VBIO

Potential Fourth-Quarter 2026 Decision Could Mark Entolimod's First National Registration and Open a Pathway to Strategic Stockpiling and Government Procurement Formal review accepted July 22 • Ministry begins technical assessment • Regulatory requirements defined • Potential decision as early as Q4 2026 Near-Term Regulatory Catalyst Formal review underway: Ukraine's Ministry of Health accepted the Entolimod dossier for formal review on July 22, 2026. Technical assessment underway: Ukraine's Ministry of Health has 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.

AFRRI/NIAID Program to Advance Safety and Therapeutic Studies in Rapid Sequence; Top-Line Therapeutic Data Expected in Early Fall Study drug delivered • IACUC approval secured • Safety study planned to start this week Near-Term Program Milestones Study readiness: Entolimod has been delivered to AFRRI, IACUC approval has been obtained, and study animals are being acclimated ahead of dosing. Dosing will begin this week.

Government acceptance initiates formal regulatory review of Entolimod under Ukraine's Regulatory Equivalency pathway, with a potential review expected in as few as 45- to 60-days. Ukraine Ministry of Health Accepts Entolimod for Formal Review — Following its request for submission, Ukraine's Ministry of Health has accepted Valion Bio's Entolimod regulatory dossier for formal review under the country's Regulatory Equivalence Pathway, initiating the Ministry's scientific and regulatory evaluation.

Strategic execution across multiple initiatives positions the Entolimod platform to pursue opportunities in government preparedness, domestic biomanufacturing and oncology supportive care SAN ANTONIO, July 14, 2026 /PRNewswire/ -- Valion Bio, Inc. (Nasdaq: VBIO) ("Valion Bio" or the "Company") is pleased to report across a series of strategic initiatives for its Entolimod program — including continued engagement with U.S. government agencies and allied nations on Acute Radiation Syndrome (ARS) preparedness, a demonstrated 200-fold manufacturing scale-up through its wholly owned subsidiary Velocity Bioworks®, and planned expansion into innovative oncology supportive care. These developments reflect the Company's evolution from a single product candidate into an integrated biotechnology platform.

AFRRI/NIAID partnership and validated animal models significantly derisk regulatory and commercial advancement of Company's lead candidate Positive momentum further positions Entolimod as a potential first and only treatment for GI-ARS, representing a multi-billion-dollar commercial opportunity SAN ANTONIO, June 25, 2026 /PRNewswire/ -- Valion Bio, Inc. (Nasdaq: VBIO) ("Valion Bio" or the "Company") today announced that the Armed Forces Radiobiology Research Institute ("AFRRI"), a division of the U.S. Department of War ("DoW"), in partnership with the National Institute of Allergy and Infectious Diseases ("NIAID"), has completed design of the survival efficacy protocol that will be used to evaluate the Company's lead candidate, Entolimod™, for the treatment of Gastrointestinal Acute Radiation Syndrome ("GI-ARS"). The final AFRRI/NIAID protocol design for Entolimod emanates from the Company's previously announced non-clinical evaluation agreement with NIAID, and closely follows the U.S. House Armed Services Committee's direction to the DoW to develop a resources and fielding plan for prioritizing radiation/nuclear countermeasures that, like Entolimod, are both prophylactic (pre-exposure) and therapeutic (post-exposure).

Cross-Agency Discussion Highlights Interest in Oral Formulation as Field-Deployable Medical Countermeasure SAN ANTONIO, May 19, 2026 /PRNewswire/ -- Valion Bio, Inc. (Nasdaq: VBIO), a late-stage innate immunotherapeutics company, today announced that it presented Entolimod for acute radiation syndrome (ARS) to senior officials from the U.S. Department of War and the Biomedical Advanced Research and Development Authority (BARDA) in a joint briefing held on May 14, 2026. The session was Valion Bio's second engagement with senior Department of War officials, following the Company's April 28, 2026, Pentagon briefing on Entolimod.

First Commercial Installation Targeted for July 2026 in San Antonio; Strategic Reference Site Positions Velocity Bioworks at the Forefront of Next-Generation NMR-Based Diagnostics SAN ANTONIO, May 14, 2026 /PRNewswire/ -- Valion Bio, Inc. (formerly Tivic Health Systems, Inc.) (Nasdaq: VBIO), a clinical-stage immunotherapeutics company, today announced that its wholly owned subsidiary, Velocity Bioworks, has entered into an exclusive commercial development and license agreement with LarmorBio, Inc. ("LarmorBio") for LarmorBio's BioScan-NMR™ platform, a next-generation nuclear magnetic resonance (NMR) system. Under the agreement, Velocity Bioworks will host the first commercial deployment of the BioScan-NMR platform, with installation and commissioning at the Company's San Antonio facility targeted for July 2026.

First Reporting Quarter as Valion Bio Marked by Continued Advancement of the Entolimod Platform, Broader Government Engagement, and Continued Integration of Velocity Bioworks Conference Call to be Held Today at 1:30 PM PT / 4:30 PM ET SAN ANTONIO  , May 14, 2026 /PRNewswire/ -- Valion Bio, Inc. (formerly Tivic Health Systems, Inc.) (Nasdaq: VBIO), a clinical-stage immunotherapeutics company, today reported financial results for the three months ended March 31, 2026 — the company's first full reporting quarter under its new corporate identity — and provided a business update on the continued advancement of its Entolimod platform, ongoing engagement with U.S. government agencies, and continued integration of wholly owned manufacturing subsidiary Velocity Bioworks. First Quarter 2026 Highlights and Subsequent Events Completed corporate transformation, including the change of the company's legal name from Tivic Health Systems, Inc. to Valion Bio, Inc. and the change of the company's Nasdaq listing symbol from TIVC to VBIO, consolidating the company's identity as a focused clinical-stage immunotherapeutics platform.

SAN ANTONIO, Texas, May 11, 2026 /PRNewswire/ -- Valion Bio, Inc. (formerly Tivic Health Systems, Inc.) (Nasdaq: VBIO), a clinical-stage immunotherapeutics company developing Entolimod™ for Acute Radiation Syndrome (ARS) and oncology supportive care, today announced that it will report financial results for the first quarter ended March 31, 2026, after market close on Thursday, May 14, 2026. Management will host a conference call and webcast to discuss the Company's financial results and provide a business update.

Senator John Cornyn recognizes facility's role in advancing radiation countermeasures for cancer patients and U.S. warfighters; Mayor Gina Ortiz Jones, Office of Senator Cornyn, and Velocity Bioworks leadership join Valion Bio at ribbon cutting ceremony SAN ANTONIO, May 6, 2026 /PRNewswire/ -- Valion Bio, Inc. (Nasdaq: VBIO), a clinical-stage immunotherapeutics company developing Entolimod™ for acute radiation syndrome, oncology supportive care, and longevity indications, today celebrated the grand opening of its wholly-owned biomanufacturing subsidiary, Velocity Bioworks, at a ribbon-cutting ceremony in San Antonio. The facility, located on the VelocityTX innovation campus on San Antonio's historic East Side, marks the formal activation of the company's vertically integrated manufacturing strategy and positions Valion Bio as one of the few clinical-stage biotechs with end-to-end domestic biomanufacturing capability for its lead asset.