Entera Bio(US:ENTX)2025-05-09 20:05Financial Performance - The net loss for Q1 2025 was $2.6 million, or $0.06 per ordinary share, compared to a net loss of $2.0 million, or $0.05 per ordinary share, for Q1 2024[10]. - Total revenues for the three months ended March 31, 2025, were $42,000, compared to $0 for the same period in 2024[18]. - The net loss for the three months ended March 31, 2025, was $2,567,000, compared to a net loss of $2,017,000 in the same period last year, indicating a 27.3% increase in losses[18]. - Loss per share for Q1 2025 was $0.06, compared to $0.05 for Q1 2024[18]. Expenses - Research and development expenses increased to $1.1 million in Q1 2025 from $0.7 million in Q1 2024, primarily due to consulting fees and collaboration costs[12]. - General and administrative expenses rose to $1.4 million in Q1 2025 from $1.3 million in Q1 2024, mainly due to increased IP costs and legal fees related to the OPKO collaboration[12]. - Total operating expenses for Q1 2025 were $2,563,000, compared to $2,062,000 in Q1 2024, marking a 24.3% increase[18]. - Research and development expenses increased to $1,123,000, up from $735,000 year-over-year, representing a 52.7% increase[18]. - General and administrative expenses rose to $1,440,000, compared to $1,327,000 in the prior year, reflecting an 8.5% increase[18]. Assets and Equity - Total assets as of March 31, 2025, were $21,600,000, significantly up from $9,390,000 as of December 31, 2024, representing a 130.5% increase[16]. - Total shareholders' equity increased to $19,379,000 from $8,080,000, reflecting a growth of 140.0%[16]. - Total liabilities rose to $2,221,000 from $1,310,000, indicating a 69.3% increase[16]. Collaboration and Development - Entera is preparing to initiate a Phase 3 registrational study for EB613, the first oral anabolic treatment for osteoporosis, pending FDA qualification of a quantitative BMD endpoint[11]. - The company plans to submit an Investigational New Drug application for the Oral OXM program later in 2025 or early 2026, with OPKO holding a 60% stake in the program[7]. - Entera's collaboration with OPKO includes the development of the first oral GLP-1/glucagon peptide tablet for obesity and the first oral GLP-2 peptide tablet for short bowel syndrome[4]. Team and Market Focus - Entera has strengthened its core team with key appointments, including Leslie Gautam as Chief Business Officer and Cherin Smith as Head of Clinical Operations, both bringing extensive experience in women's health[8]. - The company aims to address significant unmet needs in osteoporosis treatment, with over 54 million individuals in the U.S. at risk for bone health issues[2]. - EB613 has shown promising results in increasing bone mineral density and fracture resistance in postmenopausal women, with data consistent with subcutaneous teriparatide[7]. Cash Position - As of March 31, 2025, Entera had cash and cash equivalents of $20.6 million, with $8 million allocated for collaboration activities with OPKO, expected to support operations through mid-Q3 2026[9].