Company: SMNR
Filing Date: 2025-07-23
Form Type: S-4/A
Source: 0001193125-25-163401
Chunk: 164

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-07-23
Form: S-4/A
Chunk 164
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 educate the medical community and third-party payors on the benefits of our product candidates may require significant resources, including our management’s time and financial resources, and may not be successful. Even if any product candidate we develop receives marketing approval, it may nonetheless fail to gain sufficient market acceptance by physicians, patients, healthcare payors and others in the medical community. The degree of market acceptance of any product candidate we develop, if approved for commercial sale, will depend on a number of factors, including:

| • |     | the efficacy and safety of such product candidate as demonstrated in clinical trials; |

| • |     | the efficacy and safety of other products that are used in combination or in sequence with our product candidates; |

| • |     | the potential and perceived advantages of our product candidates compared to alternative treatments; |

| • |     | the limitation to our targeted patient population and limitations or warnings contained in approved labeling by the FDA or other regulatory authorities; |

| • |     | the ability to offer our products for sale at competitive prices; |

| • |     | convenience and ease of administration compared to alternative treatments; |

| • |     | the clinical indications for which the product candidate is approved by the FDA, the EMA or other regulatory agencies; |

| • |     | the willingness of the target patient population to try novel biologics and of physicians to prescribe these treatments, as well as their willingness to accept an intervention that involves the alteration of the patient’s gene; |

| • |     | product labeling or product insert requirements of the FDA, the EMA or other regulatory authorities, including any limitations or warnings contained in a product’s approved labeling; |

| • |     | relative convenience and ease of administration; |

| • |     | the strength of marketing and distribution support; |

| • |     | availability of third-party coverage and sufficiency of reimbursement; and |

| • |     | the prevalence and severity of any side effects. |

Even if a product candidate is approved, such product may not achieve an adequate level of acceptance, we may not generate significant product revenues, and we may not become profitable. The third-party payor coverage and reimbursement status of newly approved products is uncertain. Failure to obtain or maintain coverage and adequate reimbursement for our current or future product candidates, if approved, could decrease our ability to generate product revenue. There is significant uncertainty related to the third-party coverage and reimbursement of existing and newly approved products. Market acceptance and sales of our current and future product candidates, if approved,