On March 27, 2026, Entera Bio Ltd. (NASDAQ: ENTX) announced its financial results for the year ended December 31, 2025, alongside significant business updates. The company reported a net loss of $11.4 million, or $0.25 per ordinary share, compared to a net loss of $9.5 million, or $0.25 per ordinary share, for the previous year. Cash and cash equivalents stood at $14.9 million, including $7.8 million in restricted cash designated for the OPKO collaboration. Entera's research and development expenses increased to $6.0 million, reflecting ongoing regulatory and Phase 3 preparation activities for its lead product, EB613, an oral anabolic peptide for osteoporosis.

The company highlighted key advancements in its pipeline, particularly the EB613 program, which aims to democratize anabolic treatment for osteoporosis. The FDA has aligned with Entera on the primary endpoint of bone mineral density (BMD) for its Phase 3 study, which is expected to begin in late 2026. This study will evaluate the efficacy of EB613 in postmenopausal women with osteoporosis, potentially leading to topline results by the second half of 2028, a year earlier than previously anticipated.

Additionally, Entera is progressing with its other oral peptide candidates, including EB612, a long-acting oral PTH replacement for hypoparathyroidism, and EB618, an oral dual GLP-1/glucagon peptide for metabolic syndromes. The company is actively preparing for IND filings for these candidates, with significant milestones expected in the coming years. Entera's CEO, Miranda Toledano, expressed optimism about the company's trajectory and the potential impact of its innovative therapies on patient care.

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