Company: SMNR
Filing Date: 2025-07-23
Form Type: S-4/A
Source: 0001193125-25-163401
Chunk: 354

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-07-23
Form: S-4/A
Chunk 354
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 estimates the number of ESI administered LR injections to be approximately 12.7 million. Semnur’s management estimates 0.9% growth in ESI administered LR injections in 2028 and 0.5% thereafter, with the estimate in 2028 being higher due to the initial significant promotional efforts for the launch of SP-102 in 2027 and 2028. Such estimate is based on the growth of the U.S. population which typically ranges from 0.5% to 1.0% annually. 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 |

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| 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 epid