Current Report Filing (8-k)
July 16 2021 - 9:21AM
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): July 13, 2021
Adial
Pharmaceuticals, Inc.
(Exact
name of registrant as specified in charter)
Delaware
(State
or other jurisdiction of incorporation)
001-38323
|
|
82-3074668
|
(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)
(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)
|
|
|
☐
|
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
|
|
NASDAQ
|
|
|
|
|
|
Warrants
|
|
ADILW
|
|
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 (§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 þ
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
7.01 Regulation FD Disclosure.
On
July 13, 2021, Adial Pharmaceuticals, Inc. (the “Company”) issued a press release providing an update regarding certain advancements
and positive pre-clinical data for its adenosine analog development platform being developed by Purnovate, Inc. (“Purnovate”),
a division of the Company.
The
information in this Item 7.01 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K 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. The information contained in this
Item 7.01 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K 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
press release attached as Exhibit 99.1 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.
The
Company undertakes no duty or obligation to update or revise the information contained in this Current Report on Form 8-K, although
it may do so from time to time if its management believes it is appropriate. Any such updating may be made through the filing of other
reports or documents with the Securities and Exchange Commission, through press releases or through other public disclosures.
Item
8.01 – Other Events.
On
July 13, 2021, the Company issued a press release providing an update regarding certain advancements and positive pre-clinical data for
its adenosine analog development platform being developed by Purnovate. Additionally, Adial reported it intends to proceed with development
of these compounds to determine if they may have broad implications as a replacement therapy for opioids or, when used in combination,
as a way to support lower dose administration of opioids. The information in the Press Release included the following:
|
●
|
Compounds
have been developed that are potent against specifically targeted adenosine receptors while
being selective over the adenosine A1 receptor, which is known to have cardiovascular and
central nervous system effects that can be problematic for many therapeutic indications.
|
|
●
|
Solubility
more than 50 times greater than other known selective adenosine compounds of the same class
has been demonstrated.
|
|
●
|
Testing
to date indicates good oral bioavailability so that oral administration (e.g., tablets) is
likely to be one of the options for dosing these compounds.
|
|
●
|
Initial
animal studies indicate the compounds to be pharmacologically active.
|
|
●
|
Multiple
compounds have demonstrated a meaningful in vivo reduction in pain (rodents).
|
|
●
|
All
tested compounds appear synergistic with morphine.
|
|
●
|
Certain
compounds with higher solubility appear synergistic with acetaminophen (Tylenol).
|
|
●
|
In
vivo studies suggest that certain compounds may have effects against insulin insensitivity,
which makes them potential candidates for licensing or partnership.
|
|
●
|
Purnovate
is establishing relationships to test its compounds in models of asthma, cancer, and inflammation,
also with the intent of licensing products that show initial success or advancing partnerships.
|
The
Company has filed patent applications with regard to these molecules.
Item
9.01. Financial Statements and Exhibits.
(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:
July 15, 2021
|
ADIAL
PHARMACEUTICALS, INC.
|
|
|
|
|
By:
|
/s/
William B. Stilley, III
|
|
Name:
|
William
B. Stilley
|
|
Title:
|
President
and Chief Executive Officer
|
2
Adial Pharmaceuticals (NASDAQ:ADIL)
Historical Stock Chart
From Mar 2024 to Apr 2024
Adial Pharmaceuticals (NASDAQ:ADIL)
Historical Stock Chart
From Apr 2023 to Apr 2024