Multi-center, international, double-blind, randomized, placebo-controlled trial to enroll 100 patients

Oakville, ON – August 3, 2022 – Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) (“Cardiol” or the “Company”), a clinical-stage life sciences company focused on the research and clinical development of cannabidiol as an anti-inflammatory and anti-fibrotic therapy for the treatment of cardiovascular diseases (“CVD”), announced today that the first patient has been enrolled in ARCHER, the Company’s Phase II, multi-center, international, double-blind, randomized, placebo-controlled trial designed to study the safety and tolerability of CardiolRx™, as well as its impact on myocardial recovery, in patients presenting with acute myocarditis. CardiolRx is a pharmaceutically produced oral cannabidiol formulation being developed for the treatment of acute and chronic inflammation associated with heart disease.

Dennis McNamara, MD, MS, Professor of Medicine at the University of Pittsburgh, Director of the Center for Heart Failure Research at the University of Pittsburgh Medical Center, and Chair of the study steering committee commented, “We have long suspected that it is the response to injury that needs to be addressed to improve outcomes in myocarditis. Given its impact limiting these inflammatory mechanisms, we believe cannabidiol has the potential to truly benefit patients with this condition. I am pleased this important milestone has now been achieved and the ARCHER study, designed to investigate CardiolRx’s therapeutic potential in myocarditis, is formally underway.”

ARCHER has received regulatory clearance in multiple jurisdictions, including IND authorization from the FDA, and is expected to enroll 100 patients at major cardiac centers in North America, Europe, Latin America, and Israel. The primary endpoints of the trial, which will be evaluated after 12 weeks of double-blind therapy, consist of the following cardiac magnetic resonance imaging measures: left ventricular function (ejection fraction and longitudinal strain) and myocardial edema/fibrosis (extra-cellular volume), each of which has been shown to predict long-term prognosis of patients with acute myocarditis.

Myocarditis is an acute inflammatory condition of the heart muscle (myocardium) characterized by chest pain, impaired cardiac function, atrial and ventricular arrhythmias, and conduction disturbances. Although the symptoms are often mild, myocarditis remains an important cause of acute and fulminant heart failure and is a leading cause of sudden cardiac death in people under 35 years of age. In addition, some patients proceed to develop chronic dilated cardiomyopathy which continues to be the leading indication for cardiac transplantation. Although viral infection is the most common cause of myocarditis, the condition can also result from administration of therapies used to treat several common cancers, including chemo-therapeutic agents and immune checkpoint inhibitors. Myocarditis has also been described as a complication of COVID-19 and, more recently, has been reported as a rare complication associated with certain vaccines for COVID-19. Acute myocarditis should be managed with guideline directed therapies for heart failure, arrhythmia and conduction disturbances; however, there is no uniformly accepted treatment for the underlying inflammatory processes associated with this condition.

The Company believes there is a significant opportunity to develop an important new therapy for acute myocarditis that would also be eligible for designation as an orphan drug in the United States. The U.S. Orphan Drug Designation program was created to provide the sponsor of a drug significant incentives, including seven-year marketing exclusivity and exemptions from certain FDA fees, to develop treatments for diseases that affect fewer than 200,000 people in the U.S. (73,000 myocarditis cases are estimated in the U.S. annually). Products with Orphan Drug Designation also frequently qualify for accelerated regulatory review. The program was successfully utilized to support the first FDA approval of cannabidiol for the treatment of seizures associated with rare pediatric epilepsy syndromes. Cardiol believes there is a similar opportunity to develop its CardiolRx formulation as an orphan drug for the treatment of acute myocarditis.

About Cardiol Therapeutics

Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) is a clinical-stage life sciences company focused on the research and clinical development of cannabidiol as an anti-inflammatory and anti-fibrotic therapy for the treatment of CVD. The Company’s lead product candidate, CardiolRx™, is a pharmaceutically produced oral cannabidiol formulation that is being clinically developed for use in cardiovascular medicine. CardiolRx is currently being evaluated in a Phase II/III multi-national, randomized, double-blind, placebo-controlled study (the “LANCER” trial). LANCER is designed to evaluate the efficacy and safety of CardiolRx as a cardioprotective therapy to reduce major cardiovascular and respiratory events in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, CVD, and to investigate the influence CardiolRx has on key biomarkers associated with heart disease.

