Minerva Neurosciences, Inc · NASDAQ:NERV
Minerva Neurosciences — Investor Presentation (January 2022)
27 slides from Minerva Neurosciences's investor presentation, Jan 5, 2022
Slide 1: Corporate Presentation January 2022
Corporate Presentation January 2022 Exhibit 99.1
Slide 2: Forward-Looking Safe Harbor Statement
Forward-Looking Statement Safe-Harbor Forward-Looking Safe Harbor Statement This presentation contains forward-looking statements. Forward-looking statements are statements that are not historical facts, reflect management’s expectations as of the date of this presentation, and involve certain risks
Slide 3: Founded in 2014: Transforming lives of patients with CNS disease
Founded in 2014 Our goal is to transform the lives of patients suffering from CNS disease including schizophrenia, depression, insomnia and Parkinson’s disease. Roluperidone is our lead program for the treatment of negative symptoms in patients diagnosed with schizophrenia. Minerva Neurosciences (NA
Slide 4: Roluperidone: Treatment of negative symptoms in schizophrenia
Roluperidone Treatment of negative symptoms in patients diagnosed with schizophrenia
Slide 5: Negative Symptoms a Key Unmet Need in Schizophrenia
Physicians Cite Negative Symptoms as One of the Key Unmet Needs in Schizophrenia Improvements with roluperidone observed in these needs
Slide 6: Large Patient Population and No Approved Treatments in the US
Large Patient Population and Currently No Approved Treatments in the US SZ=schizophrenia. 1.Wu et al. Psychol Medicine. 2006; 2. Millier et al. J Market Acc Health Policy. 2017; 3.Haro et al. Schizophr Research. 2015; 4. Nordstroem et al. J Social Psychiatry. 2017 Phase 3 enrolled patients are repre
Slide 7: Roluperidone's Path: Summary of Progress
Roluperidone’s path: Summary of Progress Following successful completion of the pivotal Phase 2b study in 2016 Pivotal Phase 3 12 week DB phase completed May 2020 Type-C Meeting Completed November 2020 Pivotal Phase 3 40 week open-label extension completed May 2021 2020 2020 2021 2021 Pivotal Bioequ
Slide 8: Phase 2b Recap
CY MINERVA Phase 2b Recap
Slide 9: Phase 2b: Marder's Negative Symptom Factor Score – Post Hoc
Phase 2b: Marder’s Negative Symptom Factor Score – Post Hoc
Slide 10: Phase 3: Recap
CY MINERVA Phase 3: Recap
Slide 11: Phase 3 Study Design Schematic and Key Study Elements
Phase 3 (MIN-101C07) Study Design Schematic and Key Study Elements Primary Endpoint Change from Baseline to Week 12 in the Positive and Negative Syndrome Scale (PANSS) Negative Symptoms Factor Score (NSFS; Marder score) Key Secondary Endpoint Change from Baseline to Week 12 in the Personal and Socia
Slide 12: Phase 3 Disposition Flow Chart: Open-Label Extension
Phase 3 Disposition Flow Chart: Open-Label Extension 857 Patients screened 342 Patients screen failed MIN-101 64 mg Continued to OLE, n=104 Completed OLE, n=59 Withdrew, n=45 Adverse events, n=17 Death, n=0 Lost to follow-up, n=2 Non-compliance, n=0 Moved out of area, n=0 Lack of efficacy, n=1 Withd
Slide 13: Phase 3 Double-Blind: NSFS (ITT population)
Phase 3 Double-Blind: NSFS (ITT population)
Slide 14: Phase 3 Double-Blind: NSFS (mITT population)
Phase 3 Double-Blind: NSFS – (mITT population)
Slide 15: Phase 3: Personal and Social Performance Total Score – Key Secondary Endpoint
Phase 3: Personal and Social Performance Total Score – Key Secondary Endpoint (ITT population) p ≤0.005 p ≤0.019 p ≤0.021
Slide 16: Phase 3 Extension: Recap
CY MINERVA Phase 3 Extension: Recap
Slide 17: Key Objectives of the Open-Label Extension
Key Objectives of the open-Label Extension (OLE) Long term safety Long term efficacy: Negative Symptoms Marder Negative Symptom Factor Score (NSFS) (Primary Endpoint) Functioning Personal and Social Performance Total score (PSP) (Key Secondary Endpoint) Overall Psychopathology Other dimensions of th
Slide 18: NSFS: Double-Blind & Open-Label Extension
NSFS: Double-Blind & Open-Label Extension – Study Baseline Figure depicting the observed data for the 3 treatment arms during double-blind phase and the 2 active treatment arms during the open-label extension phase
Slide 19: PSP Total Score: Double-Blind & Open-Label Extension
PSP Total Score: Double-Blind & Open-Label Extension – Study Baseline Figure depicting the observed data for the 3 treatment arms during double-blind phase and the 2 active treatments arms during the open-label extension phase
Slide 20: Other Key Efficacy Parameters: Double-Blind & Open-Label Extension
Other Key Efficacy Parameters: Double-Blind & Open-Label Extension – Study Baseline CGI-S PANSS Total Score PANSS Positive Symptoms Score Reduced Emotional Experience Score
Slide 21: Relapse Rate in the Double-Blind Phase and Open-Label Extension
Relapse* rate in the Double-Blind Phase and Open-Label Extension * Relapse is defined as worsening of schizophrenia symptoms that lead to permanent discontinuation from the study Study Phase Placebo (N=172) MIN-101 32 mg (N=170) MIN-101 64 mg (N=171) Double-Blind # of Patients 8 (4.7%) 18 (10.6%) 9
Slide 22: Pivotal BE Study: Recap
CY MINERVA Pivotal BE study: Recap
Slide 23: Bioequivalence Study (MIN-101C15) Design Schema and Key Elements
Bioequivalence Study (MIN-101C15) Design Schema and Key Study Elements Objectives Relative bioavailability of 64 mg single dose roluperidone Commercial (GR-01C) form relative to reference Phase 2b (MR-32) form in fasted state Relative bioavailability of 64 mg single dose roluperidone Commercial (GR-
Slide 24: Bioequivalence Demonstrated for Ph2b and Ph3 Formulations
Bioequivalence Demonstrated for Key Parameters for Ph2b and Ph3 Formulations
Slide 25: Summary
Summary O MINERVA
Slide 26: Summary: Roluperidone, Seltorexant and Cash
Summary Roluperidone Negative Symptoms in Schizophrenia Regulatory Process Phase 3 Double-Blind TLR data announced in May 2020 Phase 3 40 week OLE data announced in May 2021 Bioequivalence Study data announced in September 2021 Type C meeting scheduled NDA filing targeted H1 2022 (Subject to FDA fee
Slide 27: Thank you
Thank you O MINERVA
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