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
Date of Report (Date of earliest event reported): |
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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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Trading |
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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 5.07 Submission of Matters to a Vote of Security Holders.
On August 11, 2023, Tivic Health Systems, Inc. (the “Company”) held a Special Meeting of Stockholders (the “Special Meeting”) in a virtual format. At the close of business on July 11, 2023, the record date for the Special Meeting, there were 62,177,734 shares of Company common stock issued and outstanding, which constituted all of the issued and outstanding capital stock of the Company as of the record date. At the Special Meeting, 36,286,719 of the Company’s 62,177,734 outstanding shares of common stock entitled to vote as of the record date, or approximately 58.4%, were represented by proxy or in person (virtually), and, therefore, a quorum was present.
The proposals voted on at the Special Meeting are more fully described in the Definitive Proxy Statement on Schedule 14A filed by the Company with the Securities and Exchange Commission (the “Commission”) on July 24, 2023, and those Definitive Additional Materials filed by the Company with the Commission on July 28, 2023, which information is incorporated herein by reference.
The final voting results on the proposals presented for stockholder approval at the Special Meeting were as follows:
Proposal No. 1: The Company’s stockholders approved the Company’s proposal to authorize the Company to amend its amended and restated certification of incorporation to effect, at the discretion of its board of directors (the “Board”), a reverse stock split of all of the Company’s issued and outstanding shares of common stock at a ratio of not less than 1-for-5 and not greater than 1-for-100, such ratio to be determined by its Board at any time within twelve months, without further approval or authorization of its stockholders. The final voting results as follows:
Votes For |
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Votes Against |
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Abstentions |
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Broker Non-Votes |
32,939,351 |
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797,381 |
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2,550,259 |
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0 |
Proposal No. 2: The Company’s stockholders approved the Company’s proposal to authorize the Board, in its discretion, to adjourn the Special Meeting to another place, or a later date or dates, if necessary or appropriate, to solicit additional proxies in favor of Proposal No. 1 at the time of the Special Meeting. The final voting results as follows:
Votes For |
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Votes Against |
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Abstentions |
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Broker Non-Votes |
32,903,493 |
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723,184 |
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2,660,314 |
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0 |
Item 7.01 Regulation FD Disclosure.
On August 14, 2023, Tivic Health Systems, Inc. (the “Company”) issued a press release regarding the Company’s financial results for its second quarter ended June 30, 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, 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.
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Exhibits. |
Exhibit |
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Description |
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99.1 |
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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: |
August 14, 2023 |
By: |
/s/ Jennifer Ernst |
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Name: Jennifer Ernst |
Exhibit 99.1
Tivic Reports Second Quarter 2023 Financial Results
SAN FRANCISCO – (Business Wire) – August 14, 2023 – Tivic Health® Systems, Inc. (“Tivic”, Nasdaq: TIVC), a health tech company that develops and commercializes bioelectronic medicine, announced its financial results for the second quarter 2023 ended June 30, 2023 (“Q2 2023”).
Second Quarter 2023 Financial Summary
Second Quarter 2023 Business Highlights
Recent Developments
Management Commentary
“This quarter was, in many ways, a reset for the company. Q2 included tough decisions necessary to move the company forward. As I discussed in a Letter to Shareholders a few weeks ago, we faced compliance issues with our Nasdaq listing, which we believe are now on the verge of being resolved following a positive shareholder vote. In addition, we brought $4.8M of new capital into the company.
"Internally we downsized the team, reduced operating overhead, and narrowed our focus to critical strategic areas. We are working with a strong marketing leader, Elizabeth Jackson, and an interim CFO, Kim Bambach -- both of whom have successfully developed and executed transformational business strategies to drive growth and enhance operating performance.
"Several of those decisions had a significant short-term impact on revenue this quarter. The pricing increase, while making product sales more profitable, negatively impacted near-term sales. Additionally, we held back on marketing spend where it was unproductive as we retooled the marketing strategy. We began to refine the market to address segments having highest likelihood of purchase and willingness to pay, as well as develop the tools needed to address new healthcare-oriented sales channels, such as the recently announced Cardinal Health agreement.
"We were to begin the active phase of our collaboration at Feinstein Institutes for Medical Research on a pilot study using a new neurostimulation approach, one expected to enable a more precise targeting of vagus nerve activity for treatment of neurologic, cardiac and auto-immune responses."
Ernst concluded, "This quarter was all about ensuring cost cutting measures were implemented, processes were streamlined, and market and sales targets were realigned. These decisions, while difficult on a quarterly basis, are essential to strengthening company performance and we expect to see growth and improved performance in the second half of 2023.”
Second Quarter 2022 Financial Review
Net revenue for the second quarter 2023 was $161 thousand, a decrease of $367 thousand (or 70%) compared to $528 thousand in the same period 2022, primarily due to significant reductions in marketing expense resulting in a unit sales decline of 82% offset by a 69% increase in the average price point per unit.
