TIVC to present Entolimod radiation data at BARDA Techwatch session

Rhea-AI Filing Summary

Tivic Health Systems, Inc. reported that it secured a Techwatch meeting with the Biomedical Advanced Research and Development Authority’s Radiological and Nuclear Medical Countermeasures Program staff to present clinical data on Entolimod’s effects on radiation-induced injury and acute radiation syndrome.

The company also plans to discuss its progress on manufacturing readiness and preparations for a biologics license application, as described in a press release furnished as an exhibit. The report emphasizes that these plans and expectations are forward-looking and subject to significant risks and uncertainties that could cause actual results to differ materially.

8-K Event Classification

Item 9.01 — Financial Statements and Exhibits

1 item

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

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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): November 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. Suite 100
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. ☐

8.01: Other Events

On November 18, 2025, Tivic Health Systems, Inc. (the “Company”) issued a press release announcing that it has secured a Techwatch meeting with the Biomedical Advanced Research and Development Authority’s Radiological and Nuclear Medical Countermeasures Program staff to present clinical data on Entolimod’s effects on radiation-induced injury and acute radiation syndrome, its progress on manufacturing readiness and the preparations it has been making for a biologics license application. A copy of this press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K (this “Current Report”) and is incorporated by reference herein.

Forward-Looking Statements

This Current Report, including Exhibit 99.1 attached hereto, 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 attached hereto, or hereafter, including in other publicly available documents filed with the Securities and Exchange Commission (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
99.1		Press Release of Tivic Health Systems, Inc., dated November 18, 2025.
104		Cover Page Interactive Data File (embedded within the XBRL document).

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:	November 18, 2025	By:	/s/ Jennifer Ernst
			Name: Jennifer Ernst Title: Chief Executive Officer

FAQ

What did Tivic Health Systems (TIVC) announce in this 8-K?

Tivic Health Systems announced that it has secured a Techwatch meeting with the Biomedical Advanced Research and Development Authority’s Radiological and Nuclear Medical Countermeasures Program staff to present clinical data on Entolimod and related development plans.

What is the purpose of Tivic Health Systems’ BARDA Techwatch meeting?

The meeting will allow Tivic Health Systems to present clinical data on Entolimod’s effects on radiation-induced injury and acute radiation syndrome, and to discuss its progress on manufacturing readiness and preparations for a biologics license application.

What is Entolimod being discussed for by Tivic Health Systems (TIVC)?

Entolimod is being discussed in the context of clinical data on its effects on radiation-induced injury and acute radiation syndrome, which Tivic Health Systems plans to present to BARDA’s Radiological and Nuclear Medical Countermeasures Program staff.

Does this Tivic Health Systems 8-K include financial results?

No, this 8-K focuses on Tivic Health Systems’ planned Techwatch meeting with BARDA and related development activities for Entolimod; it does not present revenue, earnings, or other financial results.

Where can investors find more detail on Tivic Health Systems’ announcement?

More detail is available in the press release furnished as Exhibit 99.1, titled as a press release of Tivic Health Systems, Inc. dated November 18, 2025, which is incorporated by reference in the report.

Does Tivic Health Systems highlight any risks in connection with this announcement?

Yes, the company notes that statements about its expectations and plans, including those in the attached press release, are forward-looking and subject to substantial risks and uncertainties that could cause actual results to differ materially.