Company: NCEL
Filing Date: 2025-09-03
Form Type: F-4/A
Source: 0001213900-25-084157
Chunk: 422

Company: NewcelX Ltd.
Filing Date: 2025-09-03
Form: F-4/A
Chunk 422
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 and ensure long term function of IsletRxPlus cells. 214 iTOL-102 iTOL -102are human pluripotent (embryonic) stem -cellderived islet -likeclusters mixed with iTOL -100(biotinylated PEG microgels with surface bound SA -FasL). iTOL -102consists of IsletRxPlus cells and iTOL -100prepared for delivery into the omentum, a part of the stomach of diabetic patients. The therapeutic goal for iTOL -102is to provide an easily administered, low risk, treatment via a minimally invasive procedure with long -termglucose responsiveness, that can treat diabetes without the need for chronic immunosuppression or exogenous insulin supplementation. Data from initial proof -of-conceptstudies with iTOL -102in diabetic mouse models demonstrated potential efficacy and safety results of iTOL -102. In January 2024, iTolerance and Kadimastem held a meeting with the FDA (INTERACT) to discuss safety, functionality and planning regarding the development of the joint iTOL -102project. In June 2024, The Diabetes Research Institute at the University of Miami Miller School of Medicine presented the results of iTOL -102POC study in the American Diabetes Association’s 84th Scientific Sessions that highlights the potential of human, stem cell -derivedislets combined with an immunomodulatory microgel to reverse Type 1 diabetes (T1D). The results demonstrated that the combination of iTOL -100engineered microgel developed by iTolerance and IsletRx stem cell -derivedislets developed by Kadimastem, iTOL -102, can restore normoglycemia in a model of diabetes. Accordingly, the companies are working on submitting a pre -INDpackage in the third quarter of 2025. Encap-IsletRx Plus Microencapsulation of cells within semi -permeablehydrogels represents an immune isolation strategy for cell -basedtherapies without the need for systemic immunosuppression. Studies have demonstrated that the microencapsulation process does not hinder the function of islets, and the insulin is efficiently secreted in response to elevated blood glucose levels, using similar doses of islets as used in the Edmonton protocol. Preclinical studies have demonstrated long -term 215 Encap -IsletRxPlusfunctionality, in terms of continuous balanced glucose levels, in immunocompetent mice without immunosuppressive treatment. The microencapsulation provides