Minerva Neurosciences, Inc · NASDAQ:NERV
Minerva Neurosciences — Investor Presentation (February 2018)
32 slides from Minerva Neurosciences's investor presentation, Feb 21, 2018
Slide 1: 2018: Milestones on the Horizon
February 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: 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 MIN-101 Negative symptoms in Schizophrenia ● 5-HT2A antagonist ● Sigma2 antagonist Seltorexant MIN-202 Primary Insomnia Major Depressive Disorder as a
Slide 4: Three programs and five clinical trials
Three programs and five clinical trials Lead program MIN-101: Negative symptoms in schizophrenia, monotherapy MIN-101C07 Phase 3 ongoing (~500 patients worldwide) Seltorexant (MIN-202): Primary insomnia and major depressive disorder (MDD) MDD2001 Phase 2b ongoing in adjunctive MDD & placebo (~280 pa
Slide 5: MIN-101: A new paradigm for the treatment of schizophrenia
MIN-101 A new paradigm for the treatment of schizophrenia
Slide 6: Market Landscape: Schizophrenia (US)
Market Landscape: Schizophrenia (US) Burden of disease and market potential
Slide 7: Negative symptoms prevalence in schizophrenia patients
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 8: 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 9: 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 10: The economic burden of schizophrenia
The economic burden of schizophrenia includes1: The economic burden is particularly great during the first year following the index episode, mainly due to higher hospitalization rates vs chronic patients2 The average annual healthcare costs of newly diagnosed patients are $20,654 vs $15,489 for chro
Slide 11: 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 12: 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 13: MIN-101 Phase 2b: American Journal of Psychiatry 2017
MIN-101 Phase 2b: American Journal of Psychiatry 2017; 00:1- 8
Slide 14: MIN-101: Phase 3 initiated December 2017
MIN-101: Phase 3 initiated December 2017
Slide 15: 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 16: 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 17: Competitive landscape
Competitive landscape MINERVA
Slide 18: 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 19: MIN-101 positioned to launch without competitors in negative symptoms
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 20: Seltorexant MIN-202: insomnia & major depressive disorder
A drug to treat insomnia & major depressive disorder by restoring physiological sleep A co-development/co-commercialization program with: Seltorexant MIN-202 / JNJ42847922
Slide 21: Orexin system: neurobiology targets circuits that mediate sleep and mood
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 22: Seltorexant studies in MDD with comorbid insomnia
Seltorexant studies in MDD with comorbid insomnia shows improvements of insomnia and depressive symptoms
Slide 23: 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 24: MIN-117: Addressing unmet needs in MDD and anxiety
MIN-117 Addressing the unmet medical needs of patients with Major Depressive Disorder and anxiety symptoms
Slide 25: 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 26: Phase 2a results show effect in 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 27: Sleep polysomnography shows preservation of sleep architecture
Sleep polysomnography shows intact REM latency resulting in preservation of sleep architecture and continuity of sleep, an important product differentiator
Slide 28: MIN-301: A 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 roles in neuronal development
Neuregulin-1 (NGR1) has multiple roles in neuronal development offering potential for neuronal repair in several CNS indications Axon guidance Radial neuron migration Myelination and ensheathment Synapse formation Oligodendrocyte development Neuromuscular junction formation Mei and Xiong, 2008 NRG1
Slide 30: Animal models (non-human primates): effect on AIMS
Animal models (non-human primates): Effect of treatment on abnormal involuntary movements scale (AIMS) Clear MPTP-induced increase in AIMS scores Scores in MIN-301-treated animals lower during low MPTP (< 1 mg/kg) induction as compared to placebo ■ Saline ○ MIN-301 Start MPTP 1 mg / kg Increase MPTP
Slide 31: Financial position
Financial position ~$143.3 million cash balance (cash, cash equivalents and marketable securities) at September 30, 2017 Q3 2017 cash inflow Public offering July 5, 2017 net proceeds ~ $41.6 M $30 M received from J&J in connection with renegotiation of collaboration in August 29, 2017 Shares outstan
Slide 32: 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 MIN-101 Negative symptoms in Schizophrenia ● 5-HT2A antagonist ● Sigma2 antagonist Seltorexant MIN-202 Primary Insomnia Major Depressive Disorder as a
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