Company: SMNR
Filing Date: 2025-04-21
Form Type: S-4/A
Source: 0001193125-25-087342
Chunk: 202

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-04-21
Form: S-4/A
Chunk 202
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 introduce new products or product enhancements that will be accepted by the market in a timely manner. The FDA or comparable non-U.S.regulatory authorities can delay, limit or deny approval of any product candidate for many reasons, including:

| • |     | it may disagree with the design or implementation of our clinical trials; |

| • |     | we may be unable to demonstrate to such authorities’ satisfaction that a product candidate is safe and effective for its proposed indication; |

| • |     | negative or ambiguous results from our clinical trials may not meet the level of statistical significance required for approval by the FDA; |

| • |     | it may disagree with our interpretation of data from preclinical studies or clinical trials; |

| • |     | it may not agree that the data collected from clinical trials of our product candidate are acceptable or sufficient to support the submission of an NDA or other submission or to obtain regulatory approval in the United States, and such authorities may impose requirements for additional preclinical studies or clinical trials; |

| • |     | it may disagree regarding the formulation, labeling and/or the specifications of our product candidate; |

| • |     | such authorities may decline to approve the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and |

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| • |     | the approval policies or regulations of the FDA or comparable non-U.S. regulatory authority may significantly change in a manner rendering our clinical data insufficient for approval. |

Of the large number of drugs in development, only a small percentage successfully complete the regulatory approval processes and are commercialized. This lengthy approval process, as well as the unpredictability of future clinical trial results, may result in our failing to obtain regulatory approval to market our product candidate, which would significantly harm our business, financial condition and results of operations. In addition, regulatory authorities may approve our product candidate for fewer or more limited indications than we request, may not approve the price we intend to charge for our product candidate, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve our product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate. Any of the foregoing scenarios could materially harm the commercial prospects for our product candidate. We have limited experience submitting applications for marketing authorization to the FDA, and we cannot be certain that any of our product candidates will be successful in clinical trials or receive regulatory approval. Further, our product candidates may not receive regulatory approval even if our clinical