VALION BIO BRIEFS PENTAGON LEADERSHIP ON ENTOLIMOD™ FOR ACUTE RADIATION SYNDROME

Rhea-AI Summary

Valion Bio (NASDAQ: VBIO) briefed senior Pentagon leadership on Entolimod, a TLR5 agonist being developed as a next-generation medical countermeasure for acute radiation syndrome (ARS).

The program has >$140M invested, including ~$35.6M in non-dilutive U.S. government funding, 42 non-human primate studies, ~300 human subjects, FDA Fast Track and Orphan Drug designations, and is being advanced toward a Biologics License Application under the Animal Rule.

Positive

• $140M+ total invested in Entolimod program
• $35.6M in non-dilutive U.S. government funding
• 42 non-human primate studies supporting efficacy
• Approximately 300 human subjects administered Entolimod
• Received FDA Fast Track and Orphan Drug designations

Negative

• No approved biologics license yet; BLA pending under Animal Rule
• Program reliance on continued government contracts and agency decisions

Market Context

This announcement highlights Valion Bio’s growing engagement with U.S. defense agencies, including a...

Analysis

This announcement highlights Valion Bio’s growing engagement with U.S. defense agencies, including a Pentagon briefing and prior federal support of $35.6 million within more than $140 million invested in Entolimod™. The program’s 42 non-human primate studies and roughly 300 human subjects support a well-characterized profile under the FDA Animal Rule. Investors may watch for concrete procurement steps, BLA progress, and further government contracting activity.

Key Figures

Total program investment: $140 million Non-dilutive funding: $35.6 million Non-human primate studies: 42 studies +3 more

6 metrics

Total program investment $140 million Invested in Entolimod™ program to date

Non-dilutive funding $35.6 million U.S. government funding for Entolimod™

Non-human primate studies 42 studies Entolimod™ evaluated in primate studies

Human subjects 300 subjects Entolimod™ administered to human subjects

FDA Fast Track Granted For Entolimod™ in acute radiation syndrome

Orphan Drug Granted FDA Orphan Drug designation for acute radiation syndrome

Key Terms

acute radiation syndrome, toll-like receptor 5, tlr5, nf-κb, +4 more

8 terms

acute radiation syndrome medical

"briefed senior officials at the U.S. Department of War on Entolimod™ for 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.

toll-like receptor 5 medical

"Entolimod™ is a novel Toll-like receptor 5 (TLR5) agonist that provides dual-tissue protection"

Toll-like receptor 5 (TLR5) is a protein on certain immune cells that acts like a security sensor, detecting a specific component of bacterial tails and triggering an inflammation and immune response. Investors care because drugs or vaccines that activate or block TLR5 can change how the body fights infections or cancer, serving as therapeutic targets or vaccine ingredients; progress or setbacks in TLR5-focused research can materially affect the value and prospects of biotech firms.

tlr5 medical

"Entolimod™ is a novel Toll-like receptor 5 (TLR5) agonist that provides dual-tissue protection"

TLR5 is a protein on certain immune cells that acts like a security sensor, detecting bits of bacterial tails and triggering an immune alarm. Investors watch TLR5 because drugs or vaccine additives that boost or block this sensor can change how well treatments work, affect safety profiles, and influence clinical trial results and market potential; think of it as a switch that can alter a therapy’s effectiveness and commercial value.

nf-κb medical

"Entolimod™ activates NF-κB signaling pathways to protect both bone marrow and gastrointestinal tissues"

NF-κB is a protein complex inside cells that acts like a master switch for inflammation, immune responses and cell survival; when turned on it tells many genes to produce signals that promote immune activity, cell growth or protection from stress. Investors care because drugs or diagnostics that affect NF-κB can influence treatments for cancers, autoimmune disorders and inflammatory diseases, so changes in NF-κB activity can meaningfully alter a therapy’s potential market and risk profile.

animal rule regulatory

"Entolimod™ is being developed under the FDA's Animal Rule pathway for acute radiation syndrome"

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

"The Company has received FDA Fast Track and Orphan Drug designations for Entolimod™"

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 regulatory

"The Company has received FDA Fast Track and Orphan Drug designations for Entolimod™"

A drug designated for an orphan disease is a medicine developed to treat a rare condition that affects only a small number of people. Regulators often give these drugs special incentives—such as reduced costs, faster review, and temporary exclusive selling rights—to encourage development, which matters to investors because those incentives can make a small market financially viable and reduce competition, much like a temporary patent on a niche product.

biologics license application regulatory

"and is advancing toward a Biologics License Application under the Animal Rule."

