Company: LBRX
Filing Date: 2025-09-08
Form Type: S-1/A
Source: 0001193125-25-197877
Chunk: 146

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-09-08
Form: S-1/A
Chunk 146
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 other neuropsychiatric disorders, including schizophrenia with predominantly negative symptoms,
Alzheimer’s disease-related agitation and psychosis, manic episodes associated with bipolar disorder, and cognitive impairment associated with schizophrenia, or CIAS. We believe that LB-102, if approved,
can become a mainstay of psychiatric practice by offering a potentially attractive alternative to branded and generic therapeutics for the treatment of schizophrenia, bipolar depression, and other neuropsychiatric diseases.

Our product candidate, LB-102, is a Phase 3-ready oral, small
molecule for the treatment of acute schizophrenia, defined as a sudden and severe episode of psychotic symptoms, characterized by hallucinations, delusions, and other positive symptoms. Schizophrenia is a chronic, severe, complex, and debilitating
psychiatric disorder that affects approximately 1% of the U.S. population and is a leading cause of disability. Symptoms are divided into three categories: (i) psychotic or positive symptoms, which include delusions, hallucinations, thought
disorder, and movement disorder; (ii) negative symptoms, which include lack of motivation, interest, or enjoyment in daily activities, withdrawal from social life, and difficulty showing emotions; and (iii) cognitive symptoms, which
encompass problems with attention, concentration, and memory. The disease is associated with increased mortality, with approximately 5% of schizophrenia patients dying by suicide, and average overall life expectancy decreasing by as much as 29 years
compared to the general population. There is currently no cure for schizophrenia, which means the disease must be managed with life-long therapy, increasing the importance of therapies that can improve compliance rates and dosing challenges.

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In addition to our clinical development program in schizophrenia, we plan to leverage our expertise in neuropsychiatry and the unique mechanism of action of LB-102 to develop our candidate in other indications, starting with bipolar depression. Most people living with bipolar depression experience dramatic shifts in mood, energy and behavior, alternating between manic and depressive states. It is estimated that 2.8%, or approximately seven million Americans, experience bipolar disorder in a year, and approximately 40 million people live with bipolar disorder worldwide. Our initial Phase 2 trial will explore the utility of LB-102 in controlling the depressive symptoms of the disease. We plan to initiate this potentially registrational Phase 2 trial in bipolar depression in the first quarter of 2026 with topline data expected in the first quarter of 2028. We believe LB-102’s strong antagonism of the D2, D3,