Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 161

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 161
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, narcolepsy affects an estimated 1 in every 2,000 people
in the United States, which equates to 150,000 to 200,000 patients in the United States and 3 million worldwide; however, it is estimated
that only 25% of those living with narcolepsy have been diagnosed and are receiving treatment. Most people with narcolepsy begin having
symptoms in their teenage years, but the diagnosis is usually not made until adulthood, suggesting that narcolepsy is both an underdiagnosed
and an undertreated disorder. According to the August 2018 National Know Narcolepsy Survey, most narcolepsy patients remain unsatisfied
on current treatments.

While symptomatic improvement
is possible, patients’ needs are usually not met and the therapeutic effects of the currently approved treatments remain inadequate
for most patients, including lack of symptom control, variable efficacy, rebound sleepiness and rebound cataplexy, troublesome side effects,
inconvenience, and high potential for abuse. Given the considerable burden of the condition, the adverse effects on the health of narcolepsy
patients, and the limitations of available medications, there is a critical unmet need for additional treatment options. Quilience is
a triple monoamine reuptake inhibitor, a SNDRI and partial agonist of the OX2R that may mimic the natural sleep-wake process by activating
and further enhancing the brain mechanisms that promote and regulate wakefulness. We believe Quilience may bridge this considerable treatment
gap and that the current narcolepsy landscape may provide an opportunity to establish ourselves as a leader in this space.

Real-World Evidence in Narcolepsy

The use of real-world evidence
may improve the quality and efficiency of clinical development and clinical trial design, with the potential to accelerate the development
of therapies that may provide meaningful benefits to patients. Real-world evidence is the analysis of real-world data, which can originate
from sources such as CUPs, and may provide a more complete picture of patient experience to inform patient-focused drug development, and
support the advancement of randomized, placebo-controlled clinical trials to support a marketing application.

While no longer commercially
available in the United States or Europe, the active molecule in Quilience, mazindol, was previously widely used off-label and for several
decades for the treatment of narcolepsy. Additionally, it was prescribed under a long-term CUP administered and regulated by ANSM (“ L’agence
nationale de