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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): September 17,
2026
Valion
Bio, Inc.
(Exact name of Registrant as Specified in Its
Charter)
| Delaware |
001-41052 |
81-4016391 |
| (State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
| |
|
|
1305 E. Houston Street,
Building 1, Suite 311 |
|
|
| San Antonio, Texas |
|
78205 |
| (Address of Principal Executive Offices) |
|
(Zip Code) |
| Registrant’s Telephone Number, Including Area Code: 888 276-6888 |
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 |
|
VBIO |
|
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 5.02 Departure of Directors or Certain Officers; Election of
Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
Appointment of Dean Zikria as Interim Chief
Executive Officer
On September 22, 2026, Valion Bio, Inc. (the “Company”),
a Delaware corporation, appointed Dean Zikria as Interim Chief Executive Officer of the Company, effective immediately. Mr. Zikria remains
a member of the Company’s Board of Directors (the “Board”).
Mr. Zikria, 58, has served as a director on our
Board since July 10, 2019. Mr. Zikria brings deep industry experience in allergy and asthma as well as other chronic diseases to the board.
Since August 2019, Mr. Zikria has been the Founder, CEO and Chairman of Mind Machine LLC, a Silicon Valley based marketing/advertising
agency—focused on the MedTech industry. From June 1, 2021, until January 2023, he served as the Chief Commercial Officer at Intuity
Medical Inc., a Silicon Valley MedTech company launching a highly disruptive glucose meter in the diabetes industry. In addition, he has
served as Chairman of DZ Advisors, LLC, a company founded by Mr. Zikria in 2017 that provides consulting and advisory services to the
medtech, biotech, digital health and pharmaceutical industries; since inception, where he also served as President from December 2017
until May 31, 2021. Mr. Zikria also sits on the boards of the following privately held companies: AsthmaTek, Inc., a startup digital health
company in the asthma space; Brev.Dev, Inc., a technology company developing a disruptive platform to aid developers. Mr. Zikria previously
served as Chief Executive Officer of Spirosure Inc., a FeNO detection company for asthma diagnostics, from 2014 to 2017. Additionally,
he previously served as head of global marketing for Johnson & Johnson’s Animas Corporation within their medical device &
diagnostics division. He was head of strategy for Pfizer Pharmaceuticals U.S. Cardiovascular Unit, a division with approximately $7 billion
in annual revenues. Mr. Zikria also brings experience in strategic planning, scenario planning and analysis, and mergers and acquisitions,
including sourcing, transactions and integration.
On September 22, 2026, in connection with his
appointment as Interim Chief Executive Officer of the Company, the Company and Mr. Zikria entered into a consulting agreement (the “Consulting
Agreement”), pursuant to which Mr. Zikria (i) is entitled to receive a monthly fee of $23,333 per month; (ii) is entitled to receive
50,000 restricted stock units (“RSUs”) to be issued pursuant to a nonstatutory equity grant under the Company’s Amended
and Restated 2021 Equity Incentive Plan, as amended (the “Plan”); (iii) is entitled to receive another 50,000 RSUs upon an
increase in the Company’s Plan by the Company’s stockholders, and subject to the approval of the Special Committee of the
Board and (iv) may be eligible to receive a cash bonus, as determined by the Board or the Compensation Committee of the Board, upon closing
of a strategic transaction (i.e., a reverse merger, a merger, or acquisition).
Pursuant to the Consulting Agreement, Mr. Zikria
is and will be an independent contractor. Nothing contained in the Consulting Agreement is intended or should be construed to make or
constitute Mr. Zikria as an employee or agent of the Company or a partner or co-venturer with the Company. The Consulting Agreement will
terminate on January 22, 2027, unless mutually extended by the parties up to twelve (12) months from the effective date of the Consulting
Agreement.
The foregoing summary of the Consulting Agreement
does not purport to be complete and is qualified in its entirety by reference to the full text of the Consulting Agreement, a copy of
which is filed as Exhibit 10.1 to this Current Report on Form 8-K (this “Current Report”) and is incorporated herein by reference.
There are no family relationships between Mr.
Zikria and any of the Company’s directors, executive officers or persons nominated or chosen by the Company to become a director
or executive officer. Other than as previously disclosed, the Company is not aware of any transactions or relationships between Mr. Zikria
and the Company that would require disclosure under Item 404(a) of Regulation S-K under the Securities Exchange Act of 1934, as amended
(the “Exchange Act”).
Board Resignation
On September 17, 2026, Sheryle Bolton notified
the Company of her decision to resign from the Company’s Board, effective immediately. Ms. Bolton’s resignation was not
the result of any disagreement with the Company on any matter relating to the Company’s operations, policies or practices.
Board Committee Appointments
On September 17, 2026, the Company appointed Thomas
Jensen as Chair of the Board and Chair of the Board’s Compensation Committee, effective immediately.
On September 17, 2026, the Company appointed Jared
Malbin as Chair of the Board’s Audit and Risk Committee, effective immediately.
Mr. Zikria was removed as an independent member
from the Board’s Audit and Risk Committee, Compensation Committee and Nominations and Corporate Governance Committee while he serves
as Interim Chief Executive Officer.
Item 7.01 Regulation FD Disclosure.
On September 23, 2026, the Company issued a press
release announcing its leadership changes discussed in Item 5.02 above. A copy of the press release is being furnished as Exhibit 99.1
to this Current Report and is incorporated by reference herein.
