Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 24

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 24
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iluzole and/or
edaravone or PB (sodium phenylbutyrate) /TURSO (taurursodiol), 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