Mr. Thomas Smeenk reports

HEMOSTEMIX ADDS THE TREATMENT OF REFRACTORY ANGINA TO ITS PHASE 1 BASKET PROTOCOL

Hemostemix Inc. has completed the drafting of its clinical trial protocol titled "Treatment of Refractory Angina with Angiogenic Cell Precursors (ACP-01)."

The second protocol for its basket phase 1 clinical trial advances Hemostemix's regenerative cardiology program toward addressing patients who suffer persistent chest pain despite maximal medical and surgical therapy.

Plain-language summary

Hemostemix will officially apply for ethics approval to begin a new clinical trial testing its ACP-01 stem cell therapy in people with severe chest pain (angina) who no longer respond to standard drugs or surgery. This marks the next step in bringing a new option to patients who live with constant, disabling heart pain.

Significance of the filing

Scientific paragraph

Angina pectoris -- chest pain from insufficient blood supply to the heart -- is a major symptom of ischemic heart disease and affects roughly 5 per cent of adults over 40 in developed countries (Rinaldi, 2025; and Vos, 2020). Refractory angina, defined as angina that persists despite optimal therapy, causes marked reductions in quality of life and functional capacity, frequent emergency visits, and substantial health care costs (Fox, 2020; and Manolis, 2019). Although one-year mortality is only about 4 per cent, many patients live with disabling pain due to limited revascularization options. Current management focuses on symptom relief rather than cure.

Plain-language summary

Angina happens when the heart does not get enough blood. For many people, medicine or bypass surgery helps, but some continue to have severe chest pain every day. These patients often cannot work, exercise or even sleep comfortably. Hemostemix's trial targets this group, offering hope where conventional treatments have failed.

Scientific rationale

Scientific paragraph

ACP-01 cells, derived from a patient's own hematopoietic lineage, are programmed to form endothelial cells that release vascular endothelial growth factor and angiogenin, promoting new blood vessel formation and microcirculatory repair. The cell population is rich in CD34+ progenitors known to drive angiogenesis. ACP-01 expresses the CXCR4 receptor, which enables the cells to home toward CXCL12, a chemokine released by ischemic myocardium. Hemostemix's previous open-label trial in refractory angina and ischemic or dilated cardiomyopathy reported improved left-ventricular ejection fraction, longer six-minute-walk distances, and better New York Heart Association and Canadian Cardiovascular Society functional class (Chaithiraphan, 2009; Arom, 2008; and Schubart, 2023).

Plain-language summary

ACP-01 comes from the patient's own blood. These cells naturally grow into new blood vessel tissue and release healing proteins that improve circulation in the heart. Earlier studies showed patients could walk farther, had increased heart function as measured by the volume of blood ejected with each heart beat and needed fewer emergency treatments after ACP-01 therapy.

Study design and objectives

Scientific paragraph

This phase 1, multicentre, open-label, non-randomized study will enroll 20 to 100 adults aged 40 to 90 years with recurrent or refractory severe angina. ACP-01 will be administered by intracoronary injection in an outpatient cardiac catheterization setting. The study's primary end points are feasibility and safety, including incidence of adverse events. Secondary end points include improvement (decrease) in chest pain frequency, increased six-minute-walk distance, increased quality-of-life and Karnofsky performance scores, reduced need for emergency care, improved LVEF, and enhanced NYHA and CCS functional classifications. Exploratory end points will compare outcomes from one versus two ACP-01 treatments (day 0 and day 90) and analyze serum brain natriuretic peptide levels as predictors of response.

Plain-language summary

The trial will test whether giving ACP-01 cells directly into the heart through the arteries is safe and practical. Up to 100 men and women will take part. Doctors will look for fewer chest pain attacks, better stamina, stronger heart function and improved day-to-day quality of life. Some patients will get a second dose at three months to see if two treatments work better than one dose.

Mechanism of delivery

Scientific paragraph

ACP-01 will be infused through an intracoronary route under fluoroscopic guidance. Direct intracoronary delivery allows cells to localize precisely to ischemic territories while minimizing systemic exposure. Prior Hemostemix experience in ischemic cardiomyopathy and non-ischemic dilated cardiomyopathy demonstrates the procedure's safety and feasibility in outpatient interventional settings with no procedure complications.

Plain-language summary

Doctors will use a thin catheter -- similar to an angioplasty -- to place the patient's own stem cells straight into the heart's arteries. The procedure is done under local anesthesia and takes about an hour, and patients can usually go home the same day.

Safety oversight

Scientific paragraph

All interventions will be conducted by qualified interventional cardiologists with continuous ECG and hemodynamic monitoring. A data safety monitoring board will review all adverse events and procedural data. All prior ACP-01 trials have reported no serious product-related toxicities.

Plain-language summary

The study will be closely supervised by heart specialists and an independent safety board. Every patient's heart rhythm and blood pressure will be monitored during and after the procedure to make sure the treatment is safe.

Executive commentary

"Completing our phase 1 refractory angina protocol builds directly on more than two decades of real-world data showing ACP-01's ability to regrow blood vessels and restore circulation," said Thomas Smeenk, president and chief executive officer of Hemostemix. "For patients living with daily chest pain who have no other options, this trial represents a meaningful step toward a restorative, rather than purely palliative, therapy."

About Hemostemix Inc.

Hemostemix is an autologous stem cell therapy platform company, founded in 2003. A winner of the World Economic Forum technology pioneer award, the company has developed, has patented, is scaling and is selling autologous (patient's own) blood-based stem cell therapy, VesCell (ACP-01). Hemostemix has completed seven clinical studies of 318 subjects and published its results in 11 peer-reviewed publications. ACP-01 is safe, clinically relevant and statistically significant as a treatment for peripheral arterial disease, chronic limb threatening ischemia, non-ischemic dilated cardiomyopathy, ischemic cardiomyopathy, congestive heart failure and angina. Hemostemix completed its phase 2 clinical trial for chronic limb threatening ischemia, and published its results in the Journal of Biomedical Research & Environmental Science. As compared with a five-year mortality rate of 60 per cent in the CLTI patient population, the University of British Columbia and the University of Toronto reported to the 41st meeting of vascular surgeons: 0 per cent mortality, cessation of pain and wound healing in 83 per cent of patients followed for up to 4.5 years as a midpoint result.

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