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Investor.Coffee (11.24.2023): Optimism in Canadian Markets, Wall Street to Continue Winning Streak

In the Canadian markets, there’s a sense of optimism as investors await the release of the country’s retail sales data for September. This anticipation is amidst a global backdrop where U.S. stock index futures remain relatively unchanged in a shortened trading session due to Thanksgiving. Wall Street, however, appears poised to continue its weekly winning streak, buoyed by beliefs that U.S. interest rates may have reached their peak. European shares are also experiencing an upswing, fueled by new economic data from Germany, while Japanese stocks closed higher. This positive sentiment in the stock market is mirrored in the commodities market, with gold prices benefiting from a weakened U.S. dollar. Meanwhile, oil prices hold steady as the market anticipates the upcoming OPEC+ meeting and its potential decision on further supply adjustments.

The world also watches a significant development in the Middle East, where a ceasefire between Israel and Hamas has commenced. This temporary peace, the first since the conflict’s escalation in mid-October, was facilitated by Qatar, Egypt, and the U.S. It’s a four-day truce intended to allow humanitarian aid and the exchange of hostages, marking a critical moment in the region’s recent history.

Today, the U.S. stock market operates on a reduced schedule, leading to expectations of a quieter trading day. This comes as major U.S. stock indexes like the Dow Jones Industrial Average, the S&P 500, and the Nasdaq Composite have all seen nearly 1% gains over the week, signaling a robust performance in the financial markets.

In corporate news, Canadian mining giant First Quantum Minerals Ltd. (TSX: FM) faces a critical juncture as Panama’s top court begins deliberations on the constitutionality of its contract for the Cobre Panama mine. This ruling could have far-reaching implications for the global copper market and Panama’s economy, given the mine’s significant contribution to the country’s GDP. The company has already suffered a substantial loss in market value due to the uncertainty surrounding this issue.

Elsewhere, Europe and Asia are witnessing notable events. In Israel, the truce with Hamas has led to the release of hostages, a much-needed respite in the ongoing conflict. In Europe, there are planned demonstrations against Amazon, aiming to disrupt one of the busiest shopping days of the year. Additionally, France’s foreign minister is visiting Beijing to address trade tensions, particularly concerning a recent EU probe into Chinese electric vehicles.

In the technology sector, Quantum eMotion Corp. (TSXV: QNC | OTCQB: QNCCF) reports significant advancements in digital health with its partner Greybox Solutions Inc. Their recent clinical study in heart failure treatment using a digital therapeutics platform has shown promising results. This breakthrough is crucial for Canada, where heart failure is a leading cause of hospitalization, and healthcare costs are projected to rise significantly.

Mark your calendar for next week’s InvestorTalk, and go sign up for our pre-market events next week!

For more information, email us at [email protected].




With an effective anti-inflammatory and anti-fibrotic agent, Cardiol Therapeutics is focused on our hearts

Trialing cannabidiol-based therapies for pericarditis and myocarditis while developing new therapies for heart failure — Cardiol is well-capitalized to achieve corporate milestones into 2026

Two very serious heart conditions are pericarditis and myocarditis. Both involve heart infection and can occur after having a flu, Covid-19, or other infection typically occurring in otherwise healthy young adults or in immune suppressed individuals (such as those undergoing cancer chemotherapy). ‘Pericarditis’ is an infection in the sack around the heart and ‘myocarditis’ is an infection in the heart’s muscle tissue.

In a 2023 InvestorIntel interview, David Elsley stated that acute myocarditis,

“is a leading cause of sudden cardiac death in people under the age of 30 and there is currently no accepted standard of care for that condition. Furthermore, the current treatments come at an exceptionally high cost. The market is wide open for a more cost-effective solution for both conditions.”

David’s company is working to develop and prove via clinical trials the effectiveness of their therapies used to combat recurrent pericarditis and acute myocarditis, and ultimately to prevent both inflammatory and fibrotic heart disease, as well as developing novel therapies for heart failure. The company is using ‘cannabidiol’ based therapies because cannabidiol has been shown to be a very effective anti-inflammatory and anti-fibrotic agent.

The Company is Cardiol Therapeutics Inc. (NASDAQ: CRDL | TSX: CRDL) (“Cardiol”).

The market opportunity for pericarditis and myocarditis is very significant. There is an opportunity for new medicines that can be proven effective and come at a lower cost to the current very expensive options

Source: Cardiol Therapeutics company presentation

Cardiol Therapeutics and their two heart disease therapies CardiolRx™ and CRD-38

Cardiol 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.

