Relmada Therapeutics, Inc. · NASDAQ:RLMD
Relmada Therapeutics — Investor Presentation (May 2026)
40 slides from Relmada Therapeutics's investor presentation, May 12, 2026
Slide 1: Corporate Overview
Unlocking Life Changing Therapies May 2026 C O R P O R A T E O V E R V I E W
Slide 2: Disclosures
©2026 R elm ada - Al l ri ghts r eserved Disclosures 2 The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements which constitute "forward-looking statements" within the meaning of Se
Slide 3: Investment Thesis
©2026 R elm ada - Al l ri ghts r eserved Investment Thesis 3 Innovative pipeline of potential high-value assets, led by NDV-01 for non- muscle invasive bladder cancer (NMIBC) NDV-01, a late-stage sustained-release Gem/Doce with attractive commercial profile and well-defined regulatory pathway Improv
Slide 4: Innovative Pipeline of Potential High-Value Assets
©2026 R elm ada - Al l ri ghts r eserved Innovative Pipeline of Potential High-Value Assets 4 Candidate / Indication Phase 1 Phase 2 Phase 3 Status / Potential Next Steps NDV-011 High-Risk NMIBC (Study TRCG-001) 2026: Present data at upcoming medical meetings, continue enrollment NDV-01 Intermediate
Slide 5: NDV-01
©2026 R elm ada - Al l ri ghts r eserved 5 NDV-01 A sustained-release intravesical formulation of gemcitabine/docetaxel (Gem/Doce) for patients with NMIBC, with positive Phase 2a data1 1. Relmada press release March 9, 2025 NMIBC: Non-muscle invasive bladder cancer. The graphic is for artistic purpo
Slide 6: Our Focus: Non-Muscle Invasive Bladder Cancer (NMIBC)
©2026 R elm ada - Al l ri ghts r eserved Our Focus: Non-Muscle Invasive Bladder Cancer (NMIBC) 6 1. Shih K et al. Aging Dis. 2021. 2. Aldousari S et al. Can Urol Assoc J. 2013. 80% of new cases1,2 20% of new cases1,2 Muscle-invasive Non-muscle invasive NMIBC • Papillary tumors: non-invasive projecti
Slide 7: NMIBC Represents Multi-Billion Dollar Market Opportunity
©2026 R elm ada - Al l ri ghts r eserved NMIBC Represents Multi-Billion Dollar Market Opportunity 7 1. National Cancer Institute (SEER). Cancer Stat Facts: Bladder Cancer. 2. American Cancer Society. Key Statistics for Bladder Cancer. 3. National Cancer Institute. Bladder Cancer Survival Data. 4. Am
Slide 8: Potential 2L NDV-01 Usage: NMIBC Patient Journey
©2026 R elm ada - Al l ri ghts r eserved Potential 2L NDV-01 Usage * NMIBC Patient Journey 8 Initial Testing Urologist performs cystoscopy and urine cytology. TURBT TURBT to stage, risk-stratify, and treat disease. Symptoms Patient presents to physician; most common presenting symptom is hematuria (
Slide 9: Overview of NMIBC Treatment Landscape
©2026 R elm ada - Al l ri ghts r eserved Systemic Therapy Overview of NMIBC Treatment Landscape 9 Intravesical Chemotherapy Gene Therapy/ Immunotherapy TURBT Surgery Relmada internal market research, 2025. 1. Pycha A et al. Urology. 2003. 2. Białek, Ł. (2024, August 1). EORTC Bladder Cancer Recurren
Slide 10: The Burden of Recurrences and TURBT is High
©2026 R elm ada - Al l ri ghts r eserved The Burden of Recurrences and TURBT is High 10 • Complication rate > 15%2 • Grade 3/4 complication rate = 9.4%3 • Readmission rate = 5%4 • Procedural Cost = $7,000-$10,0005, 7 • Worsening mental health, physical health and lower urinary tract symptom scores6
Slide 11: Gem/Doce Combination Stands Out in Urology Times Survey
©2026 R elm ada - Al l ri ghts r eserved Gem/Doce Combination Stands Out in Urology Times Survey1 11 What is your preferred treatment for patients with BCG-unresponsive NMIBC? When selecting intravesical therapy after BCG- unresponsive NMIBC, which agent do you most commonly use? 1. Derived from Uro
Slide 12: Significant Issues with Conventional Gem/Doce Intravesical Therapy for NMIBC
©2026 R elm ada - Al l ri ghts r eserved vs. <5 minutes for NDV-01 Significant Issues with Conventional Gem/Doce Intravesical Therapy for NMIBC 12 NMIBC: Non-muscle invasive bladder cancer; Gem/Doce: Gemcitabine plus Docetaxel 4-hour total procedure time First administration Preparation by specializ
Slide 13: NDV-01 - Targeted Sustained-Release Intravesical Gem/Doce
©2026 R elm ada - Al l ri ghts r eserved NDV-01 - Targeted Sustained-Release Intravesical Gem/Doce 13 Diffusion through pores Diffusion through the polymer Osmotic pumping Erosion Bladder-targeted solid matrix enables prolonged tumor exposure to the cytotoxic drug combination via multiple delivery m
