Hemostemix Files for Ethics Approval of its Study of Vascular Dementia

Rhea-AI Summary

Hemostemix (OTCQB: HMTXF) filed an Institutional Review Board application on October 9, 2025 for a Phase 1 study titled "Treatment of Vascular Cognitive Impairment and Dementia with Angiogenic Cell Precursors (ACP-01)."

The open‑label, multi‑center protocol plans 20–100 adults (ages 50–100), intrathecal autologous ACP-01 delivery with an optional second dose at 3 months, and follow‑up at 3, 6, and 12 months. Primary endpoints are safety and feasibility; secondary endpoints include cognition tests, EEG BNA, and MRI perfusion.

Positive

• IRB application filed on October 9, 2025
• First intrathecal CNS trial of autologous ACP-01
• Protocol sized for 20–100 participants aged 50–100
• Primary endpoints focused on safety and feasibility with 12‑month follow-up

Negative

• Phase 1 open‑label, nonrandomized design limits efficacy evidence
• Maximum cohort 100 may be underpowered for clinical efficacy signals
• Efficacy in central nervous system unproven despite prior peripheral/ cardiac use

Calgary, Alberta--(Newsfile Corp. - October 9, 2025) - Hemostemix (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0) ("Hemostemix" or the "Company") is pleased to announce it has filed its Institutional Review Board (IRB) application for approval of its Phase 1 clinical trial titled "Treatment of Vascular Cognitive Impairment and Dementia with Angiogenic Cell Precursors (ACP-01)." The 102-page submission marks a critical milestone in expanding the therapeutic reach of ACP-01.

Plain-language summary:
Hemostemix has officially applied for ethics approval to begin a new clinical study testing its stem-cell therapy, ACP-01, for people suffering from vascular dementia — a form of memory loss caused by poor blood flow to the brain. This is an important step toward treating a disease for which no current cure exists.

Significance of the Filing

Vascular dementia (VaD) and vascular cognitive impairment (VCID) represent the second most common cause of dementia worldwide, accounting for up to 20% of all cases. With no FDA-approved therapies, VCID remains a major unmet medical need. The IRB submission positions Hemostemix at the forefront of regenerative neuroscience by proposing the first autologous intrathecal stem-cell therapy designed to restore brain perfusion and neurovascular integrity in affected patients.

Plain-language summary:
Vascular dementia is the second-most common cause of dementia after Alzheimer's. It happens when blood flow problems damage brain tissue. No approved drugs exist to stop or reverse it. Hemostemix's new trial aims to repair blood vessels in the brain using the patient's own stem cells injected safely into the spinal fluid to reach the brain directly.

ACP is Safe and Effective

ACP-01, a population of angiogenic cell precursors derived from autologous peripheral blood, has demonstrated strong safety and efficacy in clinical trials for refractory angina, ischemic cardiomyopathy, non ischemic dilated cardiomyopathy and peripheral arterial disease as chronic limb-threatening ischemia. The vascular dementia trial represents the first direct application of ACP-01 to the central nervous system, leveraging its pro-angiogenic, anti-apoptotic, and neurotrophic mechanisms.

Plain-language summary:
ACP-01 is made from a person's own blood. It's been safely used to grow new blood vessels in the heart and legs of patients with blocked arteries. This new study is the first to see if those same cells can improve blood flow and nerve health in the brain.

Key Highlights of the Protocol

Study Title:
Phase 1 Study: Treatment of Vascular Cognitive Impairment and Dementia with Angiogenic Cell Precursors (ACP-01)

Objective:
To evaluate the safety, feasibility, and preliminary efficacy of intrathecal ACP-01 administration in patients diagnosed with vascular cognitive impairment or vascular dementia.

Plain-language summary:
The study will test whether it's safe and practical to give the patient their own stem cells directly into the spinal fluid, and whether this treatment shows early signs of improving memory, thinking ability, and improve their quality of life.

Design:

• Phase 1, multi-center, open-label, non-randomized study

• 20-100 adult participants (ages 50-100)

• Intrathecal (lumbar puncture) administration of autologous ACP-01, with optional second dose at 3 months

• Follow-up at 3, 6, and 12 months post-treatment

Plain-language summary:
The study will include between 20 and 100 people, aged 50 and older. Each will receive an injection of their own stem cells into their spinal fluid. Several will get a second dose three months later, to study the effect of one dose verses two doses. The team will then monitor the patients for one year to track safety and changes in brain function and quality of life improvements following one or two treatments.

