Calgary, Alberta--(Newsfile Corp. - August 1, 2024) - Hemostemix Inc. (TSXV: HEM) (OTC Pink: HMTXF) (FSE: 2VF0) is pleased to announce it and CytoImmune Therapuetics ("CytoImmune") today signed a binding and funded definitive Manufacturing Services Agreement that re-establishes production of ACP-01 ("ACP") in CytoImmune's state-of-the-art clinical cell manufacturing facility in Toa Baja, Puerto Rico.
CytoImmune Therapeutics, Toa Baja, Puerto Rico
To view an enhanced version of this graphic, please visit:
https://images.newsfilecorp.com/files/5065/218540_1be360ece42ada77_003full.jpg
Hemostemix and CytoImmune have successfully completed the initial setup of the manufacturing facility and are on track to produce the first ACP-01 therapy by Q1 2025. A renewable two year agreement, the contract is fully funded by the issuance to CytoImmune of 30,140,000 x $0.05 Common Shares of Hemostemix Inc. Additionally, the agreement funds the production of the first 22 ACP-01 commercial therapies, which Hemostemix will sell for $1,100,000 ($50,000 each).
ACP-01 is a safe and effective stem cell solution for patients suffering from cardiovascular disease who have no other treatment options. It regenerates circulation where the body signals that need, improving heart function by 27%, as supported by clinical data.
"We are very pleased to partner with CytoImmune, to re-establish production, to help no-option patients while generating significant net cash flow for our shareholders," stated Thomas Smeenk, CEO. "At the initial sales levels, Hemostemix becomes self-funding with respect to future development of our autologous platform technologies," Smeenk stated.
"We are thrilled to be delivering on our promise to Puerto Rico and advancing the production of ACP-01. This partnership with Hemostemix marks a significant milestone for CytoImmune as we expand our cell therapy capabilities. By leveraging our state-of-the-art facility and expert team, we aim to provide life-changing treatments to patients with cardiovascular diseases and other severe conditions. Our commitment to innovation and patient care drives us to continually improve our processes and explore new opportunities for growth," stated CytoImmune's CEO Jose E. Vidal, PhD.
Looking ahead, the companies are exploring additional collaborations for phase 1 clinical trials in Puerto Rico that qualify for 50% cash reimbursement of trial expenses under PR's Technology and Inovation incentives, followed by phase II trials in North America and Europe.
Sold at $50,000 per therapy under special access programs, Hemostemix expects to be generating substantial and growing positive net cash flow from the treatment of 480 no option patients per year who are suffering from the following cardiovascular diseases (Table 1):
| Medical Indication | Global Patients (Millions) | Clinical Trial Completed | Results |
| Angina | 110 | Phase 1 | Safe & Statistically Efficacious |
| Chronic Limb Threatening Ischemia | 23 | Phase 2 | Safe & Statistically Efficacious in the healing of wounds, for patients who started the trial with ulcers |
| Peripheral Arterial Disease | 236 | Phase 1 + Randomized Phase 1 | Safe & Statistically Efficacious |
| Ischemic Cardiomyopathy | 372 | Two Phase 1s + 1 Retrospective Study | Safe & Statistically Efficacious |
| Dilated Cardiomyopathy | Orphan Disease | Phase 1 and 1 Retrospective Study | Safe & Statistically Efficacious |
| Long COVID Myocarditis | 1 in 7 Cases | ACT 60 | TBD |
| Congestive Heart Failure | 64 | Treated as co-morbidity in Phase 1 | Safe & Statistically Efficacious |
| Small Vessel Vascular Dementia | 16.5 | 1 Compassionate Treatment | Safe & Statistically Efficacious for 10 Years |
| Longevity Study (Fountain of Youth) | ACT 60 | TBD |
Non-Brokered Private Placement (the "Offering")
As announced on June 3, 2024, the Company will close the first tranche of its private placement of up to $2,000,000 from the sale of 40 Million 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.
Proceeds from the Offering will be used for sales and marketing expenses, 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 full pre-clinical studies, process 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 multiple modalities cell therapies. At CytoImmune, we are dedicated to fostering collaborations that drive the future of cell therapy and improve the lives of patients in multiple indications. 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 therapy 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: the definitive manufacturing services agreement, the financing of the Company and its lead product ACP-01, 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/218540
SOURCE: Hemostemix Inc.
