Tivic Reports Full Year 2025 Results

Rhea-AI Summary

Tivic (NASDAQ:TIVC) completed a strategic transformation into an immunotherapy company centered on Entolimod and next-generation Entolasta, acquiring exclusive global rights and related development assets.

The company formed Velocity Bioworks CDMO, relocated headquarters to San Antonio, discontinued ClearUP consumer operations, and engaged U.S. government agencies for potential funding. 2025 operating expenses rose to $7.9M and cash totaled $12.6M at year-end.

Positive

• Acquired global rights to Entolimod with clinical and regulatory package
• Velocity Bioworks established as CDMO, enabling manufacturing control and new revenue stream
• Cash position improved to $12.6M at December 31, 2025

Negative

• Operating expenses increased to $7.9M from $4.5M (2025 vs 2024)
• Net loss widened to a $8.8M–$9.1M range in 2025 versus $5.7M in 2024
• Issued a $16.3M senior secured convertible note, pending accounting finalization

News Market Reaction – TIVC

-13.26%

14 alerts

-13.26% News Effect

+20.4% Peak Tracked

-9.1% Trough Tracked

-$456K Valuation Impact

$2.98M Market Cap

0.1x Rel. Volume

On the day this news was published, TIVC declined 13.26%, reflecting a significant negative market reaction. Argus tracked a peak move of +20.4% during that session. Argus tracked a trough of -9.1% from its starting point during tracking. Our momentum scanner triggered 14 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $456K from the company's valuation, bringing the market cap to $2.98M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Operating expenses 2025: $7.9 million Loss from discontinued ops: $0.9 million Net loss before discontinued ops: $7.9–$8.1 million +5 more

8 metrics

Operating expenses 2025 $7.9 million Year ended December 31, 2025 vs $4.5 million in 2024

Loss from discontinued ops $0.9 million Year ended December 31, 2025; decreased by $0.3 million

Net loss before discontinued ops $7.9–$8.1 million Expected range for year ended December 31, 2025 vs $4.5 million in 2024

Net loss total 2025 $8.8–$9.1 million Expected range for year ended December 31, 2025 vs $5.7 million in 2024

Senior Secured Convertible Note $16.3 million Convertible note payable dated December 10, 2025 funding Velocity Bioworks assets

Cash and cash equivalents $12.6 million At December 31, 2025 vs $2.0 million at December 31, 2024

Working capital $12.4 million At December 31, 2025

New CDMO employees 45 employees Hired in December 2025 to support Velocity Bioworks operations

Market Reality Check

Price: $0.9888 Vol: Volume 90,006 is well bel...

low vol

$0.9888 Last Close

Volume Volume 90,006 is well below the 20-day average of 525,005, indicating subdued trading ahead of/around the release. low

Technical Shares at $1.02 are trading below the $2.43 200-day moving average, reflecting a longer-term downtrend into these results.

Peers on Argus

TIVC was up 3.04% while peers showed mixed moves: VERO up 8.28%, MOVE and NUWE m...

1 Up

TIVC was up 3.04% while peers showed mixed moves: VERO up 8.28%, MOVE and NUWE modestly higher, NAOV and AMIX down. Only 1 peer appeared in the momentum scanner, suggesting a stock-specific move.

Previous Earnings Reports

5 past events · Latest: Nov 14 (Negative)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 14	Q3 2025 earnings	Negative	-21.3%	Reported Q3 losses and highlighted biologics transformation and financing.
Aug 14	Q2 2025 earnings	Neutral	+8.3%	Q2 loss with revenue decline but key financings and Entolimod progress.
May 15	Q1 2025 earnings	Neutral	-1.2%	Q1 loss, lower revenue, but improved margins and major funding lines.
Mar 21	FY 2024 results	Neutral	-3.9%	Year-end 2024 loss with revenue decline and early Entolimod licensing.
Nov 14	Q3 2024 earnings	Neutral	-21.1%	Q3 2024 device-focused update with revenue decline and reduced loss.

