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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): August 27,
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 1.01 Entry into a Material Definitive
Agreement.
Valion Bio, Inc., a Delaware corporation (the
“Company”) and 3i, LP (“3i”) are parties to that certain Securities Purchase Agreement, dated as of April 29,
2025 (as assigned and amended as of December 9, 2025, the “Series B Preferred Purchase Agreement”), with respect to the purchase
and sale of (a) up to 8,400 shares of the Company’s Series B Non-Voting Convertible Preferred Stock (“Series B Preferred Shares”)
and (b) warrants (“Series B Warrants”) to purchase a number of shares of common stock, par value $0.0001 per share, of the
Company (the “Common Stock”) at an initial exercise price per share determined pursuant to Section 2.2 of the Series B Preferred
Purchase Agreement, for an aggregate purchase price of up to $8,400,000 in a series of closings.
The Company, 3i and certain other purchasers are
parties to that certain Securities Purchase Agreement, dated as of December 9, 2025 (the “Series C Preferred Purchase Agreement”),
with respect to the purchase and sale of (a) up to 75,000 shares of the Company’s Series C Non-Voting Convertible Preferred Stock
(“Series C Preferred Shares”) and (b) warrants (“Series C Warrants”) to purchase a number of shares of Common
Stock at an initial exercise price per share equal to the Fixed Conversion Price as defined in the Certificate of Designation of Rights
and Preferences of the Series C Preferred Shares (the “Series C Certificate of Designation”), for an aggregate purchase price
of up to $75,000,000 in a series of closings.
On August 31, 2026, the Company and 3i entered
into a letter agreement (the “Letter Agreement”), pursuant to which the Company agreed to issue to 3i (a) 100 Series B Preferred
Shares (the “Closing Series B Shares”), (b) Series B Warrants to purchase 3,077 shares of Common Stock at an initial exercise
price of $3.62 per share (the “Closing Series B Warrants”), (c) 7,637 Series C Preferred Shares (the “Closing Series
C Shares” and, together with the Closing Series B Shares, the “Closing Shares”), and (d) Series C Warrants to purchase
1,053,969 shares of Common Stock for an initial exercise price of $3.62 per share (the “Closing Series C Warrants” and,
together with the Closing Series B Warrants, the “Closing Warrants”), for an aggregate purchase price of $7,737,000, to be
paid on or about August 31, 2026 (the “Closing Purchase Price” and the closing of such purchase and sale, the “Closing”).
The Closing Purchase Price shall consist of (a) $6,137,000 to be retained by 3i to satisfy overdue cash true-up payments pursuant to Section
6(b) of the Series C Certificate of Designation, (b) $100,000 to be retained by 3i to pay the fees of its legal counsel in connection
with the purchase of the Company’s securities by 3i and (c) $1,500,000 to be paid to the Company in immediately available funds
by wire transfer. The number of shares of Common Stock underlying the Closing Warrants and the exercise price thereof give effect to the
Company’s 1-for-25 reverse stock split effective at 12:01 a.m. Eastern Time on August 31, 2026. Such securities were issued under
an exemption from registration pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, and/or Rule 506(b) promulgated thereunder.
The form of the Letter Agreement is attached to this Current Report as Exhibit 10.1.
Pursuant to the Letter Agreement, the Company
also agreed to use its commercially reasonable efforts to (a) file with the Securities and Exchange Commission (the “SEC”),
no later than 30 days from the date of the Closing, a registration statement (the “Registration Statement”) covering the maximum
number of shares of Common Stock issuable upon conversion of the Closing Shares and the shares of Common Stock issuable upon exercise
of the Closing Warrants so as to permit the resale of such securities by 3i, (b) have the Registration Statement declared effective by
the SEC no later than 60 days from the date of the Closing, and (c) keep the Registration Statement effective, including but not limited
to pursuant to Rule 415 promulgated under the Securities Act of 1933, as amended, and available for the resale by 3i of all of the securities
covered thereby at all times until the date on which 3i shall have sold all the securities covered thereby or they cease to require registration
pursuant to the Letter Agreement.
Item 3.02 Unregistered Sales of Equity Securities.
The information contained in Item 1.01 is hereby
incorporated by reference into this Item 3.02.
Item 5.02 Departure of Directors or Certain
Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
Appointment of Jared Malbin to the Board
On August 27, 2026, the Company appointed Jared
Malbin as a member of the board of directors (the “Board”), effective immediately.
Mr. Malbin, 47, has more than 25 years of experience
in the financial services industry, spanning broker-dealer operations, compliance, finance and capital markets. Since 2024, Mr. Malbin
has served as Chief Operating Officer of Lucid Capital Markets, LLC, a boutique investment banking broker-dealer, where he oversees firm
operations and regulatory strategy across the firm’s capital markets and trading businesses. Prior to that, from 2019 to 2024, Mr.