A biologics license application is a formal request submitted to regulatory authorities seeking approval to market a new biological medicine, such as vaccines or treatments made from living organisms. It is a comprehensive review process that evaluates the safety, effectiveness, and manufacturing quality of the product. For investors, receiving approval signals that a biological therapy can be sold to the public, potentially leading to revenue growth and market success.

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

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Company Presented Entolimod™ from its TLR5 Platform to the Deputy Assistant Secretary of Defense for Nuclear, Chemical, and Biological Defense Programs

SAN ANTONIO, April 28, 2026 /PRNewswire/ -- Valion Bio, Inc. (formerly Tivic Health Systems, Inc.) (Nasdaq: VBIO), a late-stage immunotherapeutics company, today announced that it briefed senior officials at the U.S. Department of War on Entolimod™ for acute radiation syndrome. The briefing, facilitated by American Defense International (ADI), was presented to the Deputy Assistant Secretary of Defense for Nuclear, Chemical, and Biological Defense Programs and his team at the Pentagon.

The briefing reflects growing U.S. government interest in Entolimod™ as a next-generation medical countermeasure for radiological threats. Entolimod™ is a novel Toll-like receptor 5 (TLR5) agonist that provides dual-tissue protection against ionizing radiation-induced damage, addressing both hematopoietic and gastrointestinal acute radiation syndrome — a differentiated mechanism not available in currently stockpiled countermeasures.

"Engaging directly with senior leadership at the Pentagon marks a significant milestone in our work with the Department of War," said Michael K. Handley, Chief Executive Officer of Valion Bio. "The Deputy Assistant Secretary of Defense for Nuclear, Chemical, and Biological Defense Programs oversees critical national preparedness capabilities, and the opportunity to present Entolimod™ at this level validates our strategic positioning at the intersection of biodefense and medical countermeasures. We were able to demonstrate the strength of our data package and how Entolimod™ addresses current gaps in the Strategic National Stockpile."

Entolimod™ is being developed under the FDA's Animal Rule pathway for acute radiation syndrome, with over $140 million invested in the program to date, including approximately $35.6 million in non-dilutive U.S. government funding. The compound has been evaluated in 42 non-human primate studies and administered to approximately 300 human subjects, demonstrating a well-characterized safety and efficacy profile.

Unlike currently stockpiled agents such as Neupogen® (filgrastim), Neulasta® (pegfilgrastim), and Leukine® (sargramostim), which target hematopoietic recovery alone, Entolimod™ activates NF-κB signaling pathways to protect both bone marrow and gastrointestinal tissues simultaneously. This dual-organ mechanism addresses a critical unmet need, as gastrointestinal damage is often the limiting factor for survival at higher radiation doses.

"The current geopolitical environment has elevated radiological preparedness to a national security priority," Handley continued. "Our engagements with BARDA, DTRA, NIAID, and now direct Pentagon leadership demonstrate that Entolimod™ is being recognized at the highest levels of the U.S. defense establishment as a differentiated solution to protect both military personnel and civilian populations. We are committed to moving with the urgency this threat environment demands."

The Pentagon briefing follows Valion Bio's recent selection for the Department of War's Tech Watch program and ongoing engagements with multiple U.S. government agencies regarding the inclusion of Entolimod™ in national preparedness planning. The Company has received FDA Fast Track and Orphan Drug designations for Entolimod™ in acute radiation syndrome and is advancing toward a Biologics License Application under the Animal Rule.

Strategic and Competitive Positioning

• National preparedness relevance: Dual GI and bone marrow protection addresses critical gaps in current stockpiled countermeasures
• Differentiated mechanism: TLR5 agonist provides pleiotropic cytoprotection versus single-target G-CSF therapies
• Regulatory pathway: Animal Rule framework reduces clinical development risk for biodefense applications
• Government validation: $35.6 million in prior federal contracts and ongoing multi-agency engagement

About Entolimod™ for Acute Radiation Syndrome

Entolimod™ (CBLB502) is a recombinant deletion variant of Salmonella FliC flagellin engineered to activate TLR5 selectively. Upon engagement, Entolimod™ triggers NF-κB-dependent signaling to stimulate G-CSF, PI3K, and IL-6 production, promote multi-tissue cytoprotection, and inhibit apoptosis in radiosensitive hematopoietic and gastrointestinal tissues. The compound has demonstrated survival benefit as both a radioprotectant and a radiomitigant in controlled non-human primate studies under the FDA's Animal Rule.

