Company: NCEL
Filing Date: 2025-06-09
Form Type: F-4/A
Source: 0001213900-25-052354
Chunk: 101

Company: NewcelX Ltd.
Filing Date: 2025-06-09
Form: F-4/A
Chunk 101
---
 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. 25 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 experience 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 -