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OS Therapies Appoints Biotech Industry Luminary Robert "Bob" S. Langer, PhD as Strategic Advisor

MWN-AI** Summary

OS Therapies, Inc. (NYSE American: OSTX), a pioneer in gene-edited, listeria-based cancer immunotherapies, has appointed Dr. Robert S. Langer, an eminent figure in biotechnology and co-founder of Moderna, to its strategic advisory board. Dr. Langer's extensive experience spans over 40 biotech startups, 16 IPOs, and significant contributions to drug discovery and development, positioning him as a critical asset for OS Therapies as it advances its listeria oncology pipeline.

Dr. Langer will focus on prioritizing the listeria oncology pipeline, exploring potential combinations with other oncology biotech products, and selecting candidates for the tunable Antibody Drug Conjugate (tADC) platform. His insights are expected to enhance the development strategy for OS Therapies’ lead asset, OST-HER2, which leverages listeria to stimulate immune responses against cancer. Acknowledging the promise of listeria monocytogenes in oncology, Dr. Langer emphasized its potential to effectively treat cancers resistant to existing therapies and improve outcomes for patients on other treatments.

Highlighting his impressive credentials, Dr. Langer has authored over 1,600 scientific papers and holds 44 honorary doctorates. His revolutionary work includes the development of angiogenesis inhibitors and nanoparticles for drug delivery. Under his guidance, OS Therapies aims to bolster its position in the biotechnology landscape and refine its market approach for OST-HER2, which has received several designations from the FDA and EMA, facilitating its anticipated Biologics License Application in 2026.

OS Therapies is focused on treating osteosarcoma and other solid tumors, with robust clinical data supporting OST-HER2’s efficacy. The company continues to develop its next-generation tADC technology, incorporating innovative silicone-based payload systems designed for targeted cancer treatment.

MWN-AI** Analysis

The recent appointment of Dr. Robert "Bob" S. Langer as a strategic advisor at OS Therapies (NYSE American: OSTX) signifies a pivotal moment for the company and could present a compelling investment opportunity for those looking to enter or expand their holdings in the biotech sector. Dr. Langer's impressive track record—co-founding over 40 biotech companies including Moderna—adds immense credibility to OS Therapies' ambitions, particularly regarding its listeria-based cancer immunotherapy pipeline.

Dr. Langer's expertise in drug delivery systems and oncology will be invaluable as OS Therapies focuses on advancing its novel therapies, such as OST-HER2, into critical regulatory processes. The company has already achieved Orphan Drug Designation and Fast Track Designation from the FDA, positioning it favorably within the competitive landscape for rare diseases, particularly osteosarcoma, where treatment options remain limited.

Given the strategic insight that Dr. Langer brings, investors might expect an acceleration in the development and prioritization of the oncology pipeline and innovative combination therapies that leverage listeria's inherent properties. The potential for entrenching partnerships with other biotech firms could enhance OS Therapies' market position, particularly in targeting cancers that resist existing therapies.

The company’s focus on regulatory execution and market access, especially with anticipated Biologics License Applications (BLA) in the U.S. and Europe, will be critical. If the anticipated approvals materialize, the company could see a substantial increase in its valuation, especially considering the historical value of Priority Review Vouchers, with the last reported transaction at $205 million.

In conclusion, OS Therapies presents a noteworthy investment thesis. Investors should consider the company's promising clinical pipeline, the strategic advantage brought by Dr. Langer, and the potential for substantial regulatory milestones ahead, which collectively indicate an upward trajectory in value for OSTX in the coming years.

**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.

Source: TMX Newsfile
  • Co-founder of more than 40 biotechnology companies, including 16 IPOs and 19 successful acquisitions
  • Scientific and medical titan focused on driving innovation for human health
  • Will assist with listeria oncology pipeline prioritization, combinations with other oncology-focused biotechnologies and tADC candidate selection for further development

New York, New York--(Newsfile Corp. - April 13, 2026) - OS Therapies, Inc. (NYSE American: OSTX("OS Therapies" or "the Company"), the world leader in gene-edited, listeria-based cancer immunotherapies, announced today that Dr. Robert "Bob" S. Langer, co-founder of Moderna, was appointed to the Company's strategic advisory board. Dr. Langer will assist management with listeria oncology pipeline prioritization, combinations of listeria product candidates with other oncology-focused biotechnologies, as well as tunable Antibody Drug Conjugate (tADC) candidate selection for further development. Dr. Langer is a luminary in the field of biotechnology, having developed core technologies used ubiquitously throughout the field for drug discovery and development, improving the health of millions worldwide.

"The use of listeria monocytogenes as a vehicle to activate the immune system to kill cancer has been studied for decades but may soon become a medical reality thanks to OS Therapies," said Dr. Langer, newly-appointed member of the Company's strategic advisory board. "Listeria's unique properties as an intracellular bacterium create major opportunities both to treat cancers which have not responded to existing immunotherapies and to enhance outcomes for patients already receiving other anti-cancer agents, given the strong safety profile exhibited in the Phase 2b study of OST-HER2 and the more than one thousand patients treated with the platform. I will be working with the OS Therapies team implement a robust pipeline development strategy for both standalone and combination product development. Moreover, the unique proprieties of silicone dioxide that underlie the tADC linker/cap technology present tremendous opportunities to design more comprehensive and efficacious candidates which can deliver combinations of cytotoxic and immune stimulatory compounds in a targeted way: this means we can more effectively treat solid tumors and ultimately aim to improve patient outcomes."

