CRDL Cardiol Therapeutics Inc.

1.82
-0.16  -8%
Previous Close 1.98
Open 1.94
52 Week Low 1.55
52 Week High 4.96
Market Cap $107,919,801
Shares 61,922,999
Float 59,296,594
Enterprise Value $74,994,086
Volume 376,327
Av. Daily Volume 580,064
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Drug Pipeline

Drug Stage Notes
CardiolRx - LANCER
Cardiovascular disease (CVD) in COVID-19 pateints
Phase 2/3
Phase 2/3
Enrollment expanded to Brazil, Mexico, and Canada, noted October 18, 2021.
CardiolRx
Myocarditis
Phase 2
Phase 2
Phase 2 FDA clearance of IND August 24, 2021.

Latest News

  1. Oakville, Ontario--(Newsfile Corp. - January 19, 2022) - Cardiol Therapeutics Inc. (NASDAQ:CRDL) (TSX:CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory therapies for the treatment of cardiovascular disease, today announced the appointment of Paul M. Ridker, MD, MPH, Bruce McManus, PhD, MD, and Joseph A. Hill, MD, PhD, to its Scientific Advisory Board (SAB).

    "We are pleased to welcome distinguished thought leaders in cardiovascular medicine to our Scientific Advisory Board," said David Elsley, President and Chief Executive Officer of Cardiol Therapeutics. "Their expertise in cardiovascular research will provide invaluable guidance to our research and…

    Oakville, Ontario--(Newsfile Corp. - January 19, 2022) - Cardiol Therapeutics Inc. (NASDAQ:CRDL) (TSX:CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory therapies for the treatment of cardiovascular disease, today announced the appointment of Paul M. Ridker, MD, MPH, Bruce McManus, PhD, MD, and Joseph A. Hill, MD, PhD, to its Scientific Advisory Board (SAB).

    "We are pleased to welcome distinguished thought leaders in cardiovascular medicine to our Scientific Advisory Board," said David Elsley, President and Chief Executive Officer of Cardiol Therapeutics. "Their expertise in cardiovascular research will provide invaluable guidance to our research and clinical programs focused on the development of novel anti-inflammatory therapies for the treatment of heart disease."

    Cardiol Therapeutics' new SAB members include:

    Paul M. Ridker, MD, MPH
    Dr. Ridker is director of the Center for Cardiovascular Disease Prevention, a translational research unit at Brigham and Women's Hospital (BWH), Boston. A cardiovascular medicine specialist, he is also the Eugene Braunwald Professor of Medicine at Harvard School of Medicine (HMS). Dr. Ridker received his medical degree from HMS and then completed an internal medicine residency and a cardiology fellowship at BWH. Dr. Ridker is board certified in internal medicine. His clinical interests include coronary artery disease and the underlying causes and prevention of atherosclerotic disease. Dr. Ridker is the author of over 900 peer-reviewed publications and reviews, 64 book chapters, and six textbooks related to cardiovascular medicine. His primary research focus has involved inflammatory mediators of heart disease and the molecular and genetic epidemiology of hemostasis and thrombosis, with particular interests in biomarkers for coronary disease, "predictive" medicine, and the underlying causes and prevention of atherosclerotic disease. Notably, Dr. Ridker has been the Principal Investigator or Study Chairman of several large international trials that have demonstrated the role of inflammation in the genesis and management of coronary artery disease. He was included in TIME magazine's list of 100 most influential people of 2004, and between the years 2000 and 2010, Dr. Ridker was among the ten most often cited researchers in cardiovascular medicine worldwide. Amongst many other honors, he received the American Heart Association Distinguished Scientist Award in 2013, gave the Braunwald Lecture of the American College of Cardiology in 2019, was awarded the Gotto Prize for Atherosclerosis Research from the International Atherosclerosis Society in 2021, and is an elected Member of the National Academy of Medicine (USA).

