1. Charlottesville, Virginia--(Newsfile Corp. - March 23, 2021) -  Adial Pharmaceuticals, Inc. (NASDAQ:ADIL) (NASDAQ: ADILW) ("Adial"), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that William Stilley, Chief Executive Officer of Adial Pharmaceuticals will be presenting at the Benzinga Biotech Small Cap Conference at 1:40 pm EST on Wednesday, March 24, 2021. The Benzinga Biotech Small Cap Conference will be taking place from March 24-25, 2021.

    Investors interested in joining the Adial presentation can register for a free spectator pass at the link below: 
    https://www.benzinga.com/events/small-cap/biotech/

    About Adial Pharmaceuticals, Inc.

    Adial Pharmaceuticals is a clinical-stage…

    Charlottesville, Virginia--(Newsfile Corp. - March 23, 2021) -  Adial Pharmaceuticals, Inc. (NASDAQ:ADIL) (NASDAQ: ADILW) ("Adial"), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that William Stilley, Chief Executive Officer of Adial Pharmaceuticals will be presenting at the Benzinga Biotech Small Cap Conference at 1:40 pm EST on Wednesday, March 24, 2021. The Benzinga Biotech Small Cap Conference will be taking place from March 24-25, 2021.

    Investors interested in joining the Adial presentation can register for a free spectator pass at the link below: 
    https://www.benzinga.com/events/small-cap/biotech/

    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) 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 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.

    About the Benzinga Biotech Small Cap Conference

    The Benzinga Biotech Small Cap Conference bridges the gap between biotech companies, investors, and traders. Discover the companies in the biotech space who are helping to bring the world back to normalcy in the wake of the COVID-19 pandemic.

    For more information and/or to register for the conference please visit: https://www.benzinga.com/events/small-cap/biotech/

    Note on 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 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 enroll patients within the timelines anticipated and 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 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, 2019, 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: 

    To view the source version of this press release, please visit https://www.newsfilecorp.com/release/78265

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  2. CHARLOTTESVILLE, Va., March 17, 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 Dr. Bankole Johnson, founder and Chief Medical Officer of Adial, was honored to be a guest on The Black News Channel (BNC). During the interview, he offered insights into the long-term effects of the COVID-19 pandemic on mental health and addiction. Dr. Johnson may serve as a featured guest on BNC in future interviews to discuss related topics.

    A replay of the interview is available on the media section of the Company's website at: https://www.adialpharma.com/newsroom/media/

    CHARLOTTESVILLE, Va., March 17, 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 Dr. Bankole Johnson, founder and Chief Medical Officer of Adial, was honored to be a guest on The Black News Channel (BNC). During the interview, he offered insights into the long-term effects of the COVID-19 pandemic on mental health and addiction. Dr. Johnson may serve as a featured guest on BNC in future interviews to discuss related topics.

    A replay of the interview is available on the media section of the Company's website at: https://www.adialpharma.com/newsroom/media/.

    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.

    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 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 enroll patients within the timelines anticipated and 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 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, 2019, 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:



    Primary Logo

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  3. CHARLOTTESVILLE, Va., March 15, 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 entered into Securities Purchase Agreements ("SPAs") for the private placement of 700,001 shares of common stock at a price of $3.00 per share (the "Shares"), for total proceeds of $2,100,000. The private placement investors include members of Management and the Board of Directors of the Company and Keystone Capital Partners, LLC (collectively, "Investors"). No warrants or brokers fees were issued in this financing transaction.

    In accordance…

    CHARLOTTESVILLE, Va., March 15, 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 entered into Securities Purchase Agreements ("SPAs") for the private placement of 700,001 shares of common stock at a price of $3.00 per share (the "Shares"), for total proceeds of $2,100,000. The private placement investors include members of Management and the Board of Directors of the Company and Keystone Capital Partners, LLC (collectively, "Investors"). No warrants or brokers fees were issued in this financing transaction.

    In accordance with the terms of the SPAs, the Investors are obligated to fund $1,809,000 upon the registration of the Shares. The Company received $291,003 upon the parties' execution of the SPAs in accordance with the terms contained therein.

    Details of the private placement are available in the Company's Form 8-K, which has been filed with the securities and Exchange Commission and is available at www.sec.gov or by visiting the Company's web site here.

    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 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 enroll patients within the timelines anticipated and 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 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, 2019, 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:



    Primary Logo

    View Full Article Hide Full Article
  4. CHARLOTTESVILLE, Va., Feb. 26, 2021 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial"), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that it will host a Town Hall at 1 P.M., Eastern Time on Thursday, March 18, 2021.

    Information for shareholders interested in attending will be available at the Company's Investors section of the website: https://ir.adialpharma.com/

    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…

    CHARLOTTESVILLE, Va., Feb. 26, 2021 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial"), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that it will host a Town Hall at 1 P.M., Eastern Time on Thursday, March 18, 2021.

    Information for shareholders interested in attending will be available at the Company's Investors section of the website: https://ir.adialpharma.com/

    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) 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 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.

    Note on 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 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 enroll patients within the timelines anticipated and 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 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, 2019, 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:



    Primary Logo

    View Full Article Hide Full Article
  5. CHARLOTTESVILLE, Va., Feb. 26, 2021 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced the exercise of 712,500 warrants from its June 2020 financing for net proceeds to the company of $1,425,000.

    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) and is currently being investigated in…

    CHARLOTTESVILLE, Va., Feb. 26, 2021 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced the exercise of 712,500 warrants from its June 2020 financing for net proceeds to the company of $1,425,000.

    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) 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 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 enroll patients within the timelines anticipated and 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 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, 2019, 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:



    Primary Logo

    View Full Article Hide Full Article
  6. CHARLOTTESVILLE, Va., Feb. 25, 2021 (GLOBE NEWSWIRE) -- 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…

    CHARLOTTESVILLE, Va., Feb. 25, 2021 (GLOBE NEWSWIRE) -- 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
      • 830 patients screened out of 1,254 patients expected to be required to achieve full enrollment (more than 20 screened patients are currently pending enrollment)
    • 32% of patients screened are genetically positive for treatment with AD04
      • Percentage of genetically positive patients consistent with Phase 2b prevalence and expected U.S. and European prevalence
    • 75% of patients screened as genetically positive have been enrolled
      • Patient enrollment exceeds projected rate of 50% for genetically positive patients
    • 86% ONWARD™ patient retention rate to date
      • Retention 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."

    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.

    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) 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.

    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 having the ONWARD™ trial fully enrolled this summer 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 enroll patients within the timelines anticipated and 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 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, 2019, 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:



    Primary Logo

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  7. CHARLOTTESVILLE, Va., Feb. 23, 2021 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that it will be filing an application for "Fast Track" with the U.S. Food and Drug Administration (FDA) for its lead drug candidate, AD04, which is a therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in persons with certain target genotypes.

    Adial previously announced on September 25, 2020, that the Company had submitted a formal request to the FDA in support of Adial's position that AD04 should be considered eligible for an FDA expedited review program. Adial and its regulatory…

    CHARLOTTESVILLE, Va., Feb. 23, 2021 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that it will be filing an application for "Fast Track" with the U.S. Food and Drug Administration (FDA) for its lead drug candidate, AD04, which is a therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in persons with certain target genotypes.

    Adial previously announced on September 25, 2020, that the Company had submitted a formal request to the FDA in support of Adial's position that AD04 should be considered eligible for an FDA expedited review program. Adial and its regulatory advisors had previously concluded that AD04, which is being developed for a serious condition that is an unmet medical need, is a candidate for this FDA program.

    "Adial's correspondence and consultation with the FDA following its expedited review filing in September 2020, leads us to believe that AD04 qualifies for Fast Track consideration," said Adial's Head of Regulatory, Dr. Jack Reich. "I am confident Alcohol Use Disorder qualifies as a serious condition and that there is an unmet medical need, based on our communication with the FDA and as set forth in the FDA's Guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics."

    "We are working with our regulatory counsel to prepare our Fast Track submission after consultation with the FDA," commented Adial's CEO, William Stilley. "Following our submission, the FDA is expected to review the request and make a decision within 60 days."

    The FDA's Fast Track is a process designed to facilitate development and expedite the regulatory review of drugs that treat serious conditions and address unmet medical needs with the purpose of getting important drugs to patients earlier. While the FDA judges the seriousness of a condition on a case-by-case basis, the FDA generally considers whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the condition, left untreated, will progress to a more serious state. Depression is one such disease that is considered to be a serious condition for Fast Track purposes, and Adial believes that Alcohol Use Disorder will be treated similarly.

    When reviewing a Fast Track application where there are available therapies, the Fast Track drug must demonstrate advantages over the available therapy currently approved for the indication in order to be considered as meeting an unmet medical need. Examples of advantages considered by the FDA that Adial believes are applicable to AD04 include: (1) has an effect on a serious outcome of the condition in patients who are unable to tolerate or failed to respond to available therapy; (2) decreases a clinical significant toxicity of an available therapy that is common and causes discontinuation of a treatment; (3) provides safety and efficacy comparable to those of available therapy but has a benefit that is expected to lead to an improvement in serious outcomes; and (4) has the ability to address emerging or anticipated public health need.

    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) and is currently being investigated in the Company's landmark ONWARD™ Phase 3 Pivotal 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.

    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 AD04 qualifying for Fast Track consideration, the FDA treating AD04 similarly to depression for Fast Track designation purposes, Alcohol Use Disorder qualifying as a serious condition and being an unmet medical need and the timing of the FDA review and decision process for the Company's Fast Track Designation request 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, to the FDA determining that AD04 qualifies for Fast Track Designation, our ability to enroll patients within the timelines anticipated and 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 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, 2019, 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:



    Primary Logo

    View Full Article Hide Full Article
  8. CHARLOTTESVILLE, VA / ACCESSWIRE / January 11, 2021 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that William Stilley, Chief Executive Officer of Adial Pharmaceuticals has been invited to present a Company overview at the 23rd Annual ICR Conference on Thursday, January 14, 2021 at 3:15pm-3:55pm Eastern Time.

    A live webcast of the Company's presentation will be available on the Investors section of the Company's website (https://www.adialpharma.com/). A webcast replay will be accessible for 90 days following the live presentation.

    About Adial Pharmaceuticals, Inc.

    Adial Pharmaceuticals is a clinical-stage…

    CHARLOTTESVILLE, VA / ACCESSWIRE / January 11, 2021 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that William Stilley, Chief Executive Officer of Adial Pharmaceuticals has been invited to present a Company overview at the 23rd Annual ICR Conference on Thursday, January 14, 2021 at 3:15pm-3:55pm Eastern Time.

    A live webcast of the Company's presentation will be available on the Investors section of the Company's website (https://www.adialpharma.com/). A webcast replay will be accessible for 90 days following the live presentation.

    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) and is currently being investigated in the Company's landmark ONWARD™ Phase 3 Pivotal 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. Additional information is available at www.adialpharma.com.

    Contact:

    Crescendo Communications, LLC
    David Waldman / Natalya Rudman
    Tel: 212-671-1021
    Email:

    SOURCE: Adial Pharmaceutical, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/623791/Adial-Pharmaceuticals-to-Present-at-23rd-Annual-ICR-Conference

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  9. CHARLOTTESVILLE, VA / ACCESSWIRE / January 11, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced receipt of a Notice of Allowance for its third U.S. patent relating to the use of AD04 for the treatment of opioid use disorder (OUD). The patent covers the use of the Company's lead product, AD04, as a treatment of Opioid Use Disorder in patients with a specific genetic biomarker in the serotonin transporter gene.

    William Stilley, Chief Executive Officer of Adial Pharmaceuticals, commented, "We are pleased to announce our third patent for AD04 for the treatment of Opioid Use Disorder, which is both a large and an underserved…

    CHARLOTTESVILLE, VA / ACCESSWIRE / January 11, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced receipt of a Notice of Allowance for its third U.S. patent relating to the use of AD04 for the treatment of opioid use disorder (OUD). The patent covers the use of the Company's lead product, AD04, as a treatment of Opioid Use Disorder in patients with a specific genetic biomarker in the serotonin transporter gene.

    William Stilley, Chief Executive Officer of Adial Pharmaceuticals, commented, "We are pleased to announce our third patent for AD04 for the treatment of Opioid Use Disorder, which is both a large and an underserved market. As we continue to study AD04 in our landmark ONWARD™ Phase 3 pivotal clinical trial for the treatment of Alcohol Use Disorder, our goal is to confirm the findings of the Phase 2b trial, which demonstrated the efficacy of AD04 as a treatment for Alcohol Use Disorder. We believe the primary mechanism of action through which AD04 produces its pharmacological effect is through inhibiting activation of the serotonin-3 receptor in the brain, thereby blocking effects on the dopamine system. We see significant potential in AD04 for the treatment of Opioid Use Disorder since the physiology and neuro-transmitters involved in opioid addiction are similar to alcohol and could be expected to be modulated by a serotonin-3 receptor antagonist."

    According to the U.S. Centers for Disease Control and Prevention, an estimated 2 million people in the U.S. had an opioid use disorder in 2018 and nearly 70% of drug overdose deaths were attributed to opioids. "Sadly, we believe these numbers have grown significantly due to the ongoing pandemic, and we are hopeful that AD04 may provide a desperately needed treatment option for those suffering from opioid addiction," added Mr. Stilley.

    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) and is currently being investigated in the Company's landmark ONWARD™ Phase 3 pivotal 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. Additional information is available at www.adialpharma.com.

    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 confirming the findings in the Phase 2b trial that the primary mechanism of action through which AD04 produces its pharmacological effect is through inhibiting activation of the serotonin-3 receptor in the brain and blocking effects on the dopamine system, the potential in AD04 for the treatment of Opioid Use Disorder and the potential of AD04 to treat other addictive disorders such as alcohol 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 confirm the findings in the Phase 2b trial that the primary mechanism of action through which AD04 produces its pharmacological effect is through inhibiting activation of the serotonin-3 receptor in the brain, thereby blocking effects on the dopamine system, the ability of AD04 to be a treatment option for those suffering from opioid addiction and other addictive disorders, our ability to enroll patients within the timelines anticipated and 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 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, 2019, 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:

    SOURCE: Adial Pharmaceutical, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/623785/Adial-Pharmaceuticals-Receives-Notice-of-Allowance-for-Third-US-Patent-Covering-AD04-for-the-Treatment-for-Opioid-Use-Disorder

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  10. ONWARD™ Trial Remains on Track to be Fully Enrolled During Q2 2021

    CHARLOTTESVILLE, VA / ACCESSWIRE / December 17, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced it has reached the 35% enrollment target in the Company's landmark ONWARD™ Phase 3 pivotal trial in Europe. 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.

    William Stilley, Chief Executive Officer of Adial Pharmaceuticals, commented, "Reaching the 35% enrollment…

    ONWARD™ Trial Remains on Track to be Fully Enrolled During Q2 2021

    CHARLOTTESVILLE, VA / ACCESSWIRE / December 17, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced it has reached the 35% enrollment target in the Company's landmark ONWARD™ Phase 3 pivotal trial in Europe. 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.

    William Stilley, Chief Executive Officer of Adial Pharmaceuticals, commented, "Reaching the 35% enrollment target reaffirms the continued progress in our ONWARD™ Phase 3 trial in Europe. Additionally, there has been an uptick in screenings, and, based on our enrollment rates to date, we anticipate having the ONWARD trial 50% enrolled in the next month. We are encouraged that the early termination rate is lower than we had expected. Importantly, there have been no serious adverse events to date. We are also adding additional sites in high enrolling countries, which we believe will further enhance the trial enrollment. In response to the COVID-19 pandemic, a protocol amendment was successfully implemented at all sites to incorporate remote procedures and reduce clinical trial participant time on site. As a result, we remain on track to complete enrollment by the second quarter of 2021 and look forward to providing further updates as we advance the trial."

    "We are especially proud to achieve these milestones on schedule, despite the impact of COVID-19 on clinical trials around the globe, and we remain fully committed to advancing our goal of bringing this meaningful new treatment for AUD to patients worldwide. Today, there is no adequate treatment for AUD as current therapies have limited efficacy and significant side effects. It is widely reported that the alcohol problem has grown worse during the COVID-19 lockdown, heightening the urgency for pharmacological interventions such as AD04."

    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) and is currently being investigated in the Company's landmark ONWARD™ Phase 3 Pivotal 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. Additional information is available at www.adialpharma.com.

    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 having the ONWARD trial 50% enrolled in the next month, additional sites in high enrolling countries further enhancing the trial enrollment, remaining on track to complete enrollment by the second quarter of 2021 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, our ability to enroll patients within the timelines anticipated and 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 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, 2019, 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:

    SOURCE: Adial Pharmaceutical, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/621391/Adial-Pharmaceuticals-Reaches-35-Enrollment-in-ONWARDTM-Pivotal-Phase-3-Trial-of-AD04-for-the-Treatment-of-Alcohol-Use-Disorder

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  11. CHARLOTTESVILLE, VA / ACCESSWIRE / December 15, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced the appointment of Dr. Jack Reich as Head of Regulatory, effective December 14, 2020. As part of his transition to Company management, Dr. Reich stepped down from the Board of Directors to serve in his new full-time role.

    Dr. Jack Reich's career spans over 35 years in the pharmaceutical, biotechnology, and venture capital industries. Since 1987, Dr. Reich has been involved in more than 30 medical and biotech companies. He was a founding officer of Gensia, Inc. and co-founded the first gene therapy company, Viagene, Inc. Following…

    CHARLOTTESVILLE, VA / ACCESSWIRE / December 15, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced the appointment of Dr. Jack Reich as Head of Regulatory, effective December 14, 2020. As part of his transition to Company management, Dr. Reich stepped down from the Board of Directors to serve in his new full-time role.

    Dr. Jack Reich's career spans over 35 years in the pharmaceutical, biotechnology, and venture capital industries. Since 1987, Dr. Reich has been involved in more than 30 medical and biotech companies. He was a founding officer of Gensia, Inc. and co-founded the first gene therapy company, Viagene, Inc. Following its public listing, Gensia soon became the second-largest market cap biotech on NASDAQ, and Viagene was acquired by Chiron after its public listing. Dr. Reich also co-founded the first cardiovascular gene therapy company, Collateral Therapeutics, Inc., which he took public on NASDAQ in 1997 as Chairman and CEO. Subsequently, Collateral was sold to Schering AG in 2002. In 2009, Dr. Reich co-founded Renova Therapeutics, where he served as CEO until 2019.

    William Stilley, President and Chief Executive Officer of Adial Pharmaceuticals, commented, "We are pleased to announce Dr. Reich's new role as Head of Regulatory. To say that Dr. Reich's career has been impressive does not do justice to what he has accomplished as an innovator and leader in the pharmaceutical field, particularly his regulatory accomplishments. We look forward to Dr. Reich contributing his experience at Adial as we advance AD04 for the treatment of Alcohol Use Disorder (AUD) and in particular his guidance as we pursue expedited review programs for AD04 in genetically identified subjects, where he has already been instrumental. Dr. Reich's broad industry experience and his past tenure on our Board of Directors provides him unique insight into the significant potential of AD04, which addresses a multi-billion-dollar, underserved AUD market with few viable options for effective treatment of patients. The addition of an industry leader of Dr. Reich 's caliber to our management team will also assist us in evaluating other regulatory opportunities and strategic options in the field of addiction and integration of the Purnovate assets we anticipate acquiring as recently disclosed."

    "It is with great pleasure that I join the Adial management team full time," stated Dr. Jack Reich, the new Head of Regulatory for Adial Pharmaceuticals. "Having joined the Board of Directors earlier this year, I was able to further assess the company, its products and its needs. After my full evaluation of the data and strategy, I became even more excited by the opportunities and believe I can have a greater impact on the company and drive more benefit for our patients by joining management and being involved on a day-to-day basis. I have been involved in developing treatments for numerous diseases over my career and can think of no indication I would rather target as a capstone than addiction."

    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) and is currently being investigated in the Company's landmark ONWARD™ Phase 3 Pivotal 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. Additional information is available at www.adialpharma.com.

    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 the expected contribution of Dr. Reich 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 successfully integrate Dr. Reich into the management team, the ability to expand the use of AD04 for use in patients with Opioid Use Disorder, gambling and obesity, the ability of AD04 therapy to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, 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, 2019, 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:

    SOURCE: Adial Pharmaceuticals, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/620958/Adial-Pharmaceuticals-Appoints-Dr-Jack-Reich-as-Head-of-Regulatory

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  12. CHARLOTTESVILLE, VA / ACCESSWIRE / December 10, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial"), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it will host a conference call at 11:00 AM, Eastern Time on Wednesday, December 16, 2020, to discuss the planned acquisition of Purnovate as well as additional recent developments.

    The conference call will be available via telephone by dialing toll free 877-407-0782 for U.S. callers or + 201-689-8567 for international callers, or on the Company's Investors section of the website: https://ir.adialpharma.com/.

    A webcast replay will be available on the Company's Investor section of the website, https://ir.adialpharma.com/

    CHARLOTTESVILLE, VA / ACCESSWIRE / December 10, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial"), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it will host a conference call at 11:00 AM, Eastern Time on Wednesday, December 16, 2020, to discuss the planned acquisition of Purnovate as well as additional recent developments.

    The conference call will be available via telephone by dialing toll free 877-407-0782 for U.S. callers or + 201-689-8567 for international callers, or on the Company's Investors section of the website: https://ir.adialpharma.com/.

    A webcast replay will be available on the Company's Investor section of the website, https://ir.adialpharma.com/, through December 16, 2021. A telephone replay of the call with be available approximately one hour following the call, through Wednesday, December 30, 2020 and can be accessed by dialing 877-481-4010 for U.S. callers or + 919-882-2331 for international callers and entering conference ID: 39164.

