Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 24

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 24
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candidates, if approved, we could become subject to significant liability, which would materially adversely affect our business and
financial condition.

Obtaining and maintaining regulatory approval
of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product
candidates in other jurisdictions. Our failure to obtain regulatory approval in foreign jurisdictions would prevent our product candidates
from being marketed abroad, and any approval we are granted for our product candidates in the United States would not assure approval
of product candidates in foreign jurisdictions.

In order to market any products
outside of the United States, we must establish and comply with numerous and varying regulatory requirements of other countries regarding
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 we obtain and maintain regulatory approval of our product candidates in one jurisdiction,
such approval does not guarantee that we 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
pre-clinical 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 we intend to charge for our 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 expenses for conducting complex clinical trials.

Finally, we do not have any
products approved for sale in any jurisdiction, including international markets, and we do not have experience in obtaining regulatory
approval. If we, or any third parties with whom we work, fail to comply with regulatory requirements in the United States or international
markets or to obtain and maintain required approvals or if regulatory approvals in international markets are