Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 61

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 61
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 foreign countries until it receive the requisite approval from regulatory authorities in such countries.

Even if Kadimastem completes
its planned clinical trials and believe the results to be successful, all of which are uncertain, obtaining regulatory approval is an
extensive, lengthy, expensive and uncertain process, and the FDA and EMA, and other regulatory authorities may delay, limit or deny approval
of its products for many reasons, including, but not limited to:

| ● | Kadimastem may not be able to demonstrate to their satisfaction that the product candidate is a safe or effective treatment for a given indication; |
| ● | the results of clinical trials may not meet the level of statistical significance or clinical significance required by the regulatory agencies;     |

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| ● | disagreements regarding the number, design, size, conduct or implementation of Kadimastem’s clinical trials, or with its interpretation of data from pre-clinical studies or clinical trials;                                                         |
| ● | a lack of acceptance of the accuracy or sufficiency of the data generated at Kadimastem’s clinical trial sites to demonstrate, among others, that clinical and other benefits outweigh its safety risks or to support the submission of a BLA or MAA; |

| ● | difficulties scheduling an advisory committee meeting in a timely manner or the advisory committee, or such other similar committee, may recommend against approval of Kadimastem’s application or may recommend that such regulators require, as a condition of approval, additional pre-clinical studies or clinical trials, improvements in the manufacturing facility and stability transportation processes and durability limitations on approved labelling, or distribution and use restrictions; |
| ● | the requirement that Kadimastem develop a Risk Evaluation and Mitigation Strategy, or REMS, as a condition of approval, which may or may not be feasible for Kadimastem;                                                                                                                                                                                                                                                                                                                                 |
| ● | the identification of deficiencies in the manufacturing processes in its manufacturing facility or facilities of third-party manufacturers with which Kadimastem enter into agreements for clinical and commercial supplies;                                                                                                                                                                                                                                                                             |
| ● | 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