Original-Research: Cardiol Therapeutics - von GBC AG
Einstufung von GBC AG zu Cardiol Therapeutics
Unternehmen: Cardiol Therapeutics
Anlass der Studie: Research Comment
Kursziel: 17,49 CAD
Kursziel auf Sicht von: 31.12.2022
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
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.
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
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
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.
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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