Tivic Delivers 200x Scale-up in Manufacturing for Lead Drug Candidate Entolimod(TM) And Achieves Reproducible Yields, Potency and Purity
Rhea-AI Summary
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.
Positive
- 200x scale-up achieved in manufacturing volume
- 50‑liter batch validated as ~1.3 million human doses
- Purity, potency, and yields met drug release requirements
- Acquisition of Velocity Bioworks improved manufacturing efficiency
Negative
- BLA filing for Entolimod has not yet been submitted
- Commercial cGMP production at 200 liters remains to be completed
News Market Reaction – TIVC
On the day this news was published, TIVC gained 2.22%, reflecting a moderate positive market reaction. Argus tracked a trough of -7.9% from its starting point during tracking. Our momentum scanner triggered 11 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $73K to the company's valuation, bringing the market cap to $3M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
TIVC fell 4.93% while peers showed mixed moves: NAOV (-1.95%), AMIX (-12.2%) down, VERO (+1.96%), MOVE (+4.61%), NUWE (+2.56%) up. With no peers in the momentum scanner and mixed direction, trading appeared more stock-specific than sector-driven.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Jan 08 | CDMO acquisition update | Positive | +6.0% | Webcast announcement highlighting Velocity Bioworks acquisition and Entolimod acceleration. |
| Dec 11 | CDMO acquisition | Positive | +11.8% | Acquisition of cGMP assets and launch of Velocity Bioworks with large financing package. |
| Nov 18 | BARDA meeting news | Positive | +25.1% | Securing BARDA Techwatch meeting and outlining BLA pathway for Entolimod. |
| Nov 14 | Earnings update | Negative | -8.2% | Q3 2025 financials with low revenue, losses, and cash details. |
| Nov 13 | Clinical device data | Positive | -7.1% | ncVNS clinical optimization findings with improved heart rate variability. |
Recent positive strategic and BARDA-related updates often coincided with positive price reactions, while earnings and device data updates saw negative moves.
Over the past few months, Tivic has steadily advanced its biologics strategy. On Nov 13, 2025, it reported ncVNS optimization data, followed by Q3 results on Nov 14 showing $146,000 in revenue and a $2.6M net loss. A BARDA Techwatch meeting for Entolimod was disclosed on Nov 18, with a 25.08% next-day gain. The December CDMO asset acquisition and launch of Velocity Bioworks on Dec 11 and the related webcast announcement on Jan 8, 2026 drove gains of 11.76% and 5.97%, underscoring investor focus on Entolimod and manufacturing readiness.
Regulatory & Risk Context
An effective S-3 resale registration filed on Oct 17, 2025 covers up to 1,580,437 shares of common stock held by selling stockholders. The company is not selling shares under this registration and would only receive cash if warrants are exercised. The filing highlights potential resale pressure and dilution risk for existing shareholders.
Market Pulse Summary
This announcement details a 200x scale-up for Entolimod, with a verified 50-liter batch yielding about 1.3 million doses and meeting purity and potency standards, and outlines plans for 200-liter cGMP production ahead of a BARDA TechWatch on January 26. Recent history shows investor attention on Entolimod, BARDA engagement, and the Velocity Bioworks CDMO build-out. The active S-3 resale registration for up to 1,580,437 shares also remains a structural factor to monitor alongside future clinical and regulatory milestones.
Key Terms
toll-like receptor 5 (tlr5) medical
acute radiation syndrome (ars) medical
neutropenia medical
cdmo technical
current good manufacturing practice (cGMP) regulatory
biologics license application (bla) regulatory
u.s. food and drug administration (fda) regulatory
biomedical advance research and development authority (barda) regulatory
AI-generated analysis. Not financial advice.
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.
"In less than one year, Tivic has accomplished extraordinary acceleration in the potential commercialization of Entolimod -- from initial licensing through completion of cell validation, and now verification of a scale-up batch that represents a 200-fold increase in volume without compromising the drug substance or yields," said Tivic CEO Jennifer Ernst.
