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Associated Press
24-02-2025
- Business
- Associated Press
Tivic Health Names Biotech Industry Veteran Michael K. Handley to Executive Leadership Team
FREMONT, Calif.--(BUSINESS WIRE)--Feb 24, 2025-- Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified therapeutics company, announced today that Michael K. Handley, formerly Chief Executive Officer, President and Chairman of Statera Biopharma, Inc., has joined Tivic Health as the President of Tivic Biopharma, a newly formed division of Tivic Health. Additionally, he will assume the role of Chief Operating Officer of Tivic Health and will work closely with the CEO and other leadership team members to develop and operationalize company-wide strategies. His key responsibilities will include building and leading Tivic's Biopharma team, advancing Tivic's recently licensed, late-stage product candidate, Entolimod™, through manufacturing validation, regulatory approval processes and commercialization, and directing pipeline development activity. 'Mike brings to Tivic a rare blend of device and pharmaceutical background, as well as proven operational, business and scientific experience that sets Tivic up for a smooth and successful expansion into drug development,' stated Tivic Health Chief Executive Officer, Jennifer Ernst. 'With our recent licensing of the late-stage TLR5 agonist, Entolimod, from Statera Biopharma, and Mike's deep experience in immunology and biotech, we believe that he is the ideal leader to establish Tivic's biopharmaceutical capabilities and advance our therapeutics pipeline. In tandem, we continue to pursue the development and exciting promise of our non-invasive bioelectronic vagus nerve stimulation, creating a portfolio of device and drug therapeutics from which to build shareholder value,' added Ernst. Over the course of his career, Michael has successfully led or assisted in the global commercialization of 17 drugs and devices that represented ~$7 billion in annual sales. Additionally, he served as part of the management teams of successful exits to Johnson & Johnson and Boston Scientific. He has successfully led teams in a variety of capacities in high growth organizations. As CEO, President and Chairman of the Board of Statera, Michael created and executed the company's growth strategy, advanced clinical development and intellectual property strategies, and spearheaded the company's business development and financing activities. 'This is an exciting and critical time at Tivic Health, and I am thrilled to join the Tivic leadership team to continue the essential work of advancing Entolimod towards potential commercialization,' stated Handley. 'With compelling evidence of preventing death following a potential lethal dose of radiation and the opportunity to expand to adjacent indications in radiation toxicity and immune system dysregulation, I believe that Entolimod serves as a great foundation on which to build and potentially expand Tivic Health's biopharma pipeline.' Inducement Grants under Nasdaq Listing Rule 5635(c)(4) In connection with, and as a material inducement to, the hiring and appointment of Michael as Chief Operating Officer of Tivic Health and President of Tivic Biopharma, Tivic agreed to grant Michael 600,000 restricted stock units (RSUs), which shall vest over four years, with one fourth of the RSUs vesting on the one-year anniversary of the date of grant and the remaining RSUs vesting in 12 equal quarterly installments thereafter until fully vested. The vesting of shares of common stock underlying the RSUs will be subject to Michael's continuous service with Tivic through each applicable vesting date. The foregoing RSU grant was unanimously approved by Tivic's board of directors and the compensation committee of the board, and such grants were inducements material to Michael entering into employment with Tivic, in accordance with Nasdaq Listing Rule 5635(c)(4). The foregoing equity grant was made outside of Tivic's Amended and Restated 2021 Equity Incentive Plan or any other equity incentive plan of the company. About Tivic Health 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 takes a multi-pronged approach to treating diseases caused by immune and autonomic nervous system dysregulation. The complement of bioelectronic and biologic medicines allows Tivic to target disorders and disease via both neural pathways and molecular approaches. Tivic Health's first FDA approved product ClearUP™ is clinically proven to treat sinus pain and pressure, and is available through online retailers and commercial distributors. For more information about Tivic Health, visit: 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. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: statements regarding Tivic Health's development and advancement of Entolimod for the treatment of acute radiation syndrome (ARS) and any other indications that it may elect to license from Statera in the future; the future development of ncVNS treatment, Tivic Health's ability to commercialize products arising out of the license from Statera and Tivic Health's ncVNS treatment; the Tivic Health's plans to seek regulatory approval for such clinical products and Tivic Health's continued focus on developing Entolimod, including for the treatment of ARS and/or any other indications it may elect to license in the future, and its ncVNS treatment, including in the epilepsy, post-traumatic stress disorder, and/or ischemic stroke space; expected clinical utility, including which patient populations may be pursued; the timing and success of clinical studies and trials; market and other conditions; macroeconomic factors; and unexpected costs, charges or expenses that reduce Tivic Health's capital resources. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Tivic Health's actual results to differ from those contained in the forward-looking statements, see Tivic Health's filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 29, 2024, 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. Hanover International, Inc. SOURCE: Tivic Health Systems, Inc. Copyright Business Wire 2025. PUB: 02/24/2025 08:15 AM/DISC: 02/24/2025 08:15 AM
Yahoo
12-02-2025
- Business
- Yahoo
Tivic Health Acquires Exclusive Worldwide Rights to Phase III TLR5 Agonist from Statera Biopharma
