Cardiol Therapeutics Completes US$11.4 Million Financing and Extends Cash Runway into Q3 2027October 21, 2025 7:27 AM EDT | Source: Cardiol Therapeutics Inc.MAVERIC Phase III pivotal trial of orphan drug candidate CardiolRx™ in recurrent pericarditis is fully funded through to a planned New Drug Application submission with the FDA.New data from the ARCHER trial, highlighting the magnitude of reduction in left ventricular (LV) mass and the read through to heart failure, to be presented at a car ...

Core Viewpoint - Cardiol Therapeutics has successfully completed a private placement offering, securing US$11 million in net proceeds to enhance its financial position and support the development of its heart failure drug, CRD-38, following promising results from its ARCHER trial [3][4]. Financing Details - The company completed an initial closing of US$10 million, with an additional US$1 million expected to close on October 20, 2025 [3]. - A total of 11 million units were sold at a price of US$1.00 per unit, with each unit consisting of one common share and one-half of a common share purchase warrant [4]. - The warrants allow the holder to acquire one additional common share at an exercise price of US$1.35 for 24 months, with an acceleration provision if the share price exceeds US$2.00 for five consecutive trading days [4]. Clinical Development - The funds will support operations into Q3 2027, enabling the advancement of the MAVERIC Phase III trial for CardiolRx™ and the development of the next-generation CRD-38 formulation [4][5]. - Topline results from the ARCHER trial indicated a significant reduction in left ventricular (LV) mass, marking a key clinical validation in treating inflammatory heart disease [4]. - The company aims to pursue an additional Orphan Drug Designation for CardiolRx™ in myocarditis, leveraging the ARCHER findings to target a broader heart failure market [4]. Market Context - Heart failure remains a significant health issue, with five-year mortality rates exceeding 50%, highlighting the clinical potential of Cardiol's therapies [4]. - The healthcare costs associated with heart failure in the U.S. exceed US$30 billion annually, indicating a substantial market opportunity for effective treatments [12].

Core Viewpoint - Cardiol Therapeutics Inc. is participating in Canaccord Genuity's 45th Annual Growth Conference, highlighting its focus on developing therapies for heart disease [1][2]. Company Overview - Cardiol Therapeutics Inc. is a clinical-stage life sciences company specializing in anti-inflammatory and anti-fibrotic therapies for heart disease [3]. - The company's lead drug candidate, CardiolRx™ (cannabidiol) oral solution, is in clinical development and aims to treat heart disease by inhibiting the inflammasome pathway [3][4]. Clinical Development - Cardiol has received Investigational New Drug Application authorization from the US FDA to conduct clinical studies for CardiolRx™ in recurrent pericarditis and acute myocarditis [4]. - The MAVERIC Program focuses on recurrent pericarditis, with a completed Phase II study and an ongoing Phase III trial [4]. - The completed ARCHER trial is a Phase II study in acute myocarditis, a significant cause of heart failure in young adults [4]. Additional Drug Development - Cardiol is also developing CRD-38, a novel subcutaneously administered drug formulation for heart failure, which is a leading cause of death and hospitalization, with healthcare costs in the US exceeding $30 billion annually [5].

Core Insights - Cardiol Therapeutics announced topline results from the Phase II ARCHER trial of CardiolRx™ in patients with acute myocarditis, showing a notable improvement in extracellular volume (ECV) compared to placebo [2][4] - The trial demonstrated safety and tolerability of CardiolRx™, supporting its advancement in clinical development for cardiomyopathies, heart failure, and myocarditis [2][5] Clinical Trial Results - The primary endpoints of the ARCHER trial were ECV and global longitudinal strain (GLS), with ECV showing significant improvement (p = 0.0538) after 12 weeks of treatment [2][4] - Improvements in ECV were associated with reductions in multiple cardiac magnetic resonance imaging (CMR) endpoints, including a significant reduction in left ventricular (LV) mass [4][5] - The trial enrolled 109 patients across multiple countries, including the United States, France, Brazil, and Israel [5][8] Company Overview - Cardiol Therapeutics is focused on developing anti-inflammatory and anti-fibrotic therapies for heart disease, with its lead drug candidate being CardiolRx™, a pharmaceutically manufactured cannabidiol oral solution [7][9] - The company has received FDA authorization for clinical studies evaluating CardiolRx™ in recurrent pericarditis and acute myocarditis, with ongoing Phase III trials [8][9] Industry Context - Acute myocarditis is a significant cause of heart failure and sudden cardiac death, particularly in individuals under 35 years of age, with no FDA-approved drug therapies currently available [6] - The healthcare costs associated with heart failure in the U.S. exceed $30 billion annually, highlighting the potential market for effective treatments [9]

