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.
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.