Valion Bio and Shear Kershman Laboratories Successfully Formulate Oral Mucosal Entolimod; Valion Sees Potential for Multi-Fold Expansion of Long-Term Opportunity

Bloodstream exposure is the next development milestone before further formulation optimization and dosing work.

Rhea-AI Summary

Valion Bio (NASDAQ:VBIO) and Shear Kershman Laboratories completed formulation work on oral mucosal Entolimod, advancing a potential alternative to injections. The investigational radiation-protection biologic was incorporated into SKL's BioViscid platform for delivery through the mouth lining. The next milestone is determining whether this route produces measurable exposure in the bloodstream and characterizing absorption.

Published studies of injected Entolimod showed protection in mice treated before radiation and improved survival in non-human primates treated 48 hours afterward. These results do not establish oral formulation performance. Valion estimates potential U.S. dose requirements could be approximately 10 to 40 times those of its injectable program if development and authorization or approval succeed. This is not a revenue forecast or committed demand; realization depends on performance, regulatory decisions, procurement priorities and funding.

Positive

• Minor pointOral mucosal Entolimod formulation work completed with Shear Kershman Laboratories using BioViscid.
• Minor pointInjected Entolimod protected mice against gastrointestinal and bone-marrow acute radiation syndrome when given before lethal radiation.
• Minor pointInjected Entolimod improved survival in non-human primates treated 48 hours after exposure, with faster marrow and gut-lining recovery.
• Minor point. Forward-looking: it has not happened yet and may not happen.Systemic-exposure evaluation is the next milestone to inform formulation optimization, dosing and development.

Negative

• Minor pointOral mucosal systemic exposure remains unproven; measurable bloodstream delivery and absorption characteristics still require evaluation.
• Minor point. Forward-looking: it has not happened yet and may not happen.Potential deployment expansion depends on product performance, regulatory decisions, procurement priorities and funding.

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Details

Market move: VBIO +33.19% vs previous close. oral formulation milestone

+38.2% Peak in 25 min

$2.73 – $3.92 Day Range

$3.35M Market Cap

On Sep 30, the day this news came out, the latest delayed price for VBIO is 33.19% above the previous close. Argus tracked a peak move of +38.2% during the session. Our momentum scanner has recorded 43 alerts for this stock so far that day. The latest delayed price is $3.77. Relative volume is exceptionally heavy at 10497.0x the average.

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Key Figures

Potential dose requirement: 10 to 40 times Military personnel in estimate: about 2.0 million people Firefighters in estimate: 1.0 million people +1 more

Potential dose requirement

10 to 40 times

Potential U.S. doses versus Valion's injectable program if oral mucosal Entolimod is developed and authorized or approved

Military personnel in estimate

about 2.0 million people

Active-duty and Selected Reserve members included in the addressable-opportunity estimate

Firefighters in estimate

1.0 million people

Population included in the addressable-opportunity estimate

Law enforcement officers in estimate

790,000 officers

Full-time sworn officers included in the addressable-opportunity estimate

Key Terms

acute radiation syndrome, myelosuppressive doses, first-pass metabolism, pharmacokinetic profile, +1 more

5 terms

acute radiation syndrome medical

"mice were protected from both the gastrointestinal and hematopoietic forms of acute radiation syndrome"

Acute radiation syndrome is the sudden illness that happens after a person absorbs a large dose of ionizing radiation in a short time, damaging blood cells, the gut, skin, and other organs. Think of it like a severe, internal burn that can impair a person’s ability to heal and fight infection. Investors watch it because outbreaks, accidents, or tests can trigger urgent regulatory action, reshape demand for medical treatments and protective equipment, create liability risks, and affect the operations and stock prices of companies in healthcare, energy, insurance, and related supply chains.

myelosuppressive doses medical

"patients who have already been exposed to myelosuppressive doses of radiation"

Doses of a drug or radiation large enough to significantly reduce bone marrow activity, lowering production of blood cells (white cells, red cells and platelets). The effect happens because the therapy damages dividing marrow cells; the severity and duration depend on the specific agent, dose and individual patient, and may require medical monitoring and supportive measures such as growth factors or transfusions.

first-pass metabolism medical

"degradation and first-pass metabolism associated with conventional oral delivery"

First-pass metabolism is the process by which a drug taken by mouth is partly broken down in the gut wall and liver before it reaches the bloodstream, so less active medicine is available to the body. For investors, it matters because a high first-pass effect can force higher doses, different formulations or alternative delivery methods, increasing development cost, regulatory complexity and the commercial attractiveness of a drug—think of it as a filter that removes part of the product before it reaches customers.

pharmacokinetic profile medical

"characterizing the pharmacokinetic profile of that absorption"

The pharmacokinetic profile describes how a drug moves through the body over time, including how quickly it is absorbed, how it spreads, and how it is eventually eliminated. For investors, understanding this profile helps gauge the drug’s effectiveness, safety, and the appropriate dosing schedule, which can influence a company’s potential success and market value. It provides insight into how a medication behaves, impacting its overall commercial viability.

animal rule regulatory

"evaluated in animal models under the U.S. Food and Drug Administration's ("FDA") Animal Rule"

A regulatory pathway that allows safety and effectiveness of drugs or vaccines to be judged primarily from well-controlled animal studies when human trials would be unethical or impossible, such as for treatments against rare, lethal exposures. It matters to investors because approval via this route can speed a product to market for urgent or niche needs but carries extra scientific and regulatory risk—think of it as accepting a high-quality dress rehearsal instead of a live show, with requirements for strong animal models and often additional post-approval obligations.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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SAN ANTONIO, TX / ACCESS Newswire / 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

SOURCE: Valion Bio, Inc.

View the original press release on ACCESS Newswire

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What milestone did Valion Bio complete for oral mucosal Entolimod?

Valion Bio and Shear Kershman Laboratories completed formulation work incorporating Entolimod into BioViscid for delivery through the mouth lining. The next milestone is evaluating whether administration produces measurable exposure in the bloodstream and characterizing absorption.

What does Valion Bio's 10-to-40-times Entolimod opportunity estimate mean?

Valion estimates potential U.S. dose requirements could be approximately 10 to 40 times those of its injectable program if oral mucosal Entolimod is successfully developed and authorized or approved. The estimate assumes supplying every member of the identified military, firefighter and law-enforcement populations; it is not a revenue forecast, committed purchases or demonstrated demand.

What development possibilities is Valion Bio evaluating for oral mucosal Entolimod?

Valion believes successful development could support evaluating advance distribution to designated military or emergency-response personnel, reduced reliance on injections, and simpler storage and transport. Stability testing would assess whether refrigeration needs could be eliminated or reduced; those storage benefits have not been established.

What rights does Valion Bio hold to develop Entolimod?

Valion holds an exclusive worldwide license from Statera Biopharma to develop and commercialize Entolimod for acute radiation syndrome and radiation-induced neutropenia. The license also includes an exclusive option for other indications.