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 ...

Financial Restrictions and Cash Transfers - As of September 30, 2023, the total amounts restricted for dividends from PRC subsidiaries include $37,621,838, $25,958,620, and $24,753,990 for the years 2025, 2024, and 2023 respectively[46]. - For the fiscal year ended September 30, 2025, cash transferred to subsidiaries from Jiangsu Austin amounted to $9,313,712, while cash transferred to Jiangsu Austin from its subsidiaries was $57,000[49]. - Ostin provided funding to its PRC subsidiaries of $4,635,000 for the fiscal year ended September 30, 2025, with no funding provided in the previous two years[48]. - Cash transfers from PRC subsidiaries to entities outside of China are subject to PRC government controls on currency conversion, which may limit the availability of cash for operations outside of China[47]. - The PRC subsidiaries are required to make appropriations to certain statutory reserve funds, which are not distributable as cash dividends except in the event of liquidation[46]. - The total cash transferred among PRC subsidiaries is regulated under the Provisions on Private Lending Cases, which govern financing activities between entities[49]. - The company relies on dividends and distributions from its PRC subsidiaries to fund offshore cash requirements, and any limitations on cash transfers could adversely affect liquidity[56]. - Limitations on remittance from PRC subsidiaries could hinder the company's ability to access cash for investments, acquisitions, or shareholder dividends[110]. - The company relies on dividends from its PRC subsidiaries for cash needs, and any limitations on these dividends could materially affect its ability to fund operations and pay dividends to shareholders[173]. Regulatory Environment and Compliance Risks - The PCAOB has secured complete access to inspect and investigate registered public accounting firms in mainland China and Hong Kong as of December 15, 2022[44]. - The Holding Foreign Companies Accountable Act may lead to the delisting of Class A Ordinary Shares if the PCAOB cannot inspect the auditors for three consecutive years[39]. - The SEC has established procedures for identifying "Commission-Identified Issuers" under the HFCA Act, which could affect trading of the company's shares[40]. - The company has not been identified by the SEC under the HFCA Act as of the date of the report, but future inspections by the PCAOB remain uncertain[41]. - The company is subject to uncertainties regarding the interpretation and enforcement of PRC laws, which could impact business operations and financial results[65]. - The company has applied for a security assessment regarding cross-border data transfers, but the interpretation and implementation of new regulations may change, introducing additional compliance risks[73]. - The company is not classified as a "data processor" under the Personal Information Protection Law and does not engage in data activities as defined by the law[74]. - The company may incur substantial costs to comply with the Measures for Cybersecurity Review (2021 version), which could adversely affect its business operations and financial position[75]. - The Overseas Listing Trial Measures became effective on March 31, 2023, requiring PRC domestic companies to fulfill filing procedures with the CSRC for overseas offerings[78]. - Companies that fail to complete the filing procedure or falsify information may face administrative penalties, including fines and warnings[89]. - The company must file with the CSRC within three business days after completing offerings related to its shelf registration statement on Form F-3[91]. - The 2021 Negative List for Foreign Investment Access, effective January 1, 2022, requires domestic companies in prohibited businesses to obtain government approval for overseas offerings[93]. - There are uncertainties regarding the interpretation and implementation of new regulatory requirements, which could materially affect the company's operations and financial condition[92]. - The company is subject to potential investigations and penalties if it fails to maintain compliance with filing procedures under PRC laws[91]. - The PRC government may strengthen oversight over overseas offerings, which could limit the company's ability to offer securities and affect their value[79]. - The company has not received any denial to list on U.S. exchanges but may face adverse effects from future regulatory changes[84]. - The CSRC released new regulations on overseas securities offerings, effective March 31, 2023, requiring domestic enterprises to complete approval and filing procedures if they disclose state secrets[94]. - Companies may face additional compliance costs and delays due to the new regulations, impacting their ability to raise capital[95]. - Future regulatory changes could impose further requirements on offshore offerings, potentially leading to sanctions or operational restrictions[96]. - Acquisitions in China are subject to significant regulatory approval, with transactions exceeding RMB 400 million requiring SAMR review, which may delay business expansion[99]. - PRC regulations on offshore investments may limit capital injection into PRC subsidiaries and restrict profit distributions, affecting financial operations[100]. - Non-compliance with SAFE registration requirements for beneficial owners could result in fines and limit the ability to distribute dividends[101]. - Employee share incentive plans must comply with SAFE regulations, and failure to do so may lead to legal sanctions and restrict capital contributions[102]. - Loans to PRC subsidiaries are subject to government approval and limitations, which may hinder liquidity and business expansion[103]. - Recent SAFE circulars may allow foreign-invested enterprises to make equity investments in China, but practical implementation remains uncertain[106]. - The PRC government may restrict access to foreign currencies, affecting the ability to fund PRC operations and complete necessary registrations[107]. Business Risks and Financial Performance - The company is subject to significant risks related to doing business in China, including potential adverse effects from changes in political and economic policies, which could impact growth and expansion strategies[56]. - A majority