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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): October 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 |
Not applicable.
(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 |
|
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.
Item 5.02(b)
On October 27, 2026, Valion Bio, Inc. (the “Company”)
notified Melinda Lackey, the Company’s General Counsel and Senior Vice President of Legal Affairs, of the termination of her employment,
effective October 30, 2026.
Item 5.02(e)
On October 31, 2026, the Company entered into
a Separation Agreement and General Release (the “Separation Agreement”) with Melinda Lackey.
Under the Separation Agreement, subject to Ms.
Lackey’s compliance with its terms and the satisfaction of the conditions set forth therein, the Company agreed to pay Ms. Lackey
a gross cash severance payment of $26,750, less applicable taxes and withholdings, in a single lump-sum payment no later than 30 days
following the effective date of the Separation Agreement.
In addition, if Ms. Lackey is eligible for and
properly elects continued medical or dental coverage under COBRA, the Company agreed to pay the applicable COBRA premiums for Ms. Lackey
and her covered dependents until the earlier of November 30, 2026 or the date on which she becomes eligible for healthcare coverage under
a subsequent employer’s health plan.
The Separation Agreement also provides for a general
release of claims by Ms. Lackey in favor of the Company and certain related parties and includes customary confidentiality, non-disparagement,
cooperation, return-of-property and other continuing obligations. Ms. Lackey agreed to forfeit any unvested equity awards and may exercise
any vested stock options only in accordance with the applicable equity plan documents.
The foregoing description of the Separation Agreement does not purport
to be complete and is qualified in its entirety by reference to the full text of the Separation Agreement, which is filed as Exhibit 10.1
to this Current Report on Form 8-K and incorporated herein by reference.
Item 8.01 Other Events.
On October 30, 2026, Valion Bio, Inc. (the “Company”)
announced the evaluation of its lead biologic drug candidate, Entolimod, by the Armed Forces Radiobiology Research Institute in connection
with research relating to gastrointestinal acute radiation syndrome in a therapeutic efficacy study.
A copy of the Company’s press release is
attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
|
Exhibit
Number
|
|
Description |
| 10.1 |
|
Separation Agreement and General Release, by and between Valion Bio, Inc. and Melinda Lackey. |
| 99.1 |
|
Press Release, dated October 30, 2026. |
| 104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document). |
* Certain personal information has been omitted
from this exhibit pursuant to Item 601(a)(6) of Regulation S-K.
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: |
November 2, 2026 |
By: |
/s/ Dean Zikria |
| |
|
|
Name: Dean Zikria
Title: Interim Chief Executive Officer |
Exhibit 99.1
Valion Bio Advancing Entolimod into
U.S. Government-Funded Therapeutic Efficacy Study Following Positive Safety Results
NIAID-RNCP elects to evaluate the efficacy
of Entolimod on gastrointestinal acute radiation syndrome (“GI-ARS”), after the announcement of positive safety findings
Fully funded study will evaluate Entolimod’s
potential to improve survival rates and gastrointestinal (“GI”) tissue recovery following radiation exposure
Top-line results anticipated in early December,
providing the next key development milestone for Valion Bio’s lead biologic drug candidate and, if positive, will further support
Entolimod’s potential role in government preparedness for radiological and nuclear mass-casualty scenarios
SAN ANTONIO, TX / October 30, 2026 / ACCESS
Newswire -- Valion Bio, Inc. (NASDAQ: VBIO) (“Valion” or the “Company”), a clinical-stage biopharmaceutical company
developing biologics that activate innate immune pathways for cytoprotection and immune modulation, today announced that the Armed Forces
Radiobiology Research Institute (“AFRRI”) will be evaluating the therapeutic efficacy of Entolimod. This phase will evaluate
whether treatment administered after radiation exposure improves survival in a model designed to assess gastrointestinal acute radiation
syndrome (“GI-ARS”).
The therapeutic study is fully funded by the National
Institute of Allergy and Infectious Diseases (“NIAID”)/Radiation and Nuclear Countermeasures Program (“RNCP”)
under an Interagency Agreement with the Uniformed Services University (“USU”)/AFRRI. Top-line results are anticipated in early
December.
The decision to advance the program to the therapeutic
phase comes just days after Valion announced positive safety results. Achieving this milestone uniquely positions Valion Bio, potentially
further strengthening its competitive position, commercial opportunities, and fundamental outlook.
“NIAID’s decision to move into therapeutic
efficacy testing at AFRRI gives Entolimod a clear next milestone following the positive safety findings,” said Dean Zikria, Interim
Chief Executive Officer of Valion Bio. “The central question is now whether treatment after radiation exposure can improve survival
in a model designed to isolate gastrointestinal injury. This fully funded study provides an opportunity to evaluate that potential while
preserving Valion’s capital and generating critical efficacy data to guide Entolimod towards its next stage of development.”
Evaluating Entolimod’s Potential to Improve
Survival Following Radiation Exposure
Entolimod is being developed as a potential medical
countermeasure for both the hematopoietic (or bone marrow) and gastrointestinal (“GI”) forms of acute radiation syndrome (“ARS”).
By shielding roughly 2.5% of the animals’ bone marrow, the upcoming study’s partial-body irradiation model will enable researchers to
differentiate between effects linked to the mitigation of gastrointestinal injury and those associated with recovery.
Mice will receive a single administration of either
Entolimod or saline control 24 hours after radiation exposure and then will be monitored for 30 days. The primary endpoint is survival,
with outcomes to be compared between the treatment and control groups.
“GI-ARS remains a critical challenge in
the development of medical countermeasures,” added Mr. Zikria. “Demonstrating a survival benefit in this model would underscore
a novel and clinically significant milestone for Entolimod and further strengthen its potential role as a medical countermeasure for radiation
emergencies. We would like to thank AFRRI and NIAID for their continued support and look forward to the results from this key study.”
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 (“ARS”) 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 holds an exclusive, worldwide license from Statera Biopharma to develop and commercialize Entolimod for ARS, radiation-induced
neutropenia, and other indications.
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. Forward-looking statements in this press release include, among others, statements regarding: the timing and success of preclinical
and clinical trials and study results, including the AFRRI/NIAID studies described herein; the development and regulatory advancement
of Entolimod under the FDA Animal Rule; the timing and outcome of regulatory or government interactions; the initiation, design,
timing and outcome of investigator-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; and the Company’s ability to obtain
additional capital and the continued listing of the Company’s common stock 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
