Minerva Neurosciences, Inc · NASDAQ:NERV
Minerva Neurosciences — Investor Presentation (March 2018)
30 slides from Minerva Neurosciences's investor presentation, Mar 22, 2018
Slide 1: 2018: Milestones on the Horizon
March 2018 2018: MILESTONES ON THE HORIZON Exhibit 99.1
Slide 2: Forward-Looking Statement Safe-Harbor
All trademarks, trade names and service marks appearing in this presentation are the property of their respective owners. Forward-Looking Statement Safe-Harbor This presentation contains forward-looking statements about Minerva Neurosciences which are subject to the safe harbor provisions of the Pri
Slide 3: Focus: address unmet needs of patients with neuropsychiatric illnesses
Focus: to address the debilitating unmet needs of millions of patients afflicted by neuropsychiatric illnesses Differentiated assets Targeting clearly recognized unmet needs Innovative mechanisms of action Advanced clinical development Lead product in pivotal Phase 3 trial Three Phase 2b studies ong
Slide 4: Innovative pipeline of four compounds and multiple indications in the CNS space
Innovative pipeline of four compounds and multiple indications in the CNS space Program Primary Indications MoA Pre- clinical Phase 1 Phase 2 Phase 3 Roluperidone MIN-101 Negative symptoms in Schizophrenia ● 5-HT2A antagonist ● Sigma2 antagonist Seltorexant MIN-202 Primary Insomnia Major Depressive
Slide 5: Roluperidone (MIN-101): A new paradigm for the treatment of schizophrenia
Roluperidone (MIN-101) A new paradigm for the treatment of schizophrenia Phase 3 initiated December 2017
Slide 6: MIN-101: Phase 2b study design
MIN-101: Phase 2b study design: monotherapy, double-blind, placebo-controlled in schizophrenic patients with confirmed negative symptoms MIN-101 64mg (n = 83) Screening Treatment & Assessments ≤ 4 weeks Screening 12 week double-blind phase ‘core study’ 24 week open-label ‘extension’ phase Placebo (n
Slide 7: Phase 2b study showed specific improvements in negative symptoms
Phase 2b study showed specific improvements in negative symptoms over 12 weeks and 36 weeks in both doses and stable positive symptoms Core Phase Extension Phase PANSS Positive Symptoms Subscale Change from Baseline PANSS Negative Symptoms Subscale Change from Baseline Statistically significant impr
Slide 8: MIN-101 Phase 2b: American Journal of Psychiatry 2017
MIN-101 Phase 2b: American Journal of Psychiatry 2017; 00:1- 8
Slide 9: MIN-101 Phase 3 study design
MIN-101 Phase 3 study design: monotherapy, double-blind, placebo-controlled in schizophrenic patients with negative symptoms MIN-101 64mg (n = 167) Screening Treatment & Assessments ≤ 4 weeks Screening 12 week double-blind phase ‘core study’ 40 week open-label ‘extension’ phase Placebo (n = 167) MIN
Slide 10: Phase 3 efficacy study: confirmatory study design
Phase 3 efficacy study: confirmatory study design guided by insights from Phase 2b and dialogue with FDA Primary endpoint: PANSS Negative Symptoms Factor Score (NSFS) according to Marder after 12 weeks administration Secondary endpoints: Clinical Global Impression of Severity (CGI-S) and Personal an
Slide 11: Market Landscape: Schizophrenia (US)
Market Landscape: Schizophrenia (US) Burden of disease and market potential
Slide 12: 59% of treated adult schizophrenia patients have negative symptoms and are clinically stable
59% of adult patients with schizophrenia who are treated have negative symptoms and are clinically stable 15%2,3 weighted-average 6-month relapse rate among patients with varying severity of negative symptoms 69% of patients have negative symptoms: ~42%2,3 predominant/ prominent symptoms; ~27%4 mild
Slide 13: Severity of Illness: Chronic Progression of Negative Symptoms & Cognitive Impairment
Severity of Illness Chronic Progression of Negative Symptoms & Cognitive Impairment Youth 0-18 Adult 18-40 Mature >40 Cognitive Symptoms Negative Symptoms Positive Symptoms Intermittent acute episodes of positive symptoms decline in frequency and severity Negative symptoms and cognitive impairment a
Slide 14: Total SZ sales for oral tablet: $1.41 billion
Total SZ sales for oral tablet: $1.41 billion Recent survey of psychiatrist ranks negative symptoms as #1 unmet medical need for patients with schizophrenia
Slide 15: Competitive landscape
Competitive landscape MINERVA
Slide 16: MIN-101: general dynamics of the schizophrenia market
