Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 123

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 123
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 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 practices of physicians. If patients are unwilling to participate in its studies for any reason, the timeline for recruiting patients, conducting studies and obtaining regulatory approval of its potential product candidates will be delayed. If NLS experiences delays in the completion or termination of any clinical trial of its product candidates, the commercial prospects of its product candidates will be harmed, and its ability to generate product candidate revenue from any of these product candidates could be delayed or prevented. In addition, any delays in completing its clinical trials will increase its costs, slow down its product candidate development and approval process and jeopardize its ability to commence product candidate sales and generate revenues. 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 product candidates. Interim topline and preliminary data from its clinical trials that NLS announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes