Hemostemix Announces Strategic Manufacturing Partnership with CytoImmune Therapeutics and $1,800,000 in Financing Commitments

Rhea-AI Summary

Hemostemix announced a strategic partnership with CytoImmune Therapeutics to re-establish ACP-01 production at CytoImmune's facility in Puerto Rico. The company secured $1,800,000 in financing commitments through a private placement at $0.05 per unit. CytoImmune will subscribe for $1,370,000 worth of these units. The partnership aims to scale production of ACP-01, a treatment for chronic limb-threatening ischemia (CLTI), potentially reaching sales of $2 million per month by 2025. Hemostemix's phase II clinical trial showed promising results, with 83% of patients experiencing ulcer healing and pain cessation. The proceeds of the financing will be used for initial batch processing and working capital.

Positive

• Signed LOI with CytoImmune to produce ACP-01.
• Secured $1,800,000 in financing commitments.
• CytoImmune's $1,370,000 subscription shows strong partner confidence.
• Potential to reach $2 million monthly sales by 2025.
• Phase II clinical trial showed 83% success in ulcer healing and pain cessation.

Negative

• Private placement at $0.05 per unit indicates low current stock value.
• Dilution risk from issuing new shares and warrants.
• Reliance on successful commercialization of ACP-01 for revenue growth.
• Significant competition in the biopharma sector for cell therapies.
• Potential regulatory and production risks in scaling up ACP-01.

Calgary, Alberta--(Newsfile Corp. - June 3, 2024) - Hemostemix Inc. (TSXV: HEM) (OTC Pink: HMTXF) (FSE: 2VF0) is pleased to announce it has signed a Letter of Intent ("LOI") with CytoImmune Therapuetics ("CytoImmune") to re-establish production of ACP-01 ("ACP") in CytoImmune's state-of-the-art clinical cell manufacturing facility. The Company is also pleased to announce that it has received commitments for $1,800,000 of Units in a non-brokered private placement as more fully described below.

CytoImmune

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CytoImmune has approximately 40 employees with hundreds of years of cumulative experience in biologics and cell manufanufacturing along with a 38,000 square foot state-of-the-art cell manufacturing facility in Toa Baja, Puerto Rico. CytoImmune is entering a technology transfer and manufacturing agreement with Hemostemix for the commercial supply of ACP-01. In addition, CytoImmune will subscribe for $1,370,000 of Units of Hemostemix at $0.05 as described below. This commitment underscores CytoImmune's dedication to fostering partnerships that fuel the future of cell therapy and improve patients' lives.

"Our company's industry-leading expertise in cell therapy development and clinical manufacturing will accelerate Hemostemix's success and expand Puerto Rico's legacy as "America's Medicine Cabinet," said Jose Vidal, CEO of CytoImmune Therapeutics, Inc. "Puerto Rico employs nearly 100,000 pharmaceutical executives and manufactures nearly 20% of the United States drug exports. Adding cell and gene therapies is driven by Puerto Rico's initiative to rejuvenate its biopharma sector with new technologies."

Globally, 236 million suffer from Peripheral Arterial Disease. Approximately 10% of these patients degenerate into CLTI. The incidence of CLTI in the U.S.A. is 1.33%, with an annual 10-40% amputation rate, and an annual 15-20% mortality rate. Globally, CLTI has a 60% mortality rate in 5 years. Therefore, saving a limb is saving a life. In Hemostemix's phase II clinical trial of ACP-01, 83% of patients followed for up to 4.5 years by the University of Toronto and University of British Columbia experienced healing of ulcers, cessation of pain, no major amputation, and improved. Unblinded, these 83% were treated with ACP.

"This is a pivotal agreement that re-establishes production of ACP for sale to patients suffering from no-option chronic limb threatening ischemia and heart disease, under physician order," stated Thomas Smeenk, CEO. "It enables Hemostemix to ramp up production with CytoImmune, and with its own staff, to reach sales volumes of up to $2 million per month in 2025," Smeenk said.

