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- **Phase II Success**: NDV-01 achieves 92% CR rate in NMIBC with no Grade 3+ adverse events, supporting Phase III启动.
- **FDA Alignment**: Two registrational tracks for high-risk (BCG-unresponsive) and intermediate-risk NMIBC, with trials starting Q2 2026.
- **Capital Strength**: $100 million financing ensures funding into 2028, enabling sepranolone Phase II and NDV-01 pivotal studies.
- **Market Potential**: Addressing 48,000 annual high-risk patients and 40,000 intermediate-risk patients, with simplified administration reducing barriers to adoption.

**【CEO Opening Remarks】**
- Highlighted three key achievements: 9-month Phase II data showing 92% overall response rate for NDV-01, FDA alignment on Phase III program with two registrational tracks, and $100 million financing to support operations into 2028.
- Emphasized NDV-01's potential to address high-risk and intermediate-risk NMIBC, with 2026 planned initiation of two Phase III studies.
- Noted strategic capitalization and clinical team expansion, including new CMO and Clinical Advisory Board.

**【CMO (Raj Pruthi) Update on NDV-01】**
- Provided NMIBC patient journey overview, highlighting high recurrence rates (60%-80%) and unmet need for effective treatments.
- Phase II data: 92% complete response (CR) rate at any time, 85% CR at 9 months, no Grade 3+ adverse events, and favorable safety profile.
- FDA alignment on Phase III plans: separate trials for BCG-unresponsive high-risk (single-arm) and intermediate-risk (randomized) populations.
- Expected Phase III initiation in Q2 2026, with high-risk trial targeting 8,000 annual patients and intermediate-risk trial targeting 40,000 annual patients.

**【CFO (Maged Shenouda) Financial Update】**
- Sepranolone: Phase II PWS study planned for Q2 2026, targeting 20,000 U.S. PWS patients with compulsive behavior needs.
- Financials: $13.9 million cash as of Q3, plus $94 million from November offering, supporting operations into 2028.
- Q3 2025 metrics: $4 million R&D (down 71% YoY), $6.3 million G&A (down 47% YoY), net loss of $10.1 million.

**【Q&A Highlights】**
- Market opportunity: High-risk second-line (8,000/year) vs. intermediate-risk adjuvant (40,000/year) populations; NDV-01's prefilled syringe eliminates need for specialized pharmacy, enabling broader adoption.
- Pricing: Acknowledged J&J's $550,000/year benchmark but noted Zosduri's $120,000/year as lower bound; final pricing will depend on clinical data and market dynamics.
- Differentiation: NDV-01's 5-minute administration vs. 4-hour Gemdoce process; potential to capture off-label use if BRIDGE trial validates Gemdoce as BCG substitute.
- Timelines: High-risk Phase III topline data in Q2 2028; intermediate-risk Phase III interim analysis at 70% events, with full readout pending FDA guidance.

Relmada Therapeutics, Inc. (RLMD) Q3 2025 Earnings Call Transcript

- **NDV-01 Phase II Success**: 91% disease-free status in high-risk NMIBC, no Grade 3+ AEs, Phase III planned for 2026.
- **Sepranolone Potential**: Targeting PWS with Phase II data in Tourette's; Phase II in PWS set for 2026.
- **Financial Strength**: $20.6M cash, reduced R&D expenses, disciplined pipeline advancement.
- **FDA Strategy**: Exploring single-arm pathway for low-grade NMIBC to accelerate approval.

**【CEO Summary Section】**
- Highlighted two new product candidates: NDV-01 (NMIBC) and sepranolone (PWS), both with proof-of-concept data and potential first-in-class status.
- Reported 91% disease-free status in NDV-01 Phase II at any time point, with 90% CR at 6 months.
- Expanded leadership with Raj Pruthi (CMO, Oncology) and Yair Lotan (Clinical Advisory Board Chair).
- Phase III for NDV-01 and Phase II for sepranolone planned for H1 2026.
- Cash balance of $20.6 million as of Q2 2025.

**【CMO Commentary on NDV-01】**
- NDV-01 is a sustained-release Gem/Doce formulation targeting high-grade NMIBC.
- Phase II data: 90% CR at 6 months, 91% CR any time, 100% CR in CIS patients, with no Grade 3+ AEs.
- FDA interaction planned for Phase III design; exploring UroGen-like single-arm pathway for low-grade market.
- Scale-up production and clinical trial prep underway for 2026 Phase III.

**【CFO Financial Commentary】**
- Sepranolone targeting PWS, with Phase II data in Tourette's showing tolerability; Phase II in PWS planned for H1 2026.
- Q2 2025: Cash $20.6M (vs. $44.9M in Q1 2024), R&D expenses $2.8M (down 76% YoY), net loss $9.9M.
- R&D cost reduction due to winding down REL-1017 trials; expenses to rise with 2026 enrollment.

