Minerva Neurosciences (NERV) Corporate presentation summary

Unmet need and market opportunity

• Negative symptoms of schizophrenia cause lifelong disability and remain untreated, with no FDA-approved therapies currently available.

• Approximately 3.1 million US adults have schizophrenia, with 60% of treated patients experiencing clinically relevant negative symptoms.

• The US schizophrenia drug market is valued at $4.2B in 2025, with global projections reaching $14–22B by 2035 if novel therapies are approved.

• Roluperidone is the only late-stage drug in development targeting primary negative symptoms, representing a first-mover opportunity with peak net sales potential over $2B.

Clinical evidence and trial results

• Roluperidone showed meaningful improvement in negative symptoms in two registrational trials (C03 & C07), with statistically significant results on primary and functional endpoints.

• Improvements were observed in avolition, functioning, and stability of positive symptoms, with low relapse rates comparable or better than standard antipsychotics.

• The drug avoids common side effects of atypical antipsychotics, such as metabolic syndrome, sedation, motor symptoms, and prolactin elevation.

• Targeting avolition leads to cascading improvements in other negative symptom domains and overall functional outcomes.

Confirmatory Phase 3 (C19) trial and regulatory alignment

• The C19 confirmatory Phase 3 trial is actively enrolling, with topline 12-week efficacy data expected in 2H 2027.

• FDA alignment was achieved on the C19 trial design, including a 12-week primary endpoint and a 52-week safety/relapse assessment.

• The trial features rigorous patient selection, centralized data collection, and independent oversight to maximize data quality and interpretability.

• The study includes a double-blind, placebo-controlled efficacy phase and an active-controlled safety/relapse phase comparing roluperidone to antipsychotics.