    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) 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. www.adialpharma.com

    Note on 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 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 expand the use of AD04 for use in patients with Opioid Use Disorder, gambling and obesity, the ability of AD04 therapy to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, our ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, 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, 2019, subsequent Quarterly Reports on Form 10-Q, current reports on Form 8-K and other documents 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:

    SOURCE: Adial Pharmaceutical, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/620422/Adial-Pharmaceuticals-Schedules-Business-Update-Conference-Call-to-Discuss-Planned-Acquisition-of-Purnovate-and-other-Recent-Developments

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  13. CHARLOTTESVILLE, VA / ACCESSWIRE / December 10, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that it has entered into a definitive agreement ("Purchase Agreement") to acquire Purnovate, LLC ("Purnovate"), a pharmaceutical development company focused on novel, drug candidates for non-opioid pain reduction and the treatment of addiction and other diseases through targeted use of adenosine analogs with promising potency, selectivity, stability, and solubility characteristics. In connection with the transaction, Purnovate's CEO, Robert D. Thompson, will join Adial as its Vice President, Chemistry…

    CHARLOTTESVILLE, VA / ACCESSWIRE / December 10, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that it has entered into a definitive agreement ("Purchase Agreement") to acquire Purnovate, LLC ("Purnovate"), a pharmaceutical development company focused on novel, drug candidates for non-opioid pain reduction and the treatment of addiction and other diseases through targeted use of adenosine analogs with promising potency, selectivity, stability, and solubility characteristics. In connection with the transaction, Purnovate's CEO, Robert D. Thompson, will join Adial as its Vice President, Chemistry.

    William Stilley, Chief Executive Officer of Adial, commented, "We are excited to announce what we expect to be a transformative acquisition, with the potential to significantly expand and diversify Adial's addiction-related pipeline. Our lead product, AD04, is undergoing testing in the landmark ONWARD™ Phase 3 pivotal trial as a genetically targeted therapeutic agent for the treatment of Alcohol Use Disorder (AUD), and we plan to test AD04 in Phase 2 clinical trials for Opioid Use Disorder and other addictive disorders. The acquisition of a product development pipeline like Purnovate's is an obvious next step in furtherance of Adial's mission to build the world's leading, addiction-focused pharmaceutical company."

    "Purnovate's lead program for non-opioid pain management provides Adial unique and differentiated compounds targeting the multi-billion-dollar pain market," continued Mr. Stilley. "By providing an alternative to opioids, we would be targeting what we call the ‘supply side of addiction' and believe these drug candidates could be important tools in fighting addiction by preventing it. Adial's integration of Purnovate's platform also provides the opportunity to advance the invention and development of adenosine analog compounds that could be drug candidates for the treatment of addiction, including cocaine addiction. Adial is the ‘Medicines for Addiction' company and by this acquisition, Dr. Thompson and his team would bring additional expertise in chemistry, analytics and manufacturing. We expect this acquisition to be accretive not only with regard to expansion of our drug portfolio targeting addiction but also in support of AD04 as we prepare for commercial manufacturing and plan to advance the formulation of a once-a-day, extended-release AD04 tablet. Purnovate's adenosine analog production capabilities may open the door to licensing and partnering opportunities for products outside the addiction space as well, including infectious diseases, inflammation, cancer, asthma, and diabetes."

    Purnovate has developed innovative technologies to enhance the drug properties of purines, a class of chemical structures that include adenosine, an important neurotransmitter, to treat serious diseases and disorders including non-opioid pain reduction, cocaine addiction, infectious diseases, inflammation, cancer, asthma, and diabetes. In addition to its current patent applications and drug candidates, Purnovate's technologies include proprietary purification and solubilizing methodologies to synthesize and develop adenosine analogs that are expected to produce additional new chemical compounds that are patentable compositions of matter.

    Dr. Thompson, Chief Executive Officer of Purnovate, is a world-renowned adenosine chemist that has been working in the field for over 35 years. He is the inventor of more than 20 adenosine analog patents covering tens of thousands of novel molecules and has authored dozens of scientific publications.

    "It is with great excitement that we look forward to joining the Adial team to advance development of our selective adenosine analogs, which have the potential to provide an attractive pathway to treat pain without the use of opioids and while avoiding the tolerability and safety issues that plague other drugs in the pain management field," stated Dr. Thompson. "We believe these compounds have the potential to provide meaningful, non-opioid treatment for pain without the side effects or delivery problems of earlier generations of adenosine compounds. These adenosine analogs may also be useful in a number of other diseases and disorders."

    There can be no assurance that the proposed acquisition will be consummated. Specific conditions must be satisfied or waived in order to complete Adial's acquisition of Purnovate, including, among others, receipt of an opinion from Adial's financial advisor that the consideration to be paid by Adial to Purnovate pursuant to the Purchase Agreement is fair, from a financial point of view, to the stockholders of the Adial. If the conditions are not satisfied or waived, the acquisition will not occur or will be delayed, and Adial and Purnovate each may lose some or all of the intended benefits of the acquisition.

    Details of the Purchase Agreement are available in the Company's Form 8-K, which has been filed with the Securities and Exchange Commission and is available at www.sec.gov or by visiting the Company's web site here.

    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 therapeutic agent for the treatment of Alcohol Use Disorder (AUD) and is currently being investigated in a Phase 3 clinical 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.

    www.adialpharma.com

    About Purnovate, LLC

    Purnovate is a pharmaceutical development and chemistry company focused on inventing and developing selective, potent, stable, and soluble adenosine analogs to treat diseases and disorders such as pain, cocaine addiction, inflammation, infectious disease, cancer, asthma, and diabetes. www.purnovate.com

    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 acquiring Purnovate pursuant to the Purchase Agreement and the consummation of the transaction, the acquisition being transformative and significantly expanding and diversifying Adial's addiction-related pipeline, the acquisition of a product pipeline like Purnovate's being an obvious next step in the continuation of Adial's mission to build the world's leading addiction-focused pharmaceutical company, Purnovate's lead program for non-opioid pain management providing Adial unique and differentiated compounds targeting the multi-billion dollar pain market, the Purnovate drug candidates being important tools in fighting addiction by preventing it, using Purnovate's platform to explore the potential for producing adenosine analog compounds that could be drug candidates for the treatment of addiction, including cocaine addiction, the synergies to be achieved from Dr. Thompson and his team's expertise in chemistry, analytics and manufacturing, preparing for commercial manufacturing, as well as developing new formulations of AD04, Purnovate's adenosine analog production platform potentially opening the door to possible licensing and partnering opportunities for products outside the addiction space, including infectious disease, inflammation, cancer, asthma, and diabetes, adenosine analogs providing an attractive pathway to treat pain without the use of opioids, while avoiding the tolerability and safety issues that plague other drugs in the pain management field without the side effects or delivery problems of earlier generations of adenosine compounds, adenosine analogs being useful in a number of other diseases and disorders 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 complete the acquisition of Purnovate pursuant to the Purchase Agreement, our ability to build the world's leading addiction-focused pharmaceutical company, the ability of Purnovate's lead program for non-opioid pain management to provide Adial a unique and differentiated compounds targeting the multi-billion dollar pain market, the ability of Purnovate's drug candidates to become important tools in fighting addiction by preventing it, our ability to use Purnovate's platform to explore the potential for producing adenosine analog compounds that could be drug candidates for the treatment of addiction, including cocaine addiction, the contribution of Dr. Thompson and his team's expertise in chemistry, analytics and manufacturing, our ability to prepare for commercial manufacturing, as well as develop new formulations of AD04, the ability of Purnovate's adenosine analog production platform to open the door to possible licensing and partnering opportunities for products outside the addiction space, including infectious disease, inflammation, cancer, asthma, and diabetes, adenosine analogs providing an attractive pathway to treat pain without the use of opioids and while avoiding the tolerability and safety issues that plague other drugs in the pain management field, without the side effects or delivery problems of earlier generations of adenosine compounds, our ability to enroll patients and 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 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, 2019, 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:

    SOURCE: Adial Pharmaceutical, Inc.



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    https://www.accesswire.com/620396/Adial-Pharmaceuticals-Enters-Agreement-to-Acquire-Purnovate-a-Developer-of-Potential-Therapies-for-Non-Opioid-Pain-Reduction-and-Treatment-of-Addiction

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  14. CHARLOTTESVILLE, VA / ACCESSWIRE / December 9, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today issued a public statement encouraging those battling alcohol and other substance use disorders to refrain from driving under the influence, especially during the holiday season.

    William Stilley, CEO of Adial Pharmaceuticals, noted, "Understanding our DNA and how it drives addiction, may play an important role in addressing the global addiction crisis. The idea you can ‘just say no' is not always the best approach to combatting addiction. Individuals with certain genetics are targeted for treatment with our lead drug candidate AD04, and…

    CHARLOTTESVILLE, VA / ACCESSWIRE / December 9, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today issued a public statement encouraging those battling alcohol and other substance use disorders to refrain from driving under the influence, especially during the holiday season.

    William Stilley, CEO of Adial Pharmaceuticals, noted, "Understanding our DNA and how it drives addiction, may play an important role in addressing the global addiction crisis. The idea you can ‘just say no' is not always the best approach to combatting addiction. Individuals with certain genetics are targeted for treatment with our lead drug candidate AD04, and we believe this therapy may help reduce cravings for alcohol and potentially other addictive substances such as opioids. We are working aggressively to move this targeted therapy through clinic testing and are now in active human trials in seven countries. In the meantime, I'd like to strongly encourage everyone to stay safe and do not drive if you have been drinking."

    Adial was featured on FOX31 Denver, and a link to the segment is available here. This interview follows several media appearances, where Adial and Mr. Stilley have been featured in a discussion on Alcohol Use Disorder and the increase in drinking during the isolation of COVID-19, particularly during this holiday season.

    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 therapeutic agent for the treatment of Alcohol Use Disorder (AUD) and is currently being investigated in a Phase 3 clinical 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. www.adialpharma.com

    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 our lead drug candidate AD04 helping reduce cravings for alcohol and potentially other addictive substances such as opioids and the potential of AD04 to treat other addictive disorders such as 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 enroll patients and 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 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, 2019, 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:

    SOURCE: Adial Pharmaceuticals, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/620155/Adial-Pharmaceuticals-CEO-Weighs-in-on-the-Alcohol-Pandemic-and-Drunk-Driving-Over-the-Holidays-FOX31-Denvers-Shaul-Turner-Interviews-Bill-Stilley

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  15. Previous news segment has appeared on dozens of media stations nationwide

    CHARLOTTESVILLE, VA / ACCESSWIRE / December 4, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, reports that its lead drug candidate, AD04, 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, has been featured on the Local 12: Healthy Perspective news segment, as a follow up to the earlier feature about Adial's AD04 on WKRC in Cincinnati, which has aired on dozens of stations nationwide. A link to the segment is available right now at: www.adialpharma.com

    Previous news segment has appeared on dozens of media stations nationwide

    CHARLOTTESVILLE, VA / ACCESSWIRE / December 4, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, reports that its lead drug candidate, AD04, 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, has been featured on the Local 12: Healthy Perspective news segment, as a follow up to the earlier feature about Adial's AD04 on WKRC in Cincinnati, which has aired on dozens of stations nationwide. A link to the segment is available right now at: www.adialpharma.com.

    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 therapeutic agent for the treatment of Alcohol Use Disorder (AUD) and is currently being investigated in a Phase 3 clinical 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. www.adialpharma.com

    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 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 enroll patients and 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 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, 2019, 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:

    SOURCE: Adial Pharmaceuticals, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/619504/Adial-Pharmaceuticals-Lead-Drug-Candidate-AD04-for-Treatment-of-Alcohol-Use-Disorder-Featured-in-Follow-up-TV-News-Story

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  16. CHARLOTTESVILLE, VA / ACCESSWIRE / November 25, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, reports that its lead drug candidate, AD04, 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, has been featured on multiple television news outlets.

    One of these segments, entitled, "Pill may be able help those addicted to alcohol control cravings," aired on aired on dozens of local TV stations throughout the country: https://local12.com/health/medical-edge-reports/pill-may-be-able-help-those-addicted-to-alcohol-control-cravings-cincinnati

    CHARLOTTESVILLE, VA / ACCESSWIRE / November 25, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, reports that its lead drug candidate, AD04, 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, has been featured on multiple television news outlets.

    One of these segments, entitled, "Pill may be able help those addicted to alcohol control cravings," aired on aired on dozens of local TV stations throughout the country: https://local12.com/health/medical-edge-reports/pill-may-be-able-help-those-addicted-to-alcohol-control-cravings-cincinnati.

    "As we prepare for Thanksgiving, we are grateful the media is highlighting AD04 and raising awareness regarding the significant alcohol use problems our country is facing," commented William Stilley, CEO of Adial Pharmaceuticals. "My heartfelt wish is that everyone will be safe during the holiday celebrations."

    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 therapeutic agent for the treatment of Alcohol Use Disorder (AUD) and is currently being investigated in a Phase 3 clinical 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. www.adialpharma.com

    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 ADO4 being able help those addicted to alcohol control cravings 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, our ability to enroll patients and 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 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, 2019, 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:

    SOURCE: Adial Pharmaceuticals, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/618400/Adial-Pharmaceuticals-Lead-Drug-Candidate-AD04-for-Treatment-of-Alcohol-Use-Disorder-Featured-on-Multiple-Television-News-Outlets

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  17. CHARLOTTESVILLE, VA / ACCESSWIRE / November 25, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that it has entered into a Common Stock Purchase Agreement (the "Purchase Agreement") with Keystone Capital Partners ("Keystone Capital"), a New York-based family office with investments in biotech, real estate and consumer products. Pursuant to the Purchase Agreement, the Company will have the right to sell to Keystone Capital up to $15 million of the Company's common stock from time-to-time during the term of the Purchase Agreement subject to certain conditions including the effectiveness of a…

    CHARLOTTESVILLE, VA / ACCESSWIRE / November 25, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that it has entered into a Common Stock Purchase Agreement (the "Purchase Agreement") with Keystone Capital Partners ("Keystone Capital"), a New York-based family office with investments in biotech, real estate and consumer products. Pursuant to the Purchase Agreement, the Company will have the right to sell to Keystone Capital up to $15 million of the Company's common stock from time-to-time during the term of the Purchase Agreement subject to certain conditions including the effectiveness of a registration statement relating to the shares. Sales of common stock, and the timing of any sales, are solely at the option of the Company and the Company is under no obligation to sell securities pursuant to this arrangement.

    "We decided to enter into this agreement with Keystone as we believe they have a strong fundamental understanding our business, and are an ideal strategic partner to support any financial needs that may arise," said William Stilley, CEO of Adial Pharmaceuticals. "We have no immediate plans to raise capital, with over $7 million of cash on hand as of September 30, 2020; however, this transaction provides additional flexibility and capability to take advantage of strategic opportunities and future growth initiatives when they may arise."

    "We are pleased to enter into this relationship with Adial," said Fred Zaino, Managing Partner and Chief Investment Officer of Keystone. "After evaluating Adial, its clinical pipeline, and its management team, and after thorough due diligence, we believe Adial represents a promising investment opportunity. Formation of this partnership memorializes our intention to build a long-term relationship with Adial, committing capital as necessary as the Company builds its business in the growing space of addiction that is currently woefully underserved."

    Details of the Purchase Agreement and Registration Rights Agreement are available in the Company's Form 8-K, which has been filed with the securities and Exchange Commission and is available at www.sec.gov or visit the Company's web site here.

    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 therapeutic agent for the treatment of Alcohol Use Disorder (AUD) and is currently being investigated in a Phase 3 clinical 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.

    www.adialpharma.com

    About Keystone Capital Partners

    Founded in 2019, Keystone Capital Partners is a family office based in New York with investments in biotech, real estate and consumer products.

    To learn more about the Keystone team, visit www.keystone-cp.com

    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 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, our ability to enroll patients and 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 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, 2019, 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.

    Adial Pharmaceuticals Investor Relations:
    Crescendo Communications, LLC
    David Waldman / Natalya Rudman
    Tel: 212-671-1021
    Email:

    Keystone Media Relations:
    ICR
    Nicole Hakimi
    Phone: +1-646-677-1802
    Email:

    SOURCE: Adial Pharmaceutical, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/618354/Adial-Pharmaceuticals-Enters-into-Common-Stock-Purchase-Agreement-with-Keystone-Capital-Partners-to-Support-Strategic-Opportunities-and-Future-Growth-Initiatives

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  18. ONWARD™ Projected to be Fully Enrolled During Q2 2021

    CHARLOTTESVILLE, VA / ACCESSWIRE / November 3, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today provided an update on its landmark ONWARD™ Phase 3 pivotal trial. ONWARD™ is investigating 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.

    Key ONWARD™ highlights include:

    • All 25 planned investigative sites are active.
    • 40% of expected Trial patient screenings have been completed and the Trial is more than 25% enrolled relative to planned…

    ONWARD™ Projected to be Fully Enrolled During Q2 2021

    CHARLOTTESVILLE, VA / ACCESSWIRE / November 3, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today provided an update on its landmark ONWARD™ Phase 3 pivotal trial. ONWARD™ is investigating 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.

    Key ONWARD™ highlights include:

    • All 25 planned investigative sites are active.
    • 40% of expected Trial patient screenings have been completed and the Trial is more than 25% enrolled relative to planned enrollment.
    • The enrollment rate has increased for four consecutive months and the Trial is projected to be fully enrolled during Q2 2021.
    • Data readout is expected in Q4 2021 or earlier.
    • AD04 has been well tolerated with no serious adverse events having been reported.

    "We are encouraged by the steady progress of our ONWARD™ Phase 3 trial and we are on track to complete enrollment during Q2 2021," commented William Stilley, Chief Executive Officer of Adial Pharmaceuticals. "AUD accounts for nearly six percent of all deaths worldwide and is the leading cause of death among men and women in their prime (ages 15 to 49). AUD also represents a dramatically underserved market, as current therapies have limited efficacy and significant side effects. We believe AD04 may represent a paradigm shift in treating this population. Among patients with the target genotype, we estimate the market for AD04 to be in excess of $35 billion in the United States where we are pursuing expedited review programs for AD04. The European market is expected to be similar in size. It has also been reported that the AUD crisis continues to escalate given the prolonged nature of the COVID-19 pandemic. We remain determined to advance ONWARD™ and look forward to providing further updates as we achieve key milestones."

    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 therapeutic agent for the treatment of Alcohol Use Disorder (AUD) and is currently being investigated in a Phase 3 clinical 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. www.adialpharma.com

    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 the Trial being projected to be fully enrolled during Q2 2021, data readout being expected in Q4 2021 or earlier, AD04 representing a paradigm shift in treating the population afflicted with AUD, the market for AD04 being in excess of $35 billion in the United States, the Company continuing its pursuit of U.S. expedited review programs for AD04, the European market being similar in size to the market in the United States, the AUD crisis continuing to escalate given the prolonged nature of the COVID-19 pandemic and providing further updates as the Company achieves key milestones, 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, our ability to enroll patients and 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 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, 2019, 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:

    SOURCE: Adial Pharmaceutical, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/614164/Adial-Pharmaceuticals-Provides-Update-on-its-ONWARDTM-Pivotal-Phase-3-Trial-of-AD04-for-Treatment-of-Alcohol-Use-Disorder

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  19. NEW YORK, NY, REHOVAT, ISRAEL, SINGAPORE, CHARLOTTESVILLE, VA, Oct. 22, 2020 (GLOBE NEWSWIRE) -- via NewMediaWire-- Todos Medical (OTCQB:TOMDF) ("Todos"), an in vitro diagnostics company focused on distributing comprehensive solutions for COVID-19 screening and diagnosis, and developing blood tests for the early detection of cancer and Alzheimer's disease, along with Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that the companies have entered into a distribution agreement whereby Adial has granted Todos Medical non-exclusive sub-distribution rights to the Assure/FaStep® and EcoStep® point-of-care (POC) antibody tests (the…

    NEW YORK, NY, REHOVAT, ISRAEL, SINGAPORE, CHARLOTTESVILLE, VA, Oct. 22, 2020 (GLOBE NEWSWIRE) -- via NewMediaWire-- Todos Medical (OTCQB:TOMDF) ("Todos"), an in vitro diagnostics company focused on distributing comprehensive solutions for COVID-19 screening and diagnosis, and developing blood tests for the early detection of cancer and Alzheimer's disease, along with Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that the companies have entered into a distribution agreement whereby Adial has granted Todos Medical non-exclusive sub-distribution rights to the Assure/FaStep® and EcoStep® point-of-care (POC) antibody tests (the "Tests"). The Assure/FaStep received the first U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for a serology (antibody) POC test for COVID-19 using fingerstick blood samples as compared with current approved tests that only utilize serum, plasma, or a venous blood draw. See the FDA news release here.

    As a result of the FDA's EUA, fingerstick blood samples can now be utilized with the Tests in POC settings, including doctors' offices, hospitals, urgent care centers, emergency rooms, or other locations where there is a licensed healthcare professional. The Tests were initially authorized for emergency use in July 2020, to help identify individuals with antibodies to SARS-CoV-2, indicating recent or prior COVID-19 infection, but as with all competing rapid COVID-19 test kits, were not yet authorized for fingerstick blood sample use.

    "Adding a rapid, fingerstick antibody test that has received Emergency Use Authorization from the FDA as a point-of-care test to our portfolio is expected to dramatically increase the settings in which we are able to provide COVID-19 antibody testing for our growing list of clients," said Gerald E. Commissiong, President and CEO of Todos Medical. "We have now established a strong network of high-complexity CLIA lab clients who are implementing our PCR solutions, and we will now add rapid tests to our emerging pharmacy and skilled nursing facility point-of-care sales channel. We believe there is significant synergy in selling complementary COVID-19 tests in the marketplace."

    "This agreement with Todos adds a new element to our sales strategy," said William Stilley, Chief Executive Officer of Adial Pharmaceuticals. "Todos is seeking to provide comprehensive solutions for COVID-19 testing to their clients, and this agreement allows us to access a new category of clients for Adial. Our agreement was entered into following multiple sales of these Tests to Todos and therefore, we see a market demand from Todos' clients for these instant and efficient antibody tests to help combat the international COVID-19 pandemic."

