Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 3

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 3
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 regulatory approval, if received, will be within
a timeframe that allows us to effectively compete with our competitors, or be successfully marketed and commercialized.

Our initiation of clinical trials for Quilience
is dependent upon the review and approval of the relevant regulatory agencies and authorities and if we are required to conduct pre-clinical
trials, approval of an NDA or MAA, if any, for Quilience would be delayed and we may require additional capital as a result thereof.

Based in part on the prior
use and FDA approval of mazindol to manage exogenous obesity, we have been able to commence our Phase 2 clinical trials for Quilience
without having to do prior pre-clinical and/or early-stage clinical trials, such as Phase 1 trials. No assurance can be given that the
EMA or FDA will agree to allow us to initiate Phase 3 clinical trials for Quilience without conducting such pre-clinical clinical trials.
If the FDA or EMA, or any other applicable regulatory agency, were to require us to conduct additional pre-clinical trials, our planned
development strategy for Quilience would be materially impacted and approval of an NDA or MAA, if any, for Quilience would be delayed
and we may require additional capital as a result thereof.

In addition, we may request
a Paediatric Investigation Plan, or PIP, deferral in order to delay conducting clinical trials for Quilience in children until after we
receive an MAA from the EMA for the use of Quilience in adults. A PIP deferral, as can be agreed upon by the EMA, allows an applicant
to delay studies in children until after there is sufficient data on use in adults; we anticipate that we will be able to receive a PIP
deferral from the EMA for Quilience; however, there is no guarantee that this deferral will be granted, which could impact our planned
development process and would make the product candidate approval process more costly.

The commencement and completion of clinical
trials can be delayed or prevented for a number of reasons.

We may not be able to commence
or complete the clinical trials that would support our submission of an NDA to the FDA or MAA to the EMA. Drug development is a long,
expensive and uncertain process, and delay or failure can occur at any stage of any of our clinical trials. Clinical trials can be delayed
or prevented for a number of reasons