Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 383

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 383
---
 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 chronic disease with a worldwide prevalence of 0.3 – 0.8% in the human population. Profound mental and physical fatigue and cognitive impairment are amongst the key symptoms of ME/CFS. ME/CFS is classified by the World Health Organization as a neurological disease. In a recent study published in the journal, Clinical Infectious