Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 367

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 367
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 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, patients must be at least 18 years of age and have been diagnosed with narcolepsy with cataplexy. As agreed with the FDA, NLS intends to submit the NDA for Quilience as a new NDA. Nevertheless, a large amount of the original NDA data will be used for this submission. To license the original mazindol data, NLS entered into an agreement with Novartis in March 2021 to obtain all preclinical and clinical data for studies previously conducted on mazindol by Novartis. This data may potentially provide NLS another avenue to streamline and/or reduce the costs of its preclinical and clinical programs. NLS’s ability to rely on the FDA’s