Relmada Issues Mid-Year CEO Letter to Shareholders

Core Insights - Relmada Therapeutics has experienced a transformational year in 2025, with significant progress in its clinical development and strategic initiatives [1] Strategic Review and Portfolio Expansion - A comprehensive strategic review was completed, reaffirming the mission to develop life-changing treatments and diversify the portfolio [2] - Two new Phase 2 product candidates were added, enhancing the long-term value proposition of the company [2] NDV-01 Development - NDV-01 has shown a 91% complete response rate in a Phase 2 study for non-muscle invasive bladder cancer (NMIBC), affecting approximately 600,000 patients in the U.S. [2] - Preparations are underway to initiate a Phase 3 registrational trial in the first half of 2026, including regulatory filings and manufacturing scale-up [3][8] - The NDV-01 program is further supported by the addition of two experts in bladder cancer to the team [4] Sepranolone Advancement - Positive proof-of-concept data in Tourette's syndrome indicates potential for sepranolone in treating compulsive disorders [5] - A Phase 2 study for sepranolone in Prader-Willi Syndrome (PWS) is planned to begin in the first half of 2026, targeting a rare genetic disorder affecting 350,000–400,000 people worldwide [5][13] Key Upcoming Milestones - Upcoming milestones include Phase 2 results for NDV-01 in Q4 2025 and Q1 2026, product supply scale-up in the second half of 2025, and U.S. IND clearance in the first half of 2026 [8] - The initiation of the Phase 3 registrational trial for NDV-01 is also scheduled for the first half of 2026 [8] Company Outlook - The company remains optimistic about its future, with the progress of NDV-01 and sepranolone, alongside a strengthened team, positioning it well for value creation [9]