Company: SMNR
Filing Date: 2025-07-02
Form Type: S-4/A
Source: 0001193125-25-154936
Chunk: 155

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-07-02
Form: S-4/A
Chunk 155
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 clinical trial sites or subjects dropping out of a trial; |

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

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

80

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

| • |     | 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 amending or submitting new clinical protocols; |

| • |     | a facility manufacturing our product candidates or any of their components being ordered by the FDA to temporarily or permanently shut down due to violations of cGMP regulations or other applicable requirements; |

| • |     | any changes to our manufacturing process that may be necessary or desired; |

| • |     | third-party clinical investigators losing the licenses or permits necessary to perform our clinical trials and/or not performing our clinical trials on our anticipated schedule or consistent with the clinical trial protocol, GCP, or other regulatory requirements; |

| • |     | third-party contractors not performing data collection or analysis in a timely or accurate manner; or |

| • |     | third-party contractors becoming debarred or suspended or otherwise penalized by the FDA or other government or regulatory authorities for violations of regulatory requirements, in which case we may need to find a substitute contractor, and we may not be able to use some or all of the data produced by subcontractors in support of our marketing applications. |

We could also encounter delays if a clinical trial is suspended or terminated by us, by the IRBs of the institutions in which such trials are being conducted, by a Data Safety Monitoring Board for such trial or by the FDA. Such authorities may impose such a suspension or termination due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, participants being exposed to unacceptable health risks, failure to demonstrate a benefit from using a drug, changes in governmental regulations or