Breakeven Date Change • May 19
No longer forecast to breakeven The 5 analysts covering Cardiol Therapeutics no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of CA$4.54m in 2028. New consensus forecast suggests the company will make a loss of CA$8.68m in 2028. Breakeven Date Change • May 12 The 5 analysts covering Cardiol Therapeutics previously expected the company to break even in 2028. New consensus forecast suggests losses will reduce by 11% per year to 2027. The company is expected to make a profit of CA$4.54m in 2028. Average annual earnings growth of 83% is required to achieve expected profit on schedule.
Announcement • Apr 30
Cardiol Therapeutics Inc. Expands Maveric Phase III Trial Network and Provides Clinical Updates on Cardiolrx Cardiol Therapeutics Inc. announced the continued expansion of its pivotal Phase III MAVERIC trial in the United States, 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 Second Quarter 2026, with the potential to extend into Third Quarter to accommodate patient enrollment from additional clinical sites. 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, 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. 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. 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. Food and Drug Administration 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 USD 30,000 million per year. Announcement • Apr 13
Cardiol Therapeutics Inc., Annual General Meeting, Jun 24, 2026 Cardiol Therapeutics Inc., Annual General Meeting, Jun 24, 2026. Breakeven Date Change • Apr 04
Forecast to breakeven in 2028 The 5 analysts covering Cardiol Therapeutics expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of CA$4.54m in 2028. Average annual earnings growth of 66% is required to achieve expected profit on schedule. New Risk • Apr 02
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: CA$35m Forecast net loss in 3 years: CA$292k This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (34% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (CA$292k net loss in 3 years). New Risk • Jan 26
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 36% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (36% increase in shares outstanding). Revenue is less than US$1m. Announcement • Jan 24
Cardiol Therapeutics Inc. announced that it has received CAD 13.500001 million in funding On January 23, 2026. Cardiol Therapeutics Inc. announced that it has closed the transaction. Pursuant to the offering, the company issued an aggregate of 11,423,078 units at a price of CAD 1.30 per unit for aggregate gross proceeds of CAD 14.85 million, which includes the full exercise by the underwriter of the overallotment option. In connection with the offering, the company paid the underwriter a cash commission equal to 6 per cent of the aggregate gross proceeds of the offering. The offering was completed by way of a private placement pursuant to National Instrument 45-106. The units issued under the listed issuer financing exemption are not subject to resale restrictions in Canada pursuant to applicable Canadian securities laws. Announcement • Jan 17
Cardiol Therapeutics Inc. announced that it expects to receive CAD 13.500001 million in funding Cardiol Therapeutics Inc. announces that it has entered into an agreement to issue 10,384,616 units of the Company at a price of CAD 1.30 per Unit on a bought deal basis in a private placement offering for gross proceeds of CAD 13,500,000.8 million on January 16, 2026. Each Unit will consist of one Class A common share of the Company and one-half of one Common Share purchase warrant. Each Warrant shall entitle the holder thereof to purchase one Common Share at an exercise price of CAD 1.75 per Warrant Share at any time for a period of 24 months from the date of issuance. The Offering is scheduled to close on or about January 23, 2026, or such other date as the Company and the Underwriter may agree upon, and is subject to the receipt of all necessary approvals; including, the approval of the TSX and the negotiation of an underwriting agreement between the Company and the Underwriter. Notwithstanding the foregoing, the closing of any Units issued pursuant to the Listed Issuer Financing Exemption must occur no later than the 45th day following the date hereof. Upon closing of the Offering, the Company shall pay to the Underwriter a cash commission equal to 6% of the aggregate gross proceeds of the Offering. The Company has also granted the Underwriter the option to purchase up to an additional 10% of the number of Units sold in the Offering, being up to 1,038,462 Units, at the Offering Price to raise additional gross proceeds of up to CAD 1,350,000.6, exercisable in whole or in part at any time up to 48 hours prior to the closing of the Offering to cover over-allotments Announcement • Jan 14
Cardiol Therapeutics Achieves Key 50% Patient Enrollment Milestone in Pivotal Phase III MAVERIC Trial in Recurrent Pericarditis Cardiol Therapeutics Inc. 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. 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). Breakeven Date Change • Dec 31
Forecast to breakeven in 2028 The 5 analysts covering Cardiol Therapeutics expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of CA$15.4m in 2028. Average annual earnings growth of 59% is required to achieve expected profit on schedule. New Risk • Oct 24
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 19% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (CA$1.4m net loss in 3 years). Shareholders have been diluted in the past year (19% increase in shares outstanding). Announcement • Oct 21
Cardiol Therapeutics Inc. announced that it has received $11.4 million in funding On October 21, 2025, Cardiol Therapeutics Inc. closed the transaction. The company issued 1,400,000 units in its second and last tranche. The company issued a total of 11,400,000 units at an issue price of $1 per unit for gross proceeds of $11,400,000. Each unit consists of one class A common share of the company and one-half of one common share purchase warrant. Each whole warrant entitles the holder to acquire one additional common share at an exercise price of $1.35 for a period of 24 months from the date of issuance. Certain insiders of the Company participated in the Offering. Announcement • Oct 18
Cardiol Therapeutics Inc. announced that it expects to receive $11 million in funding Cardiol Therapeutics Inc. announced a private placement to issue 11,000,000 units at an issue price of $1 per unit for gross proceeds of $11,000,000 on October 17, 2025. Each unit consists of one class A common share of the company and one-half of one common share purchase warrant. Each whole warrant entitles the holder to acquire one additional common share at an exercise price of $1.35 for a period of 24 months from the date of issuance. Certain insiders of the company participated in the offering.
On the same date, the company issued 10,000,000 units at an issue price of $1 for gross proceeds of $10,000,000 in its first tranche. The company will receive remaining $1,000,000 proceeds on October 20, 2025. New Risk • Aug 21
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Canadian stocks, typically moving 13% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-CA$25m free cash flow). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (CA$1.4m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (20% increase in shares outstanding). Market cap is less than US$100m (CA$134.0m market cap, or US$96.4m). New Risk • Aug 07
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: CA$36m Forecast net loss in 3 years: CA$16m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-CA$25m free cash flow). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (CA$16m net loss in 3 years). Shareholders have been diluted in the past year (19% increase in shares outstanding). Market cap is less than US$100m (CA$122.3m market cap, or US$89.0m). New Risk • Jul 18
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: CA$133.1m (US$97.0m) This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-CA$25m free cash flow). Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (19% increase in shares outstanding). Market cap is less than US$100m (CA$133.1m market cap, or US$97.0m). New Risk • Jul 02
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -CA$25m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-CA$25m free cash flow). Revenue is less than US$1m. Minor Risk Shareholders have been diluted in the past year (20% increase in shares outstanding). Announcement • May 29