    Bruce McManus, PhD, MD
    Dr. McManus is Professor Emeritus, Department of Pathology and Laboratory Medicine, the University of British Columbia. He has served as CEO, Centre of Excellence for Prevention of Organ Failure (PROOF Centre), Director, UBC Centre for Heart Lung Innovation, and Scientific Director, Institute of Circulatory and Respiratory Health, CIHR. Dr. McManus received BA and MD degrees (University of Saskatchewan), an MSc (Pennsylvania State University), and a PhD (University of Toledo). He pursued post-doctoral fellowships at the University of California, Santa Barbara (Environmental Physiology) and at the National Heart, Lung, and Blood Institute, Bethesda, MD (Cardiovascular & Pulmonary Pathology), and residency training at the Peter Bent Brigham Hospital, Harvard University (Internal Medicine and Pathology). Dr. McManus' investigative passion relates to mechanisms, consequences, detection and prevention of injury and aberrant repair in inflammatory diseases of the heart and blood vessels. He has had a longstanding interest in the diagnosis and management of acute viral myocarditis. His life's scholarship is reflected in more than 400 original peer-reviewed publications, over 60 chapters, and several books. He is an extraordinary mentor. Dr. McManus has been widely appreciated for his research, mentoring, and leadership contributions to the health sciences. Amongst many awards and honors, Dr. McManus received the prestigious Max Planck Research Award in 1991, was elected a Fellow of the Royal Society of Canada in 2002, was appointed a Member of the Order of Canada in 2018, and to the Order of British Columbia the following year.

    Joseph A. Hill, MD, PhD
    Dr. Hill is Professor of Internal Medicine and Molecular Biology, Chief of Cardiology at UT Southwestern Medical Center, Dallas, TX, and Director of the Harry S. Moss Heart Center. Dr. Hill holds both the James T. Willerson, MD, Distinguished Chair in Cardiovascular Diseases, and the Frank M. Ryburn Jr. Chair in Heart Research. He graduated from Duke University with MD and PhD degrees in 1987. His PhD dissertation research was in the field of cardiac ion channel biophysics. Dr. Hill then worked for five years as a postdoctoral fellow at the Institut Pasteur in Paris studying central and peripheral nicotinic receptors. He next completed an internal medicine internship and residency, as well as a clinical cardiology fellowship, at the Brigham and Women's Hospital, Harvard Medical School. He served on faculty at the University of Iowa for five years before moving in 2002 to the UT Southwestern. Dr. Hill's research examines molecular mechanisms of structural, functional, metabolic, and electrophysiological remodeling in cardiac hypertrophy and heart failure. He has served on many NIH panels and committees and delivered numerous invited lectures in the U.S. and around the world. Dr. Hill has received many recognitions and awards, including election to the Association of American Professors and the 2018 Research Achievement Award from the International Society for Heart Research. For the past six years, Dr. Hill has been the Editor-in-Chief of the prestigious American Heart Association journal Circulation.

    About Cardiol Therapeutics

    Cardiol Therapeutics Inc. (NASDAQ:CRDL) (TSX:CRDL) is a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory therapies for the treatment of cardiovascular disease ("CVD"). The Company's lead product, CardiolRx™, is an oral cannabidiol formulation pharmaceutically manufactured under cGMP that is being investigated in a Phase II/III outcomes study (the LANCER trial). The LANCER trial is designed to evaluate the efficacy and safety of CardiolRx as a cardioprotective therapy to reduce mortality and major cardiovascular events in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, CVD, and to investigate the influence CardiolRx has on key markers of inflammatory heart disease.

    Cardiol has also received clearance from the FDA for its investigational new drug ("IND") application for a Phase II international trial that will investigate the anti-inflammatory and anti-fibrotic properties of CardiolRx in acute myocarditis, a condition caused by inflammation in heart tissue, which remains a leading cause of sudden cardiac death in people under 35 years of age. In addition, Cardiol is developing a subcutaneous formulation of CardiolRx for the treatment of inflammation in the heart that is associated with the development and progression of heart failure.

    For more information about Cardiol Therapeutics, please visit cardiolrx.com.

    Cautionary statement regarding forward-looking information:

    This news release contains "forward-looking information" within the meaning of applicable securities laws. All statements, other than statements of historical fact, that address activities, events, or developments that Cardiol believes, expects, or anticipates will, may, could, or might occur in the future are "forward-looking information". Forward-looking information contained herein may include, but is not limited to, statements relating to the Company's focus on developing innovative anti-inflammatory therapies for the treatment of CVD. Forward-looking information contained herein reflects the current expectations or beliefs of Cardiol based on information currently available to it and is based on certain assumptions and is also subject to a variety of known and unknown risks and uncertainties and other factors that could cause the actual events or results to differ materially from any future results, performance or achievements expressed or implied by the forward-looking information, and are not (and should not be considered to be) guarantees of future performance. These risks and uncertainties and other factors include the risks and uncertainties referred to in the Company's Annual Information Form dated March 31, 2021, as well as the risks and uncertainties associated with product commercialization and clinical studies. These assumptions, risks, uncertainties, and other factors should be considered carefully, and investors should not place undue reliance on the forward-looking information. Any forward-looking information speaks only as of the date on which it is made and, except as may be required by applicable securities laws, Cardiol disclaims any intent or obligation to update or revise such forward-looking information, whether as a result of new information, future events, or results, or otherwise.

