Highest-materiality recent filing
Entera Bio appoints Riccardo Paolo Camisasca as CMO ahead of EB613 Phase 3
Dr. Riccardo Paolo Camisasca appointed Chief Medical Officer effective Aug 18, 2026.
Entera Bio reports Q2 2026 results; FDA agrees to 12-month Phase 3 for EB613, $275M PIPE led by BVF
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.
Entera Bio raises ~$275M in private placement for phase 3 osteoporosis trial; BVF gets board seats
Raised ~$275M via private placement of 122.96M shares and 11.84M pre-funded warrants at $2.04/share.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Net loss for FY2023 was $8.9M ($0.31/share), down from $13.1M ($0.45/share) in FY2022.
Entera Bio receives 180-day Nasdaq extension to June 24, 2024 to meet $1.00 bid price rule
Nasdaq granted 180-day extension on Dec 27, 2023; new compliance deadline is June 24, 2024.
Entera Bio raises ~$6.6M in registered direct offering; issues shares and warrants
Aggregate proceeds ~$6.6M from sale of 7,916,879 units at $0.835 each.
Net loss $2.4M ($0.08/share) vs $3.1M ($0.11) in Q3 2022; cash $7.6M sufficient into Q3 2024.
Entera Bio reports H1 net loss $4.5M, cash $9.1M; updates on EB613 and EB612 trials
H1 2023 net loss $4.5M ($0.16/share) vs $7.0M ($0.24) in H1 2022.
Entera Bio receives Nasdaq minimum bid price deficiency notice; faces potential delisting
Received Nasdaq notice for failing $1.00 minimum bid price for 30 consecutive business days.
Net loss $13.1M ($0.45/share) vs $12.2M ($0.47/share) in 2021; revenues $134K, down from $571K.
Entera Bio receives Nasdaq delinquency notice for minimum bid price non-compliance
Nasdaq notified Entera Bio on Nov 21, 2022 that ordinary shares fail minimum $1.00 bid price for 30 consecutive business days.
FDA agreed that a single placebo-controlled Phase 3 study with total hip BMD as primary endpoint can support NDA for EB613.
Entera Bio receives FDA agreement that single Phase 3 study could support NDA for EB613
FDA agreed single Phase 3 placebo-controlled trial could support NDA for oral teriparatide EB613 via 505(b)(2) pathway.
Entera Bio reports Q2 results: submits EB613 protocol to FDA, net loss $7.0M, cash $17.3M
Submitted proposed registrational protocol for EB613 (oral PTH) to FDA; expects Type C meeting in H2 2022.
Appointed Miranda Toledano as CEO effective July 15, 2022; she had served as CBO/CFO and director since 2018.
Entera Bio President of R&D & Director resigns under separation deal with cash and option benefits
Dr. Phillip Schwartz resigns as President of R&D (effective July 21, 2022) and from Board (immediate); no disagreement.
Entera Bio Q1 net loss $3.8M ($0.13/shr); cash $20.1M, expects funding into Q4 2022
Revenue $68K from Amgen R&D services, down from $157K YoY; operating expenses $3.8M vs $2.4M.
Revenue $571k in 2021 vs $365k in 2020; net loss $12.2M ($0.47 per share) vs $11.2M ($0.67 per share).
Each of Haya Taitel and Yonatan Malca has communicated to the Board that he or she will either resign from the Board or not stand for reelection to the Board, in either case, effective upon the date that a corresponding New Independent Director is appointed or elected to the Board.
Each of Haya Taitel and Yonatan Malca has communicated to the Board that he or she will either resign from the Board or not stand for reelection to the Board, in either case, effective upon the date that a corresponding New Independent Director is appointed or elected to the Board.
On June 4, 2023, the Board of Directors (the “ Board ”) of Entera Bio Ltd., a company organized under the laws of the State of Israel (the “ Company ”), expanded Class II of the Board from one to two directors and appointed Ms. Haya Taitel to fill the resulting vacancy.
appointed Miranda J. Toledano, one of the Company’s existing directors and the Company’s Chief Business Officer, Chief Financial Officer and Head of Corporate Strategy, as the Company’s Chief Executive Officer
separation from the Company of Dr. Spiros Jamas
would resign from the Company’s Board of Directors (the “Board”), effective as of the Effective Date
Dr. Schwartz would resign from his position as the Company’s President of R&D, effective July 21, 2022
appointed Ms. Miranda J. Toledano, one of the Company’s existing directors, to serve as the Company’s Chief Business Officer, Chief Financial Officer and Head of Corporate Strategy, effective as of May 16, 2022
Max materiality 0.90 · Median 0.60 · Most common event earnings