Blog: ADIAL PHARMACEUTICALS, INC. : Regulation FD Disclosure, Other Events, Financial Statements and Exhibits (form 8-K) – Marketscreener.com

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.



Exhibit
Number    Exhibit Description
99.1        Adial Pharmaceuticals, Inc. press release dated March 6, 2023
99.2        Adial Pharmaceuticals, Inc. investor presentation dated March 7,
          2023
104       Cover Page Interactive Data File (the cover page XBRL tags are embedded
          within the inline XBRL document)




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