Valion Bio, Inc 8-K, filed Aug 14, 2025
Valion Bio, Inc. (VBIO)
About this 8-K
Valion Bio, Inc filed this 8-K on August 14, 2025.
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 8-K
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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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 7.01 Regulation FD Disclosure.
On August 14, 2025, Tivic Health Systems, Inc. (the “Company”) issued a press release regarding the Company’s financial results for its quarter ended June 30, 2025. 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 attached hereto, 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, 2025 |
By: |
/s/ Jennifer Ernst |
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Name: Jennifer Ernst |
Exhibit 99.1
Tivic Reports Second Quarter 2025 Financial Results
Company advances its TLR5 agonist program and prepares to report VNS clinical data
FREMONT, Calif. – August 14, 2025 – Tivic Health® Systems, Inc. a diversified immunotherapeutics company, today announced financial results for the second quarter and six months ended June 30, 2025.
“We have established a strong foundation for Tivic’s strategic transformation with our expansion into biopharmaceuticals, making us unique in treating disease by addressing both the body’s biochemical and bioelectronic systems,” stated Tivic CEO Jennifer Ernst.
"To maximize our focus on the compelling, late-stage clinical pipeline, we have increasingly shifted resources away from consumer healthtech and are now planning to exit the ClearUP business by the end of this year," continued Ernst. "I look forward to advancing the commercialization of these life-saving therapies, supporting our strategy to increase shareholder value through this transformation."
Corporate Highlights from the Second Quarter and Subsequent Weeks, included:
Financial Performance:
Conference Call and Webcast Information
Management will host a webcast/conference call today, Thursday, August 14, at 1:30 p.m. PT / 4:30 p.m. ET to discuss the company’s second quarter 2025 financial results and provide a business update.
Teleconference Details:
Toll Free: 877-545-0523
International: 973-528-0016
Participant Access Code: 793820
Webcast Link
https://www.webcaster4.com/Webcast/Page/2865/52776
An audio replay of the call will be available for the next 90 days from the investor page on the Tivic Health website at https://tivichealth.com/investor/.
About Tivic
Tivic’s dual platform utilizes the body’s biopharmaceutical and bioelectronic systems to treat unmet medical needs through targeting the immune system.
Tivic’s biologics compounds activate an innate immune pathway to prevent cell death in the bone marrow and epithelial tissues across systems impacted by radiation and age. The company's lead drug candidate, Entolimod™ for acute radiation syndrome, is a novel TLR5 agonist that has been granted Fast Track designation and is in late stage development.
Tivic’s bioelectronic program is developing a novel, non-invasive medical device designed to target the neural pathways implicated in many prevalent and debilitating diseases. Early trials show promising signals that Tivic’s approach may regulate specific biologic responses, and the company believes its early-stage vagus nerve stimulation device has the potential to deliver clinical outcomes similar to or better than those of surgically implanted devices. To learn more about Tivic, visit: https://ir.tivichealth.com
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, including as a result of interactions with and guidance from the FDA and other regulatory authorities; changes to the company’s relationship with the its partners; the failure to obtain FDA or similar clearances or approvals and noncompliance with FDA or similar regulations; the company’s future development of its ncVNS treatment, Entolimod and Entolasta; changes to the company’s business strategy; timing and success of clinical trials and study results; regulatory requirements and pathways for approval; consummation of any strategic transactions; the company’s need for, and ability to secure when needed, additional working capital; the company’s ability to maintain its Nasdaq listing; and changes in tariffs, inflation, legal, regulatory, political and economic risks. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of risks and uncertainties relevant to the company, and other important factors, see Tivic Health’s filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 21, 2025, 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)
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June 30, 2025 |
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December 31, 2024 |
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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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$ |
1,184 |
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$ |
2,002 |
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Other current assets |
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658 |
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637 |
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TOTAL CURRENT ASSETS |
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1,842 |
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2,639 |
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PROPERTY AND EQUIPMENT, NET |
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120 |
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119 |
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NONCURRENT ASSETS |
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2,546 |
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49 |
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TOTAL ASSETS |
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$ |
4,508 |
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$ |
2,807 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Accounts payable and accrued expenses |
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$ |
821 |
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$ |
272 |
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TOTAL CURRENT LIABILITIES |
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821 |
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272 |
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TOTAL LONG-TERM LIABILITIES |
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— |
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— |
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STOCKHOLDERS' EQUITY |
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Preferred stock |
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— |
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— |
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Common stock |
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1 |
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1 |
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Additional paid in capital |
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50,661 |
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46,075 |
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Accumulated deficit |
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(46,975 |
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(43,541 |
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TOTAL STOCKHOLDERS' EQUITY |
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3,687 |
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2,535 |
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TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY |
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$ |
4,508 |
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$ |
2,807 |
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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 June 30, |
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2025 |
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2024 |
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2025 |
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2024 |
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REVENUES |
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$ |
86 |
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$ |
140 |
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$ |
156 |
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$ |
474 |
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COST OF SALES |
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32 |
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110 |
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52 |
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277 |
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GROSS PROFIT |
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54 |
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30 |
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104 |
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197 |
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OPERATING EXPENSES |
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Research and development |
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655 |
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302 |
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990 |
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558 |
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Sales and marketing |
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426 |
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207 |
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605 |
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712 |
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General and administrative |
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907 |
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787 |
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1,949 |
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1,674 |
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TOTAL OPERATING EXPENSES |
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1,988 |
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1,296 |
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3,544 |
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2,944 |
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NET OPERATING LOSS |
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(1,934 |
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(1,266 |
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(3,440 |
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(2,747 |
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OTHER INCOME, NET |
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3 |
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0 |
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7 |
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0 |
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NET LOSS |
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$ |
(1,931 |
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$ |
(1,266 |
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$ |
(3,433 |
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$ |
(2,747 |
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NET LOSS PER SHARE - BASIC AND DILUTED |
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$ |
(2.19 |
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$ |
(5.37 |
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$ |
(4.64 |
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$ |
(17.05 |
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WEIGHTED-AVERAGE NUMBER OF SHARES - BASIC AND DILUTED |
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881,294 |
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235,868 |
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739,618 |
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161,103 |
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