Core Viewpoint - Cardiol Therapeutics has announced the database lock for its Phase II ARCHER trial of CardiolRx™ in patients with acute myocarditis, marking a significant milestone in the study and paving the way for statistical analysis and topline results expected within two weeks [2][3]. Company Overview - Cardiol Therapeutics Inc. is a clinical-stage life sciences company focused on developing anti-inflammatory and anti-fibrotic therapies for heart disease, with its lead asset being CardiolRx™, a cannabidiol oral solution [2][7]. - The company has received Investigational New Drug Application authorization from the US FDA to conduct clinical studies for CardiolRx™ in acute myocarditis and recurrent pericarditis [8]. Trial Details - The ARCHER trial is a Phase II multi-national, randomized, double-blind, placebo-controlled study investigating the safety and efficacy of CardiolRx™ on myocardial recovery in patients with acute myocarditis, enrolling over 100 patients from various countries [3][5]. - The primary outcome measures include cardiac magnetic resonance imaging parameters such as global longitudinal strain and extra-cellular volume, which are critical for assessing myocardial function and fibrosis [3][5]. Significance of Acute Myocarditis - Acute myocarditis is a serious cardiovascular condition with no FDA-approved pharmacological therapies, characterized by symptoms such as chest pain, shortness of breath, and fatigue, and can lead to severe complications including heart failure and sudden cardiac death [5][6]. - The condition is notably prevalent among younger populations, with viral infections being the most common cause [6]. Future Directions - Results from the ARCHER trial are anticipated to provide insights that will guide the broader development strategy for Cardiol Therapeutics, particularly in heart diseases where fibrosis is a significant factor [3][8]. - The company is also advancing its Phase III MAVERIC trial of CardiolRx™ in recurrent pericarditis, further emphasizing its commitment to addressing unmet medical needs in cardiovascular diseases [3][8].

Core Viewpoint - Cardiol Therapeutics has nominated Dr. Timothy Garnett, a veteran in the pharmaceutical industry, to its Board of Directors, which is expected to enhance the company's strategic vision and clinical development capabilities as it advances its heart disease therapies [1][3]. Company Overview - Cardiol Therapeutics Inc. is a clinical-stage life sciences company focused on developing anti-inflammatory and anti-fibrotic therapies for heart disease [4]. - The company's lead drug candidate, CardiolRx™ (cannabidiol) oral solution, is in clinical development for treating heart disease, specifically targeting inflammation and fibrosis associated with conditions like myocarditis and pericarditis [4][5]. Dr. Timothy Garnett's Background - Dr. Garnett has over 30 years of experience in the pharmaceutical industry, including 20 years at Eli Lilly, where he served as Chief Medical Officer from 2008 to 2021 [2]. - He has a proven track record in leading the development of therapeutics across various fields, including women's health, endocrinology, and neuroscience, resulting in multiple global commercial launches [2]. Clinical Trials and Drug Development - Cardiol has received Investigational New Drug Application authorization from the US FDA to conduct clinical studies for CardiolRx™ in recurrent pericarditis and acute myocarditis [5][6]. - The ongoing MAVERIC trial is a pivotal Phase III study for recurrent pericarditis, while the ARCHER trial is a Phase II study for acute myocarditis, which is a significant cause of heart failure in young adults [6]. Financial Context - Heart failure is a leading cause of death and hospitalization in developed countries, with associated healthcare costs in the US exceeding $30 billion annually [7].

