VBIO 8-K
Valion Bio, Inc. (VBIO)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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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:
Securities registered pursuant to Section 12(b) of the Act:
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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 7.01 Regulation FD Disclosure.
On March 31, 2023, Tivic Health Systems, Inc. (the “Company”) issued a press release regarding the Company’s financial results for its fiscal year ended December 31, 2022. A copy of that press release is furnished as Exhibit 99.1 hereto and incorporated herein by reference.
In addition, on March 31, 2023, the Compnay began using a new corporate presentation. A copy of that corporate presentation is furnished as Exhibit 99.2 hereto and incorporated herein by reference. A copy of the presentation is also available on the Company’s website located at https://tivichealth.com/investor/.
The information set forth under Item 7.01 of this Current Report, including Exhibits 99.1 and 99.2 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 Exhibits 99.1 and 99.2, 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 Exhibits 99.1 and 99.2 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 Exhibits 99.1 and 99.2 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.
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Exhibits. |
Exhibit |
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Description |
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99.1 |
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99.2 |
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104 |
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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.
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TIVIC HEALTH SYSTEMS, INC. |
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Date: |
March 31, 2023 |
By: |
/s/ Veronica Cai |
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Name: Veronica Cai |
Exhibit 99.1
Tivic Health Reports Fiscal Year 2022 Financial Results
SAN FRANCISCO – (Business Wire) – March 31, 2022 – Tivic Health® Systems, Inc. (“Tivic Health”, Nasdaq: TIVC), a commercial-phase health technology company that develops and commercializes bioelectronic medicine, today announced its financial results for the year ending December 31, 2022.
Year over Year Highlights
Jennifer Ernst, CEO of Tivic Health, commented, “We executed our 2022 strategy of increasing our direct-to-consumer sales, reducing the overall manufacturing costs of ClearUP, and seeding our product pipeline. However, supply chain shortages, market volatility and economic uncertainty left us, along with others, with challenges to overcome. With the changes we are making to improve product economics and streamline operations, as well as partnerships under development, I believe that Tivic is positioned to manage the challenges and deliver growth in 2023.”
Comparison of the Years Ended December 31, 2022 and 2021
Revenue
Cost of Sales
Research and Development Expenses
Sales and Marketing Expenses
General and Administrative Expenses
As of December 31, 2022, we had cash and cash equivalents of $3.5 million, with no debt on the balance sheet.
Conference Call: Update
Management will host a pre-recorded conference call and webcast on Friday, March 31, 2023 at 1:30 PM PT / 4:30 PM ET to discuss the Company’s year-end financial results and provide a business update.
The conference call will be available via telephone by dialing toll-free 888-506-0062 for local callers; or 973-528-0011 for international callers; using Participant Access Code: 990339 to access the call.
The conference call will also be available via Webcast link: https://www.webcaster4.com/Webcast/Page/2865/47805
An audio replay of the call will be available from the “Recent Press” page on the Tivic Health website at https://tivichealth.com/investor/.
About Tivic Health
Tivic Health Systems, Inc. is a commercial-phase health technology company delivering non-invasive bioelectronic treatments that provide consumers with a choice in the treatment of inflammation and related conditions. For more information visit https://tivichealth.com @TivicHealth.
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. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: market, economic and other conditions; supply chain constraints; macroeconomic factors, including inflation; the company’s ability to raise additional capital on favorable terms; changes in regulatory requirements; and unexpected costs, charges or expenses that reduce Tivic’s capital resources. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Tivic’s actual results to differ from those contained in the forward-looking statements, see Tivic’s filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 31, 2023, 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.
[email protected]
Tivic Health Systems, Inc.
