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): June 1, 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, 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:
| ☐ | 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 (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 3.02. Unregistered Sales of Equity Securities.
On June 1, 2021, Adial Pharmaceuticals, Inc. (the “Company”), following the effectiveness of the registration statement on Form S-3 (File No. 333-255352) that the Company filed with the U.S. Securities and Exchange Commission on April 20, 2021 (the “Registration Statement”), closed the second tranche of its private offering of common stock (the “2nd Tranche”) pursuant to those certain Securities Purchase Agreements, dated March 11, 2021 (the “Securities Purchase Agreements”), with each of Bespoke Growth Partners, Inc. (“Bespoke”), a company controlled by Mark Peikin, the Company’s Chief Strategy Officer, three entities controlled by James W. Newman, Jr., a member of the Company’s Board of Directors, and Keystone Capital Partners, LLC (“Keystone”), pursuant to which: (i) Bespoke purchased 303,000 shares of the Company’s common stock upon the effectiveness of the Registration Statement; and (ii) Keystone purchased 300,000 shares of the Company’s common stock upon the effectiveness of the Registration Statement. The shares of common stock issued in the 2nd Tranche were priced at $3.00 per share of common stock for proceeds to the Company of $1,809,000. No warrants were issued and no brokers fees were incurred.
The shares of the Company’s common stock issued under the Securities Purchase Agreements were pursuant to an exemption from the registration requirements under Section 4(a)(2) of the Securities Act of 1933, as amended, and Rule 506 of Regulation D promulgated thereunder. Bespoke and Keystone are accredited investors who have purchased the securities as an investment in the private placement, which did not involve a general solicitation. This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state.
The foregoing description of the Securities Purchase Agreements is qualified in their entirety by reference to the form of Securities Purchase Agreement filed hereto as Exhibit 10.1, which is incorporated herein by reference.
Item 8.01. Other Events.
On June 3, 2021, the Company issued a press release announcing the closing of the second tranche under the Securities Purchase Agreements, a copy of which is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
| (d) | Exhibits. |
| 2 |
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: June 4, 2021 | ADIAL PHARMACEUTICALS, INC. | |
| By: | /s/ William B. Stilley, III | |
| Name: | William B. Stilley | |
| Title: | President and Chief Executive Officer | |
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Exhibit 99.1
ADIAL ANNOUNCES FUNDING OF MANAGEMENT-LED $2,100,000 ABOVE MARKET PRIVATE PLACEMENT AT $3.00 PER SHARE
June 03, 2021
CHARLOTTESVILLE, Va., June 03, 2021 (GLOBE NEWSWIRE) -- 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 completed the $2,100,000 private placement of 700,001 shares of common stock at a price of $3.00 per share (the “Shares”) on June 1, 2021. The private placement investors included Bespoke Growth Partners, Inc., a company controlled by a member of management, a member of the Board of Directors of the Company, and Keystone Capital Partners, LLC. No warrants were issued and no brokers fees were incurred in this financing transaction.
As previously disclosed, the Company received $291,003 upon the parties’ execution of their respective Securities Purchase Agreements and the balance of $1,809,000 following the U.S. Securities and Exchange Commission declaring the registration statement on Form S-3 registering the resale of the private placement shares effective on May 26, 2021.
“We are excited to expand our relationship with Adial through this financing,” said Fred Zaino, Managing Partner and Chief Investment Officer of Keystone Capital Partners. “Adial has continued to execute and we remain as encouraged as ever by the outlook for the business. AD04 addresses a multi-billion-dollar, underserved market for alcohol use disorder, with potential for expansion into new indications such as opioid use disorder. Moreover, Keystone believes that through the acquisition of Purnovate and its expansion plans, Adial is positioning itself become a leader in the broader addiction market, including with a drug candidate for non-opioid pain reduction that addresses one of the key contributors to addiction.”
“Purpose-driven investment is paramount to us at Bespoke,” said Mark H. Peikin, CEO of Bespoke Growth Partners and Chief Strategy Officer of Adial. “Addiction has affected so many of us and our families, and has been further exacerbated by the pandemic. Importantly, Adial is mid-stage in the landmark ONWARD Phase 3 clinical trial testing AD04 for alcohol use disorder, and we are looking forward to the completion of the trial.”
About Adial Pharmaceuticals, Inc.
Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders. 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) and is currently being investigated in the Company’s landmark ONWARD™ pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes, which are to be identified using the Company’s proprietary companion diagnostic genetic test. A Phase 2b clinical trial of AD04 for the treatment of AUD showed promising results in reducing frequency of drinking, quantity of drinking and heavy drinking (all with statistical significance), and no overt safety concerns (there were no statistically significant serious adverse events reported). AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity, and the Company develops adenosine analogs for the treatment of pain and other disorders. Additional information is available at www.adialpharma.com.
About the Landmark ONWARD™ Pivotal Phase 3 Clinical Trial
The ONWARD trial is a 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 3 clinical study to evaluate the efficacy, safety and tolerability of AD04 in patients with Alcohol Use Disorder (AUD) and selected polymorphisms in the serotonin transporter and receptor genes. Patients are genetically screened prior to enrollment in the ONWARD trial so that only genetically positive patients are enrolled. The primary endpoint for analysis of efficacy is the change from baseline in the monthly number of heavy drinking days during the last 8 weeks of the 24-week treatment period. ONWARD is currently being conducted in 25 clinical sites in seven countries in Scandinavia and Central and Eastern Europe (Sweden, Finland, Poland, Latvia, Estonia, Bulgaria and Croatia). The principal investigator is Professor Hannu E.R. Alho, Emeritus Professor of Addiction Medicine at the University of Helsinki.
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 Adial positioning itself become a leader in the broader addiction market 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 leverage the acquisition of Purnovate and our other expansion plans to position ourself as a leader in the broader addiction market, our ability to enroll patients within the timelines anticipated and complete clinical trials on time and achieve desired results and benefits as expected, the ability of AD04 to treat other addictive disorders such as opioid use disorder, gambling, and obesity, 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 its product candidates in the marketplace and the successful development, marketing or sale of 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 its 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, 2020, 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
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