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    Tivic Health Systems Inc. filed SEC Form 8-K: Entry into a Material Definitive Agreement, Financial Statements and Exhibits

    6/25/25 4:31:27 PM ET
    $TIVC
    Biotechnology: Electromedical & Electrotherapeutic Apparatus
    Health Care
    Get the next $TIVC alert in real time by email
    8-K
    0001787740false00017877402025-06-182025-06-18

     

    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): June 18, 2025

     

     

    Tivic Health Systems, Inc.

    (Exact name of Registrant as Specified in Its Charter)

     

     

    Delaware

    001-41052

    81-4016391

    (State or Other Jurisdiction
    of Incorporation)

    (Commission File Number)

    (IRS Employer
    Identification No.)

     

     

     

     

     

    47685 Lakeview Blvd.

     

    Fremont, California

     

    94538

    (Address of Principal Executive Offices)

     

    (Zip Code)

     

    Registrant’s Telephone Number, Including Area Code: 888 276-6888

     

     

    (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:

    ☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
    ☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
    ☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
    ☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

    Securities registered pursuant to Section 12(b) of the Act:


    Title of each class

     

    Trading
    Symbol(s)

     


    Name of each exchange on which registered

    Common Stock, par value $0.0001 per share

     

    TIVC

     

    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 1.01 Entry into a Material Definitive Agreement.

    As previously disclosed in that Current Report on Form 8-K filed by Tivic Health Systems, Inc. (the “Company”) with the Securities and Exchange Commission (the “Commission”) on February 12, 2025 (the “Prior 8-K”), on February 11, 2025, the Company entered into an exclusive license agreement (the “Original License Agreement”) with Statera Biopharma, Inc. (“Statera”) whereby the Company acquired (i) an exclusive worldwide license to the proprietary Toll-like Receptor 5 (“TLR5”) agonist program of Statera known as Entolimod as it relates to the Acute Radiation Syndrome indication and (ii) an exclusive option to acquire the exclusive worldwide license to additional indications, including Lymphocyte Exhaustion, Immunosenescence, Neutropenia and/or Vaccine Adjuvant and to the TLR5 agonist program of Statera known as Entolasta, in each case as more particularly described in the Prior 8-K. The Original License Agreement transaction was consummated concurrently therewith on February 11, 2025 (the “Closing”).

    On June 18, 2025, the Company and Statera entered into an Amended and Restated Exclusive License Agreement (the “A&R License Agreement”), which supersedes the Original License Agreement in all respects. The terms and conditions of the A&R License Agreement are substantially similar to those included in the Original License Agreement, with the exception of the following material changes: (i) the payment of royalties pursuant to the A&R License Agreement, if any, may be made by the Company in either cash or securities of the Company, at the discretion of the Company; and (ii) other than the original license fee paid by the Company to Statera in connection with the Closing, all subsequent payments due to Statera under the A&R License Agreement, up to an amount equal to an aggregate of up to $5.6 million, shall be paid by the Company directly to Avenue Capital on behalf of Statera.

    This Current Report on Form 8-K should be read together with the Prior 8-K, which includes a summary of the material terms and conditions of the Original License Agreement. The foregoing description of the A&R License Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the License Agreement, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.

    Item 9.01 Financial Statements and Exhibits.

    (d)

    Exhibits.

    Exhibit No.

    Description

    10.1*†

    Amended and Restated Exclusive License Agreement, dated June 18, 2025, by and between Tivic Health Systems, Inc. and Statera Biopharma, Inc.

    104

    Cover Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101).

    * 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.

    † Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted by means of marking such portions with asterisks as the identified confidential portions are both not material and are the type of information that the registrant treats as private or confidential. The registrant agrees to supplementally furnish an unredacted copy of this exhibit to the SEC upon its 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.

     

     

     

    TIVIC HEALTH SYSTEMS, INC.

     

     

     

     

    Date:

    June 25, 2025

    By:

    /s/ Lisa Wolf

     

     

     

    Name: Lisa Wolf
    Title: Interim Chief Financial Officer

     


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