Cardiol Therapeutics is commercializing its THC-free cannabidiol formulation to treat heart disease

• Proprietary formulation produces ultra-pure pharmaceutical cannabidiol (CBD) without the psychotropic effects of THC for the treatment of inflammatory heart disease
• Received US FDA approval to commence a Phase II/III COVID-19 trial investigating the cardioprotective properties of CardiolRx
• Has launched Cortalex through a national agreement with Medical Cannabis by Shoppers to retail it on an exclusive basis across Canada

What Cardiol Therapeutics does:

Cardiol Therapeutics Inc (TSE:CRDL) (OTCQX:CRTPF) is a clinical-stage biotechnology company focused on developing innovative therapies for inflammatory heart disease.

The Canadian specialty pharmaceutical company has developed a proprietary formula of ultra-pure pharmaceutical cannabidiol (CBD) that does not contain THC – less than 5 parts per million (ppm) – and consequently none of the psychotropic effects of THC.

Its flagship product, CardiolRx, is formulated to be one of the safest and most consistent CBD medicines available on the market. CardiolRx has been developed and manufactured to the highest standards of cGMP to ensure consistency, stability, and purity in every dose.

Cardiol is also developing a proprietary subcutaneous formulation to uniquely deliver pharmaceutical cannabidiol to sites of inflammation in the heart associated with heart failure, a major healthcare burden in North America, costing the US healthcare system over US$30 billion a year.

While advancing important clinical trials in inflammatory heart disease, Cardiol is generating a near-term revenue opportunity in the growing Canadian medical cannabinoid market, currently exceeding $600 million annually, with its recently launched commercial product, Cortalex, the first THC-free extra-strength formulation of cannabidiol oil available across Canada exclusively online at Medical Cannabis by Shoppers.

With all the pieces in place to commercialize its THC-free cannabidiol formulation and an international research program focused on advancing its product pipeline for the treatment of heart failure, the company is positioned for significant growth.

How is it doing:

Cardiol has been making good progress so far in 2021.

On April 28, the company announced that the first patient had been randomized in the LANCER Phase II/III trial of its oral cannabidiol formulation CardiolRx. The trial is a randomized, double-blind, placebo-controlled study that will test the efficacy and safety of CardiolRx in preventing cardiovascular complications in 422 hospitalized patients who have a confirmed coronavirus (COVID-19) diagnosis and pre-existing (or at risk for) cardiovascular disease.

LANCER is being run in major hospitals across the US. The study’s primary endpoint will be the difference between the active and placebo groups in the percentage of patients who develop one or more outcomes – cardiovascular complications, ICU admission rates, ventilatory support – during the first 28 days following randomization and the first dose of study medication.

The trial is expected to be completed during 2021 and will support an emergency use authorization for the treatment of COVID-19 patients who would have qualified for enrollment in LANCER, according to Cardiol, which added that successful trial results may also be used to support a new drug application. LANCER should also generate “invaluable” clinical data about the potential of CardiolRx to treat of other cardiac inflammatory disorders, including acute myocarditis and heart failure, the company added.

On April 12, Cardiol announced topline results from its Phase I clinical trial of CardiolRx. The company said the results from the single and multiple ascending dose trial indicate that the drug was safe and well-tolerated at all dose levels, with no serious side effects reported.  As well, pharmacokinetic studies determined that blood levels of the drug tended to rise hand-in-hand with an increasing dose. 

CardiolRx is being developed to treat acute and chronic inflammation associated with heart disease. Currently, the treatment is being studied as a cardioprotective therapy to reduce mortality and major cardiovascular events in coronavirus (COVID-19) patients, who have a prior history of, or risk factors for, cardiovascular disorder.

Cardiol told investors that the results are expected to support its plans to file an investigational new drug (IND) application with the US Food and Drug Administration for a Phase II international trial in acute myocarditis.

In January, the company had announced the formation of two committees for its Phase II/III trial examining the efficacy of CardiolRx in high-risk coronavirus (COVID-19) patients. Cardiol said that the Data Safety Monitoring Committee (DSMC) and the Clinical Endpoint Committee (CEC) would be involved in the ongoing trial, which looks at 422 patients hospitalized with COVID-19 at clinics throughout the US.

