Company: NCEL
Filing Date: 2025-09-03
Form Type: F-4/A
Source: 0001213900-25-084157
Chunk: 131

Company: NewcelX Ltd.
Filing Date: 2025-09-03
Form: F-4/A
Chunk 131
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, 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 or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of its product candidates and jeopardize its ability to commence sales and generate revenues. International expansion of its business exposes it to business, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States, Switzerland or the EU. Other than its headquarters and other operations which are located in Switzerland and its wholly owned U.S. subsidiary, NLS Pharmaceutics Inc., a Delaware corporation (as further