Company: LBRX
Filing Date: 2025-09-08
Form Type: S-1/A
Source: 0001193125-25-197877
Chunk: 49

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-09-08
Form: S-1/A
Chunk 49
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 product that we may otherwise establish in the future;                 |

| • |     | receive regulatory approval for the targeted patient populations and efficacy/safety claims that are necessary or 
 desirable for successful marketing;                                                                               |

| • |     | price our product competitively such that third-party and government reimbursement permits broad product 
 adoption;                                                                                                |

| • |     | manufacture our product candidate through contract development and manufacturing organizations, or CDMOs, in               
 sufficient quantities and at acceptable quality and manufacturing cost to meet commercial demand at launch and thereafter; |

| • |     | establish and maintain agreements with wholesalers, distributors, pharmacies, and group purchasing organizations 
 on commercially reasonable terms;                                                                                |

| • |     | obtain, maintain, protect, and enforce patent and other intellectual property protection and regulatory 
 exclusivity for our product, if approved;                                                               |

| • |     | maintain compliance with applicable laws, regulations, and guidance specific to commercialization including                                                
 interactions with health care professionals, patient advocacy groups, and communication of health care economic information to payors and formularies; and |

| • |     | assure that our product candidate, if approved, will be used as directed and that additional unexpected safety 
 risks will not arise.                                                                                          |

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 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. We conduct much of our clinical trial work (e.g., clinical and medical monitoring, data management, and project management) with CROs as well as utilizing internal personnel to augment and oversee our CROs. Although we believe that our CROs currently have the capabilities to conduct clinical trials in collaboration with our internal staff, we may need to rely on additional third party CROs to conduct clinical trials if our internal and existing CRO capabilities cannot scale as we work to progress LB-102through development, as we potentially expand our product candidate portfolio, or if we do not have sufficient personnel to support our clinical program. Our failure or the failure of any CROs we may employ to conduct the trials in compliance with FDA regulations could result in a delay or failure in obtaining FDA approval and could require us to repeat any