Relmada Therapeutics, Inc. · NASDAQ:RLMD
Relmada Therapeutics — Investor Presentation (January 2021)
30 slides from Relmada Therapeutics's investor presentation, Jan 7, 2021
Slide 1: Targeting Major Advances in Treatment of CNS Disorders
be Relmada THERAPEUTICS Targeting Major Advances in Treatment of CNS Disorders January 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 Highly-compelling de- risked lead product opportunity Key catalysts expected over next 3-18 months of Relmada +. nips:nm.who.invnews-roonviact-sheets/detaldepression THERAPEUTICS — 2. _hitps:/iwww.ncbi.nlm.nih.gov/pmc/articles/PMC3363299) Depression remains the leading cause of
Slide 4: REL-1017 as a Potential Treatment for Depression
REL-1017 as a Potential Treatment for Depression Relmada THERAPEUTICS
Slide 5: REL-1017: A Novel, Selective NMDAR Blocker being developed for MDD
REL-1017: A Novel, Selective NMDAR Blocker being developed for MDD Potentially significantly differentiated profile = Potential to be the first rapid-acting, oral, once-daily antidepressant treatment = Completed Phase 1 trials and Phase 2 for Adjunctive Treatment of MDD = Ina Phase 2 trial, both dos
Slide 6: Major Depressive Disorder (MDD) Market: Large, Debilitating, Underserved
Major Depressive Disorder (MDD) Market: Large, Debilitating, Underserved 50% of MDD patients receive medication treatment! Individuals in 2017 with at least 1 MDE episode’ ~17M U.S. 9 @ Relmada | SA'S nipsiimausinh nh, goubeathstatsicsinair depression shin text-The%s20preralnce 20 2omalor20depessve%
Slide 7: Significant Limitations Characterize Current Standard of Care in MDD
Significant Limitations Characterize Current Standard of Care in MDD * ~65% MDD patients do not respond to first antidepressant treatment * ~30% MDD patients do not respond to up to 4 different antidepressant treatments * Standard antidepressants take 4-6 weeks to reach efficacy * Sleep disturbance,
Slide 8: REL-1017: A Novel NMDAR Channel Blocker with Preferential Activity
REL-1017: A Novel NMDAR Channel Blocker with Preferential Activity = 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 treat
Slide 9: Phase 1 SAD & MAD Studies Data Published 2019
Phase 1 SAD & MAD Studies Data Published 2019 Multiple Ascending Dose (MAD) Study Design Parallel group, double-blind, placebo controlled Objectives Objectives E lish PK, PD fety of ily, 1 inistrati Establish PK, PD and safety of single dose administration SEIS , ENR CCIEOGENY Wek celntiistenten Tre
Slide 10: Phase 2 Study in Adjunctive Treatment of MDD — Overview
Phase 2 Study in Adjunctive Treatment of MDD — Overview Primary Objectives Secondary Objectives Safety and tolerability of 25 mg and 50 mg of REL-1017 vs Evaluate efficacy of 25 mg and 50 mg of REL-1017 as adjunctive placebo as adjunctive treatment treatment in patients with MDD To characterize phar
Slide 11: REL-1017 Phase II Trial Design
REL-1017 Phase II Trial Design N= 62 * 62-patient, three-arm, placebo-controlled trial * 7 days daily treatment in clinic + 7 days observation as outpatient * Follow up at Day 14 for efficacy and safety * Follow up at Day 21 for safety only Dosing Days 1 to 7 Days -30 to -2 Days 8 to 14 Days 15-21 R
Slide 12: REL-1017 Phase 2 Study - Baseline Patient Characteristics
REL-1017 Phase 2 Study - Baseline Patient Characteristics 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%)
Slide 13: REL-1017 Phase 2 Study Efficacy (MADRS)
REL-1017 Phase 2 Study Efficacy (MADRS) Statistically Significant Difference -@-Placebo —t-REL-1017 25mg @—REL-1017 50mg -10 =/0.0096; d = 0.8 1 P= 0.0103; d= 0.9 P = 0.0087; d=0.9 Least-Square Mean Change 20 P= 0.0122; d=0.8 P = 0.0039; d= 1.0 -25 Day 2 Day 4 Day 7 Day 14 o_@ Relmada THERAPEUTICS M
Slide 14: REL-1017 Phase 2 Study Efficacy
REL-1017 Phase 2 Study Efficacy Response Rates Remission Rates (>50% Change vs. Baseline) (MADRS <10 Points) 60% 57% 60% 3 tl 50% 2 50% 5 % 5 42% _ sox 40% 4 0, ey 32% 31% 33% 2 30% 30% | 2 24% 2 20% 19% D 2% 20% = 3 % & 10% 10% 5% 2% |_| PBO REL REL PBO REL REL REL REL PBO REL REL 25mg 50mg 25mg 50
Slide 15: REL-1017 Phase 2 Study Safety & Tolerability
REL-1017 Phase 2 Study Indicated Favorable Safety & Tolerability, Consistent with Phase 1 = 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
