Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 724

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 724
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 to protect the cells from the immune system of the transplanted person. The company is developing a micro -encapsulationwrapping technology which, as its development is completed, will enable the detection of sugar levels and insulin secretion accordingly, and at the same time, will protect the cells from the immune system of the patient in whose body the cells will be transplanted, so that this wrapping will be a solution to the phenomenon of transplant rejection, without the need to administer drugs to weaken the system the patient’s immune system. F. Implantation in the patient’s body — the implantation of the capsule containing the cells of Langerhans’ islets in the patient’s body, once for a certain period (as opposed to insulin injections that are carried out daily) so that the transplanted cells carry out independent monitoring in a biologically normal way of the blood sugar level, without the need for external monitoring. The cells produce insulin and other hormones and release them into the bloodstream at a physiological level as needed. IsletRx, the company’s product that combines the islet -likecells of Langerhans wrapped in the unique technology that the company is developing to wrap them, has successfully passed pre -clinicalfeasibility trials, and the company continues the development procedures. It should be noted that in addition to the wrapping technologies that the company is developing independently, the company is examining the use of various delivery technologies, including the purchase of licenses, marine equipment, and materials. Accordingly, the company is exploring the possibility of entering into agreements with owners of rights in relevant technologies. If the company enters into such agreements, it may be required to pay royalties to the owners of the rights in the technology or payments for milestones or both. At this stage, the company is unable to estimate the costs accurately. As of the date of the report, the company has a collaboration with iTolerance Inc., for the joint development of an innovative treatment in the field of diabetes based on the company’s IsletRx product and iTolerance’s 100 -iTOLtechnology. During the reporting period, the joint venture was awarded a $1 million grant from the BIRD Foundation. After the reporting period, the parties held a preliminary meeting with the FDA in which the FDA was briefed on the company’s plans for the planned safety and efficacy trials. Stages of drug development As of the date of this report, the company is in the pre -clinicalstage (the stage where the feasibility and safety of the product are proven in laboratory equipment and animals).