Company: SMNR
Filing Date: 2025-08-08
Form Type: S-4/A
Source: 0001193125-25-177097
Chunk: 506

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-08-08
Form: S-4/A
Chunk 506
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| (2) | Quartiles are estimated using Kaplan-Meier estimation. |

| (3) | A Cox proportional hazards model was utilized to test the treatment difference while adjusting for site and Pain Catastrophizing Scale (<30 or ≥30). |

CI: confidence interval; 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           |     |            |

303

| (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) Interpreting Clinical Meaningfulness of SP-102 for the Treatment of LRP: a Post-Hoc Analysis of the CLEAR-1 Trial and a Systematic Review of Literature Analgesic clinical trial studies performed to assess the efficacy of a pharmacological interventions produce results that require interpretation to fully understand their clinical meaningfulness. Commonly, these results are misinterpreted, with the most common source of confusion arising when the magnitude of group differences (typically between active and placebo) are conflated with the determination of the magnitude of improvement within subjects (as