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): May 15, 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 May 15, 2025, Tivic Health Systems, Inc. (the “Company”) issued a press release regarding the Company’s financial results for its quarter ended March 31, 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 May 15, 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: | May 15, 2025 | By: | /s/ Jennifer Ernst |
| Name: Jennifer Ernst<br>Title: Chief Executive Officer |
EX-99.1
Exhibit 99.1
Tivic Reports First Quarter 2025 Financial Results and Provides Updates on Business Transformation
Pre-recorded Conference Call to Follow at 1:30 p.m. PDT/4:30 p.m. EDT
FREMONT, Calif. – May 15, 2025 – Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified immunotherapeutics company, today announced financial results for the first quarter ended March 31, 2025 and outlined operational highlights based on its newly expanded clinical pipeline.
“This is a defining time for the company. During the quarter we initiated a significant strategic shift, dramatically expanding Tivic's clinical pipeline for restoring immune system health," stated Tivic CEO Jennifer Ernst.
“In February, we executed a comprehensive worldwide exclusive licensing agreement for the Phase III TLR5 agonist, Entolimod and its molecular derivative, Entolasta, with the agreement encompassing multiple indications. Phase III validation of Entolimod for treatment of acute radiation syndrome, or ARS, has been completed via the FDA's animal rule pathway and we have initiated manufacturing validation procedures that are required prior to regulatory filings.
"We have met with and provided briefings to senior leadership at the White House and FDA, securing positive interest in potential military and defense applications of Entolimod for treatment of ARS, for our country and our allies. We also discussed applications of our non-invasive vagus nerve stimulation, or VNS, program, which was of high interest to the defense community.
“Our ongoing study of non-invasive VNS continues to show noteworthy signs of its potential to improve outcomes in inflammatory, cardiac and neurologic disorders relative to current treatment options. As we have moved through the currently active optimization study for our non-invasive VNS, we have created new intellectual property. This includes IP captured in patent filings that cover potential breakthroughs in personalizing and optimizing the clinical effects of vagus nerve stimulation.
"Finally, we have entered into financing agreements that we expect will provide sufficient funding to take us through the manufacturing validation for Entolimod and the upcoming VNS data readouts. We believe that the advancements in and expansion of our clinical pipeline well position Tivic to increase shareholder value as we execute on our transformation strategy.”
First Quarter and Subsequent Weeks Business and Operational Updates
In the first quarter of 2025 and subsequent weeks, the company announced the following developments:
Provided briefings to senior leadership at the White House and at the FDA, which garnered significant positive interest in potential military and defense applications for the company’s biologic and bioelectronic product candidates. The meeting with the FDA explored potential expedited pathways to approval for Entolimod and Entolasta. The company also discussed Tivic’s
ncVNS program, including the potential to treat post-traumatic stress disorder, one of several neurologic areas of strong interest to military and defense organizations globally.
Secured a $25 million equity line of credit and also entered into a purchase agreement that provides for the sale of up to $8.4 million of company securities.
Exercised the option to license the Phase II drug candidate Entolimod for the treatment of neutropenia. This is the second indication Tivic has licensed from Statera and for which Phase II trials are expected to be initiated later this year.
In collaboration with The Feinstein Institute for Medical Research, presented a poster at the Sixth Bioelectronic Medicine Summit showing that personalizing Tivic’s ncVNS technology resulted in optimized effects on autonomic nervous system activity.
Regained compliance with Nasdaq Minimum Bid Price Listing rule, which followed the 1-for-17 reverse stock split that took effect on March 7.
Further expanded the scope of the optimization study currently underway for its ncVNS device following positive findings related to achieving enhanced effects on autonomic nervous system function.
Following the quarter close, entered an agreement for GMP manufacturing process validation for Entolimod in advance of filing a Biologics License Application (BLA) with the FDA.
Financial Performance for the first quarter of 2025 compared with the first quarter of 2024:
- Revenue totaled $70,000, compared with $334,000 a year ago, reflecting lower unit sales of Tivic's ClearUP™ device to treat sinus pain and pressure. The lower sales are attributable to a 92% decrease in advertising expenses as the company focused resources on research and development programs, including securing the Entolimod and Entolasta license agreement.
- Gross profit was $50,000, compared with $167,000, for the year ago quarter.
