Cardiol Therapeutics Announces Year-End 2024 Update on Operations

Rhea-AI Summary

Cardiol Therapeutics (NASDAQ: CRDL) provided its year-end 2024 operational update, highlighting significant progress in its clinical programs. The company reported positive data from the Phase II MAvERIC-Pilot study for CardiolRx™ in recurrent pericarditis patients, showing marked reductions in pain and inflammation.

Key developments include:

• Completion of patient enrollment in Phase II ARCHER trial for acute myocarditis, with topline data expected Q2 2025
• FDA Orphan Drug Designation granted for CardiolRx™ in pericarditis treatment
• Advancement to Phase III MAVERIC trial for recurrent pericarditis
• Strong financial position with $30.6 million cash as of December 31, 2024, funding operations into Q3 2026

The company plans to initiate patient enrollment in Phase III MAVERIC trial, targeting 50% enrollment in H2 2025 and completion in H1 2026. Additionally, Cardiol is advancing CRD-38, their proprietary subcutaneous formulation of cannabidiol, for heart failure treatment.

Positive

• Positive Phase II MAvERIC-Pilot study results showing efficacy in recurrent pericarditis
• FDA Orphan Drug Designation received for CardiolRx™
• Strong cash position of $30.6M funding operations into Q3 2026
• Early completion of Phase II ARCHER trial enrollment
• Successful public offering raising US$15.5M in October 2024

Negative

• Phase III MAVERIC trial yet to begin patient enrollment
• Final efficacy data from ARCHER trial still pending

Insights

Biotech Clinical Development Analyst

Cardiol Therapeutics has achieved multiple clinical milestones that significantly strengthen its development pipeline for cardiovascular diseases. The positive Phase II MAvERIC-Pilot data for CardiolRx in recurrent pericarditis demonstrates meaningful clinical benefits including reduced pain, inflammation, and recurrence episodes in a patient population with high disease burden. These compelling results justify advancement to the Phase III MAVERIC trial, a critical step toward potential FDA approval.

The FDA Orphan Drug Designation for pericarditis provides substantial regulatory benefits including seven years of market exclusivity upon approval, tax credits, and development incentives - strategic advantages for addressing this underserved condition affecting 38,000 recurrent patients in the US annually.

Completing enrollment ahead of schedule in the Phase II ARCHER trial for acute myocarditis accelerates the development timeline, with topline data expected in Q2 2025. The study's 34 clinical sites across five countries and rigorous imaging endpoints (global longitudinal strain and extra-cellular volume) should provide robust efficacy signals for this indication with no currently approved therapies.

With $30.6 million cash providing runway into Q3 2026, Cardiol has sufficient capital to advance through multiple value-inflection points, including initiating Phase III enrollment, reporting ARCHER data, and progressing CRD-38's IND-enabling work for heart failure. The financial position supports execution across all three development programs without immediate dilution concerns.

Cardiovascular Medicine Specialist

From a clinical perspective, CardiolRx's data in recurrent pericarditis represents a potentially significant advancement. Current treatment options for recurrent pericarditis are , with many patients experiencing inadequate symptom control and recurrent episodes despite conventional therapies including NSAIDs, colchicine, and corticosteroids.

The MAvERIC-Pilot results presented at AHA 2024 are particularly noteworthy because they demonstrate rapid, marked, and durable reductions in both pain and inflammation over the 6-month study period. Most importantly, the reduction in recurrence episodes addresses the primary clinical challenge in managing these patients. The pericarditis patient population, while smaller than some cardiovascular indications at 38,000 recurrent cases annually, represents a high-unmet need with substantial disease burden.

For acute myocarditis, the ARCHER trial's design deserves recognition for employing cardiac MRI endpoints that correlate with long-term prognosis. Myocarditis remains a diagnostic and therapeutic challenge, particularly concerning as it affects younger patients and can lead to sudden cardiac death. The trial's enrollment of over 100 patients across multiple countries should provide sufficient statistical power to detect meaningful changes in cardiac function and inflammation.

The preclinical research on CRD-38 published in JACC: Basic to Translational Science highlights promising cardioprotective mechanisms through preservation of mitochondrial function and calcium handling – fundamental processes in heart failure pathophysiology. Heart failure with preserved ejection fraction remains one of cardiology's most challenging conditions, with few effective therapies despite its prevalence and mortality burden.

