8-K

Valion Bio, Inc. (VBIO)

8-K 2022-10-26 For: 2022-10-26
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Added on April 10, 2026

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): October 26, 2022

TIVIC HEALTH SYSTEMS, INC.

(Exact name of registrant as specified in its charter)

Delaware 001-41052 81-4016391
(State or other jurisdiction<br>of incorporation) (Commission<br>File Number) (IRS Employer<br>Identification No.)
25821 Industrial Blvd., Suite 100
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Hayward, CA 94545
(Address of principal executive offices, including zip code)

Registrant’s telephone number, including area code: (888) 276-6888

N/A

(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)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:

Title of each class Trading<br> <br>symbol(s) Name of each exchange<br>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 October 26, 2022, Tivic Health Systems, Inc., a Delaware corporation (the “Company”), will participate in the ThinkEquity Conference. The Company’s Chief Executive Officer is scheduled to present at the ThinkEquity Conference at 4:00 pm Eastern Time. A copy of the investor conference presentation is attached to this Current Report on Form 8-K (this “Current Report”) as Exhibit 99.1. The presentation has also been posted to the Company’s website in the “Investors” section.

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, 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<br>No. Description
99.1 Think Equity Investor Conference Presentation, dated October 26, 2022.
104 Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURE

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.

Dated: October 26, 2022

TIVIC HEALTH SYSTEMS, INC.
By: /s/ Veronica Cai
Name: Veronica Cai
Title: Chief Financial Officer

EX-99.1

Exhibit 99.1 Make text into real text. Use vector graphic for logo. 72? Or 150? The future of medicine is electronic. N A S D A Q I N V E S T O R P R E S E N T A T I O N N A S D A Q I N V E S T O R P R E S E N T A T I O N T I V C 2 0 2 2 S E P T T I V C 2 0 2 2 O C T O B E R

F O R W A R D L O O K I N G S T A T E M E N T S This presentationcontains forward-looking statements. All statements other than statements of historical facts contained inthis presentationmay be forward-looking statements. Statementsregarding 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 andcontrol.Although we believethat theexpectations reflected inthese forward-looking statements arereasonable as of the datemade, 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: our anticipated needs for working capital; our ability to secure additional financing; regulatory or legal developments in the United States and other countries; our expectation regarding timing, costs, conduct and development of our product candidates; supply chain constraints; our efforts to expand our products and business; and Tivic is not able to complete the contemplated Reliefband acquisition, and even if the transaction gets completed, that the expected benefits of the transaction are not achieved. 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. New factors emerge from time to time, and it is not possible for us to predict which will arise. 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“webelieve” 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 necessarilysubjecttouncertaintyand riskduetoa varietyof factors,whichcould cause resultstodiffermateriallyfromthoseexpressedin theestimatesmadeby theindependentpartiesand by us. This presentationshall notconstitutean offertosell or thesolicitationofan offer tobuyoursecurities. T I V I C H E A L T H . C O M 2 NASDAQ: TIVC

T H E B I G I D E A The body is an electrochemical system. Bioelectronic medicine restores health by tuning body’s electrical signals. Bioelectronic medicine has the “potential to become a pillar of medical treatment.” Bioelectronics ‘jump-start the next wave of device therapeutics. October 2019 3

B I O E L E C T R O N I C S T R A J E C T O R Y Moving from Implants to Non-invasive IMPLANTS NON-INVASIVE 1960s 1990s 2010s 2020s Pacemakers Deep Brain, Sleep Apnea Non-Invasive Spinal Cord Bioelectronics • Bioelectronics historically required implanted technology. • Tivic Health has delivered ways to tune neural signals non-invasively. • Lower risk, shorter development time, broader applicability T I V I C H E A L T H . C O M 4 NASDAQ: TIVC

C L E A R S C O N G E S T I O N , S T O P S P A I N 99 $ 169 • Pulsed current flows from tip through sinuses MSRP • 5 minutes, 2x per day Sinus Relief R&D PRODUCT PIPELINE T I V I C H E A L T H . C O M 5 NASDAQ: TIVC

H A N D H E L D P L A T F O R M FOR Non-invasive Peripheral Nerve Stimulation Proprietary Programmable Patented Algorithms Parameters Form Factor % Peripheral nerve stimulation market forecast to grow at CAGR. 35 ~ IDTechEx. Bioelectronic Medicine 2019-2029. T I V I C H E A L T H . C O M 6 NASDAQ: TIVC