Cardiol’s lead drug candidate is CardiolRx™ (cannabidiol) oral solution. CardiolRx™ is pharmaceutically manufactured under cGMP to meet the highest standards for product purity, consistency, and stability. A Phase I safety and pharmacokinetic study of single and multiple ascending doses of CardiolRx™ was completed and demonstrated that CardiolRx™ was safe and generally well tolerated at all dose levels, with no serious adverse events reported. CardiolRx™ is eligible for FDA orphan drug and EMA orphan medicine designations for recurrent pericarditis and acute myocarditis. The US orphan drug program offers an accelerated path to development for new drugs to treat rare diseases with reduced cost of development via tax incentives and exemption from user fees. Once developed the new drug is typically offered a 7 year plus period of exclusivity to assist the companies to recoup their development costs.

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

“Our research collaborators have shown that cannabidiol, when administered subcutaneously, is effective in a pre-clinical model of heart failure.”

Cardiol’s two key products in their pipeline

Source: Cardiol Therapeutics company presentation

Cardiol currently has two clinical trials for CardiolRx™ in the early stages:

  1. A Phase II U.S 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. The Study seeks to evaluate the tolerability, safety, and efficacy of CardiolRx™ in patients with recurrent pericarditis.
  2. 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.

Cardiol’s game plan is stated as:

“We plan to pursue the development of CardiolRx™ as an orphan drug for the treatment of these heart conditions under the U.S. Orphan Drug Designation program and the European Medicine Agency’s orphan medicine product program.”

CardiolRx™ (cannabidiol) oral solution

Source: Cardiol Therapeutics website

Cardiol lists its next 3 major milestones over the next 1-2 years 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.

The outcome of these two clinical trials will be a key factor in determining the potential success of CardiolRx™ and for Cardiol Therapeutics as a company. Furthermore, the development and potential future success of CRD-38 in treating heart failure will also be one to follow closely, especially given that heart failure is a huge global market.

Closing remarks

Cardiol is debt free with $49.5 million in cash as of the end of Q1, 2023. This means they are well-capitalized to achieve their corporate milestones into 2026. To watch a great CEO interview you can click the link here. The interview gives more details about the current Company activities and the next steps ahead.

Cardiol Therapeutics trades on a market cap of C$70 million. One to watch in 2023 and beyond.




Cardiol Furthers Clinical Trials to Advance Disruptive Cannabidiol-Based Therapies for Heart Disease

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

Source: Cardiol Therapeutics company presentation

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

Source: Cardiol Therapeutics company presentation

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.




David Elsley of Cardiol Therapeutics talks about their global Phase II clinical trials for the treatment of heart diseases

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

Disclaimer: Cardiol Therapeutics Inc. is an advertorial member of InvestorIntel Corp.

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.

If you have any questions surrounding the content of this interview, please contact us at +1 416 792 8228 and/or email us direct at [email protected].




Cardiol Therapeutics is concerned with affairs of the heart

One thing I really enjoy about writing for InvestorIntel is all the random learning I get from reading MD&As of the various companies I write about. Some of it is very informative, some of it is fascinating and some of it is just plain entertaining. Today’s company falls into the first two categories, at least for me, as it sent me down a bit of a rabbit hole on cardiovascular disease (CVD). Coming from a long family history of unfortunate events related to the heart and its functions, I’m always keen to understand more about the prevention and cure of various heart maladies.

You may or may not be curious about which specific diseases we are dealing with today, but I’m going to tell you anyway – acute myocarditis and recurrent pericarditis, two underserved diseases affecting the heart. Acute myocarditis is an inflammatory condition of the heart muscle (myocardium) characterized by chest pain, impaired cardiac function, atrial and ventricular arrhythmias, and conduction disturbances. While recurrent pericarditis refers to inflammation of the pericardium (the membrane or sac that surrounds the heart) that follows an initial episode (frequently resulting from a viral infection). Perhaps that’s too much information but it’s important to understand if you have any interest in today’s company.

That company is Cardiol Therapeutics Inc. (NASDAQ: CRDL | TSX: CRDL), 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™, is a pharmaceutically manufactured oral cannabidiol formulation that is being clinically developed for use in heart diseases. 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 the two aforementioned 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.

