In this InvestorIntel interview, Tracy Weslosky talks with Hemostemix Inc.’s (TSXV: HEM | OTCQB: HMTXF) Co-Founder, CEO, and President Thomas Smeenk about the significance of engaging Dr. Chris McNorgan, Ph.D., to drive a license agreement of NCP-01 (Neural Cellular Precursors) with a neural electrode brain implant company.

Dr. McNorgan directs the Computational Cognitive Neuroscience (CCN) laboratory at the University of Buffalo and his research – the neural bases of cognition, including AI methods to decode and simulate neocortical representations of knowledge and motor intention – is directly relatable to neural electrode-based implantation.

With Dr. McNorgan’s appointment, it brings another expert onto the team that includes Dr. Henderson, a neurosurgeon, and Dr. Inna Sorel, the mother of the invention of NCP itself, to help drive the legitimacy of licensing the NCP-01 platform. Thomas discusses the potential for licensing and partnerships to take NCP-01 to the neural electrode-based implantation market, an industry that is being led by players such as Elon Musk’s Neuralink.

NCP is a neuronal cell precursor generated from a patient’s own blood, which homes to the site of injury and regenerates the site of injury on a neuronal cell basis. Thomas explains how Hemostemix’s NCP-01 has the potential to regenerate injured neuronal cells to support the implantations of electrodes. Thomas also discusses a pre-clinical study conducted in animals using Hemostemix’s NCP-01 that showed positive results with more than 90% of the NCP color-coded cells ending up at the site of stroke, embedding at the site, and regenerating neuronal factors that would repair the site of a stroke.

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About Hemostemix Inc.

Hemostemix is an autologous stem cell therapy company, founded in 2003. A winner of the World Economic Forum Technology Pioneer Award, the Company has developed, patented, and is scaling a patient’s blood-based stem cell therapeutics platform that includes angiogenic cell precursors, neuronal cell precursors, and cardiomyocyte cell precursors.

To learn more about Hemostemix Inc., click here

Disclaimer: Hemostemix 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].

Hemostemix Inc. (TSXV: HEM | OTCQB: HMTXF | FSE: 2VF0) has developed an effective “stem cell therapy” for the treatment of ischemic (lack of blood flow) disease and several other diseases including cardiomyopathy (heart tissue disease) and neuropathy (nerve cell disease). Hemostemix’s initial goal is to treat heart attack (ischemic heart disease) and various ischemic conditions such as ischemic limb disease.

Hemostemix’s Product Platform (targets to repair) – ACP-01 (blood vessel cells), NCP-01 (nerve cells), CCP-01 (heart cells)

Source: Hemostemix company presentation

Hemostemix’s leading product is called ACP-01. It refers to Hemostemix’s first stem cell treatment called angiogenic cell precursor (“ACP”) one (“01”). The ACP technology uses a patient’s own stem cells to treat that patient’s disease by extracting the stem cells, growing the number of cells within 7 days, then using them to treat the patient with their own harvested stem cells. According to Hemostemix: “ACP-01 has been used as a treatment of 500 subjects, studied in including clinical trials, and are demonstrated to be completely safe and effective as a treatment of Angina, Dilated and Ischemic Cardiomyopathy, Peripheral Arterial Disease and Critical Limb Ischemia.”

Hemostemix plans to increase production of their ACP stem cell therapy for ischaemic disease

In some recent news announced in January this year, Hemostemix has ramped up their team in order to increase the production of ACP-01. Hemostemix President and CEO, Thomas Smeenk, stated: “Adding four employees to our team enables Hemostemix to produce up to 20 ACP treatments per month for clinical trials and compassionate treatments approved by regulators……We expect up to 174 revenue production slots for the first full year of production. To fill them and balance our production schedule, we are working on a forward sales plan.“

A “sales plan” suggests that the commercialization of ACP is potentially in the near term.

In a recent InvestorIntel CEO video, Thomas Smeenk revealed more about Hemostemix’s master plan. He said Hemostemix’s goal is to scale up production of ACP to “4,000 or more batches per month” and “the numbers are very significant, at $25,000 per treatment…$30,000 per treatment…..the numbers get very large very fast”.

