Cardiol Therapeutics Completes US$11.4 Million Financing and Extends Cash Runway into Q3 2027October 21, 2025 7:27 AM EDT | Source: Cardiol Therapeutics Inc.MAVERIC Phase III pivotal trial of orphan drug candidate CardiolRx™ in recurrent pericarditis is fully funded through to a planned New Drug Application submission with the FDA.New data from the ARCHER trial, highlighting the magnitude of reduction in left ventricular (LV) mass and the read through to heart failure, to be presented at a car ...

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].

Core Viewpoint - The drug and biotech sector is experiencing a recovery driven by a landmark drug-pricing deal between Pfizer and the Trump administration, which includes tariff exemptions and price cuts, alongside increased M&A activity in the sector [1]. Group 1: Industry Overview - The Zacks Medical-Drugs industry consists of small to medium-sized drug companies that primarily focus on developing medicines, often relying on collaborations with larger firms for revenue [3]. - The industry is currently ranked 68 in the Zacks Industry Rank, placing it in the top 28% of 243 Zacks industries, indicating strong prospects for growth [9]. Group 2: Market Performance - The Zacks Medical-Drugs industry has seen a year-to-date stock increase of 6.2%, outperforming the Zacks Medical sector, which decreased by 0.2%, but underperforming the S&P 500, which rose by 12.2% [11]. - The industry is trading at a trailing 12-month price-to-sales ratio of 2.37, lower than the S&P 500's 5.82 and the Zacks Medical sector's 2.45 [13]. Group 3: Key Trends and Innovations - There is a strong focus on innovation in areas such as rare diseases, next-generation oncology treatments, obesity, immunology, and neuroscience, which are attracting investor interest [5]. - Investment in technology and personalized medicine is crucial for smaller companies to adapt to the evolving healthcare landscape [7]. Group 4: Company Highlights - **Ironwood Pharmaceuticals**: The company is advancing its key pipeline candidate, apraglutide, for treating short bowel syndrome, with a stock increase of 115.5% in the past three months [16][17]. - **Pyxis Oncology**: The company is progressing with its lead candidate, micvotabart pelidotin, for treating head and neck cancer, with a stock increase of 197.4% in the past three months [20][21]. - **Plus Therapeutics**: Focused on targeted radiotherapeutics for CNS cancers, the company has seen its stock rise by 113.6% in the past three months [24][26]. - **Cardiol Therapeutics**: Developing CardiolRx for heart disease, the company has experienced an 18.6% decline in stock over the past three months [29][31]. - **Akebia Therapeutics**: The company launched Vafseo for anemia due to chronic kidney disease, but its stock has declined by 28.3% in the past three months [33][34].

[Financial Statements](index=2&type=section&id=Financial%20Statements) This section presents the condensed interim consolidated financial statements, including statements of financial position, loss and comprehensive loss, cash flows, and changes in equity, for the periods ended June 30, 2025 [Condensed Interim Consolidated Statements of Financial Position](index=2&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Financial%20Position) As of June 30, 2025, Cardiol Therapeutics Inc. reported a decrease in total assets and total equity compared to December 31, 2024, while total liabilities increased. Cash and cash equivalents significantly declined | Metric | June 30, 2025 (CAD) | December 31, 2024 (CAD) | | :-------------------------------- | :-------------------- | :---------------------- | | Cash and cash equivalents | $18,195,052 | $30,580,029 | | Total current assets | $19,774,185 | $31,668,159 | | Total assets | $19,937,699 | $31,863,751 | | Total current liabilities | $8,022,826 | $7,009,745 | | Total liabilities | $8,129,824 | $7,135,268 | | Total equity | $11,807,875 | $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 six months ended June 30, 2025, the company reported an increased net loss compared to the same period in 2024, primarily driven by changes in foreign exchange and the absence of derivative liability changes seen in the prior year. Basic and diluted net loss per share decreased | Metric (Six Months Ended June 30) | 