Quarterly ResultMay 12, 2026, 05:01 PM
Relmada Q1 2026 Net Loss $19.1M; Positive NDV-01 Phase 2 Data
AI Summary
Relmada Therapeutics reported a net loss of $19.1 million, or $0.22 per share, for the first quarter ended March 31, 2026, compared to a net loss of $17.6 million, or $0.58 per share, in the prior year period. The company highlighted positive 12-month Phase 2 data for NDV-01 in non-muscle invasive bladder cancer (NMIBC), demonstrating high complete response rates. With a cash balance of $234.0 million, Relmada expects to fund operations through 2029, including the initiation of the NDV-01 Phase 3 RESCUE program and a Sepranolone Phase 2 study in mid-2026.
Key Highlights
- Net loss for Q1 2026 was $19.1 million, or $0.22 per basic and diluted share.
- Research and development expense decreased to $8.1 million in Q1 2026 from $12.0 million in Q1 2025.
- General and administrative expense increased to $11.4 million in Q1 2026 from $6.3 million in Q1 2025.
- Cash, cash equivalents, and short-term investments totaled $234.0 million as of March 31, 2026, expected to fund operations through 2029.
- NDV-01 Phase 2 data showed a 95% complete response (CR) rate at any time and 76% CR at 12 months in high-risk NMIBC.
- NDV-01 Phase 2 data showed a 94% CR rate at any time and 80% CR at 12 months in BCG-unresponsive NMIBC.
- Relmada filed a provisional patent application for NDV-01 in April 2026, potentially protecting until April 2047.
- The company is on track to initiate the NDV-01 Phase 3 RESCUE program and Sepranolone Phase 2 study in mid-2026.