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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

Revenue

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RLMD

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