Company: SXTPW
Filing Date: 2025-03-27
Form Type: S-1/A
Source: 0001013762-25-003353
Chunk: 35

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: S-1/A
Chunk 35
---
          
 degree of market acceptance by physicians, patients, third-party payors and others in the         
 medical community necessary for commercial success, in which case we may not generate significant 
 revenues or become profitable;                                                                    |

| ● | Any                                                                                                
 future clinical trial for Arakoda will require screening for G6PD deficiency in order to           
 safely administer the product. In the United States, G6PD testing can be obtained through          
 commercial pathology services which is associated with delays. The use of a third-party diagnostic 
 provider of point of care testing may be required and we do not directly control the timing,       
 conduct, expense of such testing or the timing of market entry into the US;                        |

| ● | Our                                                                                             
 product candidates are subject to extensive regulation, which can be costly and time-consuming, 
 and unsuccessful or delayed regulatory approvals could increase our future development costs    
 or impair our future revenue;                                                                   |

| ● | If                                                                                               
 our product candidates receive regulatory approval, we would be subject to ongoing regulatory    
 obligations and restrictions, which will continue to change, and which may result in significant 
 expenses and limit our ability to develop and commercialize other potential products;            |

| ● | We                                                                                            
 have no manufacturing capacity which puts us at risk of lengthy and costly delays of bringing 
 our products to market;                                                                       |

| ● | We                                                                                        
 rely on relationships with third-party contract manufacturers and raw material suppliers, 
 which limits our ability to control the availability of, and manufacturing costs for, our 
 product candidates;                                                                       |

| ● | Our                                                                                              
 future growth depends on our ability to successfully commercialize Arakoda, Tafenoquine (Arakoda 
 or other regimen) for non-malaria prevention indications, Celgosivir and our other product       
 candidates, and we can provide no assurance that we will successfully commercialize Arakoda,     
 Tafenoquine (Arakoda or other regimen) for non-malaria prevention indications, Celgosivir        
 and other product candidates;                                                                    |

| ● | Health                                                                   
 care reform measures could materially and adversely affect our business; |

| ● | Our                                                                                        
 competitors may be better positioned in the marketplace and thereby may be more successful 
 than us at developing, manufacturing and marketing approved products;                      |

19

| ● | We                                                                                           
 compete in an industry characterized by extensive research and development efforts and rapid 
 technological progress. New discoveries or commercial developments by our competitors could  
 render our potential products obsolete or non-competitive;                                   |

| ● | We