secwatch.observer — SEC 8-K summary
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Issuer:     Entera Bio Ltd. (ENTXW)
CIK:        0001638097
Form:       8-K
Filed at:   2026-08-07T20:06:22+00:00
Accession:  0001178913-26-003946
Event type: earnings
Sentiment:  positive
Materiality: 0.90
Item codes: 2.02, 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1638097/000117891326003946/0001178913-26-003946-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1638097/000117891326003946/zk2635891.htm
  HTML page:      https://secwatch.observer/filing/0001178913-26-003946

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