Meeting with the FDA on December 11, 2025."

CHMP • FDA event • Regulatory • Osteosarcoma

Upcoming 2025 Milestones (OS Therapies Press Release) - "Type C with FDA scheduled for December 11, 2025 to address key items following August 27, 2025 End of Phase 2 Meeting about Phase 2b clinical trial of OST-HER2 in preparation for January 2026 BLA filing; UK MHRA pre-MAA meeting scheduled for December 8, 2025 in preparation for January 2026 MAA filing."

FDA event • FDA filing • MHRA filing • Osteosarcoma

OS Therapies Inc…announced that the International Nonproprietary Names (INN) Expert Committee of the World Health Organization (WHO) approved 'daznelimgene lisbac' for the non-proprietary name for the Company's HER2 targeted Listeria monocytogenes-based cancer immunotherapy product candidate OST-HER2. (FinancialContent) - "OS Therapies will begin to transition towards the use of diznalimgene lisbac alongside the OST-HER2 in future communications."

Commercial • Osteosarcoma

OS Therapies Granted Final Type C Meeting by U.S. FDA and pre-MAA Meeting by U.K. MHRA for OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma (Newsfile) - "The primary purpose of the meeting is to gain alignment on the clinical efficacy data endpoints to support a Biologics Licensing Application ('BLA') under the Accelerated Approval Program ('Accelerated Approval') for OST-HER2 following a successful Phase 2b clinical trial in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma (the 'Metastatic Osteosarcoma Program'). The meeting is scheduled for December 11, 2025, which allows for sufficient time for the Company to receive biomarker data from the Phase 2b trial to correlate immune activation with clinical outcomes....The Company will be reviewing the data it has submitted as part of an expected rolling review process targeted to begin in November 2025."

FDA event • MHRA filing • Osteosarcoma

OS Therapies Announces Statistically Significant Positive Final 2-Year Overall Survival Data from Phase 2b Trial of OST-HER2 in the Prevention or Delay of Recurrent, Fully-Resected, Pulmonary Metastatic Osteosarcoma (Newsfile) - "75% (27 out of 36 evaluable patients; 5 patients were lost to follow-up) of OST-HER2 treated patients achieved 2-year overall survival as measured from most recent pulmonary resection, compared with 40% of historical control patients (p < 0.0001) Subgroup analyses showed that 100% of patients who achieved 12-month Event Free Survival (EFS) achieved 2-year overall survival, whereas 59% of patients who did not achieve EFS achieved 2-year overall survival."

P2b data • Osteosarcoma

OS Therapies Inc…announced a positive regulatory update following an October 6, 2025 meeting with its European Medicines Agency (EMA) rapporteur, the Dutch Medicines Evaluation Board (MEB). (Newsfile) - "During the meeting, OS Therapies and the Dutch Rapporteur aligned on key areas, including safety, non-clinical and chemistry, manufacturing, and controls (CMC) data in support of the Company's ongoing OST-HER2 Phase 2b clinical trial in the prevention or delay of recurrent, fully-resected, pulmonary metastatic osteosarcoma. The Rapporteur advised that the overall survival results, demonstrating statistically significant, final two-year data, may serve as an appropriate primary endpoint for consideration of conditional marketing authorization (CMA)."

European regulatory • Osteosarcoma

UK MHRA conditional MAA and US FDA Biologics Licensing Application (BLA) submissions expected to be completed within 30 days of each other, between December 2025 and January 2026 (OS Therapies Press Release) - "Company updates sequence of OST-HER2 regulatory submissions, prioritizing UK MHRA conditional Marketing Authorisation Application (MAA) submission following positive August 2025 Scientific Advice Meeting feedback from UK MHRA....Company to propose use of immune activation biomarker coupled with overall survival data as surrogate efficacy endpoint to support Accelerated Approval in Type C Meeting invited by FDA, following positive End of Phase 2 Meeting and follow-up interactions."

FDA filing • MHRA filing • Osteosarcoma

…the Company announced that updated 2-year overall survival data from all 40 patients in the Company's Phase 2b clinical trial of OST-HER2 in the prevention of delay of recurrent, fully resected, pulmonary metastatic osteosarcoma (NCT04974008) to be released on October 10, 2025. (Newsfile)

P2b data • Osteosarcoma

OS Therapies…Provides Business Update (OS Therapies Press Release) - "End of Phase 2 Meeting with FDA scheduled for August 27, 2025 regarding the OST-HER2 osteosarcoma program that is anticipated to provide the Company with the necessary insight to allow it to begin a rolling BLA submission; Projected initiation of BLA submission in late Q3 2025 for OST-HER2, targeting the prevention of recurrent, fully resected, lung metastatic pediatric osteosarcoma following End of Phase 2 Meeting with FDA."

FDA event • FDA filing • Osteosarcoma

OS Therapies…Provides Business Update (OS Therapies Press Release) - "Upcoming 2025 Milestones: Rapporteur meeting with EMA scheduled for October 2025; Potential regulatory approval for OST-HER2 in the prevention or delay or recurrent, pulmonary metastatic osteosarcoma in the U.S. and U.K. as early as year-end 2025."

European regulatory • FDA approval • MHRA approval • Osteosarcoma

OS Therapies Advances Toward 2026 Osteosarcoma Therapy Launch Following FDA Recognition and Clinical Milestones (City Buzz) - "OS Therapies has secured a U.S. commercial partnership with Eversana and is positioning for a potential launch in the first half of 2026."

Launch US • Osteosarcoma

OS Therapies Provides OST-HER2 Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma Program Update Following FDA End of Phase 2 Meeting (OS Therapies Press Release) - "The Company remains on track to begin rolling submission of a Biologics Licensing Application ('BLA') request to FDA for the Metastatic Osteosarcoma Program in September 2025....FDA committed to working closely with the Company by prioritizing formal and informal meetings, with the first informal meeting scheduled for mid-September 2025....Additionally, the Company received confirmation from FDA that it is eligible for a Prescription Drug User Fee Act ('PDUFA') small business fee waiver, with a final decision on the PDUFA fee waiver anticipated by the end of the third quarter of 2025. FDA has also accepted the Company’s Expression of Interest for the Commissioner’s National Priority Voucher (CNPV)."

FDA event • FDA filing • Osteosarcoma

OS Therapies Announces Statistically Significant Positive Interim 2-Year Overall Survival Data from Phase 2b Clinical Trial of OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma (Newsfile) - P2 | N=39 | NCT04974008 | "OS Therapies...announced statistically significant positive updated interim 2-year overall survival data from the Company's Phase 2b trial of off-the-shelf immunotherapy candidate OST-HER2 in the prevention of delay of recurrent, fully resected, pulmonary metastatic osteosarcoma. 66.6% (18 out of 27) of OST-HER2 treated patients achieved 2-year overall survival compared with 40% of historical control1 (p = 0.0046)."

P2b data • Osteosarcoma