Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 163

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 163
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 was well-tolerated and effective, in terms of improvement
in EDS and the reduction in cataplexy events, with a conclusion of an overall positive benefit-risk ratio in the majority of patients.
In their report concluding the results of the study (Nittur et. al, Sleep Med. 2013 Jan;14(1):30-6), the researchers found that Mazindol
has a long-term, favorable benefit/risk ratio in 60% of drug-resistant hypersomniacs, including a clear benefit on cataplexy and that
the data, taken altogether, suggest that mazindol has a major effect on sleepiness, possibly greater than that of modafinil (Provigil).

Narcolepsy Overview and Market Opportunity

Narcolepsy is the inability
to stay awake and arises from the dysregulation of the sleep-wake cycle, and in most individuals is thought to be caused by an immune
system mediated destruction of brain cells that contain orexin. Orexin is a neuropeptide and is critical to the maintenance of wakefulness,
continuity of sleep and coordination of the timing and features of REM sleep. Narcolepsy is often debilitating and incapacitating for
those affected and with no known cure, it usually requires life-long symptomatic treatment. Narcolepsy symptoms significantly interfere
with and cause a negative impact on cognitive, psychological and social functioning and can greatly affect daily activities.

The clinical hallmark of narcolepsy
is EDS, which is present in all narcolepsy patients and is generally the first symptom to occur. EDS manifests as sudden irresistible
bouts of sleep throughout the day, which can strike at any time, leading to inadvertently falling asleep during a variety of situations,
such as while at work or at school, when having a conversation, playing a game, eating a meal, or, most dangerously, when driving or operating
other types of machinery. A prominent and distinctive symptom of narcolepsy is cataplexy, which occurs in approximately 70% of those patients
with narcolepsy. Although the severity of cataplexy is variable, it can be very frightening and usually causes additional disability.
In addition to cataplexy, individuals with narcolepsy may also have symptoms indicative of altered REM sleep. REM sleep is normally characterized
by dreaming and muscle paralysis that prevents an individual from acting out their dreams. In narcolepsy however, REM sleep can occur
at any time of day and elements of