Relmada Therapeutics, Inc. · NASDAQ:RLMD
Relmada Therapeutics — Investor Presentation (November 2025)
39 slides from Relmada Therapeutics's investor presentation, Nov 13, 2025
Slide 1: Corporate Overview: Unlocking Life Changing Therapies
Relmada THERAPEUTICS CORPORATE OVERVIEW Unlocking Life Changing Therapies November 2025
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 staternents which constitute "forward-looking statements’ within the meaning of Section 27A of the Securities Act of 1933 a
Slide 3: 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 Phase1 Phase 2 Phase 3 Potential populations Status / potential next steps , NMIBG US prevalence’ Q1 2026: 12 Month data NDv-OT 600K patients? H2 2025: FDA interaction and
Slide 4: NDV-01
NDV-O1 A sustained-release intravesical formulation of gemcitabine/docetaxel (Gem/Doce) for patients with NMIBC, with positive Phase 2a data!
Slide 5: Our focus: non-muscle invasive bladder cancer (NMIBC)
Our focus: non-muscle invasive bladder cancer (NMIBC) 80% of new cases7® 20% of new cases?® Non-muscle invasive High incidence! 4.2% of all new cancer cases in the US High recurrence? ~30%-61% of high-risk patients recur within one year High-risk population* 74% of patients 65 y/o TS y/o median age
Slide 6: NMIBC opportunity
NMIBC opportunity US prevalence of Bladder Cancer! (Overall Bladder Cancer) New bladder cancer cases? 71-97% 5-year overall survival, 8% with advanced disease? NMIBC cancer cases (80% of bladder cancers)*®*:> 50-80% recurrence rate (over five years) Intermediate-risk and high-risk have increased ris
Slide 7: Current NMIBC patient care journey
Current NMIBC patient care journey Urologists diagnose suspected cases of bladder cancer using cystoscopy and cytology. (Most common presenting symptom is blood in urine.) Treatment begins with TURBT (transurethral resection of bladder tumor) surgery to stage, risk-stratify, and treat patients. Foll
Slide 8: Overview of NMIBC treatment landscape
Overview of NMIBC treatment landscape Complications (15%) OR procedure under TURBT anesthesia surgery Patient burden Risk of recurrence Risk of immune-mediated Systemic or systemic side effects treatment (KEYTRUDA®, sasanlimab} Approved and emerging treatments Bcc / immunotherapy Intravesical chemot
Slide 9: The burden of recurrences and TURBT is high
The burden of recurrences and TURBT is high Frequent recurrences for IR NMIBC Recurrences typically require TURBT patients': ~ 1 recurrence / year’ Invasive OR procedure with anesthesia S-year risk of initial recurrence: 54.4%, After initial recurrence 60.1% x ee of patients had a second recurrence
Slide 10: Gem/Doce combination stands out in Urology
Gem/Doce combination stands out in Urology Times survey! What is your preferred treatment for When selecting intravesical therapy after BCG- patients with BCG-unresponsive NMIBC? unresponsive NMIBC, which agent do you most commonly use? Pereereererr rrr ire! = intravesical = chemotherapy “Canannenea
Slide 11: Gem/Doce combination has been embraced by the urologic oncology community