of the company's revenues are sourced from the PRC, making its financial condition highly sensitive to economic, political, and legal developments in China[61]. - The company is dependent on a few major customers without long-term contracts, and the loss of any could lead to a significant decline in revenues[57]. - The company faces cyclical industry risks, including price fluctuations due to supply and demand imbalances, which could harm operational results[57]. - The company is still in the process of obtaining necessary manufacturing facility certifications in Chengdu, China, and failure to do so could materially affect its business[57]. - The company may need to raise additional capital or obtain loans, and inability to secure funding could curtail operations[57]. - The trading price of the company's Class A Ordinary Shares has recently declined significantly, and there is a risk of delisting from Nasdaq, which could adversely affect investment value[57]. - The company incurred a net loss of $10,311,035 for the year ended September 30, 2025, resulting in an accumulated deficit of $28,543,211[132]. - As of September 30, 2025, the company had approximately $26 million of debt outstanding, which may restrict operations and cash flows[135]. - The display panel industry is cyclical, with potential price declines due to supply and demand imbalances, which could adversely affect results of operations[130]. - The company does not enter into long-term agreements with customers, increasing the risk of revenue fluctuations[128]. - The company relies heavily on a key equipment supplier, Shanghai Inabata, for polarizer manufacturing, which poses risks if the agreement is terminated[136]. - The company may face significant liabilities if its products or manufacturing processes are found to infringe upon third-party rights, which could materially affect its operations and financial condition[166]. - The company must develop or acquire advanced manufacturing process technologies to remain competitive, and failure to do so may adversely affect its profitability[169]. - The enforcement of labor-related regulations in China may lead to fines and operational disruptions if the company fails to comply with the Labor Dispatch Provisions[171]. - The market price of the Class A Ordinary Shares has significantly declined, leading to a notification from Nasdaq regarding non-compliance with the minimum bid price requirement of $1.00 per share[188]. - The Company was provided 180 calendar days until July 17, 2024, to regain compliance with the minimum bid price requirement, with an additional 180 days granted until January 13, 2025[188]. - Trading of Class A Ordinary Shares has been suspended since September 12, 2025, pending a response to Nasdaq's request for information related to a DOJ investigation[192]. - The halt of trading has eliminated liquidity in the Class A Ordinary Shares, potentially leading to a significant decline in market price when trading resumes[194]. - If the Class A Ordinary Shares are delisted from Nasdaq, they may be classified as penny stocks, which could severely limit market liquidity and impede sales in the secondary market[195]. - The Company does not expect to pay dividends in the foreseeable future, relying instead on price appreciation for returns on investment[199]. - The board of directors has complete discretion over dividend distribution, which will depend on future results of operations and other financial factors[200]. - The Company may be classified as a passive foreign investment company (PFIC), which could result in adverse U.S. federal income tax consequences for U.S. taxpayers holding its shares[201]. Corporate Governance and Shareholder Rights - The Fifth Amended and Restated Memorandum and Articles of Association contain anti-takeover provisions that may adversely affect the rights of Class A Ordinary Shareholders[205]. - Tao Ling, the CEO, holds 32.04% of the voting power, including 100% of Class B Ordinary Shares, which may lead to conflicts of interest with other shareholders[206]. - The company is incorporated under Cayman Islands law, limiting shareholders' rights to inspect corporate records and potentially complicating legal actions in the U.S.[207][208]. - The company is classified as an "emerging growth company," allowing it to take advantage of reduced reporting requirements, including exemptions from certain accounting standards[213][214]. - The company completed its initial public offering on April 29, 2022, raising gross proceeds of $15,525,000 from the sale of 3,881,250 Ordinary Shares at $4.00 per share[226]. - As of January 2023, Nanjing Aosa directly holds 92.56% of Jiangsu Austin's issued shares, with an additional 7.44% held indirectly through Suhong Yuanda[228]. - On June 18, 2023, Austin Optronics Technology Co., Ltd. acquired a majority ownership of Pintura.Life LLC, promoting and selling Pintura products in the U.S. market[229]. - Jiangsu Austin transferred its entire share ownership in Austin Optronics Technology Co., Ltd. to Ostin Technology Limited on July 24, 2023, aligning with strategic adjustments[230]. - The company consolidated the financial results of Jiangsu Austin and its subsidiaries in accordance with U.S. GAAP due to the VIE Arrangements, which were fully terminated in February 2022[222][225]. - The company has a less developed body of securities laws compared to the U.S., which may afford shareholders less protection[210]. - The company’s Articles of Association allow shareholders holding at least 10% of the share capital to requisition a general meeting, but advance notice of at least 5 clear days is required[211]. - Sichuan Ausheet transferred 71.43% equity interest in Sichuan Auniu to Nanjing Oni, resulting in ownership of 28.57% and 71.43% respectively[231]. - Following a capital injection agreement, Sichuan Ausheet and Nanjing Oni now hold 20% and 52% of shares in Sichuan Auniu respectively[232]. - The Company's authorized share capital increased from US$50,000 to US$500,000, with a total of 4,991,000,000 class A ordinary shares and 8,000,000 class B ordinary shares[233]. - The Company approved the repurchase of 2,000,000 Class A Ordinary Shares at an aggregate par value of US$200, maintaining unchanged issued share capital[234].

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]