11:21:59 EDT Sun 16 Jun 2024
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Hemostemix Inc (2)
Symbol HEM
Shares Issued 87,122,334
Close 2024-05-31 C$ 0.04
Market Cap C$ 3,484,893
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Hemostemix to begin production at CytoImmune facility

2024-06-03 13:08 ET - News Release

Mr. Thomas Smeenk reports


Hemostemix Inc. has signed a letter of intent (LOI) with CytoImmune Therapuetics 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.CytoImmuneTo view an enhanced version of this graphic, please visit:https://images.newsfilecorp.com/files/5065/211432_d5eb183b744488cb_002full.jpg

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 7th, 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.

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