Relmada Therapeutics, Inc. · NASDAQ:RLMD
Relmada Therapeutics — Investor Presentation (November 2022)
23 slides from Relmada Therapeutics's investor presentation, Nov 14, 2022
Slide 1: Targeting Major Advances in Treatment of CNS Disorders
Targeting Major Advances in Treatment of CNS Disorders November 11th , 2022 I Nasdaq: RLMD 1
Slide 2: Disclosures
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 - lookin g statements.” These statem
Slide 3: Investment Highlights
Investment Highlights Highly Compelling Opportunity in REL - 1017 Multiple Catalysts Expected Over the Next 12 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 ye
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 • People of all ages suffer
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. Ashto
Slide 7: Unique Profile of Potential as a rapid, oral, once-daily antidepressant for MDD
Unique Profile of REL - 1017 7 Potential as a rapid, oral, once - daily antidepressant for MDD, if approved MDD = major depressive disorder; NMDAR = N - methyl - D - aspartate receptor *Diagram reflects chemical structure of REL - 1017 ( esmethadone ); molecules are CH 3 = Methyl Group, O = Oxygen,
Slide 8: Phase 1 & 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, MADRS change vs. placebo
Phase 2 Study REL - 1017: Primary Efficacy Endpoint 10 REL - 1017 showed rapid and sustained differences in MADRS change vs. placebo Day 2 Day 4 Day 7 Day 14 5 0 - 5 - 25 Least - Square Mean Change in MADRS - 10 - 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.
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 • 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 treatment groups vs placebo • No evidence of treatm
Slide 13: Phase 2 Study Safety: Treatment Emergent Adverse Events
REL - 1017 Phase 2 Study Safety: Treatment Emergent Adverse Events 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 serious adverse event 0 0.0 0 0.0 0 0.0 0 0.0 Patients with a severe treatment - emergent adverse event 0
Slide 14: Abuse potential studies and DEA statement
14 The results of experimental studies predictive of human abuse potential 1 and the results of human abuse potential studies in recreational opioid users 2 and in recreational ketamine users 3 indicate no meaningful abuse potential and support the DEA statement below: “The d - isomer lacks signific
Slide 15: Reliance: The Phase 3 Program
Reliance: The Phase 3 Program for REL - 1017
Slide 16: Phase 3 Program for the Treatment of MDD
REL - 1017 Phase 3 Program for the Treatment of MDD 16 Two sister two - arm, placebo - controlled pivotal studies in patients with MDD and inadequate response to ongoing standard antidepressant treatment: • In MDD patients with inadequate response to 1 - 3 ADT • Primary Endpoint: Change in MADRS at
Slide 17: Pivotal Phase 3 Trial Design
Screening confirms MDE with inadequate response to 1 - 3 ADT ADT + 25 mg REL - 1017 ADT + Matching Placebo Pivotal Phase 3 Trial Design for patients with MDD and inadequate response to ongoing standard antidepressant treatment: 17 1:1 randomization 28 Days of Dosing (QD) Follow - Up Assessments & RE
Slide 18: Relmada Development Programs & Timeline
Relmada Development Programs & Timeline* 18 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 qua rters Program 1Q 22 2Q 22 3Q 22 4Q 23 1H 23 REL - 1017 RELIANCE I: 1st P
Slide 19: Neuroplastogen Program
Neuroplastogen TM Program
Slide 20: 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 20 We are developing a novel psilocybin formulation and we are synthetizing psilocybin derivatives with promising therapeutic activity We have synthesized a series of novel esmethadone deriv
Slide 21: Corporate Information
B Corporate Information
Slide 22: Financial Overview
Financial Overview Cash, Cash Equivalents & Short - Term Investments (as of 09/30/2022) $184.2 million Warrants Outstanding (as of 09/30/22, weighted average exercise price, $11.50) ~4.5 million Operating Cash Burn 2Q22 $26.9 million Common Shares Outstanding** (as of 11/7/2022) ~30.1 million 22 **A
Slide 23: Investment Highlights
Investment Highlights Highly Compelling Lead Product Opportunity in REL - 1017 Key Catalysts Expected Over the Next 12 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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