Summary of Entera Bio Conference Call Company Overview - **Company**: Entera Bio - **Focus**: Development of first-in-class oral peptides, specifically targeting osteoporosis and metabolic diseases [2][34] Key Programs - **EB613**: - First and only osteoanabolic bone-building tablet treatment for postmenopausal women with osteoporosis [2][34] - Recently received FDA green light for registrational phase three study [2][34] - Aims to address the treatment gap in osteoporosis, where less than 25% of women receive treatment post-fracture [8][34] - **Other Programs**: - Long-acting PTH variants for hyperparathyroidism, with preclinical data expected by end of 2025 [3][34] - Dual agonist GLP-1 glucagon tablet treatment, IND filing planned for first half of 2026 [3][34] - GLP-2 tablet for short bowel syndrome, exploring additional indications [3][34] Clinical Development Insights - **Phase Two Data**: - EB613 showed significant improvements in bone mineral density (BMD) across spine, hip, and femoral neck [15][19] - The same 2.5 mg dose will be used in phase three trials [15][19] - **Phase Three Trial**: - Planned as a 24-month multinational study with at least 20% U.S. patient representation [29][31] - Aims to start in the first half of 2026 [31][34] Regulatory and Market Context - **FDA Engagement**: - Entera has had multiple productive meetings with the FDA, clarifying requirements for NDA submission [7][12] - The FDA's acceptance of total hip bone mineral density as a surrogate endpoint is a significant advancement for EB613 [4][10] - **Market Opportunity**: - Osteoporosis has seen little innovation in recent years, with the last approved drug being Evanity in 2019 [8][34] - Entera aims to fill this gap with a novel oral treatment that is easier for patients to use [34] Investment Considerations - **Valuation**: - Entera is positioned as an attractive investment opportunity due to its innovative approach and the potential to change osteoporosis treatment paradigms [34] - The company is focused on closing the treatment gap in osteoporosis, which is a significant unmet medical need [34] Additional Insights - **Geographic Strategy**: - The decision to include 20% U.S. patients is strategic, aiming to align with regulatory expectations while managing costs [29][30] - The company is also exploring markets in Europe and Asia, particularly in regions with high osteoporosis prevalence [30][34] - **Future Milestones**: - Anticipated phase one data for next-generation EB613 in Q1 2026 [32][34] - Plans to report on a third variant of long-acting PTH for hypoparathyroidism preclinically [32][34] This summary encapsulates the key points discussed during the conference call, highlighting Entera Bio's strategic direction, clinical advancements, and market positioning.

Core Viewpoint - OPKO Health and Entera Bio are advancing the development of an oral treatment, OPK-88006, for obesity and metabolic disorders, with new pharmacologic data to be presented at the ENDO 2025 annual meeting [1][2]. Company Overview - OPKO Health is a multinational biopharmaceutical and diagnostics company focused on establishing leading positions in rapidly growing markets through its discovery, development, and commercialization expertise [5]. - Entera Bio is a clinical-stage company developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ technology to address significant unmet medical needs [4]. Product Development - OPK-88006 is a dual agonist GLP-1/glucagon peptide being developed as both a once-daily oral tablet and a weekly injectable treatment [2][3]. - The oral formulation aims to provide a simpler titration process and improved tolerability for patients, with a focus on sustainable weight loss to mitigate comorbidities like severe fatty liver and sleep apnea [3]. - Both companies plan to file an Investigational New Drug application with the U.S. FDA for OPK-88006 later this year, with Phase 1 clinical studies in preparation [3]. Clinical Trials and Research - The upcoming presentation at the ENDO 2025 meeting will showcase in vivo pharmacokinetic and pharmacodynamic results for OPK-88006 [4]. - Entera's advanced product candidate, EB613, is also in development as the first oral treatment for post-menopausal women with low bone mineral density and high-risk osteoporosis, with a Phase 2 study already meeting its endpoints [4].