Company: NCEL
Filing Date: 2025-06-09
Form Type: F-4/A
Source: 0001213900-25-052354
Chunk: 378

Company: NewcelX Ltd.
Filing Date: 2025-06-09
Form: F-4/A
Chunk 378
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 and all were resolved. Three patients reported 4 AEs related to mycophenolate mofetil, including headache, nausea, anemia, and hyperhidrosis. All the immunosuppression -relatedAEs were graded as mild to moderate, and all were resolved. The main outcome efficacy measure in the study was ALSFRS -R. At baseline visit (1 day before treatment) the mean ALSFRS -Rscore was 35.6 ± 3.7, 34.2 ± 7.0 and 34.9 ± 5.3, for Group A, Group B, and combined Group A + B, respectively. The mean decline in the ALSFRS -Rslope for patients in Group A was − 0.88/month during the run -in(3 – 4 months before treatment). In the first 3 months after AstroRx ®cell injection, the mean decline of the ALSFRS -Rslope was attenuated to − 0.3/month (p = 0.039), reflecting an attenuation of 66% in ALSFRS -Rdeterioration. Combining the data of both groups demonstrated an attenuation of 53% in ALSFRS -Rover the first 3 months post AstroRx ®IT injection (p < 0.001) (a p -valueis a conventional statistical method for measuring the statistical significance of experimental results; p -valueof less than 0.05 indicates statistically significant result), which was not maintained at 6- and 12 -monthfollow -up. The change in the ALSFRS -Rslope was also analyzed in a subpopulation of rapid progressors from both groups (n = 5). Rapid progressors were defined as patients who deteriorated ≥ 1.1 ALSFRS -Rpoints per month during the run -inperiod. The mean improvement in ALSFRS -Rslope between the run -inperiod and 3 -monthfollow -upin these patients was 58% (− 1.58/month vs. − 0.65/month, p < 0.001). Also in this subpopulation, after 3 months post single dosing the ALSFRS -Rslope returned to a similar rate that was recorded before treatment (Fig. 2). 204 An improvement ≥ 25% in the ALSFRS -Rslope is considered clinically meaningful. The individual ALSFRS -Rslopes demonstrated an improvement of at