Company: SMNR
Filing Date: 2025-07-02
Form Type: S-4/A
Source: 0001193125-25-154936
Chunk: 142

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-07-02
Form: S-4/A
Chunk 142
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 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 only have one product candidate, SP-102.Our ability to generate revenue from product sales and achieve profitability will depend on our ability, alone or with collaborators, to successfully complete the development of, and obtain the regulatory approvals necessary to commercialize, SP-102and any future product candidates, if any. As a result, we intend to devote a substantial portion of our research and development resources and business efforts to the development of SP-102.We do not anticipate generating revenues from product sales for the next several years, if ever. Our ability to generate future revenue from product sales depends heavily on our, or our future collaborators’, ability to successfully:

| • |     | identify additional product candidates and complete research and preclinical and clinical development of SP-102 and any other product candidates we may identify; |

| • |     | seek and obtain regulatory and marketing approvals for any product candidates for which we complete clinical trials; |

| • |     | launch and commercialize any product candidates for which we obtain regulatory and marketing approval by establishing a sales force, marketing and distribution infrastructure or, alternatively, collaborating with a commercialization partner; |

| • |     | qualify for coverage and adequate reimbursement by government and third-party payors for any product candidates for which we obtain regulatory and marketing approval; |

| • |     | develop, maintain, and enhance a sustainable, scalable, reproducible, and transferable manufacturing process for the product candidates we may develop; |

| • |     | establish and maintain supply and manufacturing relationships with third parties that can provide adequate, in both amount and quality, products and services to support clinical development and the market demand for any product candidates for which we obtain regulatory and marketing approval; |

| • |     | obtain market acceptance of any product candidates as viable treatment options; |

| • |     | address competing technological and market developments; |

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| • |     | implement internal systems and infrastructure, as needed; |

| • |     | negotiate favorable terms in any collaboration, licensing or other arrangements into which we may enter, and perform our obligations in such arrangements; |

| • |     | maintain, protect, enforce, defend and expand our portfolio of intellectual property rights, including patents, trade secrets and know-how, in the United States and internationally; |

| • |     | avoid and defend against third-party interference, infringement and other intellectual property claims in the United