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Key Takeaway: Animal models (non human primates): Effect of treatment on abnormal involuntary movements scale (AIMS) 29 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

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Animal models (non human primates): Effect of treatment on abnormal involuntary movements scale (AIMS) 29 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 1.5 mg / kg Day number AIMS score MPTP effect NRG 101 Saline 14 21 28 35 42 49 56 0 1 2 3 4 5 6 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 outstanding October 31, 2017: ~38.7 M (~42.9 M fully diluted) 30 31 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 HT 2A antagonist Sigma 2 antagonist Seltorexant MIN 202 Primary Insomnia Major Depressive Disorder as adjunctive therapy Selective Orexin2 antagonist MIN 117 Major Depressive Disorder in monotherapy 5 HT 1A 5HT transporter Alpha 1a, b Dopamine 5 HT 2A antagonist MIN 301 Parkinson s Disease Neuregulin 1 1 activating ErbB4 Phase 3 initiated Dec 2017 (MIN 101 C07) Phase 2b initiated Dec 2017 (ISM2005) Pre clinical Phase 2b planned H1 2018 (MIN 117 C03) Phase 2b initiated Sep 2017 (MDD2001) Phase 2b initiated Dec 2017 (MDD2002) transporter
Wu 2006; 2. Toumi 2017; 3. Haro 2015; 4. Nordstroem 2017; 5. www.census.gov/quickfacts (July 1, 2016 adult population) Prevalence of US adults with schizophrenia in treatment/yr: 0.53% 1 Schizophrenia.com : 2.2 million patients in U.S. WHO website: 26 million with schizophrenia worldwide (0.34% prevalence) and 0.1 0.75% 1 yr prevalence. 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 18 Population estimates: w ww.census.gov/quickfacts/ , www.ons.gov.uk/peoplepopulationandcommunity/, www.insee.fr/en/statistiques/ , www.istat.it/en / , www.ine.es/dyngs/INEbase/en/ , www.destatis.de/EN/ www.stat.go.jp/english/data/jinsui/tsuki/ , en.wikipedia.org (populations of IT, DE, ES), populationpymamid.net (for % adults in IT, DE, ES) Schizophrenia treatment prevalence estimate, proportion of patients with negative symptoms and % clinically stable(same as prior slide, same references). 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 Adults with schizophrenia Negative Symptoms Clinically stable Number of patients in major markets (millions) Treated patients 3.2 M Patient with negative symptoms 2.2 M Clinically stable patients 1.9 M Confidential Proprietary 19 A drug to treat insomnia major depressive disorder by restoring physiological sleep A co development/co commercialization program with: Seltorexant MIN 202 / JNJ42847922 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 system: neurobiology targets circuits that mediate sleep and mood symptoms 20 Seltorexant Selective Orexin 2 Antagonist Highly selective for Orexin 2 (relative to Orexin 1) Short Tmax (30 minutes) produces rapid onset of effect Short half life (2 hours) minimizes daytime hangover Seltorexant studies in MDD with comorbid insomnia shows improvements of insomnia and depressive symptoms 21 Seltorexant Phase 2b program: two trials in MDD and one in Insomnia ongoing 22 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 up ~ 280 patients planned to be enrolled at 85 clinical sites in the U.S., Europe, Russia and Japan safety tolerability and dose response and efficacy in up to 3 doses of seltorexant Second MDD trial initiated Dec 2017 (clinicaltrials.gov: NCT03321526) Double blind, randomized, flexible dose parallel group study 4 week screening, 6 month double blind treatment and 2 week follow up ~ 100 patients planned to be enrolled at ~34 clinical sites in the U.S. assess the efficacy of flexibly dosed seltorexant compared to flexibly dosed quetiapine as adjunctive therapy to baseline antidepressant therapy (either an SSRI or SNRI) in