Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 113

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 113
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 clinical trial design, safety and efficacy. The research, testing, manufacturing, labeling, approval,
sale, marketing and distribution of drugs are subject to extensive regulation by the FDA in the United States and other
regulatory authorities in other countries. These regulations differ from country to country. Even if Kadimastem obtains and
maintains regulatory approval of its product candidates in one jurisdiction, such approval does not guarantee that Kadimastem will
be able to obtain or maintain regulatory approval in any other jurisdiction, but a failure or delay in obtaining regulatory approval
in one jurisdiction may have a negative effect on the regulatory approval process in others. For example, even if the FDA grants
marketing approval of a product candidate, comparable regulatory authorities in foreign jurisdictions must also approve the
manufacturing, marketing and promotion of the product candidate in those countries.

Approval procedures vary among
jurisdictions and can involve requirements and administrative review periods different from those in the United States, including
additional nonclinical studies or clinical trials as investigations conducted in one jurisdiction may not be accepted by regulatory authorities
in other jurisdictions. In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before
it can be approved for sale in that jurisdiction. In some cases, the price that Kadimastem intends to charge for its products is also
subject to approval. These regulatory procedures can result in substantial delays in such countries. In other countries, product approval
depends on showing superiority to an approved alternative therapy. This can result in significant expense for conducting complex clinical
trials.

If Kadimastem, or any third
parties with whom it works, fail to comply with regulatory requirements in the United States or international markets, or fail to
obtain and maintain required approvals, or if regulatory approvals in international markets are delayed, Kadimastem’s target market
may be reduced and its ability to realize the full market potential of its products will likely be harmed. The inability to meet continuously
evolving regulatory standards for approval may result in its failing to obtain regulatory approval to market Kadimastem’s current
product candidates, which could significantly harm its business, results of operations and prospects.

Kadimastem’s market is subject to
intense competition, which may result in others commercializing products before or more successfully. If Kadimastem is unable to compete
effectively, its products may be rendered noncompetitive or obsolete, which may adversely affect its operating results.

The development and commercialization
of new products is highly competitive