Company: SMNR
Filing Date: 2025-06-11
Form Type: S-4/A
Source: 0001193125-25-139124
Chunk: 495

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-06-11
Form: S-4/A
Chunk 495
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 more commonly reported in subjects exposed to SP-102 than in subjects not exposed to SP-102 through 12 weeks (6.5% vs 2.1%). Headaches were generally mild, transient, and associated with the epidural injection. Pain at the site of injection was only reported for subjects receiving SP-102 following the initial injection (2.0%) and repeat injection (0.7%). Otherwise, TEAEs occurring ≥2% of subjects were low and balanced between SP-102 and placebo. TEAEs occurring with an incidence ≥2% remained low following the repeat injection. |

| • |     | There were no meaningful differences observed in physical examinations, vital signs, or laboratory parameters between treatment groups. |

The data from the primary endpoint analyses is graphically presented below. Summary tables are also provided for primary and secondary endpoints. Mean Change From Baseline in NPRS Average Pain Score (Standard Error) in the Affected Leg (ITT Population) SP-102vs Placebo Weeks 1,2,3,4: p = 0.002, 0.005, 0.003, 0.003. Overall treatment Effect (Mean SP-102vs Placebo difference): Diff = -0.52,SE= 0.163, p = 0.002. Error Bars: 95% Confidence Limits. 301

Primary and Secondary Outcomes: NPRS Average Leg Pain In Affected Leg, ODI Total Score, Mean Daily NPRS (worst, current, and lower back), PainDetect, BPI-SF(Change from Baseline to Four Weeks; ITT Population)

| Endpoint                                                          |                  | SP-102         
 N=202          |               | Placebo        
 N=199          |     | LSM (SE)      |     | 95% CI       |     | P-value |
|                                                                   | Mean Change      
 from Baseline(1) |                | Mean Change   
 from Baseline |                |     |               |     |              |     |         |
| NPRS Average Pain Score in the Affected Leg (primary endpoint)(2) |                  | -1.81 (1.896)  |               | -1.29 (1.814)  |     | -0.55 (0.187) |     | -0.92, -0.18 |     |   0.003 |
| ODI total score (key secondary endpoint)(3)                       |                  | -8.