Core Insights - Entera Bio Ltd. has achieved a significant milestone with the FDA agreeing to use Bone Mineral Density (BMD) as the primary endpoint for the Phase 3 study of EB613, an oral treatment for osteoporosis [5][2] - The company reported strong Phase 2 data showing EB613's efficacy in increasing BMD in younger post-menopausal women, highlighting its potential to address a significant unmet medical need in osteoporosis treatment [5][2] - Entera's pipeline includes promising programs for obesity and short bowel syndrome in collaboration with OPKO, with preclinical data showing favorable pharmacokinetics for these oral therapies [4][6] EB613 Developments - EB613 is positioned as the first oral PTH(1-34) anabolic tablet for osteoporosis, with a Phase 3 study designed to evaluate its impact on total hip BMD and vertebral fractures [5][3] - Phase 2 results presented at major medical conferences indicate significant increases in trabecular and cortical bone indices after six months of treatment, comparable to injectable alternatives [5] - New analyses show EB613's ability to drive consistent BMD gains in younger post-menopausal women, with less than 15% of women currently willing to use existing injectable treatments [5] Financial Performance - As of September 30, 2025, Entera reported cash and cash equivalents of $16.6 million, with $8.0 million in restricted cash for OPKO collaboration [8] - The company incurred a net loss of $3.2 million for the quarter, slightly higher than the $3.0 million loss in the same period of 2024, with R&D expenses increasing to $1.6 million [9][10] - Total operating expenses for the quarter were $3.3 million, reflecting ongoing regulatory and Phase 3 preparation activities for EB613 [10] Collaboration and Future Plans - Entera is collaborating with OPKO on the GLP-2 program for short bowel syndrome, with positive pharmacokinetic data indicating a significant improvement over existing therapies [4] - The company is also developing an oral dual GLP-1/glucagon OXM tablet for obesity, with an IND submission planned for H1 2026 [6] - Next-generation EB613 is on track for a Phase 1 trial initiation in late 2025, with preclinical data validating the N-Tab™ platform [5]

Core Insights - Entera Bio Ltd. has presented new clinical data supporting the efficacy of EB613, an oral anabolic treatment for postmenopausal women, at the 2025 NAMS Annual Meeting [1][2] - EB613 is positioned as a first-in-class oral therapy that could significantly improve patient access to bone-building treatments, addressing the limitations of injectable therapies [1][4] Clinical Data Summary - In a Phase 2 trial, EB613 demonstrated statistically significant increases in bone mineral density (BMD) in early postmenopausal women, with a 3.2% increase in femoral neck BMD (p=0.02) and a 2.5% increase in lumbar spine BMD (p=0.08) [3][6] - The trial involved 161 patients and met all primary and secondary endpoints, showing rapid increases in bone formation markers and reductions in bone resorption markers [5][7] Market Potential - EB613 aims to transform osteoporosis treatment by providing an oral option that can be introduced earlier in the treatment journey, potentially increasing patient compliance and access [2][4] - The oral formulation of EB613 addresses a significant barrier in osteoporosis care, as current anabolic therapies are primarily injectable and underutilized [2][5]

Core Insights - Entera Bio Ltd. has presented new clinical data for EB613, an oral anabolic treatment for osteoporosis, demonstrating significant efficacy in increasing bone mineral density (BMD) in postmenopausal women [1][2][4] Group 1: Clinical Findings - EB613 showed statistically significant BMD increases in early postmenopausal women (≤10 years since last menstrual period) compared to placebo, with a 3.2% increase in femoral neck BMD (p=0.02) and a 2.5% increase in lumbar spine BMD (p=0.08) [3][6] - The treatment produced a 3.1% increase in lumbar spine BMD (p=0.05) and a 2.3% increase in total hip BMD (p=0.03) at six months, indicating meaningful improvements in bone strength [6] Group 2: Treatment Potential - EB613 is positioned as the first oral anabolic therapy for osteoporosis, addressing a significant barrier in osteoporosis care by providing a convenient oral option instead of injectable therapies [2][4][5] - The consistency of BMD improvements across different stages of menopause suggests that EB613 could transform osteoporosis treatment by allowing earlier intervention [2][4] Group 3: Future Developments - Entera plans to initiate a global registrational Phase 3 study for EB613 following FDA concurrence in July 2025, aiming to expand patient access to this innovative treatment [1][4]

