Relmada Therapeutics, Inc. · NASDAQ:RLMD

Relmada Therapeutics — Investor Presentation (April 2023)

33 slides from Relmada Therapeutics's investor presentation, Apr 19, 2023

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

    Targeting Major Advances in the Treatment of CNS Disorders April 19th, 2023

  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 Significant lessons learned from post - hoc analyses of Phase 3 data provide confidence in the path forward to ongoing and future studies Highly experienced clinical team with a successful track record advancing CNS programs through NDA approval Efficacy and safet

  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: Prevalence of depression

    ©2023 Relmada - All rights reserved Prevalence of depression 5 ~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

  6. Slide 6: Limitations of current treatments for MDD

    ©2023 Relmada - All rights reserved Limitations of current treatments for MDD 6 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

  7. Slide 7: Unique profile addresses limitations of current treatments

    ©2023 Relmada - All rights reserved Unique profile of REL - 1017 addresses limitations of current treatments Potential as a rapid, oral, once - daily antidepressant for MDD, if approved 7 MDD = major depressive disorder; NMDAR = N - methyl - D - aspartate receptor 1) Bettini E al. Pharmacological Co

  8. Slide 8: Phase 1 & 2 Efficacy and Safety Data

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

  9. Slide 9: All Phase 1 studies are completed

    ©2023 Relmada - All rights reserved All phase 1 studies for REL - 1017 are completed 9 Multiple Ascending Dose (MAD) study Single Ascending Dose (SAD) study Oxycodone Human Abuse Potential (HAP) study Intravenous Ketamine Human Abuse Potential (HAP) study Renal Impairment study Hepatic Impairment st

  10. Slide 10: Lack of abuse potential

    ©2023 Relmada - All rights reserved 10 “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

  11. Slide 11: Phase 2 study: 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 11 Least - Square Mean Change in MADRS 5 0 - 5 - 10 - 15 - 20 - 25 P=0.0

  12. Slide 12: Phase 2 study efficacy: response & remission

    ©2023 Relmada - All rights reserved REL - 1017 phase 2 study efficacy: response & remission 12 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

  13. Slide 13: Reliance: The Phase 3 Program

    ©2023 Relmada - All rights reserved 13 Reliance: The Phase 3 Program for REL - 1017

  14. Slide 14: Reliance Phase 3 study designs

    ©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 -

  15. Slide 15: Reliance I and Reliance III results overview

    ©2023 Relmada - All rights reserved Reliance I and Reliance III results overview 15 * 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

  16. Slide 16: Pivotal Phase 3 trial design for adjunctive therapy

    ©2023 Relmada - All rights reserved Pivotal phase 3 trial design for adjunctive therapy 16 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

  17. Slide 17: Reliance I primary efficacy endpoint at Day 28

    ©2023 Relmada - All rights reserved LS mean change from baseline in MADRS10 total score (+/ - 95% CI) 0 - 5 - 10 - 15 Reliance I primary efficacy endpoint: REL - 1017 showed a clinically meaningful - 2.3 MADRS point difference vs. placebo at Day 28 in the full analysis set 17 Day 28: last efficacy a

  18. Slide 18: 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 18 N= 0% 10% 20% 30% 4

  19. Slide 19: Reliance I per protocol set results

    ©2023 Relmada - All rights reserved Reliance I: REL - 1017 showed a clinically meaningful - 3.1 MADRS point difference vs. placebo at Day 28 in the Reliance I per protocol set* 19 - 3.1 diff. REL - 1017 vs. placebo p= 0.051 ES= - 0.29 LS mean score with 95% CI Placebo REL - 1017 25mg *Per - Protocol

  20. Slide 20: Reliance I with post-hoc removal of two sites

    ©2023 Relmada - All rights reserved 20 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) -

  21. Slide 21: Patient sources: verifiable vs. unverifiable

    ©2023 Relmada - All rights reserved Patient sources: verifiable vs. unverifiable 21 Verifiable sources • Past patients at site* • Current patient* • Site database** • HCP referral Unverifiable sources • Radio/TV AD • Banner/Pop AD • Social media • Internet search • Friend • Recruitment company • Ref

  22. Slide 22: Reliance I: verifiable vs unverifiable sources

    ©2023 Relmada - All rights reserved Baseline/ Day 4 Day 1 Day 7 Day 14 Day 21 Day 28 Reliance I: MADRS10 results for patients from verifiable sources vs unverifiable sources 22 REL 52 50 50 50 49 49 PLA 40 39 39 39 37 37 Average change from baseline on Day 28 REL - 1017 - 17.22 PLACEBO - 11.76 Avera

  23. Slide 23: Potential impact of COVID-19 pandemic on Reliance I

    Baseline/ Day 4 Day 1 Day 7 Day 14 Day 21 Day 28 Potential impact of the COVID - 19 pandemic on Reliance I: MADRS10 results for patients enrolled* before vs. after April 1st, 2022 23 REL 65 63 62 62 62 62 PLA 64 63 62 60 59 61 Average change from baseline on Day 28 REL - 1017 - 14.52 p = 0.89048 PLA

  24. Slide 24: Robust safety profile and no abuse potential

    ©2023 Relmada - All rights reserved REL - 1017 displays a robust safety profile and confirms no evidence for abuse potential or dissociative effects across studies 24 1.) C - SSRS: Columbia Suicide Severity Rating Scale; 2.) CADDS: Clinician - Administered Dissociative States Scale; 3.) SOWS: Subjec

  25. Slide 25: 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 25 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

  26. Slide 26: Key learnings from stakeholders following Reliance I and III

    ©2023 Relmada - All rights reserved Key learnings from stakeholders following Reliance I and Reliance III results Study site visits were too long and entailed too many assessments High enrolling sites with high placebo rates were over - represented in the final dataset Study screening eligibility ad

  27. Slide 27: Changes to improve subject quality and manage placebo response

    ©2023 Relmada - All rights reserved Changes to improve subject quality and better manage placebo response for ongoing and new studies 27 Requirement of medical records to verify depression diagnoses and ADT history to ensure enrollment of patients with true clinical depression Increased clinical tri

  28. Slide 28: Significant progress on the path to NDA

    ©2023 Relmada - All rights reserved Significant progress on the path to NDA 28 All non - clinical & phase 1 studies completed All Human Abuse Potential studies (HAPs) completed Stability testing of primary packaging completed and production at scale completed Considerable safety data collected from

  29. Slide 29: Corporate Information

    ©2023 Relmada - All rights reserved 29 Corporate Information

  30. Slide 30: Financial overview

    ©2023 Relmada - All rights reserved Warrants outstanding Operating cash burn Common shares outstanding* Financial overview 30 Cash, cash equivalents & short - term investments $148.3 million ~3.0 million $35.9 million ~30.1 Million As of 12/31/22, weighted average exercise price, $17.02 4Q22 As of 1

  31. Slide 31: Relmada development program & timeline

    ©2023 Relmada - All rights reserved Relmada development program & timeline 31 Program 1Q 23 2Q 23 3Q 23 4Q 23 1H 24 2H 24 REL - 1017 Upcoming events • Complete Reliance - OLS mid - 2023 • Complete ongoing Reliance II 1H 2024 • Initiating additional phase 3 adjunctive MDD trial mid - 2023 with comple

  32. Slide 32: Investment summary

    ©2023 Relmada - All rights reserved Investment summary 32 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 cale

  33. Slide 33: Thank you

    Thank you 33

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