MIN-101: general dynamics of the schizophrenia market MIN-101 is unique in the late-stage schizophrenia pipeline: a monotherapy targeting negative symptoms in maintenance phase Phase 3 studies: Acute Phase 3 studies: Maintenance & Sub-population studies Negative Symptoms, Treatment-resistance, Resid
Slide 17: MIN-101 is positioned to launch without competitors
MIN-101: general dynamics of the schizophrenia market MIN-101 is positioned to launch without competitors in negative symptoms as it is the only compound in Phase 3 and sole study in monotherapy Clinical Trials in Negative Symptoms in Schizophrenia in ClinicalTrials.Gov Phase 3 in Negative Symptoms
Slide 18: Seltorexant MIN-202 / JNJ42847922
A drug to treat insomnia & major depressive disorder by restoring physiological sleep A co-development/co-commercialization program with: Seltorexant MIN-202 / JNJ42847922
Slide 19: Orexin system: neurobiology targets circuits that mediate sleep and mood symptoms
Name MoA PK/PD profile Depressive Symptom Orexinergic Domain Depression/Irritability Emotion/Arousal Low Self View/Guilt Emotion Loss of Interest & Pleasure Reward/Motivation Suicide/Death Ideation Reward/Motivation Sleep Disturbance Sleep-Wake Agitation, Restlessness Arousal/Energy Balance Orexin s
Slide 20: Seltorexant study in MDD with comorbid insomnia shows improvements
Seltorexant study in MDD with comorbid insomnia shows improvements of insomnia and depressive symptoms
Slide 21: Seltorexant Phase 2b program
Seltorexant Phase 2b program: two trials in MDD and one in Insomnia ongoing First MDD trial initiated Sep 2017 (clinicaltrials.gov: NCT03227224) Double-blind, randomized, parallel-group, placebo-controlled adaptive-dose finding study 4-week screening, 6-week double-blind treatment and 2-week follow-
Slide 22: MIN-117: Addressing unmet needs in Major Depressive Disorder and anxiety
MIN-117 Addressing the unmet medical needs of patients with Major Depressive Disorder and anxiety symptoms
Slide 23: Phase 2a study designed to explore unmet needs in patients with MDD
Phase 2a study designed to explore unmet needs in patients with MDD MIN-117 2.5mg (n = 21) Screening Treatment & Assessments 4 weeks Screening Day -28 to -1* 6 week double blind treatment phase 2 wk post treatment follow-up phase MIN-117 0.5mg (n = 21) R Paroxetine 20mg (n = 21) Placebo (n = 21) *In
Slide 24: Phase 2a results show effect on depression and anxiety
The Phase 2a results show effect on primary endpoint in depression as well as noted effect on anxiety Exploratory study for dose finding, safety and efficacy – not statistically powered: Results: Efficacy on depressive symptoms Onset evident as early as 2 weeks Efficacy on anxiety symptoms Both dose
Slide 25: Sleep polysomnography shows intact REM latency
Sleep polysomnography shows intact REM latency resulting in preservation of sleep architecture and continuity of sleep, an important product differentiator
Slide 26: Planned Phase 2b study in moderate to severe MDD
Planned Phase 2b study designed to evaluate MIN-117 in patients with moderate to severe MDD MIN-117 5.0 mg (N=81) Screening Treatment & Assessments Up to 3-weeks Screening Day -21 to -1 6-week double blind treatment phase 2-week post-treatment follow-up MIN-117 2.5 mg (N=81) R Placebo (N=162) 324 pa
Slide 27: Planned MIN-117 Phase 2b study objectives
Primary: To evaluate the efficacy of 5.0 mg or 2.5 mg of MIN-117 compared with placebo in reducing the symptoms of MDD as measured by the change from baseline in Montgomery-Asberg Rating Depression Scale (MADRS) score over 6 weeks of treatment Secondary: To evaluate the efficacy of 5.0 mg or 2.5 mg
Slide 28: MIN-301: protein drug for Parkinson's Disease
MIN-301 A protein drug with disease modifying potential for the treatment of unmet medical needs in Parkinson’s Disease and other major CNS indications
Slide 29: Neuregulin-1 has multiple roles in neuronal development
Neuregulin-1 (NGR-1) has multiple roles in neuronal development offering potential for neuronal repair in several CNS indications; initial clinical focus will be Parkinson’s disease Axon guidance Radial neuron migration Myelination and ensheathment Synapse formation Oligodendrocyte development Neuro
Slide 30: Financial position
Financial position ~$133.2 million cash balance (cash, cash equivalents and marketable securities) at December 31, 2017 Shares outstanding at March 9, 2018: ~38.7 M (~45.1 M fully diluted)
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