About Valion Bio, Inc.

Valion Bio, Inc. (Nasdaq: VBIO), the new corporate identity of Tivic Health Systems, Inc., 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 acute radiation syndrome (ARS), has been extensively studied and has demonstrated survival benefits and improved tissue recovery in animal models under the FDA's Animal Rule. Entolimod™ is a novel Toll-like receptor 5 (TLR5) agonist that activates NF-κB signaling pathways to protect cells from damage and stimulate immune responses. Entolimod™ for ARS has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration. Valion Bio is also advancing Entolasta™, a next-generation TLR5 agonist designed for potential broader therapeutic applications, including oncology supportive care. Valion Bio's wholly owned subsidiary, Velocity Bioworks, is a full-service contract development and manufacturing organization (CDMO) that provides biomanufacturing services to third-party biotech companies. Valion Bio also leverages Velocity Bioworks' manufacturing capabilities to advance its own drug pipeline with the expected benefits of lower costs, accelerated manufacturing outcomes, and 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 Bio, Inc.'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, including as a result of the company's interactions with and guidance from the FDA and other regulatory authorities; the continued interest of BARDA and other U.S. government agencies in Entolimod™; the ability of the company to achieve the expected benefits from the acquisition of development and manufacturing assets within expected time frames or at all; changes to the company's relationship with its partners; failure to obtain FDA or similar clearances or approvals and noncompliance with FDA or similar regulations, including related to the Animal Rule; the company's future development of Entolimod or Entolasta; changes to the company's business strategy; timing and success of pre-clinical and clinical trials and study results; regulatory requirements and pathways for approval; the company's ability to successfully commercialize its product candidates in the future; changes in the markets and industries in which the company does business; consummation of any strategic transactions; the company's need for, and ability to secure when needed, additional working capital; the company's ability to maintain its Nasdaq listing; and changes in tariffs, inflation, legal, regulatory, political and economic risks. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of risks and uncertainties relevant to the company, and other important factors, see Valion Bio'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 the company undertakes no duty to update such information except as required by applicable law.

Investor Contact:
Rich Cockrell
CG Capital
vbio@cg.capital

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SOURCE Valion Bio, Inc.

FAQ

What did Valion Bio (VBIO) present to the Pentagon on April 28, 2026?

They briefed Pentagon leadership on Entolimod as a next-generation ARS countermeasure. According to Valion Bio, the presentation highlighted dual GI and bone marrow protection and supporting preclinical and clinical data.

How much has Valion Bio (VBIO) invested in Entolimod and what government funding was received?

Valion Bio has invested over $140 million in the Entolimod program. According to Valion Bio, approximately $35.6 million was non-dilutive U.S. government funding supporting development and studies.

What evidence supports Entolimod's effectiveness for acute radiation syndrome (VBIO)?

Entolimod has been evaluated in 42 non-human primate studies and given to ~300 human subjects. According to Valion Bio, these data characterize safety and efficacy supporting Animal Rule development.

What regulatory designations does Entolimod (VBIO) hold and what pathway is it using?

Entolimod holds FDA Fast Track and Orphan Drug designations and is advancing under the Animal Rule. According to Valion Bio, the Animal Rule framework guides BLA preparation for ARS indications.

How does Entolimod differ from current stockpiled ARS therapies like Neupogen or Neulasta?

Entolimod targets TLR5 to protect both gastrointestinal and hematopoietic tissues simultaneously. According to Valion Bio, this dual-organ mechanism differs from G-CSF therapies that target hematopoietic recovery only.

What are the near-term risks for investors regarding Valion Bio's (VBIO) Entolimod program?

Primary near-term risks include reliance on government funding and regulatory outcomes for a BLA under the Animal Rule. According to Valion Bio, continued agency engagement and contracts remain necessary for advancement.