Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 358

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 358
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 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 undiagnosed and/or because of inadequate treatments. One FDA approved medication for both EDS and cataplexy associated with narcolepsy, sodium oxybate franchise (Xyrem/Xywav), although marketed with significant limitations impeding its use, generated revenues of over $2.0 billion in 2022 according to Jazz Pharmaceuticals’ 2022 full year financial results issued on March 1, 2023. On October 15, 2024, CoherentMI published a report titled “Narcolepsy Market Outlook 2024 – 2031,” which estimated that the global narcolepsy market would be valued at approximately $ 2.53 billion in 2024, and projected it would grow to $ 4.68 billion by 2031, reflecting a CAGR of 9.3% over the forecast period. As partial agonist of the OX2R and a triple monoamine reuptake inhibitor, NLS believes that Quilience reflects a unique mechanism of action to address the shortcomings of the approved medications and the unmet needs of patients. Quilience is being designed as an oral,