Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 27

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 27
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 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 glucose levels, with secretion of adequate amounts of insulin in direct response to glucose levels.
Thus, IsletRx has the potential to functionally replace patients’ malfunctioning Islet cells by secreting physiological levels of
insulin to maintain long-term continuous balanced glucose. IsletRx, as allogeneic islet cells for diabetic patients derived from an unlimited
source of pluripotent stem cells, can overcome the shortage in adequate biological material for islet transplantation therapy.

Conventional treatments (Insulin
syringes and pumps) are designed to monitor blood glucose levels in diabetics externally, and to inject insulin artificially according
to the amount needed (insulin is given directly into the blood by injections or by the pumps). This treatment has several disadvantages,
including: dependence on injections and external monitoring of blood glucose levels; the necessity to operate, maintain and fill the pumps,
which affects the patients’ quality of life; artificial injection of insulin, which does not prevent the deterioration of diabetes
over time; and excessive insulin injection, which may cause the glucose level to drop and lead to fainting, loss of consciousness and
even death in extreme situations. On the contrary, IsletRx has the potential to functionally replace patients’ malfunctioning Islet
cells by secreting the