Malbin served in senior executive and management roles at investment firms. He has extensive experience building regulatory and compliance
functions and guiding firms through regulatory examinations and approval processes. Mr. Malbin also serves on the boards of two private
insurance companies. Mr. Malbin holds a Bachelor of Arts degree from Tufts University.
There are no family relationships between Mr. Malbin
and any of the Company’s directors, executive officers or persons nominated or chosen by the Company to become a director or executive
officer. The Company is not aware of any transactions or relationships between Mr. Malbin 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”).
Appointment of Thomas Jensen to the Board
On August 27, 2026, the Company appointed Thomas Jensen
as a member of the Board, effective immediately.
Mr. Jensen, 47, has more than 20 years of global biotechnology
and oncology experience spanning research and development, corporate strategy and business leadership. Since December 2023, Mr. Jensen
has served as Chief Executive Officer of Allarity Therapeutics, Inc. (Nasdaq: ALLR) (“Allarity”), a clinical-stage pharmaceutical
company, where he oversees the advancement of stenoparib, a dual PARP/WNT inhibitor, through Phase 2 trials in advanced ovarian cancer.
Prior to that, Mr. Jensen served as Chief Technology Officer and Head of IT/Investor Relations at Allarity from August 2021 to December
2023. Mr. Jensen currently serves as a director of Allarity and previously served as a director of a Swedish publicly traded investment
company. Mr. Jensen holds a Bachelor of Science degree in Biology from the Technical University of Denmark and conducted further studies
in Biology at the University of Copenhagen.
There are no family relationships between Mr. Jensen
and any of the Company’s directors, executive officers or persons nominated or chosen by the Company to become a director or executive
officer. The Company is not aware of any transactions or relationships between Mr. Jensen and the Company that would require disclosure
under Item 404(a) of Regulation S-K under the Exchange Act.
Item 7.01 Regulation FD Disclosure.
On September 1, 2026, the Company issued a press
release announcing the changes to the Board discussed in Item 5.02 above. A copy of that press release is furnished as Exhibit 99.1 of
this Current Report 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 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 |
|
Letter Agreement between the Company and 3i, LP, dated August 31, 2026. |
| 99.1 |
|
Press Release, dated September 1, 2026. |
| 104 |
|
Cover Page Interactive
Data File (formatted in iXBRL, and included in exhibit 101) |
Forward-Looking Statements
This Current Report 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
or hereafter, including in other publicly available documents filed with the 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 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.
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 1, 2026 |
By: |
/s/ Melinda Lackey |
| |
|
|
Name: Melinda Lackey
Title: General Counsel and Senior Vice President of Legal Affairs |
Exhibit 99.1
FOR IMMEDIATE RELEASE
Valion Bio Announces Changes to Management
and Board of Directors
Current CFO, Lisa Wolf named President and
COO, assuming expanded executive and operational leadership. Jared Malbin and Thomas Jensen appointed as directors.
| · | Lead Asset Positioned for Significant Markets:
Entolimod targets the projected $7.8 billion Acute Radiation Syndrome (“ARS”) market by 2032 and a multi-billion-dollar oncology
supportive-care opportunity through its differentiated dual-tissue cytoprotection platform¹˒² |
| | | |
| · | Focused on Value Creation: Streamlined
leadership and additional Board expertise are designed to accelerate execution, strengthen commercial opportunities and better align Valion’s
market valuation with the underlying value of its assets, capabilities, and future prospects |
SAN ANTONIO, TX
/ September 1, 2026 / -- Valion Bio, Inc. (Nasdaq: VBIO) (“Valion” or the “Company”), a clinical-stage
biopharmaceutical company, today announced strategic changes to its management team and Board of Directors designed to accelerate
execution across its clinical and commercial initiatives and position the Company for its next phase of growth.
The Company’s Board
of Directors has unanimously appointed Lisa Wolf to the expanded roles of President and Chief Operating Officer (“COO”), effective
immediately. Ms. Wolf will continue to serve as Chief Financial Officer (“CFO”) and will assume executive leadership of the
Company following the departure of former Chief Executive Officer, Michael K. Handley.
The expanded role brings
Valion’s financial, operational and strategic functions under unified leadership at an important inflection point for the Company.
Ms. Wolf will oversee the continued advancement of Valion’s lead product candidate, Entolimod, while directing the Company’s
efforts to expand government, international and commercial partnership opportunities.
“Lisa has earned
the deep respect and confidence of the Board, and she is uniquely qualified to lead Valion through this next phase of execution and growth,”
said Sheryle Bolton, Chair of Valion’s Board of Directors. “Valion has built a differentiated combination of proprietary science,
biomanufacturing infrastructure and significant market opportunities. Our priority now is execution — advancing Entolimod, pursuing
commercial and government opportunities, and creating a business model capable of generating sustainable value for shareholders.”
“I am energized
to assume expanded leadership of Valion at this pivotal stage in the Company’s development,” Ms. Wolf said. “Our objective
is clear: translate the potential of Entolimod and our manufacturing platform into meaningful commercial opportunities while maintaining
disciplined capital allocation and execution.
