Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 164

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 164
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 REM sleep can mix into wake, manifesting as cataplexy, hallucinations that occur when going to sleep
or upon waking, and sleep paralysis, a transitional state between wakefulness and sleep in which one is aware but cannot move, speak,
or react.

Narcolepsy is classified into
two subtypes, narcolepsy type 1 and narcolepsy type 2. Type 1 is characterized by cataplexy or an undetectable or low level of orexin
in the cerebrospinal fluid, or CSF. In type 2, patients generally have less severe symptoms and do not experience cataplexy attacks. The
underlying cause of narcolepsy type 2 is unknown and many patients have normal CSF orexin levels; however, 25% of patients with narcolepsy
type 2 do have intermediate CSF orexin levels and these individuals are more likely to develop cataplexy and subsequently be diagnosed
with narcolepsy type 1.

Cataplexy is a symptom
that occurs almost exclusively in people with narcolepsy type 1, so its presence strongly suggests this diagnosis. However,
cataplexy can sometimes be subtle or mild, making additional testing sometimes necessary, with the diagnosis depending on ruling out
causes of secondary hypersomnia and performing an overnight sleep test with MSLT. On the MSLT, it takes less than eight minutes on
average for people with narcolepsy type 1 to fall asleep, and REM sleep is observed on at least two naps. People with narcolepsy
type 2 show the same results on MSLT as those with cataplexy.

In addition to EDS, cataplexy
and other symptoms of altered REM sleep, people with narcolepsy type 1 are prone to gain significant weight, which may be due to the loss
of orexin. Soon after narcolepsy onset, children can rapidly gain 5-15 kg (approximately 11 to 33 pounds) and adults with type 1 are often
overweight or obese, despite normal caloric intake and activity levels. Given that the active molecule in Quilience was previously approved
for the management of exogenous obesity and its multifunctional mechanism of action targets two pathways known to be implicated in obesity,
Quilience may also help to counter this negative effect of weight gain associated with narcolepsy.

Recently, we received a granted
patent (U. S