Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 121

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 121
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ilience would be delayed and NLS may require additional capital as a result thereof. Based in part on the prior use and FDA approval of mazindol to manage exogenous obesity, NLS has been able to commence its Phase 2 clinical trials for Quilience without having to do prior pre -clinicaland/or early -stageclinical trials, such as Phase 1 trials. No assurance can be given that the EMA or FDA will agree to allow it to initiate Phase 3 clinical trials for Quilience without conducting such pre -clinicaltrials. If the FDA or EMA, or any other applicable regulatory agency, were to require it to conduct additional pre -clinicaltrials, its planned development strategy for Quilience would be materially impacted and approval of an NDA or MAA, if any, for Quilience would be delayed and NLS may require additional capital as a result thereof. In addition, NLS may request a Paediatric Investigation Plan, or PIP, deferral in order to delay conducting clinical trials for Quilience in children until after NLS receives an MAA from the EMA for the use of Quilience in adults. A PIP deferral, as can be agreed upon by the EMA, allows an applicant to delay studies in children until after there is sufficient data on use in adults; NLS anticipates that NLS will be able to receive a PIP deferral from the EMA for Quilience; however, there is no guarantee that this deferral will be granted, which could impact its planned development process and would make the product candidate approval process more costly. The commencement and completion of clinical trials can be delayed or prevented for a number of reasons. NLS may not be able to commence or complete the clinical trials that would support its submission of an NDA to the FDA or MAA to the EMA. Drug development is a long, expensive and uncertain process, and delay or failure can occur at any stage of any of its clinical trials. Clinical trials can be delayed or prevented for a number of reasons, including: •difficulties obtaining regulatory approval to commence a clinical trial or complying with conditions imposed by a regulatory authority regarding the scope or term of a clinical trial; 25 •delays in reaching or failing to reach agreement on acceptable terms with prospective contract research organizations, or CROs, and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; •ins