Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 213

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 213
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 run, but strongly believe it has a competitive
edge on them.

There are currently on the market several products
(not based on the use of cells) or under development for the treatment of ALS, which are in various stages of development, as well as
three products approved by the FDA: (1) Rilutek, which has been marketed since the 1990s; (2) Edaravone, which was approved
in mid-2017 as an intra venous agent and again in late 2022 as an oral drug (Marketed by Mitsubishi Tanabe Pharmaceuticals as Radicava®),
which, to the best of Kadimastem’s knowledge, each has limited efficacy; and (3) RELYVRIO®(sodium phenylbutyrate
and taurursodiol, AMX0035) which is marketed by Amylyx, which has been approved by the FDA and the Ministry of Health in Canada, and is
in the stages of evaluation by EMA regarding the granting of a marketing authorization for its use. Kadimastem sees these products as
potential indirect competition with the drug that Kadimastem is developing.

IsletRx - Development of
a Drug for the Treatment of Diabetes

Development of Cell Therapies in the Field
of Regenerative Medicine for the Treatment of Insulin-Dependent Diabetes

Diabetes is a chronic disease that occurs when
the insulin-secreting beta cells in the pancreas do not produce enough insulin (such as after the immune-mediated destruction of beta
cells in Type 1 diabetes), or when the body cannot effectively use the insulin the beta cells produce (such as in Type 2 diabetes due
to insulin resistance in liver, fat and muscle tissues). Type 2 diabetes accounts for about 90% to 95% of all diagnosed cases of diabetes;
Type 1 diabetes accounts for about 5% to 10%.

Kadimastem’s Solution

IsletRx is a cellular therapy product based on
pancreatic islet-like clusters, or ILCs, derived from human embryonic stem cells for the treatment of Type 1 diabetes and possibly also
for insulin-dependent Type 2 diabetes. The ILCs are differentiated stepwise from the GMP-grade HAD C-100 hESC line. At the end of the
differentiation protocol, the hESC-derived pancreatic ILCs contain mainly insulin secreting cells that have the capability to sense and
respond to alterations in