UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 18, 2025 |
Tivic Health Systems, Inc.
(Exact name of Registrant as Specified in Its Charter)
Delaware |
001-41052 |
81-4016391 |
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(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
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47685 Lakeview Blvd. |
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Fremont, California |
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94538 |
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(Address of Principal Executive Offices) |
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(Zip Code) |
Registrant’s Telephone Number, Including Area Code: 888 276-6888 |
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(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Trading |
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Common Stock, par value $0.0001 per share |
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TIVC |
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The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On February 18, 2025, Michael Handley was appointed as Chief Operating Officer of Tivic Health Systems, Inc., a Delaware corporation (the “Company”), and President of the Company’s Tivic Biopharma division. Mr. Handley, 53 years of age, 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. 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.
On February 12, 2025, in connection with his appointment as Chief Operating Officer of the Company and President of the Tivic Biopharma division, the Company and Mr. Handley entered into an executive employment agreement (the “Employment Agreement”), pursuant to which Mr. Handley (i) is entitled to receive a base salary of $300,000 per annum (subject to review and adjustment in accordance with the Company’s normal performance review practices); (ii) will be eligible to receive, at the sole discretion of the Company’s Board of Directors (“Board”), an annual end-of-year incentive bonus in an amount up to 35% of his base salary, commencing the year following the start of his employment; and (iii) may be eligible to receive annual focal grants, as determined by the Board or the Compensation Committee of the Board, pursuant to the Company’s Amended and Restated 2021 Equity Incentive Plan (the “2021 Plan”).
In addition to the foregoing compensation, as an inducement material to his entering into employment with the Company, effective as of February 18, 2025, Mr. Handley was granted 600,000 restricted stock units (the “Inducement Grant”), 25% of which shall vest upon the first anniversary of the grant date and the remaining 75% of which will vest in equal quarterly installments over the three years thereafter. The Inducement Grant was granted outside of the 2021 Plan in reliance on the employment inducement exemption provided under the Nasdaq Listing Rule 5635(c)(4). Although the Inducement Grant was granted outside of the 2021 Plan, except as otherwise set forth in the grant notice and grant agreement, the terms, conditions, and definitions set forth in 2021 Plan will apply to the Inducement Grant as though it had been granted under the 2021 Plan.
Pursuant to the Employment Agreement, Mr. Handley’s employment is “at will,” meaning that either he or the Company are entitled to terminate Mr. Handley’s employment at any time and for any reason, with or without cause. In the event that his employment with the Company is terminated for any reason before December 31 of any given year, he will not be entitled to receive an annual end-of-year bonus. In the event that (i) Mr. Handley elects to terminate his employment with the Company other than for good reason, (ii) the Company terminates his employment for cause, or (iii) his employment is terminated as a result of his death or disability, then Mr. Handley will not be entitled to receive any separation benefits. In the event that Mr. Handley terminates his employment for good reason or the Company terminates his employment without cause, provided that his employment with the Company continues for at least six months after execution of the Employment Agreement, then Mr. Handley shall be entitled to receive payment equal to his base salary for a period of six months after termination, payable in accordance with the Company’s standard payroll procedures, and the Company shall pay his COBRA coverage for a period of six months after termination.
The foregoing summary of the Employment Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Employment Agreement, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K (this “Current Report”) and is incorporated herein by reference.
Mr. Handley was appointed as Chief Operating Officer of the Company and President of Tivic Biopharma in connection with, and pursuant to, that Exclusive License Agreement entered into by and between the Company and Statera Biopharma, Inc. on February 11, 2025, which the Company disclosed in that Current Report on Form 8-K filed with Securities and Exchange Commission (the “Commission”) 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. Mr. Handley has not engaged in any related-person transactions required to be disclosed by Item 404(a) of Regulation S-K under the Securities Exchange Act of 1934, as amended (the “Exchange Act”).
Item 7.01 Regulation FD Disclosure.
On February 24, 2025, the Company issued a press release announcing Mr. Handley’s appointment as Chief Operating Officer of the Company and President of the Company’s Tivic Biopharma division, among other things. 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 |
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Description |
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10.1* |
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99.1 |
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Press Release of Tivic Health Systems, Inc., dated February 24, 2025. |
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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Certain annexes, schedules and exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The registrant agrees to furnish supplementally a copy of any omitted attachment to the SEC on a confidential basis upon request. |
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.
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TIVIC HEALTH SYSTEMS, INC. |
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Date: |
February 24, 2025 |
By: |
/s/ Lisa Wolf |
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Name: Lisa Wolf |
Exhibit 10.1
TIVIC HEALTH EXECUTIVE EMPLOYMENT AGREEMENT
This Employment Agreement (this “Agreement”) is made and entered into as of February 18, 2025 (the “Effective Date”) by and between Tivic Health Systems, Inc., a Delaware limited liability company (the “Company”) and Michael Handley (“Employee”).
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An event or action will not constitute Good Reason unless (1) you give the Company written notice within 60 days after you know or should know of the initial existence of such event or action, (2) such event or action is not reversed, remedied or cured, as the case may be, by the Company as soon as possible but in no event later than 30 days of receiving such written notice from you, and (3) you terminate employment within 60 days following the end of the cure period.
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TIVIC HEALTH SYSTEMS, INC.
By: /s/ Jennifer Ernst
Name: Jennifer Ernst, Chief Executive Officer
ACCEPTED AND AGREED:
Michael Handley
/s Michael Handley
Signature
Date: February 18, 2025
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ATTACHMENT A
EMPLOYEE INVENTION ASSIGNMENT AND
CONFIDENTIALITY AGREEMENT
ATTACHMENT B
ARBITRATION AGREEMENT
ATTACHMENT C
APPROVED DISCLOSURES
Exhibit 99.1
TIVIC HEALTH NAMES BIOTECH INDUSTRY VETERAN MICHAEL K. HANDLEY
TO EXECUTIVE LEADERSHIP TEAM
Handley Joins as President of Tivic Biopharma and Chief Operating Officer of Tivic Health Following its Licensing of Strategic Biopharma Assets from Statera Biopharma
FREMONT, Calif. – February 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: 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. 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.
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Investor Contact:
Hanover International, Inc.
ir@tivichealth.com