Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 185

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 185
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the clinician to rate the severity of a patient’s illness and improvement over time. There was a significant improvement in ADHD-RS-DSM5
scores by Week 6 for Nolazol compared with the placebo. At Week 6, 70% of the Nolazol-treated patients, compared with 21% of the placebo-treated
patients, had at least a 30% reduction in their ADHD-RS-5 score (p < 0.001), and 55% of the Nolazol-treated patients, compared with
15.8% of the placebo-treated patients, had at least a 50% reduction in their ADHD-RS-5 score (p = 0.002). There were significantly more
“responders,” defined as a ≥ 30% reduction from baseline in ADHD-RS-5 scores, present in those receiving
Nolazol compared with placebo at the first assessment point Week 1, and at each subsequent assessment. Furthermore, there were significantly
more “excellent” responders, defined as a ≥ 50% reduction from baseline in ADHD-RS-5 score, 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-I analysis,
which indicated significantly more CGI-I responders on Nolazol compared with placebo on Week 2 and at each subsequent visit (p ≤ 0.003).
The sensitivity analyses resulted in a similar magnitude of difference between Nolazol and placebo for all responder definitions. The
figure below summarizes the patient responder results.

Safety and Tolerability

Nolazol was well-tolerated
and there were no deaths or serious adverse events reported and no discontinuations in the Nolazol treated group due to adverse events
or lack of efficacy. Adverse events reported were mild to moderate and the more prevalent reported events in the Nolazol treated group,
as compared to placebo, included constipation, dry mouth, nausea, fatigue, somnolence, middle insomnia and heart rate increased. Relative
to placebo, on Week 6, the Nolazol treated group had a minimal increase in diastolic and systolic blood pressure, a small increase in
heart rate, and no significant changes in electrocardiography, or ECG, parameters. There were no remarkable findings on physical examination,
hematology, serum