Company: LBRX
Filing Date: 2025-08-22
Form Type: S-1
Source: 0001193125-25-186467
Chunk: 47

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-08-22
Form: S-1
Chunk 47
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 we will continue to invest heavily in such product candidate, as well as in any future product candidates we may develop. Our business and our ability to generate revenue, which we do not expect will occur for many years, if ever, are
substantially dependent on our ability to develop, obtain regulatory approval for, and then successfully commercialize LB-102, which may never occur.

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If approved for marketing by applicable regulatory authorities, our ability to generate revenue from our product candidate will depend on our ability to:

| • |     | achieve market acceptance of our future approved product by patients, the medical community, and third-party 
 payors;                                                                                                      |

| • |     | create market demand for our approved product through our own marketing and sales activities, and any other 
 arrangements to promote the approved 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