Company: LBRX
Filing Date: 2025-09-08
Form Type: S-1/A
Source: 0001193125-25-197877
Chunk: 186

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-09-08
Form: S-1/A
Chunk 186
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 in bipolar depression, we may also develop LB-102 in MDD. We believe the mechanism of LB-102 as well as preclinical and clinical data for amisulpride and the non-racemic version of amisulpride support development of LB-102 in bipolar depression and MDD. Our mechanism and clinical trials to date support our belief that LB-102 has the potential to benefit people living with other 
 psychosis-related diseases such as bipolar mania and Alzheimer’s disease-related psychosis. We continue to assess other mood disorders and neuropsychiatric diseases for potential future development.                                                                                                                                                                                                                                                                                                                                        |

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| • |     | Extend the life-cycle and global reach of LB-102                                                                                                                                                                                                    
 by advancing alternate formulations. We are investigating alternate LAI formulations of LB-102. We believe that such formulations have the potential to provide improved clinical results and                                                       
 treatment adherence for schizophrenia and bipolar depression patients compared to oral formulations, for which compliance may be lower. We believe that the success of the 50 mg dose in our schizophrenia Phase 2 trial affords the opportunity to 
 develop an LAI. Additionally, we believe that an LAI formulation of LB-102, if approved, could have additional advantages, including extending the commercial protection for                                                                        
 LB-102, potentially providing a better alternative to the currently limited option set of approved LAI antipsychotic drugs for other neuropsychiatric disorders, such as bipolar disorder or Alzheimer’s                                            
 psychosis, and potentially enhancing LB-102’s competitive positioning outside of the United States.                                                                                                                                                 |

| • |     | Maximize the commercial opportunity of                                                                                                                                                                            
 LB-102. We currently own global rights to LB-102 and intend to retain commercialization rights in the United States. If approved for schizophrenia, we                                                            
 expect to commercialize the oral formulation of LB-102 in jurisdictions where amisulpride is unavailable as a generic, and we expect to commercialize an LAI form of                                              
 LB-102 worldwide. If approved for bipolar depression, we expect to commercialize both the oral and LAI forms of LB-102 worldwide. We expect to expand our team and                                                
 develop internal resources to support the potential commercialization of LB-102. Additionally, we may opportunistically evaluate potential commercial collaborations outside of the United States to maximize the 
 value of LB-102.                                                                                                                                                                                                  |

Schizophrenia Overview and Disease Background Schizophrenia is a chronic, severe, complex, and debilitating psychiatric disorder that affects approximately 1% of the U.S. population and is