Company: SMNR
Filing Date: 2025-06-11
Form Type: S-4/A
Source: 0001193125-25-139124
Chunk: 149

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-06-11
Form: S-4/A
Chunk 149
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 the requirements of the Sarbanes-Oxley Act, we may be unable to accurately report our financial results or report them within the timeframes required by law or stock exchange regulations. Failure to comply with Section 404 of the Sarbanes-Oxley Act could also potentially subject us to sanctions or investigations by the SEC or other regulatory authorities. If additional material weaknesses exist or are discovered in the future, and we are unable to remediate any such material weakness, our business, financial condition and results of operations could suffer. Risks Related to Semnur’s Product Development We are substantially dependent on the success of our only product candidate, SP-102.If we are unable to complete development of, obtain approval for and commercialize SP-102in a timely manner or at all, our business will be harmed. Our future success is dependent on our ability to timely advance and complete clinical trials, obtain marketing approval for and successfully commercialize our product candidate, SP-102.We are not permitted to market or promote SP-102or any other future product candidate before we receive marketing approval from the FDA and comparable foreign regulatory authorities, and we may never receive such marketing approvals. The success of SP-102and any future product candidates, if any, will depend on several factors, including the following:

| • |     | the acceptance of individual investigational review boards (“IRBs”) and scientific review committees at each clinical trial site as to the adequacy of the preclinical data package to support clinical development of SP-102 and their overall general agreement with the use of SP-102 in the intended patient population in the intended manner; |

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| • |     | the initiation and successful patient enrollment and completion of additional clinical trials of SP-102 on a timely basis; |

| • |     | the frequency and severity of adverse events (“AEs”) in the clinical trials; |

| • |     | maintaining and establishing relationships with contract research organizations (“CROs”) and clinical sites for the clinical development of SP-102 both in the United States and internationally; |

| • |     | successful completion of toxicology studies, biodistribution studies and minimally efficacious dose studies in animals, where applicable; |

| • |     | successful completion of clinical trials, under the FDA’s current Good Clinical Practices (“GCP”) and the FDA’s current Good Laboratory Practices (“GLPs”); |

| • |     | effective investigational new drug applications or Clinical Trial Authorizations that allow commencement of our planned clinical trials or future clinical trials for