TEL AVIV, Feb. 26, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) ("Entera" or the "Company"), a leader in the development of oral peptide and protein replacement therapies, today announced that the Company’s Chief Executive Officer, Miranda Toledano, will be participating in a fireside chat at the Leerink Partners Global Healthcare Conference 2026, details as below. Leerink Partners Global Healthcare Conference 2026 (Fireside Chat and 1x1 Meetings) Date and Time: March 11, 2026 at 10:40 a.m. Easte ...

Core Insights - Entera Bio Ltd. has appointed Geno J. Germano as the new Chairman of the Board, effective February 4, 2026, succeeding Gerald Lieberman [1] - The company is advancing two oral PTH peptide programs into clinical testing in 2026, including a Phase 3 study for EB613 in osteoporosis and a first-in-human study for Long-Acting Oral PTH in hypoparathyroidism [2] Leadership Changes - Geno J. Germano brings over three decades of leadership experience in the pharmaceutical and life sciences sectors, having held senior roles at Pfizer, including Group President of Pfizer's Global Innovative Pharmaceutical Business, managing a portfolio worth approximately $14 billion [4] - The CEO of Entera, Miranda Toledano, expressed gratitude for the contributions of the outgoing Chairman and emphasized the importance of Germano's experience in scaling therapeutic platforms [3] Product Development - Entera's lead clinical asset, EB613, is positioned to transform osteoporosis treatment by providing an oral anabolic therapy, which could facilitate earlier intervention in treatment paradigms [3] - The company is also developing other oral peptide therapies, including EB612 for hypoparathyroidism and a dual-targeted GLP-1/glucagon peptide for obesity and metabolic syndromes [5]

Core Viewpoint - OPKO Health and Entera Bio are expanding their collaboration to develop innovative oral peptide therapies, including a long-acting PTH analog for hypoparathyroidism and an oral oxyntomodulin for metabolic disorders, with IND applications expected in late 2026 [3][4][5]. Group 1: Collaboration and Development Programs - The collaboration between OPKO and Entera aims to advance the first oral long-acting PTH analog (LA-PTH) as a once-daily tablet for hypoparathyroidism, with an IND application planned for late 2026 [3][4]. - The companies are also developing an injectable and oral oxyntomodulin (OXM) for metabolic and fibrotic disorders, with initial Phase 1 data from the injectable form expected in late 2026 [1][8]. - Under the expanded collaboration agreement, both companies will hold a 50% ownership interest in the LA-PTH program and share development costs equally, while maintaining a 60%/40% ownership structure for the oral OXM program [5]. Group 2: Key Personnel Changes - Steve Rubin, an industry veteran with extensive experience in corporate governance and drug development, has joined Entera's board of directors, replacing Gerry Ostrov [2][6]. Group 3: Clinical Data and Market Potential - Preclinical data for the oral LA-PTH program suggests it could transform treatment for hypoparathyroidism, which currently relies on daily injections of the only approved PTH replacement therapy [7]. - Entera's previous clinical data for its EB612 program indicated significant reductions in calcium supplement use and maintenance of serum calcium levels, although the regimen required multiple daily doses [7]. - The oral oxyntomodulin is positioned as a dual GLP-1/glucagon agonist with potential benefits for obesity and metabolic disorders, with no approved dual agonists currently available [8].

Core Insights - Entera Bio Ltd. is set to achieve significant milestones in Q1 2026, focusing on the development of oral peptide therapies for osteoporosis and hypoparathyroidism [2][3] Group 1: Corporate Milestones - The company plans to submit its final Phase 3 protocol for EB613 to the FDA in Q1 2026, following a favorable FDA ruling on December 19, 2025 [4] - Results from the Phase 1 bridging study of Next-Gen EB613 are expected by the end of Q1 2026, indicating progress in the development of this next-generation candidate [5] - Entera aims to accelerate its hypoparathyroidism program in 2026, leveraging robust preclinical data for a long-acting PTH analog [6] Group 2: Product Development - EB613 is being developed as the first oral PTH(1-34) anabolic tablet treatment specifically for post-menopausal women with osteoporosis [4][6] - The company is also advancing its EB612 program, which focuses on an oral long-acting PTH(1-34) peptide tablet for patients with hypoparathyroidism [6] - Entera is exploring strategic partnerships to optimize the development and commercialization of its oral peptide programs [6] Group 3: Company Vision - Entera Bio is committed to addressing significant unmet medical needs through innovative oral peptide therapies, aiming to transform the standard of care in various therapeutic areas [7]

