Company: LBRX
Filing Date: 2025-07-23
Form Type: DRS/A
Source: 0000950123-25-006557
Chunk: 202

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-07-23
Form: DRS/A
Chunk 202
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 have been shown to help manage periods of acute mania as well as depression. Based on third-party market research conducted for us, an important
advantage of certain antipsychotic drugs in the treatment of bipolar depression is the ability to control depressive symptoms while preventing the emergence of mania. Antidepressants, such as selective serotonin reuptake inhibitors, can be effective
in controlling depressive symptoms but also carry a risk of triggering manic events and therefore are typically reserved for later lines of therapy. This market research, together with an advisory board that we held, also highlight unmet needs in
the treatment of bipolar depression. These unmet needs include fewer adverse events, better efficacy, including improvements in cognition and anhedonia, improved compliance to treatment, and a desire for therapies with novel mechanisms of action.

Our Solution: LB-102for the Treatment of Bipolar Depression

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 for further development in bipolar depression. If successful in bipolar depression, we may also develop LB-102 in MDD. In the future, we may also
develop LB-102 for other psychiatric disorders, including schizophrenia with predominantly negative symptoms, CIAS, manic episodes of bipolar disorder, as well as psychosis and agitation in Alzheimer’s
disease. We plan to initiate a registrational-quality randomized Phase 2 trial in this indication in the first quarter of 2026, with topline data expected in the first quarter of 2028. Our initial Phase 2 trial will explore the utility of LB-102 in controlling the depressive symptoms of the disease. We may also develop LB-102 as a potential treatment for the manic episodes of bipolar disorder in the future.

We believe LB-102’s strong antagonism of the D, D, and 5HT7 receptors makes it well suited for treating bipolar depression, providing potential to control psychosis and mania through its
effects on Dand potential for antidepressive and pro-cognitive effects through its antagonism of 5HT7 and D. Our Phase 2 trial of LB-102 in acute schizophrenia demonstrated strong antipsychotic activity and suggests opportunities for potential differentiation in
bipolar depression given the observed tolerability profile (low rates of EPS, sedation, and gastrointestinal side effects) and positive impact on cognition. Amisulpride is approved in certain countries outside of the United States for the treatment
of dysthymia, a