Cardiol Therapeutics Achieves Key 50% Patient Enrollment Milestone in Pivotal Phase III MAVERIC Trial in Recurrent Pericarditis

Rhea-AI Summary

Cardiol Therapeutics (NASDAQ: CRDL) announced it has surpassed 50% patient enrollment in MAVERIC, its pivotal Phase III randomized, double-blind, placebo-controlled trial of CardiolRx for recurrent pericarditis. More than 15 U.S. cardiovascular centers are actively enrolling, with additional sites in Europe and Canada being activated. MAVERIC plans ~110 patients across ~25 centers, a primary endpoint of freedom from new recurrent pericarditis at 6 months, and secondary endpoints including pericarditis pain days, pain score changes, and CRP. Full enrollment is expected in Q2 2026.

Positive

• Enrollment >50% in pivotal Phase III MAVERIC
• 15+ U.S. cardiovascular centers actively enrolling
• Full enrollment targeted by Q2 2026
• MAVERIC sized at ~110 patients across ~25 centers
• Primary endpoint: freedom from recurrence at 6 months

Negative

• Enrollment only at ~50%—trial completion not yet assured
• Activation of Europe and Canada sites is ongoing
• Relatively small trial size: ~110 patients

News Market Reaction

+1.29%

1 alert

+1.29% News Effect

+$1M Valuation Impact

$96M Market Cap

0.0x Rel. Volume

On the day this news was published, CRDL gained 1.29%, reflecting a mild positive market reaction. This price movement added approximately $1M to the company's valuation, bringing the market cap to $96M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

MAVERIC enrollment: 50% of planned patients Active U.S. centers: More than 15 centers Full enrollment timeline: Q2 2026 +4 more

7 metrics

MAVERIC enrollment 50% of planned patients Pivotal Phase III recurrent pericarditis trial

Active U.S. centers More than 15 centers Cardiovascular sites actively enrolling in MAVERIC

Full enrollment timeline Q2 2026 Expected completion of MAVERIC enrollment

Planned enrollment Approximately 110 patients Target MAVERIC Phase III trial size

Clinical sites Some 25 centers Research centers in U.S., Canada, and Europe

Primary endpoint window Six months Double-blind treatment period before primary endpoint assessment

Biologic therapy market Over $800 million Forecast U.S. biologic revenues in 2026 for recurrent pericarditis

Market Reality Check

Price: $0.9948 Vol: Volume 479,343 is 1.59x t...

high vol

$0.9948 Last Close

Volume Volume 479,343 is 1.59x the 20-day average of 302,257, indicating elevated pre-news trading interest. high

Technical Shares at $0.96 were trading below the 200-day MA of $1.13 and 39.62% below the 52-week high.

Peers on Argus

CRDL was down 3.74% while peers were mixed: BIOA was highlighted with a 19% gain...

1 Up

CRDL was down 3.74% while peers were mixed: BIOA was highlighted with a 19% gain and appeared in momentum scanners, whereas INCR, DRRX, and ANIK showed smaller declines. This pattern points to stock-specific trading rather than a coordinated sector move.

Historical Context

5 past events · Latest: Dec 01 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 01	Phase II data update	Positive	-9.5%	Detailed ARCHER Phase II myocarditis data showing heart structure improvements.
Nov 13	IP/patent news	Positive	-1.9%	U.S. patent allowance protecting CardiolRx and CRD-38 to October 2040.
Nov 05	Conference presentation	Positive	+3.8%	Announcement of full ARCHER results presentation at ESC cardiology meeting.
Oct 21	Financing and runway	Positive	+15.2%	US$11.4M private placement extending cash runway into Q3 2027.
Oct 17	Financing secured	Positive	-1.0%	US$11M financing supporting MAVERIC program and CRD-38 development.

Pattern Detected

Positive clinical and financing updates have often seen mixed or negative next-day reactions, with 3 divergences versus 2 alignments, suggesting a tendency for the stock to underreact or sell off on good news.

Recent Company History

Over the past nine months, Cardiol reported multiple clinical and financing milestones. Phase II ARCHER data on myocarditis showed structural heart improvements and proof-of-concept for CardiolRx™, yet reactions were mixed, including a -20.74% move on topline ARCHER results and -9.52% on detailed data. In parallel, the company secured financings totaling over US$11 million, extending its cash runway into Q3 2027 and fully funding the pivotal Phase III MAVERIC trial, where today’s update marks a 50% enrollment milestone building on the first-patient-enrolled news from Apr 16, 2025.

Market Pulse Summary

This announcement marks a key operational milestone, with the pivotal MAVERIC Phase III trial now ov...

Analysis

This announcement marks a key operational milestone, with the pivotal MAVERIC Phase III trial now over 50% enrolled toward approximately 110 patients across some 25 centers in North America and Europe. It builds on prior Phase II data from ARCHER and MAvERIC-Pilot supporting CardiolRx™ in inflammatory heart disease. Recent financings extended the company’s cash runway into Q3 2027, fully funding MAVERIC. Investors may focus on enrollment completion by Q2 2026, upcoming efficacy readouts, and consistency with earlier structural heart improvements.

Key Terms

phase iii, randomized, double-blind, placebo-controlled, +2 more

6 terms

phase iii medical

"its Phase III randomized, double-blind, placebo-controlled, multi-center international trial"

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.

randomized medical

"its Phase III randomized, double-blind, placebo-controlled, multi-center international 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

"its Phase III randomized, double-blind, placebo-controlled, multi-center international 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

"its Phase III randomized, double-blind, placebo-controlled, multi-center international 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.

interleukin-1 inhibitors medical

"immunosuppressive biologics such as interleukin-1 inhibitors"

Interleukin-1 inhibitors are medicines that block a specific protein (interleukin-1) that tells the body to create and sustain inflammation; think of them as turning down an overactive thermostat that fuels pain and tissue damage. They matter to investors because successful inhibitors can become treatments for multiple inflammatory and autoimmune diseases, so clinical trial results, regulatory approvals, safety profiles and market adoption directly affect a drug maker’s revenue potential and valuation.

c-reactive protein (crp) medical

"changes in the inflammatory biomarker C-reactive protein (CRP)."