Cardiol has also received IND authorization from the FDA to conduct clinical studies to evaluate the efficacy and safety of CardiolRx in two orphan drug indications: (i) the ARCHER trial, a Phase II multi-national, randomized, double-blind, placebo-controlled trial in acute myocarditis, an important cause of acute and fulminant heart failure in young adults and the leading cause of sudden cardiac death in people less than 35 years of age; and (ii) a Phase II multi-center open-label pilot study in recurrent pericarditis (inflammation of the pericardium), which is associated with symptoms including debilitating chest pain, shortness of breath, and fatigue, and results in physical limitations, reduced quality of life, emergency department visits, and hospitalizations.

In addition, Cardiol is developing a subcutaneous formulation of cannabidiol for the treatment of inflammation and fibrosis associated with the development and progression of heart failure – a leading cause of death and hospitalization in the developed world, with associated healthcare costs in the U.S. exceeding $30 billion annually.

For more information about Cardiol Therapeutics, please visit cardiolrx.com.

Cautionary statement regarding forward-looking information:

This news release contains “forward-looking information” within the meaning of applicable securities laws. All statements, other than statements of historical fact, that address activities, events, or developments that Cardiol believes, expects, or anticipates will, may, could, or might occur in the future are “forward-looking information”. Forward looking information contained herein may include, but is not limited to, statements relating to the Company’s focus on developing anti-inflammatory and anti-fibrotic therapies for the treatment of cardiovascular disease; the belief that cannabidiol has the potential to truly benefit patients with myocarditis; the Company’s expectation of enrolling 100 patients at major cardiac centers in North America, Europe, Latin America, and Israel pursuant to the ARCHER study; the Company’s belief that there is a significant opportunity to develop an important new therapy for acute myocarditis that would also be eligible for designation as an orphan drug in the United States; the Company’s belief that there is an opportunity to develop its CardiolRx™ formulation as an orphan drug for the treatment of acute myocarditis. Forward-looking information contained herein reflects the current expectations or beliefs of Cardiol based on information currently available to it and is based on certain assumptions and is also subject to a variety of known and unknown risks and uncertainties and other factors that could cause the actual events or results to differ materially from any future results, performance or achievements expressed or implied by the forward-looking information, and are not (and should not be considered to be) guarantees of future performance. These risks and uncertainties and other factors include the risks and uncertainties referred to in the Company’s Annual Information Form dated March 23, 2022, as well as the risks and uncertainties associated with product commercialization and clinical studies. These assumptions, risks, uncertainties, and other factors should be considered carefully, and investors should not place undue reliance on the forward-looking information. Any forward-looking information speaks only as of the date on which it is made and, except as may be required by applicable securities laws, Cardiol disclaims any intent or obligation to update or revise such forward-looking information, whether as a result of new information, future events, or results, or otherwise.

For further information, please contact:

trevor.burns@cardiolrx.com

• Third IND authorization for CardiolRx™ in cardiovascular disease
• Study to run in parallel with Company’s multi-national Phase II acute myocarditis trial, expected to commence imminently
• CardiolRx™ is now eligible for orphan drug status in two indications

Oakville, ON – May 17, 2022 – Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) (“Cardiol” or the “Company”), a clinical-stage life sciences company focused on the research and clinical development of anti-fibrotic and anti-inflammatory therapies for the treatment of cardiovascular disease (“CVD”), is pleased to announce the U.S. Food and Drug Administration (FDA) has authorized the Company’s Investigational New Drug Application (IND) to commence a Phase II open-label pilot study designed to evaluate the tolerance and safety of CardiolRx™, a pharmaceutically manufactured oral cannabidiol drug formulation, in patients with recurrent pericarditis. The study will also assess the improvement in objective measures of disease, and during an extension period, assess the feasibility of weaning concomitant background therapy including corticosteroids, while taking CardiolRx™. Recurrent pericarditis is an orphan disease in the United States, thereby making CardiolRx™ eligible for orphan drug status under the FDA’s Orphan Drug Designation program.

