Relmada Therapeutics, Inc. · NASDAQ:RLMD

Relmada Therapeutics — Investor Presentation (January 2023)

35 slides from Relmada Therapeutics's investor presentation, Jan 9, 2023

  1. Slide 1: Targeting Major Advances in the Treatment of CNS Disorders

    Targeting Major Advances in the Treatment of CNS Disorders January 9, 2023 EXHIBIT 99.2

  2. Slide 2: Disclosures

    ©2023 Relmada - All rights reserved Disclosures 2 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 “forwar

  3. Slide 3: Investment highlights

    ©2023 Relmada - All rights reserved Investment highlights 3 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 and quarters. Highly compelling opportunity in REL - 1

  4. Slide 4: Major Depressive Disorder and Novel Mechanism of Action

    ©2023 Relmada - All rights reserved 4 Major Depressive Disorder and REL - 1017’s Novel Mechanism of Action

  5. Slide 5: Limitations of current treatments for MDD

    ©2023 Relmada - All rights reserved Limitations of current treatments for MDD 5 MDD = major depressive disorder 1.) Trivedi MH, et al. Am J Psychiatry. 2006;163:28 - 40; 2.) Ashton AK, et al. Curr Ther Res. 2005;66(2):97 - 106; 3.) US Prescribing Information, brexpiprazole, quetiapine, aripiprazole

  6. Slide 6: Prevalence of depression

    ©2023 Relmada - All rights reserved Prevalence of depression 6 ~10M Patients in the US treated for a major depressive episode in the last year 1 40% required 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 suffering fro

  7. Slide 7: Unique profile of REL-1017

    ©2023 Relmada - All rights reserved 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 1) Bettini E al. Pharmacological Comparative Characterization of REL - 1017 (Es

  8. Slide 8: Phase 2 Efficacy and Safety Data

    ©2023 Relmada - All rights reserved 8 REL - 1017 Phase 1 & 2 Efficacy and Safety Data

  9. Slide 9: Phase 1 SAD & MAD studies: safety and tolerability comparable to placebo

    ©2023 Relmada - All rights reserved Phase 1 SAD & MAD studies for REL - 1017 9 Safety & tolerability comparable to placebo APPROACH OBJECTIVES STUDY CONCLUSIONS Multiple Ascending Dose (MAD) study design Parallel group, double - blind, placebo controlled Establish PK, PD, and safety of single dose a

  10. Slide 10: Phase 2 primary efficacy endpoint: MADRS change vs. placebo

    ©2023 Relmada - All rights reserved Phase 2 study REL - 1017: primary efficacy endpoint REL - 1017 25 and 50 mg (Day 1 loading dose 75 and 100 mg, respectively) showed rapid and sustained differences in MADRS change vs. placebo 10 Least - Square Mean Change in MADRS 5 0 - 5 - 10 - 15 - 20 - 25 P=0.0

  11. Slide 11: Phase 2 study efficacy: response & remission

    ©2023 Relmada - All rights reserved REL - 1017 phase 2 study efficacy: response & remission 11 50% 44% 20% 0% 13% 25% 38% 50% 63% PBO REL 25 mg REL 50 mg Day 14 Percent Subjects per ITT Group Percentage of subjects achieving response (≥ 50% MADRS improvement from baseline) N = 20 16 18 31% 39% 0% 10

  12. Slide 12: Safety & tolerability findings from Phase 2

    ©2023 Relmada - All rights reserved Safety & tolerability findings from phase 2 12 • 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 gr

  13. Slide 13: The d-isomer lacks significant respiratory depressant action and addiction liability

    ©2023 Relmada - All rights reserved 13 “The d - isomer lacks significant respiratory depressant action and addiction liability...” US Drug Enforcement Administration December 2019 4 1.) Henningfield, et al. REL - 1017 (esmethadone; D - methadone) does not cause reinforcing effect, physical dependenc

  14. Slide 14: Reliance: The Phase 3 Program

    ©2023 Relmada - All rights reserved 14 Reliance: The Phase 3 Program for REL - 1017

  15. Slide 15: Phase 3 program design

    ©2023 Relmada - All rights reserved Randomized, two - arm, placebo - controlled pivotal study as a monotherapy treatment for patients with MDD. In patients experiencing an untreated MDE (patients receiving no ADT) Primary Endpoint: Change in MADRS at Day 28 Key Secondary Endpoints: • Change in CGI -

  16. Slide 16: Reliance I and Reliance III results overview

    ©2023 Relmada - All rights reserved Reliance I and Reliance III results overview 16 * Center - specific factors in these top - enrolling centers yielded paradoxical results: placebo robustly outperformed REL - 1017. The top enrolling center in Reliance III had a mean placebo response of 23 MADRS poi

  17. Slide 17: Pivotal Phase 3 trial design for monotherapy

    ©2023 Relmada - All rights reserved Pivotal phase 3 trial design for monotherapy 17 Follow - up assessments & Reliance OLS 1:1 RANDOMIZATION 28 DAYS OF DOSING (QD) Start dosing** D 1 D 4 D 7 D 14 D28 End of treatment D 21 25 mg REL - 1017 (Day 1 loading dose 75 mg) Placebo SAFER INTERVIEW* Screening

  18. Slide 18: Reliance III primary efficacy endpoint

    ©2023 Relmada - All rights reserved Reliance III primary efficacy endpoint: REL - 1017 showed non - significant difference in MADRS vs placebo at Day 28 18 MADRS (N=232) Placebo N=116, 25 mg N=116, 45 sites Day 4 Day 7 Day 14 Day 21 Day 28 End of treatment Placebo Mean (SD) - 8.5, (8.9) - 9.2 (9.5)

