Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 80

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 80
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 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. Kadimastem’s potential competitors include major pharmaceutical companies, specialty pharmaceutical
companies and biotechnology companies worldwide with respect to its products or any future product candidate that Kad