Minerva Neurosciences, Inc · NASDAQ:NERV
Minerva Neurosciences — Investor Presentation (January 2017)
53 slides from Minerva Neurosciences's investor presentation, Jan 6, 2017
Slide 1: Innovation to treat unmet medical needs in CNS disorders
Innovation to treat unmet medical needs in CNS disorders January 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: A CNS company targeting schizophrenia, MDD, insomnia and Parkinson's
Merger Nov ‘13 Acquisition Feb ‘14 Co-development Feb ‘14 July 2014 NASDAQ: NERV Cyrenaic (MIN-101) Sonkei (MIN-117) MIN-202 Mind-NRG SA (MIN-301) A CNS company targeting schizophrenia, major depressive disorder, insomnia and Parkinson’s disease
Slide 4: Investment highlights
Investment highlights Broad late-stage pipeline Lead asset, MIN-101, has differentiated MoA with specific effect on negative symptoms and is planned to initiate pivotal Phase III trials for treatment of schizophrenia in Q3 2017 Compelling efficacy and safety data generated in randomized, double-blin
Slide 5: A portfolio of innovative product candidates to treat various CNS diseases
A portfolio of innovative product candidates to treat various CNS diseases Program Origin Primary Indications Mechanisms of Action Pre- clinical Phase I Phase II Status MIN-101 Mitsubishi Tanabe Schizophrenia ● 5-HT2A antagonist ● Sigma2 antagonist Positive results announced May & October 2016 MIN-2
Slide 6: CNS expertise
CNS expertise Extensive knowledge of the pathology, course and impact of CNS diseases Focus on desired outcomes that address unmet patient needs Understanding of the impact of novel MOAs Insights into CNS clinical trial design and conduct based on extensive hands-on experience Ability to characteriz
Slide 7: Summary of Partnerships
Summary of Partnerships MINERVA
Slide 8: MIN-101: In-licensed from Mitsubishi Tanabe Pharmaceutical Company
MIN-101: In-licensed from Mitsubishi Tanabe Pharmaceutical Company (MTPC) Minerva: exclusive worldwide license includes rights to develop, commercialize and sub-license MIN-101 (and back-ups) outside of certain Asian countries MTPC: retains rights to commercialize and sell MIN-101 in certain Asian c
Slide 9: MIN-117: In-licensed from Mitsubishi Tanabe Pharmaceutical Company
Minerva: exclusive worldwide license includes rights to develop, commercialize and sub-license MIN-117 outside of certain Asian countries MTPC: retains rights to commercialize and sell MIN-117 in certain Asian countries including China, Japan, India and South Korea (MTPC Territory) Milestones upon l
Slide 10: MIN-202: Co-development and license agreement with Janssen
MIN-202: Co-development and license agreement with Janssen Pharmaceutica NV (Janssen) Minerva has commercialization rights for EU, Switzerland, Liechtenstein, Iceland & Norway (Minerva Territory) with rights to sub-license Minerva pays quarterly high single digit % royalty to Janssen on Minerva Terr
Slide 11: MIN-101: A paradigm shift in the treatment of schizophrenia
MIN-101 A paradigm shift in the treatment of schizophrenia
Slide 12: Schizophrenia: three symptom domains
Schizophrenia: three symptom domains Positive Symptoms - delusions - hallucinations - thought disorder Negative Symptoms - avolition - apathy - restricted social interaction - restricted emotional feelings and display - physical and mental slowness - depressed mood Impaired Cognition
Slide 13: Current standard of care: significant unmet needs exist
Current standard of care: ‘Major tranquilizers’ or atypical antipsychotics (block dopamine D2 receptors) – Significant unmet needs exist 75% patients are non-adherent to existing therapies within 2 years of being discharged from hospital1 Reduce agitation and therefore the need for physical restrain
Slide 14: MIN-101: a differentiated approach/MoA
Receptor subtypes Materials Ki values, nmol/L Serotonin 5-HT2a Rat, cerebral cortex Human recombinant 7.5 5.2 Sigma2 Guinea pig, brain 8.2 Sigma1 Guinea pig, brain 253.8 A1 adrenergic Rat, brain 14.4 MIN-101: a differentiated approach/MoA Unique combination of pharmacological targets without any dir
Slide 15: Phase IIb in schizophrenic patients (MIN-101C03)
Phase IIb in schizophrenic patients (MIN-101C03) Core study results published in May 2016 & 6 months extension results published in October 2016
Slide 16: MIN-101 Phase IIb study design
MIN-101 Phase IIb study design: monotherapy, double-blind, placebo-controlled in schizophrenic patients with negative symptoms MIN-101 64mg (n = 78) Screening Treatment & Assessments < 4 weeks Screening 12 week double blind phase ‘core study’ 24 week open label ‘extension’ phase Placebo (n = 78) MIN
Slide 17: Summary findings from Phase IIb trial with MIN-101
Summary findings from Phase IIb trial with MIN-101 MIN-101 treatment resulted in statistically significant improvement in PANSS negative symptoms and total PANSS scores MIN-101 also shown to be statistically superior to placebo on multiple key secondary endpoints Effect of MIN-101 demonstrated to be
Slide 18: Efficacy: Summary table of statistically significant results
Efficacy: Summary table of statistically significant results Endpoint 32 mg 64 mg 32 mg 64 mg PANSS Negative Subscale Score (Pentagonal Structure Model) 0.0213 0.0030 0.45 0.58 PANSS Total Score 0.0714 0.0027 0.35 0.59 PANSS Positive Subscale Score (Pentagonal Structure Model) 0.5933 0.1926 -0.10 0.
