LB Pharmaceuticals (LBRX) investor relations material

Strategic positioning

• Late-stage development across schizophrenia and bipolar depression, with adjunctive MDD planned; additional opportunities include negative symptoms, Alzheimer’s psychosis/agitation and long-acting injectable formulations.

• 2025 U.S. branded antipsychotic market was ~$12B; schizophrenia development is intended to support expansion into mood disorders.

• Issued composition-of-matter IP is expected to extend through ~2041 including potential patent term extension; underlying COM IP expires in 2037.

• Cash, cash equivalents and marketable securities totaled $327.8M at June 30, 2026, excluding a subsequent $150M private placement; runway expected beyond Q2 2029.

LB-102 profile

• Methylated amisulpride derivative designed for improved blood-brain barrier penetration; 50 mg LB-102 was described as equivalent to 400 mg amisulpride and supports once-daily dosing.

• Selective D2, D3 and 5HT7 activity is intended to address psychosis, mood, cognition and negative symptoms, with few off-target effects.

• Low-dose presynaptic autoreceptor activity may enhance dopamine signaling in depression; higher-dose postsynaptic receptor blockade may suppress dopamine signaling in psychosis.

Schizophrenia clinical evidence

• NOVA-1 was a 4-week Phase 2 trial with 359 participants; FDA feedback indicated the study appeared to have many characteristics of an adequate and well-controlled trial, potentially enabling approval with one successful Phase 3 trial.

• At Day 28, PANSS change was -14.3, -14.0 and -16.1 at 50, 75 and 100 mg, respectively, versus -9.3 for placebo; all doses were statistically superior to placebo.

• Phase 2 cognition effect sizes versus placebo were 0.26 at 50 mg, 0.41 at 75 mg and 0.66 at 100 mg; post hoc analysis excluded outliers failing test quality-control criteria.

• Total EPS rates were 1.0%, 5.6% and 5.6% at 50, 75 and 100 mg, versus 3.7% for placebo; QT prolongation was 4.3–5.4 ms, with no patients meeting stopping criteria.

• Phase 3 topline data are expected in 1H 2027; the planned trial uses 50 mg, 100 mg and placebo over six weeks, with an open-label extension of ~900 patients planned.