"Last month," she added, "Tivic acquired, at a favorable valuation, certain CDMO assets that are now branded as Velocity Bioworks. This acquisition has immediately enhanced our operational and cost efficiencies for manufacturing Entolimod. We anticipate rapidly advancing to commercial-scale production at 200 liters under cGMP conditions, the next step in our path to a BLA filing, and ultimately commercialization."
Ernst concluded, "As we prepare for our meeting with BARDA later this month, we have demonstrated large-scale manufacturing readiness, with the capability to produce millions of doses of Entolimod for ARS. We will also present robust clinical evidence supporting Entolimod's differentiated potential versus existing ARS countermeasures, including its ability to mitigate and prevent both gastrointestinal and hematopoietic injury, reinforcing our strategy to advance Entolimod as a priority therapeutic asset for government partnership or potential acquisition."
About BARDA TechWatch Meetings
BARDA is part of the Administration for Strategic Preparedness and Response and operates within the U.S. Department of Health and Human Services agency to develop, procure, and stockpile medical countermeasures that address chemical, biologic, radiologic, and nuclear public health threats. The TechWatch format enables BARDA and other US agencies to evaluate technology and manufacturing readiness, and potential pathways to funding and purchasing of new technologies. Tivic anticipates exchanging technical information with BARDA, presenting potential development pathways for Entolimod for ARS as a potential mitigant and/or therapeutic in mass-casualty or field deployment situations, and as part of the strategic national stockpile.
About Entolimod
Entolimod is a novel Toll-like Receptor 5 (TLR5) agonist that triggers NF-kappaB pathway signaling, activating anti-apoptotic and cell protective mechanisms. Entolimod for Acute Radiation Syndrome (ARS) has been the subject of extensive trials under the FDA's Animal Rule and in animal models has demonstrated robust survival rates, enhanced gastrointestinal tract recovery, and improved hematopoiesis. To see the complete Tivic pipeline visit: https://tivichealth.com/pipeline/
About Tivic
Tivic is a late-stage immunotherapeutics company whose lead drug candidate, Entolimod to treat ARS, is in late-stage development. Entolimod is a TLR5 agonist that activates an innate immune pathway to prevent cell death in the bone marrow and epithelial tissues across systems impacted by radiation and age. The pipeline includes Entolimod to treat Neutropenia, and lymphocyte exhaustion, as well as Entolasta™, an immunologically optimized variant of Entolimod for chronic applications.
Tivic's wholly owned subsidiary, Velocity Bioworks, is a full-service CDMO based in San Antonio, Texas. Tivic also leverages Velocity Bioworks' manufacturing capabilities to advance its own drug pipeline with the expected benefits of lower costs, accelerated manufacturing outcomes and supply chain security. To learn more about Tivic, visit: https://tivichealth.com/
Forward-Looking Statements
This press release may contain "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim, "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Tivic Health Systems Inc.'s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate, including as a result of the company's interactions with and guidance from the FDA and other regulatory authorities; the ability of the company to achieve the expected benefits from the acquisition of development and manufacturing assets within expected time frames or at all; changes to the company's relationship with its partners; failure to obtain FDA or similar clearances or approvals and noncompliance with FDA or similar regulations; the company's future development of its ncVNS treatment, Entolimod and Entolasta; changes to the company's business strategy; timing and success of clinical trials and study results; regulatory requirements and pathways for approval; the company's ability to successfully commercialize its product candidates in the future; changes in the markets and industries in which the company does business; consummation of any strategic transactions; the company's need for, and ability to secure when needed, additional working capital; the company's ability to maintain its Nasdaq listing; and changes in tariffs, inflation, legal, regulatory, political and economic risks. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of risks and uncertainties relevant to the company, and other important factors, see Tivic Health's filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 21, 2025, under the heading "Risk Factors", as well as the company's subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and the company undertakes no duty to update such information except as required by applicable law.
Investor Contact:
Hanover International, Inc.
ir@tivichealth.com
Media Contact:
DJ Freyman
DJ@fastrackPR.com
SOURCE: Tivic Health Systems
View the original press release on ACCESS Newswire
FAQ
What manufacturing milestone did Tivic (TIVC) announce on January 12, 2026?
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