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

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 16
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 the FDA for the pivotal trials before commencing those trials. Pivotal trials frequently produce unsatisfactory
results even though prior clinical trials were successful. Therefore, the results of the additional trials that we conduct may or may
not be successful. The FDA may suspend all clinical trials or require that we conduct additional clinical, nonclinical, manufacturing
validation or drug product quality studies and submit those data before it will consider or reconsider the NDA. Depending on the extent
of these or any other studies, approval of any applications that we submit may be delayed by several years, or may require us to expend
more resources than we have available. It is also possible that additional studies, if performed and completed, may not be considered
sufficient by the FDA to approve the NDA. If any of these outcomes occur, we would not receive approval for Quilience or Nolazol at such
time, if any, when we seek FDA approval. We may face similar risks with respect to obtaining regulatory approval from the EMA for Quilience,
and for Nolazol, at such time, if any, when we seek EMA approval. The risks that we face in obtaining applicable approvals from the FDA
and EMA for Quilience and/or Nolazol or any other product candidate that we may seek to develop, may also exist with other regulatory
authorities, such as those in Latin America.

Even if we obtain FDA, EMA
or other regulatory approval for Quilience and/or Nolazol, the approval might contain significant limitations related to use restrictions
for certain age groups, warnings, precautions or contraindications, or may be subject to significant post-marketing studies or risk mitigation
requirements. In addition, even if we obtain an MAA from the EMA for the use of Quilience in adults, there can be no guarantee that we
will receive an MAA for Quilience for the use in children. If we are unable to successfully commercialize Quilience and/or Nolazol we
may be forced to cease operations.

The results of clinical trials conducted
at clinical sites outside the United States may not be accepted by the FDA and the results of clinical trials conducted at clinical sites
in the United States may not be accepted by international regulatory authorities.

We are conducting our
Phase 2 clinical trials in the United States. In future, we are planning to conduct Phase 2b and or Phase 3 clinical trials in the
United States