F R O M I P O N O V E M B E R 2 0 2 1 2022: A Year of Upwards Momentum Post-operative Pain • Clinical program in progress Migraine • Commercial evaluation complete • Clinical program in development M&A / Licensing • Reliefband acquisition agreement signed T I V I C H E A L T H . C O M 7 NASDAQ: TIVC Q 2 . 2 0 2 2 v s . Q 2 . 2 0 2 1 Increase Revenue Increase Margin Build the Pipeline

Expanding Our On October 7, 2022, Tivic entered a definitive agreement for the purchase of the Reliefband product line for the treatment of nausea and retching. Product Offerings 99 99 99 99 $ $ $ $ 279 239 139 99 MSRP MSRP MSRP MSRP Similar version sold Rx as Reletex P R O D U C T L I N E T I V I C H E A L T H . C O M 8 NASDAQ: TIVC

F O U N D A T I O N S Both Rooted in Strong Foundations Sinus Pain, Pressure, Congestion Nausea and Vomiting Products in Market 1 OTC 4 OTC & 1 Rx FDA & CE Mark Indications 3 7 Issued Patents 5 5 Patents Pending 18 1 Registered Trademarks 9 13 Peer-Reviewed Publications 2 40 Reimbursed - YES T I V I C H E A L T H . C O M 9 NASDAQ: TIVC

T R I E D & T R U E A P P R O A C H Parallel and Complementary Sales Channels direct-to-consumer . . company website . . . . . . .com . . . . T I V I C H E A L T H . C O M 10 NASDAQ: TIVC

B A S E D O N N E U R O M O D U L A T I O N S C I E N C E Similar Mechanisms of Action Trigeminal nerve mediates Median nerve pain relief disrupts nausea signals in brain stem Sympathetic nerve induces vasoconstriction Vagus nerve restores normal gastric functioning and prevents vomiting T I V I C H E A L T H . C O M 11 NASDAQ: TIVC

T I V I C H E A L T H . C O M T I V I C H E A L T H . C O M 12 NASDAQ: TNIASVDC AQ: TIVC

T I V I C H E A L T H . C O M 13 NASDAQ: TIVC

C L E A R U P & R E L I E F B A N D * unaudited Sales Revenue History $10.0 $20.0 $9.0 $18.0 $8.0 $16.0 14.3 $ 11.1B $7.0 $14.0 US Segment Over-the-counter $6.0 $12.0 Sinus Care $ $5.0 $10.0 2.4B US Segment 7.5 $4.0 $8.0 Over-the-counter Nausea Care $3.0 $6.0 4.3 $2.0 $4.0 1.3 2.5 1.8 1.8 0.9 $1.0 $2.0 0.4 - -

  • $- $- 2016* 2017* 2018* 2019 2020 2021 2022 2016* 2017* 2018* 2019* 2020 2021 2022 T I V I C H E A L T H . C O M 14 NASDAQ: TIVC Millions Millions

M A R K E T D E V E L O P M E N T Structured Approach to Growth 2016 – 2019 2020 – 2021 2022 2023 2024 – 2026 New indications Reliefband Product Build credibility Harden integration development and grow New product platforms ecommerce FDA clearance Healthcare Staged international practitioner market entries (HCP) Market engagement introduction Target customers expect to purchase online T I V I C H E A L T H . C O M 15 NASDAQ: TIVC

F I N A N C I A L S Tivic Operations Results Twelve Months Six Months High growth momentum in Ended December 31 Ended June 30 revenue FY 2021 FY 2020 Interim 2022 Interim 2021 (in thousands) • 36% YOY revenue growth in FY 2021 Revenues $ 1,166 $ 860 $ 956 $ 591 • 62% YOY revenue growth in Q2 2022 Gross Profit (Loss) (129) (225) 196 (11) Increasing revenue while lowering cost of goods sold Operating Profit (Loss) (5,632) (3,204) (5,258) (2,112) • Significantly invested in DTC channels, improved ASP TTM Income Twelve Months Interim 1.7 • Exited low margin reseller channels 1.2 2020 – 2022 2020 – 2021 2021 – 2022 • Rolled out manufacturing and (in millions) 1.5 6 months end June 30 (in millions) 0.96 (in millions) distribution optimization program 0.86 1.3 and reduced cost of product (this efficiency was reduced by global 1.1 0.59 supply chain constraints in 2021/2022) 0.9 • Achieved positive gross profit in Q1 2022 0.7 0.5 Q1.20 Q2.22 FY 2020 FY 2021 1H 2021 1H 2022 T I V I C H E A L T H . C O M 16 NASDAQ: TIVC

