Relmada Therapeutics, Inc. · NASDAQ:RLMD
Relmada Therapeutics — Investor Presentation (February 2022)
30 slides from Relmada Therapeutics's investor presentation, Feb 23, 2022
Slide 1: Targeting Major Advances in Treatment of CNS Disorders
Targeting Major Advances in Treatment of CNS Disorders February 23, 2022 I Nasdaq: RLMD 1
Slide 2: Disclosures
D i sc l o s u r e s 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
Investment Highlights Highly Compelling Opportunity in REL - 1017 Multiple Catalysts Expected Over Next 18 Months CNS Focus with Lead Program in Major Depressive Disorder (MDD) CNS= Central Nervous System **Our fiscal year end is December 31. The periods referred to in this slide are calendar years
Slide 4: Major Depressive Disorder
Major Depressive Disorder & REL - 1017
Slide 5: Prevalence of Depression
Prevalence of Depression ~ 10M • 50% of patients in the US experiencing a major depressive episode in the last year received medication treatment 1 • 40% require combination Rx 2 ~ 19 . 3M • Individual adults in the US had at least one major depressive episode in 2019 1 > 280M from depression, globa
Slide 6: Limitations of Current Treatments for MDD
Limitations of Current Treatments for MDD ~65% MDD patients do not respond to first antidepressant treatment 1 Standard antidepressants, even when effective, may take up to 8 weeks to reach efficacy 1 MDD = major depressive disorder 1. Trivedi MH, et al. Am J Psychiatry. 2006;163:28 - 40; 2. Ashton
Slide 7: Unique Profile of REL-1017
Unique Profile of REL - 1017 7 Potential as a rapid, oral, once - daily antidepressant for MDD, if approved REL - 1017 * CH 3 CH 3 CH 3 O N 3 H C • Orally administered, once - daily tablet MDD = major depressive disorder; NMDAR = N - methyl - D - aspartate receptor *Diagram reflects chemical structu
Slide 8: Phase 2 Efficacy & Safety Data
REL - 1017 Ph 1 & 2 Efficacy & Safety Data
Slide 9: Phase 1 SAD & MAD Studies, Data Published 2019
Phase 1 SAD & MAD Studies for REL - 1017, Data Published 2019 PK = pharmacokinetics; PD = pharmacodynamics; MTD: =maximum tolerated dose; C max = maximum plasma concentration ; AUC 0 - inf = area under the curve 0 to infinite time; AUC t = area under the curve to the end of dosing period; N = number
Slide 10: Phase 2 Study: Primary Efficacy Endpoint
D a y 2 D a y 4 D a y 7 D a y 1 4 5 0 - 5 - 25 Least - Square Mean Change in MADRS - 15 - 20 P=0.0103; d=0.9 P=0.0039; d=1.0 P=0.0308; d=0.7 P=0.0122; d=0.8 P=0.0096; d=0.8 P=0.0087; d=0.9 P= 0 . 9092 ; d=0.0 P= 0 . 4340 ; d=0.3 - 10 Placebo REL - 1017 25 mg REL - 1017 50 mg Phase 2 Study REL - 1017
Slide 11: Phase 2 Study Efficacy: Response & Remission
REL - 1017 Phase 2 Study Efficacy: Response & Remission % of Subjects Achieving Remission (MADRS ≤10) Percent Subjects per ITT Group % of Subjects Achieving Response (≥ 50% MADRS Improvement from Baseline) 11 Day 14: last efficacy assessment, 7 days after last dose of study drug MADRS=Montgomery - A
Slide 12: Safety & Tolerability Findings from Phase 2
Safety & Tolerability Findings from Phase 2 Safety & Tolerability Comparable to Placebo • Only Mild and Moderate transient AEs – no SAEs • No increased prevalence of specifically relevant organ group AEs in treatment groups vs placebo • No evidence of opiate effects or withdrawal symptoms in treatme
Slide 13: Phase 2 Study Safety: Treatment Emergent Adverse Events
REL - 1017 Phase 2 Study Safety: Treatment Emergent Adverse Events Treatment - emergent adverse events by preferred term in patients with MDD in the safety analysis set * Variable Placebo (N = 23) REL - 1017 25 mg (N=19) REL - 1017 50 mg (N=21) All Patients (N = 62) N % N % N % N % Patients with a s
Slide 14: Human Abuse Potential (HAP) Studies: vs. Oxycodone vs. Ketamine
Human Abuse Potential (HAP) Studies: REL - 1017 vs. Oxycodone REL - 1017 vs. Ketamine
Slide 15: Human Abuse Potential (HAP) Studies
Human Abuse Potential (HAP) Studies of REL - 1017 15 HAP Studies, per FDA’s Guidance for Industry 1 : The HAP Program for REL - 1017 includes two studies: • Mu Opioid Agonist HAP • Oxycodone as active control • Completed in July 2021 • NMDA Receptor Antagonist HAP • Ketamine as active control • Comp
Slide 16: HAP Studies vs. Oxycodone
