Entera Bio(ENTX) - 2025 Q4 - Annual Results

Financial Performance - Entera Bio reported a net loss of $11.4 million, or $0.25 per ordinary share, for the year ended December 31, 2025, compared to a net loss of $9.5 million, or $0.25 per ordinary share, for 2024[9]. - Total operating expenses for 2025 were $11.5 million, compared to $9.6 million in 2024, reflecting increased costs associated with research and administrative activities[11]. - Cash and cash equivalents were $14.9 million as of December 31, 2025, including $7.8 million in restricted cash for the OPKO collaboration, expected to support operations through mid-Q3 2026[8]. Research and Development - Research and development expenses increased to $6.0 million for the year ended December 31, 2025, up from $4.5 million in 2024, primarily due to ongoing regulatory and Phase 3 preparation activities for EB613[10]. - Entera submitted a streamlined Phase 3 protocol for EB613 to the FDA in March 2026, aiming for topline results in the second half of 2028, one year earlier than previously expected[3]. - The planned Phase 3 trial for EB613 will involve 750 postmenopausal women with osteoporosis, with the primary outcome measure being the percentage change in total hip bone mineral density from baseline to month 12[3]. Collaborations and Product Development - Entera's collaboration with OPKO for the development of the oral long-acting PTH tablet (EB612) is fully funded through Phase 1, with an IND application expected to be filed in late 2026[7]. - The company achieved positive preclinical data for its long-acting PTH analogs, showing a significantly longer plasma half-life compared to existing treatments[7]. - Entera's N-Tab® oral peptide platform has shown differentiated preclinical data for multiple targets, including LA-PTH and GLP-1/Glucagon, which are expected to drive value for patients[2]. - The company is developing the first oral dual GLP-1/Glucagon tablet (EB618) for obesity and metabolic diseases, with Phase 1 data expected by year-end 2026 to catalyze its advancement[5].