8-K
Valion Bio, Inc. (VBIO)
UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, 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): March 25, 2024 |
|---|
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 File Number) | (IRS Employer<br>Identification No.) |
| 25821 Industrial Blvd.,<br><br>Suite 100 | ||
| Hayward, California | 94545 | |
| (Address of Principal Executive Offices) | (Zip Code) | |
| Registrant’s Telephone Number, Including Area Code: 888 276-6888 | ||
| --- |
(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)
☐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 | Trading<br>Symbol(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 2.02 Results of Operations and Financial Condition.
The information provided below in “Item 7.01 - Regulation FD Disclosure” of this Current Report is incorporated by reference into this Item 2.02.
Item 7.01 Regulation FD Disclosure.
On March 25, 2024, Tivic Health Systems, Inc. (the "Company") issued a press release regarding the Company’s financial results for its fiscal year ended December 31, 2023. A copy of that press release is furnished as Exhibit 99.1 hereto and incorporated herein by reference.
The information set forth under Item 7.01 of this Current Report on Form 8-K (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 | Press Release, dated March 25, 2024. |
| 104 | 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.
| TIVIC HEALTH SYSTEMS, INC. | |||
|---|---|---|---|
| Date: | March 25, 2024 | By: | /s/ Jennifer Ernst |
| Name: Jennifer Ernst<br>Title: Chief Executive Officer |
EX-99.1
Exhibit 99.1
Tivic Reports Fiscal Year 2023 Financial Results
SAN FRANCISCO – (Business Wire) – March 25, 2024 – Tivic Health® Systems, Inc. (“Tivic”, Nasdaq: TIVC), a health tech company that develops and commercializes bioelectronic medicine, today announced its financial results for the year ending December 31, 2023.
Tivic’s commercial platform is a handheld design that interfaces non-invasively with the trigeminal, sympathetic, and other facial and cranial nerve structures. This platform is the basis for Tivic’s existing product, currently marketed with FDA approval as ClearUP Sinus Pain Relief, for the treatment of sinus pain and congestion. In 2023, the company also began investment in a new platform for vagus nerve stimulation. Study enrollment for the pilot clinical study of a proprietary approach to non-invasive vagus nerve stimulation (VNS) was completed on in February 2024. Results of the study have not yet been announced.
“2023 was a year for both streamlining our commercial business and defining new opportunities for value creation,” stated Jennifer Ernst, CEO of Tivic. "We have taken substantial steps towards improving the company’s financial health by implementing a new pricing structure on our commercial product, reducing costs of goods, improving marketing efficiency, and decreasing headcount to align with current revenue. We opened new channels directed to less price-sensitive healthcare segments. And, we strategically invested in clinical programs to create new paths for value creation for our shareholders, including a program in vagus nerve stimulation and one targeted to opiate-use reduction following sinus and facial surgeries."
As a result, the company was named to Fast Company’s prestigious annual list of the World’s Most Innovative Companies for 2023 in the Medical Device category and Global Health & Pharma (GHP) named Tivic Health the Most Pioneering Bioelectronic Medicine Company.
2023 Financial Performance
• Revenue (net of returns) for 2023 was $1.2M compared to $1.8M for the year ended December 31, 2022. The decrease of $664 thousand, or 36%, was due to a 52% decrease in ClearUP unit sales, offset by 46% higher average selling price per unit. Greater than 90% of sales were direct to consumer in 2023.
• Cost of sales was $889 thousand in 2023 compared to $1.5M for the year ended December 31, 2022, a decrease of $652 thousand, or 42%. The decrease was due to the 52% decrease in overall unit sales, offset by $172 thousand of costs related to write-offs or reserves on old inventory and components primarily related to our ClearUP 1.0 units as our ClearUP 2.0 units began shipping in December of 2023. We do not expect to incur similar costs in 2024.
• Gross profit for the year ended December 31, 2023 was $330 thousand compared to a gross profit of $299 thousand for the year ended December 31, 2022.
• Research and development expenses were approximately $1.7M for each of the years ended December 31, 2023 and December 31, 2022. The emphasis of research and development activities in 2023 was primarily related to our work with The Feinstein Institutes.
• Sales and marketing expenses decreased to $2.1M for the year ended December 31, 2023, compared to $2.8M for the year ended December 31, 2022. The decrease was primarily due to reduction of advertising and agency costs.
• General and administrative expenses decreased to $4.8M in 2023, compared to $5.9M for the year ended December 31, 2022. The decrease is primarily due to a reduction in legal and professional fees and other corporate expenses as the company worked to reduce overhead costs.
• As a result, our 2023 full year net loss was $8.2M, compared to $10.1M in 2022.
