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Thereafter, the AIMS scores of both groups were found to be equal. A : saline control B : MIN 301 analog 50 PRIMOMED Project: MIN 301 Analog Results Effect of Treatment on Locomotor Activity (Bungalow Test) A : saline control B : MIN 301 analog Start MPTP 1 mg / kg Increase MPTP 1.5 mg / kg In the bugalow test there was a drop of activity after treatment of MIN 301 analog and placebo in healthy monkeys, measured by the number of compartment changes (from baseline week 0 to week 1).
A : saline control B : MIN 301 analog 49 PRIMOMED Project: MIN 301 Analog Results Effect Of Treatment On Abnormal Involuntary Movements Scale (AIMS) Start MPTP 1 mg / kg Increase MPTP 1.5 mg / kg On AIMS: The MIN 301 analog group generally performed better than saline during the first 32 days. After increasing the dose of MPTP an increase of AIMS score was observed in the MIN 301 analog group.
After start of MPTP treatment, the CS stayed very low (below 6) until day 28. During this period, the MIN 301 analog group did better compared to the vehicle group. After increase of MPTP dose to 1.5 mg/kg a huge increase of the CS in both groups was observed. The MPTP dose did lead to a saw tooth pattern on the CS indicating direct MPTP toxic effects next to the Parkinson progression effects.
Patient with a clinically significant electrocardiogram (ECG) abnormality that could be a safety issue in the study, including QT interval value corrected for heart rate using the Fridericia s formula (QTcF) 430 msec for males and 450 msec for females. Confidential Proprietary MIN 301: Summary/Key results 46 47 PRIMOMED Project: MIN 301 Analog Results Effect Of Treatment On Body Weight Start MIN 301 analog treatment (1 w before MPTP) Start MPTP 1 mg / kg Increase MPTP 1.5 mg / kg Body weight during the complete study showed no remarkable effect in both groups A : saline control B : MIN 301 analog 48 PRIMOMED Project: MIN 301 Analog Results Effect Of Treatment On Parkinsonian Clinical Signs Start MIN 301 analog treatment (1 w before MPTP) Start MPTP 1 mg / kg Increase MPTP 1.5 mg / kg MIN 301 analog alone did not affect the clinical score (CS).
Patient receiving treatment with depot antipsychotic medication can be enrolled in the study 4 weeks after the last injection. Patient with a history of significant other major or unstable neurological, neurosurgical (e.g., head trauma), metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, metabolic, gastrointestinal, or urological disorder.
Patient s condition is due to direct physiological effects of a substance (e.g., a drug of abuse, or medication) or a general medical condition. Significant risk of suicide or attempted suicide, or of danger to self or others. Patient who cannot be discontinued from psychotropics other than those allowed. Patient who received clozapine within 6 months of the Screening visit.
Sleep initiation parameters (sleep onset latency, latency to persistent sleep). Subjective sleep quality as measured by PSQI improved and this improvement was greater with MIN 101 than with placebo although not statistically significant. MIN 101C03: Phase IIb in Patients with Schizophrenia 45 Main Exclusion Criteria Current bipolar disorder, panic disorder, obsessive compulsive disorder, or evidence of mental retardation.
MIN 101 showed effects on sleep architecture in the previous Phase 2a study that could possibly be linked to the improvements observed on negative symptoms and cognition, thus they will be further investigated in the present study. In a subgroup of patients (20) who underwent sleep recordings (PSG), sleep was evaluated at Baseline and Day 14. MIN 101 had an effect on Slow Wave Sleep (SWS) distribution: it shifted SWS from the end to the beginning of the night: MIN 101 significantly increased SWS in the first third of the night and decreased it in the last third of the night.
Patients with insomnia report lower quality of life greater symptom severity worse adherence/compliance to treatment Sleep disturbances have also been associated with enhanced psychosis Sleep is important for memory consolidation, thus disturbances in sleep architecture, or circadian de synchronization could also contribute to the cognitive impairment observed in schizophrenia.
To evaluate the effects versus placebo of MIN 101 on social functioning by means of the Personal and Social Performance (PSP) over 12 weeks of double blind treatment. To assess the effects versus placebo of MIN 101 on sleep architecture and continuity as measured with the help of the V Watch methodology over 12 weeks of double blind treatment. MIN 101C03: Phase IIb in Patients with Schizophrenia 44 Sleep Assessment Sleep and circadian rhythm disruptions are reported in 30% to 80% of patients with schizophrenia.