Pattern Detected

Earnings releases have historically led to moves that generally align with the tone of results, with an average move of about -7.84% and several past reports followed by notable declines.

Recent Company History

Over the past five earnings-related announcements from Nov 2024 through Nov 2025, Tivic has used results updates to highlight its shift from consumer devices to biopharma centered on Entolimod. These reports often paired small revenues and recurring net losses with financing arrangements and restructuring steps. Stock reactions have mostly been negative, with one positive spike in Aug 2025, framing today’s full-year 2025 update within a pattern of transformative but loss-making financials.

Historical Comparison

-7.8% avg move · Past earnings and annual results for TIVC (5 events, avg move -7.84%) often coincided with losses an...

earnings

-7.8%

Average Historical Move earnings

Past earnings and annual results for TIVC (5 events, avg move -7.84%) often coincided with losses and strategic shifts, framing this 2025 report within a history of transformation-driven but volatile reactions.

Earnings updates trace Tivic’s evolution from a device-focused business toward a biopharma model centered on Entolimod, with ClearUP wound down and resources redirected to immunotherapy and CDMO operations.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2025-10-17

An effective S-3 resale registration filed on Oct 17, 2025 covers up to 1,580,437 shares of common stock issuable from preferred share conversions and warrants. The company does not receive proceeds from resale by holders, but would receive cash upon any warrant exercises.

Market Pulse Summary

The stock dropped -13.3% in the session following this news. A negative reaction despite the higher ...

Analysis

The stock dropped -13.3% in the session following this news. A negative reaction despite the higher cash balance of $12.6 million would fit prior earnings patterns, where the average move around such events was -7.84%. The widening 2025 net loss and added leverage from the $16.3 million senior secured convertible note may heighten concerns. Historical dilution mechanisms and resale overhangs could also weigh on sentiment following transformation-focused but loss-making updates.

Key Terms

immunotherapy, medical countermeasure, acute radiation syndrome, neutropenia, +4 more

8 terms

immunotherapy medical

"a development-stage immunotherapy company, today reported financial and operational"

Treatment that uses or enhances the body’s immune system to detect and fight disease, most often cancers or chronic infections; think of it as training or arming the body’s own soldiers to find and destroy targets. It matters to investors because successful immunotherapies can lead to high-value drug approvals, recurring revenue from long-term treatments, and changes in competitive dynamics, while failures or safety issues in clinical trials can materially affect company valuations.

medical countermeasure medical

"regarding its potential as a medical countermeasure. We believe that Entolimod's"

Medical countermeasures are medicines, vaccines, tests, devices or procedures designed to prevent, diagnose, treat or reduce harm from infectious diseases, toxins or other public health emergencies. Think of them as a society’s safety gear—like masks, fire extinguishers or antivirus software for people—that reduce damage when a health threat appears. Investors watch them because successful development, regulatory approval or government purchasing can create large, time-sensitive revenue opportunities and change a company’s risk profile.

acute radiation syndrome medical

"While Entolimod for acute radiation syndrome remains our lead indication, its"

Acute radiation syndrome is the sudden illness that happens after a person absorbs a large dose of ionizing radiation in a short time, damaging blood cells, the gut, skin, and other organs. Think of it like a severe, internal burn that can impair a person’s ability to heal and fight infection. Investors watch it because outbreaks, accidents, or tests can trigger urgent regulatory action, reshape demand for medical treatments and protective equipment, create liability risks, and affect the operations and stock prices of companies in healthcare, energy, insurance, and related supply chains.

neutropenia medical

"Our immediate focus is on Neutropenia, where we are targeting the severe and"

