Company: NCEL
Filing Date: 2025-03-31
Form Type: F-4/A
Source: 0001213900-25-026428
Chunk: 265

Company: NewcelX Ltd.
Filing Date: 2025-03-31
Form: F-4/A
Chunk 265
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 neurodegenerative diseases and a cure for diabetes. Kadimastem is developing revolutionary regenerative therapies based on stem cells -derivedtherapeutic cells, moving away from the traditional curative therapies. The technology has been developed as a platform enabling the manufacturing of islet -likeendocrine 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 133 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. For example, NCT04786262 trial evaluates the safety, tolerability and efficacy of VX -880infusion in participants with Type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia. VX -880, an investigational stem cell -derived, fully differentiated islet cell therapy. Data on 12 patients who received the full dose as a single infusion. At baseline, all patients in the study had undetectable fasting C -peptide(a marker of endogenous insulin secretion), a history of recurrent SHEs in the year prior to screening, and required an average of 39.3 (min, max; 19.8, 52.0) units of insulin per day. Following a single infusion of VX -880at the full dose, all 12 patients demonstrated islet cell engra