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Relmada Therapeutics Reports Fourth Quarter and Full Year 2024 Results and Provides Business Update
RLMDRelmada Therapeutics(RLMD) GlobeNewswire·2025-03-27 20:05

Core Insights - Relmada Therapeutics is advancing its clinical pipeline with a focus on two key programs: NDV-01 for high-grade non-muscle invasive bladder cancer and sepranolone for Tourette syndrome and other compulsion-related disorders [1][2][4] Company Updates - The company has a cash balance of 44.8millionasofDecember31,2024,whichisdeemedsufficienttosupportoperationsthroughkeymilestonesintothefirsthalfof2026[2][9]−Managementishostingaconferencecalltodiscussrecentbusinessprogressandfinancialresults[1][8]ClinicalDevelopment−NDV−01isinasingle−armPhase2studyforhigh−gradenon−muscleinvasivebladdercancer,withtoplinedataexpectedtobepresentedattheAmericanUrologicalAssociationmeetinginApril2025[4][5]−SepranoloneisbeingpreparedforaPhase2bstudyinTourettesyndrome,withplanstoevaluateitspotentialinothercompulsion−relateddisorders,includingPrader−Willisyndrome[1][2][4]FinancialPerformance−Forthefourthquarterof2024,researchanddevelopmentexpensestotaled44.8 million as of December 31, 2024, which is deemed sufficient to support operations through key milestones into the first half of 2026 [2][9] - Management is hosting a conference call to discuss recent business progress and financial results [1][8] Clinical Development - NDV-01 is in a single-arm Phase 2 study for high-grade non-muscle invasive bladder cancer, with topline data expected to be presented at the American Urological Association meeting in April 2025 [4][5] - Sepranolone is being prepared for a Phase 2b study in Tourette syndrome, with plans to evaluate its potential in other compulsion-related disorders, including Prader-Willi syndrome [1][2][4] Financial Performance - For the fourth quarter of 2024, research and development expenses totaled 11.0 million, down from 14.7millioninthesameperiodof2023,primarilyduetoreducedstudycosts[9]−Thenetlossforthefourthquarterof2024was14.7 million in the same period of 2023, primarily due to reduced study costs [9] - The net loss for the fourth quarter of 2024 was 18.6 million, or 0.62pershare,comparedtoanetlossof0.62 per share, compared to a net loss of 25.1 million, or 0.84pershare,forthesameperiodin2023[9]−Forthefullyear2024,thenetlosswas0.84 per share, for the same period in 2023 [9] - For the full year 2024, the net loss was 80 million, or 2.65pershare,comparedtoanetlossof2.65 per share, compared to a net loss of 98.8 million, or $3.28 per share, for 2023 [9][28] Market Opportunity - The U.S. market for non-muscle invasive bladder cancer is significant, with an estimated prevalence of approximately 450,000 patients, and the potential for NDV-01 to become a first-line therapy [4][14] - Sepranolone targets a market with a U.S. prevalence of around 350,000 for Tourette syndrome, with additional potential in other compulsion-related disorders [4][19]