Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 728

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 728
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, pharmacists, physical, occupational, speech, and respiratory therapists, nutritionists, social workers, clinical psychologists, and home care and hospice nurses. These teams can design an individualized treatment plan and provide special equipment aimed at keeping people as mobile, comfortable, and independent as possible. Doctors may use the following medications approved by the U.S. Food and Drug Administration (FDA) to support a treatment plan for ALS: •Riluzole (Rilutek) is an oral medication believed to reduce damage to motor neurons by decreasing levels of glutamate, which transports messages between nerve cells and motor neurons. Clinical trials in people with ALS showed that riluzole may prolong survival by a few months. The thickened liquid form (Tiglutik) or the tablet (Exservan) that dissolves on the tongue may be preferred if the person has swallowing difficulties. •Edaravone (Radicava) is an antioxidant given either orally or intravenously and has been shown to slow functional decline in some people with ALS. RADICAVA ORS is a form of edaravone that can be taken orally or via feeding tube. •Sodium phenylbutyrate/taurursodiol (Relyvrio) is an oral medication that was proposed to prevent nerve cell death by blocking stress signals in cells. The FDA approved Relyvrio based on safety and efficacy data from a single, smaller ALS clinical trial in September 2022. However, a larger clinical trial failed to confirm the earlier findings, and the manufacturer of Relyvrio removed the drug from the market in 2024. •Tofersen (Qalsody) is given through a spinal injection to people with ALS who have been determined to have a mutation in the SOD1 gene. While the benefits of this drug are still under study, it may work by decreasing one of the markers of damage to neurons.

| Moore Financial Consulting |

Annex E-15

ALS Prevalence In The following table can be found data regarding the prevalence of ALS in the population of the US, Japan and the five European largest economies 1 2 3:

|          |     |             |     | Prevalence |     |        |
| Country  |     | Population1 |     |   per 100k |     |  Total |
| USA2     |     | 345,426,571 |     |       8.63 |     | 29,824 |
| Germany