Tivic and BARDA Continue Discussions of Entolimod for Acute Radiation Syndrome on March 10
Rhea-AI Summary
Tivic (Nasdaq:TIVC) announced a follow-up meeting with the Biomedical Advanced Research and Development Authority (BARDA) on March 10, 2026 to continue discussions about clinical data, potential funding, and possible stockpiling of Entolimod for Acute Radiation Syndrome (ARS).
Entolimod, a TLR5 agonist, has shown improved survival and gastrointestinal and hematopoietic protection in animal studies under the FDA Animal Rule; Tivic also highlighted manufacturing readiness via its new biomanufacturing subsidiary Velocity Bioworks.
Positive
- BARDA follow-up meeting scheduled for March 10, 2026
- Entolimod showed improved survival in Animal Rule studies
- Manufacturing readiness via new subsidiary Velocity Bioworks
Negative
- No binding BARDA funding or stockpiling commitment yet
- No FDA approval; data limited to Animal Rule studies
News Market Reaction – TIVC
On the day this news was published, TIVC gained 0.67%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
TIVC is up about 0.95% while only one momentum peer (NUWE) appears and is down 3.31%, suggesting a stock-specific move rather than a sector-wide shift.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| 2026-01-28 | BARDA TechWatch recap | Positive | -1.6% | BARDA TechWatch meeting recap on Entolimod and potential Strategic Stockpile role. |
| 2026-01-26 | Conference presentation | Positive | -4.4% | DealFlow conference preview outlining strategic pivot toward Entolimod commercialization. |
| 2026-01-20 | Investor conference | Positive | +0.8% | Virtual conference update on Entolimod milestones and Velocity Bioworks integration. |
| 2026-01-12 | Manufacturing scale-up | Positive | +2.2% | Announcement of 200x Entolimod manufacturing scale-up and BARDA meeting plans. |
| 2026-01-08 | CDMO acquisition webcast | Positive | +6.0% | Webcast on CDMO asset acquisition and strategic impact via Velocity Bioworks. |
Recent news has been consistently positive on Entolimod and manufacturing, with price reactions mixed: three aligned gains and two divergences where shares fell despite favorable updates.
Over the past months, Tivic has repeatedly highlighted progress around Entolimod and its Velocity Bioworks CDMO. Updates included a 200x manufacturing scale-up, a validated 50-liter batch, and BARDA engagement for Acute Radiation Syndrome. Investor events and BARDA-focused releases sometimes saw negative next-day reactions, while the CDMO acquisition webcast on Jan 8, 2026 and the scale-up news on Jan 12, 2026 drew positive moves. Today’s BARDA follow-up meeting fits this ongoing commercialization and government-partnering narrative.
Regulatory & Risk Context
The company has an effective S-3 resale registration filed on 2025-10-17, covering up to 1,580,437 shares of common stock for resale by existing holders. Tivic does not receive proceeds from these resales except upon warrant exercise. The shelf remains active through 2028-10-17 and has been utilized via multiple 424B3 filings.
Market Pulse Summary
This announcement highlights Tivic’s progression from an initial BARDA TechWatch session on January 26, 2026 to a scheduled follow-up on March 10, 2026, focused on Entolimod’s clinical data and potential U.S. government support. It fits a broader pivot toward late-stage immuno-therapeutics and in-house manufacturing via Velocity Bioworks. Investors may watch for outcomes around potential funding, FDA pathways under the Animal Rule, and Strategic National Stockpile discussions.
Key Terms
acute radiation syndrome medical
ionizing radiation medical
biomedical advanced research and development authority regulatory
toll-like receptor 5 (tlr5) medical
tlr5 agonist medical
strategic national stockpile regulatory
animal rule regulatory
radiation countermeasure medical
AI-generated analysis. Not financial advice.
Initial presentation on January 26, 2026 showcased Entolimod's potential to mitigate and prevent both gastrointestinal and hematopoietic injury from ionizing radiation exposure.
FREMONT, CA / ACCESS Newswire / February 18, 2026 / Tivic (Nasdaq:TIVC), a late-stage immuno-therapeutics company, today announced that a second, follow-up meeting with the Biomedical Advanced Research and Development Authority (BARDA) has been scheduled for March 10, 2026, to continue discussions focused on clinical data and the potential for funding and, ultimately, stockpiling Entolimod™ for Acute Radiation Syndrome (ARS).
On January 26, 2026, Tivic attended an initial TechWatch meeting with BARDA and presented clinical data for Tivic's Toll-like Receptor 5 (TLR5) agonist, Entolimod™, to potentially be used as a radiation countermeasure. The presentation discussed characteristics of Entolimod that are expected to distinguish it mechanistically from currently approved ARS therapies. Tivic also highlighted the company's manufacturing readiness, enabled through Tivic's newly formed biomanufacturing subsidiary Velocity Bioworks.
Following this meeting, key government attendees recommended a follow-up meeting as soon as possible.
"We see this invitation by the U.S. government to return for further discussions on the differentiated properties of Entolimod as a promising sign," said Tivic Chief Executive Officer Jennifer Ernst. "Our goal for this meeting is to explore potential government support for continued development of Entolimod, including activities necessary to pursue FDA approval and potentially incorporating Entolimod into the Strategic National Stockpile."
"In studies conducted under the FDA's Animal Rule framework, Entolimod has demonstrated improved survival in relevant animal models of radiation exposure, along with evidence of gastrointestinal and hematopoietic protection," said Michael K. Handley, COO of Tivic and President of Biopharma. "Entolimod represents a highly differentiated approach compared to currently approved ARS treatments. We look forward to further discussing its strategic benefits with the U.S. government."
About BARDA
BARDA is part of the Administration for Strategic Preparedness and Response operating 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.
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 improved survival rates in well characterized animal models, 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™ for Acute Radiation Syndrome, is in advanced development under the FDA's Animal Rule. 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. Tivic's 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 contract development and manufacturing organization 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 continued interest of BARDA and other U.S. government agencies in Entolimod; 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 Entolimod, Entolasta or its previously developed bioelectronic platform; 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 is Tivic announcing about Entolimod and BARDA on March 10, 2026 (TIVC)?
Has Entolimod demonstrated efficacy for Acute Radiation Syndrome in Tivic studies (TIVC)?
Does the March 10 BARDA meeting mean Tivic has government funding or stockpiling guaranteed (TIVC)?
What manufacturing readiness did Tivic highlight for Entolimod ahead of the BARDA meeting (TIVC)?
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