    For further information, please contact:

    Trevor Burns, Investor Relations +1-289-910-0855

    To view the source version of this press release, please visit https://www.newsfilecorp.com/release/110733

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  2. Oakville, Ontario--(Newsfile Corp. - November 5, 2021) - Cardiol Therapeutics Inc. (NASDAQ:CRDL) (TSX:CRDL) ("Cardiol" or the "Company"), a clinical-stage biotechnology company focused on developing anti-inflammatory therapies for the treatment of cardiovascular disease, announced today the closing of its previously announced public offering (the "Offering") of 16,350,000 units of the Company (the "Units") at a price to the public of US$3.07 per Unit for gross proceeds of US$50,194,500, before deducting the underwriting discounts and commissions and estimated expenses incurred in connection with the Offering. Each Unit is comprised of one Class A common share of the Company (each, a "Unit Share") and one-half of one Class A common share purchase…

    Oakville, Ontario--(Newsfile Corp. - November 5, 2021) - Cardiol Therapeutics Inc. (NASDAQ:CRDL) (TSX:CRDL) ("Cardiol" or the "Company"), a clinical-stage biotechnology company focused on developing anti-inflammatory therapies for the treatment of cardiovascular disease, announced today the closing of its previously announced public offering (the "Offering") of 16,350,000 units of the Company (the "Units") at a price to the public of US$3.07 per Unit for gross proceeds of US$50,194,500, before deducting the underwriting discounts and commissions and estimated expenses incurred in connection with the Offering. Each Unit is comprised of one Class A common share of the Company (each, a "Unit Share") and one-half of one Class A common share purchase warrant of the Company (each, a "Warrant"). Each Warrant entitle the holder thereof to purchase one Class A common share of the Company (each, a "Warrant Share") at a price of US$3.75 per Warrant Share, subject to adjustment in certain events, until November 5, 2024.

    The Company intends to use the net proceeds from the Offering to advance the Company's research and clinical development programs, additional product development, and for general corporate purposes.

    Canaccord Genuity and Cantor Fitzgerald (the "Underwriters") acted as joint bookrunners in connection with the Offering.

    The Offering was made pursuant to a U.S. registration statement on Form F-10, declared effective by the U.S. Securities and Exchange Commissions (the "SEC") on August 4, 2021 (the "Registration Statement"), and the Company's existing Canadian short form base shelf prospectus (the "Base Prospectus") dated August 3, 2021. A final prospectus supplement (the "Supplement") relating to the Offering was filed with the securities commission in all of the provinces and territories of Canada, except Quebec, and with the SEC in the United States. The Supplement and accompanying Base Prospectus contain important detailed information about the Offering. The Supplement and accompanying Base Prospectus can be found on SEDAR at www.sedar.com and on EDGAR at www.sec.gov. Copies of the Supplement and accompanying Base Prospectus may also be obtained from Canaccord Genuity LLC, Attn: Syndicate Department, 99 High Street, Suite 1200, Boston, Massachusetts 02110, or by email at or from Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 4th floor, New York, New York 10022; Email: .

    This news release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any province, state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such province, state or jurisdiction.

    About Cardiol Therapeutics

    Cardiol Therapeutics Inc. is a clinical-stage biotechnology company focused on the research and clinical development of anti-inflammatory therapies for the treatment of cardiovascular disease.

    Cautionary statement regarding forward-looking information:

    This news release contains "forward-looking information" under applicable securities laws. All information that addresses activities or developments that we expect to occur in the future is forward-looking information. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. In this news release, such forward-looking statements include, but are not limited to, statements regarding the anticipated use of proceeds from the Offering. However, they should not be regarded as a representation that any of the plans will be achieved. Actual results may differ materially from those set forth in this news release due to known and unknown risks and uncertainties affecting the Cardiol, including access to capital, the successful design and completion of clinical trials, the receipt and timely receipt of all regulatory approvals and other risks detailed in the Supplement, the accompanying Base Prospectus and the documents incorporated by reference therein. Any forward-looking information speaks only as of the date on which it is made and, except as may be required by applicable securities laws, Cardiol disclaims any intent or obligation to update or revise such forward-looking information, whether as a result of new information, future events or results or otherwise. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read the Supplement, the accompanying Base Prospectus and the documents incorporated by reference therein.