**【Q&A Highlights】**
- **Market Focus**: Both high-grade (tougher, smaller) and low-grade (larger, faster path) markets viable; FDA precedent for single-arm studies in low-grade.
- **FDA Strategy**: Seeking guidance on UroGen-like pathway for chemoablation; Phase III design discussions pending.
- **R&D Costs**: Current low due to preclinical/preparation phase; expects increase with 2026 trials.


Relmada Therapeutics, Inc. (RLMD) Q2 2025 Earnings Call Transcript

- **Breakthrough Bladder Cancer Therapy**: NDV-01 achieves 85% response rate with no serious side effects, positioning for FDA clearance via streamlined trials.
- **Innovative CNS Disorder Treatment**: Sepranolone shows promise in Tourette syndrome with no off-target effects, targeting 2026 clinical development.
- **Strong Financial Position**: $27M cash balance and disciplined spending support dual pipeline advancement.
- **Manufacturing Readiness**: Scaling production for potential 2026 commercial launch of NDV-01.

**【CEO Summary Section】**
- **NDV-01 Phase 2 Data Highlights**: 85% overall response rate at 3 months, 100% disease-free status at 6 months, with no Grade 2+ adverse events. The sustained-release formulation enables office-based administration in <10 minutes, addressing the limitations of traditional gemcitabine/docetaxel therapy.
- **Sepranolone Potential**: Acquired for Prader-Willi syndrome and Tourette syndrome, with Phase 2 data showing 28% peak tic reduction (p=0.051) and no CNS side effects. FDA interactions and clinical supply development planned for 2026.
- **Pipeline Momentum**: $27.1M cash balance, clean balance sheet, and disciplined development plan to advance both programs toward clinical milestones.

**【CFO Financial Commentary】**
- **Q1 2025 Financials**: Cash balance of $27.1M (down from $44.9M in Q4 2024), net loss of $17.6M. R&D expenses decreased 10% YoY to $12M due to completion of REL-1017 trials, offset by licensing payments. G&A expenses decreased 35% YoY to $6.3M due to reduced stock-based compensation.
- **Cash Runway**: Focus on securing U.S. IND clearance for NDV-01 and advancing sepranolone. Expecting better visibility on clinical/regulatory timelines in coming months.

**【Q&A Key Takeaways】**
- **FDA Interaction Strategy**: Leveraging gemcitabine/docetaxel's established efficacy and NDV-01's safety profile to seek registrational pathway alignment. Potential single-arm trials for chemoablation or randomized trials in intermediate-risk NMIBC.
- **Manufacturing Scale-Up**: Planning for dual manufacturers to ensure commercial readiness. Product simplicity supports scalable production.
- **Future Data Updates**: Six-month follow-up on initial 20 patients (June/July 2025), with 9- and 12-month data to follow. FDA engagement expected in H2 2025 to define Phase 3 design.

Relmada Therapeutics (RLMD)-12 May 25-2025 Q1 Earnings call transcript

- **Pipeline Expansion**: Acquired NDV-01 (bladder cancer) and sepranolone (Tourette's/PWS) with Phase II data expected Q2 2025.
- **Financial Discipline**: Reduced R&D (-26%) and G&A (-29%) YoY, cash runway managed to 2026 trials.
- **Innovative Therapies**: NDV-01's 10-day sustained release vs. daily instills; sepranolone targets unmet compulsivity needs.
- **Strategic Focus**: 2 lead programs with FDA meetings planned; no immediate additional licensing.

**【CEO Strategic Update】**
- Acquired NDV-01 (bladder cancer) and sepranolone (Tourette's/Prader-Willi) to expand pipeline. 
- NDV-01 Phase II data expected at AUA 2025; sepranolone Phase IIb for Tourette's and PWS planned Q4 2025.
- Focused on 4 criteria: innovation, proof-of-concept, near-term value, underserved markets.

**【CFO Financial Overview】**
- Cash balance $44.9M (down from $96.3M YoY) with Q4 2024 net loss $18.6M.
- R&D expenses down 26% YoY ($11M vs $14.7M) due to completed REL-1017 trials.
- G&A expenses down 29% YoY ($8.1M vs $12.1M) from lower stock comp.

**【Key Pipeline Updates】**
- **NDV-01**: Sustained-release gem/doce matrix for high-grade NMIBC. AUA 2025 to report safety/efficacy from ~20 pts. Potential first-line therapy with 10-day release vs. daily instills.
- **Sepranolone**: GAMSA neurosteroid for Tourette's (350k+ US pts) and PWS (350k-400k global). Phase IIa data shows safety/tolerability; Phase IIb targeting Q4 2025.
- **REL-P11**: Psychedelic for obesity on hold due to competitive landscape.

**【Q&A Highlights】**
- **Acquisition Process**: Trigone chose Relmada for development expertise, focused pipeline, and equity alignment. Asarina partnership longstanding.
- **AUA Data Expectations**: No abstracts; real-time data presentation. Urologists benchmark ~75% CR at 3mos for competitive eval.
- **Safety Profile**: Sepranolone well-tolerated with mild injection site reactions in 350+ pts.
- **Future Licensing**: Open to new assets but selective; no immediate plans beyond 2025 trials.


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