Company: SXTPW
Filing Date: 2025-03-27
Form Type: S-1/A
Source: 0001013762-25-003353
Chunk: 52

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: S-1/A
Chunk 52
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 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; |

| ● | unforeseen                                                                  
 safety issues, including negative results from ongoing preclinical studies; |

| ● | inability                                                 
 to monitor patients adequately during or after treatment; |

| ● | difficulty                                          
 recruiting and monitoring multiple study sites; and |

| ● | failure                                                                                   
 of our third-party contract research organizations, clinical site organizations and other 
 clinical trial managers, to satisfy their contractual duties, comply with regulations or  
 meet expected deadlines; and                                                              |

| ● | an                                                                                       
 insufficient number of patients who have, or are willing to have, a device implanted for 
 monitoring and recording data.                                                           |

30 In addition, any approvals we may obtain may not cover all of the clinical indications for which we seek approval or permit us to make claims of superiority over currently marketed competitive products. Also, an approval might contain significant limitations in the form of narrow indications, warnings, precautions or contraindications with respect to conditions of use. If the FDA determines that a risk evaluation and mitigation strategy (“REMS”) is necessary to ensure that the benefits of the drug outweigh the risks, we may be required to include as part of the NDA a proposed REMS that may include a package insert directed to patients, a plan for communication with healthcare providers, restrictions on a drug’s distribution, or a medication guide to provide better information to consumers about the drug’s risks and benefits. Finally, approval could