Relmada Therapeutics, Inc. · NASDAQ:RLMD
Relmada Therapeutics — Investor Presentation (November 2021)
26 slides from Relmada Therapeutics's investor presentation, Nov 23, 2021
Slide 1: Targeting Major Advances in Treatment of CNS Disorders
Targeting Major Advances in Treatment of CNS Disorders November 23, 2021 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 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 • 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 take 2 - 8 weeks to reach efficacy 1 MDD = major depressive disorder 1. Trivedi MH, et al. Am J Psychiatry. 2006;163:28 - 40; 2. Ashton AK, et al. Curr Ther Res.
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 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
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=0.8 P=0.0087; d=0.9 P=0.9092; d=0.0 P=0.4340; d=0.3 Placebo REL - 1017 25 mg REL - 1017 50 mg Phase 2 Study REL - 1017: Primary Efficac
Slide 11: Safety & Tolerability Findings from Phase 2
Safety & Tolerability Findings from Phase 2 • Only Mild and Moderate 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 treatment - indu
Slide 12: Human Abuse Potential (HAP) Study vs. Oxycodone
Human Abuse Potential (HAP) Study of REL - 1017 vs. Oxycodone
Slide 13: Human Abuse Potential (HAP) Study
Human Abuse Potential (HAP) Study of REL - 1017 13 HAP Studies, per FDA’s Guidance for Industry 1 : The HAP Program for REL - 1017 includes two studies: 1 Assessment of Abuse Potential of Drugs Guidance for Industry 2017 https:// www.fda.gov /media/116739/download • Typically required for CNS - acti
Slide 14: US DEA Statement for Methadone and Pharmacologic Role of Isomers
US DEA Statement for Methadone and Pharmacologic Role of Isomers 14 July 2019 “Analgesic activity of racemic methadone is entirely due to its l - isomer, 8 to 50 times more potent than d - isomer. The d - isomer lacks significant respiratory depressant action and addiction liability, but possesses a
Slide 15: Human Abuse Potential Study vs Oxycodone: Top-line Results Summary
Human Abuse Potential (HAP) Study of REL - 1017 vs Oxycodone • All REL - 1017 doses tested showed highly statistically significant differentiation vs. oxycodone 40 mg (p<0.001) • REL - 1017 therapeutic doses did not differ significantly from placebo • Key secondary endpoint results were consistent w
Slide 16: Primary Endpoint - Drug Liking [Emax] vs. Oxycodone
Primary Endpoint - Drug Liking [Emax] REL - 1017 vs. Oxycodone Statistic Parameter Placebo REL - 1017 25 mg REL - 1017 75 mg REL - 1017 150 mg Oxycodone 40 mg n 44 44 44 44 44 Mean 51.7 53 58.2 64.9 85 Median 50 50 50 58 89 SD 4.28 8.67 14.98 16.74 15.4 SE 0.64 1.31 2.26 2.52 2.32 Treatment 1 Treatm
Slide 17: RELIANCE: The Phase 3 Program
RELIANCE: The Phase 3 Program for REL - 1017
Slide 18: Phase 3 Program for the Treatment of MDD
REL - 1017 Phase 3 Program for the Treatment of MDD 18 Two sister two - arm, placebo - controlled pivotal studies as adjunctive treatment for MDD: • In MDD patients with inadequate response to 1 - 3 ADT (n= ~364 per study) • Primary Endpoint: Change in MADRS at Day 28 • Key Secondary Endpoints: • Ch
Slide 19: 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 19 1:1 randomization (n= ~ 364 ) 28 Days of Dosing (QD) Follow - Up Assessments & RELIANCE - OLS SAFER Interview* D 1 Start Dosing D 4 D 7 D
Slide 20: 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 20 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 21: Relmada Development Programs & Timeline
Relmada Development Programs & Timeline* 21 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 4Q 21 1Q 22 2Q 22 3Q 22 4Q 22 REL - 1017 RELIANCE - III: M
Slide 22: Novel Psilocybin and Derivatives
Novel Psilocybin and Derivatives
Slide 23: Novel Psilocybin and Derivatives
Novel Psilocybin and Derivates • July 2021 announcement of licensing agreement: development and commercial rights to a novel psilocybin and derivatives program • Complementary focus: potential therapies for neurodegenerative conditions • Synergy in neuroplasticity: Expands R&D portfolio while buildi
Slide 24: Corporate Information
B Corporate Information
Slide 25: Financial Overview
Financial Overview Cash, Cash Equivalents & Short - Term Investments (as of 9/30/2021) $88.1 million Warrants Outstanding (as of 9/30/21, weighted average exercise price, $16.08) ~3.2 million Operating Cash Burn 3Q21 $ 21.0 million Common Shares Outstanding* (as of 9 /30/2021) ~17.5 million 25 *As c
Slide 26: 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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