Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 166

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 166
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 depression, or ADHD, which further delays treatment.

Current Treatment Landscape and Treatment Limitations

Until a cure is available,
the current treatment of narcolepsy focuses on symptom control, with the goal of keeping the patient alert during the day, primarily by
improving EDS and minimizing the occurrence of cataplexy. More than 90% of individuals with narcolepsy require chronic use of medication
to manage symptoms, in order to allow for important everyday activities to be performed safely, such as attending school, going to work
and caring for a child.

The current available treatment
options require the careful balancing of the drug’s efficacy, convenience of administration, development of drug tolerance, adverse
effects, comorbidities, monitoring for evidence of drug abuse, and new life circumstances, such as school, pregnancy and parenthood. In
narcolepsy, several classes of drugs are used for the treatment of EDS, including a CNS depressive agent, wake-promoting agents, a histamine
3 receptor antagonist/inverse agonist, and CII controlled stimulants.

Sodium oxybate (commercial
brands: Xyrem (Jazz), Xywav (Jazz), Lumryz (Avadel)) is the legally manufactured form of gamma hydroxybutyrate, an illicit drug of abuse.
It was the first FDA approved treatment for cataplexy and is also approved for EDS, and as such, is often used as a first-line therapeutic.
While it has been reported to have a positive impact for patients, sodium oxybate also has many challenges with significant limitations
that can often impede its use. As a severe CNS depressant with a rapid onset of sedation with both hypnotic and amnestic effects, it is
abused to incapacitate victims for sexual assault. Sodium oxybate is a CIII controlled drug and with the potential for an adverse outcome,
it is further subject to higher CI controls for abuse and is only available through an FDA imposed restricted-access REMS program. It
carries a Black Box warning for respiratory depression and abuse, which can lead to seizures, decreased consciousness, coma and death,
and at doses lower than those used to treat narcolepsy. The occurrence of experiencing adverse effects is more common with sodium oxybate
compared to other medications used in narcolepsy and adverse effects, even at recommended doses, include nausea, confusion, CNS and respiratory
depression, neuropsychiatric depression and confusion, bed-wetting, sleepwalking, automatic