Tivic Health Systems Files 8-K with Key Agreements and Filings

TL;DR

TIVC filed an 8-K on 2/10 reporting material agreements, equity sales, and charter changes.

AI Summary

Tivic Health Systems, Inc. filed an 8-K on February 12, 2025, reporting several key events. These include entering into a material definitive agreement, unregistered sales of equity securities, amendments to its articles of incorporation or bylaws, and a Regulation FD disclosure. The filing also includes financial statements and exhibits.

Why It Matters

This 8-K filing indicates significant corporate actions and potential changes for Tivic Health Systems, Inc., including new agreements and equity transactions that could impact its financial structure and operations.

Risk Assessment

Risk Level: medium — The filing involves material definitive agreements and unregistered sales of equity, which can introduce financial and operational risks.

Key Players & Entities

• Tivic Health Systems, Inc. (company) — Registrant
• February 10, 2025 (date) — Date of earliest event reported
• February 12, 2025 (date) — Date of Report
• Delaware (jurisdiction) — State of Incorporation
• 47685 Lakeview Blvd. (address) — Principal Executive Offices
• Fremont, California (location) — Principal Executive Offices City and State
• 94538 (zip_code) — Principal Executive Offices Zip Code

FAQ

Key Financial Figures

• $0.0001 — ch registered Common Stock, par value $0.0001 per share TIVC The Nasdaq Stock Mar
• $1,500,000 — agreed to pay Statera a license fee of $1,500,000 consisting of (i) $300,000 in cash cons
• $300,000 — nse fee of $1,500,000 consisting of (i) $300,000 in cash consideration and (ii) $1,200,0
• $1,200,000 — $300,000 in cash consideration and (ii) $1,200,000 in stock consideration, as described be
• $1 — ials, the Company will be negotiating a $1 per year lease with an affiliate of Sta
• $750,000 — Materials for distribution and sales $750,000 Filing of BLA with FDA for Acute Radi
• $1,000,000 — with FDA for Acute Radiation Syndrome $1,000,000 Total Acute Radiation Syndrome Develo
• $1,750,000 — ation Syndrome Development Milestones $1,750,000 Upon exercise of an Exclusive Option
• $500,000 — hase 2 Clinical Study for Neutropenia $500,000 Phase III Completion - successfully m
• $6,500,000 — dditional Indications (as applicable) $6,500,000 In conjunction with the License Agree
• $105,000 — t, the Company paid Craft a cash fee of $105,000 equal to seven percent (7%) of the valu
• $1.2 million — for an aggregate price of approximately $1.2 million. Each share of Series A Preferred Stock

Filing Documents

• tivc-20250210.htm (8-K) — 106KB
• tivc-ex3_1.htm (EX-3.1) — 140KB
• tivc-ex10_1.htm (EX-10.1) — 310KB
• tivc-ex10_2.htm (EX-10.2) — 326KB
• tivc-ex99_1.htm (EX-99.1) — 34KB
• img553027_0.jpg (GRAPHIC) — 2KB
• 0000950170-25-018419.txt ( ) — 1163KB
• tivc-20250210.xsd (EX-101.SCH) — 25KB
• tivc-20250210_htm.xml (XML) — 5KB

01

Item 1.01. Entry into a Material Definitive Agreement. Exclusive License Agreement On February 11, 2025, Tivic Health Systems, Inc., a Delaware corporation (the "Company") entered into an exclusive license agreement (the "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 (the "Licensed Molecules") as it relates to the Acute Radiation Syndrome ("ARS") indication (the "Initial Indication") and (ii) an exclusive option (the "Exclusive Option") to acquire the exclusive worldwide license to additional indications, including Lymphocyte Exhaustion, Immunosenescence, Neutropenia and/or Vaccine Adjuvant (the "Subsequent Indications") and to the TLR5 agonist program of Statera known as Entolasta, in each case as described in more detail below. The License Agreement transaction was consummated concurrently therewith on February 11, 2025 (the "Closing Date"). Under the terms of the License Agreement, Statera has granted the Company an exclusive worldwide license, with the right to grant and authorize sublicenses, under Statera's patents and know-how to develop, test, make and use Entolimod to develop, test, make, have made, use, sell, offer for sale, import and otherwise exploit the product as it relates to the Initial Indication during the term of the License Agreement. As consideration for the License Agreement, the Company agreed to pay Statera a license fee of $1,500,000 consisting of (i) $300,000 in cash consideration and (ii) $1,200,000 in stock consideration, as described below. The Company remains liable to Statera for certain royalty payments on net sales for ARS as monotherapy, and, if it exercises the Exclusive Option, net sales for all Subsequent Indications, within certain royalty periods. The License Agreement further provides the Company with the Exclusive Option to expand the Initial

