Relmada Therapeutics (RLMD) Q1 2026 earnings summary

Executive summary

• Achieved robust 12-month Phase II data for NDV-01 in NMIBC, showing high response rates, durable efficacy, and favorable safety profile, especially in BCG-unresponsive patients.

• Completed $160 million private placement/PIPE financing, strengthening the balance sheet and funding operations through 2029.

• On track to initiate Phase III RESCUE program for NDV-01 in mid-2026, targeting both BCG-unresponsive and intermediate-risk NMIBC.

• Filed a provisional U.S. patent for NDV-01 in April 2026, potentially extending exclusivity to 2047.

• Terminated esmethadone and psilocybin programs in 2025 after strategic review.

Financial highlights

• Ended Q1 2026 with $234 million in cash, cash equivalents, and short-term investments, up from $93–94 million at year-end 2025, reflecting $150 million in net proceeds from private financing.

• Net loss for Q1 2026 was $19.1 million ($0.22 per share), compared to $17.6 million ($0.58 per share) in Q1 2025.

• Research and development expenses decreased to $8.1 million from $12 million year-over-year, mainly due to non-recurrent 2025 costs and program terminations.

• General and administrative expenses rose to $11.4 million from $6.3 million year-over-year, mainly due to higher compensation and consulting costs.

• Net cash used in operating activities was $15.1 million, down from $18.1 million year-over-year.

Outlook and guidance

• Cash resources expected to fund operations through 2029, including completion of Phase III NDV-01 program.

• Phase III RESCUE program for NDV-01 to begin mid-2026, with first three-month response data anticipated by year-end 2026.

• Proof-of-concept/Phase 2b study for sepranolone in Prader-Willi syndrome planned for mid-2026.

• NDV-01 IND filing planned for mid-2026.