- Gross margin was 72%, compared with 50% for the first quarter of 2024.
- Operating expenses totaled $1.6 million and remained flat compared with $1.6 million for the same period in 2024.
- Net loss of $1.5 million remained flat compared to $1.5 million in the first quarter of 2024.
- At March 31, 2025, cash and cash equivalents totaled $669,000. Cash at year end 2024 totaled $2.0 million. Subsequent to the quarter, the company raised net proceeds of $1.7 million under its ATM. The company has no debt on its balance sheet.
Conference Call and Webcast Information
Management will host a webcast/conference call today, Thursday, May 15, at 1:30 p.m. PT / 4:30 p.m. ET to discuss the company’s first quarter 2025 financial results and provide a business update. The company invites investors to submit questions in advance to ir@tivichealth.com.
Teleconference Details:
Toll Free: 1-877-407-0779
International: 1-201-389-0914
Conference ID: 13753498
Webcast Link
https://viavid.webcasts.com/starthere.jsp?ei=1717125&tp_key=322c3ca4f6
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 Health Systems, Inc.
Tivic Health is a diversified immunotherapeutics company harnessing the power of the immune and autonomic nervous systems to fight disease and restore health. Tivic Health's bioelectronic program is focused on developing personalized non-invasive therapeutic devices for vagus nerve stimulation to improve clinical outcomes in inflammatory, neurologic and cardiac disease. The program also includes Tivic Health's first FDA approved product, ClearUP®, which has been proven to provide temporary relief of sinus pain, pressure and congestion and is available through top-tier online retail and distribution partners. The company's newly formed biopharmaceutical program is focused on commercial advancement of the toll-like receptor 5 drugs Entolimod™ and Entolasta™, including lead product candidate Entolimod for acute radiation syndrome. The company is also driving expansion into additional indications for Entolimod and Entolasta.
For more information about Tivic Health, 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)
| March 31, 2025 | December 31, 2024 | |||||
|---|---|---|---|---|---|---|
| (Unaudited) | (Audited) | |||||
| ASSETS | ||||||
| Cash and cash equivalents | $ | 669 | $ | 2,002 | ||
| Other current assets | 592 | 637 | ||||
| TOTAL CURRENT ASSETS | 1,261 | 2,639 | ||||
| PROPERTY AND EQUIPMENT, NET | 118 | 119 | ||||
| NONCURRENT ASSETS | 2,398 | 49 | ||||
| TOTAL ASSETS | $ | 3,777 | $ | 2,807 | ||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||
| Accounts payable and accrued expenses | $ | 741 | $ | 272 | ||
| TOTAL CURRENT LIABILITIES | 741 | 272 | ||||
| TOTAL LONG-TERM LIABILITIES | — | — | ||||
| STOCKHOLDERS' EQUITY | ||||||
| Preferred stock | — | — | ||||
| Common stock | 1 | 1 | ||||
| Additional paid in capital | 48,078 | 46,075 | ||||
| Accumulated deficit | (45,043 | ) | (43,541 | ) | ||
| TOTAL STOCKHOLDERS' EQUITY | 3,036 | 2,535 | ||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 3,777 | $ | 2,807 |
Tivic Health Systems, Inc.
Condensed Statements of Operations
(in thousands, except share and per share data)
| Three Months Ended March 31, | ||||||
|---|---|---|---|---|---|---|
| 2025 | 2024 | |||||
| REVENUES | $ | 70 | $ | 334 | ||
| COST OF SALES | 20 | 167 | ||||
| GROSS PROFIT | 50 | 167 | ||||
| OPERATING EXPENSES | ||||||
| Research and development | 335 | 256 | ||||
| Sales and marketing | 179 | 505 | ||||
| General and administrative | 1,042 | 887 | ||||
| TOTAL OPERATING EXPENSES | 1,556 | 1,648 | ||||
| NET OPERATING LOSS | (1,506 | ) | (1,481 | ) | ||
| Other Income | 4 | — | ||||
| NET LOSS | $ | (1,502 | ) | $ | (1,481 | ) |
| NET LOSS PER SHARE - BASIC AND DILUTED | $ | (2.52 | ) | $ | (17.15 | ) |
| WEIGHTED-AVERAGE NUMBER OF SHARES - BASIC AND DILUTED | 596,368 | 86,338 |