---
schema_version: "secwatch.filing_event.v1"
accession: "0001178913-25-002701"
form_type: "8-K"
ticker: "ENTXW"
cik: "0001638097"
company_name: "Entera Bio Ltd."
filed_at: "2025-08-08T23:59:59+00:00"
generated_at: "2026-05-17T16:37:40.532423+00:00"
event_type: "earnings"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Entera Bio Q2 net loss $2.7M; FDA agrees on EB613 Phase 3 design with BMD endpoint

## Summary
- FDA provided written concurrence on Phase 3 study for EB613, using total hip BMD as primary endpoint for NDA via 505(b)(2) pathway.
- FDA waived dedicated oral carcinogenicity and DART studies for EB613, reducing regulatory burden.
- Next-generation EB613 enters Phase 1 in November 2025; OPKO collaboration GLP-1/glucagon candidate OPK-88006 IND expected H1 2026.
- Cash $18.9M including $8M restricted for OPKO; runway through mid-Q3 2026.
- Q2 net loss $2.7M ($0.06 per share) vs $2.1M ($0.06 per share) a year ago; R&D up to $1.5M from $1.1M.

## SEC filing metadata
- accession: 0001178913-25-002701
- form_type: 8-K
- ticker: ENTXW
- cik: 0001638097
- company_name: Entera Bio Ltd.
- filed_at: 2025-08-08T23:59:59+00:00
- event_type: earnings
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 2.02, 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1638097/000117891325002701/0001178913-25-002701-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1638097/000117891325002701/zk2533576.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001178913-25-002701
- JSON: https://secwatch.observer/filing/0001178913-25-002701.json
- Plain text: https://secwatch.observer/filing/0001178913-25-002701.txt

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