Valion Bio Regains Compliance with NASDAQ Minimum Bid Price Listing Rule

Valion Bio has restored compliance with Nasdaq’s $1 minimum bid rule while continuing to advance its immunotherapy pipeline.

Rhea-AI Summary

Valion Bio (VBIO) reports that Nasdaq has confirmed the company has regained compliance with the $1.00 minimum bid price requirement under Listing Rule 5550(a)(2), after VBIO shares traded at or above $1.00 for the requisite period, closing the matter with Nasdaq’s Listing Qualifications Staff.

The company states that regaining compliance supports its ongoing growth strategy, which prioritizes advancing its lead candidate Entolimod, pursuing commercial and government opportunities, and achieving long-term shareholder value milestones. Entolimod, a Toll-like Receptor 5 agonist for potential use as a medical countermeasure for Acute Radiation Syndrome, has been evaluated in animal models under the FDA’s Animal Rule and has Fast Track and Orphan Drug designations. Valion is also developing Entolasta and operates its own CDMO subsidiary, Velocity Bioworks, to support pipeline development.

Positive

• Nasdaq bid-price compliance restored, with VBIO trading at or above $1.00 for the required period, closing the listing deficiency matter
• Entolimod holds FDA Fast Track and Orphan Drug designations as a potential medical countermeasure for Acute Radiation Syndrome

Negative

• None.

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-0.21% vs previous close $2.38 last price 27.3x rel. volume Open Argus

Details

Market Reaction – VBIO

$2.32 $2.55 Day Range

$2.11M Market Cap

Following this news, VBIO has declined 0.21%, reflecting a mild negative market reaction. Our momentum scanner has triggered 2 alerts so far, indicating moderate trading interest and price volatility. The stock is currently trading at $2.38. Trading volume is exceptionally heavy at 27.3x the average, suggesting significant selling pressure.

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Key Figures

Minimum closing bid price: $1.00 per share

Minimum closing bid price

$1.00 per share

Nasdaq Listing Rule 5550(a)(2) requirement

Historical Context

1 past event · Latest: Aug 27

1 event

1. Aug 27

   Reverse stock split

   24h Move

   -21.4%

   1-for-25 split intended to help regain Nasdaq minimum bid compliance before deadline

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

Key Terms

animal rule, fast track, orphan drug designation, tlr5 agonist

4 terms

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.

tlr5 agonist medical

"Entolasta, a next-generation TLR5 agonist designed for potential use"

A TLR5 agonist is a molecule that activates the immune receptor TLR5, which detects bacterial flagellin and helps kick-start the body's defense response. Think of it like a fire alarm trigger that alerts and strengthens immune activity; in drugs and vaccines it can boost or direct immunity. Investors care because TLR5 agonists are a clear drug mechanism influencing clinical risk, regulatory review, safety, and market potential for vaccines and immunotherapies.

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

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SAN ANTONIO, TX / ACCESS Newswire / September 22, 2026 / Valion Bio, Inc. (Nasdaq:VBIO) ("Valion" or the "Company) announced today that it has received formal written notification from The Nasdaq Stock Market LLC ("Nasdaq") confirming that the Company has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2).

Nasdaq Listing Rule 5550(a)(2) requires listed securities to maintain a minimum closing bid price of $1.00 per share. Valion satisfied the requirement by maintaining a closing bid price of at least $1.00 per share for the requisite period. Accordingly, Nasdaq's Listing Qualifications Staff has determined that the Company has regained compliance, and the matter is now closed.

"Regaining compliance with Nasdaq's minimum bid price requirement represents an important step for Valion as we continue executing our growth strategy," said Lisa Wolf, President, COO and CFO of Valion. "Our priorities remain clear: advancing Entolimod, pursuing commercial and government opportunities, and achieving milestones that we believe can create meaningful long-term value for our shareholders."

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 exposure. Entolimod is a novel Toll-like Receptor 5 agonist designed to activate 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 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. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the continued listing of the Company's common stock on the Nasdaq Capital Market; and the Company's ability to maintain compliance with applicable listing standards 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 specific Nasdaq listing rule did Valion Bio regain compliance with?

Valion Bio regained compliance with Nasdaq Listing Rule 5550(a)(2), which requires listed securities on the relevant Nasdaq market to maintain a minimum closing bid price of $1.00 per share.

How did Valion Bio satisfy Nasdaq’s minimum bid price requirement?

The company satisfied the requirement by maintaining a closing bid price of at least $1.00 per share for the requisite period specified by Nasdaq, after which Nasdaq’s Listing Qualifications Staff determined that Valion had regained compliance and closed the matter.

What is Entolimod and how has it been evaluated so far?

Entolimod is Valion’s lead biologic candidate, a Toll-like Receptor 5 agonist designed to activate NF-">B signaling pathways associated with cellular protection, tissue recovery and immune response. It is being developed as a potential medical countermeasure for Acute Radiation Syndrome and has been evaluated in animal models under the FDA’s Animal Rule, which permits approval based on animal efficacy when human trials are not ethical or feasible.

What other pipeline assets and capabilities is Valion Bio developing?

Valion is also advancing Entolasta, a next-generation TLR5 agonist intended for potential broader therapeutic applications, including oncology supportive care and programs in neutropenia and immune dysfunction. In addition, its wholly owned subsidiary Velocity Bioworks operates as a biologics contract development and manufacturing organization, providing development and manufacturing services to support Valion’s internal pipeline with the stated goals of increasing manufacturing control, reducing costs, accelerating development timelines and strengthening domestic supply-chain security.