Relmada Therapeutics, Inc. · NASDAQ:RLMD
Relmada Therapeutics — Investor Presentation (September 2025)
32 slides from Relmada Therapeutics's investor presentation, Sep 17, 2025
Slide 1: Unlocking Life Changing Therapies: Corporate Overview
Unlocking Life Changing Therapies September 2025 C O R PO R AT E O VER VI E W
Slide 2: Disclosures
©2025 Relmada - All rights reserved 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: Innovative pipeline of potential high-value assets
©2025 Relmada - All rights reserved Innovative pipeline of potential high - value assets 3 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 20
Slide 4: NDV-01 sustained-release intravesical Gem/Doce for NMIBC
©2025 Relmada - All rights reserved 4 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 NMIBC
Slide 5: Our focus: non-muscle invasive bladder cancer (NMIBC)
©2025 Relmada - All rights reserved Our focus: non - muscle invasive bladder cancer (NMIBC) 5 25% of new cases Muscle - invasive 75% of new cases Non - muscle invasive 1. SEER Cancer Stat Facts: Bladder Cancer. National Cancer Institute. Bethesda, MD, https://seer.cancer.gov/statfacts/html/urinb.htm
Slide 6: NMIBC opportunity
©2025 Relmada - All rights reserved NMIBC opportunity 1 6 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 - 80% of bladder cancers) 4, 6 50 - 80% recurren
Slide 7: Overview of NMIBC treatment landscape
©2025 Relmada - All rights reserved Risk of recurrence (50 - 80%) Supply issues Complex handling requirements (BCG TICE®, Adstilaradin, Anktiva, Cretostimogene) Emerging dataset (NDV - 01, INLEXZO , ZUSDURI ) Complications (>15%) OR procedure under anesthesia Patient burden Risk of recurrence Risk o
Slide 8: NMIBC patient care journey
©2025 Relmada - All rights reserved 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 adjunctive treatment Physic
Slide 9: The burden of recurrences and TURBT is high
©2025 Relmada - All rights reserved The burden of recurrences and TURBT is high 9 Recurrence frequency for IR NMIBC patients 1 : ~ 1/ year 1 • 5 - year risk of initial recurrence: 54.4%. After initial recurrence (n=137), 60.1% of patients had a second recurrence by 2 years • After 2nd recurrence (n=
Slide 10: Gem/Doce combination stands out in Urology Times survey
©2025 Relmada - All rights reserved Gem/Doce combination stands out in Urology Times survey 1 10 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 Urol
Slide 11: Gem/Doce combination embraced by the urologic oncology community
©2025 Relmada - All rights reserved 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: Conventional Gem/Doce vs NDV-01 administration
©2025 Relmada - All rights reserved Conventional Gem/Doce intravesical therapy for NMIBC 12 4 - hour total procedure time ~ 5 minutes for NDV - 01 Requires specialized pharmacy preparation NDV - 01 comes ready for use in pre - filled plastic syringes First administration Preparation by specialized p
Slide 13: Targeted intravesical therapy
©2025 Relmada - All rights reserved Targeted intravesical therapy 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 modalities
Slide 14: NDV-01 in-vitro drug release profile
©2025 Relmada - All rights reserved NDV - 01 In - vitro drug concentrations show continuous & optimized drug release in the bladder 14 In - vitro profiles demonstrate stable and predictable drug levels, minimizing peaks and troughs associated with systemic side effects. Controlled drug exposure can
Slide 15: NDV-01 competitive advantages
©2025 Relmada - All rights reserved NDV - 01 Competitive advantages 15 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 ins
Slide 16: Study TRCG-011 in high-risk NMIBC patients
©2025 Relmada - All rights reserved 16 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 Investor
Slide 17: TRCG-011 study design
©2025 Relmada - All rights reserved Inclusion criteria Purpose Primary endpoint Secondary endpoint Exploratory Study design 17 N=70 High - risk 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
Slide 18: TRCG-011 demographic data
©2025 Relmada - All rights reserved ONGOING TRCG - 011 STUDY Demographic data 18 American Urological Association 2025 presentation. Relmada press release and Investor Event April 28, 2025. % N=29 Characteristics Age 73 (54 - 93) yr Median (range) Sex 83% 24 Male 17% 5 Female BCG doses 7 (0 - 18) Med
Slide 19: TRCG-011 efficacy and tolerability
©2025 Relmada - All rights reserved ONGOING TRCG - 011 STUDY Efficacy and tolerability 19 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
Slide 20: Demonstrated durable response over time
©2025 Relmada - All rights reserved Demonstrated durable response over time 20 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 Withdre
Slide 21: NDV-01 compared with approved products
©2025 Relmada - All rights reserved NDV - 01 compared 21 American Urological Association 2025 presentation. Relmada press release and Investor Event April 28, 2025. 1. “TAR - 200 - General Overview.” J&J Medical Connect , 21 July 2025, www.jnjmedicalconnect.com/products/tar - 200/medical - content/t
Slide 22: Expecting to advance NDV-01 towards registration-track studies in H1 2026
©2025 Relmada - All rights reserved Expecting to advance NDV - 01 towards registration - track studies in H1 2026 22 Phase 2 data update Results from 9 - month follow - up FDA engagement Including planned FDA interactions and manufacturing Initiate Phase 3 study Target population to be confirmed thr
Slide 23: Sepranolone
©2025 Relmada - All rights reserved Sepranolone A novel candidate, with potential to overcome the challenges of current therapies for compulsivity disorders
Slide 24: Sepranolone potential to normalize GABA A receptor activity
©2025 Relmada - All rights reserved Sepranolone has the potential to normalize GABA A receptor activity 24 GABA ( Υ - aminobutyric acid) is the primary neurotransmitter, involved in anxiety and compulsive disorders Allopregnanolone (ALLO) typically enhances GABA A calming effects In some individuals
Slide 25: Positive Phase 2 data and unique MOA give sepranolone broad potential
©2025 Relmada - All rights reserved 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 Neuro
Slide 26: Advancing sepranolone towards Phase 2 studies in Prader-Willi Syndrome in H1 2026
©2025 Relmada - All rights reserved Expecting to advance sepranolone towards Phase 2 studies in Prader - Willi Syndrome in H1 2026 26 Phase 2 PWS preparations Including planned FDA interactions and further development of product supply Initiation of Pilot Phase 2 study in Prader - Willi Syndrome Foc
Slide 27: Corporate summary
©2025 Relmada - All rights reserved 27 Corporate summary
Slide 28: Financial overview
©2025 Relmada - All rights reserved Financial overview 28 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 29: NDV-01 and sepranolone poised to make important progress in 2025-2026
©2025 Relmada - All rights reserved NDV - 01 and sepranolone poised to make important progress in 2025 - 2026 29 Q4 2025 H1 2026 NDV - 01 Sepranolone NDV - 01 Sepranolone Planned FDA interactions, manufacturing build - out Planned FDA interactions, product supply expansion Initiate registration - tr
Slide 30: Thank you!
B Thank you!
Slide 31: Appendix
Appendix
Slide 32: Sepranolone has the potential to normalize GABA A receptor activity
©2025 Relmada - All rights reserved Sepranolone has the potential to normalize GABA A receptor activity 32 GABA PAM https://asarinapharma.com/sepranolone/how - does - sepranolone - work/
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