---
schema_version: "secwatch.filing_event.v1"
accession: "0001178913-26-003946"
form_type: "8-K"
ticker: "ENTXW"
cik: "0001638097"
company_name: "Entera Bio Ltd."
filed_at: "2026-08-07T20:06:22+00:00"
generated_at: "2026-08-07T20:08:17.832117+00:00"
event_type: "earnings"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Entera Bio reports Q2 2026 results; FDA agrees to 12-month Phase 3 for EB613, $275M PIPE led by BVF

## Summary
- 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.

## SEC filing metadata
- accession: 0001178913-26-003946
- form_type: 8-K
- ticker: ENTXW
- cik: 0001638097
- company_name: Entera Bio Ltd.
- filed_at: 2026-08-07T20:06:22+00:00
- event_type: earnings
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 2.02, 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1638097/000117891326003946/0001178913-26-003946-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1638097/000117891326003946/zk2635891.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001178913-26-003946
- JSON: https://secwatch.observer/filing/0001178913-26-003946.json
- Plain text: https://secwatch.observer/filing/0001178913-26-003946.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.