Broad licensing agreement accelerates Tivic's transformation into a diversified therapeutics company, adds late-stage immunotherapeutic to clinical pipeline. Potential for FDA approval within 24 months. FREMONT, Calif., February 12, 2025--(BUSINESS WIRE)--Tivic Health Systems, Inc., (Nasdaq: TIVC) today announced it has acquired worldwide exclusive license rights from Statera Biopharma (OTC: STAB) to the late-stage Toll-like Receptor 5 (TLR5) agonist Entolimod™ for the treatment of acute radiation syndrome (ARS). In addition, the company has acquired an exclusive option to license five additional indications and clinical use cases for Entolimod and its derivative, Entalasta™. This broad licensing agreement establishes Tivic as a diversified therapeutics company, with complementary bioelectronic and biologic product candidates in its clinical pipeline. "Today, we have aggressively accelerated Tivic's strategic transformation from a single-product, direct-to-consumer company to a diversified therapeutics company—one with a growing pipeline of clinically validated product candidates," said Jennifer Ernst, Chief Executive Officer of Tivic. "Statera's TLR5 immunotherapy program strongly complements our work on non-invasive vagus nerve stimulation, positioning us to address immune and autonomic dysregulation—and associated diseases—through both neural and molecular pathways." The lead product candidate in the licensing program is a TLR5 agonist, Entolimod for the treatment of acute radiation syndrome (ARS). Market research firm CoherentMI estimates the global acute radiation syndrome (ARS) market to be valued at USD 5.2 billion in 2024 with a compound annual growth rate of five percent from 2024 to 2031. CoherentMI goes on to identify Statera Biopharma as one of the key market leaders. Entolimod and its immunologically optimized derivative, Entalasta, have been the subject of more than forty animal and human trials and $140 million of prior investment. The FDA has granted Fast Track and Orphan Drug designation to Entolimod for the prevention or treatment of ARS and to prevent death following a potential lethal dose of total body ionization irradiation during or after a radiation disaster. "Based on extensive prior research, development and numerous clinical trials of Entolimod, this important immunotherapy drug will now be advanced through the final steps toward a BLA filing and potential FDA approval under the skilled execution of the Tivic team," added Michael K. Handley, Chief Executive Officer of Statera. "We believe this agreement has the potential to provide considerable value for both Statera and Tivic shareholders." About the TLR5 Immunotherapy Program TLRs play a key role in the innate immune system. Entolimod's mechanism of action provides unique, highly sought-after attributes in the treatment of radiation-related illness. For ARS, animal studies have shown a three-fold increase in survival with a single dose 25-hours after exposure to lethal levels of radiation. Entolimod was effective without additional supportive care, showed gastrointestinal protective attributes, and exhibited no dose-limiting toxicity at even the highest dosing levels. Other studies have shown the potential to address additional applications. Tivic has secured exclusive options to these indications subject to certain milestones and payment conditions. These include: Immunosenescence - the gradual age-related decline in the immune system's ability to fight infections and respond to vaccines. Lymphocyte exhaustion – a condition in which immune cells, particularly T cells, become less effective after being exposed to infection, cancer, and/or cancer treatments. Neutropenia - a condition characterized by an abnormally low number of neutrophils, which can result from chemotherapy, radiation, bone marrow disorders, and certain autoimmune conditions. Vaccine enhancement – use as a vaccine adjuvant to enhance immune response to vaccines. Chronic radiation syndrome - a condition caused by long-term exposure to low levels of radiation that gradually damages tissues and organs. Terms of the Agreement Under the agreement, Tivic will initially pay Statera $1,200,000 in equity consideration and $300,000 cash to Statera for the use of Entolimod to treat ARS. Tivic can, at its discretion, subsequently add one or more indications, as well as expand its license to include an Entolimod derivative, Entalasta, by exercising the exclusive options granted in the agreement. Tivic has no obligation to exercise such options on any specific timeline or at all; but should it do so, Tivic agrees to fund development of each such indication. Additional future payments will be royalty and milestone-driven, ensuring alignment with the clinical and commercial success of Entolimod and, after exercise of the option granted in the agreement, Entalasta. Importantly, the structure of the agreement allows Tivic to strategically manage its investment while maximizing potential returns in line with shareholder interests. Select team members of Statera will join Tivic to establish Tivic's biopharmaceutical capabilities and advance product candidates towards commercialization. The transaction also includes exclusive rights and options for more than sixty patents and patents pending, associated know-how, and ownership of previously manufactured and tested materials. Additional information about this news, including an informational PowerPoint presentation, will be available at: Craft Capital Management LLC acted as the sole and exclusive investment banking firm in the transaction. About Tivic Health 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 takes a multi-pronged approach to treating diseases caused by immune dysregulation and dysautonomia. The complement of bioelectronic and biologic medicines allows Tivic to target disorders and disease via both neural pathways and molecular approaches. Tivic Health's first FDA approved product ClearUP™ is clinically proven to treat sinus pain and pressure. ClearUP is available through online retailers and commercial distributors. For more information about Tivic Health, visit: About Statera Biopharma Statera Biopharma, Inc. is a clinical-stage biopharmaceutical company developing novel immunotherapies targeting autoimmune, neutropenia/anemia, emerging viruses and cancers based on a proprietary platform designed to rebalance the body's immune system and restore homeostasis. Statera has a large platform of toll-like receptor (TLR) agonists with TLR4 and TLR9 antagonists, and the TLR5 agonists, Entolimod and Entalasta. Statera has clinical and preclinical programs for Crohn's disease (STAT-201), hematology (Entolimod) and inflammation (STAT-300) in addition to potential expansion into fibromyalgia and multiple sclerosis. To learn more about Statera, visit 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 Tivic's ability to maintain its Nasdaq listing; the development of Tivic's vaccine candidates; the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any vaccine under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tivic does not undertake an obligation to update or revise any forward-looking statement. Investors should read Tivic's filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 29, 2024, under the heading "Risk Factors", as well as the company's subsequent filings with the SEC. All of Tivic's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof. View source version on Contacts Investor Contact Information: Hanover International,
