Company: NCEL
Filing Date: 2025-07-29
Form Type: F-4/A
Source: 0001213900-25-068765
Chunk: 354

Company: NewcelX Ltd.
Filing Date: 2025-07-29
Form: F-4/A
Chunk 354
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 the shareholders and warrant holders of NLS as of immediately prior to the Effective Time pursuant to the terms and conditions of the CVR Agreement, subject to the adjustments set forth therein. NLS’s discovery platform currently focuses on single molecules that operate through multiple mechanisms designed to target the complexity of the CNS disease state, and, it believes 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, NLS’s 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. NLS’s current focus is in the therapeutic areas of rare hypersomnia disorders (conditions highlighted by EDS) and complex neurodevelopmental disorders, and includes its lead product candidate: Quilience, for the treatment of EDS and cataplexy associated with narcolepsy, and its follow -oncandidate Nolazol, for the treatment of ADHD. NLS initiated its clinical development with a Phase 2 clinical trial in the third quarter of 2021, in adult patients with narcolepsy. NLS published positive interim top -lineresults from its Phase 2 clinical trial in March 2022. As a result, NLS 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 has 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 NLS receives approval to commercialize Quilience. NLS also intends 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, NLS intends to seek a label expansion for the treatment of narcolepsy in pediatric patients, which may require additional pre -clinicaland clinical studies. Quilience and Nolazol both contain maz