World-Premier Cancer Center Sheba Medical Center Selects Entolimod for Clinical Trial, Potentially Expanding Valion Bio into the Multi-Billion-Dollar Neutropenia Market

Sheba Medical Center, which is ranked the #7 hospital in the world, has chosen to evaluate and fund a trial of Valion Bio's Entolimod in cancer patients, creating a second clinical development pathway beyond Acute Radiation Syndrome.

Highlights

• Independent Validation — Sheba Medical Center, ranked the #7 hospital in the world, selected Entolimod for clinical evaluation in cancer patients based on its potential to reduce radiation-induced neutropenia and protect healthy tissue during radiation therapy.
• Second Major Commercial Opportunity — This study expands Entolimod beyond Acute Radiation Syndrome into radiation-induced neutropenia and supportive oncology care, representing a substantially larger commercial market.
• Independent Clinical Value Driver — The study establishes a second clinical development pathway alongside Valion Bio's FDA Animal Rule program, as a medical countermeasure for Acute Radiation Syndrome (ARS).
• Capital Efficient Development — Sheba is planning to fund and conduct the trial, enabling Valion Bio to generate independent clinical data with minimal incremental investment.

SAN ANTONIO, July 20, 2026 /PRNewswire/ -- Valion Bio, Inc. (Nasdaq: VBIO) today announced a major clinical development milestone with the finalization of an clinical trial protocol at Sheba Medical Center, one of the world's leading hospitals, to evaluate Entolimod in cancer patients receiving high doses of irradiation for a rare form of cancer.

The study, which will enroll up to 10 adult patients, will be conducted by Sheba Medical Center, which approached Valion Bio after recognizing Entolimod's potential to reduce radiation-induced neutropenia and protect healthy tissue during radiation therapy. Under the collaboration, Sheba is planning to fund and conduct the clinical trial, while Valion Bio will provide the investigational drug and support only limited study-related activities outside the standard of care, creating a potential highly capital-efficient opportunity to generate independent clinical data.

"This is a major value-creation milestone for Valion Bio and our shareholders," said Michael K. Handley, President and Chief Executive Officer of Valion Bio. "One of the world's premier hospitals and research centers recognized the potential of Entolimod and approached us to conduct this study. Their willingness to invest their own resources to evaluate Entolimod represents meaningful external validation of our science. More importantly, this collaboration could expand Entolimod beyond biodefense into the multi-billion-dollar supportive oncology market. If successful, Entolimod has the potential to become an important therapy for reducing radiation-induced neutropenia and protecting healthy tissue during cancer treatment, creating a second and potentially much larger commercial opportunity for our lead drug, Entolimod."

Expanding Beyond Biodefense

Entolimod is currently being developed under the U.S. FDA's Animal Rule as a medical countermeasure for Acute Radiation Syndrome. The Sheba study is the first reported formal clinical evaluation of Entolimod in cancer patients receiving therapeutic radiation and represents an important step toward expanding the platform into oncology.

Cancer patients receiving high doses of radiation frequently develop neutropenia, leading to infections, treatment delays, and reduced treatment intensity. The Sheba study will evaluate whether Entolimod can preserve bone marrow function, reduce neutropenia, and improve patients' ability to complete potentially curative radiation therapy.

Sheba Neutropenia Study Near-Term Clinical Catalysts

The Company expects the following development milestones, subject to regulatory and operational requirements:

• Institutional Review Board approval: Expected Q3 2026
• First patient enrolled: Expected Q4 2026-Q1 2027
• Interim data readout: Expected during early 2027
• Topline data: Expected in 2027

Each milestone represents an anticipated opportunity to further demonstrate Entolimod's clinical and market potential, as well as a potential opportunity to expand shareholder value.

About Sheba Medical Center

Sheba Medical Center, located in Tel Hashomer, Israel, is the largest medical center in the Middle East. Sheba was ranked the #7 hospital in the world in Newsweek's 2026 World's Best Hospitals ranking and is recognized among the World's Best Specialized Hospitals for Oncology. The Benjamin Davidai Department of Radiation Oncology, which will conduct the study, is one of the largest and most sophisticated radiation oncology programs in Israel. For additional information, please visit www.shebaonline.org.

About Valion Bio, Inc.

Valion Bio, Inc. (Nasdaq: VBIO) is a clinical-stage immunotherapeutics company developing Entolimod, a Toll-like receptor 5 (TLR5) agonist, as a first-in-class radioprotector and radiomitigator for medical countermeasure and supportive-care applications. Entolimod is being developed under the U.S. Food and Drug Administration's Animal Rule for Acute Radiation Syndrome (ARS) and has received Fast Track and Orphan Drug designations. Valion Bio's wholly-owned subsidiary Velocity Bioworks®, based in San Antonio, Texas, is a microbial  fermentation contract development and manufacturing organization (CDMO). For additional information, please visit www.valionbio.com.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, without limitation, statements regarding the initiation, conduct, timing, enrollment pace, and potential results of the clinical study at Sheba Medical Center evaluating Entolimod; the anticipated timing of Institutional Review Board approval, first patient enrollment, interim data readout, and topline data; the potential of Entolimod as a radioprotector, radiomitigator, and supportive-care agent, including in cancer patients receiving therapeutic radiation and other radiation exposure settings; market size and commercial-opportunity references, including with respect to neutropenia and supportive-care oncology; potential strategic partnership interest; the Company's Animal Rule development program for Acute Radiation Syndrome; the integration and operations of Velocity Bioworks®; the Company's Nasdaq listing and continued listing compliance; the Company's working capital and financing plans; and the Company's ability to consummate strategic transactions. Forward-looking statements are based on the Company's current expectations and are subject to a variety of risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, those described in the Company's Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on March 30, 2026, and in the Company's other filings with the SEC. Forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

Investor + Media Contact
Rich Cockrell
CG Capital
[email protected]
404.736.3838

SOURCE Valion Bio, Inc.