SAN ANTONIO, TX / ACCESS Newswire / March 31, 2026 / Tivic Health Systems, Inc. (Nasdaq:TIVC), a clinical-stage immunotherapeutics company, today announced it has received a formal Request for Information (RFI) from the Ukrainian Ministry of Health. The RFI initiates the formal evaluation of Entolimod Tivic's late-stage Toll-like Receptor 5 (TLR5) agonist for potential inclusion in Ukraine's national strategic reserves as a countermeasure against Acute Radiation Syndrome (ARS). Additionally, the Ukrainian Ministry of Health has requested to schedule a pre-submission meeting for Entolimod.
"Tivic's Entolimod, from our TLR5 platform, has catalyzed significant interest from international governments that recognize its potential as a cornerstone of national preparedness," said Michael K. Handley, chief executive officer of Tivic. "We are working closely with the Ukrainian Ministry of Health to establish a pathway toward potential accelerated approval and a formal stockpiling agreement. Our goal is to provide a superior therapeutic solution that addresses the complex requirements of regional security and patient survival."
A Differentiated Mechanism: Beyond Hematopoietic Recovery
Entolimod represents a paradigm shift in the treatment of Acute Radiation Syndrome. While currently stockpiled treatments, such as Neupogen (filgrastim), Neulasta (pegfilgrastim), and Leukine (sargramostim), are effective at stimulating the recovery of white blood cells after depletion, they do not address the lethal damage caused to the gastrointestinal (GI) tract at higher radiation doses.
As a selective TLR5 agonist, Entolimod activates the NF-?B signaling pathway, through a cascade of cell signaling pathways, actively prevents programmed cell death (apoptosis) in both bone marrow and GI epithelial tissues. This dual-system protection offers a comprehensive survival benefit that currently approved G-CSF therapies cannot provide, positioning Entolimod as a unique and essential candidate for national defense and emergency response.
Bridging Biodefense and Oncology: The Neutropenia Opportunity
The same mechanism that protects the body from high-dose radiation holds transformative potential for the multi-billion-dollar oncology supportive care market. Myelosuppression and neutropenia (a severe depletion of white blood cells) are the primary dose-limiting side effects for the 60 percent of cancer patients undergoing chemotherapy and radiation.
Unlike existing standard-of-care treatments that reactively stimulate cell production after the damage has occurred, Entolimod is being developed as a protective agent to prevent cell death in the bone marrow. By mitigating the underlying tissue damage, Entolimod has the potential to reduce the incidence of life-threatening infections, minimize treatment delays, and improve overall clinical outcomes for cancer patients. The Company is currently preparing to advance this program into physician-sponsored clinical trials later this year.
Advancing U.S. Strategic Engagement and Manufacturing Readiness
The engagement in Ukraine follows substantial progress in the United States. Tivic recently completed focused TechWatch meetings with the Biomedical Advanced Research and Development Authority (BARDA) and adjacent departments on January 26, 2026, followed by an expedited follow-up session on March 10, 2026. These discussions focused on Entolimod's clinical data and the Company's domestic manufacturing readiness.
About Tivic
Tivic Health is developing biologics that activate innate immune pathways for cytoprotection and modulate immune responses in conditions driven by radiation, disease, and immune dysregulation. The company's lead candidate, Entolimod for acute radiation syndrome (ARS), has been extensively studied having demonstrated survival benefits and improved tissue recovery in animal models under the FDA's Animal Rule.
Entolimod is a novel Toll-like receptor 5 (TLR5) agonist that activates NF-?B signaling pathways to protect cells from damage and stimulate immune responses. Entolimod for ARS has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration.
Tivic is also advancing Entolasta, a next-generation TLR5 agonist designed for potential broader therapeutic applications, including oncology supportive care. Tivic's clinical pipeline includes potential treatments for neutropenia, which is most commonly caused by chemotherapy, and a state of T-cell dysfunction known as lymphocyte exhaustion.
Tivic's wholly owned subsidiary, Velocity Bioworks, is a full-service contract development manufacturing organization, (CDMO) offering biomanufacturing services to third-party biotech companies. 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. For more information, visit https://ir.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; expectations regarding the potential benefits of the leadership transition; failure to obtain FDA or similar clearances or approvals and noncompliance with FDA or similar regulations, including related to the Animal Rule; the company's future development of Entolimod or Entolasta; changes to the company's business strategy; timing and success of pre-clinical and 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.
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SOURCE: Tivic Health Systems
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https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/tivic-receives-formal-request-for-information-from-ukrainian-ministry-1153585
