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Hotstocks Feature Article:
Cardiol Therapeutics Inc
NASDAQ : CRDL
TSX : CRDL

Overview

A clinical-stage life sciences company focused on the research and and clinical development of cannabidiol as an anti-fibrotic and anti-inflammatory therapy for the cardiovascular disease

The Company’s lead product candidate, CardiolRx™, is a pharmaceutically produced oral cannabidiol formulation that is being clinically developed for use in cardiovascular medicine. CardiolRx™ is currently being evaluated in a Phase II/III multi-national, randomized, double-blind, placebo-controlled study (the LANCER trial). LANCER is designed to evaluate the efficacy and safety of CardiolRx™ as a cardioprotective therapy to reduce major cardiovascular and respiratory 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 biomarkers associated with heart disease. Cardiol has also  received IND authorization from the FDA to conduct a Phase II multi-national, randomized, double-blind,  placebo-controlled trial designed to evaluate the efficacy and safety of CardiolRx™ in acute myocarditis, which remains an important cause of acute and fulminant heart failure in young adults and is a leading cause of sudden cardiac death in people less than 35 years of age. In addition, Cardiol is developing a subcutaneous formulation of CardiolRx™ for the treatment of fibrosis and inflammation in the heart that is associated with the development and progression of heart failure – a leading cause of death and hospitalization in the developed world, with associated healthcare costs in the U.S. exceeding $30 billion annually

Leadership

David Elsley, MBA
President & Chief Executive Officer

Andrew Hamer, MB, Chb
Chief Medical officer

Chris Waddick, MBA, CPA, CMA
Chief Financial Officer

Bernard Lim, MIET, CEng (UK)
Chief Operating Officer

Andrea B. Parker, MSc, PhD
Senior Director of Clinical Operations

Anne Tomalin, BA, BSc, RAC
Director of Regulatory and Quality

Blagoja Ristevski, BSc, CHE
Director of Chemical Engineering
and Manufacturing

Capital Structure April 2022
Market Cap   ~$130 M
Current Share Price (2022/4/8)  $1.15
52 Week Range6.19/1.58
YTD (%)-9.48%
Common Shares Outstanding    61.9 M
Fully Diluted Common Shares   81.6 M
Insider & Employee Ownership  11%
Pharmaceutical Partners &
Research Collaborators  4%
Cash & Cash Equivalents   $83.9 M
(as of December 31, 2021)
Current Debt
$0.0 M

A superior oral formulation of CBD

• High-concentration oral cannabidiol formulation for acute inflammatory heart disease.
• In Phase II/III clinical development as a cardiorespiratory protective drug for patients with acute inflammatory heart disease.
• FDA clearance for its IND application for a Phase II international trial in acute myocarditis.
• Manufactured under cGMP to meet the highest standards for product purity, consistency, and stability

Phase II/III cardiovascular risk mitigation outcomes study in COVID-19 patients

Final data: Expected in H2 2022
Trial design: 422 Patients with confirmed COVID-19 diagnosis
                      that have been admitted to a hospital and have
                      either pre-existing, or risk factors for, CVD.
• A positive outcome should allow it to serve as a pivotal trial for the basis of a registration study in support of an U.S. New Drug Application (NDA) filing.
• The COVID-19 pandemic is providing Cardiol with a unique opportunity to rapidly study the cardioprotective properties of CardiolRx.

Subcutaneous Formulation for Heart Failure

• 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.
• Published third-party research has shown that cannabidiol reduces inflammatory activation of the endothelial lining of blood vessels and aids endothelial vasorelaxation, resulting in improved blood flow. Cannabidiol has lining of blood vessels and aids endothelial vasorelaxation, resulting in improved blood flow. Cannabidiol has in heart failure patients, and to reduce myocardial fibrosis in a model of inflammatory heart disease. 

Upcoming Milestones

Complete
patient enrollment
and report
top line results
in the Phase III/III
international
LANCER trial
examining the
cardioprotective
properties of
CardiolRx™

Initiate
patient enrollment
in a Phase II
international trial
of CardiolRx™ in
acute myocarditis

Advance
development of a
subcutaneous
formulation of
CardiolRx™ into an
IND enabling
program

Conduct further
discovery research
focused on
additional
anti-inflammatory
strategies

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