Company: SMNR
Filing Date: 2025-08-13
Form Type: 424B3
Source: 0001193125-25-179226
Chunk: 153

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-08-13
Form: 424B3
Chunk 153
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 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, in domestic markets will depend significantly on the availability of coverage and adequacy of reimbursement from third-party payors, including government programs (such as Medicare and Medicaid) and private payor 86

healthcare and insurance programs. In the United States, no uniform policy of coverage and reimbursement for products exists among third-party payors. Coverage and reimbursement for a product
candidate, if approved, may differ significantly from payor to payor, and we may not be able to obtain adequate coverage and reimbursement in the future.

Further, obtaining coverage and reimbursement approval for a product from a government or other third-party payor is a time-consuming and costly process that
could require us to provide supporting scientific, clinical and cost-effectiveness data for the use of such product candidate, if approved, to each third-party payor separately, with no assurance that coverage and adequate reimbursement