Company: NCEL
Filing Date: 2025-06-09
Form Type: F-4/A
Source: 0001213900-25-052354
Chunk: 685

Company: NewcelX Ltd.
Filing Date: 2025-06-09
Form: F-4/A
Chunk 685
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 Cohort and B Cohort of the trial conducted in Israel.

| Moore Financial Consulting |

Annex E-8

December 2020 — The company announced the trial results at the end of a 6 -monthfollow -upperiod. In this context, encouraging results were observed in slowing the rate of disease progression for 3 months after treatment in the first and second treatment groups. In both groups, 10 patients were treated, 5 patients in the first treatment group and 5 patients in the second treatment group with a single dose of 100 million and 250 million AstroRx ®cells, respectively. Patients completed a 6 -monthfollow -upperiod after receiving treatment. During this period, no serious adverse events (SAEs) related to treatment or adverse events that limited the treatment dose were reported, indicating a good safety profile at both treatment doses. Analysis of product efficacy over a 6 -monthfollow -upperiod from the start of treatment showed a statistically significant clinical effect for the first 3 months out of 6 months of follow -upin both study groups. At the end of the 6 -monthfollow -upperiod, the rate of change in the ALSFRS -Rmeasure returned to being like that measured before treatment. The clinical trial results were included in the IND application submitted by the company to the FDA after the reporting period, as detailed below, for conducting the subsequent clinical trial in ALS patients. In this context, it should be noted that after the reporting date, a scientific article was published for the first time in a journal on the Phase I/IIa clinical trial for the treatment of ALS in the prestigious scientific journal Transitional Medicine, which underwent a successful independent peer review. The Year 2021 — In light of the company’s decision to act against the submission of an IND to the FDA to start the multi -siteclinical trial in the USA, during the year 2021, the company’s main clinical activity in relation to ALS focused on two primary levels: (1) completion of all the trials required for IND submission for the company’s AstroRx ®product for the multi -sitetrial (2) Completion of the development of the ability to freeze (off -the-shelf) and thaw the AstroRx ®cells as before the development of this ability, as mentioned, the AstroRx ®cells could be transplanted into the patient’s body within a limited period of 24 hours only. The company completed these objectives. The year 2022 — The company completed the experiments