Slide 14: NDV-01 in-vitro Drug Concentrations Show Continuous & Optimized Drug Release
©2026 R elm ada - Al l ri ghts r eserved NDV-01 in-vitro Drug Concentrations Show Continuous & Optimized Drug Release 14 • In-vitro profiles demonstrate stable and predictable drug levels, minimizing peaks and troughs associated with systemic side effects. • Controlled drug exposure can potentially
Slide 15: NDV-01: Clinically De-Risked with Clear Competitive Advantages
©2026 R elm ada - Al l ri ghts r eserved NDV-01: Clinically De-Risked with Clear Competitive Advantages 15 Ready for Use: Rapid, Office-Based Administration NDV-01 comes as two prefilled syringes instilled in < 5 minutes Convenience: Unlocks Community-Based Treatment In-office administration by MA/R
Slide 16: Study TRCG-011 for High-Risk NMIBC
©2026 R elm ada - Al l ri ghts r eserved 16 Study TRCG-011 for High-Risk NMIBC An open-label, single-arm, single-center Phase 2a study to evaluate safety and efficacy of NDV-01 in HR NMIBC patients (NCT06663137) HR: High Risk; NMIBC: Non-muscle invasive bladder cancer
Slide 17: TRCG-011 Study Design
©2026 R elm ada - Al l ri ghts r eserved Inclusion Criteria Purpose Primary Endpoint Secondary Endpoint Exploratory Study Design 17 ONGOING TRCG-011 STUDY • High-risk disease with CIS, Ta/T 1 tumors1, 2 • BCG-naive, BCG- unresponsive, intolerant and experienced patients Evaluate the potential of NDV
Slide 18: Demographic Data
©2026 R elm ada - Al l ri ghts r eserved Demographic Data 18 ONGOING TRCG-011 STUDY Characteristics N=48 % Age Median (range) 75 (52-93) yr Sex Male 42 87.5% Female 6 12.5% BCG doses Median BCG doses (range) 9 (3-23) BCG-status BCG-naive 23 47.9% BCG-exposed 5 10.4% BCG-unresponsive 20 41.7% Stage C
Slide 19: ghts r eserved 01-002 CIS BCG-UR 01-007 T1 BCG-exposed 01-009 T1 BCG-UR 01-010 T1
©2026 R elm ada - Al l ri ghts r eserved 01-002 CIS BCG-UR 01-007 T1 BCG-exposed 01-009 T1 BCG-UR 01-010 T1 BCG-naive 01-011 T1+CIS BCG-naive 01-013 Ta BCG-exposed 01-014 Ta BCG-naive 01-015 Ta BCG-naive 01-020 Ta BCG-UR 01-022 Ta BCG-naive 01-023 Ta BCG-naive 01-024 Ta BCG-naive 01-025 Ta BCG-naive
Slide 20: Efficacy Results
©2026 R elm ada - Al l ri ghts r eserved Efficacy Results 20 ONGOING TRCG-011 STUDY n/N % Anytime 36/38 95% 3-month 33/38 87% 6-month 25/29 86% 9-month 22/26 85%* 12-month 19/25 76%* 12-month KM analysis - 83% • No patient had progression to muscle invasive disease • No patient underwent a radical c
Slide 21: Treatment-Related AE and Tolerability
©2026 R elm ada - Al l ri ghts r eserved Treatment-Related AE and Tolerability 21 ONGOING TRCG-011 STUDY No patient had ≥ Grade 3 TRAE No patients discontinued treatment due to AEs Of the 48 patients who received ≥ 1 dose of NDV-01, 30 (63%) had a TRAE • 54% transient uncomfortable urination (dysuri
Slide 22: BCG-Unresponsive NMIBC: The Presence of CIS Does NOT Impact Gem/Doce RFS
©2026 R elm ada - Al l ri ghts r eserved BCG-Unresponsive NMIBC: The Presence of CIS Does NOT Impact Gem/Doce RFS1 22 1. As demonstrated by third-party data: Steinberg et al. J Urol. 2020;203:902–909; BCG: Bacillus Calmette-Guérin; CIS: carcinoma in situ; RFS: recurrence-free survival; HG: High grad
Slide 23: Phase 3 Program
©2026 R elm ada - Al l ri ghts r eserved 23 Recurrent / Endovesical / Surgery-sparing / Combination therapy for / Urothelial cancer / Effectiveness Phase 3 Program
Slide 24: Two Independent NDV-01 Approval Pathways Provide Significant Market Opportunity
©2026 R elm ada - Al l ri ghts r eserved Two Independent NDV-01 Approval Pathways Provide Significant Market Opportunity 24 PHASE 3 RESCUE TRIAL 1. Based on Internal estimates. 2. Grabe-Heyne et al. Front Oncol. 2023. 3. FDA approval summaries; company disclosures; published clinical trial data. NMI
Slide 25: Cohort 2A: 2L BCG-Unresponsive NMIBC
©2026 R elm ada - Al l ri ghts r eserved Cohort 2A: 2L BCG-Unresponsive NMIBC 25 PHASE 3 RESCUE TRIAL Open-label, single-arm study to evaluate safety and efficacy of NDV-01 in BCG-UR refractory to first-line therapy Study design Inclusion Criteria Purpose • HR BCG-UR with CIS refractory to first-lin
