Minerva Neurosciences, Inc · NASDAQ:NERV
Minerva Neurosciences — Investor Presentation (March 2015)
50 slides from Minerva Neurosciences's investor presentation, Mar 3, 2015
Slide 1: Investor Presentation
Exhibit 99.1 Investor Presentation March 2015 Confidential & Proprietary
Slide 2: Forward-Looking Statement Safe-Harbor
Forward-Looking Statement Safe-Harbor This presentation contains certain forward-looking statements about Minerva Neurosciences that are intended to be covered by the safe harbor for “forward-looking statements” provided by the Private Securities Litigation Reform Act of 1995, as amended. Forward-lo
Slide 3: Investment Highlights
Investment Highlights Focus on leadership in CNS clinical development Portfolio of First in Class Four clinical-stage compounds with transformative potential Neuropsychiatric Validated MOAs differentiated by additional innovative receptor activities Drugs Multiple significant milestones over next 15
Slide 4: Robust Pipeline of Transformative CNS Therapies
Robust Pipeline of Transformative CNS Therapies Next Generation of First in Class Neuropsychiatry Pharmaceuticals Program Primary Unique Preclinical Phase 1 Phase 2 Prevalent Existing 1 Indication MOA Population Drug Sales MIN-101 Schizophrenia 5-HT2A Sigma2 Phase IIa Completed Ph IIb 4.3M $4.5B US
Slide 5: Significant Progress Since IPO in 2014
Significant Progress Since IPO in 2014 MIN-101: Oncea dayformulation withimprovedsafetyprofileselected forPhaseIIbstudy(IIaconducted with bid) Phase IIb protocol submitted to several European countries MIN-202: Two Phase 1 studies completed; – MAD study in healthy volunteers showing MIN-202 is well
Slide 6: MIN-101
MIN-101 Our lead compound with a clear path through clinical development Confidential & Proprietary 6
Slide 7: MIN-101: Innovative Mechanism of Action (MoA)
MIN-101: Innovative Mechanism of Action (MoA) Next Generation Typicals Atypicals Other Strategies MIN-101 5HT2A antagonists DA blockers 5HT2A antagonist DA blockers + Effect on + symptoms (not better than atypicals) + 5HT2A Signals onsymptoms – and Sigma 2 cognition blockers Good safety Antagonist S
Slide 8: MIN-101: Clear understanding of the MoA
MIN-101: Clear understanding of the MoA 8
Slide 9: MIN-101: Phase IIa completed
MIN-101: Phase IIa completed A Multi-center, Inpatient and ambulatory, Phase 2, Double-blind, Randomized, Placebo-controlled Proof of Concept Study of MIN-101in 96 Patients with DSM-IV Schizophrenia (PANSS > 60) Primary Endpoint: Explore safety & tolerability of MIN-101 at a dose two or three times
Slide 10: MIN-101 Phase IIa Study Design
MIN-101 Phase IIa Study Design MIN-101 10
Slide 11: MIN-101: Phase IIa Compelling Efficacy On Spectrum of Symptoms
MIN-101: Phase IIa Compelling Efficacy On Spectrum of Symptoms Positive and Negative Syndrome Scale (PANSS) 5 Factors (PPC) After Three Months Total Weighted Score Decrease: -24.1 for MIN-101 versus -17.9 Placebo -7 -4 -4 -4 -4 -3.5 -3.5 -3.5 -3.5 -6 p < 0.05 p = 0.08 -3 -3 -3 -3 -5 -2.5 -2.5 -2.5 -
Slide 12: MIN-101: Phase IIa improvement in psychopathology, efficacy on negative symptoms
MIN-101: Phase IIa showed improvement in overall psychopathology of schizophrenia with outstanding efficacy on Negative Symptoms (32mg bid) 0 -1 -2 -3 Plateau Placebo -4 p = 0.0178 -5 -6 -7 MIN-101 -8 D6 D14 D21 D28 D42 D56 D70 D84 Treatment Day 12 1. As measured by PANSS scale
Slide 13: MIN-101: Compelling Efficacy On Sleep
MIN-101: Compelling Efficacy On Sleep 1 2 Objective (PSG) and Subjective (PSQI) Measurements (Phase IIa) Objective Measures of Sleep Onset Subjective Measures By PSG By PSQI Scale min 100 0 80 60 -2 40 -4 20 0 -6 Day -1 Day 14 Day -1 Day 14 Day 84 Day 84 MIN-101 Placebo MIN-101 Placebo Quicker onset
