Relmada Therapeutics, Inc. · NASDAQ:RLMD
Relmada Therapeutics — Investor Presentation (November 2020)
31 slides from Relmada Therapeutics's investor presentation, Nov 16, 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 November 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 • Novel MOA with successful Phase II trial in adjunctive MDD that showed statistically significant, rapid and sustained anti - depressant effects with favorable safety and tolerability profile • Successful EoP2 meeting with the FDA with clear pathway to NDA • Fast track
Slide 4: REL-1017 as a Potential Treatment for Depression
2020 Corporate Presentation I 4 as a Potential Treatment for Depression REL - 1017
Slide 5: REL-1017: A Novel, Selective NMDAR Blocker being developed for MDD
2020 Corporate Presentation I REL - 1017: A Novel, Selective NMDAR Blocker being developed for MDD ▪ Potential to be the first rapid - acting, oral, once - daily antidepressant treatment ▪ Completed Phase 1 and Phase II trial for Adjunctive treatment of MDD ▪ In a Phase II trial, both doses of REL -
Slide 6: Major Depressive Disorder (MDD) Market: Large, Debilitating, Underserved
2020 Corporate Presentation I ~8M U.S. 50% of MDD patients receive medication treatment 1 ~17M U.S. Individuals in 2017 with at least 1 MDE episode 1 ~65M U.S. Individuals with at least 1 lifetime episode 2 6 Major Depressive Disorder (MDD) Market: Large, Debilitating, Underserved 1. SAMHSA https://
Slide 7: Significant Limitations Characterize Current Standard of Care in MDD
2020 Corporate Presentation I • ~65% MDD patients do not respond to first antidepressant treatment • ~30% MDD patients do not respond to up to 4 different antidepressant treatments Relmada — Corporate presentation 7 • Sleep disturbance, sexual dysfunction, GI distress and weight gain limit adoption
Slide 8: REL-1017: A Novel NMDAR Channel Blocker with Preferential Activity
2020 Corporate Presentation I ▪ Traditional MDD therapeutics have been based on MAO hypothesis ▪ Increasingly, NMDA receptor recognized for significance in pathophysiology of depression • NMDA blockade presents potential mechanism for safe and effective MDD treatment with rapid onset ▪ REL - 1017 is
Slide 9: 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 10: Phase II Study in Adjunctive Treatment of MDD – Overview
2020 Corporate Presentation I 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 Efficacy Endpoints Secondary Obj
Slide 11: REL-1017 Phase II 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 REL - 1017 Ph
Slide 12: REL-1017 Phase II Trial Design
2020 Corporate Presentation I Inpatient Days - 1 to 9 12 REL - 1017 Phase II Trial Design MDD = Major Depressive Disorder; RDPC = randomized double - blind placebo controlled; MADRS = Montgomery - Asberg Depression Rating Scale; SDQ = Symptoms of Depression Questionnaire; CGIs = Clinical Global Impr
Slide 13: REL-1017 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: Phase II Efficacy: MADRS Scores Statistically Significant 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 REL - 1017 Phase II Study Efficacy MAD
Slide 15: Phase II Efficacy: Remission and Response Rates
2020 Corporate Presentation I 15 REL - 1017 Phase II Study Efficacy Remission Rates (MADRS <10 Points) Percent Subjects per ITT Group 14% 5% 32% 31% 19% 33% 0% 10% 20% 30% 40% 50% 60% Day 7 Day 14 24% 20% 42% 50% 57% 44% 0% 10% 20% 30% 40% 50% 60% Day 7 Day 14 Response Rates (>50% Change vs. Baselin
Slide 16: Phase II Study Indicated Favorable Safety & Tolerability
2020 Corporate Presentation I ▪ 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 induced dissociative symptoms in the treatment groups vs placebo ▪ No evidence of treatment induced psycho
Slide 17: End of Phase II 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 b
Slide 18: End of Phase II Meeting Outcome
2020 Corporate Presentation I Dosing: 25 mg dose of REL - 1017 to be evaluated. PD relationship in Phase II 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: REL-1017 (dextromethadone): Abuse Potential Assessments
2020 Corporate Presentation I REL - 1017 ( dextromethadone ) • REL - 1017 is dextromethadone , the dextro - isomer of parent, racemic methadone – NCE with unique pharmacology – Per DEA, distinct from parent and levo - isomer responsible for opioid effects of methadone – Phase II assessments during i
Slide 20: REL-1017: Anticipated Development Timeline
2020 Corporate Presentation I 20 REL - 1017: Anticipated Development Timeline* Q4 2020 H1 2021 H2 2021 H1 2022 Adjunctive Treatment of Major Depressive Disorder (MDD) Major Depressive Disorder (MDD) 1 st Pivotal Adjunctive MDD trial MDD Monotherapy Phase II *subject to FDA feedback Indication 2 nd P
Slide 21: Potential Competitive Advantages of Dextromethadone
2020 Corporate Presentation I 21 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 II Once Daily Esketamine/ Spravato (Janssen
Slide 22: Corporate Information
2020 Corporate Presentation I 22 Corporate Information
Slide 23: Financial Overview
2020 Corporate Presentation I 23 Financial Overview Cash, Cash Equivalents & ST Investments (as of 09/30/20) $123.1 million ~2.7 million $12.5 million ~16.2 million Warrants Outstanding (as of 09/30/20, weighted average exercise price, $7.81) Operating Cash Burn 3Q20 Common Shares Outstanding (as of
Slide 24: Management Team and Key Scientific Advisors
2020 Corporate Presentation I Management Team and Key Scientific Advisors Management Sergio Traversa Chief Executive Officer Paolo Manfredi, MD Acting Chief Scientific Officer Marco Pappagallo, MD Acting Chief Medical Officer Tom Wessel, MD, Ph.D Head of Research & Development Maged Shenouda Chief F
Slide 25: Advisors
2020 Corporate Presentation I Advisors Maurizio Fava, MD, Chair Stephen M. Stahl, MD Luca Pani, MD Thomas Laughren, MD Dan Iosifescu , MD, MSc Sanjay Johan Mathew, MD Charles Inturrisi , PhD Scientific Advisors 25
Slide 26: Key Catalysts Expected Over Next 12-18 Months
2020 Corporate Presentation I • 4Q20 – Start of first pivotal Phase III adjunctive MDD trial • 1H21 – Start of second pivotal Phase III adjunctive MDD trial • 1H21 – Start of Phase II monotherapy MDD trial • 2Q21 – Results of human abuse potential studies • 4Q21 – Results of Phase II monotherapy MDD
Slide 27: Investment Highlights
2020 Corporate Presentation I • Novel MOA with successful Phase II trial in adjunctive MDD that showed statistically significant, rapid and sustained anti - depressant effects with favorable safety and tolerability profile • Successful EoP2 meeting with the FDA with clear pathway to NDA • Fast track
Slide 28: Back Up
2020 Corporate Presentation I BACK UP Sept 2020 I Nasdaq: RLMD
Slide 29: 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 29 Forced Swim Test * = p<0.05 compared to placebo group
Slide 30: 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 30 * * * * Female Urine Smell Test Novelty Suppressed Feeding Test
Slide 31: REL-1017 Phase II Key Efficacy Findings
2020 Corporate Presentation I Study REL - 1017 Phase II Key Efficacy Findings 31 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 <
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