secwatch.observer — SEC 8-K summary
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Issuer:     Entera Bio Ltd. (ENTXW)
CIK:        0001638097
Form:       8-K
Filed at:   2025-08-08T23:59:59+00:00
Accession:  0001178913-25-002701
Event type: earnings
Sentiment:  positive
Materiality: 0.80
Item codes: 2.02, 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1638097/000117891325002701/0001178913-25-002701-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1638097/000117891325002701/zk2533576.htm
  HTML page:      https://secwatch.observer/filing/0001178913-25-002701

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer