Company: NCEL
Filing Date: 2025-06-09
Form Type: F-4/A
Source: 0001213900-25-052354
Chunk: 330

Company: NewcelX Ltd.
Filing Date: 2025-06-09
Form: F-4/A
Chunk 330
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’ recent likelihood of falling asleep in everyday activities and is the same primary outcome measure widely used in other narcolepsy -relatedPhase 3 clinical trials. An analysis was also performed assessing the effectiveness of mazindol in controlling cataplexy in 62 patients and demonstrated a statistically significant reduction in the frequency of cataplexy episodes (p<0.0001). The ESS score before mazindol was 18.0 ± 3.1 and decreased to 13.6 ± 5 after mazindol, for a change of -4.2 (p<0.0001). In addition, the change in weekly cataplexy rate before and after mazindol changed from 4.6 ± 3.1 (before mazindol) to 2.0 ± 2.8 after mazindol (for a change of -2.7) (p<0.0001). This retrospective study with analysis of real -worlddata, provides positive real -worldevidence that the treatment was well -toleratedand effective, in terms of improvement in EDS and the reduction in cataplexy events, with a conclusion of an overall positive benefit -riskratio in the majority of patients. In their report concluding the results of the study (Nittur et.al, Sleep Med. 2013 Jan;14(1):30 -6), the researchers found that Mazindol has a long -term, favorable benefit/risk ratio in 60% of drug -resistanthypersomniacs, including a clear benefit on cataplexy and that the data, taken altogether, suggest that mazindol has a major effect on sleepiness, possibly greater than that of modafinil (Provigil). Narcolepsy Overview and Market Opportunity Narcolepsy is the inability to stay awake and arises from the dysregulation of the sleep -wakecycle, and in most individuals is thought to be caused by an immune system mediated destruction of brain cells that contain orexin. Orexin is a neuropeptide and is critical to the maintenance of wakefulness, continuity of sleep and coordination of the 168 timing and features of REM sleep. Narcolepsy is often debilitating and incapacitating for those affected and with no known cure, it usually requires life -longsymptomatic treatment. Narcolepsy symptoms significantly interfere with and cause a negative impact on cognitive, psychological and social functioning and can greatly affect