Relmada Therapeutics, Inc. · NASDAQ:RLMD
Relmada Therapeutics — Investor Presentation (August 2026)
32 slides from Relmada Therapeutics's investor presentation, August 2026
Slide 1: Unlocking Life Changing Therapies
Unlocking Life Changing Therapies Corporate Overview | August 2026
Slide 2: Disclosures
Disclosures 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 Section 27A of the Securities Act of 1933 and
Slide 3: Investment Thesis
Investment Thesis 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 Improvement vs. conventional Gem/Doce, positionin
Slide 4: Innovative Pipeline of Potential High-Value Assets
Innovative Pipeline of Potential High-Value Assets Focused on programs with positive proof-of-concept data Candidate / Indication Phase 1 Phase 2 Phase 3 Status / Potential Next Steps 2H26: Continued enrollment and NDV-011 long-term follow-up High-Risk NMIBC (Study TRCG-001) By YE26: File NDV-01 IND
Slide 5: NDV-01
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 purposes only, not a factual representation ©202
Slide 6: NMIBC Represents Multi-Billion Dollar Market Opportunity
NMIBC Represents Multi-Billion Dollar Market Opportunity US prevalence of New bladder cancer cases2 Bladder Cancer1 ~744,000 71-97% 5-year overall survival, 8% with advanced disease3 (Overall Bladder Key Highlights Cancer) High incidence1 ~85,000 4.2% of all new cancer cases in the US High recurrenc
Slide 7: NMIBC Patient Journey
NMIBC Patient Journey (*) Initial NDV-01 Registrational Pathways Risked-Based Therapies 4 Adjuvant therapy (chemotherapy, immunotherapy, systemic therapy) based on patients risk category. Symptoms 1 Patient presents to physician; most common Low-Risk Intermediate-Risk High-Risk BCG-Unresponsive pres
Slide 8: Overview of NMIBC Treatment Landscape
Overview of NMIBC Treatment Landscape Approved and emerging treatments TURBT Intravesical Gene Therapy/ Systemic Surgery Chemotherapy Immunotherapy Therapy Complications (>15%)1 Emerging dataset Risk of recurrence (50-80%)2 Risk of recurrence OR procedure under Conventional Chemotherapies: Supply is
Slide 9: Gem/Doce Combination Stands Out in Urology Times Survey
Gem/Doce Combination Stands Out in Urology Times Survey1 What is your preferred treatment for When selecting intravesical therapy after BCG- patients with BCG-unresponsive unresponsive NMIBC, which agent do you most NMIBC? commonly use? Intravesical Gemcitabine plus chemotherapy docetaxel (Gem/Doce)
Slide 10: Significant Issues with Conventional Gem/Doce Intravesical Therapy for NMIBC
Significant Issues with Conventional Gem/Doce Intravesical Therapy for NMIBC 4-hour total conventional vs. <5 minutes Gem/Doce procedure time for NDV-01 Requires specialized vs. NDV-01 comes ready for use in two pharmacy preparation pre-filled plastic syringes Utilization concentrated in vs. NDV-01
Slide 11: NDV-01 - Targeted Sustained-Release Intravesical Gem/Doce
NDV-01 - Targeted Sustained-Release Intravesical Gem/Doce Bladder-targeted solid matrix enables prolonged tumor exposure to the cytotoxic drug combination via multiple delivery modalities Diffusion Diffusion Osmotic Erosion through through the pumping pores polymer ©2026 Relmada - All rights reserve
Slide 12: NDV-01 in-vitro Drug Concentrations Show Continuous & Optimized Drug Release
NDV-01 in-vitro Drug Concentrations Show Continuous & Optimized Drug Release NDV-01 Gem/Doce Concentration Over Time NDV-01 Cumulative Release Profile 3000 30 100 90 2500 Gem, µg/ml 25 80 DCTX, µg/ml 70 2000 20 Gemcitabine Release, % Docetaxel 60 1500 15 50 40 1000 10 30 Gemcitabine Release % 20 500
Slide 13: NDV-01: Clinically De-Risked with Clear Competitive Advantages
NDV-01: Clinically De-Risked with Clear Competitive Advantages 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/RN/LPN without specialized infusion infrastru
Slide 14: Study TRCG-011 for High-Risk NMIBC
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 ©2026 Relmada - All rights reserved 14
Slide 15: Study Design
ONGOING TRCG-011 STUDY Study Design Inclusion Criteria Purpose Primary Endpoint Secondary Endpoint Exploratory • High-risk disease with Evaluate the potential • Safety • DOR • PK CIS, Ta/T 1 tumors1, 2 of NDV-01 as a safe • CR Rate at 12 months • EFS • BCG-naive, BCG- and effective unresponsive, tre
Slide 16: Demographic Data
ONGOING TRCG-011 STUDY Demographic Data 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 CIS +/- Ta/T1 12 25.0% Ta HG 29 60.4% T1 HG 7