F I N A N C I A L S Tivic Financial Position (in thousands) June 30, 2022 Cash and Cash Equivalents $ 9,049 Total Assets 11,026 Total Liabilities 2,839 Total Stockholders’ Equity $ 11,026 • Simple balance sheet • No debt T I V I C H E A L T H . C O M 17 NASDAQ: TIVC

F I N A N C I A L S Cap Table October 5, 2022 Common Stock 9,679,295 Options (WAEP: $2.00) 1,268,850 Warrants (WAEP: $4.34) 272,680 Fully Diluted Shares 11,220,825 • Single class of shares T I V I C H E A L T H . C O M 18 NASDAQ: TIVC

L E A D E R S H I P T E A M Experienced, Execution-oriented Leadership Veronica Cai Blake Gurfein Ryan Sabia Sanjay Ahuja Jennifer Ernst Chief Financial Officer, Chief Scientific Officer, Chief Operations Officer SVP, Quality & Chief Executive Officer, MBA CPA Ph.D. Regulatory Affairs Global sales, marketing, and Founded and built Tivic Health from operations for omnichannel 25 years broad-based public Neuroscientist, Asst. Prof. of Regulatory affairs, and and ecommerce growth founding to IPO in 5 years. Took prior and private company finance Medicine, UCSF. Pfizer, EMD quality systems for companies. Background in and accounting leadership Serono. Named to 40 under company (Thin Film Electronics) medical devices, both health and consumer for high-growth medical and 40, Silicon Valley Business diagnostic systems, from 8-person R&D team to $480MM products. life science companies. Journal. Four prior biologics, evidence-based market cap in < 5 years, as CEO of neuromodulation products. pharma, and combination US subsidiary. products. T I V I C H E A L T H . C O M 19 NASDAQ: TIVC

H I G H L I G H T S Investor Summary FDA-cleared products in high-growth sector. Large available markets - $13.5B combined US markets. Established Tier 1 channels growing. Regulatory clearances for both US and international sales. Robust IP portfolio, recently issued patents. Clinical validation with leading institutions, peer-reviewed publications. Extensible platforms with multiple product opportunities. J e n n i f e r E r n s t st Growth strategy built for 21 century. CEO, Tivic Health Experienced leadership, with public company growth experience. ir@tivichealth.com T I V I C H E A L T H . C O M 20 NASDAQ: TIVC

Jennifer Ernst CEO, Tivic Health i r @ t i v i c h e a l t h . c o m T I V I C H E A L T H . C O M NASDAQ: TIVC

APPENDIX S I M I L A R M E C H A N I S M S O F A C T I O N 1. Maul, Ximena A., et al. Microcurrent 1. Guo ZL, Malik S. Acupuncture activates a technology for rapid relief of sinus pain: a direct pathway from the nucleus tractus randomized, placebo‐controlled, solitarii to the rostral ventrolateral medulla. double‐blinded clinical trial. International Brain Res. 2019 Apr 1;1708:69-77. doi: forum of allergy & rhinology. Vol. 9. No. 4. 10.1016/j.brainres.2018.12.009. 2019. 2. Malik, S., Samaniego, T., & Guo, Z. L. (2019). 2. Mandel, Yossi, et al. Vasoconstriction by Adenosine receptor A2a, but not A1 in the electrical stimulation: new approach to rVLM participates along with opioids in control of non-compressible acupuncture-mediated inhibition of excitatory hemorrhage. Scientific reports 3.1 (2013): cardiovascular reflexes. Frontiers in 1-7. Neuroscience, 1049. 3. Franco, O.S., et al. “Effects of different 3. Zhang, C., Vincelette, L. K., Reimann, F., & frequencies of transcutaneous electrical Liberles, S. D. (2022). A brainstem circuit for nerve stimulation on venous vascular nausea suppression. Cell reports, 39(11), reactivity.” Brazilian Journal of Medical and 110953. Biological Research 47.5 (2014): 411-418. 4. Napadow V, Sheehan JD, Kim J, et al. The 4. Malm, L. “Stimulation of sympathetic nerve Brain Circuitry Underlying the Temporal fibres to the nose in cats.” Acta Evolution of Nausea in Humans. Cereb otolaryngologica 75.2-6 (1973); 519-526. Cortex 2013; 23: 806-13. 5. Fischer, Laurent, et al. “Adrenergic and non- adrenergic vasoconstrictor mechanisms in the human nasal mucosa.” Rhinology 31.1 (1993): 11-15. T I V I C H E A L T H . C O M 22 NASDAQ: TIVC