Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 53

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 53
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ical and 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;                                                                                                                                                                                                           |

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| ● | obtaining market acceptance of Kadimastem’s product candidates, if approved for marketing, as viable treatment options; |
| ● | 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 about Kadimastem’s
ability to continue as a going concern. If Kadimastem cannot continue as a going concern, its investors may lose their entire investment
in its common shares. Until Kadimastem can generate significant revenues, if ever, it expects to satisfy its future cash needs through
debt or equity financing. Kadimastem cannot be certain that additional funding will be available to it on acceptable terms, if at all.
If funds are not available, Kadimastem may be required to delay, reduce the scope of, or eliminate research or development plans for,
or commercialization efforts with respect to its products.

Even if the Merger is completed, Kadimastem expects that it will need to raise substantial additional funding before it can expect to complete the development of AstroRx ®and IsletRx or any other product candidate. This