Entera Bio(ENTX) - 2025 Q2 - Quarterly Results

Entera Bio Second Quarter 2025 Results Entera Bio reported its second quarter 2025 results, highlighting a pivotal FDA agreement for EB613's Phase 3 trial, significant pipeline advancements, and a strengthened financial position CEO Statement & Key Highlights Entera Bio secured FDA agreement on EB613's Phase 3 trial design, validating BMD as the primary endpoint, and strengthened its cash position to $18.9 million, extending operational runway through mid-Q3 2026 - The FDA agreed to use Bone Mineral Density (BMD) as the primary endpoint for the EB613 Phase 3 program, creating a streamlined pathway for the first oral anabolic osteoporosis treatment[3][5][6] - The company's cash position is $18.9 million as of June 30, 2025, which is expected to fund operations through the middle of the third quarter of 2026[3][5][9] - Promising pharmacokinetic data was presented for the oral GLP-1/glucagon dual agonist program for obesity, developed in collaboration with OPKO[3][12] Pipeline Updates Entera Bio reported significant pipeline progress, including a key regulatory agreement for EB613, advancements in hypoparathyroidism, and positive preclinical data from the OPKO collaboration EB613 (Osteoporosis) Entera secured FDA agreement on Bone Mineral Density (BMD) as the primary endpoint for EB613's Phase 3 trial, reducing regulatory burden and advancing a next-generation tablet into Phase 1 by November 2025 - The FDA concurred on a single 24-month Phase 3 study design using change in total hip BMD as the primary endpoint and vertebral fracture incidence as the key secondary endpoint[6] - The regulatory burden was significantly reduced as the FDA agreed that dedicated oral carcinogenicity and comprehensive DART studies are not warranted[6] - A next-generation EB613 tablet, utilizing the N-Tab™ technology, is expected to enter a Phase 1 Safety and PK Study in November 2025[5][12] Hypoparathyroidism Program Entera is developing EB612, an oral PTH(1-34) replacement for hypoparathyroidism, with initial preclinical PK/PD data for a long-acting PTH agonist expected by year-end - First pre-clinical PK/PD data for a once-daily tablet format for hypoparathyroidism is expected by the end of the year[7] OPKO Health Collaboration Programs The OPKO Health collaboration shows promising preclinical PK data for oral obesity treatment OPK-88006, with an IND filing planned for H1 2026, and advances in the short bowel syndrome program - Obesity (OPK-88006): A mini-pig study showed plasma levels consistent with the highest subcutaneous dose of Wegovy™, supporting a once-daily tablet regimen. An IND filing is expected in H1 2026[12] - Short Bowel Syndrome (GLP-2): An abstract for the first-in-class oral GLP-2 analog was selected for a poster presentation at the 47th ESPEN Congress[12] Second Quarter 2025 Financial Results Entera Bio reported a $2.7 million net loss for Q2 2025, driven by increased R&D for EB613, while maintaining a strong $18.9 million cash position with runway through mid-Q3 2026 Financial Position (Balance Sheet) As of June 30, 2025, cash and cash equivalents, including restricted cash, significantly increased to $18.9 million, driving total assets to $19.7 million - Cash and cash equivalents were $18.9 million as of June 30, 2025, including $8.0 million in restricted cash designated for the OPKO collaboration[9] - The current cash on hand is expected to support operations through the mid-third quarter of 2026[9] Balance Sheet Summary (in thousands) | (in thousands) | June 30, 2025 (Unaudited) | December 31, 2024 (Audited) | | :--- | :--- | :--- | | Cash and cash equivalents | $10,858 | $8,660 | | Restricted cash | $8,015 | - | | Total Assets | $19,667 | $9,390 | | Total Liabilities | $2,411 | $1,310 | | Total Shareholders' Equity | $17,256 | $8,080 | Financial Performance (Statement of Operations) For Q2 2025, the company reported a $2.7 million net loss, or $0.06 per share, primarily due to a $0.4 million increase in R&D expenses for EB613 Phase 3 planning Statement of Operations Summary (in thousands, except per share data) | (in thousands, except per share data) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Research and development | $1,520 | $1,086 | | General and administrative | $1,148 | $1,088 | | Total Operating Expenses | $2,668 | $2,174 | | Net Loss | $2,656 | $2,145 | | Loss Per Share | $0.06 | $0.06 | - The increase in R&D expenses by $0.4 million year-over-year was primarily due to regulatory activities and Phase 3 planning for EB613[10]