2025 (CAD) | 2024 (CAD) | Change (YoY) | | :-------------------------------- | :------------ | :------------ | :----------- | | General and administration | $9,616,128 | $10,114,254 | -4.92% | | Research and development | $6,489,093 | $6,032,573 | +7.57% | | Loss before other income | $(16,105,221) | $(16,146,827) | -0.26% | | Interest income | $428,936 | $684,703 | -37.35% | | Gain (loss) on foreign exchange | $(965,739) | $780,952 | N/A | | Change in derivative liability | $- | $(1,117,556) | N/A | | Net loss and comprehensive loss | $(16,642,024) | $(15,770,505) | +5.53% | | Basic and diluted net loss per share | $(0.20) | $(0.23) | -13.04% | [Condensed Interim Consolidated Statements of Cash Flows](index=4&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2025, net cash used in operating activities remained stable year-over-year, while cash used in investing activities increased. Net cash provided by financing activities significantly decreased, leading to a larger net change in cash and cash equivalents | Metric (Six Months Ended June 30) | 2025 (CAD) | 2024 (CAD) | Change (YoY) | | :-------------------------------- | :------------ | :------------ | :----------- | | Net cash used in operating activities | $(11,704,341) | $(11,698,496) | +0.05% | | Net cash used in investing activities | $(18,378) | $(7,260) | +153.14% | | Net cash provided by financing activities | $6,572 | $154,437 | -95.75% | | Net change in cash and cash equivalents | $(11,716,147) | $(11,551,319) | +1.43% | | Cash and cash equivalents, end of period | $18,195,052 | $24,021,237 | -24.25% | [Condensed Interim Consolidated Statements of Changes in Equity](index=5&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Changes%20in%20Equity) Total equity decreased significantly from December 31, 2024, to June 30, 2025, primarily due to the net loss for the period, partially offset by share-based compensation and proceeds from stock option exercises Total Equity as of June 30, 2025 | Metric (As of June 30, 2025) | Amount (CAD) | | :----------------------------- | :----------- | | Share capital | $179,538,695 | | Contributed surplus | $28,165,305 | | Deficit | $(195,896,125) | | Total equity | $11,807,875 | - Total equity decreased from **$24,728,483** at December 31, 2024, to **$11,807,875** at June 30, 2025, mainly due to a net loss of **$16,642,024** for the period, partially offset by **$3,687,156** in share-based compensation and **$34,260** from stock options exercised[8](index=8&type=chunk) [Notes to Condensed Interim Consolidated Financial Statements](index=6&type=section&id=Notes%20to%20Condensed%20Interim%20Consolidated%20Financial%20Statements) This section provides detailed disclosures on the company's operations, accounting policies, and specific financial statement line items, including cash, property, liabilities, equity, and commitments [Note 1. Nature of operations](index=6&type=section&id=Note%201.%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™, in clinical development. The company's common shares are listed on the Toronto Stock Exchange (TSX) and The Nasdaq Capital Market (Nasdaq) under the symbol "CRDL" - Cardiol Therapeutics Inc. is a clinical-stage life sciences company developing anti-inflammatory and anti-fibrotic therapies for heart disease, with CardiolRx™ (cannabidiol) oral solution as its lead drug candidate[11](index=11&type=chunk) - The Corporation's common shares trade on the Toronto Stock Exchange (TSX) and The Nasdaq Capital Market under the symbol "**CRDL**"[12](index=12&type=chunk) [Note 2. Material accounting policy information](index=6&type=section&id=Note%202.%20Material%20accounting%20policy%20information) These unaudited condensed interim consolidated financial statements comply with International Accounting Standard 34, Interim Financial Reporting, and are prepared on a historical cost and accrual basis. The accounting policies are consistent with the most recent annual consolidated financial statements as of December 31, 2024 - The financial statements are prepared in accordance with International Accounting Standard 34, Interim Financial Reporting, and do not include all information required for full annual financial statements under IFRS Accounting Standards[13](index=13&type=chunk) - Statements are prepared on a historical cost basis using the accrual basis of accounting, except for cash flow information[14](index=14&type=chunk) - Accounting policies and methods are consistent with the annual consolidated financial statements for the year ended December 31, 2024[15](index=15&type=chunk) [Note 3. Cash and cash equivalents](index=6&type=section&id=Note%203.