Company: SMNR
Filing Date: 2025-06-11
Form Type: S-4/A
Source: 0001193125-25-139124
Chunk: 342

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-06-11
Form: S-4/A
Chunk 342
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 Semnur Management Projections include two parts, including base case projections and best case projections. The assumptions and material differences of each case is set out below. The Semnur Management Projections were prepared using a 19 to 20-yeartime horizon, as Semnur believes such time-frameis necessary for long-termstrategic forecasting for pipeline projects. Semnur believes the peak sales for SP-102is expected to occur five to seven years following its commercial launch. Given that Semnur anticipates that SP-102will be launched in 2027, a 19 to 20-yeartime horizon would capture those anticipated peak sales periods. However, there is no guarantee that Semnur will be able to commence a commercial launch of SP-102in 2027 or ever, as any such launch would be subject to regulatory approval, which Semnur may not receive. In addition, given the SP-102patent expires in 2036, the Denali Board requested that Semnur’s 197

management prepare revenue projections for a six to seven year period post-expiration of the SP-102patent. Accordingly, Semnur’s management prepared a 19 to 20-yeartime forecast to capture anticipated peak sales periods and to address Denali’s request for revenue projections after the expiration of the SP-102patent. All amounts set forth in each of the base case and best case scenarios of the Semnur Management Projections are estimates as of the date such projections were prepared by Semnur. These projections assume that Semnur’s product candidate, SP-102, receives regulatory approval in the first half of 2027 with commercial launch in the second half of 2027. To achieve that timeline, Semnur intends to (i) commence the Phase 3 CLEAR-2 trial in the second half of 2025 (as described in more details elsewhere in this proxy statement/prospectus under the section titled “ Business of Semnur – Our Company”) and (ii) seek FDA approval through the Section 505(b)(2) regulatory pathway during the second half of 2026, which allows Semnur to rely in part on the FDA’s prior conclusions regarding the safety and effectiveness of previously approved compounds, which Semnur believes improves the chance of regulatory approval. Given that SP-102 has been granted fast track designation for the treatment of sciatica, the Company expects that following the submission of a 505(b)(2) N