Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 62

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 62
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 (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 studies, approval of any applications that Kadimastem
submit may be delayed by several years, or may require it to expend more resources than it has available. It is also possible that additional
studies, if performed and completed, may not be considered sufficient by the FDA to approve the BLA. If any of these outcomes occur, Kadimastem
would not receive approval at such time, if any, that it seeks FDA approval. Kadimastem may face similar risks with respect to obtaining
regulatory approval from the EMA at such time, if any, that it seeks EMA approval. The risks that it faces in obtaining applicable approvals
from the FDA and EMA for AstroRx and/or IsletRx, or any other product candidate that it may seek to develop, may also exist with