Company: NCEL
Filing Date: 2025-06-23
Form Type: F-4/A
Source: 0001213900-25-056787
Chunk: 351

Company: NewcelX Ltd.
Filing Date: 2025-06-23
Form: F-4/A
Chunk 351
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azol Clinical Trial Results Phase 2 Clinical Trial NLS completed a Phase 2 clinical trial in 2017 in the United States, in which 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. 182 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