Minerva Neurosciences, Inc · NASDAQ:NERV
Minerva Neurosciences — Investor Presentation (February 2017)
37 slides from Minerva Neurosciences's investor presentation, Feb 27, 2017
Slide 1: Innovation to change the way we treat CNS disease
Innovation to change the way we treat CNS disease February / March 2017 Nasdaq: NERV Exhibit 99.1
Slide 2: Forward-looking statements
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-looking statements are statements that a
Slide 3: Investment highlights
Investment highlights Late-stage pipeline targets schizophrenia, major depressive disorder (MDD), insomnia and Parkinson’s Our product candidates represent true innovation in disease treatment and management by addressing significant unmet needs of large patient populations MIN-101 may change schizo
Slide 4: Our team
Our team Remy Luthringer, Ph.D., President and Chief Executive Officer Deep clinical development experience with > 150 CNS molecules Previous head of FORENAP Institute for Research in Neurosciences and Neuropsychiatry Extensive practice in clinical psychiatry, with Ph.D. in neurosciences and clinica
Slide 5: True differentiation in our approach
True differentiation in our approach Extensive knowledge of the pathology, course and impact of CNS diseases Focus on outcomes that address unmet needs (no “me-too” products) and on patient populations who will benefit from treatment with our compounds Understanding of the impact of novel MOAs and t
Slide 6: Pipeline programs
Program Origin Primary Indications Mechanisms of Action Pre- clinical Phase I Phase II Status Next Steps MIN-101 Mitsubishi Tanabe Schizophrenia ● 5-HT2A antagonist ● Sigma2 antagonist Results announced May & October 2016 End of Phase II meeting with FDA scheduled early in Q2 2017 Initiation of pivo
Slide 7: MIN-101: A new paradigm for the treatment of schizophrenia
MIN-101 A new paradigm for the treatment of schizophrenia
Slide 8: Schizophrenia: a devastating chronic disease with a high burden
Schizophrenia: a devastating chronic disease with a high burden for patients, families and society Affects ~30 million people worldwide1 Often starts in late teens or early adulthood2 75% patients are non-adherent to existing therapies within 2 years of being discharged from hospital3 Medication non
Slide 9: Chronic progression of negative symptoms and 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 Schizophrenia is a dynamic chronic disease - prevalence of symptoms changes over the lifetime of the patient
Slide 10: The unmet needs in schizophrenia
The unmet needs in schizophrenia Tranquilizers and antipsychotics treat Positive Symptoms delusions and hallucinations but not Cognition Negative Symptoms and have - debilitating side effects caused by blocking D2 3. Negative Symptoms - apathy - restricted social interaction - poor emotional feeling
Slide 11: Responding to unmet needs in schizophrenia
Responding to unmet needs in schizophrenia Lack of efficacy of current Rx on negative symptoms Substantial side effect burden Lack of efficacy of current Rx on cognitive decline In addition, positive symptom scores remained stable over ~9 months when patients were taking MIN-101 Unmet need MIN-101 c
Slide 12: MIN-101: a new approach and MOA
MIN-101: a new approach and MOA A unique dual MOA; 5-HT2A antagonist + Sigma2 antagonist No direct dopamine blocking, unlike most (or all) available antipsychotics Specific affinity for s2, 5-HT2A and a1-adrenergic receptors No affinity (>1000 nM) for other receptors including dopaminergic, muscarin
Slide 13: MIN-101 Phase IIb study design
MIN-101 Phase IIb study: monotherapy, double-blind, placebo-controlled in schizophrenic patients with 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 = 83) MIN-101 32
Slide 14: MIN-101 Phase IIb data – setting a new standard
MIN-101 Phase IIb data – setting a new standard Treatment resulted in statistically significant improvement in PANSS negative symptoms and total PANSS scores Statistically superior to placebo on multiple key secondary endpoints Positive effects were specific for negative symptoms and not secondary t
Slide 15: Endpoints at 12 weeks: p-values and effect sizes
p-value (MIN-101 vs placebo) Effect size (MIN-101 vs placebo) Endpoint at 12 weeks 32mg 64mg 32mg 64mg Primary objective 5-Factor Negative Score (i.e., Negative Symptoms, Pentagonal Structure): 0.0240 0.0036 0.45 0.57 Secondary objectives PANSS total score 0.0819 0.0031 0.34 0.57 3-Factor Negative S
Slide 16: Efficacy: primary endpoint on negative symptoms
