Relmada Therapeutics, Inc. · NASDAQ:RLMD
Relmada Therapeutics — Investor Presentation (December 2019)
26 slides from Relmada Therapeutics's investor presentation, Dec 3, 2019
Slide 1: Targeting Major Advances in Treatment of CNS Disorders
December 2019 | December 2019 Targeting Major Advances in Treatment of CNS Disorders Nasdaq: RLMD
Slide 2: Disclosures
December 2019 | 2 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 - looking statements . ” Thes
Slide 3: Investment Highlights
December 2019 | Management team and scientific advisors have considerable CNS expertise Johnson & Johnson, Eli Lilly, Pfizer, Shire, Harvard, Yale, Cornell Multiple key catalysts expected over next 12 - 18 months* Presentation of REL - 1017 Phase 2 TRD study full data H1 2020 End of TRD Phase 2 meet
Slide 4: d-Methadone (REL-1017) as a Potential Treatment for Depression
December 2019 | as a Potential Treatment for Depression d - Methadone (REL - 1017)
Slide 5: Compelling Lead Product Candidate: REL-1017
December 2019 | Compelling Lead Product Candidate: REL - 1017 • REL - 1017 is a non - competitive N - methyl - D - aspartate Receptor (NMDAR) antagonist • REL - 1017 has the potential to be the first oral NMDAR antagonist for the treatment of depression and treatment resistant depression • Completed
Slide 6: d-Methadone is an NMDAR antagonist with Significant Potential Advantages
December 2019 | Rapid onset 6 d - Methadone is an NMDAR antagonist with Significant Potential Advantages in the Treatment of Depression 1 Source: Am J Psychiatry. 2006 Nov;163(11):1905 - 17, https://www.samhsa.gov/data/sites/default/files/cbhsq - reports/NSDUHDetailedTabs2017/NSDUHDetailedTabs2017.h
Slide 7: Effective Treatment for TRD Remains a High Unmet Need
December 2019 | 7 An Effective Treatment for Treatment - Resistant Depression (TRD) Remains a High Unmet Need ~10 to 30% of MDD patients suffers from TRD 1 ~17.3M U.S. MDD patients 2 1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3363299/ 2. https://www.nimh.nih.gov/health/statistics/major - depres
Slide 8: Expanding Focus on NMDAR's Role in Treatment of Depression
December 2019 | 8 Expanding Focus on NMDAR’s Role in Treatment of Depression Johnson & Johnson Is Reinventing the Party Drug Ketamine to Treat Depression
Slide 9: Strong Anti-Depressant Effects Observed in Three Animal Models of Depression
December 2019 | 9 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 Forced Swim Test * = p<0.05 compared to placebo group PsychoGenics – Dr. Taleen Hanania Data published: Hanania , T
Slide 10: Strong Anti-Depressant Effects Observed in Three Animal Models of Depression
December 2019 | * * 10 Strong Anti - Depressant Effects Observed in Three Animal Models of Depression Improved performance on the rat FUST and the NSFT 24 hours after d - methadone treatment * * = p<0.05 compared to placebo group - Dr. Ron Duman’s laboratory - Yale Medical School Data published: Fog
Slide 11: Phase 1 SAD and MAD Study Designs
December 2019 | 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 well tole
Slide 12: d-Methadone Significantly Increased BDNF Plasma Levels Compared to Placebo
December 2019 | 12 d - Methadone Significantly Increased BDNF Plasma Levels Compared to Placebo in Phase 1 MAD Study in Healthy Volunteers 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
Slide 13: REL-1017 Phase 2a Study Evaluated Safety, Tolerability, PK and Efficacy
December 2019 | 13 REL - 1017 – Phase 2a Study Evaluated Safety and Tolerability, PK and Efficacy in Treatment Resistant Depression • RDPC study of 7 - day dosing at 25 mg and 50 mg QD as adjunctive therapy in MDD subjects who did not respond to adequate antidepressant treatments (TRD) • 11 U.S. sit
Slide 14: Study Designed to Provide Data on Safety, PK and Efficacy in TRD
December 2019 | Study REL - 1017 - 202 Was Designed to Provide Data on Safety, PK and Efficacy of REL - 1017 in Treatment Resistant Depression Primary Objectives Primary Endpoints Safety and tolerability of 25 mg and 50 mg of REL - 1017 vs placebo as adjunctive treatment PE, Laboratory studies, ECG,
Slide 15: Subject Disposition, Demographics and Depression Severity Distributed Homogeneously
December 2019 | 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 (45.2%) Subject
Slide 16: Phase 2a Key Safety Findings
December 2019 | 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 of treatment ind
Slide 17: Phase 2a Key Efficacy Findings
December 2019 | 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 . 03 and large effect sizes ( 0 . 7 - 1 . 0 ) from Day 4 to Day 1
Slide 18: MADRS Scores Achieved Statistically Significant Difference vs Placebo
December 2019 | MADRS Scores in the Treatment Groups Achieved Statistically Significant Difference vs Placebo from Day 4 through Day 14 MADRS: Montgomery - Asberg Depression Rating Scale; ITT: Intent - To - Treat; Error Bars: Standard Errors; P and d values as Treatment vs Placebo -25 -20 -15 -10 -5
Slide 19: CGI-S Scores Achieved Statistically Significant Difference vs Placebo
December 2019 | CGI - S Scores Achieved Statistically Significant Difference vs Placebo from Day 4 for REL - 1017 50 mg and for both Doses on Day 7 and Day 14 CGI - S: Clinical Global Impression of Severity; ITT: Intent - To - Treat; Error Bars = Standard Errors; P and d values as Treatment v s Plac
Slide 20: Anticipated Development Timeline REL-1017
December 2019 | 20 Anticipated Development Timeline REL - 1017* * May be delayed based on FDA feedback and other factors . Indication 2019 2020 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Treatment Resistant Depression (TRD) Major Depressive Disorder (MDD) REL - 1017 Top Line Phase 2 Data End of Phase 2 meeting 1 st Pi
Slide 21: Potential Competitive Advantages of d-Methadone
December 2019 | 21 Potential Competitive Advantages of d - Methadone 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 (Janssen/J&J) Nasal (administered i
Slide 22: Corporate Information
December 2019 | Corporate Information
Slide 23: Financial Overview
December 2019 | 23 Financial Overview Cash & Cash Equivalents (as of 9/30/19) $7.8 million Common Shares Outstanding (as of 11/8/19) ~10.3 million
Slide 24: Investment Highlights
December 2019 | Management team and scientific advisors have considerable CNS expertise Johnson & Johnson, Eli Lilly, Pfizer, Shire, Harvard, Yale, Cornell Multiple key catalysts expected over next 12 - 18 months* Presentation of REL - 1017 Phase 2 TRD study full data H1 2020 End of TRD Phase 2 meet
Slide 25: Management Team and Key Scientific Advisors
December 2019 | 25 Management Team and Key Scientific Advisors Management Sergio Traversa PharmD, MBA, Chief Executive Officer Ottavio Vitolo Senior Vice President, Head of R&D and Chief Medical Officer Chuck Ence Chief Financial Officer Advisors Maurizio Fava Scientific Advisor Charles Inturrisi Sc
Slide 26: Targeting Major Advances in Treatment of CNS Disorders
December 2019 | December 2019 Targeting Major Advances in Treatment of CNS Disorders Nasdaq: RLMD
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