SAN ANTONIO, April 15, 2026 /PRNewswire/ — Tivic Health Systems, Inc. (Nasdaq: TIVC), a clinical-stage immunotherapeutics company, today announced it has been selected to present at the U.S. Department of War’s Tech Watch program on May 7, 2026. The Tech Watch initiative identifies emerging technologies with high-value defense and dual-use applications.
Tivic Health will present its Entolimod™ TLR5 agonist lead drug candidate and its plans for an oral transmucosal delivery program for Entolimod™ — a delivery concept the Company believes has compelling and immediate relevance for both individual warfighter care and large-scale mass casualty response. The Company is currently in the process of engaging a specialized formulation development partner to advance this program.
“The geopolitical environment has fundamentally changed the calculus around medical countermeasure preparedness,” said Michael K. Handley, chief executive officer of Tivic Health Systems. “The threats are no longer theoretical — governments around the world are actively reassessing their readiness, and the window to establish Entolimod™ as a cornerstone of national and allied defense stockpiles has never been more open. We believe this is the right technology, at exactly the right time.”
Entolimod™ is a selective Toll-like receptor 5 (TLR5) agonist that activates NF-κB signaling pathways to protect cells from radiation-induced damage across both bone marrow and gastrointestinal tissues simultaneously. This dual-system mechanism represents a meaningful advance over currently stockpiled ARS countermeasures, including Neupogen® (filgrastim), Neulasta® (pegfilgrastim), and Leukine® (sargramostim), which are designed to stimulate hematopoietic recovery but do not address the lethal damage caused to the gastrointestinal tract at higher radiation doses — a key determinant of survival that remains a significant unmet need.
The Company is in early-stage exploration of an oral transmucosal delivery formulation intended to extend this radioprotection advantage by making Entolimod™ faster to administer, more stable, and accessible in scenarios where intravenous or injectable delivery is not practical. If successfully developed, an oral transmucosal formulation could be administered rapidly, without needles, and without the need for trained medical personnel — a critical advantage in combat environments and mass casualty events where speed of treatment and ease of administration can determine survival outcomes. The Company believes this delivery approach, if realized, could meaningfully expand access to life-saving countermeasures in scenarios where conventional medical infrastructure is unavailable, overwhelmed, or destroyed.
“Our Entolimod™ platform was built to address the most urgent unmet needs in radiation medicine, and we believe an oral transmucosal approach, if successfully developed, would take that mission to the next level,” Mr. Handley continued. “For the warfighter in the field and for first responders managing a mass casualty event, the ability to administer an effective radiation countermeasure quickly, simply, and without specialized equipment would be transformative. We look forward to presenting this vision to the Department of War on May 7th and to advancing what we believe is a critical component of national preparedness.”
The Department of War has expressed encouraging interest in advancing discussions with Tivic Health regarding Entolimod™ and its potential applications for national defense preparedness.
Strategic and Competitive Positioning
- Warfighter relevance: Addresses a critical unmet need in military radiation casualty care with a mechanism that protects both GI and hematopoietic tissues
- Mass casualty potential: Early-stage oral transmucosal delivery concept, if developed, could enable rapid treatment of large numbers of casualties without trained personnel or medical infrastructure
- Differentiated mechanism: Dual GI and bone marrow protection versus currently stockpiled G-CSF therapies, which address only hematopoietic recovery
- Administration simplicity (target profile): No needle, no IV, no specialized equipment required — subject to successful formulation development
- Regulatory pathway: Advancing toward BLA submission under the FDA’s Animal Rule
About Tivic Health Systems
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-κB 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; the ability to successfully engage a formulation development partner and develop an oral transmucosal delivery formulation; 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, 2025, filed with the SEC, 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:
Tivic Investor Relations
[email protected]
Media Contact:
DJ Freyman
[email protected]
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