Minerva Neurosciences (NERV) Corporate presentation summary

Unmet need and market opportunity

• Negative symptoms of schizophrenia cause lifelong disability and lack any FDA-approved treatments, representing a significant unmet need.

• 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 positioned as the only late-stage drug targeting primary negative symptoms, with a peak net sales potential estimated at over $2B.

Clinical evidence and trial results

• Roluperidone showed meaningful improvement in negative symptoms in two registrational trials (C03 & C07), with statistically significant results at the 64 mg dose.

• Improvements were observed in both negative symptoms and patient functioning, with stable positive symptoms and low relapse rates.

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

• The unique pharmacological profile underpins differentiated clinical benefits.

Confirmatory Phase 3 (C19) trial and regulatory alignment

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

• Extensive engagement with the FDA led to alignment on trial design, including a 12-week primary endpoint and a 52-week safety/relapse assessment.

• The trial uses a double-blind, placebo-controlled design for efficacy, followed by an active-controlled safety phase.

• Improvements in trial design aim to maximize data quality and reduce placebo response.