Core Insights - Entera Bio Ltd. will present new clinical data from its Phase 2 trial of EB613 at the North American Menopause Society (NAMS) 2025 Annual Meeting, marking its first presentation at this event [1][2] - The presentation will focus on bone mineral density outcomes in early postmenopausal women with low bone mass or osteoporosis, highlighting the potential role of EB613 in earlier treatment stages [2][3] Company Overview - Entera Bio is a clinical stage company developing oral peptide and protein replacement therapies, aiming to transform the standard of care for significant unmet medical needs [6] - The company's lead product candidate, EB613, is being developed as the first oral, once-daily anabolic tablet treatment for osteoporosis, specifically targeting postmenopausal women with low bone mass [5][6] Product Details - EB613 has shown efficacy in a Phase 2, 6-month, placebo-controlled study involving 161 patients, meeting all biomarker and bone mineral density endpoints without significant safety concerns [5] - The treatment produced rapid increases in biochemical markers of bone formation and reductions in markers of bone resorption, along with increased bone mineral density in key areas [5] Market Context - Anabolic therapies for osteoporosis are underutilized, primarily due to their availability only as injections, which limits access for many eligible patients [3][5] - Entera Bio's oral formulation of EB613 has the potential to broaden access for over 200 million women worldwide living with osteoporosis, addressing a critical gap in treatment options [3][5]

Core Insights - Entera Bio Ltd. is set to present data on three key programs in September 2025, focusing on oral peptide and protein replacement therapies for significant medical needs [1][4][7] Osteoporosis Program - EB613 is being developed as the first once-daily oral anabolic tablet for postmenopausal women with osteoporosis, showing rapid onset of action and increases in bone mineral density (BMD) in a Phase 2 study involving 161 participants [1][7] - A global Phase 3 registration study for EB613 is planned following alignment with the FDA, with BMD as the primary endpoint [7] Short Bowel Syndrome and Rare GI Disorders - The oral GLP-2 tablet program combines a long-acting GLP-2 agonist with Entera's proprietary N-Tab™ technology, providing an injection-free alternative for patients with short bowel syndrome and related gastrointestinal disorders [2][7] Upcoming Presentations - Entera's CEO will present at the H.C. Wainwright 27th Annual Global Investment Conference on September 5, 2025, highlighting the company's advancements in oral peptide therapies [3][4] - Specific presentations include the effects of EB613 on trabecular and cortical bone and pre-clinical data for Next-Gen EB613 [5][6]

Core Insights - Entera Bio Ltd. has achieved a significant milestone with the FDA's agreement to use Bone Mineral Density (BMD) as the primary endpoint for the Phase 3 program of EB613, marking a step towards the first oral anabolic osteoporosis treatment [2][4][5] - The company reported a cash position of $18.9 million as of June 30, 2025, which is expected to support operations through mid-Q3 2026 [9][10] - Entera is advancing multiple programs, including the oral GLP-1/glucagon dual agonist in collaboration with OPKO Health, and is preparing for a Phase 1 study of the next-generation EB613 [2][4][14] Financial Results - For the quarter ended June 30, 2025, Entera reported a net loss of $2.7 million, or $0.06 per share, compared to a net loss of $2.1 million, or $0.06 per share, for the same period in 2024 [10][19] - Research and development expenses increased to $1.5 million from $1.1 million year-over-year, primarily due to regulatory activities and Phase 3 planning for EB613 [10][11] - Total operating expenses for the quarter were $2.7 million, up from $2.2 million in the previous year [11][19] Business Updates - The FDA has waived additional safety studies for EB613, allowing for a streamlined pathway to market [4][5] - Entera's collaboration with OPKO Health is showing strong momentum, particularly in obesity and hypoparathyroidism programs [2][4][14] - The next-generation EB613 is expected to enter Phase 1 clinical trials in November 2025, utilizing Entera's proprietary N-TAB™ technology [4][12]

