Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 748

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 748
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. Quilience has a mechanism of action that is distinct from existing and emerging therapies. If approved, Quilience may represent a substantial improvement to existing treatments. Mazindol’s mechanism of action, which may restore orexin signaling in the brain and further enhance monoamine availability in promoting wakefulness and reducing cataplexy has the potential to be a breakthrough treatment and thereby offering a significant treatment advancement. After obtaining an IND approval mid -2021, the Company initiated a Phase 2 clinical trial in the third quarter of 2021 to evaluate Quilience as a once -dailymonotherapy for the treatment of EDS and cataplexy, the primary symptoms of narcolepsy. This proof -of-concept, or PoC, trial was conducted in approximately 20 -25specialized centers across the U.S. and positive top -lineresults were announced on September 27, 2022. On January 30, 2023, NLS announced the completion of an open label extension study with Quilience(R) (Mazindol ER) for the treatment of narcolepsy. On March 27, 2023, they announced open label extension study six -monthdata for Quilience(R) (Mazindol ER) in the treatment of narcolepsy Type 1 and Type 2. Quilience Label Expansion — following the current focus on the development of Quilience for narcolepsy in adults, and if approved for marketing, NLS intends to seek a label expansion for the treatment of narcolepsy in pediatric patients, which may require additional nonclinical and clinical studies.

| Moore Financial Consulting |

Annex E-37

The Company is also aiming to develop Quilience for the treatment of IH, a rare and chronic hypersomnia disorder for which there are currently no effective or approved treatments available. Its hallmark symptom is chronic EDS and a craving to sleep during the day, regardless of how many hours slept at night, which results in such people taking daytime naps that are usually long and not refreshing. Individuals with IH struggle to wake, despite setting multiple alarms and may have difficulty rising from bed, called sleep inertia. Sleep inertia also includes feelings of grogginess upon waking and can result in impaired alertness and interfere with the ability to perform mental or physical tasks. Like Narcolepsy, people with IH may also suffer from hallucinations and sleep paralysis when going to bed or upon waking. The active molecule in Quilience was also