[8-K] Tivic Health Systems, Inc. Reports Material Event

Rhea-AI Filing Summary

Tivic Health Systems, Inc. (TIVC) filed an 8-K to disclose that it has entered into an Amended & Restated Exclusive License Agreement (A&R License) with Statera Biopharma covering the TLR5 agonist programs Entolimod and Entolasta. The new agreement fully supersedes the original license executed on 11 Feb 2025.

Key changes versus the February 2025 agreement:

• Royalty flexibility – future royalties may be paid in cash or in Tivic common stock, solely at Tivic’s discretion. This could conserve cash but may cause shareholder dilution if equity is used.
• Directed payments – aside from the original license fee already paid, up to an additional $5.6 million in milestone or other payments owed to Statera will be remitted directly to Avenue Capital on Statera’s behalf.

All other material terms, including Tivic’s worldwide exclusivity for the Acute Radiation Syndrome indication and its option on additional indications (Lymphocyte Exhaustion, Immunosenescence, Neutropenia, Vaccine Adjuvant), remain unchanged.

Strategic implications: The amended structure preserves Tivic’s strategic control of a potentially high-value immunomodulatory asset while improving liquidity management through optional equity settlement. However, the commitment to fund up to $5.6 million—whether in cash or shares—represents a meaningful obligation for a micro-cap issuer and may introduce dilution or leverage pressure depending on financing choices.

Positive

• Royalty payment flexibility allows Tivic to preserve cash by issuing equity if needed, improving liquidity management.
• Global exclusivity for Entolimod in Acute Radiation Syndrome and options on additional indications remain intact, maintaining long-term growth optionality.

Negative

• Potential shareholder dilution if Tivic elects to pay royalties in stock.
• Up to $5.6 million in future payments still required, representing a significant obligation for a micro-cap company.

Insights

Financial Analyst

TL;DR: A&R license preserves drug rights, adds payment flexibility; modest cash burden but dilution risk.

The amendment keeps Tivic’s access to Entolimod intact while adding an equity-settlement option for royalties. For a company with limited cash, this flexibility is positive because it can preserve runway. Directing up to $5.6 million of future payments to Avenue Capital clarifies creditor priorities but does not eliminate the liability. Overall, no immediate revenue impact is disclosed, and milestones remain speculative. I view the filing as strategically prudent yet financially neutral until clinical or commercial catalysts materialize.

Biotechnology Industry Specialist

TL;DR: Maintains global TLR5 rights; terms shift risk from cash to equity, modestly improves partnership clarity.

The license confirms Tivic’s commitment to radiation counter-measure markets and optional expansion into broader immunology indications. Allowing stock-based royalties could align Statera with Tivic’s equity upside, a common practice among early-stage biotechs. Direct milestone payments to Avenue Capital suggest Statera’s lender influence but should not impede Tivic’s development timeline. No new IP, clinical data, or regulatory milestones are included, limiting near-term valuation impact. Therefore, I assign a neutral impact with a slight positive tilt for financial flexibility.

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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

FAQ

What did Tivic Health (TIVC) announce in its June 18 2025 8-K?

Tivic executed an Amended & Restated Exclusive License Agreement with Statera Biopharma, replacing the February 2025 agreement.

How much could Tivic still owe under the amended license?

Up to $5.6 million in future payments will be made directly to Avenue Capital on Statera’s behalf.

Can Tivic pay royalties in stock under the new agreement?

Yes. Tivic may choose to pay any royalties in cash or in its common shares at its sole discretion.

Does the amendment change Tivic’s exclusive rights to Entolimod?

No. The A&R License maintains worldwide exclusivity for Acute Radiation Syndrome and options on additional indications.

Is there any immediate impact on Tivic’s earnings?

The filing does not include earnings data; financial impact depends on future milestone triggers and royalty decisions.