Valion Bio Inc（VBIO）のニュースとイベントVBIOValion Bio Inc

Valion Bio Appoints Lisa Wolf as President and COO

Valion Bio (VBIO) announced strategic changes to its management team and Board of Directors designed to accelerate execution across its clinical and commercial initiatives and position the Company for its next phase of growth. The Company's Board of Directors has unanimously appointed Lisa Wolf to the expanded roles of President and COO. Ms. Wolf will continue to serve as CFO and will assume executive leadership of the Company following the departure of former CEO Michael Handley. The Company also announces the recent appointments of Thomas Jensen and Jared Malbin as directors to its Board. Malbin currently serves as COO of Lucid Capital Markets. Jensen currently serves as CEO, Co-Founder and Director of Nasdaq-listed Allarity Therapeutics (ALLR).

Valion Bio's Entolimod Regulatory Dossier Accepted by Ukraine's Ministry of Health

Valion Bio announced that Ukraine's Ministry of Health has accepted the Company's regulatory dossier for Entolimod for formal review under the country's Regulatory Equivalence Pathway. Entolimod is Valion Bio's investigational medical countermeasure for acute radiation syndrome. The dossier was accepted on July 22, 2026. The Ministry has since begun technical assessment of the dossier and issued its first round of questions, relating to the physicochemical characterization of the drug product that would be supplied under a potential stockpiling arrangement, which the Company is preparing to address. Valion Bio has since identified the documentation, analytical-testing, quality-control, manufacturing, import, and labeling requirements needed to advance the review. The Company believes a regulatory decision could occur as early as the fourth quarter of 2026, although timing and outcome remain subject to the Ministry's review, any additional information requests, and operational circumstances.

Valion Bio Launches Entolimod Study for Radiation Injury

Valion Bio announced that the Armed Forces Radiobiology Research Institute, under its contract with the National Institute of Allergy and Infectious Diseases, is conducting a U.S. Department of War government-funded program evaluating Entolimod for radiation-induced gastrointestinal injury. The program is expected to advance through a safety study and, upon its successful completion, a therapeutic study in rapid sequence. The safety study is planned to start this week. The therapeutic study will evaluate whether Entolimod, administered after radiation exposure, can support survival and GI tissue recovery following lethal doses of ionizing radiation. Top-line therapeutic data are anticipated in early fall. Radiation-induced GI injury is a major potential cause of mortality following high-dose radiation exposure and remains a key focus of U.S. medical-countermeasure development. Successful development could support Entolimod's potential role in government preparedness for radiological and nuclear mass-casualty scenarios. The therapeutic study uses a shielded-mouse model designed to preserve the majority of the animals' bone marrow. This should allow investigators to evaluate survival and tissue-recovery effects attributable specifically to GI protection, rather than confounding results with bone-marrow outcomes. The Company believes Entolimod's ability to support survival while promoting GI recovery in this model would represent a result not previously demonstrated by a U.S. government-tested countermeasure.