Company: ENTXW
Filing Date: 2025-03-17
Form Type: 8-K
Source: 0001178913-25-000857
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Company: Entera Bio Ltd.
Filing Date: 2025-03-17
Form: 8-K
Item: Item 1.01
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Item 1.01 Entry into a Material Definitive Agreement

On March 16, 2025 (the “ Effective Date”),
Entera Bio Ltd., a company organized under the laws of the State of Israel (the “Company”), entered into collaboration and license agreement (the “ Collaboration Agreement”) with OPKO Health, Inc., a Delaware corporation (“ OPKO
Health”), and OPKO Biologics Ltd., a company organized under the laws of the State of Israel (“ OPKO Biologics” and, together with OPKO
Health, “ OPKO”), to collaborate with respect to the preclinical and clinical development and decision making related to the oral delivery of a dual agonist
GLP-1/glucagon peptide in an oral dosage form using Entera’s N-Tab™ technology platform 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.

License. Under the
Collaboration Agreement, the Company has granted to OPKO an exclusive, sublicensable and non-transferable, worldwide license to certain of its 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 the Company a non-exclusive, non-sublicensable and non-transferable license
to certain of its intellectual property and technology to the extent necessary for the Company to perform its obligations in relation to the Program, in each case subject to the exceptions contained therein.

Development Program; Costs;
Financial Interests. Under the terms of the Collaboration Agreement, the Company and OPKO will retain 40% and 60%, respectively, of all proceeds deriving from the Program, and will be responsible for 40% and 60% of the Program’s
development costs, respectively. Following the completion of the Phase 1 stage, the Company has the option to continue to fund its 40% share of the Program to maintain its right to proceeds or to opt-out (the “ Opt-Out”). If the Company exercises its right to Opt-Out, then the Company and OPKO will retain 15% and 85%, respectively, of all proceeds deriving