Reported positive data from the Phase II MAvERIC-Pilot study investigating the impact of CardiolRx™ administered to patients with symptomatic recurrent pericarditis; results support advancing to the Phase III MAVERIC trial

Completed patient enrollment in the Phase II ARCHER trial evaluating CardiolRx™ in patients
with acute myocarditis, with topline data expected in Q2 2025

CardiolRx™ granted U.S. FDA Orphan Drug Designation for the treatment of pericarditis,
which includes recurrent pericarditis

Cash and cash equivalents of $30.6 million as of December 31, 2024,
to fund operations into Q3 2026

Toronto, Ontario--(Newsfile Corp. - April 1, 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, announced today its year-end 2024 update on operations following the filing of its audited Financial Statements and Management's Discussion and Analysis for the year ended December 31, 2024. Both are available under the Company's profile on EDGAR at www.sec.gov, on SEDAR+ at sedarplus.ca and on the Company's website at cardiolrx.com.

"Cardiol Therapeutics achieved significant milestones during 2024 which have supported advancing CardiolRx into the Phase III MAVERIC trial in recurrent pericarditis - a debilitating heart disease that remains underserved by available medicine," said David Elsley, President and Chief Executive Officer of Cardiol Therapeutics. "We are very encouraged by the compelling Phase II data presented at the American Heart Association Scientific Sessions 2024, demonstrating that CardiolRx™ reduced pericarditis pain, inflammation, and episodes of recurrence in patients presenting with a high degree of disease burden. We were also pleased that our Phase II ARCHER trial surpassed expectations by completing patient enrollment ahead of schedule, positioning the Company to report topline data in Q2. With operations funded into the second half of 2026, we remain committed to advancing our late-stage clinical development pipeline in pericarditis and myocarditis, and to progressing the IND-enabling program to support the clinical development of CRD-38 for heart failure. We would like to express our sincere gratitude to our clinical collaborators and patients whose support has enabled our progress."

Key Highlights:

MAVERIC Program in Recurrent Pericarditis

• In February 2024, CardiolRx™ was granted Orphan Drug Designation by the United States Food and Drug Administration for the treatment of pericarditis, which includes recurrent pericarditis. Pericarditis refers to inflammation of the pericardium (the membrane or sac that surrounds the heart) frequently resulting from a viral infection. Following that initial episode patients may have multiple recurrences, and the primary goal of treatment is recurrence prevention. Symptoms include debilitating chest pain, shortness of breath and fatigue, resulting in physical limitations, reduced quality of life, emergency department visits, and hospitalizations. Pericarditis affects approximately 160,000 individuals in the United States annually, with 38,000 suffering from recurrent episodes.
• In June 2024, Cardiol reported topline 8-week clinical data from its Phase II MAvERIC-Pilot study demonstrating a marked reduction in pericarditis pain, and in November 2024, the Company reported full results from the study concurrent with the American Heart Association Scientific Sessions 2024 ("AHA 2024"). The data were included in an oral presentation as part of the Laennec Clinician-Educator Award & Lecture at the AHA 2024. Dr. S. Allen Luis, Co-Director of the Pericardial Diseases Clinic and Associate Professor of Medicine in the Department of Cardiovascular Medicine at the Mayo Clinic, presented on behalf of the MAvERIC-Pilot investigators. MAvERIC-Pilot enrolled 27 participants with symptomatic recurrent pericarditis at eight clinical sites across the United States. The results showed that patients, despite the severity of their disease, experienced marked, rapid, and durable reductions in both pericarditis pain and inflammation and importantly these reductions were maintained throughout the 6-month study. In addition, the results demonstrated a notable reduction in pericarditis episodes per year. Treatment with CardiolRx™ was shown to be safe and well tolerated.
• Based on the compelling results from MAvERIC-Pilot, in October 2024, Cardiol announced advancing to the Phase III MAVERIC trial, a randomized, double-blind, placebo-controlled trial expected to enroll 110 patients at high risk for disease recurrence at approximately 20 clinical sites in the United States and Europe. The primary clinical objective of the trial will be to assess the impact of CardiolRx™ versus placebo on freedom from a new episode of recurrent pericarditis. Other clinical endpoints of interest include time to a new episode of pericarditis recurrence, and changes in patient-reported pericarditis chest pain score and the inflammatory marker C-reactive protein.

