VALION BIO RECEIVES FIRST FDA-PRECEDENT STUDY PROTOCOL FROM NIAID FOR ENTOLIMOD™; FEDERAL AGENCY TO FULLY FUND BLA-ENABLING IN VIVO PROGRAM AND CO-NAVIGATE FDA SUBMISSION

Rhea-AI Summary

Valion Bio (Nasdaq: VBIO) received an FDA‑precedent study protocol from NIAID for Entolimod™, triggering NIAID to fully fund up to $7 million of BLA‑enabling in vivo studies and to co‑navigate the FDA Animal Rule submission if studies are favorable.

Studies will run at AFRRI; protocol matches a prior FDA‑accepted design, which the company says reduces regulatory design risk. Entolimod has prior nonhuman primate and human exposure data, plus Fast Track and Orphan Drug designations for ARS.

Positive

• NIAID funding up to $7 million for BLA‑enabling in vivo studies
• FDA‑precedent protocol provided, matching a previously accepted ARS study design
• Studies to be conducted at AFRRI, the U.S. radiobiology research facility
• Government committed to co‑navigate FDA submission upon favorable outcomes
• $140 million total program investment to date, including ~$35.6 million prior U.S. government funding

Negative

• None.

News Market Reaction – VBIO

-3.35% 11.3x vol

17 alerts

-3.35% Session close to close

+7.3% Peak Tracked

-21.6% Trough Tracked

$3.01M Market Cap

11.3x Rel. Volume

In the May 5 session, VBIO declined 3.35%, reflecting a moderate negative market reaction. Argus tracked a peak move of +7.3% during that session. Argus tracked a trough of -21.6% from its starting point during tracking. Our momentum scanner triggered 17 alerts that day, indicating notable trading interest and price volatility. Trading volume was exceptionally heavy at 11.3x the daily average, suggesting significant selling pressure.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights that NIAID will fund up to $7 million of BLA-enabling in vivo studies f...

Analysis

This announcement highlights that NIAID will fund up to $7 million of BLA-enabling in vivo studies for Entolimod™, adding to more than $140 million already invested and $35.6 million in prior U.S. government funding. The protocol leverages FDA precedent under the Animal Rule for Acute Radiation Syndrome, with extensive experience from 42 non-human primate studies and about 300 human subjects. Investors may watch upcoming in vivo readouts and regulatory interactions as key milestones.

Key Figures

NIAID program value: $7 million Total Entolimod™ investment: $140 million Prior U.S. government funding: $35.6 million +5 more

8 metrics

NIAID program value $7 million Non-clinical evaluation agreement funding BLA-enabling in vivo studies

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

Prior U.S. government funding $35.6 million Previous U.S. government funding for Entolimod™

Non-human primate studies 42 studies Entolimod™ non-human primate study count

Human subjects dosed 300 subjects Approximate number of human subjects receiving Entolimod™

GI failure outcome window 24–48 hours Time to potential death from GI failure after radiation exposure

Price move on news day 13.59% VBIO 24h price change at <b>$1.045</b> ahead of the session

52-week trading range $0.86–$1.21 52-week low and high before this announcement

Key Terms

biologics license application, animal rule, acute radiation syndrome, gastrointestinal acute radiation syndrome, +4 more

8 terms

biologics license application regulatory

"in vivo studies required to support the Company's Biologics License Application (BLA)"

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.

animal rule regulatory

"for Entolimod™ under the FDA's Animal Rule pathway"

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.

acute radiation syndrome medical

"developing Entolimod™ for Acute Radiation Syndrome (ARS)"

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.

gastrointestinal acute radiation syndrome medical

"Partial-Body Irradiation Gastrointestinal Acute Radiation Syndrome (PBI-GI-ARS) pilot"

