Company: NCEL
Filing Date: 2025-07-29
Form Type: F-4/A
Source: 0001213900-25-068765
Chunk: 731

Company: NewcelX Ltd.
Filing Date: 2025-07-29
Form: F-4/A
Chunk 731
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ulate the cells before implantation into the patient, thus protecting them from the patient’s immune system if necessary. After conducting a thorough examination of a variety of medical indications in which the technological platform can be used as a basis for drug development, as of the date of the periodic report, the company decided to focus on developing cell therapies for the treatment of two diseases: amyotrophic lateral sclerosis (ALS) and insulin -dependentdiabetes, as detailed below: AstroRx ®— clinical development of groundbreaking cell therapy for treating amyotrophic lateral sclerosis, an incurable disease. The company completed a Phase I/IIa clinical trial at Hadassah Hospital, Israel, focusing on the implantation of healthy supporting cells of the nervous system (astrocytes) that support the survival of motor neurons and received orphan drug status from the FDA. As of the report’s publication, the company received approval from the FDA 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