Allan L. Klein, MD, FRCP (C), FACC, FAHA, FASE, FESC, Director Center of Pericardial Diseases and Professor of Medicine, Heart and Vascular Institute, Cleveland Clinic, will serve as study Chair and provide leadership throughout the course of the trial. Dr. Klein commented, “I look forward to investigating the potential of this treatment in patients with recurrent pericarditis, a cardiovascular inflammatory disease and the most common of pericardial diseases. We look forward to evaluating whether this intervention could be a therapeutic option for those who are intolerant to current medical treatment or who require long-term administration of corticosteroids to control their disease.”

Cardiol’s study is expected to enroll 25 patients at major clinical centers specializing in pericarditis in the United States. The study protocol has been designed in collaboration with thought leaders in pericardial disease. The trial’s primary efficacy endpoint is the change, from baseline to 8 weeks, in patient-reported pericarditis pain using an 11-point numeric rating scale (NRS). The NRS is a validated clinical tool used across multiple conditions with acute and chronic pain, including previous studies of recurrent pericarditis. Secondary endpoints include the pain score after 26 weeks of treatment, and changes in C-reactive protein (CRP).

“We are pleased that Dr. Klein will provide his expertise and leadership to Cardiol’s study, and his contributions thus far with respect to protocol design and facilitating clinical trial site recruitment have been invaluable,” commented Dr. Andrew Hamer, Cardiol’s Chief Medical Officer. “We believe there is a significant opportunity to develop a new oral, well tolerated therapy for treating recurrent pericarditis to prevent multiple recurrences, for colchicine refractory, intolerant, and contraindicated patients, as well as steroid-dependent patients. With IND authorization now in place, we look forward to ramping up initiation of this important study. We also anticipate benefiting from the clinical trial infrastructure already established for our multi-national acute myocarditis study, which is expected to commence patient enrollment imminently.”

Pericarditis refers to inflammation of the pericardium – the membrane, or sac, that surrounds the heart. Symptoms include debilitating chest pain, shortness of breath, and fatigue, which result in physical limitations, reduced quality of life, emergency department visits, and hospitalizations. Causes of pericarditis can include infection (e.g., tuberculosis), systemic disorders such as autoimmune and inflammatory diseases, cancer, and post-cardiac injury syndromes. Based on time of presentation, acute pericarditis is a symptomatic event lasting less than four to six weeks, the diagnosis of which is based on meeting two of four criteria:  chest pain; pericardial rub; electrocardiogram changes; and new or worsening pericardial swelling. Elevation of inflammatory markers such as CRP, and evidence of pericardial inflammation by an imaging technique (computed tomography scan or cardiac magnetic resonance) may help the diagnosis and the monitoring of disease activity. Although generally self-limited and not life-threatening, acute pericarditis is diagnosed in 0.2% of all cardiovascular in-hospital admissions and is responsible for 5% of emergency room admissions for chest pain in North America and Western Europe.

Recurrent pericarditis is the reappearance of symptoms after a symptom-free period of at least 4–6 weeks following an episode of acute pericarditis. These recurrences appear in 15% to 30% of acute cases and usually within 18 months. Further, up to 50% of patients with a recurrent episode of pericarditis experience more recurrences. Standard first-line medical therapy consists of non-steroidal anti-inflammatory drugs or aspirin with or without colchicine. Corticosteroids such as prednisone are second-line therapy in patients with continued recurrence and inadequate response to conventional therapy. Recently a potent subcutaneously injected interleukin-1 inhibitor has been approved by the FDA for patients with recurrent pericarditis; however, this immunosuppressant is primarily used in patients with a third or fourth recurrence.

