Cardiol Therapeutics Expands U.S. MAVERIC Phase III Trial Network to Address Growing Interest in the Pivotal Program

Rhea-AI Summary

Cardiol Therapeutics (NASDAQ: CRDL) announced expansion of its pivotal Phase III MAVERIC trial in the U.S., planning up to seven additional clinical centers to reach an anticipated total of 25 sites.

Patient enrollment has reached 75%, with target recruitment expected by end of Q2 2026 but potentially extending into Q3 2026. MAVERIC is a randomized, placebo-controlled trial of CardiolRx™ designed with FDA alignment and intended to support a future NDA.

Positive

• Enrollment 75% of target achieved
• Planned activation of up to 7 additional U.S. sites, targeting 25 total centers
• Trial design aligned with FDA at end-of-Phase II meeting (April 2025)

Negative

• Target recruitment may extend into Q3 2026, posing timeline risk

News Market Reaction – CRDL

-2.14%

4 alerts

-2.14% Session close to close

-11.6% Trough Tracked

$156.54M Market Cap

0.2x Rel. Volume

In the Apr 28 session, CRDL declined 2.14%, reflecting a moderate negative market reaction. Argus tracked a trough of -11.6% from its starting point during tracking. Our momentum scanner triggered 4 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement reinforces Cardiol’s execution on its pivotal MAVERIC Phase III program, with enro...

Analysis

This announcement reinforces Cardiol’s execution on its pivotal MAVERIC Phase III program, with enrollment reaching 75% and plans for up to 25 U.S. centers. It builds on prior ARCHER Phase II myocarditis results and earlier MAVERIC updates that moved enrollment past 50%. Investors tracking this story may focus on recruitment timelines into Q2–Q3 2026, forthcoming efficacy and safety data, and how these clinical outcomes shape CardiolRx™’s potential positioning in recurrent pericarditis.

Key Figures

Enrollment progress: 75% of target patients Prior enrollment level: 50%+ of target patients Planned additional centers: Up to 7 U.S. sites +4 more

7 metrics

Enrollment progress 75% of target patients MAVERIC Phase III trial enrollment status

Prior enrollment level 50%+ of target patients Enrollment threshold surpassed in early January

Planned additional centers Up to 7 U.S. sites Further expansion of MAVERIC trial network

Total clinical centers 25 sites anticipated Planned MAVERIC Phase III trial footprint

Planned enrollment Approximately 110 patients MAVERIC Phase III trial design

Recruitment target timing End of Q2 2026, possibly Q3 2026 Target completion of trial recruitment

First patient randomized April 2025 MAVERIC Phase III trial initiation at Northwestern University

Previous Clinical trial Reports

5 past events · Latest: Apr 14 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Apr 14	Clinical program update	Positive	+2.9%	Live Barchart interview on MAVERIC Phase III, ARCHER data, and CRD-38.
Feb 10	Phase II results	Positive	+1.9%	Publication of ARCHER Phase II myocarditis results showing significant LV mass reduction.
Jan 13	Enrollment milestone	Positive	+1.3%	MAVERIC Phase III surpasses 50% enrollment across >15 U.S. cardiovascular centers.
Dec 01	Phase II data detail	Positive	-9.5%	Detailed ARCHER data show structural heart improvements in acute myocarditis patients.
Nov 05	Conference presentation	Positive	+3.8%	Announcement of upcoming full ARCHER Phase II data presentation at ESC meeting.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Clinical-trial headlines have generally led to modest positive moves, with one notable selloff on ARCHER data despite positive efficacy signals.

Recent Company History

Over the past several months, CRDL has repeatedly highlighted CardiolRx™ across Phase II ARCHER myocarditis data and the pivotal Phase III MAVERIC trial in recurrent pericarditis. Prior updates showed significant structural heart improvements, growing enrollment past 50%, and plans for ~110 patients across ~25 centers. These clinical communications, including conference presentations and media interviews, set the stage for today’s update that enrollment in MAVERIC has reached 75% and U.S. site expansion is continuing.

