Company: SCLXW
Filing Date: 2025-05-14
Form Type: 424B3
Source: 0001193125-25-119831
Chunk: 247

Company: Scilex Holding Co
Filing Date: 2025-05-14
Form: 424B3
Chunk 247
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 are labeled to avoid contact with water such as bathing, swimming or showering, as these products may not stick if they get wet. With ZTlido, patients can engage in these activities within the 12-houradministration period. Investigator-Sponsored Studies We plan to support several investigator-initiated research studies to evaluate the clinical benefits of using ZTlido in patients with carpal tunnel syndrome, neck pain, intercostal neuralgia and other possible indications. SP-102(SEMDEXA) We have completed a Phase 3 pivotal study of SP-102.The CLEAR study is a randomized, double-blind, placebo-controlled Phase 3 trial that enrolled 401 patients with sciatica to compare the epidural administration of SP-102to placebo. We announced final results from this study in March 2022. We also presented the pivotal Phase 3 trial results at the American Society of Interventional Pain Physicians annual meeting in Las Vegas, Nevada in May 2022. Clinical Trial Highlights SP-102has been evaluated in a number of preclinical studies and clinical trials as a potential treatment for sciatica. Key findings from the preclinical studies and clinical trials include:

| • |     | Repeat injections of SP-102 showed continued pain reduction with no              
 unexpected adverse events based on preliminary results from the SP-102-03 study; |

| • |     | SP-102 showed an extended local activity with epidural administration in 
 the ES-1504 study;                                                       |

| • |     | SP-102 showed an extended residence time and tolerability in the 
 1014-1512 and the 1014-2847, preclinical studies; and            |

| • |     | The introduction of SP-102 into blood vessels did not result in             
 neurological complications in the UPD003-IS21 preclinical toxicology study. |

SP-102(SEMDEXA) Study Details Phase 3 Pivotal Clinical Trial — CLEAR We have completed a pivotal, randomized, double-blind, placebo-controlled Phase 3 trial, CLEAR, that enrolled 401 patients with sciatica at over 40 sites across the United States. The study included an open-label extension where subjects were followed for up to 24 weeks after treatment to evaluate the safety of administering SP-102in a larger patient population. After week 4, subjects who met certain pain criteria received open-label SP-102to investigate the safety of repeat injections and the duration of pain relief following injection. This well-controlled, randomized trial was designed to demonstrate evidence of