Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 52

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 52
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 | expand the scope of Kadimastem’s current clinical studies for its product candidates; |

| ● | seek regulatory and marketing approvals for Kadimastem’s product candidates that successfully complete clinical studies; |

| ● | establish a sales, marketing, and distribution infrastructure to commercialize Kadimastem’s product candidates;                                                                      |
| ● | seek to identify, assess, acquire, license, and/or develop other product candidates and subsequent generations of Kadimastem’s current product candidates;                           |
| ● | seek to maintain, protect, and expand Kadimastem’s intellectual property portfolio;                                                                                                  |
| ● | seek to attract and retain skilled personnel; and                                                                                                                                    |
| ● | create additional infrastructure to support Kadimastem’s operations as a public company and Kadimastem’s product candidate development and planned future commercialization efforts. |

Kadimastem has not generated revenue from any product candidate and may never be profitable, even if Kadimastem receives regulatory approval to commercialize its products in additional geographical territories and indications.

Kadimastem’s ability
to become profitable depends upon Kadimastem’s ability to generate revenue. To date, Kadimastem have not generated any revenue from
Kadimastem’s development stage product candidates, AstroRx and/or IsletRx. In order to generate significant revenue, it will
need to obtain additional regulatory approvals in jurisdictions within which it already has certain regulatory approvals, and also in
jurisdictions in which it currently has no regulatory approvals to market Kadimastem’s products. Even if Kadimastem’s current
products or any future products are approved for marketing and sale, it anticipates incurring significant incremental costs associated
with commercializing such products.

Kadimastem’s ability
to become profitable depends upon Kadimastem’s ability to generate revenue. To date, Kadimastem has not generated any revenue from
Kadimastem’s development stage product candidates, AstroRx and/or IsletRx, and do not know when, or if, it will generate any
such revenue. Kadimastem does not expect to generate significant revenue unless or until Kadimastem obtains marketing approval of, and
commercializes, AstroRx and/or IsletRx. Kadimastem’s ability to generate future revenue from product candidate sales depends
heavily on its success in many areas, including but not limited to:

| ● | obtaining favorable results from and progress the pre-clin