OS Therapies

OS Therapies (OSTX) is the leading Osteosarcoma biotechnology company.

08/27/2026

Cancer cells are often skilled at evading immune detection, even when the immune system is fully capable of identifying abnormal cells.

OS Therapies' engineered Listeria monocytogenes platform is designed to help close that gap, presenting HER2 antigens to immune cells in a way intended to activate targeted T-cell responses. In osteosarcoma, where HER2 is expressed in most tumors, this mechanism forms the basis of our OST-HER2 development program.

Explore the science driving OST-HER2: https://ostherapies.com/technology/

08/26/2026

On National Dog Day, Parade Pets shares how dogs with osteosarcoma have become part of a larger conversation about canine cancer research and its connection to pediatric oncology.

OS Therapies CEO Paul Romness discusses how naturally occurring osteosarcoma in dogs gives researchers the opportunity to study the disease in a real-world setting and how lessons from canine and human research can inform the development of OST-HER2 through separate pathways.

Read the interview: https://bit.ly/4gQmn8J

08/25/2026

Osteosarcoma doesn't only affect people. Dogs develop the disease naturally, often in the same bones and with a similar pattern of spreading to the lungs as seen in human patients.

That biological overlap is the basis of comparative oncology, a research approach OS Therapies applies across its OST-HER2 program. Studying naturally occurring disease in both humans and canines gives researchers insight that a single species alone cannot provide.

Explore our approach to comparative oncology: https://bit.ly/3QX7irr

08/21/2026

How do you train the immune system to recognize a cancer it doesn't typically notice?

OST-HER2 is built on a live-attenuated Listeria monocytogenes platform engineered to deliver HER2-targeted antigens directly into immune cells. The goal is to stimulate T-cell activity capable of recognizing and responding to HER2-expressing tumor cells, a mechanism OS Therapies is studying in osteosarcoma, where HER2 is expressed in most tumors.

Discover how the platform works: https://ostherapies.com/technology/

08/20/2026

The biotech funding environment has become more selective, putting greater emphasis on clinical evidence and measurable patient impact.

In an op-ed for BioSpace, OS Therapies Chairman, CEO and President Paul Romness explores what that environment means for pediatric rare oncology. Drawing on more than 25 years of experience across the biopharma industry, he discusses the role of unmet medical need, biological rationale, meaningful outcomes and tailored regulatory pathways in rare pediatric cancer development.

Read the op-ed: https://bit.ly/4bWw5nh

08/19/2026

OS Therapies' latest regulatory update includes new meeting grants from both the U.S. FDA and U.K. MHRA related to OST-HER2.

The FDA granted a Type C Statistical Methods Meeting expected in mid-September to review the 2.5-year overall survival data and statistical methods for evaluating clinical efficacy. The MHRA also granted a Scientific Advice Meeting expected in September to review statistical methods supporting the Company's pending U.K. Conditional Marketing Authorisation Application.

The release also reports that overall survival at the 2.5-year timepoint remained unchanged from the 2-year timepoint. Interim 3-year overall survival data is expected in early September.

ICYMI, read the update: https://bit.ly/4qcQdY2

08/18/2026

Dogs develop osteosarcoma at a much higher rate than humans, creating opportunities to study naturally occurring disease through comparative oncology.

OS Therapies has incorporated both human and canine research into the development of OST-HER2, helping expand scientific understanding of osteosarcoma while evaluating the platform across complementary clinical settings.

Learn more: https://ostherapies.com

08/17/2026

OS Therapies (NYSE: OSTX) Reports Second Quarter 2026 Financials and Provides Business and Regulatory Updates.

Read the press release: https://bit.ly/4qmqYml

08/14/2026

Osteosarcoma hasn't seen a newly approved treatment in more than four decades.

OST-HER2 has been granted Rare Pediatric Disease, Fast Track, and Orphan Drug designations from the FDA, along with Orphan Drug designation from the EMA, recognition that reflects both the severity of the disease and the scarcity of treatment options for patients with fully resected, pulmonary metastatic osteosarcoma.

OS Therapies is advancing OST-HER2 through these regulatory pathways as part of our work toward potential approval.

Learn more about our regulatory strategy: https://bit.ly/4jqxWSg

08/13/2026

OS Therapies (NYSE: OSTX) has been granted a U.S. FDA Type C Statistical Methods Meeting to review 2.5-year overall survival data from the Phase 2b trial of OST-HER2 in the prevention of recurrence in fully resected, pulmonary metastatic osteosarcoma.

The meeting is expected in mid-September 2026, with interim 3-year overall survival data expected in early September. Decisions regarding the appropriate comparator arm to interpret OST-HER2 clinical efficacy, the pending RMAT designation submission and FDA Rolling Review are expected following the meeting.

In parallel, the U.K. MHRA has granted a Scientific Advice Meeting to review the statistical methods supporting OS Therapies’ pending Conditional Marketing Authorisation Application submission.

Read more: https://bit.ly/4qcQdY2

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101 6th Avenue, 3rd Floor
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10013

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https://www.ostherapies.com/

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