Hemostemix Forms Manufacturing Partnership with CytoImmune and Secures $1.8M Funding

Hemostemix Inc., a Calgary-based company, has announced a significant partnership and funding development. The company has signed a Letter of Intent (LOI) with CytoImmune Therapeutics to restart the production of ACP-01 (ACP) at CytoImmune’s advanced cell manufacturing facility. Additionally, Hemostemix has secured commitments for $1,800,000 in a non-brokered private placement.

CytoImmune Therapeutics, located in Toa Baja, Puerto Rico, boasts a 38,000-square-foot state-of-the-art cell manufacturing facility staffed by approximately 40 employees with extensive experience in biologics and cell manufacturing. The agreement establishes a technology transfer and manufacturing partnership for ACP-01’s commercial supply. CytoImmune has also committed to purchasing $1,370,000 worth of Hemostemix's Units at $0.05 each. This partnership emphasizes CytoImmune's commitment to advancing cell therapy and enhancing patient care.

Jose Vidal, CEO of CytoImmune Therapeutics, highlighted the potential impact of this collaboration. He noted that Puerto Rico employs nearly 100,000 pharmaceutical professionals and is responsible for almost 20% of U.S. drug exports. The inclusion of cell and gene therapies is part of Puerto Rico’s strategy to revitalize its biopharma sector with innovative technologies.

Globally, Peripheral Arterial Disease affects 236 million individuals, with about 10% progressing to Chronic Limb-Threatening Ischemia (CLTI). In the United States, CLTI has an incidence rate of 1.33%, with annual amputation rates ranging from 10% to 40% and annual mortality rates between 15% and 20%. The global five-year mortality rate for CLTI stands at 60%. Hemostemix’s phase II clinical trial demonstrated that 83% of patients treated with ACP-01 experienced ulcer healing, pain cessation, no major amputations, and overall improvement, emphasizing the treatment's potential to save lives and limbs.

Thomas Smeenk, CEO of Hemostemix, described the agreement as pivotal, enabling the company to ramp up ACP production to meet patient needs for conditions like no-option CLTI and heart disease. The collaboration with CytoImmune is expected to support sales volumes reaching up to $2 million per month in 2025.

Hemostemix has arranged with key investigators from its phase II trial to handle up to 226 CLTI patients per month. This provides patients worldwide facing severe pain and potential limb amputation a crucial second opinion before amputation. Additionally, Hemostemix has coordinated with invasive cardiologists to treat 100 heart patients per month, leveraging their experience from 200 regulatory-approved ACP heart treatments.

In terms of funding, Hemostemix aims to raise up to $2,000,000, with potential for oversubscription, through the sale of Units at $0.05 each. Each Unit includes one common share and one common share purchase warrant, allowing holders to purchase an additional share at $0.12 within 24 months, subject to an accelerated expiry condition. Should the common shares' trading price exceed $0.15 for ten consecutive trading days after a specified period, the company may accelerate warrant expiry.

The funds raised will be used to initiate the processing of initial batches in 2024 and for general working capital purposes. Certain company directors may participate in this private placement, constituting a "related party transaction" under relevant regulations, although exemptions apply.

CytoImmune Therapeutics is at the forefront of developing natural killer cell therapies for lung cancer, currently in phase 1 clinical trials. They offer cell therapy development and clinical manufacturing services from their facility in Puerto Rico, supporting the advancement of cutting-edge T cell and NK cell therapies.

Hemostemix, founded in 2003, specializes in autologous stem cell therapy. The company has developed a platform of blood-based stem cell therapeutics, including angiogenic, neuronal, and cardiomyocyte cell precursors, and continues to scale its innovative therapies.