Now that we’ve covered a small encyclopedia worth of medical terminology, let’s get down to the business catalysts behind Cardiol. In early October the Company announced data that was presented at The Annual Scientific Meeting of the Heart Failure Society of America (is it just me or does this seem like an awful name for a society?). The study results demonstrate the active pharmaceutical ingredient in CardiolRx™ inhibits and also promotes the reversal of mechanisms known to play a role in the occurrence and development of fibrotic CVD. Cardiol is currently advancing its Phase II ARCHER trial, designed to assess CardiolRx™ in acute myocarditis. The Company has received regulatory clearance in multiple jurisdictions and is expected to enroll 100 patients at major cardiac centers in North America, Europe, Latin America, and Israel. The primary endpoints of the trial will be evaluated after 12 weeks of double-blind therapy. Concurrent with the ARCHER trial, the Company is also undertaking a Phase II pilot study in recurrent pericarditis. Cardiol’s study is expected to enroll 25 patients at major clinical centers specializing in pericarditis in the U.S.

But now, possibly the most interesting thing about Cardiol, is the fact that it is trading at or even below its current cash value. The Company ended Q2/22 with working capital of C$62 million and currently has a market cap of just over C$50 million. With a quarterly burn rate of roughly C$6.5 million, that suggests the cash value alone in Cardiol is somewhere in the neighborhood of C$54 million give or take, which is C$0.06/share or 8% higher than yesterday’s close. Regardless of what the back of the envelope math says, the Company itself has stated that its cash runway now extends into 2026. That is plenty of time to see the ARCHER trial through to completion as well as the pilot study in recurrent pericarditis.

It appears Cardiol has plenty of available resources to make something happen over the coming weeks and months.




Hemostemix adds depth and strength to its scientific bench on the road to commercialization

Since we last covered Hemostemix where they released the promising results of their retrospective study of heart disease and the phase II clinical trial results of ACP-01 as a treatment for critical limb ischemia, their team has been making serious moves.

You may recall that Hemostemix Inc. (TSXV: HEM | OTCQB: HMTXF) is developing new treatments to treat ischemic (restricted blood flow) diseases by collecting a patient’s own cells from their blood and manufacturing a personalized regenerative therapy that can be administered to a patient within 7 days. The efficient, scalable, and cost-effective platform has the potential to generate therapies for a broad range of ischemic diseases.

In a quartet of recent press releases, Hemostemix announced the addition of four new distinguished members to its Scientific Advisory Board – Dr. Terry Hébert, Ph.D., Dr. Nadia Giannetti, MD, Dr. Johannes Grillari, and Dr. Renzo Cecere, MD, FRCSC. They are all internationally recognized experts in their respective fields with a wealth of experience in cardiovascular care, clinical research, and drug development.

Through his research, Dr. Hébert strives to improve our understanding of G protein-coupled receptor (GPCR) and G protein signaling architectures to enhance drug discovery for heart disease and other serious diseases. Dr. Hébert’s expertise will be a valuable asset to the Hemostemix team as they continue to work to develop innovative treatments for patients with cardiovascular disease.

Dr. Giannetti is a highly respected researcher and physician who has worked with more than 1000 patients with heart failure. She is a clinical researcher interested in improving care and outcomes for patients with heart failure and dilated cardiomyopathy. She is also the co-principal investigator of a large initiative looking at the role of stem cells in personalized therapy for cardiomyopathy, making her an excellent addition to Hemostemix’s Scientific Advisory Board.

Dr. Grillari is a renowned expert on cellular aging and tissue regeneration, with over 20 years of research experience in the field. His appointment will bring a wealth of knowledge and expertise to the Hemostemix team and will help to further their understanding of the molecular and physiological changes that occur during cell aging. His contributions will be invaluable in helping their team to achieve their goal of improving heart disease patient outcomes.

Dr. Cecere is an expert in the field of stem cell research and has been investigating novel methods to strengthen the stem-cell-induced regeneration of infarcted heart tissue for over a decade. In fact, Dr. Cecere’s recent publication–systematic review and meta-analysis–demonstrates that stem cells, along with bioactive scaffolds, provide enhanced tissue regeneration in animal models of myocardial infarction (MI) compared to stem cells injected alone.  His study gives more backing to the theory that ACP-01 bioactive scaffolds improve stem cell-induced repair after a patient suffers a MI.

The new Scientific Advisory Board members’ experience should greatly assist in advancing to their phase II clinical trial, a step towards the goal of bringing ACP-01 to market and potentially improving the lives of heart failure patients around the world.

