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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):
August 21, 2023
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.) |
1180 Seminole Trail, Ste 495
Charlottesville, VA 22901
(Address of principal executive offices and zip
code)
(434) 422-9800
(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 |
|
ADIL |
|
The Nasdaq Stock Market LLC
(Nasdaq Capital Market) |
|
|
|
|
|
Warrants |
|
ADILW |
|
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 August 21, 2023, Adial Pharmaceuticals, Inc. (the “Company”),
received a notice from the Listing Qualifications Department (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”)
notifying the Company that the Staff has determined that for 10 consecutive business days, from August 7, 2023 to August 18, 2023, the
closing bid price of the Company’s common stock has been at $1.00 per share or greater. Accordingly, the Staff has determined that
the Company has regained compliance with Nasdaq Listing Rule 5550(a)(2) and that the matter is now closed.
On August 22, 2023, the Company also received a notice from the Staff
that it now complies with Nasdaq Listing Rule 5550(b)(1), which requires listed companies to maintain stockholders’ equity of at least $2,500,000
and that the matter is now closed.
On August 23, 2023, the Company issued a press release announcing that
the Company received the notices and regained compliance with Nasdaq’s minimum bid price requirement and stockholder’s equity
requirement. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
The following exhibits are furnished with this
Current Report on Form 8-K:
* * *
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: August 23, 2023 |
ADIAL PHARMACEUTICALS, INC. |
|
|
|
By: |
/s/ Cary J. Claiborne |
|
Name: |
Cary J. Claiborne |
|
Title: |
President and Chief Executive Officer |
2
Exhibit 99.1
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Adial Pharmaceuticals Regains Compliance with
Nasdaq Listing Requirements
Charlottesville,
VA – August 23, 2023 – Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) (“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 received notice from Nasdaq on August 21, 2023 that the Company has regained compliance with the minimum
bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2). Nasdaq determined that for the last 10 consecutive business days,
from August 7 through August 18, 2023, the closing bid price of the Company’s common stock has been at $1.00 per share or greater.
Additionally,
on August 22, 2023, the Company received notice from Nasdaq that it has regained compliance with Nasdaq Listing Rule 5550(b)(1), which
requires listed companies to maintain stockholders' equity of at least $2,500,000.
The Company
has now successfully resolved both outstanding Nasdaq compliance issues and Nasdaq has advised that the matters are now closed.
About Adial Pharmaceuticals, Inc.
Adial Pharmaceuticals
is a clinical-stage biopharmaceutical company focused on the development of therapies for the treatment and prevention of addiction and
related disorders. The Company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist,
therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients and was recently investigated in the Company’s
ONWARD™ pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes (estimated
to be approximately one-third of the AUD population) identified using the Company’s proprietary companion diagnostic genetic test.
ONWARD showed promising results in reducing heavy drinking in heavy drinking patients, and no overt safety or tolerability 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 the potential of AD04 to treat other addictive disorders
such as opioid use disorder, gambling, and obesity. Any forward-looking statements included herein reflect our current views, and they
involve certain risks and uncertainties, including, among others, our ability to pursue our regulatory strategy, our ability to maintain
our Nasdaq listing, our ability to advance ongoing partnering discussions, our ability to obtain regulatory approvals for commercialization
of product candidates or to comply with ongoing regulatory requirements, our
ability to develop strategic partnership opportunities and maintain collaborations, our ability to obtain or maintain the capital or
grants necessary to fund our research and development activities, our ability to retain our key employees or maintain our Nasdaq listing,
our ability to complete clinical trials on time and achieve desired results and benefits as expected, regulatory limitations relating
to our ability to promote or commercialize our product candidates for specific indications, acceptance of our product candidates in the
marketplace and the successful development, marketing or sale of our products, our ability to maintain our license agreements, the continued
maintenance and growth of our patent estate and our ability to retain our key employees or maintain our Nasdaq listing,. These risks
should not be construed as exhaustive and should be read together with the other cautionary statement included in our Annual Report on
Form 10-K for the year ended December 31, 2022, subsequent Quarterly Reports on Form 10-Q and current reports on Form 8-K filed with
the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake
no obligation to publicly update or revise any forward-looking statement, 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
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Adial Pharmaceuticals (NASDAQ:ADIL)
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