Every 8-K that Entera Bio Ltd. (ENTX) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow ENTX and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full ENTX filings page.
Entera Bio Ltd. appointed Riccardo Paolo Camisasca, M.D. as Chief Medical Officer effective August 18, 2026. He brings more than 30 years of experience in clinical development, medical affairs, regulatory strategy and R&D leadership, including serving as Global Head of R&D at Sumitomo Pharma Switzerland and prior senior roles at Bial, Syneos Health, Takeda and Novartis.
The appointment is positioned to support late-stage development of Entera’s lead oral peptide candidate EB613, an oral PTH(1-34) tablet for osteoporosis. A 6‑month, 161‑patient, placebo-controlled Phase 2 study of EB613 met primary biomarker and secondary BMD endpoints without significant safety concerns, and the company is planning Phase 3 initiation.
Entera Bio Ltd. reported second-quarter 2026 results and major financing and pipeline milestones. For the three months ended June 30, 2026, the company generated no revenue, incurred research and development expenses of $3.2 million and general and administrative expenses of $1.4 million. Net loss was $7.3 million, or $0.14 per share, compared with $2.7 million, or $0.06 per share, a year earlier, driven in part by a $2.7 million non-cash fair value remeasurement of pre-funded warrants issued in April 2026. As of June 30, 2026, cash and cash equivalents were $11.3 million and restricted cash was $7.1 million.
The company highlighted U.S. FDA alignment on a 12‑month registrational Phase 3 study of EB613 for osteoporosis, with study initiation planned for late 2026 and topline data anticipated in the second half of 2028, to support a New Drug Application. Entera completed an oversubscribed $275.0 million private placement led by BVF Partners L.P., which it expects will fully fund the EB613 Phase 3 program through topline results and anticipated NDA submission and support operations into 2030. IND-enabling studies are ongoing for EB612 for hypoparathyroidism, with an IND filing intended in the first half of 2027, alongside additional oral peptide programs EB618 and an oral GLP‑2 tablet in collaboration with OPKO Health.
Entera Bio Ltd. completed a private placement with institutional and accredited investors for 134,803,910 ordinary shares (or pre-funded warrants) at $2.04 per share, raising approximately $275.0 million. On July 28, 2026 it issued 122,961,215 ordinary shares and 11,842,695 pre-funded warrants.
The pre-funded warrants are immediately exercisable at an exercise price of NIS 0.0000769 per ordinary share, have no expiration date and include 4.99% or 9.99% beneficial ownership limits, with potential increases up to 19.99%. Net proceeds are intended to support initiation of a phase 3 registrational study of EB613 in postmenopausal women with osteoporosis and for general working capital and corporate purposes.
Funds affiliated with BVF Partners L.P. obtained rights to designate up to two directors, which step down at 75.0%, 50.0% and 10.0% ownership thresholds, and one designee is expected to serve on the Nominating and Governance Committee. Purchasers agreed to support proposals to increase the 2018 Equity Incentive Plan share reserve and approve executive equity grants restoring pre-transaction beneficial ownership levels. Entera Bio agreed to file a resale registration statement within 30 days of closing and to use reasonable best efforts to have it declared effective.
Entera Bio Ltd. held its 2026 Annual Meeting of Shareholders on July 14, 2026. Shareholders approved an amendment to the 2018 Equity Incentive Plan adding a one-time 2,500,000 Ordinary Shares to the pool available for equity awards. They also approved an Articles Amendment increasing authorized Ordinary Shares from 140,010,000 to 350,000,000.
Shareholders re-elected Sean Ellis, Steven D. Rubin and Geno H. Germano as Class III directors for terms running until the 2029 Annual Meeting. They approved revised non-executive director compensation, several one-time and share-based compensation grants, an advisory say-on-pay proposal, and the appointment of Kesselman & Kesselman as independent auditors for the fiscal year ending December 31, 2026.
Entera Bio Ltd. reported a net loss of $3.5M, or $0.07 per share, for the quarter ended March 31, 2026, compared with a $2.6M loss, or $0.06 per share, a year earlier. R&D expenses increased to $2.3M while G&A held roughly flat at $1.3M.
Cash and cash equivalents were $11.9M as of March 31, 2026 and $20.4M as of May 8, 2026, including $7.8M in restricted cash for the OPKO collaboration. Management expects current funds to support operations through the first quarter of 2027 as it advances oral peptide programs EB613, EB612, and EB618.
