Tivic Health Systems reported that it is changing its corporate name to Valion Bio, Inc. and will begin trading under the new Nasdaq ticker symbol VBIO effective at market open on April 28, 2026. The CUSIP number for the company’s common stock will remain unchanged. The company stated that the rebrand follows a strategic shift from a consumer medical device business to a late-stage biopharmaceutical platform supported by an internal biomanufacturing operation.
A central component of the new strategy is Velocity Bioworks, Valion Bio’s wholly owned contract development and manufacturing (CDMO) subsidiary. Acquired in December 2025 for approximately 16.3 million dollars, Velocity Bioworks provides domestic, controlled manufacturing capabilities for the company’s biologic programs, including its lead candidate Entolimod. The subsidiary recently completed a 200‑fold manufacturing scale-up of Entolimod using 50‑liter fermentation, with production reported as on time, within budget, and meeting purity and potency specifications. In addition to supporting internal programs, Velocity Bioworks operates as a standalone CDMO targeting early-stage biotechnology clients with Phase I and Phase II biologics manufacturing needs, with the potential to generate independent, non‑dilutive revenue at higher utilization.
Valion Bio’s lead drug candidate, Entolimod, is a Toll-like receptor 5 (TLR5) agonist in late-stage development with a dual profile in medical countermeasures and oncology supportive care. As a medical countermeasure for acute radiation syndrome, Entolimod has received U.S. FDA Fast Track and Orphan Drug designations and is being advanced under the FDA’s Animal Rule pathway. The company is in active discussions with U.S. government agencies, including BARDA, DTRA and NIAID, regarding potential inclusion of Entolimod in the U.S. Strategic National Stockpile. The same TLR5-mediated cytoprotective mechanism is being pursued for development in chemotherapy-induced neutropenia, with physician-sponsored trials targeted for 2026 and Phase IIb readiness identified as a goal. A next‑generation TLR5 agonist, Entolasta, is being advanced to extend the pipeline and intellectual property coverage across these indications.
The company noted that the rebrand to Valion Bio is intended to reflect its transition to a late-stage biopharmaceutical organization centered on Entolimod and supported by internal manufacturing through Velocity Bioworks, as well as its pursuit of multiple potential revenue streams spanning government procurement, oncology supportive care, and CDMO services.