Tivic Health briefed White House and FDA on TLR5 candidates and ncVNS; positive interest noted

Valion Bio, Inc.

On April 17, 2025, briefed White House senior leadership on Entolimod for acute radiation syndrome and need for advanced treatments.
Met with FDA to discuss expedited pathways for Entolimod, Entolasta (second-gen TLR5 agonist), and non-invasive cervical VNS technology.
Previous U.S. government funding from BARDA, NASA, DTRA, DoD, and Army for TLR5 program highlighted.
Positive interest in military/defense applications; FDA explored breakthrough device designations for ncVNS after clinical work.
CEO Jennifer Ernst expects continued discussions as programs progress toward potential FDA approval.

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