Slide 17: NDV-01 Provided Durable Response Over Time
ONGOING TRCG-011 STUDY NDV-01 Provided Durable Response Over Time Patient # Stage BCG status 3 months 6 months 9 months 12 months 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
Slide 18: Efficacy Results
ONGOING TRCG-011 STUDY Efficacy Results Efficacy Evaluable Patients1 (Complete Response) BCG-UR Subpopulation (Complete Response) n/N % n/N % Anytime 36/38 95% Anytime 16/17 94% 3-month 33/38 87% 3-month 14/17 82% 6-month 25/29 86% 6-month 12/14 86% 9-month 22/26 85%* 9-month 10/11 91% 12-month 19/2
Slide 19: Treatment-Related AE and Tolerability
ONGOING TRCG-011 STUDY Treatment-Related AE and Tolerability 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 (dysuria) • 8% asymptomatic positive urine culture
Slide 20: Phase 3 Program
Phase 3 Program Recurrent / Endovesical / Surgery-sparing / Combination therapy for / Urothelial cancer / Effectiveness ©2026 Relmada - All rights reserved 20
Slide 21: Two Independent NDV-01 Approval Pathways Provide Significant Market Opportunity
PHASE 3 RESCUE TRIAL Two Independent NDV-01 Approval Pathways Provide Significant Market Opportunity Registrational Pathway 1 Registrational Pathway 2 Single-arm trial in 2L BCG-unresponsive Open label randomized controlled trial in NMIBC with CIS who are refractory to intermediate-risk NMIBC – adju
Slide 22: Cohort 2A: 2L BCG-Unresponsive NMIBC
PHASE 3 RESCUE TRIAL Cohort 2A: 2L BCG-Unresponsive NMIBC Open-label, single-arm study to evaluate safety and efficacy of NDV-01 in BCG-UR refractory to first-line therapy Inclusion Criteria Purpose Primary Endpoint Secondary Endpoint Other • HR BCG-UR with CIS • Safety and efficacy of • CR anytime
Slide 23: Cohort 1: Adjuvant Intermediate-Risk NMIBC
PHASE 3 RESCUE TRIAL Cohort 1: Adjuvant Intermediate-Risk NMIBC Registrational Randomized study of TURBT + NDV-01 vs. TURBT in IR NMIBC Inclusion Criteria Primary Endpoint Secondary Endpoint • IR NMIBC • DFS* • HG-RFS • IBCG risk factors ≥ 1 • Safety • PFS • QOL Study design Intravesical NDV-01 Indu
Slide 24: Expect to File NDV-01 IND By YE26 and Initiate Phase 3 RESCUE Program
Expect to File NDV-01 IND By YE26 and Initiate Phase 3 RESCUE Program Upon IND Clearance YE26 NDV-01 United States IND Filing Initiate Phase 3 RESCUE Trial Upon IND Target two independent registrational pathways: Clearance • 2L BCG-Unresponsive NMIBC patients • Adjuvant Intermediate-Risk NMIBC patie
Slide 25: Sepranolone
Sepranolone A novel candidate, with potential to overcome the challenges of current therapies for compulsivity disorders ©2026 Relmada - All rights reserved 25
Slide 26: Sepranolone Has the Potential to Normalize GABAA Receptor Activity
Sepranolone Has the Potential to Normalize GABAA Receptor Activity GABA (Υ-aminobutyric In some Sepranolone Allopregnanolone acid) is the primary individuals, normalizes GABAA (ALLO) typically neurotransmitter, ALLO exacerbates receptor activity enhances GABAA involved in anxiety anxiety and without
Slide 27: Positive Phase 2 Data and Unique MOA Give Sepranolone Broad Potential
Positive Phase 2 Data and Unique MOA Give Sepranolone Broad Potential Neurological disorder Genetic disorder often defined characterized by repetitive, by persistent hunger and Prader-Willi Tourette involuntary tics, with overeating childhood onset Syndrome Syndrome Global prevalence US prevalence 3
Slide 28: Sepranolone: Highlights & Development Value
Sepranolone: Highlights & Development Value 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, targeting a rare genetic disorder affecting 350,0
Slide 29: Expect to File Sepranolone IND By YE26 and Initiate Phase 2 Trial in PWS
Expect to File Sepranolone IND By YE26 and Initiate Phase 2 Trial in PWS Upon IND Clearance YE26 Sepranolone United States IND Filing Upon IND Initiation of Phase 2 study in Prader-Willi Syndrome Clearance Focus on evaluating early proof-of-concept PWS: Prader-Willi syndrome ©2026 Relmada - All righ
Slide 30: Corporate Summary
Corporate Summary ©2026 Relmada - All rights reserved 30
Slide 31: Financial Overview
Financial Overview $217.7 ~106.7 million1 million1 Cash, cash Common shares equivalents & outstanding short-term ~127.9M as converted – includes ~14.9M investments outstanding options (weighted average exercise price of $12.58/share) As of June 30, 2026 and ~6.3M outstanding warrants 1. As of June 3
Slide 32: Thank You!
B Thank You!
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