Minerva Neurosciences, Inc · NASDAQ:NERV
Minerva Neurosciences — Investor Presentation (January 2018)
31 slides from Minerva Neurosciences's investor presentation, Jan 8, 2018
Slide 1: Corporate Presentation
Exhibit 99.1 CORPORATE PRESENTATION San Francisco January 2018 Confidential & Proprietary
Slide 2: Forward-Looking Statement Safe-Harbor
Forward-Looking Statement Safe-Harbor This presentation contains forward-looking statements about Minerva Neurosciences which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historic
Slide 3: Focus: to address the debilitating unmet needs of millions of patients
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 stu
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 Primary Program MoA Pre- clinical Phase 1 Phase 2 Phase 3 Indications Negative symptoms in 5-HT2A antagonist MIN-101 Schizophrenia Phase 3 initiated Dec 2017 (MIN-101-C07) Sigma 2 antagonist Primary Insomnia Phase 2b ini
Slide 5: Five clinical trials anticipated to read out in 2019
Five clinical trials anticipated to read out in 2019 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 &
Slide 6: MIN-101
MIN-101 A new paradigm for the treatment of schizophrenia Confidential & Proprietary 6
Slide 7: Schizophrenia has three symptom domains
Schizophrenia has three symptom domains: positive symptoms fluctuate over time while negative & cognitive symptoms persist and cause lifelong disability Negative symptoms and cognitive impairment are evident at onset of illness and are lifelong debilitating symptoms Youth 0-18 Adult 18-40 Mature >40
Slide 8: MIN-101 has a unique MoA with potential to address negative symptoms
MIN-101 has a unique MoA with the potential to be the first to address negative symptoms and shift the treatment paradigm of schizophrenia • A unique MOA: 5-HT2A antagonist + Sigma2 antagonist • No direct dopamine blocking, unlike most available antipsychotics • Avoids antipsychotic side-effects • E
Slide 9: MIN-101: Phase 2b study design
MIN-101: Phase 2b study design: monotherapy, double-blind, placebo- controlled in schizophrenic patients with confirmed negative symptoms 4 weeks 12 week double-blind Screening phase ‘core study’ 24 week open-label ‘extension’ phase MIN-101 64mg (n = 83) Randomization R MIN-101 32mg (n = 78) MIN-101
Slide 10: 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 Extension PANSS Negative Symptoms Subscale Change from Baseline Statistically significant improvements in the primary endpoint PANSS Negative Symptoms Factor Score (
Slide 11: MIN-101 Phase 2b: American Journal of Psychiatry 2017
MIN-101 Phase 2b: American Journal of Psychiatry 2017; 00:1- 8 11
Slide 12: MIN-101: Phase 3 initiated December 2017
MIN-101: Phase 3 initiated December 2017 12
Slide 13: 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 Persona
Slide 14: MIN-101 Phase 3 study design
MIN-101 Phase 3 study design: monotherapy, double-blind, placebo- controlled in schizophrenic patients with negative symptoms 4 weeks 12 week double-blind phase ‘core study’ 40 week open-label ‘extension’ phase Screening MIN-101 64mg (n = 167) Randomization R MIN-101 32mg (n = 167) MIN-101 64mg Plac
Slide 15: MIN-101: Route to the schizophrenia market
MIN-101: Route to the schizophrenia market 15
Slide 16: MIN-101 is unique in the late-stage schizophrenia pipeline
MIN-101 is unique in the late-stage schizophrenia pipeline: a monotherapy targeting negative symptoms in maintenance phase Acute studies Maintenance & Sub-population studies Negative Symptoms, Residual positive symptoms, Long-Acting Injectables or Patch and Niche populations MIN-101 (5-HT2A & 2R ant
Slide 17: Studies show 69% of adult patients with schizophrenia have negative symptoms
Studies show 69% of adult patients with schizophrenia have negative symptoms and 85% are clinically stable, U.S. 2016 patient estimates below Schizophrenia.com: Estimated prevalence 2.2 million patients in U.S. Of SZ (0.88%) (2.2 million US adults) WHO website: 26 million with schizophrenia worldwid
Slide 18: Approximately 2.2 million patients in major markets have negative symptoms
Approximately 2.2 million patients with schizophrenia in major markets (US, EU5, Japan) have negative symptoms and nearly 2 million are stable and may be eligible for MIN-101 monotherapy Number of patients in major markets (millions) 3.5 3.0 Treated patients 2.5 3.2 M 2.0 Patient with negative Clini
Slide 19: Seltorexant
Seltorexant MIN-202 / JNJ42847922 A drug to treat insomnia & major depressive disorder by restoring physiological sleep A co-development/co-commercialization program with: 19 Confidential & Proprietary
Slide 20: Orexin system: neurobiology targets circuits mediating sleep and mood
Orexin system: neurobiology targets circuits that mediate sleep and mood symptoms 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-W
Slide 21: Seltorexant studies in MDD with comorbid insomnia
Seltorexant studies in MDD with comorbid insomnia shows improvements of insomnia and depressive symptoms 21
Slide 22: 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 fol
Slide 23: MIN-117
MIN-117 Addressing the unmet medical needs of patients with Major Depressive Disorder and anxiety symptoms Confidential & Proprietary 23
Slide 24: Phase 2a study designed to explore unmet needs in patients with MDD
Phase 2a study designed to explore unmet needs in patients with MDD 4 weeks Screening 2 wk post treatment 6 week double blind treatment phase Day -28 to -1* follow-up phase *Includes overlapping Study drug is double-blind and double- washout period of up to dummy 4 weeks MIN-117 2.5mg (n = 21) MIN-1
Slide 25: The 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 26: 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 26
Slide 27: MIN-301
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 Confidential & Proprietary 27
Slide 28: Neuregulin-1 has multiple 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 29: Animal models: effect of treatment on AIMS
Animal models (non-human primates): Effect of treatment on abnormal involuntary movements scale (AIMS) AIMS score MPTP effect 6 NRG-101 5 Saline 4 Saline MIN-301 3 2 1 0 14 21 28 35 42 49 56 Day number Start MPTP Increase MPTP 1 mg / kg 1.5 mg / kg • Clear MPTP-induced increase in AIMS scores • Scor
Slide 30: 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 out
Slide 31: Innovative pipeline of four compounds and multiple indications in the CNS space
Innovative pipeline of four compounds and multiple indications in the CNS space Primary Program MoA Pre- clinical Phase 1 Phase 2 Phase 3 Indications Negative symptoms in • 5-HT2A antagonist MIN-101 Schizophrenia Phase 3 initiated Dec 2017 (MIN-101-C07) • Sigma 2 antagonist Primary Insomnia Phase 2b
Minerva Neurosciences — Investor Presentation (January 2018) on 6ix