Company: NCEL
Filing Date: 2025-06-09
Form Type: F-4/A
Source: 0001213900-25-052354
Chunk: 352

Company: NewcelX Ltd.
Filing Date: 2025-06-09
Form: F-4/A
Chunk 352
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 represented by “*.” P -valuesof less than 0.01 or less than 0.001 are represented by “**” or “***” respectively, and are considered to have higher statistical significance. Secondary efficacy endpoints included patient response to treatment, as measured by the reduction of the ADHD -RS-5score by at least 30% and by at least 50% from baseline, and as measured by the Clinical Global Impressions -Improvement, or CGI -I. The CGI -Iis a standardized and validated assessment used by the clinician to rate the severity of a patient’s illness and improvement over time. There was a significant improvement in ADHD -RS-DSM5scores by Week 6 for Nolazol compared with the placebo. At Week6, 70% of the Nolazol -treatedpatients, compared with 21% of the placebo -treatedpatients, had at least a 30% reduction in their ADHD -RS-5score (p < 0.001), and 55% of the Nolazol -treatedpatients, compared with 15.8% of the placebo -treatedpatients, had at least a 50% reduction in their ADHD -RS-5score (p = 0.002). There were significantly more “responders,” defined as a ≥ 30% reduction from baseline in ADHD -RS-5scores, present in those receiving Nolazol compared with placebo at the first assessment point Week1, and at each subsequent assessment. Furthermore, there were significantly more “excellent” responders, defined as a ≥ 50% reduction from baseline in ADHD -RS-5score, compared with placebo present by Week 2 and at each subsequent assessment point. The excellent response by Week 2 was also evident in the CGI -Ianalysis, which indicated significantly more CGI -Iresponders on Nolazol compared with placebo on Week 2 and at each subsequent visit (p ≤ 0.003). The sensitivity analyses resulted in a similar magnitude of difference between Nolazol and placebo for all responder definitions. The figure below summarizes the patient responder results. Safety and Tolerability Nolazol was well -toleratedand there were no deaths or serious adverse events reported and no discontinuations in the Nolazol treated group due to adverse events or lack of efficacy. Adverse events reported were mild to moderate and the more prevalent reported events in the Nolazol treated group,