Relmada Therapeutics, Inc. · NASDAQ:RLMD
Relmada Therapeutics — Investor Presentation (August 2025)
36 slides from Relmada Therapeutics's investor presentation, Aug 7, 2025
Slide 1: Unlocking Life Changing Therapies: Corporate Overview
Unlocking Life Changing Therapies August 2025 CORPORATE OVERVIEW
Slide 2: Disclosures
©202 5 Relmada - All rights reserve d 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
Slide 3: Targeting life changing treatments with a diversified portfolio
©202 5 Relmada - All rights reserve d Potential use in Prader Willi syndrome (PWS) backed by positive POM data in Tourette syndrome Phase 2b trial planned for H1 2026 Positive Phase 2a data showed 90% ORR at anytime 2 Phase 3 trial planned for H1 2026 Proven team with strong development skills $21M
Slide 4: Innovative pipeline of potential high-value assets
©202 5 Relmada - All rights reserve d Innovative pipeline of potential high - value assets 4 Focused on programs with positive proof - of - concept data Status / potential next steps Potential populations Phase 3 Phase 2 Phase 1 Candidate / indication Q4 2025: 9 Month data Q1 2026: 12 Month data H2
Slide 5: NDV-01 for NMIBC
©202 5 Relmada - All rights reserve d 5 NDV - 01 A sustained - release intravesical formulation of gemcitabine/docetaxel (Gem/Doce) for patients with NMIBC, with positive Phase 2a data 1 1. American Urological Association 2025 presentation. Relmada press release and Investor Event April 28, 2025 NMI
Slide 6: Class leading therapy in NMIBC
©202 5 Relmada - All rights reserve d Class leading therapy in NMIBC 6 Use of intravesical Gem/Doce high efficacy in BCG - naïve, - exposed, and - unresponsive disease 4 - 7 Phase 2 data presented at AUA show 90% ORR at any time point 6 Potent and durable cytotoxic activity and optimized drug exposu
Slide 7: NMIBC opportunity: high prevalence and high recurrence rate
©202 5 Relmada - All rights reserve d NMBIC opportunity 1 — high prevalence and high recurrence rate 7 Supply issues for prior BCG - standard and gaps in care driving NMIBC innovation New Bladder cancer cases 2 70 - 96% 5 - year overall survival, 6% with advanced disease 3 NMIBC cancer cases (75 - 8
Slide 8: NMIBC patient care journey
©202 5 Relmada - All rights reserve d NMIBC patient care journey 8 Treatment begins with TURBT (transurethral resection of bladder tumor) surgery to stage, risk - stratify, and treat patients. Following surgery, patients with HR - NMIBC typically receive intravesical BCG as primary treatment Physici
Slide 9: Targeted intravesical therapy
©202 5 Relmada - All rights reserve d Targeted intravesical therapy 9 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 modalities
Slide 10: NDV-01's innovative approach
©202 5 Relmada - All rights reserve d > 10 days of drug exposure Fully clears the body in 12 – 14 days < 5 minutes procedure in the doctor’s office NDV - 01’s innovative approach 10 GRAS: Generally Regarded as Safe Reservoir matrix disintegrates, and is safely excreted via the urine Followed by the
Slide 11: Gem/Doce combination embraced by urologic oncology community
©202 5 Relmada - All rights reserve d Gem/Doce combination has been embraced by the urologic oncology community 11 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
Slide 12: Gem/Doce stands out in Urology Times survey
©202 5 Relmada - All rights reserve d Gem/Doce combination stands out in Urology Times survey 1 12 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 Ur
Slide 13: In-vitro drug concentrations show continuous optimized release
©202 5 Relmada - All rights reserve d NDV - 01 In - vitro drug concentrations show continuous & optimized drug release in the bladder 13 In - vi tr o profiles demonstrate stable and predictable drug levels, minimizing peaks and troughs associated with systemic side effects . Controlled drug exposure
Slide 14: Study TRCG-011 high-risk NMIBC patients
©202 5 Relmada - All rights reserve d 14 Study TRCG - 011 high - risk NMIBC patients An open - label, single - arm, single - center study to evaluate safety and efficacy of NDV - 01 in HR NMIBC patients (NCT06663137 ) American Urological Association 2025 presentation. Relmada press release and Inv
Slide 15: Study design
©202 5 Relmada - All rights reserve d Inclusion criteria Purpose Primary endpoint Secondary endpoint Exploratory Study design 15 N=70 HR NMIBC • High - risk disease with CIS/Tis, Ta, T 1 tumors 1, 2 • BCG naïve, BCG - unresponsive, intolerant and experienced patients Evaluate the potential of NDV -
Slide 16: Demographic data
©202 5 Relmada - All rights reserve d Demographic data 16 ONGOING TRCG - 011 STUDY American Urological Association 2025 presentation. Relmada press release and Investor Event April 28, 2025. ECOG : Eastern Cooperative Oncology Group; PS Performance Status % N=29 Characteristics Age 73 (54 - 93) yr M
Slide 17: Treatment emergent AE and tolerability
©202 5 Relmada - All rights reserve d Treatment emergent AE and tolerability 17 Of the 28 patients who received >= 1 dose of NDV - 01, 21 (72%) had a TRAE ONGOING TRCG - 011 STUDY No patient had >= Grade 3 TRAE American Urological Association 2025 presentation. Relmada press release and Investor Eve
Slide 18: Efficacy
©202 5 Relmada - All rights reserve d Efficacy 18 ONGOING TRCG - 011 STUDY 1. Includes 2 patients with CR after re - induction. 4 subjects underwent re - induction due to non - CR at 3 months, of which 3 had a 6 - month assessment (1 pending). Of these 3 subjects, 2 had a 6 - month CR (66% CR rate a
