Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 156

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 156
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 could be useful in individuals who have a low level of arousal or motivation,
as is not infrequently the case in individuals with ADHD. To the best of our knowledge, no currently available medication for ADHD or
for the treatment of EDS and cataplexy, the two main symptoms associated with narcolepsy, has effects on the orexin system. In addition
to narcolepsy and ADHD, we believe that our product compound, Mazindol ER, may have therapeutic potential across a range of diverse CNS
conditions such as RLS, IH, OSA, Kleine-Levin-syndrome, daytime sleepiness due to myotonic dystrophy Type 1 (DM1) and Prader Willi Syndrome,
given the mechanism of action.

Relationship Between Narcolepsy and ADHD

Narcolepsy and psychiatric
disorders have a significant but unrecognized relationship in which the two can coexist. However, narcolepsy is frequently misdiagnosed
initially as a psychiatric condition, contributing to the protracted time for accurate diagnosis and treatment. Narcolepsy is a disabling
neurological condition that carries a high risk for development of social and occupational dysfunction. Deterioration in function associated
with narcolepsy may lead to the secondary development of psychiatric symptoms and inversely, the development of psychiatric symptoms can
lead to the deterioration in function and quality of life. The overlap in treatments may further enhance the difficulty to distinguish
between diagnoses.

ADHD is the most common
neurobehavioral disorder characterized by symptoms of inattention, impulsivity and hyperactivity with an estimated prevalence rate
of approximately 4-12% worldwide, as reported by the paper, “ Understanding Attention Deficit/Hyperactivity Disorder from
Childhood to Adulthood,” by Drs. Timothy E. Wilens and Thomas J. Spencer. On the surface, ADHD may appear to be the opposite
of narcolepsy; however, there may actually be significant clinical similarity between the two. Cumulative data about sleep problems
in children and adolescents with ADHD has shown that children with ADHD have had a higher rate of restless sleep, impaired sleep,
and daytime sleepiness than children without ADHD. However, it is unclear whether EDS in ADHD is due to nocturnal sleep disturbances
or primary vigilance disorders because shorter sleep onset latency is assessed by the Multiple Sleep Latency Test, or MSLT (an
objective physiologic measure of sleepiness), in ADHD, rather than in the control group irrespective of