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].

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]

[Financial Statements](index=1&type=section&id=Financial%20Statements) [Condensed Interim Consolidated Statements of Financial Position](index=2&type=section&id=Condensed%20Interim%20Consolidated%20Financial%20Statements) As of March 31, 2025, total assets decreased to $25.5 million from $31.9 million at the end of 2024, primarily due to reduced cash and cash equivalents, while total liabilities slightly increased to $7.9 million and total equity significantly decreased to $17.6 million due to net loss Consolidated Balance Sheet Summary (unaudited) | Balance Sheet Items | March 31, 2025 ($) | December 31, 2024 ($) | | :--- | :--- | :--- | | **Current Assets** | | | | Cash and cash equivalents | 23,292,701 | 30,580,029 | | Total current assets | 25,272,350 | 31,668,159 | | **Total Assets** | **25,454,895** | **31,863,751** | | **Current Liabilities** | | | | Accounts payable and accrued liabilities | 7,716,431 | 6,976,736 | | Total current liabilities | 7,750,683 | 7,009,745 | | **Total Liabilities** | **7,867,091** | **7,135,268** | | **Total Equity** | **17,587,804** | **24,728,483** | [Condensed Interim Consolidated Statements of Loss and Comprehensive Loss](index=3&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Loss%20and%20Comprehensive%20Loss) For the three months ended March 31, 2025, the company reported a net loss of $8.3 million, an improvement from the $9.2 million net loss in the same period of 2024, primarily due to the absence of a significant loss from derivative liability Statement of Loss Summary (unaudited) | Income Statement Items | Three Months Ended Mar 31, 2025 ($) | Three Months Ended Mar 31, 2024 ($) | | :--- | :--- | :--- | | General and administration | 4,671,651 | 5,082,552 | | Research and development | 3,757,412 | 3,322,929 | | Loss before other income (expenses) | (8,429,063) | (8,405,481) | | **Net loss and comprehensive loss** | **(8,287,653)** | **(9,179,632)** | | **Basic and diluted net loss per share** | **(0.10)** | **(0.14)** | [Condensed Interim Consolidated Statements of Cash Flows](index=4&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Cash%20Flows) In Q1 2025, net cash used in operating activities increased slightly to $7.2 million, with minimal investing and financing activities, resulting in cash and cash equivalents decreasing to $23.3 million from $30.6 million Cash Flow Summary (unaudited) | Cash Flow Items | Three Months Ended Mar 31, 2025 ($) | Three Months Ended Mar 31, 2024 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | (7,153,767) | (6,922,793) | | Net cash used in investing activities | (11,939) | (3,460) | | Net cash provided by (used in) financing activities | (13,844) | 76,353 | | **Net change in cash and cash equivalents** | **(7,179,550)** | **(6,849,900)** | | Cash and cash equivalents, beginning of period | 30,580,029 | 34,931,778 | | **Cash and cash equivalents, end of period** | **23,292,701** | **28,572,975** | [Condensed Interim Consolidated Statements of Changes in Equity](index=5&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Changes%20in%20Equity) Total equity decreased from $24.7 million at the end of 2024 to $17.6 million as of March 31, 2025, primarily due to the $8.3 million net loss, partially offset by $1.1 million in share-based compensation Changes in Equity Summary (unaudited) | Equity Items | Three Months Ended Mar 31, 2025 ($) | | :--- | :--- | | Balance, December 31, 2024 | 24,728,483 | | Share-based compensation | 1,146,974 | | Net loss and comprehensive loss for the period | (8,287,653) | | **Balance, March 31, 2025** | **17,587,804** | [Notes to Condensed Interim Consolidated Financial Statements](index=6&type=section&id=Notes%20to%20Condensed%20Interim%20Consolidated%20Financial%20Statements) [1. Nature of operations](index=6&type=section&id=1.%20Nature%20of%20operations) 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 CardiolRx™ trading on the TSX and Nasdaq under 'CRDL' - The company is a clinical-stage life sciences entity focused on developing treatments for heart disease[11](index=11&type=chunk) - The lead drug candidate is CardiolRx™ (cannabidiol) oral solution, which is currently in clinical development[11](index=11&type=chunk) - The company's common shares are listed on the TSX and The Nasdaq Capital Market under the ticker 'CRDL'[12](index=12&type=chunk) [2. Material accounting policy information](index=6&type=section&id=2.