Core Insights - Cardiol Therapeutics presented positive results from its Phase II MAvERIC-Pilot study, demonstrating significant reductions in pericarditis pain and inflammation over a 26-week period [1][2][9] - The findings support the advancement of CardiolRx™ into Phase II/III MAVERIC-2 and Phase III MAVERIC-3 clinical trials [1][9] Study Results - The MAvERIC-Pilot study involved 27 participants with an average age of 53 years, showing a mean reduction in pericarditis pain from 5.8 at baseline to 2.1 at week 8, and further to 1.5 at week 26 [2][4][5] - 93% of patients reported a reduction in pain at week 8, and 80% of patients with elevated C-reactive protein (CRP) levels normalized their CRP by week 8 [6][8] - The number of pericarditis episodes per year decreased from an average of 5.8 prior to the study to 0.9 during the study [7] Safety and Tolerability - CardiolRx™ was reported to be safe and well tolerated, with 89% of patients progressing to the extension period and an overall study drug compliance of 95% [8][9] Future Trials - The results from MAvERIC-Pilot support the initiation of the MAVERIC-3 trial, which aims to assess CardiolRx™ for preventing recurrence in pericarditis patients [1][9] - The MAVERIC-2 trial will evaluate the impact of CardiolRx™ in recurrent pericarditis patients after stopping interleukin-1 blocker therapy [1][9]

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 candidate being CardiolRx, an oral solution of cannabidiol [5][6] - The company is debt-free and well-capitalized to achieve its corporate milestones into 2026 [4] Product Development - CardiolRx has received Orphan Drug Designation from the US FDA for the treatment of pericarditis, including recurrent pericarditis, which affects approximately 38,000 patients annually in the United States [2][3][6] - The MAVERIC Program for recurrent pericarditis includes the Phase II MAvERIC-Pilot study, the Phase II/III MAVERIC-2 trial, and the planned Phase III MAVERIC-3 trial, with MAVERIC-2 expected to initiate in Q4 2024 [2][6] - Cardiol is also advancing CRD-38, a proprietary subcutaneously administered therapy for heart failure, a leading cause of death and hospitalization in developed countries [4][7] Market Insights - The global pericarditis market was valued at $2.44 billion in 2023 and is projected to grow at a CAGR of 5.24%, reaching $3.87 billion by 2032 [3] - Healthcare costs associated with heart failure in the United States exceed $30 billion annually [7] Industry Recognition - Cardiol Therapeutics has been added to the PRISM Emerging Biotech Index, highlighting its role in innovation and market impact within the biotech sector [1]

Core Viewpoint - Cardiol Therapeutics is advancing its lead drug candidate CardiolRx™ into a late-stage clinical trial (MAVERIC-2) to evaluate its efficacy in patients with recurrent pericarditis after stopping interleukin-1 blocker therapy, aiming for accelerated regulatory approval [1][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 drug candidate being CardiolRx™, an oral solution of cannabidiol [7][8] Clinical Development - The MAVERIC-2 trial will be a randomized, double-blind, placebo-controlled Phase II/III study involving approximately 110 patients, assessing the impact of CardiolRx™ on freedom from recurrent pericarditis episodes after IL-1 blocker cessation [3][4] - The trial is expected to start in Q4 2024 at major pericardial disease centers in the U.S. and Europe, with results anticipated before the pivotal Phase III study (MAVERIC-3) [2][3] Scientific Rationale - IL-1 is a key pro-inflammatory cytokine in recurrent pericarditis, and current IL-1 blockers are costly and associated with immunosuppressive risks, leading to high recurrence rates of up to 75% after treatment cessation [4][5] - CardiolRx™ has shown potential in inhibiting the NLRP3 inflammasome and reducing pericarditis pain, offering a non-immunosuppressive alternative for patients intolerant to existing therapies [5][6] Previous Study Results - The MAvERIC-Pilot study demonstrated significant efficacy, with 80% of patients normalizing inflammation (CRP levels) and a substantial reduction in pericarditis pain reported at the end of the 8-week treatment period [5][6] - Full clinical data from the MAvERIC-Pilot study will be presented at the American Heart Association Scientific Sessions 2024, including outcomes related to recurrence and safety [5][6] Market Context - The only FDA-approved therapy for recurrent pericarditis is costly and primarily used as a third-line intervention, with an estimated 38,000 patients in the U.S. experiencing at least one recurrence annually [6][8] - Hospitalization costs for recurrent pericarditis range from $20,000 to $30,000 per stay, highlighting the need for more accessible treatment options [6][8]

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Oakville, Ontario--(Newsfile Corp. - October 11, 2024) - 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 and anti-fibrotic therapies for the treatment of heart disease, is pleased to announce that, further to its successfully completed public offering of an aggregate of 8,437,500 Class A common shares of the Company (the "Common Shares") at a price to the public of ...