Slide 14: MIN-101: Phase IIa Study Safety Evaluation
MIN-101 : Phase IIa Study Safety Evaluation Side Effect Evaluation Relative to Atypicals AEs and SAEs Limited and minor Better Weight gain, Waist Circumference No increase on measurement Better Prolactin and Laboratory tests No clinically significant effects Better Extra-pyramidal symptoms No effect
Slide 15: MIN-101: Phase IIb
MIN-101: Phase IIb Reformulated compound with improved safety profile A Phase IIb, Multi-centre, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy, Tolerability and Safety of MIN-101 in 234 patients with Negative Symptoms of Schizophrenia followed by a 24-we
Slide 16: MIN-101CO3: Phase IIb Design in Patients with Schizophrenia
MIN-101CO3: Phase IIb Design in Patients with Schizophrenia TITLE: A Phase IIb, Multi-centre, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy, Tolerability and Safety of MIN-101 in Patients with Negative Symptoms of Schizophrenia Followed by a 24-week, Ope
Slide 17: MIN-101C03: Phase IIb in Patients with Schizophrenia
MIN-101C03: Phase IIb in Patients with Schizophrenia Primary Study Objectives To evaluate the efficacy of MIN-101 compared to placebo in improving the negative symptoms of schizophrenia as measured by the change from Baseline in the Positive and Negative Syndrome Scale (PANSS) negative subscale scor
Slide 18: MIN-101C03: Phase IIb Timelines
MIN-101C03: Phase IIb in Patients with Schizophrenia Timelines Country Submissions December 2014 January 2015 Romania (16 sites) Estonia (3 sites) Russia (9 sites) Bulgaria (3 sites) Latvia (3 sites) Ukraine (10 sites) Enrollment: April –December 2015 Treatment (Primary Study): April 2015 March – 20
Slide 19: MIN-202
MIN-202 An Orexin2 antagonist for the treatment of primary and comorbid insomnia Confidential & Proprietary 19
Slide 20: MIN-202: Phase IB Study Design in MDD Patients
MIN-202: Phase IB Study Design in MDD Patients • Placebo controlled, cross-over, single dose study • 3 doses (10mg, 20mg, 40mg) • Washout period between periods of ~1 week • 20 MDD patients treated with SSRI/SNRI having comorbid insomnia • Diagnostic and drug effect evaluated with objective sleep me
Slide 21: MIN-202: Phase IB Preliminary Efficacy Results
MIN-202: Phase IB study in MDD patients Positive – Preliminary Efficacy Results Latency to Persistent Sleep 70 MIN-202 vs placebo *** p<0.001 60 50 40 30 20 *** 10 *** *** Placebo 10 mg 20 mg 40 mg 0 21
Slide 22: MIN-202: Phase IB Preliminary Efficacy Results
MIN-202: Phase IB Study in MDD Patients Positive – Preliminary Efficacy Results Total Sleep Time 440 MIN-202 vs placebo ** p<0.005 *** 420 *** p<0.001 *** ** 400 380 360 340 Placebo 10 mg 20 mg 40 mg 320 22
Slide 23: MIN-202: Phase I MAD Study Design
MIN-202: Phase I Study MAD Study Design 5, 10,20,40and60mgMADascending dosesof10daystreatment duration Young healthy volunteers 2 placebo subjects and 6 verum subjects per dose group; equally randomized between females and males Study objectives – Safety and tolerability – C-SSRS (Columbia Suicide S
Slide 24: MIN-202: Phase I MAD Key PK Results Conclusion
MIN-202: PhaseI MAD– KeyPKResultsConclusion 1. Clear efficacy on sleep induction & sleep maintenance with all doses tested 2. REM sleep is preserved 3. Good safety and tolerability up to 60 mg/day after repeated administration 4. PK and PK/PD are adapted for the therapeutic indications pursued 5. Fi
Slide 25: MIN-117
MIN-117 Potential for a more effective and safer treatment to address the unmet medical needs of Major Depressive Disorder patients Confidential & Proprietary 25
