Company: LBRX
Filing Date: 2025-07-23
Form Type: DRS/A
Source: 0000950123-25-006557
Chunk: 27

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-07-23
Form: DRS/A
Chunk 27
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 significant impact on our ability to obtain approval of our product candidate in the future. Similar decisions may also be
made by foreign regulatory authorities and have a similar impact.

17

Most product candidates that commence clinical trials are never approved as commercial products and there can be no assurance that any of our current or future clinical trials will ultimately be successful or support the approval of our current or any future product candidates. We expect to continue to rely on our clinical trial sites and clinical trial teams to ensure the proper and timely conduct of our clinical trials, including the participant enrollment process, and we have limited influence over their performance. In addition, we may in the future enter into collaboration agreements pursuant to which our collaborator would be responsible for clinical development. We or our collaborators may experience delays in initiating or completing clinical trials due to unforeseen events or otherwise, which could delay or prevent our ability to receive marketing approval or commercialize our current and any future product candidates, including:

| • |     | regulators, such as the FDA or comparable foreign regulatory authorities, Institutional Review Boards, or IRBs,                                                                                                                                           
 or ethics committees may impose additional requirements before permitting us to initiate a clinical trial, may not authorize us or our investigators to commence or conduct a clinical trial at a prospective trial site, may not allow us to amend trial 
 protocols, or regulators may disagree as to the design or implementation of our clinical trials and require that we modify or amend our clinical trial protocols, statistical analysis plans, or diversity action plans developed for recruitment in      
 pivotal clinical trials;                                                                                                                                                                                                                                  |

| • |     | we may experience delays in reaching, or fail to reach, agreement on acceptable terms with contract research                                                              
 organizations, or CROs, or with individual clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among trial sites; |

| • |     | delays in identifying, recruiting, and training suitable clinical investigators; |

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

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

| • |     | clinical trial sites may deviate from the trial protocol, fail to ensure the integrity of the data being 
 collected at the site, or drop out of a trial;                                                           |

| • |     | failure by any of our third-party contractors to perform in accordance with good clinical practices, or GCP