Valion Bio Receives First Study Protocol Under Non-Clinical Evaluation Agreement With National Institute Of Allergy And Infectious Diseases; NIAID To Fully Fund In Vivo Studies Required To Support BLA For Entolimod Under FDA's Animal Rule Pathway

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.