earnings
confidence high
sentiment positive
materiality 0.90
Entera Bio reports Q2 2026 results; FDA agrees to 12-month Phase 3 for EB613, $275M PIPE led by BVF
Entera Bio Ltd.
- FDA accepted plan for single Phase 3 trial in ~750 postmenopausal women with osteoporosis, primary endpoint total hip BMD at Month 12; topline expected 2H 2028.
- Oversubscribed $275M private placement led by BVF with participation from Longitude, Vivo, RA Capital, etc.; funds EB613 through NDA submission and extends cash runway into 2030.
- Q2 2026 net loss $7.3M ($0.14/share) vs $2.7M ($0.06) in Q2 2025; R&D expenses $3.2M vs $1.5M.
- Cash and equivalents $11.3M plus restricted cash $7.1M as of June 30, 2026; pro forma with $275M proceeds expected to fund operations into 2030.
- EB612 IND filing planned 1H 2027 with OPKO; EB618 preclinical data presented at ENDO 2026.