    For information related to Todos Medical's COVID-19 testing capabilities, please visit www.todoscovid19.com

    For testing and PPE inquiries, please email 

    About Todos Medical Ltd.

    Headquartered in Rehovot, Israel, Todos Medical Ltd. (OTCQB:TOMDF) engineers life-saving, diagnostic solutions for the early detection of a variety of cancers. The Company's state-of-the-art and patented Todos Biochemical Infrared Analyses (TBIA) is a proprietary cancer-screening technology using peripheral blood analysis that deploys deep examination into cancer's influence on the immune system, looking for biochemical changes in blood mononuclear cells and plasma. Todos' two internally-developed cancer-screening tests, TMB-1 and TMB-2, have received a CE mark in Europe. Todos recently entered into an exclusive option agreement to acquire U.S.-based medical diagnostics company Provista Diagnostics, Inc. to gain rights to its Alpharetta, Georgia-based CLIA/CAP certified lab and Provista's proprietary commercial-stage Videssa® breast cancer blood test. The transaction is expected to close in the third quarter of 2020.

    Todos is also developing blood tests for the early detection of neurodegenerative disorders, such as Alzheimer's disease. The Lymphocyte Proliferation Test (LymPro Test™) is a diagnostic blood test that determines the ability of peripheral blood lymphocytes (PBLs) and monocytes to withstand an exogenous mitogenic stimulation that induces them to enter the cell cycle. It is believed that certain diseases, most notably Alzheimer's disease, are the result of compromised cellular machinery that leads to aberrant cell cycle re-entry by neurons, which then leads to apoptosis. LymPro is unique in the use of peripheral blood lymphocytes as a surrogate for neuronal cell function, suggesting a common relationship between PBLs and neurons in the brain.

    Additionally, Todos has entered into distribution agreements with companies to distribute certain novel coronavirus (COVID-19) test kits. The agreements cover multiple international suppliers of PCR testing kits and related materials and supplies, as well as antibody testing kits from multiple manufacturers after completing validation of said testing kits and supplies in its partner CLIA/CAP certified laboratory in the United States. Todos has formed strategic partnerships with Integrated Health LLC and MOTOPARA Foundation to deploy mobile COVID-19 testing in the United States.

    For more information, please visit https://www.todosmedical.com/.

    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 therapeutic agent for the treatment of Alcohol Use Disorder (AUD) and is currently being investigated in a Phase 3 clinical 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. www.adialpharma.com.

    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 adding a rapid antibody test that has received an Emergency Use Authorization as a point of care test dramatically increasing the settings in which Todos is able to provide for its growing list of clients, there being significant synergy in selling complementary COVID-19 tests in the marketplace, Todos developing blood tests for the early detection of neurodegenerative disorders, such as Alzheimer's disease, and the potential of Adial's 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, Todos ability to dramatically increasing the settings in which it is able to provide for a growing list of clients, Todos ability to sell complementary COVID-19 tests in the marketplace, Todos ability to develop blood tests for the early detection of neurodegenerative disorders, such as Alzheimer's disease, Adial's ability to enroll patients and complete clinical trials on time and achieve desired results and benefits, Adial's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to its ability to promote or commercialize its product candidates for specific indications, Adial's and Todos' respective ability to maintain their license agreements, continue maintenance and growth of their patent estates and to establish and maintain collaborations, Adial's and Todos' respective ability to obtain or maintain the capital or grants necessary to fund research and development activities, and Adial's and Todos' respective ability to retain key employees or maintain their respective Nasdaq and OTCQB listings. These risks should not be construed as exhaustive and should be read together with the other cautionary statements included in Adial's Annual Report on Form 10-K for the year ended December 31, 2019, subsequent Quarterly Reports on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission and Todos' Annual Report on Form 20-F for the year ended December 31, 2019 and subsequent Reports on Form 6-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.

    For Adial Pharmaceuticals, Inc.

    Crescendo Communications, LLC

    David Waldman / Natalya Rudman

    Tel: (212) 671-1021

    Email:

    For Todos Medical Ltd.

    Kim Sutton Golodetz

    LHA Investor Relations

    Senior Vice President

    (212) 838-3777

    Todos Corporate Contact:

    Priyanka Misra

    Todos Medical

    (917) 983-4229 ext. 103

    Primary Logo

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  20. Assure/Fastep® COVID-19 Point-of-Care Antibody Test is the First Test Granted FDA Emergency Use Authorization for Use with Fingerstick Blood Samples

    FREEHOLD, NJ and CHARLOTTESVILLE, VA / ACCESSWIRE / October 22, 2020 / Avalon GloboCare Corp. (AVCO) ("Avalon"), a clinical-stage, global developer of cell-based technologies and therapeutics and Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial"), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced formation of a strategic collaboration for global distribution of the Assure/Fastep® COVID-19 IgG/IgM Rapid Test device and the Assure/EcoStep® COVID-19 IgG/IgM Rapid Test device, point-of-care (POC) COVID-19 antibody tests. The FaStep…

    Assure/Fastep® COVID-19 Point-of-Care Antibody Test is the First Test Granted FDA Emergency Use Authorization for Use with Fingerstick Blood Samples

    FREEHOLD, NJ and CHARLOTTESVILLE, VA / ACCESSWIRE / October 22, 2020 / Avalon GloboCare Corp. (AVCO) ("Avalon"), a clinical-stage, global developer of cell-based technologies and therapeutics and Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial"), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced formation of a strategic collaboration for global distribution of the Assure/Fastep® COVID-19 IgG/IgM Rapid Test device and the Assure/EcoStep® COVID-19 IgG/IgM Rapid Test device, point-of-care (POC) COVID-19 antibody tests. The FaStep COVID-19 IgG/IgM Rapid Test Device is the first serology (antibody) POC test for COVID-19 using fingerstick blood samples approved by the U.S. Food and Drug Administration (FDA), which has issued an emergency use authorization (EUA) for the FaStep COVID-19 IgG/IgM Rapid Test Device and the EcoStep COVID-19 IgG/IgM Rapid Test Device. Under the agreement, Adial has granted Avalon non-exclusive, sub-distribution rights worldwide for the FaStep COVID-19 IgG/IgM Rapid Test Device and the Assure/EcoStep COVID-19 IgG/IgM Rapid Test Device, POC COVID-19 antibody tests.

    As a result of the FDA's EUA, fingerstick blood samples can now be utilized with the FaStep COVID-19 IgG/IgM Rapid Test Device for the test in POC settings, including doctors' offices, hospitals, urgent care centers, emergency rooms, or other locations where there is a licensed healthcare professional. The FaStep COVID-19 IgG/IgM Rapid Test Devices are lateral flow assay, 10-minute, ‘instant,' POC test devices for the qualitative detection of lgG and lgM antibodies specific to SARS-CoV-2 virus in fingerstick whole blood, venous whole blood, serum, and plasma. During testing, the specimen reacts with antigen coated particles in the test cassette after droplets of blood from the subject are placed on the cassette's coated membrane.

    "We believe there is significant market potential for these differentiated test kits, as these tests are able to detect IgG antibodies at a 98.6% accuracy and IgM antibodies at a 92.9% accuracy and provide results within 10-minutes," said David Jin, M.D., Ph.D., President and Chief Executive Officer of Avalon. "Our goal is to leverage our international distribution network and channel partners to bring the product to market globally."

    William Stilley, Chief Executive Officer of Adial, commented, "We are pleased to enter into this strategic collaboration with Avalon. Avalon has an established global distribution network that we believe will facilitate further sales of these COVID-19 Rapid Test Devices worldwide. The rapid proliferation of COVID-19 around the world has driven demand for SARS-CoV-2 detection, and a widespread need for rapid antibody testing. We look forward to working with Avalon in order to help meet the global demand for rapid result COVID-19 serology testing."

    About Avalon GloboCare Corp.

    Avalon GloboCare Corp. (NASDAQ:AVCO) is a clinical-stage, vertically integrated, leading CellTech bio-developer dedicated to advancing and empowering innovative, transformative immune effector cell therapy, exosome technology, as well as COVID-19 related diagnostics and therapeutics. Avalon also provides strategic advisory and outsourcing services to facilitate and enhance its clients' growth and development, as well as competitiveness in healthcare and CellTech industry markets. Through its subsidiary structure with unique integration of verticals from innovative R&D to automated bioproduction and accelerated clinical development, Avalon is establishing a leading role in the fields of cellular immunotherapy (including CAR-T/NK), exosome technology (ACTEX™), and regenerative therapeutics. For more information about Avalon, please visit www.avalon-globocare.com.

    For the latest updates on Avalon GloboCare's developments, please follow them on twitter using their Twitter Handle: @avalongc_avco

    About Adial Pharmaceuticals, Inc.

    Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) 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. www.adialpharma.com

    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 leveraging Avalon's international distribution network and channel partners to rapidly and cost effectively bring the product to market globally, Adial working with Avalon in order to help meet the global demand for rapid result COVID-19 serology testing 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, Avalon's ability through its international distribution network and channel partners to rapidly and cost effectively bring product to market globally, Adial's and Avalon's respective ability to meet the global demand for rapid result COVID-19 serology testing, Adial's ability to enroll patients and complete clinical trials on time and achieve desired results and benefits, Adial's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to its ability to promote or commercialize its product candidates for specific indications, Adial's [and Avalon's] respective ability to maintain its license agreements, continue maintenance and growth of its patent estate and to establish and maintain collaborations, Adial's and Avalon's respective ability to obtain or maintain the capital or grants necessary to fund its research and development activities, and Adial's and Avalon's respective ability to retain its key employees or maintain their Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the other cautionary statement included in Adial's Annual Report on Form 10-K for the year ended December 31, 2019, subsequent Quarterly Reports on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission and Avalon's Annual Report on Form 10-K for the year ended December 31, 2019, 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.

    Avalon Contact Information:

    Avalon GloboCare Corp.
    4400 Route 9, Suite 3100
    Freehold, NJ 07728

    Avalon Investor Relations:

    Crescendo Communications, LLC
    Tel: (212) 671-1020 Ext. 304

    Adial Contact Information

    Crescendo Communications, LLC
    David Waldman / Natalya Rudman
    Tel: 212-671-1021
    Email:

    SOURCE: Adial Pharmaceutical, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/611734/Avalon-GloboCare-and-Adial-Pharmaceuticals-Announce-Strategic-Collaboration-for-Global-Distribution-of-COVID-19-Point-of-Care-Antibody-Rapid-Test-Devices

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  21. FREEHOLD, N.J. and CHARLOTTESVILLE, Va., Oct. 22, 2020 (GLOBE NEWSWIRE) -- Avalon GloboCare Corp. (NASDAQ:AVCO) ("Avalon"), a clinical-stage, global developer of cell-based technologies and therapeutics and Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial"), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced formation of a strategic collaboration for global distribution of the Assure/Fastep® COVID-19 IgG/IgM Rapid Test device and the Assure/EcoStep® COVID-19 IgG/IgM Rapid Test device, point-of-care (POC) COVID-19 antibody tests. The FaStep COVID-19 IgG/IgM Rapid Test Device is the first serology (antibody) POC test for COVID-19 using fingerstick blood samples approved

    FREEHOLD, N.J. and CHARLOTTESVILLE, Va., Oct. 22, 2020 (GLOBE NEWSWIRE) -- Avalon GloboCare Corp. (NASDAQ:AVCO) ("Avalon"), a clinical-stage, global developer of cell-based technologies and therapeutics and Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial"), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced formation of a strategic collaboration for global distribution of the Assure/Fastep® COVID-19 IgG/IgM Rapid Test device and the Assure/EcoStep® COVID-19 IgG/IgM Rapid Test device, point-of-care (POC) COVID-19 antibody tests. The FaStep COVID-19 IgG/IgM Rapid Test Device is the first serology (antibody) POC test for COVID-19 using fingerstick blood samples approved by the U.S. Food and Drug Administration (FDA), which has issued an emergency use authorization (EUA) for the FaStep COVID-19 IgG/IgM Rapid Test Device and the EcoStep COVID-19 IgG/IgM Rapid Test Device. Under the agreement, Adial has granted Avalon non-exclusive, sub-distribution rights worldwide for the FaStep COVID-19 IgG/IgM Rapid Test Device and the Assure/EcoStep COVID-19 IgG/IgM Rapid Test Device, POC COVID-19 antibody tests.

    As a result of the FDA's EUA, fingerstick blood samples can now be utilized with the FaStep COVID-19 IgG/IgM Rapid Test Device for the test in POC settings, including doctors' offices, hospitals, urgent care centers, emergency rooms, or other locations where there is a licensed healthcare professional. The FaStep COVID-19 IgG/IgM Rapid Test Devices are lateral flow assay, 10-minute, ‘instant,' POC test devices for the qualitative detection of lgG and lgM antibodies specific to SARS-CoV-2 virus in fingerstick whole blood, venous whole blood, serum, and plasma. During testing, the specimen reacts with antigen coated particles in the test cassette after droplets of blood from the subject are placed on the cassette's coated membrane.

    "We believe there is significant market potential for these differentiated test kits, as these tests are able to detect IgG antibodies at a 98.6% accuracy and IgM antibodies at a 92.9% accuracy and provide results within 10-minutes," said David Jin, M.D., Ph.D., President and Chief Executive Officer of Avalon. "Our goal is to leverage our international distribution network and channel partners to bring the product to market globally."

    William Stilley, Chief Executive Officer of Adial, commented, "We are pleased to enter into this strategic collaboration with Avalon. Avalon has an established global distribution network that we believe will facilitate further sales of these COVID-19 Rapid Test Devices worldwide. The rapid proliferation of COVID-19 around the world has driven demand for SARS-CoV-2 detection, and a widespread need for rapid antibody testing. We look forward to working with Avalon in order to help meet the global demand for rapid result COVID-19 serology testing."

    About Avalon GloboCare Corp.

    Avalon GloboCare Corp. (NASDAQ:AVCO) is a clinical-stage, vertically integrated, leading CellTech bio-developer dedicated to advancing and empowering innovative, transformative immune effector cell therapy, exosome technology, as well as COVID-19 related diagnostics and therapeutics. Avalon also provides strategic advisory and outsourcing services to facilitate and enhance its clients' growth and development, as well as competitiveness in healthcare and CellTech industry markets. Through its subsidiary structure with unique integration of verticals from innovative R&D to automated bioproduction and accelerated clinical development, Avalon is establishing a leading role in the fields of cellular immunotherapy (including CAR-T/NK), exosome technology (ACTEX™), and regenerative therapeutics. For more information about Avalon, please visit www.avalon-globocare.com.

    For the latest updates on Avalon GloboCare's developments, please follow them on twitter using their Twitter Handle: @avalongc_avco    

    About Adial Pharmaceuticals, Inc.

    Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) 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. www.adialpharma.com

    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 leveraging Avalon's international distribution network and channel partners to rapidly and cost effectively bring the product to market globally, Adial working with Avalon in order to help meet the global demand for rapid result COVID-19 serology testing 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, Avalon's ability through its international distribution network and channel partners to rapidly and cost effectively bring product to market globally, Adial's and Avalon's respective ability to meet the global demand for rapid result COVID-19 serology testing, Adial's ability to enroll patients and complete clinical trials on time and achieve desired results and benefits, Adial's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to its ability to promote or commercialize its product candidates for specific indications, Adial's [and Avalon's] respective ability to maintain its license agreements, continue maintenance and growth of its patent estate and to establish and maintain collaborations, Adial's and Avalon's respective ability to obtain or maintain the capital or grants necessary to fund its research and development activities, and Adial's and Avalon's respective ability to retain its key employees or maintain their Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the other cautionary statement included in Adial's Annual Report on Form 10-K for the year ended December 31, 2019, subsequent Quarterly Reports on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission and Avalon's Annual Report on Form 10-K for the year ended December 31, 2019, 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.

    Avalon Contact Information:

    Avalon GloboCare Corp.

    4400 Route 9, Suite 3100

    Freehold, NJ 07728

    Avalon Investor Relations:

    Crescendo Communications, LLC

    Tel: (212) 671-1020 Ext. 304

    Adial Contact Information

    Crescendo Communications, LLC

    David Waldman / Natalya Rudman

    Tel: 212-671-1021

    Email:

    Primary Logo

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  22. CHARLOTTESVILLE, VA / ACCESSWIRE / October 21, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that the U.S. Food and Drug Administration (FDA) has reactivated Adial'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 (AUD). 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…

    CHARLOTTESVILLE, VA / ACCESSWIRE / October 21, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that the U.S. Food and Drug Administration (FDA) has reactivated Adial'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 (AUD). 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.

    Reactivation of Adial's IND allows the Company to continue its pursuit of U.S. expedited review programs for AD04 and for the initiation of a planned Phase 1 pharmacokinetics (PK) clinical study in the U.S., which is intended to be supportive of a New Drug Application (NDA) submission with the FDA.

    William Stilley, Chief Executive Officer of Adial Pharmaceuticals, commented, "Given the prolonged nature of the COVID-19 pandemic, the AUD crisis continues to escalate. For this reason, we have filed for an expedited review of AD04 with the FDA. The acceptance of our manufacturing data, as well as our plan for the proposed clinical study, marks an important milestone as we progress towards evaluating AD04 clinically in the United States. We continue to enroll patients in our landmark ONWARD™ pivotal Phase 3 clinical trial of AD04 in Europe and look forward to providing further updates as our progress continues."

    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 therapeutic agent for the treatment of Alcohol Use Disorder (AUD) and is currently being investigated in a Phase 3 clinical 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. www.adialpharma.com

    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 the the Company continuing its pursuit of U.S. expedited review programs for AD04, the initiation of a planned Phase 1 pharmacokinetics (PK) clinical study in the U.S., which is intended to be supportive of a New Drug Application (NDA) submission with the FDA, progression towards evaluating AD04 clinically in the United States 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 commence evaluating AD04 clinicaly in the United States, our ability to advance pursuit of U.S. expedited review programs for AD04 and to initiate a planned Phase 1 pharmacokinetics (PK) clinical study in the U.S, our ability to enroll patients and complete clinical trials on time and achieve desired results and benefits, 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, 2019, 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:

    SOURCE: Adial Pharmaceutical, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/611528/Adial-Pharmaceuticals-Announces-FDA-Reactivation-of-its-Investigational-New-Drug-Application-for-AD04-in-Alcohol-Use-Disorder

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  23. CHARLOTTESVILLE, VA / ACCESSWIRE / September 30, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial"), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it has received an initial firm order for the purchase of 10,000 Assure/FaStep® COVID-19 IgG/IgM Rapid Test Devices from a California-based technology corporation. As reported yesterday, the FaStep COVID-19 IgG/IgM Rapid Test Device is the first serology (antibody) point-of-care (POC) test for COVID-19 using fingerstick blood samples approved by the U.S. Food and Drug Administration (FDA), which has issued an emergency use authorization (EUA) for the FaStep COVID-19 IgG/IgM Rapid Test Device. See the FDA news…

    CHARLOTTESVILLE, VA / ACCESSWIRE / September 30, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial"), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it has received an initial firm order for the purchase of 10,000 Assure/FaStep® COVID-19 IgG/IgM Rapid Test Devices from a California-based technology corporation. As reported yesterday, the FaStep COVID-19 IgG/IgM Rapid Test Device is the first serology (antibody) point-of-care (POC) test for COVID-19 using fingerstick blood samples approved by the U.S. Food and Drug Administration (FDA), which has issued an emergency use authorization (EUA) for the FaStep COVID-19 IgG/IgM Rapid Test Device. See the FDA news release here.

    "We are pleased to report that that among other orders that we have received for the FaStep COVID-19 IgG/IgM Rapid Test Device, yesterday we received an initial purchase order for 10,000 FaStep COVID-19 IgG/IgM Rapid Test Devices from a California-based technology company," said William Stilley, Chief Executive Officer of Adial Pharmaceuticals. "The availability of convenient, rapid coronavirus testing is critical to adequately assess the virus's prevalence to limit outbreaks as the U.S. continues the reopening process and as we prepare as a nation for a possible second-wave of infections. The issuance of the EUA for the first point-of-care antibody test for COVID-19 in the U.S. using fingerstick blood samples is an important advancement, which we believe will lead to significant demand for the FaStep COVID-19 IgG/IgM Rapid Test Device as a fast, convenient and reliable method for COVID-19 serology testing."

    The FaStep COVID-19 IgG/IgM Rapid Test Devices distributed by Adial are lateral flow assay, 10-minute, ‘instant' point-of-care test devices for the qualitative detection of lgG and lgM antibodies specific to SARS-CoV-2 virus in fingerstick whole blood, venous whole blood, serum, and plasma. During testing, the specimen reacts with antigen coated particles in the test cassette after droplets of blood from the subject are placed on the cassette's coated membrane. Adial has now opened multiple sales channels for the sale of the FaStep COVID-19 IgG/IgM Rapid Test Devices including The iRemedy Healthcare Companies, Inc. (iRemedy) network and ecommerce platform. See here to purchase the FaStep COVID-19 IgG/IgM Rapid Test Devices.

    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 therapeutic agent for the treatment of Alcohol Use Disorder (AUD) and is currently being investigated in a Phase 3 clinical 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. www.adialpharma.com

    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 the issuance of the EUA for the first point-of-care antibody test for COVID-19 in the U.S. using fingerstick blood samples leading to significant demand for the FaStep COVID-19 IgG/IgM Rapid Test Device as a fast, convenient and reliable method for COVID-19 serology testing 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 use the issuance of the EUA for the first POC Antibody Test for COVID-19 using fingerstick blood samples for competitive advantage and support more widespread adoption of the FaStep® COVID-19 IgG/IgM Rapid Test Device, our ability to enroll patients and complete clinical trials on time and achieve desired results and benefits, 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, 2019, 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:

    For Adial Pharmaceuticals, Inc.
    Crescendo Communications, LLC
    David Waldman / Natalya Rudman
    Tel: 212-671-1021
    Email:

    For iRemedy Healthcare Companies, Inc.
    Keisha Graham
    Tel: 407-395-4283

    SOURCE: Adial Pharmaceutical, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/608468/Adial-Pharmaceuticals-Announces-Sale-of-10000-COVID-19-Antibody-Rapid-Test-Devices

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  24. CHARLOTTESVILLE, VA / ACCESSWIRE / September 29, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that the U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the Assure/FaStep® COVID-19 IgG/IgM Rapid Test Device. This marks the first FDA EUA for a serology (antibody) point-of-care (POC) test for COVID-19 using fingerstick blood samples as compared with current approved tests that only utilize serum, plasma, or a venous blood draw. See the FDA news release here.

