Company: SXTPW
Filing Date: 2025-02-14
Form Type: S-1
Source: 0001213900-25-014334
Chunk: 59

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-02-14
Form: S-1
Chunk 59
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 https://ivd.solutions/grant/. |

32 To receive regulatory approval for the commercial sale of any product candidates, we must demonstrate safety and efficacy in humans to the satisfaction of regulatory authorities through preclinical studies and adequate and well-controlled clinical trials of the product candidates. This process is expensive and can take many years, and failure can occur at any stage of the testing. Our failure to adequately demonstrate the safety and efficacy of our product candidates will prevent regulatory approval and commercialization of such products. In the event that we or our collaborators conduct preclinical studies that do not comply with Good Laboratory Practices (“GLP”), or incorrectly design or carry out human clinical trials in accordance with Good Clinical Practices (“GCP”), or those clinical trials fail to demonstrate clinical significance, it is unlikely that we will be able to obtain FDA approval for product development candidates. Our inability to successfully initiate and effectively complete clinical trials for any product candidate on schedule, or at all, will severely harm our business. Significant delays in clinical development could materially increase product development costs or allow our competitors to bring products to market before we do, impairing our ability to effectively commercialize any future product candidate. We do not know whether planned clinical trials will begin on time, will need to be redesigned or will be completed on schedule, if at all. Clinical trials can be delayed for a variety of reasons, including:

| ● | delays                                                                                                                                 
 or failures in obtaining regulatory authorization to commence a trial because of safety concerns of regulators relating to our product 
 candidates or similar product candidates of our competitors or failure to follow regulatory guidelines;                                |

| ● | delays                                                                                                                           
 or failures in obtaining clinical materials and manufacturing sufficient quantities of the product candidates for use in trials; |

| ● | delays                                                                              
 or failures in reaching agreement on acceptable terms with prospective study sites; |

| ● | delays                                                                                                                   
 or failures in obtaining approval of our clinical trial protocol from an Institutional Review Board (“IRB”) to conduct a 
 clinical trial at a prospective study site;                                                                              |

| ● | delays                                                                                                                                    
 in recruiting patients to participate in a clinical trial, which may be due to the size of the patient population, eligibility criteria,  
 protocol design, perceived risks and benefits of the drug, availability of other approved and standard of care therapies or, availability 
 of clinical trial sites;                                                                                                                  |

| ● | other                                                            
 clinical trials seeking to enroll subjects with similar profile; |

| ● | failure                                                                         
 of our clinical trials and clinical investigators to be in compliance with GCP; |

| ● |