Duodenum and jejunum: pH 6.5 Ileum and colon: pH 7.4 Note 1: The two parts of the graph correspond to P app values without (P app ) or with rinse step (P app last ) Note 2: For intestinal tissues with preserved integrity, atenolol P app is expected to be less than 7 10 6 cm/s and the antipyrine/atenolol P app ratio 2 MIN 101C02: Once A Day Formulation Study Cmax of MIN 101, BFB 520 and BFB 999 with the new formulation 42 Selected formulation for Phase 2b study 32 mg and 64 mg slow will be the doses used in the Phase IIb study Cmax is linear to dose: 64mg is expected to give twice the levels of 32mg The observed Cmax levels are far below that inducing QTc increases Increased safety margin by at minimum 5 times Target at CMax: 40ng/ml 6ng/ml MIN 101C03: Phase IIb in Patients with Schizophrenia 43 Exploratory Objectives To evaluate the effects versus placebo of MIN 101 on depressive symptoms as measured by the Calgary Depression Scale for Schizophrenia (CDSS) over 12 weeks of double blind treatment.
Represents discontinuation rate over the course of 18 months. Schizophrenia: An Effective and Safe Lifelong Treatment Remains A Significant Unmet Need 60% to 80% Discontinuation Rate 1 Lack of efficacy on negative symptoms Lack of efficacy on cognitive symptoms Lack of efficacy on insomnia Progression of side effects Current Treatments Focus On Positive Symptoms Adult 18 40 Mature 40 39 MIN 101: Compelling Efficacy on Cognition (Phase IIa) Improves Several Cognitive Dimensions After Three Months (1) (1) As measured at day 84 by BACS Subscales Score PPC 2.4X 1.5X 2.0X (Motivation) 0 2 4 6 8 10 12 14 16 0 1 2 3 4 5 6 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5 6.0 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5 6.0 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5 6.0 Verbal Fluency Verbal Memory Attention and Speed Executive Function Working Memory Motor Speed 40 MIN 101: PK results MIN 101 BFB 520 41 MIN 101: PC Reformulation Work Permeability Properties in Rat Intestine Segments In all intestinal segments, the permeability of MIN 101 is higher than that of atenolol (low permeability reference) and lower than that of antipyrine (high permeability reference) across the duodenum and jejunum, but similar across ileum and colon.
Expiry Term Extension Regulatory Exclusivity MIN 101 U.S., Europe, Canada, Australia, New Zealand, Russia and Israel Composition of matter 2021 May be eligible for extension in the U.S. for up to 5 years U.S., Brazil, Canada, China, Europe, Hong Kong, Indonesia, Japan, Korea, Taiwan and Russia Methods of use / treatment 2031 (Pending) MIN 117 U.S., Germany, Spain, France, Italy, Netherlands, U.K. and Canada Composition of matter 2020 May be eligible for extension in the U.S. for up to 5 years U.S., To be filed in: Australia, Brazil, Canada, Chile, Colombia, Germany, Spain, France, Italy, Netherlands, U.K., Israel, Mexico, New Zealand, Peru, Russia, South Africa Methods of use / treatment 2034 (Pending) MIN 202 European patent pending Composition of matter Application in process; if granted, would expire no earlier than 2030 10 years in Europe MIN 301 U.S., Canada, Australia, Brazil, China, Japan, Mexico and Russia patents pending Methods of use / treatment Application in process; if granted, would expire no earlier than 2028 New Chemical Entity 5 years in US Pediatric 6 months in US Possible Orphan Drug 7 years in US 10 years in Europe New Chemical Entity 5 years in US Pediatric 6 months in US Possible Orphan Drug 7 years in US 10 years in Europe New Chemical Entity 5 years in US Pediatric 6 months in US Possible Orphan Drug 7 years in US 10 years in Europe End of bar = expected availability of topline results MIN 101 MIN 202 MIN 117 MIN 301 34 Multiple Significant Clinical Milestones Ahead Once A Day Formulation Phase IIb in Schizophrenia Phase IIb Extension Parallel clinical pharmacology studies phase III preparation Phase IB in MDD (single dose) PK/Safety Study in HV (MAD) BA Study in HV (solid) Phase IIa in Primary Insomnia Phase IB in Comorbid Insomnia (MDD) Phase II in MDD MPTP Primate Study (Parkinson s model) IND enabling studies clinical batch production Phase I in Healthy Volunteers (Parkinson s) Phase / Event 2014 2015 2016 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Confidential Proprietary Thank You Minerva Neurosciences, Inc. 1601 Trapelo Road, Suite 284, Waltham, MA 02451 Back up Building Minerva 37 Merger Nov 13 Acquisition Feb 14 License Feb 14 IPO July 7 th 2014 NASDAQ:NERV $m: Index, LRM, JJDC, Care Fidelity, Federated and others Cyrenaic Inc (MIN 101) Sonkei Inc (MIN 117) MIN 202 Mind NRG SA (MIN 301) 38 MIN 101: Positioning Youth 0 18 Positive Symptoms $3.9B R x Sales MIN 101 for Potential Lifelong Treatment of Negative Symptoms Cognitive Impairment 1.