Balance Sheets
December 31, 2022 and 2021
(in thousands, except share and per share data)
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December 31, |
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December 31, |
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ASSETS |
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Current assets |
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Cash and cash equivalents |
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$ |
3,517 |
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$ |
12,975 |
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Accounts receivable, net |
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88 |
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92 |
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Inventory, net |
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863 |
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429 |
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Deferred offering costs |
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584 |
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— |
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Prepaid expenses and other current assets |
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235 |
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793 |
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Total current assets |
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5,287 |
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14,289 |
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Property and equipment, net |
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12 |
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11 |
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Right-of-use assets, operating lease |
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523 |
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687 |
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Other assets |
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34 |
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49 |
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Total assets |
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$ |
5,856 |
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$ |
15,036 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities |
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Accounts payable |
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$ |
1,323 |
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$ |
789 |
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Other accrued expenses |
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373 |
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267 |
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Operating lease liability, current |
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163 |
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163 |
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Total current liabilities |
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1,859 |
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1,219 |
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Operating lease liability |
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367 |
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545 |
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Total liabilities |
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2,226 |
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1,764 |
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Commitments and contingencies (Note 6) |
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Stockholders’ equity |
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Preferred stock, $0.0001 par value, 10,000,000 shares authorized, no shares issued and outstanding at December 31, 2022 and 2021, respectively |
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— |
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— |
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Common stock, $0.0001 par value, 200,000,000 shares authorized; 9,677,734 and 9,715,234 shares issued and outstanding at December 31, 2022 and 2021, respectively |
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1 |
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1 |
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Additional paid in capital |
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33,271 |
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32,817 |
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Accumulated deficit |
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(29,642 |
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(19,546 |
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Total stockholders’ equity |
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3,630 |
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13,272 |
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Total liabilities and stockholders’ equity |
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$ |
5,856 |
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$ |
15,036 |
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Tivic Health Systems, Inc.
Statements of Operations
Years Ended December 31, 2022 and 2021
(in thousands, except share and per share data)
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Years Ended December 31, |
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2022 |
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2021 |
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Revenue |
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$ |
1,840 |
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$ |
1,257 |
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Cost of sales |
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1,541 |
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1,295 |
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Gross profit (loss) |
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299 |
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(38 |
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Operating expenses: |
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Research and development |
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1,730 |
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878 |
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Sales and marketing |
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2,792 |
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1,787 |
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General and administrative |
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5,875 |
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2,930 |
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Total operating expenses |
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10,397 |
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5,595 |
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Loss from operations |
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(10,098 |
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(5,633 |
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Other income (expense): |
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Interest income (expense) |
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2 |
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(1,823 |
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Change in fair value of derivative liabilities |
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— |
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436 |
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Loss on extinguishment of debt |
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— |
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(1,636 |
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Other income (expense) |
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— |
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162 |
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Total other income (expense) |
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2 |
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(2,861 |
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Net loss |
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$ |
(10,096 |
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$ |
(8,494 |
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Net loss per share - basic and diluted |
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$ |
(1.04 |
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$ |
(2.43 |
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Weighted-average number of shares - basic and diluted |
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9,672,957 |
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3,493,267 |
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NASDAQ TIVC INVESTOR PRESENTATION 2022 SEPT Make text into real text. Use vector graphic for logo. 72? Or 150? The future of medicine is electronic. NASDAQ TIVC INVESTOR PRESENTATION 2023 March
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: 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; and our efforts to expand our products and business. 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 “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. FORWARD LOOKING STATEMENTS
Investment Highlights TIVIC HEALTH Commercial-stage company in high-growth, emerging market: Bioelectronic Medicine. Built with vision to become a market leader in clinically validated, non-invasive bioelectronic therapeutics. Projected to grow at 35% CAGR.1 FDA-approved, award-winning product in market for sinus pain & congestion. $8B2 market opportunity. Strong IP. Peer-reviewed publications. Partnerships with leading medical research facilities. Extensible platform with potential applications in migraine and other indications. High safety profile, low-risk, and broad application space. Experienced management team. Strong reputation and network in bioelectronic medicine. 2 FDA Clearances + CE Mark $8BE US Addressable Market2 114% year-over-year DTC revenue growth (1) IDTechEx Bioelectronic Medicine, 2019-2029 (2) Data from publicly available information (that has not been independently verified by the company) combined with company sponsored market research study of 600 people with recurring sinus conditions (conducted by consumer research firm, Research America).