Slide 19: Efficacy: Primary endpoint PANSS negative subscale
Effect size 32 mg: 0.45 64 mg: 0.58 Onset of effect observed after 2 weeks (measured at first visit) Efficacy: Primary endpoint PANSS negative subscale (pentagonal structure)
Slide 20: Efficacy: Secondary endpoint (1) PANSS negative symptom score
Efficacy: Secondary endpoint (1) PANSS negative symptom score (3 Factors) Onset of effect observed after 2 weeks (measured at first visit)
Slide 21: Efficacy: Secondary endpoint (2) PANSS total score
Efficacy: Secondary endpoint (2) PANSS total score
Slide 22: Extension Phase
Extension Phase Baseline for patients who crossed from placebo to MIN-101 is start of open label (Week 12)
Slide 23: MIN-101C03: Negative Symptoms (Pentagonal Structure)
MIN-101C03: Negative Symptoms (Pentagonal Structure) 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 24: MIN-101C03: Negative Symptoms (3-Factors)
MIN-101C03: Negative Symptoms (3-Factors) Core Phase Extension Phase Baseline for Placebo-to-MIN-101 is From Start of Open Label (Week 12)
Slide 25: Safety
Safety (complete study) MINERVA
Slide 26: MIN-101C03: Common Adverse Events
MIN-101C03: Common Adverse Events (≥ 5% of Patients) MIN-1012 System Organ Class Preferred Term Placebo1 (N = 83) 32 mg (N = 103) 64 mg (N = 102) Total (N = 205) Overall (N = 244) Subjects with Any Common TEAE 20 ( 24.1%) 24 ( 23.3%) 29 ( 28.4%) 53 ( 25.9%) 69 ( 28.3%) Investigations 0 ( 0.0%) 0 ( 0
Slide 27: The negative symptom hypothesis
“D2 blocking drugs should only be prescribed for acute episodes of psychosis/positive symptoms.” Data indicate that for the majority of young individuals the first episode of psychosis would ameliorate and occasionally disappear within 2-6 weeks without continuous DA blocking. However In the majorit
Slide 28: MIN-202: A drug to treat insomnia & depressive disorders
MIN-202 (JNJ42847922) A drug to treat insomnia & depressive disorders by restoring physiological sleep A co-development/co-commercialisation program with;
Slide 29: 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
Slide 30: MIN-202: Exploratory study in patients with MDD and comorbid insomnia
MIN-202: Exploratory study in patients with MDD and comorbid insomnia (n=20)
Slide 31: Phase IIa in primary insomnia: sleep efficiency
Phase IIa in primary insomnia: primary endpoint of sleep efficiency on days 1/2 and 5/6 Δ 8.12 % p <0.001 Δ 5.77 % p <0.001 Sleep Efficiency = (Total Sleep Time/480) * 100% PSG recording = 480 min
Slide 32: Phase IIa in primary insomnia: total sleep time
Phase IIa in primary insomnia: total sleep time is observed to increase Δ 39 min p <0.001 Δ 27.8 min p <0.001
Slide 33: Phase Ib: efficacy on depressive symptoms independent of sleep
Phase Ib: observed efficacy on depressive symptoms is independent of effects on sleep HDRS17 = Hamilton Depression Rating Scale Adjusted HDRS17 = Hamilton Depression Rating Scale with 3 sleep items removed DAY 11, N=47
Slide 34: MIN-117: More effective and safer treatment for MDD
MIN-117 Potential for a more effective and safer treatment to address the unmet medical needs of Major Depressive Disorder patients
Slide 35: Major Depressive Disorder: better treatments critically needed
Major Depressive Disorder: treatments with faster onset and better response, without side effects, are critically needed 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 Fre
Slide 36: 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 37: Efficacy: MADRS primary endpoint in Phase IIa
