Form 8-K

8-K — Valion Bio, Inc.

Accession: 0001683168-26-007514

Filed: 2026-10-01

Period: 2026-09-30

CIK: 0001787740

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Other Events

Item: Financial Statements and Exhibits

Documents

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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 30, 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

8.01. Other Matters.

On September

30, 2026, Valion Bio, Inc. (the “Company”) issued a press release announcing the completion of formulation work to develop

a novel oral mucosal formulation of Entolimod using Shear Kershman Laboratories’ proprietary BioViscid™ drug-delivery platform.

A copy of

the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K (this “Current Report”) and is incorporated

herein by reference.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

Exhibit

Number

Description

99.1

Press Release, dated September 30, 2026.

104

Cover Page Interactive Data File (embedded within the Inline XBRL document).

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 Exhibits

99.1 and 99.2 attached hereto, or hereafter, including in other publicly available documents filed with the Securities and Exchange Commission

(the “SEC”), 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 SEC, 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 and adversely 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:

October 1, 2026

By:

/s/ Dean Zikria

Name: Dean Zikria

Title: Interim Chief Executive Officer

EX-99.1 — PRESS RELEASE

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Exhibit 99.1

Valion Bio and Shear Kershman Laboratories

Successfully Formulate Oral Mucosal Entolimod; Valion Sees Potential for Multi-Fold Expansion of Long-Term Opportunity

Needle-free program creates a potential second development pathway

alongside Valion's injectable Entolimod program

Next study will test whether the formulation

delivers measurable amounts of Entolimod into the bloodstream

SAN ANTONIO, TX / September 30, 2026 / -- Valion

Bio, Inc. (Nasdaq: VBIO) ("Valion" or the "Company") and Shear Kershman Laboratories ("SKL") today announced

the successful completion of formulation work under the companies' ongoing program to develop a novel oral mucosal formulation of Entolimod*,

Valion's investigational biologic aimed at protecting cells from severe damage or death from radiation exposure, using SKL's proprietary

BioViscid™ drug-delivery platform.

The milestone advances a potential second delivery

pathway for Entolimod, which has historically been administered by injection. The BioViscid™-Entolimod formulation is designed to

deliver Entolimod through the lining of the mouth. If further studies demonstrate effective delivery and the product receives appropriate

authorization or approval, a needle-free formulation could significantly expand how and where Entolimod is deployed during radiological

or nuclear emergencies.

"The opportunity we are investigating goes

beyond changing how Entolimod is administered," said Dean Zikria, Interim Chief Executive Officer of Valion. "An oral gel formulation

with demonstrated systemic delivery, appropriate stability and an approved or authorized use could allow us to explore deployment models

that are difficult to achieve with an injectable product."

A Potential Role for Entolimod Before and After

Exposure

In published animal studies of injected Entolimod

given before lethal radiation, mice were protected from both the gastrointestinal and hematopoietic forms of acute radiation syndrome

("ARS"). In a separate study, non-human primates given injected Entolimod 48 hours after exposure showed improved survival,

with faster recovery of the bone marrow and the lining of the gut.1,2

The distinction matters for preparedness. All

current U.S. Food and Drug Administration (FDA)-approved products address only the hematopoietic, or bone marrow, form of ARS in patients

who have already been exposed to myelosuppressive doses of radiation. No treatment is currently approved for the gastrointestinal indication.3

A product demonstrated to work for both forms, before and/or after exposure, and suitable for distribution to personnel in advance, could

serve an additional use case.

Valion believes successful development could support

evaluation of:

· Distributed readiness: Supplying Entolimod

doses to designated military or emergency-response personnel in advance of potential exposure.

· Needle-free administration: Reducing reliance

on injections and the personnel and supplies needed to give them.

· Simpler storage and transport: Testing

whether the formulation can achieve stability that eases storage and deployment, potentially including eliminating or reducing refrigeration

needs.

How Valion Views the Potential Oral Mucosal

Delivery Opportunity

If oral mucosal Entolimod is successfully developed

and authorized or approved, the number of doses potentially required in the United States could be approximately 10 to 40 times that of

Valion's injectable program. The estimate assumes that every one of about 2.0 million active-duty and Selected Reserve service members,

1.0 million firefighters and 790,000 full-time sworn law enforcement officers is supplied.4,5,6,7,8 It is an estimate of a

possible addressable opportunity, not a revenue forecast, an estimate of committed purchases, or a measure of demonstrated demand. Its

realization depends on product performance, regulatory decisions, procurement priorities and funding.

