Company: NCEL
Filing Date: 2025-02-05
Form Type: F-3
Source: 0001213900-25-010223
Chunk: 23

Company: NewcelX Ltd.
Filing Date: 2025-02-05
Form: F-3
Chunk 23
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 predicted capacity for age, height and gender. Participants on a stable dose of riluzole and/or edaravone or PB/TURSO, and those not taking riluzole and/or edaravone or PB/TURSO at screening are eligible for inclusion as long as they meet specific protocol requirements. Approximately 30 adult participants will be enrolled into the double-blind study with a randomization ratio of 2:1 (20 participants in the AstroRx ®arm and 10 participants in the placebo arm). Kadimastem began preparations for the clinical trial including extensive contact with key opinion leader and clinical centers in the United States and signing a tech-transfer agreement with qualified Contract Development and Manufacturing Organization for the manufacturing of clinical grade AstroRx ®product.

Kadimastem’s AstroRx®
has received orphan drug status from the FDA, a status given to certain drugs called orphan drugs, which show promise in the treatment,
prevention, or diagnosis of orphan diseases. Kadimastem believes that the granting of orphan drug status for the AstroRx®
product is an acknowledgment of the uniqueness and medical potential of the product and will give a significant boost to its entry into
the market once it's approved for marketing. The FDA grants orphan drug status in order to provide an incentive for the development of
drugs and medical treatments. Companies whose drugs have been awarded this status enjoy exclusive marketing rights for the drugs for seven
years after marketing approval is obtained. This recognition is also useful in obtaining grants and financial concessions in development
and registration of drugs for marketing. Orphan drug status provides faster testing tracks and responses from the FDA and other regulatory
agencies.

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Competition

Kadimastem faced substantial competition in all fields of business in which Kadimastem engages. That competition is likely to intensify as new products and technologies reach the market. Superior new products are likely to sell for higher prices and generate higher profit margins if acceptance by the medical community is achieved. Those companies that are successful at being the first to introduce new products and technologies to the market may gain significant economic advantages over their competitors in the establishment of a customer base and track record for the performance of their products and technologies. Such companies will also benefit from revenues from sales that could be used to strengthen their research and development, production, and marketing resources. Companies engaged in the medical products industry face the risk of obsolescence of their products and technologies as more advanced or cost-effective products and technologies are