Cardiol Therapeutics' Phase II MAvERIC Results Accepted for Publication in the Journal of the American Heart Association

Cardiol Therapeutics (NASDAQ: CRDL) announced Phase II MAvERIC results have been accepted for publication in the Journal of the American Heart Association.

Rhea-AI Summary

Cardiol Therapeutics (NASDAQ: CRDL) announced Phase II MAvERIC results have been accepted for publication in the Journal of the American Heart Association.

The peer-reviewed report links CardiolRx treatment to rapid, sustained reductions in pericarditis pain and inflammation, a substantial reduction in yearly pericarditis episodes, a favorable safety profile, and supports the ongoing pivotal Phase III MAVERIC trial, which has surpassed 75% enrollment.

Positive

• Phase II MAvERIC results accepted in Journal of the American Heart Association
• Treatment associated with rapid and sustained pain and inflammation reductions
• Reported substantial reduction in pericarditis episodes per year
• Favorable safety and tolerability profile reported
• MAVERIC Phase III trial surpassed 75% enrollment

Negative

• None.

Argus May 7 session

-1.52% close to close Open Argus

Details

News Market Reaction – CRDL

In the May 7 session, CRDL declined 1.52%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement underscores that Phase II MAvERIC results in recurrent pericarditis have been acce...

Analysis

This announcement underscores that Phase II MAvERIC results in recurrent pericarditis have been accepted by the Journal of the American Heart Association, providing external validation for CardiolRx™. The publication supports the ongoing pivotal Phase III MAVERIC trial, which has surpassed 75% enrollment. In the past, similar clinical-trial updates have produced mixed stock reactions, so investors often focus on continued trial execution, eventual Phase III outcomes, and how consistently safety and efficacy signals hold across indications.

Key Figures

Phase II study: Phase II Phase III trial: Phase III MAVERIC enrollment: 75% enrolled

Phase II study

Phase II

CardiolRx™ recurrent pericarditis trial underlying JAHA publication

Phase III trial

Phase III

Pivotal MAVERIC trial in recurrent pericarditis

MAVERIC enrollment

75% enrolled

Ongoing Phase III MAVERIC trial for recurrent pericarditis

Previous Clinical trial Reports

5 past events · Latest: Apr 28

Same Type 5 events

1. Apr 28

   MAVERIC expansion

   24h Move

   -2.1%

   Expanded U.S. Phase III MAVERIC network and reported 75% patient enrollment.

2. Apr 14

   Clinical programs update

   24h Move

   +2.9%

   CEO live interview highlighting MAVERIC, ARCHER results, and CRD-38 program.

3. Feb 10

   ARCHER publication

   24h Move

   +1.9%

   Phase II ARCHER myocarditis results published showing structural heart improvements.

4. Jan 13

   MAVERIC 50% enrolled

   24h Move

   +1.3%

   Surpassed 50% enrollment in pivotal Phase III MAVERIC recurrent pericarditis trial.

5. Dec 01

   ARCHER data update

   24h Move

   -9.5%

   New Phase II ARCHER myocarditis data showing LV mass and atrial volume reductions.

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

Key Terms

recurrent pericarditis, pericarditis, phase ii, phase iii, +4 more

8 terms

recurrent pericarditis medical

"paradigm shift in the treatment of patients with recurrent pericarditis"

Inflammation of the thin sac around the heart that comes back after a first episode. Like a door that keeps sticking shut even after being fixed, recurrent pericarditis involves repeated bouts of chest pain, fever, or fatigue that can require ongoing treatment, tests, or even procedures. Investors track it because recurrent disease affects healthcare spending, drug trial design, regulatory review, and the potential market for therapies aimed at preventing or managing flare-ups.

pericarditis medical

"rapid and sustained reductions in pericarditis pain and inflammation"

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.

phase ii medical

"results from its Phase II study evaluating CardiolRx™ in patients"

Phase II is the mid-stage clinical trial where a potential drug or medical treatment is tested in a larger group of patients to see if it works and to help determine the best dose and common side effects. For investors, Phase II results matter because they give the first meaningful evidence about effectiveness and safety—like a road test that shows whether a product has real promise before a much bigger, costly final trial and potential regulatory approval.

phase iii medical

"ongoing pivotal Phase III MAVERIC trial ("MAVERIC"), evaluating CardiolRx™"

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.

double-blind medical

"MAVERIC, 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, 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.

pivotal medical

"pivotal Phase III trial evaluating CardiolRx™ for the prevention"

Pivotal describes a test, event, or decision that is decisive for whether a product, idea, or plan moves forward—most often used for a late-stage clinical trial or a regulatory review whose result determines approval or rejection. Investors care because a positive outcome typically unlocks major value (like market access or sales), while a negative one can sharply reduce expected future revenue; think of it as the final exam that decides whether a project passes or fails.

journal of the american heart association medical

"accepted for publication in a forthcoming issue of the Journal of the American Heart Association"

A peer-reviewed medical journal that publishes research, reviews and clinical studies about heart and circulatory health. Investors watch it like a trusted weather report for cardiovascular science: new findings published there can change expectations about the safety, effectiveness or market potential of drugs, devices and treatments, which in turn can affect company valuations and regulatory or clinical decision-making.

