Market Overview - U.S. stock futures rose on Monday after a significant sell-off on Friday, with major indices entering correction territory, falling more than 10% from their 52-week highs [1] - The S&P 500 marked a fifth consecutive weekly loss with a 2.1% drop, while the Nasdaq declined by 3.2% and the Dow Jones retreated by 0.9% [7] Economic Indicators - The 10-year Treasury bond yielded 4.39%, and the two-year bond was at 3.89%, with a 96.4% likelihood of the Federal Reserve maintaining current interest rates in its April meeting according to CME Group's FedWatch tool [3] Company Performance - Palantir Technologies (PLTR) shows a weak price trend over the medium term but a strong trend in the long and short medium terms, with a solid growth score [3] - Entera Bio Ltd. (ENTX) dropped 8.85% after reporting a loss of 6 cents per share for the fourth quarter, maintaining a weak price trend across all time frames [6] - TotalEnergies SE (TTE) rose 2.01% after signing a long-term partnership with EDF Group for low-carbon electricity supply, maintaining a strong trend across all time frames [6] - Progress Software Corp. (PRGS) was up 0.04% with expected quarterly earnings of $1.57 per share on revenue of $246.40 million, but maintains a weak price trend across all time frames [14] Analyst Insights - Mohamed El-Erian warns of "stagflationary winds" affecting the U.S. economy and stock market, with major indices falling into correction territory and significant economic damage already evident [8] - El-Erian highlights energy supply shortages and persistent inflation as undermining resilient growth, suggesting a deeper disruption to the global economy [9] - The classic 60/40 portfolio has suffered one of its worst monthly declines, indicating a shift in market dynamics [9] - Future market narratives are expected to revolve around volatility, dispersion, and fragmentation, with central banks adopting a more hawkish stance [10] Commodities and Global Markets - Crude oil futures increased by 1.23% to around $100.87 per barrel, while gold rose by 0.96% to approximately $4,535.91 per ounce [12] - Bitcoin traded 1.59% higher at $67,728.30 per coin [12] - Asian markets closed lower, while European markets were mostly higher in early trade [13]

Market Overview - U.S. stock futures rose on Monday after a significant sell-off on Friday, with major benchmark indices entering correction territory, falling more than 10% below their 52-week highs [1] - The S&P 500 marked a fifth consecutive weekly loss with a 2.1% drop, while the Nasdaq slid 3.2% over the week, and the Dow Jones Industrial Average retreated by 0.9% [7] Economic Indicators - The 10-year Treasury bond yielded 4.39%, and the two-year bond was at 3.89%, with a 96.4% likelihood of the Federal Reserve keeping interest rates unchanged in its April meeting [3] Company Performance - **Palantir Technologies (PLTR)**: Maintains a weak price trend over the medium term but shows strong trends in the long and short medium terms, with a solid growth score [3] - **Entera Bio Ltd. (ENTX)**: Dropped 8.85% after posting a loss of 6 cents per share for the fourth quarter, maintaining a weak price trend across all time frames [6] - **TotalEnergies SE (TTE)**: Rose 2.01% after signing a long-term partnership with EDF Group for low-carbon electricity supply, maintaining a strong trend across all time frames [6] - **Progress Software Corp. (PRGS)**: Up 0.04% with expected quarterly earnings of $1.57 per share on revenue of $246.40 million, maintaining a weak price trend across all time frames [13] Analyst Insights - Mohamed El-Erian warns of "stagflationary winds" affecting the U.S. economy and stock market, with major indices falling into correction territory and significant economic damage already evident [8] - El-Erian highlights energy supply shortages and persistent inflation undermining resilient growth, suggesting a deeper disruption to the global economy [9] - The classic 60/40 portfolio has suffered one of its worst monthly declines, indicating a shift in market dynamics [9] - Future market narratives are expected to revolve around "volatility, dispersion, and fragmentation," with central banks adopting a more hawkish stance [10]

