Tivic Health Systems Delivers 200x Scale-Up In Manufacturing Volume For Lead Drug Candidate Entolimod

Company demonstrates commercial-scale production of its Toll-like Receptor 5 (TLR5) agonist for Acute Radiation Syndrome (ARS) and Neutropenia through wholly owned contract development manufacturing organization (CDMO), Velocity Bioworks

Company's next step is to initiate production under current Good Manufacturing Practice (cGMP), a critical milestone moving towards filing a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA)

Milestone achieved in advance of January 26 TechWatch meeting with the Biomedical Advance Research and Development Authority (BARDA) to discuss federal strategic relevance of Entolimod™ for ARS

FREMONT, CA AND SAN ANTONIO, TX / ACCESS Newswire / January 12, 2026 / Tivic Health® Systems, Inc. (NASDAQ:TIVC), a late-stage immunotherapeutics company, today announced it has delivered a 200x scale-up in manufacturing volume for Tivic's lead drug candidate Entolimod™. Entolimod is a TLR5 agonist in development to treat ARS, as well as Neutropenia and other cancer-related conditions. This scale-up was completed by Tivic's wholly owned CDMO, Velocity Bioworks, the acquisition of which has enabled Tivic to quickly advance towards cGMP manufacturing, a requirement for filing a BLA for Entolimod for ARS with the FDA.

As part of the verification and validation process, Tivic successfully demonstrated Entolimod at a 50-liter production volume, equivalent to approximately 1.3 million human doses, with purity and potency meeting all drug release requirements. In addition, yields were consistent with historical batches produced.