Request for FDA Rolling Review submitted to FDA on January 30, 2026Non-Clinical and CMC BLA modules submitted to FDAAt 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 caninesFinal 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 updat ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended September 30, 2025 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of event requiring this shell company report: For the transition period from ________ ...

Core Insights - OS Therapies Inc. is positioned to enhance the standard of care for metastatic osteosarcoma with its lead candidate OST-HER2, with significant regulatory submissions planned for 2026 [3][4][5] Regulatory Submissions - The company plans to submit a Biologics License Application (BLA) to the U.S. FDA by the end of January 2026 under the Accelerated Approval Program [4] - Marketing Authorization Applications (MAA) for conditional approval are expected to be submitted to the U.K. MHRA and the European EMA by the end of February 2026 and March 2026, respectively [4][5] Clinical Data and Milestones - Phase 2b biomarker data from the Metastatic Osteosarcoma Program is anticipated to be released during the week of the J.P. Morgan Healthcare Conference in January 2026 [2][12] - The company expects to engage in multiple meetings with regulatory authorities in the first half of 2026 to discuss clinical efficacy endpoints and trial designs [5] Designations and Incentives - OST-HER2 has received Orphan Disease Designation (ODD), Fast Track Designation, and Rare Pediatric Disease Designation (RPDD) from the FDA, making it eligible for a Priority Review Voucher (PRV) if approved before September 30, 2026 [6][9] Future Developments - The company is advancing its OS Animal Health subsidiary towards a go-public transaction, with a confidential SEC filing expected in early January 2026 [7][12] - Additional oncology programs, including OST-503 and OST-504, are also in development, with key meetings with the FDA planned for 2026 [8][12]

Core Viewpoint - OS Therapies Inc. has made significant progress in discussions with the FDA regarding the Phase 2b clinical trial of its lead product candidate, OST-HER2, for the treatment of recurrent pulmonary metastatic osteosarcoma, with plans to submit a Biologics Licensing Application (BLA) by the end of January 2026 [1][2][7]. Company Overview - OS Therapies is a clinical-stage oncology company focused on developing treatments for osteosarcoma and other solid tumors, leading in listeria-based cancer immunotherapies [4]. - OST-HER2 is an innovative immunotherapy that utilizes a bioengineered form of Listeria monocytogenes to elicit a strong immune response against cancer cells expressing HER2 [2][4]. FDA Meeting Highlights - The FDA confirmed that data from single-arm studies in ultra-rare pediatric cancer osteosarcoma could support a BLA under the Accelerated Approval Program [7][8]. - The FDA suggested a confirmatory study design that includes additional osteosarcoma disease settings, such as the prevention of recurrence following primary tumor resection [7][8]. - The FDA indicated that the use of canine data to support the correlation between immune biomarker activation and clinical benefit will depend on the chosen biomarkers and their clinical validation [7][8]. Upcoming Milestones - The company expects to complete the immune activation biomarker analysis soon, with data to be released during the JP Morgan Healthcare Conference in January 2026 [2][3]. - Following the BLA submission, the company plans to hold additional meetings with the FDA to review biomarker data and confirmatory study design [2][3][7].

Core Viewpoint - OS Therapies has successfully completed a pre-Marketing Authorisation Application meeting with the UK MHRA for its Phase 2b clinical trial of OST-HER2, aimed at preventing or delaying recurrent pulmonary metastatic osteosarcoma [2][4] Group 1: Clinical Trial and Regulatory Progress - The company achieved full alignment on key points regarding non-clinical, chemistry, manufacturing, and controls (CMC), and post-market authorization confirmatory study design during the pre-MAA meeting [6] - The company plans to submit a conditional MAA for the Metastatic Osteosarcoma Program to the MHRA by the end of January 2026 [4][6] - A meeting with the US FDA is scheduled for December 11, 2025, to discuss biomarker data analysis, which is crucial for supporting a Biologics Licensing Application under the Accelerated Approval Program [3][6] Group 2: Clinical Efficacy and Future Plans - The Phase 2b clinical trial of OST-HER2 demonstrated statistically significant benefits in the 12-month event-free survival primary endpoint [7] - The company anticipates submitting a Biologics Licensing Application to the US FDA for OST-HER2 in osteosarcoma in the first quarter of 2026, which could lead to eligibility for a Priority Review Voucher [7] - OST-HER2 has received various designations from the US FDA, including Rare Pediatric Disease Designation and Fast-Track designation, indicating its potential significance in treating osteosarcoma [5][7] Group 3: Product Development and Innovation - OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC), known as tunable ADC (tADC), utilizing proprietary technology for enhanced delivery of therapeutic payloads [8]

Core Insights - OS Therapies has received a waiver from the U.S. FDA for the application fee related to BLA 125867 for its lead product OST-HER2, which is a listeria-based cancer immunotherapy [1][6] - The European Medicines Agency (EMA) has granted eligibility for Union Marketing Authorisation for OST-HER2 in the prevention or delay of recurrent, fully-resected pulmonary metastatic osteosarcoma, with a request for an accelerated Marketing Authorisation Application by February 28, 2026 [2] - The company is preparing for pre-Marketing Authorisation Application meetings with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and the U.S. FDA to discuss final commercial considerations and study designs [3][6] Company Overview - OS Therapies is a clinical-stage oncology company focused on developing treatments for osteosarcoma and other solid tumors, leading in listeria-based cancer immunotherapies [4] - OST-HER2 has received multiple designations from regulatory bodies, including Rare Pediatric Disease Designation and Fast-Track and Orphan Drug designations from the U.S. FDA and EMA [4] - The company reported positive results from its Phase 2b clinical trial of OST-HER2, showing statistically significant benefits in the 12-month event-free survival primary endpoint [4] Future Developments - The company anticipates submitting a Biologics Licensing Application (BLA) for OST-HER2 in early 2026, which could lead to eligibility for a Priority Review Voucher [4] - OS Therapies is also advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC), known as tunable ADC (tADC), utilizing proprietary technology for enhanced delivery [5][7]

