Company: SCLXW
Filing Date: 2025-12-29
Form Type: 424B3
Source: 0001193125-25-335429
Chunk: 55

Company: Scilex Holding Co
Filing Date: 2025-12-29
Form: 424B3
Chunk 55
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 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 institutional review boards (“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; |

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| • |     | 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;                                                                                           |

| • |     | 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