Key Terms

pericarditis, randomized, double-blind, placebo-controlled, +3 more

7 terms

pericarditis medical

"unmet need in recurrent pericarditis"

Pericarditis is inflammation of the thin sac that surrounds the heart, like irritation of a protective sleeve or a balloon around the organ. It can cause chest pain, fatigue and other symptoms and is important to investors because cases linked to a drug, vaccine or medical device can change regulatory decisions, affect sales and trigger safety reviews or legal risk, which can move a company’s stock and future outlook.

randomized medical

"MAVERIC is a randomized, double-blind, placebo-controlled pivotal Phase III trial"

Randomized means participants or units in a study are assigned to different groups by chance rather than by choice, like flipping a coin to decide who gets a new treatment and who gets a comparison. For investors, randomized designs matter because they reduce bias and make results more trustworthy, so outcomes from randomized studies carry more weight when assessing regulatory approval, commercial prospects, and the risk that trial results will change a company’s valuation.

double-blind medical

"MAVERIC is a randomized, double-blind, placebo-controlled pivotal Phase III trial"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

placebo-controlled medical

"MAVERIC is a randomized, double-blind, placebo-controlled pivotal Phase III trial"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

Phase III medical

"pivotal Phase III MAVERIC trial in the United States"

A Phase III trial is the late-stage clinical study that tests whether a medical treatment works and is safe in a large group of patients, often comparing it to standard care. Think of it as a final dress rehearsal or full-scale road test before regulators decide on approval; positive or negative results strongly influence a drug maker’s chance to sell the treatment, future revenue, and investment risk.

New Drug Application regulatory

"expected to support a New Drug Application with the U.S. FDA"

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

U.S. Food and Drug Administration regulatory

"with input from the U.S. Food and Drug Administration ("FDA")"

The U.S. Food and Drug Administration is the federal agency that evaluates and enforces safety, effectiveness and labeling standards for medicines, medical devices, vaccines, food and related products before they reach consumers. For investors it matters because FDA approvals, warnings or recalls determine whether a product can be sold, how quickly it reaches the market and how costly compliance will be—changes that directly affect a company’s revenue, costs and stock value.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• Leading enrolling centers include Cleveland Clinic, three major campuses of the Mayo Clinic, Northwestern University, Massachusetts General Hospital, Columbia University–NewYork-Presbyterian, NYU Langone Health, Lenox Hill Hospital/Northwell Health, and Houston Methodist Hospital.
• Growing interest in MAVERIC is expected to support the activation of up to seven additional U.S. clinical centers, with the total number anticipated to reach 25.
• Patient enrollment surpassed 50% in early January and has now reached 75%.
• Target recruitment is anticipated by the end of Q2 2026, with the potential to extend into Q3 to accommodate patient enrollment from the additional clinical sites.
• MAVERIC builds on positive Phase II data and is expected to support a New Drug Application with the U.S. FDA.

TORONTO, April 28, 2026 /PRNewswire/ - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a late-stage life sciences company advancing anti-inflammatory and anti-fibrotic therapies for heart disease, today announced the continued expansion of its pivotal Phase III MAVERIC trial in the United States ("U.S."), with the planned activation of up to seven additional clinical centers. Patient enrollment in MAVERIC surpassed the 50% threshold in early January and has now reached 75%. Target recruitment is anticipated by the end of Q2 2026, with the potential to extend into Q3 to accommodate patient enrollment from additional clinical sites.

"Broadening the MAVERIC clinical site network reflects the strong interest we have received from leading clinical centers across the United States and underscores the level of investigator conviction in both the therapeutic rationale and the unmet need in recurrent pericarditis," said David Elsley, President and Chief Executive Officer of Cardiol Therapeutics. "The participation of multiple premier cardiovascular research institutions gives us confidence that MAVERIC will generate a robust dataset to define the clinical profile of CardiolRx™ and support its potential as a non-immunosuppressive oral, more accessible therapy earlier in the treatment pathway."

MAVERIC Phase III Trial

MAVERIC is a randomized, double-blind, placebo-controlled pivotal Phase III trial evaluating CardiolRx^™ for the prevention of disease recurrence in patients with recurrent pericarditis. The study is designed to enroll approximately 110 patients. MAVERIC was designed with input from the U.S. Food and Drug Administration ("FDA"), with alignment on trial design achieved at an end-of-Phase II meeting in April 2025. The first patient was randomized at Northwestern University in April 2025.

Phase II Foundation

MAVERIC builds on the clinical evidence established in the Phase II MAvERIC study, which demonstrated that CardiolRx^™ produced rapid and sustained reductions in pericarditis pain and inflammation, along with a substantial decrease in recurrent episodes per year. These findings, presented at the American Heart Association Scientific Sessions 2024, provide a compelling clinical and mechanistic foundation for the ongoing pivotal Phase III program and support the potential for CardiolRx^™ to address a significant unmet need in recurrent pericarditis.