    As a result of the FDA's EUA, fingerstick blood samples can now be utilized with the FaStep COVID-19 IgG/IgM Rapid Test…

    CHARLOTTESVILLE, VA / ACCESSWIRE / September 29, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that the U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the Assure/FaStep® COVID-19 IgG/IgM Rapid Test Device. This marks the first FDA EUA for a serology (antibody) point-of-care (POC) test for COVID-19 using fingerstick blood samples as compared with current approved tests that only utilize serum, plasma, or a venous blood draw. See the FDA news release here.

    As a result of the FDA's EUA, fingerstick blood samples can now be utilized with the FaStep COVID-19 IgG/IgM Rapid Test Device for the test in POC settings, including doctors' offices, hospitals, urgent care centers, emergency rooms, or other locations where there is a licensed healthcare professional. The FaStep COVID-19 IgG/IgM Rapid Test Device was initially authorized for emergency use in July 2020 to help identify individuals with antibodies to SARS-CoV-2, indicating recent or prior COVID-19 infection, but as with all competing rapid COVID-19 test kits, was not yet authorized for fingerstick blood sample use.

    Adial has commenced sales of the FaStep COVID-19 IgG/IgM rapid antibody test kits to healthcare providers and hospitals through The iRemedy Healthcare Companies, Inc. (iRemedy) network and ecommerce platform. See here. Antibody test kits distributed by Adial are lateral flow assay, 10-minute, ‘instant' point-of-care test devices for the qualitative detection of lgG and lgM antibodies specific to SARS-CoV-2 virus in fingerstick whole blood, venous whole blood, serum, and plasma. During testing, the specimen reacts with antigen coated particles in the test cassette after droplets of blood from the subject are placed on the cassette's coated membrane.

    William Stilley, Chief Executive Officer of Adial Pharmaceuticals, commented, "The issuance of the EUA for the first point-of-care antibody test for COVID-19 in the U.S. using fingerstick blood samples is expected to provide an important competitive advantage, which should support more widespread adoption of the Assure/FaStep COVID-19 IgG/IgM Rapid Test Device as a fast, convenient and reliable method for COVID-19 serology testing. We see a market demand for these instant and efficient antibody tests to help combat the international COVID-19 pandemic with the addressable global COVID-19 rapid test kits market expected to reach $3.52 billion by the end of 2020."

    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 therapeutic agent for the treatment of Alcohol Use Disorder (AUD) and is currently being investigated in a Phase 3 clinical 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. www.adialpharma.com.

    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 the issuance of the EUA for the first POC Antibody Test for COVID-19 using fingerstick blood providing an important competitive advantage and supporting more widespread adoption of the Assure/FaStep® COVID-19 IgG/IgM Rapid Test Device, the addressable global COVID-19 rapid test kits market reaching $3.52 billion by the end of 2020 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 use the issuance of the EUA for the first POC Antibody Test for COVID-19 using fingerstick blood for competitive advantage and support more widespread adoption of the Assure/FaStep® COVID-19 IgG/IgM Rapid Test Device, our ability to enroll patients and complete clinical trials on time and achieve desired results and benefits, 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, 2019, 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:

    For Adial Pharmaceuticals, Inc.
    Crescendo Communications, LLC
    David Waldman / Natalya Rudman
    Tel: 212-671-1021
    Email:

    For iRemedy Healthcare Companies, Inc.
    Keisha Graham
    Tel: 407-395-4283

    SOURCE: Adial Pharmaceuticals, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/608255/Adial-Pharmaceuticals-Announces-COVID-19-Point-of-Care-Antibody-Test-Granted-First-Ever-FDA-Emergency-Use-Authorization-for-Use-with-Fingerstick-Blood-Samples

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  25. CHARLOTTESVILLE, VA / ACCESSWIRE / September 25, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that it has submitted a formal request to the U.S. Food and Drug Administration (FDA) in support of Adial's position that AD04 should be considered eligible for an FDA expedited review program. Adial's lead drug candidate, AD04, is a therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in persons with certain target genotypes and the Company and regulatory advisors have concluded that AD04, which is being developed for a serious condition that is an unmet medical need, is a candidate for this FDA program.

    William…

    CHARLOTTESVILLE, VA / ACCESSWIRE / September 25, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that it has submitted a formal request to the U.S. Food and Drug Administration (FDA) in support of Adial's position that AD04 should be considered eligible for an FDA expedited review program. Adial's lead drug candidate, AD04, is a therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in persons with certain target genotypes and the Company and regulatory advisors have concluded that AD04, which is being developed for a serious condition that is an unmet medical need, is a candidate for this FDA program.

    William Stilley, Chief Executive Officer of Adial Pharmaceuticals, stated, "We are making rapid progress enrolling patients in our landmark ONWARD™ pivotal Phase 3 clinical trial of AD04. Sadly, now more than ever, the AUD crisis continues to escalate. As recently reported by the NIAAA, ‘the COVID-19 pandemic has increased stress for people worldwide, with millions experiencing prolonged periods of fear, anxiety and social isolation - conditions that are known to increase craving, consumption, and risk of relapse in individuals with alcohol and substance use disorders.' AD04 is designed to address this serious condition for which existing treatment options have low retention rates and potentially inferior safety profiles. Given the significant results of our Phase 2 trial, the progress of our Phase 3 trial, and the gravity of the social and economic impacts of alcohol use disorder, exacerbated by this pandemic, we believe this is the appropriate time to seek FDA expedited review of AD04."

    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 therapeutic agent for the treatment of Alcohol Use Disorder (AUD) and is currently being investigated in a Phase 3 clinical 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. www.adialpharma.com

    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 AD04 being considered eligible for an FDA expedited review program, this being the appropriate time to seek FDA expedited review of AD04and 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 be granted expedited review by the FDA, our ability to enroll patients and complete clinical trials on time and achieve desired results and benefits, 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, 2019, 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:

    SOURCE: Adial Pharmaceutical, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/607805/Adial-Pharmaceuticals-Files-for-Expedited-Review-of-AD04-with-the-FDA

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  26. CHARLOTTESVILLE, VA / ACCESSWIRE / September 22, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions and The iRemedy Healthcare Companies, Inc. ("iRemedy"), pioneers of the iRemedy medical supply marketplace platform, today announced that the two companies have commenced sales of FaStep COVID-19 IgG/IgM rapid antibody test kits to healthcare providers and hospitals through the iRemedy network and ecommerce platform.

    As reported previously, Adial has secured rights to distribute COVID-19 antibody tests to designated channel partners and customers. Antibody test kits distributed by Adial are FDA emergency use authorization (EUA) registered…

    CHARLOTTESVILLE, VA / ACCESSWIRE / September 22, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions and The iRemedy Healthcare Companies, Inc. ("iRemedy"), pioneers of the iRemedy medical supply marketplace platform, today announced that the two companies have commenced sales of FaStep COVID-19 IgG/IgM rapid antibody test kits to healthcare providers and hospitals through the iRemedy network and ecommerce platform.

    As reported previously, Adial has secured rights to distribute COVID-19 antibody tests to designated channel partners and customers. Antibody test kits distributed by Adial are FDA emergency use authorization (EUA) registered, 10-minute, ‘instant' point-of-care test devices for the qualitative detection of lgG and lgM antibodies specific to SARS-CoV-2 virus in human whole blood, serum or plasma specimens. During testing, the specimen reacts with antigen coated particles in the test cassette after droplets of blood from the subject are placed on the cassette's coated membrane.

    Tony Paquin, Co-Founder and Chief Executive Officer of iRemedy, commented, "We are delighted to partner with Adial to advance sales of the FaStep COVID-19 antibody test kits across our network of U.S. healthcare providers and hospitals in order to help address the unmet market need for these differentiated test kits, given the prolonged and devastating impact of COVID-19. We see a significant market potential in these instant and efficient tests that provide results within 10-minutes, with the ability to detect IgG antibodies at a 97.3% accuracy and IgM antibodies at a 99.1% accuracy. With established relationships with over 5,000 healthcare provider clients nationwide, ranging from private medical practices to major hospitals, we believe iRemedy is an exemplary commercial partner for Adial and we look forward to continuing to build our sales and distribution relationship."

    "We have experienced first-hand the value of COVID-19 antibody tests, which are being used to enhance patient safety and maximize subject retention during our ongoing landmark ONWARD™ pivotal Phase 3 clinical trial of AD04, for the treatment of Alcohol Use Disorder," stated William Stilley, Chief Executive Officer of Adial Pharmaceuticals. "Given iRemedy's healthcare customer base and distinguished Medical Advisory Board, we are confident that iRemedy is an ideal partner for Adial. Along with Tony and the entire iRemedy team, we are aligned in the goal to bring these COVID-19 antibody tests to market in a timely and cost-effective manner. In addition to the partnership, we are especially excited to have already commenced sales of these important tests on iRemedy.com and appreciate the support of iRemedy in helping to make these tests broadly available."

    For more information on purchasing FaStep COVID-19 antibody test kits, please contact Keisha Graham at 407-395-4283 or via email at keish.

    About The iRemedy Healthcare Companies

    With 15 years in healthcare supply, iRemedy is a trusted partner for acquiring medical supplies and Personal Protective Equipment. iRemedy guarantees the access to verified supplies by sourcing directly from established manufacturers and distributors around the world. The industry-leading technology and group purchasing power help enable transparency and competition, driving low pricing for customers. iRemedy is headquartered in Stuart, Florida and has offices in New York, California and Washington, and distribution centers in Florida and Arizona. For more information, please visit www.iremedy.com.

    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 therapeutic agent for the treatment of Alcohol Use Disorder (AUD) and is currently being investigated in a Phase 3 clinical 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. www.adialpharma.com

    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 building sales and distribution of FaStep COVID-19 antibody tests through the iRemedy network and ecommerce platform, the market potential in instant and efficient tests that provide results within 10-minutes, iRemedy's healthcare customer base and distinguished Medical Advisory Board making iRemedy an ideal partner for Adial, bringing COVID-19 antibody tests to market in a timely and cost-effective manner 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 build sales and distribution of FaStep COVID-19 antibody tests through the iRemedy network and ecommerce platform, our ability to enroll patients and complete clinical trials on time and achieve desired results and benefits, 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, 2019, 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:

    For Adial Pharmaceuticals, Inc.
    Crescendo Communications, LLC
    David Waldman / Natalya Rudman
    Tel: 212-671-1021
    Email:

    For iRemedy Healthcare Companies, Inc.
    Keisha Graham

    SOURCE: Adial Pharmaceuticals, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/607230/Adial-Pharmaceuticals-and-iRemedy-Partner-to-Sell-COVID-19-Antibody-Test-Kits-to-US-Medical-Providers-and-Commence-Sales

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  27. CHARLOTTESVILLE, VA / ACCESSWIRE / September 9, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that it will be presenting at the H.C. Wainwright Annual Global Investment Conference, being held virtually on September 14-16, 2020.

    William Stilley, Chief Executive Officer of Adial Pharmaceuticals, is scheduled to present on Wednesday, September 16th at 1:30 p.m., Eastern Time. The presentation will be webcast live on the conference event platform, which can be accessed here.

    About Adial Pharmaceuticals, Inc.

    Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions…

    CHARLOTTESVILLE, VA / ACCESSWIRE / September 9, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that it will be presenting at the H.C. Wainwright Annual Global Investment Conference, being held virtually on September 14-16, 2020.

    William Stilley, Chief Executive Officer of Adial Pharmaceuticals, is scheduled to present on Wednesday, September 16th at 1:30 p.m., Eastern Time. The presentation will be webcast live on the conference event platform, which can be accessed here.

    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 therapeutic agent for the treatment of Alcohol Use Disorder (AUD) and is currently being investigated in a Phase 3 clinical 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. www.adialpharma.com

    Contact:

    Crescendo Communications, LLC
    David Waldman / Natalya Rudman
    Tel: 212-671-1021
    Email:

    SOURCE: Adial Pharmaceutical, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/605356/Adial-Pharmaceuticals-to-Present-at-the-HC-Wainwright-22nd-Annual-Global-Investment-Conference-on-September-16th

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  28. CHARLOTTESVILLE, VA / ACCESSWIRE / August 6, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial"), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it has entered into an agreement with Brik LLC ("Brik"), an independent sales and marketing firm, to act as a third-party agent to Adial for the sale and distribution of Rapid Result COVID-19 antibody test kits. As reported on June 8, 2020, Adial and BioLab Sciences, Inc. entered into a distribution agreement, whereby Adial has the exclusive rights to sell and distribute the Rapid Result COVID-19 antibody tests to designated channel partners and customers.

    Gérard Brikkenaar Van Dijk, Principal and co-founder of Brik…

    CHARLOTTESVILLE, VA / ACCESSWIRE / August 6, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial"), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it has entered into an agreement with Brik LLC ("Brik"), an independent sales and marketing firm, to act as a third-party agent to Adial for the sale and distribution of Rapid Result COVID-19 antibody test kits. As reported on June 8, 2020, Adial and BioLab Sciences, Inc. entered into a distribution agreement, whereby Adial has the exclusive rights to sell and distribute the Rapid Result COVID-19 antibody tests to designated channel partners and customers.

    Gérard Brikkenaar Van Dijk, Principal and co-founder of Brik, commented, "We are delighted to partner with Adial to advance the sales, marketing and distribution of the Rapid Result COVID-19 antibody test kits. These FDA emergency use authorization (EUA) registered tests provide results within 10-minutes, with the ability to detect both lgG and lgM antibodies specific to SARS-CoV-2. Importantly, these tests are able to detect IgG antibodies at a 98.6% accuracy and IgM antibodies at a 92.9% accuracy. We see significant market potential for this differentiated test kit, given the prolonged and devastating impact of COVID-19. We look forward to leveraging our global network of suppliers and end-users to help bring the product to market in a timely and cost-effective manner."

    William Stilley, Chief Executive Officer of Adial Pharmaceuticals, commented, "This distribution partnership is important, as Brik has a proven track record and established relationships that we believe will help us better attack the market given the urgent need. Moreover, this agreement also allows us to focus internal resources on advancing the ongoing ONWARD™ Phase 3 pivotal clinical trial of our lead drug candidate, AD04, for the treatment of Alcohol Use Disorder, which is now well underway across Europe. We are already incorporating the use of these Rapid Result COVID-19 antibody test kits in our ONWARD™ trial, which was our original goal. We believe these tests have proven beneficial in enhancing patient safety during the current pandemic and that offering them to study subjects will increase trial subject retention rates."

    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) 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. www.adialpharma.com

    About Brik, LLC

    Focused on quality and upscale markets, both consumer and industrial, Brik, LLC helps clients connect and converse, and establish new operations and markets. Co-founded by Gerard Brikkenaar van Dijk and Keith Rosenfeld in 2002, Brik LLC brings together American and global investors, purchasers and suppliers. Our experience spans numerous industries, including: medical; online transaction security; pharmaceuticals; consumer electronics; multinational data centers; food production/retailing; and education.

    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 the significant market potential for this differentiated test kit, given the prolonged and devastating impact of COVID-19 and Brik leveraging its global network of suppliers and end-users to help bring the product to market in a timely and cost-effective manner, Brik's track record and established relationships helping us better attack the market given the urgent need, these tests having proven beneficial in enhancing patient safety during the current pandemic and that offering them to study subjects will increase trial subject retention rates 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, Brik's ability to leverage its relationships, including its global network of suppliers and end-users to help bring the product to market in a timely and cost-effective manner, our ability to increase trial subject retention rates by offering study subject the tests,, our ability to enroll patients and complete clinical trials on time and achieve desired results and benefits, 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, 2019, 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:

    SOURCE: Adial Pharmaceutical, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/600599/Adial-Pharmaceuticals-Announces-Third-Party-Sales-and-Distribution-Agreement-with-Brik-for-Rapid-Result-COVID-19-Antibody-Test-Kits

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  29. Developments to be Shared by Dr. Jack Reich, Director, Dr. Bankole A. Johnson, Chief Medical Officer, William B. Stilley, III, Chief Executive Officer, and Joseph A. M. Truluck, Chief Financial Officer

    CHARLOTTESVILLE, VA / ACCESSWIRE / July 28, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial"), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it will host a conference call at 11:00 AM, Eastern Time on Thursday, July 30, 2020, to provide material updates regarding the Company's business and operations and landmark ONWARD™ pivotal Phase 3 trial.

    The conference call will be available via telephone by dialing toll free 844-407-9500 for U.S. callers or + 862-298-0850…

    Developments to be Shared by Dr. Jack Reich, Director, Dr. Bankole A. Johnson, Chief Medical Officer, William B. Stilley, III, Chief Executive Officer, and Joseph A. M. Truluck, Chief Financial Officer

    CHARLOTTESVILLE, VA / ACCESSWIRE / July 28, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial"), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it will host a conference call at 11:00 AM, Eastern Time on Thursday, July 30, 2020, to provide material updates regarding the Company's business and operations and landmark ONWARD™ pivotal Phase 3 trial.

    The conference call will be available via telephone by dialing toll free 844-407-9500 for U.S. callers or + 862-298-0850 for international callers, or on the Company's Investors section of the website: https://ir.adialpharma.com/.

    A webcast replay will be available on the Company's Investor section of the website, https://ir.adialpharma.com/, through July 30, 2021. A telephone replay of the call with be available approximately one hour following the call, through Thursday, August 13, 2020 and can be accessed by dialing 877-481-4010 for U.S. callers or + 919-882-2331 for international callers and entering conference ID: 36297.

    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) 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. www.adialpharma.com

    Note on 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 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 expand the use of AD04 for use in patients with Opioid Use Disorder, gambling and obesity, the ability of AD04 therapy to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, our ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, 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, 2019, subsequent Quarterly Reports on Form 10-Q, current reports on Form 8-K and other documents 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:

    SOURCE: Adial Pharmaceutical, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/599206/Adial-Pharmaceuticals-Schedules-Business-and-Clinical-Update-Conference-Call

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  30. EMA Agreement paves the way for a marketing authorization in Europe after Phase 3

    CHARLOTTESVILLE, VA / ACCESSWIRE / July 22, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial"), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, is pleased to report that the European Medicines Agency (EMA) has accepted its Pediatric Investigation Plan (PIP) for development of the Company's lead drug candidate, AD04, for the treatment of Alcohol Use Disorder (AUD) in the pediatric population, ages 12 to 17. The approved PIP does not require additional clinical trials, and all requirements can be accommodated in the current Phase 3 program.

    AD04 is under development for the treatment of AUD in persons…

    EMA Agreement paves the way for a marketing authorization in Europe after Phase 3

    CHARLOTTESVILLE, VA / ACCESSWIRE / July 22, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial"), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, is pleased to report that the European Medicines Agency (EMA) has accepted its Pediatric Investigation Plan (PIP) for development of the Company's lead drug candidate, AD04, for the treatment of Alcohol Use Disorder (AUD) in the pediatric population, ages 12 to 17. The approved PIP does not require additional clinical trials, and all requirements can be accommodated in the current Phase 3 program.

    AD04 is under development for the treatment of AUD in persons with certain target genotypes related to the serotonin transporter and receptor genes, and is currently the subject of the landmark ONWARD™ Phase 3 trial that initiated in early 2020. As part of the regulatory process for the registration of new medicines in Europe, pharmaceutical companies are required to provide a PIP outlining their strategy for investigation of the new medicinal product in the pediatric population. An approved PIP is a prerequisite for filing a Marketing Authorization Application (MAA) for a new medicinal product in the European Union.

    "We are delighted by this outcome, which we regard as an important milestone for Adial and young patients suffering from AUD," stated Dr. Bankole Johnson, Adial's Chief Medical Officer. "Early alcohol use is associated with more regular and higher levels of alcohol use and dependence in adulthood, along with increased mental health issues and propensity to incur social harms. With a development plan in place for patients aged 12 to 17, Adial should be well-positioned to address this unmet medical need. The EMA's decision to allow Adial to use historical data to inform pediatric dose through modeling and simulation is notable as this mitigates practically any impact on cost and timeline. Acceptance of Adial's PIP paves the way for the Company's potential submission of an MAA in Europe following completion of AD04's ongoing Phase 3 program."

    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) 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. www.adialpharma.com

    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 being well-positioned to address the unmet medical need for patients aged 12 to 17, acceptance of the PIP paving the way for the potential submission of an MAA in Europe following completion of the ongoing Phase 3 program for AD04 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 address the unmet medical need for patients aged 12 to 17, our ability to submit an MAA in Europe following completion of the ongoing Phase 3 program for AD04, our ability to enroll patients and complete clinical trials on time and achieve desired results and benefits, 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, 2019, 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:

    SOURCE: Adial Pharmaceutical, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/598456/Adial-Pharmaceuticals-Receives-European-Medicines-Agency-EMA-Agreement-on-the-Pediatric-Investigation-Plan-PIP-for-AD04-in-Alcohol-Use-Disorder

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  31. CHARLOTTESVILLE, VA / ACCESSWIRE / July 6, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL) ("Adial"), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it has received approvals in Sweden and Estonia to commence the Company's landmark ONWARD™ pivotal Phase 3 clinical trial to investigate its 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. The Swedish Medical Products Agency and Swedish Ethical Review Authority have provided approval for ONWARD™ to commence in Sweden; and the Estonian State Agency of Medicines and Ethics Review…

    CHARLOTTESVILLE, VA / ACCESSWIRE / July 6, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL) ("Adial"), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it has received approvals in Sweden and Estonia to commence the Company's landmark ONWARD™ pivotal Phase 3 clinical trial to investigate its 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. The Swedish Medical Products Agency and Swedish Ethical Review Authority have provided approval for ONWARD™ to commence in Sweden; and the Estonian State Agency of Medicines and Ethics Review Committee overseeing human trials granted approval to commence ONWARD™ in Estonia.

