Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 66

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 66
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 approval, if obtained.

During the conduct of clinical
trials, patients may experience changes in their health, including illnesses, injuries, discomforts or a fatal outcome. It is possible
that as Kadimastem develops AstroRx and/or IsletRx, or other drug substances and product candidates that Kadimastem 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 2 and 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 AstroRx and/or
IsletRx, or other drug substances and product candidates that Kadimastem may seek to develop, have side effects or cause serious or life-threatening
side 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
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-clinical studies or clinical trials; |
| ● | Kadimastem may need to voluntarily recall its products; and                                                                                                                      |
| ● | Kadimastem could be sued and held liable for harm