"Our injectable program remains a priority,"

said Mr. Zikria. "The oral mucosal program allows us to investigate whether Entolimod could eventually serve additional preparedness

needs. We look forward to additional stability, systemic-delivery, safety and efficacy data, which will help us determine the full potential

of this program."

Next Milestone: Evaluating Systemic Exposure

Oral mucosal delivery is being investigated because

it is designed to enable absorption across the oral mucosa and into systemic circulation, potentially avoiding gastrointestinal degradation

and first-pass metabolism associated with conventional oral delivery of biologic molecules, such as swallowing tablets or capsules.9

"Successfully incorporating Entolimod into

BioViscid™ and completing this stage of formulation work represents an important technical milestone," said Dr. Blake Hawley,

Principal of Shear Kershman Laboratories. "We can now move toward answering the next key question: whether oral mucosal administration

produces measurable systemic exposure to Entolimod and, if so, characterizing the pharmacokinetic profile of that absorption."

Demonstration of systemic exposure would represent

the next key development milestone for the needle-free program and would inform subsequent formulation optimization, dosing and development

activities.

* Valion holds an exclusive worldwide license

from Statera Biopharma to develop and commercialize Entolimod for acute radiation syndrome, radiation-induced neutropenia with an exclusive

option for other indications.

Sources

1 Burdelya LG, et al. Science. 2008;320(5873):226-230.

doi:10.1126/science.1154986. .

2 Krivokrysenko VI, et al. PLoS One.

2015;10(9):e0135388. doi:10.1371/journal.pone.0135388

3 U.S. FDA, Radiological and Nuclear

Emergency Preparedness, approved medical countermeasures (accessed September 2026).

4 Radiation Injury Treatment Network.

Concept of Operations (CONOPS), November 13, 2020, Table 1. ritn.net.

5 Knebel AR, Coleman CN, Cliffer KD,

et al. (HHS/ASPR). Allocation of scarce resources after a nuclear detonation: setting the context. Disaster Med Public Health Prep. 2011;5(Suppl

1):S20–S31. doi:10.1001/dmp.2011.25.

6 U.S. Department of Defense. 2024

Demographics: Profile of the Military Community. Table 1.02 and Table 2.03. militaryonesource.mil.

7 National Fire Protection Association.

Number of Firefighters in the U.S. 2023: nfpa.org.

8 U.S. Bureau of Justice Statistics.

Census of State and Local Law Enforcement Agencies, 2018 Statistical Tables (NCJ 302187, October 2022): bjs.ojp.gov.

9 Zhang H, Zhang J, Streisand JB. "Oral

mucosal drug delivery: clinical pharmacokinetics and therapeutic applications." Clin Pharmacokinet. 2002;41(9):661-80. doi: 10.2165/00003088-200241090-00003.

PMID: 12126458.

About Shear Kershman

Laboratories

Shear Kershman Laboratories

is a pharmaceutical technology company developing proprietary drug-delivery technologies designed to address formulation and delivery

challenges across a range of therapeutic compounds. SKL’s lead platform, BioViscid™, is a proprietary amphipathic, bio-adhesive

mucosal delivery system designed for application to oral and other mucosal tissues. The platform is being developed for use with a range

of active pharmaceutical ingredients, including small molecules, peptides and proteins. SKL is headquartered in Chesterfield, Missouri.

For more information,

visit www.shearkershmanlabs.com

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

product 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.

Beyond its ARS medical

countermeasure development program, Entolimod is also being evaluated for its potential to protect healthy tissue during cancer treatment.

Sheba Medical Center, a leading global clinical research institution, recently selected Entolimod for an investigator-sponsored clinical

trial evaluating its potential to reduce radiation-induced neutropenia and protect healthy tissue in patients undergoing radiation therapy.

Valion Bio is also advancing

Entolasta, a next-generation TLR5 agonist designed for potential use in broader therapeutic applications, including oncology supportive

care.

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 development and regulatory advancement of Entolimod under the FDA Animal Rule; the timing and outcome of regulatory or

government interactions; the potential of oral mucosal administration to produce measurable systemic exposure to Entolimod and, if so,

the potential to characterize the pharmacokinetic profile of that absorption; the potential use of Entolimod before or after radiation

exposure; the product candidate’s potential to address gastrointestinal or hematopoietic radiation injury; the portability and stability

of an oral mucosal version of the product candidate, the interest of governments or other entities in stockpiling and/or prophylactic

administration to its personnel, the addressable opportunity scale, interest and/or success, 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

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