Rising electricity demand from AI and data centers is driving plans to expand nuclear power capacity, possibly including on-site small modular reactors (SMRs)¹
Medical countermeasures need to scale along with that infrastructure
Valion is developing an oral mucosal formulation of Entolimod that could potentially provide a needle-free administration option for acute radiation syndrome ("ARS")
SAN ANTONIO, TX / ACCESS Newswire / October 9, 2026 / As nuclear power assumes an increasingly important role in meeting the growing electricity requirements of artificial intelligence, data centers and other digital infrastructure, the expansion of the U.S. nuclear-energy landscape that has been increasingly making headlines across the country is also highlighting the importance of resilient emergency preparedness and medical countermeasures for potential radiological and nuclear events.
Against this backdrop, Valion Bio, Inc. (Nasdaq:VBIO) ("Valion" or the "Company"), a clinical-stage biopharmaceutical company developing biologics that activate innate immune pathways for cytoprotection, believes the evolving U.S. nuclear energy landscape reinforces the importance of advancing medical countermeasures that could be deployed rapidly and at population scale in the event of a radiological or nuclear emergency.
"The significance of the changing nuclear landscape1 extends beyond how electricity is generated - it also raises important questions about how communities and emergency systems prepare for low-probability, high-consequence radiation events," said Dean Zikria, Interim Chief Executive Officer of Valion Bio.
Entolimod, Valion's investigational drug biologic being developed for ARS is designed to potentially protect cells from severe damage or death both prophylactically (pre-exposure) and therapeutically (post-exposure). Historically administered by intramuscular injection, Entolimod is now the subject of an oral mucosal formulation-development program with Shear Kershman Laboratories ("SKL") utilizing SKL's proprietary BioViscid drug-delivery platform.
Valion and SKL recently successfully completed formulation work under their ongoing program to develop a novel oral mucosal formulation of Entolimod. The resulting BioViscid-Entolimod formulation is designed to enable absorption through the oral mucosa, potentially providing a needle-free alternative to injectable administration.
A Countermeasure Designed for Scale
If successfully developed and approved, Valion believes a needle-free formulation of Entolimod could potentially change how a radiation countermeasure is stored, distributed and administered. Potential operational advantages include:
- Utility potential before and after radiation exposure: Published animal studies of injected Entolimod have demonstrated protection against lethal radiation when administered before exposure, including protection involving both hematopoietic and gastrointestinal tissues. Separate non-human-primate research has reported improved survival and recovery of bone marrow and intestinal tissue when Entolimod was administered after radiation exposure.2,3 These findings support the scientific rationale for investigating Entolimod as a potential countermeasure across different phases of a radiation event.
- Potential multi-tissue cytoprotection: Current FDA-approved medical countermeasures for ARS address the hematopoietic, or bone-marrow, component of radiation injury in patients exposed to myelosuppressive doses of radiation. No treatment is currently approved for the gastrointestinal component of ARS.4 Entolimod's development program is investigating its potential to provide broader cytoprotection, including effects involving both hematopoietic and gastrointestinal tissues.
- Needle-free administration at potentially unprecedented scale: In a mass-casualty radiological or nuclear event, the number of people requiring medical countermeasures could quickly exceed the capacity of conventional healthcare delivery systems. A successfully developed oral mucosal formulation could potentially reduce dependence on trained personnel to administer injections and create new models for rapid distribution and administration across large populations.
- Two potential paths to preparedness, injectable and needle-free: Valion's oral mucosal program is intended to create an additional development and deployment pathway alongside its injectable Entolimod program. Different formulations could ultimately serve different preparedness requirements depending on pharmacokinetics, stability, dosing, regulatory status and procurement needs.
"Nuclear power, AI-driven data centers and the push for resilient critical infrastructure are converging at the same time, and we believe medical preparedness should evolve alongside them," Mr. Zikria continued. "Our goal is to create the ability to administer Entolimod in a more flexible, scalable and field-deployable approach to radiation protection for both military and civilian populations."
Sources
1 International Atomic Energy Agency, Wolfgang Picot, "Reimagining emergency preparedness and response for tomorrow's nuclear fleet," https://www.iaea.org/bulletin/reimagining-emergency-preparedness-and-response-for-tomorrows-nuclear-fleet
2 Burdelya LG, et al. Science. 2008;320(5873):226-230. doi:10.1126/science.1154986.
3 Krivokrysenko VI, et al. PLoS One. 2015;10(9):e0135388. doi:10.1371/journal.pone.0135388.
4 U.S. FDA, Radiological and Nuclear Emergency Preparedness, approved medical countermeasures (last accessed October 2026).
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 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 Syndrome ("ARS"). Entolimod is a novel Toll-like Receptor 5 agonist designed to activate NF-?B 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 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.
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