Tivic Reports Third Quarter 2025 Financial Results

Rhea-AI Summary

Tivic Health (Nasdaq: TIVC) reported third quarter 2025 results on November 14, 2025 and outlined progress on its biologics transformation.

Key points: Revenue $146,000 vs $126,000 year-ago; gross loss $145,000 driven by a $230,000 inventory reserve; operating expenses $2.3M; net loss $2.6M. At September 30, 2025 cash and equivalents were $3.5M and the company reported no debt and approximately $3.5M in committed funding.

Corporate advances include transfer of two INDs for Entolimod, completion of cell line verification toward cGMP manufacturing, wind-down of the ClearUP consumer business, and $3.8M net proceeds from financing tranches in Q3.

Positive

• Transfer of two INDs enabling neutropenia and cancer trials
• Completed cell line verification toward cGMP manufacturing
• Cash and equivalents of $3.5M at Sept 30, 2025
• Approximately $3.5M committed via preferred equity purchase
• Closed $3.8M net financing proceeds in Q3 2025
• Reported 42% gross margin excluding inventory reserve

Negative

• Net loss widened to $2.6M in Q3 2025
• Operating expenses increased to $2.3M year-over-year
• Recorded $230,000 inventory reserve and $117,000 other write-off
• Discontinued direct ClearUP consumer sales beginning October 1, 2025
• Reported gross loss $145,000 for Q3 2025

Insights

Life Sciences / Biotech Strategy Expert

Tivic reports early biologics manufacturing progress, IND transfers, modest financing, and continued losses; developments are strategically constructive but not transformative yet.

Tivic Health advanced prerequisites for a biologics program by completing cell line verification, starting the cGMP manufacturing process, and acquiring two INDs to enable clinical trials for neutropenia and cancer-related indications using Entolimod. These steps establish regulatory and operational foundations needed before a BLA pathway and justify continued R&D spending. The company also reported intellectual property activity from its VNS Optimization Trial, which supports commercialization and licensing options for its device work.

The near-term financing and cash position provide runway but remain limited: the company recorded $3.5 million in cash and noted a committed $3.5 million through a preferred equity purchase agreement, while reporting a $2.6 million net loss for the quarter and increased operating expenses tied to its biopharma transition. The consumer business wind‑down drove a $230,000 inventory reserve and write‑downs, which weighed on gross profit but once excluded produced a 42% comparable gross margin.

Watch execution milestones over the next 6–18 months: completion of cGMP validation and reproducible manufacturing runs, initiation and enrolment starts for the transferred IND trials, and any additional non‑dilutive funding or government contract progress for a military stockpile pathway discussed at the 2025 Military Health System Research Symposium. These specific events will materially change program risk and clarity; until then, the announcement is strategically positive but operationally early, so impact is neutral on standing facts.

Continues Execution of Strategic Transformation and Advancement of Biologics Pipeline

FREMONT, CA / ACCESS Newswire / 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

SOURCE: Tivic Health Systems

View the original press release on ACCESS Newswire

FAQ

What were Tivic (TIVC) Q3 2025 revenue and net loss?

Tivic reported Q3 2025 revenue $146,000 and a net loss of $2.6M.

How much cash did Tivic (TIVC) have at September 30, 2025?

Cash and cash equivalents were $3.5M at September 30, 2025.

What progress did Tivic (TIVC) report toward Entolimod manufacturing in Q3 2025?

Tivic completed cell line verification, a key step toward cGMP manufacturing.

Did Tivic (TIVC) receive any INDs or approvals in Q3 2025?

Tivic completed the transfer of two INDs, enabling clinical trials for neutropenia and cancer-related uses.

What financing did Tivic (TIVC) complete during Q3 2025?

Tivic closed additional tranches of an $8.4M financing, generating $3.8M net proceeds in Q3 2025.

Why did Tivic (TIVC) stop ClearUP consumer sales and what is the impact?

Tivic is winding down its ClearUP consumer business, discontinuing direct sales after October 1, 2025, and recorded inventory and equipment write-offs impacting Q3 results.