C-reactive protein (CRP) is a blood marker that rises when the body has inflammation or infection; think of it as a smoke alarm signaling that something is wrong. For investors, CRP matters because it is used in clinical trials and routine tests to track disease activity, predict cardiovascular risk, and measure how well treatments work—information that can affect the market value of diagnostics, drugs, and healthcare companies.

AI-generated analysis. Not financial advice.

• Clinical trial infrastructure fully operational in the U.S. with more than 15 leading cardiovascular centers actively enrolling patients.

• Activation of additional top-tier clinical sites in Europe and Canada underway, further accelerating enrollment momentum.

• Full enrollment expected in Q2 2026.

Toronto, Ontario--(Newsfile Corp. - January 13, 2026) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a late-stage life sciences company focused on advancing the development of anti-inflammatory and anti-fibrotic therapies for heart disease, today announced that it has surpassed 50% patient enrollment in MAVERIC, its Phase III randomized, double-blind, placebo-controlled, multi-center international trial evaluating CardiolRx™ for the prevention of disease recurrence in patients with recurrent pericarditis.

Reaching this enrollment milestone represents a key execution and risk-reduction inflection point for Cardiol's lead registrational program and underscores strong investigator interest in advancing new treatment options for this underserved patient population.

"Surpassing 50% enrollment in MAVERIC is an important milestone for our Phase III program and reflects both the high unmet medical need in recurrent pericarditis and the confidence investigators have in the scientific rationale and rigorous design of this pivotal trial," said Dr. Andrew Hamer, Chief Medical Officer and Head of Research & Development at Cardiol Therapeutics. "More than 15 leading cardiovascular centers across the United States are now actively enrolling patients, and with additional premier sites coming online in Europe and Canada, we are well positioned to sustain recruitment momentum, complete enrollment in Q2 2026, and deliver high-quality clinical data supporting CardiolRx™ as a differentiated oral therapy for this challenging disease."

"The continued expansion of the MAVERIC program underlines the importance of evaluating additional treatment options for use earlier in the recurrent pericarditis treatment paradigm—before patients are exposed to prolonged corticosteroid use or immunosuppressive biologics such as interleukin-1 inhibitors," said David Elsley, President and Chief Executive Officer. "Importantly, data from the recent ARCHER study demonstrating improvements in cardiac structure in patients with myocarditis reinforce our position that CardiolRx™ has the potential to meaningfully change the management of recurrent pericarditis. Taken together, these findings support our conviction that CardiolRx™'s oral, non-immunosuppressive profile positions it as a more accessible therapeutic option for a substantially broader patient population than is currently served by biologic therapies, which are forecast to generate over $800 million in U.S. revenues in 2026."

The MAVERIC Phase III trial was designed in collaboration with an international steering committee of independent pericarditis experts and builds on the positive results from Cardiol's Phase II MAvERIC-Pilot study. In that study, patients treated with CardiolRx™—despite a high baseline disease burden—experienced rapid and sustained reductions in pericarditis pain and inflammation, along with a marked reduction in recurrence events per year. CardiolRx™ was shown to be safe and well tolerated, providing the scientific and clinical rationale for advancement into this pivotal Phase III trial.

MAVERIC is expected to enroll approximately 110 patients across some 25 leading cardiovascular research centers in the United States, Canada, and Europe. The primary endpoint, assessed after six months of double-blind treatment, is freedom from a new episode of recurrent pericarditis. Secondary efficacy endpoints include the percentage of days with no or minimal pericarditis pain, changes in pericarditis pain scores, and changes in the inflammatory biomarker C-reactive protein (CRP).

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 is also studying 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 the first-in-human clinical evaluation, the Company's belief that results from the ARCHER trial provide compelling clinical proof of concept for CardiolRx™, strengthen the scientific and clinical rationale for Cardiol's lead Phase III program in recurrent pericarditis, the Company's beliefs and expectations regarding future enrollment in its Phase III study in recurrent pericarditis and the timelines to reach its enrollment goal, the Company's beliefs regarding the quality of future clinical data resulting from the Phase III study in recurrent pericarditis with CardiolRx, and the Company's conviction that CardiolRx™'s oral, non-immunosuppressive profile positions it as a more accessible therapeutic option for a substantially broader patient population than is currently served by biologic therapies. 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, 2025, 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.

For further information, please contact:
Investor.relations@cardiolrx.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/280170

FAQ

What milestone did Cardiol Therapeutics (CRDL) announce on January 13, 2026?

Cardiol announced it surpassed 50% patient enrollment in the MAVERIC Phase III trial.

How many patients and sites will MAVERIC (CRDL) enroll and use?

MAVERIC is expected to enroll ~110 patients across about 25 research centers in the U.S., Canada, and Europe.

When does Cardiol expect MAVERIC full enrollment to complete for CRDL?

The company expects to complete full enrollment in Q2 2026.

What is the primary endpoint of MAVERIC in Cardiol's CRDL trial?

Primary endpoint is freedom from a new episode of recurrent pericarditis after six months of double-blind treatment.

Which secondary endpoints will MAVERIC evaluate for CRDL?

Secondary endpoints include percentage of days with no/minimal pain, pericarditis pain score changes, and changes in CRP.

How many U.S. centers are actively enrolling in MAVERIC for CRDL?

More than 15 leading cardiovascular centers in the United States are actively enrolling patients.