%20Material%20accounting%20policy%20information) The unaudited condensed interim consolidated financial statements were prepared in accordance with International Accounting Standard 34 (IAS 34), Interim Financial Reporting, with consistent accounting policies and computation methods as the 2024 annual financial statements - The financial statements adhere to International Accounting Standard 34, Interim Financial Reporting[13](index=13&type=chunk) - Accounting policies are consistent with the annual consolidated financial statements for the year ended December 31, 2024[15](index=15&type=chunk) [6. Derivative liability](index=8&type=section&id=6.%20Derivative%20liability) The derivative liability related to 8,175,000 warrants issued in November 2021 is no longer on the balance sheet as they expired unexercised during 2024, eliminating the $1.8 million non-cash revaluation expense seen in Q1 2024 - The **8,175,000** warrants previously classified as a derivative liability expired unexercised during 2024[20](index=20&type=chunk) - In Q1 2024, the company recorded a **$1.8 million** loss from the change in value of this derivative liability; this expense was absent in Q1 2025[20](index=20&type=chunk) [7. Share capital](index=8&type=section&id=7.%20Share%20capital) As of March 31, 2025, the company's authorized share capital consists of an unlimited number of common shares, with the number of issued and outstanding common shares remaining unchanged at 82,608,992 during Q1 2025 Common Shares Issued | Date | Number of common shares | Amount ($) | | :--- | :--- | :--- | | Balance, Dec 31, 2024 | 82,608,992 | 179,335,421 | | **Balance, Mar 31, 2025** | **82,608,992** | **179,335,421** | [8. Share-based payments](index=8&type=section&id=8.%20Share-based%20payments) The company recorded $1.15 million in share-based compensation expenses in Q1 2025, an increase from $0.90 million in Q1 2024, driven by the issuance of 1.2 million new stock options and an increase in outstanding stock options to 2.52 million - Total share-based compensation expense for Q1 2025 was **$1,146,974**, compared to **$902,100** for Q1 2024[24](index=24&type=chunk) [Stock Options](index=9&type=section&id=8.1%20Stock%20Options) Stock Option Activity | | Number of stock options | Weighted average exercise price ($) | | :--- | :--- | :--- | | Balance, Dec 31, 2024 | 1,487,500 | 2.76 | | Issued | 1,200,000 | 1.63 | | Expired | (170,000) | 2.68 | | **Balance, Mar 31, 2025** | **2,517,500** | **2.22** | [Performance Share Units (PSUs)](index=10&type=section&id=8.2%20Performance%20Share%20Units) - There were no outstanding Performance Share Units (PSUs) as of December 31, 2024, and March 31, 2025[29](index=29&type=chunk) - Subsequent to the quarter end, **74,000** PSUs were granted[30](index=30&type=chunk) [Restricted Share Units (RSUs)](index=11&type=section&id=8.3%20Restricted%20Share%20Units) - The number of outstanding Restricted Share Units (RSUs) remained unchanged at **4,852,299** during Q1 2025[32](index=32&type=chunk) - As of March 31, 2025, there were **4,852,299** RSUs outstanding, of which **2,157,715** were vested and exercisable[33](index=33&type=chunk) [9. Warrants](index=11&type=section&id=9.%20Warrants) As of March 31, 2025, the company had no warrants outstanding, as the previous balance of 11,628,178 warrants expired during 2024 - The company had no warrants outstanding as of March 31, 2025[34](index=34&type=chunk) [10. Loss per share](index=11&type=section&id=10.%20Loss%20per%20share) The basic and diluted loss per share for Q1 2025 was $0.10, an improvement from $0.14 per share in Q1 2024, based on an $8.3 million net loss and 82.6 million weighted average shares outstanding Loss Per Share Calculation | Metric | Three Months Ended Mar 31, 2025 ($) | Three Months Ended Mar 31, 2024 ($) | | :--- | :--- | :--- | | Net loss ($) | (8,287,653) | (9,179,632) | | Weighted average shares | 82,608,992 | 67,259,344 | | **Loss per share ($)** | **(0.10)** | **(0.14)** | [11. Commitments](index=12&type=section&id=11.%20Commitments) The company has future commitments totaling approximately $2.25 million, including $384,211 for leased premises, $197,969 for consultant services, and $1.66 million for contract research services, all extending through 2028 Summary of Financial Commitments | Commitment Type | Total Amount ($) | | :--- | :--- | | Leased Premises (through 2028) | 384,211 | | Consultant Services (2025) | 197,969 | | Contract Research Services (through 2028) | 1,663,063 | [13. Related party transactions](index=13&type=section&id=13.%20Related%20party%20transactions) Remuneration for key management personnel, including directors, totaled $1.77 million in Q1 2025, an increase from $1.39 million in Q1 2024, primarily driven by higher share-based payments Key Management Remuneration | Compensation Type | Three Months Ended Mar 31, 2025 ($) | Three Months Ended Mar 31, 2024 ($) | | :--- | :--- | :--- | | Salaries and benefits | 1,305,013 | 1,264,404 | | Share-based payments | 468,960 | 121,440 | | **Total** | **1,773,973** | **1,385,844** |

