Recent 8-K filings for ENTXW

• May 8, 2026, 7:59 PM ET earnings materiality 0.60 neutral item 2.02item 7.01item 9.01 ◈ Earnings Releases

  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.

• April 3, 2026, 7:59 PM ET other material materiality 0.75 positive item 1.01item 3.02item 9.01 ◈ Material Agreements

  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.

• March 27, 2026, 7:59 PM ET earnings materiality 0.65 neutral item 2.02item 7.01item 9.01 ◈ Earnings Releases

  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.

• March 4, 2026, 6:59 PM ET regulatory materiality 0.90 positive item 7.01item 9.01

  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.

• February 4, 2026, 6:59 PM ET other material materiality 0.60 positive item 1.01item 5.02item 7.01item 9.01 ◈ Material Agreements

  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.

• November 14, 2025, 6:59 PM ET earnings materiality 0.80 positive item 2.02item 7.01item 9.01

  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.

• August 8, 2025, 7:59 PM ET earnings materiality 0.80 positive item 2.02item 7.01item 9.01

  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.

• July 28, 2025, 7:59 PM ET regulatory materiality 0.80 positive item 7.01item 8.01item 9.01

  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.

• March 17, 2025, 7:59 PM ET other material materiality 0.75 positive item 1.01item 3.02item 7.01item 9.01

  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.

• November 8, 2024, 6:59 PM ET earnings materiality 0.60 neutral item 2.02item 7.01item 9.01

  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.

• August 9, 2024, 7:59 PM ET earnings materiality 0.65 neutral item 2.02item 7.01item 9.01

  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.

Earnings & guidance

Materiality & sentiment trend

Max materiality 0.90 · Median 0.60 · Most common event earnings

7 positive 1 negative 11 neutral

source · ENTXW on sec.gov