Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 60

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 60
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 to conduct its clinical trials properly and on schedule, marketing approval may be delayed or
denied by the FDA, EMA, MOH, and other regulatory authorities.

Kadimastem cannot market and sell its cell therapy drug substances and product candidates in the United States, Europe, or in other countries if it fails to obtain the necessary regulatory approvals or licensure.

Kadimastem cannot sell its
cell therapy drug substances and product candidates until regulatory agencies grant marketing approval, or licensure. The process of obtaining
regulatory approval is lengthy, expensive, and uncertain. It is likely to take at least several years to obtain the required regulatory
approvals for its cell therapy product candidates, or it may never gain the necessary approvals.

Any difficulties that Kadimastem
encounters in obtaining regulatory approval may have a substantial adverse impact on its operations and cause its share price to decline
significantly.

To obtain marketing approvals
in the United States and Europe for cell therapy drug substances and product candidates Kadimastem must, among other requirements, complete
carefully controlled and well-designed clinical trials sufficient to demonstrate to the FDA, the EMA and the PMDA that the cell therapy
drug substances and product candidates is safe and effective for each disease for which Kadimastem seeks approval. Several factors could
prevent completion or cause significant delay of its clinic trials, including an inability to enroll the required number of patients or
failure to demonstrate adequately that cell therapy drug substances and product candidates are safe and effective for use in humans. Negative
or inconclusive results from or adverse medical events during a clinical trial could cause the clinical trial to be repeated or a program
to be terminated, even if other studies or trials relating to the program are successful. The FDA or EMA can place a clinical trial on
hold if, among other reasons, it finds that patients enrolled in the trial are or would be exposed to an unreasonable and significant
risk of illness or injury. If safety concerns develop, Kadimastem, the FDA, the EMA or other regulatory bodies could stop its trials before
completion, which could harm its business, operating results, prospects or financial condition.

Obtaining approval of a BLA or a MAA even after clinical trials that are believed to be successful is an uncertain process.

Kadimastem are not permitted
to market its products in the United States or the EU until it receives regulatory approval of a BLA from the FDA or MAA from the EMA,
or in any