Welcome to our dedicated page for Entera Bio Ltd. SEC filings (Ticker: ENTX), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
Entera Bio Ltd. filings document a Nasdaq-listed Israeli clinical-stage biopharmaceutical company developing oral peptide and protein replacement therapies. Its recent Form 8-K disclosures cover financial results, Regulation FD updates, EB613 regulatory and clinical-development communications, and business updates across oral peptide programs.
The filing record also documents material agreements and capital structure matters, including collaboration and license arrangements with OPKO, a private placement involving ordinary shares, pre-funded warrants and ordinary share warrants, and governance disclosures related to board appointments. These filings frame ENTX's operating updates, securities structure, partnership obligations and public-company governance.
Burshtein Gregory reported acquisition or exercise transactions in this Form 4 filing.
Entera Bio Ltd. reported that its Chief of R&D, Gregory Burshtein, received an equity grant rather than cash. He was awarded 87,591 ordinary shares in the form of stock-settled restricted stock units, approved by the Board on May 7, 2026, in lieu of a cash bonus.
The restricted stock units vest ratably on a quarterly basis over one year, beginning May 1, 2026. After this grant, Burshtein directly owns 189,033 ordinary shares, reflecting routine, compensation-related equity that does not involve any open-market buying or selling.
Entera Bio Ltd. files a shelf resale registration to permit the selling shareholders to offer up to 19,569,472 ordinary shares. The amount comprises 2,425,000 issued shares, up to 5,402,789 ordinary shares issuable upon exercise of pre-funded warrants and up to 11,741,683 ordinary shares issuable upon exercise of warrants issued in a private placement on April 2, 2026. The company will pay registration expenses and will not receive proceeds from resale by the selling shareholders, although it may receive proceeds from cash exercise of the warrants (if exercised), which would be approximately $14.5 million if all Ordinary Share Warrants were exercised for cash in full. The prospectus discloses 49,225,321 ordinary shares outstanding as of May 5, 2026 and a Nasdaq close price of $1.37 on May 7, 2026.
Entera Bio Ltd. reported a Q1 2026 net loss of $3.5 million, up 37% from Q1 2025, driven mainly by higher research and development spending as its oral peptide pipeline advances.
Revenue was zero in Q1 2026 compared with $42 thousand a year earlier, reflecting completion of a prior research services agreement. Research and development expenses rose to $2.3 million, a 100% increase, as the company invested in EB613 Phase 3 preparation and its OPKO collaboration programs EB612 and EB618. General and administrative costs edged down 11% to $1.3 million.
As of March 31, 2026, Entera held $11.9 million in cash, cash equivalents and restricted cash, including $7.8 million earmarked for its OPKO collaboration. A private placement completed in April 2026 added approximately $10.0 million in gross proceeds. Even with this financing, management states that current resources are expected to fund operations only through the first quarter of 2027 and do not fully cover the planned Phase 3 osteoporosis program for EB613, leading to substantial doubt about the company’s ability to continue as a going concern without additional capital.
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 is a clinical-stage company developing first-in-class oral peptide and protein replacement therapies using its N-Tab® platform. Its lead candidate, EB613, an oral teriparatide tablet for postmenopausal osteoporosis, has completed Phase 2 and is moving toward a planned ~750-patient multinational Phase 3 trial using total hip bone mineral density as the primary endpoint under a 505(b)(2) pathway referencing Forteo®.
The company is also advancing EB612, an oral long-acting PTH(1-34) tablet for hypoparathyroidism, and EB618, an oral GLP-1/Glucagon dual agonist for obesity and metabolic disorders, both in collaboration with OPKO, as well as an oral GLP-2 program for short bowel syndrome. Entera reports a broad global patent estate covering EB613, EB612, GLP-1/Glucagon, GLP-2 and the N-Tab® platform, with nominal patent terms extending into the 2030s and 2040s. The company notes Israeli Innovation Authority grants with associated royalty obligations and discloses that, as of June 30, 2025, non-affiliate voting stock held a market value of approximately $84.6 million, with 46,622,239 ordinary shares outstanding as of March 23, 2026.
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. director Germano Geno J reported an open-market purchase of 20,000 Ordinary Shares on March 9, 2026 at a price of 1.30 per share. After this transaction, he directly owns 40,000 Ordinary Shares, doubling his reported direct stake.
Entera Bio Ltd. director Sean Ellis reported an open-market purchase of 10,000 ordinary shares of Entera Bio on March 5, 2026. The weighted average purchase price was $1.23 per share, with individual trades executed between $1.2287 and $1.245. Following this transaction, Ellis directly owns 188,098 ordinary shares of Entera Bio.
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.