Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 88

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 88
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, pure and potent or effective in humans. Further,
the process of obtaining regulatory approval is expensive, often takes many years following the commencement of clinical trials and
can vary substantially based upon the type, complexity and novelty of the drug substances and product candidates involved, as well as
the target indications and patient population. Prior to obtaining approval to commercialize a product candidate in the United States
or abroad, Kadimastem or its potential future collaborators must demonstrate with substantial evidence from adequate and well-controlled
clinical trials, and to the satisfaction of the FDA, or comparable foreign regulatory authorities, that such drug substances and product
candidates are safe and effective for their intended uses. Additionally, clinical testing is expensive and can take many years to
complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial process and its future clinical
trial results may not be successful.

Kadimastem may not be able
to commence or complete the clinical trials that would support its submission of a BLA to the FDA or an MAA to the EMA, and other regulatory
approvals from the Israeli Mistry of Health, or MOH. Drug development is a long, expensive and uncertain process, and delay or failure
can occur at any stage of any of its clinical trials. Clinical trials can be delayed or prevented for a number of reasons, including:

  difficulties obtaining regulatory approval to commence a clinical                                                      

  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 negotiation  
  and may vary significantly among different CROs and trial sites;                                                                              
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  insufficient or inadequate supply or quality of a product               

  if the FDA or EMA elect to enact policy changes;  
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  difficulties obtaining institutional review board, or IRB,       

  challenges recruiting and enrolling patients to participate                                                                               

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 Kadimastem, 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: