ティビックヘルスシステムズの適時開示・決算・その他

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 12, 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. ☐

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 2.05 Costs Associated with Exit or Disposal Activities.

On November 12, 2025, after considering all reasonably available options and a broader strategic reassessment, the board of directors of Tivic Health Systems, Inc. (the “Company”) determined that it is in the best interests of the Company and its stockholders to wind down and exit the Company’s ClearUP business, which the Company intends to substantially complete prior to the end of the year. Following the wind down of its ClearUP business, the Company will focus primarily on its biopharma program and continue to advance the development of its biopharmaceutical product candidates.

In connection with the wind down of the ClearUP business, the Company incurred approximately $347 thousand in charges during the quarter ended September 30, 2025 and expects to incur additional related expenditures in the range of approximately $20 thousand to $50 thousand through the end of the year. Additionally, as a result of its exit from the ClearUP business, the Company expects that it will generate minimal to no revenue until such time that it is able to obtain regulatory approval of and commercialize its other product candidates.

The estimates of the charges and costs that the Company expects to incur, and the timing thereof, as well as its revenue expectations, are subject to a number of assumptions and actual results may differ materially from those described above. In addition, the Company may incur other charges or cash expenditures not currently contemplated due to unanticipated events that may occur as a result of or in connection with the wind down of the ClearUP business.

Item 7.01 Regulation FD Disclosure.

On November 14, 2025, the Company issued a press release regarding the Company’s financial results for its quarter ended September 30, 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 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 November 14, 2025.
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:	November 14, 2025	By:	/s/ Jennifer Ernst
			Name: Jennifer Ernst Title: Chief Executive Officer

EX-99.1 2 ex_860071.htm EXHIBIT 99.1 ex_860071.htm

Exhibit 99.1

Tivic Reports Third Quarter 2025 Financial Results

Continues Execution of Strategic Transformation and

Advancement of Biologics Pipeline

FREMONT, Calif. – November 14, 2025 – Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified immunotherapeutics company, today announced financial results for the third quarter and nine months ended September 30, 2025 and provided a business update.

“Following our discussions at the Military Health System Research Symposium and continued engagement with key government agencies, we are encouraged by the interest in our lead product candidate, Entolimod for acute radiation syndrome (ARS), as a military medical countermeasure and stockpile drug," stated Tivic CEO, Jennifer Ernst. "This quarter, we continued the advancement towards commercial readiness. Starting the cGMP manufacturing process with successful cell line verification was a critical first step to establishing reproducibility and scalability in our drug manufacturing. ”

Tivic also completed the transfer of two INDs to Tivic from Statera Biopharma. These two INDs allow Tivic to initiate clinical trials for the use of Entolimod in the treatment of neutropenia and cancer-related conditions.

“Subsequent to the quarter’s end, we also reported the compelling findings from Tivic’s VNS Optimization Trial. These findings uncovered new insights into vagus nerve stimulation and have led to additional patent filings intended to protect Tivic’s prescription device development for commercialization and licensing,” added Ernst.

Corporate Highlights from the Third Quarter and Subsequent Weeks:

●

Successfully completed the transfer of two INDs to Tivic from Statera Biopharma, which allows Tivic to conduct clinical trials in neutropenia and lymphocyte exhaustion, and to explore Entolimod’s anti-tumor activity to potentially treat certain other cancer-related conditions.

●

Completed the cell line verification, a key step to enable Current Good Manufacturing Practices (cGMP), required prior to filing a biologics license application (BLA) with the U.S. Food & Drug Administration (FDA).

●

Moved forward with the wind down of Tivic's consumer health tech business, including discontinuing the allocation of any significant resources toward ClearUP sales, and the write-off of inventory, which was completed during the third quarter. As part of this progression, Tivic launched a new corporate website that emphasizes its transformed mission and expanded clinical pipeline.

●

Advanced discussions of potential pathways to deploying Entolimod™ as a military countermeasure and stockpile drug through participation in the 2025 Military Health System Research Symposium (MHSRS) in August. The Department of Defense holds this annual scientific meeting to bring together military, academic, and industry experts to discuss innovations in health and medical research for warfighters.

●

Closed the second, third and fourth tranches of Tivic’s $8.4 million financing for a total of $3.8 million in net proceeds during the third quarter.

Financial Performance for the third quarter of 2025 compared with the third quarter of 2024:

●

Revenue totaled $146,000, compared with $126,000 a year ago. While unit sales of ClearUP™ to treat sinus pain and pressure rose slightly, the third quarter was the final quarter that Tivic will sell ClearUP directly to consumers, and we discontinued all advertising and marketing initiatives on October 1, 2025. We will continue to fulfill orders from our resellers through the fourth quarter to support their holiday promotions.


	●	Gross loss was $145,000, compared with gross profit of $44,000, for the year-ago quarter. The gross loss in 2025 was a result of $230,000 of inventory reserves recorded in the third quarter in connection with the wind down of the consumer business. Gross margin, excluding the $230,000 inventory reserve, was 42%, compared with 35% for the third quarter of 2024.


	●	Operating expenses totaled $2.3 million, compared with $1.5 million for the same period in 2024. The increase was due to the addition of the biopharma business in February 2025 as well as increased corporate costs and advertising as we pushed to sell through our remaining ClearUP inventory prior to exiting the consumer business.


	●	During the quarter, executed the write-down of the ClearUP inventory and equipment, which resulted in $230,000 of cost of goods sold and $117,000 of other expenses as part of the exit from the consumer business and the focus on our transformation plan that seeks to advance the clinical pipeline for licensed Entolimod and Entolasta indications.


	●	Net loss of $2.6 million compared to $1.4 million in the third quarter of 2024.


