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

NEW YORK--(BUSINESS WIRE)--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.

Contacts

OS Therapies Contact Information:

Jack Doll 571.243.9455 [email protected]

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