The MIN 301 analog treated group did not show this huge drop of activity. After increasing the MPTP dose, the activity of both groups gradually merged to a same performance level. Start MPTP 1.0 mg/kg Increase MPTP 1.5 mg/kg saline control MIN 301 analog 0.0 5.0 10.0 15.0 20.0 25.0 30.0 1 2 3 4 5 6 7 8 Week Confidential Proprietary Financial Overview 31 Financial Summary 32 At July 2014 IPO approximately 5.6M shares sold and a private placement of 0.7M shares at $6/share resulting in net proceeds of $29.9M Approximately 3.3M shares sold to Johnson Johnson in a second private placement at $6/share resulting in proceeds of $19.7M Minerva paid a $22M license fee to Janssen for certain rights to the MIN 202 program $23.6M cash balance at 9/30/14 $15M credit facility with Oxford and SVB announced 1/20/15 ($10m drawn down) Accumulated Net Operating Losses of $67.3M as at 9/30/14 2014 IPO proceeds fund core MIN 101 MIN 202 programs to end 2015 MIN 117 MIN 301 clinical initiation subject to additional funding 18,439,482 shares outstanding Approximately 2.1M options outstanding 9/30/14 (adjusted for cancellation of options in Nov 2014) 40,790 warrants issued in connection with the debt facility at exercise price of $5.516 Patent Protection Patent Jurisdiction Type U.S.
After increasing the dose of MPTP an increase of AIMS score was observed in the MIN 301 analog group. Thereafter, the AIMS scores of both groups were found to be overlapping. MIN 301 Analog: PRIMOMED Study 30 Results: effect of treatment on locomotor activity (bungalow test) Summary After the start of the MPTP treatment, the saline group showed a clear drop in performance.
Clear path forward in terms of next steps development in both indications (i.e. primary and comorbid insomnia in MDD) Confidential Proprietary MIN 117 25 Potential for a more effective and safer treatment to address the unmet medical needs of Major Depressive Disorder patients MIN 117: Preserving cognition and sexual function Effects on Immediate Memory (a model of cognition) Placebo Imipramine: Stress Impairs Memory * P=0.029 (vs placebo) ** P=0.019 (vs placebo) Effects on Sexual Function * p 0.05 vs other groups on same test day MIN 117: Preserves Sexual Function Paroxetine: Impairs Sexual Function 0% 10% 20% 30% 40% 50% 60% 70% Placebo Imipramine 0.010 mg/kg 0.10 mg/kg MIN 117 MIN 117 0 50 100 150 200 250 300 Baseline Day 1 One Week Two Weeks Treatment Duration Placebo MIN 117 / 0.03 mg Paroxetine MIN 117: Shows Preserved Memory Under Stress 26 Confidential Proprietary MIN 301 27 Potential for next generation of therapy for neurodegenerative diseases PRIMOMED Project: MIN 301 Analog 28 Read outs: Disease Progression Week 4 to 0 Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Habituation and establishment of baseline MIN 301a or vehicle daily dosing End MPTP dosing x x x x x x x x Daily clinical score (Parkinson signs) body weight (twice weekly) Circadian rhythm: 24 h home cage activity (once / week) Sleep with EEG recording (once / week) Motor function (once / week) Locomotor activity Righting reflex Pathology of substantia nigra Immunology: profiling of cytokines involved in inflammation and/or neurodegeneration, including IL1 , MCP 1, MIP 1 , TNF , IL6, IFN , IL4, IL10, + inflammatory mediators (COX 2, NO synthetase and leukotrienes), + trophic factors (GDNF, BDNF and TGF ) MIN 301 Analog: PRIMOMED Study 29 Results: effect of treatment on abnormal involuntary movements scale (AIMS) Summary saline control MIN 301 analog Start MPTP 1.0 mg/kg Increase MPTP 1.5 mg/kg 0.0 1.0 2.0 3.0 4.0 5.0 6.0 0 7 14 21 28 35 42 Days The MIN 301 analog group generally performed better than saline during the first 32 days.
