Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 83

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 83
---
 increasing operating losses for the foreseeable future. Because of the numerous risks and uncertainties associated
with developing drug substances and product candidates, Kadimastem is unable to predict the extent of any future losses or when Kadimastem
will become profitable, if at all.

Kadimastem expects to continue
to incur significant losses until Kadimastem is able to commercialize Kadimastem’s product candidates, which it may not be successful
in achieving. Kadimastem anticipate that Kadimastem’s expenses will increase substantially if and as we:

  continue the research and development of Kadimastem’s  

  expand the scope of Kadimastem’s current clinical studies  

  seek regulatory and marketing approvals for Kadimastem’s         

  establish a sales, marketing, and distribution infrastructure  

  seek to identify, assess, acquire, license, and/or develop                                       

  seek to maintain, protect, and expand Kadimastem’s intellectual  

  seek to attract and retain skilled personnel; and  

  create additional infrastructure to support Kadimastem’s                                                                     

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