Recent 8-K filings for MREO
Highest-materiality recent filing
Mereo BioPharma Q1 net loss $6.7M; setrusumab Phase 3 fails primary endpoint, regulator engagement begun
- Net loss of $6.7M in Q1 2026 vs $12.9M in Q1 2025; cash and equivalents $36.2M as of March 31, 2026.
- Setrusumab Phase 3 studies in OI did not meet primary fracture-rate endpoints; high significance on BMD, vertebral fracture reduction, and PROs.
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Net loss of $6.7M in Q1 2026 vs $12.9M in Q1 2025; cash and equivalents $36.2M as of March 31, 2026.
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Cash $41.0M as of Dec 31, 2025; expected runway into mid-2027 (from $69.8M end 2024).
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Mereo BioPharma reports setrusumab Phase 3 miss; extends cash runway to mid-2027
Cash and equivalents $41M as of Dec 31, 2025; reduced pre-commercial spend extends runway to mid-2027.
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Mereo setrusumab Phase 3 trials miss primary fracture endpoints; BMD improvements seen
Neither ORBIT (placebo) nor COSMIC (bisphosphonate) achieved statistical significance on annualized clinical fracture rate.
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Mereo BioPharma Q3 2025 net loss narrows to $7.0M; cash $48.7M; setrusumab data expected year-end
Net loss of $7.0M in Q3 2025 vs $15.0M in Q3 2024; operating loss of $10.0M.
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The Phase 3 Orbit study final analysis is expected around end of 2025, with a threshold of p<0.04.
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Mereo BioPharma Q1 net loss $12.9M; setrusumab Phase 3 Orbit on track for mid-year readout
Net loss widened to $12.9M (Q1 2024: $9.0M) on operating loss of $11.2M.
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Mereo BioPharma FY2024 net loss $43.3M; cash $69.8M funds operations into 2027
Net loss of $43.3M in FY2024 vs $29.5M in FY2023; R&D expenses rose $3.5M to $20.9M driven by alvelestat and setrusumab.
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Phase 3 Orbit study of setrusumab in OI progressing to second interim analysis expected mid-2025; final analysis possible Q4 2025.
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Amended AstraZeneca license agreement modifies development milestones; potential future payments up to $114.3M in cash and ADSs; issued 2.04M shares and paid $0.5M.
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Mereo BioPharma Q2 net loss $12.3M; setrusumab studies fully enrolled, fracture rate cut 67%
Cash $87.4M as of June 30, 2024, including $50M June offering; runway into 2027.
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Mereo BioPharma prices $50M registered direct offering of 12.5M ADS at $3.99/ADS
Gross proceeds $50M from 12,531,300 ADS at $3.99 each; net proceeds ~$45.9M after expenses.
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Setrusumab Phase 2 data: 67% fracture rate reduction in OI at 14 months
Median annualized fracture rate reduced 67% to 0.00 (p=0.0014, n=24) vs pre-treatment 0.72.
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Mereo BioPharma Q1 net loss $9.0M, cash $48.7M; setrusumab enrollment complete
Net loss $9.0M in Q1 2024 vs $12.1M in Q1 2023; operating loss $9.9M.
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Mereo BioPharma reports FY2023 revenue $10M, net loss $29.5M; cash $57.4M funds ops into 2026
Revenue $10.0M from Ultragenyx milestone and ReproNovo upfront; net loss $29.5M vs $42.2M in 2022.
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Setrusumab OI trials on track; alvelestat FDA alignment; leflutrozole licensed for up to $64.25M
Setrusumab: Phase 3 Orbit study (195 patients) expected full enrollment around end Q1 2024; Cosmic study (~65 patients) expected full enrollment 1H 2024.
Earnings & guidance
Materiality & sentiment trend
Max materiality 0.95 · Median 0.62 · Most common event earnings