Cardiol Therapeutics Inc. reports clinical, financing, and corporate updates as a late-stage life sciences company developing anti-inflammatory and anti-fibrotic therapies for heart disease. Its lead oral small-molecule candidate, CardiolRx, modulates inflammasome pathway activation associated with inflammation and fibrosis in pericarditis, myocarditis, and heart failure.
Recurring developments include the MAVERIC program in recurrent pericarditis, the completed ARCHER Phase II study in acute myocarditis, peer-reviewed publication of clinical data, U.S. trial-network updates, intellectual-property disclosures, and development of CRD-38 for heart failure and other inflammatory heart diseases. Company news also covers bought deal financings, common share and warrant offerings, annual operating updates, and healthcare conference presentations.
Cardiol Therapeutics (NASDAQ: CRDL) has initiated its pivotal Phase III MAVERIC trial by enrolling the first patient at Northwestern University, evaluating CardiolRx™ for preventing recurrent pericarditis. The multi-center, randomized, double-blind, placebo-controlled trial will enroll 110 patients across the US, Canada, and Europe.
The trial follows positive Phase II MAvERIC-Pilot results presented at AHA Scientific Sessions 2024, which demonstrated marked reductions in pericarditis pain, inflammation, and yearly recurrences. CardiolRx™, granted FDA Orphan Drug Designation, is an oral drug targeting the inflammasome pathway.
MAVERIC will assess patients who have been treated with IL-1 blockers for at least 12 months and are scheduled to discontinue treatment. The primary endpoint is freedom from pericarditis recurrence at 24 weeks. The study is being conducted at approximately 20 clinical sites under FDA-authorized IND application.
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.
Cardiol Therapeutics (NASDAQ/TSX: CRDL), a clinical-stage life sciences company specializing in anti-inflammatory and anti-fibrotic therapies for heart disease treatment, has announced its upcoming presentation at the TD Cowen 45th Annual Health Care Conference.
The presentation is scheduled for March 5, 2025, at 11:10 a.m. EST in Boston, MA. Interested parties can access a replay of the live webcast through the 'Events & Presentations' section of Cardiol's investor relations website at cardiolrx.com.
Cardiol Therapeutics (NASDAQ: CRDL) announced the publication of research in the Journal of the American College of Cardiology: Basic to Translational Science supporting their subcutaneous drug candidate CRD-38 for heart failure treatment. The research, conducted by scientists from Tecnológico de Monterrey and DeBakey Heart and Vascular Center, demonstrates that subcutaneously administered cannabidiol improves cardiac function and reduces cardiac hypertrophy, remodeling, inflammation, and cell death.
The study results show that CRD-38 provides cardioprotection through multiple mechanisms, including preservation of mitochondrial function and calcium handling in heart cells. The research utilized multiple heart failure models, including in vivo, ex vivo, and in vitro investigations. Key findings revealed that the drug's cardioprotective effect may depend on PPAR-γ activation, which helps prevent mitochondrial dysfunction.
This research is particularly significant as heart failure with preserved ejection fraction remains a leading cause of hospitalization worldwide, with a five-year mortality exceeding 75% in hospitalized patients.
Cardiol Therapeutics (NASDAQ: CRDL) (TSX: CRDL), a clinical-stage life sciences company specializing in anti-inflammatory and anti-fibrotic therapies for heart disease treatment, has announced its upcoming presentation at the Oppenheimer 35th Annual Healthcare Life Sciences Conference. The presentation is scheduled for February 11, 2025, at 4:00 p.m. EST.
Interested parties can access a live webcast of the presentation through the 'Events & Presentations' section of Cardiol's investor relations website at www.cardiolrx.com/investors/events-presentations/.
Cardiol Therapeutics (NASDAQ: CRDL) reported positive Phase II MAvERIC-Pilot clinical results for CardiolRx™ in treating recurrent pericarditis. The study showed marked improvements in pericarditis pain and inflammation maintained throughout the 26-week study. The trial enrolled 27 participants across eight U.S. clinical sites. Key results include: pain reduction from 5.8 to 1.5 at week 26, CRP normalization in 80% of patients at week 8, and reduction in pericarditis episodes from 5.8 to 0.9 per year. The data supports advancing to Phase II/III MAVERIC-2 and Phase III MAVERIC-3 trials. CardiolRx™ demonstrated safety and tolerability with 95% compliance.
Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) announced plans to advance CardiolRx™ into a late-stage clinical trial called MAVERIC-2. This trial will evaluate the impact of CardiolRx™ in recurrent pericarditis patients following cessation of interleukin-1 (IL-1) blocker therapy. MAVERIC-2 is expected to be initiated during Q4 at major pericardial disease centers in the United States and Europe.
The trial is designed as a randomized, double-blind, placebo-controlled Phase II/III study with approximately 110 patients. The primary clinical objective is to assess the impact of CardiolRx™ versus placebo on freedom from a new episode of recurrent pericarditis. This study is expected to run concurrently with the Company's planned Phase III program and report results ahead of the pivotal Phase III study in recurrent pericarditis.
Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) has announced the successful exercise and closing of the over-allotment option for its public offering. Canaccord Genuity purchased an additional 1,265,625 Class A common shares at US$1.60 per share, resulting in additional gross proceeds of $2,025,000. The total offering, including the over-allotment, now comprises 9,703,125 shares for aggregate gross proceeds of US$15,525,000.
The company plans to use the net proceeds to support the clinical development of CardiolRx for treating recurrent pericarditis, as well as for general and administrative expenses, working capital, and other expenses. The offering was made pursuant to U.S. and Canadian regulatory filings, including a U.S. registration statement on Form F-10 and a Canadian short form base shelf prospectus.
Cardiol Therapeutics (NASDAQ: CRDL) (TSX: CRDL) has successfully closed its public offering of 8,437,500 Class A common shares at US$1.60 per share, raising gross proceeds of US$13.5 million. The company plans to use the net proceeds to support the clinical development of CardiolRx for treating recurrent pericarditis, as well as for general and administrative expenses, working capital, and other expenses.
Canaccord Genuity acted as the sole bookrunner for the offering. The offering was made pursuant to a U.S. registration statement on Form F-10 and the company's existing Canadian short form base shelf prospectus. A final prospectus supplement was filed with securities commissions in Canada (except Quebec) and the SEC in the United States.
Cardiol Therapeutics (NASDAQ: CRDL) (TSX: CRDL) has announced the pricing of its public offering of 8,437,500 Class A common shares at US$1.60 per share, aiming to raise US$13.5 million in gross proceeds. The company plans to use the funds to support the clinical development of CardiolRx for treating recurrent pericarditis, as well as for general expenses and working capital. Canaccord Genuity is acting as the sole bookrunner for the offering, which is expected to close around October 10, 2024. The offering is being made under a U.S. registration statement and Canadian short form base shelf prospectus, with a final prospectus supplement to be filed with relevant securities commissions.