OS Therapies to Attend the 43rd Annual J.P. Morgan Healthcare Conference

Rhea-AI Summary

OS Therapies (NYSE-A: OSTX) announced its CEO Paul Romness will attend the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco from January 13-16, 2025. Following their 2024 IPO and completion of Phase 2b clinical trial for OST-HER2 in treating recurrent, resected metastatic Osteosarcoma, the company plans to release trial data updates during the conference week.

The company anticipates potential FDA approval in 2025, which could earn them a Priority Review Voucher (PRV) valued at approximately $150 million. This voucher could be sold to fund OST-HER2's development for other HER2-positive cancers like Breast and Colorectal cancer. Despite recent changes in PRV program reauthorization, OS Therapies remains eligible for the voucher due to receiving rare pediatric disease designation before December 20, 2024, with approval targeted before September 30, 2026.

• CEO Paul Romness available to meet with institutional investors

NEW YORK--(BUSINESS WIRE)-- OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company advancing immunotherapies and targeted drug conjugates for cancer treatment, today announced that its Chair & CEO Paul Romness has accepted an invitation to attend the 43^rd Annual J.P. Morgan Healthcare Conference in San Francisco, CA taking place on January 13-16, 2025 in San Francisco, CA. This premier conference is the largest and most informative health care investment symposium in the industry which connects global industry leaders, emerging fast-growth companies, innovative technology creators and members of the investment community.

“After having successfully completed our IPO in 2024 and finished the treatment phase of our potentially pivotal Phase 2b clinical trial of lead therapeutic immunotherapy candidate OST-HER2 in the treatment of the rare pediatric disease recurrent, resected metastatic Osteosarcoma, we are excited to begin to engage with the institutional investor community and raise the profile of OS Therapies in the capital markets,” said Paul Romness, MHP, Chair and CEO of OS Therapies. “We intend to announce an update of the data from this trial throughout the week of the conference and expect that this will provide a good opportunity for the markets to get a better understanding of our Company’s potential for an approval in 2025 that would not only change the lives of families afflicted by this devastating childhood cancer, but would also make the Company eligible to be granted a Priority Review Voucher (PRV), currently valued at approximately $150 million, that would further capitalize the Company to allow it expand the clinical development of OST-HER2 into other HER2 positive cancers such as Breast cancer and/or Colorectal cancer.”

The US FDA granted OST-HER2 Rare Pediatric Disease Designation for Osteosarcoma in 2021. The US FDA rare pediatric disease PRV program aims to incentivize drug development for rare pediatric diseases. Under this voucher program, a sponsor who receives an approval for a drug or biological product for a rare pediatric disease qualifies for a voucher that can be redeemed to receive priority review for a different product. The sponsor may also transfer or sell the voucher to another sponsor. OS Therapies intends to sell the PRV it would earn upon receiving approval of OST-HER2 for recurrent, resected metastatic Osteosarcoma. The most recent publicly disclosed sale price of a PRV was on November 27, 2024 when PTC Therapeutics announced selling its PRV to Kebilidi for $150M. With emerging scarcity in the PRV market, the Company expects the value of PRVs to increase going forward. The maximum sale price of a PRV was in 2015 when AbbVie bought a PRV from United Therapeutics for $350 million.

The most recent continuing resolution (CR) negotiations in the US House of Representatives failed to reauthorize the PRV program for pediatric cancers such as Osteosarcoma. Despite this, as a result of OS Therapies’ having been granted OST-HER2’s rare pediatric disease designation prior to December 20, 2024 in addition to the Company’s aim to receive an approval for OST-HER2 in the rare pediatric disease osteosarcoma in 2025, prior to the September 30, 2026 deadline, OS Therapies remains eligible to receive the PRV upon FDA approval of OST-HER2 in recurrent, resected metastatic Osteosarcoma.

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. The Company has completed enrollment for a 41-patient Phase 2b clinical trial of OST-HER2 in resected, recurrent osteosarcoma, 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 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250102353806/en/

OS Therapies Contact Information:

Jack Doll

410-297-7793

Irpr@ostherapies.com



https://x.com/OSTherapies

https://www.instagram.com/ostherapies/

https://www.facebook.com/OSTherapies/

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

Source: OS Therapies, Inc.

FAQ

What are the key dates for OS Therapies (OSTX) at the 2025 J.P. Morgan Healthcare Conference?

OS Therapies will attend the conference from January 13-16, 2025 in San Francisco, where they plan to release updates on their OST-HER2 clinical trial data.

How much is the Priority Review Voucher (PRV) worth that OSTX could receive for OST-HER2?

The PRV is currently valued at approximately $150 million, based on the most recent sale by PTC Therapeutics to Kebilidi on November 27, 2024.

What is the deadline for OSTX to receive FDA approval for the Priority Review Voucher?

OS Therapies must receive FDA approval for OST-HER2 before September 30, 2026, to remain eligible for the PRV.

What additional cancer types could OSTX target with OST-HER2 after initial approval?

After initial approval, OS Therapies plans to expand OST-HER2 clinical development into other HER2 positive cancers, including Breast cancer and Colorectal cancer.

When did OSTX receive Rare Pediatric Disease Designation for OST-HER2?

The US FDA granted OST-HER2 Rare Pediatric Disease Designation for Osteosarcoma in 2021.