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 expansion potential across psychosis and mood disorders.

• Positive Phase 2 data in schizophrenia supports a streamlined path to approval with a single Phase 3 trial, following favorable FDA feedback.

• Robust intellectual property protection extends through approximately 2041, including potential patent term extension.

• Strong financial position with $365.6 million in cash and runway into Q2 2029, supporting multiple clinical milestones.

LB-102: Mechanism, differentiation, and clinical profile

• LB-102 is a methylated derivative of amisulpride, designed for improved blood-brain barrier penetration, potency, and once-daily dosing.

• Demonstrates selective D2, D3, and 5HT7 receptor binding, supporting efficacy in psychosis, mood disorders, cognition, and anhedonia.

• Phase 2 data show rapid, sustained, and statistically significant reduction in PANSS scores at all tested doses, with robust effects on cognition and negative symptoms.

• Effect sizes for 50 mg and 100 mg doses are at or above those of leading antipsychotics, with dose-dependent cognitive improvement.

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

Clinical development and regulatory pathway

• Phase 3 schizophrenia trial initiated in Q1 2026, with topline data expected in 2H 2027 and a pre-NDA meeting in 1Q 2028.

• Bipolar depression Phase 2 trial started in Q1 2027, topline data expected 1Q 2028; adjunctive MDD Phase 2 trial to begin early 2027, topline data in 1H 2029.

• Open-label extension studies will support safety database and provide additional data on cognition and negative symptoms.