Financial Performance - Entera Bio Ltd. reported revenues of $42,000 for the year ended December 31, 2025, a decrease of 76.6% compared to $181,000 in 2024[514]. - The company incurred a net loss of $11,439,000 in 2025, compared to a net loss of $9,541,000 in 2024, reflecting an increase in losses of approximately 19.9%[514]. - The company reported a net loss of $11,439,000 for the year ended December 31, 2025, compared to a net loss of $9,541,000 for 2024, indicating an increase in losses of approximately 20%[522]. - The total revenues were $42,000, a decrease of 76.8% compared to $181,000 in 2024[609]. - The net loss for the year ended December 31, 2025, was $11,439,000, compared to a net loss of $9,541,000 in 2024, representing a 19.9% increase in losses[609]. Expenses and Liabilities - Research and development expenses rose to $6,004,000 in 2025, up 33.4% from $4,499,000 in 2024[514]. - Total liabilities increased to $2,892,000 in 2025 from $1,310,000 in 2024, representing a significant increase of 120.5%[513]. - The company incurred share-based compensation expenses of $2,750,000 in 2025, up from $2,556,000 in 2024, reflecting an increase of approximately 8%[522]. - The severance payment expenses were $181,000 and $144,000 for the years ended December 31, 2025 and 2024, respectively[548]. - The operating lease cost for the year ended December 31, 2025, was $240,000, compared to $198,000 for the year ended December 31, 2024[573]. Assets and Cash Flow - Total current assets increased to $15,298,000 as of December 31, 2025, compared to $8,972,000 in 2024, marking a growth of 70.5%[513]. - Total cash and cash equivalents, including restricted cash and deposits, increased to $14,973,000 at the end of 2025 from $8,740,000 at the end of 2024, representing a growth of approximately 71%[522]. - The company reported a net cash used in operating activities of $7,370,000 for 2025, compared to $6,818,000 for 2024, indicating an increase of approximately 8% in cash outflows[522]. - The balance of carryforward losses for Entera Bio Ltd. as of December 31, 2025, was approximately $91.8 million, an increase from $83.5 million in 2024[612]. Capital and Funding - The company is highly dependent on raising additional capital or entering into agreements with collaborators to support its product development and commercialization efforts[27]. - The company issued 2,731,574 ordinary shares under the ATM program in 2025, raising $6,067,000, compared to $3,960,000 raised from 2,236,126 shares in 2024, reflecting a 53% increase in funds raised[522]. - The Company issued 3,685,226 ordinary shares to OPKO for a total purchase price of $8.0 million, at approximately $2.17 per share[581]. - As of December 31, 2025, approximately $29.95 million of ordinary shares remained available for sale under the Leerink ATM Program[592]. Regulatory and Development Activities - The company plans to submit a final protocol to the FDA and initiate a Phase 3 registrational study for its product candidate EB613, which is aimed at treating post-menopausal women with low bone mineral density[525]. - The company is developing EB612 as the first oral PTH(1-34) tablet for hypoparathyroidism, with a collaboration agreement with OPKO Biologics, Inc. to advance this product[526]. - The company is also developing EB618, a proprietary dual agonist GLP-1/glucagon peptide for obesity and metabolic disorders, in collaboration with OPKO[527]. - Under the 2025 Collaboration Agreement with OPKO, the Company will retain 40% of all proceeds and be responsible for 40% of the Program's development costs[580]. Concerns and Uncertainties - The company has substantial doubt about its ability to continue as a going concern due to recurring losses and cash outflows from operating activities[503]. - The ongoing Israel-Hamas conflict and its implications for operations and workforce remain uncertain and could impact the company's business[27]. Royalties and Obligations - The Company is committed to pay royalties to the Israel Innovation Authority on proceeds from sales of products developed with government grants, contingent on successful project development[574]. - As of December 31, 2025, the total royalty amount payable by the Company to the IIA was approximately $460,000[576]. - The Company is obligated to pay Oramed royalties equal to 3% of its net revenues as per the patent transfer agreement[577]. Stock Options and Compensation - The total fair value of options granted during the year ended December 31, 2025 was $2,943,000[602]. - As of December 31, 2025, the Company had 2,989,046 unvested options outstanding with a total unrecognized compensation cost of $1,735,000[601]. - The total unrecognized compensation cost of employee RSUs as of December 31, 2025, was $57,000, expected to be recognized over a weighted average period of 0.33 years[605]. - The total vesting-date value of equity classified RSUs that vested during 2025 was $676,000[606]. - The aggregate intrinsic value of the outstanding options as of December 31, 2025, was $3,121,000[603].

