- Hemostemix (TSXV:HEM), a stem cell therapy stock, is up substantially after amending its manufacturing services agreement with CytoImmune Therapeutics in the areas of regulatory consulting and engineering services
- The companies see the potential to generate hundreds of millions in revenue per year from Hemostemix’s flagship ACP-01 therapies
- Hemostemix is an autologous stem cell therapy company developing a patented blood-based stem cell therapeutics platform
- Hemostemix stock has added 162.50 per cent year-over-year but remains down by 30 per cent since 2020
Hemostemix (TSXV:HEM), a stem cell therapy stock, is up substantially after amending its manufacturing services agreement with CytoImmune Therapeutics in the areas of regulatory consulting and engineering services.
CytoImmune’s regulatory expert brings ample experience with the U.S. Food and Drug Administration and is advising Hemostemix on protocol development and phase I-III clinical trials.
CytoImmune’s engineering team is developing Hemostemix’s patented Automated Cell Therapy System (ACTS), a robotics-based manufacturing platform designed to produce up to 2,880 of Hemostemix’s ACP-01 therapies annually per 10′ x 10′ clean room.
ACP-01 therapies address conditions including peripheral arterial disease, diabetic foot ulcers, critical limb-threatening ischemia, ischemic and dilated cardiomyopathy, congestive heart failure and vascular dementia.
According to Thursday’s news release, “scaled to 10 production cells operating at 80 per cent efficiency, the system could deliver up to 23,040 ACP-01 therapies annually, each priced at US$37,000.”
Payment structure amendments will allow for ACT 60 reimbursement, with CytoImmune set to invest its proceeds for services into Hemostemix stock at the then market value.
The companies are currently conducting a feasibility study to determine production capacity at CytoImmune’s 38,000-square-foot facility in San Juan, Puerto Rico.
Leadership insights
“CytoImmune is very bullish on Hemostemix’s equity for good reason,” Thomas Smeenk, Hemostemix’s chief executive officer (CEO), said in a statement. “Our automated production system will allow us to produce therapies at scale, transforming access to innovative treatments for cardiovascular diseases.”
“With over 200 years of combined biologics and cell therapy manufacturing experience, our team is equipped to scale Hemostemix’s ACP-01 globally,” added Dr. Jose E. Vidal, CEO of CytoImmune. “This partnership reinforces our commitment to advancing cell therapies and creating meaningful economic impact in Puerto Rico.”
About CytoImmune Therapeutics
CytoImmune is a Puerto-Rico based cell therapy company specializing in process development and clinical manufacturing services.
About Hemostemix
Hemostemix, founded in 2003, is an autologous stem cell therapy company developing a patented blood-based stem cell therapeutics platform. Its therapy pipeline includes angiogenic cell precursors, neuronal cell precursors and cardiomyocyte cell precursors.
Hemostemix stock (TSXV:HEM) is up by 44.83 per cent on the news trading at C$0.21 per share as of 11:10 am ET. The stock has added 162.50 per cent year-over-year but remains down by 30 per cent since 2020.
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(Top photo of CytoImmune Therapeutics’ production facility: CytoImmune Therapeutics)
