8-K - VBIO - Equibles

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the SecuritiesExchange Act of 1934

Date of Report (Dateof earliest event reported): January20, 2026

Tivic Health Systems, Inc.

(Exact name of Registrant as Specified in ItsCharter)

Delaware	001-41052	81-4016391
(State or Other Jurisdiction	(Commission File Number)	(IRS Employer
of Incorporation)		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
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(Former Name or Former Address, if Changed SinceLast 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	TradingSymbol(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 7.01 Regulation FD Disclosure.

On January 20, 2026, Tivic Health Systems, Inc. (the “Company”) made available to investors a presentation on its website at https://tivichealth.com. The presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K (the “Report”).

The information set forth under Item 7.01 of this 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 Report, including Exhibit 99.1, 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 Report will not be deemed an admission as to the materiality of any information in this Report that is required to be disclosed solely by Regulation FD.

Forward-Looking Statements

This 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 Report, including Exhibit 99.1 attached hereto, or hereafter, including in other publicly available documents filed with the Securities and Exchange Commission (the “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 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
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99.1	Corporate Presentation, dated January 2026.
104	Cover Page Interactive Data File (formatted in Inline XBRL and contained<br>in Exhibit 101).

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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:	January 20, 2026	By:	/s/ Jennifer Ernst
			Name: Jennifer Ernst<br><br>Title: Chief Executive Officer

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Exhibit 99.1

Nasdaq: TIVC | www.tivichealth.com ® ir@tivichealth.com – January 2026 – Jennifer Ernst, CEO, Tivic Health Harnessing the immune system to save lives and improve clinical outcomes • Late - stage, highly de - risked assets • Competitively differentiated treatments for radiation damage, oncology, and immune system modification • Experienced management team • Targeting multiple high value inflection points expected in the next 18 - 24 months Nasdaq: TIVC

Nasdaq: TIVC | www.tivichealth.com Slide # 2 Safe Harbor This presentation contains forward - looking statements . All statements other than statements of historical facts contained in this presentation may be forward - looking statements . Statements regarding our future results of operations and financial position, economic performance, business strategy and plans and objectives of management for future operations, including, among others, statements regarding our expected growth, acquisition strategies, investments, and future capital expenditures are all forward looking statements . Without limiting the generality of the foregoing, words such as “may,” “will,” “should,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate,” “target,” “project,” “might,” “plan,” “predict” or “continue” or the negative or other variations thereof or comparable terminology are intended to identify forward - looking statements . We caution you that any such forward - looking statements are not guarantees of future performance, and are subject to risks, assumptions and uncertainties that are difficult to predict and beyond our ability and control . Although we believe that the expectations reflected in these forward - looking statements are reasonable as of the date made, actual results may prove to be materially different from the results expressed or implied by the forward - looking statements . Any differences could be caused by a number of factors, including but not limited to : the future development of our products and product candidates ; our plans to seek, and ability to obtain, regulatory approval for our product candidates ; timing and progress of clinical development of our product candidates ; our ability to commercialize products arising out of our programs ; our future development of Entolimod and Entolasta ; changes to our business strategy ; our ability to successfully generate revenue opportunities via our CDMO subsidiary ; the potential opportunities that may be available to us and our product candidates in the future ; our anticipated needs for working capital ; our ability to secure additional financing ; regulatory or legal developments in the United States and other countries ; and market and other conditions ; macroeconomic factors, including tariffs and economic uncertainty arising from geopolitical tensions . Many of the important factors that will determine these results are beyond our ability to control or predict . Accordingly, you should not place undue reliance on any such forward - looking statements . Any forward - looking statement speaks only as of the date on which it is made, and, except as otherwise required by law, we do not undertake any obligation to publicly update or review any forward - looking statement, whether as a result of new information, future developments or otherwise . We cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward - looking statements . In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject . These statements are based upon information available to us as of the date made, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information . These statements are inherently uncertain, and you are cautioned not to place undue reliance upon these statements . Unless otherwise indicated, information contained in this presentation concerning our industry, competitive position and the markets in which we operate is based on information from independent industry and research organizations, other third - party sources, as well as data from our internal research, and are based on assumptions made by us upon reviewing such data, and our experience in, and knowledge of, such industry and markets, which we believe to be reasonable . In addition, projections, assumptions and estimates of the future performance of the industry in which we operate, and our future performance are necessarily subject to uncertainty and risk due to a variety of factors, which could cause results to differ materially from those expressed in the estimates made by the independent parties and by us . This presentation shall not constitute an offer to sell or the solicitation of an offer to buy our securities .

