Company: SMNR
Filing Date: 2025-10-21
Form Type: S-1
Source: 0001193125-25-245178
Chunk: 210

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-10-21
Form: S-1
Chunk 210
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 last score prior to |

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#### treatment. Baseline ODI is defined as the last ODI assessment score prior to the first dose on Day 1.(2)The analysis uses a REML-based MMRM with fixed effects for treatment (SP-102 or placebo), week, site, Pain Catastrophizing Scale group (<30 or ≥30), baseline score, and treatment-by-week interaction.(3)The analysis uses an ANCOVA model with fixed effects for treatment (SP-102 or placebo), site, Pain Catastrophizing Scale group (<30 or ≥30), and baseline score.ANCOVA: analysis of covariance; ANOVA: analysis of variance; BPI-SF: Brief Pain Inventory – Short Form; CI: confidence interval; ITT: intent-to-treat (randomized population); LSM: least-squares mean; MMRM: mixed model for repeated measures; NPRS: numeric pain rating scale; REML: restricted maximum likelihood; SE: standard errorPatient Global Impression of Change (PGIC) and Clinical Global Impression of Change (CGIC) – ITT PopulationSP-102N=202PlaceboN=199PGIC Responders (number of patients who responded with “very much improved” or “much improved”(1)71 (35.1%)39 (19.6%)Chi-SquareP<0.001Logistic regression (odds ratio [95% CI])(2)2.25 (1.42, 3.54)P<0.001CGIC Responders (number of patients assessed as “very much improved” or “much improved”(1)76 (37.6%)39 (19.6%)Chi-SquareP<0.001Logistic regression (odds ratio [95% CI])(2)2.49 (1.58, 3.91)P<0.001(1)7-point scale rating patient’s overall improvement. Patient change is rated from “very much improved”, “much improved”, “minimally improved”, “no change”, “minimally worse”, “much worse” or “very much worse”.(2)Logistic regression models with treatment (SP-102 or placebo), site, and Pain Catastrophizing Scale group(<30 or ≥30) as factors.CI: confidence interval; ITT: intent-to-treat (randomized population)Time to Repeat Injection – ITT PopulationSP-102N=202Placebo