Company: NCEL
Filing Date: 2025-09-03
Form Type: F-4/A
Source: 0001213900-25-084157
Chunk: 374

Company: NewcelX Ltd.
Filing Date: 2025-09-03
Form: F-4/A
Chunk 374
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 178 For patients diagnosed with cataplexy and treated with Mazindol ER in the randomized Phase 2 trial, the mean number of weekly cataplexy episodes was approximately 10 at the end of the 4 -weekDB 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 NLS’s Phase 2 clinical trial, NLS intends to commence two identical, placebo -controlledPhase 3 trials in adult patients with narcolepsy type 1. On March 29, 2023, NLS met with the FDA for an end of Phase 2 meeting. On May 2, 2023, NLS announced that the FDA provided authorization to proceed with the Phase 3 clinical program (AMAZE) for Mazindol ER. In July 2023, NLS announced that the first Phase 3 clinical trial protocol received approval from the independent IRB. The AMAZE Program encompasses two almost -identicaldouble -blindPhase 3 studies (N=50 each) investigating Mazindol ER versus placebo in adult patients with narcolepsy. Along with 179 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, NLS expects 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, NLS intends to conduct these studies in parallel with its Phase 3 program, subject to agreement with the FDA and other applicable regulatory authorities. Both phase 3 trials, NLS -1031and NLS -1032, will measure the weekly cataplexy episodes as the primary endpoint over eight weeks of treatment. Patients will then continue into a 12 -monthOLE phase of each study. To be eligible for enrollment into the program