Relmada Therapeutics CEO remains ‘optimistic’ about company’s future

In a letter to shareholders, CEO Sergio Traversa said, “2025 has been a truly transformational year for Relmada Therapeutics (RLMD). With the year now well into its second half, I am pleased to share an update on our recent progress and to thank you for your continued support. Earlier this year, we completed a comprehensive strategic review that reaffirmed our mission to develop life-changing treatments while building a diversified portfolio. As a result, we added two differentiated Phase 2 product candidates that significantly strengthen Relmada’s long-term value proposition: NDV-01, a sustained-release formulation of gemcitabine and docetaxel in development for non-muscle invasive bladder cancer; Sepranolone, being developed for compulsivity disorders such as Prader-Willi Syndrome. Six-month follow-up data from our Phase 2 study of NDV-01 demonstrated impressive results, with a 91% complete response rate at any time point following treatment. These findings build on the positive three-month data presented at the 2025 American Urological Association Annual Meeting and reinforce the potential of NDV-01 as a transformative, bladder-sparing therapy for NMIBC, a condition that affects approximately 600,000 patients in the U.S. We are actively preparing to initiate a Phase 3 registrational trial in the first half of 2026, with key activities underway including regulatory filings and manufacturing scale-up. To further support NDV-01, we added two experts in bladder cancer to the Relmada team: Raj S. Pruthi, MD as Chief Medical Officer-Oncology; Yair Lotan, MD as Chair of the Clinical Advisory Board. Their expertise will be invaluable as we advance the program toward late-stage development. Positive proof-of-concept data in Tourette’s syndrome suggest that sepranolone may hold promise as a therapy for compulsive disorders. In the first half of 2026, we plan to initiate a Phase 2 study in PWS, a rare genetic disorder affecting 350,000-400,000 people worldwide and characterized by compulsive behaviors such as hyperphagia. Preparations, including regulatory engagement and manufacturing activities, are underway. NDV-01 Phase 2 nine-month results, Q4 2025, and twelve months, Q1 2026; Product supply scale-up – 2H 2025; U.S. IND clearance – 1H 2026 Initiation of Phase 3 registrational trial – 1H 2026 Sepranolone FDA engagement and manufacturing activities – 2H 2025; Initiation of Phase 2 PWS study – 1H 2026; As we begin the autumn season, we remain optimistic about Relmada’s future. The progress of NDV-01 and sepranolone, combined with the expertise of our strengthened team, positions us well for value creation through disciplined execution and capital-efficient development. On behalf of the entire Relmada team, thank you for your continued trust and confidence. We look forward to keeping you updated on our progress in the months ahead.”