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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
Date of Report (Date
of earliest event reported): April 22,
2026
Tivic
Health Systems, Inc.
(Exact name of Registrant as Specified in Its
Charter)
| Delaware |
|
001-41052 |
|
81-4016391 |
| (State or Other Jurisdiction |
|
(Commission File Number) |
|
(IRS Employer |
| of Incorporation) |
|
|
|
Identification No.) |
| |
|
|
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|
1305 E. Houston Street,
Building 1, Suite 311 |
|
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|
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| San Antonio, Texas |
|
|
|
78205 |
| (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
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 5.03 Amendments to Articles of Incorporation or Bylaws; Change
in Fiscal Year.
On April 22, 2026, Tivic Health Systems, Inc. (the “Company”)
filed a certificate of amendment (“Certificate of Amendment”) to its amended and restated certificate of incorporation filed
with the Delaware Secretary of State to change its corporate name to Valion Bio, Inc. (the “Name Change”), effective as of
April 28, 2026. Pursuant to Delaware law, a shareholder vote was not necessary to effectuate the Name Change and it does not affect the
rights of the Company’s shareholders.
The Company intends for its common stock, par value
$0.0001 per share, to cease trading under the ticker symbol ‘TIVC’ and begin trading under its new ticker symbol ‘VBIO’
on The Nasdaq Capital Market LLC, which the Company expects to be effective on April 28, 2026.
A copy of the Company’s Certificate of Amendment
is filed as Exhibit 3.1, with this Current Report on Form 8-K and is incorporated herein by reference.
On April 23, 2026, the Company issued a press release
announcing the Name Change. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by
reference.
Item 9.01 Financial Statements and Exhibits.
| Exhibit No. |
|
Description |
| |
|
| 3.1 |
|
Certificate of Amendment to the Amended and Restated Certificate of Incorporation, filed April 22, 2026 (effective April 28, 2026). |
| 99.1 |
|
Press Release, dated April 23, 2026. |
| 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.
| |
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Tivic Health Systems, Inc.
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| |
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|
|
| Date: |
April 23, 2026 |
By: |
/s/ Lisa Wolf |
| |
|
|
Name: Lisa Wolf
Title: Chief Financial Officer |
Exhibit 99.1
FOR IMMEDIATE RELEASE
Tivic Health Systems Rebrands as
Valion Bio, Reflecting Completed Transformation into a Late-Stage Biopharmaceutical Company with Government-Backed Asset and Potential
Multiple Revenue Stream Model
Ticker Symbol to Change from TIVC to VBIO Effective April 28, 2026;
Company Advancing Entolimod™ Toward BARDA Funding and Strategic National Stockpile Procurement While Velocity Bioworks CDMO Builds
Independent Revenue Base
SAN ANTONIO,
April 23, 2026 /PRNewswire/ — Tivic Health Systems, Inc. (Nasdaq: TIVC) today announced it is changing its corporate
name to Valion Bio, Inc. and its Nasdaq ticker symbol from TIVC to VBIO, effective at market open on Tuesday, April
28, 2026. The CUSIP number for the company’s common stock will remain unchanged.
The rebrand is not merely cosmetic. It reflects the completion of a
fundamental strategic transformation — the deliberate unwinding of a consumer medical device business and its replacement with a
focused late-stage biopharmaceutical platform anchored by a government-priority asset with over 15 years and more than $140 million in
cumulative development investment, and supported by a wholly owned biomanufacturing subsidiary.
A Differentiated Asset at the Intersection of National Preparedness
and Oncology
Valion Bio’s lead drug candidate,
Entolimod™, is a novel Toll-like receptor 5 (TLR5) agonist with a differentiated, dual-utility profile. As a medical countermeasure
for Acute Radiation Syndrome (ARS), Entolimod has received FDA Fast Track and Orphan Drug designations and is being advanced under the
FDA’s Animal Rule pathway — a regulatory framework that enables approval based on animal efficacy data when human trials are
not feasible or ethical, substantially reducing clinical execution risk. The company is actively engaged with BARDA, DTRA, NIAID, and
allied government agencies regarding Entolimod’s inclusion in the U.S. Strategic National Stockpile (SNS), where a procurement contract
— if secured — would represent a non-dilutive, potentially nine-figure revenue event.
