Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 184

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 184
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period.

Efficacy Results

The primary efficacy endpoint
was the change from baseline in the total ADHD-RS score at Week 6, as compared to placebo, and measured by the clinician-administered
ADHD Rating Scale with DSM-5 symptoms, or the ADHD-RS-5. ADHD-RS-5 is 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.

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-adjusted effect size of 1.09 was not biased by any
of the statistical methods used.

In addition, Nolazol provided
a significant reduction in ADHD-RS-5 scores starting as early as Week 1, 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-5 total
score symptoms as compared to placebo treated patients. The figures below summarize the results of the primary endpoint observed in our
Phase 2 trial.

A p-value is a conventional
statistical method for measuring the statistical significance of experimental results. A p-value of 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-values are included, a p-value of less than 0.05 is represented by “*.”
P-values of 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-5 score 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-I is a standardized and validated assessment used