	●	At September 30, 2025, cash and cash equivalents totaled $3.5 million, compared with $2.0 million at December 31, 2024. The company has no debt on its balance sheet. Approximately $3.5 million remained available at September 30 as a committed investment in Tivic through a preferred equity purchase agreement. The company believes the current and committed funding is sufficient to make meaningful progress toward manufacturing validation for Entolimod.

Conference Call and Webcast Information

Management will host a webcast/conference call today, November 14, at 1:30 p.m. PT / 4:30 p.m. ET to discuss the company’s third quarter 2025 financial results and provide a business update.

Teleconference Details:

Toll Free: 888-506-0062
International: 973-528-0011
Participant Access Code: 230582

Webcast Link:

https://www.webcaster5.com/Webcast/Page/2865/53145

An audio replay of the call will be available for the next 90 days from the investor page on the Tivic Health website at: https://tivichealth.com/investors/corporate-presentations/

About Entolimod

Entolimod is a novel Toll-like Receptor 5 (TLR5) agonist that triggers NF-kB signaling, activating antiapoptotic and cell protective mechanisms. Under the FDA’s Animal Rule, Entolimod™ has been the subject of extensive trials for the treatment of acute radiation syndrome (ARS), and has demonstrated robust survival, enhanced GI tract recovery and improved hematopoiesis in animal models. Entolimod has been granted Fast Track Designation for ARS.

About Tivic Health Systems, Inc.

Tivic’s dual platform utilizes the body’s biopharmaceutical and bioelectronic systems to treat unmet medical needs through targeting the immune system.

Tivic’s biologics compounds activate an innate immune pathway to prevent cell death in the bone marrow and epithelial tissues across systems impacted by radiation and age. The company’s lead drug candidate, Entolimod™ for acute radiation syndrome, is a novel TLR5 agonist that has been granted Fast Track and Orphan Drug designations and is in late-stage development. In addition to Entolimod™ for ARS, Tivic’s pipeline includes and Entolimod™ for the treatment of neutropenia, and lymphocyte exhaustion, and Tivic has the exclusive option to license additional indications, including Entolasta to treat immunosenescence, and chronic radiation syndrome.

Tivic’s bioelectronic program has been developing a novel, non-invasive medical device designed to target the neural pathways implicated in many prevalent and debilitating diseases. Early trials show promising signals that Tivic’s approach may regulate specific biologic responses, and the company believes its early-stage vagus nerve stimulation device has the potential to deliver clinical outcomes similar to or better than those of surgically implanted devices.

To learn more about Tivic, visit: https://ir.tivichealth.com.

Forward-Looking Statements

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 interactions with and guidance from the FDA and other regulatory authorities; timing and success of clinical trials and study results; the failure to obtain FDA or similar clearances or approvals and noncompliance with FDA or similar regulations; the company's ability to secure orders for its product candidates, if regulatory approvals are obtained; the company’s future development of its ncVNS treatment, Entolimod and Entolasta; changes to the company’s business strategy, regulatory requirements and pathways for approval; changes to the company’s relationship with its partners, including its manufacturing partners and other third-party providers; consummation of any strategic transactions; the company’s need for, and ability to secure when needed, additional working capital; unexpected costs or expenses that the company may incur, or other issues that may arise, in connection with the wind down of its consumer health business; the company’s ability to maintain its Nasdaq listing; and changes in tariffs, inflation, legal, regulatory, political and economic risks. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. 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 Tivic Health Systems, Inc. undertakes no duty to update such information except as required by applicable law.

Investor Contact:
Hanover International, Inc.
ir@tivichealth.com

Tivic Health Systems, Inc.

Condensed Balance Sheets

(in thousands, except share and per share data)

	September 30, 2025			December 31, 2024
	(Unaudited)			(Audited)
ASSETS
Cash and cash equivalents	$	3,450		$	2,002
Other current assets		290			637
TOTAL CURRENT ASSETS		3,740			2,639
PROPERTY AND EQUIPMENT, NET		12			119
NONCURRENT ASSETS		2,477			49
TOTAL ASSETS	$	6,229		$	2,807

LIABILITIES AND STOCKHOLDERS’ EQUITY
Accounts payable and accrued expenses	$	638		$	272
TOTAL CURRENT LIABILITIES		638			272
TOTAL LONG-TERM LIABILITIES		—			—
STOCKHOLDERS' EQUITY
Preferred stock		—			—
Common stock		2			1
Additional paid in capital		55,206			46,075
Accumulated deficit		(49,617	)		(43,541	)
TOTAL STOCKHOLDERS' EQUITY		5,591			2,535
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$	6,229		$	2,807

Tivic Health Systems, Inc.

Condensed Statements of Operations

(in thousands, except share and per share data)

	Three Months Ended September 30,						Nine Months Ended September 30,
	2025			2024			2025			2024
REVENUES	$	146		$	126		$	302		$	600
COST OF SALES		291			82			343			359
GROSS PROFIT		(145	)		44			(41	)		241
OPERATING EXPENSES
Research and development		858			422			1,848			980
Sales and marketing		415			234			1,020			946
General and administrative		1,065			819			3,014			2,493
TOTAL OPERATING EXPENSES		2,338			1,475			5,882			4,419
NET OPERATING LOSS		(2,483	)		(1,431	)		(5,923	)		(4,178	)
OTHER EXPENSE, NET		(113	)		—			(106	)		—
NET LOSS	$	(2,596	)	$	(1,431	)	$	(6,029	)	$	(4,178	)
NET LOSS PER SHARE - BASIC AND DILUTED	$	(1.97	)	$	(3.93	)	$	(6.49	)	$	(18.22	)
WEIGHTED-AVERAGE NUMBER OF SHARES - BASIC AND DILUTED		1,320,778			364,184			928,971			229,291