Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 167

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 167
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 behaviors, and involuntary movements. Sodium
oxybate has a short half-life and is administered in a split dose, once at bedtime and again two and a half to four hours later, which
can be difficult for patients to manage. In addition, generally, an extensive titration period is required, which can take upwards of
seven months to achieve a complete optimal response.

Many patients with narcolepsy
have cardiovascular risk concerns, including hypertension, and treatment with sodium oxybate contributes 1,100-1,640 milligrams, or mg,
to an individual’s daily sodium intake, in comparison to a total daily intake of 1,500 mg as recommended by the American Heart Association.
Additionally, life-style changes are also often needed when being treated with sodium oxybate, including the avoidance of alcohol and
other medications that may cause sedation and due to its profound sedation and hypotonic effects, a change in living arrangements may
be needed if living alone or the need to seek different and multiple treatment options when becoming a parent. Yet, despite these severe
limitations, sodium oxybate continues to be the market leader in the United States in terms of revenues.

Our Solution: Quilience for Narcolepsy -
A Well-Suited Approach for the Disease Pathology

Narcolepsy is a debilitating
neurological disorder and the currently available treatment options are not considered sufficiently effective for most patients. This
is highlighted by the results of the recent 2018“ Know Narcolepsy Survey,”conducted by Versta Research, that emphasizes
the continuing and substantial burden of narcolepsy with an astonishing 88% of patients indicating that their current treatments are not
effectively managing their symptoms, while 94% and 93% stated that new treatment options are needed and expressed frustration with current
treatment options, respectively.

Quilience has a mechanism
of action that is distinct from existing and emerging therapies and we believe that, if approved, Quilience may represent a substantial
improvement to existing treatments. Mazindol’s mechanism of action, which may restore orexin signaling in the brain and further
enhance monoamine availability in promoting wakefulness and reducing cataplexy has the potential to be a breakthrough treatment and thereby
offering a significant treatment advancement. Furthermore, in November 2019, the Swiss Narcolepsy Network endorsed Quilience as a potential
novel treatment of narcolepsy. The Swiss Narcolepsy Network stated that its decision is based on several