LB Pharmaceuticals (LBRX) Investor presentation summary

Strategic focus and pipeline

• Advancing late-stage clinical trials for schizophrenia, bipolar depression, and adjunctive major depressive disorder, with a streamlined path to approval in schizophrenia based on positive FDA feedback.

• LB-102, a novel derivative of amisulpride, is designed to address limitations of existing therapies, offering improved blood-brain barrier penetration, once-daily dosing, and a favorable tolerability profile.

• Robust intellectual property portfolio with composition of matter protection through 2041 and a strong balance sheet supporting operations into Q2 2029.

• Expansion potential includes long-acting injectable formulations and additional neuropsychiatric indications such as Alzheimer's disease psychosis.

Clinical data and efficacy

• Phase 2 trial in schizophrenia demonstrated statistically significant and rapid reduction in PANSS scores at all tested doses, with effect sizes near the top of approved antipsychotics.

• Dose-dependent improvements in cognition and negative symptoms were observed, addressing key unmet needs in schizophrenia and mood disorders.

• Favorable safety profile with low rates of extrapyramidal symptoms, minimal sedation, and mild to moderate adverse events similar to placebo.

• Phase 3 trial in schizophrenia is underway, with topline data expected in 2H 2027 and an open-label extension to support safety database accrual.

Market opportunity and expansion

• U.S. branded antipsychotic market estimated at $12B, with blockbuster potential requiring expansion beyond schizophrenia into bipolar depression and MDD.

• LB-102's differentiated efficacy and safety profile positions it as a potential first-in-class benzamide antipsychotic in the U.S.

• Planned Phase 2 trials in bipolar depression and adjunctive MDD are designed as potentially registrational, with topline data expected in 2028 and 2029, respectively.

• Long-acting injectable formulation development is planned for 2026, targeting a $6B global market and supporting improved compliance and outcomes.