Company: SMNR
Filing Date: 2025-10-21
Form Type: S-1
Source: 0001193125-25-245178
Chunk: 31

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-10-21
Form: S-1
Chunk 31
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 with third-party suppliers and manufacturers for clinical development of SP-102; |

| • |     | the maintenance of existing, or the establishment of new, scaled production arrangements with third- party manufacturers to obtain finished products that are appropriate for commercial sale of SP-102, if it is approved; |

| • |     | obtaining and maintaining patent protection, trade secret protection and regulatory exclusivity, both in the United States and internationally; |

| • |     | a continued acceptable safety profile following any marketing approval; |

| • |     | commercial acceptance by patients, the medical community and third-party payors; |

| • |     | our ability to obtain coverage and adequate reimbursement from third-party payors for our product candidates, if approved, and patients’ willingness to pay out-of-pocket in the absence of such coverage and adequate reimbursement; and |

| • |     | our ability to compete with other treatments. |

**We do not have complete control over many of these factors, including certain aspects of clinical development and the regulatory submission process, potential threats to our intellectual property rights and the manufacturing, marketing, distribution and sales efforts of any future collaborator. If we are not successful with respect to one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize SP-102, which would materially harm our business. If we do not receive marketing approvals for SP-102, we may not be able to continue our operations. 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 in the delivery of our clinical supplies which could affect the development of SP-102. Historically, we have purchased our clinical and commercial supply requirements for sodium hyaluronate, one of the excipients for SP-102, solely from Genzyme Corporation (“Genzyme”) pursuant to a supply agreement, which terminated as of May 31, 2024. We anticipate that our current supply of sodium hyaluronate will be sufficient to satisfy our clinical and commercial supply requirements for sodium hyaluronate for at least 12 months following our expected commercial launch of SP-102 in 2027. Although we are currently in