Lovaxin B (OST-HER2) / OS Therapies - LARVOL DELTA

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

OS Therapies Submits Request for Regenerative Medicine Advanced Therapy (RMAT) Designation to U.S. FDA for OST-HER2 in the Prevention of Metastases in Recurrent, Fully-Resected, Lung Metastatic Pediatric Osteosarcoma (Businesswire) - "OS Therapies Inc...announced it has submitted a request for Regenerative Medicine Advanced Therapy (RMAT) Designation to U.S. FDA for OST-HER2 in the prevention of metastases in recurrent, fully-resected, lung metastatic pediatric osteosarcoma....If OST-HER2 receives a conditional BLA via Accelerated Review prior to September 30, 2026, the Company will become eligible to receive a Priority Review Voucher (PRV) that it intends to immediately sell....The Company is awaiting feedback by mid-June 2025 from a Type D meeting with FDA regarding the statistical analysis plan to be used in an End of Phase 2 meeting for OST-HER2 in the prevention of metastases in recurrent, fully-resected, lung metastatic pediatric osteosarcoma. Upon receipt of the Type D Meeting feedback, the Company intends to promptly request the End of Phase 2 meeting with FDA in which it will be seek agreement to allow it to begin a rolling BLA submission in the third quarter of 2025."

FDA event • Osteosarcoma

OS Therapies Reports First Quarter 2025 Financial Results and Provides Business Update (Businesswire) - "Upcoming 2025 Milestones...EMA National Competent Authority Scientific Advice Meeting Request (Medicines Evaluation Board, Netherlands) for OST-HER2 osteosarcoma program, EMA PRIME, EMA-FDA Parallel Scientific Advice application and EMA Conditional Marketing Authorisation application & decision....The Company recorded a net operating loss of $3.876 million in the first quarter of 2025 compared with a net operating loss of $1.490 million in the first quarter of 2024. The increase in net loss was largely due to expenses associated with closing of the OST-HER2 Phase 2b osteosarcoma trial and expenses associated with initiating regulatory affairs activities associated with seeking Accelerated Approval with US FDA for OST-HER2 in osteosarcoma."

Commercial • European regulatory • Osteosarcoma

Upcoming 2025 Milestones - "Feedback from Type D meeting with the FDA on the proposed statistical analysis plan of the OST-HER2 osteosarcoma program that will be used to support pending Accelerated Approval, Regenerative Medicine Advanced Therapy and Breakthrough Therapy designation requests on or before June 16, 2025; Presentation of the OST-HER2 Phase 2b osteosarcoma program data analyzed based upon FDA feedback at MIB Factor on June 28, 2025; End of Phase 2 Meeting with FDA in Q3 2025 to review OST-HER2 Phase 2b osteosarcoma program data Projected BLA submission in Q3 2025 for OST-HER2 in the prevention of recurrent, fully resected, lung metastatic pediatric osteosarcoma; Summer 2025 Scientific Advice Meeting (SAM) with MHRA for OST-HER2 osteosarcoma program, ILAP application submission and MHRA Conditional Marketing Authorisation application & decision."

FDA event • FDA filing • MHRA filing • P2b data • Osteosarcoma

OS Therapies Announces Issuance of U.S. Patent #12,239,738 Protecting Commercial Manufacturing Market Exclusivity for OST-HER2 in Rare Pediatric Cancer Osteosarcoma and Full Listeria Cancer Immunotherapy Platform into 2040 (BioSpace) - "OS Therapies...today announced the issuance of United States Patent #12,230,738 protecting proprietary commercial manufacturing methods for the Company’s listeria monocytogenes (Lm) cancer immunotherapy platform technology into 2040. The Company is seeking to gain FDA approval for lead asset OST-HER2 in the treatment of pediatric recurrent, fully-resected, lung metastatic osteosarcoma by the end of 2025...Phase 2-stage OST-503 for NSCLC & GBM, Phase 1-stage OST-504 for Prostate cancer, 8 pre-clinical stage immunotherapy candidates are also protected under this patent."

