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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (date of earliest event reported): September 2, 2025
Adial Pharmaceuticals, Inc.
(Exact name of registrant as specified in charter)
| Delaware | 001-38323 | 82-3074668 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
4870 Sadler Road, Suite 300
Glen Allen, VA 23060
(Address of principal executive offices and zip code)
(804) 487-8196
(Registrant’s telephone number including area code)
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12(b) under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbols | Name of each exchange on which registered | ||
| Common Stock, par value $0.001 per share |
ADIL | The Nasdaq Stock Market LLC (Nasdaq Capital Market) |
Indicate by check mark whether the registrant is an emerging growth company as defined in in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by checkmark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 3.01. Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing.
On September 2, 2025, Adial Pharmaceuticals, Inc. (the “Company”) received a letter (the “September 2025 Nasdaq Letter”) from The Nasdaq Stock Market (“Nasdaq”) stating that the Company is eligible for an additional 180 calendar days, or until March 2, 2026, to regain compliance with Nasdaq’s requirement to maintain a minimum closing bid price of $1.00 per share as required by Nasdaq Listing Rule 5550(a)(2) (the “Rule”) for continued listing on Nasdaq (the “Minimum Bid Price Requirement”), following the expiration of the initial 180 calendar day period granted to the Company by Nasdaq to regain compliance by September 1, 2025 (the “Initial Compliance Date”). Nasdaq initially notified the Company of (i) its failure to meet the Minimum Bid Price Requirement and (ii) the Initial Compliance Date in a letter sent by Nasdaq and addressed to the Company, dated March 5, 2025.
The Staff of the Nasdaq (the “Staff”) determined that the Company is eligible for the second 180 calendar day period, or until March 2, 2026, to regain compliance with the Rule based on the Staff’s determination that the Company must continue to meet the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on the Nasdaq Capital Market, with the exception of the Minimum Bid Price Requirement, and the Company’s written notice of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary. If at any time during this additional time period, the closing bid price of the Company’s common stock on the Nasdaq is at least $1.00 per share for a minimum of ten (10) consecutive business days, the Staff will provide written confirmation of compliance with the Rule and this matter will be closed. The September 2025 Nasdaq Letter from Nasdaq also stated that if the Company chooses to implement a reverse stock split, it must complete the split no later than ten (10) business days prior to the expiration date in order to timely regain compliance.
If compliance with the Rule cannot be demonstrated by March 2, 2026, the Staff will provide written notification that the Company’s common stock will be delisted from the Nasdaq. At that time, the Company may appeal the Staff’s determination to a Hearings Panel (the “Panel”). If the Company appeals, it will be asked to provide a plan to regain compliance to the Panel, and that historically Panels have generally viewed a near-term reverse stock split as the only definitive plan acceptable to resolve a deficiency of the Minimum Bid Price Requirement.
An indicator will continue to be broadcast over Nasdaq’s market data dissemination network noting the Company’s non-compliance. In addition, a list of all non-compliant Nasdaq companies and the reason(s) for such non-compliance is posted on Nasdaq’s website at listingcenter.nasdaq.com. The Company will continue to be included in this list until it regains compliance. Nonetheless, the September 2025 Nasdaq Letter has no immediate effect on the Company’s continued listing on the Nasdaq Capital Market, subject to the Company’s compliance with the other continued listing requirements of Nasdaq.
The Company intends to actively monitor the bid price of its common stock and will consider available options to regain compliance with the Minimum Bid Price Requirement and the other Nasdaq listing requirements. Such available options will include effecting a reverse stock split of the Company’s common stock, if necessary, in order to maintain the Company’s Nasdaq listing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit Number |
Exhibit Description | |
| 99.1 | Press Release, dated September 3, 2025, issued by Adial Pharmaceuticals, Inc. | |
| 104 | Cover Page Interactive Data File (the cover page XBRL tags are embedded within the inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: September 3, 2025 | ADIAL PHARMACEUTICALS, INC. | |
| By: | /s/ Cary J. Claiborne | |
| Name: | Cary J. Claiborne | |
| Title: | President and Chief Executive Officer | |
Exhibit 99.1
Adial Pharmaceuticals Granted a 180 Calendar Day Extension by Nasdaq to Regain Compliance with the Minimum Bid Price Rule
GLEN ALLEN, Va., September 3, 2025 — Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today announced that it has been granted a 180 calendar day extension from The Nasdaq Stock Market LLC (“Nasdaq”) to regain compliance with the Nasdaq’s minimum $1.00 bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) (the “Rule”) for continued listing on Nasdaq (the “Minimum Bid Price Requirement”), following the expiration of the initial 180 calendar day period to regain compliance on September 1, 2025, which was initially granted on March 5, 2025.
The Company now has until March 2, 2026 to meet the Minimum Bid Price Requirement set forth in Nasdaq Listing Rule 5550(a)(2).
The notification has no immediate effect on the listing or trading of the Company’s shares of common stock, which will continue to trade on the Nasdaq Capital Market under the symbol “ADIL.”
To regain compliance with the Rule, the Company must maintain a closing bid price of at least $1.00 per share for a minimum of ten (10) consecutive business days on or prior to the 180-day extension period, or March 2, 2026. The Company will continue to monitor the closing bid price of its common stock between now and the end of the extension period and intends to take all appropriate actions to cure the deficiency and regain compliance with the Rule prior to the end of the compliance period.
About Adial Pharmaceuticals, Inc.
Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions and related disorders. The Company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, being developed for the treatment of Alcohol Use Disorder (AUD). AD04 was recently investigated in a Phase 3 clinical trial ONWARD™ and showed promising results with reduced drinking in patients with AUD, and was well tolerated with no overt safety concerns. AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity. Additional information is available at www.adial.com.
Forward-Looking Statements
This communication contains certain “forward-looking statements” within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans” and similar expressions or future or conditional verbs such as “will,” “should,” “would,” “may” and “could” are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. The forward-looking statements include statements regarding continuing to monitor the closing bid price of the Company’s common stock on Nasdaq between now and the end of the extension period (March 2, 2026), and taking all appropriate actions to cure the Minimum Bid Price Requirement deficiency and regain compliance with the Rule prior to the end of the compliance period maintain its Nasdaq listing. Any forward-looking statements included herein reflect the Company’s current views, and they involve certain risks and uncertainties, including, among others, the Company’s ability to regain compliance with the Rule and all other applicable requirements for the initial listing on the Nasdaq Capital market prior to the end of the compliance period, and our ability to maintain the Company’s listing on the Nasdaq Capital market. These risks should not be construed as exhaustive and should be read together with the other risk factors and cautionary statements included in our Annual Report on Form 10-K for the year ended December 31, 2024, subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other documents filed by the Company from time to time with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was initially made. The Company does not undertake or accept any obligation to release publicly any updates or revisions to any forward-looking statements, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law.
Contact:
Crescendo Communications, LLC
David Waldman / Alexandra Schilt
Tel: 212-671-1020
Email: adil@crescendo-ir.com