From GlobeNewswire: 2025-03-28 16:05:00

Entera Bio Ltd. (NASDAQ: ENTX) reported strong financial results and key business achievements for 2024. The company advanced its oral peptide programs, including PTH(1-34), GLP1/Glucagon, and GLP2 tablets, increasing shareholder value and strengthening its balance sheet.

Entera Bio is dedicated to developing EB613, the first oral PTH(1-34) peptide treatment candidate for women with osteoporosis. The company aims to address the significant treatment gap in osteoporosis, a condition that affects millions of women globally.

In 2024, Entera achieved key milestones for EB613, including publishing Phase 2 trial results in the Journal of Bone and Mineral Research and presenting new comparative pharmacological data at the ASBMR Annual Meeting. The company is hopeful for potential updates from the FDA and SABRE on the ruling to qualify the treatment-related change in bone mineral density as a surrogate endpoint for fractures.

Additionally, Entera and OPKO Health announced promising topline PK/PD results for the oral oxyntomodulin (OXM) tablet program, focusing on developing the first oral dual agonist GLP-1/glucagon peptide for obesity. The program showed significant systemic exposure, favorable PK profile, and bioavailability, indicating potential as a once-daily treatment for patients with obesity and metabolic disorders. In March 2025, Entera entered a collaboration with OPKO for the development of Oral OXM, showing significant reduction in plasma glucose levels. The companies expect to file an IND application with the FDA later this year. They also completed a proof of concept study for Oral GLP-2 tablets in 2024, with promising results compared to teduglutide.

Entera presented Phase 1 data for EB612, the first oral PTH(1-34) tablet for hypoparathyroidism, at the ENDO 2024 Annual Meeting. The company plans to move the tablet dose to Phase 2 development. Financially, Entera had $21 million in cash as of March 28, 2025, expected to fund operations into the third quarter of 2026.

Research and development expenses were $4.5 million for both 2023 and 2024, with a decrease due to study completion offset by optimization costs. General and administrative expenses rose to $5.1 million in 2024, mainly due to expanding intellectual property. Operating expenses were $9.6 million in 2024, with a net loss of $9.5 million. Entera is focused on oral peptide therapies for unmet medical needs. Entera Bio is developing oral peptide programs targeting PTH(1-34), GLP-1, and GLP-2. Their lead candidate, EB613, a once-daily tablet for osteoporosis, showed positive results in a Phase 2 study. A Phase 3 study is planned. They are also working on oral oxyntomodulin for obesity and an oral GLP-2 peptide for rare conditions.

Entera Bio’s disruptive N-Tab™ technology platform is driving advancements in oral peptide therapies. EB613, their lead candidate for osteoporosis, met primary and secondary endpoints in a Phase 2 study. Plans for a Phase 3 registrational study are in progress. They are also developing oral peptide therapies for obesity and rare conditions like short bowel syndrome.

Entera Bio is leveraging their N-Tab™ platform to develop oral peptide treatments, including EB613 for osteoporosis. Positive results from a Phase 2 study have led to plans for a Phase 3 registrational study. Additionally, they are working on oral peptide therapies for obesity and rare conditions like short bowel syndrome.



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