    "We are pleased that the regulatory authorities and the ethics committees in Sweden and Estonia have recognized that AD04's safety and efficacy data profile support conducting the ONWARD™ trial in Sweden and Estonia," commented William Stilley, Chief Executive Officer of Adial Pharmaceuticals. "We intend to initiate sites in both countries in the coming weeks. With the relaxing of COVID-19 lockdown restrictions, Adial is working to achieve full operation of ONWARD™ clinical sites as rapidly as possible, with the trial goal to bring a meaningful new treatment for Alcohol Use Disorder to patients in Scandinavia, Eastern Europe and around the world. It is widely reported that the alcohol problem has grown worse during the COVID-19 lockdown, heightening the urgency for pharmacological interventions."

    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) 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. www.adialpharma.com

    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 initiating sites in Sweden and Estonia to commence the Company's landmark ONWARD™ pivotal Phase 3 clinical trial in the coming weeks and working to achieve full operation of ONWARD™ clinical sites as rapidly as possible, 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 initiate sites in Sweden and Estonia to commence the Company's landmark ONWARD™ pivotal Phase 3 clinical trial as planned, our ability to achieve full operation of the ONWARD™ clinical sites , our ability to expand the use of AD04 for use in patients with Opioid Use Disorder, gambling and obesity, the ability of AD04 therapy to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, our ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, 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, 2019, 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:

    SOURCE: Adial Pharmaceuticals, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/596360/Adial-Pharmaceuticals-Announces-Approval-to-Commence-Landmark-ONWARDTM-Pivotal-Phase-3-Trial-in-Sweden-and-Estonia

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  32. ONWARD™ trial progresses with the opening of sites in Latvia

    CHARLOTTESVILLE, VA / ACCESSWIRE / June 17, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial"), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it has opened clinical trial sites and is recruiting trial subjects in Latvia after receiving all necessary approvals to commence the landmark ONWARD™ pivotal Phase 3 clinical trial in Latvia, including from the State Agency of Medicines of the Republic of Latvia and the Latvian Central Ethics Committee. The ONWARD™ trial is investigating Adial's lead drug candidate, AD04, as a therapeutic agent for the treatment of Alcohol Use Disorder in persons with certain…

    ONWARD™ trial progresses with the opening of sites in Latvia

    CHARLOTTESVILLE, VA / ACCESSWIRE / June 17, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial"), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it has opened clinical trial sites and is recruiting trial subjects in Latvia after receiving all necessary approvals to commence the landmark ONWARD™ pivotal Phase 3 clinical trial in Latvia, including from the State Agency of Medicines of the Republic of Latvia and the Latvian Central Ethics Committee. The ONWARD™ trial is investigating Adial's lead drug candidate, AD04, as a therapeutic agent for the treatment of Alcohol Use Disorder in persons with certain target genotypes related to the serotonin transporter and receptor genes.

    Shortly following approval, two investigative ONWARD™ clinical trial sites were initiated in Latvia and commenced trial activities, and one more site is planned in Latvia. Commenting on the opening of these sites, Schuyler Vinzant, Adial's Vice President of Development, said, "We are pleased to expand our collaboration in the Baltic region, optimizing our enrollment efforts as we work to demonstrate the efficacy and safety of AD04 for the treatment of persons suffering with Alcohol Use Disorder."

    Dr. Jelena Sorokina, Principal Investigator at the Liepaja Regional Hospital in Latvia stated, "It has been many years since the medical community has had a new option for treating Alcohol Use Disorder. We are already seeing evidence that the alcohol problem has become worse during the COVID-19 lockdown, making the development of pharmacological interventions even more urgent and important. We are honored to be part of the landmark ONWARD™ trial, as it evaluates AD04 as a meaningful potential treatment for the many Latvian patients and other patients globally suffering from this terrible disease."

    "Adial's ability to initiate sites in the ONWARD™ trial had been on hold in Latvia due to the COVID-19 lockdown," said William Stilley, Chief Executive Officer of Adial. "During the lockdown, Mr. Vinzant and our contract research organization, Crown CRO, completed all preparatory work necessary to allow for the immediate activation of our first two Latvian trial sites and we intend to open our third and final site in Latvia shortly. The ONWARD™ trial has already been running in Finland and Bulgaria for several months and we recently announced approval to commence the trial in Poland."

    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) 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. www.adialpharma.com

    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 initiating sites in the ONWARD™ trial in Latvia and the potential of AD04 as a therapeutic agent for the treatment of Alcohol Use Disorder in persons with certain target genotypes related to the serotonin transporter and receptor genes and 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 continue to open sites in Latvia, our ability to expand the use of AD04 for use in patients with Opioid Use Disorder, gambling and obesity, the ability of AD04 therapy to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, our ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, 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, 2019, 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:

    SOURCE: Adial Pharmaceutical, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/594197/Adial-Pharmaceuticals-Announces-Commencement-of-the-Landmark-ONWARDTM-Pivotal-Phase-3-Clinical-Trial-in-Latvia

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  33. CHARLOTTESVILLE, VA / ACCESSWIRE / June 15, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial" or the "Company"), a biopharmaceutical company focused on the development of treatments for addiction and currently conducting the ONWARD™ pivotal Phase 3 clinical trial of its lead drug candidate, AD04, for the treatment of Alcohol Use Disorder, today announced the closing on June 11,2020 of its previously announced registered direct offering of 2,820,000 shares of its common stock at a purchase price of $1.85 per share for gross proceeds of $5,217,000 priced at-the-market under Nasdaq rules. In a concurrent private placement, Adial also issued warrants to purchase 2,115,000 shares of common stock, which warrants are immediately exercisable…

    CHARLOTTESVILLE, VA / ACCESSWIRE / June 15, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial" or the "Company"), a biopharmaceutical company focused on the development of treatments for addiction and currently conducting the ONWARD™ pivotal Phase 3 clinical trial of its lead drug candidate, AD04, for the treatment of Alcohol Use Disorder, today announced the closing on June 11,2020 of its previously announced registered direct offering of 2,820,000 shares of its common stock at a purchase price of $1.85 per share for gross proceeds of $5,217,000 priced at-the-market under Nasdaq rules. In a concurrent private placement, Adial also issued warrants to purchase 2,115,000 shares of common stock, which warrants are immediately exercisable, will expire 5 years from the date of issuance and will have an exercise price of $2.00 per share of common stock. Adial intends to use the net proceeds to advance its ONWARD™ pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes, as well as for working capital and for other general corporate purposes.

    Maxim Group LLC acted as the lead placement agent for the offering and Joseph Gunnar & Co., LLC acted as the co-placement agent for the offering.

    The common shares were offered pursuant to a shelf registration statement on Form S-3 (File No. 333-237793) previously filed and declared effective by the Securities and Exchange Commission (SEC). The offering of the shares of common stock was made by means of a prospectus supplement that was filed with the SEC and forms a part of the registration statement.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. A prospectus supplement relating to the shares of common stock was filed by Adial with the SEC. Copies of the prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, can be obtained at the SEC's website at www.sec.gov or from Maxim Group LLC, 405 Lexington Avenue, New York, NY 10174, Attention: Syndicate Department, or via email at or telephone at (212) 895-3745.

    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) 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. www.adialpharma.com

    Note on 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 the expected use of proceeds 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 expand the use of AD04 for use in patients with Opioid Use Disorder, gambling and obesity, the ability of AD04 therapy to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, our ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, 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, 2019, subsequent Quarterly Reports on Form 10-Q, current reports on Form 8-K and other documents 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
    Tel: 212-671-1021
    Email:

    SOURCE: Adial Pharmaceutical, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/593906/Adial-Pharmaceuticals-Closes-Previously-Announced-52-Million-Registered-Direct-Offering

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  34. Initial Customer Order Scheduled for Immediate Delivery

    Test Kits to Support Efforts in City of Phoenix, Arizona and Surrounding Communities

    CHARLOTTESVILLE, VA / ACCESSWIRE / June 10, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial"), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it has received an initial firm order for the purchase of 1,000 Rapid Result COVID-19 antibody test kits. The customer intends to utilize the test kits for understanding exposure to the virus in the City of Phoenix, Arizona and surrounding communities and to advance efforts to protect the health and safety of frontline workers.

    As reported on June 8, 2020, Adial and BioLab Sciences…

    Initial Customer Order Scheduled for Immediate Delivery

    Test Kits to Support Efforts in City of Phoenix, Arizona and Surrounding Communities

    CHARLOTTESVILLE, VA / ACCESSWIRE / June 10, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial"), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it has received an initial firm order for the purchase of 1,000 Rapid Result COVID-19 antibody test kits. The customer intends to utilize the test kits for understanding exposure to the virus in the City of Phoenix, Arizona and surrounding communities and to advance efforts to protect the health and safety of frontline workers.

    As reported on June 8, 2020, Adial and BioLab Sciences, Inc. have entered into a distribution agreement, whereby Adial has the exclusive rights to sell and distribute Rapid Result COVID-19 antibody tests to designated channel partners and customers. The U.S. Food and Drug Administration ("FDA") registered, Rapid Result COVID-19 test is a 10-minute, 'instant' point-of-care test device for the qualitative detection of lgG and lgM antibodies specific to 2019-nCoV in human whole blood, serum or plasma specimens. The Rapid Result COVID-19 antibody test detects IgG antibodies at a 98.6% accuracy and detects IgM antibodies at a 92.9% accuracy.

    Adial is incorporating the use of Rapid Result COVID-19 antibody test kits in its landmark ONWARD™ pivotal Phase 3 clinical trial of its lead drug candidate, AD04, for the treatment of Alcohol Use Disorder. Adial intends to enhance the safety of trial administration with a parallel goal of increasing trial subject retention rates.

    William Stilley, Chief Executive Officer of Adial Pharmaceuticals, commented, "While our initial desire to procure the Rapid Result COVID-19 antibody test kits was to ensure the safe and efficient progress of our ongoing landmark ONWARD™ pivotal Phase 3 clinical trial, we quickly realized that our access to these important antibody tests could provide significant benefits to other end users as we all strive to keep our fellow citizens and our critical frontline workers safe as we reopen our country. Our due diligence revealed a significant demand for these test kits and, through this sale, we are pleased to contribute to the health and safety of citizens of the City of Phoenix, Arizona and surrounding communities. While we remain laser focused on our core mission as the "Medicines for Addiction™" company, the demand for the Rapid Result COVID-19 antibody test kits appears robust. We believe it is our corporate obligation to make these important tests available to communities and corporations, and ultimately the people who need them, as we all make our best efforts to remain healthy and safe as we protect ourselves, our loved ones, and strive to preserve the sanctity of life."

    "Adial's mission is to combat our amazing country's severe addiction problem, by recognizing that addiction is not the same for all patients and that genetics can play a role in both the onset of addiction disorders and in determining the most effective treatment," continued Mr. Stilley. "By addressing patients' unique physiology with a drug that is targeted to treat their disorder based on their genetics, we believe we can improve the quality of life for patients facing a disease where there is a lack of adequate solutions available today. We are progressing in our landmark ONWARD™ pivotal Phase 3 clinical trial of our lead drug candidate, AD04, for the treatment of Alcohol Use Disorder in patients with certain genetics, and we plan to commence additional clinical trials to address another systemic epidemic, Opioid Use Disorder. While these trials and serving those so afflicted with addiction is the great force driving us forward, our entire team is grateful for this opportunity we have to provide antibody tests as a necessary and important resource to the communities in which we live, work and raise our children."

    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) 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. www.adialpharma.com

    About BioLab Sciences, Inc.

    BioLab Sciences is a regenerative medicine company focused on creating new ways to regenerate the body for optimal performance. Headquartered in Scottsdale, Arizona, BioLab Sciences is expanding the human body's ability to regenerate by developing and manufacturing human cell and tissue therapies as an alternative to invasive, painful and expensive treatment protocols. Through research and innovation, BioLab Sciences is uncovering better ways to address orthopedic injuries, wound care, pain management, aesthetic medicine, respiratory ailments, cardiovascular indications, ophthalmic issues, and more. Learn more at www.biolabsciences.net.

    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 the Rapid Result COVID-19 antibody test kits enhancing the safety of trial administration and increasing trial subject retention rates, improving the quality of life for patients by addressing patients' unique physiology with a drug that is targeted to treat their disorder based on their genetics, plans to commence additional clinical trials to address another systemic epidemic, Opioid Use Disorder 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 enhance both safety and trial retention rates in our ONWARD™ pivotal Phase 3 clinical trial, our ability to expand the use of AD04 for use in patients with Opioid Use Disorder, gambling and obesity, the ability of AD04 therapy to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, our ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, 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, 2019, 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:

    SOURCE: Adial Pharmaceutical, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/593410/Adial-Pharmaceuticals-Receives-Order-for-1000-COVID-19-Antibody-Test-Kits

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  35. CHARLOTTESVILLE, VA / ACCESSWIRE / June 9, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial" or the "Company"), a biopharmaceutical company focused on the development of treatments for addiction and currently conducting the ONWARD™ pivotal Phase 3 clinical trial of its lead drug candidate, AD04, for the treatment of Alcohol Use Disorder, today announced that it has entered into a securities purchase agreement with institutional investors to purchase approximately $5.2 million of its common stock in a registered direct offering priced at-the-market under Nasdaq rules and warrants to purchase common stock in a concurrent private placement. The combined purchase price for one share of common stock and a warrant to purchase 0.75…

    CHARLOTTESVILLE, VA / ACCESSWIRE / June 9, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial" or the "Company"), a biopharmaceutical company focused on the development of treatments for addiction and currently conducting the ONWARD™ pivotal Phase 3 clinical trial of its lead drug candidate, AD04, for the treatment of Alcohol Use Disorder, today announced that it has entered into a securities purchase agreement with institutional investors to purchase approximately $5.2 million of its common stock in a registered direct offering priced at-the-market under Nasdaq rules and warrants to purchase common stock in a concurrent private placement. The combined purchase price for one share of common stock and a warrant to purchase 0.75 shares of common stock will be $1.85.

    Under the terms of the securities purchase agreement, Adial has agreed to sell 2,820,000 shares of common stock. In a private placement, which will be consummated concurrently with the Offering, Adial also has agreed to issue warrants to purchase up to an aggregate of 2,115,000 shares of common stock. The warrants will be immediately exercisable, will expire 5 years from the date of issuance and will have an exercise price of $2.00 per share of common stock.

    Maxim Group LLC is acting as the lead placement agent for the offering and Joseph Gunnar & Co., LLC is acting as the co-placement agent for the offering.

    The offering is expected to close on or about June 11, 2020, subject to the satisfaction of customary closing conditions.

    The common shares are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-237793) previously filed and declared effective by the Securities and Exchange Commission (SEC). The offering of the shares of common stock will be made only by means of a prospectus supplement that forms a part of the registration statement.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. A prospectus supplement relating to the shares of common stock will be filed by Adial with the SEC. When available, copies of the prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, can be obtained at the SEC's website at www.sec.gov or from Maxim Group LLC, 405 Lexington Avenue, New York, NY 10174, Attention: Syndicate Department, or via email at or telephone at (212) 895-3745.

    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) 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. www.adialpharma.com

    Note on 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 the expected closing of the offering and fulfillment of customary closing conditions, 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 consummate the offering, our ability to expand the use of AD04 for use in patients with Opioid Use Disorder, gambling and obesity, the ability of AD04 therapy to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, our ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, 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, 2019, subsequent Quarterly Reports on Form 10-Q, current reports on Form 8-K and other documents 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
    Tel: 212-671-1021
    Email:

    SOURCE: Adial Pharmaceuticals, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/593271/Adial-Pharmaceuticals-Announces-Pricing-of-52-Million-Registered-Direct-Offering-Priced-At-The-Market

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  36. Antibody Testing Available for Landmark ONWARD(TM) Pivotal Phase 3 Trial Participants

    BioLab Sciences Grants Adial Exclusive Rights to Sell and Distribute Rapid Result COVID-19 Antibody Tests to Designated Channel Partners

    CHARLOTTESVILLE, VA / ACCESSWIRE / June 8, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial"), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, and BioLab Sciences, Inc. ("BioLab"), a regenerative biotechnology company, which manufactures and sells Rapid Result COVID-19 antibody test kits, announced that they have entered into a Distribution Agreement (the "Agreement") by which Adial has purchased Rapid Result COVID-19 antibody test kits from BioLab for use in…

    Antibody Testing Available for Landmark ONWARD(TM) Pivotal Phase 3 Trial Participants

    BioLab Sciences Grants Adial Exclusive Rights to Sell and Distribute Rapid Result COVID-19 Antibody Tests to Designated Channel Partners

    CHARLOTTESVILLE, VA / ACCESSWIRE / June 8, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial"), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, and BioLab Sciences, Inc. ("BioLab"), a regenerative biotechnology company, which manufactures and sells Rapid Result COVID-19 antibody test kits, announced that they have entered into a Distribution Agreement (the "Agreement") by which Adial has purchased Rapid Result COVID-19 antibody test kits from BioLab for use in Adial's landmark ONWARDÔ pivotal Phase 3 clinical trial of its lead drug candidate, AD04, for the treatment of Alcohol Use Disorder (AUD) and BioLab has granted Adial exclusive rights to sell Rapid Result COVID-19 antibody test kits to designated channel partners.

    The Rapid Result COVID-19 test is a 10-minute, ‘instant' point-of-care test device for the qualitative detection of lgG and lgM antibodies specific to 2019-nCoV in human whole blood, serum or plasma specimens. During testing, the specimen reacts with 2019-nCoV antigen coated particles in the test cassette after droplets of blood from the subject are placed on the cassette's coated membrane.

    • The Rapid Result COVID-19 antibody test kits have been registered with the U.S. Food and Drug Administration ("FDA").

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=653267&lpcd=QKO

    • The Rapid Result COVID-19 antibody test kits are marketed and may be used in accordance with FDA policy originally issued on February 29, 2020 and last updated on May 11, 2020.

    https://www.fda.gov/media/135659/download

    • The Rapid Result COVID-19 antibody test kits are 100% USA manufactured.
    • The Rapid Result COVID-19 antibody test detects IgG antibodies at a 98.6% accuracy.

    IgG antibodies develop in most patients within 7 to 10 days after COVID-19 symptoms begin. IgG antibodies remain in the blood after an infection has passed and indicate that the patient may have had COVID-19 in the recent past and may have developed protective antibodies.

    • The Rapid Result COVID-19 antibody test detects IgM antibodies at a 92.9% accuracy.

    The IgM antibody is usually the first antibody produced when the virus attacks. A positive IgM test indicates that you may have been infected with COVID-19 and that your immune system has started responding to the virus and you may still be infected or recently recovered from COVID-19.

    • The Rapid Result COVID-19 antibody test kits are in wide use globally and are produced for use by government and distributed for diagnostic use in laboratories or by healthcare workers at point-of-care facilities.
    • Millions of Rapid Result COVID-19 antibody test kits have been manufactured and shipped worldwide including to New York City and other COVID-19 epicenters.
    • The Rapid Result COVID-19 antibody test kits have received European CE mark Number 146198600 with an effective date of February 18, 2020.

    Under the Agreement, Adial secured access to the Rapid Result COVID-19 antibody test kits manufactured by BioLab for use as an indicator of whether subjects participating in clinical trials conducted by Adial have developed the antibodies associated with an immune response to the SARS-Cov-2 virus (i.e., the virus that causes COVID-19). Adial initially purchased 500 Rapid Result COVID-19 antibody tests, which are intended to be used to test subjects enrolled in Adial's landmark ONWARD™ pivotal Phase 3 clinical trial. The Agreement also provides Adial exclusive rights to sell Rapid Result COVID-19 antibody test kits to designated channel partners.

    William Stilley, Chief Executive Officer of Adial Pharmaceuticals, commented, "The safety of our clinical trial subjects is of the utmost importance to Adial. In addition to advancing our goal to protect the health of our study subjects, securing access to a large quantity of Rapid Result COVID-19 antibody test kits is expected to allow us to identify people in our studies that potentially have less or greater risk of a COVID-19 infection so that we may potentially tailor visits and other trial activities to maintain the safest environment reasonably possible for our participants. Our plan is to offer the test to each subject enrolled in our landmark ONWARD™ pivotal Phase 3 clinical trial four times during the trial to enhance both safety and trial retention rates. We believe the impact on retention rates due to providing this service to our trial participants could be material."

    "BioLab Sciences is pleased to partner with Adial for the distribution of the Rapid Result COVID-19 antibody test kits we manufacture. Our high-quality tests are in high demand as our country continues to reopen and return to work. We are pleased to see the Rapid Result COVID-19 antibody test kits being utilized in such an important Phase 3 trial and we look forward to building a large and important distribution relationship to serve Adial's partners," said Jaime Leija, Co-Founder and Chief Commercialization Officer of BioLab Sciences.

    "As part of securing distribution rights for BioLab's state-of-the-art Rapid Result COVID-19 antibody tests, Adial has also secured exclusive rights for the Rapid Result COVID-19 antibody test kits for sale to certain partners that have demand for these tests," continued Mr. Stilley. "While our ONWARDÔ pivotal Phase 3 clinical trial is Adial's primary focus for these antibody tests, in procuring the tests for our trial, we took the decision to leverage our expertise and sales capabilities to make these important tests for a safe return to the workplace and for understanding our community's exposure to the virus more widely available to Adial's channel partners and other qualified purchasers."

