Heart disease continues to be a leading cause of death globally. According to Cardiol Therapeutics Inc. (NASDAQ: CRDL | TSX: CRDL) (“Cardiol”), there is a prevalence of 160,000 cases per year of pericarditis and 46,000 cases per year of myocarditis in the USA. Globally heart failure affects more than 64 million people with health costs in excess of US$100 billion. In other words, this is a huge industry ideally suited for disruptive new therapies. Of course, getting FDA approval is a major challenge all new drug companies face and investors need to be mindful of this risk.

Cardiol Therapeutics Inc.

Cardiol Therapeutics is a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease.

CardiolRx™ and CRD-38

Cardiol’s lead drug candidate is CardiolRx™ (cannabidiol) oral solution. It is recognized that ‘cannabidiol’ inhibits the activation and progression of inflammation and fibrosis associated with:

• Myocarditis, inflammation and damage of the heart muscle known as the myocardium;
• Pericarditis, inflammation of the thin membrane around the heart known as the pericardium; and,
• Heart failure.

CardiolRx™ is currently being evaluated in a Phase II multi-national study (the ARCHER trial) to evaluate its safety and tolerability as well as its impact on myocardial recovery, in patients presenting with acute myocarditis.

Cardiol’s other product undergoing development is CRD-38. It is a novel subcutaneously administered drug formulation of cannabidiol intended for use in heart failure.

FIGURE 1: Cardiol Therapeutics product pipeline and stage of development

Latest update on Cardiol Therapeutics

As announced on March 29, 2023, Cardiol is advancing its Phase II open-label clinical trial investigating the safety, tolerability, and efficacy of CardiolRx™ in patients with recurrent pericarditis.

Cardiol is also advancing its ARCHER Trial – a Phase II multi-national, randomized, placebo-controlled clinical trial evaluating the safety and efficacy of CardiolRx™ in patients with acute myocarditis.

Cardiol also reported that, in 2022, it had presented at the American Heart Association 2022 scientific sessions and at the Annual Scientific Meeting of the Heart Failure Society of America. These presentations highlighted data on the cardioprotective effects of CardiolRx™ in a model of acute pericarditis and pre-clinical study results demonstrating CardiolRx™ inhibits and promotes reversal mechanisms leading to cardiac fibrosis.

Next steps over the next 12-24 months

Cardiol lists its next 3 major milestones as:

1. Complete Phase II U.S. study in recurrent pericarditis with CardiolRx™.
2. Complete patient enrollment in the global ARCHER trial in acute myocarditis with CardiolRx™.
3. Advance the development of a subcutaneously administered formulation intended for use in heart failure.

Cardiol has an extensive and very experienced team – Board, Management, and Advisers

Cardiol has a strong board and management team led by President and CEO David Elsley (MBA), Chief Medical Officer and Head of Research & Development Andrew Hamer (MBChB), and Chief Operating Officer Bernard Lim (MIET, CEng (UK)). Members of the Scientific Advisory Board are shown here.

David Elsley founded Vasogen Inc., a biotechnology company focused on the research and commercial development of novel therapeutics for the treatment of heart failure and other inflammatory conditions. Cardiol’s website states:

“Mr. Elsley managed and directed Vasogen’s growth from start-up to an organization employing over 250 people with operations and R&D programs in Canada, the United States and Europe. He established the research and development infrastructure, partnerships, manufacturing capability, and corporate quality systems necessary to advance two anti-inflammatory therapies from concept to completion of international multi-center pivotal phase III clinical trials involving 2,500 patients. Vasogen went public on the TSX and the Nasdaq, raising over $200 million to support corporate development and reached a market capitalization of over US$ 1 billion.“

Note: Investors should note that Vasogen later had various setbacks, the stock declined and was taken over in 2009.

FIGURE 2: Cardiol Therapeutics highlights

Closing remarks

Cardiol continues to work to further prove the effectiveness of its two drug candidates CardiolRx™ and CRD-38, whilst also presenting results at various leading U.S heart scientific sessions and conferences.

The next 2 years will be focused on Phase II clinical trials, so investors will need some patience. Cardiol’s experienced management team and high cash levels help reduce risk, but FDA approval remains a significant hurdle.

