Interview with Cardiol Therapeutics: How the heart disease specialist company plans to take off on the Nasdaq in 2021

That foundation is very broad. The active ingredient cannabidiol has been extensively researched in hundreds of studies, and there is significant evidence in the published scientific literature demonstrating the anti-inflammatory properties and effects of CBD. Our interest in developing cannabidiol as a cardioprotective drug stems from an article in the Journal of the American College of Cardiology (JACC) that examined the effects of CBD on heart disease. This scientific journal has an excellent reputation worldwide and is read widely by the cardiology community. The article on which Cardiol Therapeutics' work is based showed that CBD can prevent and potentially reverse cardiac fibrosis, a potentially fatal disease process that is caused by chronic inflammation in heart tissue. Since inflammation is a cause of heart failure, and heart failure in turn is one of the leading causes of death in the Western world, we have used these findings as an opportunity to further research and develop medicines around CBD.

There are numerous pre-clinical and clinical studies being conducted with CBD around the world. There is also a growing body of scientific evidence supporting the cardioprotective role of CBD in the cardiovascular system. For these reasons, we firmly believe that CBD has the potential to revolutionize the treatment of inflammatory diseases of the heart. CBD is already being used successfully in the U.S. as an approved medication for epilepsy and we believe that the benefits of CBD in the context of heart disease may exceed this benefit.

One of the key differentiating features of CBD is its extraordinary safety profile. Other anti-inflammatory agents, such as steroids, have been studied in inflammatory heart disease, but their use has been limited as a result of toxicology concerns and risk of serious adverse side effects. CBD, on the other hand, has an excellent safety profile which has now been demonstrated in thousands pediatric patients in the U.S. and internationally. For drugs to be approved for children, they must be very safe. We believe the substantial body of evidence supporting the safety of CBD provides another major reason for advancing its development as a potentially breakthrough therapy for the treatment of cardiovascular disease.

We are pursuing two approaches for delivering therapeutic doses of CBD to patients. One is oral administration and the other is subcutaneous injection, which is similar to administering insulin. With oral administration, we benefit from the fact that we manufacture our CBD as part of a pharmaceutical process and can therefore offer high purity, very high concentration, and consistent quality. You can compare our approach to manufacturing CardiolRx™ to the approach Bayer has utilized for decades to mass manufacture Aspirin. Like Aspirin, which was first discovered and extracted from a botanical source and later produced in a laboratory, Cardiol’s approach to producing its pure CBD medicines also follows a pharmaceutical production process to ensure drug purity, consistency, stability, and affordability. The huge success of Aspirin shows just one of many examples where pharmaceutical production processes allow new important medicines to be mass produced.

We will be talking more about this innovation in the coming months. But this much is already clear: through subcutaneous injection, the active ingredient reaches the bloodstream far more effectively which allows more drug to reach the site of disease by avoiding the digestive system and metabolism by the liver. In this way, the CBD active ingredient in CardiolRx™ targets sites of inflammation more efficiently. We have already had initial data utilizing our injectable formulation accepted for presentation at the 2020 sessions of the American College of Cardiology that took place virtually. The findings from this pre-clinical study showed that our injectable formulation had a significant impact on inflammation and fibrosis utilizing only one tenth of the typical CBD dose required to achieve a therapeutic effect. We believe this represents a potential breakthrough that could lead to a completely new way to treat heart failure, which remains a leading cause of death and disability in the developed world.

We are not manufacturing a drug for COVID-19. It is also far from our intention to push ourselves into the foreground in this way. However, people with cardiovascular disease are at-risk patients who are much more vulnerable to the damaging effects of COVID-19. Even when the pandemic is over, the virus will remain and be with us, much like the annual wave of influenza. Patients who develop severe courses, often associated with inflammation, will need to be treated. The pandemic opens up the opportunity for us to conduct our studies in an accelerated manner, as there is great interest on the part of clinics and regulatory authorities to obtain effective drugs. For this reason, we are pushing ahead with studies around COVID-19, which, by the way, are well advanced. That said, our drug is intended to address heart disease in general.

Cortalex™ is a very important product for us. The Canadian market for medical cannabinoids is approximately CAD 600 million, making it one of the largest markets in the world. Cortalex™ is characterized by its extraordinary purity. Those who use the product receive a pure, consistent CBD product that is free of THC (<10ppm). THC is the active ingredient in the cannabis plant that induces intoxication, promotes memory lapses, or causes a slowed response. These effects are usually undesirable in a medical product, especially for children and elderly patients. This is why we expect many doctors to recommend Cortalex™. For example, we have seen substantial interest from pediatricians in recommending CBD as a treatment for children and adolescents with epilepsy and other central nervous system disorders. This is a patient population where it is extremely important that the CBD formulation be pure and THC free, as THC can have negative effects on brain development. From our perspective, Cortalex™ is the purest CBD in the world, and its purity even exceeds the standard set by the CBD medicine approved by the U.S. Food and Drug Administration.

We launched Cortalex™ in Canada in late 2020 and plan to ramp up marketing later this year. We believe the product can generate meaningful sales over the next twelve to eighteen months. Due to its high quality and the great importance of product purity for younger patients, we are convinced that we can gain a significant share of this market.

Many of the most prominent biotechnology and life sciences companies are listed on the Nasdaq in the United States. The U.S. also represents the largest healthcare market in the world. To create broader awareness of the potential for the heart medicines we are developing, we are now pursuing an application for uplisting on the Nasdaq. We believe the potential impact such a listing can have on our current valuation is illustrated by the example of GW Pharma. This British company was initially traded on the London Stock Exchange for many years prior to uplisting on the Nasdaq. Within a very short time following its Nasdaq listing, GW Pharma’s market capitalization jumped from approximately USD 100 million to over USD 1 billion and it was recently acquired for more than USD 7 billion by Jazz Pharmaceuticals. Another interesting example is a company called MyoKardia which was valued at approximately USD 200 million when incidentally, it was at a similar stage of development as Cardiol Therapeutics is today. Following the release of MyoKardia’s Phase II trial results in a rare heart condition, its valuation rose to over USD $2 billion. Given Cardiol’s current market valuation of approximately USD 130 million and the fact that we are entering a Phase II/III program, I believe the GW Pharma and MyoKardia examples underscore the potential for a significant revaluation of Cardiol to occur after a successful uplisting on the Nasdaq. In this regard, we are in active discussions with U.S. analysts, investment firms, and biotech investment funds to support this important initiative and I am pleased to say that the responses we are receiving from our initial meetings has been very positive and we look forward to securing a Nasdaq listing as soon as possible.

The recent proceeds from the exercise of warrants and options have further strengthened Cardiol’s financial position. We will be utilizing these funds to support our important research and clinical development programs in heart disease, with a primary focus on our landmark Phase II/III study in high-risk CCOVID-19 patients with cardiovascular disease or risk factors for heart disease. We expect this program will also provide invaluable information concerning the cardioprotective properties of CadiolRx that may extend its therapeutic potential to a broad range of inflammatory heart disorders, including acute myocarditis and heart failure– a condition that remains a leading cause of death and disability throughout the world.

We believe we are just at the beginning of discovering the cardioprotective benefits of CBD. Beyond the focus of our current Phase II/III clinical programs that we have discussed today, we look forward to advancing the next generation of CBD-based medicines utilizing an injectable formulation to increase the efficiency by which this drug reaches sites of disease, as well as exploring its potential to reduce cardiotoxicity associated with chemotherapy.