Hemostemix’s scalable production plans over a 60-month period

Hemostemix’s sales target is to reach $360 million of risk-adjusted sales in 2027 (see below or page 14). Quite impressive given Hemostemix’s current market cap is C$16 million.

Hemostemix’s sales target is to reach $360 million of risk-adjusted sales in 2027

Source: Hemostemix company presentation

Is Hemostemix’s stem cell therapy effective?

Hemostemix’s ACP treatments have been successful to date. For example, in a 2019 Phase II CLI Trial with 12 randomized double-blind subjects, the results included: “Healing of ulcers and resolution of ischemic rest pain occurred in 10 of the 12 patients (83%). There were no clinically significant safety issues. Outcomes were maintained for up to 4.5 years……“

You can see more results including pictures in a past InvestorIntel article here.

Closing remarks

Some risks apply and there is still work ahead for Hemostemix to implement its plan of action. At this stage, the Company has received US FDA Clinical Trial approval and further regulatory approvals may be necessary, as well as further funding to achieve the Company’s goals.

The best companies develop effective products that both help society and fill a strong need. Tesla (NASDAQ: TSLA) is doing this with electric vehicles (EVs) and sustainable energy. Hemostemix is working towards becoming a leading biotech health company using stem cells to significantly help some of society’s most common and severe diseases. They have already won the World Economic Forum Technology Pioneer Award, have proven their treatment efficacy in clinical trials, and have a highly qualified management team and reputable advisors.

2023 could potentially be a breakout year for Hemostemix Inc.

Peter Clausi interviews Hemostemix Inc.’s (TSXV: HEM | OTCQB: HMTXF) Co-Founder, President and CEO Thomas Smeenk about an update on their stem cell therapeutics to treat heart diseases and critical limb ischemia. Providing an update on the production timeline for ACP-01, Thomas discusses how Hemostemix has strengthened its scientific advisory board.

Thomas talks about the appointment of Dr. Nadia Giannetti and Dr. Renzo Cecere, two of the world’s top cardiovascular physicians and stem cell scientists, as Co-Lead Medical Consultants, Cardiovascular Medicine and Clinical Trials. He explains how the recent addition to its scientific advisory board is a significant validation of ACP-01 to be “a first-to-patient approved therapeutic to treat heart disease and critical limb ischemia amongst other diseases of ischemia.”

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About Hemostemix Inc.

Hemostemix is an autologous stem cell therapy company, founded in 2003. A winner of the World Economic Forum Technology Pioneer Award, the Company has developed, patented, and is scaling a patient’s blood-based stem cell therapeutics platform that includes angiogenic cell precursors, neuronal cell precursor and cardiomyocyte cell precursors. Seven studies including 260 ACP-01 recipients define its safety and efficacy profile as a treatment for heart diseases such as Dilated and Ischemic Cardiomyopathy, Angina, and diseases of Ischemia such as Critical Limb Ischemia. The Company owns 91 patents across five patent families. For more information, please visit www.hemostemix.com.

To learn more about Hemostemix Inc., click here.

Disclaimer: Hemostemix 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].

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 Inc. (TSXV: HEM | OTC: HMTXF) continues to move forward with its FDA Phase II clinical trial program of its blood-derived, stem cell therapeutics product (ACP-01) at sites in the United States and Canada.

ACP-01 is being tested as a treatment for medical conditions such as Critical Limb Ischemia (CLI). CLI is a blockage in the arteries, which reduces blood flow and oxygen in the limbs, and can cause conditions such as severe pain in the feet or toes, wounds that won’t heal, and if left untreated, could result in the amputation of the affected limb.

Although ACP-01 has been used to treat over 500 patients, currently it is part of a Phase II clinical trial of its safety and efficacy in patients with advanced CLI who have exhausted all other options to save their limb from amputation.

Recently, Hemostemix announced an update on the ACP-01 clinical trial as the company believes that all follow-up visits of the enrolled trial subjects should be completed by March 31, 2021.