Neutropenia is a medical condition where the blood has an unusually low number of neutrophils, the white blood cells that act like the body’s front-line security guards against bacterial and fungal infections. For investors, it matters because neutropenia can signal safety or tolerability problems for drugs or treatments, driving clinical trial setbacks, regulatory scrutiny, additional monitoring costs, or label warnings that can influence a company’s commercial outlook and stock value. Monitoring for neutropenia is a common part of assessing medical risk and long-term financial impact.

contract development and manufacturing organization technical

"as a standalone contract development and manufacturing organization, or CDMO, to service"

A contract development and manufacturing organization (CDMO) is a specialized service provider that helps other companies design, test, produce and package drugs or medical products on a hired basis. Think of it as an outsourced factory and R&D partner that lets a company scale production without building its own plants. Investors watch CDMO relationships because they affect a drug’s time-to-market, manufacturing costs, supply reliability and overall project risk, all of which influence future revenue and valuation.

cdmo technical

"organization, or CDMO, to service third-party development projects. This creates"

A contract development and manufacturing organization (CDMO) is a company that provides specialized services to help develop and produce pharmaceutical products for other businesses. Think of it as a contract factory that takes a company's recipe and makes the product on their behalf. For investors, CDMOs are important because they support the growth of pharmaceutical companies and can be key partners in bringing new medicines to market.

neuromodulation medical

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

Neuromodulation is the use of devices or targeted treatments to change how nerves or brain circuits send signals, much like adjusting the volume or tuning on an audio system to alter what you hear. For investors, it matters because these therapies can treat chronic conditions (pain, movement disorders, depression) where existing medicines fall short, creating potential markets, regulatory milestones, and durable revenue streams if technologies prove safe and effective.

vns medical

"operations and suspended the non-core neuromodulation, or VNS, program"

VNS stands for vagus nerve stimulation, a medical therapy that uses a small implanted or wearable device to send mild electrical pulses to the vagus nerve, which helps regulate brain and body functions. For investors, VNS matters because its devices and related treatments are subject to clinical trial results, regulatory approvals, and insurance reimbursement decisions—events that can directly affect a company’s sales, growth prospects and valuation, similar to how a breakthrough feature can change demand for a consumer gadget.

AI-generated analysis. Not financial advice.

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, TX / ACCESS Newswire / 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. We believe that 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 the 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, Defense Threat Reduction Agency, National Institutes of Health, 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 the year ended December 31, 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 cash 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 December 31, 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://tivichealth.com/investors/.

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 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^TM; 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^TM 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

SOURCE: Tivic Health Systems

View the original press release on ACCESS Newswire

FAQ

What did Tivic announce about Entolimod rights on March 25, 2026 (TIVC)?

Tivic acquired exclusive global rights to Entolimod and its development package for acute radiation syndrome. According to Tivic, the transaction includes clinical, regulatory, and nonclinical assets and supports its immunotherapy focus and potential government partnerships.

How did Tivic's financial position change at December 31, 2025 (TIVC)?

Tivic ended 2025 with $12.6M in cash and $12.4M working capital. According to Tivic, cash rose from $2.0M in 2024 after financing and asset acquisitions supporting Velocity Bioworks operations.

What were Tivic's 2025 operating expenses and net loss guidance (TIVC)?

Tivic reported 2025 operating expenses of $7.9M and net loss guidance of $8.8M–$9.1M. According to Tivic, increases reflect biopharma launch costs and hiring for Velocity Bioworks CDMO operations.

What is Velocity Bioworks and how does it affect Tivic (TIVC)?

Velocity Bioworks is Tivic's wholly owned CDMO subsidiary intended to reduce manufacturing timelines and costs. According to Tivic, it also creates an immediate third-party revenue opportunity and supports long-term margin objectives.

Is Tivic pursuing government funding or procurement for Entolimod (TIVC)?

Yes, Tivic is engaged with BARDA, DTRA, NIH, and NIAID regarding potential funding and Strategic National Stockpile procurement. According to Tivic, discussions aim to advance toward funding or sponsorship arrangements for Entolimod.