Company: SCLXW
Filing Date: 2025-12-29
Form Type: 424B3
Source: 0001193125-25-335429
Chunk: 279

Company: Scilex Holding Co
Filing Date: 2025-12-29
Form: 424B3
Chunk 279
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 proportion of subjects in the SP-102 group had treatment emergent AEs (“TEAEs”) than in the placebo                                                                                                                                            |

190

| group, (60 [29.7%] subjects vs 42 [21.1%] subjects with any TEAE). The most common TEAEs by system organ class (SOC) were nervous system disorders: 20 (9.9%) in the 
 SP-102 group, 16 (8.0%) in the placebo group, and 20 (7.0%) in the SP-102 repeat injection group. The most common TEAEs by preferred term (“PT”) were                
 headache, reported in 13 (6.4%) subjects in the SP-102 group, 11 (5.5%) subjects in the placebo group, and 10 (3.5%) subjects the SP-102 repeat injection group.     |

| • |     | Overall, headaches were more commonly reported in subjects exposed to                                                                                                                                
 SP-102 than in subjects not exposed to SP-102 through 12 weeks (6.5% vs 2.1%). Headaches were generally mild, transient, and associated with the epidural injection. Pain                            
 at the site of injection was only reported for subjects receiving SP-102 following the initial injection (2.0%) and repeat injection (0.7%). Otherwise, TEAEs occurring >2% of subjects were low and 
 balanced between SP-102 and placebo. TEAEs occurring with an incidence >2% remained low following the repeat injection.                                                                              |

| • |     | There were no meaningful differences observed in physical examinations, vital signs, or laboratory parameters 
 between treatment groups.                                                                                     |

The data from the primary endpoint analyses is graphically presented below. Summary tables are also provided for primary and secondary endpoints. Mean Change From Baseline in NPRS Average Pain Score (Standard Error) in the Affected Leg (ITT Population) SP-102vs Placebo Weeks 1,2,3,4: p = 0.002, 0.005, 0.003, 0.003. Overall treatment Effect (Mean SP-102vs Placebo difference): Diff = -0.52,SE= 0.163, p = 0.002. Error Bars: 95% Confidence Limits. Primary and Secondary Outcomes: NPRS Average Leg Pain In Affected Leg, ODI Total Score, Mean Daily NPRS (worst, current, and lower back),