Tivic Health (Nasdaq: TIVC) pivots to Entolimod immunotherapy and CDMO model

Rhea-AI Filing Summary

Tivic Health Systems reported its full-year 2025 results and highlighted a major strategic shift into immunotherapy centered on its Entolimod™ platform and next-generation molecule Entolasta™. Management described 2025 as a defining year, securing global rights to Entolimod and advancing regulatory and development readiness.

The company is prioritizing Entolimod for acute radiation syndrome while planning to extend into oncology supportive care, initially targeting neutropenia via physician-sponsored trials expected later in the year. Through its Velocity Bioworks subsidiary, Tivic is vertically integrating manufacturing, positioning it as a standalone CDMO to both lower internal costs and pursue third-party revenue opportunities.

Insights

Biotech and healthcare equity analyst

Tivic highlights a strategic pivot to immunotherapy and CDMO services, but provides no detailed 2025 financial metrics here.

Tivic Health is repositioning itself around the Entolimod™ and Entolasta™ immunotherapy platform, with an initial focus on acute radiation syndrome and future expansion into oncology supportive care such as neutropenia. The company also emphasizes interactions with U.S. government agencies about Entolimod as a potential medical countermeasure.

In parallel, the Velocity Bioworks subsidiary is being built out as a contract development and manufacturing organization to handle Tivic’s own biologics and third-party projects. This dual-track strategy blends a high-risk, high-reward drug development pipeline with a potentially steadier CDMO revenue stream, though timelines and financial impact are not quantified in the excerpt.

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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): March 25, 2026

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.)
1305 E. Houston Street, Building 1 Suite 311
San Antonio, Texas		78205
(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 2.02 Results of Operations and Financial Condition.

The information provided below in “Item 7.01 - Regulation FD Disclosure” of this Current Report on Form 8-K (this “Current Report”) is incorporated by reference into this Item 2.02.

Item 7.01 Regulation FD Disclosure.

On March 25, 2026, Tivic Health Systems, Inc. (the "Company") issued a press release regarding the Company’s financial results for its year ended December 31, 2025. A copy of that press release is furnished as Exhibit 99.1 hereto and incorporated herein by reference.

The information set forth under Item 7.01 of this Current Report, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of such section. The information in Item 7.01 of this Current Report, including Exhibit 99.1 attached hereto, shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any incorporation by reference language in any such filing, except as expressly set forth by specific reference in such a filing. This Current Report will not be deemed an admission as to the materiality of any information in this Current Report that is required to be disclosed solely by Regulation FD.

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, 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 Securities and Exchange 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 and adversely 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, dated March 25, 2026.
104		Cover Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101).

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:	March 25, 2026	By:	/s/ Lisa Wolf
			Name: Lisa Wolf Title: Chief Financial Officer

Exhibit 99.1

For Immediate Release

Tivic Reports Full Year 2025 Results

Completes Strategic Transformation into an Immunotherapy Company and Continues to Advance Entolimod Platform Toward Potential Funding Partnerships

Conference Call to be Held Today at 1:30 PM PT / 4:30 PM ET

SAN ANTONIO, March 25, 2026 — Tivic Health Systems, Inc. (Nasdaq: TIVC), a development-stage immunotherapy company, today reported financial and operational results for the year ended December 31, 2025, and provided a business update highlighting the company’s strategic transformation and focus on the development of its Entolimod™ platform.

“2025 was a defining year for Tivic as we marked our transformation into a focused immunotherapy company anchored by Entolimod and its next-generation molecule, Entolasta,” said Michael K. Handley, chief executive officer of Tivic. “During the year, we secured global rights to Entolimod and advanced regulatory and development readiness, while initiating discussions with U.S. government agencies regarding its potential as a medical countermeasure. Entolimod’s differentiated cytoprotective properties, immune-enhancing mechanism, and extensive development history make it a promising candidate for national preparedness programs. We are optimistic that our ongoing discussions with BARDA, the Department of War, and the National Institute of Allergy and Infectious Disease will advance toward a potential funding or sponsorship arrangement.”

