Minerva Neurosciences, Inc · NASDAQ:NERV
Minerva Neurosciences — Investor Presentation (September 2015)
37 slides from Minerva Neurosciences's investor presentation, Sep 24, 2015
Slide 1: Innovative Mechanisms With Transformative Potential in CNS Diseases
Exhibit 99.2 Innovative Mechanisms With Transformative Potential in Central Nervous System (CNS) Diseases September 24, 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- l
Slide 3: Minerva: Unique presence in CNS
Minerva: Unique presence in CNS • Extensive management leadership and expertise in CNS • Experience in more than 750 clinical trials includes multiple products approved by the FDA • Harnessing innovative mechanisms of action • Biological insights and unmet needs drive development of differentiated p
Slide 4: Pipeline of potentially transformative CNS therapies
Pipeline of potentially transformative CNS therapies Program Primary Indication Preclinical Phase I Phase II Milestones Topline IIb data MIN-101 Schizophrenia Phase IIa completed, Phase IIb ongoing expected Q2 2016 Topline IIa data Major Depressive Phase Ib completed, Phase IIa ongoing MIN-117 expec
Slide 5: Schizophrenia: a devastating chronic disease
Schizophrenia: a devastating chronic disease High burden for patients, families and society • Affects~30millionpeopleworldwide 1 • Oftenstartsinlateteensorearlyadulthood 2 • 75% patients are non-adherent to existing therapies within 2 years of being discharged from hospital3 • The largest unmet medi
Slide 6: MIN-101 for Schizophrenia
MIN-101 for Schizophrenia Mechanism of action Potential benefits / differentiation Address negative 5-HT2A antagonist symptoms, cognition and sleep disorders, Sigma2 antagonist in addition to positive symptoms 6
Slide 7: An effective and safe lifelong treatment for schizophrenia remains a significant unmet need
An effective and safe lifelong treatment for schizophrenia remains a significant unmet need $3.9B R Rate1 60%to80%Discontinuation x Sales Current Treatments Lack of efficacy on negative symptoms Lack of efficacy on cognitive symptoms Focus On Positive Lack of efficacy on insomnia Symptoms Progressio
Slide 8: MIN-101: Phase IIa completed
MIN-101: Phase IIa completed A Multi-center, Inpatient and Ambulatory, Phase IIa, Double-blind, Randomized, Placebo-controlled Proof of Concept Study of MIN-101 in 96 Patients with DSM-IV Schizophrenia (PANSS > 60) Primary Endpoint: Explore safety & tolerability of MIN-101 at a dose two or three tim
Slide 9: MIN-101: Phase IIa compelling efficacy on spectrum of symptoms
MIN-101: Phase IIa compelling efficacy on spectrum of symptoms Total Weighted Score Decrease: -24.1 for MIN-101 versus -17.9 Placebo Positive and Negative Syndrome Scale (PANSS) 5 Factors (PPC) After Three Months -7 -4 -4 -4 -4 -6 -3.5 -3.5 -3.5 -3.5 p < 0.05 p = 0.08 -3 -3 -3 -3 -5 -2.5 -2.5 -2.5 -
Slide 10: MIN-101: Phase IIa improvement in overall psychopathology of schizophrenia
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 10 1. As measured by PANSS scale
Slide 11: MIN-101: Compelling efficacy on cognition (Phase IIa)
MIN-101: Compelling efficacy on cognition (Phase IIa) Improves SeveralCognitive Dimensions AfterThreeMonths (1) 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
Slide 12: MIN-101: Compelling efficacy on sleep (Phase IIa)
1 MIN-101: Compelling efficacy on sleep objective (PSG) and 2 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 13: MIN-101: Phase IIa safety evaluation
MIN-101: Phase IIa safety evaluation Relative to Atypical Side Effect Evaluation Antipsychotics AEs and SAEs Limited and comparable to placebo Improved WeightGain, Waist Circumference No increase Improved Prolactin and Laboratory Tests No increase Improved Extra-pyramidal Symptoms No effect on Simps
Slide 14: MIN-101CO3: Phase IIb currently recruiting
MIN-101CO3: Phase IIb currently recruiting A Phase IIb, Multi-Centre, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled 12 Week Study to Evaluate the Efficacy, Tolerability and Safety of MIN-101 in Patients with Negative Symptoms of Schizophrenia Followed by a 24-Week, Open-Label Extensio
Slide 15: MIN-101CO3: Primary Objective
MIN-101CO3: Primary Objective 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 score of the pentagonal model over 12 weeks of treat
Slide 16: MIN-101CO3: Secondary Objectives
MIN-101CO3: Secondary Objectives To evaluate the efficacy of MIN-101 compared to placebo in improving other symptoms of schizophrenia as measured by the change from Baseline in the PANSS total score, positive symptoms score, dysphoric mood, activation, and autistic preoccupation sub-scores of the pe
Slide 17: Insomnia affects about 10% of adults and the majority of people with depression
Insomnia affects about 10% of adults and the majority of people with depression 17
Slide 18: MIN-202 (JNJ-42847922) for Insomnia
MIN-202 (JNJ-42847922) for Insomnia (primary and co- morbid) Mechanism of action Potential benefits / differentiation Physiological Selective Orexin2 regulation of biological rhythm antagonist and control of wake drive 18
Slide 19: Potential differentiation based on selectivity for the Orexin-2 receptor and half-life
Potential differentiation based on selectivity for the Orexin-2 receptor and half-life 19
Slide 20: MIN-202: Selective Orexin-2 antagonist