In the clinical trial, 65 subjects were enrolled and randomly 2/3 of the participants received ACP-01 with the other participants receiving a placebo. Once the last follow-up appointment is completed and trial data has been analyzed, the company will provide an update. We expect this information in late April or early May.

The earlier clinical trials have shown that ACP-01 is safe and effective in the treatment of CLI. The data collected will include treatment success or failure, pain, quality of life, and any adverse effects.

Signs “BREAD” Contract with Canadian Department of Foreign Affairs

In January, Hemostemix also announced it signed the Building Relationships Entrepreneurs & Dealmakers (BREAD) contract with the Department of Foreign Affairs, Trade and Development.

The BREAD agreement is a Canadian government initiative to assist high-potential, biotech-focused Canadian Small and Medium Enterprises and is designed to accelerate the growth of Canadian biotechnology companies.

The Trade Commissioner Service (TCS) department, within the Department of Foreign Affairs, helps Canadian companies grow into international markets by assessing market potential, finding qualified partners, and resolving problems.

Hemostemix is working with the TCS to source qualified partners to license ACP-01 in foreign markets including the United States, Japan, and South Korea,

Hemostemix – a Platform for Stem Cell Therapies

Hemostemix’s stem cell therapy platform uses the patient’s own blood to harvest the stem cells and the treatment helps to restore circulation in damaged tissues.

Advantages with Hemostemix’s process include the use of blood, which is safer and less invasive than other methods, and since you are using the patient’s own blood, there is no immune rejection.

ACP-01 has the potential to treat other conditions such as Angina, Ischemic & Dilated Cardiomyopathy, and Peripheral Artery Disease. Currently, Hemostemix is preparing for Phase 2 trials for the treatment of Angina and is seeking joint-venture partners to fund other Phase 2 trials.

The company is also investigating the use of ACP-01 to treat patients hospitalized with COVID-19 that exhibit low oxygen levels and significant inflammation.

Hemostemix has also developed NCP-01 (Neural Cellular Precursor) from blood with the potential to treat neurological conditions such as Alzheimer’s, Amyotrophic Lateral Sclerosis (“ALS”), Parkinson’s, spinal cord injuries, and stroke-related issues. NCP-01 is currently in the R&D phase and is pre-clinical.

Fully Funded for the Year

In December 2020, Hemostemix raised $2.75 million at $0.30 per unit that comprised of a share and a warrant priced at $1.00 for a period of 12 months. Proceeds from the offering are expected to be used to pay for various corporate expenses and to fund the clinical trial costs.

In addition to the cash on hand, Hemostemix has a strong intellectual property (IP) portfolio of 91 patents.

To generate some cash flow, Hemostemix plans to ramp up the revenue side of the business by reinstating its compassionate care revenue stream in the United States.

Final Thoughts

Stem cell treatments have been used for over 30 years to treat people with cancer conditions such as leukemia and lymphoma and earlier trials of Hemotemix’s ACP-01 have shown positive effects in the treatment of CLI.

Factors that increase the risk of CLI include diabetes, high cholesterol levels, high blood pressure, obesity, or smoking. Unfortunately, most of these factors are increasing at an alarming rate. Treatment for these conditions has a billion-dollar market potential.

Currently, Hemostemix has a market cap of only C$25 million with similar-sized biotech companies focusing on CLI trading much higher.

As a company shifts from FDA Phase II to Phase III clinical trials, we expect the share price and market cap to shift higher to reflect the potential of ACP-01.

With a new management team spearheading Hemostemix Inc. (TSXV: HEM | OTC: HMTXF), the Company started 2021 with its critical clinical study data in hand. Raising over $4 million in 2020 and then in December adding an additional $4 million to the coffers ($2.75 million at a 50% premium), Hemostemix completed a 1-for-20 share consolidation as it charges into the New Year.

Receiving a copy of its entire clinical trial database relating to the clinical trial for Critical Limb Ischaemia (CLI) using its ACP-01 therapy (Angiogenic Cell Precursors) in November 2020 was a key event for Hemostemix’s management team and it garnered real interest from the market.

Hemostemix – Platform for Stem Cell Therapies

Based in Calgary and founded in 2006, Hemostemix is a clinical-stage biotechnology company specializing in blood-derived stem cell therapeutics with its lead product (ACP-01) in Stage 2 clinical trials for the treatment of CLI.