Hemostemix is also poised to gain more value from its NCP-01, which are autologous neuronal cell precursors. These precursors have the potential to treat the central and peripheral nervous systems. Hemostemix has announced Mr. Thomas Abraham has been appointed as President of PreCerv Inc., a wholly owned subsidiary of Hemostemix. PreCerv has obtained a global field of use license to NCP-01 and its autologous stem cell technologies from Hemostemix. This license will allow PreCerv to fund its studies to unlock NCP’s value for the shareholders of Hemostemix. Mr. Abraham is a highly accomplished business professional with more than 25 years of experience in financing, business development, governance, and risk management. He will be responsible for financing and leading the team that studies, develops, and commercializes NCP-01 and ACP-01 in the neuronal field, and bringing them to market for the benefit of patients suffering from neurological diseases.

Success for a public company often owes a lot to the team and talent it assembles, especially in the field of biotech and therapeutics. With these additions, Hemostemix has taken a big step toward advancing its suite of products in development.




Hemostemix posts promising clinical trial results from heart failure and limb ischemia treatment

Heart failure (HF) is a growing epidemic in the United States, with an estimated 6 million people affected. HF is a debilitating condition that can significantly reduce patient quality of life and, in severe cases, prove fatal. Within five years of hospitalization, the death rate for HF patients ranges from 45% to 60%. Given the high mortality rate and the significant impact on quality of life, there is a great need for effective treatments for HF.

Stem cell therapy has been touted as a revolutionary medical treatment for a variety of conditions for some time. Stem cells have a number of properties, including paracrine and anti-inflammatory effects, that are potentially useful for conditions where conventional medical treatments do not lead to enough optimal patient outcomes.

Acute cardiac progenitor cells (ACP-01) have emerged as a promising therapeutic option for HF. These cells have the ability to replace damaged cells, stimulate new blood vessel growth, and reduce inflammation. One company, in particular, has been working for years to develop and commercialize these cells in new treatments.

Hemostemix Inc. (TSXV: HEM | OTCQB: HMTXF) is developing new treatments to treat ischemic (restricted blood flow) diseases. Hemostemix’s technology uses a patient’s own cells, collected through a simple blood draw, to treat that patient’s disease. Its proprietary technology collects synergetic cell population and manufactures a personalized regenerative therapy that can be administered to a patient within 7 days of the initial cell collection. The efficient, scalable, and cost-effective platform has the potential to generate therapies for a broad range of ischemic diseases.

On August 30th, 2022, Hemostemix announced the results of their retrospective study of heart disease and the phase II clinical trial results of  ACP-01 as a treatment for critical limb ischemia.

In the heart disease study, patients received a direct injection into the heart, or a balloon angioplasty-like release of ACP-01 into the heart’s vasculature to address either hardening of the arteries (ischemic cardiomyopathy), or thickening of the heart wall (dilated cardiomyopathy).

The study showed that ACP-01 positively affects cardiac function in patients with both types of severe heart failure. The researchers measured cardiac function in terms of the volume of blood the heart pumps with each beat, the ejection fraction of the left ventricle (LVEF%) before and after ACP treatment at an average of 4 and 12 months. It was found that the LVEF% was increased by 16.08% in all patients at first follow-up and by 26.88% on final follow-up. These results suggest that ACP-01 may be a viable treatment option for patients with severe heart failure.

The results of ACP-01 treatment for critical limb ischemia showed that ACP-01 was safe, trended to improve the healing of ulcers at 3, 6, and 12 months, and trended to a reduction in pain at 12 months. In a previous randomized trial of 20 subjects, after 2 years there were no deaths and 7 of 10 limbs were saved from amputation, compared to the control group where 2 patients died and 6 of 8 limbs were lost to amputation. Hemostemix’s press release noted that its previous management team truncated the trial to 65 subjects, which effected the power of the study. The overall encouraging results of these studies showcase the need for further clinical trials of ACP-01.

Thomas Smeenk, CEO of Hemostemix, commented in the press release that the results show ACP-01 is safe and statistically effective as a treatment of heart disease, safe as a treatment of critical limb ischemia, and worthy of additional clinical trials. “Proving the efficacy of ACP-01 in prospective, blinded, randomized clinical trial, to gain regulatory approval is next,” he said.

Hemostemix has said that its next move is to go “forward with a phase II clinical trial of heart disease financed, ideally, through a partnership.” Clinical trials can be expensive, and it is not uncommon for smaller biotechnology companies to partner with larger companies or pharmaceutical giants to fund their way through different levels of trials to regulatory approval, provided early results are promising. Hemostemix’s results could well attract the right kind of attention.