Company: ENTXW
Filing Date: 2025-11-14
Form Type: 10-Q
Source: 0001178913-25-003852
Chunk: 17

Company: Entera Bio Ltd.
Filing Date: 2025-11-14
Form: 10-Q
Item: Part I, Item 2
Chunk 17
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 of obesity. The reported pharmacological data supports a once-daily tablet regimen of this first-in-class oral dual agonist. A Phase 1 study is being planned and an Investigational New Drug (IND) application is expected to be filed with the FDA in the first half of 2026.

In September 2025 pharmacokinetic data from a mini-pig study of OPK-8801003, our oral GLP-2 analog developed in collaboration with OPKO, were presented at the 47th European Society for Clinical Nutrition & Metabolism (ESPEN) Congress. The data demonstrated a plasma half-life approximately 18 times longer than teduglutide, in the same species. Oral administration achieved peak plasma levels of ~200 ng/mL and maintained systemic exposure (AUC ≈ 2 h•μg/mL) for over 24 hours with low variability, supporting once-daily oral dosing.

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Patent Transfer, Licensing Agreements and Grant Funding

Collaboration and License Agreement with OPKO

On March 16, 2025, we entered into a collaboration and license agreement (the “2025 Collaboration Agreement”) with OPKO to collaborate with respect to the preclinical and clinical development and decision making related to the Oral OXM program for the treatment of obesity, metabolic and fibrotic disorders in humans (the “Program”). The Program combines OPKO’s proprietary long-acting oxyntomodulin (OXM, dual targeted GLP-1/Glucagon agonist, OPK-88006) analog and Entera’s proprietary N-Tab™ technology.

Under the 2025 Collaboration Agreement, we granted to OPKO an exclusive, sublicensable and non-transferable, worldwide license to certain of our intellectual property and technology solely to develop, manufacture, and commercialize any GLP-1/Glucagon  dual agonist as an oral treatment form for the treatment of obesity, metabolic, cardiovascular, and fibrotic disorders in humans, and OPKO has granted to us a non-exclusive, non-sublicensable and non-transferable license to certain of its intellectual property and technology to the extent necessary for us to perform our obligations in relation to the Program, in each case subject to the exceptions contained therein.

Under the terms of the 2025 Collaboration Agreement, we and OPKO will retain 40% and 60%, respectively, of all proceeds deriving from the Program, and will be responsible for 40% and 60%