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“expects,” “estimates,” “believes,” “will” and similar expressions, as they relate to
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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