Core Insights - Entera Bio Ltd. is set to submit its final Phase 3 protocol for EB613 to the FDA in Q1 2026, following a favorable ruling in December 2025 [1][3] - The company is advancing its Next-Generation EB613 Phase 1 bridging study, with results anticipated by the end of Q1 2026 [1][4] - Entera is accelerating its oral hypoparathyroidism tablet program with long-acting PTH variants and is engaged in strategic partnership discussions to enhance its pipeline [1][5] Company Overview - Entera Bio is focused on developing oral peptide and protein replacement therapies for significant unmet medical needs, utilizing its proprietary N-Tab™ technology [6] - The company's lead product, EB613, is an oral PTH(1-34) anabolic tablet aimed at post-menopausal women with osteoporosis, having met primary and secondary endpoints in a Phase 2 study [6] - Entera is also developing EB612, an oral long-acting PTH(1-34) peptide tablet for hypoparathyroidism, and other oral peptide therapies targeting obesity and rare malabsorption conditions [6]

Core Insights - Entera Bio Ltd. announced new in vivo pharmacokinetic and pharmacodynamic data supporting the development of a long-acting parathyroid hormone (PTH) analog for hypoparathyroidism, aiming to create the first once-daily tablet treatment [1][4] Company Overview - Entera Bio is focused on developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab® platform to address significant unmet medical needs [7] - The company is advancing multiple programs, including EB612 for hypoparathyroidism and EB613 for osteoporosis, with a goal of transforming the standard of care through oral formulations [7] Product Development - The EB612 program aims to provide a single, once-daily PTH tablet, addressing the dosing burden associated with current treatments that require daily or weekly injections [3][4] - Recent preclinical findings showed that the proprietary PTH analog achieved a significantly longer plasma half-life and sustained calcium elevation for over three days, compared to unmodified PTH(1-34) controls, which did not elicit a calcium response [1][9] Clinical Evidence - A previous Phase 2 study demonstrated a 42% reduction in median calcium supplement use while maintaining serum calcium levels above the lower limit for hypoparathyroidism patients, although it involved a four-times-a-day dosing regimen [3] - The recent minipig study confirmed the pharmacokinetic and pharmacodynamic profile of the new PTH analog, supporting its potential for once-daily dosing [5][9] Future Plans - Entera plans to present the new data at an upcoming medical conference, indicating ongoing commitment to advancing its clinical programs [6]

Core Insights - Entera Bio Ltd. announced new in vivo pharmacokinetic and pharmacodynamic data supporting the development of a long-acting parathyroid hormone (PTH) analog for hypoparathyroidism, which could lead to a once-daily oral tablet treatment [1][4] Group 1: Product Development - The proprietary PTH analog achieved sustained calcium elevation for over three days from a single oral tablet, contrasting with unmodified PTH(1-34) controls that showed no calcium response [1][8] - Entera's previous Phase 2 study demonstrated a 42% reduction in median calcium supplement use while maintaining serum calcium levels above the lower limit for hypoparathyroidism patients [3] - The current preclinical data represent a significant advancement towards a single, once-daily tablet, addressing the dosing burden of existing treatments [3][5] Group 2: Market Context - Hypoparathyroidism is a rare endocrine disorder characterized by deficient PTH production, leading to hypocalcemia and hyperphosphatemia, with current treatments requiring daily or weekly injections [2] - The only approved PTH replacement treatment requires daily injections, highlighting the need for more convenient alternatives [2] Group 3: Company Overview - Entera Bio is focused on developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab platform [7] - The company is also developing other oral peptide programs targeting conditions such as osteoporosis and obesity, indicating a broad pipeline aimed at significant unmet medical needs [7]

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]