ARCHER Trial in Acute Myocarditis

• In May 2024, the ARCHER trial was the subject of an oral presentation at the World Congress on Acute Heart Failure 2024 in Lisbon, Portugal, at the annual congress of the Heart Failure Association of the European Society of Cardiology ("ESC"). The trial design and rationale were presented by Univ.-Prof. Dr. med. Carsten Tschöpe from the Berlin Institute of Health - Charité, on behalf of the ARCHER Study Group, an independent steering committee comprising distinguished thought leaders in heart failure and myocarditis from international centers of excellence. Concurrent with the presentation the journal ESC Heart Failure, which is dedicated to advancing knowledge about heart failure worldwide, accepted the manuscript describing the rationale and design of the ARCHER trial and it was published in June 2024.
• In September 2024, Cardiol announced the completion of patient enrollment in ARCHER with topline results expected to be reported in Q2 2025. ARCHER enrolled over 100 patients at 34 clinical sites in the United States, Canada, France, Brazil, and Israel. The two primary outcome measures of the trial consist of myocardial magnetic resonance imaging parameters: global longitudinal strain and extra-cellular volume, which measure heart dysfunction and edema/fibrosis, respectively. Each of these parameters has been shown to associate with adverse outcomes and predict long-term prognosis in patients with acute myocarditis. There are no FDA-approved therapies for myocarditis, and it remains an important cause of acute and fulminant heart failure and is a leading cause of sudden cardiac death in people under 35 years of age.

CRD-38 Pre-Clinical Development

• In February 2025, Cardiol announced the publication of research in the Journal of the American College of Cardiology: Basic to Translational Science, titled "Cannabidiol Prevents Heart Failure Dysfunction and Remodeling Through Preservation of Mitochondrial Function and Calcium Handling" (www.jacc.org/doi/abs/10.1016/j.jacbts.2024.12.009). This research was conducted by scientists from Tecnológico de Monterrey who, together with researchers from the DeBakey Heart and Vascular Center in Houston, TX, are collaborating with Cardiol on the development of the Company's proprietary subcutaneous formulation of cannabidiol, CRD-38, to treat heart failure with preserved ejection fraction. This common form of heart failure remains a leading cause of hospitalization worldwide and is associated with a five-year mortality that exceeds 75% in hospitalized patients.
• These newly published data demonstrate that pharmaceutically manufactured cannabidiol, administered subcutaneously, provides cardioprotection in a pre-clinical model of heart failure by improving cardiac function and reducing cardiac hypertrophy, remodeling, inflammation, and cell death, and provides additional important rationale for the development of CRD-38 as a new approach to the treatment of heart failure.

Capital Management

• In October 2024, Cardiol successfully closed a public offering for gross proceeds of US$15,525,000. Cash and cash equivalents were $30.6 million as of December 31, 2024. Based on current projections, the Company believes current cash will fund operations and capital requirements, associated with achieving corporate milestones into Q3 2026.

Outlook

During the next 12 - 18 months, the Company expects to achieve a number of significant corporate milestones, including:

• Enrollment of first patient in the Phase III MAVERIC clinical trial evaluating CardiolRx™ in pericarditis patients at high risk for disease recurrence. MAVERIC has been designed in collaboration with experts in pericarditis from around the world and, subject to study outcomes, is expected to support a New Drug Application with the FDA. The Company anticipates achieving 50% of patient enrollment during H2 2025 and completing patient enrollment in H1 2026.
• Report topline date from the Phase II ARCHER trial investigating the impact of CardiolRx™ on myocardial recovery in patients with acute myocarditis. ARCHER results are expected to further inform the cardiology community concerning the anti-fibrotic and anti-inflammatory effects of CardiolRx™.
• Based on recent data published in the Journal of the American College of Cardiology that provides new insights concerning the ability of CRD-38 to protect cardiomyocytes (the muscle cells of the heart) and preserve mitochondrial function (the energy-producing structures in cardiac cells), the Company will advance the IND-enabling work necessary to support the clinical development of CRD38 for heart failure.

About Cardiol Therapeutics

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 modulates activation of the inflammasome pathway, an intracellular process known to play an important role in the development and progression of inflammation and fibrosis associated with myocarditis, pericarditis, and heart failure.