Patent • Glioblastoma • Non Small Cell Lung Cancer • Osteosarcoma • Prostate Cancer

OS Therapies FDA Meeting Request Granted (Businesswire) - "OS Therapies...announced that the US Food & Drug Administration ('FDA') granted the Company’s meeting request to gain alignment on the surrogate endpoint to support Breakthrough Therapy Designation & Accelerated Approval of OST-HER2 in the Prevention of Recurrence of Fully Resected, Lung Metastatic Osteosarcoma. FDA granted a written response-only meeting and confirmed that its response would be received by mid-June 2025, in time for the Company to present the statistical analysis as part of the keynote presentation closing out major osteosarcoma conference MIB Factor on June 28, 2025 at 3:30pm MDT."

FDA event • Osteosarcoma

OS Therapies Requests Meeting with FDA to Gain Agreement on Surrogate Endpoint(s) for Breakthrough Therapy Designation & Accelerated Approval of OST-HER2 in the Prevention of Recurrence of Fully Resected, Lung Metastatic Osteosarcoma (Businesswire) - "OS Therapies applies for meeting per FDA suggestion received on April 2, 2025....OS Therapies...today announced that it has submitted a request for a formal meeting with the Center for Biologics Evaluation and Research (CBER) of the United States Food & Drug Administration (FDA) to gain alignment on the clinical endpoints required to support Breakthrough Therapy Designation (BTD) and Accelerated Approval...The meeting is expected to occur in the second quarter of 2025, and thereafter the Company intends to initiate a rolling BLA submission with the potential to receive Accelerated Approval as early as year-end 2025. The Company has sufficient cash on hand to operate into mid-2026....OST-HER2 has received Rare Pediatric Disease Designation (RPDD) for osteosarcoma from the US FDA, and if it receives a conditional BLA via Accelerated Review prior to September 30, 2026, it will become eligible to receive a Priority Review Voucher (PRV) that it intends to immediately sell."

FDA event • FDA filing • Osteosarcoma

OS Therapies Provides Regulatory Update on Rare Pediatric Cancer Immunotherapy Candidate OST-HER2 for Human Osteosarcoma (Businesswire) - "FDA: Q1/25: Regulatory communication regarding endpoints for accelerated approval; Q2/25: End of Phase 2 Meeting; Q3/25: Initiation of rolling BLA submission; Q4/25: Conditional BLA via Accelerated Approval Program. MHRA: Q1/25: Scientific Advice Meeting requested and granted; Q3/25: Scientific Advice Meeting with MHRA and ILAP application submission; Q4/25: Application for joint Scientific Advice Meeting with MHRA and National Institute for Health and Care Excellence (NICE); Q4 25: MHRA Conditional Marketing Authorisation application."

European regulatory • FDA event • FDA filing • MHRA filing • Osteosarcoma

OS Therapies Provides Regulatory Update on Rare Pediatric Cancer Immunotherapy Candidate OST-HER2 for Human Osteosarcoma (Businesswire) - "EMA: Q2/25: EMA National Competent Authority Scientific Advice Meeting Request (Medicines Evaluation Board, Netherlands); Q3/25: EMA PRIME and EMA Orphan Designation applications; Q4/25: EMA-FDA Parallel Scientific Advice application; Q1 26: EMA Conditional Marketing Authorisation application."

EMA filing • European regulatory • Orphan drug • Osteosarcoma

OS Therapies’ OST-HER2 Immunotherapy for Osteosarcoma Featured in Upcoming Movie Shelter Me: The Cancer Pioneers (Businesswire) - "OS Therapies...announced that OST-HER2 is featured in the upcoming movie Shelter Me: The Cancer Pioneers. The movie offers a look into canine comparative oncology, a field that compares treatment of cancers in dogs to those in people, and covers developing treatments for rare forms of cancer.... The movie will premiere on April 3, 2025 at AMC Century City in Los Angeles and will be available to stream through the PBS app and on PBS.org starting in May."

