Company: SMNR
Filing Date: 2025-04-21
Form Type: S-4/A
Source: 0001193125-25-087342
Chunk: 489

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-04-21
Form: S-4/A
Chunk 489
---
 [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           |     |            |

| (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) Phase 2 Repeat Dose Study — SP-102-03 We conducted an open-label, single-arm,pharmacodynamics (“PD”) and tolerability study of repeat epidural injections of SP-102in patients with sciatica. We conducted this study to characterize repeat dose PD with respect to hypothalamic-pituitary-adrenal suppression using plasma cortisol levels, white blood cell count and blood glucose levels. The study enrolled 19 subjects, of which 15 received repeat SP-102epidural injections four to eight weeks after the initial injection. Four of the subjects did not experience recurrent pain and thus did not require a repeat injection. The daily average, current and worst pain in the affected leg and back showed continuous reduction throughout the 28-dayobservation period for both treatments. Based on a preliminary review of the results, SP-102injections were generally well tolerated and there were no new unexpected adverse events observed. Mean Percentage Change in Sciatica-Related Leg Pain as Measured by NPRS Phase 1 Trial of SP-102Compared to RLD—ES-1504 We conducted an open-label, single-arm, two-period,fixed sequential-dose study to evaluate the PK, PD and tolerability of SP-102when administered by epidural injection. SP-102was compared to intravenous dexamethasone sodium phosphate injection in subjects with lumbosacral radiculopathy. There were 12 subjects enrolled in this study