Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 362

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 362
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 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 -stylechanges 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. NLS’s 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 NLS believes 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 decades of highly promising off -labeluse and compassionate use of mazindol in patients with narcolepsy. Quilience Label Expansion Following NLS’s current focus on the development of Quilience for narcolepsy in adults, and if approved for marketing, NLS intends to seek a label expansion for the treatment of narcolepsy in pediatric patients, which may require additional nonclinical and clinical studies. NLS is also aiming to develop Quilience for the treatment of IH, a rare and chronic hypersomnia disorder for