Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 188

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 188
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 real academic
environment, including the potential for interaction and distraction among children, and allows for assessment by trained observers over
the course of a typical extended school day.

Our Research Pipeline

In addition to our product
candidates, Quilience and Nolazol, we have early and mid-stage compounds that we may seek to further develop in the future. We may seek
to develop these 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 our rare hypersomnia and complex neurodevelopmental disorder franchises. Additionally,
we intend to continue to invest in our discovery research and development programs, with the goal of adding what we believe to be promising
new compounds and indications to our product candidate development pipeline.

NLS-4

NLS-4 is a next-generation
selective dopamine reuptake inhibitor. We believe that NLS-4 is the only wake-promoting compound without any rebound hypersomnia. This
“hypnolytic effect” of NLS-4 is thought to be due to the compound’s ability to prevent increased sleep need following
sleep loss as supported by the recently published pre-clinical results. With the promising results from the cutting-edge preclinical fatigue
study in animals, and the apparent absence of CYP450 enzyme induction, NLS-4 appears 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-promoting agent.

On June 1, 2023, we presented
final results from a preclinical study for NLS-4 at annual meeting of the American Society of Clinical Psychopharmacology (ASCP) in Miami.
The aim of the study was to examine the effectiveness of NLS-4 in comparison with modafinil. NLS-4 is designed to be a more potent next
generation modafinil that does not induce the hepatic toxicity associated with long-term modafinil use. In the study’s Long-COVID
animal model, NLS-4 improved circadian rhythm dysregulation and CFS in subject animals. Based on the results, we believe that NLS-4 should
improve recovery from CFS in humans at a dose that is four times lower than that used for modafinil.

Based on the results, we believe
that NLS-4 offers promise to become a foundational treatment for