Company: SCLXW
Filing Date: 2025-05-07
Form Type: POS AM
Source: 0001193125-25-115054
Chunk: 252

Company: Scilex Holding Co
Filing Date: 2025-05-07
Form: POS AM
Chunk 252
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 ITT: intent-to-treat(randomized population); SD: standard deviation Responder Analysis (Change from Baseline in Mean NPRS, Average Daily Pain in Affected Leg) (1)– ITT Population

|                                              |     | SP-102            
 N=202             |     | Placebo 
 N=199   |            |
| 30% reduction                                |     | 88 (43.6%)        |     |         | 57 (28.6%) |
| Chi-Square                                   |     | P=0.002           |     |         |            |
| Logistic regression(2) (odds ratio [95% CI]) |     | 1.96 (1.28, 2.98) |     |         |            |
|                                              |     | P=0.002           |     |         |            |
| 50% reduction                                |     | 58 (28.7%)        |     |         | 41 (20.6%) |
| Chi-Square                                   |     | P=0.060           |     |         |            |
| Logistic regression(2) (odds ratio [95% CI]) |     | 1.58 (0.99, 2.52) |     |         |            |
|                                              |     | P=0.055           |     |         |            |

| (1) | Patients that discontinued or have missing scores at Week Four were considered non-responders. |

| (2) | Logistic regression models with treatment (SP-102 or placebo), site, and Pain Catastrophizing Scale group (<30 or ≥30), and baseline averaged daily pain score as factors were used to compare the treatment groups at each week. |

CI: confidence interval; ITT: intent-to-treat(randomized population) 164

Phase 2 Repeat Dose Study - SP-102-03

We conducted an open-label, single-arm, pharmacodynamics (“PD”) and tolerability study of repeat epidural injections of SP-102 in patients with sciatica. We conducted this study to characterize repeat dose PD with respect to hypothalamic-pituitary-adrenal suppression using plasma cortisol levels, white blood cell count and blood glucose levels.

The study enrolled 19 subjects, of which 15 received repeat SP-102 epidural injections four to eight weeks after the initial injection. Four of the subjects did not experience recurrent pain and thus did not require a repeat injection. The daily