Current Report Filing (8-k)
February 26 2021 - 9:52AM
Edgar (US Regulatory)
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): February 25, 2021
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
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(Commission File
Number)
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(IRS Employer
Identification No.)
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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:
☐
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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☐
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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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☐
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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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☐
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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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
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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
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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. ☐
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Item
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7.01. Regulation
FD Disclosure.
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On
February 25, 2021, Adial Pharmaceuticals, Inc. (the “Company”) issued a press release (the “Press Release”)
providing an update regarding its landmark ONWARD™ pivotal Phase 3 clinical trial (the “Trial”) investigating
the Company’s lead drug candidate, AD04, as a therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in persons
with certain target genotypes related to the serotonin transporter and receptor.
A
copy of the Press Release is attached as Exhibit 99.1 to this Report on Form 8-K. The information contained in the Press Release
is being furnished to the Securities and Exchange Commission (the “Commission”) and shall not be deemed incorporated
by reference into any of the Company’s registration statements or other filings with the Commission.
On
February 25, 2021, the Company issued the Press Release providing the following highlighted updates on the Trial:
●
50% enrollment reached in the Trial
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o
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Trial is expected to be fully enrolled Summer of 2021
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66% of planned patient screening visits completed
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o
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830
patients screened out of 1,254 patients expected to be required to achieve full enrollment
(more than 20 screened patients are currently pending enrollment)
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32% of patients screened are genetically positive for treatment with AD04
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o
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Percentage
of genetically positive patients consistent with Phase 2b prevalence and expected U.S.
and European prevalence
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●
75% of patients screened as genetically positive have been enrolled
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o
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Patient
enrollment exceeds projected rate of 50% for genetically positive patients
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●
86% ONWARD™ patient retention rate to date
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o
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Retention
rate significantly greater than projected 70% retention rate
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Item
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9.01.
Financial Statements and Exhibits.
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(d)
Exhibits.
The
following exhibit is 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: February
26, 2021
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ADIAL
PHARMACEUTICALS, INC.
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By:
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/s/
William B. Stilley, III
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Name:
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William B. Stilley
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Title:
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President
and Chief Executive Officer
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