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Mereo BioPharma Reports Full Year 2024 Financial Results and Provides Corporate Highlights
MREOMereo BioPharma(MREO) Newsfilter·2025-03-26 11:30

Core Insights - Mereo BioPharma is advancing its lead programs, particularly the Phase 3 Orbit study of setrusumab for osteogenesis imperfecta, with key milestones expected in mid-2025 and late 2025 [2][6] - The company received European Orphan Designation for alvelestat, enhancing its positioning for treatment of Alpha-1 Antitrypsin Deficiency-associated Lung Disease [2][6] - Mereo reported a cash balance of 69.8 million as of December 31, 2024, which is expected to fund operations into 2027 [10] Financial Performance - Total R&D expenses increased by 3.5 million from 17.4millionin2023to17.4 million in 2023 to 20.9 million in 2024, driven by higher costs for alvelestat and setrusumab [5][8] - General and administrative expenses rose by 8.0millionfrom8.0 million from 18.4 million in 2023 to 26.4millionin2024,primarilyduetopre−commercialactivitiesforsetrusumab[8]−ThenetlossforthefullyearendedDecember31,2024,was26.4 million in 2024, primarily due to pre-commercial activities for setrusumab [8] - The net loss for the full year ended December 31, 2024, was 43.3 million, compared to 29.5millionin2023,reflectingincreasedoperatingexpenses[9][19]OperationalHighlights−ThePhase3Orbitstudyisongoing,withasecondinterimanalysisexpectedmid−2025andafinalanalysisinQ42025[2][6]−Pre−commercialactivitiesforsetrusumabareinprogresstoprepareforapotentiallaunchfollowingregulatoryapproval[2][6]−Alvelestathasreceivedmultipledesignations,includingOrphanDrugDesignationandFastTrackDesignationfromtheFDA,supportingitsdevelopmentandcommercializationefforts[6][12]ShareholderInformation−AsofDecember31,2024,thecompanyhad775,728,034ordinarysharesissued,withtotalADSequivalentsof155,145,606[11]−Thecompany’saccumulateddeficitincreasedto29.5 million in 2023, reflecting increased operating expenses [9][19] Operational Highlights - The Phase 3 Orbit study is ongoing, with a second interim analysis expected mid-2025 and a final analysis in Q4 2025 [2][6] - Pre-commercial activities for setrusumab are in progress to prepare for a potential launch following regulatory approval [2][6] - Alvelestat has received multiple designations, including Orphan Drug Designation and Fast Track Designation from the FDA, supporting its development and commercialization efforts [6][12] Shareholder Information - As of December 31, 2024, the company had 775,728,034 ordinary shares issued, with total ADS equivalents of 155,145,606 [11] - The company’s accumulated deficit increased to 462.9 million as of December 31, 2024, from $419.6 million in the previous year [17][19]