Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 409

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 409
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 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 -2017as 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 -secretingbeta cells in the pancreas do not produce enough insulin (such as after the immune -mediateddestruction 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%. 211 Kadimastem’s Solution IsletRx is a cellular therapy product based on pancreatic islet -likeclusters, or ILCs, derived from human embryonic stem cells for the treatment of Type 1 diabetes and possibly also for insulin -dependentType 2 diabetes. The ILCs are differentiated stepwise from the GMP -gradeHAD C -100hESC line. At the end of the differentiation protocol, the hESC -derivedpancreatic 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