Efficacy: MADRS primary endpoint (ITT pop) in Phase IIa Effect size MIN-117 0.5 mg: 0.24 MIN-117 2.5 mg: 0.34
Slide 38: Efficacy: HAM-A secondary endpoint in Phase IIa
Efficacy: HAM-A secondary endpoint in Phase IIa Effect size MIN-117 0.5 mg: 0.49 MIN-117 2.5 mg: 0.45
Slide 39: Next steps
Next steps Program Primary Indication Status MIN-101 Schizophrenia End of Phase II meeting with FDA planned to be scheduled in Q1 2017 Initiation of pivotal Phase III trials planned in Q3 2017 MIN-202 Primary Insomnia and Major Depressive Disorder Phase II trial preparation underway Next trials in i
Slide 40: Financial update
Financial update ~$91.9 million cash balance (cash, cash equivalents and marketable securities) at September 30, 2016 expected to fund operations into 2018 ~$57.5 million (before fees) received from follow-on stock offering in June 2016 (~6 million shares sold at $9.50/share) Outstanding shares at O
Slide 41: Investment highlights
Investment highlights Broad late-stage pipeline Lead asset, MIN-101, has differentiated MoA with specific effect on negative symptoms and is planned to initiate pivotal Phase III trials for treatment of schizophrenia in Q3 2017 Compelling efficacy and safety data generated in randomized, double-blin
Slide 42: Appendix
Appendix MINERVA
Slide 43: 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 44: Are negative symptoms, apathy and mild cognitive impairment specific to schizophrenia?
Are negative symptoms, apathy and mild cognitive impairment specific to schizophrenia? Idiopathic Parkinson 0.3% Major depression 3% Alzheimer’s Disease1% Frontal dementia0.01% Mental retardation 0.5% Post-brain trauma0.01% Post-CVA0.3% Autism spectrum1.2% Schizophrenia0.7% Schizophrenia spectrum1%
Slide 45: Percentage of people diagnosed with schizophrenia who have negative symptoms
What percentage of people diagnosed with schizophrenia have negative symptoms? Depending on the population surveyed and on the criteria, between 60% and 95%. 8 https://www.ncbi.nlm.nih.gov/pubmed/10427607 9 http://schizophreniabulletin.oxfordjournals.org/content/26/3/737.full.pdf 10 https://www.ncbi
Slide 46: No drug approved to treat negative symptoms
The pharma industry is not blind to the need for a drug to treat negative symptoms – but there is currently no drug approved for this indication
Slide 47: Patient inclusion criteria
244 patients Patient or patient's legal representative has provided informed consent. Male or female patient, 18 to 60 years of age, inclusive. Patient meets the diagnostic criteria for schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-V), as es
Slide 48: Efficacy: Secondary endpoint (3) PANSS positive symptom score
Efficacy: Secondary endpoint (3) PANSS positive symptom score (3 Factors)
Slide 49: Extension Phase
Extension Phase Baseline for patients who crossed from placebo to MIN-101 is start of open label (Week 12)
Slide 50: MIN-101C03: Brief Negative Symptom Score
MIN-101C03: Brief Negative Symptom Score 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 51: MIN-101C03: Positive Symptoms (3-Factors)
MIN-101C03: Positive Symptoms (3-Factors) Core Phase Extension Phase Baseline for Placebo-to-MIN-101 is From Start of Open Label (Week 12)
Slide 52: MIN-101C03: Total PANSS
MIN-101C03: Total PANSS 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 53: Sleep polysomnography: REM latency in Phase IIa
Sleep polysomnography: REM latency in Phase IIa
Minerva Neurosciences — Investor Presentation (January 2017) on 6ix