Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 59

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 59
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| ● | 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;                                                                                                                                            |
| ● | insufficient or inadequate supply or quality of a product candidate or other materials necessary to conduct its clinical trials;                                                                                                                                                                                                                                                                                        |
| ● | if the FDA or EMA elect to enact policy changes;                                                                                                                                                                                                                                                                                                                                                                        |
| ● | 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, eligibility criteria for the trial, nature of trial protocol, the availability of approved effective treatments for the relevant disease and competition from other clinical trial programs for similar indications. |

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:

| ● | failure to conduct the clinical trial in accordance with regulatory requirements or its clinical protocols; |
| ● | inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities;      |
| ● | inspection of the drug substance manufacturing facility by the FDA or other regulatory authorities;         |
| ● | unforeseen safety issues or lack of effectiveness (futility); and                                           |
| ● | lack of adequate funding to continue the clinical trial.                                                    |

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Any of these occurrences may
harm its business, financial condition and prospects significantly. In addition, many of the factors that cause, or lead to, a delay in
the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of its drug substances
and product candidates or result in the development of its drug substances and product candidates being stopped early.

Kadimastem’s development
costs will increase if Kadimastem has material delays in its clinical trials, or if it is required to modify, suspend, terminate or repeat
a clinical trial. If Kadimastem is unable