Company: SMNR
Filing Date: 2025-07-23
Form Type: S-4/A
Source: 0001193125-25-163401
Chunk: 507

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-07-23
Form: S-4/A
Chunk 507
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S, 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           |     |            |

304

| (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 assessed by subjects and/or clinicians) that can be considered clinically important. Consequentially, substantial work by researchers, clinicians, and regulatory authorities has been done to establish consensus benchmarks for what constitutes clinically meaningful changes. The analgesic efficacy of SP-102 for the treatment of LRP was evaluated in the pivotal Phase 3 CLEAR-1 clinical trial. The objective of this post-hoc analysis was to interpret the clinical