OS Therapies Forms Subsidiary OS Drug Conjugates and Initiates Review of Strategic Options for its tunable ADC & Drug Conjugates Platforms

Business Wire 24-Feb-2025 7:25 AM

OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company advancing immunotherapies and targeted drug conjugates for cancer treatment, announced the formation of subsidiary OS Drug Conjugates (OSDC). The formation of OSDC coincides with formal strategic options initiatives to create value from the Company's leading-edge, patented silicone dioxide-based, pH sensitive tunable antibody drug conjugates (tADC) & other tunable drug conjugates (tDC) platforms. The Company has initiated discussions with clinical-stage ADC therapeutics companies in the U.S., China and other jurisdictions to form joint ventures (JVs) pairing those companies' clinical-stage assets with certain assets from the tADC and/or tDC platforms and spinning the JVs into standalone public companies. If successful, OS Therapies intends to provide stock dividends of the public JVs to shareholders.

The OST-tADC and OST-tDC technologies are centered around the Company's proprietary next-generation tunable Antibody Drug Conjugate (tADC) and tunable Drug Conjugates (tDC) platforms. These advanced technologies incorporate pH-sensitive silicon-based linkers: SiLinkers™ to link the targeting antibodies (or antibody fragments) and therapeutic moieties together while coating the entire package with pH sensitive coating. This strategy can release multiple therapeutic agents selectively within the tumor and tumor microenvironment, which have lower pH levels than the rest of the body. This approach aims to maximize the therapeutic effects while minimizing damage to healthy cells.

BCC Research estimates that the global market for antibody-drug conjugates is estimated to increase from $10.8 billion in 2023 to $47.0 billion by 2029, at a compound annual growth rate (CAGR) of 28.4% from 2024 through 2029.

About OS Therapies

OS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for Osteosarcoma (OS) and other solid tumors. OST-HER2, the Company's lead asset, is an immunotherapy leveraging the immune-stimulatory effects of Listeria bacteria to initiate a strong immune response targeting the HER2 protein. OST-HER2 has received rare pediatric disease, fast-track and orphan drug designations from the USFDA. The Company has completed enrollment for a 41-patient Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, lung metastatic osteosarcoma, with positive results released in the first quarter of 2025. The Company anticipates submitting a Biologics Licensing Application (BLA) to the US FDA for OST-HER2 in osteosarcoma in 2025 and, if approved, would become eligible to receive a Priority Review Voucher that it could then sell. OST-HER2 has completed a Phase 1 clinical study primarily in breast cancer patients, in addition to showing preclinical efficacy data in various models of breast cancer. OST-HER2 has been conditionally approved by the U.S. Department of Agriculture for the treatment of canines with osteosarcoma.

In addition, OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which features tunable, tailored antibody-linker-payload candidates. This platform leverages the Company's proprietary silicone linker and Conditionally Active Payload (CAP) technology, enabling the delivery of multiple payloads per linker. For more information, please visit www.ostherapies.com.

Forward-Looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of the federal securities laws. These forward-looking statements and terms such as "anticipate," "expect," "intend," "may," "will," "should" or other comparable terms involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Those statements include statements regarding the intent, belief or current expectations of OS Therapies and members of its management, as well as the assumptions on which such statements are based. OS Therapies cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to the approval of OST-HER2 by the US FDA and grant of a priority review voucher and other risks and uncertainties described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Company's registration statement on Form S-1 filed with the Securities and Exchange Commission (the "SEC") on November 12, 2024, as amended on November 27, 2024, and other subsequent documents we file with the SEC, including but not limited to our Quarterly Reports on Form 10-Q. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by the federal securities laws, OS Therapies specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

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OS Therapies Contact Information: Jack Doll 571.243.9455 Irpr@ostherapies.com

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