Gem/Doce combination has been embraced by the urologic oncology community Effective salvage treatment for patients who have failed or are intolerant to BCG with reported 2-year RFS ~SO%!:2;4 Gem/Doce is an effective alternative first-line agent in high-risk BCG naive patients with 2-year RFS of 82%*
Slide 12: Conventional Gem/Doce intravesical therapy for NMIBC
Conventional Gem/Doce intravesical therapy for NMIBC 4-hour total procedure ‘ime Preparation by specialized pharmacy ~S minutes for NDV-01 First administration Requires specialized ~90-120 min dwell time pharmacy preparation NDV-01 comes ready for use in ies eon Manure Eel pre-filled plastic syringe
Slide 13: Targeted intravesical therapy
Targeted intravesical therapy “Urine uri CO Be Bladder-targeted solid matrix enables prolonged tumor exposure to the cytotoxic drug combination via multiple delivery modalities Diffusion Diffusion Osmotic through through the pumping pores polymer Erosion
Slide 14: NDV-01 In-vitro drug concentrations show continuous & optimized drug release
NDV-01 In-vitro drug concentrations show continuous & optimized drug release in the bladder NDV-01 Gem/Doce concentration over time NDV-01 cumulative release profile Gem, ya/mi = CT% pg/ml ‘Gemeitabine Docetaxel Release, % Gemcitabine Release % 4 —*Docetaxel Release % o 0 7% 4 6 © wo Bo Mo 0 1 200 0
Slide 15: NDV-01 Competitive advantages
NDV-01 Competitive advantages NDV-01 is an investigational intravesical therapy designed for the extended release of gemcitabine and docetaxel (Gem/Doce) g Ready for use NDV-01 is supplied as a prefilled syringe ready for use, easily instilled manually in <5 minutes Sustained release NDV-O1 releases
Slide 16: Study TRCG-011
Study TRCG-O11 high-risk NMIBC patients An open-label, single-arm, single-center study to evaluate safety and efficacy of NDV-0O1 in HR NMIBC patients (NCTO6663137)
Slide 17: Ongoing TRCG-011 Study: Study design
ONGOING TRCG-OTI STUDY Study design Inclusion crite! High-risk disease with CIS/Tis, Ta, T1 tumors}? BCG-naive, BCG- unresponsive, intolerant and experienced patients Purpose Evaluate the potential of NDV-Ol asa safe and effective treatment for patients with high-risk NMIBC Primary endpoint + Safety
Slide 18: Ongoing TRCG-011 Study: Demographic data
ONGOING TRCG-OTI STUDY Demographic data Characteristics N=36 % Age Median (range) 75 (54-93) yr Sex Male 30 83% Female 6 7% BCG doses Median BCG doses (range) 6 (0-21) BCG-status BCG-naive 6 42% BCG-exposed 4 11% BCG-unresponsive iv 47% Stage cs 3 8% CIS + Ta/Tl 7. 19% Ta HG a 58% TIHG 6 17%
Slide 19: Ongoing TRCG-011 Study: Efficacy and tolerability
ONGOING TRCG-OTI STUDY Efficacy and tolerability Complete response n/N % Anytime 23/25 92% 3-month 2/25 84% 6-month 20/23 87%" 9-month 17/20 85%" » No patient had progression to muscle invasive disease » No patient underwent a radical cystectomy * Two subjects have reached 12-month assessment, and b
Slide 20: Efficacy in BCG-UR subpopulation
ONGOING TRCG-OTI STUDY Efficacy in BCG-UR subpopulation Complete response n/N Anytime 1oM 3-month 9M 6-month 719 9-month 7/8 * n=18 patients dosed in BCG-UR subpopulation » BCG-UR defined by FDA definition!
