secwatch.observer — SEC 8-K summary
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Issuer:     Entera Bio Ltd. (ENTXW)
CIK:        0001638097
Form:       8-K
Filed at:   2023-11-14T23:59:59+00:00
Accession:  0001178913-23-003664
Event type: earnings
Sentiment:  neutral
Materiality: 0.70
Item codes: 2.02, 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Entera Bio reports Q3 net loss $2.4M; advances oral peptide pipeline with OPKO collaboration, Phase 3-ready EB613
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- Net loss $2.4M ($0.08/share) vs $3.1M ($0.11) in Q3 2022; cash $7.6M sufficient into Q3 2024.
- FDA concurred that 2-year Phase 3 study with BMD endpoint could support NDA for EB613 (oral PTH) in osteoporosis.
- Collaboration with OPKO to develop oral GLP-2 for short bowel syndrome and oxyntomodulin for obesity; updates expected H1 2024.
- EB612 (oral PTH for hypoparathyroidism) Phase 2a met endpoints; ongoing PK/PD study results expected end of 2023.
- Operating expenses $2.4M, down from $2.9M YoY.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1638097/000117891323003664/0001178913-23-003664-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1638097/000117891323003664/zk2330537.htm
  HTML page:      https://secwatch.observer/filing/0001178913-23-003664

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