Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 160

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 160
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 Novartis Pharma AG, whereby we obtained, on an exclusive basis in the U. S., all of
the available data referred to and included in the original NDA for Sanorex® (mazindol) submitted to the FDA in February 1972. The
agreement encompasses all preclinical and clinical studies, data used for manufacturing including stability and other chemistry manufacturing
and controls data, formulation data and know-how for all products containing mazindol as an active substance, and all post-marketing clinical
studies and periodic safety reports from 1973 onwards. Under the agreement, we have obtained the same rights on a non-exclusive basis
in all territories outside of the U. S. except for Japan, with the right to cross-reference the Sanorex® NDA with non-U. S. regulatory
agencies in the licensed territories.

We believe that previous off-label
use of Quilience’s active molecule, mazindol, in treating narcolepsy, which was prescribed under a regulatory authorized CUP in
France for 17 years in patients who failed to respond or could not tolerate the available approved treatments, supports our development
of Quilience. We believe this positive real-world evidence in improving both EDS and reducing cataplexy demonstrates the potential for
Quilience to be a treatment for patients suffering from narcolepsy, and notably, also the potential to provide an alternative treatment
for patients who have not had a successful outcome with approved treatments, such as sodium oxybate, modafinil, methylphenidate-based,
and amphetamine-based products.

In most patients, narcolepsy
is caused by the permanent loss of orexin (also called hypocretin), which has been identified as the major regulator in the brain that
modulates the stability of the sleep-wake cycle. Individuals with narcolepsy often emphasize that their symptoms go beyond falling asleep
during the day and report feeling chronically tired, fatigued, or sleep deprived and also struggle with cognitive difficulties that interfere
with their ability to perform at work or school and devastating cataplexy attacks that can be debilitating and frightening. These impairments
are associated with an increased risk of accidents, trauma, and difficulties in maintaining personal relationships. The economic burden
of narcolepsy is also extensive and people with narcolepsy have above-average rates of health care visits, medication use, and unemployment,
and those employed have lower income levels. According to the Narcolepsy Network