Company: SMNR
Filing Date: 2025-07-02
Form Type: S-4/A
Source: 0001193125-25-154936
Chunk: 154

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-07-02
Form: S-4/A
Chunk 154
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es between us and our collaborators may result in litigation or arbitration which would increase our expenses and divert the attention of our management. Further, these transactions and arrangements are contractual in nature and may be terminated or dissolved under the terms of the applicable agreements and, in such event, we may not continue to have rights to the products relating to such transaction or arrangement or may need to purchase such rights at a premium. Delays in clinical trials could result in increased costs to us and delay our ability to obtain commercial approval and generate revenue. Before obtaining marketing approval for the sale of any of our current or future product candidates, we must conduct extensive clinical trials to demonstrate the safety and efficacy of our product candidates for their intended indications. Clinical testing is expensive, time-consuming and uncertain as to outcome. We cannot guarantee that any clinical trials will be conducted as planned or completed on schedule, if at all. A failure of one or more clinical trials can occur at any stage of testing. Events that may prevent successful or timely completion of clinical development include:

| • |     | delays in obtaining regulatory authorizations to commence a clinical trial or reaching a consensus with regulatory authorities on trial design; |

| • |     | delays in identifying prospective clinical investigators or clinical trial sites that have necessary qualifications, interest and capacity to perform a requested protocol; |

| • |     | delays in reaching agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites; |

| • |     | delays in obtaining approval from one or more IRBs; |

| • |     | IRBs refusing to approve, suspending or terminating the trial at the investigational site, precluding enrollment of additional subjects, or withdrawing their approval of the trial; |

| • |     | changes to the clinical trial protocol; |

| • |     | delays in recruiting suitable subjects to participate in our clinical trials; |

| • |     | failure by us, any CROs we engage or any other third parties to adhere to clinical trial requirements; |

| • |     | failure to perform in accordance with GCPs; |

| • |     | delays in the testing, validation, manufacturing and delivery of our product candidates to the clinical sites, including delays by third parties with whom we have contracted to perform certain of those functions; |

| • |     | delays in subjects completing participation in a trial or returning for post-treatment follow-up; |

| • |     |