Company: NCEL
Filing Date: 2025-09-03
Form Type: F-4/A
Source: 0001213900-25-084157
Chunk: 732

Company: NewcelX Ltd.
Filing Date: 2025-09-03
Form: F-4/A
Chunk 732
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 the FDA viewed positively many aspects of the clinical development outline that the company proposed for the product. As of this date, the company continues the development procedures, among other things, in accordance with the recommendations received by the FDA. The Year 2022 — The company made progress in searching for solutions for macro -encapsulationand micro -encapsulationof the IsletRx product. As mentioned above, in December 2022, the company reported the approval of a grant in the amount of one million US dollars to the company from the Israel -USABinational Research and Development Fund (BIRDF) for sharing Potential action between the company and the American company iTolerance. May 2023 — In May 2023, the company and iTolerance signed a cooperation agreement to develop an innovative treatment for diabetes. As part of the agreement, iTolerance will provide the 100 -iTOLtechnology, and the company will provide the IsletRx product. January 2024 — The company and iTolerance held a preliminary meeting with the FDA (INTERACT), during which the FDA was briefed on the company’s plans in connection with the safety and efficacy trials planned in connection with the joint development. As mentioned, at the time of the report, the company is still in the pre -clinicalphase of the diabetes drug development process. According to the findings of the preclinical studies, the in -vivoproduction of human c -peptidewas demonstrated, which proves the function in the cells, as well as the release of c -peptideand insulin depending on the glucose levels blood (proof that the cells respond to changing glucose levels). An experiment in diabetic animals showed that the IsletRx cells could cure the disease in the model animals. As of the date of the report, the company continues to examine various options for providing optimal protection to the cells from the immune system, including a solution based on cooperation.

| Moore Financial Consulting |

Annex E-12

Kadimastem’s Financials Following are the Company’s audited balance sheets as of December 31 of the years 2019 – 2023 and the proforma balance as of 30.06.2024:

| USD 000’                                        |     | 31.12.2019 |   |     | 31.12.2020 |   |     | 31.12.2021 |   |     | 31.12.2022 |   |     | 31.12.2023 |