Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 19

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 19
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 names of other drug products. The FDA may object
to any product name we submit if it believes the name inappropriately implies medical claims. If the FDA objects to any of our
proposed product names, we may be required to adopt an alternative name for our product candidates, which could result in further
evaluation of proposed names with the potential for additional delays and costs.

Obtaining regulatory approval for clinical
trials of Nolazol in children will be more difficult than obtaining such approvals for adult clinical trials since the requirements for
regulatory approval to conduct pediatric clinical trials are more stringent.

Pediatric drug development
requires additional nonclinical work (such as animal studies in juvenile animals and additional reproductive toxicity work), as well as
staged clinical work in determining safe dosing and monitoring. These additional tasks involve investment of significant additional resources
beyond those needed for approval of the drug for adults. Approval of Nolazol for use in children may be significantly delayed due to these
additional requirements and this may have an adverse effect on the commercial prospects for Nolazol and our ability to generate product
revenues would be delayed, possibly materially. We cannot guarantee that we will receive any regulatory approvals to commercialize our
product candidates in children.

Changes in regulatory requirements and guidance
or unanticipated events during our clinical trials may occur, which may result in necessary changes to clinical trial protocols, which
could result in increased costs to us, delay our development timeline or reduce the likelihood of successful completion of our clinical
trials.

Changes in regulatory requirements
and guidance or unanticipated events during our clinical trials may occur, as a result of which we may need to amend clinical trial protocols.
Amendments may require us to resubmit our clinical trial protocols to IRBs for review and approval, which may impact the cost, timing
or successful completion of a clinical trial. If we experience delays in completion of, or if we terminate, any of our clinical trials,
the commercial prospects for Quilience and Nolazol would be harmed and our ability to generate product revenues would be delayed, possibly
materially.

Our development and regulatory strategy
for our product candidates depends in part on published scientific literature and the FDA’s prior findings regarding the safety
and efficacy of approved products containing mazindol. If the FDA does not conclude that our product candidates satisfy the requirements
for the Section 505(b)(2) regulatory approval pathway, or if the requirements for our product candidates under Section 505(b)(