Handley added, “While Entolimod for acute radiation syndrome remains our lead indication, its development is the first phase of a broader strategic roadmap to penetrate the multi-billion-dollar oncology supportive care market. Our immediate focus is on Neutropenia, where we are targeting the severe and often fatal side effects of chemo and radiation therapy. We are on track to advance this program into physician-sponsored clinical trials later this year.

“Simultaneously, the vertical integration provided by Velocity Bioworks has already significantly reduced our manufacturing timelines and costs. Beyond internal efficiencies, we have positioned Velocity Bioworks as a standalone contract development and manufacturing organization, or CDMO, to service third-party development projects. This creates an immediate opportunity for a new revenue stream and supports our long-term objective of transforming our manufacturing capabilities into a high margin profit center for the broader biotech industry.”

2025 Corporate Highlights and Subsequent Events

● Acquired exclusive global rights to Entolimod™ for acute radiation syndrome, including a comprehensive clinical, regulatory, and nonclinical development package from Statera Biopharma, Inc. Statera’s CEO Michael K. Handley joined Tivic in 2025, and in March 2026 was appointed CEO, succeeding Jennifer Ernst, who was Tivic's CEO since 2016

● Engaged with U.S. government agencies, including BARDA, DTRA, NIH, and NIAID, regarding potential development funding and Strategic National Stockpile procurement of Entolimod™

● Acquired biomanufacturing assets to establish Velocity Bioworks®, a wholly owned CDMO subsidiary

● Discontinued ClearUP® operations and suspended the non-core neuromodulation, or VNS, program

● Relocated corporate headquarters to San Antonio, Texas

Financial Results for the Year Ended December 31, 2025, Compared to 2024

● Operating expenses for 2025 were $7.9 million, compared to $4.5 million for the year ended December 31, 2024. The increase was primarily due to the introduction of the biopharma business in February 2025, when the company licensed certain biologics assets and increased headcount and consultant services to support the development of Entolimod.  Additional increases occurred in December 2025 when we formed Velocity Bioworks and hired 45 employees to support the CDMO operations.

● Loss from discontinued operations decreased by $300,000 to $900,000 for the year ended December 31, 2025. Discontinued operations included all activities related to the consumer product business that Tivic exited in 2025.

● Net loss before discontinued operations for the year ended December 31, 2025 is expected to be in the range of $7.9 million to $8.1 million, compared with $4.5 million for the year ended December 31, 2024.

● Net loss for the year ended December 31, 2025 is expected to be in the range of $8.8 million to $9.1 million, compared with $5.7 million for the year ended December 31, 2024.

● The company is in the process of finalizing certain accounting matters related to the $16.3 million Senior Secured Convertible Note Payable dated December 10, 2025. All of the proceeds from the debt offering were used to acquire the assets now used by Velocity Bioworks,

● Cash and equivalents at December 31, 2025 totaled $12.6 million, compared with $2.0 million at December 31, 2024. The company had working capital of $12.4 million at year end 2025.

Conference Call and Webcast Information

Teleconference

Toll Free:   888-506-0062

International:   973-528-0011

Participant Access Code:   910220

Webcast Link

https://www.webcaster5.com/Webcast/Page/2865/53678 

An audio replay of the call will be available for 90 days on the investor page of the company’s website at https://tivichealth.com/investor/.

About Tivic

Tivic Health is developing biologics that activate innate immune pathways for cytoprotection and modulate immune responses in conditions driven by radiation, disease, and immune dysregulation. The company’s lead candidate, Entolimod™ for acute radiation syndrome (ARS), has been extensively studied, having demonstrated survival benefits and improved tissue recovery in animal models under the FDA’s Animal Rule.

Entolimod™ is a novel Toll-like receptor 5 (TLR5) agonist that activates NF-κB signaling pathways to protect cells from damage and stimulate immune responses. Entolimod™ has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration.

Tivic is also advancing Entolasta™, a next-generation TLR5 agonist designed for potential broader therapeutic applications, including oncology supportive care. Tivic’s clinical pipeline includes potential treatments for neutropenia, which is most commonly caused by chemotherapy, and a state of T-cell dysfunction known as lymphocyte exhaustion.

