Cardiol Therapeutics (CRDL:TSX; CRDL:NASDAQ), an Ontario-based developer of small-molecule drugs for cardiovascular diseases, has reported headline Phase II data from its 109-patient acute myocarditis study, known as the ARCHER trial, Douglas Loe noted in an updated research note for Leede Financial Inc. on August 6.
This trial tested the company's orally active, ultra-pure synthetic cannabidiol formulation, CardiolRx, for this specific condition. Patient enrollment for the 12-week trial concluded in late FQ324, and we were expecting the final data analysis by FQ225, which was only slightly delayed into FQ325.
"ARCHER data deemed favorable by Cardiol and its collaborators on at least one primary endpoint, but abundant biomarker and cardiac function data are still pending," wrote the analyst, who rated the stock a Speculative buy with a price target of US$11 per share. Loe said at the time of writing the price was US$1.85, which would have netted a return of 495%.
Patients Showed Measurable Improvement
The trial had two primary endpoints: one was nearly met, though not quite to a statistically significant level (cardiac MR-assessed change in extracellular volume), and the other was not met (global longitudinal strain, also assessed by cardiac MR), which was unlikely to be met based on patient enrollment characteristics, Loe wrote.
In the press release about the ARCHER update, Cardiol indicated that patients treated with CardiolRx showed measurable improvement in extracellular volume on cardiac MR images after three months of treatment compared to placebo patients, with a p-value close to statistical significance (0.054, near the 0.05 threshold, suggesting clear efficacy trends for CardiolRx).
Analyst: Slight Miss on Achieving Statistical Significance
The company's share price performance on Wednesday, which sank more than 20%, was somewhat unsurprising given the slight miss on achieving statistical significance in extracellular volume reduction, a measure of reduced myocardium inflammation/fibrosis, Loe said.
Capital markets rarely show tolerance for missing statistical significance, even when considering factors like the small magnitude of the miss (extremely small in ARCHER), trial size (109 patients in ARCHER is not trivial, but not powered to the level needed for a pivotal Phase III registration study), target indication (acute myocarditis, where efficacy assessment involves interpretation of radiographic images rather than hard endpoints like survival in oncology or microbial load in infectious diseases), or the nature of standard-of-care (there is no approved pharmacopeia for myocarditis other than off-label use of glucocorticoids or antihypertensive agents), the analyst note.
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Disclosures for Leede Financial Inc., Cardiol Therapeutics, August 6, 2025:
Important Information and Legal Disclaimers
Leede Financial Inc. (Leede) is a member of the Canadian Investment Regulatory Organization (CIRO) and a member of the Canadian Investor Protection Fund (CIPF). This document is not an offer to buy or sell or a solicitation of an offer to buy or sell any security or instrument or to participate in any particular investing strategy. Data from various sources were used in the preparation of these documents; the information is believed but in no way warranted to be reliable, accurate and appropriate.
All information is as of the date of publication and is subject to change without notice. Any opinions or recommendations expressed herein do not necessarily reflect those of Leede. Leede cannot accept any trading instructions via e-mail as the timely receipt of e-mail messages, or their integrity over the Internet, cannot be guaranteed. Dividend yields change as stock prices change, and companies may change or cancel dividend payments in the future. All securities involve varying amounts of risk, and their values will fluctuate, and the fluctuation of foreign currency exchange rates will also impact your investment returns if measured in Canadian Dollars. Past performance does not guarantee future returns, investments may increase or decrease in value, and you may lose money. Leede employees may buy and sell shares of the companies that are recommended for their own accounts and for the accounts of other clients. Disclosure codes are used in accordance with Policy 3600 of CIRO.
Description of Disclosure Codes
1. Leede and its affiliates collectively beneficially own 1% or more of any class of equity securities of the company as of the end of the preceding month or the month prior to the preceding month if the report was issued prior to the 10th.
2. The analyst or any associate of the analyst responsible for the report or public comment hold shares or is short any of the company's securities directly or through derivatives.
3. Leede or a director or officer of Leede or any analyst provided services to the company for remuneration other than normal investment advisory or trade execution services within the preceding 12 months.
4. Leede provided investment banking services for the company during the 12 months preceding the publication of the research report.
5. Leede expects to receive or intends to seek compensation for investment banking services in the next three months.
6. The analyst preparing the report received compensation based upon Leede investment banking revenues for this issuer within the preceding 12 months.
7. The director, officer, employee, or research analyst is an officer, director or employee of the company, or serves in an advisory capacity to the company.
8. Leede acts as a market maker of the company.
9. The analyst has conducted a site visit and has viewed a major facility or operation of the issuer.
10. The company has paid for all, or a material portion, of the travel costs associated with the site visit by the analyst.
Dissemination
All final research reports are disseminated to existing and potential institutional clients of Leede Financial Inc. (Leede) in electronic form to intended recipients thorough e-mail and third-party aggregators. Research reports are posted to the Leede website and are accessible to customers who are entitled to the firm’s research. Reproduction of this report in whole or in part without permission is prohibited.
Research Analyst Certification
The Research Analyst(s) who prepare this report certify that their respective report accurately reflects his/her personal opinion and that no part of his/her compensation was, is, or will be directly or indirectly related to the specific recommendations or views as to the securities or companies. Leede Financial Inc. (Leede) compensates its research analysts from a variety of sources and research analysts may or may not receive compensation based upon Leede investment banking revenue.
Canadian Disclosures
This research has been approved by Leede Financial Inc. (Leede), which accepts sole responsibility for this research and its dissemination in Canada. Leede is registered and regulated by the Canadian Investment Regulatory Organization (CIRO) and is a member of the Canadian Investor Protection Fund (CIPF). Canadian clients wishing to effect transactions in any designated investment discussed should do so through a Leede Registered Representative.
U.S. Disclosures
This research report was prepared by Leede Financial Inc. (Leede). Leede is registered and regulated by the Canadian Investment Regulatory Organization (CIRO) and is a member of the Canadian Investor Protection Fund (CIPF). This report does not constitute an offer to sell or the solicitation of an offer to buy any of the securities discussed herein. Leede is not registered as a broker-dealer in the United States and is not subject to U.S. rules regarding the preparation of research reports and the independence of research analysts. Any resulting transactions should be effected through a U.S. broker-dealer.
