Company: NCEL
Filing Date: 2025-06-09
Form Type: F-4/A
Source: 0001213900-25-052354
Chunk: 688

Company: NewcelX Ltd.
Filing Date: 2025-06-09
Form: F-4/A
Chunk 688
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 drugs to weaken the patient’s immune system. The wrapped islets will be implanted in the patient’s body in a defined anatomical area containing islet -likeaggregates. According to the company, this method will make it possible to control and replace the cells, if necessary, with new cells. As the product development is completed, it will solve the problem of imbalance in diabetics, which brings long -termhealth complications. Thus, by achieving balance in blood sugar levels, there will be a stop in the deterioration of the disease and the patient’s quality of life will improve. The model developed by the company in relation to the development of the drug for the treatment of diabetes, which is based on the technological platform, is divided into six main stages as detailed schematically below: A. Cell proliferation (Expansion) produces large amounts of pluripotent stem cells, which are the starting material for the differentiation processes. B. Differentiation into cells resembling islets of Langerhans — induction of differentiation processes of pluripotent stem cells into cells like islets of Langerhans under laboratory conditions in cell clusters, in a suspension stirred tanks under conditions simulating the development of islets of Langerhans. C. Separation and selection (enrichment) of the relevant cells created by differentiation — clarification of the cells like the islets of Langerhans produced from the pluripotent stem cells to collect only the types of cells relevant for therapeutic function.

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Annex E-10

D. Re -aggregation(re -clustering) of the cells that have undergone selection — the cells undergo spontaneous re -aggregationinto clusters like the islets of Langerhans under conditions developed by the company and found effective for the procedure. E. Encapsulation of the cells before they are transplanted into the patient — 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’ is