Consistency of BMD gains presented at NAMS 2025 demonstrate EB613's efficacy in both young postmenopausal women and in women 10 years post-menopause Data further support EB613 potential as a first-in-class oral anabolic treatment option that could dramatically expand patient access to bone-building therapyEntera Plans to Initiate Global Registrational Phase 3 Study Following July 2025 FDA ConcurrenceJERUSALEM, Oct. 23, 2025 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:ENTX), a leader in the development of or ...

Consistency of BMD gains presented at NAMS 2025 demonstrate EB613’s efficacy in both young postmenopausal women and in women 10 years post-menopause Data further support EB613 potential as a first-in-class oral anabolic treatment option that could dramatically expand patient access to bone-building therapy Entera Plans to Initiate Global Registrational Phase 3 Study Following July 2025 FDA Concurrence JERUSALEM, Oct. 23, 2025 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (Nasdaq: ENTX), a leader in the development o ...

First-time presentation examining bone outcomes in early postmenopausal womenJERUSALEM, Oct. 16, 2025 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptide and protein replacement therapies, today announced that it will present new clinical data from its Phase 2 trial of EB613 at the upcoming North American Menopause Society (NAMS) 2025 Annual Meeting, taking place October 21–25, 2025, in Orlando, Florida. This will mark Entera’s first presentation at NAMS. The pres ...

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]

Osteoporosis Program: Phase 2 analysis exploring the dual actions of oral PTH(1-34) tablet treatment, EB613 on trabecular and cortical bone, and Next-Gen EB613 PK/PD data slated for oral and poster presentations at ASBMRShort Bowel Syndome and Rare GI Disorders: PK/PD of oral GLP-2 tablet candidate poster presentation at ESPENCorporate Overview at H.C. Wainwright Investor Conference JERUSALEM, Aug. 28, 2025 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptides and ...

Core Insights - Entera Bio reported a better-than-expected GAAP earnings per share of $0.06 for Q2 2025, contrasting with Wall Street's estimate of a loss of $(0.11) [1] - The company did not report any revenue for the quarter, down from $57,000 in Q2 2024, indicating a 100% year-over-year decline [2] - A significant regulatory breakthrough was achieved with the FDA's concurrence on the design for the Phase 3 trial of EB613, marking a key advancement in the company's product pipeline [5][6] Financial Performance - GAAP EPS for Q2 2025 was $(0.06), better than the estimated $(0.11) [2] - No revenue was reported for Q2 2025, compared to $57,000 in Q2 2024, reflecting a 100% decrease [2] - Research and Development expenses increased by 39.9% to $1.52 million from $1.09 million in Q2 2024 [2] - General & Administrative expenses rose by 5.5% to $1.15 million [2] - Cash and cash equivalents increased by 25.4% to $10.86 million compared to $8.66 million as of December 31, 2024 [2][8] Business Overview - Entera Bio focuses on oral delivery of protein and peptide drugs, utilizing its N-Tab™ technology to enhance stability and absorption of peptides [3] - The company aims to address challenges in pharmaceutical development by providing oral alternatives to injectable therapies [3][4] Key Developments - The FDA's agreement on using total hip bone mineral density as the primary measure of effectiveness for EB613's Phase 3 trial streamlines the regulatory process [5] - Positive results from a completed Phase 2 study of EB613 were presented, showing improvements in bone strength and mineralization compared to placebo [6] - The company is preparing to initiate a pivotal Phase 3 trial for EB613 with the new design [6] Future Outlook - Entera Bio plans to launch a Phase 1 trial for an updated version of EB613 in November 2025 [9] - Development of OPKO-partnered candidates, including an oral GLP-1/glucagon product, is expected to progress in H1 2026 [9] - Management did not provide specific revenue or earnings guidance but highlighted key operational milestones for the upcoming year [9][10]