Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 170

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 170
---
), at week 3 -5.0 (1.18) versus -1.6
(1.09) (p=0.0045), and at week 4 -5.8 (1.23) versus -2.1 (1.14) (-6.26, -1.15; p=0.0045).

Observed Mean Change from
Baseline in ESS:

The change from baseline to
Week 4 in the weekly average number of cataplexy episodes decreased over time in both treatment groups. The change from Baseline to Week
4 in Average Weekly Cataplexy Episodes was statistically significantly greater in the Mazindol ER group (mean [SD] - 14.3 [9.50])
than in the placebo group ( - 6.1 [6.30]) (p = 0.019) despite the smaller sample size (only 1/3 of the study population were NT1 patients).

Observed Mean Change from
Baseline in Weekly Cataplexy Episodes:

The treatment arms were balanced
in terms of patient demographics, baseline levels, and disease characteristics. Mazindol ER was well-tolerated and no safety concerns
were identified. No serious adverse events were reported.

Mazindol ER was generally
safe and well-tolerated in the completed Phase 2 trial. There were 66 patients in the Safety Population (all patients who received at
least one dose of Mazindol ER). Treatment emergent adverse events (TEAEs), were reported by 48.5% (16/34) of patients receiving Mazindol
ER and 23.5% (8/33) of patients receiving placebo. There were no unexpected adverse events. There were no severe and no serious TEAEs
reported for either the placebo or the Mazindol ER groups. In addition, no patients discontinued Mazindol ER due to TEAEs. The most common
TEAEs for the Mazindol ER group was dry mouth (21.2% [7/34]) followed by nausea (9.1% [3/34]), and decreased appetite (9.1% [3/34]). The
most common TEAEs for the placebo group were dry mouth (2.9% [1/34]), urinary tract infection, (2.9% [1/34]), and headache (2.9% [1/34]).
Other than an expected reduction in body weight (~1