Entera Bio(US:ENTX)2025-11-14 21:06Financial Performance - Entera Bio reported a net loss of $3.2 million, or $0.07 per ordinary share, for Q3 2025, compared to a net loss of $3.0 million, or $0.08 per ordinary share, in Q3 2024[8]. - Total operating expenses for Q3 2025 were $3.3 million, compared to $3.0 million in Q3 2024[9]. - Entera Bio's total assets increased to $17.4 million as of September 30, 2025, from $9.4 million as of December 31, 2024[14]. Cash Position - Cash and cash equivalents were $16.6 million as of September 30, 2025, including $8.0 million in restricted cash for the OPKO collaboration[7]. Research and Development - Research and development expenses increased to $1.6 million in Q3 2025 from $1.5 million in Q3 2024, reflecting ongoing regulatory and Phase 3 preparation activities for EB613[8]. - The FDA agreed to use bone mineral density (BMD) as the primary endpoint for the Phase 3 study of EB613, which is designed to support a New Drug Application (NDA)[3]. - Phase 2 data for EB613 showed significant increases in trabecular and cortical bone indices after six months of treatment, comparable to injectable therapies[3]. - The company plans to initiate a Phase 1 trial of Next-Gen EB613 in late 2025, with preclinical data supporting its pharmacokinetic profile[3]. Product Development - The dual GLP-1/glucagon OXM tablet program demonstrated plasma levels consistent with the highest subcutaneous dose of Wegovy, indicating potential for obesity treatment[5]. - The oral GLP-2 program for short bowel syndrome showed a plasma half-life of approximately 15 hours, an 18-fold improvement over the current approved therapy[4].