Interview Cardiol Therapeutics: 'We have two potential blockbusters in our portfolio'

It is important to understand that our study does not investigate the effect of CardiolRx™ on COVID-19 disease. We are studying concomitant cardiovascular diseases of COVID-19 infection, such as strokes or heart attacks. There are an appreciable number of patients at risk of developing such diseases of the cardiovascular system. We believe that we can effectively protect this group with CardiolRx™. We have, therefore, specifically designed the study to enroll at-risk patients with diabetes, obesity, hypertension, or other pre-existing conditions who have already been admitted to clinics. When these patients come to the clinics, the time window for other therapeutic measures, such as antibodies, which usually must be given very early in the course of an infection, is already closed. Our study will provide us with data on the impact of CardiolRx™ on the inflammatory processes, and we believe that these findings could be of great benefit in protecting at-risk patients, not only in the context of the pandemic, but also in the anticipated endemic.

Typically, the only drugs given in the hospital to high-risk COVID-19 patients in an advanced stage of disease are steroids, such as dexamethasone. These drugs sometimes have major side effects. In addition, CardiolRx™ addresses a different type of inflammation than steroids do. Our active ingredient is unique in its safety profile and mode of action. Since these high-risk patients are very much at risk of dying because of COVID-19 infection, we see a lot of arguments in favor of our active ingredient.

The study has been approved by the U.S. Food and Drug Administration, and the same is true for the corresponding agencies in Brazil, Mexico, and Canada. We are studying 422 patients in a double-blind study. This means that 211 patients will receive CardiolRx™ and 211 patients will receive a placebo. Neither doctors nor patients know who belongs to which group. This is how we ensure that the results are not biased. We study the patients over a long period of time and administer our active ingredient twice a day for 28 days. In this way, we cover the acute phase of the infection, when patients are most at risk. At the end of the 28 days, we look at the differences in cardiovascular complications, ICU admission and/or ventilatory support, and mortality. Furthermore, we measure various inflammatory markers. Sixty days after the first drug administration, we do a follow up and collect additional data. We also focus on the patients’ quality of life and safety.

Yes, the study is designed in such a way that we should achieve robust results. One must consider that we are grouping the different complications together and not looking at them in isolation. CardiolRx™ is effective if the overall risk decreases. So, we are looking at mortality or heart failure or heart attack or stroke or ICU transfer, not each specific factor by itself. This is statistically permissible because different factors can equally lead to increased mortality.

We see several areas where our scheduled pivotal study in myocarditis can benefit from the LANCER trial. COVID-19 is now recognized as a trigger for myocarditis. If myocarditis causes are now either weaker or prevented in the LANCER trial, that will be a strong signal for our myocarditis trial. As we recently announced, we are now enrolling vaccinated patients in our LANCER trial. Doing so could allow us to also show whether the administration of our active ingredient has an impact on certain side effects from mRNA vaccination.

These statements are speculative at this point. However, it is important to remember that there has been no significant advancement in therapies surrounding myocarditis for more than a decade. Untreated myocarditis is one of the leading causes of death in children and young, healthy adults. Until now, influenza viruses were often the causative agent for these complications. Today, in addition, we have COVID-19 and the side effects of mRNA vaccination. To find a remedy here with an effective and very safe drug is a great opportunity for all of us. Many clinics that want to participate in our study also see it that way. Instead of the planned 25 to 30 clinical sites, we now have more than double these numbers of interested clinics. With the possibility of many more clinics participating, we may be able to accelerate the progression of the trial. Because acute myocarditis in both the U.S. and Europe is considered an orphan disease due to the rarity of the disease, if our CardiolRx was approved for treatment, we could be granted marketing exclusivity for several years.

I don't want to speculate. But I can give an example from history. The first FDA approved CBD drug was directed at rare forms of child-onset epilepsy. At the time, these conditions’ rarity allowed the approval process to be expedited, and extended market exclusivity for several years was granted. The biotech company that developed the compound was ultimately acquired for USD 7 billion. The market for myocarditis is approaching three times the size than that for these rare forms of child-onset epilepsy.

What you are talking about is spontaneous remission of myocarditis. This can occur in young and healthy patients if a doctor carefully monitors them. However, and especially in the absence of medical monitoring, there is still a great risk that myocarditis will not heal as desired. The result can be sudden heart failure, other fatal outcomes, or even heart transplantation. Even the administration of steroids is often associated with severe side effects. I do not disagree that in many cases myocarditis can subside with minimal intervention. But there remains a group of patients in whom this is not so. Now, what if you had an active ingredient that was non-toxic, did not carry significant side effects, and could drastically reduce this residual risk associated with myocarditis through its preventive administration? Think of people in the prime of their lives who suddenly suffer a heart attack. We believe we must do everything we can to prevent such things.

The subcutaneous approach, where we inject our compound under the skin in a similar way to insulin, is possibly the most exciting project of all. The fact that the market is not considering this project at all is downright ridiculous, as we see the potential for a blockbuster drug. While we use our oral version of CardiolRx™ for acute conditions, a subcutaneous administration of CardiolRx™ once or twice a week should help with chronic inflammation and the risk of heart failure. In western industrialized countries, the market for these diseases covers 26 million people and the trend is upward. We look forward to initiating clinical studies around our subcutaneous administration of CardiolRx™.

Companies in our sector must do extensive research over a period of years to implement their plans. It is essential to have sufficient capital to work in peace. In our case, the demand from professional investors for our finance offering was great. So, we future-proofed Cardiol Therapeutics to be able to address our goals. That is my responsibility as CEO of Cardiol Therapeutics. In retrospect, the current uncertain situation on the capital markets further confirms our approach. We have enough money in our treasury to implement our plans and potentially even start further projects.

Many of Cardiol’s medical team have been researching and investigating inflammatory heart disease and associated therapies for thirty years and are in contact with many scientific institutions. Indeed, there are some options, such as new delivery forms or new active ingredients. However, it is not my place to comment on such plans before officially announcing them. But investors can be excited – Cardiol Therapeutics has further plans, besides the outlined advanced projects. As soon as these become more concrete, we will provide information to the market.

Our move to the NASDAQ has paid off. We are building relationships with more and more life science investors. Our November financing round showed that we are now in the focus of many investors in the U.S.: 90% of the participants in the financing round were from the U.S. The listing on NASDAQ was a pre-requisite for a large proportion of these investors. Also, two analysts from the U.S. now cover Cardiol Therapeutics – this would also be less likely without the listing. We are also in talks with various fund managers who have not yet included Cardiol Therapeutics in their portfolios. Their reasons lie in the situation with the overall market.

There is great interest in Cardiol Therapeutics, and, as far as we can tell from the questions we have been asked, it is also long-term oriented. We are facing landmark clinical trials in 2022, the Company is funded for all projects and beyond, and we can now focus on what we have been successful at as a team for many years. These are excellent pre-requisites for convincing the stock market.