Recent 8-K filings for ENTXW
Highest-materiality recent filing
Entera Bio submits streamlined Phase 3 protocol for EB613 to FDA; topline data H2 2028
- Phase 3 trial to enroll 750 postmenopausal women with osteoporosis; primary endpoint total hip BMD at 12 months.
- Single tablet final commercial formulation (Next-Gen EB613) replaces multi-tablet candidate; no bridging needed.
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Entera Bio Q1 net loss $3.5M; cash $20.4M; EB613 Phase 3 protocol submitted to FDA
Net loss of $3.5M ($0.07/share) vs $2.6M in Q1 2025; R&D expenses rose to $2.3M from $1.1M.
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Entera Bio raises $10M in private placement with BVF Partners to fund phase 3 osteoporosis study
Gross proceeds of ~$10.0M from sale of 7,827,789 units at $1.2775/unit to funds affiliated with BVF Partners LP.
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Entera Bio FY2025 net loss $11.4M, cash runway to mid-Q3 2026; EB613 Phase 3 submitted
Net loss $11.4M ($0.25/sh) vs $9.5M in FY2024; R&D expenses $6.0M up from $4.5M.
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Entera Bio submits streamlined Phase 3 protocol for EB613 to FDA; topline data H2 2028
Phase 3 trial to enroll 750 postmenopausal women with osteoporosis; primary endpoint total hip BMD at 12 months.
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Entera Bio appoints former Pfizer exec Geno J. Germano as Chairman, replacing Gerald Lieberman
Geno Germano appointed Class III director and Chairman of the Board effective February 4, 2026.
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Entera Bio expands OPKO pact to include oral LA-PTH; appoints OPKO exec Rubin to board
Expanded collaboration covers once-daily oral LA-PTH tablet for hypoparathyroidism; 50/50 cost sharing.
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Entera Bio reports Q3 net loss $3.2M; FDA agrees BMD endpoint for EB613 Phase 3
Net loss $3.2M ($0.07/share) vs $3.0M ($0.08/share) in Q3 2024; cash $16.6M through mid-Q3 2026.
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Entera Bio Q2 net loss $2.7M; FDA agrees on EB613 Phase 3 design with BMD endpoint
FDA provided written concurrence on Phase 3 study for EB613, using total hip BMD as primary endpoint for NDA via 505(b)(2) pathway.
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Entera Bio wins FDA agreement to use BMD as primary endpoint for EB613 Phase 3 osteoporosis study
FDA agreed single 24-month, placebo-controlled Phase 3 study with total hip BMD as primary endpoint; fracture incidence as key secondary.
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Entera Bio shareholders elect Haya Taitel to board; approve executive compensation amendments
Haya Taitel elected as director for three-year term with 17,288,920 votes for, 3,069,140 against.
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Entera Bio Q1 net loss $2.6M ($0.06/sh); cash runway to mid-Q3 2026; pipeline advances
Net loss of $2.6M ($0.06 per share) for Q1 2025 vs $2.0M ($0.05) in Q1 2024; operating expenses $2.6M.
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Entera Bio reports FY2024 net loss of $9.5M; cash $21M as of March 28, 2025
Net loss $9.5M ($0.25 per share) vs $8.9M ($0.31 per share) in FY2023.
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Entera Bio-OPKO collaboration: oral GLP-1/glucagon tablet, $8M equity investment
OPKO purchased 3,685,226 Entera shares at ~$2.17/share ($8M) to fund Entera's 40% development cost share through Phase 1.
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Entera Bio files legal opinion exhibit, no material business update
Filing solely to submit Exhibit 5.1 (legal opinion of Herzog Fox & Neeman) and Exhibit 23.1 (consent).
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Entera Bio Board sets annual say-on-pay votes after shareholder vote
Shareholders at July 31, 2024 annual meeting voted on frequency of advisory votes on executive compensation.
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Entera Bio Q3 net loss $3.0M ($0.08/shr); cash $6.9M; awaits FDA SABRE ruling Jan 2025
Net loss of $3.0M ($0.08 basic/diluted EPS) for Q3 2024 vs $2.4M ($0.08) in Q3 2023; operating expenses $3.0M vs $2.4M.
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Entera Bio Q2 2024 net loss $2.1M; cash runway into Q3 2025; EB613 milestone expected
Net loss of $2.1M ($0.06 per share) vs $2.3M ($0.08) in Q2 2023; cash $9.1M at June 30, 2024.
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Entera Bio shareholders approve all 8 proposals at 2024 annual meeting
Elected Miranda Toledano and Yonatan Malca to three-year board terms with ~99% of votes cast.
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Entera Bio Q1 net loss $2.0M; cash $9.2M; FDA catalyst path for EB613
Q1 net loss $2.0M ($0.05 per share) vs $2.2M ($0.08) in Q1 2023.
Earnings & guidance
Materiality & sentiment trend
Max materiality 0.90 · Median 0.60 · Most common event earnings