As of December 31, 2022, Cardiol stated that they had cash and cash equivalents of C$59.5 million, enough capital to achieve corporate milestones and fund operations into 2026.

That’s a huge cash buffer and very attractive considering Cardiol Therapeutics’ market cap of just US$39 million (C$53 million) and a negative Enterprise Value (“EV”).

Definitely worth putting Cardiol Therapeutics on your watch list. Stay tuned.

In this InvestorIntel interview, Chris Thompson talks to Cardiol Therapeutics Inc.’s (NASDAQ: CRDL | TSX: CRDL) CEO, President and Director David Elsley about Cardiol’s therapies for the treatment of heart diseases. Currently targeting recurrent pericarditis and acute myocarditis, David discusses how these two forms of heart diseases generally affect younger populations who are otherwise healthy.

David tell Chris that there is no currently no FDA-approved therapy on the market for acute myocarditis, and only one FDA approved treatment for recurrent pericarditis which “costs upwards of $200,000 per patient per year.” Currently in Phase II clinical trials, David discusses how Cardiol is developing CardiolRx™ as an “orphan drug” for the treatment of acute myocarditis and recurrent pericarditis. He tells Chris that the current global Phase II trial is “the largest clinical program ever to be undertaken in acute myocarditis.” He goes on to provide an update on Cardiol’s new formulation in the pipeline for the treatment of heart failure.

To access the full InvestorIntel interview, click here.

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About Cardiol Therapeutics Inc.

Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) is a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart diseases. The Company’s lead product candidate, CardiolRx™ (cannabidiol), is a pharmaceutically manufactured oral solution formulation that is being clinically developed for use in heart diseases. It is recognized that cannabidiol inhibits activation of the inflammasome pathway, an intracellular process known to play an important role in the inflammation and fibrosis associated with myocarditis, pericarditis, and heart failure.

Cardiol has received Investigational New Drug Application authorization from the United States Food and Drug Administration to conduct clinical studies to evaluate the efficacy and safety of CardiolRx™ in two diseases affecting the heart: (i) a Phase II multi-national, randomized, double-blind, placebo-controlled trial (the “ARCHER” trial) in acute myocarditis, an important cause of acute and fulminant heart failure in young adults and a leading cause of sudden cardiac death in people less than 35 years of age; and (ii) a Phase II multi-center open-label pilot study in recurrent pericarditis (inflammation of the pericardium), which is associated with symptoms including debilitating chest pain, shortness of breath, and fatigue, and results in physical limitations, reduced quality of life, emergency department visits, and hospitalizations.

Cardiol is also developing a novel subcutaneously administered drug formulation of cannabidiol intended for use in heart failure – a leading cause of death and hospitalization in the developed world, with associated healthcare costs in the United States exceeding $30 billion annually.

To learn more about Cardiol Therapeutics Inc., click here

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This interview, which was produced by InvestorIntel Corp., (IIC), does not contain, nor does it purport to contain, a summary of all the material information concerning the “Company” being interviewed. IIC offers no representations or warranties that any of the information contained in this interview is accurate or complete.

This presentation may contain “forward-looking statements” within the meaning of applicable Canadian securities legislation. Forward-looking statements are based on the opinions and assumptions of the management of the Company as of the date made. They are inherently susceptible to uncertainty and other factors that could cause actual events/results to differ materially from these forward-looking statements. Additional risks and uncertainties, including those that the Company does not know about now or that it currently deems immaterial, may also adversely affect the Company’s business or any investment therein.

Any projections given are principally intended for use as objectives and are not intended, and should not be taken, as assurances that the projected results will be obtained by the Company. The assumptions used may not prove to be accurate and a potential decline in the Company’s financial condition or results of operations may negatively impact the value of its securities. Prospective investors are urged to review the Company’s profile on Sedar.com and to carry out independent investigations in order to determine their interest in investing in the Company.

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Stem cell therapy is potentially one of the greatest medical breakthroughs of our time. It is truly amazing that we can use our own bodies’ stem cells to heal certain diseases. The technology is evolving, but today’s company is making great steps forward to bringing stem cell therapy to patients.