Cardiol has received Investigational New Drug Application authorization from the United States Food and Drug Administration ("US FDA") to conduct clinical studies to evaluate the efficacy and safety of CardiolRx™ in two diseases affecting the heart: recurrent pericarditis and acute myocarditis. The MAVERIC Program in recurrent pericarditis, an inflammatory disease of the pericardium which is associated with symptoms including debilitating chest pain, shortness of breath, and fatigue, and results in physical limitations, reduced quality of life, emergency department visits, and hospitalizations, comprises the completed Phase II MAvERIC-Pilot study (NCT05494788) and the ongoing Phase III MAVERIC trial (NCT06708299). The ongoing ARCHER trial (NCT05180240) is a Phase II study in acute myocarditis, an important cause of acute and fulminant heart failure in young adults and a leading cause of sudden cardiac death in people less than 35 years of age. The US FDA has granted Orphan Drug Designation to CardiolRx™ for the treatment of pericarditis, which includes recurrent pericarditis.

Cardiol is also developing CRD-38, a novel subcutaneously administered drug formulation intended for use in heart failure - a leading cause of death and hospitalization in the developed world, with associated healthcare costs in the United States exceeding $30 billion annually.

For more information about Cardiol Therapeutics, please visit cardiolrx.com.

Cautionary statement regarding forward-looking information:

This news release contains "forward-looking information" within the meaning of applicable securities laws. All statements, other than statements of historical fact, that address activities, events, or developments that Cardiol believes, expects, or anticipates will, may, could, or might occur in the future are "forward-looking information". Forward looking information contained herein may include, but is not limited to statements regarding the Company's focus on developing anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, the molecular targets and mechanism of action of the Company's product candidates, the Company's intended clinical studies and trial activities and timelines associated with such activities, including the Company's plan to complete the Phase III study in recurrent pericarditis with CardiolRx, the Company's plan to advance the development of CRD-38, a novel subcutaneous formulation of cannabidiol intended for use in heart failure, the Company's expectation that operations will be funded into Q3 2026, the Company's expectation of reporting ARCHER topline data in Q2 2025 and the Company's expectation that it will achieve significant corporate milestones during the next 12 - 18 months. Forward-looking information contained herein reflects the current expectations or beliefs of Cardiol based on information currently available to it and is based on certain assumptions and is also subject to a variety of known and unknown risks and uncertainties and other factors that could cause the actual events or results to differ materially from any future results, performance or achievements expressed or implied by the forward looking information, and are not (and should not be considered to be) guarantees of future performance. These risks and uncertainties and other factors include the risks and uncertainties referred to in the Company's Annual Information Form and Annual Report on Form 40-F filed with the U.S. Securities and Exchange Commission and Canadian securities regulators on March 31, 2025, as well as the risks and uncertainties associated with product commercialization and clinical studies. These assumptions, risks, uncertainties, and other factors should be considered carefully, and investors should not place undue reliance on the forward-looking information, and such information may not be appropriate for other purposes. Any forward-looking information speaks only as of the date of this press release and, except as may be required by applicable securities laws, Cardiol disclaims any intent or obligation to update or revise such forward-looking information, whether as a result of new information, future events, or results, or otherwise. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read the Supplement, the accompanying Base Prospectus and the documents incorporated by reference therein.

For further information, please contact:
Trevor Burns, Investor Relations +1-289-910-0855
trevor.burns@cardiolrx.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/246890

FAQ

What were the key results of CRDL's Phase II MAvERIC-Pilot study for recurrent pericarditis?

The study showed marked, rapid, and durable reductions in pericarditis pain and inflammation, maintained throughout the 6-month study period, with CardiolRx™ demonstrating safety and tolerability.

How many patients will CRDL's Phase III MAVERIC trial enroll?

The Phase III MAVERIC trial will enroll 110 patients at approximately 20 clinical sites in the United States and Europe.

When will CRDL report topline data from the Phase II ARCHER trial?

Cardiol Therapeutics expects to report topline data from the ARCHER trial in Q2 2025.

How long will CRDL's current cash position support operations?

The company's $30.6 million cash position as of December 31, 2024, is expected to fund operations into Q3 2026.

What is the market size for pericarditis in the United States?

Pericarditis affects approximately 160,000 individuals annually in the US, with 38,000 suffering from recurrent episodes.