Company: NCEL
Filing Date: 2025-07-29
Form Type: F-4/A
Source: 0001213900-25-068765
Chunk: 363

Company: NewcelX Ltd.
Filing Date: 2025-07-29
Form: F-4/A
Chunk 363
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, 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 2,000 people in the United States, which equates to 150,000 to 200,000 patients in the United States and 3 million worldwide; however, it is estimated that only 25% of those living with narcolepsy have been diagnosed and are receiving treatment. Most people with narcolepsy begin having symptoms in their teenage years, but the diagnosis is usually not made until adulthood, suggesting that narcolepsy is both an underdiagnosed and an undertreated disorder. According to the August 2018 National Know Narcolepsy Survey, most narcolepsy patients remain unsatisfied on current treatments. While symptomatic improvement is possible, patients’ needs are usually not met and the therapeutic effects of the currently approved treatments remain inadequate for most patients, including lack of symptom control, variable efficacy, rebound sleepiness and rebound cataplexy, troublesome side effects, inconvenience, and high potential for abuse. Given the considerable burden of the condition, the adverse effects on the health of narcolepsy patients, and the limitations of available medications, there is a critical unmet need for additional treatment options. Quilience is a triple monoamine reuptake inhibitor, a SNDRI and partial agonist of the OX2R that may mimic the natural sleep -wakeprocess by activating and further enhancing the brain mechanisms that promote and regulate wakefulness. NLS believes Quilience may bridge this considerable treatment gap and that the current narcolepsy landscape may provide an opportunity to establish NLS as a leader in this space. Real-World Evidence in Narcolepsy The use of real -worldevidence may improve the quality and efficiency of clinical development and clinical trial design, with the potential to accelerate the development of therapies that may provide meaningful benefits to patients. Real -worldevidence is the analysis of real -worlddata, which can originate from sources such as CUPs, and may provide a more complete picture of patient experience to inform patient -focuseddrug development, and support the advancement of randomized, placebo -controlledclinical trials to support a marketing application. While no longer commercially available in the United States or Europe, the active molecule in Quilience, maz