Relmada Therapeutics, Inc. · NASDAQ:RLMD
Relmada Therapeutics — Investor Presentation (December 2021)
26 slides from Relmada Therapeutics's investor presentation, Dec 20, 2021
Slide 1: Targeting Major Advances in Treatment of CNS Disorders
Relmada o~ THERAPEUTICS \ A Targeting Major Advances in Treatment of CNS Disorders December 20, 2021 | Nasdaq: RLMD
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-looking statements.” These statement
Slide 3: Investment Highlights
Investment Highlights CNS Focus with Lead Program in Major Depressive Disorder (MDD) Highly Compelling Opportunity in REL-1017
Slide 4: Major Depressive Disorder & REL-1017
B Major Depressive Disorder & REL-1017
Slide 5: Prevalence of Depression
Prevalence of Depression
Slide 6: Limitations of Current Treatments for MDD
Limitations of Current Treatments for MDD Safety & Tolerability Challenges Slow Onset of Action Limited Efficacy ~65% MDD patients do not Standard antidepressants Risks for atypical antipsychotics respond to first antidepressant take 2-8 weeks to reach approved as adjunctive treatment! efficacy’ tre
Slide 7: Unique Profile of REL-1017
Unique Profile of REL-1017 Potential as a rapid, oral, once-daily antidepressant for MDD, if approved * Novel Mechanism of Action: preferential targeting of NMDAR channels potentially associated with MDD‘ * Available clinical data demonstrated: + Robust, rapid, and sustained statistically significan
Slide 8: REL-1017 Phase 1 & 2 Efficacy & Safety Data
B REL-1017 Ph 1 & 2 Efficacy & Safety Data
Slide 9: Phase 1 SAD & MAD Studies for REL-1017, Data Published 2019
Phase 1 SAD & MAD Studies for REL-1017, Data Published 2019 Single Ascending Dose (SAD) Study Design Multiple Ascending Dose (MAD) Study Design Parallel group, double-blind, placebo controlled Parallel group, double-blind, placebo controlled Objectives Objectives Establish PK, PD, and safety of Esta
Slide 10: Phase 2 Study REL-1017: Primary Efficacy Endpoint
Phase 2 Study REL-1017: Primary Efficacy Endpoint REL-1017 showed rapid and sustained differences in MADRS change vs. placebo Placebo 4 REL-1017 25mg @ REL-1017 50mg 10 P=0,0096; d=0.8 P=0,0087; d=0. 18 P=0.0308; d=0.7 Least-Square Mean Change in MADRS P=0.0122; d=0. 20 28 Day2 Day 4 Day7 Day 14 (MA
Slide 11: Safety & Tolerability Findings from Phase 2
Safety & Tolerability Findings from Phase 2 Safety & Tolerability Comparable to Placebo ° 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
Slide 12: Human Abuse Potential (HAP) Study of REL-1017 vs. Oxycodone
B Human Abuse Potential (HAP) Study of REL-1017 vs. Oxycodone
Slide 13: Human Abuse Potential (HAP) Study of REL-1017
Human Abuse Potential (HAP) Study of REL-1017 HAP Studies, per FDA’s Guidance for Industry’: * Typically required for CNS-active drugs * Should be conducted in experienced recreational drug users + Use standardized questionnaires at specific timepoints + Positive controls should be FDA-approved cont
Slide 14: US DEA Statement for Methadone and Pharmacologic Role of Isomers
US DEA Statement for Methadone and Pharmacologic Role of Isomers July 2019 “Analgesic activity of racemic methadone is entirely due to its /- isomer, 8 to 50 times more potent than d-isomer. The d-isomer lacks significant respiratory depressant action and addiction liability, but possesses antitussi
Slide 15: Human Abuse Potential (HAP) Study of REL-1017 vs Oxycodone
Human Abuse Potential (HAP) Study of REL-1017 vs Oxycodone Top-line Results Summary ¢ 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 result
Slide 16: Primary Endpoint - Drug Liking [Emax]
Primary Endpoint - Drug Liking [Emax] REL-1017 vs. Oxycodone Statistic Parameter Placebo Ber ON bee 44 44 44 Mean 51.7 53 58.2 64.9 85 Median 50 50 50 58 89 sD 4.28 867 14.98 16.74 15.4 SE 0.64 1.31 2.26 262 2.32 Statistical Analysis Treatment 4 Treatment 2 P-value ‘Oxycodone 40 mg Placebo <0.001 Ox
Slide 17: RELIANCE: The Phase 3 Program for REL-1017
B RELIANCE: The Phase 3 Program for REL-1017
Slide 18: REL-1017 Phase 3 Program for the Treatment of MDD
REL-1017 Phase 3 Program for the Treatment of MDD - Reliance | - Reliance II ‘Two sister two-arm, placebo-controlled pivotal studies as adjunctive treatment for MDD: + In MDD patients with inadequate response to 1-3 ADT (a2 =368 per study) Ne OP + Primary Endpoint: Change in MADRS at Day 28 + Key Se
Slide 19: Pivotal Phase 3 Trial Design for Adjunctive Therapy - Reliance I
Pivotal Phase 3 Trial Design for Adjunctive Therapy = Reliance! D Reliance II Primary Endpoint: * Change in MADRS at Day 28 28 Days of Dosing (QD) Key Secondary Endpoints: * Change in MADRS score at Day 7 + Change in CGI-S score at Day 28 ADT + 25 mg REL-1017 Follow-Up Assessments & RELIANCE-OLS ‘Sc
Slide 20: Pivotal Phase 3 Trial Design for Monotherapy - Reliance III
Pivotal Phase 3 Trial Design for Monotherapy - Reliance III Primary Endpoint: * Change in MADRS at Day 28 28 Days of Dosing (@D) Key Secondary Endpoints: * Change from baseline in CGI-S score at Day 28 25 mg REL-1017 * Change from baseline in MADRS score at Day 7 Follow-Up Assessments & RELIANCE-OLS
Slide 21: Relmada Development Programs & Timeline
Relmada Development Programs & Timeline* Program Human Abuse Potential vs. Ketamine RELIANCE-III: MDD Monotherapy REL-1017 RELIANCE |: 1st RELIANCE II: 2nd Pivotal Adjunctive MDD RELIANCE-OLS: Long-Term, Open-Label Study in MDD a
Slide 22: Novel Psilocybin and Derivatives
B Novel Psilocybin and Derivatives
Slide 23: Novel Psilocybin and Derivates
Novel Psilocybin and Derivates Rights to Co-Develop and Commercialize ¢ 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 neuroplastic
Slide 24: Corporate Information
B Corporate Information
Slide 25: Financial Overview
Financial Overview Cash, Cash Equivalents Warrants Outstanding Common Shares Outstanding Operating & Short-Term Investments’ Cash Burn 3Q21 million 4 fering which closed on 12/14 nd does not include 10.1 milion shares from an equity offering which closed on 12/14/2021 2
Slide 26: Investment Highlights
Investment Highlights Focus on CNS diseases and Lead Program in Major Depressive Disorder (MDD) : Highly Compelling Lead Product Opportunity in REL-1017 i Key Catalysts Expected Over Next 3-18 Months g REL-1017, lead candidate, is in Phase 3 for depression, a leading cause of disability worldwide" C
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