Company: LBRX
Filing Date: 2025-07-23
Form Type: DRS/A
Source: 0000950123-25-006557
Chunk: 36

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-07-23
Form: DRS/A
Chunk 36
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 or other side effects not observed in our preclinical studies or previous clinical trials. Even if such side effects do not preclude the product candidate from obtaining or maintaining regulatory approval, undesirable side effects may inhibit market acceptance due to tolerability concerns as compared to other available therapies. Any of these developments could materially harm our business, financial condition, and prospects. Additionally, if our product candidate receives regulatory approval, and we or others later identify undesirable side effects caused by such product, a number of potentially significant negative consequences could result. For example, the FDA could require us to adopt a Risk Evaluation and Mitigation Strategy, or REMS, to ensure that the benefits of treatment with such product candidate outweigh the risks for each potential patient, which may include, among other things, a communication plan to health care practitioners, patient education, extensive patient monitoring, or distribution systems and processes that are highly controlled, restrictive, and more costly than what is typical for the industry. Other potentially significant negative consequences associated with post-marketing identification of adverse events or other safety risks include:

| • |     | we may be required to suspend marketing of a product, or we may decide to remove such product from the 
 marketplace;                                                                                           |

| • |     | regulatory authorities may withdraw or modify their approvals of a product; |

| • |     | regulatory authorities may require additional warnings or new contraindications on the label, or may limit access                                                                               
 of a product to selective specialized centers with additional safety reporting and with requirements that patients be geographically close to these centers for all or part of their treatment; |

| • |     | we may be required to create a medication guide outlining the risks of a product for patients, or to conduct 
 post-marketing studies;                                                                                      |

| • |     | we may be required to change the way a product is distributed or administered; |

| • |     | we could be subject to fines, injunctions, or the imposition of criminal or civil penalties, or be sued and held 
 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