Cardiol Therapeutics

Cardiol Therapeutics, Inc. is a clinical-stage life sciences company focused on the research and clinical of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease. Its lead product candidate, CardiolRx, is a pharmaceutically manufactured oral cannabidiol formulation that is being clinically developed for use in heart diseases. The firm is conducting clinical studies to evaluate the efficacy and safety of CardiolRx in diseases affecting the heart: a Phase II multi-national, randomized, double-blind, placebo-controlled trial (the ARCHER trial) in acute myocarditis; and a Phase II multi-center open-label pilot study in recurrent pericarditis. It is also involved in developing a novel subcutaneously administered drug formulation of cannabidiol intended for use in heart failure. The company was founded by David Elsley, Eldon Smith, and Anthony Bolton on January 19, 2017 and is headquartered in Oakville, Canada.

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Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL) said it had made significant strides in 2023 and early 2024 to advance its offerings of novel therapeutic solutions to patients with underserved heart diseases. In an operational update looking at the 2023 calendar year, CEO David Elsley highlighted some of the main milestones the company achieved.

Cardiol Therapeutics surpasses enrollment goals, prepares for topline results

Completed patient enrollment in the Phase II MAvERIC-Pilot study evaluating CardiolRx™ in patients withrecurrent pericarditis, with topline results expected in Q2 2024 CardiolRx™ granted U.S. FDA Orphan Drug Designation for the treatment of pericarditis,which includes recurrent pericarditis Exceeded 50% enrollment in the Phase II ARCHER trial evaluating CardiolRx™in patients with acute myocarditis; study expected to reach full enrollment during Q3 2024 Data presented at the HFSA Annual Scientific Sessions 2023 demonstrated that the API in Cardiol's novelCRD-38 formulation attenuates harmful fat distribution and key markers of cardiac inflammation andremodelling in a model of heart failure with preserved ejection fraction Cash and cash equivalents of $34.9 million as of December 31, 2023,which funds operations into 2026 Toronto, Ontario--(Newsfile Corp. - April 2, 2024) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, today announces its year-end 2023 update on operations following the filing of its audited Financial Statements and Management's Discussion and Analysis for the year ended December 31, 2023. Both are available under the Company's profile on SEDAR+ at sedarplus.ca and on the Company's website at cardiolrx.com.

Cardiol Therapeutics Announces Year-End 2023 Update on Operations

Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL) has reached a significant milestone in its mission to combat heart disease. The company has wrapped up patient enrollment for its Phase II open-label pilot study, known as MAvERIC-Pilot, which focuses on patients suffering from recurrent pericarditis.

Cardiol Therapeutics wraps up patient enrollment for Phase II open label study

Topline Results Expected in Q2 2024 This is a Designated News Release. Toronto, Ontario--(Newsfile Corp. - February 21, 2024) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, today announced completion of patient enrollment in its Phase II open-label pilot study ("MAvERIC-Pilot") investigating the safety, tolerability, and efficacy of CardiolRx™ in patients with recurrent pericarditis.

Cardiol Therapeutics Completes Patient Enrollment in its Phase II MAvERIC-Pilot Study Investigating CardiolRx(TM) for Recurrent Pericarditis

Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL) made headlines earlier in the week when it revealed that the US Food and Drug Administration had granted its lead drug candidate CardiolRx orphan drug designation, indicating potential efficacy in treating recurrent pericarditis. The designation provides benefits such as marketing exclusivity and fee reduction, and the company's share prices have surged as a result.

Cardiol CEO David Elsley unpacks FDA Orphan Drug Designation for Cardiol

Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL), the pharmaceutical company, has been awarded Orphan Drug Designation for its lead drug candidate. The US Food and Drug Administration (FDA) awarded Cardiol the orphan status for the drug due to its potential use in helping treat both one-time and recurrent pericarditis, the inflammation of the lining around the heart.

Cardiol Therapeutics receives orphan drug status for its lead drug candidate

Designation Based on Pre-Clinical Data and Initial Clinical Data from the Company's MAvERIC-Pilot Phase II Study This is a Designated News Release. Toronto, Ontario--(Newsfile Corp. - February 15, 2024) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, announces that the United States Food and Drug Administration ("FDA") has granted Orphan Drug Designation ("ODD") for the Company's lead small molecule drug candidate for the treatment of pericarditis, which includes recurrent pericarditis.

Cardiol Therapeutics Granted Orphan Drug Designation for its Lead Drug Candidate for the Treatment of Pericarditis

Toronto, Ontario--(Newsfile Corp. - January 24, 2024) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, today announced that it received notice on January 23, 2024 from The Nasdaq Stock Market LLC ("Nasdaq") stating that the Company has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) ("Minimum Bid Requirement") for continued listing on The Nasdaq Capital Market. Accordingly, the Company is now in compliance with all applicable listing standards.