    For further information, please contact:

    Trevor Burns, Investor Relations
    +1-289-910-0855

    To view the source version of this press release, please visit https://www.newsfilecorp.com/release/102124

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  3. OAKVILLE, ON, Nov. 3, 2021 /CNW/ - Cardiol Therapeutics Inc. (NASDAQ:CRDL) (TSX:CRDL) ("Cardiol" or the "Company"), a clinical-stage biotechnology company focused on developing anti-inflammatory therapies for the treatment of cardiovascular disease (CVD), announced today the pricing of its previously announced public offering (the "Offering") of 16,350,000 units of the Company (the "Units") at a price to the public of US$3.07 per Unit for gross proceeds of US$50,194,500, before deducting the underwriting discounts and commissions and estimated expenses incurred in connection with the Offering. Each Unit will be comprised of one Class A common share of the Company (each, a "Unit Share") and one-half of one Class A common share purchase…

    OAKVILLE, ON, Nov. 3, 2021 /CNW/ - Cardiol Therapeutics Inc. (NASDAQ:CRDL) (TSX:CRDL) ("Cardiol" or the "Company"), a clinical-stage biotechnology company focused on developing anti-inflammatory therapies for the treatment of cardiovascular disease (CVD), announced today the pricing of its previously announced public offering (the "Offering") of 16,350,000 units of the Company (the "Units") at a price to the public of US$3.07 per Unit for gross proceeds of US$50,194,500, before deducting the underwriting discounts and commissions and estimated expenses incurred in connection with the Offering. Each Unit will be comprised of one Class A common share of the Company (each, a "Unit Share") and one-half of one Class A common share purchase warrant of the Company (each, a "Warrant"). Each Warrant will entitle the holder thereof to purchase one Class A common share of the Company (each, a "Warrant Share") at a price of US$3.75 per Warrant Share, subject to adjustment in certain events, for a period of 36 months following the closing date of the Offering.

    The Company intends to use the net proceeds from the Offering to advance the Company's research and clinical development programs, additional product development, and for general corporate purposes.

    Canaccord Genuity and Cantor Fitzgerald (the "Underwriters") are acting as joint bookrunners in connection with the Offering.

    The Offering is expected to close on or about November 5, 2021, subject to the satisfaction of customary closing conditions, including the listing of the Unit Shares to be issued under the Offering and the Warrant Shares to be issued upon the exercise of any Warrants issued under the Offering on the TSX and Nasdaq, receipt of any required approvals of each exchange, and the entering into of an underwriting agreement between the Company and the Underwriters.

    The Offering is being made pursuant to a U.S. registration statement on Form F-10, declared effective by the U.S. Securities and Exchange Commissions (the "SEC") on August 4, 2021 (the "Registration Statement"), and the Company's existing Canadian short form base shelf prospectus (the "Base Prospectus") dated August 3, 2021. A preliminary prospectus supplement relating to the Offering has been filed with the securities commission in all of the provinces and territories of Canada, except Quebec, and with the SEC in the United States, and a final prospectus supplement relating to the Offering (the "Supplement") will be filed with the securities commissions in all of the provinces and territories of Canada, except Quebec, and with the SEC in the United States. The Supplement and accompanying Base Prospectus contain important detailed information about the Offering. The Supplement and accompanying Base Prospectus can be found on SEDAR at www.sedar.com and on EDGAR at www.sec.gov. Copies of the Supplement and accompanying Base Prospectus may also be obtained from Canaccord Genuity LLC, Attn: Syndicate Department, 99 High Street, Suite 1200, Boston, Massachusetts 02110, or by email at or from Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 4th floor, New York, New York 10022; Email: . Prospective investors should read the Supplement and accompanying Base Prospectus and the other documents the Company has filed before making an investment decision.

    This news release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any province, state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such province, state or jurisdiction.

