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.
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.