Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 189

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 189
---
 the chronic fatigue associated with the symptoms of Long-COVID (also
known as Myalgic encephalomyelitis/chronic fatigue syndrome, or ME/CFS). We intend 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-19 and 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-documented psychostimulant 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-sensitization to d-amphetamine test pointing-out this stimulant
as less addictive than marketed Scheduled II drugs in ADHD.

NLS-8

NLS-8 (Melafenoxate) is a
melatonin ML1A receptor agonist, improved scopolamine-induced amnesia. In a preclinical study to test the effects of NLS-8 on memory in
a model of Alzheimer’s Disease, the scopolamine-induced amnesia in the novel object recognition test in mice. C57BL/6 male mice,
6 groups (N=16 mice/group), were subjected to two 12-min trials