Relmada Therapeutics Appoints Distinguished Urologic Oncologist, Max Kates, MD, to the Clinical Advisory Board to Support Development of NDV-01

Dr. Kates’ experience as chair of the landmark Phase 3 BRIDGE bladder cancer trial and dedication to patient care will be invaluable to the NDV-01 Phase 3 program

Phase 3 program for NDV-01 expected to begin in H1 2026

CORAL GABLES, Fla., Oct. 07, 2025 (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 indications, today announced the appointment of Max Kates, MD, Associate Professor of Urology and Oncology at Johns Hopkins University School of Medicine, to Relmada’s Clinical Advisory Board (CAB) to support the development of NDV-01 for the potential treatment of non-muscle invasive bladder cancer (NMIBC). Relmada intends to initiate the Phase 3 program for NDV-01 in H1 2026.

“With preparations actively underway for the Phase 3 NDV-01 clinical program in NMIBC, we are very pleased to welcome Dr. Kates to the Relmada Clinical Advisory Board. We believe that Max’s experience chairing the landmark Phase 3 BRIDGE trial and leading several other practice-changing studies gives him a unique clinical perspective that will be invaluable to the design and conduct of the Phase 3 program,” said Raj Pruthi, MD, Chief Medical Officer-Urology, Relmada. “In addition, Max’s first-hand knowledge of the operational complexities inherent to a high-volume urologic oncology practice will help us to strengthen the Phase 3 program for NDV-01 and ensure its real-world applicability.”

“As the chair of the international Phase 3 Bridge Study, I have gained a deep appreciation for the clinical community’s optimism for the intravesicular delivery of gemcitabine and docetaxel as a potential bladder sparing treatment for NMIBC,” said Dr. Kates. “The initial safety and efficacy data for NDV-01, presented at the American Urologic Association in April, 2025, and updated in August, underscore the significant benefit that a sustained release formulation of “Gem/Doce” could offer urologic oncology practices and bladder cancer patients. I believe NDV-01 has the potential to transform the treatment of NMIBC and I am pleased to join the Relmada Clinical Advisory Board and eager to contribute my expertise to the pivotal program.”