Company: NCEL
Filing Date: 2025-07-29
Form Type: F-4/A
Source: 0001213900-25-068765
Chunk: 390

Company: NewcelX Ltd.
Filing Date: 2025-07-29
Form: F-4/A
Chunk 390
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 other compounds, comprising of NCEs, as well as repurposed compounds, in order to build a pipeline of product candidates at various stages of development that further complement NLS’s rare hypersomnia and complex neurodevelopmental disorder franchises. Additionally, NLS intends to continue to invest in its discovery research and development programs, with the goal of adding what NLS believes to be promising new compounds and indications to its product candidate development pipeline. NLS-4 NLS -4is a next -generationselective dopamine reuptake inhibitor. NLS believes that NLS -4is the only wake -promotingcompound without any rebound hypersomnia. This “hypnolytic effect” of NLS -4is thought to be due to the compound’s ability to prevent increased sleep need following sleep loss as supported by the recently published pre -clinicalresults. With the promising results from the cutting -edgepreclinical fatigue study in animals, and the apparent absence of CYP450 enzyme induction, NLS -4appears to have a superior profile compared to the widely used drug modafinil, and potentially represents an important milestone in the development of this next generation wake -promotingagent. On June 1, 2023, NLS presented final results from a preclinical study for NLS -4at annual meeting of the American Society of Clinical Psychopharmacology (ASCP) in Miami. The aim of the study was to examine the effectiveness of NLS -4in comparison with modafinil. NLS -4is designed to be a more potent next generation modafinil that does not induce the hepatic toxicity associated with long -termmodafinil use. In the study’s Long -COVIDanimal model, NLS -4improved circadian rhythm dysregulation and CFS in subject animals. Based on the results, NLS believes that NLS -4should improve recovery from CFS in humans at a dose that is four times lower than that used for modafinil. Based on the results, NLS believes that NLS -4offers promise to become a foundational treatment for the chronic fatigue associated with the symptoms of Long -COVID(also known as Myalgic encephalomyelitis/chronic fatigue syndrome, or ME/CFS). NLS intends to advance the clinical development of NLS -4, as the unmet medical need for improved fatigue treatments is growing with more patients surviving infection with COVID -19and its variants. ME/CFS is a debilitating