Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 129

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 129
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 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 pharmaceutical and biotechnology industries have suffered significant setbacks in clinical development even after achieving promising results in earlier studies, and any such setbacks in its clinical development could have a negative impact on its business. NLS may find it difficult to enroll patients in its clinical trials. Difficulty in enrolling patients could delay or prevent clinical trials of its product candidates. Identifying and qualifying patients to participate in clinical trials of its product candidates is critical to its success. The timing of its clinical trials depends in part on the speed at which NLS can recruit patients to participate in testing its product candidates, and NLS may experience delays in its clinical trials if NLS encounters difficulties in enrollment. In addition, as a rare disorder, there is a limited patient pool from which to draw for its clinical trials for Quilience. Further, the eligibility criteria of its clinical trials will further limit the pool of available study participants as NLS will require that patients have specific characteristics that NLS can measure or to assure their disease is either severe enough or not too advanced to include them in a study. 26 Additionally, the process of finding patients may prove costly. NLS also may not be able to identify, recruit and enroll a sufficient number of patients to complete its 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