Final EB613 Phase 3 Protocol Submission to FDA Planned for Q1 2026, Following December 19th 2025 FDA RulingNext-Generation EB613 Phase 1 Bridging Study Progressing with Results Expected During Q1 2026                   Oral Hypoparathyroidism Tablet Program to Accelerate with Lead Long-Acting PTH VariantsStrategic Partnership Discussions Advancing Across PipelineJERUSALEM, Jan. 21, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:ENTX) ("Entera" or the "Company"), a leader in the development of oral peptide ...

Final EB613 Phase 3 Protocol Submission to FDA Planned for Q1 2026, Following December 19th 2025 FDA Ruling Next-Generation EB613 Phase 1 Bridging Study Progressing with Results Expected During Q1 2026 Oral Hypoparathyroidism Tablet Program to Accelerate with Lead Long-Acting PTH Variants Strategic Partnership Discussions Advancing Across Pipeline JERUSALEM, Jan. 21, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) ("Entera" or the "Company"), a leader in the development of oral peptide and protein ...

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. has received FDA qualification for total hip bone mineral density (BMD) as a validated regulatory endpoint for osteoporosis drug development, which supports the company's strategy for its product EB613 [1][2] - The FDA's position may simplify the regulatory pathway for Entera, allowing a single Phase 3 study with total hip BMD as the primary endpoint to support a New Drug Application (NDA) for EB613 [2] Company Overview - Entera Bio is focused on developing oral peptide and protein replacement therapies, aiming to transform the standard of care for significant unmet medical needs [7] - The company's lead product candidate, 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] Industry Context - Osteoporosis affects over 200 million women globally, with a significant number remaining undertreated; no new osteoporosis drug has been approved by the FDA since 2019 [2][5] - Osteoporosis is a major public health issue, leading to over 2 million fractures annually in the US, with projected medical costs for osteoporotic fractures expected to rise from $57 billion in 2018 to $95 billion by 2040 [5] 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 novel treatment option [4] - The development of validated surrogate endpoints like BMD may facilitate faster drug development and address the ethical challenges associated with osteoporosis clinical trials [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]

Summary of Entera Bio Conference Call Company Overview - **Company**: Entera Bio - **Focus**: Development of first-in-class oral peptides, specifically targeting osteoporosis and metabolic diseases [2][34] Key Programs - **EB613**: - First and only osteoanabolic bone-building tablet treatment for postmenopausal women with osteoporosis [2][34] - Recently received FDA green light for registrational phase three study [2][34] - Aims to address the treatment gap in osteoporosis, where less than 25% of women receive treatment post-fracture [8][34] - **Other Programs**: - Long-acting PTH variants for hyperparathyroidism, with preclinical data expected by end of 2025 [3][34] - Dual agonist GLP-1 glucagon tablet treatment, IND filing planned for first half of 2026 [3][34] - GLP-2 tablet for short bowel syndrome, exploring additional indications [3][34] Clinical Development Insights - **Phase Two Data**: - EB613 showed significant improvements in bone mineral density (BMD) across spine, hip, and femoral neck [15][19] - The same 2.5 mg dose will be used in phase three trials [15][19] - **Phase Three Trial**: - Planned as a 24-month multinational study with at least 20% U.S. patient representation [29][31] - Aims to start in the first half of 2026 [31][34] Regulatory and Market Context - **FDA Engagement**: - Entera has had multiple productive meetings with the FDA, clarifying requirements for NDA submission [7][12] - The FDA's acceptance of total hip bone mineral density as a surrogate endpoint is a significant advancement for EB613 [4][10] - **Market Opportunity**: - Osteoporosis has seen little innovation in recent years, with the last approved drug being Evanity in 2019 [8][34] - Entera aims to fill this gap with a novel oral treatment that is easier for patients to use [34] Investment Considerations - **Valuation**: - Entera is positioned as an attractive investment opportunity due to its innovative approach and the potential to change osteoporosis treatment paradigms [34] - The company is focused on closing the treatment gap in osteoporosis, which is a significant unmet medical need [34] Additional Insights - **Geographic Strategy**: - The decision to include 20% U.S. patients is strategic, aiming to align with regulatory expectations while managing costs [29][30] - The company is also exploring markets in Europe and Asia, particularly in regions with high osteoporosis prevalence [30][34] - **Future Milestones**: - Anticipated phase one data for next-generation EB613 in Q1 2026 [32][34] - Plans to report on a third variant of long-acting PTH for hypoparathyroidism preclinically [32][34] This summary encapsulates the key points discussed during the conference call, highlighting Entera Bio's strategic direction, clinical advancements, and market positioning.