THE BIG IDEA The body is an electrochemical system. Bioelectronic medicine restores health by tuning body’s innate electrical signals. 4 Bioelectronic medicine represents a multi-billion-dollar opportunity and has the “potential to become a pillar of medical treatment.” Bioelectronics ‘jump-start the next wave of device therapeutics. – October 2019
IMPLANTS NON-INVASIVE Moving from Implants to Non-invasive BIOELECTRONICS TRAJECTORY 1960s Pacemakers 2010s Sleep Apnea 1990s Deep Brain, Spinal Cord Bioelectronics historically implanted technology. Tivic Health tunes signals non-invasively. Strong safety profiles, broader applicability, emerging as first-line therapeutics. 2020s Non-Invasive Bioelectronics $7.7B1 mkt cap private private
BIOELECTRONIC PLATFORM FOR Non-invasive Peripheral Nerve Stimulation Programmable Parameters Proprietary Algorithms Patented Form Factor produces varied biological responses for different diseases and conditions enables low-level electrical current to penetrate deeply through tissue detects optimal treatment zones, personalize therapeutic stimulation
COMMON PLATFORM, MULTIPLE OPPORTUNITIES Active Clinical Pipeline 7 NASDAQ: TIVC TIVICHEALTH.COM 600K US adults annually3 39M US adults: up to 1B globally4 * Investigational use only (1) Data from publicly available information (that has not been independently verified by the company) combined with company sponsored market research study of 600 people with recurring sinus conditions (conducted by consumer research firm, Research America). (2) Post-operative pain from Functional Endoscopic Sinus Surgery (FESS). (3) Bhattacharyya N. Ambulatory sinus and nasal surgery in the United States: demographics and perioperative outcomes. Laryngoscope. 2010 Mar (4) https://americanmigrainefoundation.org/resource-library/what-is-migraine/; Amiri P, Kazeminasab S, Nejadghaderi SA, Mohammadinasab R, Pourfathi H, Araj-Khodaei M, Sullman MJM, Kolahi AA, Safiri S. Migraine: A Review on Its History, Global Epidemiology, Risk Factors, and Comorbidities. Front Neurol. 2022 Feb 23
CLEARS CONGESTION, RELIEVES SINUS PAIN FDA-approved and CE-marked Proven in double-blind RCT @ Stanford Medical Center $169 MSRP $11.1B sinus, cold & allergy sector, dominated by pharmaceuticals1 90% of sinus sufferers want to reduce use of pharmaceuticals2 82% prefer ClearUP to current treatments3 Sinus Relief Available for purchase at: tivichealth.com Fast Acting No Drug Side Effects Clinically Proven Trigeminal Nerve Stimulation Patented Peer-Reviewed Publications ClearUP is indicated for use for temporary relief of sinus pain from allergic rhinitis (US FDA), for temporary relief of moderate to severe congestion (US FDA), and for temporary relief of sinus pain, pressure and congestion (CE Mark). (1) Data from Mintel Group Ltd. (2) Market research study of 600 people with recurring sinus conditions. Company sponsored research conducted by Research America. (3) Maul XA, Borchard NA, Hwang PH, Nayak JV. Microcurrent technology for rapid relief of sinus pain: a randomized, placebo‐controlled, double‐blinded clinical trial. Int Forum Allergy Rhinol. 2019;9:352–356. Pulsed, low-level current Guided treatment 5 minutes, 2x / day
Decongestants Antihistamines Not effective for congestion and pain Headache, sleepiness, fatigue, dry mouth, and sore throat Oral and intranasal Insomnia, nervousness, heart palpitations, headache, sweating, nausea, trembling, weakness, rebound Daily Saline Irrigation Most commonly recommended option for regular maintenance $706M US market2 Intranasal Steroids Burning, stinging, nose bleeds, headache, nausea, vomiting, diarrhea, sore throat, dizziness, cough $11.1B US Market in OTC Sinus Care Market1 MARKET LANDSCAPE (1) Data from Mintel Group Ltd. (2) USA Nasal Irrigation Devices Industry & Market Research Report 2021. Maia Research.
Dual Mechanisms of Action BASED ON SCIENCE OF NEUROMODULATION Trigeminal nerve mediates pain relief1 Sympathetic nerves induce vasoconstriction2-5 * References for footnotes 1-11 are on appendix slide 23. ClearUP has been proven effective in treating sinus and nasal inflammatory conditions. Other inflammatory conditions associated with nerve activity in the head and neck represent potential product candidates: migraines (39 million U.S., $1B est. globally) 6 pain and swelling from facial and sinus surgeries (600,000 functional endoscopic surgeries annually, U.S.)7 temporomandibular joint disorder (31 million U.S.)8 tinnitus (50 million U.S.)9 trigeminal neuralgia (150,000 U.S., rare severe condition)10 ear infections (50% of children)11 More than a sinus treatment
Maul XA, Borchard NA, Hwang PH, Nayak JV. Microcurrent technology for rapid relief of sinus pain: a randomized, placebo‐controlled, double‐blinded clinical trial. Int Forum Allergy Rhinol. 2019;9:352–356. Fast-acting Double-blind, randomized, sham-controlled trial examined acute response. Reduction in pain and congestion, 10-minutes after first use. #p = 0.007; *p = 0.008; two-tailed unpaired t-test comparing Sham vs. ClearUP RESULTS PUBLISHED IN CLINICAL: PEER-REVIEWED PUBLICATION Runner-Up Best Clinical Manuscript Effective for 74% of users 10 minutes after use Clinically meaningful reduction in pain and congestion 10 minutes after use.
