Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 384

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 384
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 Nolazol was well -toleratedand demonstrated statistically significant improvement over placebo. The clinical trial met the primary and all secondary endpoints and had a robust effect on ADHD symptoms with a large placebo -adjustedeffect size of 1.09 in the investigator -ratedADHD symptom scores. NLS believes that the magnitude of this effect is comparable to currently leading CII stimulants and considerably larger than the available non -stimulanttreatment options. The table below summarizes the results of NLS’s Phase 2 clinical trial in adults in terms of adverse events. NLS’s Phase 2 clinical trial evaluated the efficacy, safety and tolerability of Nolazol in a randomized, double -blind, placebo -controlled, multi -center, parallel trial in 85 adults with a diagnosis of ADHD. Subjects were administered Nolazol or matching placebo once a day for six weeks, dosed flexibly (between 1mg/day and 3mg/day) during a three -weekdouble -blindoptimization period, followed by a three -weekdouble -blindfixed dosing period. Efficacy Results The primary efficacy endpoint was the change from baseline in the total ADHD -RSscore at Week6, as compared to placebo, and measured by the clinician -administeredADHD Rating Scale with DSM -5symptoms, or the ADHD -RS-5. ADHD -RS-5is a standardized, “gold standard endpoint” validated test for measuring severity of ADHD symptoms and assessing response to treatment. The scale is based on the ADHD diagnostic criteria as defined in the DSM -5. 185 The primary endpoint was met, showing statistically significant improvement versus placebo, in favor of Nolazol. 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