Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 155

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 155
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 with narcolepsy. A retrospective analysis (Nittur et.al, Sleep Med. 2013 Jan;14(1):30-6) showed that mazindol has         
  a long-term, favorable benefit/risk ratio in 60% of drug-resistant hypersomniacs, including a clear benefit on the two primary symptoms        
  of narcolepsy, EDS and cataplexy.                                                                                                              
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  Quilience is expected to have minimal drug interactions. Based on the results of five in vitro metabolism studies, Mazindol ER has a very low potential for drug interactions In the lab, mazindo...  

  Quilience is being developed as a once-daily oral tablet administered in the morning upon wakening. Patients have identified a need for treatment options that are easier to take, dosed less fre...  
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Leveraging our scientific
insights and direct hands-on clinical experience, we are developing compounds that we believe have innovative mechanisms of action with
positive therapeutic profiles and represent a differentiated treatment option to overcome the limitations of the current therapies. For
example, Quilience and Nolazol are agents that differ significantly from available treatments in their apparent dual mechanism of action.
In addition to their action as a triple monoamine reuptake inhibitor that blocks serotonin, norepinephrine, and dopamine transporters,
they also target the orexin pathway as a selective (in relation to the orexin-1 receptor) partial agonist of the OX2R. This activity could
provide cortical regulation of the lower brain, and thereby lead to improved attention and inhibitory control, while also improving regulation
of executive function and inhibitory control which would provide both “top down” and “bottom up” regulation of
the brain. Orexin neurons (located in a part of the brain known as the hypothalamus) are multi-tasking neurons that serve as key modulators
to several vital functions, including sleep-wake states, attention, feeding behavior, energy homeostasis, reward systems, cognition and
mood throughout the cerebral cortex, and as such, the orexin system is a central promoter of wakefulness. A drug that targets orexin could
potentially increase arousal in individuals with ADHD, which