New Biologics Patent Application Covers Potential Applicability of TLR5 Agonists to Improve Outcomes for Late-stage Cancer Therapies; Bioelectronic Patent Covers Optimized ncVNS Device Specifications

Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified therapeutics company, today announced it is expanding its intellectual property portfolio with the recent filing of two additional patent applications with the United States Patent and Trademark Office.

The first application applies to Tivic’s TLR5 agonist portfolio, which includes Entolimod and Entolasta. The patent titled “Immunomodulatory Pathway Modifying Agents and Uses of Same for Cancer Therapy” relates to the potential newly identified applications of TLR5 agonists such as Entolimod and Entolasta, as an adjunctive therapy to improve the effectiveness of T-cell, NK-cell and other immuno-oncology cell-based therapies for advanced-stage cancer. Patients receiving such therapies are often immunocompromised from earlier treatment regimens, and TLR5 agonists, used as an adjunctive therapy, may enhance outcomes. The second application, “Vagus Nerve Electrical Stimulation System,” covers device parameters that have been shown to have optimal impact on autonomic system activity via non-invasive vagus nerve stimulation.

“As we expand and protect our intellectual property rights, we are creating new potential areas for partnerships that can expand the market opportunities for our product candidates,” stated Jennifer Ernst, CEO of Tivic. “While our commercial focus remains on the advancement of Entolimod toward a biologics license application for acute radiation syndrome, we would welcome opportunities to partner with other therapeutic companies whose products may benefit from enhanced immune activation.”

About Tivic Health Systems, Inc.

Tivic’s dual platform utilizes the body’s biopharmaceutical and bioelectronic systems to treat unmet medical needs through targeting the immune system.

Tivic’s biologic compounds activate an innate immune pathway to prevent cell death in the bone marrow and epithelial tissues across systems impacted by radiation and age. The company’s lead drug candidate, Entolimod™, is a novel TLR5 agonist that has been granted Fast Track and Orphan Drug designations for acute radiation syndrome and is in late-stage development. The company also holds rights to develop Entolimod and its immunologically optimized derivative, Entolasta, for neutropenia.

Tivic’s bioelectronic program has been developing a novel, non-invasive medical device designed to target the neural pathways implicated in many prevalent and debilitating diseases. Early trials showed promising signals that Tivic’s approach may regulate specific biologic responses and downregulate an overactive immune system. The company believes its early-stage vagus nerve stimulation device has the potential to deliver clinical outcomes similar to or better than those of surgically implanted devices. To learn more about Tivic, 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 interactions with and guidance from the FDA and other regulatory authorities, as well as interactions with governmental agencies, such as BARDA, the AFRRI and the MCDC; changes to the company’s relationship with the its partners; the failure to obtain FDA or similar clearances or approvals and noncompliance with FDA or similar regulations; the company’s future development of its ncVNS treatment, Entolimod and Entolasta; changes to the company’s business strategy; timing and success of clinical trials and study results; regulatory requirements and pathways for approval; Tivic’s ability to successfully manufacture its product candidates; Tivic’s reliance on third party manufacturers; 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. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. 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 Tivic Health Systems, Inc. undertakes no duty to update such information except as required by applicable law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20251110887302/en/