Slide 26: Cohort 1: Adjuvant Intermediate-Risk NMIBC
©2026 R elm ada - Al l ri ghts r eserved Cohort 1: Adjuvant Intermediate-Risk NMIBC 26 PHASE 3 RESCUE TRIAL Registrational Randomized study of TURBT + NDV-01 vs. TURBT in IR NMIBC Inclusion Criteria Primary Endpoint • IR NMIBC • IBCG risk factors ≥ 1 • DFS* • Safety Intravesical NDV-01 Induction 6 b
Slide 27: Expecting to Advance NDV-01 Towards Registration-Track Studies in Mid-2026
©2026 R elm ada - Al l ri ghts r eserved Expecting to Advance NDV-01 Towards Registration-Track Studies in Mid-2026 27 Interim Phase 3 2L BCG-Unresponsive 3-month Data Initial 3-month CR data + safety Mid 2026 YE 2026 BCG: Bacillus Calmette-Guérin (BCG); NMIBC: No muscle invasive bladder cancer; IR:
Slide 28: Sepranolone
©2026 R elm ada - Al l ri ghts r eserved Sepranolone A novel candidate, with potential to overcome the challenges of current therapies for compulsivity disorders 28
Slide 29: Sepranolone Has the Potential to Normalize GABAA Receptor Activity
©2026 R elm ada - Al l ri ghts r eserved Sepranolone Has the Potential to Normalize GABAA Receptor Activity 29 GABA (Υ-aminobutyric acid) is the primary neurotransmitter, involved in anxiety and compulsive disorders1,2 Allopregnanolone (ALLO) typically enhances GABAA calming effects3, 4 In some indi
Slide 30: Positive Phase 2 Data and Unique MOA Give Sepranolone Broad Potential
©2026 R elm ada - Al l ri ghts r eserved OCD is characterized by intrusive, unwanted thoughts (obsessions) and repetitive behaviors (compulsions) US prevalence 8.2M people4 Neurological disorder characterized by repetitive, involuntary tics, with childhood onset US prevalence 350-450K children and a
Slide 31: Sepranolone: Highlights & Development Value
©2026 R elm ada - Al l ri ghts r eserved Sepranolone: Highlights & Development Value 31 Differentiated therapeutic candidate for compulsivity-related disorders, supported by positive proof-of-concept data in Tourette's syndrome Phase 2 study in Prader-Willi syndrome (PWS) planned for mid-2026, targe
Slide 32: Expecting to Advance Sepranolone Towards Phase 2 Study in Prader-Willi Syndrome
©2026 R elm ada - Al l ri ghts r eserved Expecting to Advance Sepranolone Towards Phase 2 Study in Prader-Willi Syndrome in Mid-2026 32 Initiation of Pilot Phase 2 study in Prader-Willi Syndrome Focus on evaluating early proof-of-concept PWS: Prader-Willi syndrome Mid 2026
Slide 33: Corporate Summary
©2026 R elm ada - Al l ri ghts r eserved 33 Corporate Summary
Slide 34: Financial Overview
©2026 R elm ada - Al l ri ghts r eserved Financial Overview 34 Gross proceeds from PIPE (net ~$150M million) Provides cash runway through 2029 Cash, cash equivalents & short-term investments As of March 31, 2025 Common shares outstanding ~127.9 million as converted – includes ~15.0M outstanding opti
Slide 35: Thank You!
B Thank You!
Slide 36: Appendix
Appendix
Slide 37: Gem/Doce combination has been embraced by the urologic oncology community
©2026 R elm ada - Al l ri ghts r eserved Gem/Doce combination has been embraced by the urologic oncology community 37 Effective salvage treatment for patients who have failed or are intolerant to BCG with reported 2-year RFS ~50%1, 2, 3 Gem/Doce is an effective alternative first-line agent in high-r
Slide 38: Cohort 2B: 2L BCG-Unresponsive NMIBC
©2026 R elm ada - Al l ri ghts r eserved Cohort 2B: 2L BCG-Unresponsive NMIBC 38 Open-label, single-arm study to evaluate safety and efficacy of NDV-01 in BCG-UR refractory to first-line therapy Study design PHASE 3 RESCUE TRIAL Inclusion Criteria Purpose • HR BCG-UR papillary only refractory to fir
Slide 39: Sepranolone Has the Potential to Normalize GABAA Receptor Activity
©2026 R elm ada - Al l ri ghts r eserved Sepranolone Has the Potential to Normalize GABAA Receptor Activity 39 GABA PAM https://asarinapharma.com/sepranolone/how-does-sepranolone-work/
Slide 40: Management Leadership
©2026 R elm ada - Al l ri ghts r eserved Management 40 Leadership Sergio Traversa Chief Executive Officer Maged Shenouda Chief Financial Officer Chuck Ence Chief Accounting and Compliance Officer Paul Kelly Chief Operating Officer Raj S. Pruthi, MD Chief Medical Officer Charles J. Casamento Chairman
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