Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 186

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 186
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 chemistry, or urinalysis values from baseline to Week 6 between Nolazol and placebo groups. Mean weight loss of the
Nolazol group was 1.73 kg, compared to a mean weight increase for the placebo group of 1.07 kg.

Phase 1 Clinical Trial

We completed a Phase 1
randomized, open-label, cross-over clinical trial in the United States in 2016, which characterized the pharmacokinetics and
evaluated the safety and tolerability of Nolazol following a single dose in the fasted and fed state in normal healthy adult
subjects. Subjects received a single, fixed dose of Nolazol under fasted conditions in one dosing period and the same single, fixed
dose 30 minutes prior to a high-fat breakfast in another dosing period. Nolazol demonstrated a predictable, dose-dependent, and
linear pharmacokinetics profile. This study is intended to serve as the basis of our Phase 3 clinical trials, if any, by providing a
preliminary understanding of the concentration-time profile of Nolazol under the fed and fasted conditions.

Food administered 30 minutes
after administration of Nolazol resulted in similar exposure and a slightly lower peak concentration compared to administration in the
fasted state, while the time to reach the peak concentration was similar in the fasted and fed states. These results suggest that our
Phase 3 trials will not need to include dosing restrictions in terms of meal timing relative to dose administration, which is an important
feature for increased compliance in ADHD patients. A definitive food-effect study with the final formulation of Nolazol will be conducted
during the Phase 3 program. The figure below shows the pharmacokinetic curve of Nolazol under the fed and fasted conditions utilized in
this clinical trial.

Nolazol was well-tolerated
and there were no deaths, serious adverse events or withdrawals due to adverse events. Adverse events were reported in 30% of the Nolazol-treated
subjects and included dizziness and somnolence and there were no clinically significant changes in laboratory values, ECG, blood pressure,
or heart rate.

Phase 2 Pediatric Clinical Trial

A Phase 2 open-label pilot
study in France was conducted in 2015 by Eric Konofal, one of our founders and Chief Scientific Officer, and others while at AP-HP. This
study evaluated the efficacy, safety,