Michael Handley takes over Tivic Health (Nasdaq: TIVC) CEO role from founder
Rhea-AI Filing Summary
Tivic Health Systems, Inc. announced a leadership transition, appointing Michael K. Handley as Chief Executive Officer and a member of the board of directors, effective immediately. Handley, a life sciences executive with more than two decades of commercialization and regulatory experience, has been the company’s Chief Operating Officer and President of Tivic Biopharma since February 2025.
Jennifer Ernst resigned as Chief Executive Officer effective March 2, 2026 and will step down from the board on March 5, 2026. Under a Separation Agreement, she will receive an aggregate cash payment of $325,000 over a 12‑month severance period, continued COBRA coverage during that period, continued vesting of her unvested equity awards over the severance period, and $50,000 in restricted common stock, subject to shareholder approval. The company emphasized that her resignation was not due to any dispute or disagreement regarding operations, policies or practices.
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Insights
CEO transition with structured severance; strategic biopharma focus highlighted.
Tivic Health Systems appointed Michael K. Handley as CEO and director, replacing founder-CEO Jennifer Ernst. The filing highlights Handley’s extensive biopharma and medical device leadership background, aligning with Tivic’s increased focus on late-stage immunotherapies and its Velocity Bioworks contract biomanufacturing subsidiary.
Ernst’s resignation is stated as not stemming from any dispute with the company, which can reduce perceived governance friction. Her separation package includes
The press release frames the change as part of a shift toward high-growth biopharma opportunities and advancing assets such as Entolimod. Actual impact will depend on how effectively leadership executes the stated strategy and progresses late-stage development and potential commercialization activities described in the company’s broader disclosures.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Item 5.02 Departure of Directors or Principal Officers; Election of Directors; Appointment of Principal Officers.
Appointment of Michael K. Handley as Chief Executive Officer and Board Member
On March 3, 2026, Tivic Health Systems, Inc. (the “Company”), a Delaware corporation, appointed Michael K. Handley as Chief Executive Officer of the Company and a member of the board of directors (the “Board”), effective immediately.
Mr. Handley, 54, is a successful life science business professional with over two decades of cross-functional experience in drug/device commercialization, regulatory/clinical affairs, operations, strategic transactions, market development and partnering/licensing. He has served as the Company’s Chief Operating Officer and President of Tivic Biopharma since February 18, 2025. Prior to joining the Company, from July 2021 until February 2025, Mr. Handley served as President, Chief Executive Officer and Chairman of Statera Biopharma, Inc. From July 2019 to March 2020, he served as the Chief Executive Officer and a director of Immune Therapeutics. Prior to that, from 2012 to 2018, Mr. Handley served as the Chief Executive Officer and a director of Armis Biopharma, a development-stage healthcare company, where Mr. Handley was responsible for day-to-day operations, executing a profitable growth strategy, obtaining global product approvals, overseeing intellectual property strategy, product commercialization, business development and financing. Mr. Handley founded Vessix Vascular, Inc. in 2011 and served as its Vice President of Clinical, Quality and Regulatory until 2012, when it was acquired. Mr. Handley also served as the Global Head of Regulatory at Acclarent, Inc. from 2010 to 2011 until it was acquired. Prior to that, he served in senior executive roles at Spectranetics (Nasdaq: SPNC), a medical device company, and Accelapure Corporation, a biotechnology company. Prior to beginning his business career, Mr. Handley spent several years in various consulting and drug development roles at the public biotech companies Genentech, Inc. (Nasdaq: DNA), Amgen Inc. (Nasdaq: AMGN) and Gliatech Inc. (formerly Nasdaq: GLIA). Mr. Handley graduated cum laude from Colorado State University with Bachelor of Science degrees in molecular biology, physiology and minors in chemistry, and neurobiology in 1995. Mr. Handley attended The Graziadio Business School of Pepperdine University for his Executive Master of Business Administration degree.
There are currently no changes to Mr. Handley’s existing employment agreement entered into with the Company on February 12, 2025.
