VBIO

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.

Initial Study to Evaluate Entolimod™ for Gastrointestinal Tissue Preservation in Partial-Body Acute Radiation Syndrome — an Indication for Which No Currently Approved or Stockpiled Countermeasure Has Demonstrated Efficacy SAN ANTONIO, May 5, 2026 /PRNewswire/ -- Valion Bio, Inc. (Nasdaq: VBIO) (formerly Tivic Health Systems, Inc.), a clinical-stage immunotherapeutics company developing Entolimod™ for Acute Radiation Syndrome (ARS) and oncology supportive care, today announced it has received the first study protocol under its previously announced non-clinical evaluation agreement with the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health. Under the agreement — valued at up to $7 million — NIAID will fully fund the in vivo studies required to support the Company's Biologics License Application (BLA) for Entolimod™ under the FDA's Animal Rule pathway, with the agency further committed to co-navigate the FDA submission process alongside Valion Bio upon favorable study outcomes.

Company Presented Entolimod™ from its TLR5 Platform to the Deputy Assistant Secretary of Defense for Nuclear, Chemical, and Biological Defense Programs SAN ANTONIO, April 28, 2026 /PRNewswire/ -- Valion Bio, Inc. (formerly Tivic Health Systems, Inc.) (Nasdaq: VBIO), a late-stage immunotherapeutics company, today announced that it briefed senior officials at the U.S. Department of War on Entolimod™ for acute radiation syndrome. The briefing, facilitated by American Defense International (ADI), was presented to the Deputy Assistant Secretary of Defense for Nuclear, Chemical, and Biological Defense Programs and his team at the Pentagon.