Cardiol Therapeutics Inc. Announces Board Changes Cardiol Therapeutics Inc. approved the appointment of Dr. Timothy Garnett as director following its Annual General Meeting of Shareholders held on May 28, 2025. Dr. Garnett is a distinguished pharmaceutical industry executive with over 30 years' experience, including two decades at Eli Lilly and Company, where he served as Chief Medical Officer from 2008 until his retirement in 2021. During his tenure at Eli Lilly, he led the successful development of therapeutics in women's health, endocrinology, and neuroscience, resulting in multiple global commercial launches. Dr. Garnett has played a key role in the successful development of numerous drugs across both early- and late-stage clinical development. He has broad experience leading clinical development, portfolio management, medical affairs, regulatory strategy, and safety functional areas, and has a strategic understanding of the evolving metabolic therapy landscape. Dr. Garnett currently serves as Chair of Ophirex and a Director of MapLight Therapeutics. In addition, he is a member of the Advisory Panel of Cambridge Innovation Capital and an equity partner at Recode Health Ventures LLC. Dr. Garnett holds a Bachelor of Medicine and Bachelor of Surgery (MBBS) from St. George's, University of London. He is a Fellow of both the Faculty of Pharmaceutical Medicine (FFPM), and the Royal College of Obstetricians and Gynaecologists (FRCOG). The company would also like to take this opportunity to thank Michael Willner for his service as a Board member since September 2021 and for his valuable contributions to the Company's development. Mr. Willner has agreed to continue to assist the Company in an advisory capacity. New Risk • May 15
New minor risk - Financial position The company has less than a year of cash runway based on its current free cash flow. Free cash flow: -CA$25m This is considered a minor risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Less than 1 year of cash runway based on current free cash flow (-CA$25m). Currently unprofitable and not forecast to become profitable over next 3 years (CA$1.9m net loss in 3 years). Shareholders have been diluted in the past year (20% increase in shares outstanding). Market cap is less than US$100m (CA$128.0m market cap, or US$91.5m). Announcement • Apr 16
Cardiol Therapeutics Inc. Enrolls First Patient in Pivotal Phase III Maveric Trial in Recurrent Pericarditis Cardiol Therapeutics Inc. announced that Northwestern University has enrolled the first patient in the pivotal Phase III MAVERIC trial ("MAVERIC") evaluating Cardiol's lead drug candidate CardiolRx™? for the prevention of recurrent pericarditis. This multi-center, randomized, double-blind, placebo-controlled trial is designed to definitively assess the impact of CardiolRx™? on preventing recurrent pericarditis in patients at high risk for disease relapse and to support regulatory approval. MAVERIC is currently being initiated at pre-eminent cardiovascular clinical research sites throughout the United States under an Investigational New Drug application authorized by the United States Food and Drug Administration ("US FDA"). The MAVERIC Program and Phase III leadership comprises an independent committee of international thought leaders in pericardial disease and clinical trial design: Allan Klein, MD, CM from Cleveland Clinic (MAVERIC Program Chair); Massimo Imazio, MD, FESC from University of Udine, Italy (MAVERIC Program Co-Chair); Other clinical endpoints include time to a new episode of pericarditis recurrence, and changes in patient-reported pericarditis chest pain score and changes to the inflammatory marker C-reactive protein. Data from MAvERIC-Pilot were previously reported on November 18 at the American Heart Association Scientific Sessions 2024 and showed that patients experienced marked and rapid reductions in both pericarditis pain and inflammation that were maintained throughout the study. In addition, the results demonstrated a substantial reduction in pericarditis episodes per year. The only FDA-approved therapy for recurrent pericarditis, launched in 2021, is costly and is primarily used as a third-line intervention. Cardiol has received Investigational New Drug Application authorization from the United States Food and Drug administration ("US FDA") to conduct clinical studies to evaluate the efficacy and safety of CardiolRx™™? in two diseases affecting the heart: recurrent pericarditis and acute myocarditis. The MAVERIC Program in recurrent pericarditis, an inflammatory disease of the pericardium which is associated with symptoms including debilitating chest pain, shortness of breath, and fatigue, and results in physical limitations, reduced quality of life, emergency department visits, and hospitalizations, comprises the completed Phase II MAvERIC-P pilot study (NCT05494788) and the ongoing Phase III MAVERIC trial (NCT06708299). The US FDA has granted Orphan Drug Designation to CardiolRx™? For the treatment of pericarditis, which includes recurrent pericarditis. Breakeven Date Change • Apr 01
No longer forecast to breakeven The 5 analysts covering Cardiol Therapeutics no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of CA$53.7m in 2027. New consensus forecast suggests the company will make a loss of CA$17.6m in 2027. Announcement • Mar 18
Cardiol Therapeutics Inc., Annual General Meeting, May 28, 2025 Cardiol Therapeutics Inc., Annual General Meeting, May 28, 2025. New Risk • Jan 17
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: CA$140.4m (US$97.3m) This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (CA$24m net loss in 3 years). Shareholders have been diluted in the past year (25% increase in shares outstanding). Market cap is less than US$100m (CA$140.4m market cap, or US$97.3m). Recent Insider Transactions • Dec 19
President recently bought CA$75k worth of stock On the 16th of December, David Elsley bought around 40k shares on-market at roughly CA$1.88 per share. This transaction amounted to 3.3% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. David has been a buyer over the last 12 months, purchasing a net total of CA$214k worth in shares. New Risk • Nov 18
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 2.8% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 2.8% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (CA$36m net loss in 2 years). Shareholders have been diluted in the past year (23% increase in shares outstanding). Announcement • Oct 22
Cardiol Therapeutics Inc. to Advance CardiolRx into A Late-Stage Trial in Patients with Recurrent Pericarditis Cardiol Therapeutics Inc. announced plans to expand the MAVERIC clinical development program and advance CardiolRxTM into a late-stage clinical trial ("MAVERIC-2") to evaluate the impact of CardiolRxTM in recurrent pericarditis patients following cessation of interleukin-1 ("IL-1") blocker therapy. MAVERIC-2 is expected to be initiated during Fourth Quarter at major pericardial disease centres in the United States and Europe and to report results ahead of the Company's planned pivotal Phase III study in recurrent pericarditis. MAVERIC-2 is a randomized, double-blind, placebo-controlled Phase II/III trial in approximately 110 patients. Patients with stable disease who are receiving IL-1 blocker treatment will be randomly assigned to receive either CardiolRxTM or placebo following cessation of the IL-1 blocker. The primary clinical objective of the trial will be to assess the impact of CardiolRxTM versus placebo on freedom from a new episode of recurrent pericarditis. Other clinical endpoints of interest include time to a new episode of pericarditis recurrence and change in patient-reported pericarditis chest pain score and the inflammatory marker C-reactive protein ("CRP"). IL-1 is a key pro-inflammatory cytokine in the pathophysiology of recurrent pericarditis. It is generated downstream following activation of the NLRP3 inflammasome and amplifies the autoinflammatory response characteristic of the disease. IL-1 blockers (rilonacept or anakinra) target and negate the activity of IL-1, but given their expense and immunosuppressant risks, they are generally prescribed as a third-line intervention in difficult-to-treat patients. There is a growing body of evidence indicating pericarditis recurrence rates are as high as seventy-five percent and onset is rapid following cessation of IL-1 blocker therapy. Currently, many patients who discontinue IL-1 blocker therapy and subsequently suffer a recurrence require rescue treatment with further administration of these biologics, potentially leading to IL-1 blocker dependence. The Company previously announced positive topline data from MAvERIC-Pilot investigating CardiolRxTM for recurrent pericarditis which showed a substantial reduction in the primary efficacy endpoint of patient- reported pericarditis pain at the end of the 8-week treatment period ("TP"), as well as normalization of inflammation - as measured by CRP - in 80% of the patients with elevated CRP at baseline. Eighty-nine percent of patients (24/27) progressed from the TP into the now completed extension period ("EP") of the study, defined as the additional 18-week period where background therapy was weaned and patients were followed on monotherapy of CardiolRxTM. Full clinical data will be reported in an oral presentation November 18, 2024, at the American Heart Association Scientific Sessions 2024 and will include freedom from pericarditis recurrence during the 18-week EP, 26-week pericarditis pain score and inflammatory marker levels, and safety and tolerability outcomes. The totality of the MAvERIC-Pilot data will support and further inform the Company's plans related to a second late-stage study called MAVERIC-3, a Phase III pivotal trial designed to assess CardiolRxTM for the treatment of the broader population of pericarditis patients to prevent recurrence. Announcement • Oct 10
Cardiol Therapeutics Inc. has completed a Follow-on Equity Offering in the amount of $13.5 million. Cardiol Therapeutics Inc. has completed a Follow-on Equity Offering in the amount of $13.5 million.
