Company: NCEL
Filing Date: 2025-07-29
Form Type: F-4/A
Source: 0001213900-25-068765
Chunk: 759

Company: NewcelX Ltd.
Filing Date: 2025-07-29
Form: F-4/A
Chunk 759
---
 the CNS disease state, and these may potentially offer new treatment options for patients, including for those patients who are refractory to currently available treatments. NLS recently announced pre -clinicalresults of NLS -4, the next -generationwake -promotingdrug candidate, for the chronic fatigue syndrome, or CFS, associated with the symptoms of Long -COVID, also known as Chronic Fatigue, caused by COVID -19infection. The Company’s current focus is in the therapeutic areas of rare hypersomnia disorders (conditions highlighted by EDS) and complex neurodevelopmental disorders, and includes it’s lead product candidate: Quilience, for the treatment of EDS and cataplexy associated with narcolepsy, and the follow -oncandidate Nolazol, for the treatment of ADHD. In the third quarter of 2021 the company initiated its clinical development with a Phase 2 clinical trial, in adult patients with narcolepsy and published positive interim top -lineresults from the Phase 2 clinical trial in March 2022. The company intends to apply for expedited development program(s) facilitated by the FDA, such as Breakthrough Therapy and/or Fast Track designations and by the European Medicines Agency, or EMA, such as PRIME. NLS completed a Phase 2 clinical trial evaluating the safety and efficacy of Nolazol in adults with ADHD in the U.S. Although further clinical development of Nolazol in ADHD is on hold, given the positive outcome of this trial, NLS may initiate Phase 3 clinical trials after it receives approval to commercialize Quilience. They also intend to seek FDA and other regulatory approval for Nolazol for use in children with ADHD, which requires additional nonclinical work, as well as staged clinical work in determining safe dosing and monitoring. In addition, following its current focus on the development of Quilience for narcolepsy in adults, and if approved for marketing, they intend to seek a label expansion for the treatment of narcolepsy in pediatric patients, which may require additional pre -clinicaland clinical studies.

| Moore Financial Consulting |

Annex E-36

Quilience and Nolazol both contain mazindol as the active ingredient in a proprietary controlled release, or CR, formulation developed for a once -a-daydosing. Mazindol has a well -establishedsafety record from its extended history of clinical use across the United States and several countries in Europe, where mazindol