Valion Bio Reinforces Commitment to American Troops; Discusses Entolimod with Attendees at RW Baird's National Security Conference

NIAID is funding the Entolimod therapeutic study through its Radiation and Nuclear Countermeasures Program.

Rhea-AI Summary

Valion Bio (NASDAQ:VBIO) will attend RW Baird’s National Security Conference on November 17 in Washington, D.C., to discuss Entolimod.

Management plans to discuss the drug candidate’s potential to protect service members from radiation exposure. Following positive findings in a preclinical safety study, Valion is working with the government to evaluate whether a single dose given 24 hours after radiation exposure improves survival in an animal model of gastrointestinal acute radiation syndrome, which affects the digestive tract. The company anticipates top-line results in early December.

Positive

• Minor pointEntolimod showed positive findings in a preclinical safety study.
• Minor pointNIAID funding supports the therapeutic study through its Radiation and Nuclear Countermeasures Program.
• Minor point. Forward-looking: it has not happened yet and may not happen.Valion anticipates top-line results in early December from the animal-model therapeutic study.

Negative

• None.

Key Figures

Dose regimen: 1 dose Treatment timing: 24 hours after radiation exposure Top-line results timing: Early December

Dose regimen

1 dose

Entolimod therapeutic study in an animal model

Treatment timing

24 hours after radiation exposure

Entolimod therapeutic study

Top-line results timing

Early December

Entolimod therapeutic study

Historical Context

2 past events · Latest: Oct 30

2 events

1. Oct 30

   Funded efficacy study

   24h Move

   -10.8%

   Announced a funded post-radiation efficacy study with a survival endpoint and early-December results.

2. Oct 28

   Preclinical safety results

   24h Move

   -13.2%

   Reported no treatment-related toxicity, supporting planned therapeutic evaluation for gastrointestinal radiation syndrome.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

acute radiation syndrome, animal rule, fast track, orphan drug designation, +2 more

6 terms

acute radiation syndrome medical

"both the bone marrow and gastrointestinal 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.

animal rule regulatory

"evaluated in animal models under the U.S. Food and Drug Administration's 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.

fast track regulatory

"received Fast Track and Orphan Drug designations from the FDA"

A fast track designation is a regulatory label that speeds up the review and communication between a drug developer and regulators for treatments addressing serious illnesses or unmet medical needs. For investors, it matters because it can shorten development time and reduce regulatory delays—like getting a VIP lane at the airport—raising the chance of earlier market access and potential revenue, though it does not guarantee approval.

orphan drug designation regulatory

"received Fast Track and Orphan Drug designations from the FDA"

Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

toll-like receptor 5 agonist medical

"a novel Toll-like Receptor 5 (TLR5) agonist designed to activate"

A toll-like receptor 5 (TLR5) agonist is a drug or molecule that binds to and activates TLR5, a protein on certain immune cells that senses bacterial flagellin and triggers innate immune responses. Think of TLR5 as a doorbell on immune cells and an agonist as the button that rings it, prompting inflammation or immune activation; investors care because this mechanism is used in vaccines and cancer or infectious‑disease therapies and affects clinical effects, safety, and regulatory review.

biologics contract development and manufacturing organization technical

"a biologics contract development and manufacturing organization (CDMO)"

A biologics contract development and manufacturing organization (biologics CDMO) is a company that provides outsourced services to create and make biological medicines for other firms. Services typically include process development, technology transfer, scale-up, Good Manufacturing Practice (GMP) clinical and commercial production, analytical testing, and filling/finishing for products such as proteins, monoclonal antibodies, vaccines, cell and gene therapies; the CDMO operates under regulatory quality systems and produces batches to a client's specifications rather than marketing the drug itself. The term applies specifically to work on large-molecule, biologically derived therapies (not conventional small‑molecule drugs) and can cover anything from early clinical supply to full commercial manufacturing depending on the provider's capabilities.

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

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

SAN ANTONIO, TX / ACCESS Newswire / November 11, 2026 / Valion Bio, Inc. (NASDAQ:VBIO) ("Valion" or the "Company"), a clinical-stage biopharmaceutical company developing biologics that activate innate immune pathways for cytoprotection and immune modulation, today, on Veterans Day, announced that it will attend RW Baird's 2026 National Security Conference on November 17 in Washington, D.C. In conversations with defense stakeholders and institutional investors at the conference, management will discuss how Entolimod, Valion's lead biologic drug candidate, could help protect U.S. service members from the effects of radiation exposure.

Following positive findings in a preclinical safety study, Valion is currently working with the government to evaluate whether a single dose of Entolimod given 24 hours after radiation exposure improves survival in an animal model of gastrointestinal acute radiation syndrome (GI-ARS). The National Institute of Allergy and Infectious Diseases ("NIAID") is funding the therapeutic study through its Radiation and Nuclear Countermeasures Program. Top-line results are anticipated in early December.

Valion Bio is developing Entolimod as a potential countermeasure for both the bone marrow and gastrointestinal forms of acute radiation syndrome. Valion briefed Pentagon officials on Entolimod in April and held a joint briefing in May for senior U.S. defense officials and the Biomedical Advanced Research and Development Authority (BARDA). In June, the U.S. House Armed Services Committee called for a plan to develop a resources and fielding plan for prioritizing radiation/nuclear countermeasures that, like Entolimod, are designed to be both prophylactic (pre-exposure) and therapeutic (post-exposure).

"We hope U.S. service members never face a nuclear or radiological incident. But if they do, the military needs medical options it can use in the field," said Dean Zikria, Valion's Interim Chief Executive Officer. "With imminent NIAID-funded efficacy data on the horizon and clear legislative momentum from the House Armed Services Committee, our participation at RW Baird's National Security Conference provides a timely platform to engage directly with defense stakeholders on the potential of Entolimod to meet their immediate preparedness requirements."

About Valion Bio, Inc.

Valion (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 ("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 ("TLR5") agonist designed to activate nuclear factor kappa (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. 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 (CDMO) with mammalian and microbial capabilities, focused on 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 timing and success of preclinical and clinical trials and study results, including the AFRRI/NIAID study described herein; the development and regulatory advancement of Entolimod under the FDA Animal Rule; the timing and outcome of regulatory or government interactions;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 is Valion Bio’s current Entolimod radiation study evaluating?

The study evaluates whether a single dose of Entolimod given 24 hours after radiation exposure improves survival in an animal model of gastrointestinal acute radiation syndrome. Valion anticipates top-line results in early December.