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

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• Results demonstrate CardiolRx™ may represent a paradigm shift in the treatment of patients with recurrent pericarditis and further validate the ongoing Phase III trial, which recently surpassed 75% enrollment.

TORONTO, ON, May 7, 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 that the results from its Phase II study evaluating CardiolRx™ in patients with recurrent pericarditis have been accepted for publication in a forthcoming issue of the Journal of the American Heart Association ("JAHA").

The peer-reviewed publication highlights clinical findings demonstrating that treatment with CardiolRx™ was associated with rapid and sustained reductions in pericarditis pain and inflammation in patients with a high baseline disease burden. The study also reported a substantial reduction in pericarditis episodes per year and a favorable safety and tolerability profile, supporting its continued development in a Phase III program. These findings provide important clinical rationale for the ongoing pivotal Phase III MAVERIC trial ("MAVERIC"), evaluating CardiolRx™ in patients with recurrent pericarditis, which recently surpassed 75% enrollment.

"The upcoming publication provides important independent validation of the clinical findings generated in our Phase II MAvERIC study and further supports the potential of CardiolRx™ as a differentiated, non-immunosuppressive therapy for recurrent pericarditis," said David Elsley, President and Chief Executive Officer of Cardiol Therapeutics. "Publication in the Journal of the American Heart Association underscores the clinical relevance of the observed reductions in pericarditis pain and inflammation, together with the favorable safety and tolerability profile demonstrated in this patient population. We believe these data strengthen the foundation for MAVERIC and reinforce the broader opportunity for CardiolRx™ to address a significant unmet medical need in recurrent pericarditis."

The Phase II MAvERIC results published in JAHA represent another important step in advancing clinical understanding of the potential role of CardiolRx™ in the treatment of inflammation-driven heart diseases and helped inform the design and advancement of MAVERIC, a randomized, double-blind, placebo-controlled, pivotal Phase III trial evaluating CardiolRx™ for the prevention of 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. Current treatment options are limited and often involve prolonged use of immunosuppressive therapies including corticosteroids and injectable biologics, which are associated with risk of significant side effects and dependency. 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.

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™ 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 the upcoming publication provides important independent validation of the clinical findings generated in the Phase II MAvERIC study and further supports the potential of CardiolRx™ as a differentiated, non-immunosuppressive therapy for recurrent pericarditis, validate and provide important clinical rationale for the ongoing pivotal Phase III MAVERIC trial, reinforce the broader opportunity to improve treatment options for patients and are an important step in disseminating and advancing clinical understanding of the potential role of CardiolRx™ in the treatment of inflammation-driven heart diseases; the Company's expectation that MAVERIC will support an NDA with the U.S. FDA.; 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

What did Cardiol Therapeutics (CRDL) announce on May 7, 2026 about MAvERIC Phase II results?

They announced acceptance of the Phase II MAvERIC results for publication in JAHA, highlighting clinical findings. According to the company, the report shows rapid and sustained reductions in pericarditis pain and inflammation and supports ongoing Phase III development.

How did CardiolRx perform in the Phase II MAvERIC study reported by Cardiol Therapeutics (CRDL)?

CardiolRx was associated with rapid, sustained reductions in pain and inflammation in high-burden patients. According to the company, the study also reported a substantial reduction in pericarditis episodes per year and favorable tolerability.

What is the clinical significance of the JAHA publication for Cardiol Therapeutics (CRDL)?

Publication in JAHA provides independent peer-reviewed validation of the Phase II findings. According to the company, it reinforces the clinical rationale for the pivotal Phase III MAVERIC trial and broader development of CardiolRx for recurrent pericarditis.

What is the status of the Phase III MAVERIC trial for CardiolRx (CRDL)?

The MAVERIC pivotal Phase III trial is ongoing and has surpassed 75% enrollment. According to the company, the Phase II data helped inform MAVERIC's design and support continued enrollment and evaluation.

Does the Phase II MAvERIC publication mention safety results for CardiolRx from Cardiol Therapeutics (CRDL)?

Yes. The Phase II report describes a favorable safety and tolerability profile for CardiolRx in the studied population. According to the company, safety findings support continued development into the Phase III MAVERIC program.