Critically, Entolimod’s mechanism — cytoprotection of bone
marrow and gastrointestinal epithelial tissue through NF-κB signaling — positions it for parallel development in oncology
supportive care. The global neutropenia treatment market exceeds $22 billion and is projected to approach $30
billion by the early 2030s. Valion Bio is targeting physician-sponsored clinical trials in chemotherapy-induced neutropenia in 2026, with
Phase IIb readiness as the objective. Entolasta™, a next-generation TLR5 agonist, provides additional pipeline depth and intellectual
property extension across both indications.
“The Valion Bio name
reflects the company we have become. We have a late-stage asset with validated biology, regulatory designations, a clear government procurement
pathway, and a world-class manufacturing operation under one roof. This is a different company than the one that existed 18 months ago
— and the new name should make that unmistakable to every investor, partner, and government stakeholder we engage.”
— Michael K. Handley, Chief Executive Officer, Valion
Bio
Handley, who previously served as CEO of Statera Biopharma, where he
led the advancement of Entolimod, brings direct institutional knowledge of the asset, its regulatory history, and its government agency
relationships. His appointment as CEO of Valion Bio in March 2026 consolidated scientific, commercial, and operational leadership of the
program under a single decision-maker with a proven track record in biologic drug development at scale.
Velocity Bioworks: Manufacturing as a Strategic and Financial
Asset
Valion Bio’s wholly owned CDMO subsidiary, Velocity Bioworks,
was acquired in December 2025 for approximately $16.3 million and represents a core pillar of the company’s strategy — not
a peripheral asset. Velocity Bioworks provides the company with domestic, controlled manufacturing capability for Entolimod, enabling
supply chain security that is increasingly a prerequisite for government procurement partnerships. The subsidiary also recently completed
a 200-fold manufacturing scale-up of Entolimod using 50-liter fermentation — on time, within budget, and meeting all purity and
potency specifications.
Beyond its internal role, Velocity Bioworks operates as a standalone
CDMO with the ability to serve third-party early-stage biotech clients, targeting the historically underserved Phase I and Phase II biologics
manufacturing gap. At full utilization, management believes Velocity Bioworks has the potential to evolve into a self-sustaining, cash
flow-positive operation — providing the company a path to non-dilutive commercial revenue independent of the drug development timeline.
Strategic Positioning and Macro Tailwinds
Valion Bio is deliberately headquartered in San Antonio, Texas —
proximity to the DoD biodefense ecosystem, including Brooke Army Medical Center, is not coincidental. The company’s ARS countermeasure
program sits at the intersection of several converging macro forces: a renewed federal focus on domestic biomanufacturing, accelerating
global demand for national preparedness infrastructure following heightened nuclear threat awareness, and a bipartisan mandate to rebuild
and modernize the Strategic National Stockpile. Allied government agencies are independently evaluating Entolimod for their own national
stockpiling programs, creating a potential multi-jurisdictional procurement opportunity.
About Valion Bio (Tivic Health Systems, Inc.)
Valion Bio is a late-stage
biopharmaceutical company developing biologics that activate innate immune pathways for cytoprotection and immune modulation. The company’s
lead candidate, Entolimod™, is a TLR5 agonist with over 15 years of development history, FDA Fast Track and Orphan Drug designations,
and active engagement with U.S. government agencies for potential Strategic National Stockpile inclusion. The company also advances Entolasta™,
a next-generation TLR5 agonist, and targets the neutropenia oncology supportive care market. Velocity Bioworks, Valion Bio’s wholly
owned CDMO subsidiary, supports internal manufacturing and services third-party biotech clients. For more information, 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 Valion Bio, 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 the company’s interactions with and guidance from the FDA and
other regulatory authorities; the continued interest of BARDA and other U.S. government agencies in Entolimod™; the ability of the
company to achieve the expected benefits from the acquisition of development and manufacturing assets within expected time frames or at
all; changes to the company’s relationship with its partners; failure to obtain FDA or similar clearances or approvals and noncompliance
with FDA or similar regulations, including related to the Animal Rule; the company’s future development of Entolimod or Entolasta;
changes to the company’s business strategy; timing and success of pre-clinical and clinical trials and study results; regulatory
requirements and pathways for approval; the company’s ability to successfully commercialize its product candidates in the future;
changes in the markets and industries in which the company does business; 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. 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 Valion Bio’s filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2025, filed with
the SEC on March 30, 2026, 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 the company undertakes no duty to update such
information except as required by applicable law.
Investor Contact
ir@tivichealth.com
SOURCE: Valion Bio, Inc.
