Company: LBRX
Filing Date: 2025-07-23
Form Type: DRS/A
Source: 0000950123-25-006557
Chunk: 207

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-07-23
Form: DRS/A
Chunk 207
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 have observed to date in our schizophrenia trials and are also assessing the
potential to study LB-102 as a treatment for cognitive impairment of schizophrenia, an indication for which there are no approved therapies. In both negative symptoms of schizophrenia and CIAS, we will need to
study LB-102 in patients who have been stabilized with respect to the positive symptoms of their disease.

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Potential New Formulations of LB-102

We are also developing an LAI formulation of LB-102, which may improve treatment compliance, a common
issue in patients with schizophrenia and bipolar disorder. LB-102’s consistent dopamine receptor engagement over 24 hours and the lower administered dose may allow
LB-102 to be administered as an LAI. We believe an effective LAI form of LB-102 has the potential to benefit patients worldwide, as relatively few approved agents are
available as long-acting formulations. The American Psychiatric Association recommends injectable formulations in circumstances where doing so will improve adherence, decrease mortality, reduce hospitalization risk, and decrease treatment
discontinuation rates.

We believe LAI formulations can have additional benefits in treating symptoms of schizophrenia, such as consistent
drug exposure, which is potentially beneficial compared to orally dosed antipsychotic drugs, as it relieves the requirement for patients or their caregivers to rely on often self-enforced daily oral dosing to maintain efficacy. The latest guidance
from the American Psychiatric Association calls for the use of LAI with patients who have a history of poor adherence. Using LAI antipsychotic drugs to treat schizophrenia patients may decrease mortality risk, reduce hospitalization risk, and
decrease rates of treatment discontinuation. We believe such a formulation of LB-102 would potentially benefit patients both in the United States and globally. We have commenced LAI formulation development and
expect to continue these efforts in 2026. We believe that the success of the 50 mg dose in our Phase 2 acute schizophrenia trial affords the opportunity to develop an LAI.

Market Opportunity

Schizophrenia is
one of the top 15 leading causes of disability in the world and affects approximately 3 million Americans, or approximately 1% of the U.S. population. The United States market for branded antipsychotic drugs in 2024 was approximately
$12 billion, where despite the widespread use of generic drugs, several branded antipsychotic drugs each generate sales in excess of $1 billion per year. The chart below depict the United States market share of branded antipsychotic