Regarding 2023 financing activities, on February 13, 2023, we sold shares of common stock to investors in a registered public offering, resulting in net proceeds of approximately $3.6M. From July 11, 2023 to August 9, 2023, we sold shares of common stock to investors in a series of registered public offerings, resulting in aggregate net proceeds to the company of approximately $4.3M.
On August 23, 2023, we implemented a 1-for-100 reverse stock split, and on September 15, 2023, we received confirmation from NASDAQ that we had regained compliance with the minimum bid price continued listing requirement.
As of December 31, 2023, the company had $3.4 million of cash and cash equivalents and we continued to maintain a no debt balance sheet.
The company’s MD&A and consolidated financial statements for the year-ended December 31, 2023 will be filed with the Securities and Exchange Commission on March 25, 2024 with the company’s Annual Report on Form 10-K. The company's previous public filings may be found on www.sec.gov and can also be located on Tivic’s website at: https://tivichealth.com/investor/#SEC.
Conference Call and Webcast Information
Management will host a webcast/conference call on Monday, March 25, 2024, at 1:30 PM PT / 4:30 PM ET to discuss the company’s year-end 2023 financial results and provide a business update, including comments on research directions undertaken in 2023.
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 and using entry code 434944.
The conference call will also be available via Webcast link: https://www.webcaster4.com/Webcast/Page/2865/50026
An audio replay of the call will be available from the “Investor” page on the Tivic Health website at https://tivichealth.com/investor/.
About Tivic
Tivic is a commercial health tech company advancing the field of bioelectronic medicine. Tivic’s patented technology platform leverages stimulation on the trigeminal, sympathetic, and vagus nerve structures. Tivic’s non-invasive and targeted approach to the treatment of inflammatory chronic health conditions gives consumers and providers drug-free therapeutic solutions with high safety profiles, low risk, and broad applications. Tivic’s first commercial product, ClearUP, is an FDA approved, award-winning, handheld bioelectronic sinus device. ClearUP is clinically proven, doctor-recommended, and is available through online retailers and commercial distributors. For more information, visit http://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 financial condition; the company’s ability to raise additional capital on favorable terms if and when necessary; 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, 2023, to be filed with the SEC on March 25, 2024, under the heading “Risk Factors,” as well as the company’s subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and Tivic Health Systems, Inc. undertakes no duty to update such information except as required by applicable law.
Investor Contact: Hanover International, Inc. ir@tivichealth.com
Tivic Health Systems, Inc.
Condensed Balance Sheets
(in thousands, except share and per share data)
| December 31, 2023 | December 31, 2022 | |||||
|---|---|---|---|---|---|---|
| ASSETS | ||||||
| Cash and cash equivalents | $ | 3,395 | $ | 3,517 | ||
| Other current assets | 1,257 | 1,789 | ||||
| TOTAL CURRENT ASSETS | 4,652 | 5,306 | ||||
| PROPERTY AND EQUIPMENT, NET | 122 | 12 | ||||
| NONCURRENT ASSETS | 383 | 557 | ||||
| TOTAL ASSETS | $ | 5,157 | $ | 5,875 | ||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||
| Accounts payable and accrued expenses | $ | 1,208 | $ | 1,715 | ||
| Other current liabilities | 193 | 163 | ||||
| TOTAL CURRENT LIABILITIES | 1,401 | 1,878 | ||||
| TOTAL LONG-TERM LIABILITIES | 176 | 367 | ||||
| STOCKHOLDERS' EQUITY | ||||||
| Common stock | — | — | ||||
| Additional paid in capital | 41,466 | 33,272 | ||||
| Accumulated deficit | (37,886 | ) | (29,642 | ) | ||
| TOTAL STOCKHOLDERS' EQUITY | 3,580 | 3,630 | ||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 5,157 | $ | 5,875 |
Tivic Health Systems, Inc.
Condensed Statements of Operations
(in thousands, except share and per share data)
| Year Ended December 31, | ||||||
|---|---|---|---|---|---|---|
| 2023 | 2022 | |||||
| REVENUES | $ | 1,176 | $ | 1,840 | ||
| COST OF SALES | 889 | 1,541 | ||||
| GROSS PROFIT | 287 | 299 | ||||
| OPERATING EXPENSES | ||||||
| Research and development | 1,655 | 1,730 | ||||
| Sales and marketing | 2,125 | 2,792 | ||||
| General and administrative | 4,752 | 5,875 | ||||
| TOTAL OPERATING EXPENSES | 8,532 | 10,397 | ||||
| NET OPERATING LOSS | (8,245 | ) | (10,098 | ) | ||
| NET LOSS | $ | (8,244 | ) | $ | (10,096 | ) |
| NET LOSS PER SHARE - BASIC AND DILUTED | $ | (10.40 | ) | $ | (104.32 | ) |
| WEIGHTED-AVERAGE NUMBER OF SHARES - BASIC AND DILUTED | 793,043 | 96,778 |