Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 5

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 5
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(or lack of trial endpoints in exploratory studies), subject population, number of subjects, subject selection criteria, trial duration,
drug dosage and formulation and lack of statistical power in the earlier studies. There can be no assurance that any of our clinical trials
will ultimately be successful or support further clinical development of any of our product candidates. A number of companies in the pharmaceutical
and biotechnology industries have suffered significant setbacks in clinical development even after achieving promising results in earlier
studies, and any such setbacks in our clinical development could have a negative impact on our business.

We may find it difficult to enroll patients
in our clinical trials. Difficulty in enrolling patients could delay or prevent clinical trials of our product candidates.

Identifying and qualifying
patients to participate in clinical trials of our product candidates is critical to our success. The timing of our clinical trials depends
in part on the speed at which we can recruit patients to participate in testing our product candidates, and we may experience delays in
our clinical trials if we encounter difficulties in enrollment.

In addition, as a rare disorder,
there is a limited patient pool from which to draw for our clinical trials for Quilience. Further, the eligibility criteria of our clinical
trials will further limit the pool of available study participants as we will require that patients have specific characteristics that
we can measure or to assure their disease is either severe enough or not too advanced to include them in a study.

Additionally, the process
of finding patients may prove costly. We also may not be able to identify, recruit and enroll a sufficient number of patients to complete
our clinical trials because of the perceived risks and benefits of the product candidate under study, the availability and efficacy of
competing therapies and clinical trials, the proximity and availability of clinical trial sites for prospective patients and the patient
referral practices of physicians. If patients are unwilling to participate in our studies for any reason, the timeline for recruiting
patients, conducting studies and obtaining regulatory approval of our potential product candidates will be delayed.

If we experience delays in
the completion or termination of any clinical trial of our product candidates, the commercial prospects of our product candidates will
be harmed, and our ability to generate product candidate revenue from any of these product candidates could be delayed or prevented. In
addition, any delays in completing our clinical trials will increase our costs, slow down our product candidate development and approval
process and jeopardize our ability to commence product candidate sales and generate revenues. Any of these occurrences may harm our business,
financial condition and prospects