Core Insights - Cardiol Therapeutics has initiated the pivotal Phase III MAVERIC trial to evaluate CardiolRx™ for preventing recurrent pericarditis, with the first patient enrolled at Northwestern University [3][4][6] - The trial is a multi-center, randomized, double-blind, placebo-controlled study designed to assess the efficacy of CardiolRx™ in patients at high risk for disease relapse [3][5][8] - CardiolRx™ has received Orphan Drug Designation from the US FDA and targets the inflammasome pathway, which is crucial in the development of pericarditis [6][12] Company Overview - Cardiol Therapeutics Inc. is a clinical-stage life sciences company focused on developing anti-inflammatory and anti-fibrotic therapies for heart disease [11] - The lead drug candidate, CardiolRx™, is an oral solution that aims to inhibit the inflammasome pathway, which is linked to inflammation and fibrosis in heart conditions [11][12] - The company has received FDA authorization for clinical studies evaluating CardiolRx™ in recurrent pericarditis and acute myocarditis [12] Trial Details - The MAVERIC trial aims to enroll 110 patients across approximately 20 clinical sites in the US, Canada, and Europe [8][9] - The primary objective is to evaluate the impact of CardiolRx™ on preventing new episodes of recurrent pericarditis at 24 weeks [8][9] - Previous Phase II data indicated significant reductions in pericarditis pain and inflammation, with a notable decrease in recurrence rates [6][9] Market Context - Recurrent pericarditis affects an estimated 38,000 patients annually in the US, with a significant portion experiencing multiple recurrences [10] - Current treatment options are limited, with the only FDA-approved therapy being costly and primarily used as a third-line intervention [10] - The trial addresses a critical need for new treatment options earlier in the care pathway for patients suffering from this debilitating condition [5][10]

Core Insights - Cardiol Therapeutics has reported positive data from the Phase II MAvERIC-Pilot study, supporting the advancement to the Phase III MAVERIC trial for CardiolRx™ in recurrent pericarditis [1][2] - The company completed patient enrollment in the Phase II ARCHER trial for acute myocarditis, with topline data expected in Q2 2025 [1][9] - CardiolRx™ has received Orphan Drug Designation from the U.S. FDA for the treatment of pericarditis, including recurrent cases [3][11] - As of December 31, 2024, the company has cash and cash equivalents of $30.6 million, which is projected to fund operations into Q3 2026 [1][7] MAvERIC Program in Recurrent Pericarditis - CardiolRx™ was granted Orphan Drug Designation in February 2024, addressing a significant unmet need in recurrent pericarditis, which affects approximately 160,000 individuals annually in the U.S. [3][11] - The Phase II MAvERIC-Pilot study demonstrated a marked reduction in pericarditis pain and inflammation, with results presented at the AHA 2024 [2][3] - The Phase III MAVERIC trial will enroll 110 patients at high risk for disease recurrence, focusing on the impact of CardiolRx™ versus placebo [4][11] ARCHER Trial in Acute Myocarditis - The ARCHER trial has completed patient enrollment with over 100 participants across multiple countries, and topline results are expected in Q2 2025 [9][11] - The trial's primary outcome measures include myocardial magnetic resonance imaging parameters, which are critical for assessing heart dysfunction and prognosis in acute myocarditis [9][11] CRD-38 Pre-Clinical Development - Cardiol is developing CRD-38, a subcutaneously administered formulation intended for heart failure treatment, with promising pre-clinical data published in the Journal of the American College of Cardiology [9][14] - The research indicates that CRD-38 may provide cardioprotection by improving cardiac function and reducing inflammation [9][14] Capital Management - Cardiol successfully closed a public offering in October 2024, raising gross proceeds of approximately $15.5 million [7] - The current cash position is expected to support operations and capital requirements through Q3 2026 [7] Outlook - The company anticipates significant milestones in the next 12-18 months, including the enrollment of the first patient in the Phase III MAVERIC trial [8] - The MAVERIC trial is designed in collaboration with global experts and aims to support a New Drug Application with the FDA [8]