Company: ENTXW
Filing Date: 2025-05-09
Form Type: 10-Q
Source: 0001178913-25-001674
Chunk: 54

Company: Entera Bio Ltd.
Filing Date: 2025-05-09
Form: 10-Q
Item: Part I, Item 8
Chunk 54
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(U.S. dollars in thousands, except share and per share data)

(Unaudited)

            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 tablet formats of peptides or protein replacement therapies. 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) once-daily tablet treatment for post-menopausal women with low bone mineral density (“BMD”) and high-risk osteoporosis with no prior fracture. The Company is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint.
                 
                The Company’s product candidate, EB612, is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for hypoparathyroidism. Additionally, the Company intends to license its N-Tab™ technology to biopharmaceutical companies for use with their proprietary compounds.

                      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”.

                      c.
                      
                        Because the Company is engaged in research and development activities, it has not derived significant income from its activities and, since its inception in 2009, has incurred an accumulated deficit in the amount of $116.5 million as of March 31, 2025 and negative cash flows from operating activities. The Company's management is of the opinion that its available funds as of March 31, 2025 will be sufficient to support the Company’s operations under its current plans through the middle of the third quarter of 2026. This assumes the use of the Company’s capital to fund its ongoing operations, including regulatory and intellectual property expenses, optimization related to the preparation of the EB613 phase 3 program in osteoporosis, ongoing N- TabTM research and development, the