Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 183

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 183
---
 relative to other ADHD treatments. In our clinical studies conducted to date, Nolazol
has been well-tolerated and there were no treatment-related serious adverse effects or discontinuations. In terms of abuse potential,
Nolazol has an already established low risk of abuse, as previously determined by the DEA when mazindol, its active ingredient, was scheduled
as a CIV substance, underscoring the awareness and agreement that Nolazol has a lower risk of abuse than CII stimulants. In addition,
based on the current DEA classification of mazindol as a CIV stimulant, we expect that Nolazol will continue to be without a Black Box
warning in the U. S., which is another important differentiator relative to both CII stimulants and the current non-stimulants in use today
to treat ADHD.

Our Phase 2 trial showed significant
improvement in ADHD symptoms, met all primary and secondary study endpoints and was well-tolerated and with no clinically significant
adverse effects over placebo. In light of its innovative mechanism of action and low potential for abuse, we believe Nolazol, if approved
for marketing, could represent a highly differentiated alternative to the CII treatments in use today to treat ADHD.

Nolazol Clinical Trial Results

Phase 2 Clinical Trial

We completed a Phase 2 clinical
trial in 2017 in the United States, in which Nolazol was well-tolerated and 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-adjusted
effect size of 1.09 in the investigator-rated ADHD symptom scores. We believe that the magnitude of this effect is comparable to currently
leading CII stimulants and considerably larger than the available non-stimulant treatment options.

The table below summarizes
the results of our Phase 2 clinical trial in adults in terms of adverse events.

Our 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-week double-blind optimization period, followed by a three-week double-blind fixed dosing