Slide 26: MIN-117: Preserving cognition and sexual function
MIN-117: Preserving cognition and sexual function Effects on Immediate Memory Effects on Sexual Function (a model of cognition) MIN-117: MIN-117: Paroxetine: ShowsPreserved MemoryUnderStress Preserves Sexual Function Impairs Sexual Function Placebo & Imipramine: 300 70% Stress Impairs Memory 250 60%
Slide 27: MIN-301
MIN-301 Potential for next generation of therapy for neurodegenerative diseases Confidential & Proprietary 27
Slide 28: PRIMOMED Project: MIN-301 Analog
PRIMOMED Project: MIN-301 Analog Disease Progression >>>> Week - 4 to 0 Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Habituation and MIN-301a or vehicle establishment of baseline daily dosing End MPTP dosing x x x x x x x x Read-outs: Daily clinical score (Parkinson signs) & body weight (
Slide 29: MIN-301 Analog: PRIMOMED Study
MIN-301 Analog: PRIMOMED Study Results: effect of treatment on abnormal involuntary movements scale (AIMS) 6.0 saline control MIN-301 analog 5.0 4.0 3.0 2.0 1.0 0.0 0 7 14 21 28 35 42 Days Start MPTP Increase MPTP 1.0 mg/kg 1.5 mg/kg Summary The MIN-301 analog group generally performed better than s
Slide 30: MIN-301 Analog: PRIMOMED Study
MIN-301 Analog:PRIMOMED Study Results: effect of treatment on locomotor activity (bungalow test) 30.0 saline control MIN-301 analog 25.0 20.0 15.0 10.0 5.0 0.0 1 2 3 4 5 6 7 8 Week Start MPTP Increase MPTP 1.0 mg/kg 1.5 mg/kg Summary • After the start of the MPTP treatment, the saline group showed a
Slide 31: Financial Overview
Financial Overview Confidential & Proprietary 31
Slide 32: Financial Summary
Financial Summary At July 2014 IPO approximately 5.6M shares sold and a private placement of 0.7M shares at $6/share resulting in net proceeds of $29.9M Approximately 3.3M shares sold to Johnson & Johnson in a second private placement at $6/share resulting in proceeds of $19.7M Minervapaida $22Mlice
Slide 33: Patent Protection
Patent Protection Term Patent Jurisdiction Type U.S. Expiry Regulatory Exclusivity Extension May be eligible New Chemical Entity – 5 years in US U.S., Europe, Canada, Australia, New Composition for extension in Pediatric – 6 months in US 2021 Zealand, Russia and Israel of matter the U.S. for up Poss
Slide 34: Multiple Significant Clinical Milestones Ahead
Multiple Significant Clinical Milestones Ahead 2014 2015 2016 Phase / Event Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 MIN-101 Once A Day Formulation Phase IIb in Schizophrenia Phase IIb Extension Parallel clinical pharmacology studies & phase III preparation MIN-202 Phase IB in MDD (single dose) PK/Safety
Slide 35: Thank You
Thank You Minerva Neurosciences, Inc. 1601 Trapelo Road, Suite 284, Waltham, MA 02451 Confidential & Proprietary
Slide 36: Back up
Back up
Slide 37: Building Minerva
Building Minerva Cyrenaic Inc Sonkei Inc (MIN-101) (MIN-117) Merger Nov ‘13 Mind-NRG SA MIN-202 (MIN-301) Acquisition License Feb ‘14 Feb ‘14 th $m: Index, LRM, JJDC, Care IPO July 72014 Fidelity, Federated and others NASDAQ:NERV 37
Slide 38: MIN-101: Positioning
MIN-101: Positioning Schizophrenia: An Effective and Safe Lifelong Treatment Remains A Significant Unmet Need $3.9B R Sales 60% to 80% Discontinuation1 Rate x Current Treatments Lack of efficacy on negative symptoms Focus On Positive Lack of efficacy on cognitive symptoms Lack of efficacy on insomni
Slide 39: MIN-101: Compelling Efficacy on Cognition (Phase IIa)
