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Relmada Therapeutics (RLMD) investor relations material
Relmada Therapeutics Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary13 Nov, 2025
Executive summary
Achieved 92% overall response rate at any time in 9-month follow-up for NDV-01 in NMIBC, with favorable safety profile and no progression to muscle-invasive disease.
Secured FDA alignment for two distinct Phase III registrational tracks for NDV-01, de-risking the program and broadening market potential; studies to begin in H1 2026.
Strategic pivot in early 2025 included acquisition of Sepranolone and licensing of NDV-01, while terminating esmethadone and psilocybin programs.
Completed $100 million underwritten offering in November 2025 to fund operations and clinical programs into 2028.
Appointed leading urologic oncologist to Clinical Advisory Board, enhancing clinical expertise.
Financial highlights
Cash, cash equivalents, and short-term investments were $13.9 million as of September 30, 2025, excluding $94 million net proceeds from a recent offering.
Q3 2025 net loss was $10.1 million ($0.30 per share), improved from $21.7 million ($0.72 per share) in Q3 2024.
Nine months ended September 30, 2025: net loss $37.5 million ($1.16 per share), down from $61.3 million ($2.03 per share) year-over-year.
R&D expenses for Q3 2025 were $4 million (down from $11.1 million), and G&A expenses were $6.3 million (down from $11.9 million) year-over-year.
Cash used in operations for Q3 2025 was $6.7 million, down from $16.7 million in Q3 2024.
Outlook and guidance
NDV-01 Phase III registrational studies for NMIBC and Sepranolone Phase II study in Prader-Willi syndrome are planned to start in the first half of 2026.
Twelve-month Phase II NDV-01 data expected Q1 2026; IND clearance targeted for H1 2026.
Current cash position, including recent offering, expected to fund operations and planned studies into 2028.
NDV-01 top-line data timeline for each track?
How does NDV-01 formulation expand market access?
Sepranolone's broader indication strategy beyond PWS?
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Next Relmada Therapeutics earnings date
Q4 202527 Mar, 2026
Next Relmada Therapeutics earnings date
Q4 202527 Mar, 2026
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Frequently asked questions
Relmada Therapeutics Inc. is a clinical-stage biotechnology company focusing on developing innovative treatments for central nervous system (CNS) diseases, with a particular emphasis on major depressive disorder. The company's flagship product, esmethadone (d-methadone, dextromethadone, REL-1017), is a novel N-methyl-D-aspartate (NMDA) receptor antagonist currently inclinical trials, aimed at serving as an adjunctive or monotherapy treatment for MDD in adults. The company is headquartered Coral Gables, Florida. Its shares are listed on the Nasdaq.
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