Calgary, Alberta, February 19, 2025 – Hemostemix Inc. (“Hemostemix” or the “Company”) (TSXV: HEM; OTC: HMTXF) (FSE:2VF0) is pleased to announce a strategic breakthrough that secures its leadership position in the global stem cell market. By securing a perpetual, royalty-free global license for CytoImmune’s bioreactor stem cell technologies, Hemostemix has gained an economic and competitive advantage that enhances its ability to scale ACP-01, protect its autologous stem cell market, and develop a cost-effective strategy for expanding allogeneic stem cells.
Subject to TSXV Exchange approval, Hemostemix will pay CytoImmune $5,000,000 (twenty million shares) for a perpetual, worldwide, royalty-free license.
Strategic Advantages for Hemostemix through Licensing CytoImmune’s BioReactor Technologies
• Lowest manufacturing costs for allogeneic products.
• Strategic fence around autologous stem cell manufacturing.
• Scalability and commercialization of ACP-01 behind the fence.
Lowest Cost of Goods Sold (COGS) in the Industry
One of the most significant advantages of integrating CytoImmune’s BioReactor technologies into Hemostemix’s allogeneic stem cell manufacturing processes is the drastic reduction in the cost of goods sold. Conventional stem cell expansion methods are expensive, labor-intensive, and often rely on inefficient batch processes. Key benefits of the BioReactor technology include:
• Automated cell expansion: Continuous and scalable production reduces manual labor and batch-to-batch variations, ensuring consistent, high-quality stem cell production.
• High yield and efficiency: The BioReactor platform maximizes cell proliferation rates and produces exponentially more therapeutic doses per donor stem cell input.
• Reduced facility and personnel costs: The efficiency of automated BioReactor systems minimizes the need for extensive cleanroom environments and skilled labor, resulting in significant cost reductions.
• Economies of scale: Mass production becomes possible at a fraction of the cost of traditional autologous methods.
Building an Allogeneic Stem Cell Moat Around Hemostemix’s Autologous Market
By leveraging CytoImmune’s bioreactor technologies, Hemostemix secures an allogeneic supply of stem cells that strategically complements the autologous offering. This creates a “stem cell fence” – a protective market barrier that prevents competitors from encroaching on Hemostemix’s territory.
Here’s how:
• Market dominance through vertical integration: With the ability to mass-produce allogeneic stem cells at the lowest COGS, Hemostemix can selectively offer stem cell therapies while ensuring its proprietary ACP-01 remains the gold standard for personalized regenerative medicine.
• Regulatory and competitive barriers: Owning a perpetual, royalty-free global license ensures no external company can levy royalties, limiting competitors’ ability to scale with similar cost-efficiency.
• Dual market penetration: Hemostemix maintains its leadership in autologous treatments while developing allogeneic applications to serve broader patient populations and licensing partners.
Scalability and Commercial Growth Behind the Moat
With its allogeneic stem cell moat in place, Hemostemix is positioned to:
1. Expand clinical trials: Thanks to cost-effective production scalability, Hemostemix can increase the number of indications treated and studied. The company will shortly announce the current status of its clinical trials.
2. Accelerate regulatory approvals: Efficient manufacturing supports larger-scale clinical trials and shortens time-to-market for new applications.
3. Pursue strategic partnerships and licensing: Hemostemix gains leverage to negotiate licensing and supply agreements from a position of strength globally.
4. Increase profitability: Lower COGS leads to higher gross margins and improved financial sustainability.
The CytoImmune Leadership Team
CytoImmune Therapeutics has a team of pioneers in bioreactor construction with extensive experience in applying Computational Fluid Dynamics to optimize reactor applications, ranging from peptides to immune cells and scaling from pilot runs to industrial capacities of up to 20,000 liters. CytoImmune has achieved a significant milestone with the first confirmed stirred tank bioreactor design and process for allogeneic T-cell production. Furthermore, CytoImmune is leading the integration of machine learning into bioreactor control systems to increase the production efficiency of its cells. This combination of expertise in bioreactor technology and AI integration positions CytoImmune as a leader in the biotechnology sector.
