Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 158

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 158
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 Jazz Pharmaceuticals’ 2022 full year financial results issued on March 1, 2023. On October
15, 2024, CoherentMI published a report titled “ Narcolepsy Market Outlook 2024 - 2031,” which estimated that the global
narcolepsy market would be valued at approximately US$ 2.53 billion in 2024, and projected it would grow to US$ 4.68 billion by 2031,
reflecting a CAGR of 9.3% over the forecast period.

As partial agonist of the
OX2R and a triple monoamine reuptake inhibitor, we believe that Quilience reflects a unique mechanism of action to address the shortcomings
of the approved medications and the unmet needs of patients. Quilience is being designed as an oral, once-daily treatment, intended for
long-term use. Through the use of mazindol in Quilience and the expected benefits of our proprietary controlled-release formulation, we
hope that regulatory agencies will conclude that Quilience has a desirable balance of efficacy, safety and tolerability to support marketing
authorization.

We also anticipate developing
additional mazindol based ER product(s) for broader hypersomnia indications, such as IH, where there is a critical unmet need and no currently
approved treatments available, in addition to other disorders, such as neurocognitive disorders implicated by EDS.

Quilience has been granted
orphan drug designation by both the FDA and European Commission for the treatment of narcolepsy, and if approved for marketing in adults,
this designation is expected to provide 7 years and 10 years of market exclusivity in the United States and Europe, respectively, and
with the potential for additional market exclusivity, if and when further developed and approved in pediatrics (extended for an aggregate
of 7.5 years and 12 years in the United States and Europe, respectively). Additionally, we have been granted formulation patents in several
countries including the U. S., Europe, Canada and South Korea for our proprietary ER formulation, which provide patent protection through
2037.

After obtaining an IND approval
mid-2021, we initiated a Phase 2 clinical trial in the third quarter of 2021 to evaluate Quilience as a once-daily monotherapy for the
treatment of EDS and cataplexy, the primary symptoms of narcolepsy. This proof-of-concept, or PoC, trial was conducted in