Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 201

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 201
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 others, ALS,
an incurable disease, for which Kadimastem received an orphan drug designation status from the FDA, as well as cell therapy in the field
of regenerative medicine for the treatment of diabetes, a disease that affects hundreds of millions of people worldwide, and its product
has the potential to provide a cure for the disease. Kadimastem intends to be a leading company in the field of regenerative medicine
products for the treatment of neurodegenerative diseases and a cure for diabetes.

Kadimastem is developing revolutionary regenerative
therapies based on stem cells-derived therapeutic cells, moving away from the traditional curative therapies. The technology has been
developed as a platform enabling the manufacturing of islet-like endocrine cells and glia restricted progenitors thus having potential
applications for diabetes, and for neurodegenerative diseases such as ALS. The therapy is scalable and industrialized, to be commercialized
as a stable “off the shelf” product and reduce the cost of treatments. For this, Kadimastem uses pluripotent cells (e. g. embryonic
stem cells - hESCs) that have a unique ability to multiply infinitely without losing their “naivety” and to
be able to become any cell type. The cell therapy products manufactured under Good Manufacturing Practices, or GMP, guidelines (similar
to traditional therapeutics) in order to reach optimal clinical results. Kadimastem developed a new process to differentiate the cells
in the lab to their mature phenotype, before their implantation to the patient, unlike other technologies which transplant immature precursor
cells. Thus, Kadimastem believes that its process will markedly enhance the efficiency of the treatment. The transplantation of immature
cells depends on exact signals from the surrounding tissues to support their maturation into functional cells. This process in vivo cannot
be controlled, and as such the outcome of such is variable. In contrast, mature cells are ready to use and do not require specific signals
to confer their function. Furthermore, we have observed, based on our data, that the transplantation of these mature cells enhances treatment.
Furthermore, we have observed, based on our data, that the transplantation of these mature cells slows disease progression. In NCT0348205010
phase 1/2a clinical trial, 10 ALS patients were injected with AstroRx® and as a result, in the first three months post treatment the
disease progression was slowed significantly (study outline is described below beginning