Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 73

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 73
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 countries;                                                                                                                                                                                                                    |
| ● | different reimbursement systems;                                                                                                                                                                                                                                                                                          |
| ● | economic weakness, including inflation, or political instability in particular foreign economies and markets;                                                                                                                                                                                                             |
| ● | multiple, conflicting and changing laws and regulations such as privacy regulations, tax laws, export and import restrictions, employment laws, regulatory requirements and other governmental approvals, permits and licenses;                                                                                           |
| ● | complexities associated with managing multiple payor reimbursement regimes, government payors or patient self-pay systems;                                                                                                                                                                                                |
| ● | financial risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises on demand and payment for its products and exposure to foreign currency exchange rate fluctuations, which could result in increased operating expenses and reduced revenues; |

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| ● | workforce uncertainty in countries where labor unrest is more common than in the United States;                    |
| ● | production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; |

| ● | regulatory and compliance risks that relate to maintaining accurate information and control over sales and activities that may fall within the purview of the U.S. Foreign Corrupt Practices Act, its books and records provisions or its anti-bribery provisions; |
| ● | potential liability resulting from development work conducted by these distributors; and                                                                                                                                                                           |
| ● | business interruptions resulting from a local or worldwide pandemic, such as geopolitical actions, including war and terrorism, or natural disasters.                                                                                                              |

Any of these factors could
significantly harm its future international expansion and operations and, consequently, Kadimastem’s results of operations.

Even if any of Kadimastem’s
product candidates receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.

The commercial success of
Kadimastem’s products will depend upon the acceptance of each product by the medical community, including physicians, patients and
third-party payors. The degree of market acceptance of any approved product will depend on a number of factors, including:

| ● | the efficacy and safety of the product;                                                                                                                                      |
| ● | the potential advantages of the product compared to available therapies;                                                                                                     |
| ● | the convenience and ease of administration compared to alternative treatments;                                                                                               |
| ● | limitations or warnings, including use restrictions contained in the product’s approved labeling;                                                                            |
| ● | distribution and use restrictions imposed by