Entera Bio Announces Full Year 2025 Financial Results and Provides Business Updates

Core Insights - Entera Bio Ltd. is advancing its pipeline of oral peptide therapies, with significant developments in programs targeting osteoporosis, hypoparathyroidism, and metabolic syndromes [2][3][13] Group 1: Product Development Updates - EB613, the first oral anabolic peptide tablet for osteoporosis, has a streamlined Phase 3 protocol submitted to the FDA, with results expected in late 2028, one year earlier than previously anticipated [3][4] - The FDA has aligned with Entera on using bone mineral density (BMD) as the primary endpoint for EB613, marking a significant milestone in the drug's development [3] - EB612, an oral long-acting PTH replacement tablet for hypoparathyroidism, is set to file an IND application in late 2026, in collaboration with OPKO [5][10] - EB618, an oral dual GLP-1/glucagon peptide tablet for metabolic syndromes, has completed PK/PD validation, with Phase 1 initiation expected following injectable formulation data [6] Group 2: Financial Performance - As of December 31, 2025, Entera reported cash and cash equivalents of $14.9 million, with $7.8 million in restricted cash for OPKO collaboration [8] - The net loss for the year ended December 31, 2025, was $11.4 million, consistent with the previous year, reflecting ongoing investment in R&D and operational activities [9][12] - Research and development expenses increased to $6.0 million in 2025, primarily due to regulatory preparations for EB613 and internal program costs [11] Group 3: Clinical Data and Efficacy - Phase 2 data for EB613 demonstrated significant increases in bone indices after six months of treatment, comparable to injectable therapies [10] - New analyses showed EB613's effectiveness in increasing BMD in younger postmenopausal women, highlighting its potential as a preventive treatment for osteoporotic fractures [10]