Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 74

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 74
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 the EMA, FDA or other regulatory authority or agreed to by Kadimastem as part of a mandatory or voluntary risk management plan; |
| ● | pricing and cost effectiveness in relation to alternative treatments;                                                                                                        |
| ● | if the product is included under physician treatment guidelines as a first-, second,- or third-line therapy;                                                                 |
| ● | the strength of sales, marketing and distribution support;                                                                                                                   |
| ● | the availability of third-party coverage and adequate reimbursement and the willingness of patients to pay out-of-pocket in the absence of coverage by third-party payors;   |
| ● | the strength of sales, marketing and distribution support;                                                                                                                   |
| ● | the willingness of patients to pay for drugs out of pocket in the absence of third-party coverage; and                                                                       |
| ● | the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies.                                                        |

If Kadimastem’s products
are approved but do not achieve an adequate level of acceptance by physicians, third party payors and patients, Kadimastem may not generate
sufficient revenue from the product, and Kadimastem may not become or remain profitable. In addition, its efforts to educate the medical
community and third-party payors on the benefits of the product may require significant resources and may never be successful.

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In addition, Kadimastem may
choose to collaborate with third parties that have direct sales forces and established distribution systems, either to augment its own
sales force and distribution systems or in lieu of its own sales force and distribution systems. If Kadimastem enters into arrangements
with third parties to perform sales, marketing and distribution services for its products, the resulting revenues or the profitability
from these revenues to it are likely to be lower than if Kadimastem had sold, marketed and distributed its products itself. If Kadimastem
are unable to enter into such arrangements on acceptable terms or at all, Kadimastem may not be able to successfully commercialize any
of Kadimastem’s product candidates that receive regulatory approval. Depending on the nature of the third-party relationship, Kadimastem
may have little control over such third parties, and any of these third parties may fail to devote the necessary resources and attention
to sell, market and distribute its products effectively. If Kadimastem is not successful in commercializing its product candidates, either
on Kadimastem’s own or through collaborations