Company: SMNR
Filing Date: 2025-06-11
Form Type: S-4/A
Source: 0001193125-25-139124
Chunk: 492

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-06-11
Form: S-4/A
Chunk 492
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 designed to demonstrate evidence of the analgesic effect and tolerability of SP-102.The schematic of this Phase 3 trial is demonstrated in the flowchart below. The primary objective of this study was to evaluate the analgesic effect of SP-102on average leg pain, measured using the NPRS following a single transforaminal injection. These results were compared to an intra-muscular injection of placebo over a four-week period. The secondary objectives of this study include (i) evaluation of the degree of disability over time as measured by the ODI; (ii) characterization of the change of the subject’s radiculopathy symptoms and overall condition, using a combination of PainDETECT, modified Brief Pain Inventory, Clinical Global Impression of Change (“CGIC”), and Patient Global Impression of Change (“PGIC”) and (iii) evaluation of the tolerability of a single and repeat SP-102injection. 299

Schematic of CLEAR - SP-102 (SEMDEXA) Phase 3 Pivotal Trial Results of CLEAR - SP-102Phase 3 Pivotal Trial A full six-monthdata analysis was completed in February 2022, and we announced final results from the study in March 2022, which results reflect achievement of primary and secondary endpoints. The Phase 3 study results have been published in PAIN ®Journal (Miller et al 2024) and we also presented the pivotal Phase 3 trial results at the American Society of Interventional Pain Physicians annual meeting in Las Vegas, Nevada in May 2022. The Phase 3 CLEAR trial summary results, which results reflect achievement of primary and majority of secondary endpoints, are as follows:

| • |     | For the intent-to-treat (“ITT”) population, the primary endpoint of change in average daily NPRS pain in the affected leg over four weeks following the initial injection of SP-102 demonstrated least square (“LS”) mean treatment difference (standard error (“SE”)) of -0.52 (0.163) units [95% confidence interval (“CI”): -0.84, -0.20] compared to placebo (P=0.002). The change from baseline to Week Four in the mean daily average NPRS pain score (standard deviation (“SD”)) in the affected leg was -1.81 (1.896) for SP-102 versus -1.29 (1.814) in the placebo group. The calculated standardized effect size (Cohen’s D calculated as the group mean