Valion and SKL complete oral mucosal Entolimod formulation

Valion Bio, Inc. (Nasdaq: VBIO) and Shear Kershman Laboratories, or SKL, said they have completed formulation work on an oral mucosal version of Entolimod, the company's investigational biologic for radiation exposure. The release is dated September 30, 2026, and was filed as Exhibit 99.1 to a Form 8-K. The formulation uses SKL's BioViscid platform, a bio-adhesive mucosal delivery system designed to deliver Entolimod through the lining of the mouth. Valion calls the milestone a potential second delivery pathway for Entolimod, which has historically been given by injection.

Why a second delivery route matters

Dean Zikria, Valion's interim chief executive officer, said: "The opportunity we are investigating goes beyond changing how Entolimod is administered." He added that an oral gel with demonstrated systemic delivery, appropriate stability and an approved or authorized use could allow the company to explore deployment models that are difficult to achieve with an injectable product.

The release says that in published animal studies, injected Entolimod given before lethal radiation protected mice from both the gastrointestinal and hematopoietic forms of acute radiation syndrome. 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. Valion notes that all current U.S. Food and Drug Administration-approved products address only the hematopoietic, or bone marrow, form of the syndrome, and that no treatment is currently approved for the gastrointestinal indication.

Valion believes a product that works for both forms, before or after exposure, and that can be given to personnel in advance could serve an additional use case. The release lists three possible benefits: doses supplied in advance to designated military or emergency-response personnel, needle-free administration, and simpler storage and transport, potentially including reduced refrigeration needs.

The opportunity Valion describes

Valion says that 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 its 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. The release calls this an estimate of a possible addressable opportunity, not a revenue forecast, an estimate of committed purchases, or a measure of demonstrated demand. It says realization depends on product performance, regulatory decisions, procurement priorities and funding.

The next milestone

SKL's principal, Dr. Blake Hawley, said the next key question is whether oral mucosal administration produces measurable systemic exposure to Entolimod and, if so, what the pharmacokinetic profile of that absorption looks like. The release describes demonstration of systemic exposure as the next key development milestone for the needle-free program.

Background and financial position

Valion holds an exclusive worldwide license from Statera Biopharma to develop and commercialize Entolimod for acute radiation syndrome and radiation-induced neutropenia, with an exclusive option for other indications. It has received Fast Track and Orphan Drug designations from the FDA.

The company's SEC financial data show the following. Valion Bio reported revenue of $780,000 for 2024. Its net loss was $8.9 million for 2025, against $5.7 million for 2024. Cash used in operations was $7.0 million for 2025, compared with $5.7 million for 2024. Research and development expense was $3.1 million for 2025, compared with $1.3 million for 2024. Cash and cash equivalents were $2.0 million at the end of 2024. At June 30, 2026, cash and cash equivalents were $2.1 million, according to the quarterly report.

The risks ahead

Systemic exposure from the oral gel has not been shown, and the release calls it the next key development milestone. It gives no date for that study. Valion says its dose estimate is not a revenue forecast or a measure of demonstrated demand, and that realization depends on product performance, regulatory decisions, procurement priorities and funding. Cash and cash equivalents were $2.1 million at June 30, 2026, against cash used in operations of $7.0 million for 2025 and a net loss of $8.9 million. The animal results the release cites are for injected Entolimod, and it reports no data on the oral gel in animals or people.

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