Cardiol Therapeutics Regains Compliance with all Applicable Listing Standards of The Nasdaq Capital Market

Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL) told investors it has exceeded 50% patient enrollment for its Phase II ARCHER trial. The multi-center, international, double-blind, randomized, placebo-controlled trial is investigating the safety, tolerability, and impact of CardiolRx on myocardial recovery in patients presenting with acute myocarditis.

Cardiol Therapeutics exceeds 50% enrollment in Phase II ARCHER trial in acute myocarditis

Toronto, Ontario--(Newsfile Corp. - January 9, 2024) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, is pleased to announce that it has exceeded 50% patient enrollment for ARCHER, the Company's Phase II, multi-center, international, double-blind, randomized, placebo-controlled trial investigating the safety, tolerability, and impact of CardiolRx™ on myocardial recovery in patients presenting with acute myocarditis. "Achieving this milestone reflects the commitment and interest demonstrated by our clinical collaborators and participating patients, and we thank them for their contribution to the progress being made in this important clinical trial," said David Elsley, Cardiol Therapeutics' President and Chief Executive Officer.

Cardiol Therapeutics Announces it has Exceeded 50% Enrollment in its Phase II ARCHER Trial in Acute Myocarditis

Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL) has added Massachusetts General to the enrollment process for the MAvERIC-Pilot, a Phase II open-label pilot study of lead candidate CardiolRx in patients suffering from recurrent pericarditis. The renowned Mass General, recognized for its top-notch medical research programs, joins eight other leading medical research centers in the United States dedicated to pericarditis care.

Cardiol Therapeutics expands study with addition of Massachusetts General hospital

MAvERIC-Pilot is a Phase II Study in Recurrent Pericarditis and is Anticipated to Complete Patient Recruitment during Q1 2024 Toronto, Ontario--(Newsfile Corp. - December 5, 2023) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, is pleased to announce that Massachusetts General Hospital ("Mass General") has been initiated and is eligible to enroll patients in MAvERIC-Pilot, the Company's Phase II open-label pilot study, investigating the safety, tolerability, and efficacy of CardiolRx™ in patients with recurrent pericarditis. In addition to standard safety assessments, the study is designed to evaluate improvement in objective measures of this rare disease, and during an extension period, assess the feasibility of weaning concomitant background therapy including corticosteroids, while taking CardiolRx™ and to assess freedom from pericarditis recurrence.

Cardiol Therapeutics Announces Massachusetts General Hospital, Largest Teaching Hospital of Harvard Medical School, as the 8th Major Medical Centre Participating in MAvERIC-Pilot

Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL) announced that study results have demonstrated an experimental model of pericarditis induces mesothelial to mesenchymal transition (MMT) and that this process is inhibited by cannabidiol treatment, the active pharmaceutical ingredient in its lead candidate, CardiolRx. The study results were presented at the 2023 Annual Meeting of the European Society of Cardiology Working Group on Myocardial and Pericardial Diseases (MPD2023), held on November 15 and 16, 2023, in Belgrade, Serbia.

Cardiol Therapeutics says study results further support anti-fibrotic benefit of lead candidate CardiolRx

Toronto, Ontario--(Newsfile Corp. - November 16, 2023) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, announced today that study results demonstrated an experimental model of pericarditis induces mesothelial to mesenchymal transition ("MMT") and that this process is inhibited by cannabidiol treatment, the active pharmaceutical ingredient in CardiolRx™. An abstract summarizing these results was submitted by the Company's international research collaborators from the University of Virginia and Houston Methodist DeBakey Heart & Vascular Center to the 2023 Annual Meeting of the European Society of Cardiology Working Group on Myocardial and Pericardial Diseases ("MPD2023") held on November 15 and 16, 2023 in Belgrade, Serbia.

Cardiol Therapeutics Announces Study Results Presented at the 2023 Annual Meeting of the European Society of Cardiology Working Group on Myocardial and Pericardial Diseases

Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL) announced it has successfully enrolled over 50% of the targeted number of patients for its Phase II open-label pilot study on its lead candidate CardiolRx. The primary objective of the MAvERIC-Pilot study is to assess the safety, tolerability, and efficacy of CardiolRx in patients with recurrent pericarditis, a rare and debilitating inflammatory heart disease is known for negatively impacting the quality of life and physical well-being of those affected.

Cardiol Therapeutics reaches new milestone in Phase II study for recurrent pericarditis

Toronto, Ontario--(Newsfile Corp. - November 1, 2023) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, is pleased to announce that it has exceeded 50% of the patient enrollment target for its Phase II open-label pilot study ("MAvERIC-Pilot"), investigating the safety, tolerability, and efficacy of CardiolRx™ in patients with recurrent pericarditis. In addition to standard safety assessments, the study is designed to evaluate improvement in objective measures of this rare disease, and during an extension period, assess the feasibility of weaning concomitant background therapy including corticosteroids, while taking CardiolRx™.