Clear efficacy on sleep induction sleep maintenance with all doses tested 2. REM sleep is preserved 3. Good safety and tolerability up to 60 mg/day after repeated administration 4. PK and PK/PD are adapted for the therapeutic indications pursued 5. First solid formulation bio equivalent with the liquid formulation used in the 3 trials carried out in 2014 6.
Patient with PANSS item score of 4 on: P4 Excitement, hyperactivity P7 Hostility P6 Suspiciousness G8 Uncooperativeness G14 Poor impulse control No change in psychotropic medication during the last month Patient must be extensive metabolizers for P450 CYP2D6 Efficacy Assessments Positive and Negative Symptoms Scale (PANSS) The study is powered to reach statistical significance on total score and negative score Brief Negative Symptoms Scale (BNSS) Brief Assessment of Cognition in Schizophrenia (BACS) Personal and Social Performance (PSP): assess social functioning; clinician rated Sleep architecture and continuity 17 MIN 101C03: Phase IIb in Patients with Schizophrenia Timelines 18 Enrollment: Treatment (Primary Study): Parallel non clinical Phase III Prep; Topline results (Primary Study) : Mid 2016 DDI, Carcinogenicity, CMC, Analytics December 2014 Romania (16 sites) Russia (9 sites) Latvia (3 sites) January 2015 Estonia (3 sites) Bulgaria (3 sites) Ukraine (10 sites) April December 2015 April 2015 March 2016 Country Submissions Confidential Proprietary MIN 202 19 An Orexin2 antagonist for the treatment of primary and comorbid insomnia MIN 202 : Phase IB Study Design in MDD Patients 20 Placebo controlled, cross over, single dose study 3 doses (10mg, 20mg, 40mg) Washout period between periods of ~1 week 20 MDD patients treated with SSRI/SNRI having comorbid insomnia Diagnostic and drug effect evaluated with objective sleep measurements; PSG MIN 202: Phase IB study in MDD patients Positive Preliminary Efficacy Results 21 MIN 202 vs placebo *** p 0.001 *** *** *** 0 10 20 30 40 50 60 70 Latency to Persistent Sleep Placebo 10 mg 20 mg 40 mg MIN 202: Phase IB Study in MDD Patients Positive Preliminary Efficacy Results 22 MIN 202 vs placebo ** p 0.005 *** p 0.001 *** *** ** Placebo 10 mg 20 mg 40 mg 320 340 360 380 400 420 440 Total Sleep Time MIN 202: Phase I Study MAD Study Design 23 5, 10, 20, 40 and 60 mg MAD ascending doses of 10 days treatment duration Young healthy volunteers 2 placebo subjects and 6 verum subjects per dose group; equally randomized between females and males Study objectives Safety and tolerability C SSRS (Columbia Suicide Severity Rating Scale) Pharmacodynamics: CFF: Critical Flicker Fusion Simple and multiple choice reaction time 24 MIN 202: Phase I MAD Key PK Results Conclusion 1.
Main Inclusion Criteria Male or female patient, 18 to 60 years of age, inclusive. Patient meets the diagnostic criteria for schizophrenia as defined in DSM V Patient being stable in terms of positive symptoms over the last three months Patient presenting with negative symptoms over the last three months Patient with PANSS negative sub score of at least 20.