About Pericarditis

Pericarditis refers to inflammation of the pericardium (the membrane or sac that surrounds the heart), which frequently results from a viral infection. Patients may have multiple recurrences following that initial episode, 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. Significant accumulation of pericardial fluid and scarring can progress to life-threatening constriction of the heart. On an annual basis, the number of patients in the United States experiencing at least one recurrence is estimated at 40,000. Approximately 60% of patients with more than one recurrence suffer for more than two years, and one third remain impacted at five years. Hospitalization due to recurrent pericarditis is typically associated with a 6-8-day stay and cost per stay is estimated to range between $20,000 and $30,000 in the United States.

About Cardiol Therapeutics

Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) is a late-stage life sciences company focused on advancing the development of anti-inflammatory and anti-fibrotic therapies for heart disease. The Company's lead small-molecule drug candidate, CardiolRx™, modulates inflammasome pathway activation, an intracellular process known to play an important role in the development and progression of inflammation and fibrosis associated with pericarditis, myocarditis, and heart failure.

The MAVERIC Program is evaluating CardiolRx^™ for the treatment of recurrent pericarditis, an inflammatory disease of the pericardium associated with symptoms including debilitating chest pain, shortness of breath, and fatigue, which can lead to physical limitations, reduced quality of life, emergency department visits, and hospitalizations. The program comprises the completed Phase II MAvERIC-Pilot study (NCT05494788) and the ongoing pivotal Phase III MAVERIC trial (NCT06708299). The U.S. FDA has granted Orphan Drug Designation to CardiolRx^™ for the treatment of pericarditis, including recurrent pericarditis.

The ARCHER Program also studied CardiolRx^™, specifically in acute myocarditis—an important cause of acute and fulminant heart failure in young adults and a leading cause of sudden cardiac death in individuals under 35 years of age. The program comprises the completed Phase II ARCHER study (NCT05180240), which evaluated the safety, tolerability, and efficacy of CardiolRx^™ in this patient population.

The Company is also developing CRD-38, a novel, subcutaneously administered drug formulation intended for the treatment of inflammatory heart disease, including heart failure—a leading cause of death and hospitalization in the developed world, with associated healthcare costs in the United States exceeding US$30 billion per year.

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 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 intended for the treatment of inflammatory heart disease, including heart failure, including through the initiation of a Phase I clinical program; the Company's belief that results from the ARCHER trial provide compelling clinical proof of concept for CardiolRx^™ and strengthen the scientific and clinical rationale for Cardiol's novel therapeutic approach for inflammatory cardiac conditions, including its lead Phase III program in recurrent pericarditis; the Company's expectation that the Phase III MAVERIC trial will reach full enrollment in Q2 2026 with the potential to extend into Q3 to accommodate patient enrollment from the additional clinical sites; the Company's planned activation of up to seven additional clinical centers; the Company's expectation that MAVERIC will support an NDA with the U.S. FDA; the Company's belief that the participation of multiple premier cardiovascular research institutions gives it confidence that MAVERIC will generate a robust dataset to define the clinical profile of CardiolRx^™ and support its potential as a non-immunosuppressive oral, more accessible therapy earlier in the treatment pathway; and the Company's ability to address its strategic priorities. 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 filed with the Canadian securities administrators and U.S. Securities and Exchange Commission on March 31, 2026, available on SEDAR+ at sedarplus.ca and EDGAR at sec.gov, 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.

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SOURCE Cardiol Therapeutics Inc.

FAQ

How far along is enrollment in Cardiol Therapeutics' MAVERIC Phase III trial (CRDL) as of April 28, 2026?

Enrollment in MAVERIC has reached 75% of the planned sample. According to the company, the study is designed to enroll approximately 110 patients, with recruitment expected by end of Q2 2026 but possibly extending into Q3.

What U.S. site expansion did Cardiol Therapeutics announce for MAVERIC (CRDL) on April 28, 2026?

Cardiol plans to activate up to 7 additional U.S. clinical centers, targeting about 25 sites in total. According to the company, leading institutions already involved include Cleveland Clinic and multiple Mayo Clinic campuses.

Will MAVERIC support a U.S. regulatory filing for CardiolRx™ (CRDL)?

MAVERIC is intended to support a New Drug Application with the FDA. According to the company, trial design was aligned with the FDA at an end-of-Phase II meeting in April 2025.

What is the MAVERIC trial design and primary purpose for CardiolRx™ (CRDL)?

MAVERIC is a randomized, double-blind, placebo-controlled Phase III trial to prevent recurrent pericarditis. According to the company, it evaluates CardiolRx™ for recurrence prevention with an enrollment target of ~110 patients.

Could the MAVERIC recruitment timeline change and why for Cardiol Therapeutics (CRDL)?

Yes. Target recruitment is expected by end of Q2 2026 but may extend into Q3 2026 to accommodate patients from additional sites. According to the company, added U.S. centers are driving the potential extension.