Gastrointestinal acute radiation syndrome is a severe illness that occurs when high doses of radiation damage the cells lining the stomach and intestines, causing nausea, vomiting, diarrhea, dehydration and inability to absorb nutrients. For investors it matters because it creates demand for medical treatments, hospital capacity, diagnostics and government preparedness programs—so companies developing drugs, protective technologies or emergency services may see regulatory attention, contracts or sales tied to managing this risk.

fast track regulatory

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

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

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

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.

non-human primate medical

"Entolimod™ has been administered in 42 non-human primate studies"

Non-human primates are animals from the primate family—such as monkeys and apes—excluding humans. Investors should care because these animals are often used in late-stage preclinical testing for drugs and vaccines; their biological similarity to humans makes test results more predictive, so outcomes can materially affect a program’s safety profile, regulatory chances, timeline and cost—like using advanced crash-test dummies that better predict real-world results.

cdmo technical

"manufactured at Velocity Bioworks, Valion Bio's wholly owned CDMO subsidiary"

A contract development and manufacturing organization (CDMO) is a company that provides specialized services to help develop and produce pharmaceutical products for other businesses. Think of it as a contract factory that takes a company's recipe and makes the product on their behalf. For investors, CDMOs are important because they support the growth of pharmaceutical companies and can be key partners in bringing new medicines to market.

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

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Initial Study to Evaluate Entolimod™ for Gastrointestinal Tissue Preservation in Partial-Body Acute Radiation Syndrome — an Indication for Which No Currently Approved or Stockpiled Countermeasure Has Demonstrated Efficacy

SAN ANTONIO, May 5, 2026 /PRNewswire/ -- Valion Bio, Inc. (Nasdaq: VBIO) (formerly Tivic Health Systems, Inc.), a clinical-stage immunotherapeutics company developing Entolimod™ for Acute Radiation Syndrome (ARS) and oncology supportive care, today announced it has received the first study protocol under its previously announced non-clinical evaluation agreement with the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health. Under the agreement — valued at up to $7 million — NIAID will fully fund the in vivo studies required to support the Company's Biologics License Application (BLA) for Entolimod™ under the FDA's Animal Rule pathway, with the agency further committed to co-navigate the FDA submission process alongside Valion Bio upon favorable study outcomes.

The protocol provided to Valion Bio is identical to a study design previously used and accepted by the FDA in support of a prior ARS medical countermeasure approval. This regulatory precedent meaningfully de-risks the design phase of the Company's BLA-enabling work, as the agency has already accepted the structure as evidentiary under the Animal Rule. The studies will be conducted at the Armed Forces Radiobiology Research Institute (AFRRI), the U.S. government's primary radiological research facility for ARS countermeasure evaluation, with NIAID serving as the contracting and funding agency.

Initial Study Targets Indication No Stockpiled Drug Currently Addresses

The first study under the protocol is a Partial-Body Irradiation Gastrointestinal Acute Radiation Syndrome (PBI-GI-ARS) pilot designed specifically to evaluate Entolimod's ability to preserve gastrointestinal tissue — including intestinal crypt cells and endothelial cells — following radiation exposure. No countermeasure currently approved by the FDA or held in the U.S. Strategic National Stockpile has demonstrated GI-tract preservation under this protocol. In real-world radiation exposure scenarios — including dirty-bomb events, nuclear reactor incidents, partial detonations, and special-operations exposures involving directional radiation sources — partial-body irradiation is the predominant injury pattern. Bone marrow is often partially shielded; the GI tract typically is not. GI failure can result in death within 24–48 hours due to loss of nutrient and water absorption, irrespective of hematopoietic function. A positive signal in this pilot would position Entolimod™ as the only medical countermeasure capable of demonstrating both hematopoietic and gastrointestinal protection — addressing the full lethal radiation injury cascade currently uncovered by stockpiled agents including Neupogen® (filgrastim), Neulasta® (pegfilgrastim), and Leukine® (sargramostim).

