American Marconi Wireless News - Tivic and BARDA Continue Discussions of Entolimod for Acute Radiation Syndrome on March 10

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.
[email protected]

Media Contact:
DJ Freyman
[email protected]

SOURCE: Tivic Health Systems

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P.Martin--AMWN