Hemostemix and CytoImmune Amend Manufacturing Agreement to Accelerate Global Scale-Up
Hemostemix (HMTXF) has amended its Manufacturing Services Agreement with CytoImmune Therapeutics, adding Regulatory Consulting and Engineering Services. The agreement aligns with TSX Venture Exchange policies and Puerto Rico's ACT 60 Program. CytoImmune's regulatory expert, with FDA experience, will advise on regulatory strategy and clinical trials.
The partnership focuses on advancing Hemostemix's Automated Cell Therapy System (ACTS), capable of producing up to 2,880 ACP-01 therapies annually per clean room. At 80% efficiency with 10 production cells, the system could deliver 23,040 therapies yearly, priced at USD $37,000 each. The companies are studying production capacity at CytoImmune's 38,000-square-foot facility in San Juan.
Under the revised agreement, Hemostemix PR Inc. will make cash payments to CytoImmune, which will reinvest in Hemostemix's equity at market value. ACP-01 therapies target conditions including Peripheral Arterial Disease, Diabetic Foot Ulcers, and Critical Limb-Threatening Ischemia.
Hemostemix (HMTXF) ha modificato il suo Accordo di Servizi di Produzione con CytoImmune Therapeutics, aggiungendo Servizi di Consulenza Regolatoria e Ingegneria. L'accordo è in linea con le politiche della TSX Venture Exchange e il Programma ACT 60 di Porto Rico. L'esperto regolatorio di CytoImmune, con esperienza FDA, fornirà consulenza sulla strategia regolatoria e sugli studi clinici.
La partnership si concentra sull'avanzamento del Sistema di Terapia Cellulare Automatica (ACTS) di Hemostemix, capace di produrre fino a 2.880 terapie ACP-01 all'anno per sala sterile. Con un'efficienza dell'80% e 10 celle di produzione, il sistema potrebbe fornire 23.040 terapie all'anno, con un costo di 37.000 USD ciascuna. Le aziende stanno studiando la capacità produttiva presso la struttura di 38.000 piedi quadrati di CytoImmune a San Juan.
In base all'accordo rivisto, Hemostemix PR Inc. effettuerà pagamenti in contante a CytoImmune, che reinvestirà nel capitale di Hemostemix al valore di mercato. Le terapie ACP-01 mirano a condizioni come la Malattia Arteriale Periferica, le Ulcere Podologiche Diabetiche e l'Ischemia Critica degli Arti.
Hemostemix (HMTXF) ha modificado su Acuerdo de Servicios de Fabricación con CytoImmune Therapeutics, añadiendo Servicios de Consultoría Regulatoria e Ingeniería. El acuerdo está alineado con las políticas de la TSX Venture Exchange y el Programa ACT 60 de Puerto Rico. El experto regulatorio de CytoImmune, con experiencia en la FDA, asesorará sobre estrategia regulatoria y ensayos clínicos.
La asociación se centra en avanzar el Sistema de Terapia Celular Automatizada (ACTS) de Hemostemix, capaz de producir hasta 2,880 terapias ACP-01 anualmente por sala limpia. Con un 80% de eficiencia y 10 celdas de producción, el sistema podría ofrecer 23,040 terapias al año, a un precio de 37,000 USD cada una. Las empresas están estudiando la capacidad de producción en la instalación de 38,000 pies cuadrados de CytoImmune en San Juan.
Según el acuerdo modificado, Hemostemix PR Inc. realizará pagos en efectivo a CytoImmune, que reinvertirá en el capital de Hemostemix al valor de mercado. Las terapias ACP-01 se dirigen a condiciones como la Enfermedad Arterial Periférica, Úlceras del Pie Diabético e Isquemia Crítica de Extremidades.
Hemostemix (HMTXF)는 CytoImmune Therapeutics와의 제조 서비스 계약을 수정하여 규제 컨설팅 및 엔지니어링 서비스를 추가했습니다. 이 계약은 TSX 벤처 거래소 정책 및 푸에르토리코의 ACT 60 프로그램에 부합합니다. CytoImmune의 규제 전문가는 FDA 경험을 바탕으로 규제 전략 및 임상 시험에 대해 조언할 것입니다.