Tivic’s wholly owned subsidiary, Velocity Bioworks, is a full-service CDMO offering biomanufacturing services to third-party biotech companies. Tivic also leverages Velocity Bioworks’ manufacturing capabilities to advance its own drug pipeline with the expected benefits of lower costs, accelerated manufacturing outcomes, and supply chain security.

For more information, visit https://ir.tivichealth.com.

Forward-Looking Statements

reminder date of 10-K to be filed on or before  March 31, 2026.

This press release may contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim, “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Tivic Health Systems Inc.’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate, including as a result of the company’s interactions with and guidance from the FDA and other regulatory authorities; the continued interest of BARDA and other U.S. government agencies in Entolimod; the ability of the company to achieve the expected benefits from the acquisition of development and manufacturing assets within expected time frames or at all; changes to the company’s relationship with its partners; expectations regarding the potential benefits of the leadership transition; failure to obtain FDA or similar clearances or approvals and noncompliance with FDA or similar regulations, including related to the Animal Rule; the company’s future development of Entolimod or Entolasta; changes to the company’s business strategy; timing and success of pre-clinical and clinical trials and study results; regulatory requirements and pathways for approval; the company’s ability to successfully commercialize its product candidates in the future; changes in the markets and industries in which the company does business; consummation of any strategic transactions; the company’s need for, and ability to secure when needed, additional working capital; the company’s ability to maintain its Nasdaq listing; and changes in tariffs, inflation, legal, regulatory, political and economic risks. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of risks and uncertainties relevant to the company, and other important factors, see Tivic Health’s filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 21, 2025, under the heading “Risk Factors”, as well as the company’s subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and the company undertakes no duty to update such information except as required by applicable law.

Investor Contact:

Hanover International, Inc.

ir@tivichealth.com

Media Contact:

DJ Freyman

DJ@FastrackPR.com

FAQ

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

Tivic Health reported full-year 2025 results and described 2025 as a defining year in its transformation into a focused immunotherapy company. The update centers on advancing its Entolimod platform, next-generation molecule Entolasta, and leveraging its Velocity Bioworks manufacturing subsidiary.

How is Tivic Health shifting its business strategy around immunotherapy?

Tivic Health is pivoting from its prior focus to become a development-stage immunotherapy company built around Entolimod and Entolasta. The strategy targets acute radiation syndrome first, then broader oncology supportive care indications, using physician-sponsored clinical trials to progress programs.

What is Tivic Health’s Entolimod platform and lead indication?

Entolimod is Tivic’s lead biologic candidate, a TLR5 agonist intended for acute radiation syndrome. It has been extensively studied under the FDA’s Animal Rule and has Fast Track and Orphan Drug designations, supporting its potential role in national preparedness and related medical countermeasure programs.

How does Velocity Bioworks fit into Tivic Health’s plans?

Velocity Bioworks is Tivic’s wholly owned CDMO subsidiary, providing biomanufacturing services. Tivic uses it to produce its own drug candidates and aims to serve external biotech clients, seeking lower internal costs, faster manufacturing timelines, and an additional revenue stream from third-party projects.

Which markets is Tivic Health targeting beyond acute radiation syndrome?

Beyond acute radiation syndrome, Tivic is targeting oncology supportive care, starting with neutropenia associated with chemo and radiation therapy. The company also references potential applications in lymphocyte exhaustion and broader immune dysregulation, positioning Entolasta as a next-generation TLR5 agonist for expanded indications.

Is Tivic Health engaging with U.S. government agencies about Entolimod?

Yes. Tivic reports ongoing discussions with agencies such as BARDA, the Department of War, and the National Institute of Allergy and Infectious Disease. These conversations focus on Entolimod’s potential as a medical countermeasure and may lead to funding or sponsorship arrangements if they progress favorably.

Filing Exhibits & Attachments

5 documents

Press Releases

• EX-99.1 EXHIBIT 99.1 27.4 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA 3.5 KB
• EX-101 XBRL TAXONOMY EXTENSION DEFINITION LINKBASE 11.9 KB
• EX-101 XBRL TAXONOMY EXTENSION LABEL LINKBASE 16.0 KB
• EX-101 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE 12.2 KB