Welcome to our dedicated page for Entera Bio 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.
The Entera Bio Ltd. (ENTX) SEC filings page on Stock Titan provides access to the company’s U.S. regulatory disclosures as a NASDAQ-listed issuer. Entera Bio is a clinical-stage biopharmaceutical company organized under the laws of Israel that develops oral peptide and protein replacement therapies using its proprietary N-Tab™ platform. Its filings with the U.S. Securities and Exchange Commission offer detailed information on clinical progress, regulatory interactions, financial position and material events.
Investors can review current reports on Form 8-K, which Entera Bio uses to announce significant developments such as FDA feedback on its EB613 Phase 3 study design, written agreements on nonclinical study requirements, and quarterly financial results. For example, recent 8-K filings describe FDA concurrence that a single 24‑month Phase 3 trial using total hip bone mineral density as the primary endpoint would support a New Drug Application for EB613, and outline the company’s financial results for specific quarters.
Over time, this page will also surface annual reports (Form 10-K or 20-F equivalents for foreign issuers), quarterly reports, and other registration or offering documents that Entera Bio files, where available in EDGAR. These filings typically discuss the company’s pipeline, including EB613 for osteoporosis, EB612 for hypoparathyroidism, and collaboration programs with OPKO Health for oral GLP-2 and oxyntomodulin tablet candidates.
Stock Titan enhances these documents with AI-powered summaries that explain the key points of lengthy filings, helping users quickly understand clinical milestones, regulatory updates, risk factors and capital structure details. Users can also monitor insider and related transaction disclosures when reported on forms such as Form 4, alongside other material events that may affect ENTX. With real-time updates from EDGAR and simplified explanations, this page is designed to make Entera Bio’s SEC reporting more accessible to both experienced and newer investors.
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.
Entera Bio Ltd. director Steven D. Rubin reported an open-market purchase of 5,000 ordinary shares at $1.49 per share on February 12, 2026. Following this transaction, he directly beneficially owns 15,000 ordinary shares of Entera Bio.
Entera Bio Ltd. director Haya Taitel reported buying 7,500 ordinary shares on February 10, 2026. The Form 4 shows a purchase at a weighted average price of $1.48 per share, executed through multiple trades between $1.47 and $1.4799, with the holding reported as direct ownership.
Entera Bio Ltd. director transaction: Director Germano J. Geno reported buying 20,000 ordinary shares of Entera Bio Ltd. on February 10, 2026. The shares, each with a par value of NIS 0.0000769, were purchased in a direct ownership transaction at a price of $1.49 per share.
Entera Bio director Steven D. Rubin reported a share purchase. On February 9, 2026, he bought 10,000 Ordinary Shares of Entera Bio Ltd. at $1.20 per share.
Following this transaction, Rubin beneficially owns 10,000 Ordinary Shares, all held in direct ownership.