ADIL Adial Pharmaceuticals Inc

1.38
-0.04  -3%
Previous Close 1.42
Open 1.42
52 Week Low 1
52 Week High 3.17
Market Cap $18,560,452
Shares 13,449,603
Float 10,581,312
Enterprise Value $14,146,805
Volume 384,945
Av. Daily Volume 506,495
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AD04
Alcohol use disorder
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Latest News

  1. 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

    View Full Article Hide Full Article
  2. 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

    View Full Article Hide Full Article
  3. 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

    View Full Article Hide Full Article
  4. 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

    View Full Article Hide Full Article
  5. 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.



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