Goldsobel, A.B., Prabhakar, N. & Gurfein, B.T. Prospective trial examining safety and efficacy of microcurrent stimulation for the treatment of sinus pain and congestion. Bioelectron Med 5, 18 (2019) doi:10.1186/s42234-019-0035-x #p < 0.01; *p < 0.0001; two-tailed paired t-test comparing pre-treatment vs. post-treatment Continued improvement with regular use CLINICAL: PEER-REVIEWED PUBLICATION 4-week open-label study showed continued reduction in pain and congestion with daily use; also showed durable effect, relief present at 6 hours after treatment. Continued week-over-week reduction in symptoms ▼43.3% Reduction in Pain ▼44.3% Reduction in Congestion RESULTS PUBLISHED IN Effective for 88% of users after 4 weeks of use
K182025 CE 704687 DEN200006 ISSUED PATENTS 96 issued claims 5 PATENTS PENDING 21 STRONG INTELLECTUAL PROPERTY THREE REGULATORY CLEARANCES PEER-REVIEWED PUBLICATIONS Open-label 4-week study. Published: Bioelectronic Medicine Double-blind, sham-controlled, randomized trial. Published: International Forum of Allergy & Rhinology ROBUST FOUNDATIONS
$11.1B1 Large Markets, Significant Growth Opportunity MARKET SIZE $8BE US TAM2 Allergy, Sinusitis, Cold & Flu, + OTC Sinus Care US Market (1) Data from Mintel Group Ltd. (2) Data from publicly available information (that has not been independently verified by the company) combined with company sponsored market research study of 600 people with recurring sinus conditions (conducted by consumer research firm, Research America). (3) IDTechEx Bioelectronic Medicine, 2019-2029 ClearUP is indicated for use for temporary relief of sinus pain from allergic rhinitis (US FDA), for temporary relief of moderate to severe congestion (US FDA), and for temporary relief of sinus pain, pressure and congestion (CE Mark). 35% Peripheral nerve stimulation market forecast to grow at CAGR.3
broad, existing CE Mark provides global clearance New Indications breathing ease (US) Connected Device • Subscription app • New business models In-store Distribution Sinus Pain, Pressure Congestion from any cause (US) Device w/data augmentation HCP referrals Sinus Pain from allergies (2019) Device Online Expanding The Growth Engine MARKET DEVELOPMENT Undiagnosed Migraine (usage frequency/relief, data on symptom & pharmaceutical use & health behaviors, reminders) Power Treaters Allergy Sufferers CPAP Users / Snoring First Responder & Military cannot be medicated on-duty High Performance Athletes Chronic Sinusitis Natural Remedy Users Bio Hackers • Market • Indication • Channel 45M US Adults 200M US Adults International Expansion Congestion from any cause (2021) Accessories • Product Active Outdoor Enth. 45M US adults suffer sinus pain from allergies. 200M US adults suffer moderate to severe congestion. Data from publicly available information combined with company sponsored market research study of 600 people with recurring sinus conditions.
Structured Approach to Growth MARKET DEVELOPMENT Product development FDA clearance Market introduction Build credibility & traction Harden and grow ecommerce Expand target segments Extend ClearUP product line Build healthcare professional (HCP) engagement 2016 – 2021 2022 2023-2024 2024 – 2026+ New indications for existing product platform New product platforms Controlled international market entries Clinical research to expand product pipeline New manufacturing partnerships Built core operating & commercial team
Experienced, Execution-oriented Leadership LEADERSHIP TEAM Jennifer Ernst Chief Executive Officer, MBA Founded and built Tivic Health from founding to IPO in 5 years. Took prior company (Thin Film Electronics) from 8-person R&D team to $480MM market cap in < 5 years, as CEO of US subsidiary. Blake Gurfein Chief Scientific Officer, Ph.D. Neuroscientist, Asst. Prof. of Medicine, UCSF. Pfizer, EMD Serono. Named to 40 under 40, Silicon Valley Business Journal. Four prior neuromodulation products. Veronica Cai Chief Financial Officer, CPA 25 years broad-based public and private company finance and accounting leadership for high-growth medical and life science companies. Ryan Sabia Chief Operations Officer Global sales, marketing, and operations for omnichannel and ecommerce growth companies. Background in both health and consumer products. Sanjay Ahuja SVP, Quality & Regulatory Affairs Regulatory affairs, and quality systems for medical devices, diagnostic systems, biologics, evidence-based pharma, and combination products.
