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. director Ellis Sean reported buying 18,000 ordinary shares on February 9, 2026. The purchase was coded as an open-market or private purchase at a weighted average price of $1.24 per share, bringing his directly held stake to 178,098 ordinary shares.
The shares were acquired in multiple trades, with prices ranging from $1.18 to $1.299 per share. Sean is listed as a director of Entera Bio, and the filing shows the ownership as held directly rather than through an intermediary entity.
Entera Bio Ltd. director Germano Geno J filed an initial Form 3 reporting no securities beneficially owned in the company. The filing identifies him as a director, with the event date listed as 02/04/2026 and the statement signed by an attorney-in-fact.
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. director Steven D. Rubin filed an initial ownership report on Form 3 related to the company. The filing identifies him as a director and states in the explanation section that "No securities are beneficially owned," indicating he reports no current beneficial ownership of Entera Bio securities.
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. filed details of equity compensation for director Dana Yaacov-Garbeli. On 01/01/2026, the director received 30,157 ordinary shares at a price of $0, bringing total directly held ordinary shares to 77,416. These shares were awarded in lieu of cash fees for services as a director for the 2025 fiscal year.
On the same date, the director was also granted a stock option to buy 33,505 ordinary shares at an exercise price of $1.94 per share, expiring on 01/01/2036. This option represents the Board’s annual option grant to directors and vests ratably on a quarterly basis over a one-year period that began on January 1, 2026. Following these grants, the director beneficially owns 33,505 derivative securities (stock options), all held directly.
Entera Bio Ltd. filed insider transaction details showing equity-based compensation for a company director. On 01/01/2026, the director received 38,294 ordinary shares with par value NIS 0.0000769 per share, reported at a price of $0, in lieu of cash fees for services as a director for the 2025 fiscal year. Following this transaction, the director reported beneficial ownership of 338,454 ordinary shares held directly.
The filing also reports a grant of a stock option on 01/01/2026 to purchase 33,505 ordinary shares at an exercise price of $1.94 per share. These options represent the Board’s annual grant to directors and vest ratably on a quarterly basis over a one-year period that commenced on January 1, 2026.
Entera Bio (ENTX) filed its Q3 2025 10‑Q, showing a clinical-stage profile with minimal revenue and ongoing losses. For the nine months ended September 30, 2025, revenue was $42 thousand and net loss was $8.4M (loss per share $0.18). In Q3, net loss was $3.2M.
Cash, cash equivalents and restricted cash totaled $16.7M at quarter‑end, including $8.0M held in escrow from OPKO’s equity purchase tied to the 2025 collaboration. Operating cash use was $5.5M year‑to‑date. R&D was $4.3M and G&A $4.2M for the period.
Management states substantial doubt about continuing as a going concern. The company believes existing cash supports operations through the middle of Q3 2026, but starting the EB613 Phase 3 program will require additional funding. The FDA agreed that a single 24‑month Phase 3 with total hip BMD as the primary endpoint could support an NDA for EB613, letting the program advance. Capital actions included net ATM proceeds of $6.1M (2,731,574 shares at a weighted average price of $2.29) and the issuance of 3,685,226 shares to OPKO for $8.0M (escrowed).
Shares outstanding were 45,664,506 as of September 30, 2025, and 45,857,242 as of November 10, 2025.
Entera Bio Ltd. reported consolidated cash, cash equivalents and restricted cash of $18.9 million as of June 30, 2025, up from $9.1 million a year earlier, driven by equity financings and a collaboration payment held in escrow. The company recorded a six‑month net loss of $5.2 million (loss per share $0.12), increasing R&D spend to $2.6 million as it prepares for an EB613 Phase 3 program and advances the OPKO collaboration on oral OXM.
Management states available funds should support operations through the middle of the third quarter of 2026 under current plans but excludes the capital required to initiate the EB613 Phase 3 study, and the filing notes this raises substantial doubt about the company’s ability to continue as a going concern. Material near‑term developments include a $8.0 million issuance to OPKO (3,685,226 shares) placed in escrow to fund collaborative program costs and the FDA’s written concurrence (July 28, 2025) that a single 24‑month multinational Phase 3 with total hip BMD primary endpoint can support an NDA for EB613.
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.