Relmada Therapeutics Reports Third Quarter 2026 Financial Results and Provides Business Update
Key Highlights
- ➤$202.1 million cash and investments expected to fund operations through 2029
- ➤NDV-01 IND submission remains on track for year-end 2026
- ➤86% of evaluable 18-month patients remained in complete response
- ➤NDV-01 Phase 3 SPECTRUM program retains two registrational pathways
- ➤Third-quarter net loss $13.9 million, or $0.12 per share
Expert Statements
Sergio Traversa, Chief Executive Officer of Relmada Therapeutics
“Relmada has made significant progress in advancing the NDV-01 CMC program and remains on track to submit the NDV-01 IND by year-end 2026. Furthermore, we have established a manufacturing plan to provide uninterrupted clinical supply through the completion of the Phase 3 SPECTRUM program.”
Bipin Dalmia, Chief Business Officer of Relmada Therapeutics
“Initial 18-month results from the ongoing NDV-01 Phase 2 study demonstrate extended durability of complete response and continued favorable tolerability.”
Sergio Traversa, Chief Executive Officer of Relmada Therapeutics
“Our Phase 3 program remains unchanged, with two independent registrational pathways in NMIBC, and we have renamed it SPECTRUM to reflect the potential breadth of NDV-01 across the NMIBC disease spectrum. We expect to begin the SPECTRUM program upon IND clearance.”
* NDV-01 CMC program on track to submit the IND by year-end 2026, with initiation of the registrational Phase 3 SPECTRUM program upon IND clearance * Long-term extension NDV-01 Phase 2 data demonstrate continued durability of response: 86% of 12-month complete responders remained in complete response at 18 months, with no Grade ≥3 treatment-related adverse events or discontinuations * Registrational Phase 3 program renamed SPECTRUM; two independent registrational pathways in NMIBC remain unchanged * Cash, cash equivalents and short-term investments of approximately $202.1 million as of September 30, 2026, expected to fund operations through 2029 CORAL GABLES, Fla., Nov. 12, 2026 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada” or the “Company”), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system disorders, today reported financial results for the third quarter ended September 30, 2026, and provided a business update, including 18-month results from the NDV-01 Phase 2 study, the registrational Phase 3 SPECTRUM program, and continued progress toward the planned year-end 2026 Investigational New Drug (IND) submission for NDV-01 and sepranolone.
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