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Valion Bio, formerly Tivic Health Systems, reports developments tied to its transformation into a biopharmaceutical company focused on innate-immune therapeutics. Company news centers on Entolimod™, a TLR5 agonist lead candidate for acute radiation syndrome, related gastrointestinal radiation-injury work, broader oncology supportive-care applications, and pipeline depth from Entolasta™.
Updates also cover the company’s wholly owned Velocity Bioworks subsidiary, a full-service CDMO providing analytical testing, process development, and cellular and biologic therapy manufacturing services. Recurring announcements include government and public-health preparedness engagement, nonclinical study agreements, financial results, corporate presentations, leadership changes, and the completed name and ticker change from TIVC to VBIO.
Tivic (Nasdaq:TIVC) presented Entolimod at a TechWatch meeting with BARDA and U.S. defense and health agencies on January 26, 2026. The company showcased clinical results and manufacturing readiness accelerated by new subsidiary Velocity Bioworks, and BARDA requested an expedited follow-up to continue discussions about potential inclusion in the Strategic National Stockpile.
The meeting started formal engagement with BARDA, DoD, DTRA, NIH and NIAID to evaluate Entolimod as a therapeutic and prophylactic radiation medical countermeasure.
Tivic Health (Nasdaq:TIVC) will present at the 3rd Annual DealFlow Discovery Conference on Jan 28-29, 2026 in Atlantic City. The CEO's presentation will outline a strategic pivot and forward outlook for advancing Entolimod™ toward commercialization.
Key topics include cell line verification success, a demonstrated 200x manufacturing scale-up with reproducible quality, progress toward cGMP manufacturing in preparation for a Biologics License Application (BLA), engagement with BARDA via a Jan 26 TechWatch meeting, and the formation/integration of Velocity Bioworks, an internal CDMO aimed at accelerating commercial readiness.
Tivic Health (NASDAQ:TIVC) announced that CEO Jennifer Ernst will present a corporate update at the Emerging Growth Virtual Conference on January 22, 2026 at 4:10–4:20 PM ET. The presentation will cover recent milestones in advancement of Entolimod, including scale-up validation for manufacturing and the vertical integration of Velocity Bioworks, a San Antonio contract development and manufacturing organization.
The company said the Velocity Bioworks addition provides in‑house manufacturing capability and potential new revenue streams, and is expected to reduce production costs, eliminate outsourcing delays, and accelerate cGMP validation for Entolimod. A live webcast and archived replay will be available.
Tivic Health (Nasdaq:TIVC) announced a 200x manufacturing scale-up for lead drug candidate Entolimod, completed by its wholly owned CDMO, Velocity Bioworks. Tivic validated a 50‑liter production batch equivalent to ~1.3 million human doses with purity, potency and yields meeting release criteria. The company said the acquisition of CDMO assets improved operational and cost efficiencies and expects to advance to 200 liters under cGMP as the next step toward a Biologics License Application (BLA) for Acute Radiation Syndrome (ARS). Tivic also noted an upcoming BARDA TechWatch meeting on January 26, 2026 to discuss strategic relevance.
Tivic Health (Nasdaq: TIVC) will host a special webcast and conference call on Monday, January 12, 2026 at 1:30 PM PT / 4:30 PM ET to discuss its December 2025 acquisition of certain CDMO assets, now branded Velocity Bioworks. Management said the in‑house CDMO has already reduced outsourcing delays and costs, accelerated validation of Entolimod™ manufacturing, and may enable an earlier biologics license application submission to the U.S. FDA. Leadership expects Velocity Bioworks to operate as a standalone CDMO and a new revenue engine by providing biologic production services to small and midsize development-stage biotech companies. The call will feature CEO Jennifer Ernst and COO Michael K. Handley and is accessible via webcast and dial-in.
Tivic (Nasdaq:TIVC) acquired cGMP manufacturing and development assets from Scorpius and launched Velocity Bioworks, a wholly owned CDMO subsidiary, to accelerate commercialization of Entolimod and serve third-party biotech customers. The company validated the Entolimod cell line at the site in Q3 and says the facility supports a BLA pathway.
Financing led by 3i, LP includes $16M debt for the asset purchase, up to $75M in preferred convertible equity (including an $18M near-term tranche), and an expected $50M equity line of credit affiliate facility.
Tivic Health (NASDAQ:TIVC) announced it secured an exclusive BARD A Techwatch meeting on November 18, 2025 to present clinical and manufacturing data for Entolimod for acute radiation syndrome (ARS).
The company said it will discuss Entolimod's animal-rule survival and organ-recovery data, manufacturing readiness, and preparations toward a biologics license application (BLA). Entolimod has FDA Fast Track and Orphan Drug designations and is being considered for mass-casualty stockpile and field deployment pathways that could lead to BARDA evaluation for funding or procurement.
Tivic Health (Nasdaq: TIVC) reported third quarter 2025 results on November 14, 2025 and outlined progress on its biologics transformation.
Key points: Revenue $146,000 vs $126,000 year-ago; gross loss $145,000 driven by a $230,000 inventory reserve; operating expenses $2.3M; net loss $2.6M. At September 30, 2025 cash and equivalents were $3.5M and the company reported no debt and approximately $3.5M in committed funding.
Corporate advances include transfer of two INDs for Entolimod, completion of cell line verification toward cGMP manufacturing, wind-down of the ClearUP consumer business, and $3.8M net proceeds from financing tranches in Q3.
Tivic Health (NASDAQ:TIVC) reported results from a collaborative clinical optimization study with The Feinstein Institutes showing personalization of non-invasive cervical vagus nerve stimulation (ncVNS) parameters strongly affected autonomic outcomes on November 13, 2025.
Key findings: personalizing stimulation frequency produced a 46% increase in heart rate variability (HRV) and was 8.9x more effective than a fixed frequency; optimal frequency varied between visits; electrode placement and configuration materially changed HRV; and 4 minutes of stimulation outperformed 20 minutes.
The study used healthy subjects and the company said the data may inform development for multiple patient populations.
Tivic Health (Nasdaq: TIVC) will report third quarter 2025 financial results on Friday, November 14, 2025 via a pre-recorded conference call and webcast.
The event is scheduled for 1:30 PM PT / 4:30 PM ET. Teleconference details: Toll Free 888-506-0062, International 973-528-0011, Participant Access Code 230582. A live webcast will be available at https://www.webcaster5.com/Webcast/Page/2865/53145.