Commercial • Osteosarcoma

OS Therapies Awarded OST-HER2 Clinical Trial Data Presentation at MIB Agents FACTOR Osteosarcoma Conference (Businesswire) - "OS Therapies, Inc...today announced that it has been awarded a presentation slot at the MIB Agents Factor Osteosarcoma Conference to be held June 26-28, 2025 in Salt Lake City, Utah. Key data will be presented from the Company’s Phase 2b clinical trial of OST-HER2 in the prevention of recurrent, fully resected, lung metastatic osteosarcoma...The Company reiterates its intention to submit a BLA with FDA for OST-HER2 in osteosarcoma in the second quarter of 2025, positioning it to receive approval in the fourth quarter of 2025."

FDA approval • FDA filing • P2b data • Osteosarcoma

OS Therapies Schedules United Kingdom’s Medicines and Healthcare products Regulatory Agency's (MHRA) Scientific Advice Meeting in the Third Quarter of 2025 for Review of its OST-HER2 Immunotherapy Candidate for Osteosarcoma (Businesswire) - "OS Therapies, Inc...announced that it has scheduled a Scientific Advice Meeting (SAM) in the third quarter of 2025 to discuss the Innovative Licensing and Access Pathway (ILAP) with the United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) for OST-HER2, its immunotherapy candidate for the prevention of recurrence of metastases in osteosarcoma. The Company released positive Phase 2b data in January 2025 that demonstrates statistically significant results in the primary endpoint of the study, 12-month event free survival (EFS). The meeting with MHRA has been scheduled to position the Company to bring OST-HER2 to market in the UK in 2025."

European regulatory • Osteosarcoma

OS Therapies Receives Patent Notice of Allowance from U.S. Patent & Trademark Office Covering Commercial Manufacturing of OST-HER2 (Businesswire) - "OS Therapies....today announced that it received a Notice of Allowance from the United States Patent & Trademark Office (USPTO) that a patent will be issued covering the manufacturing methods required for the OST-HER2 commercial product. The USPTO granted a Patent Term Adjustment of 572 days, providing market exclusivity for the OST-HER2 commercial drug product into 2040. OS Therapies is preparing to initiate discussions with the United States Food & Drug Administration (FDA) following the successful treatment phase of its Phase 2b clinical trial in the prevention of recurrent, resected, lung metastatic osteosarcoma with a view towards submitting a Biologics Licensing Application (BLA) and gaining conditional or accelerated FDA approval in 2025. The Company recently completed a $7.1 million financing in January 2025 and has sufficient capital into mid-2026."

FDA filing • Financing • Patent • Osteosarcoma • Sarcoma • Solid Tumor

Immunological responses and clinical outcomes in pet dogs with osteosarcoma receiving standard of care therapy and a recombinant Listeria vaccine expressing HER2/neu. (PubMed, Mol Ther) - "In conclusion, although ADXS31-164c did not significantly extend DFI or OS, immune responses to ADXS31-164c distinguished elite from short-term survivors. Improvement of immune responses over sequential ADXS31-164c administrations supports a future trial design of recurrent immunizations to improve outcomes of otherwise short-term survivors."

Clinical data • Journal • Oncology • Osteosarcoma • Sarcoma • Solid Tumor • HER-2 • IL6 • TNFA

OS Therapies Initiates Commercial-ready Manufacturing of OST-HER2 to Support Anticipated Biologics Licensing Authorization (BLA) Filing (Businesswire) - "OS Therapies, Inc...announced that it has entered into agreements for the commercial manufacture of OST-HER2. The Company is currently organizing additional data in relation to the recently-completed treatment phase of its Phase 2b trial of OST-HER2 in the prevention of recurrence of lung metastatic osteosarcoma in preparation for a Type B or Type C meeting with the US Food & Drug Administration ('FDA'). Following the FDA meeting, the Company anticipates that it will be submitting a Biologics Licensing Authorization (BLA) application to the FDA for accelerated or conditional approval consideration."