    About Cardiol Therapeutics

    Cardiol Therapeutics Inc. is a clinical-stage biotechnology company focused on the research and clinical development of anti-inflammatory therapies for the treatment of CVD.

    Cautionary statement regarding forward-looking information:

    This news release contains "forward-looking information" under applicable securities laws. All information that addresses activities or developments that we expect to occur in the future is forward-looking information. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. In this news release, such forward-looking statements include, but are not limited to, statements regarding the Offering, whether and when the Offering may close, and the anticipated use of proceeds from the Offering. However, they should not be regarded as a representation that any of the plans will be achieved. Actual results may differ materially from those set forth in this news release due to known and unknown risks and uncertainties affecting the Cardiol, including market conditions, access to capital, the successful design and completion of clinical trials, the receipt and timely receipt of all regulatory approvals and other risks detailed in the Supplement, the accompanying Base Prospectus and the documents incorporated by reference therein. Any forward-looking information speaks only as of the date on which it is made and, except as may be required by applicable securities laws, Cardiol disclaims any intent or obligation to update or revise such forward-looking information, whether as a result of new information, future events or results or otherwise. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read the Supplement, the accompanying Base Prospectus and the documents incorporated by reference therein. 

    SOURCE Cardiol Therapeutics Inc.

    Cision View original content: http://www.newswire.ca/en/releases/archive/November2021/03/c5333.html

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  4. OAKVILLE, ON, Nov. 2, 2021 /CNW/ - Cardiol Therapeutics Inc. (NASDAQ:CRDL) (TSX:CRDL) ("Cardiol" or the "Company"), a clinical-stage biotechnology company focused on developing anti-inflammatory therapies for the treatment of cardiovascular disease (CVD), has today filed a preliminary prospectus supplement (the "Supplement") to its short form base shelf prospectus dated August 3, 2021 (the "Base Prospectus") in connection with a proposed public offering (the "Offering") of units (the "Units"). Each Unit will consist of one Class A common share of the Company (each, a "Unit Share") and one-half of one Class A common share purchase warrant of the Company (each, a "Warrant"). The Supplement was also filed with the U.S. Securities Exchange and Commission…

    OAKVILLE, ON, Nov. 2, 2021 /CNW/ - Cardiol Therapeutics Inc. (NASDAQ:CRDL) (TSX:CRDL) ("Cardiol" or the "Company"), a clinical-stage biotechnology company focused on developing anti-inflammatory therapies for the treatment of cardiovascular disease (CVD), has today filed a preliminary prospectus supplement (the "Supplement") to its short form base shelf prospectus dated August 3, 2021 (the "Base Prospectus") in connection with a proposed public offering (the "Offering") of units (the "Units"). Each Unit will consist of one Class A common share of the Company (each, a "Unit Share") and one-half of one Class A common share purchase warrant of the Company (each, a "Warrant"). The Supplement was also filed with the U.S. Securities Exchange and Commission (the "SEC"), as part of a registration statement on Form-10, as amended, which was declared effective by the SEC on August 4, 2021, in accordance with the Multijurisdictional Disclosure System established between Canada and the United States.

    The Company intends to use the net proceeds from the Offering to advance the Company's research and clinical development programs, additional product development, and for general corporate purposes.

    Canaccord Genuity and Cantor Fitzgerald (the "Underwriters") are acting as joint bookrunners in connection with the Offering.

    The Offering is expected to be priced in the context of the market, with the final terms of the Offering to be determined at the time of pricing. There can be no assurance as to whether or when the Offering may be completed, or as to the actual size or terms of the Offering. The closing of the Offering will be subject to customary closing conditions, including the listing of the Unit Shares and the Class A common shares issuable upon exercise of the Warrants on the TSX and Nasdaq and any required approvals of each exchange.

    The Supplement and accompanying Base Prospectus contain important detailed information about the Offering. The Supplement and accompanying Base Prospectus can be found on SEDAR at www.sedar.com and on EDGAR at www.sec.gov. Copies of the Supplement and accompanying Base Prospectus may also be obtained from Canaccord Genuity LLC, Attn: Syndicate Department, 99 High Street, Suite 1200, Boston, Massachusetts 02110, or by email at or from Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 4th floor, New York, New York 10022; Email: . Prospective investors should read the Supplement and accompanying Base Prospectus and the other documents the Company has filed before making an investment decision.

    This news release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any province, state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such province, state or jurisdiction.

