Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 722

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 722
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 trial of the second treatment group (B Cohort). As mentioned, the trial’s primary objective was to assess the safety of the AstroRx ®product. Like the first treatment group (Group A), the second treatment group (Group B), which was given a higher dose of the drug, did not report serious adverse events related to the treatment, and no adverse events were found that limited the treatment dose. The secondary objective of the clinical trial included the assessment of treatment efficacy, which is based, among other things, on the ALS Functional Rating Scale -Revised(ALSFRS -R) to assess the rate of progression of ALS by monitoring different motor activities of patients over time. The encouraging conclusions from all the analyses indicated that the company’s cell therapy with AstroRx ®showed a significant slowdown in the rate of disease deterioration in the three months after treatment compared to the rate of disease deterioration before treatment. These results indicate a clinically substantial efficacy for this stage of clinical development. Considering the positive interim results received by the company until that date, and against the background of the coronavirus pandemic and the recommendation of the DSMB committee, the company made a strategic decision to move forward and work with the FDA to initiate a Phase IIa clinical trial in the US and stop the continued recruitment of additional treatment groups for the clinical trial in Israel. The company intends to conduct the trial described in the US, which will be broad in number of centers (multi -site) in parallel to continued follow -upregarding the first and second treatment groups A 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