Company: NCEL
Filing Date: 2025-06-09
Form Type: F-4/A
Source: 0001213900-25-052354
Chunk: 173

Company: NewcelX Ltd.
Filing Date: 2025-06-09
Form: F-4/A
Chunk 173
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 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 -clinicaland clinical development of Kadimastem’s product candidates, namely AstroRx and/or IsletRx; •developing and obtaining regulatory approval for registration studies protocols for Kadimastem’s product candidates, namely AstroRx ®and/or IsletRx; •subject to successful completion of registration and clinical trials of AstroRx ®and/or IsletRx, applying for and obtaining marketing approval; •establishing and maintaining supply and manufacturing relationships with third parties that can provide adequate (in amount and quality) products, and at acceptable costs, to support market demand for Kadimastem’s product candidates, if marketing approval is received; •identifying, assessing, acquiring and/or developing new product candidates; •accurately identifying demand for Kadimastem’s product candidates; •obtaining market acceptance of Kadimastem’s product candidates, if approved for marketing, as viable treatment options; 67 •negotiating favorable terms in any collaboration, licensing or other arrangements into which Kadimastem may enter; •establishing and nurturing relationships with the leading physicians in the United States; and •attracting, hiring and retaining qualified personnel. Kadimastem does not believe that its current cash on hand will be sufficient to fund its projected operating requirements. This raises substantial doubt about its ability to continue as a going concern. Kadimastem does not believe that its current cash on hand will be sufficient to fund its projected operating requirements. This raises substantial doubt