Valion Bio, Inc 8-K, filed Aug 14, 2024
Valion Bio, Inc. (VBIO)
About this 8-K
Valion Bio, Inc filed this 8-K on August 14, 2024.
Items reported
- Item 2.02: Financial results
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
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 is incorporated by reference into this Item 2.02.
Item 7.01 Regulation FD Disclosure.
On August 14, 2024, Tivic Health Systems, Inc. (the “Company”) issued a press release regarding the Company’s financial results for its second quarter ended June 30, 2024. 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.
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Exhibits. |
Exhibit |
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Description |
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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, 2024 |
By: |
/s/ Jennifer Ernst |
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Name: Jennifer Ernst |
Exhibit 99.1
Tivic Reports Second Quarter 2024 Financial Results
SAN FRANCISCO – (Business Wire) – August 14, 2024 – Tivic Health® Systems, Inc. (“Tivic”, Nasdaq: TIVC), a health tech company that develops and commercializes bioelectronic medicine, today announced its second quarter 2024 financial results and discussed growth strategies based on its investments in vagus nerve stimulation ("VNS").
“This quarter is the start of a potentially transformational period for Tivic. We announced the results of our successful Phase 1 trial of a new approach to non-invasive vagus nerve stimulation. We are partnering with The Feinstein Institute of Bioelectronic Medicine for optimization, and we are continuing to build our intellectual property portfolio in an area of significant potential value to the company and our investors,” explained Jennifer Ernst, CEO of Tivic.
"Over the last 18 months, we have improved gross margins of our ClearUP product, increased the revenue-produced-per-marketing dollar spent, and aggressively reduced operating expenses. We have relocated manufacturing and driven down costs of fulfillment with a new third-party logistics provider. We evaluated various potential licensing and strategic transaction opportunities, while simultaneously building our organic growth options. We have demonstrated industry-leading clinical results in the new high-value medical target of VNS. We are not yet done, but I am proud of what has been accomplished with a small and dedicated team.”
Ernst expanded to say, "While we expect to continue to make improvements in the economic profile of the ClearUP product line and our overall operating expenses, we believe the future growth of the company will be greatly enhanced by advancements in our vagus nerve stimulation program.”
The company will be discussing the key results from the Phase 1 VNS trial as part of its Q2 earnings call.
2024 Business and Operational Updates
In the first half of 2024, Tivic business and operational updates are as follows:
Financial Performance
The company’s MD&A and consolidated financial statements for the quarter ended June 30, 2024 will be filed with the Securities and Exchange Commission on August 14, 2024 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 webcast/conference call on Wednesday, August 14, 2024, at 1:30 PM PT / 4:30 PM ET to discuss the company’s second quarter 2024 financial results and provide a business update, including comments on the direction the company is heading in 2024.
The conference call will be available via telephone by dialing toll-free 888-506-0062for local callers; or 973-528-0011 for international callers and using entry code 316159.
The conference call will also be available via Webcast link: https://www.webcaster4.com/Webcast/Page/2865/50901
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 Health
Tivic Health is a commercial health tech company advancing the field of bioelectronic medicine. Tivic Health’s technology platforms leverage stimulation of the trigeminal, sympathetic, and vagus nerve structures. Tivic Health’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 Health’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: the future development of ncVNS treatment; Tivic Health’s ability to commercialize products arising out of the ncVNS treatment and Tivic Health’s plans to seek regulatory approval for such clinical products; Tivic Health’s continued focus on developing ncVNS treatment, including in the epilepsy, post-traumatic stress disorder, and/or ischemic stroke space; expected clinical utility, including which patient populations may be pursued; market and other conditions; supply chain constraints; macroeconomic factors, including inflation; Tivic Health's ability to raise additional capital on favorable terms, or at all, when needed; Tivic Health's ability to maintain its Nasdaq listing; and unexpected costs, charges or expenses that reduce Tivic Health’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 Health’s actual results to differ from those contained in the forward-looking statements,
see Tivic Health’s filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 29, 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.
Media Contact:
Morgan Luke
Morgan.Luke@tivichealth.com
Investor Contact:
Hanover International, Inc.
ir@tivichealth.com
Tivic Health Systems, Inc.
Condensed Balance Sheets
(in thousands, except share and per share data)
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June 30, 2024 |
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December 31, 2023 |
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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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$ |
3,693 |
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$ |
3,395 |
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Other current assets |
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970 |
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1,257 |
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TOTAL CURRENT ASSETS |
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4,663 |
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4,652 |
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PROPERTY AND EQUIPMENT, NET |
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120 |
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122 |
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NONCURRENT ASSETS |
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— |
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383 |
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TOTAL ASSETS |
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$ |
4,783 |
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$ |
5,157 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Accounts payable and accrued expenses |
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$ |
591 |
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$ |
1,208 |
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Other current liabilities |
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— |
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193 |
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TOTAL CURRENT LIABILITIES |
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591 |
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1,401 |
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TOTAL LONG-TERM LIABILITIES |
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— |
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176 |
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STOCKHOLDERS' EQUITY |
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Common stock |
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1 |
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— |
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Additional paid in capital |
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44,824 |
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41,466 |
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Accumulated deficit |
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(40,633 |
) |
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(37,886 |
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TOTAL STOCKHOLDERS' EQUITY |
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4,192 |
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3,580 |
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TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY |
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$ |
4,783 |
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$ |
5,157 |
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Tivic Health Systems, Inc.
Condensed Statements of Operations
(in thousands, except share and per share data)
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Three Months Ended June 30, |
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Six Months Ended |
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2024 |
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2023 |
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2024 |
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2023 |
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REVENUES |
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$ |
140 |
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$ |
161 |
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$ |
474 |
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$ |
537 |
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COST OF SALES |
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110 |
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100 |
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277 |
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363 |
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GROSS PROFIT |
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30 |
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61 |
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197 |
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174 |
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OPERATING EXPENSES |
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Research and development |
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302 |
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468 |
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558 |
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958 |
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Sales and marketing |
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207 |
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452 |
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712 |
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910 |
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General and administrative |
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727 |
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1,266 |
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1,614 |
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2,547 |
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TOTAL OPERATING EXPENSES |
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1,236 |
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2,186 |
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2,884 |
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4,415 |
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NET OPERATING LOSS |
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(1,206 |
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(2,125 |
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(2,687 |
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(4,241 |
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OTHER EXPENSE |
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60 |
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— |
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60 |
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— |
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NET LOSS |
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$ |
(1,266 |
) |
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$ |
(2,125 |
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$ |
(2,747 |
) |
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$ |
(4,241 |
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NET LOSS PER SHARE - BASIC AND DILUTED |
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$ |
(0.32 |
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$ |
(7.16 |
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$ |
(1.00 |
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$ |
(17.01 |
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WEIGHTED-AVERAGE NUMBER OF SHARES - BASIC AND DILUTED |
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4,009,746 |
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296,778 |
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2,738,743 |
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249,264 |
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