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Cardiol Therapeutics (NasdaqCM:CRDL) Update / Briefing Transcript
2025-12-01 14:32
Summary of Cardiol Therapeutics Archer Phase 2 Webcast Conference Call Company Overview - **Company**: Cardiol Therapeutics (NasdaqCM:CRDL) - **Focus**: Late-stage clinical development of novel therapies for inflammatory heart disease, particularly acute myocarditis, recurrent pericarditis, and heart failure [4][5][24] Key Industry Insights - **Industry Context**: The call discussed the ARCHER trial, a significant clinical study in the field of myocarditis, which is a serious inflammatory heart condition that can lead to heart failure [2][4][8] - **Market Potential**: The market for treatments related to inflammatory heart diseases is substantial, with estimates for IL-1 blockers exceeding $600 million in annual sales in the US, potentially reaching $1 billion by 2027-2028 [36] Core Findings from the ARCHER Trial - **Trial Design**: The ARCHER trial was a phase 2, multi-center, randomized, double-blind, placebo-controlled study involving 109 patients across 34 centers [14][8] - **Primary Endpoints**: The trial aimed to evaluate the safety, tolerability, and efficacy of Cardiol Rx, focusing on cardiac magnetic resonance imaging (CMR) endpoints [13][14] - **Key Results**: - **Extracellular Volume (ECV)**: A reduction of 3.7 mL was observed, indicating decreased inflammation and fibrosis [16][17] - **Intracellular Volume (ICV)**: A reduction of 5.6 mL was noted, suggesting reduced cellular swelling and edema [17] - **Left Ventricular Mass (LVM)**: A significant reduction of over 9 grams in LVM was achieved, which is comparable to reductions seen with established therapies for heart conditions [19][20] - **Safety Profile**: Cardiol Rx demonstrated a strong safety profile, with adverse event rates comparable to placebo [21][22] Implications of Findings - **Clinical Relevance**: The reductions in ECV, ICV, and LVM suggest meaningful structural recovery in patients with acute myocarditis, potentially improving clinical outcomes [20][21][23] - **Translational Insights**: The findings support the hypothesis that Cardiol Rx can remodel the heart by targeting myocardial inflammation, which is crucial for the progression of heart disease [23][28] - **Future Directions**: The results bolster confidence in ongoing trials, particularly the pivotal phase 3 MAVERICK trial for recurrent pericarditis, and highlight the potential for the next-generation drug candidate CRD38 [24][31] Expert Commentary - **Dr. Dennis McNamara**: Emphasized the significance of the ARCHER trial in demonstrating structural changes with therapeutic intervention in myocarditis [26][27] - **Dr. Leslie Cooper**: Highlighted the study's robust design and the importance of the findings in supporting further development for inflammatory heart conditions [28] Next Steps for Cardiol Therapeutics - **Ongoing Trials**: Focus on executing the MAVERICK trial and accelerating the development of CRD38 for heart failure [36][38] - **Market Strategy**: Engage with pharmaceutical companies interested in heart failure medicine to explore partnerships for the next-generation drug candidate [31][38] Conclusion - The ARCHER trial results represent a significant advancement in the treatment of inflammatory heart diseases, with promising implications for future clinical applications and market opportunities [22][24][39]
New Data from the Phase II ARCHER Trial Demonstrate CardiolRx(TM) Improves Heart Structure in Patients with Acute Myocarditis, Supporting Expansion Across Inflammatory Cardiac Conditions
Newsfile· 2025-12-01 12:27
Core Insights - Cardiol Therapeutics Inc. announced significant findings from the Phase II ARCHER trial, demonstrating that CardiolRx™ improves heart structure in patients with acute myocarditis, supporting its potential for broader applications in inflammatory cardiac conditions [2][4][5] Group 1: Trial Results - The ARCHER trial showed a significant reduction in left ventricular (LV) mass by 9.2 grams (from 130.3g in placebo to 121.1g in the active group, p=0.0117), indicating meaningful structural recovery [3][8] - Extracellular volume (ECV) decreased by 3.7 mL (from 37.3mL in placebo to 33.6mL in the active group, p=0.0538), and intracellular volume (ICV) reduced by 5.6 mL (from 91.2mL in placebo to 85.6mL in the active group, p=0.0928) [8][9] - Left atrial end systolic volume (LAESV) was reduced by 8.1 mL (p=0.0376) and left ventricular end diastolic volume (LVEDV) decreased by 7.4 mL (p=0.0981), reflecting improved heart function [8][9] Group 2: Clinical Implications - The results provide clinical evidence that CardiolRx™ can reduce inflammation-driven structural damage in the heart, a key factor in heart failure progression [4][5] - The findings support the scientific rationale for Cardiol's lead Phase III program in recurrent pericarditis and indicate potential for development across various inflammatory cardiac conditions [4][5][17] Group 3: Company Overview - Cardiol Therapeutics is a clinical-stage life sciences company focused on developing anti-inflammatory and anti-fibrotic therapies for heart disease, with CardiolRx™ as its lead candidate [15][18] - The company is also advancing CRD-38, a next-generation small molecule targeting chronic inflammatory heart conditions [18]
Cardiol Therapeutics(CRDL) - 2025 Q3 - Quarterly Report
2025-11-13 21:24
Exhibit 99.1 CARDIOL THERAPEUTICS INC. CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2025 Approved on behalf of the Board: (EXPRESSED IN CANADIAN DOLLARS) (UNAUDITED) Cardiol Therapeutics Inc. Condensed Interim Consolidated Statements of Financial Position (Expressed in Canadian Dollars) Unaudited | | As at | | | As at | | --- | --- | --- | --- | --- | | | September 30, | | | December 31, | | | 2025 | | | 2024 | | ASSETS | | | | | | Current assets | | | | | | ...
