Mr. Thomas Smeenk reports

HEMOSTEMIX'S PITCH TO WALL STREET: ACP-01 VASCULAR DEMENTIA TRIAL WILL GENERATE $5,365,000, CAPTURE DATA, AS A PHASE 1 CLINICAL TRIAL

Hemostemix Inc. has pitched the treatment of vascular dementia with ACP-01 to Wall Street.

"The specificity of ACP-01 in promotion of angiogenesis, the molecular up-regulation of brain neurotrophic factors and specific chemokines strongly suggest ACP-01 may be efficacious as a treatment for vascular dementia," stated Dr. Fraser Henderson, neurosurgeon, chief medical officer, Hemostemix.

"Designed as phase 1 clinical trial for up to 100 patients who meet the inclusion criteria, and who will each pay Hemostemix $37,000 (U.S.) for ACP-01 ($3.7-million (U.S.), $5,365,000), we will study ACP-01's impacts using FireFly's BNA's readouts," stated Thomas Smeenk, chief executive officer. "Listen to a patient treated with ACP-01 for vascular dementia 10 years posttreatment. It reversed Mrs. L's dementia. She has gained greater than ten years of life, love and the joy of family from one ACP-01 treatment," Mr. Smeenk said.

The clinical trial of 100 patients will add to Firefly's proprietary database of 77,000 EEG brain scans across 12 disorders. The scans may objectively prove that intrathecal injection of ACP-01 is a safe, efficacious and a clinically relevant treatment for vascular dementia. In January, 2025, Firefly highlighted two impactful studies that demonstrated the utility of its AI-based BNA advanced resting electroencephalograms (EEG) and cognitive EEG (ERP) data analytics. As illustrated by the two studies, Firefly's BNA system uniquely provided objective measures of the efficacy of treatment and cognitive change.

Design of Hemostemix's vascular dementia phase 1 clinical trial of ACP-01

The phase 1 clinical trial will evaluate the safety, tolerability and preliminary efficacy of intrathecal injection of ACP-01 directly into the cerebrospinal fluid of subjects who suffer from vascular dementia.

• Primary end points include incidence of safety and adverse events; feasibility of ACP-01 delivery via intrathecal injection; safe dosage; and tolerability.
• Secondary end points include cognitive functional assessment; global clinical dementia rating; quality of life assessment; and standardized MRI metric analyses of brain volume and blood flow.
• Exploratory endpoints include FireFly's BNA readout pretreatment and at three months, and six months posttreatment.

How Hemostemix plans to use BNA in its phase I vascular dementia clinical trial

1. Firefly's BNA technology will be used pretreatment as an assessment, and posttreatment to record brain activity at resting state and during the performance of visual and auditory cognitive tasks. The wide range of functional brain measures will be compared against Firefly's Food and Drug Administration-cleared age-matched normative database. Each score will be assessed relative to the relevant reference normal range. The analyses will compare the change in different brain measures over time within the treated population, relative to the expected normative change over a range of six months based on Firefly's database.
2. Quality of life and brain function will be measured with the BNA assessment.

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, is scaling and is selling autologous (patient's own) blood-based stem cell therapies that include angiogenic cell precursors (ACP-01), and later neural cell precursors (NCP-01), and cardiomyocyte cell precursors (CCP-01). Hemostemix has treated 498 patients, completed seven clinical studies of 318 subjects and published its results in nine peer-reviewed publications. ACP-01 is safe, clinically relevant and statistically significant treatment for peripheral arterial disease, chronic limb-threatening ischemia, non-ischemic dilated cardiomyopathy, ischemic cardiomyopathy, congestive heart failure and angina. Hemostemix completed its phase II clinical trial for chronic limb-threatening ischemia (CLTI) 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.

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