Company: NCEL
Filing Date: 2025-06-09
Form Type: F-4/A
Source: 0001213900-25-052354
Chunk: 356

Company: NewcelX Ltd.
Filing Date: 2025-06-09
Form: F-4/A
Chunk 356
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inil 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 test in C57BL/6 mice, it has been reported that NLS -3(3 mg/kg) vs methylphenidate (6 mg/kg) or d -amphetamine(2 mg/kg) was not potentially addictive on this contextual sensitization and cross -sensitizationto d -amphetaminetest pointing -outthis stimulant as less addictive than marketed Scheduled II drugs in ADHD. NLS-8 NLS -8(Melafenoxate) is a melatonin ML1A receptor agonist, improved