Slide 16: End of Phase 2 Meeting Outcome
End of Phase 2 Meeting Outcome REL-1017 can advance into Phase 3 registration studies w/o additional clinical studies. =D) FDA and Relmada are aligned on all key aspects of Phase 3 program to be initiated in Q4 ’20. rr +-——} Studies will assess REL-1017 as adjunctive treatment in MDD patients who ha
Slide 17: End of Phase 2 Meeting Outcome
End of Phase 2 Meeting Outcome EW REL-1017 can advance into Phase 3 registration studies w/o additional clinical studies. r |—} FDA and Relmada are aligned on all key aspects of Phase 3 program to be initiated in Q4 ’20. Dosing: Tablet formulation Equivalence Established: Abuse Liability Testing: 25
Slide 18: REL-1017 Phase 3 Program for the Adjunctive Treatment of MDD
REL-1017 Phase 3 Program for the Adjunctive Treatment of MDD Initiated December 2020 RELIANCE | RELIANCE II * 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 Secondary Endpoint
Slide 19: RELIANCE-I: Pivotal Phase 3 Trial
RELIANCE-I: Pivotal Phase 3 Trial RELIANCE | * Primary Endpoint: Change in MADRS10 at Day 28 * Key Secondary Endpoints: * Change in MADRS10 score at Day 7 * Change in CGI-S score at Day 28 28 Days of Dosin D. ADT + 25 mg REL-1017 Follow-Up Screening Assessments & confirm MDE with inadequate 1:1 rand
Slide 20: REL-1017 (dextromethadone): Abuse Potential Assessments
REL-1017 (dextromethadone) Background & Planned Assessments re: Abuse Potential ‘Analgesic activity of racemic methadone is entirely due to its I-isomer, 8 to 50 times more potent than d-isomer. The d-isomer lacks significant respiratory depressant action and addiction liability, but possesses antit
Slide 21: REL-1017: Anticipated Development Timeline
REL-1017: Anticipated Development Timeline* Indication RELIANCE-I: 1st Pivotal Adjunctive MDD trial Adjunctive Treatment of Major Depressive RELIANCE-II: 2"¢ Pivotal Adjunctive MDD trial Disorder (MDD) RELIANCE-OLS: Long-Term, Open-Label Study in MDD Major Depressive Disorder (MDD) MDD Monotherapy P
Slide 22: Potential Competitive Advantages of REL-1017
Potential Competitive Advantages of REL-1017 Company Compound Mechanism of Action REL-1017 Novel NMDAR channel blocker Relmada doxtr thad with preferential activity for hyperactive, ( omethadone) MDD.-associated channels Janssen/J&J STTEKENS NMDA Antagonist (esketamine) AXS-05 Multimodal Axsome (DM
Slide 23: Corporate Information
Corporate Information oe el Relmada THERAPEUTICS
Slide 24: Financial Overview
Financial Overview Cash, Cash Equivalents Warrants Outstanding Operating Common Shares & ST Investments (as of 09/30/20, weighted Cash Burn 3Q20 Outstanding (as of 09/30/20) average exercise price, $7.81) (as of 11/9/20) $12.5 million o_& Relmada
Slide 25: Management Team and Key Scientific Advisors
Management Team and Key Scientific Advisors Management Sergio Traversa Paolo Manfredi, MD Marco Pappagallo, MD Maged Shenouda Marc de Somer, MD, MBA, ScD, MPH, MSc Chuck Ence Molly Harper Chief Executive Officer Acting Chief Scientific Officer Acting Chief Medical Officer Chief Financial Officer SVP
Slide 26: Scientific Advisors
Scientific Advisors Advisors Maurizio Fava, MD, Chair GENERAL HOSPITAL HARVARD MEDICAL SCHOOL California Department of Stephen M. Stahl, MD State Hospital cz) MERCK Luca Pani, MD USHealth | sisters: & Thomas Laughren, MD EDA BROW Na Dan losifescu, MD, MSc NEW YORK UNIVERSITY Sanjay Johan Mathew, MD
Slide 27: Key Catalysts Expected Over Next 3-18 Months
Key Catalysts Expected Over Next 3-18 Months 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 R
Slide 28: Investment Highlights
Investment Highlights + Depression remains the leading cause of ill health and disability worldwide’ + 50%-66% of patients with depression do not fully recover on an antidepressant medication? + Standard anti-depressants can take 4-6 weeks to work, and have significant side-effects * The only FDA-ap
Slide 29: Back Up
Le Relmada THERAPEUTICS BACK UP * | “~, \ = \ te | Jan 20211 Nasdaq: RLMD A ; ~<
Slide 30: Study REL-1017 Phase 2 Key Efficacy Findings
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 < 0.03 and large effect sizes (0.7- 1.0) f
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