Cardiol Therapeutics Receives U.S. Patent Allowance Broadly Protecting its Heart Drugs to Late 2040
Newsfile· 2025-11-13 12:45
Core Insights - Cardiol Therapeutics has received a Notice of Allowance for a U.S. patent that will protect its heart drugs until late 2040, specifically for CardiolRx™ and CRD-38 in treating various cardiac conditions [2][3][5] Intellectual Property Protection - The new patent will provide broad intellectual property protection for Cardiol's therapies against a range of heart diseases, including heart failure, myocarditis, and atherosclerosis [2][5] - This patent allowance enhances Cardiol's market position and intellectual property portfolio, complementing its existing U.S. Orphan Drug Designation for pericarditis [3][5] Clinical Development Programs - Cardiol is advancing late-stage clinical programs for recurrent pericarditis and acute myocarditis, addressing significant unmet medical needs [3][9] - The company is preparing to initiate first-in-human clinical evaluations of CRD-38, a novel therapy for inflammatory heart disease, including heart failure [3][9] Upcoming Presentations and Trials - Cardiol plans to present comprehensive data from the ARCHER trial, a Phase II study of CardiolRx™ in acute myocarditis, at the European Society of Cardiology Annual Meeting on November 29 [3][8] - An update on the pivotal Phase III MAVERIC trial in recurrent pericarditis will also be provided as patient enrollment accelerates [3][7]
Cardiol Therapeutics' Phase II ARCHER Trial Results to be Presented at the European Society of Cardiology Scientific Meeting on Myocardial & Pericardial Diseases
Newsfile· 2025-11-05 12:45
Core Insights - Cardiol Therapeutics is set to present full data from its Phase II ARCHER trial at the European Society of Cardiology meeting, focusing on the effects of CardiolRx™ in patients with acute myocarditis [2][5] - The trial demonstrated significant improvements in cardiac structure, including a notable reduction in left ventricular mass, indicating the potential of CardiolRx™ as an effective anti-inflammatory treatment for heart disease [3][4][6] Company Overview - Cardiol Therapeutics Inc. is a clinical-stage life sciences company specializing in late-stage anti-inflammatory and anti-fibrotic therapies for heart disease, with its lead drug candidate being CardiolRx™ [8] - The company is also developing CRD-38, a novel subcutaneously administered formulation aimed at treating heart failure, which is a leading cause of death and hospitalization globally [11] Trial Details - The ARCHER trial enrolled 109 patients from various countries, including the United States, France, Brazil, and Israel, to assess the safety and efficacy of CardiolRx™ in acute myocarditis [6] - The trial's design and rationale were previously published, emphasizing the importance of addressing inflammation in cardiac conditions [6] Upcoming Events - A webcast conference call is scheduled for December 1, 2025, to discuss the ARCHER trial findings and their implications for Cardiol's future programs in inflammatory heart disease [7]
Cardiol Therapeutics Completes US$11.4 Million Financing and Extends Cash Runway into Q3 2027
Newsfile· 2025-10-21 11:27
Core Insights - Cardiol Therapeutics Inc. has successfully completed a private placement offering, raising US$11.4 million to support its operations and development of heart disease therapies [3][4]. Financing Details - The company sold a total of 11.4 million units 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 holders to acquire additional common shares 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 the ongoing pivotal Phase III MAVERIC trial for CardiolRx™, which targets recurrent pericarditis, and the development of the next-generation CRD-38 formulation for heart failure [6][10]. - Recent findings from the ARCHER trial indicate a significant reduction in left ventricular (LV) mass, providing clinical validation for Cardiol's therapies in inflammatory heart disease [4][12]. Market Potential - The company aims to address a significant unmet need in heart failure, where five-year mortality rates exceed 50%, and healthcare costs in the U.S. related to heart failure exceed US$30 billion annually [4][12].
Cardiol Therapeutics Secures US$11 Million Financing and Extends Cash Runway into Q3 2027
Newsfile· 2025-10-17 20:34
Core Viewpoint - Cardiol Therapeutics has successfully completed a private placement offering, securing US$11 million in net proceeds to enhance its financial position and support the development of its heart failure drug, CRD-38, following promising results from its ARCHER trial [3][4]. Financing Details - The company completed an initial closing of US$10 million, with an additional US$1 million expected to close on October 20, 2025 [3]. - A total of 11 million units were sold at a price of US$1.00 per unit, with each unit consisting of one common share and one-half of a common share purchase warrant [4]. - The warrants allow the holder to acquire one additional common share at an exercise price of US$1.35 for 24 months, with an acceleration provision if the share price exceeds US$2.00 for five consecutive trading days [4]. Clinical Development - The funds will support operations into Q3 2027, enabling the advancement of the MAVERIC Phase III trial for CardiolRx™ and the development of the next-generation CRD-38 formulation [4][5]. - Topline results from the ARCHER trial indicated a significant reduction in left ventricular (LV) mass, marking a key clinical validation in treating inflammatory heart disease [4]. - The company aims to pursue an additional Orphan Drug Designation for CardiolRx™ in myocarditis, leveraging the ARCHER findings to target a broader heart failure market [4]. Market Context - Heart failure remains a significant health issue, with five-year mortality rates exceeding 50%, highlighting the clinical potential of Cardiol's therapies [4]. - The healthcare costs associated with heart failure in the U.S. exceed US$30 billion annually, indicating a substantial market opportunity for effective treatments [12].
5 Small Drug Stocks to Buy as the Industry Shows Some Recovery
ZACKS· 2025-10-14 16:01
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].
Cardiol Therapeutics(CRDL) - 2025 Q2 - Quarterly Report
2025-08-14 20:43
[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)
Cardiol Therapeutics (CRDL) FY Conference Transcript
2025-08-12 14:30
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]