Welcome to our dedicated page for Tivic Health Systems news (Ticker: TIVC), a resource for investors and traders seeking the latest updates and insights on Tivic Health Systems stock.
Tivic Health Systems, Inc. (Nasdaq: TIVC) generates news that reflects its evolution into a diversified immunotherapeutics and health technology company. This page aggregates coverage of Tivic’s progress in biologics, bioelectronic medicine and contract development and manufacturing, giving investors and observers a single place to review its latest corporate announcements.
Much of Tivic’s recent news flow centers on Entolimod™, its lead Toll-like Receptor 5 (TLR5) agonist drug candidate for acute radiation syndrome (ARS) and related conditions. Articles highlight milestones such as cell line verification, large-scale manufacturing runs, and steps toward current Good Manufacturing Practice (cGMP) production in preparation for a potential Biologics License Application (BLA). Releases also discuss Entolimod’s Fast Track and Orphan Drug designations, its development under the FDA’s Animal Rule, and animal data showing effects on survival, gastrointestinal recovery and hematopoiesis after radiation exposure.
Another major theme in Tivic news is its acquisition of manufacturing and development assets and the launch of Velocity Bioworks™, a wholly owned CDMO subsidiary. Coverage describes how Velocity Bioworks is expected to support Tivic’s own biologics pipeline and offer development and manufacturing services to third-party biotech companies, creating additional revenue opportunities and reducing reliance on external manufacturers.
Visitors will also find updates on Tivic’s bioelectronic program, including results from a clinical optimization trial of non-invasive cervical vagus nerve stimulation conducted with The Feinstein Institutes for Medical Research at Northwell Health. These stories detail how personalized stimulation parameters can influence autonomic measures such as heart rate variability.
In addition, Tivic regularly reports on its interactions with government and industry stakeholders, including BARDA TechWatch meetings, participation in the Military Health System Research Symposium, and conference presentations outlining its strategic transformation. For investors tracking TIVC, this news feed offers a consolidated view of clinical, manufacturing, partnership and capital markets developments.
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.
Tivic Health (Nasdaq: TIVC) announced that CEO Jennifer Ernst will join a panel at the 8th Annual Northwell Health Innovation Constellation Forum on Thursday, Oct. 23 at 11:55 a.m. ET / 8:55 a.m. PT. The panel, titled "Building a Big Tent", will discuss advancing bioelectronic medicine by aligning stakeholders across healthcare, engaging first movers, and encouraging payor and pharma participation.
Panelists include Scott Gottlieb, MD and John M. O’Brien, PharmD, with Allysia Finley moderating. The session focuses on cross-sector collaboration to accelerate adoption and impact of bioelectronic therapies.
Tivic Health (Nasdaq: TIVC), a diversified immunotherapeutics company, announced that CEO Jennifer Ernst will present at the upcoming Emerging Growth virtual conference on September 25, 2025, at 11:25 AM ET.
The presentation will focus on Tivic's strategic transformation into the biopharmaceutical sector, highlighting their February 2025 acquisition of Statera Biopharma's TLR5 agonist portfolio. Ernst will discuss Entolimod, their lead candidate for Acute Radiation Syndrome (ARS), and their second indication for Neutropenia treatment. The company's approach combines biochemical and bioelectronic systems to address diseases.