Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 157

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 157
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 the presence/absence of
sleep disturbances.

On the other hand, problems
with sleep may represent an intrinsic component of ADHD. The presence of ADHD symptoms in children and adolescents with narcolepsy has
been found to be about two-fold higher than in the general control population and adults with narcolepsy have been found to have a much
greater likelihood of having a diagnosis of ADHD in childhood compared to the general control population. Hyperactivity seen in ADHD may,
in fact, be a compensatory response for individuals who are under-aroused or sleepy and ADHD symptoms contribute to poor quality of life
and increased frequency of depressive symptoms, similar to narcolepsy. To the best of our knowledge, almost all of the treatments used
in ADHD have mechanistic overlap with treatments used in narcolepsy for EDS and researchers suggest that the symptoms of EDS, fatigue,
and sleep fragmentation may be the cause for ADHD symptoms, which is consistent with similar findings in other hypersomnia disorders.

Business Strategy

Our goal is to continue building
a differentiated, global biopharmaceutical company that is patient-focused on the development of transformative therapies that address
critical unmet needs in rare and complex CNS and neurodevelopmental disorders, such as Central Disorders of Hypersomnolence (which include
narcolepsy as well as IH) and ADHD. As we navigate the competitive landscape of our industry, while focusing on development of our product
candidates, we also intend to continually seek out-licensing and asset sale transactions that we believe will allow us to drive greater
value for our shareholders. The key elements of our business strategy are to:

  globally                                                    

  pursue                                                                               

  explore                                                                                        

Our Portfolio and Lead/Follow-On Product Candidates

Quilience for Treatment of EDS and Cataplexy
in Narcolepsy (Lead Product Candidate)

Narcolepsy is a rare chronic
primary sleep disorder characterized by two main symptoms:

  EDS:                                                                                                                                       

  Cataplexy:                                                                                                                               

Nearly all patients diagnosed
with narcolepsy require lifelong treatment to combat the daily and debilitating symptoms, yet, most continue to suffer because a large
portion remain undiagnosed and/or because of inadequate treatments. One FDA approved medication for both EDS and cataplexy associated
with narcolepsy, sodium oxybate franchise (Xyrem/Xywav), although marketed with significant limitations impeding its use, generated revenues
of over $2.0 billion in 2022 according to