Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 355

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 355
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 NLS 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 -howfor all products containing mazindol as an active substance, and all post -marketingclinical studies and periodic safety reports from 1973 onwards. Under the agreement, NLS has obtained the same rights on a non -exclusivebasis in all territories outside of the U.S. except for Japan, with the right to cross -referencethe Sanorex ®NDA with non -U.S. regulatory agencies in the licensed territories. NLS believes that previous off -labeluse 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 its development of Quilience. NLS believes this positive real -worldevidence 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 -basedproducts. 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 -wakecycle. 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 171 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 -averagerates of health care visits, medication use, and unemployment, and those employed have lower income levels. According to the Narcolepsy Network, narcolepsy affects an estimated 1 in every