Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 215

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 215
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s 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-like cell clusters (containing mainly insulin-producing
beta cells and to lesser extent glucagon-producing alpha 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 (hypoglycaemia). 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-term complications 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 hypoglycaemia (very low, abnormal blood sugar level) resulting from excess
of injected external source insulin, or events of hyperglycaemia (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-scale
stock 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, through which the technology can mimic the process of embryonic development and direct the pluripotent
stem cells to differentiate into a specific lineage in the body, according to choice and relevant needs. The differentiation process is