Slide 1: Minerva Neurosciences, Inc.
Exhibit 99.2 Minerva Neurosciences, Inc. 1601 Trapelo Road, Suite 284, Waltham, MA 02451
Slide 2: Forward-Looking Statement Safe-Harbor
2 All trademarks, trade names and service marks appearing in this presentation are the property of their respective owners. Forward-Looking Statement Safe-Harbor This presentation contains certain forward-looking statements about Minerva Neurosciences that are intended to be covered by the safe harb
Slide 3: Minerva: Overview R&D Current Status
3 Phase / Event Q1 Q1 Q1 Q2 Q2 Q2 Q3 Q3 Q3 Q4 Q4 2014 2015 2016 Minerva: Overview R&D Current Status Subject to additional financing * TBC – subject to Ph1 results ‡ Planning in progress; subject to additional financing End of bar = expected availability of topline results Once A Day Formulation Ph
Slide 4: CXMINERVA
CXMINERVA
Slide 5: R&D update
R&D update Once a day formulation results Phase IIB study design 5
Slide 6: MIN-101C02: Once a day formulation
6 MIN-101C02: Once a day formulation MIN-101C02 Study Title: A Two-Part Study Designed to Evaluate the Pharmacokinetic Profile of MIN-101 and its Main Metabolites Following Single and Multiple Dose Modified Release Prototype Formulation Administration in Healthy CYP2D6 Extensive Metaboliser Male and
Slide 7: Change in QTcF by BFB-520 concentration
7 Change in QTcF by BFB-520 concentration Plasma concentration Change in QTcF by BFB-999 concentration Plasma concentration Change in QTcF by CYR-101 concentration Plasma concentration 2 subjects with outlying values removed Dose adjustment period D2 Dose adjustment period D4 Dose adjustment period
Slide 8: Part 1 Study Design
8 Screening Day -28 to Day -2 Period 1 Period 2 Period 3 Period 4 Period 5 Period 6 Food interaction Follow up call 3 to 5 days after last Part 1 Study Design PART 1 32 mg slow release 32 mg medium release 40 mg slow release 32 mg slow release
Slide 9: Plasma Concentration-Time Profiles: MIN-101
9 Plasma Concentration-Time Profiles: MIN-101 Linear Scale
Slide 10: Plasma Concentration-Time Profiles: BFB-520
10 Plasma Concentration-Time Profiles: BFB-520 Linear Scale
Slide 11: Plasma Concentration-Time Profiles: BFB-999
11 Plasma Concentration-Time Profiles: BFB-999 Linear Scale
Slide 12: Cmax by period
CXMINERVA @ Period 1 - 32mg slow (fasted) @ Period 2 - 32mg med (fasted) Period 3 - 40mg slow (fasted) @ Period 4 - 32mg slow (fed) 50.0 46.4 ey E 45.0 400 = 35.0 £ 30.0 a rf 25.0 E 200 8 = 150 § 100 3 50 #315204 15162423 00 — MIN-101 BFB-520 BFB-999 Cmax
Slide 13: Summary of Select PK Parameters – Period 1
13 MIN-101 Tmax (h) Cmax (ng/mL) Tlag (h) t1/2 (h) AUClast (h*ng/mL) N Mean Median CV% BFB-520 Tmax (h) Cmax (ng/mL) Tlag (h) t1/2 (h) AUClast (h*ng/mL) N Mean Median CV% BFB-999 Tmax (h) Cmax (ng/mL) Tlag (h) t1/2 (h) AUClast (h*ng/mL) N Mean Median CV% Summary of Select PK Parameters – Period 1 (3
Slide 14: Conclusions – MR Formulation Under Fasted Conditions
14 Conclusions – MR Formulation Under Fasted Conditions Short lag time suggestive of fast bioavailability Exposure variability is generally low Low to non-quantifiable values for most by Hour 24 PK is generally dose proportional for MIN-101 & BFB-999, and less so for BFB-520 Inversion of BFB-520 & B
Slide 15: Conclusions – Food Effect
15 Conclusions – Food Effect Positive food effect evident – Higher exposure MR formulation behaved similar to IR formulation with rapid release and absorption, mostly prior to reaching colon • This explains further increase in BFB-520 levels Due to rapid absorption MIN-101 Cmax increase was ~ 2x, BF
