Company: NCEL
Filing Date: 2025-03-31
Form Type: F-4/A
Source: 0001213900-25-026428
Chunk: 573

Company: NewcelX Ltd.
Filing Date: 2025-03-31
Form: F-4/A
Chunk 573
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hans wrapped in the unique technology that the company is developing to wrap them, has successfully passed pre -clinicalfeasibility trials, and the company continues the development procedures. It should be noted that in addition to the wrapping technologies that the company is developing independently, the company is examining the use of various delivery technologies, including the purchase of licenses, marine equipment, and materials. Accordingly, the company is exploring the possibility of entering into agreements with owners of rights in relevant technologies. If the company enters into such agreements, it may be required to pay royalties to the owners of the rights in the technology or payments for milestones or both. At this stage, the company is unable to estimate the costs accurately. 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 was awarded a $1 million grant from the BIRD Foundation. After the reporting period, the parties held a preliminary meeting with the FDA in which the FDA was briefed on the company’s plans for the planned safety and efficacy trials. Stages of drug development As of the date of this report, the company is in the pre -clinicalstage (the stage where the feasibility and safety of the product are proven in laboratory equipment and animals). November 2019 — Completion of a preclinical feasibility trial in cellular therapy for insulin -dependentdiabetes. The experiment tested the treatment efficiency of the IsletRx product, which is based on cell clusters like the islets of Langerhans and includes pancreatic cells in combination with a unique micro -encapsulationtechnology developed by the company. Successful results were observed as part of the feasibility trial results. The Year 2020 — Continue product development and promote regulatory processes with the FDA.

| Moore Financial Consulting |

Annex E-11

The Year 2021 — In May 2021, the company submitted a preliminary application (INTERACT) to the FDA for the IsletRx product to receive a reference regarding the regulatory track for the product’s production and clinical development plans. In October 2021, the company held a meeting with the FDA (INTERACT), which included the recommendations and instructions for the company to carry out the plans required for the development of the IsletRx product in preparation for the Pre -INDsubmission of the product for the treatment of diabetes. It should be noted that the FDA viewed positively