    About Cardiol Therapeutics

    Cardiol Therapeutics Inc. is a clinical-stage biotechnology company focused on the research and clinical development of anti-inflammatory therapies for the treatment of CVD.

    Cautionary statement regarding forward-looking information:

    This news release contains "forward-looking information" under applicable securities laws. All information that addresses activities or developments that we expect to occur in the future is forward-looking information. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. In this news release, such forward-looking statements include, but are not limited to, statements regarding the Offering, the anticipated size and terms of the Offering, and the anticipated use of proceeds from the Offering. However, they should not be regarded as a representation that any of the plans will be achieved. Actual results may differ materially from those set forth in this news release due to known and unknown risks and uncertainties affecting the Cardiol, including market conditions, access to capital, the successful design and completion of clinical trials, the receipt and timely receipt of all regulatory approvals and other risks detailed in the Supplement, the accompanying Base Prospectus and the documents incorporated by reference therein.  Any forward-looking information speaks only as of the date on which it is made and, except as may be required by applicable securities laws, Cardiol disclaims any intent or obligation to update or revise such forward-looking information, whether as a result of new information, future events or results or otherwise. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read the Supplement, the accompanying Base Prospectus and the documents incorporated by reference therein. 

    SOURCE Cardiol Therapeutics Inc.

    Cision View original content: http://www.newswire.ca/en/releases/archive/November2021/02/c4116.html

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  5. Oakville, Ontario--(Newsfile Corp. - October 25, 2021) - Cardiol Therapeutics Inc. (NASDAQ:CRDL) (TSX:CRDL) ("Cardiol" or the "Company"), a clinical-stage biotechnology company focused on developing innovative anti-inflammatory therapies for the treatment of cardiovascular disease, is pleased to announce that it has received approval from Health Canada to proceed with the Company's Phase II, multi-center, double-blind, randomized, placebo-controlled trial designed to study the safety and tolerability of CardiolRx™ as well as its impact on myocardial recovery in patients presenting with acute myocarditis. The approval follows the U.S. Food and Drug Administration (FDA) providing clearance to proceed with the Company's Investigational New Drug…

    Oakville, Ontario--(Newsfile Corp. - October 25, 2021) - Cardiol Therapeutics Inc. (NASDAQ:CRDL) (TSX:CRDL) ("Cardiol" or the "Company"), a clinical-stage biotechnology company focused on developing innovative anti-inflammatory therapies for the treatment of cardiovascular disease, is pleased to announce that it has received approval from Health Canada to proceed with the Company's Phase II, multi-center, double-blind, randomized, placebo-controlled trial designed to study the safety and tolerability of CardiolRx™ as well as its impact on myocardial recovery in patients presenting with acute myocarditis. The approval follows the U.S. Food and Drug Administration (FDA) providing clearance to proceed with the Company's Investigational New Drug (IND) application to commence this trial, as announced by the Company on August 24th, 2021.

    Myocarditis is an acute inflammatory condition of the myocardium, characterized by inflammation of the heart muscle, which may result in chest pain, impaired cardiac function, atrial and ventricular arrhythmias, and conduction disturbances. Although the symptoms are often mild, myocarditis remains an important cause of acute and fulminant heart failure and is a leading cause of sudden cardiac death in people less than 35 years old. In addition, some patients proceed to develop chronic dilated cardiomyopathy which continues to be the leading indication for cardiac transplantation. Although viral causes of myocarditis are the most common, myocarditis can result from a broad range of infections and can be caused by certain drugs, including chemo-therapeutic agents used to treat several common cancers. Myocarditis has also been described as a complication of COVID-19 and, more recently, has been reported as a rare complication associated with certain vaccines for COVID-19.

    Cardiol's acute myocarditis study is expected to enroll 100 patients at clinical centers in the United States, Canada, and Europe. The primary endpoints of the trial, which will be evaluated after 12 weeks of double-blind therapy, consist of the following cardiac magnetic resonance measures: left ventricular function (ejection fraction and longitudinal strain) and myocardial edema (extra-cellular volume), each of which has been shown to predict long-term prognosis of patients with acute myocarditis.

    The study has been designed by an independent steering committee comprising distinguished thought leaders in heart failure and myocarditis from international centers of excellence, including: the Cleveland Clinic, the Mayo Clinic, the Houston Methodist DeBakey Heart and Vascular Center, the University of Ottawa Heart Institute, McGill University Health Centre, University of Pittsburgh Medical Center, Charité Hospital Berlin, and the University of South Florida Health Morsani College of Medicine/Tampa General Hospital Heart and Vascular Institute.