Nasdaq: TIVC | www.tivichealth.com Experienced Management Team Company Facts Late - stage biologics Founded: 2016 IPO: 2021 Pivot: 2025 ~50 Employees Integrated manufacturing Nasdaq: TIVC

Nasdaq: TIVC | www.tivichealth.com TLR5 Agonist Portfolio • Tivic secured worldwide exclusive rights in 2025 • Two recombinant proteins counteract radiation effects • Entolimod for acute syndromes – Late Phase III • Entolasta for chronic syndromes – Pre - clinical • $140M of prior investment, 40+ human and animal studies, 60+ patents and patents pending • US Government Agencies funded development; Now they are the lead customer opportunities • BARDA TechWatch Meeting on Jan 26 • Lucrative adjacent opportunities in oncology Slide # 4 Oncology Medical Counter Measure Acute Neutropenia Thrombocytopenia Immunosenescense Phase IIB - ready General Mucositis Phase I Acute Radiation Syndrome - Hemopoietic Acute Radiation Syndrome - Gastrointestinal Phase III Entolimod Chronic Neutropenia Chronic Immunosenescense Discovery Phase Chronic Radiation Syndrome Pre - clinical Entolasta

Nasdaq: TIVC | www.tivichealth.com January 2026 Clinical Pipeline Slide # 5 Commercial Phase III Phase II IIA IIB Phase I Pre - clinical Discovery Acute Radiation Syndrome MCM Entolimod Acute Neutropenia Oncology Thrombocytopenia Immunosenescense General Mucositis Adjunct to Cellular Therapies Chronic Radiation Syndrome MCM Entolasta Active Potential Topics for Investigator - led studies Prior work /patents pending

The Radiation Issue Ionizing radiation destroys fast - growing cells

Nasdaq: TIVC | www.tivichealth.com Slide # 7 40+ Studies = Well Characterized Mechanism of Action Hemopoietic Damage GI Tract Damage • Platelet & Neutrophil Stimulator • GI and Hemopoetic Protective & Regenerative Properties • Rapid Onset of Action • Excellent Safety Profile • No Dose - Limiting Toxicities

Nasdaq: TIVC | www.tivichealth.com Slide # 8 $9.4B+ Existing Market, under attack from biosimilars GI Tract Damage GI Tract Damage Hemopoietic Damage Current SOC New Class: TLR5 (Entolimod) Current SOC: G - CSF drugs Hemopoietic & GI Tract Hemopoietic Only Mitigates, Protects, Regenerates Mitigation Only Trials conducted with no supportive care Supportive care required 1 Global Market for G - CSF and biosimilars 1 : Direct opportunity for TLR5 Agonist $9.46 2 billion in 2024 $21.3 billion by 2032 10.7% CAGR 2024 to 2032 1. Supportive Care may include blood transfusion, bone marrow transplants, antibiotics, anti - emetic drugs 2. https://www.databridgemarketresearch.com/reports/global - colony - stimulating - factors - market