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, 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.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. |
|
Description |
| 10.1 |
|
Consulting Agreement, by and
between the Company and Dean Zikria, effective September 22, 2026. |
| 99.1 |
|
Press Release, dated September 23, 2026. |
| 104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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.
| |
|
|
VALION BIO, INC. |
| |
|
|
|
| Date: |
September 23, 2026 |
By: |
/s/ Melinda Lackey |
| |
|
|
Name: Melinda Lackey
Title: General Counsel and Senior Vice President of Legal Affairs |
Exhibit 99.1
Valion Appoints Life Sciences Veteran
Dean Zikria as Interim CEO and Announces Board Leadership Transitions
Leadership changes strengthen alignment and
execution as Company advances Entolimod and evaluates strategic, commercial and government opportunities
SAN ANTONIO, TX – September 23, 2026
– Valion Bio, Inc. (Nasdaq: VBIO) (“Valion” or the “Company”), a clinical-stage biopharmaceutical
company, today announced decisive changes to its executive leadership team and Board of Directors (the “Board”). These leadership
transitions are intended to strengthen organizational alignment and support focused execution as Valion advances its Entolimod and other
development programs and evaluates strategic opportunities.
Dean Zikria, a current member of the Board, has
been appointed Interim Chief Executive Officer (“CEO”). In this role, Mr. Zikria will oversee Valion’s strategic priorities,
including accelerating the clinical advancement of Entolimod and aggressively pursuing commercial and government partnerships.
Mr. Zikria brings a compelling blend of scientific
innovation, pharmaceutical commercialization and emerging biotech experience to Valion’s next phase of growth. His career began
at Columbia University Medical Center, where he co-invented novel therapeutics studied for potential applications in traumatic brain injury,
hemorrhagic shock and battlefield medicine, and later included seven years at Pfizer, where he held strategy and business development
roles within its $7 billion U.S. cardiovascular business, supporting a portfolio that included LIPITOR®, then the world’s best-selling
drug. Today, he remains at the forefront of emerging biotechnology as an advisor and selection committee member for UC Berkeley’s
SkyDeck accelerator, evaluating new therapeutic technologies and advising early-stage companies on R&D strategy, financing, leadership
and commercialization.
Lisa Wolf will continue to serve as Valion’s
President, Chief Operating Officer and Chief Financial Officer, leading the Company’s financial and operational functions and reporting
to Mr. Zikria.
Valion also announced that Thomas Jensen has been
appointed Chair of the Board and Chair of its Compensation Committee. He succeeds Sheryle Bolton, who has stepped down from the Board
and its committees. In addition, Jared Malbin has been appointed Chair of the Board’s Audit Committee.
“On behalf of the Board, I want to thank
Sheryle for her leadership, service and many contributions to Valion,” said Mr. Jensen. “These transitions establish clear
accountability and strengthen alignment between our Board and management team as Valion enters an important stage of its development.
Dean’s familiarity with the Company, its programs and its strategic priorities provides continuity while sharpening our focus on
disciplined capital allocation, operational execution and long-term shareholder value.”
“Dean brings the experience, judgment and
strategic perspective needed to lead Valion during this next phase,” Mr. Jensen continued. “The Board looks forward to working
closely with him and the broader management team as the Company advances Entolimod, evaluates high-potential opportunities and works toward
milestones that could create meaningful value for patients and shareholders.”
“I am honored to assume this expanded role
at an important point in Valion’s evolution,” said Mr. Zikria. “Valion has promising development programs and a dedicated
team working to translate the Company’s science into meaningful outcomes. My immediate priorities are to work closely with Lisa
and the rest of our team to maintain momentum, sharpen execution and concentrate our resources on Entolimod and the opportunities we believe
offer the greatest potential to create lasting value.”
About Valion Bio, Inc.
Valion Bio, Inc. (Nasdaq: VBIO) is developing
biologics that activate innate immune pathways for cytoprotection and modulate immune responses in conditions driven by radiation, disease
and immune dysregulation.
The Company’s lead candidate, Entolimod,
is being developed as a potential medical countermeasure for Acute Radiation Syndrome and has been evaluated in animal models under the
U.S. Food and Drug Administration’s (“FDA”) Animal Rule, which allows the Agency to approve new drugs and biological
products based on animal efficacy studies when human clinical trials are not ethical or feasible, such as in the case of acute radiation
exposure. Entolimod is a novel Toll-like Receptor 5 agonist designed to activate NF-κB signaling pathways associated with cellular
protection, tissue recovery and immune response. The product candidate has received Fast Track and Orphan Drug designations from the FDA.
Valion is also advancing Entolasta, a next-generation
TLR5 agonist designed for potential use in broader therapeutic applications, including oncology supportive care. The Company’s pipeline
includes potential programs in neutropenia and immune dysfunction.
Valion’s wholly owned subsidiary, Velocity
Bioworks, is a biologics contract development and manufacturing organization providing development and manufacturing services to Valion
to support its internal pipeline, with the objective of increasing manufacturing control, reducing costs, accelerating development timelines
and strengthening domestic supply-chain security.
For more information, visit www.valionbio.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’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 continued listing of the Company’s common stock on the Nasdaq Capital Market; and the Company's
ability to maintain compliance with applicable listing standards on the Nasdaq Capital Market. 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 Valion’s actual results to differ from those contained in the forward-looking statements,
see Valion’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 Valion undertakes no duty to update such information except as
required by applicable law.
Investor and Media Contact
Stephen Kilmer
(646) 274-3580
stephen.kilmer@valionbio.com