Commercial • Osteosarcoma

OS Therapies Agrees to Acquire All Listeria Monotygenes-based Immuno-Oncology Programs and IP Assets from Ayala Pharmaceuticals, Adding Phase 2 Lung Cancer and Phase 1 Prostate Cancer Programs to Pipeline (Businesswire) - "OS Therapies, Inc...today announced it has entered into an asset purchase agreement to acquire the listeria monocytogenes-based immuno-oncology programs and related intellectual property (IP) assets from Ayala Pharmaceuticals....The assets being acquired include a Phase 2 lung cancer and Phase1 prostate cancer program, in addition to the gaining direct ownership of the underlying IP related to OS Therapies’ lead asset OST-HER2 for osteosarcoma and other HER2-related indications....OS Therapies anticipates requesting Biologics Licensing Authorization (BLA) for OST-HER2 in osteosarcoma in the second quarter of 2025, and hopes to be granted a BLA and related Priority Review Voucher (PRV) from FDA by the end of 2025."

Commercial • FDA filing • Lung Cancer • Non Small Cell Lung Cancer • Osteosarcoma • Prostate Cancer

AOST-2121: Osteosarcoma Maintenance Therapy With OST31-164 (clinicaltrials.gov) - P2 | N=39 | Active, not recruiting | Sponsor: George Clinical Pty Ltd | Completed ➔ Active, not recruiting | Trial completion date: Sep 2023 ➔ Oct 2027

Enrollment closed • Trial completion date • Oncology • Osteosarcoma • Sarcoma • Solid Tumor

OS Therapies Announces Phase 2b Clinical Trial of OST-HER2 Achieves Primary Endpoint with Statistical Significance in the Prevention of Recurrent, Fully Resected, Lung Metastatic Osteosarcoma (Businesswire) - P2b | N=39 | NCT04974008 | "The data demonstrate statistically significant results in the primary endpoint of the study, 12-month event free survival (‘EFS’), where an event is defined as the recurrence of metastatic osteosarcoma, in OST-HER2-treated patients when compared with the leading published historical comparable control group. Further as of the most recent follow up, the data show a strong trend in favor of OST-HER2-treated patients in overall survival (‘OS’, remaining alive) at the 1-year and 2-year interim timepoints of the ongoing 3-year overall survival secondary endpoint. Notably, all patients who achieved the primary 12-month EFS endpoint remain alive....Primary Endpoint of 12-month EFS: 33% for OST-HER2 vs. 20% for historical control1 (p = 0.0158). Interim Analysis of Ongoing Secondary Endpoint, OS: 1-year OS: 91% for OST-HER2 vs. 80% for historical control2 (p = 0.0700); 2-year OS: 61% for OST-HER2 vs. 40% for historical control2 (p = 0.0576)."

P2b data • Osteosarcoma

OS Therapies Partners with B2i Digital to Engage with Biotech Investors Online (Businesswire) - "OS Therapies, Inc...has partnered with B2i Digital to enhance investor outreach. B2i Digital will implement data-driven strategies to raise awareness about OS Therapies' pioneering research and upcoming milestones, including its potentially pivotal Phase 2b clinical trial for OST-HER2 in the rare pediatric orphan disease recurrent, resected metastatic osteosarcoma....B2i Digital will highlight OS Therapies' lead candidate, OST-HER2, an off-the-shelf immunotherapy designed to activate the immune system to target HER2-positive cancer cells. The Phase 2b trial for OST-HER2 in recurrent, resected metastatic osteosarcoma has completed enrollment and all patient visits, with the next clinical data update expected to be announced during the week of the JP Morgan Healthcare Conference 2025."

Commercial • P2b data • Osteosarcoma • HER-2

OS Therapies Announces Pricing of $6 Million Private Placement (Businesswire) - "OS Therapies, Inc...announced that it has entered into securities purchase agreements with investors to sell 1.5 million units at a price of $4.00 per unit, with each unit consisting of one share of Series A Senior Convertible Preferred Stock...initially convertible into one share of common stock and one warrant to purchase one share of common stock, expected to yield gross proceeds to the Company of $6 million, before deducting offering-related expenses....The Company intends to use the proceeds from the private placement for working capital, primarily focused on the clinical and regulatory milestones to support commercialization of the Company’s lead therapeutic candidate OST-HER2 in the treatment of recurrent, resected metastatic osteosarcoma in the United States in 2025, and for general corporate purposes."

Financing • Osteosarcoma