Security Name: Class A Common Shares
Security Type: Common Stock
Securities Offered: 8,437,500
Price\Range: $1.6
Discount Per Security: $0.096 Announcement • Sep 24
Cardiol Therapeutics Inc. Achieves Target Patient Enrollment in its Phase II Archer Trial Investigating CardiolRxTM for Acute Myocarditis Cardiol Therapeutics Inc. announced it has achieved the target patient enrollment of 100 patients in "ARCHER", its Phase II randomized, double-blind, placebo-controlled trial evaluating the impact of CardiolRxTM on myocardial recovery in patients with acute myocarditis. The design and rationale for ARCHER were published June 27, 2024, in the journal ESC Heart Failure. ARCHER is a Phase II multi-national, randomized, double-blind, placebo-controlled trial investigating the safety, tolerability, and impact of CardiolRxTM on myocardial recovery in patients presenting with acute myocarditis. The study has an enrollment target of 100 patients to be recruited from pre-eminent cardiovascular research centers in the United States, Canada, France, Brazil, and Israel. The primary outcome measures of the trial, which will be evaluated following 12 weeks of double-blind therapy, consist of two cardiac magnetic resonance imaging measures: left ventricular function (longitudinal strain) and myocardial edema/fibrosis (extra-cellular volume), each of which has been shown to predict long-term prognosis of patients with acute myocarditis. Additional efficacy outcome measurements include survival, freedom from major cardiovascular events, resolution of clinical symptoms, and change in biomarkers associated with cardiac function and inflammation. Acute myocarditis is an inflammatory condition of the heart muscle (myocardium) characterized by chest pain, shortness of breath at rest or during activity, fatigue, rapid or irregular heartbeat (arrhythmias), and light-headedness or the feeling one might faint. The disease is an important cause of acute and fulminant heart failure and is a leading cause of sudden cardiac death in people under 35 years of age. Viral infection is the most common cause of myocarditis; however, it can also result from bacterial infection and commonly used drugs and mRNA vaccines, as well as therapies used to treat several common cancers, including chemo-therapeutic agents and immune checkpoint inhibitors. There are no FDA- approved therapies for acute myocarditis. Patients hospitalized with the condition experience an average seven-day length of stay and a 4 - 6% risk of in-hospital mortality, with average hospital charge per stay estimated at $110,000 in the United States. Announcement • Sep 10
Cardiol Therapeutics Announces Completion of the Maveric Phase II Study in Recurrent Pericarditis with Results to Be Presented At the American Heart Association Scientific Sessions 2024 Cardiol Therapeutics Inc. announced the data from its Phase II open-label MAvERIC-Pilot study investigating the impact of CardiolRx administered to patients with symptomatic recurrent pericarditis will be reported in an oral presentation as part of the Laennec Clinician- Educator Award & Lecture that runs from 9:45 a.m. to 11:00 a.m. Central Time, on November 18th, 2024, at the American Heart Association Scientific Sessions 2024. Dr. S. Allen Luis, Co-Director, Pericardial Diseases Clinic and Associate Professor of Medicine, Department of Cardiovascular Medicine at the Mayo Clinic, will present on behalf of the MAvERIC-P pilot study. Significant accumulation of pericardial fluid and scarring can progress to life-threatening constriction of the heart. The only FDA-approved therapy for recurrent pericarditis, launched in 2021, is costly and is primarily used as a third-line intervention. On an annual basis, the number of patients in the United States having experienced at least one recurrence is estimated at 38,000. It is recognized that cannabidiol inhibits activation of the inflammasome pathway, an intracellular process known to play an important role in the development and progression of inflammation and fibrosis associated with myocarditis, pericarditis, and heart failure. Cardiol has received Investigational New Drug Application authorization from the United States Food and Drug Administration ("US FDA") to conduct clinical studies to evaluate the efficacy and safety of Cardiol Rx in two diseases affecting the heart: (i) a Phase II multi-center open-label pilot study in recurrent pericarditis (the MAvERIC-P Pilot study; NCT05494788), an inflammatory disease of the pericardium which is associated with symptoms including debilitating chest pain, shortness of breath, and fatigue, and results in physical limitations, reduced quality of life, emergency department visits, and hospitalizations; and (ii) a Phase II multi-national, randomized, double-blind, placebo-controlled trial (the ARCHER trial; NCT05180240) in acute myocarditis, an important cause of acute and fullminant heart failure in young adults and a leading cause of sudden cardiac death in people less than 35 years of age. The US FDA has granted Orphan Drug Designation to CardiolRx for the treatment of pericarditis, which includes recurrent pericarditis. Cardiol is also developing CRD-38, a novel subcutaneously administered drug formulation intended for use in heart failure - a leading cause of death and hospitalization in the developed world, with associated healthcare costs in the United States exceeding $30 billion annually. Recent Insider Transactions • Jun 25
President recently bought CA$138k worth of stock On the 24th of June, David Elsley bought around 50k shares on-market at roughly CA$2.77 per share. This transaction amounted to 4.3% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was David's only on-market trade for the last 12 months. Announcement • Apr 20
Cardiol Therapeutics Inc., Annual General Meeting, Jul 26, 2024 Cardiol Therapeutics Inc., Annual General Meeting, Jul 26, 2024. New Risk • Mar 27
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of Canadian stocks, typically moving 19% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (19% average weekly change). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (CA$28m net loss in 3 years). Shareholders have been diluted in the past year (4.8% increase in shares outstanding). New Risk • Feb 16
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Canadian stocks, typically moving 15% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (CA$28m net loss in 3 years). Share price has been volatile over the past 3 months (15% average weekly change). Shareholders have been diluted in the past year (2.4% increase in shares outstanding). Market cap is less than US$100m (CA$92.7m market cap, or US$68.8m). Announcement • Jan 10
Cardiol Therapeutics Inc. Announces It Has Exceeded 50% Enrollment in its Phase II ARCHER Trial in Acute Myocarditis Cardiol Therapeutics Inc. announced 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 CardiolRxTM on myocardial recovery in patients presenting with acute myocarditis. The ARCHER trial has been designed in collaboration with an independent steering committee comprising distinguished thought leaders in heart failure and myocarditis from international centers of excellence. The trial is expected to enroll 100 patients at pre-eminent cardiovascular research centers in North America, France, Brazil, and Israel. The primary outcome measures of the trial, which will be evaluated following 12 weeks of double-blind therapy, consist of two cardiac magnetic resonance imaging measures: left ventricular function (longitudinal strain) and myocardial edema/fibrosis (extra- cellular volume), each of which has been shown to predict long-term prognosis of patients with acute myocarditis. Additional efficacy outcome measurements include survival, freedom from major cardiovascular events, resolution of clinical symptoms, and change in biomarkers associated with cardiac function and inflammation. Myocarditis is an acute inflammatory condition of the heart muscle (myocardium) characterized by chest pain, shortness of breath at rest or during activity, fatigue, rapid or irregular heartbeat (arrhythmias), and light-headedness or feeling one might faint. Although the symptoms are often mild, many patients will also report flu-like symptoms such as headache, body aches, joint pain, fever or sore throat prior to disease onset. Viral infection is the most common cause of myocarditis; however, this disease can also result from bacterial infection and commonly used drugs and mRNA vaccines, as well as therapies used to treat several common cancers, including chemo-therapeutic agents and immune checkpoint inhibitors. There are no FDA-approved therapies for acute myocarditis. Patients hospitalized with the condition experience an average 7-day length of stay and a 4 - 6% risk of in-hospital mortality, with average hospital charge per stay estimated at $110,000 in the United States. Cardiol believes there is a significant opportunity to develop an important new therapy for acute myocarditis that would also be eligible for designation as an orphan drug in the United States and the European Union. Orphan drug designation programs were established to provide life sciences companies with incentives to develop new therapies for rare diseases. These incentives include periods of prolonged marketing exclusivity and exemptions from certain fees. Products with orphan drug designation also frequently qualify for accelerated regulatory review. Announcement • Dec 07
Cardiol Therapeutics Inc. Announces Massachusetts General Hospital as the 8th Major Medical Centre Participating in MAvERIC-Pilot Cardiol Therapeutics Inc. announced 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 CardiolRxTM 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 CardiolRxTM and to assess freedom from pericarditis recurrence. MAvERIC-Pilot is enrolling 25 patients at eight prominent medical research centers in the United States that specialize in pericarditis care. The study recently surpassed 50% of its enrollment objective and is anticipated to complete patient recruitment during First Quarter 2024. The study Chairman is Allan L. Klein, MD, Director of the Center of Pericardial Diseases and Professor of Medicine, Heart and Vascular Institute, at the Cleveland Clinic. The primary efficacy endpoint is the change, from baseline to 8 weeks, in patient-reported pericarditis pain using an 11-point numeric rating scale ("NRS"). The NRS is a validated clinical tool employed across multiple conditions with acute and chronic pain, including previous studies of recurrent pericarditis. Secondary endpoints include the NRS score after 26 weeks of treatment, and changes in circulating levels of C-reactive protein, a commonly used clinical marker of inflammation. New Risk • Nov 19