Core Insights - Sichuan Aoniu New Materials Co., Ltd. has successfully launched its Colorless Polyimide (CPI) project, marking a significant milestone in China's new materials industry [2][3][4] - The CPI project aims to enhance China's self-reliance in high-performance materials, particularly in sectors like aerospace and electronics, which have been dominated by foreign companies [4][5] - The ignition ceremony was attended by over 120 guests, indicating strong industry and governmental support for the initiative [3][4] Company Overview - Sichuan Aoniu New Materials Co., Ltd. was established in 2022 and focuses on the R&D, production, and sales of high-quality Colorless Polyimide (CPI) [7][8] - The company collaborates with the Polymer College of Sichuan University to drive the localization of CPI, assembling a team of domestic and international experts [8] - Aoniu aims to fill the domestic gap in mass production of high-performance polyimide film, providing a stable and high-quality localized solution for downstream industries [4][9] Industry Impact - The CPI film is crucial for high-end flexible displays, foldable smartphones, and aerospace applications, and its production in China is expected to break foreign monopolies [4][5] - The successful ignition and mass production ceremony signifies a shift towards "Made-in-China" CPI, accelerating the pace of domestic substitution in the materials sector [9]

Core Viewpoint - OS Therapies has received approval from the World Health Organization for the non-proprietary name 'daznelimgene lisbac' for its cancer immunotherapy product candidate OST-HER2, which is aimed at treating pulmonary metastatic osteosarcoma [1][2][3]. Company Overview - OS Therapies is a clinical stage oncology company specializing in listeria-based cancer immunotherapies, particularly for osteosarcoma and other solid tumors [3]. - The company is recognized as a leader in listeria-based cancer immunotherapies and is developing OST-HER2 to leverage the immune-stimulatory effects of Listeria bacteria [3]. Product Development - OST-HER2 has received multiple designations from regulatory authorities, including Rare Pediatric Disease Designation (RPDD) from the U.S. FDA and Fast-Track and Orphan Drug designations from both the U.S. FDA and European Medicines Agency [3]. - The company reported positive results from its Phase 2b clinical trial of OST-HER2, showing statistically significant benefits in the 12-month event-free survival (EFS) primary endpoint [3]. - A Biologics Licensing Application (BLA) for OST-HER2 is anticipated to be submitted to the U.S. FDA in early 2026, with the potential to receive a Priority Review Voucher if approved [3]. Future Plans - OS Therapies is on track to receive regulatory feedback from U.S., UK, and European authorities in December 2025, with plans to file for regulatory approvals starting in January 2026 [3]. - The company is also advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced delivery of therapeutic payloads [4].

Core Insights - OS Therapies announced additional overall and event-free survival data from its Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, pulmonary metastatic osteosarcoma, highlighting statistically significant positive outcomes [2][4] Company Overview - OS Therapies is a clinical-stage oncology company focused on developing treatments for osteosarcoma and other solid tumors, with its lead asset OST-HER2 being an immunotherapy that targets the HER2 protein [4][6] - OST-HER2 has received several designations from regulatory agencies, including Rare Pediatric Disease Designation and Fast-Track status from the U.S. FDA [4] Clinical Trial Results - The Phase 2b Osteosarcoma Trial involved 41 patients, with subgroup analyses revealing: - For patients with a lung-only second or greater metastatic event, the 2-year overall survival rate was 80.0% [5] - For patients with a lung-only first metastatic event, the 2-year overall survival rate was 73.8%, significantly higher than the 30% natural history comparator (p < 0.0001) [5] - The company anticipates submitting a Biologics License Application (BLA) to the U.S. FDA for OST-HER2 in 2025 [6] Future Plans - OS Therapies is preparing for regulatory meetings with the FDA, MHRA, and EMA to discuss overall survival data and trial design for OST-HER2 [3] - The company is also advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced drug delivery [7]

Core Insights - OS Therapies announced statistically significant positive final 2-year overall survival data from the Phase 2b trial of OST-HER2, showing 75% of treated patients achieved 2-year overall survival compared to 40% in historical controls [1][4] - The company is on track to file for conditional marketing authorization in the UK, the US, and the EU, with key regulatory meetings planned for December 2025 [3][6] Group 1: Clinical Trial Results - 75% of OST-HER2 treated patients achieved 2-year overall survival, significantly higher than the 40% in historical controls (p < 0.0001) [1][4] - Subgroup analysis indicated that 100% of patients who achieved 12-month Event Free Survival (EFS) also achieved 2-year overall survival [1][4] Group 2: Regulatory Path and Future Plans - The company plans to submit a conditional Marketing Authorization Application (MAA) to the MHRA in December 2025 and a Biologics Licensing Application (BLA) to the FDA in January 2026 [3][6] - OS Therapies is analyzing patient samples to confirm correlations between clinical outcomes and immune system biomarker activation, with results expected in November 2025 [3] Group 3: Company Overview and Product Pipeline - OS Therapies focuses on developing treatments for Osteosarcoma and other solid tumors, with OST-HER2 as its lead asset, which has received multiple designations from regulatory agencies [6][7] - The company is also advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced treatment delivery [7]