Company: NCEL
Filing Date: 2025-02-05
Form Type: F-3
Source: 0001213900-25-010223
Chunk: 83

Company: NewcelX Ltd.
Filing Date: 2025-02-05
Form: F-3
Chunk 83
---
 may be required to limit commercialization of its product candidates. Regardless of the merits or eventual outcome, liability claims may result in:

| ● | decreased demand for its                
 drug substances and product candidates; |
| ● | termination of clinical                 
 trial sites or entire trial programs;   |

<div align='center'>57</div>

| ● | injury to its reputation                                                                  
 and negative media attention;                                                             |
| ● | product recalls or increased                                                              
 warnings on product labels;                                                               |
| ● | withdrawal of clinical                                                                    
 trial participants;                                                                       |
| ● | costs of to defend the                                                                    
 related litigation;                                                                       |
| ● | diversion of management                                                                   
 and its resources;                                                                        |
| ● | substantial monetary awards                                                               
 to, or costly settlements with, clinical trial participants, patients or other claimants; |
| ● | higher insurance premiums;                                                                |
| ● | loss of initiation of investigations                                                      
 by regulators or other authorities; and                                                   |
| ● | the inability to successfully                                                             
 commercialize its drug substances and product candidates, if approved.                    |

Kadimastem’s inability to obtain and retain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of products it develops or acquires. Kadimastem intends to obtain product liability insurance covering its clinical trials. Although Kadimastem will maintain such insurance, any claim that may be brought against Kadimastem could result in a court judgment or settlement in an amount that is not covered, in whole or in part, by its insurance or that is in excess of the limits of Kadimastem’s insurance coverage. Kadimastem’s insurance policies also have various exclusions, and it may be subject to a product liability claim for which Kadimastem has no coverage. Kadimastem may have to pay any amounts awarded by a court or negotiated in a settlement that exceed its coverage limitations or that are not covered by its insurance, and Kadimastem may not have, or be able to obtain, sufficient capital to pay such amounts.

Risks Related to Kadimastem’s Business and Industry

The operations and commercialization of stem cell therapies is a new and integral part of the emerging regenerative medicine market, but the field remains in its infancy.

As with all new technologies, products, practices and solutions, there are inherit risks related to Kadimastem’s industry and business.

The field of stem cell therapy is relatively new, and not yet widely adopted by the