Calgary, Alberta--(Newsfile Corp. - January 9, 2025) - Hemostemix Inc. (TSXV: HEM) (OTC: HMTXF) (FSE: 2VF0) is pleased to announce amendments to its Manufacturing Services Agreement with CytoImmune Therapeutics ("CytoImmune"). These amendments add Regulatory Consulting and Engineering Services and align payments made by Hemostemix PR Inc. with the policies of both the TSX Venture Exchange and Puerto Rico's ACT 60 Program.
Driving Regulatory and Engineering Innovation
CytoImmune's regulatory expert has worked as a reviewer within the Office of Blood Research & Review at the FDA for nearly seven years, followed by leading multiple successful meetings with the FDA for Phase I, II, and III cell therapy products, representing the industry. He is advising Hemostemix on its regulatory strategy, protocol development, and Phase I-III clinical trials.
Additionally, CytoImmune's engineering team is advancing Hemostemix's patented Automated Cell Therapy System (ACTS). This robotics-based manufacturing platform is designed to produce up to 2,880 ACP-01 therapies annually per 10' x 10' clean room. Scaled to 10 production cells operating at 80% efficiency, the system could deliver up to 23,040 ACP-01 therapies annually, each priced at USD $37,000.
Hemostemix and CytoImmune are conducting a feasibility study to determine the maximum production capacity of CytoImmune's 38,000-square-foot facility on two floors, located in San Juan, Puerto Rico.
Optimized Payment Structure
As part of the amended agreement:
Payments to CytoImmune will be made in cash by Hemostemix PR Inc. to qualify for ACT 60 reimbursement.
These payments will be made in arrears and comply with TSX Venture Exchange policies.
CytoImmune will reinvest these proceeds into Hemostemix's equity at the then-market value.
"CytoImmune is very bullish on Hemostemix's equity for good reason," stated Thomas Smeenk, CEO of Hemostemix. "Our automated production system will allow us to produce therapies at scale, transforming access to innovative treatments for cardiovascular diseases."
Dr. Jose E. Vidal, CEO of CytoImmune, added, "With over 200 years of combined biologics and cell therapy manufacturing experience, our team is equipped to scale Hemostemix's ACP-01 globally. This partnership reinforces our commitment to advancing cell therapies and creating meaningful economic impact in Puerto Rico."
Each therapy not only alleviates pain but also significantly reduces healthcare costs associated with prolonged hospitalizations and complications.
About CytoImmune Therapeutics
CytoImmune is a leader in cell therapy innovation, offering process development and clinical manufacturing services. The company's Puerto Rico-based facility supports cutting-edge cell therapies while fostering collaborations with biotechnology companies and academic institutions.
About Hemostemix
Founded in 2003, Hemostemix is an award-winning autologous stem cell therapy company with a patented blood-based stem cell therapeutics platform. The Company is focused on scaling therapies that include angiogenic cell precursors, neuronal cell precursors, and cardiomyocyte cell precursors.
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 sales of its lead product ACP-01, the commercialization of ACP-01 via the sale of compassionate treatments under Special Access Program. 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 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.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.