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 2.1% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (CA$28m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (2.1% increase in shares outstanding). Market cap is less than US$100m (CA$76.1m market cap, or US$55.5m). Announcement • Oct 24
Cardiol Therapeutics Receives Nasdaq Deficiency Notice Regarding Minimum Bid Price Requirement Cardiol Therapeutics Inc. announced that on October 19, 2023, it received a notice from the Nasdaq Stock Market LLC, stating that the Company is not in compliance with the minimum bid price requirement of $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 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. Under Nasdaq Listing Rule 5810(3)(A), the Company has 180 calendar days from the date of the Notice, or until April 16, 2024, to regain compliance with the Minimum Bid Requirement, during which time the Common Shares will continue to trade on Nasdaq. If at any time before April 16, 2024, the bid price of the Common Shares closes at or above $1.00 per share for a minimum of 10 consecutive business days, the Company will regain compliance with the Minimum Bid Requirement. If the Company does not regain compliance with the Minimum Bid Requirement by April 16, 2024, the Company may be eligible, upon satisfaction of certain Nasdaq listing requirements, for an additional period of 180 calendar days that would further extend the period of time to regain compliance to October 14, 2024, or the Common Shares may be subject to delisting from Nasdaq. Announcement • Oct 11
Cardiol Therapeutics Inc. Announces Positive Study Results Demonstrating Cardioprotective Effects of Subcutaneously Administered Cannabidiol in Model of Heart Failure with Preserved Ejection Fraction Cardiol Therapeutics Inc. announced 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). The poster entitled Cannabidiol As A Potential Treatment For Heart Failure With Preserved Ejection Fraction was presented on October 7, 2023 within the ePoster Viewing Session III of HFSA2023. This work was performed using a model of HFpEF that is induced using a combination of high-fat diet and hypertension that leads to an increase in heart weight to tibia length ratio, and an increase in markers for inflammation and cardiac remodeling. Cannabidiol administered SUBQ was associated with significantly lower BNP (a cardiac stress marker raised in heart failure patients), IL-10 (a promotor of fibrosis in HFpEF), and visceral adipose tissue (VAT) to subcutaneous adipose tissue (SAT) ratio. The ratio of VAT/SAT holds critical significance in the context of heart failure. Visceral adipose tissue, the fatty tissue stored around internal organs, is metabolically active and releases inflammatory factors contributing to systemic inflammation. In contrast, subcutaneous adipose tissue, found beneath the skin, has a less detrimental impact. An imbalance in this ratio with excessive visceral adipose tissue is associated with a higher risk of cardiovascular disease, including heart failure. Visceral fat accumulation increases cardiac strain, promotes hypertension, and dysregulates lipid metabolism. Additionally, it can lead to obesity-related comorbidities such as diabetes. Managing this ratio could play an important role in preventing and treating heart failure. Together these new findings expand the understanding of the cardioprotective effects of CRD-38 and suggest new therapeutic potential in HFpEF. Announcement • Sep 20
Cardiol Therapeutics Announces All Collaborating Clinical Research Centers Now Initiated and Eligible to Enroll Patients in Archer, A Phase II Trial of Cardiolrx™ for the Treatment of Acute Myocarditis Cardiol Therapeutics Inc. announced 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. The ARCHER trial has been designed in collaboration with an independent steering committee comprising distinguished thought leaders in heart failure and myocarditis from international centers of excellence. The trial is now enrolling patients at over 35 pre-eminent cardiovascular research centers in North America, France, Brazil and Israel. The co-primary outcome measures of the trial, which will be evaluated after 12 weeks of double-blind therapy, consist of the following cardiac magnetic resonance imaging measures: left ventricular function (longitudinal strain) and myocardial edema/fibrosis (extra-cellular volume), each of which has been shown to predict long-term prognosis of patients with acute myocarditis. The Company believes there is a significant opportunity to develop an important new therapy for acute myocarditis that would also be eligible for designation as an orphan drug in the United States and the European Union. Orphan drug designation programs have been created to provide the sponsors of a drug significant incentives, including periods of prolonged marketing exclusivity and exemptions from certain fees, to develop treatments for rare diseases. Products with orphan drug designation also frequently qualify for accelerated regulatory review. Major Estimate Revision • May 22
Consensus EPS estimates upgraded to CA$0.37 loss The consensus outlook for fiscal year 2023 has been updated. 2023 losses forecast to reduce from -CA$0.537 to -CA$0.37 per share. Revenue forecast unchanged from CA$6.23m at last update. Pharmaceuticals industry in Canada expected to see average net income decline 22% next year. Consensus price target of CA$4.50 unchanged from last update. Share price rose 9.5% to CA$0.81 over the past week. Announcement • May 19
Cardiol Therapeutics Inc., Annual General Meeting, Jun 28, 2023 Cardiol Therapeutics Inc., Annual General Meeting, Jun 28, 2023, at 16:30 US Eastern Standard Time. Agenda: To receive the audited financial statements of the Corporation for the fiscal year ended December 31, 2022, and the report of the auditors thereon; to elect directors of the Corporation; to appoint BDO Canada LLP as auditors of the Corporation for the current fiscal year ending December 31, 2023, and to authorize the directors of the Corporation to fix the auditors' remuneration; and to consider other matters. Announcement • Jan 18
Cardiol Therapeutics Inc. Announces First Patient Enrolled in Phase II Study Evaluating Cardiolrx for the Treatment of Recurrent Pericarditis Cardiol Therapeutics Inc. announced that the first patient has been enrolled in the Company-sponsored Phase II open-label pilot study (NCT05494788) investigating the tolerance, safety, 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 disease, and during an extension period, assess the feasibility of weaning concomitant background therapy including corticosteroids, while taking CardiolRx™. The Phase II pilot study is expected to enroll 25 patients at clinical centers in the United States that specialize in pericarditis care. The protocol has been designed in collaboration with thought leaders in pericardial disease. The study Chairman is Allan L. Klein, MD, Director of the Center of Pericardial Diseases and Professor of Medicine, Heart and Vascular Institute, at the Cleveland Clinic. The primary efficacy endpoint is the change, from baseline to 8 weeks, in patient-reported pericarditis pain using an 11-point numeric rating scale ("NRS"). The NRS is a validated clinical tool employed across multiple conditions with acute and chronic pain, including previous studies of recurrent pericarditis. Secondary endpoints include the pain score after 26 weeks of treatment, and changes in circulating levels of C-reactive protein, a commonly used clinical marker of inflammation. Pre-clinical data adding to the strong scientific basis for investigating CardiolRx™ clinically in recurrent pericarditis were presented at the American Heart Association Scientific Sessions 2022. Cardiol's research collaborators from Virginia Commonwealth University presented results demonstrating the protective effects of CardiolRx™ in a model of pericarditis, which included a significant reduction in imaging signs of pericardial effusion and thickening, and significant suppression of key pro-inflammatory markers interleukin-1ß ("IL-1ß") and interleukin-6 ("IL-6"). The release of these cytokines IL-1ß and IL-6 is responsible for the cycle of inflammation in recurrent pericarditis leading to the pericardial effusion and thickening characteristic of the disease. Announcement • Dec 13
Cardiol Therapeutics Inc. Announces the Initiation of a Phase II Open-Label Pilot Study (NCT05494788), to Investigate the Tolerance, Safety, and Efficacy of CardiolRx in Patients with Recurrent Pericarditis Cardiol Therapeutics Inc. announced the initiation of a Phase II open-label pilot study (NCT05494788), to investigate the tolerance, safety, 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 disease, and during an extension period, assess the feasibility of weaning concomitant background therapy including corticosteroids, while taking CardiolRx. The Company's Phase II pilot study is expected to enroll 25 patients at clinical centers in the United States that specialize in pericarditis care. The protocol has been designed in collaboration with thought leaders in pericardial disease. The study Chairman is Allan L. Klein, MD, Director of the Center of Pericardial Diseases and Professor of Medicine, Heart and Vascular Institute, at the Cleveland Clinic. The primary efficacy endpoint is the change, from baseline to 8 weeks, in patient-reported pericarditis pain using an 11-point numeric rating scale ("NRS"). The NRS is a validated clinical tool employed across multiple conditions with acute and chronic pain, including previous studies of recurrent pericarditis. Secondary endpoints include the pain score after 26 weeks of treatment, and changes in circulating levels of C-reactive protein, a commonly used clinical marker of inflammation. Pre-clinical data adding to the strong scientific basis for investigating CardiolRx clinically in recurrent pericarditis was recently presented at the American Heart Association Scientific Sessions 2022. Cardiol's research collaborators from Virginia Commonwealth University presented results demonstrating the protective effects of CardiolRx in a model of pericarditis, which included a significant reduction in imaging signs of pericardial effusion and thickening, and significant suppression of key pro-inflammatory markers interleukin-1 ("IL-1") and interleukin-6 ("IL-6"). The release of these cytokines IL-1 and IL-6 is responsible for the cycle of inflammation in recurrent pericarditis leading to the pericardial effusion and thickening characteristic of the disease. Breakeven Date Change • Nov 17
No longer forecast to breakeven The 4 analysts covering Cardiol Therapeutics no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of CA$38.7m in 2024. New consensus forecast suggests the company will make a loss of CA$46.0m in 2024. Announcement • Nov 16
