FREMONT, Calif., April 15, 2025--(BUSINESS WIRE)--Tivic Health Systems, Inc. (Nasdaq: TIVC), a diversified therapeutics company, today announced that, on March 28, 2025, it exercised its licensing option for the exclusive, worldwide rights to advance Entolimod™ for a second indication, Neutropenia. This expansion of commercial rights is part of the license agreement with Statera Biopharma for its late-stage Toll-like Receptor 5 (TLR5) immunotherapy program Entolimod™.
Neutropenia is a condition characterized by lower-than-normal levels of neutrophils, a type of white blood cell essential for combating infections. Causes of neutropenia include chemotherapy and radiation treatments, chronic infection, autoimmune diseases, bone marrow disorders and aging.
According to Data Bridge Market Research, the global Neutropenia market is estimated to exceed $20 billion by 2029.
Under the terms of the company’s previously announced agreement with Statera Biopharma, Inc., Tivic secured a worldwide exclusive license for Entolimod™ as a potential treatment for acute radiation syndrome, or ARS.
TLRs are a class of protein that plays a key role in the innate immune system. We believe that Entolimod’s mechanism of action provides unique, highly sought-after attributes in the treatment of a number of indications besides ARS and Neutropenia. Tivic also has the option to license three additional indications: Lymphocyte exhaustion, Immunosenescence, and chronic radiation syndrome.
"As Tivic prepares for commercial-grade manufacturing of Entolimod, we see the opportunity to leverage that investment across more than one indication," explained Jennifer Ernst, CEO of Tivic Health. "Entolimod and Entolasta have been the subject of more than 40 animal and human trials and $140 million of prior investment. Based on the prior development, we believe that this important immunotherapy drug is ready to advance through the final steps toward a biologics license application filing and potential FDA approval."
Terms of the License Agreement
As previously announced, Tivic Health entered into a license agreement with Statera Biopharma, Inc. to acquire the exclusive worldwide license for the TLR5 agonist program Entolimod™ for ARS as well as the option to acquire the exclusive worldwide license for certain additional indications.
Future payments under the agreement will be milestone-driven, ensuring alignment with the clinical and commercial success of the TLR5 program for the licensed indications. This structure allows Tivic to strategically manage investment while maximizing potential returns as the assets progress toward FDA approval and commercialization.
About Tivic Health Systems, Inc.
Tivic Health is a diversified therapeutics company harnessing the power of the immune and autonomic nervous systems to fight disease and restore health. Tivic Health’s bioelectronic division is developing non-invasive medical devices that personalize key stimulation parameters for the vagus nerve to deliver meaningfully improved effects on measures of the autonomous nervous system compared to current treatments, which are often invasive, ineffective or both.
Tivic Health’s biopharma program’s lead product candidate is the TLR5 agonist, Entolimod™, which is in late-stage studies to treat acute radiation syndrome (ARS). The FDA has granted Fast Track and Orphan Drug designation to Entolimod™ for ARS. Tivic is also preparing to file an investigational new drug (IND) application and to initiate a phase 2 clinical study for the treatment of Neutropenia.
TLRs are a class of protein that plays a key role in the innate immune system. We believe that Entolimod’s mechanism of action provides unique, highly sought-after attributes in the treatment of indications in addition to ARS and Neutropenia. Tivic has the option to license three additional indications: Lymphocyte exhaustion, Immunosenescence, and chronic radiation syndrome.
Tivic Health already has an FDA-approved over-the-counter device, ClearUP®, that treats sinus pain and pressure and is available through online retailers and commercial distributors. For more information about Tivic Health, visit: https://ir.tivichealth.com.
Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tivic’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the development of Tivic’s product candidates; Tivic Health’s interactions with and guidance from the FDA; the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of Tivic’s product candidates; the company’s need for, and ability to secure when needed, additional working capital; changes to the company’s business strategy; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; substantial competition; and the company’s ability to maintain its Nasdaq listing. 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 the company undertakes no duty to update such information except as required by applicable law.
