Company: SCLXW
Filing Date: 2025-08-04
Form Type: S-1
Source: 0001193125-25-172703
Chunk: 258

Company: Scilex Holding Co
Filing Date: 2025-08-04
Form: S-1
Chunk 258
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 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. |

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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-102 vs Placebo Weeks 1,2,3,4: p = 0.002, 0.005, 0.003, 0.003. Overall treatment Effect (Mean SP-102 vs 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), PainDetect, BPI-SF (Change from Baseline to Four Weeks; ITT Population)

| Endpoint                                                          |     | SP-102 N=202     
 Mean Change from 
 Baseline(1)      |                |     | Placebo N=199    
 Mean Change from 
 Baseline         |                |     | LSM (SE) |        |   |     | 95% CI |              |     | P-value |       |
| NPRS Average Pain Score in the Affected Leg (primary endpoint)(2) |     |                  | -1.81(1.896)   |     |                  | -1.29 (1.814)  |     |          | -0.55  
 (0.187 | ) |     |        | -0.92, -0.18 |     |         | 0.003 |
| ODI total score (key secondary endpoint)(3)                       |     |                  | -8.88 (14.684) |     |                  | -5.48 (13.083) |     |          | -3.38  
 (1.388 |