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): August 14, 2025 |
|---|
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.) |
| 47685 Lakeview Blvd.<br><br>Suite 100 | ||
| Fremont, California | 94538 | |
| (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 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.
| (d) | Exhibits. |
|---|---|
| Exhibit<br>No. | Description |
| --- | --- |
| 99.1 | Press Release, dated August 14, 2025. |
| 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: | August 14, 2025 | By: | /s/ Jennifer Ernst |
| Name: Jennifer Ernst<br>Title: Chief Executive Officer |
EX-99.1
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:
- Securing positive interest in potential military and defense applications for drug candidate Entolimod™ to treat ARS during briefings with the White House and U.S. Food & Drug Administration (FDA) officials.
- Extending the worldwide license of Entolimod™ to include the treatment of neutropenia, a condition that reduces the body’s ability to combat infections and has a wide range of causes - from genetics to cancer treatments and age.
- Entering into a GMP manufacturing validation agreement with Scorpius Biomanufacturing, Inc. as part of preparing for the FDA biologics license application process.
- Completing all study visits in the Optimization Study for its patent-pending, non-invasive cervical vagus nerve stimulation (ncVNS) device.
- Raising $1.4 million from the first and second tranche of a preferred equity purchase agreement that provides for up to $8.4 million in total financing.
- Entering into a $25 million equity line of credit that generated net proceeds of $547,000.
- Receiving shareholder approval of key measures in support of Tivic transformation strategy.
- Expanding biopharmaceutical team with regulatory, clinical and business development staff.
- Naming Lisa Wolf as CFO following her nine-month tenure as interim CFO.
Financial Performance:
- Revenue (net of returns) for the three and six months ended June 30, 2025 totaled $86,000 and $156,000, respectively, compared with $140,000 and $474,000 for 2024. The decreases are due to lower unit sales of ClearUP™ to treat sinus pain and pressure. The lower sales are attributable to decreases in advertising expenses as the company focused resources on accelerating its TLR5 program for the development of Entolimod™ for ARS.
- Gross profit in the three and six months ended June 30, 2025 was $54,000 and $104,000, respectively, compared to $30,000 and $197,000 in 2024.
- Gross margin was 67% in the six months ended June 30, 2025, compared to 42% in 2024.
- Operating expenses in the three and six months ended June 30, 2025 was $2.0 million and $3.5 million, respectively, compared to $1.3 million and $3.0 million in 2024. The increases were primarily due to the addition of the biopharma programs in February 2025.
- Net loss of $1.9 million for the three months ended June 30, 2025, compared to $1.3 million in the second quarter of 2024. Net loss of $3.4 million for the first half of 2025, compared to $2.7 million for the first half of 2024.
- At June 30, 2025, cash and cash equivalents totaled $1.2 million, compared with $2.0 million, at December 31, 2024. Subsequent to quarter’s end, the Company raised a total of $0.9 million through utilization of its equity line of credit and the sale of Series B Preferred Stock pursuant to its preferred equity purchase agreement. The company has no debt on its balance sheet.
- Approximately $7.0 million remains available as a committed investment in Tivic through a preferred equity purchase agreement. The company believes the current and committed funding is sufficient to make meaningful progress toward manufacturing validation for Entolimod.
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)
| June 30, 2025 | December 31, 2024 | |||||
|---|---|---|---|---|---|---|
| (Unaudited) | (Audited) | |||||
| ASSETS | ||||||
| Cash and cash equivalents | $ | 1,184 | $ | 2,002 | ||
| Other current assets | 658 | 637 | ||||
| TOTAL CURRENT ASSETS | 1,842 | 2,639 | ||||
| PROPERTY AND EQUIPMENT, NET | 120 | 119 | ||||
| NONCURRENT ASSETS | 2,546 | 49 | ||||
| TOTAL ASSETS | $ | 4,508 | $ | 2,807 | ||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||
| Accounts payable and accrued expenses | $ | 821 | $ | 272 | ||
| TOTAL CURRENT LIABILITIES | 821 | 272 | ||||
| TOTAL LONG-TERM LIABILITIES | — | — | ||||
| STOCKHOLDERS' EQUITY | ||||||
| Preferred stock | — | — | ||||
| Common stock | 1 | 1 | ||||
| Additional paid in capital | 50,661 | 46,075 | ||||
| Accumulated deficit | (46,975 | ) | (43,541 | ) | ||
| TOTAL STOCKHOLDERS' EQUITY | 3,687 | 2,535 | ||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 4,508 | $ | 2,807 |
Tivic Health Systems, Inc.
Condensed Statements of Operations
(in thousands, except share and per share data)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |||||||||
| REVENUES | $ | 86 | $ | 140 | $ | 156 | $ | 474 | ||||
| COST OF SALES | 32 | 110 | 52 | 277 | ||||||||
| GROSS PROFIT | 54 | 30 | 104 | 197 | ||||||||
| OPERATING EXPENSES | ||||||||||||
| Research and development | 655 | 302 | 990 | 558 | ||||||||
| Sales and marketing | 426 | 207 | 605 | 712 | ||||||||
| General and administrative | 907 | 787 | 1,949 | 1,674 | ||||||||
| TOTAL OPERATING EXPENSES | 1,988 | 1,296 | 3,544 | 2,944 | ||||||||
| NET OPERATING LOSS | (1,934 | ) | (1,266 | ) | (3,440 | ) | (2,747 | ) | ||||
| OTHER INCOME, NET | 3 | 0 | 7 | 0 | ||||||||
| NET LOSS | $ | (1,931 | ) | $ | (1,266 | ) | $ | (3,433 | ) | $ | (2,747 | ) |
| NET LOSS PER SHARE - BASIC AND DILUTED | $ | (2.19 | ) | $ | (5.37 | ) | $ | (4.64 | ) | $ | (17.05 | ) |
| WEIGHTED-AVERAGE NUMBER OF SHARES - BASIC AND DILUTED | 881,294 | 235,868 | 739,618 | 161,103 |