Core Viewpoint - Cardiol Therapeutics Inc. has successfully closed a public offering of 8,437,500 Class A common shares, raising gross proceeds of US$13.5 million to support its clinical development efforts [2][3][4]. Group 1: Offering Details - The offering was priced at US$1.60 per common share, resulting in gross proceeds of US$13.5 million before deductions [3]. - Canaccord Genuity acted as the sole bookrunner for the offering [4]. - The offering was conducted under a U.S. registration statement declared effective on July 16, 2024, and a Canadian short form base shelf prospectus dated July 12, 2024 [5]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized to support the clinical development of CardiolRx for the treatment of recurrent pericarditis, as well as for general and administrative expenses and working capital [4]. Group 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 [8].

Core Viewpoint - Cardiol Therapeutics Inc. has announced the pricing of a public offering of 8,437,500 Class A common shares at a price of US$1.60 per share, aiming to raise gross proceeds of US$13.5 million before expenses [2][3]. Group 1: Offering Details - The public offering consists of 8,437,500 Class A common shares priced at US$1.60 each, with expected gross proceeds of US$13.5 million [2]. - The net proceeds will be utilized for the clinical development of CardiolRx for recurrent pericarditis, as well as for general administrative expenses and working capital [3]. - The offering is anticipated to close on or about October 10, 2024, subject to customary closing conditions [4]. Group 2: Regulatory and Documentation - The offering is conducted under a U.S. registration statement declared effective by the SEC on July 16, 2024, and an existing Canadian short form base shelf prospectus dated July 12, 2024 [5]. - A preliminary prospectus supplement has been filed with securities commissions in Canada (excluding Quebec) and with the SEC in the U.S., with a final prospectus supplement to follow [5][6]. Group 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 [8].

Core Viewpoint - Cardiol Therapeutics Inc. has filed a preliminary prospectus supplement for a proposed public offering of Class A common shares to support the clinical development of its anti-inflammatory and anti-fibrotic therapies for heart disease [3][4]. Group 1: Offering Details - The offering is part of a registration statement declared effective by the SEC on July 16, 2024, under the Multijurisdictional Disclosure System between Canada and the United States [3]. - The net proceeds from the offering will be used for the clinical development of CardiolRx for recurrent pericarditis, as well as for general administrative expenses and working capital [4]. - Canaccord Genuity is acting as the sole bookrunner for the offering, which will be priced based on market conditions [4][5]. Group 2: Regulatory and Compliance - The closing of the offering is subject to customary conditions, including the listing of the common shares on the Toronto Stock Exchange and the Nasdaq, along with any required approvals [5]. - The preliminary prospectus supplement and accompanying base prospectus contain detailed information about the offering and can be accessed on SEDAR+ and EDGAR [6].

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [1][2] - The news team operates from key finance and investing hubs including London, New York, Toronto, Vancouver, Sydney, and Perth [2] - Proactive focuses on medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [2][3] Group 2 - The team delivers news and insights across various sectors including biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] - Proactive adopts technology to enhance workflows and improve content delivery, utilizing decades of expertise [3][4] - All content published by Proactive is edited and authored by humans, ensuring adherence to best practices in content production [4]

Core Insights - Cardiol Therapeutics has completed the MAvERIC Phase II study for recurrent pericarditis, with results to be presented at the American Heart Association Scientific Sessions 2024 on November 18, 2024 [2][3][4] Company Overview - Cardiol Therapeutics Inc. is a clinical-stage life sciences company focused on developing anti-inflammatory and anti-fibrotic therapies for heart disease [7][8] - The company's lead drug candidate, CardiolRx™, is an oral solution of cannabidiol aimed at treating heart disease by inhibiting inflammation and fibrosis [7][8] Study Details - The MAvERIC-Pilot study involved 27 adult participants with symptomatic recurrent pericarditis, assessing the efficacy of CardiolRx™ over an 8-week treatment period followed by an 18-week extension [5] - The primary endpoint was the change in patient-reported pericarditis pain from baseline to 8 weeks, with secondary endpoints including pain scores at 26 weeks and freedom from recurrence during the extension period [5] Clinical Significance - Recurrent pericarditis affects approximately 38,000 patients annually in the U.S., with significant impacts on quality of life and healthcare costs [6] - The only FDA-approved therapy for this condition is costly and primarily used as a third-line treatment, highlighting the need for more accessible options like CardiolRx™ [6] Future Plans - The company anticipates that the full clinical results from the MAvERIC-Pilot study will support plans to advance to a Phase III trial of CardiolRx™ [4][11] - Cardiol Therapeutics is also developing CRD-38, a novel subcutaneous formulation intended for use in heart failure, addressing a major healthcare challenge with significant costs [9]