Current Report Filing (8-k)
March 07 2023 - 4:06PM
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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):
March 6, 2023
Adial Pharmaceuticals, Inc.
(Exact name of registrant as specified in charter)
Delaware
(State or other jurisdiction of incorporation)
001-38323 |
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82-3074668 |
(Commission File Number) |
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(IRS Employer Identification No.) |
1180 Seminole Trail, Suite 495
Charlottesville, Virginia 22901
(Address of principal executive offices and
zip code)
(434) 422-9800
(Registrant’s telephone number including
area code)
(Former Name and Former Address)
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:
☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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☐ |
Soliciting material pursuant to Rule 14a-12(b) under the Exchange Act (17 CFR 240.14a-12) |
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☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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☐ |
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 |
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Trading Symbols |
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Name of each exchange on which registered |
Common Stock |
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ADIL |
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NASDAQ |
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Warrants |
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ADILW |
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NASDAQ |
Indicate by check mark whether the registrant
is an emerging growth company as defined in in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2
of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check
mark 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 7.01. Regulation FD Disclosure.
On March 6, 2023, Adial
Pharmaceuticals, Inc. (the “Company”) issued a press release attached hereto as Exhibit 99.1 announcing an update to the Company’s
regulatory strategy for AD04, the Company’s lead compound for the treatment of alcohol use disorder (AUD). The Company also hosted
a conference call and webcast on March 7, 2023 at which it provided an update to its regulatory and partnering strategy for the United
States and Europe. A copy of the investor presentation is furnished as Exhibit 99.2 to this Current Report on Form 8-K.
The information in this
Item 7.01 and in the press release furnished as Exhibit 99.1 and the investor presentation furnished as Exhibit 99.2 shall not be deemed
to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities
of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended, and shall not be incorporated by reference into
any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless
of any general incorporation language in such filing.
The Company’s
press release furnished as Exhibit 99.1 and the investor presentation furnished as Exhibit 99.2 to this Current Report on Form 8-K includes
“safe harbor” language pursuant to the Private Securities Litigation Reform Act of 1995, as amended, indicating that certain
statements contained therein are “forward-looking” rather than historical.
Item 8.01. Other Events.
On March 6, 2023, the
Company issued a press release announcing an update to the Company’s regulatory strategy for AD04, the Company’s lead compound
for the treatment of alcohol use disorder (AUD). Key highlights include:
| ● | ONWARD
Phase 3 clinical trial data showed that AD04 achieved a statistically significant mean reduction
in heavy drinking days among the pre-specified group of ‘heavy drinkers.” |
| ● | Additional
analysis of ONWARD™ data allowed refinement of genetic panel to target specific modulators
of the serotonin 3 receptor A & B subunit genotypes that outperformed others |
| ● | Type
C meeting with the U.S. Food and Drug Administration confirmed for Q2 2023 to discuss clinical
program in U.S. |
| ● | Meetings
scheduled with two European country-level regulatory authorities and requested with three
European country-level regulatory authorities |
| ● | Advancing
discussions with potential U.S. and European partners |
| ● | Market
research subsequent to completion of the ONWARD trial suggests unit pricing for AD04 could
be significantly higher than previous assumptions |
Item 9.01.
Financial Statements and Exhibits.
(d) Exhibits.
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: March 7, 2023 |
ADIAL PHARMACEUTICALS, INC. |
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By: |
/s/ Cary J. Claiborne |
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Name: |
Cary J. Claiborne |
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Title: |
President and Chief Executive Officer |
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