    Given the risk of significant heart failure associated with acute myocarditis, current intervention includes drugs commonly administered for heart failure. However, no generally accepted treatment exists for acute myocarditis. Some patients respond to immunosuppressive therapy in combination with steroids, or immune-modulation therapy using immune globulin. Nevertheless, the evidence for these therapies is insufficient to support their adoption as the standard of care and they carry high risk for significant adverse effects.

    Based on the large body of experimental evidence of the anti-inflammatory and cardioprotective properties of cannabidiol in models of cardiovascular disease, the Company believes there is a significant opportunity to develop an important new therapy for acute myocarditis that would be eligible for designation as an orphan drug in the United States. The U.S. Orphan Drug Designation program was created to offer companies significant incentives, including accelerated regulatory review and approval, to develop treatments for diseases that affect fewer than 200,000 people in the U.S. The program was successfully utilized to support the first FDA approval of cannabidiol for the treatment of rare child-onset epilepsy syndromes. Cardiol believes there is a similar opportunity to develop its CardiolRx formulation as an orphan drug for the treatment of acute myocarditis, for which there is currently no accepted standard of care.

    About Cardiol Therapeutics

    Cardiol Therapeutics Inc. (NASDAQ:CRDL) (TSX:CRDL) is a clinical-stage biotechnology company focused on the research and clinical development of innovative anti-inflammatory therapies for the treatment of cardiovascular disease ("CVD"). The Company's lead product, CardiolRx™, is a pharmaceutically produced oral cannabidiol formulation that is being investigated in a Phase II/III outcomes study (the LANCER trial). The LANCER trial is designed to evaluate the efficacy and safety of CardiolRx as a cardioprotective therapy to reduce mortality and major cardiovascular events in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, CVD, and to investigate the influence CardiolRx has on key markers of inflammatory heart disease.

    Cardiol has also received clearance from the FDA for its investigational new drug ("IND") application for a Phase II international trial that will investigate the anti-inflammatory and anti-fibrotic properties of CardiolRx in patients with acute myocarditis, which remains a leading cause of sudden cardiac death in people under 35 years of age. In addition, Cardiol is developing a subcutaneous formulation of CardiolRx and other anti-inflammatory therapies for the treatment of chronic heart failure - a leading cause of death and hospitalization in North America, with associated annual healthcare costs in the U.S. alone exceeding $30 billion.

    For more information about Cardiol Therapeutics, please visit cardiolrx.com.

    Cautionary statement regarding forward-looking information:

    This news release contains "forward-looking information" within the meaning of applicable securities laws. All statements, other than statements of historical fact, that address activities, events, or developments that Cardiol believes, expects, or anticipates will, may, could, or might occur in the future are "forward-looking information". Forward-looking information contained herein may include, but is not limited to, statements relating to a significant opportunity to develop an important new therapy for acute myocarditis that would be eligible for designation as an orphan drug, and the Company's focus on developing innovative anti-inflammatory therapies for the treatment of CVD. Forward-looking information contained herein reflects the current expectations or beliefs of Cardiol based on information currently available to it and is based on certain assumptions, including the assumption that, subject to positive outcomes of its clinical trials, the Company's CardiolRx™ formulation is eligible for designation as an orphan drug, and is also subject to a variety of known and unknown risks and uncertainties and other factors that could cause the actual events or results to differ materially from any future results, performance or achievements expressed or implied by the forward-looking information, and are not (and should not be considered to be) guarantees of future performance. These risks and uncertainties and other factors include the risks and uncertainties referred to in the Company's Annual Information Form dated March 31, 2021, as well as the risks and uncertainties associated with product commercialization and clinical studies. These assumptions, risks, uncertainties, and other factors should be considered carefully, and investors should not place undue reliance on the forward-looking information. Any forward-looking information speaks only as of the date on which it is made and, except as may be required by applicable securities laws, Cardiol disclaims any intent or obligation to update or revise such forward-looking information, whether as a result of new information, future events, or results, or otherwise.

    For further information, please contact:

    Trevor Burns, Investor Relations +1-289-910-0855

    Anu Kher, Media Relations

    To view the source version of this press release, please visit https://www.newsfilecorp.com/release/100691

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