Relmada Therapeutics (RLMD) Q4 2025 earnings summary

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.