Company: LBRX
Filing Date: 2025-09-08
Form Type: S-1/A
Source: 0001193125-25-197877
Chunk: 11

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-09-08
Form: S-1/A
Chunk 11
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 that faces certain challenges in drug development.                                     |

| • |     | Preclinical and clinical development involves a lengthy and expensive process, with an uncertain outcome, and                                                                                                                                          
 results of earlier studies and trials may not be predictive of future trial or real-world results. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our 
 current product candidate or any future product candidates.                                                                                                                                                                                            |

| • |     | Even if we complete the necessary preclinical studies and clinical trials, the marketing approval process is                                                                  
 expensive, time-consuming, and uncertain and may prevent us or any future collaboration partners from obtaining approvals for the commercialization of our product candidate. |

| • |     | Even if our product candidate receives regulatory approval, it may fail to achieve the degree of market                                                                                
 acceptance by physicians, patients, and others in the medical community necessary for commercial success, in which case we may not generate significant revenues or become profitable. |

| • |     | The successful commercialization of our product candidate, if approved, will depend in part on the extent to                                                                                                                                              
 which governmental authorities and health insurers establish coverage, adequate reimbursement levels, and favorable pricing policies. Failure to obtain or maintain coverage and adequate reimbursement for our product candidate could limit our ability 
 to market those products and decrease our ability to generate revenue.                                                                                                                                                                                    |

| • |     | Our business depends on the success of our product candidate. If we are ultimately unable to successfully                  
 commercialize our product candidate, or experience significant delays in doing so, our business will be materially harmed. |

| • |     | We rely on, and intend to continue to rely on, our internal clinical development expertise to conduct our current                                                                                       
 and future clinical trials. This model includes internal teams and systems as well as external vendors and CROs to comprise a full clinical trial team. If our clinical trial team does not comply with |

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| applicable regulatory requirements, meet expected deadlines, or run trials effectively, our development programs and our ability to seek or obtain regulatory approval for or commercialize our 
 product candidate may be delayed.                                                                                                                                                               |

| • |     | The loss of our third-party manufacturers or suppliers, or their failure to comply with applicable regulatory                                                                        
 requirements or to supply sufficient quantities at acceptable quality levels or prices, within acceptable timeframes, or at all, would materially and adversely affect our business. |

| • |     | The obligations from our royalty agreements may be a drain on our cash resources or may