Relmada Therapeutics reported audited financial results for the full year and fourth quarter ended December 31, 2025, with a full year net loss of $57.4 million and provided a corporate update including positive 12-month Phase 2 data for NDV-01 showing 95% complete response rate at any time and 76% at 12 months in high-risk NMIBC, a $160 million PIPE financing, and plans to initiate Phase 3 RESCUE program mid-2026.
Key takeaways
Phase 2 NDV-01 12-month data: 95% CR rate at any time and 76% durable CR at 12 months in high-risk NMIBC
BCG-unresponsive patients: 80% CR at 12 months with NDV-01
$160 million oversubscribed PIPE financing completed March 2026
Cash balance $93.0 million as of December 31, 2025, plus $160 million PIPE to fund operations through 2029
FY2025 net loss $57.4 million or $1.45 per share vs. $80.0 million or $2.65 per share in 2024
Phase 3 RESCUE program initiation in 2L BCG-unresponsive and adjuvant intermediate-risk NMIBC on track for mid-2026