Cardiol Therapeutics Receives Nasdaq Deficiency Notice Regarding Minimum Bid Price Requirement Cardiol Therapeutics Inc. announced that on November 14, 2022, 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 USD 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. Under Nasdaq Listing Rule 5810(3)(A), the Company has 180 calendar days from the date of the Notice, or until May 15, 2023, to regain compliance with the Minimum Bid Requirement, during which time the Common Shares will continue to trade on Nasdaq. If at any time before May 15, 2023, the bid price of the Common Shares closes at or above USD 1.00 per share for a minimum of 10 consecutive business days, the Company will regain compliance with the Minimum Bid Requirement. If the Company does not regain compliance with the Minimum Bid Requirement by May 15, 2023, the Company may be eligible, upon satisfaction of certain Nasdaq listing requirements, for an additional period of 180 calendar days to regain compliance or the Common Shares may be subject to delisting from Nasdaq. The company will closely monitor the situation and is considering various strategies to regain compliance with the Minimum Bid Requirement under the Nasdaq Listing Rules. This notice does not have any impact on the Company's TSX listing. Board Change • Nov 16
High number of new and inexperienced directors There are 8 new directors who have joined the board in the last 3 years. The company's board is composed of: 8 new directors. 3 experienced directors. No highly experienced directors. President, CEO & Director David Elsley is the most experienced director on the board, commencing their role in 2017. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Price Target Changed • Nov 09
Price target increased to CA$4.50 Up from CA$3.75, the current price target is provided by 1 analyst. New target price is 534% above last closing price of CA$0.71. Stock is down 76% over the past year. The company is forecast to post a net loss per share of CA$0.51 next year compared to a net loss per share of CA$0.73 last year. Announcement • Nov 08
Cardiol Therapeutics Inc. Announces Study Results Demonstrating Protective Effects of Cardiolrx in A Model of Acute Pericarditis Cardiol Therapeutics Inc. announced study results demonstrating that pharmaceutically manufactured cannabidiol (the active pharmaceutical ingredient in CardiolRx™) significantly reduces pericardial effusion and thickening in a pre-clinical model of acute pericarditis and significantly suppresses the secretion of key inflammatory markers interleukin-1ß ("IL-1ß") and interleukin-6 ("IL-6") in vitro. The data were presented by Cardiol's research collaborators from Virginia Commonwealth University ("VCU") at The American Heart Association Scientific Sessions 2022 ("AHA2022"). The poster entitled "Protective Effects of Pharmaceutically Manufactured Cannabidiol in a Mouse Model of Acute Pericarditis" was presented on November 5th within the "Late-Breaking Basic Science Posters" session of AHA2022. The authors concluded that the pharmaceutically manufactured cannabidiol administered in the study may represent a novel therapy for treating pericarditis and preventing its complications and recurrence. Data presented also demonstrated a dose-response effect on IL-1ß in vitro. In addition, cannabidiol was shown in vitro to significantly inhibit the transcription of IL-1ß and NLRP3, as measured by mRNA expression. NLRP3 is a sensor protein that comprises a part of the NLRP3 inflammasome, a large multiprotein complex that regulates inflammatory responses of the innate immune system. Cardiol has filed comprehensive patent applications with the U.S. patent office in connection with these new findings. The Company's Phase II pilot study in recurrent pericarditis is expected to enroll 25 patients at major clinical centers in the United States specializing in pericarditis. The protocol has been designed in collaboration with thought leaders in pericardial disease. The study Chairman is Allan L. Klein, MD, Director of the Center of Pericardial Diseases and Professor of Medicine, Heart and Vascular Institute, at the Cleveland Clinic. The primary efficacy endpoint is the change, from baseline to 8 weeks, in patient-reported pericarditis pain using an 11-point numeric rating scale ("NRS"). The NRS is a validated clinical tool employed across multiple conditions with acute and chronic pain, including previous studies of recurrent pericarditis. Secondary endpoints include the pain score after 26 weeks of treatment, and changes in circulating levels of C-reactive protein, a commonly used clinical marker of inflammation. In the pre-clinical in vivo study, acute pericarditis was induced by injecting Zymosan A, which activates NLRP3, into the pericardial sac thereby leading to the classical features of the inflamed pericardium: increased pericardial effusion and pericardial thickening; an accepted model of acute pericarditis. Groups were randomized to either receive intraperitoneal injections of cannabidiol, or an equal volume of vehicle control, administered following recovery from surgery. Pericarditis severity was assessed by the presence of effusion via echocardiography (measured as width of pericardial space) and pericardial thickening. Seven days after surgery the cannabidiol treated group had significantly reduced pericardial effusion (0.12 vs 0.26 mm, p<0.01) and pericardial thickness (3.6 vs 6.5 µm, p<0.05) when compared to the untreated control group. In separate in vitro experiments, immune cells (J774.1 macrophages) were stimulated with lipopolysaccharide ("LPS"), adenosine triphosphate ("ATP"), or LPS+ATP, with or without cannabidiol. LPS+ATP induces IL-1ß secretion via NLRP3 inflammasome activation. Inflammatory cytokines IL-1ß and IL-6 were measured by ELISA. The LPS+ATP combination increased IL-1ß concentration vs control (449.1 vs 6.4 pg/ml, p<0.0001); however, addition of cannabidiol treatment significantly reduced IL-1ß concentration (118.7 pg/ml, p<0.0001 vs. LPS+ATP). Furthermore, a dose-response reduction in IL-1ß was observed with additional concentrations of cannabidiol. Separately, LPS alone was shown to significantly increase IL-6 concentration and that effect was abolished with cannabidiol treatment. LPS-induced IL-6 release is independent of NLRP3 activation, and the results suggest the effect of cannabidiol is not limited solely to the NLRP3 inflammasome pathway. Finally, gene expression using real-time polymerase chain reaction was performed for IL-1ß and NLRP3 messenger RNA following LPS administration to J774.1 macrophages. LPS was shown to significantly increase the transcription of NLRP3 and IL-1ß, but treatment with cannabidiol significantly reduced the level of transcription of both. Announcement • Oct 27
Cardiol Therapeutics Prioritizes Phase II Clinical Programs in Underserved Heart Diseases Cardiol Therapeutics Inc. announced that it will discontinue the LANCER trial due to lack of eligible patients to support recruitment and will prioritize its Phase II clinical programs focused on developing CardiolRx for two underserved diseases affecting the heart - acute myocarditis and recurrent pericarditis. The Company also announced that its cash runway now extends into 2026. The LANCER trial, which was designed to investigate the cardioprotective properties of CardiolRx in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, cardiovascular disease, will be discontinued due to the continuous decline in the number of eligible patients, and a lower than anticipated event rate in the study. Over the course of the study, multiple factors contributed to the decline in the number of patients that met the inclusion criteria of the trial, including: (i) a significant increase in vaccine-induced or natural immunity in the general population; (ii) the predominant circulating variants causing milder disease than their predecessors; and (iii) an increase in the regulatory approval and usage of therapeutics for the successful treatment of mild-to-moderate disease in patients who previously would have progressed to require hospitalization. Cardiol is currently advancing its Phase II ARCHER trial, designed to assess CardiolRx in acute myocarditis, an inflammatory condition of the heart muscle (myocardium). ARCHER has received regulatory clearance in multiple jurisdictions, including Investigational New Drug Application (IND) authorization from the United States (U.S.) Food and Drug Administration (FDA), and is expected to enroll 100 patients at major cardiac centers in North America, Europe, Latin America, and Israel. The trial has been designed in collaboration with an independent steering committee comprising distinguished thought leaders in heart failure and myocarditis from international centers of excellence. The primary endpoints of the trial, which will be evaluated after 12 weeks of double-blind therapy, consist of the following cardiac magnetic resonance imaging measures: left ventricular function (ejection fraction and longitudinal strain) and myocardial edema/fibrosis (extra-cellular volume), each of which has been shown to predict long-term prognosis of patients with acute myocarditis. Concurrent with the ARCHER trial, the Company is also undertaking a Phase II pilot study in recurrent pericarditis - a debilitating inflammatory heart disease. Cardiol's study is expected to enroll 25 patients at major clinical centers specializing in pericarditis in the U.S. The study protocol has been designed in collaboration with thought leaders in pericardial disease. The study's primary efficacy endpoint is the change, from baseline to 8 weeks, in patient-reported pericarditis pain using an 11-point numeric rating scale (NRS). The NRS is a validated clinical tool employed across multiple conditions with acute and chronic pain, including previous studies of recurrent pericarditis. Secondary endpoints include the pain score after 26 weeks of treatment, and changes in C-reactive protein (CRP). Announcement • Oct 04