Efficacy: Primary endpoint – clinically meaningful effect on negative symptoms with rapid onset of effect and continuous improvement throughout the study at both doses Onset of effect observed after 2 weeks (measured at first visit) WEEK
Slide 17: Efficacy: secondary endpoint (1)
Efficacy: Secondary endpoint (1) Improvement in negative symptoms also observed with additional measurement scale PANSS Negative Symptom Score (3 Factors) - Change from Baseline (MMRM) (ITT Population) WEEK
Slide 18: Efficacy: secondary endpoint (2)
Efficacy: Secondary endpoint (2) Demonstrated improvement in Total PANSS driven by improvement in negative symptoms WEEK
Slide 19: Efficacy: secondary endpoint (4)
Efficacy: Secondary endpoint (4) PANSS positive symptoms score (3 Factors) indicates MIN-101 maintains stability in positive symptoms WEEK
Slide 20: Extension Phase
Extension Phase Baseline for patients who crossed from placebo to MIN-101 is start of open label (Week 12)
Slide 21: MIN-101C03: Negative symptoms continued improvement over 36 weeks
MIN-101C03: Negative Symptoms (Pentagonal Structure) Continued improvement over 36 weeks in both doses Baseline for Placebo-to-MIN-101 is From Start of Open Label Core Phase Extension Phase Baseline for Placebo-to-MIN-101 is From Start of Open Label (Week 12)
Slide 22: MIN-101C03: Positive symptoms stable
MIN-101C03: Positive Symptoms (3-Factors) Stable over 36 weeks in both doses Baseline for Placebo-to-MIN-101 is From Start of Open Label
Slide 23: MIN-202 (JNJ42847922)
MIN-202 (JNJ42847922) A drug to treat insomnia & depressive disorders by restoring physiological sleep A co-development/co-commercialisation program with;
Slide 24: Insomnia affects about 10% of adults
Insomnia affects about 10% of adults and the majority of people with depression
Slide 25: MIN-202: Exploratory study in MDD with comorbid insomnia
MIN-202: Exploratory study in patients with MDD and comorbid insomnia (n=20) indicate significant improvements in key sleep metrics
Slide 26: Phase IIa in primary insomnia: sleep efficiency
Phase IIa in primary insomnia: achievement of primary endpoint of improvement in sleep efficiency complemented by increase in total sleep time Δ 8.12 % p <0.001 Δ 5.77 % p <0.001 Sleep Efficiency = (Total Sleep Time/480) * 100% PSG recording = 480 min
Slide 27: MIN-117
MIN-117 Potential for a more effective and safer treatment to address the unmet medical needs of Major Depressive Disorder patients
Slide 28: Unmet need in Major Depressive Disorder
Unmet need in Major Depressive Disorder: treatments with faster onset and better response, without side effects Treatments that: Act rapidly Are effective in patients who do not respond to or receive only partial benefit from existing medicines Do not impair cognition or sexual function Free patient
Slide 29: MIN-117C01: Phase IIa study design
MIN-117C01: Phase IIa study design 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) *Includes overlapping washout period
Slide 30: Phase IIa efficacy: MADRS primary endpoint
Phase IIa efficacy: MADRS primary endpoint Clinically meaningful effect in a depressed patient population at both doses Effect size MIN-117 0.5 mg: 0.24 MIN-117 2.5 mg: 0.34
Slide 31: Phase IIa efficacy: HAM-A secondary endpoint
Phase IIa efficacy: HAM-A secondary endpoint Unexpected effect on anxiety Effect size MIN-117 0.5 mg: 0.49 MIN-117 2.5 mg: 0.45
Slide 32: Sleep polysomnography: REM latency
Sleep polysomnography: REM latency
Slide 33: MIN-301
MIN-301 A protein drug with disease modifying potential for the treatment of unmet medical needs in major CNS indications
Slide 34: Parkinson's Disease
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 Lower
Slide 35: Animal models: effect on abnormal involuntary movements scale
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 36: Upcoming milestones and value drivers
Upcoming milestones and value drivers Program Primary Indication Status MIN-101 Schizophrenia End of Phase II meeting with FDA in early Q2 2017 Initiation of pivotal Phase III trial planned in Q3 2017 MIN-202 Primary Insomnia and Major Depressive Disorder Phase II trial preparation underway Next tri
Slide 37: Financial position
Financial position ~$91.9 million cash balance (cash, cash equivalents and marketable securities) at September 30, 2016 sufficient to fund operations into 2018 2016 quarterly R&D expense (Q1 – Q3) : approx. $2.7m - $5.9m Shares outstanding at October 28, 2016: ~34.8 million (~40.8 million fully dilu
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