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): October 15, 2020

Adial Pharmaceuticals, Inc.

(Exact name of registrant as specified in charter)

Delaware

(State or other jurisdiction of incorporation)

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:

Securities registered pursuant to Section 12(b) of the Act:

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 October 21, 2020, Adial Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (FDA) has reactivated the Company’s U.S. Investigational New Drug (IND) application and lifted the clinical hold from AD04, a genetically-targeted therapeutic agent for the treatment of Alcohol Use Disorder. The IND had been on clinical hold due to insufficient manufacturing information at the time the IND was inactivated by the Company, which was done while the Company exclusively focused its efforts on the Company’s landmark ONWARD™ pivotal Phase 3 clinical trial in Europe. The manufacturing data was developed and submitted to the relevant European regulatory authorities prior to commencing the ONWARD™ trial. However, since the trial was not being conducted in the U.S., the data had not yet been submitted to the FDA.

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.

Item 8.01. Other Events.

On October 15, 2020, the Company received notice that the FDA has reactivated the Company’s IND application and lifted the clinical hold from AD04. The IND had been on clinical hold due to insufficient manufacturing information at the time the IND was inactivated by the Company, which was done while the Company exclusively focused its efforts on the Company’s landmark ONWARD™ pivotal Phase 3 clinical trial in Europe. The manufacturing data was developed and submitted to the relevant European regulatory authorities prior to commencing the ONWARD™ trial. However, since the trial was not being conducted in the U.S., the data had not yet been submitted to the FDA.

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.