    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) 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. www.adialpharma.com

    About BioLab Sciences, Inc.

    BioLab Sciences is a regenerative medicine company focused on creating new ways to regenerate the body for optimal performance. Headquartered in Scottsdale, Arizona, BioLab Sciences is expanding the human body's ability to regenerate by developing and manufacturing human cell and tissue therapies as an alternative to invasive, painful and expensive treatment protocols. Through research and innovation, BioLab Sciences is uncovering better ways to address orthopedic injuries, wound care, pain management, aesthetic medicine, respiratory ailments, cardiovascular indications, ophthalmic issues, and more. Learn more at www.biolabsciences.net.

    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 maintaining the safest environment reasonably possible for our participants in our ONWARD™ pivotal Phase 3 clinical trial, offering the test to each subject enrolled in the ONWARD™ pivotal Phase 3 clinical trial four times during the trial, the impact on retention rates due to providing this service to our trial participants, 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 enhance both safety and trial retention rates in our ONWARD™ pivotal Phase 3 clinical trial, our ability to expand the use of AD04 for use in patients with Opioid Use Disorder, gambling and obesity, the ability of AD04 therapy to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, our ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, 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, 2019, 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:

    SOURCE: Adial Pharmaceutical, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/593109/Adial-Pharmaceuticals-and-BioLab-Sciences-Enter-into-Distribution-Agreement-for-COVID-19-Antibody-Tests

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  37. CHARLOTTESVILLE, VA / ACCESSWIRE / May 28, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW)), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced the appointment of Dr. Jack Reich to the Board of Directors. The appointment increases the Board to seven members. Dr. Reich will serve on the Audit Committee as well as the Nominations and Corporate Governance Committee.

    Dr. Jack Reich's career spans over 35 years in the pharmaceutical, biotechnology, and venture capital industries. Since 1987, Dr. Reich has been involved in more than 30 medical and biotech companies. He was a founding officer of Gensia, Inc. and co-founded the first gene therapy company, Viagene, Inc. Following…

    CHARLOTTESVILLE, VA / ACCESSWIRE / May 28, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW)), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced the appointment of Dr. Jack Reich to the Board of Directors. The appointment increases the Board to seven members. Dr. Reich will serve on the Audit Committee as well as the Nominations and Corporate Governance Committee.

    Dr. Jack Reich's career spans over 35 years in the pharmaceutical, biotechnology, and venture capital industries. Since 1987, Dr. Reich has been involved in more than 30 medical and biotech companies. He was a founding officer of Gensia, Inc. and co-founded the first gene therapy company, Viagene, Inc. Following its public listing, Gensia soon became the second-largest market cap biotech on NASDAQ, and Viagene was acquired by Chiron after its public listing. Dr. Reich also co-founded the first cardiovascular gene therapy company, Collateral Therapeutics, Inc., which he took public on NASDAQ in 1997 as Chairman and CEO. Subsequently, Collateral was sold to Schering AG in 2002. In 2009, Dr. Reich co-founded Renova Therapeutics, where he served as CEO until 2019.

    William Stilley, President and Chief Executive Officer of Adial Pharmaceuticals, commented, "We are pleased to welcome Jack to the Board of Directors. His industry experience and successful track record, including oversight of the development of dozens of approved therapies, should be invaluable as we work to advance Adial's ONWARD™ Phase 3 pivotal trial of AD04 in genetically identified subjects for the treatment of Alcohol Use Disorder (AUD) and as we evaluate regulatory opportunities and strategic options in the field of addiction. The addition of an independent director of Jack's caliber also enhances our practice of maintaining strong corporate governance."

    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) and is currently being investigated in the Company's landmark ONWARD™ Phase 3 Pivotal 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. Additional information is available at www.adialpharma.com.

    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 the expected contribution of Dr. Reich 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 expand the use of AD04 for use in patients with Opioid Use Disorder, gambling and obesity, the ability of AD04 therapy to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, 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, 2019, 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:

    SOURCE: Adial Pharmaceutical, Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/591783/Adial-Pharmaceuticals-Appoints-Dr-Jack-Reich-to-Board-of-Directors

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  38. CHARLOTTESVILLE, VA / ACCESSWIRE / May 4, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW)), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, announced today that an op-ed written by William Stilley, CEO of Adial Pharmaceuticals, entitled "America's real drug problem: Foreign companies make our electronics; should they make our drugs?" was published yesterday in The Daily Progress, a newspaper covering Central Virginia since 1892.

    Sign up to follow Adial Pharmaceuticals on Twitter @AdialPharma, or William Stilley on Twitter @BillStilley. To receive Adial Pharmaceuticals updates via e-mail, subscribe here.

    About Adial Pharmaceuticals, Inc.

    Adial Pharmaceuticals is a clinical-stage biopharmaceutical…

    CHARLOTTESVILLE, VA / ACCESSWIRE / May 4, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW)), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, announced today that an op-ed written by William Stilley, CEO of Adial Pharmaceuticals, entitled "America's real drug problem: Foreign companies make our electronics; should they make our drugs?" was published yesterday in The Daily Progress, a newspaper covering Central Virginia since 1892.

    Sign up to follow Adial Pharmaceuticals on Twitter @AdialPharma, or William Stilley on Twitter @BillStilley. To receive Adial Pharmaceuticals updates via e-mail, subscribe here.

    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) and is currently being investigated in the Company's landmark ONWARD™ Phase 3 Pivotal 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. Additional information is available at www.adialpharma.com.

    Contact:

    Crescendo Communications, LLC
    David Waldman / Natalya Rudman
    Tel: 212-671-1021
    Email:

    SOURCE: Adial Pharmaceutical, Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/588236/Op-Ed-by-Adial-Pharmaceuticals-CEO-Published-in-the-Daily-Progress

    View Full Article Hide Full Article
  39. CHARLOTTESVILLE, VA / ACCESSWIRE / April 23, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW)), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, announced that it has filed with the Securities and Exchange Commission (SEC), a post-effective amendment to a previously filed registration statement on Form S-1 to register the 2,133,750 shares of common stock underlying warrants previously issued by the Company as part of its follow-on offering in 2019, and another post-effective amendment to a previously filed registration statement on Form S-1 to register 1,634,652 shares of common stock underlying warrants previously issued by the Company to investors in its initial public offering, and…

    CHARLOTTESVILLE, VA / ACCESSWIRE / April 23, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW)), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, announced that it has filed with the Securities and Exchange Commission (SEC), a post-effective amendment to a previously filed registration statement on Form S-1 to register the 2,133,750 shares of common stock underlying warrants previously issued by the Company as part of its follow-on offering in 2019, and another post-effective amendment to a previously filed registration statement on Form S-1 to register 1,634,652 shares of common stock underlying warrants previously issued by the Company to investors in its initial public offering, and warrants to purchase 58,560 shares of common stock previously issued to the underwriters. Additionally, a registration statement on Form S-3 "shelf registration" was filed with the SEC. The shelf registration provides the Company flexibility to potentially raise capital in the future to execute its strategy, including advancement of the Company's lead drug candidate, AD04, assuming positive results from the ONWARD™ Phase 3 pivotal trial of AD04 in genetically identified subjects for the treatment of Alcohol Use Disorder (AUD), as well as to consider strategic options given the interest in Adial and the strength of our platform.

    William Stilley, Chief Executive Officer of Adial Pharmaceuticals, "We filed the S-1 amendments, just as we did last year, to simply fulfill our contractual requirement as part of our IPO and 2019 follow-on financing in order to maintain the registration of the warrants already outstanding and provide ease for trading of the common stock underlying the warrants, which could result in Adial receiving funds from the possible exercise of these warrants. The filing of the S-3 provides us greater flexibility to raise capital in the future and our advisors have recommended that we make this filing, which is routine for many public companies. However, it is also important to note that we project that we have sufficient cash on hand to execute on our business model as we advance towards what we believe will be meaningful catalysts to drive shareholder value."

    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) and is currently being investigated in the Company's landmark ONWARD™ Phase 3 Pivotal 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. www.adialpharma.com

    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 potentially raising capital in the future to execute our strategy, including advancement of the Company's lead drug candidate, AD04, having sufficient cash on hand to execute on our business model, 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 expand our proprietary companion diagnostic genetic test to other clinical trials including the planned Opioid Use Disorder clinical trials, our ability to obtain FDA approval of the test as a companion diagnostic, our ability to raise capital in the future to execute our strategy, our ability to maintain sufficient cash on hand to execute on our business model, our ability to expand the use of AD04 for use in patients with Opioid Use Disorder, gambling and obesity, the ability of AD04 therapy to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, our ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, 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, 2019, 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:

    SOURCE: Adial Pharmaceutical, Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/586589/Adial-Pharmaceuticals-Files-Post-Effective-Amendments-to-Registration-Statements-For-Outstanding-Shares-Underlying-Existing-Warrants-and-Shelf-Registration-Statement-to-Provide-Financial-Flexibility

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  40. Adial Expects to Expand Use of Test to Planned Opioid Use Disorder Clinical Trials

    CHARLOTTESVILLE, VA / ACCESSWIRE / April 16, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW)), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, announced that the functionality of its proprietary companion diagnostic genetic test has been verified as clinically effective through its utilization in the landmark ONWARD™ pivotal Phase 3 clinical trial of the Company's lead drug candidate, ultra-low dose ondansetron (AD04), for the treatment of Alcohol Use Disorder (AUD). The Company expects to expand the use of the genetic test into clinical trials of AD04 in the future for the treatment of other indications…

    Adial Expects to Expand Use of Test to Planned Opioid Use Disorder Clinical Trials

    CHARLOTTESVILLE, VA / ACCESSWIRE / April 16, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW)), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, announced that the functionality of its proprietary companion diagnostic genetic test has been verified as clinically effective through its utilization in the landmark ONWARD™ pivotal Phase 3 clinical trial of the Company's lead drug candidate, ultra-low dose ondansetron (AD04), for the treatment of Alcohol Use Disorder (AUD). The Company expects to expand the use of the genetic test into clinical trials of AD04 in the future for the treatment of other indications such as Opioid Use Disorder (OUD) and is working to establish testing capacity in the United States for future studies.

    Adial's genetic test uses double-strand Sanger sequencing and fragment length analysis of polymerase chain reaction (PCR) products. These assays are being used for the analysis of subjects' blood samples for genetic variants in defined genes caused by Single Nucleotide Polymorphisms or Fragment Length Polymorphisms in order to identify subjects likely to respond to AD04 in the ONWARD™ trial. By segmenting the trial population so that only patients genetically predisposed to treatment with a drug are included as trial subjects (sometimes called, "Responders"), there is a greater likelihood that the effect can be distinguishable from placebo.

    AD04 is the first drug candidate known to us to target addiction treatment using a genetic segmentation approach. This approach appears to have been successfully demonstrated in a 283 subject, Phase 2b trial of AD04 in subjects with AUD in that those who tested positive for the targeted genetics had a statistically significant response (P = 0.004) when compared with placebo. Adial seeks to confirm this result in the ONWARD™ Phase 3 trial by only including subjects that are identified as likely Responders based on testing using the Company's proprietary companion diagnostic genetic test.

    "The potential for using ondansetron, the active ingredient in AD04 and a serotonin-3 (5-HT3) antagonist, to treat alcohol addiction was hypothesized decades ago since the 5-HT3 receptor was understood to modulate dopamine, a neurotransmitter known to affect rewards and craving," said Dr. Bankole A. Johnson, Chief Medical Officer of Adial Pharmaceuticals and inventor of AD04. "At the turn of this century, we were able to show that individuals with a biological predisposition to AUD were those that responded best to ultra-low dose ondansetron treatment. With advances in knowledge about human genetics at about the same time, I was able to theorize that targeting specific genotypes in the serotonin system would enable us to use more empirical methods to categorize likely responders to ultra-low dose ondansetron for the treatment of AUD. Indeed, in a follow up Phase 2b trial of ultra-low dose ondansetron, we confirmed that, among individuals with AUD with our predicted target genotypes, ultra-low dose ondansetron was significantly more efficacious than placebo. Now, we have designed and validated a proprietary, targeted genetic test, with very high levels of specificity and accuracy, which is currently being used to identify our target genotypes in the ongoing ONWARD™ Phase 3 trial. The ONWARD™ trial will only include patients with the target genotypes hypothesized to respond to Adial's formulation of ultra-low dose ondansetron, AD04, which should increase the prospect of demonstrating a clinically significant therapeutic effect compared to placebo.

    As previously reported, prior to Adial's commencement of its landmark ONWARD™ pivotal Phase 3 clinical trial of AD04, Adial Pharmaceuticals' proprietary companion genetic test was validated for use in ONWARD™ by its genetic testing partner Eurofins Genomics, a division of Eurofins Biopharma Services, a global scientific leader in bioanalytical testing. Adial developed the genetic test with the selectivity and sensitivity it believes will allow approval for the test as a "Companion Diagnostic" as defined by the U.S. Food and Drug Administration (FDA), meaning that the test would be approved by the FDA for use in combination with AD04 to indicate treatment with AD04.

    "We have filed patents covering the administration of our proprietary companion diagnostic genetic test to identify people with AUD and Opioid Use Disorder and possibly other addictions who will likely respond favorably to treatment with AD04 based on their genetics," added William Stilley, Chief Executive Officer of Adial Pharmaceuticals. "Adial's patents in combination with FDA regulations would be expected to prohibit a competitor from marketing or using their own genetic test to identify patients for treatment with AD04."

    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) and is currently being investigated in the Company's landmark ONWARD™ Phase 3 Pivotal 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. www.adialpharma.com.

    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 the expansion of our proprietary companion diagnostic genetic test to planned Opioid Use Disorder clinical trials, expanding the use of the genetic test into clinical trials of AD04 in the future for the treatment of other indications, the potential for using ondansetron, the active ingredient in AD04 and a serotonin-3 (5-HT3) antagonist, increasing the prospect of demonstrating a clinically significant therapeutic effect compared to placebo to treat addictions by including patients with the target genotypes hypothesized to respond to AD04, the genetic test having the selectivity and sensitivity to allow approval for the test as a "Companion Diagnostic" as defined by the U.S. Food and Drug Administration, our patents in combination with FDA regulations prohibiting a competitor from marketing or using their own genetic test to identify patients for treatment with AD04, 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 expand our proprietary companion diagnostic genetic test to other clinical trials including the planned Opioid Use Disorder clinical trials, our ability to obtain FDA approval of the test as a companion diagnostic, our ability to prohibit competitors from marketing or using their own genetic test to identify patients for treatment with AD04, our ability to continue enrollment and mitigate delays during the COVID-19 pandemic, our ability to expand the use of AD04 for use in patients with Opioid Use Disorder, gambling and obesity, the ability of AD04 therapy to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, 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, 2019, 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 or Natalya Rudman
    Tel: 212-671-1021
    Email:

    SOURCE: Adial Pharmaceuticals, Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/585384/Adial-Pharmaceuticals-Verifies-Proprietary-Genetic-Test-in-Landmark-ONWARDTM-Pivotal-Phase-3-Clinical-Trial

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  41. CHARLOTTESVILLE, VA / ACCESSWIRE / April 15, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW)), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that U.S. Patent Number 10,619,209, titled "Serotonin Transporter Gene and Treatment of Opioid-Related Disorders" issued on April 14, 2020. This patent covers the treatment of Opioid Use Disorder by administering the Company's investigational new drug product, AD04, an antagonist of the serotonin-3 receptor (5-HT3), to patients with the LL and TT genotypes, which may be identified by Adial's proprietary genetic test.

    The gene responsible for encoding the serotonin transporter (SERT), SLC6A4, located on the chromosome 17q11.1-q12…

    CHARLOTTESVILLE, VA / ACCESSWIRE / April 15, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW)), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that U.S. Patent Number 10,619,209, titled "Serotonin Transporter Gene and Treatment of Opioid-Related Disorders" issued on April 14, 2020. This patent covers the treatment of Opioid Use Disorder by administering the Company's investigational new drug product, AD04, an antagonist of the serotonin-3 receptor (5-HT3), to patients with the LL and TT genotypes, which may be identified by Adial's proprietary genetic test.

    The gene responsible for encoding the serotonin transporter (SERT), SLC6A4, located on the chromosome 17q11.1-q12, is the only known gene encoding the serotonin transporter and has a functional polymorphism at the 5'-regulatory promoter region, which results in two forms, long (L) or short (S). The LL-genotype is hypothesized to play a key role in the early onset of alcohol use. The issued patent discloses the differences in treatment and diagnosis based on the LL or SS genotypes as well as on a single nucleotide polymorphism of the SERT gene, the TT genotype of the 3' UTR SNP rs1042173. It relates to the efficacy of using the drug ondansetron (AD04 is ondansetron repurposed at a lower dose than currently approved by the Food and Drug Administration for other indications) based on variations in the polymorphisms of the SERT gene as well as methods for diagnosing susceptibility to abuse of alcohol and other addiction-related diseases and disorders including Opioid Use Disorder.

    "This is our second issued patent covering AD04 for the treatment of Opioid Use Disorder," said William Stilley, CEO of Adial Pharmaceuticals. "Importantly, as with the earlier issued patent, the author of this patent is Adial's Chief Medical Officer, Dr. Bankole Johnson. Adial's patent estate around AD04 is robust; we expect market exclusivity for AD04 through 2032, plus potential Hatch-Waxman extensions through 2037. This new patent reaffirms Adial's capacity to address Opioid Use Disorder if efficacy is demonstrated in clinical trials, which we expect to conduct in parallel with advancement of our landmark ONWARD™ Phase 3 pivotal clinical trial for the treatment of Alcohol Use Disorder."

    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) and is currently being investigated in the Company's landmark ONWARD™ Phase 3 Pivotal 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. www.adialpharma.com

    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 the role the LL-genotype is hypothesized to play in the early onset of alcohol use, market exclusivity for AD04 continuing through 2032, plus potential Hatch-Waxman extensions through 2037, conducting clinical trials in parallel with advancement of our landmark ONWARD™ Phase 3 pivotal clinical trial for the treatment of Alcohol Use Disorder, 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 establish the role the LL-genotype plays in the early onset of alcohol use, our ability to maintain market exclusivity for AD04 through 2032, plus potential Hatch-Waxman extensions through 2037, our ability to conduct clinical trials in parallel with advancement of our landmark ONWARD™ Phase 3 pivotal clinical trial for the treatment of Alcohol Use Disorder, our ability to continue enrollment and mitigate delays during the COVID-19 pandemic, our ability to expand the use of AD04 for use in patients with Opioid Use Disorder, gambling and obesity, the ability of AD04 therapy to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, 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, 2019, 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:

    SOURCE: Adial Pharmaceuticals

    View source version on accesswire.com:
    https://www.accesswire.com/585213/Adial-Pharmaceuticals-Issued-Second-Patent-Covering-AD04-as-a-Treatment-for-Opioid-Use-Disorder

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  42. Landmark Trial Addressing Global Interest in Reducing Alcohol Addiction

    CHARLOTTESVILLE, VA / ACCESSWIRE / April 9, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW)), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today provided an update on its landmark ONWARD™ Phase 3 pivotal trial of its lead drug candidate, AD04, in genetically identified subjects for the treatment of Alcohol Use Disorder (AUD).

    "Adial expects to enroll 294 trial subjects for ONWARD™. To date, 30 trial subjects have been recruited and 8 of these subjects have satisfied trial screening criteria, including our companion genetic test, and patient dosing began in March," commented William Stilley, CEO of Adial Pharmaceuticals…

    Landmark Trial Addressing Global Interest in Reducing Alcohol Addiction

    CHARLOTTESVILLE, VA / ACCESSWIRE / April 9, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW)), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today provided an update on its landmark ONWARD™ Phase 3 pivotal trial of its lead drug candidate, AD04, in genetically identified subjects for the treatment of Alcohol Use Disorder (AUD).

    "Adial expects to enroll 294 trial subjects for ONWARD™. To date, 30 trial subjects have been recruited and 8 of these subjects have satisfied trial screening criteria, including our companion genetic test, and patient dosing began in March," commented William Stilley, CEO of Adial Pharmaceuticals. "ONWARD™ is progressing during the COVID-19 pandemic with certain trial enhancements and modifications to move the trial forward diligently while reducing the potential exposure of trial subjects."

    ONWARD™ has been adapted to incorporate the use of tele-medicine and has reduced in-clinic visits and non-essential procedures:

    • Site initiation visits are now being conducted by video conference, and interim monitoring visits will also be conducted by video conference.
    • The number of in-clinic visits per subject has been reduced from 19 to 8.
    • Five in-clinic visits per subject have been replaced with tele-medicine safety and efficacy assessments and behavioral treatments.
    • The duration of in-clinic visits has been shortened by eliminating non-essential procedures.
    • Changes are not expected to negatively impact ONWARD™ reaching its primary end-points.
    • Adial expects these changes to increase ONWARD™ subject retention rates due to the reduced in-person attendance requirements and to mitigate the placebo effect in the trial due to fewer in-person counseling sessions, both of which would be expected to enhance the statistical strength of the trial.

    Regulatory approvals to commence ONWARD™ have been received for a number of countries. In order to commence the trial in each country, approval must be received by the country's Central Authority (CA) and Ethics Committee (EC). The term "on hold" pertains to COVID-19 regulations or precautions.

    Country

    CA Status

    EC Status

    Notes

    Finland

    Approved

    Approved

    6 sites expected

    • 2 sites activated (1 fully; 1 continuing with current patients but with further recruiting on hold)
    • 4 sites on hold

    Bulgaria

    Approved

    Approved

    6 sites expected

    • 3 sites continuing (2 activated by video conference; 1 pending video conference activation)
    • 3 sites located in hospitals on hold

    Estonia

    Approved

    Approved

    3 sites expected

    • Site initiations on hold

    Latvia

    Approved

    Approved

    3 sites expected

    • Site initiations on hold

    Sweden

    Approved

    Expected

    May 2020

    1 site expected

    • Plan to initiate site by video conference

    Poland

    On Hold

    Approved

    3 sites expected

    • Non-COVID-19 CA reviews temporarily suspended

    Croatia

    On Hold

    Approved

    3 sites expected

    • Non-COVID-19 CA reviews temporarily suspended

    Mr. Stilley concluded, "Even though the COVID-19 related delays are expected to extend the time to receive trial data by several weeks, we are making steady progress, and more than 25% of trial subjects screened to date have been qualified, exceeding our projections. Additionally, our cash burn has been reduced as a result of the changes. We continue to carefully manage our expenses, and remain confident we can complete the ONWARD™ trial without raising additional dilutive financing."

