Company: SMNR
Filing Date: 2025-08-12
Form Type: S-4/A
Source: 0001193125-25-178821
Chunk: 346

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-08-12
Form: S-4/A
Chunk 346
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 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 market potential are based on the underlying assumptions for market size, penetration rates, pricing strategies and competitive landscape. Denali considered the potential uptake of Semnur’s products within target markets, taking into account factors such as expected regulatory approval timeline, existing competition and market access strategies. |

| • |     | Research and Development (R&D) by reviewing the projected R&D expenses, considering the nature and scope of Semnur’s ongoing and planned development activities. This included reviewing the costs associated with clinical trials, regulatory filing and other research initiatives. |

| • |     | Regulatory milestone and timelines by reviewing and assessing the projected regulatory milestones embedded within the projections, such as clinical trials completion, regulatory submissions and approvals. |

As noted above, the Denali Board reviewed and discussed the Semnur Management Projections