Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 152

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 152
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 in other rare and complex CNS disorders. CNS disorders are a diverse group of 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-economic burden 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. We are pursuing the
development of the next generation of CNS therapies with high medical impact to address this critical and growing unmet need. Our
dual development strategy is designed to optimize the outcome of our clinical programs by developing new chemical entities, or
NCE’s, from known molecules with strong scientific rationale, and also by re-defining previously approved molecules with
well-established tolerability and safety profiles, as determined by applicable regulatory agencies. We believe that our streamlined
clinical development approach has the potential to advance our product candidates rapidly through early-stage clinical trials, while
carrying an overall lower development risk. A lower development risk, we believe, exists with respect to the development of our lead
product candidate, Quilience, and follow-on product 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).

Our discovery platform currently
focuses on single molecules that operate through multiple mechanisms designed to target the complexity of the CNS disease state, and,
we believe these may potentially offer new treatment options for patients, including for those patients who are refractory to currently
available treatments. We recently announced pre-clinical results of NLS-4, our next-generation wake-promoting drug candidate, for the
chronic fatigue syndrome, or CFS, associated with the symptoms of Long-COVID, also known as Chronic Fatigue caused by COVID -19 infection.

Our current focus is in the
therapeutic areas of rare hypersomnia disorders (conditions highlighted by EDS) and complex neurodevelopmental disorders, and includes
our lead product candidate: Quilience, for the treatment of EDS and cataplexy associated with narcolepsy, and our follow-on candidate
Nolazol, for the