Minerva Neurosciences, Inc · NASDAQ:NERV
Minerva Neurosciences — Investor Presentation (June 2016)
52 slides from Minerva Neurosciences's investor presentation, Jun 13, 2016
Slide 1: Innovative CNS therapies to address unmet medical needs
June 2016 Innovative CNS therapies to address unmet medical needs
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: Building a portfolio of innovative therapies
Building a portfolio of innovative therapies Program Origin Primary Indications Mechanisms of Action Pre- clinical Phase I Phase II Status MIN-101 Mitsubishi Tanabe Schizophrenia ● 5-HT2A antagonist ● Sigma2 antagonist TLR announced May 2016 MIN-117 Mitsubishi Tanabe Major Depressive Disorder ● 5-HT
Slide 4: MIN-101: unmet needs in schizophrenia
MIN-101 A new drug with the potential to address unmet needs in schizophrenia
Slide 5: MIN-101: non dopaminergic-blocking MoA
MIN-101: non dopaminergic-blocking MoA with the potential to address unmet medical needs Pharmacological targets Potential benefits / differentiation 5-HT2A antagonist Sigma2 antagonist Improve negative symptoms, cognition and sleep disorders, in addition to control of positive symptoms
Slide 6: 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 Current Treatments Focus On Positive Symptoms $4.6B Rx Sales1 60% to 80% Discontinuation Rate2 Lack of efficacy on negative sym
Slide 7: MIN-101 Phase IIa study design
MIN-101 Phase IIa study: monotherapy, double-blind, placebo controlled in relapsed patients Patients relapsed from previous therapy Previous therapy washed-out 3 month treatment duration 96 patients, equally randomized between MIN-101 and placebo Hospitalization of patients permitted during the firs
Slide 8: MIN-101 Phase IIa: change from baseline on negative symptoms
MIN-101 Phase IIa: Change from baseline on negative symptoms over 3 months (64 mg daily dose (32mg bid) vs placebo) Change from Baseline Placebo Plateau p = 0.0178 Regression Placebo MIN-101 MIN-101
Slide 9: MIN-101 Phase IIa study results
MIN-101 Phase IIa study results demonstrated: efficacy on broad spectrum of symptoms efficacy on dimensions of cognition improvement in objective and subjective sleep biomarkers absence of side effects commonly seen with existing therapies (EPS, weight gain, prolactin increase, sedation) minor QTc p
Slide 10: MIN-101 Phase IIb
MIN-101 Phase IIb A multi-center, randomized, double-blind, parallel-group, placebo-controlled 12 week study to evaluate the efficacy, tolerability and safety of MIN-101 in patients with negative symptoms of schizophrenia followed by a 24-week, open-label extension
Slide 11: MIN-101 Phase IIb: Study design
MIN-101 Phase IIb: Study design
Slide 12: MIN-101 Phase IIb: Primary and secondary objectives
MIN-101 Phase IIb: Primary and secondary objectives Primary: To evaluate the efficacy of MIN-101 compared to placebo in improving the negative symptoms of schizophrenia as measured by the change from Baseline in the Positive and Negative Syndrome Scale (PANSS) negative subscale score of the pentagon
Slide 13: MIN-101 Phase IIb: Statistical methods
MIN-101 Phase IIb: Statistical methods Primary endpoint analysis: Efficacy analyses are based on the Intent to Treat (ITT) population Mixed-effects model for repeated measures (MMRM) is applied Changes from baseline to week 12 in PANSS negative subscale score using the pentagonal structured model is
Slide 14: 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 15: 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 16: Efficacy: Secondary endpoint (2) PANSS total score
Efficacy: Secondary endpoint (2) PANSS total score
Slide 17: Efficacy: Secondary endpoint (3) PANSS positive symptom score
Efficacy: Secondary endpoint (3) PANSS positive symptom score (3 Factors)
Slide 18: Efficacy: Primary and secondary endpoints summary table
Efficacy: Primary and Secondary endpoints Summary table of statistically significant results
Slide 19: Safety: Reported common adverse events
Safety: Reported common adverse events
Slide 20: Safety: QTcF change from baseline
Safety: QTcF (msec) – change from baseline
Slide 21: Safety: QTcF LSMean (Upper 90% CI) of change from baseline
Safety: QTcF (msec) – LSMean (Upper 90% CI) of change from baseline
Slide 22: Safety: Summary of other safety parameters
Safety: Summary of other safety parameters Side Effect Phase IIb results showed AEs and SAEs Limited and comparable to placebo Weight Gain, Waist Circumference No increase Laboratory Tests, including Prolactin No increase Extra-pyramidal Symptoms No effect on AIMS scale Vigilance No sedation *In the
Slide 23: MIN-101 US development plan
U.S. Investigational New Drug Application (IND) accepted by FDA in December 2015 Advanced-stage U.S. clinical program to be defined following results of Phase IIb trial in Europe Under consideration Multiple potential clinical late-stage pathways / routes to registration Trials to be conducted indep
Slide 24: MIN-101: In-licensed from Mitsubishi Tanabe Pharmaceutical
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 25: MIN-117: unmet needs in major depressive disorder
MIN-117 Our objective is to develop a new drug to address unmet needs in major depressive disorder (MDD)
Slide 26: MIN-117 for Major Depressive Disorder
MIN-117 for Major Depressive Disorder 5-HT1A 5HT Transporter Alpha-1a,b Dopamine Transporter 5-HT2A antagonist Faster onset Preserve cognition and sexual function Treat partial and non-responders Potential benefits / differentiation Pharmacological targets