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]

Financial Performance - Revenues for the nine months ended September 30, 2025, were $42,000, a decrease of 57.6% from $99,000 for the same period in 2024[24] - Operating expenses for the nine months ended September 30, 2025, totaled $8,487,000, an increase of 16.9% from $7,257,000 in the same period of 2024[24] - Net loss for the nine months ended September 30, 2025, was $8,423,000, compared to a net loss of $7,183,000 for the same period in 2024, reflecting an increase of 17.3%[24] - The company reported a loss per share of $0.18 for the nine months ended September 30, 2025, compared to a loss per share of $0.19 for the same period in 2024[24] - For the nine months ended September 30, 2025, the segment net loss was $8,423, compared to a net loss of $7,183 for the same period in 2024, reflecting an increase of approximately 17.3%[66] Assets and Liabilities - Total current assets increased to $17,007,000 as of September 30, 2025, compared to $8,972,000 at December 31, 2024, representing an increase of 89.5%[21] - Total liabilities increased to $2,173,000 as of September 30, 2025, from $1,310,000 at December 31, 2024, marking a rise of 66%[21] - Shareholders' equity rose to $15,234,000 as of September 30, 2025, compared to $8,080,000 at December 31, 2024, indicating an increase of 88.5%[21] - Cash and cash equivalents at the end of the period were $8,574,000, slightly down from $8,660,000 at the end of 2024[21] Cash Flow and Financing - Cash flows from financing activities for the nine months ended September 30, 2025, amounted to $13,536,000, significantly higher than $1,259,000 for the same period in 2024[31] - The company has not anticipated paying any cash dividends in the foreseeable future, focusing on capital appreciation as the sole source of gain for shareholders[16] - The Company has agreed to use the proceeds from the sale of ordinary shares solely to fund its development cost obligations under the 2025 Collaboration Agreement[61] - In October and November 2025, 192,736 warrants were exercised for a total consideration of $155,249[68] Research and Development - Entera's most advanced product candidate, EB613, met primary and secondary endpoints in a Phase 2 study involving 161 post-menopausal women with low bone mineral density and osteoporosis[34] - Entera Bio Ltd. plans to conduct a Phase 3 study for EB613, with a primary endpoint evaluating change in total hip bone mineral density[34] - The company is developing the first oral oxyntomodulin for obesity treatment under a collaboration agreement with OPKO Health, Inc., signed in 2025[36] - As of September 30, 2025, Entera's management believes available funds will support operations through the middle of the third quarter of 2026, assuming ongoing capital use for research and development[36] - The Company completed the first stage of research services under a material transfer and research project agreement in Q1 2025, recognizing $42 in revenues for the nine months ended September 30, 2025[55] Collaboration Agreements - Under the 2025 Collaboration Agreement with OPKO, the Company will retain 40% of all proceeds from the program, while OPKO will retain 60%[58] - The company issued 3,685,226 ordinary shares to OPKO for a total purchase price of $8 million, at approximately $2.17 per share, as part of a collaboration agreement[49] - The Company recognized net expenses of $190 related to the 2025 Collaboration Agreement for the nine months ended September 30, 2025[65] - The Company incurred net expenses of $1,544 related to subcontractors and consulting for the nine months ended September 30, 2025, up from $934 in the same period of 2024, representing an increase of approximately 65.3%[66] Going Concern - The company incurred negative cash flows from operating activities since its inception in 2009, raising substantial doubt about its ability to continue as a going concern[37]

Financial Performance - Entera Bio reported a net loss of $3.2 million, or $0.07 per ordinary share, for Q3 2025, compared to a net loss of $3.0 million, or $0.08 per ordinary share, in Q3 2024[8]. - Total operating expenses for Q3 2025 were $3.3 million, compared to $3.0 million in Q3 2024[9]. - Entera Bio's total assets increased to $17.4 million as of September 30, 2025, from $9.4 million as of December 31, 2024[14]. Cash Position - Cash and cash equivalents were $16.6 million as of September 30, 2025, including $8.0 million in restricted cash for the OPKO collaboration[7]. Research and Development - Research and development expenses increased to $1.6 million in Q3 2025 from $1.5 million in Q3 2024, reflecting ongoing regulatory and Phase 3 preparation activities for EB613[8]. - The FDA agreed to use bone mineral density (BMD) as the primary endpoint for the Phase 3 study of EB613, which is designed to support a New Drug Application (NDA)[3]. - Phase 2 data for EB613 showed significant increases in trabecular and cortical bone indices after six months of treatment, comparable to injectable therapies[3]. - The company plans to initiate a Phase 1 trial of Next-Gen EB613 in late 2025, with preclinical data supporting its pharmacokinetic profile[3]. Product Development - The dual GLP-1/glucagon OXM tablet program demonstrated plasma levels consistent with the highest subcutaneous dose of Wegovy, indicating potential for obesity treatment[5]. - The oral GLP-2 program for short bowel syndrome showed a plasma half-life of approximately 15 hours, an 18-fold improvement over the current approved therapy[4].