Tivic Secures BARDA Meeting for Entolimod(TM) for Acute Radiation Syndrome

Meeting with Radiological and Nuclear Medical Countermeasures Program

FREMONT, CA / ACCESS Newswire / November 18, 2025 / Tivic Health Systems, Inc. (NASDAQ:TIVC), a late-stage therapeutics company, today announced it has secured an exclusive Techwatch meeting with the Biomedical Advanced Research and Development Authority (BARDA)'s Radiological and Nuclear Medical Countermeasures Program staff.

Tivic leadership will be presenting clinical data on Entolimod's effects on radiation-induced injury and acute radiation syndrome (ARS), its progress on manufacturing readiness and the preparations it has been making for a biologics license application, or BLA.

The Techwatch format allows Tivic and BARDA staff to exchange technical information, establish program priorities, and discuss development pathways for Entolimod to potentially be deployed in mass-casualty, stockpile, and field deployment situations. The process enables BARDA to evaluate technology readiness, understand manufacturing and approval requirements, and identify potential pathways to funding and purchasing.

"This interaction supports Tivic's strategy to develop high-value therapeutic assets with potential government partnership or acquisition pathways," said Jennifer Ernst, CEO of Tivic Health. "We believe our focus on radiation injury and host-directed countermeasures positions us well in a space with defined federal demand and long-term strategic relevance."

Entolimod, Tivic's lead drug candidate, is a novel TLR5 agonist that triggers NF-kB signaling, activating anti-apoptotic and cell protective mechanisms. Under the FDA's Animal Rule, Entolimod for ARS has been the subject of extensive trials and has demonstrated robust survival, enhanced GI tract recovery and improved hematopoiesis in animal models when administered after exposure to ionizing radiation. Clinical studies also suggest Entolimod may serve as a radioprotective agent that can be used prophylactically (prior to exposure) to reduce damage. Entolimod for ARS has been granted Fast Track and Orphan Drug designations by the FDA.

More About BARDA
BARDA is part of the Administration for Strategic Preparedness and Response (ASPR) and operates within the U.S. Department of Health and Human Services (HHS) agency to develop, procure, and stockpile medical countermeasures, including vaccines, drugs and diagnostics that address chemical, biologic, radiologic, and nuclear public health threats.