Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 95

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 95
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 conclusions regarding the results of those trials.
The clinical trial process may fail to demonstrate that its products or a product candidate is safe and effective for the proposed indicated
use, which could cause it to stop seeking additional clearances or approvals for its product candidates. Any delay or termination of Kadimastem’s
clinical trials will delay the filing of its regulatory submissions and, ultimately, Kadimastem’s ability to commercialize a product
candidate. It is also possible that patients enrolled in clinical trials will experience adverse side effects that are not currently part
of the product candidate’s profile.

Kadimastem’s drug substances and product
candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the
commercial potential or result in significant negative consequences following regulatory 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, disp