Nasdaq: TIVC | www.tivichealth.com Slide # 9 Entolimod could renew market leadership Hemopoietic Damage GI Tract Damage New Class: TLR5 (Entolimod) Current SOC: G - CSF drugs Hemopoietic & GI Tract Hemopoietic Only Mitigates, Protects, Regenerates Mitigation Only Trials conducted with no supportive care Supportive care required* Global Market for G - CSF and biosimilars 1 : Direct opportunity for TLR5 Agonist $9.46 2 billion in 2024 $21.3 billion by 2032 10.7% CAGR 2024 to 2032 1. Supportive Care may include blood transfusion, bone marrow transplants, antibiotics, anti - emetic drugs 2. https://www.databridgemarketresearch.com/reports/global - colony - stimulating - factors - market

Nasdaq: TIVC | www.tivichealth.com Slide # 10 10 Highly Differentiated Results

Nasdaq: TIVC | www.tivichealth.com Slide # 11 Competitive Landscape Leukine Nplate Neulasta Neupogen Entolimod ✓ ✓ ✓ ✓ ✓ Therapeutic - - - - ✓ Prophylactic - - - - ✓ Regenerative ✓ - ✓ ✓ ✓ Hemopoietic: Neutrophils - ✓ - - ✓ Hemopoietic: Platelets - - - - ✓ Gastrointestinal Repair Neupogen, Neulasta, Nplate and Leukine are the trademarks of their respective owners.

Nasdaq: TIVC | www.tivichealth.com Complete Engineering Scale - up Tests Commercialization Milestones Ahead for ARS Supports all other product candidates Scale - up manufacturing tests First cGMP Production Lot (<6 months) * Milestones are based on standard regulatory processes for biologic drugs. Timelines are intrinsically uncertain and Tivic’s actual timeline may vary. All milestones should be considered forward - looking statements. Stability and Other Testing (1 year) Cell line verification Sept 2025 Biologic License Application Filed w/Fast Track & Orphan Drug Designation BLA Granted Enables Stockpile Orders (~6 - 9 months )

Nasdaq: TIVC | www.tivichealth.com From ARS to Oncology • Engagements in progress with US Agencies • Demonstrated unique therapeutic value • 3x increase in survival rate for ARS • Secured production capacity • International stockpile opportunities Slide # 13 Acute Radiation Syndrome

Nasdaq: TIVC | www.tivichealth.com From ARS to Oncology: the Billion Dollar Move Entolimod is a first - in - class host - protection platform • Clinical work in ARS offers strong foundation in oncology Based on mechanism of action, Entolimod could: • Reduce severe treatment - limiting toxicities • Preserve delivery of high - value oncology therapies • Create multiple, compounding revenue streams Slide # 14 Acute Radiation Syndrome Oncology

Nasdaq: TIVC | www.tivichealth.com The problem • Radiation toxicity remains the primary limiter in cancer treatment • Severe radiation side effects drive • Hospitalizations • Treatment interruptions • Compliance • Underperformance of premium therapies (e.g. cell therapies) • Radiation toxicity is under - monetized ; it’s a value leak that hurts patients, payers and pharma • Mitigating radiation damage should reduce treatment - related side effects, reduce treatment interruptions, improve compliance, and allow increased radiation dosing Slide # 15

Nasdaq: TIVC | www.tivichealth.com Entolimod as host protection • Entolimod activates protective pathways of the innate immune system • Supports: • Neutrophil, platelet and GI endothelial recovery • Bone marrow regeneration • GI crypt preservation and regeneration • Our goal is to enable patients to stay on therapy, on schedule . Entolimod is intended to protect the patient so standard and advanced cancer therapies can be delivered as intended. Slide # 16

Nasdaq: TIVC | www.tivichealth.com Recent News: Velocity Bioworks – a Tivic Subsidiary • Newly created CDMO subsidiary Slide # 17 An integrated CDMO focused on speed to clinic Guarantees Tivic access to CMC and cGMP manufacturing Accelerates time - to - market Accelerates new formulations and doses Creates potential new revenue opportunities Strategically located: San Antonio Stock Images