Company: SMNR
Filing Date: 2025-10-21
Form Type: S-1
Source: 0001193125-25-245178
Chunk: 17

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-10-21
Form: S-1
Chunk 17
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| • |     | We have only one product candidate, SP-102, no products approved for commercial sale, have never generated any revenue from product sales and may never be profitable. |

| • |     | We currently have no sales and marketing organization and if we do not establish satisfactory sales and marketing capabilities, we may not successfully commercialize SP-102 or any future product candidates. |

| • |     | Our recurring losses from operations, negative cash flows and substantial cumulative net losses raise substantial doubt about our ability to continue as a going concern. |

Risks Related to Our Product Development

| • |     | We have historically obtained our clinical supply of our only product candidate, SP-102, and certain of the raw materials used in SP-102, from a sole or single source supplier and manufacturer, and we may not be able to find an alternative source on commercially reasonable terms, or at all. In addition, if any such supplier or manufacturer fails to comply with FDA regulations we may be subject to sanctions or delays. |

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| • |     | We rely on third parties to conduct clinical trials and intend to rely on third parties to conduct all future clinical trials. If these third parties do not successfully carry out their contractual duties, fail to comply with regulatory requirements or meet expected deadlines, we may be unable to obtain regulatory approvals. |

| • |     | Delays in clinical trials could result in increased costs to us and delay our ability to obtain commercial approval and generate revenue. |

| • |     | Even if we complete the necessary clinical trials, we cannot predict when, or if, we will obtain regulatory approval for our product candidates and the approval may be for a more narrow indication than we seek. |

Risks Related to Our Business and Operations

| • |     | If we are unable to retain our key executives, it may delay our development efforts and harm our business, financial condition and results of operations. |

| • |     | We may need to increase the size of our company and may not effectively manage our growth. |

| • |     | If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates. |

| • |     | Any disruption in our research and development facilities could adversely affect our business, financial condition and results of operations. |

Risks Related to Our Intellectual Property (“IP”)

| • |     | If we are unable to maintain patent protection for our product candidates, or if the scope of the patent