Primary Endpoints:

• Demonstrate safety and feasibility of intrathecal delivery

• Establish incidence and tolerability of adverse events

Secondary Endpoints:

• Improvement in cognition, executive function, and quality of life (via MoCA, MCI Screen, SF-36, and Barthel Index)

• Change in EEG-based Brain Network Analytics (BNA®) patterns

• MRI-assessed changes in brain perfusion and volume

Plain-language summary:
The main goal is to confirm that the treatment is safe. The study will also look for any signs of better memory, clearer thinking, improved brain activity on EEG tests, healthier blood flow on MRI scans, and improved quality of life as measured by how patients feel after the treatment, comparing one vs two treatments.

Exploratory Endpoints:

• Biomarker response (IL-6, CRP, neurofilament light chain)

• Correlation of EEG and cognitive test improvement

• Dose-response evaluation between one vs. two ACP-01 treatments

Plain-language summary:
Researchers will also look at blood and spinal-fluid markers that show inflammation or nerve damage, to see which patients respond best — and whether two treatments work better than one.

Scientific Rationale

ACP-01 cells express CXCR4, enabling homing to ischemic brain tissue via the CXCL12 chemokine gradient, and release VEGF, angiogenin, and IL-8 (CXCL8) — potent mediators of angiogenesis and neuroprotection. Of particular interest, IL-8 activates Nuclear Factor-κB (NF-κB), a transcription factor known as the "learning molecule" essential for synaptic plasticity, dendritic formation, and long-term memory consolidation.

By restoring microvascular circulation, stabilizing the blood-brain barrier, and promoting neuronal survival, ACP-01 may address the vascular basis of cognitive decline.

Plain-language summary:
Since the cells, ACP-01, are the patient's own cells, they leverage the body's natural signalling processes to navigate to damaged areas in the brain, release growth factors that help repair blood vessels, and protect nerve cells. They also switch on a key protein in the brain — called NFKB (NF-κB). NFKB helps build and maintain memory. In short, ACP-01 could help the brain heal itself, improve blood flow where the brain signals it needs new circulation most, to improve memory and the ability to learn.

Mechanism of Delivery

Unlike prior intravenous stem-cell trials that suffered from limited brain penetration, Hemostemix's protocol utilizes direct intrathecal delivery — bypassing the blood-brain barrier and exposing cerebrospinal fluid directly to the therapeutic cells.

Plain-language summary:
Instead of giving the cells through a vein (where most stem cells get trapped in the lungs), this method injects them into the spinal fluid, a fluid that surrounds the brain and spinal cord. That way, the cells reach the brain more directly and can start repairing tissue sooner.

Safety Oversight

All procedures are conducted in an outpatient setting under the supervision of licensed neurosurgeons. The protocol includes comprehensive safety monitoring under the oversight of a Data Safety Monitoring Board.

Plain-language summary:
The study will be done by qualified neurosurgeons in a clinical setting. An independent safety board will watch over every patient's experience to ensure the treatment is handled safely and ethically.

Executive Commentary

"Filing our vascular dementia Phase 1 protocol represents a major step forward in applying ACP-01's regenerative power to one of medicine's most intractable conditions," said Thomas Smeenk, President & CEO, Hemostemix. "We have already demonstrated the safety and efficacy of ACP-01 in the heart and limb. This next trial extends our platform to the brain where vascular repair may restore blood flow, memory, and cognition itself. We know ACP-01 worked for Mrs L for 10 years. who was treated for vascular dementia. This study will demonstrate its broad application is warranted," Smeenk said.

ABOUT HEMOSTEMIX
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, patented, is scaling and 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 eleven 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 II clinical trial for chronic limb threatening ischemia and published its results in the Journal of Biomedical Research & Environmental Science. As compared to a five year mortality rate of 60% in the CLTI patient population, UBC and U of T reported to the 41st meeting of vascular surgeons: 0% mortality, cessation of pain, wound healing in 83% of patients followed for up to 4.5 years, as a midpoint result. For more information, please visit www.hemostemix.com.