Core Insights - Entera Bio Ltd. reported financial results and business updates for Q1 2025, highlighting progress in its oral peptide and protein replacement therapies, particularly EB613 for osteoporosis and Oral OPK-88006 for metabolic diseases [1][2][12]. Financial Performance - As of March 31, 2025, Entera had cash and cash equivalents of $20.6 million, with $8 million allocated for collaboration with OPKO, expected to sustain operations through mid-Q3 2026 [12]. - The net loss for Q1 2025 was $2.6 million, or $0.06 per share, compared to a net loss of $2.0 million, or $0.05 per share, in Q1 2024 [13][21]. Product Development - EB613 is the first oral anabolic treatment for postmenopausal women with osteoporosis, with plans to initiate a Phase 1 study in H2 2025 [2][3]. - The company is preparing for a pivotal program for EB613, which has shown promising results in increasing bone mineral density (BMD) [3][4]. - Entera is also developing Oral OPK-88006, a dual-acting GLP1/Glucagon tablet for metabolic diseases, with a 40% stake in its economics [2][10]. Clinical Advancements - EB613's early mechanistic effects were selected for oral presentation at the 2025 World Congress on Osteoporosis, indicating strong interest in its clinical potential [2]. - The SABRE initiative is advocating for regulatory reform to qualify BMD as a surrogate endpoint for fracture risk, which could facilitate the approval of new osteoporosis treatments [3]. Team Expansion - Entera has strengthened its core team with the appointment of Leslie Gautam as Chief Business Officer and Cherin Smith as Head of Clinical Operations, both bringing extensive experience in women's health and clinical operations [8][11].

Core Insights - Entera Bio Ltd. is developing EB613, the first once-daily oral anabolic PTH(1-34) tablet for postmenopausal women with osteoporosis at high risk for fracture [1][4] - The Phase 2 study showed significant increases in bone mineral density (BMD) at various skeletal sites compared to placebo, indicating a dual effect of stimulating bone formation and inhibiting resorption [1][2] - The company plans to initiate a Phase 3 registrational study for EB613 following positive Phase 2 results [5] Company Overview - Entera Bio is a clinical-stage company focused on oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ technology [5] - The company's pipeline includes five differentiated oral peptide programs targeting conditions such as osteoporosis, hypoparathyroidism, and obesity [5] - EB613 is positioned as a solution for the treatment gap in osteoporosis care, aiming to provide a simple daily tablet for patients who currently lack effective treatment options [4][5] Clinical Study Findings - The Phase 2 study randomized 161 postmenopausal women and demonstrated early effects on trabecular and cortical bone, suggesting rapid bone strengthening and fracture resistance [2][3] - 3D-DXA analysis revealed substantial improvements in areal BMD at the total hip and femoral neck, consistent with results from subcutaneous teriparatide [3] - The study's findings indicate a broad distribution of bone loss with placebo and a similar distribution of bone gain with EB613 in the femur [2] Market Context - Osteoporosis affects approximately 200 million women globally, with a significant risk of fragility fractures, particularly in postmenopausal women [4] - Current injectable anabolic treatments are not viable for many patients, highlighting the need for an effective oral treatment like EB613 [4]

Core Insights - Entera Bio Ltd. announced positive results from a Phase 2 study of EB613, an oral PTH(1-34) tablet aimed at treating postmenopausal women with osteoporosis at high risk for fractures [1][2][4] - The study demonstrated significant increases in bone mineral density (BMD) across various skeletal sites compared to placebo, indicating the potential for rapid bone strengthening and fracture resistance [2][3] Company Overview - Entera Bio is focused on developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ technology platform [5] - The company's lead product, EB613, is positioned as the first oral anabolic treatment for postmenopausal women with low BMD and high-risk osteoporosis [5] - Entera is preparing to initiate a Phase 3 registrational study for EB613 following FDA qualification of a quantitative BMD endpoint [5] Study Details - The Phase 2 study involved 161 postmenopausal women and assessed the effects of EB613 over 6 months, showing improvements in integral volumetric BMD, trabecular volumetric BMD, cortical thickness, and cortical surface BMD compared to placebo [2][3] - 3D-DXA analysis indicated a dual effect of EB613, stimulating bone formation while inhibiting resorption, with significant improvements noted in both trabecular and cortical bone [1][2] Market Context - Osteoporosis is a significant health concern, affecting approximately 200 million women globally, with a high risk of fragility fractures [4] - Current injectable anabolic treatments are not viable for many patients, highlighting the need for an effective oral treatment option like EB613 [4]