CLI is a disease caused by the narrowing of arteries in the limbs, particularly the legs, hands, and feet, causing chronic pain and soreness. Untreated CLI can sometimes require the amputation of the specific limb.

Stem cell treatments have been used for over 30 years to treat people with cancer conditions such as leukemia and lymphoma.

There are two main types of stem cell transplants: allogeneic and autologous. In an allogeneic stem cell transplant procedure, the patient receives stem cells from a donor. In an autologous stem cell transplant procedure, the patient provides themselves the stem cells for the procedure from various sources, including bone marrow or blood.

Hemostemix’s autologous stem cell therapy platform uses the patient’s own blood to harvest the stem cells and the treatment helps to restore circulation in the damaged tissues.

Hemostemix has a strong intellectual property (IP) portfolio of 91 patents and has treated more than 500 patients with clinical results showing an improvement in 83% of the patients receiving its ACP-01 stem cell therapy.

Advantages with Hemostemix’s process include the use of blood, which is safer and less invasive than extracting bone marrow, and since you are using the patient’s own blood, there is no immune rejection.

The clinical trials have shown that ACP-01 is safe and effective in the treatment of CLI. Now that Hemostemix has received the entire clinical trial database, it has entered into a contract with a new Clinical Research Organization (CRO) to complete the midpoint statistical analyses of the efficacy of ACP-01 and expects to publish the results this quarter.

Hemostemix – Not a 1-Trick Pony Company

ACP-01 has the potential to treat other conditions such as Angina, Ischemic & Dilated Cardiomyopathy, and Peripheral Artery Disease (PAD). Currently, Hemostemix is preparing for Phase 2 trials for the treatment of Angina and is seeking joint-venture partners to fund the other Phase 2 trials.

Hemostemix has also developed NCP-01 (Neural Cellular Precursor) from blood with the potential, through building new neuronal lineage cells in a patient, to treat Alzheimer’s disease, Amyotrophic Lateral Sclerosis (ALS), Parkinson’s disease, spinal cord injuries, and stroke-related issues. NCP-01 is currently in the R&D phase and is pre-clinical.

Market Size

According to the American Heart Association, Cardiovascular disease (CVD) accounted for approximately 1 of every 3 deaths in the United States in 2019.

Factors that increase the risk of CLI include diabetes, high cholesterol levels, high blood pressure, obesity, or smoking, all risk factors also associated with CVD.

Unfortunately, most of these factors are increasing at an alarming rate – a study by the Centers for Disease Control and Prevention (CDC) in the United States, showed the prevalence of diagnosed diabetes has more than doubled from 3.3% in 1995 to 7.40% in 2015, affecting 23.4 million Americans.

According to a market research report released in 2019, the value of just the global CLI treatment market is projected to reach US$5.39 billion by 2025, up from US$3.13 billion in 2018, at an annual growth rate of 8%.

Competitive Landscape and Market Cap Comparisons

Even with Hemostemix’s recent market surge, its market cap is only C$32.5 million. Similar-sized biotech companies focusing on CLI trade much higher.

Cynata Therapeutics Limited (ASX: CYP) is an Australian biotechnology company with a Phase 2 clinical-stage trial for its stem cell therapy for CLI using bone marrow and has a market cap of C$93.6 million.

Pluristem Therapeutics Inc. (NASDAQ: PSTI) is a Phase 3 bio-therapeutics company, based in Israel, that also has an allogeneic cell therapy for the treatment of CLI using the placenta and has a market cap of C$231.9 million.

In November 2020, Bristol-Myers Squibb Company (NYSE: BMY) bought MyoKardia, Inc. for US$13.1 billion. MyoKardia was a clinical-stage biopharmaceutical company that developed therapies for the treatment of cardiovascular diseases and its lead product was a Phase III clinical trial drug used in the treatment of hypertrophic cardiomyopathy (HCM).

As a company shifts from Phase 2 to Phase 3 clinical trials, the market cap often has a step-function shift higher, making it an ideal time to look at Hemostemix.

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