Slide 1: Reliance I Topline: REL-1017 for Major Depressive Disorder (MDD)
Reliance I Topline REL - 1017 for Major Depressive Disorder (MDD) Dec 07, 2022 Nasdaq: RLMD EXHIBIT 99.2
Slide 2: Disclosures
©2022 Relmada All rights reserved 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 -
Slide 3: Topline Data Reliance I
B 4 _ = A ! Topline Data Reliance | ~~
Slide 4: Reliance I trial design
©2022 Relmada All rights reserved Phase 3 trial (Reliance I) was designed to assess efficacy and safety of REL - 1017 as treatment for MDD in subjects with inadequate response to ongoing antidepressant treatment 4 ADT=antidepressant treatment; CGI - S=Clinical Global Impression – Severity of Illness
Slide 5: Key Inclusion/Exclusion Criteria
©2022 Relmada All rights reserved Key Inclusion/ Exclusion Criteria 5 Key Inclusion Criteria Key Exclusion Criteria • Adults 18 to 65 years. • Diagnosis of MDD. • HAM - D - 17 (≥19) and Montgomery - Åsberg Depression Rating Scale - MADRS10 (≥24). • Duration of current MDE 8 weeks - 36 months . • Sta
Slide 6: Demographics
©2022 Relmada Demographics 6 Characteristics Placebo (N=114) REL - 1017 25 mg (N=113) All patients (N=227) Mean SD Mean SD Mean SD Age (years) 43.6 14.2 43.3 15.1 43.5 14.6 Body Mass Index 26.3 3.3 25.8 2.8 26.0 3.0 N % N % N % Sex Male 27 23.7 31 27.4 58 25.6 Female 87 76.3 82 72.6 169 74.4 Ethnici
Slide 7: Primary efficacy endpoint: non-significant MADRS difference vs placebo at Day 28
©2022 Relmada All rights reserved Primary efficacy endpoint: REL - 1017 showed a - 2.2 MADRS point non - significant difference vs. placebo at Day 28. 7 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 - 2.2 REL - vs Placebo Mean (SD) - 9.3 (7.
Slide 8: Statistically significant response rate of 39.8% and 22.1% remission with 25 mg
©2022 Relmada All rights reserved Reliance I achieved a statistically significant response rate of 39.8%, and 22.1% achieved remission with 25 mg REL - 1017 8 % of Subjects Achieving Remission (MADRS ≤10) Percent subjects per ITT group % of Subjects Achieving Response (≥50% MADRS Improvement From Ba
Slide 9: MADRS with post-hoc removal of two high enrolling centers
©2022 Relmada All rights reserved REL - 1017 vs placebo Day 28 MADRS with post - hoc removal of two high enrolling centers with non - plausible results across Relmada studies: modified analysis of 41 of 43 centers and 185 of 227 subjects* *These same two centers produced non - plausible results in s
Slide 10: No serious treatment related adverse events observed in Reliance I
©2022 Relmada All rights reserved No serious treatment related treatment - emergent adverse event (TEAE) was observed in Reliance I. Placebo - like adverse event profile. 10 Treatment - emergent adverse events by preferred term in patients with MDD in the safety analysis set Variable Placebo (N=114)
Slide 11: Robust safety profile: no evidence of abuse potential or dissociative effects
©2022 Relmada All rights reserved REL - 1017 displays a robust safety profile — Reliance I confirmed no evidence for abuse potential or dissociative effects 11 1. C - SSRS: Columbia Suicide Severity Rating Scale 2. CADDS: Clinician - Administered Dissociative States Scale 3. COWs: Clinical Opiate Wi
Slide 12: Summary
©2022 Relmada All rights reserved Summary 12 Efficacy • REL - 1017 shows a - 2.2 MADRS point non - significant difference to placebo • Statistically significant MADRS response rate of REL - 1017 compared to placebo • A post - hoc analysis with the exclusion of 2 non - plausible high enrolling center
Slide 13: Thank you!
Thank you!