Company: NCEL
Filing Date: 2025-03-31
Form Type: F-4/A
Source: 0001213900-25-026428
Chunk: 266

Company: NewcelX Ltd.
Filing Date: 2025-03-31
Form: F-4/A
Chunk 266
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ftment and glucose -responsiveinsulin production by Day 90. At the latest visit, all patients had improved glycemic control and achieved ADA -recommendedtargets for both HbA1c below 7.0% and time -in-rangeabove 70% on continuous glucose monitoring. Nearly all participants (11 of 12) had a reduction or elimination of exogenous insulin use at their last visit. All patients had elimination of SHEs during the evaluation period (from Day 90 onward). Finally, all three patients who had at least one year of follow -up, and are therefore evaluable for the primary endpoint, met the primary endpoint of elimination of SHEs (from Day 90 after infusion) with HbA1c <7.0% and the secondary endpoint of insulin independence. Kadimastem implements a technological platform that uses pluripotent stem cells, or PSCs, either embryonic stem cells and/or induced pluripotent stem cells for the development and production of various active cells as off -the-shelfproducts for the treatment of a wide range of diseases. Its technological platform includes processes for the development, production and biobanks of cells at various stages of differentiation. As of the date of this proxy statement/prospectus, Kadimastem focuses on the development of cell therapy products in the field of regenerative medicine for the treatment of various diseases with an emphasis on (a) treatment and/or cure of neurodegenerative diseases of the CNS, with the purpose of finding a treatment for ALS, and (b) development of a cure for Type 1 diabetes and possibly in the future, for Type 2 diabetic patients which are insulin dependent. Regenerative medicine is an innovative medical research field that focuses on regeneration of tissue/organs harmed due to disease, injury or due to birth defects in patients, using one of the following two ways: (1) creating new cells, organ parts or tissues under laboratory conditions, or using donor cells, organs or parts of organs transplanted into the patient’s body in order to replace the cells or tissues damaged by disease; (2) finding and developing drugs that will help induce a process of spontaneous regeneration of the damaged tissue/organ by encouraging the adult stem cells that are regularly present in the tissue, divide, differentiate and take their place in the affected area. 134 Below is a discussion on Kadimastem’s two primarily drug products, AstroRx ®, for the treatment for ALS, and IsletRx, for the treatment of diabetes