As measured by PANSS scale MIN 101 8 7 6 5 4 3 2 1 0 D6 D14 D21 D28 D42 D56 D70 D84 Treatment Day Plateau p = 0.0178 MIN 101: 13 Objective (PSG) 1 and Subjective (PSQI) 2 Measurements (Phase IIa) Subjective Measures By PSQI Scale MIN 101 Placebo MIN 101 Placebo Day 84 Day 84 Improved sleep quality after 3 months of treatment with MIN 101 vs Placebo (1) Polysomnography (2) Pittsburgh Sleep Quality Index (3) Standard Error of the Mean min Objective Measures of Sleep Onset By PSG Quicker onset of sleep after 2 weeks of treatment with MIN 101 vs Placebo 0 20 40 60 80 100 Day 1 Day 14 Day 1 Day 14 2 0 4 6 MIN 101: Compelling Efficacy On Sleep 14 MIN 101 : Phase IIa Study Safety Evaluation Side Effect Evaluation Relative to Atypicals AEs and SAEs Limited and minor Better Weight gain, Waist Circumference No increase on measurement Better Prolactin and Laboratory tests No clinically significant effects Better Extra pyramidal symptoms No effect showed on Simpson Angus Scale (SAS) Better Sedation No effect Better Vital signs Cardiovascular Minor QTc prolongation as expected with a supra therapeutic dose Comparable 15 MIN 101: Phase IIb Reformulated compound with improved safety profile A Phase IIb, Multi centre, Randomized, Double blind, Parallel group, Placebo controlled Study to Evaluate the Efficacy, Tolerability and Safety of MIN 101 in 234 patients with Negative Symptoms of Schizophrenia followed by a 24 week, Open label extension MIN 101CO3: Phase IIb Design in Patients with Schizophrenia 16 Screening Wash Out Period Baseline Core Study Treatment Period (12 weeks): MIN 101 (64 or 32 mg) or PLACEBO Extension 6 month: MIN 101 64 or 32 mg Obligatory In patient Day 3 to day +2 afterwards up to the end of study at the discretion of the PI A A IN A IN A D 21 D 3 to D 1 Day 1 D1 D2 W2 W4 W8 W12 W 14 W 18 W 24 W 30 W 36 W 37 V1 V2 V3 V4 V5 V6 V7 V8 V9 V 10 V 11 V 12 V 13 V 14 V 15 Core Study to include: 234 patients (78: 64mg, 78: 32mg, 78: placebo) 42 sites in 6 countries (Estonia, Russia, Ukraine, Romania, Latvia, Bulgaria) TITLE: A Phase IIb, Multi centre, Randomized, Double blind, Parallel group, Placebo controlled 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 RANDOMIZATION SINGLE BLIND RANDOMIZATION DOUBLE BLIND MIN 101C03: Phase IIb in Patients with Schizophrenia Primary Study Objectives 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 pentagonal model over 12 weeks of treatment.
Source: Datamonitor and Decision Resources. Represents 2012 drug sales. Ph IIa* Ph IIb Ongoing Phase IB Completed Phase IIa Completed Preclinical Ongoing* Ph IIa Phase IB Completed * Subject to additional financing Program Primary Indication Unique MOA Preclinical Phase 1 Phase 2 Prevalent Population Existing Drug Sales 1 MIN 101 Schizophrenia 5 HT2A Sigma2 4.3M US + EU5 $4.5B MIN 117 Major Depressive Disorder (MDD) 5 HT1A 5 HTT Alpha 1a,b Dopamine Transporter 5 HT2A 28M US + EU5 $4.6B MIN 202 Primary and Comorbid (Secondary) Insomnia Orexin 2 antagonist 53M US + EU5 + Japan $2.8B MIN 301 Parkinson s Disease ErbB4 activator 2M US + EU5 + Japan $2.3B Significant Progress Since IPO in 2014 MIN 101: Once a day formulation with improved safety profile selected for Phase IIb study (IIa conducted with bid) Phase IIb protocol submitted to several European countries MIN 202: Two Phase 1 studies completed; MAD study in healthy volunteers showing MIN 202 is well tolerated and appropriate PK/PD Bioavailability study in healthy volunteers POC study in MDD patients with comorbid insomnia showing improvement in onset and maintenance MIN 117: Phase IIa protocol finalized MIN 301: Disease modifying potential as demonstrated in MPTP primate study on analog of MIN 301 5 Confidential Proprietary MIN 101 6 Our lead compound with a clear path through clinical development 7 MIN 101: Innovative Mechanism of Action (MoA) DA blockers DA blockers + 5HT2A blockers Typicals Atypicals Other Strategies Next Generation MIN 101 5HT2A antagonists Sigma ligands Add on Therapies 5HT2A antagonist + Sigma 2 Antagonist Control of positive symptoms (hallucinations, delusions, agitation..) Major side effects Sedation Weight gain EPS Cognitive impairment Identical to Typicals Improvement of EPS Major side effects Sedation Weight gain Cognitive impairment Effect on + symptoms (not better than atypicals) Signals on symptoms and cognition Good safety DA modulation NMDA allosteric modulation Progesterone receptor binding Effect on negative symptoms (pilot) Still waiting final validation (atypicals + glycine, atypical + nicotinics failed for the moment) Effect on negative symptoms Effect on cognitive symptoms Good safety profile Effect on positive symptoms (building over time) Effect on sleep 8 MIN 101: Clear understanding of the MoA 9 MIN 101: Phase IIa completed A Multi center, Inpatient and ambulatory, Phase 