OS Therapies to Participate in Spotlight Panel at BioFuture 2025 October 13 11:00am EDT

Rhea-AI Summary

OS Therapies (NYSE American: OSTX), a clinical-stage biotech company, will participate in BioFuture 2025's Cancer Spotlight Panel on October 13, 2025 in New York City. The company plans to submit a Biologics Licensing Application (BLA) for OST-HER2 to the FDA in Q4 2025.

If approved before September 30, 2026, OS Therapies could receive a priority review voucher (PRV), which it plans to sell to fund further development of OST-HER2 for osteosarcoma and other HER2-positive cancers. The company has leveraged over $300 million in invested capital into its Listeria Platform technology, aiming to launch the first new osteosarcoma treatment in over 40 years.

The company's pipeline includes OST-504 for prostate cancer and OST-503 for non-small cell lung cancer and other solid tumors.

Positive

• Company plans to submit BLA to FDA in Q4 2025
• Potential to receive and monetize a priority review voucher
• Platform leverages over $300 million in invested capital
• Could be first new osteosarcoma treatment in 40+ years
• Strong safety profile reported for Listeria Platform

Negative

• None.

New York, New York--(Newsfile Corp. - September 19, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today announced that it has been invited to participate in the "Beyond the Cure: The Brave New World of Revolutionary Cancer Therapeutics" Spotlight Panel at BioFuture 2025 taking place at Cure in New York City on October 13, 2025 at 11:00am EDT. A virtual partnering option is offered October 21-23, 2025, including access to the event's recorded content. Company management will provide an overview of OS Therapies, with a particular emphasis on the clinical development and commercial plans for OST-HER2.

The Company is positioned to commence submission of a Biologics Licensing Application ("BLA") request to the United States Food & Drug Administration ("FDA") in the fourth quarter of 2025. If approved prior to September 30, 2026, the Company will become eligible to receive a priority review voucher ("PRV") that it intends to sell. PRV proceeds will continue further clinical development of OST-HER2 into other osteosarcoma-related indications, and into breast cancer and other HER2 positive cancers. Additionally, the Company would use proceeds to advance the other clinical candidates in its pipeline, including OST-504 in prostate cancer and OST-503 in the treatment of non-small cell lung cancer ("NSCLC") and other solid tumors.

"BioFuture 2025 is one of the premier meetings in the biotechnology sector, and we are honored to be invited to participate in the Cancer spotlight panel," said Paul Romness, MPH, Chair & CEO of OS Therapies. "The story of how OS Therapies has leveraged over $300 million in invested capital into our listeria monocytogenes platform technology (the "Listeria Platform") to potentially bring the first new treatment to market for osteosarcoma in over 40 years is compelling. What makes it even more compelling is the fact that multiple drug candidates from this platform have the potential to be additive to the standard of care (SOC) in a wide range of cancers where SOC ultimately leads to treatment resistance and fails. Given the strong safety profile of the investigational/pre-licensure Listeria Platform - and imminent transition to commercialization for the lead therapeutic - we see its potential to be applied across the spectrum of disease, helping to reduce cancer evolution and significantly extend the efficacy runway of SOC in large therapeutic indications that would ultimately lead to improved overall survival and quality of life for patients."

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 Designation (RPDD) from the U.S. Food & Drug Administration and Fast-Track and Orphan Drug designations from the U.S. FDA and European Medicines Agency. The Company reported positive data in its Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, lung metastatic osteosarcoma, demonstrating statistically significant benefit in the 12-month event free survival (EFS) primary endpoint of the study. The Company anticipates submitting a Biologics Licensing Application (BLA) to the U.S. 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) and Drug Conjugates (DC), known as tunable ADC (tADC), which features tunable, tailored antibody-linker-payload candidates. This platform leverages the Company's proprietary silicone Si-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 press 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 U.S. FDA and other risks and uncertainties described in "Risk Factors" in the Company's most recent Annual Report on Form 10-K, most recent Quarterly Report on Form 10-Q and other subsequent documents the Company files with the Securities and Exchange Commission. 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.

OS Therapies Contact Information:

Investor Relations
Harrison Seidner, PhD
WaterSeid Partners
OSTX@waterseid.com

Public Relations
Jessica Starman, MBA
Elev8 New Media
media@ostherapies.com

https://x.com/OSTherapies
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https://www.linkedin.com/company/os-therapies/

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/267123

FAQ

When will OS Therapies (OSTX) present at BioFuture 2025?

OS Therapies will present at the Cancer Spotlight Panel on October 13, 2025 at 11:00am EDT in New York City.

What is the status of OS Therapies' (OSTX) OST-HER2 FDA application?

OS Therapies plans to submit a Biologics Licensing Application (BLA) for OST-HER2 to the FDA in the fourth quarter of 2025.

What will OS Therapies (OSTX) do with the priority review voucher if received?

OS Therapies plans to sell the priority review voucher and use the proceeds to fund further development of OST-HER2 and advance other clinical candidates.

What cancer treatments are in OS Therapies' (OSTX) pipeline?

OS Therapies' pipeline includes OST-HER2 for osteosarcoma, OST-504 for prostate cancer, and OST-503 for non-small cell lung cancer and other solid tumors.

How much capital has been invested in OS Therapies' (OSTX) Listeria Platform?

OS Therapies has leveraged over $300 million in invested capital into its Listeria Platform technology.