Mereo BioPharma Reports Full Year 2024 Financial Results and Provides Corporate Highlights

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 $17.4 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 $8.0 million from $18.4 million in 2023 to $26.4 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 $29.5 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]