Cardiol Therapeutics Announces Pre-Clinical Study Results Demonstrating Cardiolrx Inhibits Cardiol Therapeutics Inc. announced that study results demonstrate the active pharmaceutical ingredient ("API") in CardiolRxTM inhibits and also promotes the reversal of mechanisms known to play a role in the occurrence and development of fibrotic CVD. The data were presented by its research collaborators from Houston Methodist DeBakey Heart & Vascular Center at The Annual Scientific Meeting of the Heart Failure Society of America ("HFSA2022"). The poster entitled "Cannabidiol Inhibits Endothelial-to-Mesenchymal Transition and also Promotes the Reverse Process in vitro" was presented within the "Basic and Translational Science" category of the HFSA2022 Scientific Programme. The authors concluded that the API in CardiolRxTM protects cardiac function and exhibits an anti-fibrotic effect, possibly mediated by endothelial-to-mesenchymal transition.EndoMT is a complex biological process whereby an endothelial cell, the main cell type found in the inside lining of blood vessels, undergoes a series of molecular events that alter its characteristics towards a mesenchymal cell, such as a myofibroblast. Myofibroblast cells are the primary cells during wound healing and fibrosis. Mounting evidence indicates EndoMT is involved in adult CVD, and the mechanism has been described to contribute to myocardial fibrosis, an important part of heartremodelling that can lead to heart failure. In the study, EndoMT was induced in HUVEC cells, a model system for studying human endothelial cell function, using a combination of agents (L-NAME and angiotensin-II). EndoMT was characterized through immunofluorescence ("IF") for endothelial (CD31) and mesenchymal (Vimentin) markers. CardiolRxTM was added during the EndoMT induction process, and on Day 4 following induction IF studies were performed. CardiolRxTM was shown to reduce the expression of the mesenchymal marker Vimentin in a dose dependent manner. Separately, CardiolRxTM was added to EndoMT transitioned cells (after Day 4 of EndoMT), and IF studies were performed on Day 8. In this experiment CardiolRxTM was shown to reduce Vimentin expression, suggesting reversal of EndoMT in vitro. This provides evidence that the cardioprotective properties of CardiolRxTM are due, in part, to the modulation of EndoMT. Major Estimate Revision • Aug 06
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast fell from CA$900.0k to CA$700.0k. EPS estimate increased from -CA$0.55 to -CA$0.50 per share. Pharmaceuticals industry in Canada expected to see average net income growth of 13% next year. Consensus price target down from CA$7.50 to CA$5.00. Share price was steady at CA$1.73 over the past week. Announcement • Aug 04
Cardiol Therapeutics Inc. Announces First Patient Enrolled in Archer, A Phase II Clinical Trial of Cardiolrx(TM) for Treatment of Acute Myocarditis Cardiol Therapeutics Inc. announced that the first patient has been enrolled in ARCHER, the Company's Phase II, multi-center, international, double-blind, randomized, placebo-controlled trial designed to study the safety and tolerability of CardiolRxTM, as well as its impact on myocardial recovery, in patients presenting with acute myocarditis. CardiolRx is a pharmaceutically produced oral cannabidiol formulation being developed for the treatment of acute and chronic inflammation associated with heart disease. ARCHER has received regulatory clearance in multiple jurisdictions, including IND authorization from the FDA, and is expected to enroll 100 patients at major cardiac centers in North America, Europe, Latin America, and Israel. The primary endpoints of the trial, which will be evaluated after 12 weeks of double-blind therapy, consist of the following cardiac magnetic resonance imaging measures: left ventricular function (ejection fraction and longitudinal strain) and myocardial edema/fibrosis (extra-cellular volume), each of which has been shown to predict long-term prognosis of patients with acute myocarditis. Myocarditis is an acute inflammatory condition of the heart muscle (myocardium) characterized by chest pain, impaired cardiac function, atrial and ventricular arrhythmias, and conduction disturbances. Although the symptoms are often mild, myocarditis remains an important cause of acute and fulminant heart failure and is a leading cause of sudden cardiac death in people under 35 years of age. In addition, some patients proceed to develop chronic dilated cardiomyopathy which continues to be the leading indication for cardiac transplantation. Although viral infection is the most common cause of myocarditis, the condition can also result from administration of therapies used to treat several common cancers, including chemo-therapeutic agents and immune checkpoint inhibitors. Myocarditis has also been described as a complication of COVID-19 and, more recently, has been reported as a rare complication associated with certain vaccines for COVID-19. Acute myocarditis should be managed with guideline directed therapies for heart failure, arrhythmia and conduction disturbances; however, there is no uniformly accepted treatment for the underlying inflammatory processes associated with this condition. The Company believes there is a significant opportunity to develop an important new therapy for acute myocarditis that would also be eligible for designation as an orphan drug in the United States. The U.S. Orphan Drug Designation program was created to provide the sponsor of a drug significant incentives, including seven-year marketing exclusivity and exemptions from certain FDA fees, to develop treatments for diseases that affect fewer than 200,000 people in the U.S. (73,000 myocarditis cases are estimated in the U.S. annually). Products with Orphan Drug Designation also frequently qualify for accelerated regulatory review. The program was successfully utilized to support the first FDA approval of cannabidiol for the treatment of seizures associated with rare pediatric epilepsy syndromes. Cardiol believes there is a similar opportunity to develop its CardiolRx formulation as an orphan drug for the treatment of acute myocarditis. Major Estimate Revision • Jun 18
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 expected loss increased from -CA$0.40 to -CA$0.51 per share. Revenue forecast of CA$900.0k unchanged since last update. Pharmaceuticals industry in Canada expected to see average net income growth of 13% next year. Consensus price target of CA$7.50 unchanged from last update. Share price fell 16% to CA$1.62 over the past week. Major Estimate Revision • May 23
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 expected loss increased from -CA$0.25 to -CA$0.40 per share. Revenue forecast of CA$900.0k unchanged since last update. Pharmaceuticals industry in Canada expected to see average net income growth of 2.4% next year. Consensus price target of CA$7.50 unchanged from last update. Share price was steady at CA$1.45 over the past week. Announcement • May 20
Cardiol Therapeutics Inc. Announces Board Appointments Cardiol Therapeutics Inc. announced that its Board of Directors has appointed Teri Loxam and Chris Waddick to serve as directors, effective immediately. Ms. Teri Loxam has over 25 years of experience in the pharmaceutical, life sciences, and entertainment industries with diverse roles spanning strategy, investor relations, finance, and communications. Ms. Loxam joined Kira Pharmaceuticals ('Kira') in November 2021 as Chief Operating Officer and Chief Financial Officer. Mr. Chris Waddick has over thirty years of experience in financial and executive roles in the biotechnology and energy industries, with substantial knowledge of public company management and corporate governance, and in designing, building, and managing financial processes, procedures, and infrastructure. Mr. Waddick has served as Chief Financial Officer and Corporate Secretary of Cardiol since August 16, 2018. He serves as Executive Vice President and Chief Financial Officer for a private Ontario energy company. Previously, Mr. Waddick spent more than twelve years at Vasogen Inc. Announcement • May 18
Cardiol Therapeutics Announces FDA Investigational New Drug Application Authorization for Multicenter Phase II Open-Label Pilot Study of Cardiolrx for Recurrent Pericarditis Cardiol Therapeutics Inc. announced the U.S. Food and Drug Administration (FDA) has authorized the Company's Investigational New Drug Application (IND) to commence a Phase II open-label pilot study designed to evaluate the tolerance and safety of CardiolRx, a pharmaceutically manufactured oral cannabidiol drug formulation, in patients with recurrent pericarditis. The study will also assess the improvement in objective measures of disease, and during an extension period, assess the feasibility of weaning concomitant background therapy including corticosteroids, while taking CardiolRx . Recurrent pericarditis is an orphan disease in the United States, thereby making CardiolRx eligible for orphan drug status under the FDA's Orphan Drug Designation program. Cardiol's study is expected to enroll 25 patients at major clinical centers specializing in pericarditis in the United States. The study protocol has been designed in collaboration with thought leaders in pericardial disease. The trial's primary efficacy endpoint is the change, from baseline to 8 weeks, in patient-reported pericarditis pain using an 11-point numeric rating scale (NRS). The NRS is a validated clinical tool used across multiple conditions with acute and chronic pain, including previous studies of recurrent pericarditis. Secondary endpoints include the pain score after 26 weeks of treatment, and changes in C-reactive protein (CRP). Pericarditis refers to inflammation of the pericardium - the membrane, or sac, that surrounds the heart. Symptoms include debilitating chest pain, shortness of breath, and fatigue, which result in physical limitations, reduced quality of life, emergency department visits, and hospitalizations. Causes of pericarditis can include infection (e.g., tuberculosis), systemic disorders such as autoimmune and inflammatory diseases, cancer, and post-cardiac injury syndromes. Based on time of presentation, acute pericarditis is a symptomatic event lasting less than four to six weeks, the diagnosis of which is based on meeting two of four criteria: chest pain; pericardial rub; electrocardiogram changes; and new or worsening pericardial swelling. Elevation of inflammatory markers such as CRP, and evidence of pericardial inflammation by an imaging technique (computed tomography scan or cardiac magnetic resonance) may help the diagnosis and the monitoring of disease activity. Although generally self-limited and not life-threatening, acute pericarditis is diagnosed in 0.2% of all cardiovascular in-hospital admissions and is responsible for 5% of emergency room admissions for chest pain in North America and Western Europe. Recurrent pericarditis is the reappearance of symptoms after a symptom-free period of at least 4-6 weeks following an episode of acute pericarditis. These recurrences appear in 15% to 30% of acute cases and usually within 18 months. Further, up to 50% of patients with a recurrent episode of pericarditis experience more recurrences. Standard first-line medical therapy consists of non-steroidal anti-inflammatory drugs or aspirin with or without colchicine. Corticosteroids such as prednisone are second-line therapy in patients with continued recurrence and inadequate response to conventional therapy. Recently a potent subcutaneously injected interleukin-1 inhibitor has been approved by the FDA for patients with recurrent pericarditis; however, this immunosuppressant is primarily used in patients with a third or fourth recurrence. The U.S. Orphan Drug Designation program was created to provide the sponsor of a drug significant incentives, including seven-year marketing exclusivity and exemptions from certain FDA fees, to develop treatments for diseases that affect fewer than 200,000 people in the U.S. Products with Orphan Drug Designation also frequently qualify for accelerated regulatory review. The prevalence of recurrent pericarditis in the U.S. is estimated at 38,000. The program was successfully utilized to support the first FDA approval of cannabidiol for the treatment of rare pediatric epilepsy syndromes. Cardiol believes there is a similar opportunity to develop its oral CardiolRx formulation as an orphan drug for the treatment of recurrent pericarditis. Price Target Changed • May 17