Slide 16: Conclusion
16 32 mg slow release in fasted condition will be the formulation used in the C03 upcoming patient study in patients suffering from schizophrenia Conclusion
Slide 17: Study Part 2
17 Screening Day -28 to Day -2 Period 1 Period 2 Period 3 Follow up visit 5 days after last dose of IMP QBR117055_ MIN-101C02 Study Part 2: 16 and 32 mg will be explored
Slide 18: Period Scheme
18 Day -1 Day 1 Day 2-5 Day 6 Day 7 Day 8 Day 9 Period Scheme • Admission • Dosing, PK profile and ECG/vital sign s • Dosing • Dosing; sleep at 22:00 • Dosing; PK profile, Triplicate ECGs • Discharge 24h post dose • Optional visit (PK 48 h post dose)
Slide 19: MIN-101C03: Phase IIB in patients suffering from schizophrenia
19 MIN-101C03: Phase IIB in patients suffering from schizophrenia MIN-101C03 Study 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 Fol
Slide 20: Global Study Design
20 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 RANDOMIZATION MIN-101C03: Phase IIB in patients with schizophrenia Obligatory In patient Day -3 to day +2 afterwards up to the end of study at the dis
Slide 21: Study Objectives: Primary
21 MIN-101C03: Phase IIB in patients with schizophrenia Study 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 s
Slide 22: Study Objectives: Main Secondary
22 MIN-101C03: Phase IIB in patients with schizophrenia Study Objectives Main Secondary • To evaluate the efficacy of MIN-101 compared to placebo in improving other symptoms of schizophrenia as measured by the change from baseline in the PANSS total score, and sub-scores of the pentagonal model AND
Slide 23: Study Objectives: Exploratory
23 MIN-101C03: Phase IIB in patients with schizophrenia Study Objectives 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. • To evaluate the e
Slide 24: Inclusion Criteria
24 MIN-101C03: Phase IIB in patients with schizophrenia Inclusion/ Exclusion Criteria Main Inclusion Criteria • 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-
Slide 25: Exclusion Criteria
25 MIN-101C03: Phase IIB in patients with schizophrenia Inclusion/ Exclusion Criteria Main Exclusion Criteria • Current bipolar disorder, panic disorder, obsessive compulsive disorder, or evidence of mental retardation. • Patient’s condition is due to direct physiological effects of a substance (e.g
Slide 26: Assessments
26 MIN-101C03: Phase IIB in patients with schizophrenia Assessments Main Efficacy Assessments – Positive and Negative Symptoms Scale (PANSS ) – Brief Negative Symptoms Scale (BNSS ): semi structured interview, designed to measure the current level of severity of negative symptoms in schizophrenia an
Slide 27: Sleep assessment
27 MIN-101C03: Phase IIB in patients with schizophrenia - Sleep assessment WHY? – Sleep and circadian rhythm disruptions are reported in 30% to 80% of patients with schizophrenia. – Patients with insomnia report • lower quality of life • greater symptom severity • worse adherence/compliance to treat
Slide 28: Monitoring sleep in MIN-101C03 using V-Watch
28 Monitoring sleep in MIN-101C03 using V-Watch, a sleep biomarker & companion diagnostic tool PSG VWATCH VWatch methodology overview-2
Slide 29: Submissions Status
29 The Submissions Status is: (1) Romania (22 sites) : End November / Beginning December Russia (11 sites) : December Latvia (4 sites) : December Estonia (3 sites) : End December/ Beginning January Bulgaria (3 sites) : January Ukraine (12 sites) : January
Slide 30: Thank you
30 Thank you