Reports Q3 revenue $347,000 vs. $110,000 last year. Vered Caplan, CEO of Orgenesis (ORGS), stated, “Orgenesis is making significant progress in redefining accessibility to cell and gene therapies through our decentralized approach. This model is designed to expedite capacity setup, enhance production efficiency, and reduce treatment costs. We are dedicated to expanding our clinical initiatives and deepening global partnerships, creating a scalable and cost-effective pathway to advanced therapies. Our goal is to bring these innovative solutions to patients worldwide, focusing on sustainable growth and pioneering advancements in cell and gene therapies. “In addition, as we previously disclosed, a recent real-world study of our CD19 CAR-T therapy, ORG-101, demonstrated efficacy and a favorable safety profile. ORG-101 achieved an 82% complete response rate in adults and a 93% complete response rate in pediatric patients with CD19+ Acute Lymphoblastic Leukemia, alongside a lower incidence of severe Cytokine Release Syndrome, 2% in adults and 6% in pediatric patients, compared to conventional CAR-T therapies. Beyond these positive clinical outcomes, we believe that the production data further validates Orgenesis’ decentralized approach as a cost-effective way to make CAR-T therapies more affordable and accessible globally. Additionally, we are excited to announce that we are initiating a Phase 1/2 multicenter clinical study of ORG-101 CAR-T therapy at the University General Hospital of Patras and “George Papanikolaou” General Hospital of Thessaloniki, in Greece, supported by the awarded grant by ‘Enterprise Greece’, with plans to expand to additional hospitals within our partnership network. “We now offer hospitals, and research centers a unique partnership that enables a swift and cost-efficient way to build up their capacity and capability to provide cell and gene therapy products to their patients. Our decentralized platforms for various indications are quick to deploy and minimize the cost of production. We continue to be supported by strategic partners and government grants who share our goal of making cell and gene therapies available to all. “Our strategic joint venture with Harley Street Healthcare Group is an additional angle of this approach, aimed at utilizing the know-how and technologies that we have developed for treatment of cancer and for the prevention of disease targeting the wellness and longevity sector. By combining our cell and gene therapy innovations with HSHG’s established healthcare network, we expect to introduce a suite of longevity and wellness services, targeting key markets such as the UK, UAE, and Canada. This partnership positions us to drive impactful healthcare innovations that can improve quality of life and longevity across diverse regions.”
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