Relmada Therapeutics, Inc. · NASDAQ:RLMD

Relmada Therapeutics — Investor Presentation (October 2023)

36 slides from Relmada Therapeutics's investor presentation, Oct 4, 2023

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

    Targeting Major Advances in the Treatment of CNS Disorders October 4 th , 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 “forwa

  3. Slide 3: Investment highlights

    ©2023 Relmada - All rights reserved Highly experienced clinical team with a successful track record advancing CNS programs through NDA approval Phase 3 program underway with two ongoing Phase 3 trials for REL - 1017 as Adjunctive Treatment for MDD Efficacy and safety profile of REL - 1017 potentiall

  4. Slide 4: The unique profile of esmethadone addresses the limitations of current treatment options

    ©2023 Relmada - All rights reserved 4 The unique profile of esmethadone (REL - 1017) addresses the limitations of current treatment options for MDD

  5. Slide 5: The prevalence of depression

    ©2023 Relmada - All rights reserved The prevalence of depression 5 ~10M Patients in the US treated for a major depressive episode in the last year 1 40% required combination Rx * ~19.3M Individual adults in the US had at least one major depressive episode in 2019 2 >280M People of all ages suffering

  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 Lim

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

    ©2023 Relmada - All rights reserved Unique profile of esmethadone (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. Phar

  8. Slide 8: Esmethadone is a novel NMDA receptor antagonist

    Esmethadone 1 (REL - 1017) is a novel NMDA receptor antagonist Esmethadone preferentially blocks tonically hyperactive GluN2D receptor subtypes 2 , potentially increasing BDNF 3 , decreasing neuroinflammation 4 and restoring physiological neuroplasticity 5,6,7 . NMDA: N - methyl - D - aspartate GluN

  9. Slide 9: Clinical development of esmethadone is steadily progressing as Adjunctive Treatment for MDD

    ©2023 Relmada - All rights reserved 9 The clinical development of esmethadone (REL - 1017) is steadily progressing as Adjunctive Treatment for MDD

  10. Slide 10: Esmethadone clinical development status

    ©2023 Relmada - All rights reserved Esmethadone (REL - 1017) clinical development status 10 All non - clinical studies have been successfully completed Stability testing of primary packaging has been completed, and production at scale has been validated The Phase 3 development program is ongoing; Re

  11. Slide 11: Data indicate favorable safety and tolerability of esmethadone

    ©2023 Relmada - All rights reserved 11 Data from the Phase 1, Phase 2, and Human Abuse Potential studies indicate favorable safety and tolerability of esmethadone (REL - 1017)

  12. Slide 12: All Phase 1 studies have been successfully completed

    ©2023 Relmada - All rights reserved All Phase 1 studies have been successfully completed 12 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 and Hepatic Impa

  13. Slide 13: Human Abuse Potential studies indicate no abuse potential

    ©2023 Relmada - All rights reserved The Human Abuse Potential studies have been successfully completed and indicate no abuse potential of REL - 1017 13 “The d - isomer lacks significant respiratory depressant action and addiction liability...” US Drug Enforcement Administration December 2019 4 1. He

  14. Slide 14: Phase 2 primary efficacy endpoint: MADRS change vs. placebo

    ©2023 Relmada - All rights reserved Phase 2 study results: 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 14 Least - Square Mean Change in MADRS 5 0 - 5 - 10 - 15 - 20 - 25 P=0.0103

  15. Slide 15: Phase 2 efficacy results: response and remission

    ©2023 Relmada - All rights reserved Phase 2 study efficacy results: response & remission 15 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 5% 31% 39% 0% 10

  16. Slide 16: The Phase 3 program as Adjunctive Treatment for MDD is currently ongoing

    ©2023 Relmada - All rights reserved 16 The Phase 3 program as Adjunctive Treatment for MDD is currently ongoing

  17. Slide 17: Esmethadone Phase 3 development program

    ©2023 Relmada - All rights reserved Esmethadone (REL - 1017) Phase 3 development program 17 H1 2022 H2 2022 H1 2023 H2 2023 H1 2024 H2 2024 COMPLETED ONGOING Relight (304): adjunctive MDD trial Expanded Access Program (EAP) Reliance I (301): adjunctive MDD trial Reliance III (303): monotherapy MDD t

  18. Slide 18: 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 18 Day 28: last efficacy a

  19. Slide 19: Reliance I per protocol set MADRS difference vs. placebo

    ©2023 Relmada - All rights reserved In 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* (p=0.051) 19 - 3.1 diff. REL - 1017 vs. placebo p= 0.051 ES= - 0.29 LS mean score with 95% CI Placebo REL - 1017 25mg *Pe

  20. Slide 20: Reliance I response and remission rates

    ©2023 Relmada - All rights reserved Percentage of subjects achieving remission (MADRS ≤10) 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

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

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

  22. Slide 22: Reliance I MADRS10 results by patient source

    ©2023 Relmada - All rights reserved Baseline/ Day 1 Day 4 Day 7 Day 14 Day 21 Day 28 Reliance I MADRS10 results for patients from verifiable sources vs unverifiable sources 22 49 49 50 50 50 52 REL 37 37 39 39 39 40 PLA Average change from baseline on Day 28 REL - 1017 - 17.22 PLACEBO - 11.76 p = 0.

