Hemostemix Closes its Funded Manufacturing Services Agreement with CytoImmune, Restarting Production of ACP-01
Hemostemix Inc. (TSXV: HEM) (OTC Pink: HMTXF) has signed a funded Manufacturing Services Agreement with CytoImmune Therapeutics to restart production of ACP-01, a stem cell therapy for cardiovascular diseases. The agreement is funded by issuing 30,140,000 common shares of Hemostemix at $0.05 each to CytoImmune. It covers the production of the first 22 ACP-01 therapies, which Hemostemix will sell for $1,100,000 ($50,000 each).
The companies aim to produce the first ACP-01 therapy by Q1 2025. Hemostemix expects to generate substantial cash flow from treating 480 no-option patients annually. The company is also closing a private placement of up to $2,000,000 from the sale of 40 Million Units at $0.05 each, with proceeds used for sales, marketing, and working capital.
Hemostemix Inc. (TSXV: HEM) (OTC Pink: HMTXF) ha firmato un Contratto di Servizi di Produzione finanziato con CytoImmune Therapeutics per riprendere la produzione di ACP-01, una terapia con cellule staminali per malattie cardiovascolari. L'accordo è finanziato mediante l'emissione di 30.140.000 azioni comuni di Hemostemix a $0,05 ciascuna a favore di CytoImmune. Esso copre la produzione delle prime 22 terapie ACP-01, che Hemostemix venderà per $1.100.000 ($50.000 ciascuna).
Le aziende intendono produrre la prima terapia ACP-01 entro il primo trimestre del 2025. Hemostemix si aspetta di generare un flusso di cassa sostanziale dal trattamento di 480 pazienti senza altre opzioni ogni anno. L'azienda sta anche chiudendo una collocazione privata fino a $2.000.000 dalla vendita di 40 milioni di unità a $0,05 ciascuna, con i proventi utilizzati per vendite, marketing e capitale circolante.
Hemostemix Inc. (TSXV: HEM) (OTC Pink: HMTXF) ha firmado un Acuerdo de Servicios de Fabricación financiado con CytoImmune Therapeutics para reiniciar la producción de ACP-01, una terapia con células madre para enfermedades cardiovasculares. El acuerdo se financia mediante la emisión de 30,140,000 acciones comunes de Hemostemix a $0.05 cada una a CytoImmune. Cubre la producción de las primeras 22 terapias ACP-01, que Hemostemix venderá por $1,100,000 ($50,000 cada una).
Las empresas tienen como objetivo producir la primera terapia ACP-01 para el primer trimestre de 2025. Hemostemix espera generar un flujo de caja sustancial al tratar anualmente a 480 pacientes sin opción. La compañía también está cerrando una colocación privada de hasta $2,000,000 mediante la venta de 40 millones de unidades a $0.05 cada una, cuyos ingresos se utilizarán para ventas, marketing y capital de trabajo.
헤모스테믹스 주식회사 (TSXV: HEM) (OTC Pink: HMTXF)는 심혈관 질환을 위한 줄기 세포 치료제 ACP-01의 생산을 재개하기 위해 사이토이미유네 치료제와 자금 지원 제조 서비스 계약을 체결했습니다. 이 계약은 헤모스테믹스의 보통주 30,140,000주를 각각 $0.05에 사이토이미유네에게 발행하여 자금을 조달합니다. 이 계약은 헤모스테믹스가 각각 $50,000에 판매할 22개의 ACP-01 치료제 생산을 포함합니다.
두 회사는 2025년 1분기까지 첫 번째 ACP-01 치료제를 생산하는 것을 목표로 하고 있습니다. 헤모스테믹스는 매년 480명의 치료 옵션이 없는 환자를 치료하여 상당한 현금 흐름을 생성할 것으로 기대하고 있습니다. 또한, 회사는 40백만 유닛을 각각 $0.05에 판매하여 최대 $2,000,000의 사모 배정을 마무리하고 있으며, 이 수익은 판매, 마케팅 및 운영 자본으로 사용될 예정입니다.
Hemostemix Inc. (TSXV: HEM) (OTC Pink: HMTXF) a signé un Contrat de Services de Fabrication financé avec CytoImmune Therapeutics pour relancer la production de l'ACP-01, une thérapie par cellules souches pour les maladies cardiovasculaires. L'accord est financé par l'émission de 30.140.000 actions ordinaires d'Hemostemix au prix de $0.05 chacune à CytoImmune. Il couvre la production des 22 premières thérapies ACP-01, que Hemostemix vendra pour un total de $1.100.000 ($50.000 chacune).
Les entreprises visent à produire la première thérapie ACP-01 d'ici le premier trimestre 2025. Hemostemix s'attend à générer un flux de trésorerie substantiel grâce au traitement de 480 patients sans option chaque année. L'entreprise clôt également une placement privé de jusqu'à $2.000.000 provenant de la vente de 40 millions d'unités au prix de $0.05 chacune, dont les recettes seront utilisées pour les ventes, le marketing et le fonds de roulement.
Hemostemix Inc. (TSXV: HEM) (OTC Pink: HMTXF) hat eine finanzierte Herstellungsdienstleistungsvereinbarung mit CytoImmune Therapeutics unterzeichnet, um die Produktion von ACP-01, einer Stammzelltherapie für Herz-Kreislauf-Erkrankungen, wieder aufzunehmen. Die Vereinbarung wird durch die Ausgabe von 30.140.000 Stammaktien von Hemostemix zu je $0,05 an CytoImmune finanziert. Sie umfasst die Produktion der ersten 22 ACP-01-Therapien, die Hemostemix für insgesamt $1.100.000 ($50.000 jede) verkaufen wird.
Die Unternehmen streben an, die erste ACP-01-Therapie bis zum ersten Quartal 2025 zu produzieren. Hemostemix erwartet, aus der Behandlung von 480 Patienten ohne Option jährlich einen erheblichen Cashflow zu generieren. Das Unternehmen schließt außerdem eine private Platzierung von bis zu $2.000.000 aus dem Verkauf von 40 Millionen Einheiten zu je $0,05 ab, deren Erlöse für Verkauf, Marketing und Betriebskapital verwendet werden.
- Secured funding for ACP-01 production through share issuance
- Expected revenue of $1,100,000 from initial 22 ACP-01 therapies
- Potential for significant cash flow from treating 480 patients annually
- Partnership with CytoImmune provides access to state-of-the-art manufacturing facility
- Exploring additional collaborations for clinical trials with 50% cash reimbursement in Puerto Rico
- Dilution of existing shareholders due to issuance of 30,140,000 new shares
- First ACP-01 therapy production not expected until Q1 2025
- Additional dilution possible from ongoing private placement of up to $2,000,000
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
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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
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
"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
Sold at
| 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
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
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
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
FAQ
What is the new agreement between Hemostemix (HMTXF) and CytoImmune?
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