Slide 27: MIN117: Phase IIa
MIN117: Phase IIa A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled Study to Evaluate the Efficacy and Safety of 2 Doses of MIN-117 in Adult Subjects with Major Depressive Disorder
Slide 28: MIN-117C01: Phase IIa study design
MIN-117C01: Phase IIa study design
Slide 29: MIN-117C01: Phase IIa objectives
MIN-117C01: Phase IIa objectives Primary: To evaluate the efficacy of MIN-117 0.5 and 2.5 mg compared to placebo in reducing the symptoms of a major depressive episode as measured by the change from Baseline in the Montgomery- Asberg Depression Rating Scale (MADRS) total score over 6 weeks of treatm
Slide 30: Efficacy: MADRS primary endpoint (ITT population)
Efficacy: MADRS primary endpoint (ITT population) Effect size MIN-117 0.5 mg: 0.24 MIN-117 2.5 mg: 0.34
Slide 31: Efficacy: MADRS primary endpoint (PP population)
Efficacy: MADRS primary endpoint (PP Population) Effect size MIN-117 0.5 mg: 0.20 MIN-117 2.5 mg: 0.39
Slide 32: Efficacy: HAM-A secondary endpoint
Efficacy: HAM-A secondary endpoint Effect size MIN-117 0.5 mg: 0.49 MIN-117 2.5 mg: 0.45
Slide 33: Sleep polysomnography: REM latency
Sleep polysomnography: REM latency
Slide 34: Safety: Common adverse events
Safety: Common Adverse Events Note: ‘Common TEAEs’ are TEAEs that occurred > 4% of subjects in any treatment group
Slide 35: MIN-117 phase IIa study demonstrated
MIN-117 phase IIa study demonstrated: Efficacy on depressive symptoms Onset evident as early as 2 weeks Efficacy on anxiety symptoms Both doses of MIN-117 are well tolerated Pharmacodynamics No impairment in cognition No impairment in sexual function Preservation of sleep architecture and continuity
Slide 36: MIN-117 in-licensed from Mitsubishi Tanabe Pharmaceutical
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 37: MIN-202: Insomnia and MDD co-development with Janssen
MIN-202 (JNJ-42847922) Insomnia Disorder and Major Depressive Disorder (MDD) A co-development & commercialization program with Janssen
Slide 38: MIN-202: A specific Orexin-2 antagonist
MIN-202: A specific Orexin-2 antagonist for insomnia and mood disorders Selective Orexin2 antagonist Physiological regulation of biological rhythms and control of wake drive Potential benefits / differentiation Pharmacological target
Slide 39: MIN-202 working hypothesis: sleep-wake balance control
More Awake More Asleep Orexin LC -> NE DR -> 5-HT TMN -> HA GABA VLPO->GABA GABA agonist (Ambien) Orexin antagonist Sleepy Awake GABA Agonist (Ambien) increases drive to sleep Orexin Antagonists decreases drive to wake MIN-202 working hypothesis: Sleep-wake balance control
Slide 40: MIN-202: Exploratory study in MDD with comorbid insomnia
MIN-202: Exploratory study in patients with MDD and comorbid insomnia (n=20)
Slide 41: MIN-202 Phase IIa trial in primary insomnia
MIN-202 Phase IIa trial in Primary Insomnia ClinicalTrials.gov identifier: NCT02464046 A Randomized, Placebo-controlled, 2-way Crossover, Double-Blind Study to Evaluate the Efficacy, Safety and Tolerability of MIN-202 (JNJ-42847922) in Subjects With Insomnia Disorder Without Psychiatric Comorbidity
Slide 42: Phase IIa in primary insomnia: primary endpoint
Phase IIa in primary insomnia: Primary endpoint 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 43: 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 44: MIN-202 Phase Ib trial in MDD patients
MIN-202 Phase Ib trial in MDD patients ClinicalTrials.gov identifier: NCT02476058 An Exploratory Multicenter, Double-Blind, Diphenhydramine- and Placebo-controlled Safety, Efficacy and Biomarker Study With MIN-202 (JNJ-42847922) in Subjects With Major Depressive Disorder MIN-202 (JNJ-42847922) Diphe
Slide 45: MIN-202: efficacy on depressive symptoms independent of sleep
MIN-202: 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 46: 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 47: MIN-301: Parkinson's Disease
MIN-301: Parkinson’s Disease
Slide 48: MIN-301 for Parkinson's Disease
MIN-301 for Parkinson’s Disease Neuregulin 1β1 activating ErbB4 Cognitive improvement and neuroprotective / neurorestorative effects Potential benefits / differentiation Pharmacological target
Slide 49: Effect of MIN-301 analog on AIMS in non-human primates
Effect of treatment with MIN-301 analog on abnormal involuntary movements scale (AIMS) in non-human primates Clear MPTP-induced AIMS scores Clinical scores in animals treated with MIN-301 analog lower during low MPTP (< 4 mg/kg) induction protocol (not significant) Start MPTP 1 mg / kg Increase MPTP
Slide 50: Financial Summary
Financial Summary ~$44.6 M cash balance (cash, cash equivalents and marketable securities) at 3/31/16 ~$17.5 million received from warrants exercised at $5.772 in Q1 2016 ~$4.7 million received from warrants exercised at $5.772 in Q2 2016 $1.0 million received from purchase of common stock at $5.51/
Slide 51: Expected and recently achieved milestones
Expected and recently achieved milestones Program Primary Indication Status MIN-101 Schizophrenia TLR May 2016 MIN-202 Primary and Comorbid (Secondary) Insomnia Results for insomnia announced January 2016 Results for MDD announced March 2016 MIN-117 Major Depressive Disorder (MDD) TLR May 2016 MIN-3
Slide 52: Thank You
Thank You Minerva Neurosciences, Inc. 1601 Trapelo Road, Suite 284, Waltham, MA 02451
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