ADIAL PHARMACEUTICALS, INC. : FD Settlement Disclosure, Other Events, Financial Statements and Exhibits (Form 8-K)

Section 7.01 Disclosure of FD Rules.

At February 9, 2022, Adial Pharmaceuticals, Inc. (the “Company”) has issued a press release announcing positive in vivo data for PNV-5032 as a potential treatment for asthma. PNV-5032 demonstrated significant inhibition of pulmonary flow resistance, which is a measure of asthmatic response, in an in vivo model.

PNV-5032 Relevant information

? More than 1000 times selective on the A1 adenosine receptor in potency

   assays



? Demonstrated solubility over 100 times greater than other selective products

adenosine compounds of the same class currently known to the Company

? The solubility of an inhaled product allows its dissolution in the aerosolized mist during

finely distributed over the bronchioles and may be important in facilitating

bronchiole membrane penetration

? The results indicate the drug development potential of molecules in this class,

   possibly to treat asthma



? Covered by a composition of matter patent application for patent protection

until 2042 with a planned statutory extension until 2047

The information contained in this Section 7.01 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K is not deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 , as amended, or otherwise subject to the responsibilities of this section or sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Section 7.01 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K is not to be incorporated by reference in any filing with the US Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of the language of general incorporation into 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 that it contains are “prospective” 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 as its management deems appropriate. Such updating may be effected by filing other reports or documents with the Security and Exchange Commissionthrough press releases or other public disclosures.

Item 8.01. Other Events.


At February 9, 2022, the Company issued a press release announcing positive in vivo data for PNV-5032 as a potential treatment for asthma. PNV-5032 demonstrated significant inhibition of pulmonary flow resistance, which is a measure of asthmatic response, in an in vivo model.

PNV-5032 Relevant information

? More than 1000 times selective on the A1 adenosine receptor in potency

   assays



? Demonstrated solubility over 100 times greater than other selective products

adenosine compounds of the same class currently known to the Company

? The solubility of an inhaled product allows its dissolution in the aerosolized mist during

finely distributed over the bronchioles and may be important in facilitating

bronchiole membrane penetration

? The results indicate the drug development potential of molecules in this class,

   possibly to treat asthma



? Covered by a composition of matter patent application for patent protection

until 2042 with a planned statutory extension until 2047

Section 9.01. Financial statements and supporting documents.



(d) Exhibits.



Exhibit
Number    Description

99.1        Press Release issued by Adial Pharmaceuticals, Inc. on February 9,
          2022

104       Cover Page Interactive Data File (the cover page XBRL tags are embedded
          within the inline XBRL document)




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