Mereo BioPharma Narrows Q1 Loss to $6.7M, Starts Pediatric Setrusumab Review
MREO•Mereo BioPharma reported a Q1 net loss of $6.7M versus $12.9M year-on-year, with cash of $36.2M funding operations into mid-2027. The company initiated regulatory engagement for pediatric setrusumab following Phase 3 data, is pursuing an alvelestat Phase 3 partnership, and expects vantictumab Phase 2 in H2 2026.
1. Q1 Financial Results
In the first quarter ended March 31, 2026, Mereo reported R&D expenses of $4.7M, up $0.8M year-over-year, and G&A expenses of $4.0M, down $3.3M. Net loss narrowed to $6.7M from $12.9M, and the company held $36.2M in cash and equivalents, providing runway into mid-2027.
2. Setrusumab Regulatory Engagement
Analysis of the Orbit and Cosmic Phase 3 studies showed no statistical significance on primary fracture-rate endpoints but high significance on secondary endpoints including bone mineral density gains, reduced vertebral fractures and improved patient-reported outcomes. Based on safety and subgroup analyses, Mereo and Ultragenyx have initiated regulatory interactions to explore a pediatric approval pathway.
3. Alvelestat Partnership Plans
Mereo is in active discussions with potential partners to support a single Phase 3 trial enrolling approximately 220 AATD-LD patients over 18 months. The U.S. primary endpoint will be the St. George’s Respiratory Questionnaire total score and the European endpoint lung density by CT scan, with trial initiation targeted within six months of a partnership closing.
4. Vantictumab Phase 2 Trial
Development partner āshibio plans to commence a global Phase 2 trial of vantictumab in autosomal dominant osteopetrosis Type 2 during the second half of 2026. āshibio will fund the program and holds commercialization rights outside Europe, where Mereo retains rights.
