Mereo BioPharma Provides Corporate Update

Core Viewpoint - Mereo BioPharma is updating its cash runway guidance and providing insights into its ongoing clinical programs, particularly focusing on setrusumab for osteogenesis imperfecta and alvelestat for alpha-1 antitrypsin deficiency-associated lung disease [1][2][3]. Group 1: Setrusumab Program - The Phase 3 Orbit and Cosmic studies of setrusumab did not achieve statistical significance for the primary endpoints related to fracture reduction compared to placebo or bisphosphonates, but showed significant improvement in bone mineral density as a key secondary endpoint [4]. - The safety profile of setrusumab remains consistent with previous studies, and further analyses are ongoing to determine the next steps, including potential regulatory interactions [5][4]. - There is a high unmet medical need for treatments in osteogenesis imperfecta, with no FDA or EMA approved therapies available, highlighting the importance of setrusumab in addressing this condition [6][7]. Group 2: Alvelestat Program - Mereo is advancing preparations for a global Phase 3 pivotal study of alvelestat, which is expected to enroll approximately 220 patients over an 18-month treatment period [8]. - The primary efficacy endpoint for U.S. approval will be the St. George's Respiratory Questionnaire Total Score, while lung density measured by CT scan will serve as the primary endpoint for potential European regulatory approval [9]. - The company is actively engaging in discussions with potential partners for the development and commercialization of alvelestat [9]. Group 3: Financial Position - As of December 31, 2025, Mereo reported a cash balance of approximately $41 million, which is expected to fund operations until mid-2027 [1][2].