Mereo BioPharma Group plc provided an update on its programs, focusing on setrusumab for osteogenesis imperfecta (OI) and alvelestat for alpha-1 antitrypsin deficiency-associated lung disease (AATD-LD).
Cash balance as of December 31, 2025, was approximately $41 million with an updated runway guidance to mid-2027.
Reductions in pre-commercial and manufacturing activities extended the cash runway, allowing further evaluation of the setrusumab program and potential next steps in partnership with Ultragenyx.
Data Analyses Ongoing
Additional data analyses from the Phase 3 Orbit and Cosmic studies of setrusumab in OI are ongoing to determine the program's path forward.
Cash Balance Update
As of December 31, 2025, cash and cash equivalents were approximately $41 million, supporting operations until mid-2027.
Program Evaluation
Management is carefully assessing the Phase 3 trial data of setrusumab to guide future steps for the program in collaboration with Ultragenyx.
- Setrusumab Phase 3 studies did not achieve statistical significance against primary endpoints but showed improvement in bone mineral density, requiring further analysis for regulatory interactions.
- High unmet medical need in OI emphasizes the importance of finding effective treatments despite the challenges of the condition and limited approved options.
- Alvelestat Phase 3 study preparations are progressing, anticipating regulatory submissions in the U.S. and Europe with active partner discussions ongoing.
Mereo BioPharma remains committed to addressing the unmet medical needs in OI and AATD-LD through ongoing evaluations and strategic partnerships, aiming to bring innovative treatments to patients in need.