"This is not a grant application waiting on a decision — the federal government is actively funding the science, providing an FDA-precedent protocol, and committing to walk our submission into the agency alongside us," said Michael K. Handley, Chief Executive Officer of Valion Bio. "When NIAID provides both the capital and the regulatory institutional knowledge to advance a program, that is a materially different risk profile than a company-sponsored study. It is, in effect, money plus knowledge — and it is the combination that historically separates programs that reach approval from those that do not."

The NIAID-funded program covers all in vivo testing remaining on the critical path to BLA filing, including bridging studies designed to confirm that Entolimod™ manufactured at Velocity Bioworks, Valion Bio's wholly owned CDMO subsidiary in San Antonio, is equivalent to drug material previously evaluated. Entolimod™ has been administered in 42 non-human primate studies and to approximately 300 human subjects, with over $140 million invested in the program to date, including approximately $35.6 million in prior U.S. government funding.

Entolimod™ has received FDA Fast Track and Orphan Drug designations for ARS and is being developed under the Animal Rule pathway, which permits approval based on animal efficacy data when human efficacy trials are not feasible or ethical. Its mechanism — TLR5 agonism driving NF-κB-mediated cytokine induction in parallel with PI3K/AKT anti-apoptotic signaling — is differentiated from currently stockpiled G-CSF agents in that it is designed to protect both hematopoietic and gastrointestinal tissues across the full lethal-dose range of radiation exposure.

"The capital we had planned to deploy on this program — approximately $7 million — can now be redirected toward advancing Entolasta™, our second-generation molecule, into clinical development," Mr. Handley continued. "We are advancing on parallel fronts: our BLA-enabling program for Entolimod™ is now government-funded and government-supported at the regulatory level, our second-generation asset is gaining real momentum, and our commercial pipeline in oncology supportive care continues to mature. These are not competing priorities — they are compounding ones."

ABOUT VALION BIO, INC.
Valion Bio, Inc. (formerly Tivic Health Systems, Inc.) (Nasdaq: VBIO) is a clinical-stage immunotherapeutics company developing Entolimod™, a TLR5 agonist, for Acute Radiation Syndrome (ARS), oncology supportive care, and longevity indications. 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. The Company's clinical pipeline includes potential treatments for neutropenia, which is most commonly caused by chemotherapy, and a state of T-cell dysfunction known as lymphocyte exhaustion. Valion Bio's wholly owned subsidiary, Velocity Bioworks, is a full-service contract development manufacturing organization (CDMO) offering 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, NIAID, 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; 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™; the company's ability to successfully commercialize its product candidates in the future; 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, 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 & MEDIA CONTACT
Rich Cockrell
CG Capital
vbio@cg.capital 

 

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SOURCE Tivic Health Systems, Inc.

FAQ

What exactly did NIAID agree to fund for Valion Bio's (VBIO) Entolimod program?

NIAID will fully fund the in vivo BLA‑enabling studies, up to $7 million. According to the company, NIAID will also contract the work at AFRRI and co‑navigate the FDA submission if study outcomes are favorable.

How does the provided protocol affect Valion Bio's (VBIO) regulatory risk for Entolimod?

The protocol matches a previously FDA‑accepted ARS study design, which the company says reduces design risk. According to the company, that precedent aligns study structure with evidentiary expectations under the Animal Rule.

Where will Valion Bio (VBIO) conduct the NIAID‑funded Entolimod studies and why does that matter?

The studies will be run at AFRRI, the U.S. government's primary radiobiology facility. According to the company, AFRRI's role centralizes expertise and infrastructure for ARS countermeasure evaluation under government oversight.

What prior data does Valion Bio (VBIO) cite for Entolimod before these new studies?

Entolimod has been administered in 42 non‑human primate studies and to ~300 human subjects. According to the company, the program has received roughly $140 million of investment, including about $35.6 million from the U.S. government.

What are the potential investor impacts of NIAID funding on Valion Bio (VBIO)'s capital plans?

Valion plans to redeploy the ~$7 million it had budgeted for Entolimod toward its second‑generation molecule, Entolasta. According to the company, government funding frees internal capital to advance parallel clinical and commercial priorities.