Company: ENTXW
Filing Date: 2025-11-14
Form Type: 10-Q
Source: 0001178913-25-003852
Chunk: 15

Company: Entera Bio Ltd.
Filing Date: 2025-11-14
Form: 10-Q
Item: Part I, Item 2
Chunk 15
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oparathyroidism. With respect to our EB612 program, since 2023 we tested new generations of our N-Tab™ Technology with the naked PTH(1-34) peptide to assess the effectiveness of once or twice a day dosing regimens, and are collaborating with a third party on another peptide in this field. In June 2024, Phase 1 clinical data for a bid regimen of EB612 using unmodified PTH(1-34) was presented at the Endocrine Society ENDO 2024 Annual Meeting.

To date, Entera’s proprietary PTH tablets have been safely administered to a total of 255 subjects in Phase 1 studies and Phase 2 studies in osteoporosis and hypoparathyroidism, two diseases that remain underserved with the current standard of care and which disproportionately affect women. We believe these product candidates, if approved, hold the potential to become standards of care for patients with osteoporosis and hypoparathyroidism.

Our ability to deliver our oral PTH(1-34) peptide in a simple mini tablet format with reproduceable, dose dependent pharmacokinetics and rapid biological responses across gender, age, and health status was highlighted as part of two poster sessions at the ASBMR 2023 Annual Meeting. We believe our work to date has built the foundation for our oral PTH (1-34) tablets to potentially treat diverse patient populations, including younger men and women athletes at risk of stress fractures.

18

Oral GLP-2 and Oral GLP-1/Glucagon Programs in Collaboration with OPKO Biologics

In September 2023, we entered into a research and collaboration agreement with OPKO Biologics, Inc., a subsidiary of OPKO Health, Inc. (collectively, “OPKO”). Under the terms of this agreement, OPKO agreed to supply its proprietary long-acting GLP-2 peptide and certain oxyntomodulin (OXM) analogs for the development of oral tablet candidates using our proprietary N-Tab™ technology. Under this agreement, we and OPKO have each agreed to be responsible for specific phases of development of the two oral peptides to the point of demonstrated in vivo feasibility.

In March 2024, we announced positive in vivo pharmacokinetic (PK) results from our collaborative research, combining a proprietary long acting GLP-2 agonist developed by OPKO with Entera’s proprietary N-Tab™ technology. The program is focused on developing the