delaying time to all cause discontinuation of study drug over a 6 month treatment period Insomnia trial initiated Dec 2017 (clinicaltrials.gov: NCT03375203) Double blind, randomized, parallel group, active and placebo controlled dose finding study Up to 61 day duration, including screening and follow up ~ 360 patients planned to be enrolled at clinical sites in the U.S., Europe and Japan assess the dose response of three doses of seltorexant compared to placebo on sleep onset as measured by latency to persistent sleep (LPS) using polysomnography (PSG) assess the dose response of these doses compared to placebo on wake after sleep onset (WASO) over the first six hours using PSG) compare the effects of seltorexant on sleep and cognition to those effects of zolpidem Confidential Proprietary MIN 117 23 Addressing the unmet medical needs of patients with Major Depressive Disorder and anxiety symptoms Phase 2a study designed to explore unmet needs in patients with MDD 24 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 of up to 4 weeks Study drug is double blind and double dummy The Phase 2a results show effect on primary endpoint in depression as well as noted effect on anxiety 25 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 doses of MIN 117 are well tolerated, no sexual s/e, cognitive benefits Assay sensitivity confirmed by positive separation of Paroxetine from placebo Sleep polysomnography shows intact REM latency resulting in preservation of sleep architecture and continuity of sleep, an important product differentiator 26 Confidential Proprietary MIN 301 27 A protein drug with disease modifying potential for the treatment of unmet medical needs in Parkinson s Disease and other major CNS indications Neuregulin 1 (NGR1) has multiple roles in neuronal development offering potential for neuronal repair in several CNS indications 28 Axon guidance Radial neuron migration Myelination and ensheathment Synapse formation Oligodendrocyte development Neuromuscular junction formation Mei and Xiong, 2008 NRG1 controls key neuronal development pathways Initial clinical focus will be on treatment of Parkinson s Disease based on preclinical models.
RIS and OLA (2ry EP negative symptoms) Negative symptoms monotherapy in stable patients with switch study Maintenance Sub population studies Negative Symptoms, Residual positive symptoms, and Niche populations Long Acting Injectables or Patch Acute studies Doria Studies show 69% of adult patients with schizophrenia have negative symptoms and 85% are clinically stable, U.S. 2016 patient estimates below 17 Estimated prevalence Of SZ (0.88%) (2.2 million US adults) Treatment prevalence of SZ (0.53%) (1.3 million US adults 5 ) Negative Sx (69%) (919,553 US adults) Stable patients (85%): (781,620 US adults) 59% of all adult patients have negative symptoms and are clinically stable based on these numbers = MIN 101 eligible 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 symptoms 1.
UK ITI 007 (lumateperone) (5 HT 2A antagonist, D 2 /D 1 modulator, SSRI ) ALKS 3831 (Mu opioid antagonist + olanzapine) Risperidone implant (6 monthly, nonbiodegradable risperidone drug eluting stent) RBP 7000 ( once monthly , SR risperidone) HP 3070 (transdermal patch of asenapine) MIN 101 (5 HT 2A 2 R antagonist) RP 5063 ( D 2,3,4 5 HT 1A +2A partial agonist + 5 HT 2B,6,7 antagonist) Risperidone ISM (once monthly IM risperidone) Lu AF35700 (D 1 , 5 HT 2A 5 HT 6 antagonist) ACP 103 (pimavanserin) (5 HT 2A inverse agonist) NaBen sodium benzoate) (D amino acid oxidase inhibitor) 3 indications: Residual positive symptoms as add on Orphan designations: Adolescent monotherapy Clozapine refractory add on 2 indications; Residual positive symptoms as add on Negative symptoms as add on Tx resistant monotherapy with switch study vs.