Twelve Months Ended December 31 (in thousands) FY 2022 FY 2021 Revenues $ 1,840 $ 1,257 Gross Profit (Loss) 299 (38) Net loss (10,096) (8,494) Operating Results FINANCIALS 46% 2022 vs 2021 highlights Revenues increased 46% YOY Direct-to-consumer revenue increased 114% YOY Gross Margin improved ~9X(1) Product Revenue by Quarter by Channel Q1 2021 – Q4 2022 Fully Year 2022 – 2021 (1) Supply chain shortage significantly impacted our gross profit in 2022 (e.g., approximately 25% of COGS in the third quarter was attributed to purchase price variance from electronic parts). We currently do not foresee similar supply chain issue in 2023 and expect gross margin improvement from partnerships with Microart and Alom. 2021 2022
Capitalization Table FINANCIALS March 24, 2023 Common Stock 29,677,734 Options (WAEP: $2.01) 1,248,850 Warrants (WAEP: $1.18) 1,272,680 Fully Diluted Shares 32,199,264
Financial Position FINANCIALS (in thousands) December 31, 2022 Cash and Cash Equivalents $ 3,517 Total Assets 5,856 Total Liabilities 2,226 Total Stockholders’ Equity $ 3,630 Clean balance sheet No debt Raised $5M in equity financing in Feb 2023
Investor Summary HIGHLIGHTS FDA-cleared products in high-growth sector. Large available market $8B1 in US; global opportunity. 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 platform with multiple product opportunities. Systematic growth strategy built for 21st century. Experienced leadership, with public company growth experience. Jennifer Ernst CEO, Tivic Health [email protected] (1) Data from publicly available information (that has not been independently verified by the company) combined with company sponsored market research study of 600 people with recurring sinus conditions (conducted by consumer research firm, Research America).
Jennifer Ernst CEO, Tivic Health [email protected]
Dual Mechanisms of Action APPENDIX Trigeminal nerve mediates pain relief1 Sympathetic nerves induce vasoconstriction2-5 More than a sinus treatment ClearUP has been proven effective in treating sinus and nasal inflammatory conditions. Other inflammatory conditions associated with nerve activity in the head and neck represent potential product candidates: migraines (39 million U.S., $1B est. globally) 6 pain and swelling from facial and sinus surgeries (600,000 functional endoscopic surgeries annually, U.S.)7 temporomandibular joint disorder (31 million U.S.)8 tinnitus (50 million U.S.)9 trigeminal neuralgia (150,000 U.S., rare severe condition)10 ear infections (50% of children)11 * References for slide 11 footnotes: Maul, Ximena A., et al. "Microcurrent technology for rapid relief of sinus pain: a randomized, placebo‐controlled, double‐blinded clinical trial." International forum of allergy & rhinology. Vol. 9. No. 4. 2019. Mandel, Yossi, et al. "Vasoconstriction by electrical stimulation: new approach to control of non-compressible hemorrhage." Scientific reports 3.1 (2013): 1-7. Franco, O.S., et al. “Effects of different frequencies of transcutaneous electrical nerve stimulation on venous vascular reactivity.” Brazilian Journal of Medical and Biological Research 47.5 (2014): 411-418. Malm, L. “Stimulation of sympathetic nerve fibres to the nose in cats.” Acta otolaryngologica 75.2-6 (1973); 519-526. Fischer, Laurent, et al. “Adrenergic and non-adrenergic vasoconstrictor mechanisms in the human nasal mucosa.” Rhinology 31.1 (1993): 11-15. https://americanmigrainefoundation.org/resource-library/what-is-migraine/; Amiri P, Kazeminasab S, Nejadghaderi SA, Mohammadinasab R, Pourfathi H, Araj-Khodaei M, Sullman MJM, Kolahi AA, Safiri S. Migraine: A Review on Its History, Global Epidemiology, Risk Factors, and Comorbidities. Front Neurol. 2022 Feb 23 Bhattacharyya N. Ambulatory sinus and nasal surgery in the United States: demographics and perioperative outcomes. Laryngoscope. 2010 Mar https://tmj.org/living-with-tmj/basics/ https://my.clevelandclinic.org/health/diseases/14164-tinnitus https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Trigeminal-Neuralgia https://jamanetwork.com/journals/jamapediatrics/fullarticle/2759422
