Relmada Therapeutics, Inc. · NASDAQ:RLMD
Relmada Therapeutics — Investor Presentation (June 2020)
28 slides from Relmada Therapeutics's investor presentation, Jun 3, 2020
Slide 1: 2020 Corporate Presentation: Targeting Major Advances in Treatment of CNS Disorders
2020 Corporate Presentation I Targeting Major Advances in Treatment of CNS Disorders June 2020 I Nasdaq: RLMD
Slide 2: Disclosures
2020 Corporate Presentation I Disclosures Certain statements contained in this presentation or in other documents of Relmada Therapeutics, Inc . (the “Company”), along with certain statements that may be made by management of the Company orally in presenting this material, may contain “forward - loo
Slide 3: Investment Highlights
2020 Corporate Presentation I • Phase 2 Adjunctive MDD trial completed with statistically significant rapid and sustained anti - depressant effects observed with favorable safety and tolerability profile • Successful EoP2 meeting with the FDA with clear pathway to NDA • Fast track designation from F
Slide 4: Dextromethadone (REL-1017) as a Potential Treatment for Depression
2020 Corporate Presentation I 4 as a Potential Treatment for Depression Dextromethadone (REL - 1017)
Slide 5: Dextromethadone (REL-1017) as a single agent rapid-acting oral treatment for depression
2020 Corporate Presentation I • REL - 1017 has the potential to be the first single agent oral NMDAR antagonist for the adjunctive treatment of depression and potentially for front line monotherapy treatment • Completed Phase 1 and Phase 2 trial for Adjunctive treatment of Major Depressive Disorder
Slide 6: A New Effective Treatment for MDD Remains a High Unmet Need
2020 Corporate Presentation I ~10M U.S. Adjunctive Patients in 2017 1,2 ~32M U.S. MDD patients in 2017 3 ~65M U.S. Individuals with at least 1 lifetime episode 3 A New Effective Treatment for Major Depressive Disorder Remains a High Unmet Need 6 1. Am J Psychiatry. 2006 Nov;163(11):1905 - 17. Acute
Slide 7: Dextromethadone Has Significant Potential Advantages in the Treatment of Depression
2020 Corporate Presentation I 1 Source: Am J Psychiatry. 2006 Nov;163(11):1905 - 17, https://www.samhsa.gov/data/sites/default/files/cbhsq - reports/NSDUHDetailedTabs2017/NSDUHDetailedTabs2017.htm#tab8 - 10A 7 Dextromethadone Has Significant Potential Advantages in the Treatment of Depression Novel
Slide 8: Phase 1 SAD and MAD Studies
2020 Corporate Presentation I Multiple Ascending Dose (MAD) Study Design Parallel group, double - blind, placebo controlled Objectives Establish PK, PD and safety of once daily, 10 day administration Treatment Administration Cohorts 25, 50, 75 mg N = 24 Study Conclusions • Doses up to 75mg per day w
Slide 9: Dextromethadone Significantly Increased BDNF Plasma Levels Compared to Placebo
2020 Corporate Presentation I 0 2 4 6 8 10 0 4 8 12 time (days) B D N F n g / m l placebo dextromethadone 0 2 4 6 8 10 0 100 200 300 400 500 time (days) d - m e t h a d o n e n g / m l 0 2 4 6 8 10 0 4 8 12 time (days) B D N F n g / m l placebo dextromethadone 0 2 4 6 8 10 0 100 200 300 400 500 time
Slide 10: Dextromethadone Phase II Study in Adjunctive Treatment of MDD – Overview
2020 Corporate Presentation I Dextromethadone Phase II Study in Adjunctive Treatment of MDD – Overview 10 Change from BSL at Day 2, 4, 7 and 14 on: • MADRS • SDQ • CGI - S Difference in CGI - I score placebo vs treatment groups Day 2 to 14 PK parameters for both 25 and 50 mg Q - day Endpoints Second
Slide 11: Dextromethadone Phase 2 Study Design
2020 Corporate Presentation I 60 patients three arm placebo - controlled trial Two doses tested 25mg and 50mg once a day versus placebo 7 days daily treatment in clinic + 7 days observation as outpatient Follow up at day 14 for efficacy and safety Follow up at day 21 for safety only 11 Dextromethado
Slide 12: Dextromethadone Phase II Study in Adjunctive Treatment of MDD – Design
2020 Corporate Presentation I Dextromethadone Phase II Study in Adjunctive Treatment of MDD – Design 12 MDD = Major Depressive Disorder; RDPC = randomized double - blind placebo controlled; MADRS = Montgomery - Asberg Depression Rating Scale; SDQ = Symptoms of Depression Questionnaire; CGIs = Clinic
Slide 13: Dextromethadone Phase II Study - Baseline Patient Characteristics
2020 Corporate Presentation I Placebo REL - 1017 25 mg REL - 1017 50 mg All Subjects Randomized Subjects 22 19 21 62 Completed all visits (Day 21) 20 18 19 57 Received all doses 21 19 21 61 Age: mean years (SD) 49.7 (11.1) 49.4 (12.4) 48.6 (10.9) 49.2 (11.3) Females 11 (50%) 8 (42.1%) 9 (42.9%) 28 (
Slide 14: MADRS Scores Achieved Statistically Significant Difference vs Placebo