02

Item 3.02 Unregistered Sales of Equity Securities The information contained in Item 1.01 of this Current Report on Form 8-K is incorporated by reference into this Item 3.02. Pursuant to the Securities Purchase Agreement, the Company issued the Securities to Statera, which represented that it was an "accredited investor," as defined in Regulation D, and was acquiring the Securities for investment only and not with a view towards, or for resale in connection with, the public sale or distribution thereof. Such issuances were exempt from the registration requirements of the Securities Act in reliance in Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder. Neither the shares of common stock or Series A Preferred Stock issued under the Securities Purchase Agreement have been registered under the Securities Act and none of such Securities may be offered or sold in the United States absent registration or an exemption from registration under the Securities Act and any applicable state securities laws. Neither this Current Report on Form 8-K nor any of the exhibits attached hereto will constitute an offer to sell or the solicitation of an offer to buy shares of common stock, Series A Preferred Stock or any other securities of the Company.

03

Item 5.03. Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year. Certificate of Designation On February 10, 2025, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of the Series A Non-Voting Convertible Preferred Stock (the "Certificate of Designation") with the Secretary of State of the State of Delaware in connection with the License Agreement referenced in Item 1.01 above. The Certificate of Designation provides for the designation of 6,000 shares of the Company's Series A Non-Voting Convertible Preferred Stock, par value $0.0001 per share (the "Series A Preferred Stock"). Holders of Series A Preferred Stock are entitled to receive dividends on shares of Series A Preferred Stock equal to, on an as-if-converted-to-Common-Stock basis, and in the same form as dividends actually paid on shares of the Common Stock. Except as otherwise required by law, the Series A Preferred Stock does not have voting rights. However, as long as any shares of Series A Preferred Stock are outstanding, the Company will not, without the affirmative vote of the holders of a majority of the then-outstanding shares of the Series A Preferred Stock, (i) alter or change adversely the powers, preferences or rights given to the Series A Preferred Stock or alter or amend the Certificate of Designation, amend or repeal any provision of, or add any provision to, the Charter or bylaws of the Company, or file any articles of amendment, certificate of designations, preferences, limitations and relative rights of any series of preferred stock, in each case if any such action would adversely alter or change the preferences, rights, privileges or powers of, or restrictions provided for the benefit of the Series A Preferred Stock, regardless of whether any of the foregoing actions shall be by means of amendment to the Charter or by merger, consolidation, recapitalization, reclassification, conversion or otherwise, (ii) issue further shares o

01

Item 7.01. Regulation FD Disclosure. Press Release On February 12, 2025, the Company issued a press release announcing the License Agreement. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information in Item 7.01 of this Current Report on Form 8-K, including the information in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K, is furnished pursuant to Item 7.01 of Form 8-K and shall not be deemed "filed" for the purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section. Furthermore, the information in Item 7.01 of this Current Report on Form 8-K, shall not be deemed to be incorporated by reference in the filings of the Company under the Securities Act.

Financial Statements and Exhibits

Financial Statements and Exhibits. (d) Exhibits Exhibit Number Description 3.1 Certificate of Designation of Series A Non-Voting Convertible Preferred Stock of Tivic Health Systems, Inc., dated February 10, 2025 . 10.1* Exclusive License Agreement, dated February 11, 2025, by and between the Tivic Health Systems, Inc. and Statera Biopharma, Inc . 10.2* Securities Purchase Agreement, dated February 11, 2025, by and between the Tivic Health Systems, Inc. and Statera Biopharma, Inc . 99.1 Press Release of Tivic Health Systems, Inc., dated February 12, 2025 . 104 Cover Page Interactive Data File (embedded within the Inline XBRL document). * 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

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: February 12, 2025 By: /s/ Jennifer Ernst Name: Jennifer Ernst Title: Chief Executive Officer

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View this 8-K filing on SEC EDGAR