Copies of reports filed with the SEC are posted on our website at www.minervaneurosciences.com. Our audience is cautioned not to place undue reliance on these forward looking statements that speak only as of the date hereof, and we disclaim any obligation to update any forward looking statements, except as required by law. Focus: to address the debilitating unmet needs of millions of patients afflicted by neuropsychiatric illnesses 3 Differentiated assets Targeting clearly recognized unmet needs Innovative mechanisms of action Advanced clinical development Lead product in pivotal Phase 3 trial Three Phase 2b studies ongoing, one planned to begin in 2018 Commercially attractive CNS markets Negative symptoms in schizophrenia beyond Major depressive and anxiety disorders Insomnia with and without comorbid psychiatric symptoms Parkinson s disease other neurodegenerative disorders Funded beyond multiple significant data read outs in 2019 $143.3 million cash balance at 9/30/17 4 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 Seltorexant MIN 202 Primary Insomnia Major Depressive Disorder as adjunctive therapy MIN 117 Major Depressive Disorder in monotherapy MIN 301 Parkinson s Disease Phase 3 initiated Dec 2017 (MIN 101 C07) Phase 2b initiated Dec 2017 (ISM2005) Pre clinical Phase 2b planned H1 2018 (MIN 117 C03) Phase 2b initiated Sep 2017 (MDD2001) Phase 2b initiated Dec 2017 (MDD2002) 5 HT 2A antagonist Sigma 2 antagonist Selective Orexin2 antagonist 5 HT 1A 5HT transporter Alpha 1a, b Dopamine transporter 5 HT 2A antagonist Neuregulin 1 1 activating ErbB4 5 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 placebo (~280 patients worldwide) MDD2002 Phase 2b ongoing in adjunctive MDD comparator (~100 patients U.S.) ISM2005 Phase 2b ongoing in insomnia monotherapy (~360 patients worldwide) MIN 117: MDD with prominent anxiety in monotherapy MIN 117C03 Phase 2b expected to begin in early 2018 (~325 patients worldwide) Confidential Proprietary MIN 101 6 A new paradigm for the treatment of schizophrenia 7 Youth 0 18 Adult 18 40 Positive Symptoms Schizophrenia has three symptom domains: positive symptoms fluctuate over time while negative cognitive symptoms persist and cause lifelong disability Intermittent acute episodes of positive symptoms decline in frequency and severity Negative symptoms and cognitive impairment are evident at onset of illness and are lifelong debilitating symptoms All antipsychotics directly target dopamine (DA) receptors and have only shown efficacy against positive symptoms; none are indicated for negative symptoms or cognitive impairment Mature 40 8 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 HT 2A antagonist + Sigma 2 antagonist No direct dopamine blocking, unlike most available antipsychotics Avoids antipsychotic side effects Exclusive worldwide rights outside of Asia Granted formulation patent and method of use exclusivity until at least 2035 Major commercial opportunity as potential first therapy in indication MIN 101: Phase 2b study design: monotherapy, double blind, placebo controlled in schizophrenic patients with confirmed negative symptoms 9 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 32mg (n = 78) R MIN 101 64mg MIN 101 32mg Crossover Randomization Specific effects on negative symptoms can only be determined in a placebo controlled study Phase 2b study showed specific improvements in negative symptoms over 12 weeks and 36 weeks in both doses and stable positive symptoms 10 PANSS Positive Symptoms Subscale Change from Baseline PANSS Negative Symptoms Subscale Change from Baseline Statistically significant improvements in the primary endpoint Extension Core Phase Extension Phase p value: * 0.05; ** 0.01 versus placebo WEEK PANSS Negative Symptoms Factor Score (Marder) Change from Baseline (MMRM) (ITT Population) Baseline Mean (SD) Placebo 25.1 (4.0) MIN 101 32 mg 25.3 (4.2) MIN 101 64 mg 25.2 (4.0) Placebo MIN 101 32 mg MIN 101 64 mg 11 MIN 101 Phase 2b: American Journal of Psychiatry 2017; 00:1 8 12 MIN 101: Phase 3 initiated December 2017 Phase 3 efficacy study: confirmatory study design guided by insights from Phase 2b and dialogue with FDA 13 Primary endpoint : PANSS N egative S ymptoms F actor S core (NSFS) according to Marder after 12 weeks administration Secondary endpoints: Clinical Global Impression of Severity (CGI S) and Personal and Social Performance scale (PSP) 40 