Tivic Health gains control of two Entolimod INDs

Rhea-AI Filing Summary

Tivic Health Systems, Inc. reported that two investigational new drug applications (INDs) for its lead candidate, Entolimod, have been transferred to the company from Statera Biopharma, Inc.

The transferred INDs cover Entolimod for treating acute radiation syndrome, including hematopoietic and gastrointestinal sub-syndromes, and for treating advanced cancers both as an anti-tumor agent and for addressing effects of cancer treatments. This step gives Tivic formal regulatory control of these development programs, which is important for planning future clinical work and potential collaborations.

Insights

Biotech regulatory and pipeline analyst

Tivic gains direct control of key Entolimod IND programs.

Tivic Health Systems now holds two transferred INDs for its lead candidate Entolimod, one for acute radiation syndrome (hematopoietic and gastrointestinal sub-syndromes) and one for advanced cancers. This consolidates regulatory responsibility for these clinical programs under Tivic.

Control of the INDs is a necessary step for Tivic to sponsor trials, interact with regulators, and explore development paths for Entolimod in radiation injury and oncology settings. The excerpt does not discuss study status, efficacy, safety results, or funding needs.

The press release filed as Exhibit 99.1, dated August 20, 2025, may provide additional operational details on how Tivic plans to advance Entolimod. Subsequent company disclosures can clarify trial designs, timelines, and any partnering or government-related opportunities tied to these indications.

8-K Event Classification

Item 8.01 — Other Events

1 item

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Tivic Health Systems (TIVC) announce regarding Entolimod?

Tivic Health Systems announced completion of the transfer of two investigational new drug applications for its lead candidate Entolimod from Statera Biopharma. These INDs now place Tivic as the sponsor for Entolimod’s development in acute radiation syndrome and advanced cancer settings.

Which medical conditions are covered by Tivic Health Systems’ Entolimod INDs?

The transferred Entolimod INDs cover treatment of acute radiation syndrome, including hematopoietic and gastrointestinal sub-syndromes, and treatment of advanced cancers. They also include Entolimod’s potential use as an anti-tumor agent and for addressing side effects associated with cancer treatments.

From which company did Tivic Health Systems acquire the Entolimod INDs?

Tivic Health Systems received the two investigational new drug applications for Entolimod from Statera Biopharma, Inc. The 8-K states that the transfer of these INDs to Tivic has been completed, making Tivic the entity responsible for these regulatory filings going forward.

When did Tivic Health Systems complete the Entolimod IND transfer?

Tivic Health Systems reported on August 20, 2025, that the transfer of two Entolimod investigational new drug applications from Statera Biopharma to the company was complete. A related press release dated the same day is filed as Exhibit 99.1 and incorporated by reference.

Where can investors find more details on Tivic Health Systems’ Entolimod update?

More details are provided in Tivic Health Systems’ press release dated August 20, 2025, filed as Exhibit 99.1. The 8-K notes that this press release is incorporated by reference, meaning it forms part of the official disclosure for the Entolimod IND transfer.

Does the Tivic Health Systems Entolimod update include forward-looking statements?

Yes. The company states the disclosure, including Exhibit 99.1, contains forward-looking statements identified by terms like “anticipates,” “expects,” and “believes.” It warns that various known and unknown risks could cause actual results to differ from those expressed or implied.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 08/20/2025 - 08:31 AM Learn about SEC filing dates

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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): August 20, 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 8.01 Other Events.

On August 20, 2025, Tivic Health Systems, Inc. (the “Company”) issued a press release announcing completion of the transfer from Statera Biopharma, Inc. to the Company of two investigational new drug applications (“INDs”) for its lead candidate, Entolimod. The transferred INDs cover the use of Entolimod to treat acute radiation syndrome, including both hematopoietic (ARS-H) and gastrointestinal (ARS-GI) sub-syndromes, and the use of Entolimod to treat advanced cancers, including as an anti-tumor agent and for effects of cancer treatments. A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K (this “Current Report”) and is incorporated herein by reference.

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 the Company or its 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, reports to the stockholders of the Company and other publicly available statements issued or released by the Company involve known and unknown risks, uncertainties and other factors which could cause the Company’s 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 Securities and Exchange Commission, each of which could adversely affect the Company’s business and the accuracy of the forward-looking statements contained herein.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.		Description
99.1		Press Release, dated August 20, 2025.
104		Cover Page Interactive Data File (embedded within the inline 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:	August 20, 2025	By:	/s/ Jennifer Ernst
			Name: Jennifer Ernst Title: Chief Executive Officer