Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 187

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 187
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 and tolerability of mazindol in 24 children, aged 9 - 12 years, and diagnosed with ADHD. All enrolled
patents had a low rate of response to methylphenidate, which is a first-line treatment in children with ADHD. All patients received the
same fixed dose of mazindol daily for seven days, followed by a three-week drug-free safety observation period. The mean change from baseline
in the parent rated and clinician rated ADHD-RS-IV total score after 7 days of treatment was -24.1, with >90% improvement in ADHD symptoms
from baseline (p<0.0001), pointing to a viable long-acting treatment option, assuming it is shown to be safe, as determined by applicable
regulatory agencies. Additionally, the mean change in the parent rated and clinician rated ADHD-RS-IV total score from end of treatment
(Week 1) to the final observation visit (Week 4) demonstrated statistical significance (p<0.0001), indicating significant alteration
in the level of symptomology of ADHD after mazindol withdrawal. The figure below summarizes the results of the primary endpoint.

Mazindol was well tolerated
in children with ADHD. Adverse events included decreased appetite, headache and abdominal pain and there were no clinically significant
changes in laboratory values, ECG, blood pressure, heart rate, or body weight. This clinical trial provided proof-of concept data, potential
benefit, and supported the advancement into a more expansive Phase 2 trial.

Phase 3 Development Strategy

Having successfully met both
the primary and secondary endpoints in our initial Phase 2 trial, we may plan to further the development of Nolazol as a follow-on or
back-up candidate to support filing for marketing and commercialization approval initially in adults in the United States, followed by
children and adolescents.

Our first Phase 3 clinical
trial may aim to evaluate doses of Nolazol in approximately 260 adults with ADHD, with subjects randomized to receive Nolazol or placebo
for 6 weeks. The primary endpoint being the change from baseline in the ADHD-RS-5 score, which was the primary endpoint in our Phase 2
trial. Our second Phase 3 clinical trial may target to evaluate doses of Nolazol in children and adolescents, with an embedded placebo-controlled
sub-study in a laboratory classroom setting for the children age group. A laboratory classroom study provides a simulation of a