2020 Corporate Presentation I -25 -20 -15 -10 -5 0 Day 2 Day 4 Day 7 Day 14 Least - Square Mean Change Placebo REL-1017 25mg REL-1017 50mg P = 0.0087; d = 0.9 P = 0.0096; d = 0.8 P = 0.0122; d = 0.8 P = 0.0308; d = 0.7 P = 0.0103; d = 0.9 P = 0.0039; d = 1.0 14 MADRS Scores in the Treatment Groups A
Slide 15: CGI-S Scores Achieved Statistically Significant Difference vs Placebo
2020 Corporate Presentation I -2.5 -2 -1.5 -1 -0.5 0 Day 2 Day 4 Day 7 Day 14 Least - Square Mean Change Placebo REL-1017 25 mg REL-1017 50 mg P = 0.0272; d = 0.7 P = 0.0951; d = 0.5 P = 0.0253; d = 0.7 P = 0.0245; d = 0.7 P = 0.0454; d = 0.7 P = 0.0043; d = 0.9 15 CGI - S Scores Achieved Statistica
Slide 16: REL-1017 Safety and Tolerability Profile
2020 Corporate Presentation I 16 REL - 1017 - 202 results confirm the favorable tolerability and safety profile observed in the Phase 1 SAD and MAD studies Only Mild and Moderate AEs - no SAEs No increased prevalence of specifically relevant organ group AEs in treatment groups vs placebo No evidence
Slide 17: End of Phase 2 Meeting Outcome
2020 Corporate Presentation I Indication: Studies will assess REL - 1017 as adjunctive treatment in MDD patients who have failed at least one prior treatment in current depression episode Two Pivotal Studies: Two sister two - arm placebo - controlled clinical studies Primary Endpoint: Change from ba
Slide 18: End of Phase 2 Meeting Outcome
2020 Corporate Presentation I Dosing: 25 mg dose of REL - 1017 to be evaluated. PD relationship in Phase 2 supports equivalence of 25 mg and 50 mg doses Tablet formulation Equivalence Established: No PK bridging studies required to support transition from powder - in - solution formulation of REL -
Slide 19: Anticipated Development Timeline REL-1017
2020 Corporate Presentation I Anticipated Development Timeline REL - 1017* 19 Q1 2020 Q2 2020 Q3 2020 Q4 2020 Adjunctive Treatment of Major Depressive Disorder (MDD) Front - line Major Depressive Disorder (MDD) P2 Full Data End of P2 FDA meeting 1 st Pivotal Adjunctive MDD trial MDD Phase 2 start P3
Slide 20: Potential Competitive Advantages of Dextromethadone
2020 Corporate Presentation I 20 Potential Competitive Advantages of Dextromethadone Compound (Company) Mechanism of Action Delivery Current Clinical Stage Dosing Regimen Dextromethadone (Relmada) Non - competitive NMDA channel blocker Oral Completed Phase 2 Once Daily Esketamine/ Spravato (Janssen/
Slide 21: Corporate Information
2020 Corporate Presentation I 21 Corporate Information
Slide 22: Financial Overview
2020 Corporate Presentation I 22 Financial Overview Cash, Cash Equivalents & ST Investments (as of 03/31/19) $114.9 million ~3.2 million $3.4 million ~15.2 million Warrants Outstanding (as of 03/31/19, weighted average exercise price, $6.79) Operating Cash Burn 1Q20 Common Shares Outstanding (as of
Slide 23: Management Team and Key Scientific Advisors
2020 Corporate Presentation I Management Team and Key Scientific Advisors Management Sergio Traversa Chief Executive Officer Tom Wessel, MD, Ph.D Head of Research & Development Maged Shenouda Chief Financial Officer Marc de Somer, MD, MBA, ScD, MPH, MSc SVP, Clinical Development and Safety Chuck Enc
Slide 24: Investment Highlights
2020 Corporate Presentation I • Phase 2 Adjunctive MDD trial completed with statistically significant rapid and sustained anti - depressant effects observed with favorable safety and tolerability profile • Successful EoP2 meeting with the FDA with clear pathway to NDA • Fast track designation from F
Slide 25: June 2020 Targeting Major Advances in Treatment of CNS Disorders
2020 Corporate Presentation I June 2020 Targeting Major Advances in Treatment of CNS Disorders Nasdaq: RLMD
Slide 26: Strong Anti-Depressant Effects Observed in Three Animal Models of Depression
2020 Corporate Presentation I Strong Anti - Depressant Effects Observed in Three Animal Models of Depression Improved performance on the rat forced swim test 24 hours after d - methadone treatment 26 Forced Swim Test * = p<0.05 compared to placebo group
Slide 27: Strong Anti-Depressant Effects Observed in Three Depression Animal Models
2020 Corporate Presentation I Strong Anti - Depressant Effects Observed in Three Depression Animal Models Improved performance on the rat FUST and the NSFT 24 hours after d - methadone treatment 27 * * * * Female Urine Smell Test Novelty Suppressed Feeding Test
Slide 28: REL-1017 Phase 2 Key Efficacy Findings
2020 Corporate Presentation I Study REL - 1017 Phase 2 Key Efficacy Findings 28 REL - 1017 25 mg and 50 mg show rapid onset and sustained antidepressant effects with statistically significant differences compared to placebo on all efficacy measures • Solid effects observed on MADRS with P values < 0
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