Slide 1: Clin301-203 Phase 2 Topline MDD Data Conference Call
Clin301-203 Phase 2 Topline MDD Data Conference Call November 29, 2016 NASDAQ:CERC www.cerecor.com
Slide 2: Agenda
Welcome Mariam E. Morris, CPA CFO Introduction Uli Hacksell, Ph.D. CEO, President and Chairman CERC-301 Phase 2 Trial Design and Results Ronald Marcus, M.D. CMO and Head, Regulatory Affairs Next Steps/Close Uli Hacksell, Ph.D. CEO, President and Chairman Q&A Cerecor Management Agenda 2
Slide 3: Forward-looking Statements
Forward-looking Statements This presentation contains forward-looking statements, including statements about our plans to develop and potentially commercialize our product candidates, our ongoing and planned clinical trials and preclinical studies for our product candidates, the timing of the availa
Slide 4: CERC-301: Novel, Oral NR2B, NMDA Antagonist
CERC-301: Novel, Oral NR2B, NMDA Antagonist Drug/Target Attributes NR2B selectivity may provide a favorable side effect profile Potential rapid onset of action Oral formulation Fast track status granted by FDA 4 Did not meet the primary endpoint Showed signals of efficacy on Day 2 after dosing with
Slide 5: Phase 2 Study Overview Clin301-203
Phase 2 Study Overview Clin301-203 3-week randomized, double-blind, placebo-controlled trial Sequential parallel comparison design (SPCD) with 2 periods of 7 days followed by a 7 day follow-up Intermittent doses of adjunctive CERC-301 (12 mg or 20 mg) or placebo Subjects with MDD currently experienc
Slide 6: Phase 2 Study Overview Clin301-203 Dosing Schedule
Phase 2 Study Overview Clin301-203 Dosing schedule: Subjects receive 2 doses of study treatment, seven days apart Primary endpoint: Change in Bech-6 (subscale of the HDRS-17) rating at Day 2 & 4 (averaged) 7 Days 7 Days Day 2 after Dose 1 Day 4 after Dose 1 Follow-up 12 mg CERC-301 20 mg CERC-301 Pl
Slide 7: SPCD, Period 1 & Period 2 Clin301-203
SPCD, Period 1 & Period 2 Clin301-203 7 Period 1 Period 2 Randomization (n=115) CERC-301 (12 mg) (n=21) CERC-301 (12 mg) (n=20) CERC-301 (20 mg) (n=21) CERC-301 (20 mg) (n=20) Placebo (n=72) Responder (n=23) Placebo (n=23) Non-Responder (n=49) CERC-301 (12 mg) (n=14) CERC-301 (20 mg) (n=14) Placebo
Slide 8: Bech-6 Subset of HDRS-17
8 *Believed to be more sensitive to rapid-acting antidepressant treatments Bech-6* Subset of HDRS-17 Bech-6 Items: Depressed mood Guilt Work and interests Psychomotor retardation Psychic anxiety Somatic symptoms Other HDRS-17 Items: Suicidality Initial insomnia Middle insomnia Late insomnia Psychomo
Slide 9: Primary Endpoint: Mean Bech-6 Averaged over Days 2 & 4
Primary Endpoint: Mean Bech-6 Averaged over Days 2 & 4 Clin301-203 9 Mean improvement from baseline on Bech-6 for Period 1 Placebo: 3.82 12 mg: 2.50 20 mg: 4.11 Mean improvement from baseline on Bech-6 for Period 2 Placebo: 2.86 12 mg: 1.64 20 mg: 3.38 Weighted average for placebo/drug difference 12
Slide 10: Secondary Endpoints: Day 2 CERC-301 20 mg
Secondary Endpoints*: Day 2 CERC-301 20 mg Clin301-203 Mean improvement from baseline on Bech-6 for Period 1 Placebo: 3.59 20 mg: 4.70 Mean improvement from baseline on Bech-6 for Period 2 Placebo: 2.30 20 mg: 3.52 Mean improvement from baseline on HDRS-17 for Period 1 Placebo: 6.24 20 mg: 9.71 Mean
Slide 11: Clinically Meaningful Changes in HDRS-17
Clinically Meaningful Changes in HDRS-17 11 According to Dr. Maurizio Fava, a minimum of 2 points of improvement on the HDRS-17 scale compared to placebo is considered by many, and noted in MDD studies, to be clinically meaningful: Abilify*: difference from placebo was -2.5 on HDRS-17 after 6 weeks
Slide 12: Safety and Tolerability
Safety and Tolerability Clin301-203 CLIN 301-203 Phase 2 12 Generally well-tolerated No SAEs reported No discontinuations due to AEs Most commonly reported: Increased blood pressure Dizziness Somnolence Paresthesia
Slide 13: Summary
Summary Clin301-203 CLIN 301-203 Phase 2 13 Did not achieve primary endpoint of improvement in Bech-6 for CERC-301 vs placebo Signals of efficacy at Day 2 with 20 mg dose Generally well-tolerated Lessons learned: Potential future studies should evaluate doses above 20 mg given at a higher frequency
Slide 14: CERC-301: Next Steps
CERC-301: Next Steps 14 We are disappointed that trial did not achieve significance for primary endpoint We believe that signal observed at Day 2 for 20 mg may indicate a meaningful treatment effect We intend to fully assess the data We will announce next steps at a later date
Slide 15: Q&A
= ” oC e Yecor Ay Q&A