Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 136

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 136
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 consequences following regulatory approval, if obtained. During clinical trials, patients may experience changes in their health, including illnesses, injuries, discomforts or a fatal outcome. It is possible that as NLS develops Quilience and Nolazol, or other product candidates that NLS may seek to develop, in larger, longer and more extensive clinical trials as use of its product candidates becomes more widespread if they receive regulatory approval, illnesses, injuries, discomforts and other adverse events that were observed in earlier clinical trials, as well as conditions that did not occur or went undetected in previous clinical trials, will be reported by subjects. Many times, side effects are only detectable after investigational products are tested in larger scale, Phase 2b/Phase 3 clinical trials or, in some cases, after they are made available to patients on a commercial scale after approval. If additional clinical experience indicates that Quilience and/or Nolazol, or other product candidates that NLS may seek to develop, have side effects or cause serious or life -threateningside effects, the development of the product candidate may fail or be delayed, or, if the product candidate has received regulatory approval, such approval may be revoked or limited. Additionally, if any of its product candidates receives marketing approval, the FDA or EMA could require it to adopt a REMS to ensure that the benefits outweigh its risks, which may include, among other things, a medication guide outlining the risks of the product for distribution to patients, a communication plan to health care practitioners, and restrictions on how or where the product can be distributed, dispensed or used. Furthermore, if NLS or others later identify undesirable side effects caused by Quilience and/or Nolazol, several potentially significant negative consequences could result, including: •regulatory authorities may suspend or withdraw approvals of such a product candidate; •regulatory authorities may require additional warnings on the label; 34 •regulatory authorities may issue negative publicity regarding the affected product, including safety communications; •NLS may be required to change the way the product is distributed, dispensed or administered, or conduct additional pre -clinicalstudies or clinical trials; •NLS may need to voluntarily recall our products; and •NLS could be sued and held liable for harm caused to patients. Any of these events could prevent it from achieving or maintaining market acceptance of the affected product candidate and could significantly harm its business, prospects, financial condition and results of operations. NLS will need to obtain FDA approval