There are no family relationships between Mr. Handley and any of the Company’s directors, executive officers or persons nominated or chosen by the Company to become a director or executive officer. Other than as previously disclosed, the Company is not aware of any transactions or relationships between Mr. Handley and the Company that would require disclosure under Item 404(a) of Regulation S-K under the Securities Exchange Act of 1934, as amended (the “Exchange Act”).
Resignation of Jennifer Ernst as Chief Executive Officer and Board Member
Effective March 2, 2026, Jennifer Ernst resigned from her positions as Chief Executive Officer and, effective March 5, 2026, as a member of the Board of Directors (the “Board”) of the Company. On March 3, 2026, the Company and Ms. Ernst entered into a Separation Agreement (the “Separation Agreement”). Ms. Ernst’s resignation was not the result of any dispute or disagreement with the Company or management on any matter relating to the Company’s operations, policies or practices.
Pursuant to the Separation Agreement and consistent with Ms. Ernst’s Executive Employment Agreement, dated October 8, 2025, Ms. Ernst will receive: (i) an aggregate cash payment of $325,000 over a 12-month period (the “Severance Period”), (ii) continued coverage under the Consolidated Omnibus Budget Reconciliation Act of 1986 (“COBRA”) for the duration of the Severance Period, (iii) continued vesting of all outstanding unvested equity awards held by Ms. Ernst as of the Effective Date for the duration of the Severance Period, and (iv) $50,000 in restricted common stock of the Company, subject to shareholder approval.
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The foregoing summary of the Separation Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Separation Agreement, a copy of which is filed as Exhibit 10.1 of this Current Report on Form 8-K (this “Current Report”) and is incorporated herein by reference.
Item 7.01 Regulation FD Disclosure.
On March 4, 2026, the Company issued a press release announcing Mr. Handley’s appointment as Chief Executive Officer and director of the Company and Ms. Ernst’s departure from the Company. A copy of that press release is furnished as Exhibit 99.1 of this Current Report and incorporated herein by reference.
The information set forth under Item 7.01 of this Current Report, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of such section. The information in Item 7.01 of this Current Report, including Exhibit 99.1, shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any incorporation by reference language in any such filing, except as expressly set forth by specific reference in such a filing. This Current Report will not be deemed an admission as to the materiality of any information in this Current Report that is required to be disclosed solely by Regulation FD.
Forward-Looking Statements
This Current Report including Exhibit 99.1, contains certain forward-looking statements that involve substantial risks and uncertainties. When used herein, the terms “anticipates,” “expects,” “estimates,” “believes,” “will” and similar expressions, as they relate to us or our management, are intended to identify such forward-looking statements.
Forward-looking statements in this Current Report, including Exhibit 99.1, or hereafter, including in other publicly available documents filed with the Commission, reports to the stockholders of the Company and other publicly available statements issued or released by us involve known and unknown risks, uncertainties and other factors which could cause our actual results, performance (financial or operating) or achievements to differ from the future results, performance (financial or operating) or achievements expressed or implied by such forward-looking statements. Such future results are based upon management’s best estimates based upon current conditions and the most recent results of operations. These risks include, but are not limited to, the risks set forth herein and in such other documents filed with the Commission, each of which could adversely affect our business and the accuracy of the forward-looking statements contained herein. Our actual results, performance or achievements may differ materially from those expressed or implied by such forward-looking statements.
Item 9.01 Financial Statements and Exhibits.
| (d) | Exhibits. |
| Exhibit No. | Description | |
| 10.1 | Separation Agreement by and between Tivic Health Systems, Inc. and Jennifer Ernst, dated March 3, 2026. | |
| 99.1 | Press Release of Tivic Health Systems, Inc., dated March 4, 2026. | |
| 104 | Cover Page Interactive Data File (embedded within the XBRL document). |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| TIVIC HEALTH SYSTEMS, INC. | |||
| Date: | March 4, 2026 |
By: | /s/ Michael K. Handley |
| Name: Michael K. Handley Title: Chief Executive Officer |
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Exhibit 99.1
FOR IMMEDIATE RELEASE
Biotech Veteran Michael K. Handley Named CEO of Tivic Health Systems to Spearhead Strategic Expansion in Biopharma
SAN FRANCISCO, CA — March 4, 2026 — Tivic Health Systems, Inc. (Nasdaq: TIVC) (“Tivic” or the “Company”), a late-stage immunotherapeutics company, today announced that its Board of Directors has appointed Michael K. Handley as Chief Executive Officer of Tivic, effective immediately. Mr. Handley succeeds Jennifer Ernst, who has served as CEO since its founding in 2016 and is stepping down from the CEO role as the Company enters its next chapter. Ms. Ernst will continue to support the Company through this strategic transition.
