Mr. Thomas Smeenk reports

HEMOSTEMIX' LONGEVITY PHASE I CLINICAL TRIAL LEVERAGING VESCELL'S EXCELLENT RESULTS

Hemostemix Inc.'s VesCell phase 1 longevity clinical trial protocol has been drafted.

The longevity protocol represents an important milestone in Hemostemix's strategy to expand the clinical application of VesCell beyond the treatment of cardiovascular diseases, toward improving healthspan -- the number of years people enjoy health, pain-free, remaining active, strong, independent, mentally sharp and cognitively competent.

The commercial phase 1 clinical trial is designed to study and leverage how VesCell improves multiple measures of healthspan, including patient-reported quality of life, muscle mass (cardiac performance), improved cognition, immune system health, physical performance and functional independence.

Hemostemix' excellent phase 1 quality-of-life survey results

In Hemostemix's ischemic phase 1 cardiomyopathy study, 30 patients with paired SF-36 assessments at three and six months showed increases across all eight quality-of-life domains, with statistically significant improvements:

• 58-per-cent improvement in physical functioning from 37.83 to 60.09 -- an increase of 22.26 points, p equals less than 0.001;
• 92-per-cent improvement in role limitations due to physical health from 31.89 to 61.21 -- up 29.32, p equals less than 0.001;
• 56-per-cent improvement in general health from 34.79 to 54.57 -- up 19.78 points, p equals less than 0.001;
• 48.6-per-cent improvement in vitality from 39.58 to 58.82 -- up 19.24 points, p equals 0.001;
• 24-per-cent improvement in social functioning from 60.83 to 75.42 -- up 14.59 points, p equals 0.014;
• 30.8-per-cent improvement in the physical component summary from 30.75 to 40.21, up 9.46 points, p equals less than 0.001.

SF-36 survey and P values explained

The SF-36 is a validated questionnaire that measures changes in quality of life based on physical health, pain, energy, emotional well-being and ability to perform everyday activities. A result of p equals less than 0.05 means there is a fewer than 5-per-cent probability that the observed difference arose from random variation alone, the conventional threshold for statistical significance. In Hemostemix's clinical trials, findings fewer than p equals less than 0.05 provide increasingly strong evidence that the improvements were not due to chance.

Thomas Smeenk, chief executive officer, said: "Given our results exactly mirror the requirements to win a nine-figure longevity competition, a commercial VesCell-based longevity clinical trial in healthy adults makes sense. Why wait for disease-related degeneration when VesCell is designed to restore circulation, cognition, increase exercise capacity, and improve the immune system by reducing inflammation?"

The longevity trial is designed to generate clinical evidence that support participation in healthspan competitions, some which offer up to $101-million (U.S.) in prize funding to accelerate innovations that improve healthy human aging. One such competition measures longevity as increases in muscle capacity (six-minute walk test), cognition and immune system function, which Hemostemix's results mirror.

Improved six-minute walk test as a result of increased heart function

The six-minute walk test measures the increased (decreased) distance a person can walk on a flat surface in six minutes before and after treatment. In the phase 1 angina trial, mean six-minute walk distance increased 81.3 metres posttreatment at three months, p equals less than 0.001; and remains as an increase of 79.6 metres six months posttreatment from baseline, p equals less than 0.001 (Tresukosol et al., 2006). In the same study, the proportion of heart that was suffering from inadequate blood circulation improved 45.3 per cent, and myocardial perfusion defects decreased 37.9 per cent at three months, p equals less than 0.004, and decreased by 45.3 per cent at six months from baseline, p equals less than 0.005 (Tresukosol et al., 2006). Improved cardiac function is consistent with an 80-metre improvement in the six-minute walk test.

Increased volume of blood ejected with each heart beat

Among patients with the most severe cardiomyopathy baseline, LVEF below 20 per cent (less than one-third normal) means LVEF increased approximately 94.5 per cent relative increase from 14.6 per cent plus or minus 3.4 per cent before treatment to 28.4 per cent plus or minus 8.0 per cent at final follow-up. Reversal of heart disease was recorded as the movement of patients into higher LVEF per cent categories (better functionality) which was statistically significant at final follow-up, p equals less than 0.004 (Schubart et al., 2023).

Reversal of heart failure as measured by New York Heart Association classification

The NYHA classification grades heart failure from Class 1, where normal activity causes no symptoms to Class 4 (end stage), where shortness of breathe and chest symptoms occur even at rest. In Hemostemix phase 1, NYHA classification decreased from Class 3/4 to Class 2/3 at 180 days, p equals less than 0.05. "These improvements reflect substantially better daily function and fewer heart failure symptoms" (Arom et al., 2008).

Saving a limb is saving a life

As compared with a five-year mortality rate of 50 per cent in the CLTI diabetes-based 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 in Hemostemix's phase 2 trial.

Next steps

The protocol is undergoing scientific review by investigators in regenerative medicine, cardiology, neurology, longevity medicine and biostatistics before submission under the Bahamas Longevity and Regenerative Therapies Act for all required institutional, ethics, hospital and regulatory acknowledgments and approvals.

The company will provide additional announcements as the program advances, including:

• Appointment of the principal investigator;
• Completion of scientific review;
• Submission under the LARTA framework;
• Ethics, institutional and regulatory acknowledgments and approvals;
• Clinical site activation;
• Enrolments and sales of longevity therapy convertible debentures;
• Interim clinical and biomarker results.

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 an investigational autologous stem cell therapy developed to support circulation in areas affected by diseases of ischemia. VesCell is derived from a patient's own blood and evaluated through structured clinical research. Hemostemix has completed seven clinical studies of 318 subjects and published its results in 11 peer-reviewed publications. ACP-01 is safe and appears clinically relevant 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 and Environmental Science. As compared with a five-year mortality rate of 50 per cent in the CLTI diabetes-based patient population, UBC and U of T 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.

We seek Safe Harbor.