Company: SXTPW
Filing Date: 2025-02-14
Form Type: S-1
Source: 0001213900-25-014334
Chunk: 41

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-02-14
Form: S-1
Chunk 41
---
 
 common stock may decline;                                                                                                              |

| ● | There                                       
 is no assurance that we will be profitable; |

| ● | There                                                                                                    
 is no assurance that we will be eligible for Australian government research and development tax rebates; |

| ● | Our                                                                                  
 financial condition and results of operations may be adversely affected by COVID-19; |

| ● | If                                                                                                                                            
 we are not able to successfully develop, obtain FDA approval for, and provide for the commercialization of non-malaria prevention indications 
 for Tafenoquine (Arakoda or other regimen) or Celgosivir in a timely manner, we may not be able to expand our business operations;            |

| ● | Our                                                                                                                                        
 clinical trials for our product candidates may not yield results that will enable us to further develop our products and obtain regulatory 
 approvals necessary to sell them;                                                                                                          |

| ● | We                                                                                                                                        
 expect to depend on existing and future collaborations with third parties for the development of some of our product candidates. If those 
 collaborations are not successful, we may not be able to complete the development of these product candidates;                            |

| ● | Even                                                                                                                                          
 if one of our 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, 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