LB Pharmaceuticals (LBRX) investor relations material

Company overview and drug profile

• Focus on LB-102, a novel, potent N-methylated analog of amisulpride with improved brain penetration and once-daily dosing, targeting multiple neuropsychiatric conditions.

• LB-102 maintains a favorable tolerability profile, low off-target effects, and targets D2, D3, and 5-HT7 receptors, supporting efficacy in psychosis and mood disorders.

• Bimodal activity allows for dose-dependent effects: high doses for antipsychotic action, low doses for antidepressant and procognitive effects.

• Dosing for clinical trials is lower than amisulpride due to improved bioavailability, with ongoing studies in schizophrenia, bipolar depression, and MDD.

Clinical development and trial progress

• Phase II schizophrenia trial (NOVA-1) with 359 patients showed robust efficacy and safety, with FDA feedback supporting its use as a registrational study.

• Ongoing phase III schizophrenia trial (NOVA-2) with 460 patients, top-line data expected in H2 2027; parallel open-label safety trial underway.

• Phase II bipolar depression data expected Q1 2028; phase II adjunctive MDD data expected H1 2029; company funded through Q2 2029.

Differentiation and unmet needs

• LB-102 demonstrates low rates of extrapyramidal symptoms and prolactin-related adverse events, with minimal sedation.

• Phase II data show dose-dependent cognitive improvement and significant benefit for negative symptoms (anhedonia), addressing key unmet needs in schizophrenia and mood disorders.

• Potential to address residual symptoms in bipolar depression and MDD, expanding therapeutic impact.