Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 89

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 89
---
  failure to conduct the clinical trial in accordance with regulatory  

  inspection of the clinical trial operations or trial sites  

  inspection of the drug substance manufacturing facility by  

  unforeseen safety issues or lack of effectiveness (futility);  

  lack of adequate funding to continue the clinical trial.  

Any of these occurrences may
harm its business, financial condition and prospects significantly. In addition, many of the factors that cause, or lead to, a delay in
the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of its drug substances
and product candidates or result in the development of its drug substances and product candidates being stopped early.

Kadimastem’s development
costs will increase if Kadimastem has material delays in its clinical trials, or if it is required to modify, suspend, terminate or repeat
a clinical trial. If Kadimastem is unable 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