Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 379

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 379
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ol. The LS scores from baseline were -18.9 for Nolazol and -5.7 for placebo, with a LS mean difference between Nolazol and placebo of -13.2 (95% CI, -18.7, -7.6). The results were found to be consistent across all sensitivity analyses, establishing that the large placebo -adjustedeffect size of 1.09 was not biased by any of the statistical methods used. In addition, Nolazol provided a significant reduction in ADHD -RS -5scores starting as early as Week1, which was also observed throughout the full treatment period. After six weeks of 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. 187 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