Company: NCEL
Filing Date: 2025-11-06
Form Type: POS AM
Source: 0001213900-25-106799
Chunk: 23

Company: NewcelX Ltd.
Filing Date: 2025-11-06
Form: POS AM
Chunk 23
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 that will help induce a process of spontaneous regeneration of the damaged tissue/organ by encouraging the adult stem cells that are regularly present in the tissue, divide, differentiate and take their place in the affected area. 12

Factors Affecting Our Performance and Related Trends(See “ Risk Factors — Risks Related to Kadimastem’s Financial Position and Capital Requirements” in the Prospectus) We believe that the key factors affecting our performance and financial performance include: Kadimastem’s ability to generate revenue from a product candidate 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. 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. Kadimastem’s ability to assure that its drug substances and product candidates will receive regulatory approval, which is necessary before they can be commercialized. Kadimastem’s ability to procure regulatory approvals for its product candidates is critical to its success. 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 -GCPE6), 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 ALS, as well as a preclinical proof of concept program, IsletRx, human pancreatic islet like clusters for the treatment of insulin dependent diabetes. Kadimastem’s ability to maintain current cash to fund its projected operating requirements. Kadimastem’s ability to maintain sufficient current cash on hand to fund its projected operating requirements is critical to its success. 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