Anti - inflammatory and anti - fibrotic therapies for heart disease
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Cardiol Therapeutics Secures US$11 Million Financing and Extends Cash Runway into Q3 2027
Newsfile· 2025-10-17 20:34
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].
Cardiol Therapeutics Announces Topline Results from the Phase II ARCHER Trial of CardiolRx(TM) in Acute Myocarditis
Newsfile· 2025-08-06 11:27
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]
Cardiol Therapeutics to Webcast Virtual Annual General Meeting of Shareholders on May 28th at 4:30 p.m. EDT
Newsfile· 2025-05-27 11:27
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 and is recognized for inhibiting the inflammasome pathway, which is crucial in inflammation and fibrosis related to myocarditis, pericarditis, and heart failure [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 [5] - The MAVERIC Program for recurrent pericarditis includes the completed Phase II MAvERIC-Pilot study and the ongoing Phase III MAVERIC trial [5] - The ongoing ARCHER trial is a Phase II study in acute myocarditis, a significant cause of heart failure and sudden cardiac death in young adults [5] 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 [6] Upcoming Events - The company's virtual Annual General Meeting (AGM) is scheduled for May 28, 2025, at 4:30 p.m. EDT, and will be accessible via live audio webcast [2][3]