Company: SMNR
Filing Date: 2025-08-08
Form Type: S-4/A
Source: 0001193125-25-177097
Chunk: 161

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-08-08
Form: S-4/A
Chunk 161
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eting clinical trials. In addition, the FDA may not approve the labeling claims that are considered necessary or desirable for the successful commercialization of a product candidate. Any of the foregoing scenarios could materially harm the commercial prospects for a product candidate. Additionally, if the results of any clinical trials are inconclusive or if there are safety concerns or SAEs associated with a product candidate, we may:

| • |     | be delayed or fail in obtaining marketing approval for a product candidate; |

| • |     | obtain approval for indications or patient populations that are not as broad as we intended or desired; |

| • |     | obtain approval with labeling that includes significant use or distribution restrictions or safety warnings; |

| • |     | be subject to changes in the way the product candidate is administered; |

| • |     | be required to perform additional clinical trials to support approval or be subject to additional post-marketing testing requirements; |

| • |     | have regulatory authorities withdraw, or suspend, their approval of the product or impose restrictions on its distribution in the form of a modified REMS; |

| • |     | be sued and held liable for harm caused to patients; or |

| • |     | experience damage to our reputation. |

We may find it difficult to enroll or maintain patients in our clinical trials, which could delay or prevent us from proceeding with clinical trials of our product candidates. Identifying and qualifying patients to participate in any clinical trials of our current and future product candidates is critical to our success. The timing of any clinical trials depends on our ability to recruit patients and to complete required follow-upperiods. If patients are unwilling to participate in our clinical trials due to negative publicity from adverse events, competitive clinical trials for similar patient populations, or for other reasons, the timeline for recruiting patients, conducting trials and potentially obtaining regulatory approval may be delayed. 83

We may also experience delays if patients withdraw from a clinical trial or do not complete the required monitoring period. These delays could result in increased costs, delays in advancing our product candidates, delays in testing the effectiveness of our product candidates or termination of clinical trials altogether. Patient enrollment is affected by many factors, including:

| • |     | the size and nature of the patient population; |

| • |     | the proximity of patients to clinical sites; |

| • |     | the eligibility and exclusion criteria for the trial; |

| • |     | the design of the clinical trial; |

| • |     | competing clinical trials; |

| • |