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Relmada Therapeutics
Relmada Therapeutics (RLMD) investor relations material
Relmada Therapeutics Q4 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q4 2025 earnings summary19 Mar, 2026
Executive summary
Achieved compelling 12-month phase II efficacy data for NDV-01 in NMIBC, with a 95% complete response rate at any time and 76% at 12 months, and FDA alignment for phase III registration strategy.
NDV-01, a sustained-release gemcitabine/docetaxel formulation, targets both BCG-unresponsive and adjuvant intermediate-risk NMIBC, with two phase III registrational pathways planned for mid-2026 initiation.
Sepranolone, with proof of concept in Tourette syndrome, is advancing to a phase II study in Prader-Willi syndrome, set to begin mid-2026.
The development team was strengthened with key appointments and a scientific advisory board.
Completed $160 million private/PIPE financing in March 2025/2026, plus a $94 million stock offering, extending capital runway through 2029.
Financial highlights
Cash balance at year-end 2025 was $93 million, up from $45 million at the end of 2024, bolstered by $94 million stock offering and $160 million PIPE/private financing.
Research and development expense for Q4 2025 was $8.1 million, down from $11 million in Q4 2024; full year 2025 R&D expense was $26.9 million, down from $46.2 million in 2024.
General and administrative expense for Q4 2025 was $12.3 million, up from $8.1 million in Q4 2024; full year 2025 G&A expense was $32.2 million, down from $37.7 million in 2024.
Net loss for Q4 2025 was $19.9 million ($0.27 per share), compared to $18.6 million ($0.62 per share) in Q4 2024; full year 2025 net loss was $57.4 million ($1.45 per share), improved from $80.0 million ($2.65 per share) in 2024.
Net cash used in operating activities for 2025 was $45.8 million, compared to $51.8 million in 2024.
Outlook and guidance
Sufficient capital is expected to fund operations through 2029, including completion of the NDV-01 phase III program.
Phase III RESCUE program for NDV-01 and phase II proof of concept trial for Sepranolone in Prader-Willi syndrome are set to begin in mid-2026.
Initial three-month response data from the phase III BCG-unresponsive study expected by end of 2026, with updates planned every three months.
Define second-line patient criteria for RESCUE
Compare NDV-01 efficacy in CIS vs papillary
Drivers for intermediate-risk market expansion
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Latest events from Relmada Therapeutics
- NDV-01 delivers high response rates in NMIBC, with Phase 3 trials and strong financial runway ahead.RLMD
Corporate presentation19 Mar 2026 - NDV-01 achieved durable, high response rates with favorable safety in high-risk NMIBC.RLMDStudy Result Presentation19 Mar 2026
- NDV-01 shows strong efficacy and convenience in bladder cancer, with pivotal trials and robust funding.RLMDLeerink Global Healthcare Conference 202610 Mar 2026
- NDV-01 and sepranolone advance toward pivotal studies, supported by strong clinical and financial positions.RLMDInvestor presentation10 Mar 2026
- Q2 net loss narrowed, cash supports late-stage CNS trials and key milestones into 2025.RLMDQ2 20242 Feb 2026
- Relight trial aims for robust efficacy in MDD with improved design and strict patient selection.RLMDGoldman Sachs 45th Annual Global Healthcare Conference1 Feb 2026
- Phase III data for REL-1017 in adjunctive depression is expected in H2 2024, with NDA filing possible in 2025.RLMDJefferies 2024 Global Healthcare Conference1 Feb 2026
- Q3 net loss was $21.7M; phase III interim analysis and liquidity concerns remain key.RLMDQ3 202415 Jan 2026
- Late-stage MDD trial nears interim data, with improved design and strong financial runway.RLMDJefferies London Healthcare Conference13 Jan 2026
Next Relmada Therapeutics earnings date
Q1 202611 May, 2026
Relmada Therapeutics
Next Relmada Therapeutics earnings date
Q1 202611 May, 2026
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Amina0781App Store
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