Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 389

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 389
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 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 Diseases, a team of researchers examined the risk factors and prevalence and impact of Long -COVID, among a representative sample of adults in the U.S. and reported that close to 19 million U.S. adults suffer from Long -COVID. According to a 2023 study by Nature Reviews Microbiology, at least 65 million individuals worldwide are estimated to have Long -COVID, with cases increasing daily. Additional Pre-Clinical Compounds NLS-3 NLS -3(Levophacetoperane SR) is a repurposed reverse ester of methylphenidate, a well -documentedpsychostimulant marketed for treatment of ADHD since the end of the 1950s. Animal experiments and tox studies have demonstrated a very satisfactory safety benefit and more recently, using the behavioral sensitization