weeks (9 months) open label extension 501 patients randomized 1:1:1 to 32mg 64mg doses of MIN 101 vs placebo Symptomatically stable patients for several months with moderate to severe negative symptoms ( 20 PANSS NSFS) and stable positive symptoms If patients are on antipsychotic medication, switch to MIN 101 without long wash out periods so as to mimic clinical practice Study carried out in US (approx 30% of patients) and Europe MIN 101 Phase 3 study design: monotherapy, double blind, placebo controlled in schizophrenic patients with negative symptoms 14 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 101 32mg (n = 167) R MIN 101 64mg MIN 101 32mg Crossover Randomization Phase 3 compared to Phase 2b: same patient population; same double blind duration; same doses; PANSS negative score primary endpoint; CGI PSP secondary endpoints; 40 weeks extension allows 1 year safety coverage 15 MIN 101: Route to the schizophrenia market 16 MIN 101 is unique in the late stage schizophrenia pipeline: a monotherapy targeting negative symptoms in maintenance phase Q1 19 Q2 19 Q3 19 Q4 19 Q1 20 Q2 20 Q3 20 Q4 20 Q1 21 Q2 21 Q3 21 Q4 21 CHR assumed earliest launch timeline Source: Dec 2017; Cambridge Healthcare Research (CHR) Limited.
These and other potential risks and uncertainties that could cause actual results to differ from the results predicted are more fully detailed under the caption Risk Factors in our filings with the Securities and Exchange Commission, including our Quarterly Report on Form 10 Q for the quarter ended September 30, 2017, filed with the Securities and Exchange Commission on November 6, 2017.
These forward looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors including, without limitation, whether any of our therapeutic products will advance further in the clinical trials process and whether and when, if at all, they will receive final approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies and for which indications; whether the results of future clinical trials of MIN 101, seltorexant, MIN 117 and MIN 301, if any, will be consistent with the results of past clinical trials; whether MIN 101, seltorexant, MIN 117 and MIN 301 will be successfully marketed if approved; whether our therapeutic product discovery and development efforts will be successful; our ability to achieve the results contemplated by our co development agreements; the strength and enforceability of our intellectual property rights; competition from pharmaceutical and biotechnology companies; the development of and our ability to take advantage of the market for our therapeutic products; our ability to raise additional capital to fund our operations on terms acceptable to us; and general economic conditions.
Food and Drug Administration or equivalent foreign regulatory agencies; estimates regarding the market potential for our products; financial projections and estimates and their underlying assumptions; and future performance. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward looking statements.
Forward looking statements are statements that are not historical facts, reflect management s expectations as of the date of this presentation, and involve certain risks and uncertainties. Forward looking statements include, but are not limited to: the benefits, efficacy and safety of our new formulations; whether studies performed on analogs or backups of our compounds are a good predictor of the clinical efficacy of our compounds; statements with respect to the timing and results of future clinical milestones with MIN 101, seltorexant (MIN 202), MIN 117 and MIN 301, including the Phase 3 trial of MIN 101; the potential for a single Phase 3 trial with supportive Phase 2b results to support the basis for an NDA for MIN 101; the Phase 2b trials of seltorexant; the planned Phase 2b trial of MIN 117; statements regarding our ability to successfully develop and commercialize our therapeutic products; our ability to expand our long term business opportunities; our expectations regarding approval for our products by the U.S.
Confidential Proprietary San Francisco January 2018 CORPORATE PRESENTATION Exhibit 99.1 All trademarks, trade names and service marks appearing in this presentation are the property of their respective owners. Forward Looking Statement Safe Harbor 2 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.
Last updated: Jan 8, 2018