Company: NCEL
Filing Date: 2025-02-05
Form Type: F-3
Source: 0001213900-25-010223
Chunk: 109

Company: NewcelX Ltd.
Filing Date: 2025-02-05
Form: F-3
Chunk 109
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 growth, enhance research and development capabilities, and improve            
 financial performance as a result of the potential merger with Kadimastem is subject to uncertainties, 
 including unforeseen costs and integration issues;                                                     |

| ● | the                                                                                             
 re-scheduling of Mazindol ER in the United States by the U.S. Drug Enforcement Agency following 
 approval by the FDA;                                                                            |

| ● | the                                                                                   
 launch of a different formulation or different dosage of Mazindol by another company; |

| ● | the                                                                                             
 use of Quilience (Mazindol ER) in a compassionate use program, or CUP, and the results thereof; |

| ● | obtaining                                                                                        
 EMA and FDA approval of, or other regulatory action in Europe or the United States and elsewhere 
 with respect to, Quilience, Nolazol NLS-4, or other product candidates that we may seek to       
 develop;                                                                                         |

| ● | the                                                                                         
 commercial launch and future sales of Quilience and/or Nolazol, or any other future product 
 candidates;                                                                                 |

| ● | the                                                             
 dosage of Quilience, Nolazol, and or any of our pipeline drugs; |

| ● | our                                                                                            
 ability to move NLS-3, NLS-8, NLS-11, NLS-12 and any of our Aexon Labs (Dual) Orexin compounds 
 (recently secured through an in-license) into investigational new drug enabling studies;       |

| ● | our                                                                                           
 expectations regarding the timing of commencing further clinical trials, the process entailed 
 in conducting each such trial, including dosages, and the order of such trials with each      
 of our product candidates or whether such trials will be conducted at all;                    |

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| ● | improved                                                                                    
 convenience relating to the prescription of and use of Nolazol for prescribers and patients 
 (and their parents);                                                                        |

| ● | our                                            
 expectations regarding the supply of mazindol; |

| ● | third-party                                                                   
 payor reimbursement for Quilience, Nolazol, and or any of our pipeline drugs; |

| ● | our                                                                                         
 estimates regarding anticipated expenses, capital requirements and our needs for additional 
 financing;                                                                                  |

| ● | changes                                                                                  
 to the narcolepsy patient market size and market adoption of Quilience by physicians and 
 patients;                                                                                |

| ● | the