Proactive news team spans the world's key finance and investing hubs with bureaus and studios in London, New York, Toronto, Vancouver, Sydney and Perth. About this content Angela Harmantas is an Editor at Proactive. She has over 15 years of experience covering the equity markets in North America, with a particular focus on junior resource stocks. Angela has reported from numerous countries around the world, including Canada, the US, Australia, Brazil, Ghana, and South Africa for leading trade publications. ...

MAvERIC-Pilot enrolled 27 patients diagnosed with symptomatic recurrent pericarditis. Each patient had a high disease burden as reflected in the mean baseline pericarditis pain score of 5.8 out of 10, and by the number of previous episodes of pericarditis: 9 patients (33%) with 2 previous episodes; 9 (33%) with 3; 4 (15%) with 4; and 5 (19%) with >4. Summary of topline findings include: Primary endpoint of patient-reported pericardial pain on an 11-point numerical rating scale ("NRS") showed a mean reductio ...

Core Insights - Cardiol Therapeutics reported earnings per share of -10 cents, which met the analyst estimate for EPS of -10 cents [3] - The company did not report any revenue for the quarter [3] Financial Performance - Earnings per share (EPS) for the first quarter of 2024 was -10 cents, aligning with analyst expectations [3] - No revenue was generated during the quarter, indicating potential challenges in revenue generation [3]

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About this content About Angela Harmantas Angela Harmantas is an Editor at Proactive. She has over 15 years of experience covering the equity markets in North America, with a particular focus on junior resource stocks. Angela has reported from numerous countries around the world, including Canada, the US, Australia, Brazil, Ghana, and South Africa for leading trade publications. Previously, she worked in investor relations and led the foreign direct investment program in Canada for the Swedish government ...