Entolimod has the potential
to address significant unmet needs across both ARS and oncology supportive care. Its differentiated approach to cytoprotection provides
a compelling foundation for pursuing government, institutional and pharmaceutical opportunities.”
Strengthening the
Board for Valion’s Next Phase
The Company also announces
the recent appointments of Thomas Jensen and Jared Malbin as directors to its Board.
Mr. Malbin brings more
than 25 years of financial-services experience spanning broker-dealer operations, compliance, finance and capital markets. He currently
serves as Chief Operating Officer of Lucid Capital Markets, LLC, a boutique investment-banking broker-dealer, where he oversees firm operations
and regulatory strategy across the firm’s capital-markets and trading businesses. He has extensive experience building regulatory
and compliance functions and guiding firms through regulatory examinations and approval processes. Mr. Malbin also serves on the boards
of two private insurance companies. He holds a Bachelor of Arts degree from Tufts University.
Mr. Jensen currently
serves as Chief Executive Officer, Co-Founder and Director of Nasdaq-listed Allarity Therapeutics. Under his leadership, Allarity is advancing
stenoparib, a dual PARP/WNT inhibitor, through Phase 2 trials in advanced ovarian cancer. Mr. Jensen brings more than 20 years of global
biotechnology and oncology experience spanning research and development, corporate strategy and business leadership. He holds a Bachelor
of Science degree in Biology from the Technical University of Denmark and conducted further studies in Biology at the University of Copenhagen.
“We are very pleased
to welcome Jared and Thomas to Valion’s Board,” said Ms. Bolton. “Their combined experience across capital markets,
regulatory strategy, biotechnology, oncology and corporate development significantly strengthens the Board as we enter our next phase.
These appointments also reflect the importance of maintaining strong alignment among Valion, its Board and its shareholders.”
Sources
1 CoherentMI
“Acute Radiation Syndrome Market Size and Share Analysis – Growth Trends and Forecasts” https://www.coherentmi.com/industry-reports/acute-radiation-syndrome-market
2 Market Research.com
“Global Chemotherapy-Induced Neutropenia Treatment Market 2026-2035” https://www.marketresearch.com/Orion-Market-Research-v4261/Global-Chemotherapy-Induced-Neutropenia-Treatment-44733511/
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 Bio 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.
For more information,
visit www.valionbio.com.
Forward-Looking Statements
This press release
contains 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
may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,”
“estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,”
“predict,” “project,” “seek,” “should,” “target,” “will,” “would,”
or similar expressions, although not all forward-looking statements contain these words.
Forward-looking statements
in this press release include, among others, statements regarding: the development and regulatory advancement of Entolimod under the FDA
Animal Rule U.S. or allied-government entities; the timing and outcome of regulatory or government interactions; the potential use of
Entolimod before or after radiation exposure; the product candidate’s potential to address gastrointestinal or hematopoietic radiation
injury; the initiation, design, timing and outcome of physician-sponsored studies in neutropenia; the development and potential applications
of Entolasta; the ability of the Company to expand the TLR5 platform into oncology supportive care or other indications; the scalability,
capacity, economics and strategic benefits of the Company’s manufacturing operations; potential third-party CDMO demand or revenue;
and the Company’s ability to obtain additional capital and execute its business strategy.
These forward-looking
statements are based on Valion Bio’s current expectations, estimates and assumptions and are subject to inherent uncertainties,
risks and assumptions that are difficult to predict. Actual results could differ materially from those expressed or implied by these forward-looking
statements as a result of numerous factors, including 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 outcome of the Company’s engagement
with Ukraine’s Ministry of Health and other allied governments; whether any Request for Information results in a pre-submission
meeting, regulatory authorization, stockpiling agreement, procurement or revenue; the Company’s ability to satisfy the requirements
of the FDA Animal Rule; the timing and success of preclinical and clinical studies; the Company’s ability to achieve expected benefits
from its development and manufacturing assets; changes in relationships with partners, government agencies or other stakeholders; manufacturing,
supply-chain and quality risks; the ability to attract and retain CDMO customers; the Company’s need for and ability to secure additional
working capital; the Company’s ability to maintain its Nasdaq listing; changes in tariffs, inflation, political conditions, legal
requirements, regulatory policy and economic conditions; and other risks described in the Company’s filings with the Securities
and Exchange Commission.
Readers are cautioned
not to place undue reliance on these forward-looking statements. For a discussion of risks and uncertainties relevant to Valion Bio, see
the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, including the section titled “Risk Factors,”
as well as the Company’s subsequent filings with the SEC.
Forward-looking
statements contained in this press release speak only as of the date of this release. Valion Bio undertakes no obligation to update any
forward-looking statement except as required by applicable law.
Investor and Media Contact:
Stephen Kilmer
(646) 274-3580
Stephen.Kilmer@valionbio.com