Human Abuse Potential (HAP) Studies of REL - 1017 vs. Oxycodone Primary endpoint, Drug Liking (Emax) Completer Population* • All REL - 1017 doses including 150 mg (6x therapeutic dose and MTD) were statistically different from oxycodone 40 mg (p<0.05) • All REL - 1017 doses including 150 mg (6x ther
Slide 17: Primary Endpoint: Drug Liking vs. Oxycodone
Primary Endpoint – “Drug Liking at This Moment” [Emax] REL - 1017 vs. Oxycodone, Completer Population* Statistic Parameter Placebo REL - 1017 25 mg REL - 1017 75 mg REL - 1017 150 mg Oxyc odon e 40 mg n 47 47 47 47 47 Mean 52.7 54.2 58.7 64.9 83.2 Median 50 50 50 58 85 SD 6.52 10.35 15.82 16.58 16.5
Slide 18: HAP Studies vs. IV Ketamine
Human Abuse Potential (HAP) Studies of REL - 1017 vs. IV Ketamine, Primary endpoint, Drug Liking (Emax) Completer Population* • All REL - 1017 doses including 150 mg (6x therapeutic dose and MTD) were statistically different from IV ketamine 0.5 mg/Kg (p<0.05) • All REL - 1017 doses including 150 mg
Slide 19: Primary Endpoint: Drug Liking vs. IV Ketamine
Primary Endpoint – “Drug Liking at This Moment” [Emax] REL - 1017 vs. IV Ketamine, Completer Population Statistic Parameter Placebo REL - 1017 25 mg REL - 1017 75 mg REL - 1017 150 mg Ketamine 0.5mg/Kg n 51 51 51 51 51 Mean 50.9 51.4 54.9 59.2 90 Median 50 50 50 51 100 SD 2.23 3.28 9.58 14.38 14.52
Slide 20: Results support DEA conclusion of no meaningful abuse liability
These results support the DEA conclusion that REL - 1017 has no meaningful abuse liability 20 “ The d - isomer lacks significant respiratory depressant action and addiction liability.. .” US Drug Enforcement Administration December 2019 1 1.US DEA Statement on Methadone, December 2019 https:// www.d
Slide 21: RELIANCE: The Phase 3 Program
RELIANCE: The P hase 3 P r og r am for REL - 1017
Slide 22: Phase 3 Program for the Treatment of MDD
REL - 1017 Phase 3 Program for the Treatment of MDD 22 MDD = major depressive disorder; ADT = antidepressant treatment ; OLS = open label study; MADRS = Montgomery - Asberg Depression Rating Scale; CGIs = Clinical Global Impression scales; MDE = major depressive episode Two sister two - arm, placebo
Slide 23: Pivotal Phase 3 Trial Design for Adjunctive Therapy
Screening confirms MDE with inadequate response to 1 - 3 ADT ADT + 25 mg REL - 1017 ADT + Matching Placebo Pivotal Phase 3 Trial Design for Adjunctive Therapy 23 1:1 randomization (n= ~364) 28 Days of Dosing (QD) Follow - Up Assessments & RELIANCE - OLS SAFER Interview* D 1 Start D o s ing D 4 D 7 D
Slide 24: Pivotal Phase 3 Trial Design for Monotherapy
Screening confirms ≤ 1 prior use of ADT for current MDE 25 mg REL - 1017 Matching Placebo Pivotal Phase 3 Trial Design for Monotherapy 24 Primary Endpoint: • Change in MADRS at Day 28 Key Secondary Endpoints: • Change from baseline in CGI - S score at Day 28 • Change from baseline in MADRS score at
Slide 25: Relmada Development Programs & Timeline
Relmada Development Programs & Timeline* 25 MDD = Major Depressive Disorder; OLS = Open Label Study *Subject to FDA feedback **Our fiscal year end is December 31. The periods referred to in this slide are calendar years and quarters P r og r a m 4Q 21 1Q 22 2Q 22 3Q 22 4Q 22 REL - 1017 RELIANCE I: 1
Slide 26: Neuroplastogen Program
Ne u r oplas t og e n TM Program
Slide 27: Pipeline of molecules with neural plasticity modulating activity
We have a pipeline of molecules with neural plasticity modulating activity for the treatment of CNS disorders 27 We are developing a novel psilocybin formulation and we are synthetizing psilocybin derivatives with promising activity for the treatment of CNS disorders We have synthesized a series of
Slide 28: Corporate Information
B Corporate Information
Slide 29: Financial Overview
Financial Overview Cash, Cash Equivalents & Short - Term Investments* (as of 9/30/2021) $88.1 milli on Warrants Outstanding (as of 9/30/21, weighted average exercise price, $16.08) ~3.2 million Operating Cash Burn 3Q21 $21.0 milli on Common Shares Outstanding** (as of 9/30/2021) ~17.5 milli on 29 *
Slide 30: Investment Highlights
Investment Highlights Highly Compelling Lead Product Opportunity in REL - 1017 Key Catalysts Expected Over Next 3 - 18 Months Focus on CNS diseases and Lead Program in Major Depressive Disorder (MDD) CNS= Central Nervous System;; MDD = major depressive disorder; MOA = mechanism of action **Our fisca
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