For further information, please contact: Thomas Smeenk, President, CEO & Co-Founder: EM: tsmeenk@hemostemix.com / PH: 905-580-4170

Neither the TSX Venture Exchange nor its Regulation Service Provider (as that term is defined under the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-Looking Information: This news release contains "forward-looking information" within the meaning of applicable Canadian securities legislation. All statements, other than statements of historical fact, included herein are forward-looking information. In particular, this news release contains forward-looking information in relation to the Lead Order and contemplated Closing of a non brokered private placement, in furtherance of sales in Florida of VesCell™ (ACP-01), and the commercialization of ACP-01 via the sale of compassionate treatments under Florida SB 1768. There can be no assurance that such forward-looking information will prove to be accurate. Actual results and future events could differ materially from those anticipated in such forward-looking information. This forward-looking information reflects Hemostemix's current beliefs and is based on information currently available to Hemostemix and on assumptions Hemostemix believes are reasonable. These assumptions include, but are not limited to: the underlying value of Hemostemix and its Common Shares; the successful resolution of any litigation that Hemostemix is pursuing or defending (the "Litigation"); the results of ACP-01 research, trials, studies and analyses, including the analysis being equivalent to or better than previous research, trials or studies; the receipt of all required regulatory approvals for research, trials or studies; the level of activity, market acceptance and market trends in the healthcare sector; the economy generally; consumer interest in Hemostemix's services and products; competition and Hemostemix's competitive advantages; and, Hemostemix obtaining satisfactory financing to fund Hemostemix's operations including any research, trials or studies, and any Litigation. Forward-looking information is Subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of Hemostemix to be materially different from those expressed or implied by such forward-looking information. Such risks and other factors may include, but are not limited to: the ability of Hemostemix to complete clinical trials, complete a satisfactory analyses and file the results of such analyses to gain regulatory approval of a phase II or phase III clinical trial of ACP-01; potential litigation Hemostemix may face; general business, economic, competitive, political and social uncertainties; general capital market conditions and market prices for securities; delay or failure to receive board or regulatory approvals; the actual results of future operations including the actual results of future research, trials or studies; competition; changes in legislation affecting Hemostemix; the timing and availability of external financing on acceptable terms; long-term capital requirements and future developments in Hemostemix's markets and the markets in which it expects to compete; lack of qualified, skilled labour or loss of key individuals; and risks related to the COVID-19 pandemic including various recommendations, orders and measures of governmental authorities to try to limit the pandemic, including travel restrictions, border closures, non-essential business closures service disruptions, quarantines, self-isolations, shelters-in-place and social distancing, disruptions to markets, disruptions to economic activity and financings, disruptions to supply chains and sales channels, and a deterioration of general economic conditions including a possible national or global recession or depression; the potential impact that the COVID-19 pandemic may have on Hemostemix which may include a decreased demand for the services that Hemostemix offers; and a deterioration of financial markets that could limit Hemostemix's ability to obtain external financing. A description of additional risk factors that may cause actual results to differ materially from forward-looking information can be found in Hemostemix's disclosure documents on the SEDAR website at www.sedarplus.ca. Although Hemostemix has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. Readers are cautioned that the foregoing list of factors is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking information as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Forward-looking information contained in this news release is expressly qualified by this cautionary statement. The forward-looking information contained in this news release represents the expectations of Hemostemix as of the date of this news release and, accordingly, it is Subject to change after such date. However, Hemostemix expressly disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as expressly required by applicable securities law.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/269797

FAQ

What did Hemostemix (HMTXF) file on October 9, 2025?

Hemostemix filed an IRB application for a Phase 1 intrathecal ACP-01 trial in vascular cognitive impairment and dementia.

How many participants will the HMTXF vascular dementia Phase 1 study enroll?

The protocol plans to enroll between 20 and 100 adult participants aged 50–100.

What is the administration method and dosing schedule in the HMTXF ACP-01 trial?

ACP-01 is delivered intrathecally via lumbar puncture with an optional second dose at 3 months and follow-up at 3, 6, and 12 months.

What are the primary endpoints of Hemostemix's HMTXF Phase 1 trial?

Primary endpoints are the safety and feasibility of intrathecal ACP-01 and incidence/tolerability of adverse events.

Which secondary measures will HMTXF assess for efficacy signals?

Secondary endpoints include cognitive tests (MoCA, MCI Screen), EEG BNA patterns, MRI perfusion/volume, and quality‑of‑life scores.

Does Hemostemix claim prior clinical use of ACP-01?

The company states ACP-01 showed safety and efficacy in prior cardiac and peripheral arterial indications, now being applied to the CNS.