Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 727

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 727
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, which causes the muscles to weaken, start to twitch (fasciculations), and waste away (atrophy). Eventually, in people with ALS, the brain loses its ability to initiate and control voluntary movements such as walking, talking, chewing and other functions, as well as breathing. ALS is progressive, meaning the symptoms get worse over time. The U.S. Food and Drug Administration has approved several drugs for ALS that may prolong survival, reduce the rate of decline, or help manage symptoms. However, there is currently no known treatment that stops or reverses the progression of ALS. Early symptoms include: •Muscle twitches in the arm, leg, shoulder, or tongue •Muscle cramps •Tight and stiff muscles (spasticity) •Muscle weakness affecting an arm, a leg, or the neck •Slurred and nasal speech •Difficulty chewing or swallowing As the disease progresses, muscle weakness and atrophy spread to other parts of your body. People with ALS may develop problems with: •Chewing food and swallowing (dysphagia) •Drooling (sialorrhea)

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Annex E-14

•Speaking or forming words (dysarthria) •Breathing (dyspnea) •Unintended crying, laughing, or other emotional displays (pseudobulbar symptoms) •Constipation •Maintaining weight and getting enough nutrients Eventually, people with ALS will not be able to stand or walk, get in or out of bed on their own, use their hands and arms, or breathe on their own. Because they usually remain able to reason, remember, and understand, they are aware of their progressive loss of function. This can cause anxiety and depression in the person with ALS and their loved ones. Although not as common, people with ALS also may experience problems with language or decision -making. Most people with ALS die from being unable to breathe on their own (known as respiratory failure,) usually within three to five years from when the symptoms first appear. However, about 10% survive for a decade or more. Treating ALS There is no treatment to reverse damage to motor neurons or cure ALS currently. However, some treatments may slow progression of the disease, improve quality of life, and extend survival. New treatments have become available in the past several years, and researchers continue to explore diverse avenues to slow or stop progression of ALS. Supportive health care is best provided by integrated, multi -disciplinaryteams of professionals that may include physicians