Minerva Neurosciences, Inc · NASDAQ:NERV
Minerva Neurosciences — Investor Presentation (September 2026)
19 slides from Minerva Neurosciences's investor presentation, Sep 7, 2026
Slide 1: From Unmet Need to Reality
From Unmet Need to Reality Roluperidone is potentially the first treatment for negative symptoms of schizophrenia Corporate deck I Fall 2026 1 Updated: 2026.09.07
Slide 2: Forward-Looking Statement
Forward-Looking Statement This presentation contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, reflect management’s expectati
Slide 3: De-risked path to first approved therapy for negative symptoms of schizophrenia
De-risked path to first approved therapy for negative symptoms of schizophrenia Unmet need Negative symptoms drive profound, lifelong disability and remain untreated, with no FDA-approved therapies and clinical practice focused primarily on positive symptoms Only therapy Roluperidone is only late-st
Slide 4: Large US patient population — roluperidone addresses a significant unmet need
Large US patient population — roluperidone addresses a significant unmet need Estimated Schizophrenia Current market1 ~3.1M prevalence (US) US adults 1.17% age-adjusted prevalence ~$4.2B US schizophrenia drugs market (Krasa et al., JAMA Psychiatry 2026) 2025 (North America ~63% of global) Growing at
Slide 5: Negative symptoms of schizophrenia drive lifelong disability and remain untreated
Negative symptoms of schizophrenia drive lifelong disability and remain untreated 5
Slide 6: Current treatment options improve positive symptoms, but negative symptoms remain untreated
Current treatment options improve positive symptoms, but negative symptoms remain untreated and drive long-term disability Worse Schizophrenia has three symptom domains 1) Positive Symptoms - delusions, Illness Severity hallucinations, disorganized behavior 2) Negative Symptoms - diminution or absen
Slide 7: Functional disability more closely correlates with negative symptoms than positive symptoms
Functional disability more closely correlates with negative symptoms rather than positive symptoms over time “While positive symptoms are often the most recognized features of schizophrenia due to their 80%–90% of people with schizophrenia are unemployed external observation of distorted normal func
Slide 8: Targeting avolition improves entire constellation of negative symptoms & functional outcomes
Targeting avolition improves entire constellation of negative symptoms & functional outcomes Avolition (lack of motivation) Avolition is a determinant of poor functional outcome Disrupts goal-directed behavior and Avolition reward processing Appetite drive (“wanting”) Significantly impacts other the
Slide 9: Roluperidone for negative symptoms of schizophrenia: Clinical data that matters
Roluperidone for negative symptoms of schizophrenia Clinical data that matters 9
Slide 10: C03 & C07 Studies: similar designs and significant results
C03 & C07 Studies: similar designs and significant results – guiding C19 confirmatory trial C03 (MIN101C03) · Phase 2b C07 (MIN101C07) · Phase 3 Design and number of 244 patients randomized 1:1:1 (monotherapy) 515 patients randomized 1:1:1 (monotherapy) patients Placebo · 32 mg · 64 mg PO, QD Placeb
Slide 11: C03 & C07 Studies: Negative Symptom Factor Score
C03 & C07 Studies: Negative Symptom Factor Score C03 Study C07 Study PANSS Marder NSFS Score* Baseline Mean (SD) PANSS Marder NSFS Score Baseline Mean (SD) Change from Baseline Placebo roluperidone 64 mg Change from Baseline Placebo roluperidone 64 mg 25.0 (4.0) 25.2 (3.9) 24.3 (3.0) 25.3 (3.3) (C03
Slide 12: C03 & C07 Studies: Personal and Social Performance (PSP) Score
C03 & C07 Studies: Personal and Social Performance (PSP) Score C03 Study C07 Study PSP Total Score PSP Total Score Baseline Mean (SD) Baseline Mean (SD) Change from Baseline Placebo roluperidone 64 mg Change from Baseline Placebo roluperidone 64 mg (C03; ITT Population) 51.4 (13.9) 50.8 (14.4) (C07;
Slide 13: Conclusions from C03 and C07 Studies
Conclusions from C03 and C07 Studies Roluperidone demonstrated clear statistical significance on multiple efficacy endpoints: Improves primary negative symptoms (i.e., NSFS) Improves functioning (i.e., PSP) Improves avolition Stable positive symptoms, with a low relapse rate Roluperidone avo
Slide 14: De-risked, execution-focused confirmatory C19 trial design
De-risked, execution-focused confirmatory C19 trial design 14
Slide 15: FDA Alignment on C19, confirmatory trial design: actively enrolling
FDA Alignment on C19, confirmatory trial design: actively enrolling NCT07565428 Excerpts from FDA Meeting Minutes Alignment reached on design of a confirmatory • FDA acknowledges Minerva’s position that a population of people with schizophrenia can be Phase 3 study following identified with high neg
Slide 16: C19 trial design: trial actively enrolling
C19 trial design: trial actively enrolling Screening (28 days) – to ensure patients meet eligibility criteria for stable symptoms prior to randomization Efficacy Assessment (12 weeks): Two parallel treatment arms randomized (1:1) to roluperidone or placebo using a double-blind study design Safety/Re
Slide 17: Execution-focused trial maximizes probability of a clean, interpretable C19 Study outcome
Execution-focused trial maximizes probability of a clean, interpretable C19 Study outcome Scale, Monitoring and Data Quality Trial Design Improvements Controls • 64 mg of roluperidone in treatment arm, the dose which • ~380 patients across ~40 sites in the U.S. (25–30%) and showed greater symptom im
Slide 18: Summary: the Minerva confluence
Summary: the Minerva confluence Right Right Right Pharmacology Phase 3 Moment and MOA Trial Design Only drug to date to demonstrate Previous experience with two FDA alignment on Phase 3 trial + a significant and clinically statistically significant (one broad awareness of the unmet relevant specific
Slide 19: From Unmet Need to Reality
From Unmet Need to Reality Roluperidone is potentially the first treatment for negative symptoms of schizophrenia Corporate deck I Fall 2026 19
Minerva Neurosciences — Investor Presentation (September 2026) on 6ix