Company: SMNR
Filing Date: 2025-10-21
Form Type: S-1
Source: 0001193125-25-245178
Chunk: 36

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-10-21
Form: S-1
Chunk 36
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 on schedule, if at all. A failure of one or more clinical trials can occur at any stage of testing. Events that may prevent successful or timely completion of clinical development include:

| • |     | delays in obtaining regulatory authorizations to commence a clinical trial or reaching a consensus with regulatory authorities on trial design; |

| • |     | delays in identifying prospective clinical investigators or clinical trial sites that have necessary qualifications, interest and capacity to perform a requested protocol; |

| • |     | delays in reaching agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites; |

| • |     | delays in obtaining approval from one or more IRBs; |

| • |     | IRBs refusing to approve, suspending or terminating the trial at the investigational site, precluding enrollment of additional subjects, or withdrawing their approval of the trial; |

| • |     | changes to the clinical trial protocol; |

| • |     | delays in recruiting suitable subjects to participate in our clinical trials; |

| • |     | failure by us, any CROs we engage or any other third parties to adhere to clinical trial requirements; |

| • |     | failure to perform in accordance with GCPs; |

| • |     | delays in the testing, validation, manufacturing and delivery of our product candidates to the clinical sites, including delays by third parties with whom we have contracted to perform certain of those functions; |

| • |     | delays in subjects completing participation in a trial or returning for post-treatment follow-up; |

| • |     | clinical trial sites or subjects dropping out of a trial; |

| • |     | key investigators departing their clinical sites; |

| • |     | lack of adequate funding to continue the trial; |

| • |     | selection of clinical endpoints that require prolonged periods of clinical observation or analysis of the resulting data; |

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| • |     | subjects experiencing severe or unexpected drug-related adverse effects; |

| • |     | imposition of a clinical hold by regulatory authorities as a result of a serious adverse event, after an inspection of our clinical trial operations, trial sites or manufacturing facilities, or for other reasons; |

| • |     | occurrence of serious adverse events (“SAEs”) in our trials or in trials of the same class of agents conducted by other sponsors; |

| • |     | changes in regulatory requirements or guidance that require