Company: SMNR
Filing Date: 2025-08-13
Form Type: 424B3
Source: 0001193125-25-179226
Chunk: 485

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-08-13
Form: 424B3
Chunk 485
---
) associated with the ITT population is 0.28. A statistically significant difference in the mean daily average NPRS pain change between SP-102 and placebo was observed at Week One with a mean                                                                                                                                       
 change from baseline of -1.49 (1.519) for SP-102 and -1.02 (1.472) for placebo (P=0.002), which was maintained through Week Four.                                                                                                                                                                                                                       
 These highly significant differences between SP-102 and placebo were also observed following sensitivity analyses for fixed effects.                                                                                                                                                                                                                    |

| • |     | Likewise for the ITT population, most of the secondary endpoints at four weeks also demonstrated statistically                                                         
 significant results. For the key secondary endpoint of mean change in ODI from baseline, the LS mean treatment difference (SE) for SP-102 was -3.38 (1.388) units [95% 
 CI: -6.11, -0.65] compared to placebo (P=0.015). SP-102 treatment resulted in a -8.88 point reduction from baseline, which                                             
 exceeds the minimal clinically important difference of -8 established in a reported pain study.                                                                        |

| • |     | Additional secondary endpoints with statistically significant results for the ITT population include worst pain                                                                                    
 in affected leg at Week Four (P=0.004) and over four weeks (P=0.001), current pain in the affected leg (P=0.009), average pain in lower back (P=0.035), Brief Pain Inventory-Short Form (“BPI-SF”) 
 for pain severity (P=0.003) and pain interference (P=0.049), PGIC (P<0.001) and CGIC (P<0.001), with the proportion of patients achieving a response at 30% (P=0.002).                             |

300

| • |     | The time to repeat injection (50th quantile [95% CI]) for                                          
 the ITT population was 84 (71, 100) days for SP-102 versus 58 (50, 69) days for placebo (P=0.001). |

| • |     | Additional analyses were performed with the modified ITT population (“mITT”), the population with                                                                                                                   
 fluoroscopically confirmed needle placement. The primary endpoint group mean difference, associated standardized effect size (Cohen’s D), and statistical significance were improved for the mITT population (i.e.,