Company: NCEL
Filing Date: 2025-06-09
Form Type: F-4/A
Source: 0001213900-25-052354
Chunk: 708

Company: NewcelX Ltd.
Filing Date: 2025-06-09
Form: F-4/A
Chunk 708
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 conditions that include neurological, psychiatric, and substance use disorders. According to the World Health Organization and based on data from the Global Burden of Disease Report, CNS disorders result in a socio -economicburden of more than $317 billion annually in the United States alone. Additionally, CNS disorders were expected to account for approximately 15% of the global disease burden in 2020, the largest of any disease area. However, treatment options for these conditions are often limited, inadequate or non -existent, and the development of new CNS treatments generally trails behind other therapeutic areas. The Company is pursuing the development of the next generation of CNS therapies with high medical impact to address this critical and growing unmet need. Their dual development strategy is designed to optimize the outcome of the clinical programs by developing new chemical entities, or NCE’s, from known molecules with strong scientific rationale, and by re -definingpreviously approved molecules with well -establishedtolerability and safety profiles, as determined by applicable regulatory agencies. NLS believes that its streamlined clinical development approach has the potential to advance its product candidates rapidly through early -stageclinical trials, while carrying an overall lower development risk. A lower development risk, they believe, exists with respect to the development of their lead product candidate, Quilience, and follow -onproduct candidate, due to their use of mazindol as the active ingredient, which was previously approved and marketed in the United States, Japan and Europe to manage exogenous obesity (obesity caused by excessive eating). The Company’s discovery platform currently focuses on single molecules that operate through multiple mechanisms designed to target the complexity of 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