8-K
Adial Pharmaceuticals, Inc. (ADIL)
UNITEDSTATES
SECURITIESAND EXCHANGE COMMISSION
WASHINGTON,D.C. 20549
FORM8-K
CURRENTREPORT
Pursuantto Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (date of earliest event reported): February 25, 2021
AdialPharmaceuticals, Inc.
(Exactname of registrant as specified in charter)
Delaware
(Stateor other jurisdiction of incorporation)
| 001-38323 | 82-3074668 |
|---|---|
| (Commission File Number) | (IRS Employer Identification No.) |
1180Seminole Trail, Suite 495
Charlottesville,Virginia 22901
(Addressof principal executive offices and zip code)
(434)422-9800
(Registrant’stelephone number including area code)
(FormerName 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<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material<br> pursuant to Rule 14a-12(b) under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement<br> 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 | 7.01. Regulation FD Disclosure. |
|---|
On February 25, 2021, Adial Pharmaceuticals, Inc. (the “Company”) issued a press release (the “Press Release”) providing an update regarding its landmark ONWARD™ pivotal Phase 3 clinical trial (the “Trial”) investigating the Company’s lead drug candidate, AD04, as a therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in persons with certain target genotypes related to the serotonin transporter and receptor.
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 February 25, 2021, the Company issued the Press Release providing the following highlighted updates on the Trial:
● 50% enrollment reached in the Trial
| o | Trial is expected to be fully enrolled Summer of 2021 |
|---|
● 66% of planned patient screening visits completed
| o | 830<br> patients screened out of 1,254 patients expected to be required to achieve full enrollment<br> (more than 20 screened patients are currently pending enrollment) |
|---|
● 32% of patients screened are genetically positive for treatment with AD04
| o | Percentage<br> of genetically positive patients consistent with Phase 2b prevalence and expected U.S.<br> and European prevalence |
|---|
● 75% of patients screened as genetically positive have been enrolled
| o | Patient<br> enrollment exceeds projected rate of 50% for genetically positive patients |
|---|
● 86% ONWARD™ patient retention rate to date
| o | Retention<br> rate significantly greater than projected 70% retention rate |
|---|---|
| Item | 9.01. Financial Statements and Exhibits. |
| --- | --- |
(d) Exhibits.
The following exhibit is furnished with this Current Report on Form 8-K:
| Exhibit Number | Description |
|---|---|
| 99.1 | Press<br> Release issued by Adial Pharmaceuticals, Inc. on February 25, 2021 |
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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<br> 26, 2021 | ADIAL PHARMACEUTICALS, INC. | |
|---|---|---|
| By: | /s/<br> William B. Stilley, III | |
| Name: | William B. Stilley | |
| Title: | President<br> and Chief Executive Officer |
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Exhibit99.1
AdialPharmaceuticals Achieves 50% Enrollment in ONWARD™ Phase 3 Trial
Charlottesville,VA – February 25, 2021 – Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that it has reached 50% enrollment in the Company’s landmark ONWARD™ pivotal Phase 3 clinical trial. ONWARD is investigating the efficacy and safety of Adial’s lead drug candidate, AD04, as a therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in persons with certain target genotypes related to the serotonin transporter and receptor genes.
“We are pleased to have achieved this important enrollment milestone in our ONWARD pivotal Phase 3 clinical trial,” stated Schuyler Vinzant, Adial’s Vice President of Development. “We have a high degree of confidence that ONWARD will be fully enrolled this summer.”
Data Points – ONWARD Trial Patients
| ● | 66% of planned patient screening visits completed |
|---|---|
| o | 830<br> patients screened out of 1,254 patients expected to be required to achieve full enrollment<br> (more than 20 screened patients are currently pending enrollment) |
| --- | --- |
| ● | 32% of patients screened are genetically positive for treatment with AD04 |
| --- | --- |
| o | Percentage<br> of genetically positive patients consistent with Phase 2b prevalence and expected U.S.<br> and European prevalence |
| --- | --- |
| ● | 75% of patients screened as genetically positive have been enrolled |
| --- | --- |
| o | Patient<br> enrollment exceeds projected rate of 50% for genetically positive patients |
| --- | --- |
| ● | 86% ONWARD™ patient retention rate to date |
| --- | --- |
| o | Retention<br> rate significantly greater than projected 70% retention rate |
| --- | --- |
William Stilley, Adial’s Chief Executive Officer, commenting on the ONWARD trial protocol, stated “Telephonic pre-screening of potential study patients has allowed us to successfully reduce non-genetic screen failure rates. Moreover, streamlined site visits and patient follow-up processes have resulted in better-than-expected retention rates to date.”
Mr. Stilley continued, “Adial would like to express its genuine gratitude to all the ONWARD patients for their participation in the study and appreciation for the commitment they have made. We also appreciate the hard work of the more than 50 incredible frontline healthcare workers, including doctors, nurses and their staff, who are caring for our patients and share Adial’s commitment to improving outcomes for people suffering from Alcohol Use Disorder.”
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Aboutthe 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.
AboutAdial 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) 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. The Company is also developing adenosine analogs for the treatment of pain and other disorders. Additional information is available at www.adialpharma.com.
ForwardLooking Statements
Thiscommunication 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 andunknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially differentfrom any future results, performance or achievements expressed or implied by such forward-looking statements. Statements precededby, 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 innature and not historical facts, although not all forward-looking statements include the foregoing. The forward-looking statementsinclude statements regarding having the ONWARD™ trial fully enrolled this summer and the potential of AD04 to treat otheraddictive disorders such as opioid use disorder, gambling, and obesity. Any forward-looking statements included herein reflectour current views, and they involve certain risks and uncertainties, including, among others, our ability to enroll patients withinthe timelines anticipated and complete clinical trials on time and achieve desired results and benefits as expected, our abilityto 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, acceptanceof our product candidates in the marketplace and the successful development, marketing or sale of our products, our ability tomaintain our license agreements, the continued maintenance and growth of our patent estate, our ability to establish and maintaincollaborations, 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 exhaustiveand should be read together with the other cautionary statement included in our Annual Report on Form 10-K for the year endedDecember 31, 2019, subsequent Quarterly Reports on Form 10-Q and current reports on Form 8-K filed with the Securities and ExchangeCommission. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligationto publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstancesor 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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