Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 723

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 723
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 and release it in response to an increase in blood sugar, when functional pancreatic tissue is transplanted, the transplanted person can again produce and release insulin as needed, independently of external monitoring of the blood sugar level and regular insulin injections. Blood sugar level monitoring is done by cells, not artificial systems (such as sensors for glucose in insulin pumps). In addition, the company is developing a technology for wrapping the islets (Delivery) that will allow protection of the islets from the immune system of the patient in whose body they 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 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 —