Company: SMNR
Filing Date: 2025-10-21
Form Type: S-1
Source: 0001193125-25-245178
Chunk: 211

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-10-21
Form: S-1
Chunk 211
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N=199Number of patients with Repeat Injection of SP-102 (patients who received open-label SP-102 between 4 and 20 weeks after initial injection)134 (66.3%)152 (76.4%)Number of censored patients(1)68(33.7%)47(23.6%)Chi-SquareP=0.026Time (days) to Repeat InjectionN134(66.3%)152(76.4%)Mean (SD)67.0(33.31)57.8(31.69)Median57.543.0Min, Max27, 14326, 14825thquantile (95% CI)(2)45(43, 57)36(34, 40)50thquantile (95% CI)(2)84(71, 100)58(50, 69)75thquantile (95% CI)(2)143(141, 143)126(87, 146)Comparison to Placebo(3)(Hazard ratio [95% CI]):0.68(0.54, 0.86)P=0.001139
| (1) | Censored patients are the following: (1) patients who do not receive a repeat injection of SP-102 and (2) patients who discontinued the study prior to Week 20 without receiving a repeat injection. |

| (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                                |