MIN-101: Compelling EfficacyonCognition (PhaseIIa) ImprovesSeveralCognitive AfterThreeMonths(1) Dimensions 16 6 4.0 6.0 6.0 6.0 5.5 5.5 5.5 14 2.4X 3.5 1.5X 5 2.0X 5.0 5.0 5.0 12 3.0 4.5 4.5 4.5 4 4.0 4.0 4.0 10 2.5 3.5 3.5 3.5 8 3 2.0 3.0 3.0 3.0 2.5 2.5 2.5 6 1.5 2 2.0 2.0 2.0 4 1.0 1.5 1.5 1.5 1
Slide 40: MIN-101: PK results MIN-101 & BFB-520
MIN-101: PKresultsMIN-101&BFB-520 40
Slide 41: MIN-101: PC & Reformulation Work
MIN-101: PC&Reformulation Work Permeability Properties in Rat Intestine Segments Duodenum and jejunum: pH 6.5 Ileum and colon: pH 7.4 Note 1: The two parts of the graph correspond app to P values withoutapp (P) or with rinse stepapp-last (P ) Note 2: For intestinal tissues with preserved integrity,
Slide 42: MIN-101C02: Once-A-Day Formulation Study
MIN-101C02: Once-A-Day Formulation Study Cmax of MIN-101, BFB-520 and BFB-999 with the new formulation Selected formulation for Phase 2b study Target at CMax: <40ng/ml <6ng/ml 32 mg and 64 mg slow will be the doses used in the Phase IIb study Cmax is linear to dose: 64mg is expected to give twice th
Slide 43: MIN-101C03: Phase IIb Exploratory Objectives
MIN-101C03: PhaseIIbin PatientswithSchizophrenia Exploratory Objectives To evaluate the effects versus placebo of MIN-101 on depressive symptoms as measured by the Calgary Depression Scale for Schizophrenia (CDSS) over 12 weeks of double blind treatment. To evaluate the effects versus placebo of MIN
Slide 44: MIN-101C03: Sleep Assessment
MIN-101C03: PhaseIIbin PatientswithSchizophrenia Sleep Assessment Sleepandcircadianrhythmdisruptionsarereportedin30%to 80%ofpatientswithschizophrenia. Patients with insomnia report – lower quality of life – greater symptom severity – worse adherence/compliance to treatment Sleep disturbances have al
Slide 45: MIN-101C03: Main Exclusion Criteria
MIN-101C03: PhaseIIbin PatientswithSchizophrenia Main Exclusion Criteria Current bipolar disorder, panic disorder, obsessive compulsive disorder, or evidence of mental retardation. Patient’sconditionisduetodirectphysiologicaleffectsofa substance (e.g.,a drugofabuse,or medication) or a general medica
Slide 46: MIN-301: Summary/Key results
MIN-301: Summary/Key results Confidential & Proprietary 46
Slide 47: PRIMOMED Project: Effect Of Treatment On Body Weight
PRIMOMED Project: MIN-301AnalogResults Effect Of Treatment On Body Weight Start MIN-301 analog treatment Start MPTP (1 w before MPTP) 1 mg / kg Increase MPTP A : saline control 1.5 mg / kg B :MIN-301analog Body weight during the complete study showed no remarkable effect in both groups 47
Slide 48: PRIMOMED Project: Effect On Parkinsonian Clinical Signs
PRIMOMED Project: MIN-301AnalogResults Effect Of Treatment On Parkinsonian Clinical Signs Start A : saline control MIN-301 analog treatment B: MIN-301analog (1 w before MPTP) Start MPTP Increase MPTP 1 mg / kg 1.5 mg / kg MIN-301 analog alone did not affect the clinical score (CS). After start of MP
Slide 49: PRIMOMED Project: Effect On Abnormal Involuntary Movements Scale
PRIMOMED Project: MIN-301AnalogResults Effect Of Treatment On Abnormal Involuntary Movements Scale (AIMS) Start MPTP Increase MPTP A : saline control 1 mg / kg 1.5 mg / kg B: MIN-301analog On AIMS: The MIN-301 analog group generally performed better than saline during the first 32 days. After increa
Slide 50: PRIMOMED Project: Effect on Locomotor Activity
PRIMOMED Project: MIN-301AnalogResults Effect of Treatment on Locomotor Activity (Bungalow Test) A : saline control B: MIN-301analog Start MPTP Increase MPTP 1 mg / kg 1.5 mg / kg In the bugalow test there was a drop of activity after treatment of MIN-301analog and placebo in healthy monkeys, measur
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