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

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

OS Therapies Provides Clinical & Global Regulatory Updates (Newsfile) - "The Company announced that the End of Phase 2 Meeting granted by the US Food & Drug Administration ("FDA") to review the clinical data from its OST-HER2 recurrent, pulmonary metastatic osteosarcoma program is scheduled for August 27, 2025, during which the Company expects to seek alignment with FDA to begin a rolling review Biologics Licensing Application ('BLA') submission to FDA under its Accelerated Approval Program ('Accelerated Approval')...Further, the Company announced that it has a confirmed a Scientific Advice Meeting ('SAM') with a European Medicines Agency ('EMA') rapporteur with respect to the OST-HER2 osteosarcoma program...The Company also announced that it intends to pursue a Conditional Marketing Authorization ('CMA') in the United Kingdom via the Medicines and Health products Regulatory Agency's ('MHRA') Innovative Licensing and Access Pathway ('ILAP') in the event of a successful previously disclosed July 31st, 2025 UK SAM Meeting."

European regulatory • FDA event • Osteosarcoma

OS Therapies Granted End of Phase 2 Meeting by US FDA for OST-HER2 Program in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma (Businesswire) - "OS Therapies...announced it was granted an End of Phase 2 Meeting by the United States Food & Drug Administration ('FDA') to review the OST-HER2 program in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma. The Company expects the meeting to occur in the third quarter of 2025. The End of Phase 2 Meeting marks a pivotal point in the drug development process, and a significant milestone towards market access. The Company intends to seek alignment with FDA to begin a Rolling Review process for the forthcoming Biologics Licensing Application ('BLA') submission for OST-HER2...Under the RPDD program, if the Company receives Accelerated Approval prior to September 30, 2026, it will become eligible to receive a Priority Review Voucher (PRV) that it intends to sell."

FDA event • Osteosarcoma

OS Therapies Presents Statistically Significantly Positive 1-Year Event Free Survival, Overall Survival and Safety Clinical Data Updates for OST-HER2 at the MIB Agents Factor Osteosarcoma Conference (Businesswire) - P2 | N=39 | NCT04974008 | "In data presented by Principal Investigator Dr. Damon Reed at the MIB Factor Osteosarcoma Conference held in Salt Lake City, Utah on Saturday June 28, 2025 the following data updates were released: 35% (14 out of 40) of OST-HER2-treated patients achieved 1-year event free survival (EFS) compared with 20% of patients from peer-reviewed publication selected by Children’s Oncology Group (COG)1 as equivalent to osteosarcoma patient subpopulation enrolled (p = 0.0194); A total of 13 out of 40 patients were reported to have experienced severe adverse events (SAEs) during the trial, of which 7 patients’ adverse events were treatment-associated adverse events (TSAEs). All of the 7 patients’ TSAEs were grade 3 TSAEs; 0 patients experienced grade 4 or grade 5 TSAEs. None of the patients for whom TSAEs were reported discontinued the study."

P2b data • Osteosarcoma

OS Therapies Presents Statistically Significantly Positive 1-Year Event Free Survival, Overall Survival and Safety Clinical Data Updates for OST-HER2 at the MIB Agents Factor Osteosarcoma Conference (Businesswire) - "Additionally, the Company today announced a regulatory update regarding the submission of preliminary external control data and comprehensive plans for the finalization of this data package to the US Food & Drug Administration’s ('FDA')...The Company has submitted clarifying information to FDA Type D Meeting feedback requests regarding proposed statistical methods to be used in FDA’s assessment of external control arm(s) suitable to support Accelerated Approval....Concurrent with this announcement, the United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has agreed to support the Company in utilizing its Clinical Practice Research Datalink (CRPD) to assist the Company in developing data necessary to support potential worldwide marketing authorizations – including in the UK, US and EU - for OST-HER2."

Commercial • FDA event • Osteosarcoma

OS Therapies Receives Positive FDA Meeting Feedback on Regulatory Pathway for Accelerated Approval of OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pediatric Lung Metastatic Osteosarcoma (Businesswire) - "OS Therapies...announced that it received positive written feedback from the US Food & Drug Administration ('FDA') Type D Meeting that occurred in mid-June 2025 regarding endpoints required to support an Accelerated Approval Program marketing application for its Phase 2b trial of OST-HER2 in the prevention or delay of recurrence in fully resected, pediatric lung metastatic osteosarcoma. The Company reiterates that additional data from its Phase 2b trial will be presented at the major osteosarcoma conference MIB Factor in Salt Lake City on Saturday June 28, 2025 at 3:30pm MDT. Concurrent with this announcement, the Company announced that it has submitted End of Phase 2 Meeting and Breakthrough Therapy Designation (BTD) requests to FDA based on the positive Type D Meeting feedback. The End of Phase 2 Meeting is expected to occur in the third quarter of 2025."

FDA event • P2b data • Osteosarcoma

OS Therapies teams up with EVERSANA for cancer drug launch (Investing.com) - "OS Therapies Inc...announced a partnership with EVERSANA, a provider of global commercial services to the life sciences industry, to facilitate the U.S. commercialization of OST-HER2....A Biologics License Application (BLA) rolling submission is expected to commence in the third quarter of 2025, with potential approval by the end of the same year....EVERSANA will deploy its EVERSANA ONCOLOGY Commercialization model to increase awareness and access to OST-HER2 among healthcare providers. The model encompasses market access, medical affairs, field deployment, patient services, and stakeholder engagement, aiming to accelerate the delivery of OST-HER2 to patients."

Licensing / partnership • Osteosarcoma