  19. Slide 19: Reliance III response and remission

    ©2023 Relmada - All rights reserved Percent Subjects per ITT Group In Reliance III 39% of subjects achieved response and 22% achieved remission with 25 mg REL - 1017 in the full analysis set 19 N= 35% 39% 0% 10% 20% 30% 40% Percentage of subjects achieving response (≥ 50% MADRS improvement from base

  20. Slide 20: Reliance III: modified analysis removing four sites

    ©2023 Relmada - All rights reserved Reliance III: REL - 1017 showed a meaningful - 4.1 MADRS point difference vs. placebo at Day 28 with removal of four sites with paradoxical results 20 *These same two centers produced non - plausible results in Reliance I Day 28: last efficacy assessment Total N=1

  21. Slide 21: Pivotal Phase 3 trial design for adjunctive therapy

    ©2023 Relmada - All rights reserved Pivotal phase 3 trial design for adjunctive therapy 21 Primary endpoint: • Change in MADRS at Day 28 Key secondary endpoints: • Change in MADRS score at Day 7 • Change in CGI - S score at Day 28 Follow - up assessments & Reliance OLS 1:1 RANDOMIZATION 28 DAYS OF D

  22. Slide 22: Reliance I primary efficacy endpoint

    ©2023 Relmada - All rights reserved 22 Day 28: last efficacy assessment Total N=227 ; * p= <0.05 MADRS=Montgomery - Asberg Depression Rating Scale; Source: Relmada Data on File MADRS (N=227) Placebo N=114, 25 mg N=113, 43 sites Day 4 Day 7 Day 14 Day 21 Day 28 End of Treatment Placebo Mean (SD) - 9.

  23. Slide 23: Reliance I response and remission rates

    ©2023 Relmada - All rights reserved Percentage of subjects achieving response (≥ 50% MADRS improvement from baseline) Reliance I achieved a statistically significant response rate of 40% (p=0.044), and achieved remission rate of 22% (p=0.076) at Day 28 in the full analysis set 23 N= 0% 10% 20% 30% 4

  24. Slide 24: Reliance I: post-hoc removal of two sites

    ©2023 Relmada - All rights reserved 24 Reliance I: REL - 1017 vs placebo with post - hoc removal of two sites with paradoxical results - 4.1 diff. REL - 1017 vs. placebo MADRS (N=185) Placebo N=88, 25 mg N=97, 41 sites Day 4 Day 7 Day 14 Day 21 Day 28 End of Treatment Placebo Mean (SD) - 8.5 (7.0) -

  25. Slide 25: Robust safety profile, no abuse potential or dissociative effects

    ©2023 Relmada - All rights reserved REL - 1017 displays a robust safety profile and confirms no evidence for abuse potential or dissociative effects across studies 25 1.) C - SSRS: Columbia Suicide Severity Rating Scale; 2.) CADDS: Clinician - Administered Dissociative States Scale; 3.) SOWS: Subjec

  26. Slide 26: Reliance I adverse events

    ©2023 Relmada - All rights reserved In Reliance I no serious treatment related treatment - emergent adverse event (TEAE) and no opioid like effects were observed 26 Variable Placebo (N=114) REL - 1017 25 mg (N=113) All patients (N=227) N % N % N % Patients with at least one TEAE 61 53.5 55 48.7 116

  27. Slide 27: Reliance III adverse events

    ©2023 Relmada - All rights reserved In Reliance III no serious treatment related treatment - emergent adverse event (TEAE) and no opioid like effects were observed 27 *Treatment - emergent adverse event was defined as an adverse event that started or worsened after treatment with the trial drug Trea

  28. Slide 28: Focus and action for ongoing and new studies

    ©2023 Relmada - All rights reserved Focus and action for ongoing and new studies 28 Clinical trial management MADRS=Montgomery - Asberg Depression Rating Scale ADT =Antidepressant Patient selection Site selection • Requirement for medical/pharmacy records to confirm an existing depression diagnosis

  29. Slide 29: Path to NDA

    ©2023 Relmada - All rights reserved Path to NDA 29 All non - clinical & phase 1 studies completed All Human Abuse Potential studies (HAPs) completed ~40% NDA submission readiness Stability testing of primary packaging completed and production at scale validated Considerable safety data collected fro

  30. Slide 30: Neuroplastogen Program

    ©2023 Relmada - All rights reserved 30 Neuroplastogen TM Program

  31. Slide 31: Pipeline of molecules with neural plasticity modulating activity

    ©2023 Relmada - All rights reserved We have a pipeline of molecules with neural plasticity modulating activity for the treatment of CNS disorders 31 Novel esmethadone derivatives We have synthesized a series of novel esmethadone derivatives with NMDAR regulating activity. We are in the process of se

  32. Slide 32: Corporate Information

    ©2023 Relmada - All rights reserved 32 Corporate Information

  33. Slide 33: Financial overview

    ©2023 Relmada - All rights reserved Warrants outstanding Operating cash burn Common shares outstanding* Financial overview 33 Cash, cash equivalents & short - term investments $184.2 million ~4.5 million $26.9 million ~30.1 Million As of 09/30/22, weighted average exercise price, $11.50 3Q22 As of 1

  34. Slide 34: Investment highlights

    ©2023 Relmada - All rights reserved Investment highlights 34 Focus on CNS diseases and lead program in major depressive disorder CNS= Central Nervous System; MDD = major depressive disorder; MOA = mechanism of action \ **Our fiscal year end is December 31. The periods referred to in this slide are c

  35. Slide 35: Thank you

    Thank you 35

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