Mr. Thomas Smeenk reports

HEMOSTEMIX AND FIREFLY NEUROSCIENCE'S BRAIN NETWORK ANALYTICS (BNA) ENGAGE TO COMPLETE PHASE 1 VASCULAR DEMENTIA CLINICAL TRIAL OF ACP-01

Hemostemix Inc. has arranged a collaboration with Firefly Neuroscience Inc., an artificial intelligence (AI) company developing innovative solutions that improve brain health outcomes for patients with neurological and mental disorders.

Hemostemix and Firefly will study brain wave activity in up to 100 patients before and after treatment with ACP-01 at baseline, three months and six months after treatment (phase 1).

Hemostemix's phase 1 clinical trial of vascular dementia is in line with Firefly's collaborations with globally recognized companies, such as Bright Minds, Novartis and Takeda. Through the collaboration, Hemostemix will leverage Firefly's proprietary database of 77,000 EEG (electroencephalogram) brain scans across 12 disorders. Hemostemix and Firefly will work together to generate an exploratory end point to objectively prove that intrathecal injection of ACP-01 is a safe, preliminarily efficacious and clinically relevant treatment for vascular dementia.

"Listen to a patient treated with ACP-01 for vascular dementia 10 years posttreatment," stated Thomas Smeenk, chief executive officer of Hemostemix. "Mrs. L lost her daily function abilities and was to be admitted to a long-term care facility. Ten years after ACP-01 treatment, in 12 minutes, she discussed her career path, family-raising time, wonderful second marriage, ability to drive and the benefits of ACP treatment, including no longer suffering from ocular migraines. Then, she scheduled a lunch appointment with the physician who treated her for vascular dementia to celebrate her cognitive health 10 years posttreatment," Mr. Smeenk continued. "With BNA's readouts of ACP's impacts, I predict Hemostemix and Firefly will set the objective standard for the successful diagnoses and treatment of vascular dementia. Families who have a loved one who are suffering from vascular dementia may contact me (tsmeenk@hemostemix.com) to understand the assessment, inclusion and exclusion criteria," Mr. Smeenk said.

"We are proud that BNA continues to be at the forefront of EEG innovation, and we agree with Hemostemix that its study of ACP-01 dose response in subjects suffering from vascular dementia has the potential to exemplify how our proprietary technology may transform complex brain data into actionable insights for clinicians and researchers," said Greg Lipschitz, executive chairman of Firefly. "

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 through intrathecal injection; safe dosage; and tolerability.
• Secondary end points include cognitive functional assessment; global clinical dementia rating; quality-of-life assessment; and standardized MRI (magnetic resonance imaging) metric analyses of brain volume and blood flow.
• Exploratory end points include Firefly's BNA readout pretreatment and at three months and six months after treatment.

In January, 2025, Firefly highlighted two impactful studies that demonstrated the utility of its AI-based BNA advanced resting electroencephalogram (EEG) and cognitive EEG (ERP) data analytics. As illustrated by the two studies, Firefly's enhanced BNA system uniquely provided objective measures of the efficacy of treatment and cognitive change.

How Hemostemix plans to use BNA in its phase 1 vascular dementia clinical trial

Firefly's BNA technology will be used in pretreatment and posttreatment to record brain activity at resting state and during the performance of visual and auditory cognitive tasks. The recorded electrophysiological data are automatically cleaned and analyzed by Firefly's proprietary BNA platform. A wide range of functional brain measures will be compared against Firefly's FDA-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.

Quality of life and brain function will be measured with the Firefly BNA assessment.

"There is limited data on the use of ACP-01 in dementia; however, 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, chief medical officer of Hemostemix.

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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