Company: NCEL
Filing Date: 2025-07-29
Form Type: F-4/A
Source: 0001213900-25-068765
Chunk: 762

Company: NewcelX Ltd.
Filing Date: 2025-07-29
Form: F-4/A
Chunk 762
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 impaired alertness and interfere with the ability to perform mental or physical tasks. Like Narcolepsy, people with IH may also suffer from hallucinations and sleep paralysis when going to bed or upon waking. The active molecule in Quilience was also prescribed under compassionate use for the treatment of IH, providing positive real -worldevidence of its benefit in improving EDS specifically in patients with IH. NLS received orphan drug designation from both the FDA and the European Commission for the treatment of IH and this designation is expected to provide them initially with 7 years and 10 years of market exclusivity in the United States and Europe, respectively. Quilience Development Program — NLS conducted a Phase 2 randomized, double -blind, placebo controlled clinical trial in adult patients with narcolepsy in the third quarter of 2021 and concluded the trial in the third quarter of 2022. The primary endpoint of the study was the change from baseline in EDS, as measured by the Epworth Sleepiness Scale (ESS). The key secondary endpoint was the change from baseline in the weekly number of cataplexy attacks in the subset of patients with cataplexy. Given the success of the Phase 2 clinical trial, the Company intends to commence two Phase 3 randomized, double -blind, placebo controlled, parallel studies in adult patients with narcolepsy type 1. In 2023, the Company announced that the FDA provided authorization to proceed with the Phase 3 clinical program (AMAZE) for Mazindol ER. In July 2023, it was 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 IRB approval and the green light from the FDA, NLS has retained a CRO and has enrolled in several sites for the phase 3 studies. Once suitable capital has been secured, the phase 3 program will commence as the sites are ready to begin enrolling patients. Nolazol Nolazol is a triple monoamine reuptake inhibitor and orexin receptor -2partial agonist, and its unique pharmacological profile is expected to yield important benefits compared to existing treatments of ADHD. Enhancing the function of the three neurotransmitters well -knownto be implicated in ADHD, norepinephrine, dopamine and serotonin, along with its activity