Original-Research: Cardiol Therapeutics - von GBC AG

Einstufung von GBC AG zu Cardiol Therapeutics

Unternehmen: Cardiol Therapeutics

ISIN: CA14161Y2006

Anlass der Studie: Research Comment

Empfehlung: BUY

Kursziel: 17,49 CAD

Kursziel auf Sicht von: 31.12.2022

Letzte Ratingänderung:

Analyst: Julien Desrosiers; Felix Haugg

On August 24th, Cardiol Therapeutics received FDA Clearance of

Investigational New Drug (IND) Application for Phase II Clinical Trial of

CardiolRx(TM) for Acute Myocarditis.

Phase II trial details

The company's Investigational New Drug (IND) application approval allows

Cardiol Therapeutics to commence a Phase II, multi-center, double-blind,

randomized, placebo-controlled trial designed to study the safety and

tolerability of CardiolRx(TM), as well as its impact on myocardial recovery

in patients presenting Acute Myocarditis.

More specifically, Cardiol's Acute Myocarditis study is expected to enroll

100 patients at clinical centers in the United States 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


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, Charite Hospital Berlin, and the

University of South Florida Health Morsani College of Medicine/Tampa

General Hospital Heart and Vascular Institute.

Comments from the Company

'IND clearance to proceed with our Phase II clinical trial of CardiolRx in

patients with Acute Myocarditis represents another major milestone for

Cardiol as we continue to pursue the development of new treatment options

for patients with inflammatory Heart Disease,' said David Elsley, President

and Chief Executive Officer of Cardiol Therapeutics. 'We look forward to

further studying the cardioprotective potential of CardiolRx in this rare

but potentially devastating condition that remains an underdiagnosed cause

of Acute Heart Failure, sudden death, and chronic dilated Cardiomyopathy.'

GBC Research report update

As per our Initial Coverage report, we planned for an approval of the Phase

II clinical trial of CardiolRx in patients with Acute Myocarditis to be

received in Q3 2021. We are pleased to see the company being on track at

this point.

We view the approval of the IND Phase II clinical trials as a critical

development for the company.

This new step marks the beginning of a new phase for Cardiol Therapeutics

as treatment for Acute Myocarditis is, according to our forecast, the main

value driver for the company in the near future. We estimate patient

enrollment could begin as early as within the next few months. We maintain

our forecast of the phase II results to be announced in Q1 2023 and our

target price and rating remain unchanged.

Corporate updates

As of August 2021, the company has appointed Dr. Guillermo Torre-Amione as

its new chairman. M. Guillermo has served as an independent director since

August 2018.

Dr. Guillermo Torre-Amione

Dr. Torre-Amione received his medical degree from Tecnológico de Monterrey,

Campus Monterrey in 1985 and earned a PhD in Immunology from the University

of Chicago in 1990. He subsequently completed his training in Internal

Medicine and Cardiology with subspecialty training in Cardiac

Transplantation and Interventional Cardiology at Baylor College of Medicine

in Houston Texas.

Dr. Torre-Amione was presiding the Heart Failure and Cardiac

Transplantation Section at the Methodist Hospital in Houston from 1995 to

2010. He then became a full Professor of Medicine at Weill Cornell Medical

College at The Methodist Hospital in Houston in 2008. During his tenure at

The Methodist Hospital he was a board member of the Heart and Vascular

Center, and established the Cardiac Transplantation research endowment.

Furthermore, he was a board member of St Thomas University in Houston


After 26 years in the United States, he returned to Mexico to become

President of TEC Salud at the Tecnológico de Monterrey. He is currently an

active member of the staff of both the San Jose Tec de Monterrey Hospital

and Zambrano Hellion Medical Center. He also maintains an academic

appointment at the Methodist Hospital in Houston.

M. Torre-Amione has carried out more than 100 clinical research projects,

holds several patents in the field of Heart Failure and has published over

170 peer reviewed professional articles.

We believe that Dr. Torre-Amione is an important step forward in the

company's leadership composition. Cardiol Therapeutics will be greatly

enhanced by his vast experience in both scientific and clinical research on

Heart Failure, including the design and execution of pivotal clinical

trials in this area.

As of September 7th, 2021, the company has appointed Michael J. Willner to

its Board of Directors.

Michael J. Willner earned a bachelor's degree in Accounting and Finance

from the University of South Florida and a law degree from Emory

University, where he was a member of the Emory Law Review. Prior to

entering the legal profession, Mr. Willner worked for the former Arthur

Andersen & Company, a national accounting firm, where he practiced in the

tax department. Following that, he worked for Milbank, Tweed, Hadley &

McCloy, one of the nation's most prominent international law firms, in New

York City.

In 1990, Mr. Willner founded Willner Capital, Inc., an investment firm

specialized in public and private equities, as well as debt instruments.

Since over 30 years, Willner Capital focuses on fundamental analysis and

event-driven tactics. Willner Capital has made major investments in the

biotechnology and pharmaceutical cannabinoid industries over the last

decade, focusing on clinical-stage firms seeking to solve unmet medical


The New York Times Business Section has quoted Mr. Willner on his

investments in the pharmaceutical side of the marijuana industry, and he

has participated in various panel discussions and advisory boards.

These three news reports combined together strengthen unquestionably our

confidence in Cardiol Therapeutics' overall chances of success.

Rating: BUY

Target price: 17,49 CAD (confirmed)

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Date and time of completion of this research: 08/09/2021 (06:20 pm)

Date and time of first distribution: 09/09/2021 (02:00 am)

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