Company: NCEL
Filing Date: 2025-07-29
Form Type: F-4/A
Source: 0001213900-25-068765
Chunk: 420

Company: NewcelX Ltd.
Filing Date: 2025-07-29
Form: F-4/A
Chunk 420
---
richment” of the therapeutically relevant pancreatic islet cells that it believes will result in increased safety and efficacy profile. 212 IsletRx — Development of a Drug for the Treatment of Diabetes The IsletRx cells for diabetes therapy Kadimastem develops is based on differentiation of pluripotent stem cells received under license agreements. Kadimastem developed technologies for the cultivation of pluripotent stem cells and their differentiation into islet -likecell clusters (containing mainly insulin -producingbeta cells and to lesser extent glucagon -producingalpha cells). These cells are intended for transplantation into Type 1 diabetic patients whose beta cells are unable to produce insulin and release it in response to an increase in blood sugar, as well as adequate levels of active glucagon that can respond to a sharp drop in glucose levels (hypoglycemia). In this way, the transplant recipient can produce, and release insulin or glucagon as needed, independently of external monitoring of blood sugar and regular insulin injection. The drug Kadimastem is developing is intended for patients with Type 1 diabetes and in the future also for patients with Type 2 diabetes who are dependent on injecting insulin from an external source to maintain adequate levels of sugar (glucose) in the blood. Patients with uncontrolled diabetes suffer from long -termcomplications such as vascular damage, decreased kidney function (leading to kidney failure), impaired vision and the development of necrosis in the limbs. Therefore, by achieving strict management of blood sugar levels, the deterioration of the disease complications can be avoided. In addition, the patient’s quality of life will be improved: at current state, the patient must perform regular tests and carefully manage energy intake to prevent events of hypoglycemia (very low, abnormal blood sugar level) resulting from excess of injected external source insulin, or events of hyperglycemia (very high, abnormal blood sugar level) resulting from insufficient insulin injected from an external source. For the development of IsletRx cells, Kadimastem relies on these main technologies: Expansion:Kadimastem has the technological ability to multiply/expand the pluripotent stem cells received under license agreements and to preserve them in deep freezing, while maintaining their vitality and pluripotent fitness. This technology enables the production and storage of industrial -scalestock of pluripotent stem cells, which can then be thawed and used in production and differentiated into specific cell lineage as needed. Differentiation:Kadimastem has developed technology and know -how