%20Cash%20and%20cash%20equivalents) Interest income earned on cash and cash equivalents decreased for both the three and six months ended June 30, 2025, compared to the same periods in 2024 Interest Income on Cash and Cash Equivalents | Period Ended June 30 | 2025 (CAD) | 2024 (CAD) | | :------------------- | :--------- | :--------- | | Three months | $180,667 | $307,409 | | Six months | $428,936 | $684,703 | [Note 4. Property and equipment](index=7&type=section&id=Note%204.%20Property%20and%20equipment) The carrying value of property and equipment decreased from $195,592 at December 31, 2024, to $163,514 at June 30, 2025, primarily due to depreciation, partially offset by minor additions Property and Equipment Carrying Value | Category | Carrying Value (Dec 31, 2024) (CAD) | Carrying Value (June 30, 2025) (CAD) | | :----------------- | :---------------------------------- | :----------------------------------- | | Right-of-use asset | $80,586 | $48,594 | | Equipment | $42,307 | $35,961 | | Leasehold improvements | $- | $- | | Office equipment | $21,207 | $19,086 | | Computer equipment | $51,492 | $59,873 | | **Total** | **$195,592** | **$163,514** | - Additions to property and equipment for the six months ended June 30, 2025, amounted to **$18,378**, specifically for computer equipment[18](index=18&type=chunk) - Depreciation for the six months ended June 30, 2025, totaled **$50,456**[18](index=18&type=chunk) [Note 5. Lease liability](index=7&type=section&id=Note%205.%20Lease%20liability) The total lease liability decreased to $142,554 as of June 30, 2025, with a current portion of $35,556 and a long-term portion of $106,998. The property lease was extended to October 30, 2028, and revalued with a 15% interest rate Lease Liability Components | Lease Liability Component | Amount (CAD) | | :------------------------ | :----------- | | Balance, June 30, 2025 | $142,554 | | Current portion | $35,556 | | Long-term portion | $106,998 | - The property lease was extended to **October 30, 2028**, and the lease liability was revalued using a **15% interest rate** as of the extension date[19](index=19&type=chunk) [Note 6. Derivative liability](index=8&type=section&id=Note%206.%20Derivative%20liability) The derivative liability, related to 8,175,000 warrants issued in 2021, was re-valued at each reporting date due to being issued in a foreign currency. All warrants expired unexercised during 2024, resulting in no derivative liability as of June 30, 2025 - **8,175,000 warrants** issued on November 5, 2021, were classified as a derivative liability and re-valued at each reporting date[20](index=20&type=chunk) - All **8,175,000 warrants** expired unexercised during 2024, leading to a zero balance for derivative liability as of June 30, 2025[20](index=20&type=chunk) [Note 7. Share capital](index=8&type=section&id=Note%207.%20Share%20capital) The authorized share capital consists of an unlimited number of common shares without par value. As of June 30, 2025, the number of common shares issued increased to 82,674,725, with a total amount of $179,538,695, primarily due to the exercise of restricted share units and stock options - The authorized share capital consists of an unlimited number of common shares with no par value[21](index=21&type=chunk) Share Capital Activity | Activity | Number of common shares | Amount (CAD) | | :------------------------------------------- | :---------------------- | :----------- | | Balance, December 31, 2024 | 82,608,992 | $179,335,421 | | Restricted share units exercised (note 8) | 40,733 | $102,581 | | Stock options exercised (note 8) | 25,000 | $34,260 | | Fair value of stock options exercised (note 8) | - | $22,033 | | Performance share units exercised - shares to be issued (note 8) | - | $44,400 | | Balance, June 30, 2025 | 82,674,725 | $179,538,695 | [Note 8. Share-based payments](index=8&type=section&id=Note%208.