Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 91

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 91
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 REMS as a condition  
  of approval, which may or may not be feasible for Kadimastem;  
 ─────────────────────────────────────────────────────────────────

  the identification of deficiencies in the manufacturing processes                                                                      

  changes in approval policies or the adoption of new regulations  
  by such regulators; and                                          
 ───────────────────────────────────────────────────────────────────

  Kadimastem may be unable to be granted a PIP deferral which                                                                               
  Kadimastem intends to request from the EMA for clinical trials in children; this may delay Kadimastem’s clinical trial program            
  or approvals for adults, or it may have successful clinical trial results for adults but not children (if Kadimastem were required to     
  conduct pediatric studies prior to the receipt of a BLA or MMA for use of its drug substances and product candidates in adults), or vice  
  versa.                                                                                                                                    
 ────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────

Before Kadimastem can submit
BLA to the FDA, Kadimastem must conduct Phase 3 clinical trials, that will be substantially broader than its Phase 2 trials.
A BLA must be supported by extensive clinical and pre-clinical data, as well as extensive information regarding chemistry, manufacturing
and controls to demonstrate the safety and effectiveness of the applicable product candidate. The number and types of pre-clinical studies
and clinical trials that will be required varies depending on the product candidate, the disease or condition that the product candidate
is designed to target and the regulations applicable to any particular product candidate. Obtaining approval of a BLA is a lengthy, expensive
and uncertain process, and Kadimastem may not be successful in obtaining approval. The FDA review processes can take years to complete
and approval is never guaranteed.

In this respect,
Kadimastem will also need to agree on a protocol with the FDA for the Phase 3 clinical trials before commencing those trials.
Phase 3 clinical trials frequently produce unsatisfactory results even though prior clinical trials were successful. Therefore,
the results of the additional trials that it conducts may or may not be successful. The FDA may suspend all clinical trials or
require that Kadimastem conducts additional clinical, nonclinical, manufacturing improvements, manufacturing validation or drug
substances quality studies and submit those data before it will consider or reconsider the BLA. Depending on the extent of
these or any other