  23. Slide 23: Reliance I adverse events

    ©2023 Relmada - All rights reserved In Reliance I no serious treatment - related adverse events (AE)* and no opioid like effects were observed 23 All patients (N=227) REL - 1017 25 mg (N=113) Placebo (N=114) Variable % N % N % N 51.1 116 48.7 55 53.5 61 Patients with at least one AE 25.6 58 26.5 30

  24. Slide 24: Favorable safety and tolerability profile, no abuse potential

    ©2023 Relmada - All rights reserved REL - 1017 displays a favorable safety & tolerability profile and confirms no evidence for meaningful abuse potential across studies 24 1. C - SSRS: Columbia Suicide Severity Rating Scale; 2. CADDS: Clinician - Administered Dissociative States Scale; 3. SOWS: Subj

  25. Slide 25: Reliance-OLS change from baseline in MADRS10

    ©2023 Relmada - All rights reserved 25 OLS = Open - label study; MADRS=Montgomery - Asberg Depression Rating Scale; SD = Standard Deviation; Source: Relmada Data on File Mean CFB with 95% CI Month 12 (N=57) Month 9 (N=93) Month 6 (N=134) Month 3 (N=168) Month 1 (N=196) Day 7 (N=199) Baseline MADRS (

  26. Slide 26: Reliance-OLS adverse events

    ©2023 Relmada - All rights reserved In Reliance - OLS no serious treatment - related adverse event was observed for all patients (de novo and rollover) There was no significant safety signal for weight gain, sexual dysfunction, cardiovascular issues, dissociative effects, withdrawal phenomena or abu

  27. Slide 27: Relmada is conducting two Phase 3 trials

    ©2023 Relmada - All rights reserved 27 Relmada is conducting two Phase 3 trials Phase 3 studies, currently ongoing in the United States, to evaluate the efficacy and safety of REL - 1017 as an adjunctive treatment for MDD

  28. Slide 28: Three pillars for successful clinical execution

    ©2023 Relmada - All rights reserved Three pillars for successful clinical execution 28 Successful clinical execution Sponsor oversight Study protocol Streamlined protocol to reduce placebo response Site selection Sites with dedication to quality data Subject selection Stringent eligibility process w

  29. Slide 29: Reliance II (study 302) trial design

    ©2023 Relmada - All rights reserved Reliance II (study 302) trial design for Adjunctive Treatment of MDD 29 Follow - up assessments & EAP availability ADT + matching placebo ADT + 25 mg REL - 1017 (Day 1 loading dose 75 mg) 1:1 RANDOMIZATION 28 DAYS OF DOSING (QD) D 1 Start dosing D 7 D 14 D28 End o

  30. Slide 30: Relight (study 304) trial design

    ©2023 Relmada - All rights reserved Relight (study 304) trial design for Adjunctive Treatment of MDD 30 Follow - up assessments & EAP availability ADT + matching placebo ADT + 25 mg REL - 1017 (Day 1 loading dose 75 mg) 1:1 RANDOMIZATION 28 DAYS OF DOSING (QD) MADRS = Montgomery - Asberg Depression

  31. Slide 31: Data support efficacy, safety, and tolerability of esmethadone

    ©2023 Relmada - All rights reserved Data generated for esmethadone (REL - 1017) support efficacy, safety, and tolerability for adjunctive treatment of depression 31 Phase 2 trial reached significance p= 0.0122 (25 mg) for the primary endpoint in the Intent - to - treat (ITT) analysis Reliance I, the

  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 $118.5 million ~3.0 million $13.3 million ~30.1 Million As of 06/30/2023, weighted average exercise price, $17.02 2Q23 As of

  34. Slide 34: Neuroplastogen Program pipeline of molecules

    ©2023 Relmada - All rights reserved Through our Neuroplastogen TM Program we are developing a pipeline of molecules with neuroplastic modulating activity for a variety of indications 34 Novel esmethadone derivatives We have synthesized a series of novel esmethadone derivatives with NMDAR regulating

  35. Slide 35: Summary

    ©2023 Relmada - All rights reserved Summary 35 Focus on CNS diseases and lead program in Major Depressive Disorder CNS= Central Nervous System; MDD = major depressive disorder; MOA = mechanism of action \ 1. WHO Depression Fact Sheet; 2. Al - Harbi K.S. 2012 Patient Preference and Adherence ; 3. Fav

  36. Slide 36: Thank you

    Thank you 36

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