Company: NCEL
Filing Date: 2025-06-09
Form Type: F-4/A
Source: 0001213900-25-052354
Chunk: 683

Company: NewcelX Ltd.
Filing Date: 2025-06-09
Form: F-4/A
Chunk 683
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 to initiate a Phase IIa multi -siteclinical trial in the US, following the IND application submitted by the company, per its work plan. IsletRx— development of insulin -secretingpancreatic cells to be implanted in diabetes patients as a treatment for insulin -dependentdiabetes (type 1 diabetes and type 2 diabetes requiring insulin). As of the report’s publication, the company has completed a pre -meetingwith the FDA in which the FDA was briefed on its plans regarding its planned safety and efficacy trials. If the company’s development is completed, the developed treatment has the potential to cure diabetes. As of the date of the report, the company has a collaboration with iTolerance Inc. for the joint development of an innovative treatment in the field of diabetes based on the company’s IsletRx product and iTolerance’s 100 -iTOLtechnology. During the reporting period, the joint venture received a grant of $1 million from the BIRD Foundation. After the reporting period, the parties held a pre -meetingwith the FDA in which the FDA was briefed on the company’s plans regarding the planned safety and efficacy trials.

| Moore Financial Consulting |

Annex E-7

The company’s business model is to complete the development of the products to a stage where, in the company’s estimation, it will be possible to commercialize the development results, among other things, for each of the products through a strategic partner (international pharmaceutical companies) who will complete the development and/or market and commercialize the product if the company completes development. Considering the above, in parallel to the research and development of the drugs mentioned above, the company is continuously working to create additional strategic business and research collaborations, as well as professional ones, that will promote its activities, alongside raising the necessary financing to complete the development of the drugs mentioned above. AstroRx ® In developing the AstroRx ®product, the company assumes that implanting healthy astrocytes in ALS patients will improve the protection of neurons, slow their death, and consequently delay (even significantly) the progression of the disease. The company’s drug is based on pluripotent stem cells derived from embryonic stem cells, which, using the company’s technological platform, underwent a process of expansion and differentiation into supporting cells of the central nervous system (astrocytes). After multiplication and differentiation as described, the company freezes the cells (off -the-shelfproduct) for transportation to the required locations worldwide. After arriving at the destination and thawing, these cells will be implanted in patients