Company: NCEL
Filing Date: 2025-07-29
Form Type: F-4/A
Source: 0001213900-25-068765
Chunk: 359

Company: NewcelX Ltd.
Filing Date: 2025-07-29
Form: F-4/A
Chunk 359
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 of life and increased frequency of depressive symptoms, similar to narcolepsy. To the best of NLS’s knowledge, 169 almost all of the treatments used in ADHD have mechanistic overlap with treatments used in narcolepsy for EDS and researchers suggest that the symptoms of EDS, fatigue, and sleep fragmentation may be the cause for ADHD symptoms, which is consistent with similar findings in other hypersomnia disorders. Business Strategy NLS’s goal is to continue building a differentiated, global biopharmaceutical company that is patient -focusedon the development of transformative therapies that address critical unmet needs in rare and complex CNS and neurodevelopmental disorders, such as Central Disorders of Hypersomnolence (which include narcolepsy as well as IH) and ADHD. As NLS navigates the competitive landscape of its industry, while focusing on development of its product candidates, NLS also intends to continually seek out -licensingand asset sale transactions that it believes will allow it to drive greater value for its shareholders. The key elements of NLS’s business strategy are to: •globally develop Quilience for narcolepsy in adults (lead project); •pursue new indications beyond narcolepsy (e.g., Quilience in IH) (follow -onprojects); and •explore expansion of NLS’s growing product pipeline either through in -houseinnovation or in -licensing. NLS’s Portfolio and Lead/Follow-On Product Candidates Quilience for Treatment of EDS and Cataplexy in Narcolepsy (Lead Product Candidate) Narcolepsy is a rare chronic primary sleep disorder characterized by two main symptoms: • EDS: This symptom is the inability to stay awake or alert throughout the day and, in general, EDS interferes with normal activities on a daily basis, whether or not a person with narcolepsy has sufficient sleep at night. People with EDS report mental cloudiness, lack of energy and concentration, memory lapses, depressed mood, and/or extreme exhaustion. • Cataplexy: This symptom consists of a sudden loss of muscle tone that leads to muscle weakness and a loss of voluntary muscle control, while being fully conscious. It can cause symptoms ranging from slurred speech to total body collapse, depending on the muscles involved, and is often triggered by intense emotions such as surprise, laughter, or anger. Nearly all patients diagnosed with narcolepsy require lifelong treatment to combat the daily and debilitating symptoms, yet, most continue to suffer because a large portion remain undi