MIN-202 (JNJ-42847922): Selective Orexin-2 antagonist A promising new approach to treat primary insomnia and comorbid insomnia in MDD patients (adjunctive MDD) 20
Slide 21: MIN-202 Phase IIa trial
MIN-202 Phase IIa trial ClinicalTrials.gov identifier: NCT02464046 A Randomized, Placebo-controlled, 2-way Crossover, Double-Blind Study to Evaluate the Efficacy, Safety and Tolerability of JNJ-42847922 in Subjects With Insomnia Disorder Without Psychiatric Comorbidity Estimated enrollment: 26 patie
Slide 22: MIN-202 Phase IIa trial outcome measures
MIN-202 Phase IIa trial ClinicalTrials.gov identifier: NCT02464046 • Primary outcome measure • Sleep efficiency by polysomnography • Secondary outcome measures • Total sleep time by polysomnography • Wake time after sleep onset by polysomnography • Number of awakenings after persistent sleep by poly
Slide 23: MIN-202 Phase Ib trial
MIN-202 Phase Ib trial ClinicalTrials.gov identifier: NCT02476058 An Exploratory Multicenter, Double-Blind, Diphenhydramine- and Placebo- controlled Safety, Efficacy and Biomarker Study With JNJ-42847922 in Subjects With Major Depressive Disorder Estimated enrollment: 48 patients (3 arms); participa
Slide 24: MIN-202 Phase Ib trial outcome measures
MIN-202 Phase Ib trial ClinicalTrials.gov identifier: NCT02476058 • Primary outcome measure • Number of participants with AEs or SAEs • Secondary outcome measures • Inventory of Depressive Symptomatology-clinician Rated 30 (IDSC30) Score and Structured Interview Guide for Hamilton Depression Scale (
Slide 25: Major Depressive Disorders
Major Depressive Disorders Treatments with faster onset and better response, without side effects, are critically needed • Major depression: primary cause of disability worldwide by 2030 1 • ~6 million patients in US with treatment- resistant depression 2 • Only ~30% of patients achieve remission us
Slide 26: MIN-117 for Major Depressive Disorder
MIN-117 for Major Depressive Disorder Mechanism of action Potential benefits / differentiation 5-HT1A Faster onset 5HT Transporter Preserve cognition Alpha-1a,b and sexual function Dopamine Transporter Treat partial and non- 5-HT2A antagonist responders 26
Slide 27: MIN-117: New generation of treatment for MDD
MIN-117: New generation of treatment for MDD Acts through multiple mechanisms on several receptors associated with the control of mood AfterTwoWeeksofTreatment (PhaseI): 80 Number p<0.05(vs placebo) Rapid Onset Potential 70 of Eye Movements Antagonist on 5-HT1A receptor 60 Per Hour of Sleep Dopamine
Slide 28: MIN-117: Preserving cognition and sexual function
MIN-117: Preserving cognition and sexual function based on results of preclinical studies Effects on Immediate Memory Effects on Sexual Function (a model of cognition) MIN-117: MIN-117: Paroxetine: Shows Preserved Memory Under Stress Preserves Sexual Function Impairs Sexual Function Placebo & Imipra
Slide 29: MIN-117: Phase II currently recruiting
MIN-117: Phase II currently recruiting A Randomized, Double-Blind, Parallel-Group, Placebo- and Active- Controlled Study to Evaluate the Efficacy and Safety of 2 Doses of MIN- 117 in Adult Subjects with Major Depressive Disorder Study 4-Week Pre-Treatment Phase Phase 2-Week 6-Week Double-Blind Treat
Slide 30: MIN-117C01: Primary Objective
MIN-117C01: Primary Objective To evaluate the efficacy of MIN-117 0.5 and 2.5 mg compared to placebo in reducing the symptoms of a major depressive episode as measured by the change from Baseline in the Montgomery- Asberg Depression Rating Scale (MADRS) total score over 6 weeks of treatment. 30
Slide 31: MIN-117C01: Secondary Objectives
MIN-117C01: Secondary Objectives To evaluate the efficacy of MIN-117 0.5 and 2.5 mg compared to placebo in onset of antidepressant response as measured by the change from Baseline in the MADRS total score over 6 weeks of treatment. To assess the effects of MIN-117 compared to placebo on severity of
Slide 32: Parkinson's Disease: Large and growing prevalence
Parkinson’s Disease: Large and growing prevalence with huge burden to patients, families and society Caused by a cascade of events leading to the death of dopamine-generating cells Progressive and incurable Leads to lower quality of life, disability Loss of speech, mobility, cognitive abilities Lowe
Slide 33: MIN-301 for Parkinson's Disease
MIN-301 for Parkinson’s Disease Potential benefits / Mechanism of action differentiation Cognitive Neuregulin 1ß1 improvement and neuroprotective / activating ErbB4 neurorestorative effects 33
Slide 34: 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
Slide 35: Financial Summary
Financial Summary ~$44.8M cash balance at 6/30/15 $15M credit facility with Oxford and SVB entered into January 2015 ($10m drawn down) – 40,790 warrants issued in connection with the debt facility at exercise price of $5.516 ~$31M PIPE completed in March 2015 – 6,281,661 shares sold at $4.81/share –
Slide 36: 2016 Expected Milestones
2016 Expected Milestones Program Primary Indication Milestone Topline Phase IIb data MIN-101 Schizophrenia expected Q2 2016 Topline IIa data MIN-117 Major Depressive Disorder (MDD) expected H1 2016 Data expected from Phase IIa Primary and Comorbid MIN-202 and Phase Ib trials (Secondary) Insomnia H1
Slide 37: Thank You
Thank You Minerva Neurosciences, Inc. 1601 TrapeloRoad, Suite 284, Waltham, MA 02451 Confidential & Proprietary
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