On the personnel front, at the end of March, Cardiol bolstered its executive team with the addition of Dr. Andrew Hamer as its chief medical officer. Hamer has 30 years of experience in the global life sciences industry, medical affairs, and cardiology. He most recently served as Executive Director, Global Development-Cardiometabolic at Amgen Inc, where he led the global development of Repatha, a LDL cholesterol-lowering PCSK9 inhibitor evolocumab with around $900 million in sales last year.

Looking at financials, on April 1, Cardiol revealed that it had capped off a busy 2020 with a strengthened cash balance of C$14 million. The pharmaceutical firm had a busy 4Q 2020, having commercially introduced its THC-free (<10ppm) extra-strength oral cannabidiol formulation Cortalex and completed the Phase 1 study of CardiolRx.

Adding to that financial strength, on May 12, Cardiol closed a previously announced offering of units of the company for aggregate gross proceeds of approximately $22 million. The deal was upsized from its original $15 million offering due to strong demand. Cardiol said it is planning to use the proceeds to advance research and clinical development programs, for additional commercial product development, and for general corporate purposes.

And on March 2 the company said it had received proceeds of over $10 million from the exercise of warrants and stock options. That announcement accompanied news that Cardiol had submitted an application to uplist its shares to the tech-laden Nasdaq stock exchange in the US. If the Nasdaq listing occurs, the company said its shares would delist from the OTCQX exchange. Cardiol added that it plans to maintain its current listing on the Toronto Stock Exchange.

Inflection points:

• Commercial introduction of Cortalex across Canada through national supplier agreement with Medical Cannabis by Shoppers
• News from Phase II/III trial investigating its lead product, CardiolRx, in hospitalized COVID-19 patients with a prior history of, or risk factors for, cardiovascular disease.
• Completion of Health Canada approved Phase 1 study
• Commencement of Phase II international trial of CardiolRx in acute myocarditis

What the broker says:

On March 25, 2021, Leede Jones Gable initiated coverage on Cardiol with a ‘Speculative Buy’ rating.

In a note to clients, the research firm’s analyst, Douglas Loe cited Cardiol’s revenue potential from its ultrapure cannabidiol formulation Cortalex, which was launched last year through the Medical Cannabis by Shoppers portal.

Loe said: “Cannabidiol’s clinical prospects in cardiovascular disease are, perhaps surprisingly at least to us initially, quite well-documented in the medical literature in preclinical models of disease nd our diligence thus suggests to us that Cardiol’s initiative to more fully test cannabidiol’s clinical prospects is justified and with strong prospects for value creation based on future Phase II/III efficacy signals that we expect to transpire during our forecast period.”

“What we found most striking in our investigation of cannabidiol’s medical prospects in cardiovascular disease was just how well-characterized its prospects actually were in this disease category, despite which few if any firms other than Cardiol are exploring this activity,” he added.

The analyst cited a number of diseases that could potentially be treated with Cortalex, including coronavirus-associated cardiovascular disease, acute myocarditis and diastolic heart failure. He also noted that Cardiol’s strategic manufacturing alliance for CardiolRx with Purisys and Dalton Pharma Services provides competitive advantages in medical markets where cannabidiol purity is critical to clinical success.

What the boss says:

In the company’s statement on April 1, 2021, looking back on 2020, Cardiol CEO David Elsley said: “We made extraordinary progress in our research and clinical development programs, while significantly strengthening our financial position. We are particularly excited about the progress made across our research and development programs supporting the development of CardiolRx, our pharmaceutically produced extra-strength oral formulation of cannabidiol and lead drug candidate for the treatment of acute inflammatory heart disease.”

Elsley added: ”I believe the proposed acquisition of GW Pharma for US$7.2 billion in early 2021, together with the 2020 acquisition of MyoKardia for US$13 billion, underscores the potential value proposition for enterprises focused on cannabidiol-based medicines and on the development of new treatments for cardiovascular disease.

“With a robust research and development pipeline, world-class R&D collaborators, and an experienced management team, we are well-positioned to build a leadership position in the development of therapies to address the underlying inflammatory component in heart disease.”

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Story by ProactiveInvestors