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. (ENTX) has reported promising pharmacokinetic data for its oral GLP-2 analog therapy, OPK-8801003, aimed at treating short bowel syndrome (SBS) [1][4] - The therapy is being developed in collaboration with OPKO Health and could provide a significant alternative to the current treatment, Gattex, which requires daily injections [2][11] Group 1: Therapy Development - OPK-8801003 combines OPKO Health's long-acting GLP-2 analog with Entera's N-Tab oral peptide platform, potentially transforming treatment for approximately 30,000 SBS patients in the U.S. and Europe [2][12] - The therapy demonstrated a plasma half-life of about 15 hours, which is 18 times longer than the 0.85-hour half-life of the current injection option [9][10] - Entera's oral therapy achieved peak plasma concentrations of nearly 200 ng/ml, significantly higher than the 36.8 ng/ml for subcutaneous teduglutide [10] Group 2: Market Potential - The SBS market is valued at nearly $800 million annually, and Entera's oral GLP-2 candidate could capture a share of this market by addressing the limitations of existing treatments [5][13] - The positive pharmacokinetic results not only advance the SBS program but also validate Entera's broader N-Tab oral peptide platform, indicating strong commercial potential [4][13] Group 3: Stock Performance and Investor Sentiment - Year-to-date, Entera Bio's stock has decreased by 15.5%, contrasting with a 3.1% gain in the industry and a 13.4% increase in the S&P 500 [3] - The encouraging pharmacokinetic data is expected to improve investor sentiment, as it serves as a de-risking milestone for the company's pipeline [4][5]

Core Insights - Entera Bio Ltd. is developing an oral GLP-2 therapy, OPK-8801003, which shows a significantly longer biological half-life and comparable peak plasma levels to the only approved GLP-2 therapy, Gattex [1][2][3] Company Overview - Entera Bio is focused on oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ platform to address significant unmet medical needs [6] - The company is collaborating with OPKO Health, Inc. to develop oral peptide candidates for intestinal malabsorption syndromes [2][6] Product Development - OPK-8801003 demonstrated a plasma half-life of approximately 15 hours in preclinical studies, an 18-fold improvement over teduglutide, which has a half-life of only 0.85 hours [7] - Peak plasma concentrations of OPK-8801003 reached ~200 ng/ml, significantly exceeding the reported Cmax of 36.8 ng/ml for teduglutide [7] - The systemic exposure of OPK-8801003 was maintained for over 24 hours, supporting once-daily oral dosing [7] Market Context - Short Bowel Syndrome (SBS) affects approximately 30,000 patients in the U.S. and EU, with current annual sales of Gattex totaling around $800 million [5] - SBS is the most common cause of chronic intestinal failure, accounting for about 75% of cases in adults and 50% in children [5]

Core Viewpoint - Entera Bio Ltd. has presented promising preclinical data for its oral GLP-2 analog, OPK-8801003, which could significantly improve treatment for Short Bowel Syndrome (SBS) patients who currently rely on daily injections of the peptide [1][3]. Company Overview - Entera Bio is a clinical-stage company focused on developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ technology platform [6]. - The company is collaborating with OPKO Health, Inc. to develop oral peptide candidates for intestinal malabsorption syndromes, specifically targeting SBS [2][8]. Product Development - OPK-8801003 demonstrated a plasma half-life of approximately 15 hours in preclinical studies, an 18-fold improvement over the current treatment, teduglutide, which has a half-life of only 0.85 hours [7]. - The peak plasma concentration of OPK-8801003 reached ~200 ng/ml, significantly higher than the reported Cmax of 36.8 ng/ml for teduglutide [7]. - The systemic exposure (AUC) was maintained for over 24 hours, supporting the potential for once-daily oral dosing [7]. Market Context - Approximately 30,000 patients in the U.S. and EU suffer from SBS, with the only approved therapy, Gattex® (teduglutide), generating around $800 million in annual sales [5][2]. - SBS is a leading cause of chronic intestinal failure, accounting for about 75% of cases in adults and 50% in children [5]. Future Implications - The robust oral bioavailability and favorable safety profile of OPK-8801003 could fundamentally change the treatment landscape for SBS, offering a less invasive administration method and personalized dosing options [3][7].