Hemostemix has organized with the principal investigators of its phase II trial up to 226 patients/month of CLTI specialist capacity. Globally, this provides individuals who are suffering in significant pain and facing limb amputation a second-opinion-before-amputation. Likewise, Hemostemix has organized with invasive cardiologists who completed 200 regulatory approved ACP heart treatments, capacity to treat 100 heart patients per month.

Non-Brokered Private Placement (the "Offering")

The Company may raise up to $2,000,000, or more if oversubscribed, from the sale of Units. Each Unit at $0.05 shall consist of one common share in the capital of the Company ("Common Share") and one common share purchase warrant ("Warrant"), with each Warrant entitling the holder to acquire one Common Share at a price of $0.12 per Common Share for a period of 24 months from the closing of the Offering, subject to the accelerated expiry provision described below.

If during any 10 consecutive trading days occurring after four months and one day has elapsed following the closing date of the Offering, the weighted average closing sales price of the Common Shares (or the closing bid, if no sales were reported on a trading day) as quoted on the TSX Venture Exchange ("Exchange") is greater than or equal to $0.15 per Common Share, the Company may provide notice in writing to the holders of the Warrants by issuance of a press release that the expiry date of the Warrants will be accelerated to the 30th day after the date on which the Company issues such press release.

As announced on March 7^th, 2024, the Company is continuing to work with Oak Hill Asset Management to raise low-dilution capital and to accelerate its business plan of offering no-option CLTI patients an outpatient procedure to save their limb from amputation under physician order.

Proceeds from the Offering and other funding initiatives, will be used to initiate the processing of initial batches in 2024 and for general working capital purposes.

Certain directors of the Company may participate in the private placement, which would constitute a "related party transaction" within the meaning of Multilateral Instrument 61-101 - Protection of Minority Security Holders in Special Transactions ("MI 61-101") and the policies of the TSXV. The Company is relying upon the exemptions from the formal valuation and minority shareholder approval requirements pursuant to sections 5.5(b) and 5.7(1)(a), respectively, of MI 61-101 on the basis that the Company is not listed on a specified stock exchange and, at the time the Offering was agreed to, neither the fair market value of the subject matter of, nor the fair market value of the consideration for, the transaction insofar as it involves an interested party (within the meaning of MI 61-101) in the Offering, exceeds 25% of the Company's market capitalization calculated in accordance with MI 61-101.

All securities issued under the Private Placement will be subject to a four-month hold period from the closing date under applicable Canadian securities laws, in addition to such other restrictions as may apply.

About CytoImmune Therapeutics

CytoImmune Therapeutics is at the forefront of a novel natural killer cell therapy for lung cancer, currently in phase 1 clinical trials. In addition, we are now offering cell therapy development and clinical manufacturing services to both biotechnology companies and academia. Our state-of-the-art clinical cell manufacturing facility in Toa Baja, Puerto Rico, is custom built to support the development and commercialization of cutting-edge T cell or NK cell therapies. At CytoImmune, we are dedicated to fostering collaborations that drive the future of cell therapy and improve the lives of cancer patients. Discover how our expertise in cell therapy development and clinical manufacturing can accelerate your path to success. For additional information, please visit: Cytoimmune.com.

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 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: financing of the Company and its lead product ACP-01, and the commercialization of ACP-01 via the sale of compassionate treatments under physician order. ‎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.sedarplus.ca. 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.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/211432

FAQ

What is the significance of Hemostemix's partnership with CytoImmune?

The partnership aims to re-establish production of ACP-01, which could significantly impact Hemostemix's revenue and market position.

How much financing did Hemostemix secure?

Hemostemix secured $1,800,000 in financing commitments through a private placement.

What is ACP-01?

ACP-01 is a treatment for chronic limb-threatening ischemia (CLTI) developed by Hemostemix.

How successful was Hemostemix's phase II clinical trial for ACP-01?

The phase II trial showed that 83% of patients experienced ulcer healing and pain cessation.

What is the potential monthly sales target for ACP-01?

Hemostemix aims to reach up to $2 million in monthly sales by 2025.