Company: SCLXW
Filing Date: 2025-05-14
Form Type: 424B3
Source: 0001193125-25-119846
Chunk: 60

Company: Scilex Holding Co
Filing Date: 2025-05-14
Form: 424B3
Chunk 60
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 • |     | 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;                                                                                           |

| • |     | 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 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; |

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| • |     | 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 administrative actions or lack of adequate funding to continue the clinical trial. In addition, changes in