Core Insights - Entera Bio Ltd. announced significant results from its Phase 2 study of EB613, an oral treatment for osteoporosis, showing improvements in both trabecular and cortical bone after just 6 months of treatment [1][2][4] - The company plans to initiate a global registrational Phase 3 study following FDA concurrence in July 2025 [1][4] - EB613 is positioned as a viable alternative to injectable anabolic treatments, which are currently underutilized due to accessibility issues [2][4] Company Overview - Entera Bio is focused on developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ technology [6] - The company's lead product, EB613, is the first oral anabolic treatment for post-menopausal women with osteoporosis, aiming to address significant unmet medical needs [6] - Entera is also developing other oral peptide therapies targeting conditions such as hypoparathyroidism and obesity [6] Clinical Study Results - The Phase 2 study of EB613 involved 161 patients and met all primary and secondary endpoints, demonstrating significant increases in bone mineral density (BMD) and favorable safety profiles [4][5] - Key findings included a 1.7% increase in integral volumetric BMD of the total hip and a 2.6% increase in the femoral neck compared to placebo [5] - Improvements in cortical thickness and surface BMD were also observed, indicating early strengthening effects of EB613 [3][5] Future Developments - Entera plans to begin a Phase 1 clinical trial for its Next-Gen EB613 tablet in late 2025, which has shown comparable pharmacokinetic properties to the current formulation [3][4] - The company aims to address the treatment gap in osteoporosis care with its oral formulation, which is expected to enhance patient compliance and accessibility [2][4]

Summary of Entera Bio Ltd. Conference Call Company Overview - **Company**: Entera Bio Ltd. - **Industry**: Biopharmaceuticals - **Focus**: Development of first-in-class oral peptide therapies for unmet medical needs - **Ticker Symbol**: ENTX (listed on NASDAQ) - **Cash Runway**: Expected to last until Q3 2026 [2][24] Core Technology and Pipeline - **Technology Platform**: NTAB technology platform enables the development of oral peptide therapies in tablet form, overcoming challenges such as proteolytic degradation and molecular polarity [2][3][4] - **Lead Asset**: EB613, the only oral peptide in development for osteoporosis, is set to enter a phase 3 registrational study [2][4][17] - **Other Pipeline Assets**: Include treatments for hypoparathyroidism, metabolic disorders, obesity, and gastrointestinal inflammation [2][4] EB613 Details - **Mechanism of Action**: EB613 is a PTH(1-34) teriparatide tablet that stimulates bone formation and suppresses bone resorption, aiming to provide a validated mechanism of action in a convenient oral format [6][10][12] - **Clinical Studies**: Phase 2 studies showed favorable outcomes in bone formation markers and bone mineral density (BMD) across skeletal sites [12][13][14] - **Comparison with Forteo**: EB613 has a similar amino acid sequence to Forteo but offers a more rapid onset of action and improved BMD outcomes, particularly at the hip [6][14][15] Osteoporosis Market Insights - **Prevalence**: Approximately 200 million women globally are affected by osteoporosis, with significant fracture risks [7][8] - **Current Treatment Landscape**: Most treatments are antiresorptive drugs, with bisphosphonates being the most commonly prescribed [9][10] - **Patient Access Issues**: Many patients do not receive adequate treatment due to the limitations of injectable therapies and the need for healthcare provider resources [11][19] Phase 3 Study Plans - **Study Design**: A double-blind, placebo-controlled, 24-month study focusing on total hip BMD as the primary endpoint, with secondary endpoints including vertebral fracture trends [17][18] - **Regulatory Alignment**: Recent agreement with the FDA allows the use of total hip BMD as a primary endpoint, a significant milestone for the company [18][23] Market Research and Patient Insights - **Clinician Feedback**: 30% of osteoporosis patients experience suboptimal responses to current treatments, highlighting a need for more effective solutions [19] - **Patient Interest**: 55% of surveyed patients expressed interest in oral bone-building treatments, indicating a potential market for EB613 [19] Future Developments - **Partnership with OPKO Health**: Development of an oral oxyntomodulin tablet is underway, with an IND filing expected in early 2026 [5][20] - **Additional Programs**: Plans to validate a different peptide for hypoparathyroidism and to present supplemental data at upcoming conferences [23] Conclusion - Entera Bio Ltd. is positioned to address significant unmet needs in osteoporosis treatment with its innovative oral peptide therapies, particularly EB613, which aims to enhance patient access and compliance compared to existing injectable options [2][19][24]

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]