Summary of Cardiol Therapeutics (CRDL) FY Conference Call Company Overview - Cardiol Therapeutics focuses on developing anti-inflammatory strategies for heart disease, including conditions like pericarditis, myocarditis, and heart failure [5][8] - The lead program, MAVERICK, is a pivotal phase three trial currently enrolling patients in the United States, with plans to expand to Europe and Canada [5][6] - A second late-stage program, Archer, targets acute myocarditis, a life-threatening condition with no current standard of care [6][8] - Cardiol is also developing a subcutaneous asset for heart failure, particularly diastolic heart failure, which is a growing epidemic [6][8] Key Programs and Data - **MAVERICK Program**: Aims to support a new drug application based on strong phase two trial data presented at the American Heart Association [5][6] - **Archer Program**: Recently reported top-line data showing significant impacts on MRI measures related to prognosis and outcomes in acute myocarditis [6][28] - **Heart Failure**: Affects approximately 6 million Americans and is a leading cause of hospital admissions [8] Regulatory and Market Positioning - CardiolRx for recurrent pericarditis aims to replace corticosteroids, targeting a population with a 75% recurrence rate within three months after stopping IL-1 blockers [12][17] - The company has received orphan drug designation for recurrent pericarditis, which includes a subset of about 40,000 patients [8][12] - The regulatory path for CardiolRx is considered clear due to established precedents from competing drugs [21][22] Clinical Insights and Expert Involvement - The trial design for CardiolRx was informed by a steering committee of global leaders in pericarditis, enhancing credibility and potential for success [14][16] - Experts in myocarditis have expressed strong support for advancing the drug, indicating its potential in other inflammatory cardiac conditions [28][36] Financial and Market Implications - Heart failure treatment costs in the U.S. exceed $40 billion annually, with costs expected to rise [36] - The company is exploring partnerships with well-capitalized pharmaceutical firms to accelerate the development of its assets, particularly CRD38 for heart failure [40][43] Delivery and Administration - The lead API is designed for subcutaneous delivery, utilizing a proprietary solvent system that allows for easy administration [45][48] - This delivery method is expected to improve patient access and adherence compared to existing treatments [45][49] Conclusion - Cardiol Therapeutics is positioned as a significant player in the cardiovascular space, with innovative therapies targeting unmet medical needs in heart disease [50]

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 Topline Results from the Phase II ARCHER Trial of CardiolRx(TM) in Acute Myocarditis "We are delighted with the ARCHER trial results," said David Elsley, President and Chief Executive Officer of Cardiol Therapeutics. "We initiated this ambitious study—focused on a potentially life-threatening cardiac disorder for which there is no established standard of care—to further investigate the therapeutic potential of CardiolRx in inflammatory heart disease. We are thrilled to observe ...

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 ...

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]