Core Insights - Entera Bio Ltd. is advancing its pipeline of oral peptide therapies, with significant developments in programs targeting osteoporosis, hypoparathyroidism, and metabolic syndromes [2][3][13] Group 1: Product Development Updates - EB613, the first oral anabolic peptide tablet for osteoporosis, has a streamlined Phase 3 protocol submitted to the FDA, with results expected in late 2028, one year earlier than previously anticipated [3][4] - The FDA has aligned with Entera on using bone mineral density (BMD) as the primary endpoint for EB613, marking a significant milestone in the drug's development [3] - EB612, an oral long-acting PTH replacement tablet for hypoparathyroidism, is set to file an IND application in late 2026, in collaboration with OPKO [5][10] - EB618, an oral dual GLP-1/glucagon peptide tablet for metabolic syndromes, has completed PK/PD validation, with Phase 1 initiation expected following injectable formulation data [6] Group 2: Financial Performance - As of December 31, 2025, Entera reported cash and cash equivalents of $14.9 million, with $7.8 million in restricted cash for OPKO collaboration [8] - The net loss for the year ended December 31, 2025, was $11.4 million, consistent with the previous year, reflecting ongoing investment in R&D and operational activities [9][12] - Research and development expenses increased to $6.0 million in 2025, primarily due to regulatory preparations for EB613 and internal program costs [11] Group 3: Clinical Data and Efficacy - Phase 2 data for EB613 demonstrated significant increases in bone indices after six months of treatment, comparable to injectable therapies [10] - New analyses showed EB613's effectiveness in increasing BMD in younger postmenopausal women, highlighting its potential as a preventive treatment for osteoporotic fractures [10]

Company Overview - Entera Bio Ltd. is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs, aiming to transform the standard of care with oral tablet forms [3] - The company utilizes a proprietary technology platform known as N-Tab® and has a pipeline of first-in-class oral peptide programs targeting PTH(1-34), GLP-1, and GLP-2 [3] Product Development - The most advanced product candidate, EB613 (oral PTH(1-34)), is being developed as the first oral, osteoanabolic once-daily tablet treatment for post-menopausal women with low bone mineral density (BMD) and high-risk osteoporosis [3] - A Phase 2 study of EB613 tablets involving 161 participants met both primary (PD/bone turnover biomarker) and secondary endpoints (BMD) [3] - The EB612 program is focused on developing the first oral PTH(1-34) tablet peptide replacement therapy for hypoparathyroidism [3] - Entera is also developing the first oral oxyntomodulin, a dual-targeted GLP-1/glucagon peptide in tablet form for obesity and metabolic syndromes [3] - Additionally, the company is working on the first oral GLP-2 peptide as an injection-free alternative for patients with rare malabsorption conditions, in collaboration with OPKO Health [3] Upcoming Events - The CEO of Entera Bio, Miranda Toledano, will participate in a fireside chat at the Leerink Partners Global Healthcare Conference 2026 on March 11, 2026, at 10:40 a.m. Eastern Time [2] - The conference will take place in person from March 8–11, 2026, at W South Beach, Miami, Florida, with a live webcast available [2]

Core Viewpoint - Entera Bio Ltd. has announced that several members of its Board of Directors, including the Chairman, have made open market purchases of the Company's ordinary shares, indicating confidence in the Company's future prospects [1][2]. Group 1: Board Purchases - The purchases were made by Geno J. Germano (Chairman), Steven D. Rubin, Haya Taitel, and Sean Ellis, all Directors of the Company [2]. - These transactions were conducted at prevailing market prices and are reported in filings with the U.S. Securities and Exchange Commission [2]. Group 2: Company Overview - Entera Bio is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs [4]. - The Company utilizes a proprietary technology platform (N-Tab®) and has a pipeline of first-in-class oral peptide programs targeting PTH(1-34), GLP-1, and GLP-2 [4]. - The most advanced product candidate, EB613, is being developed as the first oral osteoanabolic treatment for post-menopausal women with low bone mineral density and high-risk osteoporosis [4]. - A Phase 2 study of EB613 met primary and secondary endpoints, demonstrating its potential effectiveness [4]. - Entera is also developing the first oral oxyntomodulin for obesity and metabolic syndromes, and the first oral GLP-2 peptide for rare malabsorption conditions in collaboration with OPKO Health [4].

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 Insights - Entera Bio Ltd. has appointed Geno J. Germano as 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] Company Developments - Entera's lead clinical asset, EB613, is positioned to transform osteoporosis treatment by providing an oral anabolic therapy, which could broaden its use among patients [3] - The company has established a foundation for its oral peptide pipeline and is transitioning to late-stage clinical testing, with Germano's leadership expected to enhance its development and commercialization efforts [3][4] Leadership Background - Geno J. Germano brings over 30 years of experience in the pharmaceutical and life sciences sectors, having held senior roles at Pfizer, including leading a $14 billion innovative medicines portfolio [4] - Germano's previous board experience includes roles at various biotechnology companies, indicating a strong background in guiding clinical-stage firms [4] Product Pipeline - Entera is focused on developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab® technology platform [5] - The company's most advanced product, EB613, is being developed as the first oral treatment for post-menopausal women with low bone mineral density and high-risk osteoporosis [5] - Additional programs include an oral PTH(1-34) tablet for hypoparathyroidism and an oral oxyntomodulin for obesity and metabolic syndromes [5]

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. has received FDA qualification for total hip bone mineral density (BMD) as a validated regulatory endpoint for osteoporosis drug development, which supports its regulatory strategy for EB613 [1][2] - The company aims to democratize anabolic treatment for osteoporosis, addressing the significant unmet medical needs of over 200 million women globally who are estimated to have osteoporosis [2][5] Company Overview - Entera is a clinical-stage company focused on developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ technology platform [7] - The company's lead product, EB613, is being developed as the first oral, once-daily anabolic tablet treatment for post-menopausal women with low BMD and high-risk osteoporosis [4][7] Product Development - EB613 has shown efficacy in a Phase 2 study, meeting all biomarker and BMD endpoints without significant safety concerns, indicating its potential as a transformative treatment option [4] - The FDA's broad qualification of total hip BMD may simplify the regulatory pathway for EB613, allowing for a single Phase 3 study to support a New Drug Application (NDA) [2][3] Industry Context - Osteoporosis is a major public health issue, responsible for over 2 million fractures annually in the US, with significant medical costs projected to rise from $57 billion in 2018 to $95 billion by 2040 [5] - The aging population is expected to increase the incidence of osteoporosis-related fractures, highlighting the need for novel products with enhanced efficacy and ease of use [6]

Core Insights - Entera Bio Ltd. is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs, utilizing its proprietary N-Tab™ technology platform [3] Company Overview - Entera Bio is developing first-in-class oral peptide programs targeting PTH(1-34), GLP-1, and GLP-2, with its most advanced product candidate, EB613, aimed at treating post-menopausal women with low bone mineral density (BMD) and high-risk osteoporosis [3] - The company has successfully completed a placebo-controlled, dose-ranging Phase 2 study of EB613 tablets, which met both primary and secondary endpoints [3] - Other product candidates include EB612 for hypoparathyroidism and an oral oxyntomodulin for obesity and metabolic syndromes, as well as an oral GLP-2 peptide for rare malabsorption conditions in collaboration with OPKO Health [3] Upcoming Events - The CEO of Entera Bio, Miranda Toledano, will participate in a fireside chat at the 8th Annual Evercore ISI Healthcare Conference on December 3, 2024, in Coral Gables, Florida [2]

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]