ADIL Adial Pharmaceuticals Inc

1.97
-0.02  -1%
Previous Close 1.99
Open 1.97
52 Week Low 1
52 Week High 4
Market Cap $28,354,407
Shares 14,393,100
Float 11,606,333
Enterprise Value $21,277,115
Volume 356,400
Av. Daily Volume 3,208,469
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
AD04
Alcohol use disorder
Phase 3
Phase 3
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.

Latest News

  1. 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

    View Full Article Hide Full Article
  2. 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

    View Full Article Hide Full Article
  3. 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

    View Full Article Hide Full Article
  4. 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

    View Full Article Hide Full Article
  5. 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

    View Full Article Hide Full Article
View All Adial Pharmaceuticals Inc News