Company: SMNR
Filing Date: 2025-06-11
Form Type: S-4/A
Source: 0001193125-25-139124
Chunk: 345

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-06-11
Form: S-4/A
Chunk 345
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 by Semnur with Syneos Health in 2021 (the “Research Report”) with respect to the SP-102 market). |

| (a) | The applicable assumed market for SP-102 is the U.S. ESI Market, covering both Lumbar Radiculopathy (“LR”) and Non-Lumbar Radiculopathy (“Non-LR”). Based on Semnur management’s internal analysis of the results of the Research Report (with respect to the SP-102 market), the U.S. ESI Market for SP-102 is expected to have an average annual market growth rate of 3.6% between 2023 and 2027. In the first year after the commercial launch of SP-102, Semnur 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,