Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 211

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 211
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status designation neither shortens the development time nor regulatory review time of a drug nor does it increase the likelihood for
any approval in the regulatory review process. Sponsors requesting designation of the same drug for the same rare disease or condition
as a previously designated product must submit their own data and information to support their designation request. Orphan drug designation
is a separate process from seeking approval or licensing. Drugs for rare diseases go through the same rigorous scientific review process
as any other drug for approval or licensing.

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 developed by competitors. As the industry matures, companies will compete based upon the performance and
cost-effectiveness of their products.

Products for Regenerative Medicine

The cell therapy industry is characterized by
rapidly evolving technology and intense competition. Kadimastem’s competitors include major multinational pharmaceutical companies,
specialty biotechnology companies, and chemical and medical products companies operating in the fields of regenerative medicine, cell
therapy, tissue engineering, and tissue regeneration. Many of these companies are well established and possess technical, research and
development, financial, and sales and marketing resources significantly greater than Kadimastem’s. In addition, certain smaller
biotech companies have formed strategic collaborations, partnerships, and other types of joint ventures with larger, well-established
industry competitors that afford the smaller companies’ potential research and development as well as commercialization advantages.
Academic institutions, governmental agencies, and other public and private research organizations are also conducting and financing research
activities, which may produce products directly competitive to those Kadimastem is developing.

Potential Competition for the AstroRx ®

To the best of Kadimastem’s knowledge, there
is currently no cell/astrocy