Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 172

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 172
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ol ER in the randomized Phase 2 trial, the mean number of weekly cataplexy episodes was approximately
10 at the end of the 4-week DB period, down from a baseline level of approximately 17.5 at the beginning of the trial. During the OLE
study, mean weekly cataplexy episodes for these patients declined to 2.1, and remained relatively stable in the 2 to 4 range through week
24 of the OLE study.

Notably, there were patients
diagnosed with Narcolepsy Type I who achieved zero weekly cataplexy episodes in the OLE study, with some of those maintaining this effect
through week 12 and beyond. Below is an example of one of those super responders:

Given the success of our Phase
2 clinical trial, we intend to commence two identical, placebo-controlled Phase 3 trials in adult patients with
narcolepsy type 1. On March 29, 2023, we met with the FDA for an end of Phase 2 meeting. On May 2, 2023, we announced that the FDA provided
authorization to proceed with the Phase 3 clinical program (AMAZE) for Mazindol ER. In July 2023, we announced that the first Phase 3
clinical trial protocol received approval from the independent IRB. The AMAZE Program encompasses two almost-identical double-blind Phase
3 studies (N=50 each) investigating Mazindol ER versus placebo in adult patients with narcolepsy. Along with IRB approval and the green
light from the FDA, NLS has retained a CRO and has enrolled a number of sites for phase 3 studies. Once suitable capital has been
secured, we expect the phase 3 program to commence as the sites are ready to begin enrolling patients.

Additional clinical studies
may be required for regulatory approval necessary to commercialize Mazindol ER, such as clinical pharmacology studies, and, if needed,
we intend to conduct these studies in parallel with our Phase 3 program, subject to agreement with the FDA and other applicable regulatory
authorities.

Both phase 3 trials, NLS-1031
and NLS-1032, will measure the weekly cataplexy episodes as the primary endpoint over eight weeks of treatment. Patients will then continue
into a 12-month OLE phase of each study. To be eligible for enrollment into the program, patients must be at least 18 years of age and