Relmada Therapeutics, Inc. · NASDAQ:RLMD
Relmada Therapeutics — Investor Presentation (December 2020)
30 slides from Relmada Therapeutics's investor presentation, Dec 14, 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 December 2020 I Nasdaq: RLMD
Slide 2: Disclosures
2 0 2 0 C o r p o r a te P r e s e n t a t i o n I 2 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
Slide 3: Investment Highlights
2 0 2 0 C o r p o r a te P r e s e n t a t i o n I 3 • Novel MOA with successful Phase 2 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 pathw
Slide 4: as a Potential Treatment for Depression
2020 Corporate Presentation I 4 REL - 1017 as a Potential Treatment for Depression
Slide 5: A Novel, Selective NMDAR Blocker being developed for MDD
2 0 2 0 C o r p o r a te P r e s e n t a t i o n I 5 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 trials and Phase 2 for Adjunctive Treatment of MDD ▪ In a Phase 2 tria
Slide 6: Major Depressive Disorder Market: Large, Debilitating, Underserved
2 0 2 0 C o r p o r a te P r e s e n t a t i o n I 6 ~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 Major Depressive Disorder (MDD) Market: Large, Debilitating, Underserv
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: A Novel NMDAR Channel Blocker with Preferential Activity
2 0 2 0 C o r p o r a te P r e s e n t a t i o n I 8 ▪ 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 rapi
Slide 9: Phase 1 SAD & MAD Studies
2 0 2 0 C o r p o r a te P r e s e n t a t i o n I 9 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 • 3 Cohorts: 25, 50, 75 mg • N = 24 Study Conclusion
Slide 10: Phase 2 Study in Adjunctive Treatment of MDD – Overview
2020 Corporate Presentation I 10 Phase 2 Study in Adjunctive Treatment of MDD – Overview 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 Obje
Slide 11: Phase II Trial Design
MDD = Major Depressive Disorder; RDPC = randomized double - blind placebo controlled; MADRS = Montgomery - Asberg Depression Rating Scal 2 e; 020 Corporate Presentation I 1 1 Inpatient Days - 1 to 9 REL - 1017 Phase II Trial Design • 62 - patient, three - arm, placebo - controlled trial • 7 days dai
Slide 12: Phase 2 Study - Baseline Patient Characteristics
2020 Corporate Presentation I 12 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%) 2
Slide 13: Phase 2 Study Efficacy (MADRS)
2020 Corporate Presentation I 13 - 2 5 - 2 0 - 1 5 - 1 0 - 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 REL - 1017 Phase 2 Study
Slide 14: Phase 2 Study Efficacy Remission and Response Rates
2020 Corporate Presentation I 14 REL - 1017 Phase 2 Study Efficacy Remission Rates (MADRS <10 Points) Percent Subjects per ITT Group 14% 5% 32% 31% 33% 19% 0% 1 0 % 2 0 % 3 0 % 4 0 % 5 0 % 6 0 % PBO REL REL 25 mg 50 mg Day 7 24% 20% 42% 50% 57% 44% 0% 1 0 % 2 0 % 3 0 % 4 0 % 5 0 % 6 0 % PBO REL REL
Slide 15: Phase 2 Study Indicated Favorable Safety & Tolerability
2020 Corporate Presentation I 15 ▪ 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 psy
Slide 16: End of Phase 2 Meeting Outcome
2020 Corporate Presentation I 16 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 fro
Slide 17: End of Phase 2 Meeting Outcome: Dosing and Formulation
2020 Corporate Presentation I 17 D o s i n g : 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
Slide 18: Phase 3 Program for the Adjunctive Treatment of MDD
2020 Corporate Presentation I 18 REL - 1017 Phase 3 Program for the Adjunctive Treatment of MDD Initiated December 2020 • Two sister two - arm, placebo - controlled clinical studies in MDD pts with inadequate response to 1 - 3 ADT in current MDE • Primary Endpoint: Change in MADRS10 at Day 28 • Key
Slide 19: RELIANCE-I: Pivotal Phase 3 Trial
2020 Corporate Presentation I 19 Screening confirm MDE with inadequate response to 1 - 3 ADT ADT + 25 mg REL - 1017 ADT + Matching Placebo RELIANCE - I: Pivotal Phase 3 Trial • Primary Endpoint: Change in MADRS10 at Day 28 • Key Secondary Endpoints: • Change in MADRS10 score at Day 7 • Change in CGI
Slide 20: Dextromethadone Background and Abuse Potential Assessments
2020 Corporate Presentation I 20 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 2 assessments during in
Slide 21: Anticipated Development Timeline
2020 Corporate Presentation I 21 REL - 1017: Anticipated Development Timeline* Q4 2020 H1 2021 H2 2021 H1 2022 Adjunctive Treatment of Major Depressive Disorder (MDD) Major Depressive Disorder (MDD) RELIANCE - I: 1 st Pivotal Adjunctive MDD trial MDD Monotherapy P hase II *subject to FDA feedback In
Slide 22: Potential Competitive Advantages of Company Compound
2020 Corporate Presentation I 22 Potential Competitive Advantages of REL - 1017 Company Compound Mechanism of Action Delivery Dosing Stage Relmada REL - 1017 (dextromethadone) Novel NMDAR channel blocker with preferential activity for hyperactive, MDD - associated channels Oral Once Daily Phase 3 Ja
Slide 23: Corporate Information
2020 Corporate Presentation I 2 3 Corporate Information
Slide 24: Financial Overview
2020 Corporate Presentation I 24 Financial Overview Cash, Cash Equivalents & ST Investments (as of 09/30/20) $ 1 2 3. 1 million ~ 2 .7 million $ 1 2 .5 million ~ 16 .2 million Warrants Outstanding (as of 09/30/20, weighted average exercise price, $7.81) Operating Cash Burn 3Q20 Common Shares Outstan
Slide 25: Management Team and Key Scientific Advisors
2020 Corporate Presentation I 25 Management Team and Key Scientific Advisors M a n a g em e n t 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 Sheno
Slide 26: Scientific Advisors
2020 Corporate Presentation I 26 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
Slide 27: Key Catalysts Expected Over Next 12-18 Months
2020 Corporate Presentation I 27 • 1H21 – Start of second pivotal Phase III adjunctive MDD trial • 1H21 – Start of Phase 2 monotherapy MDD trial • 2Q21 – Results of human abuse potential studies • 4Q21 – Results of Phase 2 monotherapy MDD trial • 1H22 – Results of Phase III adjunctive MDD trials Key
Slide 28: Investment Highlights
2020 Corporate Presentation I 28 • Novel MOA with successful Phase 2 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 tra
Slide 29: Back Up
2020 Corporate Presentation I BACK UP Dec 2020 I Nasdaq: RLMD
Slide 30: Phase 2 Study Key Efficacy Findings
2020 Corporate Presentation I 30 Study REL - 1017 Phase 2 Key Efficacy Findings 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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