Company: SMNR
Filing Date: 2025-08-13
Form Type: 424B3
Source: 0001193125-25-179226
Chunk: 492

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-08-13
Form: 424B3
Chunk 492
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102. This is to determine which patients are fit to use the 
 product. This is usually done prior to launch and every six to nine months thereafter for the first two to three years.                                                                                   |

| • |     | Quant demand study: Discuss with physicians anticipated patient demand for, and physician prescription of,                                       
 SP-102 as well as dosage requirements. This information will help us develop an accurate forecast and plan for sufficient supply of the product. |

| • |     | Forecast refresh: Ongoing analysis of product demand, patient usage, physician feedback, reimbursement 
 levels and other matters that may impact the use of SP-102 and update our forecast accordingly.        |

Clinical Development and Regulatory Our clinical development team, which, as discussed above in further detail, consists of dedicated Scilex employees and contractors, includes in-housemedical expertise and clinical development experts. The clinical development team works with our CRO to identify sites for clinical trials, support the investigator teams and develop publication plans for our product candidate. Additionally, the clinical development team also works with Key Opinion Leaders, professional societies and patient advocacy groups to educate on and support the appropriate use of pain therapeutics. Our clinical development team is responsible for determining registration or 307

supportive studies, overseeing post-approval studies and supporting investigator-sponsored trials. Our regulatory team includes in-house and consultant
regulatory professionals as well as ex-FDA regulatory expert advisors. We contract external regulatory group for publishing and performing submissions to the FDA and other regulatory agencies, including Health
Canada.

Manufacturing and Supply Chain

We currently contract with third parties for the manufacture, assembly, testing, packaging and storage of our product candidate. Our technical team has
extensive pharmaceutical development, manufacturing, analytical, quality and distribution experience and is qualified and capable of managing manufacturing and supply chain operations. Our Quality System, Standard Operating Procedures and contract
manufacturing organizations (“CMOs”) comply with cGMP and regulatory requirements. We selected our CMOs for specific competencies having met our development, manufacturing, quality and the FDA regulatory requirements. These CMOs
manufacture our clinical supplies and commercial batches. We currently have no plans to build our own manufacturing or distribution infrastructure.

As
clinical trial development progresses forward, we will continue to explore both internal capabilities as well as deepening and expanding external relationships to ensure we meet our manufacturing requirements.

SP-102 is a Phase 3 sterile dexamethasone sodium phosphate injectable viscous gel drug product containing
dexamethasone sodium phosphate equivalent