Company: LBRX
Filing Date: 2025-08-22
Form Type: S-1
Source: 0001193125-25-186467
Chunk: 37

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-08-22
Form: S-1
Chunk 37
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 liable for harm caused to subjects or patients; and                                                              |

| • |     | a product may become less competitive, and our reputation may suffer. |

In addition, participants with neuropsychiatric disorders, including schizophrenia and bipolar depression, constitute a vulnerable patient population, and any adverse side effects or adverse events may be exacerbated in such patient population. Any of these events could diminish the usage or otherwise limit the commercial success of our product candidate and prevent us from achieving or maintaining market acceptance of our product candidate, if approved by the FDA or other regulatory authorities. We have never commercialized a product candidate and may experience delays or unexpected difficulties in obtaining, or fail to obtain, regulatory approval for our product candidate. We have never obtained regulatory approval for, or commercialized, a drug product in the United States or elsewhere. Our clinical trial results may not support regulatory approval. In addition, our product candidate could fail to receive regulatory approval for many reasons, including the following:

| • |     | the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our                                                                             
 clinical trials, such as our determination that our Phase 2 acute schizophrenia trial may serve as one of the two pivotal trials required for approval of an NDA in the United States; |

| • |     | we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that 
 our product candidate is safe and effective for any of their proposed indications;                               |

| • |     | we may have negative or ambiguous results from our clinical trials, or results may not meet the level of 
 statistical significance required by the FDA or comparable foreign regulatory authorities for approval;  |

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| • |     | the population studied in the clinical trial may not be sufficiently broad or representative to assure safety in 
 the full population for which we seek approval;                                                                  |

| • |     | regulatory authorities may not accept clinical data from trials that are conducted at clinical facilities or in 
 countries where the standard of care is potentially different from that of their own country;                   |

| • |     | serious and unexpected drug-related side effects may be experienced by participants in our clinical trials or by 
 individuals using drugs similar to our product candidate;                                                        |

| • |     | the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from 
 preclinical studies or clinical trials;                                                                |

| • |     | the data collected from clinical trials of our product candidate may not be sufficient to the satisfaction of the                                                                                                                                 
 FDA or comparable foreign regulatory authorities to