Potential Fourth-Quarter 2026 Decision Could Mark Entolimod’s First National Registration and Open a Pathway to Strategic Stockpiling and Government Procurement

Formal review accepted July 22 • Ministry begins technical assessment • Regulatory requirements defined • Potential decision as early as Q4 2026

Near-Term Regulatory Catalyst

Formal review underway: Ukraine’s Ministry of Health accepted the Entolimod dossier for formal review on July 22, 2026.

Technical assessment underway: Ukraine’s Ministry of Health has begun technical assessment of the dossier and issued its first round of questions, relating to the physicochemical characterization of the drug product that would be supplied under a potential stockpiling arrangement.

Defined pathway: The Company has identified the analytical testing, quality-control validation, GMP verification, import-documentation, and Ukrainian-language labeling requirements applicable to the registration process.

Potential Q4 decision: Valion Bio believes a regulatory decision could occur as early as the fourth quarter of 2026; there can be no assurance regarding timing or outcome.

First potential national registration: A favorable decision would represent Entolimod’s first national registration.

Potential government-market pathway: Registration could establish a pathway toward possible inclusion in Ukraine’s national strategic reserves and future government procurement. No procurement, purchase, or stockpiling agreement has been executed.

SAN ANTONIO, TX / ACCESS Newswire / August 13, 2026 / Valion Bio, Inc. (Nasdaq:VBIO), a clinical-stage immunotherapeutics company, today announced that Ukraine’s Ministry of Health has accepted the Company’s regulatory dossier for Entolimod for formal review under the country’s Regulatory Equivalence Pathway. Entolimod is Valion Bio’s investigational medical countermeasure for acute radiation syndrome (ARS).

The dossier was accepted on July 22, 2026. The Ministry has since begun technical assessment of the dossier and issued its first round of questions, relating to the physicochemical characterization of the drug product that would be supplied under a potential stockpiling arrangement, which the Company is preparing to address. Valion Bio has since identified the documentation, analytical-testing, quality-control, manufacturing, import, and labeling requirements needed to advance the review. The Company believes a regulatory decision could occur as early as the fourth quarter of 2026, although timing and outcome remain subject to the Ministry’s review, any additional information requests, and operational circumstances.

Why This Matters

Ukraine’s formal review follows the Ministry’s previously disclosed Request for Information regarding the potential inclusion of Entolimod in the country’s national strategic reserves. If registered, Entolimod could advance from regulatory review toward potential government procurement and strategic stockpiling as a medical countermeasure for ARS.

The review is occurring amid heightened geopolitical concerns and increased government attention to preparedness for radiological and nuclear emergencies. Entolimod is designed to protect both the hematopoietic system and the gastrointestinal tract from radiation injury. In nonhuman primate and mouse studies, Entolimod reduced radiation-induced damage to both bone marrow and gastrointestinal tissue, an effect the Company believes may differentiate it from available or stockpiled approaches that primarily target bone-marrow recovery.

Registration and procurement are separate processes. No procurement commitment, purchase agreement, or stockpiling agreement has been established, and registration alone would not result in revenue.

Ukraine Regulatory Pathway

The filing and supporting materials remain subject to expert review by Ukraine’s State Expert Center and Ministry of Health. The identified requirements include:

  • Completion of a defined analytical-testing program

  • Formal validation of quality-control methods

  • Verification of GMP compliance for the manufacturing site

  • Applicable import documentation

  • Ukrainian-language labeling

Ukraine’s facilitated recognition process could permit a regulatory decision as early as the fourth quarter of 2026. Actual timing depends on the Ministry’s review, any additional information requests, and operational circumstances. There can be no assurance that a decision will be issued within this period or that the outcome will be favorable.

Management Commentary

“Ukraine’s acceptance of the Entolimod dossier for formal review is a concrete regulatory milestone and establishes a defined path toward a potential decision as early as the fourth quarter of 2026,” said Michael Handley, Chief Executive Officer of Valion Bio. “A favorable outcome would mark Entolimod’s first national registration and could, subject to separate procurement processes, open a pathway toward potential strategic stockpiling and government procurement.”

“According to the World Health Organization, the war in Ukraine continues to present radiological and nuclear risks, underscoring the importance of preparedness and access to medical countermeasures that could help protect the country’s citizens,” Handley continued. “Entolimod’s potential to protect both the hematopoietic system and gastrointestinal tract could address a critical need in radiation preparedness.”

About Entolimod

Entolimod is an investigational Toll-like receptor 5 (TLR5) agonist that activates NF-κB signaling pathways to protect cells from damage and stimulate immune responses. Valion Bio is developing Entolimod as a potential medical countermeasure for ARS. Entolimod has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration. These are development designations and do not constitute marketing approval in the United States or elsewhere.

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 for ARS, has been extensively studied and has demonstrated survival benefits and improved tissue recovery in animal models under the FDA’s Animal Rule.

Valion Bio is also advancing Entolasta, a next-generation TLR5 agonist designed for potential broader therapeutic applications, including oncology supportive care. The Company’s pipeline includes potential treatments for neutropenia and lymphocyte exhaustion. Valion Bio’s wholly owned subsidiary, Velocity Bioworks®, is a full-service CDMO offering biomanufacturing services to third-party biotech companies, which Valion Bio also leverages to advance its own pipeline with the expected benefits of lower costs, accelerated manufacturing outcomes, and supply-chain security. For more information, visit valionbio.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, are forward-looking statements, including without limitation statements regarding the timing and outcome of Ukraine’s regulatory review, the potential for national registration, the possibility of future government procurement or stockpiling, the Company’s product differentiation claims, and the Company’s ability to satisfy regulatory requirements. Forward-looking statements may be identified by words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or similar expressions, although not all forward-looking statements contain these words.

Forward-looking statements are based on Valion Bio, Inc.’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. These include the Company’s interactions with and guidance from the FDA and other regulatory authorities; continued interest of BARDA and other U.S. government agencies in Entolimod; the timing and outcome of engagement with the Ukrainian Ministry of Health and other allied governments; whether any Request for Information or regulatory review results in approval, a pre-submission meeting, stockpiling agreement, procurement, or revenue; the ability to satisfy analytical-testing, quality-control, GMP, import, labeling, and other requirements; geopolitical developments, including ongoing hostilities in Ukraine, that could disrupt or terminate the regulatory process; the ability to achieve expected benefits from acquired development and manufacturing assets; changes in partner relationships; failure to obtain regulatory approvals or comply with applicable regulations, including the Animal Rule; future development of Entolimod or Entolasta; timing and success of preclinical and clinical studies; commercialization and strategic-transaction risks; working-capital needs; Nasdaq-listing risks; and changes in tariffs, inflation, legal, regulatory, political, and economic conditions.

Readers are cautioned not to place undue reliance on forward-looking statements. The foregoing list of risk factors is not exhaustive. For a more detailed discussion of relevant risks and uncertainties, see Valion Bio’s filings with the SEC, including its Annual Report on Form 10-K for the year ended December 31, 2025, under “Risk Factors,” and subsequent SEC filings. Forward-looking statements are made as of the date of this release, and the Company undertakes no duty to update them except as required by applicable law.

Investor and Media Contact
Rich Cockrell
CG Capital
vbio@cg.capital
404.736.3838

Valion Bio, Inc. | Nasdaq: VBIO

SOURCE: Valion Bio, Inc.

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