Company: NCEL
Filing Date: 2025-06-23
Form Type: F-4/A
Source: 0001213900-25-056787
Chunk: 186

Company: NewcelX Ltd.
Filing Date: 2025-06-23
Form: F-4/A
Chunk 186
---
 be delayed, or, if the product candidate has received regulatory approval, such approval may be revoked or limited. Additionally, if any of its drug substances and 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 Kadimastem or others later identify undesirable side effects caused by AstroRx ®and/or IsletRx, 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; •regulatory authorities may issue negative publicity regarding the affected product, including safety communications; •Kadimastem may be required to change the way the product is manufactured, distributed, dispensed or administered, or conduct additional pre -clinicalstudies or clinical trials; •Kadimastem may need to voluntarily recall its products; and •Kadimastem 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. Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay. As drug substances and 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 and/or reduce cost of goods sold. Such changes carry the risk that they will not achieve these intended objectives. Any of these changes could cause its drug substances and 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 Kadimastem’s drug substances and product candidates and jeopardize its ability to commence sales and generate revenue. Legislative or regulatory healthcare reforms in the United States may make it more difficult and costly for