이번 파트너십은 Hemostemix의 자동화된 세포 치료 시스템 (ACTS)의 발전에 초점을 맞추고 있으며, 이 시스템은 클린룸당 연간 최대 2,880개의 ACP-01 치료제를 생산할 수 있습니다. 10개의 생산 셀에서 80%의 효율성을 보인다면, 이 시스템은 연간 23,040개의 치료제를 제공할 수 있으며, 각각의 가격은 37,000 USD입니다. 두 회사는 산후안에 위치한 CytoImmune의 38,000 제곱피트 시설에서 생산 용량을 조사하고 있습니다.
개정된 계약에 따라 Hemostemix PR Inc.는 CytoImmune에 현금 지급을 하며, CytoImmune는 이를 Hemostemix의 지분에 시장 가로 재투자할 것입니다. ACP-01 치료제는 말초동맥질환, 당뇨병 발 궤양, 중대한 사지 위협 허혈 등과 같은 질환을 대상으로 하고 있습니다.
Hemostemix (HMTXF) a modifié son Accord de Services de Fabrication avec CytoImmune Therapeutics, en ajoutant des Services de Conseil Réglementaire et d'Ingénierie. L'accord est conforme aux politiques de la TSX Venture Exchange et au Programme ACT 60 de Porto Rico. L'expert réglementaire de CytoImmune, ayant une expérience à la FDA, conseillera sur la stratégie réglementaire et les essais cliniques.
Le partenariat se concentre sur l'avancement du Système de Thérapie Cellulaire Automatisé (ACTS) de Hemostemix, capable de produire jusqu'à 2.880 thérapies ACP-01 annuellement par salle propre. Avec une efficacité de 80 % et 10 cellules de production, le système pourrait fournir 23.040 thérapies par an, au prix de 37.000 USD chacune. Les entreprises étudient la capacité de production dans l'installation de 38.000 pieds carrés de CytoImmune à San Juan.
Dans le cadre de l'accord révisé, Hemostemix PR Inc. effectuera des paiements en espèces à CytoImmune, qui réinvestira dans le capital de Hemostemix à la valeur de marché. Les thérapies ACP-01 visent des conditions telles que la Maladie Artérielle Périphérique, les Ulcères du Pied Diabétique et l'Ischémie Critique des Membres.
Hemostemix (HMTXF) hat seinen Herstellungsdienstleistungsvertrag mit CytoImmune Therapeutics geändert und Beratungs- und Ingenieurdienstleistungen hinzugefügt. Der Vertrag steht im Einklang mit den Richtlinien der TSX Venture Exchange und dem ACT 60-Programm von Puerto Rico. Der regulatorische Experte von CytoImmune, der über FDA-Erfahrung verfügt, wird Ratschläge zur regulatorischen Strategie und zu klinischen Studien geben.
Die Partnerschaft konzentriert sich auf den Fortschritt des Automatisierten Zelltherapiesystems (ACTS) von Hemostemix, das in der Lage ist, jährlich bis zu 2.880 ACP-01-Therapien pro Reinraum zu produzieren. Bei 80 % Effizienz mit 10 Produktionszellen könnte das System jährlich 23.040 Therapien liefern, die jeweils 37.000 USD kosten. Die Unternehmen untersuchen die Produktionskapazität in der 38.000 Quadratfuß großen Einrichtung von CytoImmune in San Juan.
Im Rahmen des geänderten Vertrages wird Hemostemix PR Inc. Barzahlungen an CytoImmune leisten, die in das Eigenkapital von Hemostemix zum Marktwert reinvestiert. ACP-01-Therapien richten sich an Erkrankungen wie die periphere arteriellen Erkrankung, diabetische Fußgeschwüre und kritisch limbengeschädigte Ischämie.