2, Double blind, Randomized, Placebo controlled Proof of Concept Study of MIN 101in 96 Patients with DSM IV Schizophrenia (PANSS 60) Primary Endpoint: Explore safety tolerability of MIN 101 at a dose two or three times above the estimated therapeutic dose in order to: Ensure safety of patients participating in future studies Understand the PK/PD relationship of the QTc signal observed in non clinical and Phase I studies Get first hints of therapeutic activity in schizophrenic patients Secondary Endpoints: Verify the safety and tolerability profile for three months in schizophrenic patients at a 32mg twice daily dose ( the estimated therapeutic dose) Verify the absence of the most predominant AEs associated with typical and/or atypical antipsychotics Measure effect size of CYR 101 on QTc at Tmax/Cmax after the morning administration Explore effects of the drug on overall schizophrenia psychopathology over 3 months to understand the time course in acutely relapsed patients (PANSS 60), requiring hospitalization without adequately responding to prior treatment 10 MIN 101 Phase IIa Study Design MIN 101 11 MIN 101: Phase IIa Compelling Efficacy On Spectrum of Symptoms Positive and Negative Syndrome Scale (PANSS) 5 Factors (PPC) After Three Months Total Weighted Score Decrease: 24.1 for MIN 101 versus 17.9 Placebo 7 6 5 4 3 2 1 0 Negative Score 4 3.5 3 2.5 2 1.5 1 0.5 0 Activation Score 4 3.5 3 2.5 2 1.5 1 0.5 0 Positive Score 4 3.5 3 2.5 2 1.5 1 0.5 0 Autistic Preocupation Score 4 3.5 3 2.5 2 1.5 1 0.5 0 Dysphoric Mood Score p 0.05 p = 0.08 Phase IIa showed improvement in overall psychopathology of schizophrenia with outstanding efficacy on Negative Symptoms (32mg bid) 12 Placebo 1.
Represents patients in the seven major markets (U.S., Japan, France, Germany, Italy, Spain and the United Kingdom) 2. Datamonitor, Decision Resources Portfolio of First in Class Neuropsychiatric Drugs Large Addressable Market Management Team With Demonstrated Track Record World Class Pharma Partners Focus on leadership in CNS clinical development Four clinical stage compounds with transformative potential Validated MOAs differentiated by additional innovative receptor activities Multiple significant milestones over next 15 months 8 FDA approved neuropsychiatry drugs in the last 10 years Multiple successful exits for investors 88M patients covered under our commercial rights 1 Significant unmet medical need $14B total addressable market 2 Robust Pipeline of Transformative CNS Therapies Next Generation of First in Class Neuropsychiatry Pharmaceuticals 4 1.
Our audience is cautioned not to place undue reliance on these forward looking statements that speak only as of the date hereof, and we do not undertake any obligation to revise and disseminate forward looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non occurrence of any events. Investment Highlights 3 1.
Food and Drug Administration or equivalent foreign regulatory agencies and for which indications; whether any of our therapeutic candidates 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 collaboration 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; general economic conditions; and the other risk factors contained in our periodic and interim reports filed with the Securities and Exchange Commission which are available on the SEC website at www.sec.gov.
These risks and uncertainties include, but are not limited to: the benefits, efficacy and safety of the new once a day formulation of MIN 101; whether the analog of MIN 301 is a good predictor of clinical efficacy of MIN 301 ; the timing and results of future clinical milestones; the timing of future clinical trials and results of such clinical trials; whether any of our therapeutic candidates 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; 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. Words such as expect(s), feel(s), believe(s), will, may, anticipate(s) and similar expressions are intended to identify forward looking statements. These statements include, but are not limited to: the benefits, efficacy and safety of the new once a day formulation of MIN 101; whether the results of the study of the analog of MIN 301 are applicable to MIN 301; the timing and results of future clinical milestones; the timing of future clinical trials and results of such clinical trials; 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 Investor Presentation March 2015 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 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.
After the start of the MPTP treatment, the saline group showed a clear drop in performance. The MIN 301 analog treated group did not show this huge drop of activity. After increasing the MPTP dose, the activity of both groups gradually merged to a same performance level.