Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 29

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 29
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 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
carried out under laboratory conditions, in several stages, by adding chemical and/or biological agents in controlled timings to the pluripotent
stem cell culture. Induction of differentiation processes of pluripotent stem cells into islet-like cell clusters, under laboratory conditions
is conducted in a stirred suspension bioreactor under conditions that mimic the development of the pancreatic islets.

Enrichment:Kadimastem
has developed an enrichment technology which enables improved safety and efficacy of IsletRx cells. The IsletRx cells are enriched for
insulin secreting cells, designated as IsletRx, and formulated as the drug substance.

Delivery :Several delivery strategies were developed to obviate the need for life-long immunosuppressive treatment while enabling
the long-term function of IsletRxPlus cells. These strategies include immune tolerance, microencapsulation in polymer), and scaffolding
using electrospinning of polycaprolactone. The cellular component in all products is the same, IsletRxPlus cells.

Product descriptions:

iTOL-102 Human pluripotent