%20Share-based%20payments) The Corporation operates an Omnibus Equity Incentive Plan, allowing for grants of options, RSUs, PSUs, and DSUs, with a maximum issuance of 15% of outstanding shares. Total share-based compensation expenses increased significantly for the three and six months ended June 30, 2025, compared to the prior year - The Omnibus Equity Incentive Plan permits the grant of options, RSUs, PSUs, and DSUs, with a maximum issuance of **15%** of the Corporation's issued and outstanding shares[23](index=23&type=chunk) Share-based Compensation Expenses | Share-based Compensation Expenses | Three Months Ended June 30, 2025 (CAD) | Three Months Ended June 30, 2024 (CAD) | Six Months Ended June 30, 2025 (CAD) | Six Months Ended June 30, 2024 (CAD) | | :-------------------------------- | :------------------------------------- | :------------------------------------- | :----------------------------------- | :----------------------------------- | | Total expenses | $2,540,182 | $1,805,586 | $3,687,156 | $2,707,686 | [(a) Stock Options](index=9&type=section&id=8.%20(a)%20Stock%20Options) Stock option activity for the six months ended June 30, 2025, included 1,510,000 options issued and 1,000,000 cancelled, resulting in 1,802,500 options outstanding. The fair value of stock options at grant date decreased significantly from $1.79 in 2024 to $0.73 in 2025 Stock Option Activity | Stock Option Activity (Six Months Ended June 30) | 2025 (Number) | 2024 (Number) | | :----------------------------------------------- | :------------ | :------------ | | Balance, beginning of period | 1,487,500 | 1,732,500 | | Issued | 1,510,000 | 455,000 | | Expired | (170,000) | (185,000) | | Exercised | (25,000) | (175,000) | | Cancelled | (1,000,000) | - | | Balance, end of period | 1,802,500 | 1,827,500 | Black-Scholes Assumption for Stock Options | Black-Scholes Assumption (Six Months Ended June 30) | 2025 | 2024 | | :-------------------------------------------------- | :-------- | :-------- | | Fair value of stock options at grant date | $0.73 | $1.79 | | Share price | $1.65 | $2.83 | | Exercise price | $1.65 | $2.56 | | Risk-free interest rate | 2.61% | 3.83% | | Expected volatility | 76% | 93% | | Expected life in years | 2.60 | 3.13 | - During the quarter ended June 30, 2025, **1,000,000 stock options** were cancelled and replaced with **400,000 PSUs**[27](index=27&type=chunk) [(b) Performance Share Units](index=11&type=section&id=8.%20(b)%20Performance%20Share%20Units) The number of PSUs outstanding increased to 833,000 as of June 30, 2025, with 857,000 issued and 24,000 redeemed during the period. Subsequent to June 30, 2025, an additional 2,645,000 PSUs were issued and 1,030,723 redeemed PSU Activity | PSU Activity (As of June 30) | 2025 (Number) | 2024 (Number) | | :--------------------------- | :------------ | :------------ | | Balance, beginning of period | - | 2,000,000 | | Issued | 857,000 | 300,000 | | Redeemed | (24,000) | (2,200,000) | | Balance, end of period | 833,000 | 100,000 | - Subsequent to June 30, 2025, **2,645,000 PSUs** were issued and **1,030,723 PSUs** were redeemed[32](index=32&type=chunk)[33](index=33&type=chunk) [(c) Restricted Share Units](index=12&type=section&id=8.%20(c)%20Restricted%20Share%20Units) The number of RSUs outstanding as of June 30, 2025, was 4,811,566, with 40,733 units redeemed during the period. A significant portion of these RSUs are set to expire by July 31, 2025 RSU Activity | RSU Activity (As of June 30) | 2025 (Number) | 2024 (Number) | | :--------------------------- | :------------ | :------------ | | Balance, beginning of period | 4,852,299 | 3,544,887 | | Redeemed | (40,733) | (1,596,034) | | Balance, end of period | 4,811,566 | 1,948,853 | RSUs Outstanding by Expiry Date | Expiry date | Number of RSUs outstanding | | :------------ | :------------------------- | | July 31, 2025 | 1,495,692 | | October 31, 2025 | 32,874 | | July 10, 2027 | 3,283,000 | | **Total** | **4,811,566** | [Note 9. Warrants](index=12&type=section&id=Note%209.%20Warrants) All warrants expired during 2024, resulting in no outstanding warrants as of December 31, 2024, and June 30, 2025 Warrant Activity | Warrant Activity (As of June 30) | Number of warrants | Amount (CAD) | | :------------------------------- | :----------------- | :----------- | | Balance, December 31, 2023 | 11,628,178 | $3,517,867 | | Expired | (3,453,178) | $(3,517,867) | | Balance, June 30, 2024 | 8,175,000 | $- | | Balance, December 31, 2024 and June 30, 2025 | - | $- | [Note 10. Loss per share](index=12&type=section&id=Note%2010.