Original-Research: Cardiol Therapeutics - von GBC AG

Einstufung von GBC AG zu Cardiol Therapeutics

Unternehmen: Cardiol Therapeutics

ISIN: CA14161Y2006

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

(<10ppm).

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

exclusivity.

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

treatment.

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

exercises.

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:

http://www.more-ir.de/d/22241.pdf

Kontakt für Rückfragen

Jörg Grunwald

Vorstand

GBC AG

Halderstraße 27

86150 Augsburg

0821 / 241133 0

research@gbc-ag.de

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http://www.gbc-ag.de/de/Offenlegung

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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