Slide 19: Demonstrated durable response over time
©202 5 Relmada - All rights reserve d Demonstrated durable response over time 19 ONGOING TRCG - 011 STUDY Pending Pending Pending Pending Consented 3 months 6 months 9 months CR : Complete response 91% Anytime CR rate 83% 3 - month CR rate 90% 6 - month CR rate CR Non - CR Re - induced Ongoing Withd
Slide 20: Overview of NMIBC treatment landscape
©202 5 Relmada - All rights reserve d Risk of recurrence (50 - 80%) Supply issues Complex handling requirements (BCG TICE®, Adstilaradin , Anktiva , Cretostimogene , TARA - 002) Emerging dataset (NDV - 01, TAR - 200, ZUSDURI ) Complications (>15%) OR procedure under anesthesia Patient burden Risk of
Slide 21: NDV-01: a differentiated intravesical approach
©202 5 Relmada - All rights reserve d NDV - 01: a differentiated intravesical approach 21 ZUSDURI TAR - 200 NDV - 01 Product / product profile UroGen Johnson & Johnson Relmada Sponsor Mitomycin C Gemcitabine Gemcitabine/docetaxel (Gem/Doce) Active Agent Low grade, intermediate risk High Risk High -
Slide 22: Competitive advantages
©202 5 Relmada - All rights reserve d Competitive advantages 22 Based on an existing effective treatment Gem/Doce, an existing, effective and well understood treatment for NMIBC, is frequently used by urologists Ready for use NDV - 01 is supplied as prefilled syringe ready for use, easily instilled
Slide 23: Expecting to advance NDV-01 towards registration-track studies in H1 2026
©202 5 Relmada - All rights reserve d Expecting to advance NDV - 01 towards registration - track studies in H1 2026 23 2H 2025 Phase 2 data updates Results from 9 and 12 month follow - up Q4 2025 FDA Engagement Including planned FDA interactions and manufacturing H1 2026 Initiate Phase 3 study Targe
Slide 24: Sepranolone
©202 5 Relmada - All rights reserve d Sepranolone A novel candidate, with potential to overcome the challenges of current therapies for compulsivity disorders The graphic is for artistic purposes only, not a factual representation
Slide 25: Sepranolone has the potential to normalize GABA A receptor activity
©202 5 Relmada - All rights reserve d Sepranolone has the potential to normalize GABA A receptor activity 25 GABA ( Υ - aminobutyric acid) is the primary neurotransmitter, involved in anxiety and compulsive disorders Allopregnanolone (ALLO) typically enhances GABA A calming effects In some individua
Slide 26: Sepranolone normalizes GABA A receptor activity (in vitro)
©202 5 Relmada - All rights reserve d Sepranolone normalizes GABA A receptor activity (in vitro) 26 Endogenous Sepranolone attenuates ALLO - enhanced GABA - activation of the GABA A receptor 1 in a dose - dependent manner, with with high specificity 2 Sepranolone does not interfere with GABA signali
Slide 27: Topline sepranolone safety and efficacy data
©202 5 Relmada - All rights reserve d Topline sepranolone safety and efficacy data 1 27 Sepranolone treatment produced a 28% drop in tic severity (p=0.051), with consistent positive impact on secondary endpoints Positive results across secondary Quality of Life measures , using widely accept scoring
Slide 28: Positive Phase 2 data and unique MOA give sepranolone broad potential
©202 5 Relmada - All rights reserve d OCD is characterized by intrusive, unwanted thoughts (obsessions) and repetitive behaviors (compulsions) US prevalence 8.2M people 4 Neurological disorder characterized by repetitive, involuntary tics, with childhood onset US prevalence 350 - 450K children 3 Neu
Slide 29: Impact on compulsivity could open the door to use in Prader-Willi Syndrome
©202 5 Relmada - All rights reserve d Impact on compulsivity could open the door to use in Prader - Willi Syndrome 29 Prader - Willis Syndrome is an unmet need Sepranolone is a first - in - class candidate Planning a Phase 2 study in 1H 2026 Prader - Willi syndrome (PWS) affects 350,000 to 400,000 p
Slide 30: Expecting to advance sepranolone in Prader-Willi Syndrome in H1 2026
©202 5 Relmada - All rights reserve d Expecting to advance sepranolone towards Phase 2 studies in Prader - Willi Syndrome in H1 2026 30 Q4 2025 Phase 2 PWS preparations Including planned FDA interactions and further development of product supply H1 2026 Initiation of Pilot Phase 2 study in Prader -
Slide 31: Corporate summary
©202 5 Relmada - All rights reserve d 31 Corporate summary
Slide 32: Financial overview
©202 5 Relmada - All rights reserve d Financial overview 32 Common shares outstanding (45.1 million as converted) Cash, cash equivalents & short - term investments As of June 30, 2025 No outstanding debt $20.6 million ~33.2 million Unlevered balance sheet
Slide 33: NDV-01 and sepranolone poised to make important progress in 2025-2026
©202 5 Relmada - All rights reserve d NDV - 01 and sepranolone poised to make important progress in 2025 - 2026 33 Q4 2025 Q4 2025 H1 2026 H1 2026 NDV - 01 NDV - 01 Sepranolone Sepranolone Planned FDA interactions, manufacturing build - out Planned FDA interactions, product supply expansion Initiate
Slide 34: Thank you!
B Thank you!
Slide 35: Appendix
Appendix
Slide 36: Sepranolone has the potential to normalize GABA A receptor activity
©202 5 Relmada - All rights reserve d Sepranolone has the potential to normalize GABA A receptor activity 36 GABA PAM https://asarinapharma.com/sepranolone/how - does - sepranolone - work/
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