Cardiol Therapeutics Announces It Has Exceeded 50% Enrollment in Its Phase II MAvERIC-Pilot Study in Recurrent Pericarditis

Toronto, Ontario--(Newsfile Corp. - October 20, 2023) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, announces that on October 19, 2023, it received a notice (the "Notice") from the Nasdaq Stock Market LLC ("Nasdaq"), stating that the Company is not in compliance with the minimum bid price requirement ("Minimum Bid Requirement") of US$1.00 per share under the Nasdaq Listing Rule 5550(a)(2) based upon the closing bid price of the Company's Class A common shares ("Common Shares") for the 30 consecutive business days prior to the date of the Notice. The Notice has no immediate effect on the listing or trading of the Common Shares on Nasdaq, and the Company's operations are not affected by the receipt of the Notice.

Cardiol Therapeutics Receives Nasdaq Deficiency Notice Regarding Minimum Bid Price Requirement

Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL) has reported positive study results showing that cannabidiol, the active pharmaceutical ingredient in the company's novel CRD-38 subcutaneous (SUBQ) formulation, reduces harmful fat distribution and key markers of cardiac inflammation and remodeling. Study results from one of Cardiol's international collaborating research centers demonstrated that subcutaneously administered cannabidiol slowed increases in body weight and heart weight, and prevented increases in key cardiac inflammatory and remodelling markers in a model of heart failure with preserved ejection fraction (HFpEF).

Cardiol Therapeutics says study results show positive effects of subcutaneously administered cannabidiol

Results Demonstrate the Active Pharmaceutical Ingredient in Cardiol's Novel CRD-38 Formulation Attenuates Harmful Fat Distribution and Key Markers of Cardiac Inflammation and Remodelling Data Presented at the Heart Failure Society of America Annual Scientific Meeting 2023 Toronto, Ontario--(Newsfile Corp. - October 10, 2023) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, announces positive study results from one of its international collaborating research centers demonstrating that subcutaneously administered cannabidiol, the active pharmaceutical ingredient in Cardiol's novel CRD-38 subcutaneous ("SUBQ") formulation, slowed increases in body weight and heart weight, and prevented increases in key cardiac inflammatory and remodelling markers in a model of heart failure with preserved ejection fraction ("HFpEF"). The study was presented by researchers from Tecnológico de Monterrey, Mexico ("TecSalud") at the Heart Failure Society of America Annual Scientific Meeting 2023 ("HFSA2023").

Cardiol Therapeutics Announces Positive Study Results Demonstrating Cardioprotective Effects of Subcutaneously Administered Cannabidiol in a Model of Heart Failure with Preserved Ejection Fraction

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Toronto, Ontario--(Newsfile Corp. - September 26, 2023) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, is pleased to announce that Cardiol's President and CEO, David Elsley, will present a company overview today which will be broadcast live at the Cantor Fitzgerald 2023 Global Healthcare Conference, at the InterContinental New York Barclay Hotel, on September 26, 2023, at 4:55 p.m. EDT. Date: Tuesday, September 26, 2023 Time: 4:55 p.m.

Cardiol Therapeutics to Present at Cantor Fitzgerald 2023 Global Healthcare Conference

Here is how Cardiol Therapeutics Inc. (CRDL) and DiaMedica Therapeutics, Inc. (DMAC) have performed compared to their sector so far this year.

Is Cardiol Therapeutics (CRDL) Stock Outpacing Its Medical Peers This Year?

Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL) said all of the research centers it is collaborating with on its ARCHER Phase 2 trial to study the safety and tolerability and impact on myocardial recovery of its investigative therapeutic CardiolRx in patients with acute myocarditis have been initiated and are eligible to enroll patients. The company said that ARCHER is expected to enroll 100 patients at major cardiac centres in North America, Europe, Latin America, and Israel.

Cardiol Therapeutics on track to complete enrollment for acute myocarditis trial six months ahead of schedule

Recruitment Accelerating and Full Patient Enrollment Anticipated to be Completed During Q3 2024, up to Six Months Ahead of Schedule  Multi-Center, International, Double-blind, Placebo-controlled Trial Randomizing 100 Patients Toronto, Ontario--(Newsfile Corp. - September 19, 2023) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, today announces that all collaborating research centers have been initiated and are eligible to enroll patients in ARCHER, the Company's Phase II, multi-center, international, double-blind, randomized, placebo-controlled trial designed to study the safety and tolerability of CardiolRx™, as well as its impact on myocardial recovery, in patients presenting with acute myocarditis. ARCHER is expected to enroll 100 patients at major cardiac centers in North America, Europe, Latin America, and Israel.

Cardiol Therapeutics Announces All Collaborating Clinical Research Centers Now Initiated and Eligible to Enroll Patients in ARCHER, a Phase II Trial of CardiolRx(TM) for the Treatment of Acute Myocarditis

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