Company: NCEL
Filing Date: 2025-03-31
Form Type: F-4/A
Source: 0001213900-25-026428
Chunk: 685

Company: NewcelX Ltd.
Filing Date: 2025-03-31
Form: F-4/A
Chunk 685
---
ence (which include narcolepsy as well as IH) and ADHD. As we navigate the competitive landscape of our industry, while focusing on development of our product candidates, we also intend to continually seek out -licensingand asset sale transactions that we believe will allow us to drive greater value for our shareholders. The key elements of our 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 our growing product pipeline either through in -houseinnovation or in -licensing. Our 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. According to a September 2021 report from Dun & Bradstreet, the narcolepsy market generated $2.68 billion in 2020 and is projected to reach $6.67 billion by 2030, growing at a compound annual growth rate of 9.6% from 2020 to 203