| DESCRIPTION OF BUSINESS |
NOTE 1 - DESCRIPTION OF BUSINESS
| a. |
Entera Bio Ltd. (collectively with its subsidiary, the "Company") was incorporated on September 30, 2009 and commenced operation on June 1, 2010. On January 8, 2018, the Company incorporated its wholly owned subsidiary, Entera Bio Inc., in Delaware, United States.
The Company is focused on developing first-in-class oral peptides. The Company focuses on underserved, chronic medical conditions for which oral administration of a protein therapy has the potential to significantly shift a treatment paradigm.
The Company’s most advanced product candidate, EB613, oral PTH(1-34), is being developed as the first oral, osteoanabolic (bone building) tablet treatment for post-menopausal women with osteoporosis. In February 2026, the Company submitted to the FDA a clinical amendment which included the EB613 Phase 3 protocol, statistical analysis plan and open-label extension synopsis. In June 2026, the Company received feedback from the FDA on the submitted Phase 3 protocol for EB613 and is planning to initiate the Phase 3 registrational study in late 2026. On July 28, 2026, the Company completed a private placement. The net proceeds from the private placement are expected to be used primarily to support activities related to the planned Phase 3 registrational study of EB613. See Note 8b for additional information.
The Company’s second product candidate, EB612, is being developed as the first oral PTH(1-34) tablet peptide replacement tablet for patients with hypoparathyroidism. In February 2026, the Company amended and restated the 2025 Collaboration Agreement (as defined in Note 6) with OPKO Biologics, Inc., a subsidiary of OPKO Health, Inc. (“OPKO”), to advance the first oral long-acting PTH analog (“LA-PTH”) as a once-daily tablet for patients with hypoparathyroidism.
In addition, EB618 is being developed pursuant to the Company’s collaboration with OPKO, pursuant to which the companies are advancing a proprietary novel dual agonist GLP-1/glucagon peptide as a once-daily tablet treatment for patients with obesity, metabolic and fibrotic disorders.
In addition to its internal product development programs, the Company intends to license its proprietary N-Tab® platform to biopharmaceutical companies for use with their proprietary compounds.
The Company’s second product candidate, EB612, is being developed as the first oral PTH(1-34) tablet peptide replacement tablet for patients with hypoparathyroidism. In February 2026, the Company amended and restated the 2025 Collaboration Agreement (as defined in Note 6) with OPKO Biologics, Inc., a subsidiary of OPKO Health, Inc. (“OPKO”), to advance the first oral long-acting PTH analog (“LA-PTH”) as a once-daily tablet for patients with hypoparathyroidism.
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| b. |
The Company's ordinary shares, NIS 0.0000769 par value per share (“ordinary shares”), are listed on the Nasdaq Capital Market under the symbol “ENTX”.
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| c. |
The Company has incurred recurring operating losses and negative cash flows from operations since inception and expects to continue to incur operating losses as it advances the development of its product candidates. As of June 30, 2026, the Company has incurred an accumulated deficit in the amount of $136.2 million.
As disclosed in Note 8b, in July 2026, the Company completed a private placement financing of an aggregate of 134,803,910 Ordinary Shares and pre-funded warrants to purchase Ordinary Shares resulting in gross proceeds of approximately $275.0 million, before deducting placement agent fees and other related offering expenses. The Company expects to use the net proceeds primarily to support activities related to the initiation of its Phase 3 registrational study of EB613, as well as for general working capital and corporate purposes.
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Following the closing of the private placement and receipt of the related net proceeds, management concluded that substantial doubt about the Company’s ability to continue as a going concern no longer exists. Based on the Company's current operating plan, management believes that the Company's existing cash and cash equivalents, which includes the net proceeds from the private placement, will be sufficient to fund its planned operations for at least twelve months from the date of issuance of these unaudited condensed consolidated financial statements.
| d. |
Since October 2023, Israel has been involved in an armed conflict with Hamas, which has expanded to include hostilities involving Hezbollah, Iran and other armed groups in the region. During the first half of 2026, military activity escalated, including direct military exchanges involving Israel, Iran and the United States, as well as renewed hostilities along Israel's northern border. Although ceasefire arrangements have been announced from time to time, the regional security situation remains uncertain, and there can be no assurance that hostilities will not continue or further escalate.
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The Company's research personnel and members of management are located in Israel, while its clinical, regulatory and supply chain activities are primarily conducted outside Israel. As of June 30, 2026, the Company's operations have remained largely unaffected by these events. For the six months ended June 30, 2026 and 2025, and for the year ended December 31, 2025, the impact of these events on the Company's results of operations and financial condition was not material.
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