Entera Bio(US:ENTX)2025-03-28 20:06Financial Performance - Entera Bio reported cash and cash equivalents of $8.7 million as of December 31, 2024, which increased to $21 million by March 28, 2025, primarily due to investments from institutional shareholders and OPKO[9]. - The net loss for 2024 was $9.5 million, or $0.25 per share, compared to a net loss of $8.9 million, or $0.31 per share, in 2023[10]. - Revenues for the year ended December 31, 2024, were $181 million, with no revenues reported for 2023[18]. - Gross profit for 2024 was $9 million, indicating a significant loss in revenue generation[18]. - Operating loss for 2024 was $9,585 million, compared to an operating loss of $8,891 million in 2023[18]. - Net loss for 2024 was $9,541 million, compared to a net loss of $8,889 million in 2023, reflecting a year-over-year increase of approximately 7.3%[18]. - Basic and diluted loss per share improved to $0.25 in 2024 from $0.31 in 2023[18]. - The weighted average number of shares outstanding increased to 37,650,179 in 2024 from 29,007,794 in 2023[18]. - Financial income, net, worsened to $(58) million in 2024 from $(31) million in 2023[18]. Expenses - Research and development expenses for 2024 were $4.5 million, consistent with 2023, while general and administrative expenses rose to $5.1 million from $4.4 million in 2023, reflecting an increase in intellectual property and advisor compensation[10]. - Total operating expenses increased to $9,594 million in 2024 from $8,891 million in 2023, representing an increase of approximately 7.9%[18]. - Research and development expenses slightly decreased to $4,499 million in 2024 from $4,510 million in 2023[18]. - General and administrative expenses rose to $5,095 million in 2024, up from $4,430 million in 2023, marking an increase of approximately 15%[18]. Assets and Liabilities - Entera's total assets decreased from $11.8 million in 2023 to $9.4 million in 2024, while total liabilities slightly decreased from $1.4 million to $1.3 million[16]. Product Development - Entera is developing EB613, the first oral PTH(1-34) tablet for osteoporosis, with a Phase 3 study expected to initiate following FDA's ruling on the SABRE project[4][3]. - The oral oxyntomodulin (OXM) program, in collaboration with OPKO, aims to create a once-daily treatment for obesity, with significant pharmacokinetic results indicating high plasma concentrations and prolonged exposure[7]. - Entera's oral GLP-2 tablets for short bowel syndrome showed plasma levels approximately 10-fold higher than therapeutic concentrations of subcutaneously administered teduglutide, indicating a potential for improved patient compliance[7]. - The FDA is expected to provide a ruling on the SABRE project within 10 months, which could qualify bone mineral density changes as a surrogate endpoint for future osteoporosis drug trials[4]. - Entera's collaboration with OPKO includes a 60% ownership interest for OPKO and 40% for Entera in the oral OXM program, with shared development costs[7]. - The company plans to continue its focus on execution and value addition in 2025, with ongoing work related to EB613 and other product candidates[3].