Hemostemix Inc. (TSXV: HEM | OTCQB: HMTXF | FSE: 2VFO) is a company that is developing ‘stem cell therapy’ for the treatment of ischemic (lack of blood flow) disease and several other diseases. Some examples include using the patient’s own stem cells to heal ischemic heart disease (causing angina and heart attack), limb ischemia, vascular dementia, ischemic kidney disease, possibly diabetes, and even in some cases chronic pain. Hemostemix’s stem cell therapy platform uses the patient’s own blood to harvest the stem cells and uses them in a treatment that helps to restore circulation (blood flow) in damaged tissues.

How does it work?

Hemostemix explains how their stem cell therapy works by stating:

“Hemostemix’s technology uses a patient’s own cells to treat that patient’s disease. The cornerstone of this autologous technology is a novel cell population within the blood called the synergetic cell population (SCP). The synergetic cell population, which can be collected from a simple blood draw, consists of progenitor and other supporting cells that are being developed for the treatment of ischemic diseases. Hemostemix’s proprietary technology includes methods for collecting the synergetic cell population and manufacturing (isolation, enrichment and differentiation) a personalized regenerative therapy that can be administered to a patient within 7 days of the initial cell collection.”

About Hemostemix and their lead therapy ACP

Hemostemix was founded in 2003 and is a winner of the World Economic Forum Technology Pioneer Award. Hemostemix’s pioneering stem cell treatment is called angiogenic cell precursor (ACP), or ACP-01 for the first one.

Hemostemix has published numerous peer reviewed clinical trials regarding the safety and efficacy of ACP-01 for the treatment of limb ischemia, peripheral arterial disease (PAD), angina, and ischemic cardiomyopathy, involving treatment of over 300 patients.

Case studies show that Hemostemix’s stem cell therapy (named ACP) is effective

Below are just 3 of many case study results:

For example:

1. The results of the 106 subjects suffering from ischemic cardiomyopathy “[experienced] improved cardiac function (Left Ventricle Ejection Fraction), improved exercise capacity, and improved quality of life…”
2. The results of 41 subjects treated by direct injection of ACP into the heart to treat ischemic and dilated cardiomyopathy: “Overall ejection fraction improved significantly… At a mean of 180 days after injection, NYHA functional class improved significantly…subjects …improving nearly 126 meters in walking capacity in six minutes.”
3. The 83% of subjects treated compassionately for critical limb ischemia who “… had clinically significant improvement of adequate circulation at the distal limb for…complete healing.”

Latest news

In the latest news, Hemostemix announced on February 14 that they have trademarked the term “Your Fountain of Youth” for a period of 10 years.

In other news Hemostemix recently announced a partnership with My Next Health. My Next Health Inc. (MNH) is the world’s leading patient focused, AI-functional-medicine-based genomic medical analysis company.

Finally, an exciting piece of news from January 2022, when Hemostemix announced that they plan to combine ACP-01 with Dr. James Shapiro’s Islet Cells to treat Type 1 Diabetes. The news states: “Following technology transfer, the team will create a new product by combining the two formulations, beginning with human islets. Thereafter, the team will complete preclinical studies to demonstrate the product’s characteristics in vivo, with a plan to move forward with first-in-human testing.”

Note: The global diabetes care drugs market reached US$69.7 billion in 2019. The global market for diabetes care products including drugs and devices is expected to exceed US$111.2 billion by 2027.

Closing remarks

Hemostemix is at an interesting stage of development where they have spent many years proving their science and technology works, with several favorable clinical trial results. The next stage is the most exciting for investors, when the Company gets to commercialize the technology. Of course, once this starts to gain success the stock price would typically be much higher. Hemostemix states: “91 Patents. More to follow as we scale Manufacturing and R&D.”

The market for stem cell therapy to treat various diseases is potentially huge. Just think of how many people suffer from ischemic and degenerative diseases. There may also be a market to treat diabetes if the latest Dr. Shapiro pre-clinical studies go well. If we can safely grow back healthy cells in our body to repair damaged tissue, then the potential rewards are enormous. Hemostemix gets this, as we can see from their recent trademark name – “Your Fountain of Youth”.

Hemostemix trades on a market cap of C$8 million. Patience is required but there is huge potential for reward if Hemostemix takes off.