Cardiol Therapeutics Inc (CRDL)

[12yearplan]

Oakville, Ontario--(Newsfile Corp. - March 5, 2020) - Cardiol Therapeutics Inc. (TSX: CRDL) (OTCQX: CRTPF) ("Cardiol" or the "Company"), a leader in the production of pharmaceutical cannabidiol (CBD) and the development of innovative cannabidiol medicines for heart diseases, has received a No Objection Letter from Health Canada to conduct a Phase 1 study of the Company's pharmaceutically produced (cGMP), high concentration, pure cannabidiol formulation that is THC free (<5ppm). The Company plans to initiate the study in Q2, 2020.

Cardiol's Phase 1 study is designed to measure the pharmacokinetics (blood levels of drug) following single and multiple doses of the Company's extra strength 100mg/mL concentration pharmaceutical cannabidiol formulation in up to up to 55 healthy subjects, both in the fasting and fed states. The study will also measure standard safety parameters at escalating doses to help select the optimal dosing levels for the Company's planned international Phase 2 study in acute myocarditis, an inflammatory form of heart failure that represents a leading cause of sudden cardiac death in children and young adults.

"Receiving Health Canada's No Objection Letter to conduct a Phase 1 study is an important development for Cardiol, as this will be the first study designed to investigate safety and dosing levels of our high concentration cannabidiol formulation developed for patients who should not be exposed to THC," said David Elsley, President and CEO of Cardiol Therapeutics. "The study is expected to provide important data to support the commercial and clinical development of this unique THC free (<5ppm) product which contains the same cannabidiol concentration as the medicine approved by the FDA for rare forms of paediatric epilepsy."

There is a growing demand for a cannabidiol formulation that does not contain THC. Both the College of Physicians and Surgeons of Ontario and the Canadian Paediatric Society recommend that physicians do not expose young people under the age of 25 to THC, as its effects on brain development are unknown. For elderly patients, THC exposure can lead to unfavourable drug interactions and adverse effects of intoxication. Cardiol plans to enter the Canadian medicinal cannabinoid market (estimated at $1.2 billion annually) imminently and to address the market's largest segments - people under 25 and adults over 65 years of age - by offering what the Company believes to be the purest form of cannabidiol in the world.

Cardiol's ultra-pure cannabidiol formulation is pharmaceutically produced specifically for medical purposes and is manufactured under the most stringent quality standards set by the pharmaceutical industry. It is free from the psychotropic effects of THC and is produced using controlled processes in a cGMP, Health Canada approved, FDA registered and inspected pharmaceutical facility. This allows for consistent quality and purity from batch to batch, resulting in a THC free (<5 ppm) cannabidiol oil - ideal for patients who should not be exposed to THC.

About Cardiol Therapeutics

Cardiol Therapeutics Inc. (TSX: CRDL) (OTCQX: CRTPF) is focused on producing pharmaceutical cannabidiol (CBD) products and developing innovative therapies for heart diseases, including acute myocarditis and other causes of heart failure. The Company's lead product, CardiolRx™, is formulated to be the most consistent cannabidiol formulation on the market. CardiolRx is pharmaceutically produced, manufactured under cGMP, and is THC free (<5 ppm). The Company also plans to commercialize CardiolRx in the billion-dollar market for medicinal cannabinoids in Canada and is pursuing distribution opportunities in Europe and Latin America.

In heart failure, Cardiol is planning an international clinical study of CardiolRx in acute myocarditis, a condition caused by inflammation in heart tissue, which remains the most common cause of sudden cardiac death in people less than 35 years of age. The Company is also developing proprietary nanotechnology to uniquely deliver pharmaceutical cannabidiol and other anti-inflammatory drugs directly to sites of inflammation in the heart associated with heart failure. Heart failure is the leading cause of death and hospitalization in North America with associated annual healthcare costs in the U.S. alone exceeding $30 billion. For further information about Cardiol Therapeutics, please visit cardiolrx.com.

For further information, please contact:

David Elsley, President & CEO [phone]
[e-mail]

Trevor Burns, Investor Relations [phone]
[e-mail]