Company: SCLXW
Filing Date: 2025-05-14
Form Type: 424B3
Source: 0001193125-25-119822
Chunk: 240

Company: Scilex Holding Co
Filing Date: 2025-05-14
Form: 424B3
Chunk 240
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 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; |

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| • |     | 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 the analgesic effect and safety of SP-102.The schematic of this Phase 3 trial is demonstrated in the flowchart below. The primary objective of this study was to evaluate the analgesic effect of SP-102on average leg pain, measured using the NPRS following a single transforaminal injection