The U.S. Orphan Drug Designation program was created to provide the sponsor of a drug significant incentives, including seven-year marketing exclusivity and exemptions from certain FDA fees, to develop treatments for diseases that affect fewer than 200,000 people in the U.S. Products with Orphan Drug Designation also frequently qualify for accelerated regulatory review. The prevalence of recurrent pericarditis in the U.S. is estimated at 38,000. The program was successfully utilized to support the first FDA approval of cannabidiol for the treatment of rare pediatric epilepsy syndromes. Cardiol believes there is a similar opportunity to develop its oral CardiolRx™ formulation as an orphan drug for the treatment of recurrent pericarditis.

About Cardiol Therapeutics

Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) is a clinical-stage life sciences company focused on the research and clinical development of cannabidiol as an anti-fibrotic and anti-inflammatory therapy for the treatment of cardiovascular disease (“CVD”). The Company’s lead product candidate, CardiolRx™, is a pharmaceutically produced oral cannabidiol formulation that is being clinically developed for use in cardiovascular medicine.  CardiolRx™ is currently being evaluated in a Phase II/III multi-national, randomized, double-blind, placebo-controlled study (the LANCER trial). LANCER is designed to evaluate the efficacy and safety of CardiolRx™ as a cardioprotective therapy to reduce major cardiovascular and respiratory events in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, CVD, and to investigate the influence CardiolRx™ has on key biomarkers associated with heart disease. Cardiol has also received IND authorization from the FDA to conduct a Phase II multi-national, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of CardiolRx™ in acute myocarditis (also an orphan indication), which remains an important cause of acute and fulminant heart failure in young adults and is a leading cause of sudden cardiac death in people less than 35 years of age. In addition, Cardiol is developing a subcutaneous formulation of CardiolRx™ for the treatment of fibrosis and inflammation in the heart that is associated with the development and progression of heart failure – a leading cause of death and hospitalization in the developed world, with associated healthcare costs in the U.S. exceeding $30 billion annually.

For more information about Cardiol Therapeutics, please visit cardiolrx.com.

Cautionary statement regarding forward-looking information:

This news release contains “forward-looking information” within the meaning of applicable securities laws. All statements, other than statements of historical fact, that address activities, events, or developments that Cardiol believes, expects, or anticipates will, may, could, or might occur in the future are “forward-looking information”. Forward looking information contained herein may include, but is not limited to, statements relating to the Company’s intention that the pericarditis study run in parallel with the Company’s myocarditis trial, which is expected to commence imminently; the fact that the pericarditis study is designed to evaluate the tolerance and safety of CardiolRx™; the point that the pericarditis study will also assess the improvement in objective measures of disease, and assess the feasibility of weaning concomitant background therapy including corticosteroids, while taking CardiolRx™; the fact that Allan L. Klein, MD, will serve as study Chair and provide leadership throughout the course of the trial; the possibility that CardiolRx™ may offer a therapeutic option in the patient population who are intolerant to current medical treatment or who require long-term administration of corticosteroids to control their disease; the expectation that the study will enroll 25 patients at major clinical centers specializing in pericarditis in the United States; the expectation that Cardiol will now ramp up for initiation of the study; the belief that the study will benefit from the infrastructure synergies, including streamlining of site contracting and activation; the belief there is a significant opportunity to develop a new oral, well tolerated, and safe therapy for treating recurrent pericarditis to prevent multiple recurrences, for colchicine refractory, intolerant, and contraindicated patients, as well as steroid dependent patient; the belief that there is a similar opportunity to develop the Company’s oral CardiolRx™ formulation as an orphan drug for the treatment of recurrent pericarditis; the focus on developing innovative anti-inflammatory therapies for the treatment of cardiovascular disease; the completion of patient enrollment into the LANCER Phase II/III trial; the initiation of patient enrollment into the Phase II trial; and advancing the subcutaneous formulation of CardiolRx™ as a potential anti-fibrotic and anti-inflammatory therapy. Forward-looking information contained herein reflects the current expectations or beliefs of Cardiol based on information currently available to it, including Cardiol’s ability to successfully initiate and complete patient enrollment in trials and to advance the subcutaneous formulation of CardiolRx™. This forward-looking information is based on certain assumptions and is also subject to a variety of known and unknown risks and uncertainties and other factors that could cause the actual events or results to differ materially from any future results, performance or achievements expressed or implied by the forward-looking information and are not (and should not be considered to be) guarantees of future performance. These risks and uncertainties and other factors include the risks and uncertainties referred to in the Company’s Annual Information Form dated March 23, 2022, as well as the risks and uncertainties associated with product commercialization and clinical studies. These assumptions, risks, uncertainties, and other factors should be considered carefully, and investors should not place undue reliance on the forward-looking information. Any forward-looking information speaks only as of the date on which it is made and, except as may be required by applicable securities laws, Cardiol disclaims any intent or obligation to update or revise such forward-looking information, whether as a result of new information, future events, or results, or otherwise.

