Calgary, Alberta--(Newsfile Corp. - February 20, 2025) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0) ("Hemostemix" or the "Company") is delighted to announce a strategic breakthrough that secures its leadership position in the global stem cell market. By securing an arm's length perpetual, royalty-free global license to CytoImmune's Bioreactor stem cell technologies, Hemostemix has established an economic and competitive advantage that enhances its ability to scale ACP-01, protect its autologous stem cell market, and create a cost-effective allogenic stem cell expansion strategy.
Subject to the TSXV Exchange acceptance, Hemostemix will pay CytoImmune $5,000,000 (twenty million shares) for a perpetual, global, royalty free license.
Hemostemix's Strategic Advantages from CytoImmune's Bioreactor Technologies License
Lowest cost of goods sold for allogenic products.
Strategic fence around autologous stem cell production.
Scalability and commercial-ability of ACP-01 behind the fence.
Lowest Cost of Goods Sold (COGS) in the Industry
One of the most significant benefits of integrating CytoImmune's Bioreactor technologies into Hemostemix's allogenic stem cell manufacturing processes is the dramatic reduction in the cost of goods sold. Traditional stem cell expansion methods are expensive, labor-intensive, and often reliant on inefficient batch-of-one processing. The key advantages of bioreactor technology include:
Automated Cell Expansion: Continuous and scalable production reduces manual labor and batch-to-batch variability, ensuring consistent, high-quality stem cell output.
High Yield & Efficiency: The bioreactor platform maximizes cell proliferation rates, producing exponentially more therapeutic doses per donor-derived stem cell input.
Reduced Facility and Labor Costs: The efficiency of automated bioreactor systems minimizes the need for extensive cleanroom environments and skilled labor, leading to significant cost reductions.
Economies of Scale: Mass production becomes feasible at a fraction of the cost of traditional autologous methods.
Building an Allogenic Stem Cell Fence Around Hemostemix's Autologous Market
By leveraging CytoImmune's Bioreactor technologies, Hemostemix secures an allogenic supply of stem cells that strategically complements its 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 Domination Through Vertical Integration: With the ability to mass-produce allogenic stem cells at the lowest COGS, Hemostemix can selectively supply 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 entity can impose licensing fees, limiting competitors' ability to scale at similar cost efficiencies.
Dual Market Penetration: Hemostemix retains leadership in autologous treatments while developing allogenic applications to serve broader patient populations and licensing partners.
Scalability and Commercial Growth Behind the Fence
With its allogenic stem cell fence in place, Hemostemix is poised to:
Expand its Clinical Trials: With low-cost production scalability, Hemostemix can increase the number of indications treated and studied. The Company will announce shortly its clinical trials update.
Accelerate Regulatory Approvals: Efficient manufacturing supports larger-scale clinical trials, while reducing time-to-market for new applications.
Pursue Strategic Partnerships & Licensing: Hemostemix gains leverage to negotiate licensing and supply agreements from a position of strength, globally.
Increase Profitability: Lower COGS translates into higher gross margins and improved financial sustainability.
CytoImmune's Leadership
CytoImmune Therapeutics boasts a team of pioneers in bioreactor design, with extensive experience in applying computational fluid dynamics for optimizing reactor applications ranging from peptides to immune cells, scaling from pilot runs to industrial capacities of up to 20,000 liters. CytoImmune achieved a significant milestone with the first confirmed stirred tank bioreactor design and process for allogeneic T cell production. Additionally, CytoImmune is at the forefront of integrating AI's deep machine learning into bioreactor control systems, enhancing production efficiency for its cells. This combination of expertise in bioreactor technology and AI integration positions CytoImmune as a leader in the biotechnology sector.
Conclusion: A Defensible, Scalable Future for Hemostemix
By securing a perpetual, royalty-free global license to CytoImmune's bioreactor stem cell technologies, Hemostemix has positioned itself as the lowest-cost producer of scalable autologous and allogenic stem cell therapies. This move ensures a defensible, scalable business model that maximizes shareholder 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 in the global stem cell market," said Thomas Smeenk, CEO.
ABOUT HEMOSTEMIX
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, and is scaling a patient's blood-based stem cell therapeutics platform that includes angiogenic cell precursors, neuronal cell precursor and cardiomyocyte cell precursors. 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 license of CytoImmune's bioreactor technologies, the sales of ACP-01 as an exempt compassionate treatment, the licensing of ACP-01, the Trademark Know Your Health! and related results, 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 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 the 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 Hemostemis mayface; 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.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. 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.