Financial Outlook - The corporation does not expect to generate revenue for several years from its product candidates, including those for acute myocarditis and recurrent pericarditis[85]. - The corporation has a history of operating losses and anticipates continuing to incur losses for at least the next several years as it pursues clinical trials and research efforts[90]. - The corporation may require additional financing to fund operations and product development, and failure to raise capital could delay or halt its business strategy[87]. - The corporation's product development costs may increase due to delays in clinical testing or changes in regulatory requirements[101]. - The corporation's activities are subject to comprehensive regulation, which may impact its operations and compliance requirements[103]. - The company may face significant penalties, including criminal and civil monetary penalties, if found in violation of federal and state laws, which could adversely affect its operations and financial results[125]. - The company sets public goals regarding the timing and costs of clinical trials, but actual results may vary significantly due to various factors, potentially impacting its financial condition[106]. - The company does not currently plan to pay dividends on Common Shares, focusing instead on retaining earnings for product development and reinvestment[173]. - The Corporation may face increased regulatory and compliance costs if it loses its foreign private issuer status, which could negatively impact its financial condition[187]. - The Corporation's operations could be adversely affected by macroeconomic risks, including inflation and market volatility[192]. - The Corporation's articles allow for unlimited issuance of Common Shares, which may result in dilution for current shareholders[193]. Product Development and Clinical Trials - The corporation is in the early stages of developing a subcutaneous product candidate, with no current products approved by regulatory authorities such as the FDA or Health Canada[85]. - The corporation faces significant risks related to the success of its clinical trials, which are expensive and time-consuming, with uncertain outcomes[94]. - The corporation's product candidates may fail to demonstrate safety and efficacy, which could result in additional costs or delays in commercialization[95]. - The corporation's lead drug candidate, CardiolRx™, is in clinical development for two heart diseases and has received FDA authorization for clinical studies[197][199]. - CardiolRx™ has been granted Orphan Drug Designation by the FDA for the treatment of recurrent pericarditis, providing significant incentives for development[200]. - The Corporation announced it has exceeded 50% patient enrollment for the ARCHER trial in January 2024[203]. - The Corporation completed patient enrollment in the MAvERIC-Pilot study in February 2024[205]. - The Corporation's Phase II open-label pilot study for recurrent pericarditis (MAvERIC-Pilot) has exceeded 50% of the patient enrollment target as of November 2023[243]. - The Corporation received FDA clearance to proceed with a Phase II trial for CardiolRx, focusing on safety and tolerability in patients with acute myocarditis[215]. - The Corporation initiated a Phase II study for recurrent pericarditis, assessing the feasibility of weaning corticosteroid therapy while using CardiolRx[251]. - The MAvERIC-Pilot study achieved its enrollment objective of 25 patients, with topline results expected in Q2 2024 and trial extension data in H2 2024[252]. - The Corporation's cannabidiol formulation demonstrated significant reductions in pericardial effusion and inflammatory markers in pre-clinical studies presented at AHA2022[230]. - The Corporation's cannabidiol formulation was shown to prevent cardiac dysfunction and fibrosis in a pre-clinical heart failure model, with results presented at ACC.23/WCC[235]. - The Corporation's research indicated that cannabidiol inhibits mechanisms related to cardiac fibrosis, with findings presented at HFSA2022[228]. - The Corporation's subcutaneous cannabidiol formulation showed positive results in slowing increases in body weight and heart weight in a model of HFpEF, presented at HFSA2023[240]. - Cardiol has budgeted approximately $1 million to complete the MAvERIC-Pilot study, with potential for a larger clinical study if objectives are met[253]. Regulatory and Compliance Risks - The corporation relies on key personnel for its operations, and the loss of these individuals could adversely affect its business[93]. - The company relies on third parties for conducting pre-clinical and clinical studies, and any failure by these parties could lead to delays in development programs[120]. - The company’s product candidates are subject to extensive regulatory compliance, and failure to meet these requirements could materially impact its business and financial condition[124]. - Regulatory approval for the company's product candidates may be delayed or denied due to public controversy surrounding cannabis-related products, affecting market penetration[123]. - The company may face challenges in maintaining patent protection due to procedural compliance requirements, which could result in loss of patent rights[112]. - The company is subject to various laws and regulations regarding the development and commercialization of pharmaceuticals, which may incur significant compliance costs and adversely affect business operations[126]. - The ability to research and develop product candidates is contingent on obtaining and maintaining licenses for controlled substances, with potential adverse effects if these licenses are lost or not obtained[128]. - Changes in laws and regulations could lead to increased compliance costs and may require alterations to the business plan, impacting financial condition[130]. - Compliance with anti-corruption laws may be expensive and challenging, particularly in the pharmaceutical industry, where improper payments can lead to significant penalties[179]. - The Corporation's internal control policies may not fully protect against reckless or negligent acts, potentially leading to liability under anti-corruption laws[180]. Market and Competitive Landscape - The market price for the company's common shares may experience volatility due to factors beyond its control, including fluctuations in quarterly results and changes in market conditions[107]. - There is significant uncertainty regarding reimbursement for newly approved healthcare products, which could limit market acceptance and revenue generation[148]. - The market acceptance of product candidates depends on various factors, including pricing, efficacy, safety, and competition, which could materially affect business results[137]. - The Corporation faces intense competition from larger and better-financed companies, which could adversely affect its business and financial condition[150]. - Rapidly changing markets and emerging industry standards may render the Corporation's product candidates obsolete if it fails to improve its offerings[151]. - Negative consumer perception around cannabinoids could significantly impact the demand for the Corporation's pharmaceutical cannabinoid products[154]. - The Corporation may face product liability claims if its product candidates are approved, which could adversely affect its reputation and financial condition[155]. - Product recalls due to defects or contamination could lead to unexpected expenses and harm the Corporation's image and sales[156]. - The Corporation may expand its operations outside Canada, facing new risks that could adversely affect its business and financial condition[158]. - The Corporation's business is dependent on key inputs, and any disruption in the supply chain could materially impact its operations[160]. - Global supply chain challenges may affect the Corporation's development plans, leading to increased costs and delays[161]. - Insufficient insurance coverage could materially adversely affect the Corporation's business if it incurs substantial liabilities[162]. Shareholder and Investor Considerations - The Corporation's financial results and market conditions can significantly affect the market value of Common Shares, with no assurance against future fluctuations[177]. - The Corporation is subject to different U.S. securities laws as a foreign private issuer, which may limit the information available to U.S. investors[186]. - The Corporation is classified as an "emerging growth company" and will maintain this status until total annual gross revenues exceed $1.235 billion or other specified conditions are met[189]. - The Corporation received a notice from Nasdaq regarding non-compliance with the minimum bid price requirement of US$1.00 per share, but later regained compliance in August 2023[232][237]. - The Corporation's common shares commenced trading on the Nasdaq Capital Market under the symbol "CRDL" on August 10, 2021[202]. - The Corporation's common shares began trading on Nasdaq under the symbol "CRDL" in August 2021, ceasing to be quoted on OTCQX[214]. - The Corporation completed a short form base shelf prospectus offering of units for aggregate gross proceeds of US$50,194,500, selling a total of 16,350,000 units at a price of US$3.07 each[220]. Research Collaborations - Cardiol is exploring partnerships with commercial entities to fund late-stage clinical development and commercialization of its therapies[253]. - Cardiol established a research and development collaboration with TecSalud and Nano4Heart for proprietary therapeutics targeting heart failure[278]. - The collaboration leverages TecSalud's significant research capabilities and Nano4Heart's preclinical cardiovascular research experience[278]. - Cardiol contributes its scientific, clinical, and business expertise to the partnership[278].

About this content About Angela Harmantas Angela Harmantas is an Editor at Proactive. She has over 15 years of experience covering the equity markets in North America, with a particular focus on junior resource stocks. Angela has reported from numerous countries around the world, including Canada, the US, Australia, Brazil, Ghana, and South Africa for leading trade publications. Previously, she worked in investor relations and led the foreign direct investment program in Canada for the Swedish government ...

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

About this content About Leo Grieco Leo joins us with a degree in Media Production from Bournemouth University. His work includes reporting for the UK editorial team and video editing for the broadcast team. He comes with an expertise in video editing and producing. Leo’s specialities include hospitality and leisure, support services, tech and video games. Read more About the publisher Proactive financial news and online broadcast teams provide fast, accessible, informative and actionable business and fi ...

Cardiol Therapeutics Inc. Condensed Interim Consolidated Statements of Loss and Comprehensive Loss (Expressed in Canadian Dollars) Unaudited Cardiol Therapeutics Inc. Condensed Interim Consolidated Statements of Cash Flows (Expressed in Canadian Dollars) Unaudited Cardiol Therapeutics Inc. Condensed Interim Consolidated Statements of Changes in Equity (Expressed in Canadian Dollars) Unaudited - 5 - CARDIOL THERAPEUTICS INC. CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS THREE AND NINE MONTHS ENDED SEPT ...