For further information, please contact:

trevor.burns@cardiolrx.com

LANCER Trial expanded to include up to 20 Additional Clinical Research Centers

Oakville, ON – March 1, 2022 – Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) (“Cardiol” or the “Company”), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory therapies for the treatment of cardiovascular disease (“CVD”), today announced that it has received clearance from the FDA and regulatory agencies in Brazil and Mexico to modify the inclusion criteria for the LANCER trial to allow for, amongst other things, the enrollment of vaccinated patients. Commensurate with clearance to implement these important protocol amendments which will broaden the population of patients eligible for enrollment into LANCER, the Company also announced plans to expand the clinical trial infrastructure to include up to an additional 20 clinical research centers. LANCER is designed to evaluate the efficacy and safety of CardiolRx™ as a cardiopulmonary protective therapy to reduce mortality and major cardiovascular events in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, CVD, and to investigate the impact of CardiolRx™ on symptom recovery and key biomarkers associated with inflammatory heart disease.

The Company expects the LANCER trial to achieve over 50% patient recruitment by the end of the first half of 2022 and to complete full patient enrollment during the second half of 2022. In addition to expanding site recruitment, the Company, in consultation with the LANCER Steering Committee, has amended the trial protocol in response to the evolving understanding of COVID-19 and the current standard of care. These updates are expected to remove key barriers to participation in LANCER as well as expand the eligible patient pool and include the following: (i) vaccinated people may be enrolled; (ii) use of therapies approved for treatment of COVID-19 under an emergency use authorization label is permitted; and (iii) a prior history of smoking or obesity, both CVD risk factors prevalent in younger patients, will allow entry into the trial.  Furthermore, the Company expects Brazil to be a key contributor to patient enrollment given the country is approaching its winter season, the pace of vaccine booster administration is slow, and the pre-winter case rate is currently averaging approximately 100,000 per day.

“Given the compelling evidence demonstrating cannabidiol’s anti-inflammatory and cardiopulmonary protective properties, we believe CardiolRx™ has the potential to reduce a number of cardiopulmonary complications associated with COVID-19 infection. Interest in the LANCER trial remains strong, and Cardiol continues to activate new clinical research sites to accelerate patient recruitment,” stated Dr. Andrew Hamer, Chief Medical Officer of Cardiol Therapeutics. “The repeated waves of COVID-19 outbreaks coupled with inconsistent vaccine and vaccine booster uptake, underscore the need for therapeutics for high-risk patient populations, particularly those with significant CVD risk factors. Despite challenges resulting from ongoing changes to the standard of care, we are confident that the recently cleared protocol amendments will help ensure our LANCER patient enrollment targets are achieved.”

The LANCER trial was designed and is being overseen by an independent Steering Committee, consisting of international thought leaders in inflammatory heart disease. In addition to investigating the cardiopulmonary protective properties of CardiolRx™ in high-risk COVID-19 patients, the trial is expected to generate invaluable clinical data to further elucidate the therapeutic potential of CardiolRx™ in the treatment of other inflammatory cardiac disorders, including acute myocarditis and heart failure.