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]

Core Viewpoint - Cardiol Therapeutics has published research supporting its proprietary subcutaneous drug candidate, CRD-38, for treating heart failure, demonstrating improvements in cardiac function and reductions in key mechanisms of heart failure such as cardiac hypertrophy and inflammation [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 [6][8] - The company has received Investigational New Drug Application authorization from the US FDA to conduct clinical studies for CardiolRx™ in recurrent pericarditis and acute myocarditis [7] Research Findings - The research published in the Journal of the American College of Cardiology indicates that CRD-38, a subcutaneous formulation of cannabidiol, can prevent heart failure dysfunction and remodeling by preserving mitochondrial function and calcium handling [2][3] - The study highlights that subcutaneous administration of cannabidiol resulted in reduced cardiac fibrosis, hypertrophy, and inflammation, while improving ejection fraction and cardiac output [10] Mechanism of Action - The cardioprotective effects of CRD-38 are attributed to its ability to sustain cardiomyocytes and preserve mitochondrial function, which is crucial for energy production in cardiac cells [3][5] - The research suggests that the cardioprotective effect may involve activation of peroxisome proliferator-activated receptor gamma (PPAR-γ), which helps in maintaining mitochondrial function and redox balance [10]

Company Overview - Cardiol Therapeutics Inc. is a clinical-stage life sciences company focused on developing anti-inflammatory and anti-fibrotic therapies for heart disease [3] - The company's lead drug candidate, CardiolRx™, is an oral solution containing cannabidiol, which is in clinical development for treating heart disease [3] Clinical Development - CardiolRx™ is entering a late-stage Phase III clinical trial named MAVERIC, targeting patients with recurrent pericarditis who are at high risk for recurrence [2] - The MAVERIC Program includes the Phase II MAvERIC-Pilot study, the Phase II/III MAVERIC-2 trial, and the planned Phase III MAVERIC-3 trial for recurrent pericarditis [4] - The company has also initiated the ARCHER trial, a Phase II study in acute myocarditis, which is a significant cause of heart failure and sudden cardiac death in young adults [4] Market Opportunity - The market for recurrent pericarditis is estimated to be worth $1 billion, presenting a significant opportunity for CardiolRx™ to transform heart disease care [2] - CardiolRx™ is positioned to fill critical gaps in current treatment options, potentially offering a safer, more cost-effective, and disease-modifying solution for patients [2] Regulatory Status - Cardiol Therapeutics 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 US FDA has granted Orphan Drug Designation to CardiolRx™ for the treatment of pericarditis, including recurrent pericarditis [4] Financial Position - The company is focused on maintaining a strong financial position to support its clinical development programs and upcoming milestones [2]