Entera Bio Ltd. entered a Securities Purchase Agreement with funds affiliated with BVF Partners for a private placement of 7,827,789 units at $1.2775 per Unit, for aggregate proceeds of approximately $10.0. Each Unit includes one ordinary share (or a Pre-Funded Warrant) and one warrant to purchase one and a half ordinary shares.
The Pre-Funded Warrants are immediately exercisable at NIS 0.0000769 per share with no expiration, subject to a 4.99% beneficial ownership cap that may be increased up to 19.99%. The Ordinary Share Warrants have a $1.24 exercise price, become exercisable six months after closing, and expire five years after issuance.
If all Ordinary Share Warrants are exercised for cash, Entera Bio expects to receive additional proceeds of approximately $14.5 million. The company plans to use net proceeds from the private placement to support initiation of its phase 3 registrational study of EB613 in postmenopausal women with osteoporosis and for general working capital and corporate purposes.
Entera Bio reported a full-year 2025 net loss of $11.4 million, or $0.25 per share, compared with a $9.5 million loss in 2024, as it increased investment in its oral peptide pipeline.
Cash and cash equivalents totaled $14.9 million as of December 31, 2025, including $7.8 million in restricted cash designated for the OPKO collaboration, and are expected to fund operations through the middle of the third quarter of 2026.
The company advanced three key programs: EB613, an oral anabolic osteoporosis tablet with Phase 3 protocol submitted to the FDA after a Type A endpoint alignment meeting in July 2025; EB612, a long-acting oral PTH replacement for hypoparathyroidism with final variants selected and pre-IND work underway toward a planned late-2026 IND filing with OPKO; and EB618, an oral dual GLP-1/glucagon tablet for metabolic disease with PK/PD validation complete and an IND planned based on OPKO Phase 1 data.
Entera Bio Ltd. filed a current report describing a key clinical milestone for its lead osteoporosis candidate EB613. The company has submitted to the FDA a streamlined Phase 3 protocol, statistical analysis plan, and open-label extension synopsis under its existing IND for oral teriparatide.
The planned registrational Phase 3 study will enroll 750 postmenopausal women with osteoporosis and use percentage change in total hip bone mineral density at 12 months, rather than 24 months, as the primary endpoint. Entera plans to advance a new single-tablet, once-daily formulation of EB613 directly into this trial and anticipates initiating the study in late 2026, with topline results expected in the second half of 2028.
Entera Bio Ltd. has appointed pharmaceutical industry veteran Geno J. Germano as Chairman of the Board and a Class III director, effective February 4, 2026. He will serve until the 2026 annual shareholder meeting or until a successor is chosen.
Germano brings more than three decades of leadership experience, including senior roles at Pfizer where he led a roughly $14 billion innovative medicines portfolio, and board positions at multiple biotech companies. He will receive standard non-employee director cash and equity compensation under Entera’s 2018 Equity Incentive Plan.
Gerald Lieberman resigned as Chairman and as a director effective February 4, 2026, with the company stating his resignation did not result from any disagreement over operations, policies, or practices. Entera highlighted this leadership change as it plans 2026 clinical milestones, including a Phase 3 study of EB613 for osteoporosis and a first-in-human study of Long-Acting Oral PTH for hypoparathyroidism.
Entera Bio Ltd. entered into an amended and restated collaboration and license agreement with OPKO Health and OPKO Biologics to expand their partnership. The updated agreement now includes joint preclinical and clinical development of a daily long-acting PTH tablet for hypoparathyroidism and other indications, in addition to the existing oral dual agonist GLP‑1/glucagon peptide program. Development costs for the LA‑PTH program will be shared equally between Entera Bio and OPKO, while other material terms of the original agreement remain unchanged.
The company also announced that director Gerald Ostrov will resign effective February 1, 2026, with no disagreements cited regarding operations, policies, or practices. The Board appointed Steven D. Rubin as a Class III director effective the same date, and he will also serve on the compensation committee and as Chairman of the audit committee. The Board determined that Rubin is independent and qualifies as an audit committee financial expert, and he will receive standard non‑employee director compensation.
Entera Bio Ltd. furnished a Current Report on Form 8-K stating that on August 8, 2025 the company issued a press release announcing its financial results and business updates for the three months ended June 30, 2025. The press release is furnished as Exhibit 99.1 and is incorporated by reference into Item 2.02 and Item 7.01 of the report. The filing clarifies that the information is "furnished" and not "filed" for purposes of Section 18 of the Exchange Act and therefore is not automatically subject to the liabilities of that section or to incorporation by reference in other filings unless explicitly done so.