Patients with COVID-19 primarily present with respiratory symptoms which can progress to bilateral pneumonia and serious pulmonary complications. It is now recognized that the impact of the SARS-COV-2 virus that causes COVID-19 is not limited to the pulmonary system. Individuals with pre-existing CVD or who have CVD risk factors (such as diabetes, hypertension, obesity, smoking history, dyslipidemia, or age greater than 64) are at substantially greater risk for a more severe course and higher mortality.  Moreover, people who have had COVID-19 have an increased risk and burden for adverse cardiovascular outcomes (such as acute myocardial infarction, dysrhythmias, pulmonary embolism, pericarditis, myocarditis, stroke, and heart failure) up to one year following their COVID-19 diagnosis. A therapeutic strategy to prevent or limit the number or severity of both pulmonary and cardiovascular complications will improve the socioeconomic burden of this disease.

About Cardiol Therapeutics

Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) is a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory therapies for the treatment of cardiovascular disease (“CVD”). The Company’s lead product, CardiolRx™, is an oral cannabidiol formulation pharmaceutically manufactured under cGMP that is being investigated in a Phase II/III outcomes study (the LANCER trial). The LANCER trial is designed to evaluate the efficacy and safety of CardiolRx™ as a cardioprotective therapy to reduce mortality and major cardiovascular events in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, CVD, and to investigate the influence CardiolRx™ has on key markers of inflammatory heart disease.

Cardiol has also received clearance from the FDA for its Investigational New Drug application for a Phase II international trial that will investigate the anti-inflammatory and anti-fibrotic properties of CardiolRx™ in acute myocarditis, a condition caused by inflammation in heart tissue, which remains a leading cause of sudden cardiac death in people under 35 years of age. In addition, Cardiol is developing a subcutaneous formulation of CardiolRx™ for the treatment of inflammation in the heart that is associated with the development and progression of heart failure.

For more information about Cardiol Therapeutics, please visit cardiolrx.com.

Cautionary statement regarding forward-looking information:

This news release contains “forward-looking information” within the meaning of applicable securities laws. All statements, other than statements of historical fact, that address activities, events, or developments that Cardiol believes, expects, or anticipates will, may, could, or might occur in the future are “forward-looking information”. Forward looking information contained herein may include, but is not limited to, statements relating to the Company’s focus on developing innovative anti-inflammatory therapies for the treatment of CVD, plans to expand the clinical trial infrastructure to include up to an additional 20 clinical research centers, the expectation the LANCER trial will achieve over 50% patient recruitment by the end of the first half of 2022 and complete full patient enrollment during the second half of 2022, the expectation the updates will remove key barriers to participation in LANCER as well as expand the eligible patient pool, the expectation Brazil will be a key contributor to patient enrollment and the belief CardiolRx™ has the potential to reduce a number of cardiopulmonary complications associated with COVID-19 infection. Forward-looking information contained herein reflects the current expectations or beliefs of Cardiol based on information currently available to it and is based on certain assumptions and is also subject to a variety of known and unknown risks and uncertainties and other factors that could cause the actual events or results to differ materially from any future results, performance or achievements expressed or implied by the forward-looking information, and are not (and should not be considered to be) guarantees of future performance. These risks and uncertainties and other factors include the risks and uncertainties referred to in the Company’s Annual Information Form dated March 31, 2021, as well as the risks and uncertainties associated with product commercialization and clinical studies. These assumptions, risks, uncertainties, and other factors should be considered carefully, and investors should not place undue reliance on the forward-looking information. Any forward-looking information speaks only as of the date on which it is made and, except as may be required by applicable securities laws, Cardiol disclaims any intent or obligation to update or revise such forward-looking information, whether as a result of new information, future events, or results, or otherwise.

For further information, please contact:

trevor.burns@cardiolrx.com