Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 122

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 122
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ufficient 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; •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, 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 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 NLS cannot assure you that any planned or future clinical trials will lead to results sufficient for the necessary regulatory approvals. The results of pre -clinicalstudies may not be predictive of the results of clinical trials, and the results of any completed clinical trials, including studies derived from real -worlduse and studies in published literature, or clinical trials NLS commence may not be predictive of the results of later -stageclinical 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 (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 its clinical trials will ultimately be successful or support further clinical development of any of its product candidates. A number of companies in the