%20Loss%20per%20share) Basic and diluted loss per share for the three and six months ended June 30, 2025, was $(0.10) and $(0.20) respectively. Diluted loss per share did not include the effect of stock options, PSUs, RSUs, and warrants as they were anti-dilutive Loss per Share and Weighted Average Shares | Metric (Period Ended June 30) | 2025 (CAD) | 2024 (CAD) | | :---------------------------- | :--------- | :--------- | | Basic and diluted net loss per share (three months) | $(0.10) | $(0.10) | | Basic and diluted net loss per share (six months) | $(0.20) | $(0.23) | | Weighted average number of common shares outstanding (three months) | 82,653,373 | 68,751,105 | | Weighted average number of common shares outstanding (six months) | 82,631,305 | 68,005,224 | - Stock options, PSUs, RSUs, and warrants were excluded from diluted loss per share calculations as they were anti-dilutive[38](index=38&type=chunk) [Note 11. Commitments](index=13&type=section&id=Note%2011.%20Commitments) The Corporation has various commitments including minimum lease payments totaling $357,406 through 2028, consultant service agreements totaling $317,629 through 2027, and contract research services totaling $1,372,917 through 2028 Total Lease Commitments | Year | Base rent (CAD) | Variable rent (CAD) | Total Lease Commitments (CAD) | | :--- | :-------------- | :------------------ | :---------------------------- | | 2025 | $27,688 | $25,923 | $53,611 | | 2026 | $55,376 | $51,846 | $107,222 | | 2027 | $55,376 | $51,846 | $107,222 | | 2028 | $46,146 | $43,205 | $89,351 | | **Total** | **$184,586** | **$172,820** | **$357,406** | Consultant Commitments | Year | Consultant Commitments (CAD) | | :--- | :--------------------------- | | 2025 | $200,199 | | 2026 | $83,231 | | 2027 | $34,199 | | **Total** | **$317,629** | Contract Research Services Commitments | Year | Contract Research Services Commitments (CAD) | | :--- | :------------------------------------------- | | 2025 | $1,280,272 | | 2026 | $44,306 | | 2027 | $23,085 | | 2028 | $25,254 | | **Total** | **$1,372,917** | [Note 12. Operating expenses](index=13&type=section&id=Note%2012.%20Operating%20expenses) This note details the non-cash components of general and administration (G&A) and research and development (R&D) expenses. Non-cash share-based compensation significantly increased in both G&A and R&D for the six months ended June 30, 2025, compared to the prior year Non-Cash Operating Expenses | Non-Cash Operating Expenses (Six Months Ended June 30) | 2025 (CAD) | 2024 (CAD) | | :----------------------------------------------------- | :--------- | :--------- | | **General and administration expenses:** | | | | Depreciation of property and equipment | $50,456 | $81,309 | | Amortization of intangible assets | $- | $42,222 | | Non-cash share-based compensation | $3,066,472 | $2,628,113 | | **Research and development expenses:** | | | | Non-cash share-based compensation | $620,684 | $79,573 | [Note 13. Related party transactions](index=14&type=section&id=Note%2013.%20Related%20party%20transactions) Remuneration for key management personnel, including directors, increased for both the three and six months ended June 30, 2025, compared to the prior year, primarily driven by higher share-based payments Key Management Personnel Remuneration | Key Management Personnel Remuneration | Three Months Ended June 30, 2025 (CAD) | Three Months Ended June 30, 2024 (CAD) | Six Months Ended June 30, 2025 (CAD) | Six Months Ended June 30, 2024 (CAD) | | :------------------------------------ | :------------------------------------- | :------------------------------------- | :----------------------------------- | :----------------------------------- | | Salaries and benefits | $570,714 | $540,335 | $1,875,727 | $1,804,739 | | Share-based payments | $469,829 | $154,291 | $938,789 | $275,731 | | **Total** | **$1,040,543** | **$694,626** | **$2,814,516** | **$2,080,470** | - As of June 30, 2025, no amounts were owed to key management personnel (December 31, 2024 - $nil)[43](index=43&type=chunk)

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]

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** |