- Potential annual production capacity of 23,040 ACP-01 therapies at USD $37,000 each
- Strategic partnership with experienced FDA regulatory expert
- Access to 38,000-square-foot manufacturing facility in Puerto Rico
- Automated production system enabling scalable manufacturing
- Qualification for ACT 60 reimbursement in Puerto Rico
- Production capacity estimates based on 80% efficiency, actual results may vary
- Significant capital investment required for full-scale production
- Market pricing of USD $37,000 per therapy may limit market accessibility
Calgary, Alberta--(Newsfile Corp. - January 9, 2025) - Hemostemix Inc. (TSXV: HEM) (OTC: HMTXF) (FSE: 2VF0) is pleased to announce amendments to its Manufacturing Services Agreement with CytoImmune Therapeutics ("CytoImmune"). These amendments add Regulatory Consulting and Engineering Services and align payments made by Hemostemix PR Inc. with the policies of both the TSX Venture Exchange and Puerto Rico's ACT 60 Program.
Driving Regulatory and Engineering Innovation
CytoImmune's regulatory expert has worked as a reviewer within the Office of Blood Research & Review at the FDA for nearly seven years, followed by leading multiple successful meetings with the FDA for Phase I, II, and III cell therapy products, representing the industry. He is advising Hemostemix on its regulatory strategy, protocol development, and Phase I-III clinical trials.
Additionally, CytoImmune's engineering team is advancing Hemostemix's patented Automated Cell Therapy System (ACTS). This robotics-based manufacturing platform is designed to produce up to 2,880 ACP-01 therapies annually per 10' x 10' clean room. Scaled to 10 production cells operating at
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Maximizing Production Capacity in Puerto Rico
Hemostemix and CytoImmune are conducting a feasibility study to determine the maximum production capacity of CytoImmune's 38,000-square-foot facility on two floors, located in San Juan, Puerto Rico.
Optimized Payment Structure
As part of the amended agreement:
Payments to CytoImmune will be made in cash by Hemostemix PR Inc. to qualify for ACT 60 reimbursement.
These payments will be made in arrears and comply with TSX Venture Exchange policies.
CytoImmune will reinvest these proceeds into Hemostemix's equity at the then-market value.
"CytoImmune is very bullish on Hemostemix's equity for good reason," stated Thomas Smeenk, CEO of Hemostemix. "Our automated production system will allow us to produce therapies at scale, transforming access to innovative treatments for cardiovascular diseases."
Dr. Jose E. Vidal, CEO of CytoImmune, added, "With over 200 years of combined biologics and cell therapy manufacturing experience, our team is equipped to scale Hemostemix's ACP-01 globally. This partnership reinforces our commitment to advancing cell therapies and creating meaningful economic impact in Puerto Rico."
Economic and Patient Impact
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ACP-01 therapies address conditions such as:
Peripheral Arterial Disease
Diabetic Foot Ulcers
Critical Limb-Threatening Ischemia
Ischemic and Dilated Cardiomyopathy
Congestive Heart Failure
Vascular Dementia
Each therapy not only alleviates pain but also significantly reduces healthcare costs associated with prolonged hospitalizations and complications.
About CytoImmune Therapeutics
CytoImmune is a leader in cell therapy innovation, offering process development and clinical manufacturing services. The company's Puerto Rico-based facility supports cutting-edge cell therapies while fostering collaborations with biotechnology companies and academic institutions.
About Hemostemix
Founded in 2003, Hemostemix is an award-winning autologous stem cell therapy company with a patented blood-based stem cell therapeutics platform. The Company is focused on scaling therapies that include angiogenic cell precursors, neuronal cell precursors, and cardiomyocyte cell precursors.
For more information, visit www.hemostemix.com.
Contact
Thomas Smeenk, President & CEO
Email: tsmeenk@hemostemix.com
Phone: (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 sales of its lead product ACP-01, the commercialization of ACP-01 via the sale of compassionate treatments under Special Access Program. 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 may face; 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.com. 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.
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FAQ
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