Slide 21: Durable response over time
ONGOING TRCG-OT1 STUDY Durable response over time Patient # Stage BCG status 92% Anytime CR rate Smonthe months months months ea @ once Reincuces > ongoing 84% 87% 85% Pencing Smonth CRrate E-month CR rete ‘Semonth Crate ‘completion 102 senate Aran reanet | 2
Slide 22: Treatment-related AE and tolerability
ONGOING TRCG-OTI STUDY Treatment-related AE and tolerability @ 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 patients discontinued tr
Slide 23: NDV-01 compared
NDV-01 compared Product / product profile Sponsor Active Agent NMIBC subtype Phase Dosing Format Presentation Requires device removal? Yearly costs NDV-O1 Relmada Gemcitabine/docetaxel (Gem/Doce) High-risk or intermediate-risk Phase 2 Sustained-release hydrogel Pre-filled syringe ready for intravesi
Slide 24: FDA feedback
FDA feedback details of such a design should be discussed with the FDA.” Vvaluating a til to-event endpoint, is generally acceptable, however, spe of the intended trial design, including the endpoint definition, should be submitted to the FDA in a meeting package for full review and discussion.” “We
Slide 25: Regulatory and clinical strategy
Regulatory and clinical strategy Single-arm trial in BCG-unresponsive NMIBC with CIS who are refractory to other therapies « Request type B meeting * Protocol in development RCT in IR NMIBC - adjuvant therapy after TURBT (NDV-O1 vs observation) + Type B meeting requested * Protocol is in development
Slide 26: Proposed Pivotal Trial in BCG-Unresponsive NMIBC
Proposed Pivotal Trial in 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 + HGBCG-UR With CIS + Safety and efficacy of + CRat12months + DOR +
Slide 27: Proposed Pivotal Trial in IR NMIBC
Proposed Pivotal Trial in IR NMIBC Randomized study of TURBT + NDV-O1 vs TURBT in IR NMIBC Inclusion criteria Primary endpoint + IRNMIBC + DFS" Now2ee + Safety Study design Intravesical NDV-01 Indu Follow up to 24 months 6 biweekly instillations + maintenance aacnnenennnand Observation ‘ 2 “DFS = ti
Slide 28: Expecting to advance NDV-01 towards registration-track studies in H1 2026
Expecting to advance NDV-O1 towards registration-track studies in H1 2026 FDA engagement Including planned FDA interactions and manufacturing Phase 2 data update Results from 12-month follow-up Initiate Phase 3 (Registrational) studies Target population to be confirmed through FDA discussions
Slide 29: Sepranolone
Sepranolone A novel candidate, with potential to overcome the challenges of current therapies for compulsivity disorders
Slide 30: Sepranolone has the potential to normalize GABA-A receptor activity
Sepranolone has the potential to normalize GABA, receptor activity GABA (Y-aminobutyric acid) is the primary Allopregnanolone In some Sepranolone individuals, normalizes GABA, neurotrans! ved in ALLO exacerbates receptor activit, anxiety and compulsivity>< calming e
Slide 31: Positive Phase 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 GEERT) Tourette Tnelutatecre ites tals Syndrome childhood onset Syndrome Global prevalence 350-400K people! US
Slide 32: Expecting to advance sepranolone towards Phase studies in Prader-Willi Syndrome in H1 2026
Expecting to advance sepranolone towards Phase 2 studies in Prader-Willi Syndrome in H1 2026 Phase 2 PWS preparations Including planned FDA interactions and further development of product supply Initiation of Pilot Phase 2 study in Prader-Willi Syndrome Focus on evaluating early proof-of-concept
Slide 33: Corporate
Corporate G* _
Slide 34: Financial overview
Financial overview $13.9 $100 million million! Equity Raise Cash, cash Gross proceeds from Common shares equivalents & Equity raise (net outstanding short-term ~$94m million) investments ‘As of September 30, 2025 Chiteneees -936 million as converted
Slide 35: NDV-01 and sepranolone poised to make important progress in 2025-2026
NDV-01 and sepranolone poised to make important progress in 2025-2026 NDV-O1 Planned FDA interactions, manufacturing build-out Sepranolone Planned FDA interactions, product supply expansion NDV-O1 Initiate registration-track studies Sepranolone Initiate pilot PWS study
Slide 36: Thank you!
B Thank you!
Slide 37: Appendix
Appendix
Slide 38: NDV-01 - Study TRCG-011 - Adverse Events
NDV-O1- Study TRCG-O1T1 - Adverse Events AE n (%) Grade Dysuria 22 (61%) 1 Positive urine culture 3 (9%) 1 Hematuria 3 (7%) V2 Abdominal Pain 2 (6%) 1 Urgency 1 (3%) 1 Frequency 1 (3%) 1 UTI 1 (3%) 1 Cough 1 (3%) 1
Slide 39: Sepranolone has the potential to normalize GABA-A receptor activity
Sepranolone has the potential to normalize GABA, receptor activity Extrasynapticreceptors contain a 5 subunit Extrasynaptic GABA, receptors Novel PAM bindingsite Increased tonic . GABAergiccurrent “ * * Postsynaptic terminal
Relmada Therapeutics — Investor Presentation (November 2025) on 6ix