Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 4

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 4
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, including:

  difficulties obtaining regulatory approval to commence a clinical trial or complying with conditions imposed by a regulatory authority regarding the scope or term of a clinical trial;               
  delays in reaching or failing to reach agreement on acceptable terms with prospective contract research organizations, or CROs, and trial sites, the terms of which can be subject to extensive n...  

  insufficient or inadequate supply or quality of a product candidate or other materials necessary to conduct our clinical trials;  

  if the FDA or EMA elect to enact policy changes, as a result of a pandemic threat or otherwise;  
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  difficulties obtaining institutional review board, or IRB, approval to conduct a clinical trial at a prospective site; and                                                                            
  challenges recruiting and enrolling patients to participate in clinical trials for a variety of reasons, including size and nature of patient population, proximity of patients to clinical sites...  

Clinical trials may also be
delayed or terminated as a result of ambiguous or negative interim results. In addition, a clinical trial may be suspended or terminated
by us, the FDA, the IRBs at the sites where the IRBs are overseeing a trial, a data safety monitoring board overseeing the clinical trial
at issue or by other regulatory authorities due to a number of factors, including:

  failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols;  

  inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities;  

  unforeseen safety issues (including those that result from COVID-19) or lack of effectiveness; and  

  lack of adequate funding to continue the clinical trial.  

The results of pre-clinical studies, early-stage
clinical trials, data obtained from real-world use, and published third-party studies may not be indicative of results in future clinical
trials and we cannot assure you that any planned or future clinical trials will lead to results sufficient for the necessary regulatory
approvals.

The results of pre-clinical
studies may not be predictive of the results of clinical trials, and the results of any completed clinical trials, including studies derived
from real-world use and studies in published literature, or clinical trials we commence may not be predictive of the results of later-stage
clinical trials. Additionally, interim results during a clinical trial do not necessarily predict final results. Later clinical trial
results may not replicate earlier clinical trials for a variety of reasons, including differences in trial design, different trial endpoints