Company: SMNR
Filing Date: 2025-07-23
Form Type: S-4/A
Source: 0001193125-25-163401
Chunk: 349

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-07-23
Form: S-4/A
Chunk 349
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-102 in 2027 or ever, as any such launch would be subject to regulatory approval, which Semnur may not receive. In addition, given the SP-102 patent expires in 2036, the Denali Board requested that Semnur’s management prepare revenue projections for a six to seven year period post-expiration of the SP-102 patent. Accordingly, Semnur’s management prepared a 19 to 20-year time forecast to capture anticipated peak sales periods and to address Denali’s request for revenue projections after the expiration of the SP-102 patent.

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) NDA, the FDA could target an approval decision within six months of such submission, which could lead to approval of SP-102 in the first half of 2027 with commercial launch in the second half of 2027. Although these projections assume receipt of regulatory approval for SP-102 in the first half of 2027 with commercial launch in the second half of 2027, there is also no guarantee that Semnur will be able to commence a commercial launch of SP-102 in 2027 or ever, as any such launch would be subject to regulatory approval, which Semnur may not receive.**

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Denali conducted significant due diligence on the Semnur Management Projections, focusing on the following primary areas:

| • |     | Revenue projection and