Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) is a clinical-stage life sciences company focused on developing anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease. The Company's lead small molecule drug candidate, CardiolRx™ (cannabidiol) oral solution, is pharmaceutically manufactured and in clinical development for use in the treatment of heart disease. It is recognized that cannabidiol inhibits activation of the inflammasome pathway, an intracellular process known to pl ...

Cardiol Therapeutics Announces Database Lock for Phase II ARCHER Trial of CardiolRx(TM) in Acute Myocarditis July 22, 2025 7:27 AM EDT | Source: Cardiol Therapeutics Inc. Toronto, Ontario--(Newsfile Corp. - July 22, 2025) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on developing anti- inflammatory and anti-fibrotic therapies for the treatment of heart disease, today announced database lock for ARCHER, the Company's Phase ...

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]