Dr. Bob Langer is one of nine Institute Professors at the Massachusetts Institute of Technology (MIT), MIT's highest faculty honor. His pioneering work includes isolating the first angiogenesis inhibitors (with Dr. Judah Folkman) leading to new treatments for cancer and blindness. He also created the first nanoparticles and microparticles for delivering large molecules, including nucleic acids, and helped establish the field of tissue engineering which enabled artificial skin for burn victims and organ-on-a-chip technology. Dr. Langer has authored more than 1,600 papers, cited more than 473,000 times. With an h-index of 336, Langer is the most cited engineer in history. His patents have been licensed or sublicensed to over 400 companies, and he has co-founded more than 40 ventures, including Moderna. Dr. Langer chaired the FDA's Science Board, the agency's highest advisory board, from 1999-2002 and has received over 220 awards, including the U.S. National Medal of Science and the National Medal of Technology and Innovation (one of only three living individuals to receive both). His accolades include the Draper Prize (considered engineering's Nobel Prize), Queen Elizabeth Prize for Engineering, Albany Medical Center Prize, Breakthrough Prize in Life Sciences, Kyoto Prize, Wolf Prize in Chemistry, Millennium Technology Prize, and the Kavli Prize in Nanoscience. He holds 44 honorary doctorates from institutions such as Harvard, Yale, Columbia, and Oxford, and has been elected to the National Academies of Medicine, Engineering, and Sciences, as well as the National Academy of Inventors.

"It is a tremendous honor to have a biotechnologist of Dr. Langer's distinction join our fight against cancer," said Paul Romness, MPH, Chair & CEO of OS Therapies. "Taken together with Dr. Craig Eagle's appointment last week, these recent additions to our strategic advisory board elevate the Company's standing in the biotechnology community, sending a powerful vote of confidence in our core technologies and the Company's future. We now have a tremendous opportunity to leverage Dr. Langer's unique expertise and vast network to help drive our mission forward as we engage with international regulators and potential industry partners regarding OST-HER2's potential in osteosarcoma and beyond. In the near-term, we are continuing to focus on regulatory execution surrounding gaining market access for OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma in the U.S., U.K. and Europe, as well as countries with regulatory reciprocity with these jurisdictions. We will now begin working more closely with our strategic advisory board to fully build out our strategy for the diligent development of our pipeline as resources become available from product revenues, partnership agreements and/or the sale of a potential priority review voucher following approval in the U.S."

OST-HER2 has received Orphan Drug Designation (ODD), Fast Track Designation (FTD) and Rare Pediatric Disease Designation (RPDD) from the FDA, and ODD, FTD and ATMP from the EMA. Under the RPDD program, if the Company receives a Biologics License Application (BLA) in the United States, it will become eligible to receive a Priority Review Voucher (PRV) that it intends to sell. The most recent publicly disclosed PRV transaction occurred in February 2026 at a reported value of $205 million. The Company is seeking to obtain a BLA under the Accelerated Approval Program for OST-HER2 in osteosarcoma in the second half of 2026.

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. The Company is the world leader in listeria-based cancer immunotherapies. 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 Orphan Drug Designation (ODD), Fast Track Designation (FTD) and Rare Pediatric Disease Designation (RPDD) from the U.S. Food & Drug Administration and has received ODD, FTD and ATMP from the 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 and the overall survival (OS) secondary endpoint. The Company anticipates receiving a Biologics License Application (BLA) from the U.S. FDA for OST-HER2 in osteosarcoma in 2026 and, if approved, would become eligible to receive a Priority Review Voucher that it could then sell. The Company also anticipates receiving Conditional Marketing Authorisations from the U.K.'s Medicines and Healthcare products Regulatory Agency and the EMA for OST-HER2 in 2026. 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. The Company also anticipates reading out data from a Phase 1b study of OST-504 in castration resistant prostate cancer in the first half of 2026.

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 our expected to provide cash runway into 2027, the intended use of net proceeds from the offering, the potential 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 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
Stephanie Chen
Elev8 New Media
media@ostherapies.com

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To view the source version of this press release, please visit https://www.newsfilecorp.com/release/292132

FAQ**

How does Dr. Langer's expertise specifically enhance the prioritization of the listeria oncology pipeline at OS Therapies Incorporated OSTX, and what are the expected outcomes of his involvement?

Dr. Langer's extensive background in biomedical engineering and drug delivery systems enhances OS Therapies' prioritization of the listeria oncology pipeline by fostering innovative approaches to improve efficacy and safety, with expected outcomes including accelerated development timelines and enhanced therapeutic effectiveness.

Given Dr. Langer's background with Moderna, how might his experience influence strategic partnerships and collaborations for OS Therapies Incorporated OSTX in the oncology space?

Dr. Langer's experience with Moderna may enhance strategic partnerships for OS Therapies Incorporated by leveraging his expertise in mRNA technology and fostering collaborations that advance innovative oncology therapies, ultimately driving growth and positioning OS in a competitive market.

What role will Dr. Langer play in refining the development strategy for the tunable Antibody Drug Conjugate (tADC) candidates at OS Therapies Incorporated OSTX, and what are the anticipated benefits of this technology?

Dr. Langer will leverage his expertise to enhance the development strategy for OS Therapies' tunable Antibody Drug Conjugate candidates, potentially leading to more effective and personalized cancer therapies, improved patient outcomes, and increased market competitiveness.

How is OS Therapies Incorporated OSTX preparing to leverage the regulatory designations received for OST-HER2, and what impact is Dr. Langer expected to have on navigating these processes?

OS Therapies Incorporated (OSTX) is strategically planning to utilize its regulatory designations for OST-HER2 to accelerate development and market entry while Dr. Langer's expertise is anticipated to significantly enhance the company's navigation through complex regulatory processes.

**MWN-AI FAQ is based on asking OpenAI questions about OS Therapies Incorporated (NYSE: OSTX).

OS Therapies Incorporated

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