Price target decreased to CA$7.50 Down from CA$11.16, the current price target is an average from 3 analysts. New target price is 363% above last closing price of CA$1.62. Stock is down 48% over the past year. The company is forecast to post a net loss per share of CA$0.26 next year compared to a net loss per share of CA$0.73 last year. Board Change • Apr 27
High number of new and inexperienced directors There are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. 3 experienced directors. No highly experienced directors. President, CEO & Director David Elsley is the most experienced director on the board, commencing their role in 2017. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Announcement • Apr 19
Cardiol Therapeutics Inc., Annual General Meeting, Jun 28, 2022 Cardiol Therapeutics Inc., Annual General Meeting, Jun 28, 2022. Recent Insider Transactions • Apr 06
Independent Chairman recently bought CA$121k worth of stock On the 31st of March, Guillermo Torre-Amione bought around 67k shares on-market at roughly CA$1.81 per share. This was the largest purchase by an insider in the last 3 months. This was Guillermo's only on-market trade for the last 12 months. Price Target Changed • Mar 17
Price target decreased to CA$10.83 Down from CA$11.66, the current price target is an average from 4 analysts. New target price is 522% above last closing price of CA$1.74. Stock is down 62% over the past year. The company is forecast to post a net loss per share of CA$0.74 next year compared to a net loss per share of CA$0.69 last year. Announcement • Mar 03
Cardiol Therapeutics Inc. Receives Clearance from the FDA and Regulatory Agencies in Brazil and Mexico for Important Protocol Amendments in Lancer Trial Cardiol Therapeutics Inc. announced that it has received clearance from the FDA and regulatory agencies in Brazil and Mexico to modify the inclusion criteria for the LANCER trial to allow for, amongst other things, the enrollment of vaccinated patients. Commensurate with clearance to implement these important protocol amendments which will broaden the population of patients eligible for enrollment into LANCER, the Company also announced plans to expand the clinical trial infrastructure to include up to an additional 20 clinical research centers. LANCER is designed to evaluate the efficacy and safety of CardiolRx™ as a cardiopulmonary protective therapy to reduce mortality and major cardiovascular events in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, CVD, and to investigate the impact of CardiolRx™ on symptom recovery and key biomarkers associated with inflammatory heart disease. The Company expects the LANCER trial to achieve over 50% patient recruitment by the end of the first half of 2022 and to complete full patient enrollment during the second half of 2022. In addition to expanding site recruitment, the Company, in consultation with the LANCER Steering Committee, has amended the trial protocol in response to the evolving understanding of COVID-19 and the current standard of care. These updates are expected to remove key barriers to participation in LANCER as well as expand the eligible patient pool and include the following: (i) vaccinated people may be enrolled; (ii) use of therapies approved for treatment of COVID-19 under an emergency use authorization label is permitted; and (iii) a prior history of smoking or obesity, both CVD risk factors prevalent in younger patients, will allow entry into the trial. Furthermore, the Company expects Brazil to be a key contributor to patient enrollment given the country is approaching its winter season, the pace of vaccine booster administration is slow, and the pre-winter case rate is currently averaging approximately 100,000 per day. The LANCER trial was designed and is being overseen by an independent Steering Committee, consisting of international thought leaders in inflammatory heart disease. In addition to investigating the cardiopulmonary protective properties of CardiolRx™ in high-risk COVID-19 patients, the trial is expected to generate invaluable clinical data to further elucidate the therapeutic potential of CardiolRx™ in the treatment of other inflammatory cardiac disorders, including acute myocarditis and heart failure. Patients with COVID-19 primarily present with respiratory symptoms which can progress to bilateral pneumonia and serious pulmonary complications. It is now recognized that the impact of the SARS-COV-2 virus that causes COVID-19 is not limited to the pulmonary system. Individuals with pre-existing CVD or who have CVD risk factors (such as diabetes, hypertension, obesity, smoking history, dyslipidemia, or age greater than 64) are at substantially greater risk for a more severe course and higher mortality. Moreover, people who have had COVID-19 have an increased risk and burden for adverse cardiovascular outcomes (such as acute myocardial infarction, dysrhythmias, pulmonary embolism, pericarditis, myocarditis, stroke, and heart failure) up to one year following their COVID-19 diagnosis. A therapeutic strategy to prevent or limit the number or severity of both pulmonary and cardiovascular complications will improve the socioeconomic burden of this disease. Board Change • Feb 03
High number of new and inexperienced directors There are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. 6 experienced directors. No highly experienced directors. President, CEO & Director David Elsley is the most experienced director on the board, commencing their role in 2017. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Breakeven Date Change • Dec 21
No longer forecast to breakeven The 5 analysts covering Cardiol Therapeutics no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of CA$36.6m in 2023. New consensus forecast suggests the company will make a loss of CA$9.19m in 2023. Recent Insider Transactions Derivative • Oct 16
Independent Director exercised options to buy CA$97k worth of stock. On the 12th of October, Peter Pekos exercised options to buy 20k shares at a strike price of around CA$3.25, costing a total of CA$65k. This transaction amounted to 4.5% of their direct individual holding at the time of the trade. Since June 2021, Peter has owned 447.29k shares directly. Company insiders have collectively bought CA$262k more than they sold, via options and on-market transactions, in the last 12 months. Announcement • Aug 26
Cardiol Therapeutics Receives FDA Clearance of Investigational New Drug (Ind) Application for Phase II Clinical Trial of CardiolRx(TM) for Acute Myocarditis Cardiol Therapeutics Inc. announce that the U.S. Food and Drug Administration (FDA) has provided clearance to proceed with the Company's Investigational New Drug (IND) application to commence a Phase II, multi- center, double-blind, randomized, placebo-controlled trial designed to study the safety and tolerability of CardiolRxTM, as well as its impact on myocardial recovery in patients presenting with acute myocarditis. Myocarditis is an acute inflammatory condition of the myocardium, characterized by inflammation of the heart muscle, which may result in chest pain, impaired cardiac function, atrial and ventricular arrhythmias, and conduction disturbances. Although the symptoms are often mild, myocarditis remains an important
cause of acute and fulminant heart failure and is the most common cause of sudden cardiac death in people less than 35 years old. In addition, some patients proceed to develop chronic dilated cardiomyopathy which continues to be the leading indication for cardiac transplantation. Although viral
causes of myocarditis are the most common, myocarditis can result from a broad range of infections and can be caused by certain drugs, including chemo-therapeutic agents used to treat several common cancers. Myocarditis has also been described as a complication of COVID-19 and, more recently, has been reported as a rare complication associated with certain vaccines for COVID-19. Cardiol's acute myocarditis study is expected to enroll 100 patients at clinical centers in the United States and Europe. The primary endpoints of the trial, which will be evaluated after 12 weeks of double- blind therapy, consist of the following cardiac magnetic resonance measures: left ventricular function (ejection fraction and longitudinal strain) and myocardial edema (extra-cellular volume), each of which has been shown to predict long-term prognosis of patients with acute myocarditis. The study has been designed by an independent steering committee comprising distinguished thought leaders in heart failure and myocarditis from international centers of excellence, including: the Cleveland Clinic, the Mayo Clinic, the Houston Methodist DeBakey Heart and Vascular Center, the University of Ottawa Heart Institute, McGill University Health Centre, University of Pittsburgh Medical Center, Charité Hospital Berlin, and the University of South Florida Health Morsani College of Medicine/Tampa General Hospital Heart and Vascular Institute. Announcement • Aug 11
Cardiol Therapeutics Common Shares Class A Deleted from Other OTC Cardiol Therapeutics Inc. Common Shares Class A Canada (CA) has been deleted from Other OTC effective from August 10, 2021, due to Market Center Change Listed on NASDAQ. Board Change • Aug 03
High number of new directors Independent Chairman Guillermo Torre-Amione was the last director to join the board, commencing their role in 2021. Price Target Changed • Jun 25
Price target increased to CA$9.57 Up from CA$7.58, the current price target is an average from 4 analysts. New target price is 212% above last closing price of CA$3.07. Stock is up 30% over the past year. Announcement • May 13
Cardiol Therapeutics Inc. has completed a Composite Units Offering in the amount of CAD 22.0032 million. Cardiol Therapeutics Inc. has completed a Composite Units Offering in the amount of CAD 22.0032 million.
