Relmada Therapeutics, Inc. · NASDAQ:RLMD

Relmada Therapeutics — Investor Presentation (November 2025)

39 slides from Relmada Therapeutics's investor presentation, Nov 4, 2025

1. Slide 1: Unlocking Life Changing Therapies: Corporate Overview

   Unlocking Life Changing Therapies October 2025 C O R PO R AT E O VER VI E W

2. Slide 2: Disclosures

   ©2025 Relmada - All rights reserved 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 Sect

3. Slide 3: Innovative pipeline of potential high-value assets

   ©2025 Relmada - All rights reserved 3 Innovative pipeline of potential high - value assets Focused on programs with positive proof - of - concept data Status / potential next steps Potential populations Phase 3 Phase 2 Phase 1 Candidate / indication Q1 2026: 12 Month data H2 2025: FDA interaction an

4. 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

5. Slide 5: Our focus: non-muscle invasive bladder cancer (NMIBC)

   ©2025 Relmada - All rights reserved Our focus: non - muscle invasive bladder cancer (NMIBC) 5 20% of new cases 7,8 Muscle - invasive 80% of new cases 7,8 Non - muscle invasive 1. SEER Cancer Stat Facts: Bladder Cancer. National Cancer Institute. Bethesda, MD, https://seer.cancer.gov/statfacts/html/u

6. Slide 6: NMIBC opportunity

   ©2025 Relmada - All rights reserved NMIBC opportunity 6 New bladder cancer cases 2 71 - 97% 5 - year overall survival, 8% with advanced disease 3 NMIBC cancer cases (80% of bladder cancers) 4, 6, 8, 9 50 - 80% recurrence rate (over five years) 5 US prevalence of Bladder Cancer 1 (Overall Bladder Can

7. Slide 7: Current NMIBC patient care journey

   ©2025 Relmada - All rights reserved Current NMIBC patient care journey 7 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 treatmen

8. Slide 8: Overview of NMIBC treatment landscape

   ©2025 Relmada - All rights reserved Risk of recurrence (50 - 80%) 1 Supply issues Complex handling requirements (BCG TICE®, Adstiladrin®, Anktiva®, Cretostimogene) Emerging dataset (NDV - 01, INLEXZO , ZUSDURI ) Complications (>15%) OR procedure under anesthesia Patient burden Risk of recurrence Ris

9. Slide 9: The burden of recurrences and TURBT is high

   ©2025 Relmada - All rights reserved 9 The burden of recurrences and TURBT is high Recurrences typically require TURBT Invasive OR procedure with anesthesia • Complication rate < 15% 2 • Grade 3/4 complication rate = 9.4% 3 • Readmission rate = 5% 4 • Procedural Cost = $7,000 - $10,000 5, 7 • Worseni

10. 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

11. Slide 11: Gem/Doce combination embraced by urologic oncology community

    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 - risk BCG naïve patients with 2 - ye

12. Slide 12: Approved NMIBC therapies references

    1U.S. Food and Drug Administration & Center For Biologics Evaluation And Research. (2018, February 21). TICE BCG. U.S. Food And Drug Administration. https://www.fda.gov/vaccines - blood - biologics/vaccines/tice - bc g ; 2. Liu, Y., Lu, J., Huang, Y., & Ma, L. (2019). Clinical spectrum of complicati

13. 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

14. Slide 14: NDV-01 in-vitro drug concentrations and 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

15. 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 a prefilled syringe ready for use, easily i

16. 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) HR: High Risk; NMIBC: Non muscle invasive bladder cancer

17. 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 - naive, BCG - unresponsive, intolerant and experienced patients Evaluate the potential

18. Slide 18: Demographic data

    ©2025 Relmada - All rights reserved Demographic data 18 ONGOING TRCG - 011 STUDY % N=36 Characteristics Age 75 (54 - 93) yr Median (range) Sex 83% 30 Male 17% 6 Female BCG doses 6 (0 - 21) Median BCG doses (range) BCG - status 42% 15 BCG - naive 11% 4 BCG - exposed 47% 17 BCG - unresponsive Stage 8%

19. Slide 19: Efficacy and tolerability

    ©2025 Relmada - All rights reserved ONGOING TRCG - 011 STUDY Efficacy and tolerability 19 *Includes patients with CR after re - induction. 60% CR rate after re - induction; CR = Complete Response % n/N Complete response 92% 23/25 Anytime 84% 21/25 3 - month 87%* 20/23 6 - month • No patient had prog

20. Slide 20: Efficacy in BCG-UR subpopulation

    ©2025 Relmada - All rights reserved ONGOING TRCG - 011 STUDY Efficacy in BCG - UR Subpopulation 20 BCG - UR, Bacillus Calmette - Guérin (BCG) - Unresponsive 1 https:// www.fda.gov/media/101468/download. % n/N Complete response 91% 10/11 Anytime 82% 9/11 3 - month 78% 7/9 6 - month • n = 18 patients

