Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 57

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 57
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em and NLS; |

| ● | retain Kadimastem’s relationships with its customers and successfully integrate NLS into these existing relationships; |

| ● | integrate the NLS and Kadimastem senior management teams; |

| ● | retain and integrate key NLS and Kadimastem employees; |

| ● | successfully address Kadimastem’s existing liabilities; |

| ● | coordinate operations across time zones, continents and cultures; |

| ● | manage the diversion of management’s attention from business matters to integration issues; |

| ● | retain customers; and |

| ● | combine Kadimastem’s business and management culture with the business and management culture of NLS. For more information, please see “Risks Related to the Merger” and “Risks Related to NLS After the Consummation of the Merger.” |

Risks Related to Product Development, Regulatory Approval and Commercialization

Kadimastem depends substantially on the success of its proprietary product candidates. Kadimastem cannot give any assurance that any of its drug substances and product candidates will receive regulatory approval, which is necessary before they can be commercialized.

Kadimastem has invested almost
all of its efforts and financial resources in research and development of Kadimastem’s drug substances, as defined by the Harmonised
Tripartite Guideline for Good Clinical Practice (ICH-GCP E6), and product candidates and general and administrative costs. Kadimastem’s
portfolio comprises a clinical program, AstroRx, human astrocytes derived from pluripotent stem cells for the treatment of neurodegenerative
diseases such as Amyotrophic Lateral Sclerosis, or ALS, as well as a preclinical proof of concept program, IsletRx, human pancreatic islet
like clusters for the treatment of insulin dependent diabetes. The process to develop, obtain regulatory approval for and commercialize
pharmaceutical drug substances and product candidates is long, complex, costly, and inherently uncertain of outcome. Kadimastem are not
permitted to market any of its drug substances and product candidates in the United States, European Union, or the EU, or any other jurisdiction
until Kadimastem receives the requisite regulatory approvals. Kadimastem cannot give any assurance that its current clinical development
plan will proceed as planned, that its product candidates will receive regulatory approval, or that such regulatory approval, if received,
will be within a timeframe that allows Kadimastem to effectively compete with