Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 169

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 169
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 with either 3mg of Quilience
(Mazindol ER) once daily or placebo. Patients in the trial were randomized 1:1 into each treatment arm. All patients who completed the
Phase 2 POLARIS study were eligible to participate in an open label extension (OLE) study and continued once-a-day treatment with Mazindol
ER 3 mg for up to six months as monotherapy (no concomitant wake-promoting or anti-cataplexy treatments were allowed). On January 30,
2023, we announced that 87% of patients who completed the POLARIS Phase 2 study requested to continue monotherapy treatment with Mazindol
ER in the six-month OLE study rather than transition to other therapies.

In September 2022, we announced
top-line data relating to our Phase 2 POLARIS study for the use of Mazindol ER in patients with narcolepsy. Of the 60 patients targeted
for enrollment in the U. S. Phase 2 trial (Study NLS-1021), 67 were randomized and included in the final analysis. The final database included
33 patients on treatment and 34 patients on placebo, with balanced mean baseline ESS scores (17.9 for treatment and 18.0 for placebo).
Approximately one-third of patients enrolled in the study were diagnosed with narcolepsy type 1 (NT1), and therefore presented with both
EDS and cataplexy symptoms. Eligible NT1 patients must have had moderate to severe disease according to the study protocol - defined as
having more than 3-4 cataplexy attacks per week. Study participants were required to undergo a 1-2-week wash out period (depending on
prior therapy). After the wash out period, participants were randomized to receive either once-daily treatment with Mazindol ER 2mg for
week 1 and 3mg for weeks 2-4, or matching placebo for 4 weeks.

For EDS, the ESS mean change
from baseline to each visit and the standard error (SE) of Quilience® (NLS-2) versus placebo were all statistically significant at
week 1 -4.3 (1.13) versus -1.1 (1.06) (p=0.0055), at week 2 -4.7 (1.14) versus -1.3 (1.06) (p=0.0035