21. Slide 21: - - Pending - - Pending Pending 01 - 009 01 - 010 Pending

    ©2025 Relmada - All rights reserved 01 - 002 01 - 015 Pending 01 - 003 01 - 007 Pending Pending 01 - 009 01 - 010 Pending Pending 01 - 011 01 - 013 Pending Pending 01 - 014 01 - 019 Pending Pending 01 - 020 01 - 024 Pending Pending 01 - 025 01 - 027 Pending Pending 01 - 005 01 - 004 Pending Pending

22. Slide 22: Treatment-related AE and tolerability

    ©2025 Relmada - All rights reserved Treatment - related AE and tolerability 22 No patient had >= Grade 3 TRAE Of the 36 patients who received >= 1 dose of NDV - 01, 22 (61%) had a TRAE • 62% transient uncomfortable urination (dysuria) • 9% asymptomatic positive urine culture • 7% hematuria No patien

23. Slide 23: NDV-01 compared with approved therapies

    ©2025 Relmada - All rights reserved DV - 01 comp ared 23 1 . UroGen Pharma . ( 2025 ) . HIGHLIGHTS OF PRESCRIBING INFORMATION [Press release] . https : //www . accessdata . fda . gov/drugsatfda_docs/label/ 2025 / 215793 s 000 lbl . pdf ; 2 . Janssen Biotech, Inc . ( 2025 ) . HIGHLIGHTS OF PRESCRIBIN

24. Slide 24: FDA Feedback

    ©2025 Relmada - All rights reserved FDA Feedback “Regarding the proposed trial in BCG - unresponsive setting, …The FDA stated that a single arm trial might be acceptable in a more refractory patient population, although details of such a design should be discussed with the FDA.” “The FDA agreed that

25. Slide 25: Regulatory and Clinical Strategy

    ©2025 Relmada - All rights reserved Regulatory and Clinical Strategy 25 • Single - arm trial in BCG - unresponsive NMIBC with CIS who are refractory to other therapies o Request type B meeting o Protocol in development • RCT in IR NMIBC – adjuvant therapy after TURBT (NDV - 01 vs observation) o Type

26. Slide 26: Proposed Pivotal Trial in BCG-Unresponsive NMIBC

    ©2025 Relmada - All rights reserved Proposed Pivotal Trial in BCG - Unresponsive NMIBC 26 • HG BCG - UR with CIS refractory to first - line therapy • Safety and efficacy of NDV - 01 in patients with HG BCG - UR with CIS Intravesical NDV - 01 Induction 6 biweekly instillations Maintenance Monthly ins

27. Slide 27: Proposed Pivotal Trial in IR NMIBC

    Proposed Pivotal Trial in IR NMIBC 27 Randomized study of TURBT + NDV - 01 vs TURBT in IR NMIBC Inclusion criteria • IR NMIBC N=~266 Primary endpoint • DFS* • Safety Intravesical NDV - 01 Induction 6 biweekly instillations + maintenance Observation Option to have Induction with NDV - 01 with recurre

28. Slide 28: 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 28 FDA engagement Including planned FDA interactions and manufacturing Initiate Phase 3 (Registrational) studies Target population to be confirmed through FDA discussions Phase 2 data up

29. Slide 29: Sepranolone: novel candidate for compulsivity disorders

    ©2025 Relmada - All rights reserved Sepranolone A novel candidate, with potential to overcome the challenges of current therapies for compulsivity disorders

30. Slide 30: Sepranolone has the potential to normalize GABA A receptor activity

    ©2025 Relmada - All rights reserved 30 Sepranolone has the potential to normalize GABA A receptor activity GABA ( Υ - aminobutyric acid) is the primary neurotransmitter, involved in anxiety and compulsive disorders 1,2 Allopregnanolone (ALLO) typically enhances GABA A calming effects 3, 4 In some in

31. Slide 31: 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 and adu

32. Slide 32: Expecting to advance sepranolone towards Phase 2 studies in PWS in H1 2026

    ©2025 Relmada - All rights reserved Expecting to advance sepranolone towards Phase 2 studies in Prader - Willi Syndrome in H1 2026 32 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

33. Slide 33: Corporate summary

    ©2025 Relmada - All rights reserved 33 Corporate summary

34. Slide 34: Financial overview

    ^ Expected as of September 30, 2025. We have not completed our quarter - end financial close process and this amount is preliminary, has not been audited and is subject to change upon completion of our financial statement closing procedures, and any changes could be material. Additional information

35. Slide 35: 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 35 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

36. Slide 36: Thank you!

    B Thank you!

37. Slide 37: Appendix

    Appendix

38. Slide 38: NDV-01 Study TRCG-011 Adverse Events

    ©2025 Relmada - All rights reserved Grade n (%) AE 1 22 (61%) Dysuria 1 3 (9%) Positive urine culture 1/2 3 (7%) Hematuria 1 2 (6%) Abdominal Pain 1 1 (3%) Urgency 1 1 (3%) Frequency 1 1 (3%) UTI 1 1 (3%) Cough NDV - 01 - Study TRCG - 011 - Adverse Events AE, adverse event.

39. Slide 39: 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 39 GABA PAM https://asarinapharma.com/sepranolone/how - does - sepranolone - work/

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