Conclusion: A Secure, Scalable Future for Hemostemix
By securing a perpetual, royalty-free global license for CytoImmune’s BioReactor stem cell technologies, Hemostemix has positioned itself as the most cost-effective manufacturer of scalable autologous and allogeneic stem cell therapies. This move ensures a viable, scalable business model that maximizes company value while advancing the promise of regenerative medicine.
“We invite investors to recognize the long-term impact of this milestone as we continue to expand Hemostemix’s leadership position in the global stem cell market,” said Thomas Smeenk, CEO.
ABOUT HEMOSTEMIX
Hemostemix is an autologous stem cell therapy company founded in 2003. The company, recognized with the World Economic Forum Technology Pioneer Award, has developed, patented, and scaled a patient blood-based stem cell therapy platform that includes angiogenic cell precursors, neural cell precursors, and cardiomyocyte cell precursors. For more information, please visit www.hemostemix.com.
For further information please contact: Thomas Smeenk, President, CEO &
EM:tsmeenk@hemostemix.com PH: +1 905-580-4170
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Forward-Looking Information: This press release contains “forward-looking information” within the meaning of applicable Canadian securities laws. All statements herein that are not historical facts are forward-looking information. In particular, this press release contains forward-looking information regarding: the license for CytoImmune’s bioreactor technologies, the sale of ACP-01 as an exempted compassionate treatment, the licensing of ACP-01, the Know Your Health! brand and related outcomes, including the commercialization of ACP-01. There can be no assurance that such forward-looking information will prove to be accurate. Actual results and future events may differ materially from those anticipated in such forward-looking information. This forward-looking information reflects Hemostemix’s current views and is based on information currently available to Hemostemix and on assumptions that 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 litigation pursued or defended by Hemostemix (the “Litigation”); the results of ACP-01 research, studies, and analyses, including that the analysis is equivalent to or better than previous research, studies, or investigations; the receipt of all necessary regulatory approvals for research, studies, or investigations; the activity level, market acceptance, and market trends in the healthcare sector; the economy in general; consumer interest in Hemostemix’s services and products; competition and Hemostemix’s competitive advantages; and the obtaining of satisfactory financing for Hemostemix’s operations, including research, trials, or studies, as well as any litigation. Forward-looking information is subject to known and unknown risks, uncertainties, and other factors that may cause Hemostemix’s actual results, activities, performance, or achievements to differ materially from those expressed or implied by such forward-looking information. Such risks and other factors may include: Hemostemix’s ability to complete clinical trials, conduct satisfactory analysis, and submit the results of these analyses to obtain regulatory approval for a Phase II or Phase III clinical trial of ACP-01; potential litigation to which Hemostemix may be exposed; general business, economic, competitive, political and social uncertainties; general capital market conditions and market prices for securities; delays or failure to obtain board or regulatory approvals; actual results of future operations, including 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 the company intends to compete; lack of qualified professionals or loss of key personnel; and risks related to the COVID-19 pandemic, including various recommendations, orders and measures of governmental authorities trying to contain the pandemic, including travel restrictions, border closures, closure of non-essential businesses, service disruptions, quarantines, self-isolations, shelters-in-place and social distancing, disruptions to markets, economic activity and financings, supply chain interruptions and distribution channels, and a deterioration of general economic conditions including a possible national or global recession or depression; the potential impact of the COVID-19 pandemic on Hemostemix which may result in a reduced demand for the services offered by Hemostemix; and a deterioration of financial markets that could limit Hemostemix’s ability to obtain external financing. A description of additional risk factors that could cause actual results to differ materially from forward-looking information can be found in Hemostemix’s disclosure documents on the SEDAR website at www.sedar.com. 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. The forward-looking information contained in this press release is expressly qualified by this cautionary statement. The forward-looking information contained in this press release represents the expectations of Hemostemix as of the date of this press release and, accordingly, 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.
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