# EDGAR Filing Document

**Accession Number:** 0001513525
**File Stem:** 0001213900-23-013087
**Filing Date:** 2023-2
**Character Count:** 13274
**Document Hash:** 9ab0956d2e5bc8f4db3c0ae14f4faaa4
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001213900-23-013087.hdr.sgml**: 20230221

**ACCESSION NUMBER**: 0001213900-23-013087

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 15

**CONFORMED PERIOD OF REPORT**: 20230221

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230221

**DATE AS OF CHANGE**: 20230221

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** ADIAL PHARMACEUTICALS, INC.
- **CENTRAL INDEX KEY:** 0001513525
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 800667150
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-38323
- **FILM NUMBER:** 23645543

**BUSINESS ADDRESS:**
- **STREET 1:** 1180 SEMINOLE TRAIL
- **STREET 2:** SUITE 495
- **CITY:** CHARLOTTESVILLE
- **STATE:** VA
- **ZIP:** 22901
- **BUSINESS PHONE:** 434-422-9800

**MAIL ADDRESS:**
- **STREET 1:** 1180 SEMINOLE TRAIL
- **STREET 2:** SUITE 495
- **CITY:** CHARLOTTESVILLE
- **STATE:** VA
- **ZIP:** 22901

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** ADial Pharmaceuticals, L.L.C.
- **DATE OF NAME CHANGE:** 20170515

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Adial Pharmaceuticals, L.L.C.
- **DATE OF NAME CHANGE:** 20110218

?xml version="1.0" encoding="utf-8"?

**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 21, 2023**

**Adial Pharmaceuticals, Inc.**

*(Exact name of registrant as specified in charter)*

---

| | | |
|:---|:---|:---|
| **Delaware** | **001-38323** | **82-3074668** |
| **(State or other jurisdiction<br> of incorporation)** | **(Commission File Number)** | **(IRS Employer<br> 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)

**N/A**

(Former name or former address, if changed since last report)

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 (*see* General Instruction A.2. below):

☐ 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 | **The Nasdaq Stock Market LLC<br> (Nasdaq Capital Market)** |
| Warrants | ADILW | **The Nasdaq Stock Market LLC<br> (Nasdaq Capital Market)** |

---

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 ☒

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 February 21, 2023, Adial Pharmaceuticals, Inc. (the "Company") issued a press release announcing that it has secured meetings with regulatory authorities in the U.S. and Europe to discuss and develop plans for the clinical advancement of AD04 for alcohol use disorder toward potential approvals.

The information presented in this Item 7.01 of this Current Report on Form 8-K and Exhibit 99.1 is being furnished and shall not be deemed filed for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act") or otherwise be subject to the liabilities of that section, nor is it incorporated by reference into any filing of the Company, under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

**Item 8.01. Other Events**

On February 21, 2023, the Company issued a press release announcing that it has secured meetings with regulatory authorities in the U.S. and Europe to discuss and develop plans for the clinical advancement of AD04 for alcohol use disorder toward potential approvals. In the United States, the Company has secured a Type C meeting with the Food and Drug Administration (FDA) in the second quarter of this year. This meeting will allow the Company and the FDA to discuss the clinical development program for AD04 in the U.S. and the most appropriate path toward possible approval. In Europe, the Company has meetings scheduled or planned with five national regulatory authorities in France, Sweden, Finland, the United Kingdom, and Germany.

