Company: LBRX
Filing Date: 2025-08-22
Form Type: S-1
Source: 0001193125-25-186467
Chunk: 179

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-08-22
Form: S-1
Chunk 179
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adrenaline, and dopamine, regardless of the underlying pathophysiology of the disease. Among the four antipsychotics approved for
schizophrenia and MDD or treatment resistant depression that were also studied in late-stage bipolar depression trials (quetiapine, cariprazine, aripiprazole, and olanzapine), three out of four, or 75%, generated positive data for the treatment of
bipolar depression. We believe that the approval of amisulpride in the United Kingdom for the treatment of psychosis and mania serves as additional supportive evidence for the broader utility of LB-102 to
treat neuropsychiatric disorders.

We plan to initiate this potentially registrational Phase 2 trial in bipolar depression in the first
quarter of 2026, upon the clearance of an Investigational New Drug, or IND, application for that indication. We are designing this clinical trial to be of registrational quality and if successful, we expect to ask the FDA if this trial could serve
as one of two adequate well-controlled trials needed to obtain approval of LB-102 in bipolar depression. Following a successful Phase 2 trial, we may also consider conducting two Phase 3 trials in bipolar
depression, one as a monotherapy and one as an adjunctive therapy in combination with mood stabilizers, a commonly used treatment for bipolar depression.

Based on the extensive third-party research that has been conducted on amisulpride and a non-racemic
form of the drug and our research indicating a comparable or even improved clinical activity and tolerability profile, including with respect to rates of EPS, sedation and gastrointestinal side effects, of
LB-102, we believe there is broad potential for the development of LB-102 for a variety of psychiatric indications and mood disorders. We believe the extensive body of
research on amisulpride provides a potential road map for future development opportunities for LB-102, including the potential for development of LB-102 in MDD, negative
symptoms of schizophrenia, bipolar mania, and Alzheimer’s disease psychosis and agitation.

Our Team and History

Our leadership and advisors are composed of individuals with extensive experience in the discovery, development, and commercialization of
neuropsychiatric therapeutics.

Heather Turner, J.D., our Chief Executive Officer, was previously President and Chief
Executive Officer of Carmot Therapeutics Inc., prior to its acquisition by Roche Pharmaceuticals for $3.1 billion. Anna Eramo, M.D., our Chief Medical Officer