LB Pharmaceuticals (LBRX) Corporate Presentation summary

Clinical development and pipeline

• Advancing LB-102, a novel derivative of amisulpride, for neuropsychiatric disorders including schizophrenia (SCZ), bipolar depression (BPD), and major depressive disorder (MDD).

• Phase 2 SCZ trial showed statistically significant benefit versus placebo at all doses, with robust effect sizes and improvements in cognition.

• Phase 3 SCZ trial is planned for initiation in 1Q 2026, with topline data expected in 2H 2027; a Phase 2 BPD trial is also planned with topline data anticipated in 1Q 2028.

• FDA feedback suggests potential for SCZ approval with one successful Phase 3 trial, streamlining the regulatory path.

• Additional opportunities for indication expansion into MDD and development of long-acting injectable (LAI) formulations.

Efficacy and safety profile

• LB-102 demonstrated clinically meaningful PANSS reductions and significant cognitive improvements in SCZ patients.

• Safety profile is differentiated by low rates of extrapyramidal symptoms (EPS), negligible sedation, and minimal QTc prolongation.

• Most adverse events were mild or moderate, with low rates of discontinuation and serious adverse events.

• Weight gain was modest and no concerning metabolic signals were observed.

• LB-102 retains the binding profile of amisulpride with improved blood-brain barrier permeability and potency.

Market opportunity and competitive landscape

• Multibillion-dollar sales potential for LB-102 across SCZ, BPD, and MDD, with strong IP protection expected through 2041.

• Branded antipsychotics in the U.S. generated ~$12B in 2024, with Vraylar, Abilify, Rexulti, and Caplyta accounting for ~60% of sales.

• BPD and MDD represent large, underserved markets with substantial unmet needs for better efficacy, safety, and cognitive outcomes.

• LB-102's differentiated profile positions it as a potential class leader, especially as few branded agents are expected at BPD launch.

• Development path validated by successful precedents such as Vraylar and Caplyta.