Company: NCEL
Filing Date: 2025-06-23
Form Type: F-4/A
Source: 0001213900-25-056787
Chunk: 352

Company: NewcelX Ltd.
Filing Date: 2025-06-23
Form: F-4/A
Chunk 352
---
 treatment, patients treated with Nolazol demonstrated more than three times the improvement in the ADHD -RS-5total score symptoms as compared to placebo treated patients. The figures below summarize the results of the primary endpoint observed in NLS’s Phase 2 trial. 183 A p -valueis a conventional statistical method for measuring the statistical significance of experimental results. A p -valueof less than 0.05 is generally considered to represent statistical significance, meaning that there is a less than 5% likelihood that the observed results occurred by chance. In the figure above and all subsequent figures where p -valuesare included, a p -valueof less than 0.05 is 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