Company: SMNR
Filing Date: 2025-08-13
Form Type: 424B3
Source: 0001193125-25-179226
Chunk: 140

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-08-13
Form: 424B3
Chunk 140
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 to the adequacy of the preclinical data package to support clinical development of SP-102 and their overall general agreement with the use of 
 SP-102 in the intended patient population in the intended manner;                                                                                                            |

| • |     | the initiation and successful patient enrollment and completion of additional clinical trials of SP-102 on a timely basis; |

| • |     | the frequency and severity of adverse events (“AEs”) in the clinical trials; |

| • |     | maintaining and establishing relationships with contract research organizations (“CROs”) and clinical 
 sites for the clinical development of SP-102 both in the United States and internationally;           |

| • |     | successful completion of toxicology studies, biodistribution studies and minimally efficacious dose studies in 
 animals, where applicable;                                                                                     |

| • |     | successful completion of clinical trials, under the FDA’s current Good Clinical Practices 
 (“GCP”) and the FDA’s current Good Laboratory Practices (“GLPs”);                         |

| • |     | effective investigational new drug applications or Clinical Trial Authorizations that allow commencement of our 
 planned clinical trials or future clinical trials for our product candidates;                                   |

| • |     | the efficacy, safety and tolerability profiles that are satisfactory to the FDA, EMA or any comparable foreign 
 regulatory authority for marketing approval;                                                                   |

| • |     | the timely receipt of marketing approvals for our product candidates from applicable regulatory authorities; |

| • |     | the extent of any required post-marketing approval commitments to applicable regulatory authorities; |

| • |     | the maintenance of existing or the establishment of new supply arrangements with third-party suppliers and 
 manufacturers for clinical development of SP-102;                                                          |

| • |     | the maintenance of existing, or the establishment of new, scaled production arrangements with third-party        
 manufacturers to obtain finished products that are appropriate for commercial sale of SP-102, if it is approved; |

| • |     | obtaining and maintaining patent protection, trade secret protection and regulatory exclusivity, both in the 
 United States and internationally;                                                                           |

| • |     | a continued acceptable safety profile following any marketing approval; |

| • |     | commercial acceptance by patients, the medical community and third-party payors; |

| • |     | our ability to obtain coverage and adequate reimbursement from third-party payors for our product candidates, if         
 approved, and patients’ willingness to pay out-of-pocket in the absence of such coverage and adequate reimbursement; and |

| • |