Original-Research: Cardiol Therapeutics - von GBC AG
Einstufung von GBC AG zu Cardiol Therapeutics
Unternehmen: Cardiol Therapeutics
Anlass der Studie: Research Comment
Letzte Ratingänderung: -
Analyst: Julien Desrosiers; Felix Haugg
GBC Research Watchlist: Cardiol Therapeutics Inc.
'The right moment to participate in this exciting growth story'
Cortalex - The purest form of CBD, no THC. It matters.
For many patient segments, CBD medication can be linked to the possibility
of becoming intoxicated by THC. For children, young adults under 25,
workers that cannot be intoxicated at work, or the elderly, having access
to a CBD formulation that does not contain intoxicating amounts of THC is
of the upmost importance. These consumers represent an important part of
the medical CBD market. Specifically, the elderly population (over 65 years
old) is the fastest growing segment of the almost $600 million medicinal
cannabinoid market in Canada.
One of the main issues in the medicinal cannabinoid market is purity. When
clients are looking for a high concentration of CBD, they often sacrifice
product purity as the level of THC and other impurities rises
significantly. This issue can prove to be a real challenge for those
patients mentioned above.
Cortalex(TM), the company's commercial oral CBD formulation product, is
pharmaceutically produced and formulated to be consistent from batch to
batch with proven purity and stability. Containing less than 10 parts per
million THC, it is considered THC free. Their exclusive manufacturing
partner, Dalton Pharma Services, is cGMP compliant and meets the highest
standards set by the pharmaceutical industry. CBD has been shown to be
effective in treating seizures associated with the pediatric epi- lepsies
Dravet and Lennox-Gastaut Syndromes, and tuberous sclerosis complex1. There
are also claimed benefits of CBD in the treatment of medical conditions
including: anxiety, sleep disorders, depression, and chronic pain2.
To the best of our knowledge, of the high concentration oral CBD
formulations currently available in the Canadian medical market, Cortalex
is by far the purest, containing virtually undetectable levels of THC
CardiolRx(TM) - targeting inflammatory heart disease
The company is following a strategy similar to GW Pharmaceuticals (GW), the
developer of the FDA approved high concentration CBD formulation for rare
forms of pediatric epilepsy. This strategy led to the recently announced
acquisition of GW pharma by Jazz Pharmaceuticals for over USD $7 billion.
This acquisition serves as a powerful validation of Cardiol Therapeutics'
business model, as it demon strates the magnitude of shareholder value that
can be created by developing pure cannabidiol med icines for important
disease targets. In the case of Cardiol, these disease targets include
acute myo- carditis and heart failure, poorly served inflammatory heart
diseases that represent much larger mar kets than the pediatric epilepsies.
Acute Myocarditis - Phase I completed and Phase II in the Approval Process
Cardiol Therapeutics recently successfully completed a Phase I study of
CardiolRx. The randomized controlled study was completed without any
serious adverse events reported. The complete report of the 52 healthy
adult subjects should be published during early Q2 2021. The Phase I study
is intended to test the safety, tolerability, and pharmacokinetics (PK) of
single and multiple ascending doses of Cardi- olRx(TM).
The company has announced its intention to file an IND application with the
U.S. FDA for an interna- tional Phase II clinical trial. Acute myocarditis
is recognized as an orphan disease making Cardiol's CBD formulation
eligible for orphan drug designation - the same designation GW pharma was
granted by the FDA which enabled the fast-track development of their CBD
formulation in rare pediatric epi- lepsies. In the U.S. and other major
international markets, any disease that affects fewer than 200,000 people
nationwide qualifies for orphan drug status. An orphan drug allows for
accelerated marketing approvals and the company developing the drug can
benefit from numerous incentives, such as a prolonged period of marketing
Cardiol's planned Phase II program in Acute Myocarditis is an international
study designed to recruit 100 patients at major cardiovascular research
centers in Canada, the U.S., and Europe. The study will assess the
cardioprotective effects of its high concentration CBD formulation,
CardiolRx, versus placebo, on key measures of myocardial (heart muscle)
recovery including: i) Left ventricular ejec- tion fraction, ii)
Extracellular volume and iii) Global longitudinal strain.
High risk COVID-19 patients with history of cardiovascular disease -
Cardiol could help
Following an IND application approved by the U.S. FDA, the company is
preparing a Phase II/III clinical trial to assess the safety and
effectiveness of their CardiolRx formulation on 422 COVID-19 hospitalized
patients at clinical centers throughout the U.S. Each patient will have a
history of, or risk factors for, cardiovascular disease. Due to the
severity of the COVID-19 situation worldwide, this trial could result in an
accelerated approval. The company has engaged the services of Worldwide
Clinical Trials to act as Contract Research Organization ('CRO'). The
company's independent Steering Com- mittee and Data Safety Monitoring
Committee comprise world renown specialists in heart failure, acute
myocarditis, and other inflammatory heart diseases.
Specifically, the trial will assess the cardioprotective effects of
CardiolRx on reducing a composite of the following significant adverse
outcomes: i) all-cause mortality, ii) requirement for ICU admission and/or
ventilatory support, and iii) cardiovascular complications, including the
development of heart failure, acute myocardial infarction, myocarditis,
stroke, or new sustained or symptomatic arrhythmia. The study will compare
the cardioprotective effects of CardiolRx versus placebo after 28 days of
CardiolRx, well positioned during and beyond the current pandemic
As all eyes remain on the current COVID-19 pandemic, it is important to
note that as a result of a global increase in diabetes, high blood pressure
and obesity, heart failure was an epidemic before COVID-19 and will remain
an epidemic during and after COVID-19. Regardless of how the COVID-19
pandemic plays out, there remains a desperate need for new forms of
treatment for heart failure and to the extent that COVID-19 becomes
endemic, there will be a need for a cardioprotective treatments for high-
risk patients for many years to come.
Diastolic heart failure - Incredible Future Potential
Cardiol's research has demonstrated that a new formulation of CardiolRx
that will be delivered like insulin significantly reduced inflammation in a
model of heart failure. This treatment is still in the pre- clinical
development stage but holds tremendous promise for the future. Heart
failure affects over 26 million people in the developed world and remains a
leading cause of death and hospitalization, with associated annual
healthcare costs in the U.S. alone exceeding $30 billion.
Well-funded - Cash on account for the studies
The company had cash on hand as of September 30, 2020 of $16.5M CDN and
recently raised pro- ceeds of over CAD $10M from warrant and option
Leadership - An experienced team that is up to the task at hand
Cardiol Therapeutics is led by David Elsley. He has already been through
the Phase III approval process for an inflammatory heart treatment, as CEO
of a public company prior to founding Cardiol Therapeutics. He has
surrounded himself with a team of experts with decades of experience in de-
veloping new therapeutics for cardiovascular disease. Cardiol's COVID-19
and acute myocarditis Steering Committee comprise thought leaders in heart
disease from around the globe, including representation from prestigious
institutions such as the Heart Failure/Transplantation Program at the
University of Pittsburgh Medical Center, the Mayo Clinic, McGill
University, Ottawa Heart Institute, the Charité University Hospital in
Berlin, and many more.
Entering NASDAQ - Application for up-listing recently filed
The company has filed its application to be uplisted on the NASDAQ. With a
market cap of approx.
$200M CDN, the company currently trades on the TSX: CRDL, OTCQX: CRTPF and
FSE: CT9. GBC Initial Coverage Research Report coming soon.
Die vollständige Analyse können Sie hier downloaden:
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Date (time) of completion of English version: 11/03/2021 (12:45 pm)
Date (time) of first distribution of English version: 11/03/2021 (03:15 pm)
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