Company: SMNR
Filing Date: 2025-08-13
Form Type: 424B3
Source: 0001193125-25-179226
Chunk: 341

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-08-13
Form: 424B3
Chunk 341
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. As corticosteroid injections are commonly used off-label for the management of various types of pain, especially those related to inflammation, Semnur anticipates the off-label use of SP-102 for     
 non-LR indications due to the benefit of extended local effect. Semnur estimates the number of Non-LR injections to be approximately 16.8 million per year the first year after the commercial launch of SP-102,                                          
 and the number of Non-LR injections is expected to represent 133% of the number of LR injections for each period, based on an average Non-LR ratio of 180% comparing the number of LR sciatica procedures to non-LR indications and an average            
 Non-LR utilization ratio of 74% comparing physician utilization of SP-102 to Non-LR indications. In addition, based on Semnur’s internal market assessment (including physician input and current physician practices) of off-label use of epidural       
 injections, Semnur management believes that physicians will use SP-102 “off-label” — without FDA approval — for the following Non-LR indications: cervical radiculopathy, knee                                                                            
 arthritis, hip and knee replacements, complex regional pain syndromes, lumbar spinal stenosis, acute spinal injury, discogenic pain, and injections for knee, shoulders, wrists, ankles and joints. Semnur estimates that Non-LR gross sales will account 
 for approximately 55% of estimated gross sales for each period on an aggregate basis, but has not otherwise estimated sales on a per Non-LR indication basis. Semnur is not currently targeting or otherwise seeking FDA approval for the use of SP-102   
 for any Non-LR indications.                                                                                                                                                                                                                               |

| (b) | In addition to Semnur management’s internal analysis of the results of the Research Report,                                                                                                                                                      
 Semnur’s management also considered primary market research with healthcare professional specialists as well as Semnur’s assessment of the competitive landscape and that there are currently no                                                 
 FDA-approved epidural steroid injection therapies for sciatica (which, if approved, would make SP-102 the first such product to be approved), and as a result                                                                                    
 Semnur’s management is conservatively projecting market share of 0.5% during the first year of launch with peak market share of 35.8% in the seventh year post launch, decreasing to 27.3% after the expiration of the SP-102 patent in 2036 and 
 gradually declining each