Company: ENTXW
Filing Date: 2025-08-08
Form Type: 10-Q
Source: 0001178913-25-002702
Chunk: 10

Company: Entera Bio Ltd.
Filing Date: 2025-08-08
Form: 10-Q
Item: Part I, Item 2
Chunk 10
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 trials and the enrollment of patients in clinical trials. Research and development expenses for the three and six months ended June 30, 2025 were primarily for the development of EB613 and our collaboration with OPKO related to OXM and for the three and six months ended June 30, 2024 were primarily for the development of EB613. The successful development of our product candidates is highly uncertain. At this time, we cannot reasonably estimate the nature, timing 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, OXM 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.

Our research and development expenses for the three and six months ended June 30, 2025 and June 30, 2024 are summarized as follows:

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                  Six Months Ended June 30,(unaudited)

                  Three Months Ended June 30,(unaudited)

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                  2025

                  ​2024

                  2025

                  2024

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                  (In thousands)

                  (In thousands)