January 26 Presentation highlighted Entolimod's potential to mitigate and prevent both gastrointestinal and hematopoietic injury from ionizing radiation exposure
BARDA has requested a follow-up meeting to continue the discussion on the potential utility of Entolimod as a drug for the Strategic National Stockpile
Showcased clinical results, regulatory progression, and manufacturing readiness accelerated by newly formed subsidiary Velocity Bioworks
FREMONT, CA / ACCESS Newswire / January 28, 2026 / Tivic Health Systems, Inc. (Nasdaq:TIVC), a late-stage immunotherapeutics company, today announced that it delivered an invited presentation at a TechWatch meeting with the Biomedical Advanced Research and Development Authority (BARDA) on January 26, 2026, with select members of the Department of Defense (DoD), Defense Threat Reduction Agency (DTRA), National Institutes of Health (NIH) and National Institute of Allergy and Infectious Diseases (NIAID). The company presented key clinical and manufacturing readiness data for Tivic's Toll-like Receptor 5 (TLR5) agonist, Entolimod, underscoring its potential use as a radiation countermeasure, as well as progress on manufacturing readiness that has been accelerated by newly formed subsidiary Velocity Bioworks.
TechWatch meetings enable BARDA and other U.S. agencies to evaluate technology and manufacturing readiness and to identify potential pathways for funding and purchasing new technologies. Monday's meeting initiated Tivic's discussions with the agency regarding the potential for incorporating Entolimod into the Strategic National Stockpile, with key stakeholders requesting expedited follow-up.
"We appreciate the U.S. government's interest in the differentiated properties of Entolimod compared to the other drugs already stockpiled for treating ARS," said Tivic CEO Jennifer Ernst. "We are fully committed to supporting BARDA and other agencies in their exploration of Entolimod through our upcoming engagements."
"We are pleased that BARDA has recognized Entolimod's potential to provide life-saving benefits to those exposed to lethal doses of ionizing radiation," said Michael K. Handley, COO and President of Biopharma at Tivic. "We look forward to continuing our discussions with BARDA and other federal agencies to advance Entolimod's development as both a therapeutic and prophylactic radiation medical countermeasure."
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 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. 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 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 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:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/tivic-barda-discuss-entolimodtm-for-acute-radiation-syndrome-at-techw-1131169
