Minerva Neurosciences (NERV) Corporate presentation summary

Unmet need and market

• Negative symptoms drive lifelong disability; no FDA-approved treatment targets primary negative symptoms, while current practice focuses mainly on positive symptoms.

• Estimated U.S. schizophrenia prevalence is ~3.1M adults; ~1.6M are treated, and ~60% of treated patients have clinically relevant negative symptoms.

• The 2025 U.S. schizophrenia drug market was estimated at $4.2B; the global market at $8.7B, projected to reach $14–22B by 2035 depending on novel therapy approvals.

• Roluperidone peak net sales potential is estimated at >$2B annually; the estimate incorporates market size, share, pricing, adoption and payer survey input.

• Negative symptoms are linked to functional disability and unemployment; 80%–90% of people with schizophrenia are unemployed versus ~4%–5% in the general population.

Clinical evidence

• C03 Phase 2b (n=244) and C07 Phase 3 (n=515) evaluated 32 mg and 64 mg roluperidone monotherapy versus placebo, with 12-week double-blind efficacy periods.

• At 64 mg, PANSS Marder negative symptom scores improved in C03 (p<0.001) and C07 (p=0.043, nominal; primary endpoint met only on a nominal basis after Hochberg correction).

• PSP functioning scores improved at 64 mg in C03 (p=0.003) and C07 (p=0.016); reported effect sizes were 0.56 and 0.29, respectively.

• Positive symptoms remained stable; relapse rates were 14% after 12-week double-blind plus 24-week open-label follow-up in C03 and 9% after 12 plus 40 weeks in C07.

• Prior-trial conclusions cite improvement in avolition and functioning, stable positive symptoms and low relapse rates; the presentation also cites avoidance of several common antipsychotic side effects.

Confirmatory trial and regulatory path

• FDA alignment followed discussions in 2023–2024; FDA would consider resubmission with a controlled trial lasting at least 52 weeks and did not object to a 12-week primary endpoint for negative symptoms.

• C19 is actively enrolling: ~380 patients, randomized 1:1 to 64 mg roluperidone or placebo for 12-week efficacy assessment, with PANSS negative symptom score as primary endpoint and PSP as key secondary endpoint.

• After the first 12 weeks, participants are re-randomized for 52 weeks to roluperidone or one of three antipsychotics for safety and relapse assessment; topline 12-week efficacy data are expected in 2H 2027.

• Trial execution measures include ~40 U.S. and European sites, standardized PANSS training, independent rating-quality oversight, real-time monitoring and centralized electronic data collection.