The appointment of Mr. Handley marks a decisive shift in Tivic’s strategic direction as the Company aligns its leadership and resources toward the high-growth Biopharma sector. With an increased focus on late-stage immunotherapies and the launch of Tivic’s contract biomanufacturing subsidiary, Velocity Bioworks, Mr. Handley’s extensive background in life sciences and commercialization will be instrumental in navigating the Company’s next phase of growth.
Mr. Handley brings over two decades of executive leadership in the biopharmaceutical and medical device industries. His career is distinguished by his success in navigating complex regulatory landscapes and leading multiple high-value commercial launches. Notably, Mr. Handley has played a pivotal role in the US approval and commercialization of seventeen products, generating billions of dollars in revenue and providing life-altering treatments for tens of thousands of patients. His foundational expertise was developed at world-renowned organizations, including Amgen and Genentech.
A visionary leader, Mr. Handley is a passionate advocate for the development of innovative immunotherapies that utilize immune modulation as a cornerstone for disease mitigation and correction.
“Michael is a proven leader with an exceptional track record of building and scaling high-growth life sciences companies,” said Sheryle Bolton, Chair of the Board of Tivic Health Systems. “As we transition toward late-stage immunotherapies and broader biopharma opportunities, his strategic vision and operational depth will be indispensable. On behalf of the Board, we extend our sincere appreciation to Jennifer Ernst for her dedicated leadership and meaningful contributions in positioning Tivic for its next phase of growth.”
“I am honored to lead Tivic at this pivotal juncture,” said Michael K. Handley, Chief Executive Officer. “We are entering a transformative new era for the Company, focused on high-growth biopharma opportunities and late-stage assets, such as Entolimod. By leveraging our foundational strengths and integrating advanced biomanufacturing through Velocity Bioworks, we are positioned to deliver profound value to patients and stakeholders alike.”
“I am incredibly proud of what we’ve accomplished together in transforming this company and positioning it for growth,” said Jennifer Ernst. “It has been an honor to lead such a talented team, and I look forward to watching the company continue to grow, innovate, and make an impact in the years ahead.”
About Tivic Health Systems, Inc.
Tivic is a late-stage immunotherapeutics company whose lead drug candidate, Entolimod™ to treat ARS, is in late-stage development. Entolimod™ is a TLR5 agonist that activates an innate immune pathway to prevent cell death in the bone marrow and epithelial tissues across systems impacted by radiation and age. Tivic’s pipeline includes Entolimod™ to treat Neutropenia, and lymphocyte exhaustion, as well as Entolasta™, an immunologically optimized variant of Entolimod for chronic applications.
Tivic’s wholly owned subsidiary, Velocity Bioworks, is a full-service CDMO based in San Antonio, Texas. 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. To learn more about Tivic, visit: https://tivichealth.com/
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About Entolimod
Entolimod is a novel Toll-like Receptor 5 (TLR5) agonist that triggers NF-kappaB pathway signaling, activating anti-apoptotic and cell protective mechanisms. Entolimod for Acute Radiation Syndrome (ARS) has been the subject of extensive trials under the FDA’s Animal Rule and, in animal models, has demonstrated robust survival rates, enhanced gastrointestinal tract recovery, and improved hematopoiesis. To see the complete Tivic pipeline visit: https://tivichealth.com/pipeline/
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; the company’s future development of Entolimod, Entolasta or its previously developed bioelectronic platform; changes to the company’s business strategy; timing and success of 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.
Investor Contact:
Hanover International, Inc.
ir@tivichealth.com
Media Contact:
DJ Freyman
DJ@fastrackPR.com
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FAQ
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