Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 130

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 130
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 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 in the final data. From time to time, NLS may publish interim topline or preliminary data from its clinical trials. Interim data from clinical trials that NLS may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Preliminary or topline data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data NLS previously published. As a result, interim and preliminary data should be viewed with caution until the final data are available. Adverse differences between preliminary or interim data and final data could significantly harm its reputation and business prospects. Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay. As product candidates proceed through pre -clinicalstudies to late -stageclinical trials towards potential approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an effort to optimize processes and results. Such changes carry the risk that they will not achieve these intended objectives. Any of these changes could cause its product candidates to perform differently and affect the results of planned clinical trials or other future clinical trials conducted with the materials manufactured using altered processes. Such changes may also require additional testing, FDA or EMA notification or FDA approval. This could delay completion of clinical trials, require the conduct of bridging clinical trials