    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) and is currently being investigated in the Company's ONWARD™ Phase 3 Pivotal 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. www.adialpharma.com

    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's plan to enroll 294 trial subjects for ONWARD, the changes increasing subject retention due to by reduced in-person attendance requirements and mitigating the placebo effect due to fewer in-person counseling sessions, both of which would enhance the statistical strength of the trial, COVID-19 related delays extending the time to receive trial data by several weeks, completing the ONWARD™ trial without raising additional dilutive financing, 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 continue enrollment during the COVID-19 pandemic, our ability to increase retention by reduced in-person attendance requirements and mitigate the placebo effect due to fewer in-person counseling sessions, our ability to mitigate COVID-19 related delays extending the time to receive trial data, our ability to enhance the statistical strength of the trial, our ability to complete the ONWARD™ trial without raising additional dilutive financing, our ability to expand the use of AD04 for use in patients with opioid use disorder, gambling and obesity, the ability of AD04 therapy to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, 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, 2019, 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:

    SOURCE: Adial Pharmaceutical, Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/584506/Adial-Pharmaceuticals-Provides-Update-on-ONWARD9TM-Phase-3-Pivotal-Trial

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  43. CHARLOTTESVILLE, VA / ACCESSWIRE / March 26, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL)(NASDAQ:ADILW), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it received an Issue Notification for the issuance of a patent by the United States Patent and Trademark Office (USPTO) for the treatment of Opioid Use Disorder (OUD) with its lead drug candidate, AD04, in people that are positive for select genotypes identified using the Company's propriety companion genetic test.

    The patent is scheduled to issue as U.S. Patent Number 10,603,307 on March 31, 2020. Including the patent term adjustment provided in the Issue Notification, the patent is expected to provide commercial exclusivity…

    CHARLOTTESVILLE, VA / ACCESSWIRE / March 26, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL)(NASDAQ:ADILW), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it received an Issue Notification for the issuance of a patent by the United States Patent and Trademark Office (USPTO) for the treatment of Opioid Use Disorder (OUD) with its lead drug candidate, AD04, in people that are positive for select genotypes identified using the Company's propriety companion genetic test.

    The patent is scheduled to issue as U.S. Patent Number 10,603,307 on March 31, 2020. Including the patent term adjustment provided in the Issue Notification, the patent is expected to provide commercial exclusivity for AD04 until September 2031, plus potential Hatch-Waxman extensions. Claim 1 of the patent provides for a method of treating an OUD, comprising administering to a patient in need thereof a therapeutically effective amount of AD04, wherein the patient is known to have certain genetics related to the serotonin system; AD04's primary mechanism of action is through the blockage of the serotonin-3 receptor.

    "We continue to expand our activities around AD04, which we believe represents a potentially attractive treatment option for patients with OUD, since the physiology and neuro-transmitters involved in opioid addiction are similar to alcohol and could be expected to be modulated by a serotonin-3 receptor antagonist," said William Stilley, Chief Executive Officer of Adial Pharmaceuticals. "Similar to alcohol use disorder, OUD is a massively underserved market. The NIH and CDC report that almost 50,000 people in the U.S. died of opioid overdose in 2017, and the President's Council of Economic Advisors report from 2017 estimates the cost of the opioid epidemic to be more than half a trillion dollars annually in the U.S. alone. Adding this patent to our patent estates continues to enhance and strengthen our patent portfolio around AD04 and is an important milestone since AD04 has the potential to treat a variety of addictive disorders, including OUD. It is also another important step in building Adial into a leading pharmaceutical company focused on treating the terrible affliction of addiction."

    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) and is currently being investigated in the Company's ONWARD Phase 3 pivotal 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. www.adialpharma.com

    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 the new patent providing commercial exclusivity for AD04 until September 2031, plus potential Hatch-Waxman extensions, AD04 representing a potentially attractive treatment option for patients with OUD, the physiology and neuro-transmitters involved in opioid addiction being modulated by a serotonin-3 receptor antagonist 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 maintain commercial exclusivity for AD04 until September 2031, plus potential Hatch-Waxman extensions, the ability of AD04 to become attractive treatment option for patients with OUD, our ability to modulate the physiology and neuro-transmitters involved in opioid addiction with a serotonin-3 receptor antagonist, pour ability to expand the use of AD04 for use in patients with opioid use disorder, gambling and obesity, the ability of AD04 therapy to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, 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, 2019, 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:

    SOURCE: Adial Pharmaceutical, Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/582671/Adial-Pharmaceuticals-Receives-Issue-Notification-for-Patent-Covering-AD04-for-the-Treatment-of-Opioid-Use-Disorder

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  44. CHARLOTTESVILLE, VA / ACCESSWIRE / March 17, 2019 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW)), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that, effective immediately, the Company is modifying its pivotal Phase 3 clinical trial of the Company's lead drug candidate, AD04, for the treatment of alcohol use disorder (AUD) in genetically targeted patients. In order to better protect subjects enrolled in the Phase 3 clinical trial during the COVID-19 pandemic, the Company is in the process of modifying its protocol to reduce the number of in-person visits to clinical sites and replace certain visits with tele-medicine behavioral treatments and assessments. In addition…

    CHARLOTTESVILLE, VA / ACCESSWIRE / March 17, 2019 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW)), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that, effective immediately, the Company is modifying its pivotal Phase 3 clinical trial of the Company's lead drug candidate, AD04, for the treatment of alcohol use disorder (AUD) in genetically targeted patients. In order to better protect subjects enrolled in the Phase 3 clinical trial during the COVID-19 pandemic, the Company is in the process of modifying its protocol to reduce the number of in-person visits to clinical sites and replace certain visits with tele-medicine behavioral treatments and assessments. In addition, the duration of in-person visits is being reduced through the removal of non-essential assessments. European regulators have encouraged sponsors of clinical trials to take action to reduce travel and potential exposure of study subjects and have indicated receptivity to modifications that achieve this end.

    "As always, the safety of our study participants is our first priority, and we believe it is prudent to reduce the potential exposure of participants in the Phase 3 trial of AD04 to COVID-19," stated William Stilley, Chief Executive Officer of Adial Pharmaceuticals. "Our expectation is that the changes being implemented will not affect the quality or outcome of the trial. In fact, we believe the adjustments may increase retention rates due to the in-person visit schedule being less onerous, which may materially benefit the trial by increasing statistical power. It is also our expectation that the modified visit schedule will reduce trial costs since expenses related to in-person visits will be reduced."

    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 therapeutic agent for the treatment of Alcohol Use Disorder (AUD) and is currently being investigated in a 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. www.adialpharma.com

    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 the changes to the protocol better protecting subjects enrolled in the Phase 3 clinical trial, increasing retention rates due to the in-person visit schedule being less onerous, which may materially benefit the trial by increasing statistical power, the modified visit schedule reducing trial costs and the potential of AD04 to treat AUD and 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, the protocol changes having the desired effect of better protecting subjects enrolled in our Phase 3 clinical trial, increasing retention rates, increasing statistical power and reducing trial costs, our ability to commence the Phase 3 clinical trials as expected, the ability to expand the use of AD04 for use in patients with opioid use disorder, gambling and obesity, the ability of AD04 therapy to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, 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, 2018, 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:

    SOURCE: Adial Pharmaceutical, Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/581110/Adial-Pharmaceuticals-Announces-Modifications-to-the-Phase-3-Pivotal-Trial-of-AD04-to-Protect-Subjects-from-COVID-19

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  45. CHARLOTTESVILLE, VA / ACCESSWIRE / February 19, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW)), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it has received approval to commence its Phase 3 study to investigate AD04 as a therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in Bulgaria in persons with certain target genotypes related to the serotonin transporter and receptor genes. This includes receiving approvals from both the Bulgarian Drug Agency and the Bulgarian Ethics Committee for Clinical Trials overseeing the study.

    "Bulgaria is expected be an important country in our Phase 3 trial of AD04 in biomarker-positive study participants," stated…

    CHARLOTTESVILLE, VA / ACCESSWIRE / February 19, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW)), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it has received approval to commence its Phase 3 study to investigate AD04 as a therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in Bulgaria in persons with certain target genotypes related to the serotonin transporter and receptor genes. This includes receiving approvals from both the Bulgarian Drug Agency and the Bulgarian Ethics Committee for Clinical Trials overseeing the study.

    "Bulgaria is expected be an important country in our Phase 3 trial of AD04 in biomarker-positive study participants," stated William Stilley, Chief Executive Officer of Adial Pharmaceuticals. "Approximately one-half of our planned clinical sites are located in Finland and Bulgaria, and we have already opened the trial in Finland. The approval to commence the Phase 3 trial in Bulgaria was received ahead of schedule, which we anticipate will accelerate enrollment and reduce the cost of the trial."

    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 therapeutic agent for the treatment of Alcohol Use Disorder (AUD) and is currently being investigated in a 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. www.adialpharma.com

    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 Bulgaria being an important country in our Phase 3 trial of AD04 in biomarker positive study participants, approximately one-half of our planned clinical sites being located in Finland and Bulgaria, approval to commence the Phase 3 trial in Bulgaria should help accelerate enrollment and reduce the cost of the trial 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 open the Phase 3 trial in Bulgaria and recruit patients in Bulgaria, our ability to deploy our diagnostic genetic test to avoid treating patients for whom we would not expect the drug to be effective, our ability to confirm the results of the Phase 2b trial in the Phase 3 pivotal studies, our ability to rapidly enroll the study and develop a protocol that can be successfully conducted, the ability to obtain approvals in additional countries, the ability to expand the use of AD04 for use in patients with opioid use disorder, gambling and obesity, the ability of AD04 therapy to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, 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, 2018, 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:

    SOURCE: Adial Pharmaceutical, Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/576969/Adial-Pharmaceuticals-Receives-Approval-to-Commence-Phase-3-Trial-in-Bulgaria

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  46. CHARLOTTESVILLE, VA / ACCESSWIRE / February 14, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW)), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, is pleased to announce that the Company's CEO, William Stilley, has been selected as a luncheon keynote speaker for the 2020 Wall Street Conference and Retreat to be held in West Palm Beach, Florida on February 19-20. The Company recently announced it has commenced a Phase 3 pivotal clinical trial to investigate AD04 as a genetically targeted therapeutic agent for the treatment of Alcohol Use Disorder (AUD). Mr. Stilley plans to provide an update on the Company's upcoming clinical activities and other developments.

    The 2020 Wall Street Conference…

    CHARLOTTESVILLE, VA / ACCESSWIRE / February 14, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW)), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, is pleased to announce that the Company's CEO, William Stilley, has been selected as a luncheon keynote speaker for the 2020 Wall Street Conference and Retreat to be held in West Palm Beach, Florida on February 19-20. The Company recently announced it has commenced a Phase 3 pivotal clinical trial to investigate AD04 as a genetically targeted therapeutic agent for the treatment of Alcohol Use Disorder (AUD). Mr. Stilley plans to provide an update on the Company's upcoming clinical activities and other developments.

    The 2020 Wall Street Conference and Retreat is an exclusive, invitation only, event attended by money managers, brokers, funds, and family offices to learn about opportunities to invest in selected early-stage growth companies from high-profile sectors on Wall Street, including pharmaceutical and healthcare.

    "With the initiation of our Phase 3 trial, we believe we have the only investigational drug for the treatment of alcohol addiction with pivotal trials underway and, given our recent progress, we are more confident than ever in the potential of AD04 for patients around the world," stated William Stilley, Chief Executive Officer of Adial. "Our selection as a keynote speaker at this highly regarded event is an honor, and we look forward to providing an update on our strategy and plans going forward."

    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 therapeutic agent for the treatment of Alcohol Use Disorder (AUD) and is currently being investigated in a Phase 3 clinical 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. www.adialpharma.com

    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 plans to provide an update on our upcoming clinical activities and other developments, having the only investigational drug for the treatment of alcohol addiction with pivotal trials underway, the potential of AD04 for patients around the world . 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 identify patients expected to respond to the drug, to deliver response rates and improve the efficacy rates both in the trial and commercially, our ability to deploy our diagnostic genetic test to avoid treating patients for whom we would not expect the drug to be effective, saving time and cost and leading to reimbursement at premium pricing for both the drug and our proprietary companion diagnostic genetic test, our ability to confirm the prevalence of the people with the genetic biomarkers for treatment with AD04 being of higher prevalence in Scandinavia and Eastern Europe, our ability to confirm the results of the Phase 2b trial in the Phase 3 pivotal studies, our ability to rapidly enroll the study and develop a protocol that can be successfully conducted, the ability to obtain approvals in additional countries and open twenty-four sites in seven countries, the ability to expand the use of AD04 for use in patients with opioid use disorder, gambling and obesity, the ability of AD04 therapy to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, 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, 2018, 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:

    SOURCE: Adial Pharmaceuticals, Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/576487/Adial-Pharmaceuticals-CEO-Selected-as-a-Luncheon-Keynote-Speaker-for-the-2020-Wall-Street-Conference-and-Retreat

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  47. CHARLOTTESVILLE, VA / ACCESSWIRE / January 9, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW)), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it has received favorable opinions from the Finnish Medicines Agency (FIMEA) and National Committee on Medical Research Ethics (TUKIJA) to commence its Phase 3 study to investigate AD04 as a genetically targeted therapeutic agent for the treatment of Alcohol Use Disorder (AUD).

    "Finland is the first of seven European countries in which we plan to open clinical sites as we conduct our AD04 Phase 3 trial in AUD subjects with certain target genotypes related to the serotonin transporter and receptor genes, which appeared to…

    CHARLOTTESVILLE, VA / ACCESSWIRE / January 9, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW)), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it has received favorable opinions from the Finnish Medicines Agency (FIMEA) and National Committee on Medical Research Ethics (TUKIJA) to commence its Phase 3 study to investigate AD04 as a genetically targeted therapeutic agent for the treatment of Alcohol Use Disorder (AUD).

    "Finland is the first of seven European countries in which we plan to open clinical sites as we conduct our AD04 Phase 3 trial in AUD subjects with certain target genotypes related to the serotonin transporter and receptor genes, which appeared to correlate to response to treatment with AD04 in the Phase 2b clinical trial," commented Monika Rogozinska, Chief Development Officer of Adial Pharmaceuticals. "We will be running our multicenter and multinational clinical study under the guidance of Professor Hannu E.R. Alho, Emeritus Professor of Addiction Medicine at the University of Helsinki, Finland, who is serving in a dual role as a Coordinating Principal Investigator and National Coordinator for the trial."

    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 therapeutic agent for the treatment of Alcohol Use Disorder (AUD). 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). The Company plans to commence a Phase 3 clinical trial using AD04 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. AD04 is also believed to have the potential to treat other addictive disorders such as opioid use disorder, gambling, and obesity. www.adialpharma.com

    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 Finland being the first of seven European countries in which we plan to open clinical sites , running our multicenter and multinational clinical study under the guidance of Professor Hannu E.R. Alho, Emeritus Professor of Addiction Medicine at the University of Helsinki, Finland, Adial's planned Phase 3 trial of AD04 for the treatment of AUD in genetically targeted patients and the potential of AD04 to treat AUD and 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 commence the Phase 3 clinical trials as expected in the countries anticipated, the ability to expand the use of AD04 for use in patients with opioid use disorder, gambling and obesity, the ability of AD04 therapy to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, 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, 2018, 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: r.com

    SOURCE: Adial Pharmaceutical, Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/572572/Adial-Pharmaceuticals-Receives-Approval-to-Commence-Phase-3-Trial-in-Finland

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  48. CHARLOTTESVILLE, VA / ACCESSWIRE / December 19, 2019 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW)), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it has submitted Clinical Trial Applications (CTAs) to commence its first Phase 3 trial in Finland, Estonia, Latvia, Poland, Bulgaria, and Croatia. This follows the Company's recent filing of a CTA to also commence its first Phase 3 trial in Sweden, as previously announced. In total, twenty-six clinical sites in these countries are expected to initially participate in the trial, subject to approval by each country's regulatory authority and ethics committee. The planned Phase 3 trial will test AD04 as a genetically-targeted…

    CHARLOTTESVILLE, VA / ACCESSWIRE / December 19, 2019 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW)), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it has submitted Clinical Trial Applications (CTAs) to commence its first Phase 3 trial in Finland, Estonia, Latvia, Poland, Bulgaria, and Croatia. This follows the Company's recent filing of a CTA to also commence its first Phase 3 trial in Sweden, as previously announced. In total, twenty-six clinical sites in these countries are expected to initially participate in the trial, subject to approval by each country's regulatory authority and ethics committee. The planned Phase 3 trial will test AD04 as a genetically-targeted therapeutic agent for the treatment of Alcohol Use Disorder (AUD).

    "Our Phase 3 trial is designed to enroll subjects with selected polymorphisms in the serotonin transporter and receptor genes that are expected to predict those likely to respond to AD04 and to exclude potential subjects that do not have the relevant genetic biomarkers," commented William Stilley, CEO of Adial Pharmaceuticals. "As previously reported, we estimate that the prevalence of people with the targeted genetic biomarkers is about 33% in the United States and greater than 50% in Scandinavia and certain areas of Central and Eastern Europe. The higher expected prevalence of people with the genetic biomarkers in the participating countries should result in faster enrollment and completion as well as reduced trial costs."

    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 therapeutic agent for the treatment of Alcohol Use Disorder (AUD). 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). The Company plans to commence a Phase 3 clinical trial using AD04 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. AD04 is also believed to have the potential to treat other addictive disorders such as opioid use disorder, gambling, and obesity. www.adialpharma.com

    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 commencing our Phase 3 trial in Finland, Sweden, Estonia, Latvia, Poland, Bulgaria, and Croatia with twenty-six clinical sites being expected to initially participate in the study, the prevalence of the targeted genotype for AD04 being much higher in Scandinavia and certain parts of Central and Eastern Europe resulting in faster enrollment and completion of the trial, as well as reduced study costs, the potential of AD04 to treat AUD and 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, the ability to commence the Phase 3 clinical trials as expected in Europe, the ability to achieve faster enrollment and completion of the trial, as well as reduced study costs based on the prevalence of the targeted genotype for AD04 being much higher in Scandinavia and certain parts of Central and Eastern Europe, the ability to capitalize on the market opportunity for AUD, the ability to expand the use of AD04 for use in patients with opioid use disorder, gambling and obesity, the ability of AD04 therapy to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, 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, 2018, 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:

    SOURCE: Adial Pharmaceuticals, Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/570773/Adial-Pharmaceuticals-Submits-Clinical-Trial-Applications-in-Six-Additional-European-Countries

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  49. CHARLOTTESVILLE, VA / ACCESSWIRE / December 16, 2019 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW)), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it has received a Notice of Allowance for the issuance of a patent by the United States Patent and Trademark Office (USPTO), titled: "Serotonin Transporter Gene and Treatment of Alcoholism." This patent addresses a method of treating alcohol use disorder (AUD) in patients with a specific genetic biomarker in the serotonin transporter gene by administering the Company's investigational new drug product, AD04, a 5-HT3 antagonist, to patients with the TT genotype. This patent builds upon a previous Company patent for patients…

    CHARLOTTESVILLE, VA / ACCESSWIRE / December 16, 2019 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW)), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it has received a Notice of Allowance for the issuance of a patent by the United States Patent and Trademark Office (USPTO), titled: "Serotonin Transporter Gene and Treatment of Alcoholism." This patent addresses a method of treating alcohol use disorder (AUD) in patients with a specific genetic biomarker in the serotonin transporter gene by administering the Company's investigational new drug product, AD04, a 5-HT3 antagonist, to patients with the TT genotype. This patent builds upon a previous Company patent for patients with the LL/TT genotype.

    The genetic biomarker is part of the genetic panel used to identify patients expected to respond to treatment with AD04. As previously announced, Adial recently completed the validation of its proprietary genetic test through its partnership with Eurofins Biopharma Services. This test will be used to identify potential subjects for inclusion in the planned Phase 3 trial of AD04 as a treatment for AUD in biomarker positive subjects.

    William Stilley, Chief Executive Officer of Adial Pharmaceuticals, commented, "We continue to aggressively build our patent estate around AD04. This is the second Notice of Allowance by the USPTO in the same patent family targeting patients with specific biomarkers in the serotonin transporter gene. This marks another important milestone as we progress towards commencing our Phase 3 trial of AD04. By targeting specific genotypes, we believe that we have uniquely positioned AD04 as a potential best-in-class therapy for the treatment of alcohol use disorder, and our patent strategy is to develop the broadest patent protection possible by filing multiple patents within the same patent domain to make it more difficult for potential future competitors."

    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 therapeutic agent for the treatment of Alcohol Use Disorder (AUD). 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). The Company plans to commence a Phase 3 clinical trial using AD04 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. AD04 is also believed to have the potential to treat other addictive disorders such as opioid use disorder, gambling, and obesity. www.adialpharma.com

    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 the use of the test to identify potential subjects for inclusion in the planned Phase 3 trial of AD04 as a treatment for AUD in biomarker positive subjects, the targeting of specific genotypes, uniquely positioning AD04 as a potential best-in-class therapy for the treatment of alcohol use disorder and the potential of AD04 to treat AUD and 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 commence the Phase 3 clinical trials as expected, the ability to expand the use of AD04 for use in patients with opioid use disorder, gambling and obesity, the ability of AD04 therapy to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, 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, our ability to implement our patent strategy and continue the 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, 2018, 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:

    SOURCE: Adial Pharmaceutical, Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/570351/Adial-Pharmaceuticals-Receives-Notice-of-Allowance-of-Additional-Patent-for-the-Treatment-of-Alcohol-Use-Disorder-with-AD04-in-Patients-Identified-Using-a-Molecular-Genetic-Biomarker

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  50. Reports regulatory progress in Europe and imminent commencement of clinical trial

    CHARLOTTESVILLE, VA / ACCESSWIRE / December 13, 2019 / Adial Pharmaceuticals, Inc. ("Adial") (NASDAQ:ADIL, ADILW)), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it has completed validation of its genetic biomarker test for its planned Phase 3 trial. The Phase 3 trial is designed to study AD04, a genetically targeted therapeutic agent for the treatment of Alcohol Use Disorder.

    Eurofins Genomics ("Eurofins"), a division of Eurofins Biopharma Services, a global scientific leader in bioanalytical testing, performed the laboratory validation of Adial's companion diagnostic genetic test using…

    Reports regulatory progress in Europe and imminent commencement of clinical trial

    CHARLOTTESVILLE, VA / ACCESSWIRE / December 13, 2019 / Adial Pharmaceuticals, Inc. ("Adial") (NASDAQ:ADIL, ADILW)), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it has completed validation of its genetic biomarker test for its planned Phase 3 trial. The Phase 3 trial is designed to study AD04, a genetically targeted therapeutic agent for the treatment of Alcohol Use Disorder.

    Eurofins Genomics ("Eurofins"), a division of Eurofins Biopharma Services, a global scientific leader in bioanalytical testing, performed the laboratory validation of Adial's companion diagnostic genetic test using double strand Sanger sequencing and Fragment length analysis of polymerase chain reaction (PCR) products. These assays will be used for the analysis of patients' blood samples for genetic variants in defined genes caused by Single Nucleotide Polymorphisms or Fragment Length Polymorphisms. The acceptability of the assay validation will be evaluated further by the local ethics committees and regulatory authorities during the clinical trial application (CTA) assessments.

    William Stilley, Chief Executive Officer of Adial Pharmaceuticals, commented, "Completion of the genetic test validation is a key milestone as we finalize preparations for our planned Phase 3 trial. By genetically pre-screening subjects prior to enrollment, our companion diagnostic genetic test allows us to only enroll those patients that have the genetic biomarkers indicating that they are expected to respond to AD04. We believe this approach will enhance the efficacy rates of AD04 in the trial and reduce the time and costs associated with conducting the trial. At the same time, we are making progress towards finalizing the necessary regulatory approvals in Europe and look forward to providing near-term updates on commencement of our Phase 3 clinical trial."

    Elena Logan, Senior VP, Eurofins Biopharma Services, noted, "The genetic test met or exceeded all the necessary criteria for use in the upcoming Phase 3 trial. Adial is at the forefront of precision medicine, developing a personalized approach using a genetic companion diagnostic test to identify patients likely to respond to treatment. We are delighted to support Adial in this important mission to advance AD04 as an attractive potential therapy addressing a significant unmet need among patients with Alcohol Use Disorder."

    About Eurofins Scientific

    Eurofins Scientific through its subsidiaries (hereinafter sometimes "Eurofins" or "the Group") believes it is a scientific leader in food, environment, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and for supporting clinical studies. With about 45,000 staff in more than 800 laboratories across 47 countries, Eurofins offers a portfolio of over 200,000 analytical methods for evaluating the safety, identity, composition, authenticity, origin and purity of biological substances and products, as well as for innovative clinical diagnostics. The Group objective is to provide its customers with high-quality services, accurate results on time and expert advice by its highly qualified staff.

    About Eurofins BioPharma Services

    Reliable, high quality laboratory data is pivotal to the success of clinical trials. Since laboratory testing is our sole focus, we go above and beyond to provide an array of services to ensure that any clinical trial sample is collected, transported, managed, analyzed, reported and stored to meet the objectives and purpose of your study. We are dedicated to providing the most cost effective and efficient solutions to pharmaceutical, biotech companies and CROs alike.

    Eurofins BioPharma Services supports our customers with Central Laboratory (U.S., Netherlands, Singapore, China), Large and Small Bioanalytical (U.S., U.K., France), Phase 1/Early Development (France) and Immunology/Virology (U.S.) specialization laboratories globally. This provides our client base with true end-to-end laboratory solutions for your entire clinical phase development activity.

    https://eurofinscentrallaboratory.com/biopharma-services

    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 therapeutic agent for the treatment of Alcohol Use Disorder (AUD). 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). The Company plans to commence a Phase 3 clinical trial using AD04 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. AD04 is also believed to have the potential to treat other addictive disorders such as opioid use disorder, gambling, and obesity. www.adialpharma.com

    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 plans to commence a Phase 3 clinical trial using AD04 for the potential treatment of AUD in subjects with certain target genotypes, genetically pre-screening subjects prior to enrollment allowing us to enhance the efficacy rates of AD04 in the trial and reducing the time and costs associated with conducting the trial, and the potential of AD04 to treat AUD 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 commence the Phase 3 clinical trials and enroll subjects as expected, our ability to enhance the efficacy rates of AD04 in the trial and reduce the time and costs associated with conducting the trial, our ability to expand the use of AD04 for use in patients with opioid use disorder, gambling and obesity, the ability of AD04 therapy to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, 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, 2018, 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:

    SOURCE: Adial Pharmaceutical, Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/570161/Adial-Completes-Validation-of-Genetic-Biomarker-Test-in-Collaboration-with-Eurofins-for-Upcoming-Phase-3-Trial

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  51. CHARLOTTESVILLE, VA / ACCESSWIRE / October 7, 2019 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW)) www.adialpharma.com, a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that Mark Howard Peikin, Esq., Chief Executive Officer of Bespoke Growth Partners (Bespoke), and a former General Partner of Aelius Healthcare Innovations Fund and partner within the corporate and securities group at the international law firm Brown Rudnick, was appointed as Chief Strategy Officer and Vice President of Corporate Communications. As Adial conducts its European Phase 3 clinical trial of AD04 for the treatment of Alcohol Use Disorder (AUD), which trial will study subjects for 24-weeks with 290…

    CHARLOTTESVILLE, VA / ACCESSWIRE / October 7, 2019 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW)) www.adialpharma.com, a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that Mark Howard Peikin, Esq., Chief Executive Officer of Bespoke Growth Partners (Bespoke), and a former General Partner of Aelius Healthcare Innovations Fund and partner within the corporate and securities group at the international law firm Brown Rudnick, was appointed as Chief Strategy Officer and Vice President of Corporate Communications. As Adial conducts its European Phase 3 clinical trial of AD04 for the treatment of Alcohol Use Disorder (AUD), which trial will study subjects for 24-weeks with 290 subjects projected to be enrolled in approximately 30 clinical sites in 7 European countries, Mr. Peikin will help oversee Adial's discussions with pharmaceutical companies, as well as strategic and institutional investors. The clinical trial itself will be managed by Crown CRO of Finland in conjunction with Company management.

    For the past 10 years, as CEO of Bespoke, Mr. Peikin has successfully advised healthcare, biotechnology and pharmaceutical companies regarding business strategy, mergers and acquisitions, and fundamental investments. Mr. Peikin previously co-founded and co-managed Aelius Healthcare Innovations Fund, an equity fund focused on investment in private healthcare technology businesses serving the pharmaceutical industry. Aelius was sold in 2016 to Ridgetop Health. Mr. Peikin brings relationships with many of the leading healthcare funds, as well as premier hospital organizations and academic institutions.

    Commenting on the appointment, William Stilley, CEO of Adial Pharmaceuticals, stated, "We are moving to advance our Phase 3 clinical trial of AD04. Just last week, we filed our Clinical Trial Application (CTA) in Sweden and we plan to file similar applications in 6 additional European countries in the coming weeks. We are honored that Mr. Peikin, whose company has been instrumental in advising Adial with respect to its business strategy, has agreed to accept the role of Chief Strategy Officer and Vice President of Corporate Communications. The timing is ideal in that Adial is moving forward with its Phase 3 study and we expect to begin dosing study subjects in the next few months. We look forward to leveraging Mr. Peikin's expertise, relationships and knowledge as we seek to aggressively increase awareness of Adial within both the pharmaceutical industry and the investment community."

    "We believe Adial's commencement of its Phase 3 trial is a transformative event and an important step towards our goal of having AD04 approved for the treatment of AUD, first in Europe and then in the United States," said Mr. Peikin. "As the trial progresses, given Adial's unique position in the market with AD04 as a Phase 3 asset targeting a specific but prevalent genotype of patients with AUD, we expect pharmaceutical companies and investment managers to closely monitor our progress. We are confident in our innovative approach to target a therapeutic agent in patients with AUD, and along with the rest of the Adial management team, I will be advancing our market-driven strategy as our drug development team works towards the approval of effective treatments. I am honored to be involved with Adial and I would like to thank our CEO, William Stilley, and the entire Adial Board for the confidence they have placed in me."

    "It is notable that Mr. Peikin has agreed to take this important position without salary," added Mr. Stilley. "Rather, Mr. Peikin has initially been awarded stock options that vest over 3 years and give him the right to purchase up to 225,000 shares of the Company's common stock. Of this amount,75,000 options will have an exercise price of $2.00 per share; 75,000 will have an exercise price of $3.00 per share; and 75,000 will have an exercise price of $4.00 per share. Given Mr. Peikin's vast experience, we are appreciative of his willingness to join Adial under this arrangement, which we believe is a clear vote of confidence in the future of our Company."

    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 candidate, AD04, is a genetically targeted therapeutic agent for the treatment of alcohol use disorder (AUD). 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). The Company plans to commence a Phase 3 clinical trial using AD04 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. AD04 is also believed to have the potential to treat other addictive disorders, such as opioid use disorder, gambling, and obesity.

    About Alcohol Use Disorder

    According to an article in the widely respected publication The Lancet, alcohol is the number one cause of death globally among both men and women ages 15 to 49 years. In the United States alone, approximately 35 million people have AUD resulting in significant health, social and financial costs (NIAAA Alcohol Facts & Statistics). AUD contributes to over 200 different diseases, and 10% of children live with a person that has an alcohol problem. According to the American Society of Clinical Oncologists, 5-6% of new cancers and cancer deaths globally are directly attributable to alcohol. The Centers for Disease Control (CDC) has reported that AUD costs the U.S. economy about $250 billion annually, with heavy drinking accounting for greater than 75% of the social and health related costs. In addition, according to the NIAAA, the problem in the United States appears to be growing with an approximately 50% increase in AUD prevalence between 2002 and 2013.

    Despite the high prevalence and high costs, according to an article in the JAMA 2015 publication, only 7.7% of patients (i.e., approximately 2.7 million people) with AUD are estimated to have been treated in any way and only 3.6% by a physician (i.e., approximately 1.3 million people). The most common treatments for AUD are directed at achieving abstinence, and typical treatments include psychological and social interventions. Most therapies require abstinence even prior to initiating therapy. Abstinence requires dramatic lifestyle changes often with serious work and social consequences. Significant side effects of current pharmacologic therapies include mental side effects, such as psychiatric disorders and depressive symptoms and physical side effects, such as nausea, dizziness, vomiting, abdominal pain, arthritis and joint fitness. These problems with the currently available therapies appear to limit the willingness of people with AUD to seek treatment and then to limit compliance with treatment requirements and, therefore, the ultimate results for many people attempting currently available therapies.

    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. These statements are based upon current beliefs, expectations and assumptions and include statements regarding commencing the Phase 3 clinical trials, the plan to file applications in 6 additional European countries in the coming weeks, the dosing of study subject within the next few months, leveraging Mr. Peikin's expertise, relationships and knowledge as the Company seeks to aggressively increase awareness of the Company within both the pharmaceutical industry and the investment community, the Company's commencement of its Phase 3 trial being a transformative event and an important step towards the Company's goal of having AD04 approved for the treatment of AUD, first in Europe and then in the United States, the monitoring of the Company's progress by pharmaceutical companies and investment managers, the expected benefit AD04 will bring to patients and Mr. Peikin's expected contribution to the Company and confidence in the future of the Company. Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, our ability to advance the Phase 3 clinical trials, the ability of AD04 therapy to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, the contribution of Mr. Peikin to advance our business objectives, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, 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 our filings 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:

    SOURCE: Adial Pharmaceutical, Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/562237/Adial-Pharmaceuticals-Announces-Mark-Howard-Peikin-Esq-as-Chief-Strategy-Officer-and-VP-of-Corporate-Communications-as-Adial-Advances-Phase-3-Clinical-Trial-of-AD04-for-the-Treatment-of-Alcohol-Use-Disorder

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  52. CHARLOTTESVILLE, VA / ACCESSWIRE / September 25, 2019 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW)), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today provided an update on its clinical activities. The Company reported that it is on track to complete its Clinical Trial Application (CTA) filing to commence the Phase 3 clinical trial of the Company's lead drug candidate, AD04, (the "Phase 3 Trial" or the "Trial") for the treatment of alcohol use disorder (AUD) in genetically targeted patients, on or before September 30, 2019.

    The Phase 3 Trial is expected to enroll 290 subjects across approximately 30 selected clinical sites in Sweden, Finland, Estonia, Latvia, Poland, Bulgaria and Croatia…

    CHARLOTTESVILLE, VA / ACCESSWIRE / September 25, 2019 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW)), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today provided an update on its clinical activities. The Company reported that it is on track to complete its Clinical Trial Application (CTA) filing to commence the Phase 3 clinical trial of the Company's lead drug candidate, AD04, (the "Phase 3 Trial" or the "Trial") for the treatment of alcohol use disorder (AUD) in genetically targeted patients, on or before September 30, 2019.

    The Phase 3 Trial is expected to enroll 290 subjects across approximately 30 selected clinical sites in Sweden, Finland, Estonia, Latvia, Poland, Bulgaria and Croatia. The Trial is a double-blind placebo-controlled trial with the primary objective to evaluate the efficacy of AD04 to reduce alcohol consumption in subjects with AUD that are positive for certain genetic biomarkers.

    A number of key steps, some of which have been previously announced, have been accomplished, including: (a) Crown CRO based in Finland, which has extensive experience in the European markets where the Phase 3 Trial will be conducted, has been selected to manage the Phase 3 Trial; (b) Professor Hannu E.R. Alho, Emeritus Professor of Addiction Medicine at the University of Helsinki, Finland was appointed as Coordinating Principal Investigator; (c) clinical trial material has been delivered to Catalent (Germany), and is in the process of final packaging for use in the Trial; and (d) tablets and blister packaging have been tested to demonstrate long-term stability (5-year shelf life), which is expected to allow for use in the Trial. Additional information on the planned Phase 3 trial can now be found on ClinicalTrials.gov.

    "Commencing a multinational, multicenter Phase 3 Trial is a complex undertaking, and we are pleased to report that we have completed most of the necessary steps, including selection of our CRO and principal investigator, site selection, testing of product materials and much more," stated Monika Rogozinska, Chief Development Officer of Adial Pharmaceuticals. "We look forward to commencing enrollment in the trial, which we believe will further demonstrate the safety and efficacy of AD04 as a treatment for AUD."

    "I want to thank the entire Adial team for the incredible effort that has gone into making all of our accomplishments to date possible," commented William Stilley, Chief Executive Officer of Adial Pharmaceuticals. "In particular, I want to thank Monika Rogozinska for her strong leadership. Her past experience with European Phase 3 clinical trials, including leading the team that took Bavencio® to approval, has been invaluable in helping advance the AD04 program. I would also like to thank our esteemed Scientific Advisory Board for their active involvement in this project. We look forward to reporting a number of key progress updates in the weeks and months ahead."

    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 therapeutic agent for the treatment of Alcohol Use Disorder (AUD). 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). The Company plans to commence a Phase 3 clinical trial using AD04 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. AD04 is also believed to have the potential to treat other addictive disorders such as opioid use disorder, gambling, and obesity. www.adialpharma.com

    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 that the CTA will be filed on or before September 30, 2019, the tablets and blister packaging of clinical trial material that we previously produced being be usable in our Phase 3 clinical trial of AD04 for AUD and the trial demonstrating the safety and efficacy of AD04 as a treatment for AUD, plans to commence a Phase 3 clinical trial using AD04 for the potential treatment of AUD in subjects with certain target genotypes and the potential of AD04 to treat AUD 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 commence the Phase 3 clinical trials as expected, the ability to expand the use of AD04 for use in patients with opioid use disorder, gambling and obesity, the ability of AD04 therapy to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, 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, 2018, 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:

    SOURCE: Adial Pharmaceutical, Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/560981/Adial-Provides-Update-on-Clinical-Activities-Filing-to-Commence-Phase-3-Trial-on-Track-for-Q3-2019

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  53. CHARLOTTESVILLE, VA / ACCESSWIRE / September 11, 2019 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL) (NASDAQ:ADILW), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that its previously manufactured supply of clinical trial material (CTM), consisting of blister packaged tablets of AD04, was successfully retested. All criteria, including, without limitation, identity testing, content uniformity, assay, impurities, microbial limits, and other tests showed the clinical trial materials have passed review and are within the pre-specified acceptable limits for use in clinical trials. The CTM is intended to be used in the upcoming Phase 3 clinical trial of AD04 as a treatment for alcohol…

    CHARLOTTESVILLE, VA / ACCESSWIRE / September 11, 2019 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL) (NASDAQ:ADILW), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that its previously manufactured supply of clinical trial material (CTM), consisting of blister packaged tablets of AD04, was successfully retested. All criteria, including, without limitation, identity testing, content uniformity, assay, impurities, microbial limits, and other tests showed the clinical trial materials have passed review and are within the pre-specified acceptable limits for use in clinical trials. The CTM is intended to be used in the upcoming Phase 3 clinical trial of AD04 as a treatment for alcohol use disorder (AUD) in genetically targeted patients.

    William Stilley, CEO of Adial Pharmaceuticals, stated, "We are approaching the start of our Phase 3 trial and are pleased to have completed this important step. Due to the successful retesting, we believe the approximately 52,000 blister packs of clinical trial material that we previously produced will be usable in our Phase 3 clinical trial of AD04 for AUD in biomarker positive patients. Importantly, we have already shipped drug product to Europe for the trial and it is in process for final packaging and labeling. Additionally, the retest data indicated that we have a very stable drug product that will likely achieve a commercial shelf life of five years when we take AD04 to market, assuming regulatory approval."

    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 therapeutic agent for the treatment of Alcohol Use Disorder (AUD). 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). The Company plans to commence a Phase 3 clinical trial using AD04 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. AD04 is also believed to have the potential to treat other addictive disorders such as opioid use disorder, gambling, and obesity. www.adialpharma.com

    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 that the CTM is intended to be used in the upcoming Phase 3 clinical trial of AD04 as a treatment for alcohol use disorder (AUD) in genetically targeted patients, the approximately 52,000 blister packs of clinical trial material that we previously produced will be usable in our Phase 3 clinical trial of AD04 for AUD in biomarker positive patients, the drug product will likely achieve a commercial shelf life of five years when we take AD04 to market, assuming regulatory approval plans to commence a Phase 3 clinical trial using AD04 for the potential treatment of AUD in subjects with certain target genotypes and the potential of AD04 to treat AUD and 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 commence the Phase 3 clinical trials as expected, the ability to expand the use of AD04 for use in patients with opioid use disorder, gambling and obesity, the ability of AD04 therapy to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, 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, 2018, 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:

    SOURCE: Adial Pharmaceutical, Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/559245/Adial-Pharmaceuticals-Announces-Successful-Product-Retesting-of-AD04-for-Phase-3-Clinical-Trial

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  54. Application for pediatric investigation plan waiver validated by European Medicines Agency

    CHARLOTTESVILLE, VA / ACCESSWIRE / September 5, 2019 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW)), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that the European Medicines Agency (EMA) has validated the Pediatric Investigation Plan (PIP) waiver application for AD04, the Company's lead investigational new drug product for the treatment of Alcohol Use Disorder (AUD).

    William Stilley, CEO of Adial Pharmaceuticals, stated, "We are pleased have our PIP waiver application validated by the European Medicines Agency, as it completes another important step in the process to advance AD04…

    Application for pediatric investigation plan waiver validated by European Medicines Agency

    CHARLOTTESVILLE, VA / ACCESSWIRE / September 5, 2019 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW)), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that the European Medicines Agency (EMA) has validated the Pediatric Investigation Plan (PIP) waiver application for AD04, the Company's lead investigational new drug product for the treatment of Alcohol Use Disorder (AUD).

    William Stilley, CEO of Adial Pharmaceuticals, stated, "We are pleased have our PIP waiver application validated by the European Medicines Agency, as it completes another important step in the process to advance AD04 and apply for marketing approval in Europe. AD04 is designed to reduce cravings for alcohol in subjects with certain target genotypes, without the requirement of abstinence prior to or during treatment. A Phase 2b clinical trial of our drug candidate showed promising results and we are making progress toward the start of our Phase 3 clinical trial."

    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 therapeutic agent for the treatment of Alcohol Use Disorder (AUD). 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). The Company plans to commence a Phase 3 clinical trial using AD04 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. AD04 is also believed to have the potential to treat other addictive disorders such as opioid use disorder, gambling, and obesity. www.adialpharma.com.

    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 plans to commence the first Phase 3 trial of AD04 and the potential of AD04 to treat AUD and 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 commence the Phase 3 clinical trials as expected, the ability to expand the use of AD04 for use in patients with other addictive disorders such as opioid use disorder, gambling, and obesity, the ability of AD04 therapy to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, 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, 2018, our subsequent quarterly reports on Form 10-Q and our other 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:

    SOURCE: Adial Pharmaceuticals, Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/558568/Adial-Pharmaceuticals-Completes-Key-Regulatory-Milestone-Prior-to-Commencing-European-Phase-3-Clinical-Trial-of-AD04-for-the-Treatment-of-Alcohol-Use-Disorder

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