Company: SMNR
Filing Date: 2025-10-21
Form Type: S-1
Source: 0001193125-25-245178
Chunk: 205

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-10-21
Form: S-1
Chunk 205
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 injection of open-label SP-102 was made optional at the investigator’s discretion.

### Clinical Development Overview
We have completed a Phase 3 pivotal study of SP-102. The CLEAR study is a randomized, double-blind, placebo-controlled Phase 3 trial that enrolled 401 patients with sciatica to compare the epidural administration of SP-102 to placebo. We announced final results from this study in March 2022. The Phase 3 study results have been published in PAIN Journal in June 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.

#### Preclinical and Clinical Trial and Highlights
SP-102 has been evaluated in a number of preclinical studies and clinical trials as a potential treatment for

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sciatica. Key findings from the preclinical studies and clinical trials include:

| • |     | The introduction of SP-102 into blood vessels did not result in neurological complications in the UPD003-IS21 preclinical toxicology study; |

| • |     | SP-102 showed an extended residence time and tolerability in the 1014-1512 and the 1014-2847 preclinical studies; |

| • |     | Repeat injections of SP-102 showed continued pain reduction with no unexpected adverse events based on preliminary results from the SP-102-03 study; and |

| • |     | SP-102 showed an extended local activity with epidural administration in the ES-1504 study. |

Study Details Phase 3 Pivotal Clinical Trial — CLEAR We have completed a pivotal, randomized, double-blind, placebo-controlled Phase 3 trial, CLEAR, that enrolled 401 patients with sciatica at over 40 sites across the United States. The study included an open-label extension where subjects were followed for up to 24 weeks after treatment to evaluate the tolerability of administering SP-102 in a larger patient population. After week four, subjects who met certain pain criteria received open-label SP-102 to investigate the tolerability of repeat injections and the duration of pain relief following injection. This well-controlled, double-blind, randomized trial was 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-102 on average leg pain, measured using the NPR