Security Name: Units
Security Type: Equity/Derivative Unit
Securities Offered: 6,112,000
Price\Range: CAD 3.6
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 4,167,000
Security Name: Warrants
Security Type: Equity Warrant
Securities Offered: 2,083,500 Announcement • Apr 29
Cardiol Therapeutics Announces First Patient Enrolled in Lancer, A Phase II/III Outcomes Trial in High-Risk Patients Hospitalized with Covid-19 Cardiol Therapeutics Inc. announced that the first patient has been randomized in LANCER, a Phase II/III trial of CardiolRxTM, a pharmaceutically produced oral cannabidiol formulation being developed for the treatment of acute and chronic inflammation associated with heart disease. The LANCER trial is a randomized, double-blind, placebo-controlled study, designed to assess the efficacy and safety of CardiolRx in preventing cardiovascular complications in 422 hospitalized patients with a confirmed diagnosis of COVID-19, and who have pre-existing or significant risk factors for CVD. The LANCER trial is enrolling patients at major hospital centers in the United States under an Investigational New Drug (IND) application approved by U.S. Food and Drug Administration (FDA). As peviously announced, the composite primary efficacy endpoint of the trial will be the difference between the active and placebo groups in the percentage of patients who develop, during the first twenty-eight days following randomization and first dose of study medication, one or more of several common outcomes in this patient population. These include all-cause mortality, requirement for ICU admission and/or ventilatory support, as well as cardiovascular complications, including the development of heart failure, acute myocardial infarction, myocarditis, stroke, or new sustained or symptomatic arrhythmia. Patients with COVID-19 primarily present with respiratory symptoms which can progress to bilateral pneumonia and serious pulmonary complications. It is now recognized that the impact of COVID-19 is not limited to the pulmonary system. Individuals with pre-existing CVD or who have risk factors for CVD (such as diabetes, hypertension, obesity, abnormal serum lipids, or age greater than 64) are at significantly greater risk of developing serious disease from COVID-19 and experience greater morbidity. Moreover, such COVID-19 patients are at significant risk of developing cardiovascular complications (such as acute myocardial infarction, cardiac arrhythmias, myocarditis, stroke, and heart failure) during the course of their illness, which are frequently fatal. A therapeutic strategy to prevent or limit the number or severity of these cardiovascular complications is likely to considerably improve outcomes from this disease. Major Estimate Revision • Apr 16
Consensus forecasts updated The consensus outlook for 2021 has been updated. 2021 revenue forecast fell from CA$3.81m to CA$2.87m. EPS estimate unchanged from -CA$0.55 per share at last update. Pharmaceuticals industry in Canada expected to see average net income growth of 71% next year. Consensus price target of CA$7.58 unchanged from last update. Share price rose 2.1% to CA$4.28 over the past week. Recent Insider Transactions Derivative • Feb 28
Independent Director exercised options to buy CA$88k worth of stock. On the 22nd of February, Colin Stott exercised options to buy 20k shares at a strike price of around CA$3.25, costing a total of CA$65k. This transaction amounted to 32% of their direct individual holding at the time of the trade. Since June 2020, Colin has owned 40.00k shares directly. Company insiders have collectively bought CA$929k more than they sold, via options and on-market transactions, in the last 12 months. Recent Insider Transactions • Feb 28
Independent Director recently bought CA$99k worth of stock On the 25th of February, Colin Stott bought around 23k shares on-market at roughly CA$4.42 per share. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought CA$864k more in shares than they have sold in the last 12 months. Is New 90 Day High Low • Feb 04
New 90-day high: CA$3.72 The company is up 22% from its price of CA$3.06 on 05 November 2020. The Canadian market is up 14% over the last 90 days, indicating the company outperformed over that time. However, it underperformed the Pharmaceuticals industry, which is up 70% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is CA$29.05 per share. Announcement • Jan 22
Cardiol Therapeutics Inc Announces Formation of Data Safety Monitoring and Clinical Endpoint Committees for Phase Ii/Iii Outcomes Trial in High-Risk Patients Hospitalized with Covid-19 Cardiol Therapeutics Inc. focused on the research and clinical development of anti-inflammatory therapies for the treatment of cardiovascular disease announced the formation of the Data Safety Monitoring Committee ("DSMC") and the Clinical Endpoint Committee ("CEC") for the Company's Phase II/III trial in high-risk patients hospitalized with COVID-19 at clinical centers throughout the United States. The DSMC comprises independent experts who will assess the patient safety data, and, if needed, critical efficacy endpoints of the trial. In order to do so, the DSMC may review unblinded study information (on a patient level or treatment group level) during the conduct of the trial. After each data review, the DSMC will advise the study Steering Committee with recommendations for protocol modifications, if concerns over safety have developed, or that the study should continue according to the protocol if no concerns are identified. The DSMC will also perform an interim analysis after 200 patients have completed the study, to determine if the study is likely to enroll enough patients to achieve statistical significance or if additional patients should be recruited. Announcement • Dec 18
Cardiol Therapeutics Appoints Worldwide Clinical Trials as CRO for the Company's Phase II/III Outcomes Trial in High-Risk Patients Hospitalized with Covid-19 Cardiol Therapeutics Inc. announced that it has appointed contract research organization ("CRO") Worldwide Clinical Trials ("Worldwide"), as the Company initiates it's Phase II/III trial in high-risk patients hospitalized with COVID-19 at clinical centers throughout the United States. The double-blind, placebo-controlled clinical trial is designed to investigate the efficacy and safety of CardiolRxTM, a pharmaceutically produced extra strength cannabidiol formulation, in 422 hospitalized COVID-19 patients with a prior history of, or risk factors for, cardiovascular disease. This patient population is at significant risk of developing cardiovascular complications, which are frequently fatal, during their illness. The composite primary efficacy endpoint will be the difference between the active and placebo groups in the percentage of patients who develop, during the first 28 days following first dose of study medication, one or more of the following outcomes: i) all-cause mortality, ii) requirement for ICU admission and/or ventilatory support, and iii) cardiovascular complications, including the development of heart failure, acute myocardial infarction, myocarditis, stroke, or new sustained or symptomatic arrhythmia. The study was designed by and will be overseen by an independent Steering Committee, consisting of international thought leaders in inflammatory heart disease. The Steering Committee is chaired by Dr. Dennis McNamara, Professor of Medicine and Director of the Center for Heart Failure Research, University of Pittsburgh and co-chaired by Dr. Leslie Cooper, Chair of the Mayo Clinic Enterprise Department of Cardiovascular Medicine and Chair of the Department of Cardiovascular Medicine, Mayo Clinic. The rationale for using cannabidiol to treat patients with COVID-19 is based on its reported anti-inflammatory and cardioprotective effects which are anticipated to prevent COVID-19-related cardiovascular complications, thereby reducing morbidity and mortality. Cardiovascular complications such as myocardial injury (demonstrated by elevated blood troponin levels) are common in COVID-19 patients and are linked to a higher rate of mortality. Cannabidiol has been shown to reduce elevated troponin and reduce pro-inflammatory responses in models of cardiotoxicity. In pre-clinical models of cardiac injury, cannabidiol has been shown to be cardioprotective by reducing cardiac hypertrophy, fibrosis, and the production of certain re-modelling markers, such as cardiac B-type Natriuretic Peptide (BNP), which is elevated in patients with COVID-19, cardiac damage, and/or heart failure. Is New 90 Day High Low • Dec 09
New 90-day low: CA$2.38 The company is down 23% from its price of CA$3.10 on 09 September 2020. The Canadian market is up 11% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is up 53% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is CA$24.38 per share. Price Target Changed • Oct 21
Price target raised to CA$5.28 Up from CA$4.90, the current price target is an average from 2 analysts. The new target price is 54% above the current share price of CA$3.43. As of last close, the stock is down 7.8% over the past year.