Company: ENTXW
Filing Date: 2025-05-09
Form Type: 10-Q
Source: 0001178913-25-001674
Chunk: 17

Company: Entera Bio Ltd.
Filing Date: 2025-05-09
Form: 10-Q
Item: Part I, Item 1
Chunk 17
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 and estimated costs of the efforts that will be necessary to complete the development of, or the period, if any, in which material net cash inflows may commence from any of our product candidates. This is due to numerous risks and uncertainties associated with developing drugs, including:

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                          the uncertainty of the scope, rate of progress, results and cost of our clinical trials, nonclinical testing and other related activities;

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                          the cost of manufacturing clinical supplies and establishing commercial supplies of our product candidates and any products that we may develop;

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                          the number and characteristics of product candidates that we pursue;

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                          the cost, timing and outcomes of regulatory approvals;

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                          the cost and timing of establishing any sales, marketing, and distribution capabilities; and

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                          the terms and timing of any collaborative, licensing and other arrangements that we may establish, including any milestone and royalty payments thereunder.

                  A change in the outcome of any of these variables with respect to the development of EB613, EB612 or any other product candidate that we may develop could significantly change the costs and timing associated with the development of any such product candidate. For example, if the FDA or other regulatory authority were to require us to conduct preclinical or clinical studies beyond those that we currently anticipate will be required for the completion of clinical development, if we experience significant delays in enrollment in any clinical trials or if we encounter difficulties in manufacturing our clinical supplies, then we could be required to expend significant additional financial resources and time on the completion of the clinical development.
                  
                    20

                  General and Administrative Expenses
                   
                  General and administrative expenses consist principally of salaries and related expenses, share-based compensation and related costs for directors and personnel in executive and finance functions. Other general and administrative expenses include D&O insurance and other insurance, communication expenses, professional fees for legal and accounting services, costs associated with maintaining and prosecuting our intellectual property portfolio and business development expenses.
                   
                  Financial Income, Net
                   
                  Financial income, net is composed primarily of interest income from bank deposits and exchange rate differences of certain currencies against our functional currency, which is the U.S. Dollar.
                   
                  Taxes on Income
                   
                  We have not generated taxable income since our inception, and, as of March 31, 2025, we had carryforward tax losses of $85.6 million.
                   
                  We anticipate that we will be able to carry forward these tax losses indefinitely