**Item 9.01. Financial Statements and Exhibits**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) Exhibits.

---

| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| 99.1 | [Press Release issued by Adial Pharmaceuticals, Inc.](ea173997ex99-1_adialpharma.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

---

**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 21, 2023 | **ADIAL PHARMACEUTICALS, INC.** | **ADIAL PHARMACEUTICALS, INC.** |
|  | By: | /s/ Cary J. Claiborne&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; |
|  | Name: | Cary J. Claiborne |
|  | Title: | President and Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

![](ex99-1_001.jpg)

**Adial Pharmaceuticals Confirms Scheduling of Meetings with FDA and European<br> Regulatory Agencies to Advance Clinical Development of AD04 for Alcohol Use Disorder** 

*Type C meeting with FDA set for Second Quarter*

 

*Plans in Place to Meet with Multiple Regulatory Agencies Throughout Europe*

**Charlottesville, VA, Feb. 21, 2023 –** Adial Pharmaceuticals, Inc. **(NASDAQ: ADIL; ADILW)** ("Adial" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today announced that it has secured meetings with regulatory authorities in the U.S. and Europe to discuss and develop plans for the clinical advancement of AD04 for alcohol use disorder toward potential approvals.

In the United States, Adial has secured a Type C meeting with the Food and Drug Administration (FDA) in the second quarter of this year. This meeting will allow Adial and the FDA to discuss the clinical development program for AD04 in the U.S. and the most appropriate path toward possible approval. In Europe, Adial has meetings scheduled or planned with five national regulatory authorities in France, Sweden, Finland, the United Kingdom and Germany. Adial intends to seek from the agencies a clear understanding and direction toward the most expeditious path to approval.

Cary Claiborne, Adial's President and Chief Executive Officer, said, "These meetings are the next step in our plan to complete clinical development of AD04 and bring to market a much-needed treatment for alcohol use disorder. In parallel, we are discussing opportunities with prospective pharmaceutical company partners that can help us to fund clinical development while also creating go-to market commercial strategies in the U.S. and Europe. We will provide an in-depth update on all AD04 program activities in the coming weeks."

**About Adial Pharmaceuticals, Inc.**

Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions. The Company's lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients and was recently investigated in the Company's ONWARD™ pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes (estimated to be approximately one-third of the AUD population) identified using the Company's companion diagnostic genetic test. ONWARD showed promising results in reducing heavy drinking in heavy drinking patients, and no overt safety or tolerability concerns. AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity. Additional information is available at <u>www.adial.com</u>.

**Forward Looking Statements** 

*This communication contains certain "forward-looking statements" within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words "believes," "expects," "anticipates," "intends," "projects," "estimates," "plans" and similar expressions or future or conditional verbs such as "will," "should," "would," "may" and "could" are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. The forward-looking statements include statements regarding, meetings allowing Adial and the FDA to discuss the clinical development program for AD04 in the U.S. and the most appropriate path toward approval, scheduled or planned meetings with five national regulatory authorities in France, Sweden, Finland, the United Kingdom and Germany, discussing opportunities with prospective pharmaceutical company partners that can help us to fund clinical development while also creating go-to market commercial strategies in the U.S. and Europe, AD04 being approved and brought to market, Adial partnering with another pharmaceutical company, Adial obtaining from agencies a clear understanding and direction toward the most expeditious path to regulatory approval, , AD04 appearing to be well tolerated and the potential of AD04 to treat other addictive disorders such as opioid use disorder, gambling, and obesity. Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, our ability to develop plans for the clinical advancement of AD04 for alcohol use disorder toward potential approvals with regulatory authorities in the U.S. and Europe, our ability to partner with prospective pharmaceutical companies to help the Company to fund clinical development while also creating go-to-market commercial strategies in the U.S. and Europe, our ability to complete clinical trials on time and achieve desired results and benefits as expected, our ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to our ability to promote or commercialize our product candidates for specific indications, acceptance of our product candidates in the marketplace and the successful development, marketing or sale of our products, our ability to maintain our license agreements, the continued maintenance and growth of our patent estate, our ability to establish and maintain collaborations, our ability to obtain or maintain the capital or grants necessary to fund our research and development activities, and our ability to retain our key employees or maintain our Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the other cautionary statement included in our Annual Report on Form 10-K for the year ended December 31, 2021, subsequent Quarterly Reports on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law.*

 

**Contact:**

Crescendo Communications, LLC

David Waldman / Natalya Rudman

Tel: 212-671-1021

Email: adil@crescendo-ir.com