Cost of sales for the second quarter 2023 was $100 thousand, a decrease of $304 thousand (or 75%) compared to $405 thousand in the same period 2022. The period over period decrease was primarily due to the decrease sales.
Gross profit for the second quarter 2023 was $61 thousand, a decrease of $64 thousand (or 51%) compared to $125 thousand in the same period 2022. The decrease was due to lower sales offset by higher average price point per unit.
Sales and marketing expenses were $452 thousand for the second quarter 2023, compared to $1.1 million in the same period 2022. The decrease of $673 thousand was due to reductions in unprofitable marketing spend.
Research and development expenses were $468 thousand for the second quarter 2023, a $29 thousand decrease from $497 thousand for the same period in 2022. The expense in 2023 is primarily related to initiation of the company’s vagus nerve program and development activities associated with product line expansion.
General and administrative expenses were $1.3 million for the second quarter 2023, compared to $1.5 million in the same period 2022. The decrease of $255 thousand is attributable to lower personnel, professional fees, and insurance costs offset by one-time severance expenses.
As of June 30, 2023, the company had $2.7 million of cash and cash equivalents, excluding net proceeds from the offerings closed in between July 11, 2023 to August 9, 2023 of $4.8 million.
The company’s MD&A and consolidated financial statements for the second quarter ended June 30, 2023 will be filed on August 14, 2023 with the company’s Quarterly Report on Form 10-Q. 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 conference call on Monday, August 14th, 2023 at 1:30 pm PT / 4:30 pm ET to discuss the company’s second quarter 2023 financial results and provide a business update.
The conference call will be available via telephone by dialing toll-free 877-545-0523 for local callers; or 973-528-0016 for international callers and using entry code 679005.
The conference call will also be available via Webcast link: https://www.webcaster4.com/Webcast/Page/2865/48652
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; the continued listing of the company’s common stock on the Nasdaq Capital Market; 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, 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.
Condensed Balance Sheets
(in thousands, except share and per share data)
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June 30, 2023 |
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December 31, 2022 |
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(Unaudited) |
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(Audited) |
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ASSETS |
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Cash and cash equivalents |
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$ |
2,659 |
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$ |
3,517 |
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Other current assets |
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1,341 |
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1,770 |
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TOTAL CURRENT ASSETS |
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4,000 |
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5,287 |
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PROPERTY AND EQUIPMENT, NET |
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124 |
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12 |
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NONCURRENT ASSETS |
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472 |
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557 |
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TOTAL ASSETS |
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$ |
4,596 |
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$ |
5,856 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Accounts payable and accrued expenses |
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$ |
975 |
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$ |
1,696 |
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Other current liabilities |
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185 |
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163 |
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TOTAL CURRENT LIABILITIES |
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1,160 |
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1,859 |
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TOTAL LONG-TERM LIABILITIES |
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275 |
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367 |
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STOCKHOLDERS' EQUITY |
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Common stock |
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3 |
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1 |
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Additional paid in capital |
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37,041 |
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33,271 |
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Accumulated deficit |
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(33,883 |
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(29,642 |
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TOTAL STOCKHOLDERS' EQUITY |
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3,161 |
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3,630 |
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TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY |
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$ |
4,596 |
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$ |
5,856 |
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Tivic Health Systems, Inc.
Condensed Statements of Operations
(Unaudited)
(in thousands, except share and per share data)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2023 |
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2022 |
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2023 |
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2022 |
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REVENUES |
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$ |
161 |
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$ |
528 |
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$ |
537 |
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$ |
956 |
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COST OF SALES |
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100 |
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403 |
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363 |
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760 |
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GROSS PROFIT |
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61 |
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125 |
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174 |
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196 |
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OPERATING EXPENSES |
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Research and development |
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468 |
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497 |
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958 |
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898 |
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Sales and marketing |
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452 |
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1,125 |
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910 |
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1,809 |
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General and administrative |
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1,266 |
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1,521 |
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2,547 |
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2,747 |
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TOTAL OPERATING EXPENSES |
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2,186 |
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3,143 |
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4,415 |
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5,454 |
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NET OPERATING LOSS |
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(2,125 |
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(3,018 |
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(4,241 |
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(5,258 |
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OTHER INCOME, NET |
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— |
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— |
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— |
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— |
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NET LOSS |
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$ |
(2,125 |
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$ |
(3,018 |
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$ |
(4,241 |
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$ |
(5,258 |
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NET LOSS PER SHARE - BASIC AND DILUTED |
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$ |
(0.07 |
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$ |
(0.32 |
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$ |
(0.17 |
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$ |
(0.55 |
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WEIGHTED-AVERAGE NUMBER OF SHARES - BASIC AND DILUTED |
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29,677,734 |
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9,621,484 |
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24,926,353 |
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9,668,100 |
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