Financial Performance - Entera Bio reported a net loss of $11.4 million, or $0.25 per ordinary share, for the year ended December 31, 2025, compared to a net loss of $9.5 million, or $0.25 per ordinary share, for 2024[9]. - Total operating expenses for 2025 were $11.5 million, compared to $9.6 million in 2024, reflecting increased costs associated with research and administrative activities[11]. - Cash and cash equivalents were $14.9 million as of December 31, 2025, including $7.8 million in restricted cash for the OPKO collaboration, expected to support operations through mid-Q3 2026[8]. Research and Development - Research and development expenses increased to $6.0 million for the year ended December 31, 2025, up from $4.5 million in 2024, primarily due to ongoing regulatory and Phase 3 preparation activities for EB613[10]. - Entera submitted a streamlined Phase 3 protocol for EB613 to the FDA in March 2026, aiming for topline results in the second half of 2028, one year earlier than previously expected[3]. - The planned Phase 3 trial for EB613 will involve 750 postmenopausal women with osteoporosis, with the primary outcome measure being the percentage change in total hip bone mineral density from baseline to month 12[3]. Collaborations and Product Development - Entera's collaboration with OPKO for the development of the oral long-acting PTH tablet (EB612) is fully funded through Phase 1, with an IND application expected to be filed in late 2026[7]. - The company achieved positive preclinical data for its long-acting PTH analogs, showing a significantly longer plasma half-life compared to existing treatments[7]. - Entera's N-Tab® oral peptide platform has shown differentiated preclinical data for multiple targets, including LA-PTH and GLP-1/Glucagon, which are expected to drive value for patients[2]. - The company is developing the first oral dual GLP-1/Glucagon tablet (EB618) for obesity and metabolic diseases, with Phase 1 data expected by year-end 2026 to catalyze its advancement[5].

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]

Core Viewpoint - Entera Bio Ltd. has submitted a streamlined Phase 3 protocol to the FDA for EB613, an oral anabolic treatment for postmenopausal women with osteoporosis, aiming for faster patient access and potential commercialization [6][9]. Company Overview - Entera Bio is focused on developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab® technology platform [11]. - The company's lead product, EB613, is the first oral anabolic treatment for osteoporosis, designed to be taken once daily [11]. Clinical Development - The Phase 3 study will evaluate the percentage change in total hip bone mineral density (BMD) from baseline to 12 months, with a target enrollment of 750 women [8]. - Topline data is expected in the second half of 2028, which is approximately one year earlier than previously anticipated [2][3]. - The study is designed to demonstrate increases in total hip BMD comparable to those reported for Forteo® at 12 months, which is associated with a 60% to 80% relative reduction in vertebral fracture risk [8]. Regulatory Submission - Entera has submitted a clinical amendment to the FDA, including a statistical analysis plan and an open-label extension study synopsis [6][7]. - The open-label extension study will randomize participants to receive EB613 for either 12 or 24 months or transition to a standard anti-resorptive agent [3]. Market Context - Osteoporosis is a significant public health issue, with over 2 million fractures annually in the US, and the total medical cost of osteoporotic fractures projected to rise from $57 billion in 2018 to $95 billion by 2040 [10]. - Postmenopausal women are particularly at risk, with one in three women suffering an osteoporosis-related fracture after age 50 [10]. Product Efficacy - EB613 has shown rapid dose-proportional increases in bone formation markers and significant increases in lumbar spine, total hip, and femoral neck BMD in a previous Phase 2 study [9][11]. - The product aims to democratize access to anabolic treatment for osteoporosis, addressing a significant unmet medical need [9].

Core Insights - Entera Bio Ltd. has submitted a clinical amendment to the FDA for EB613, an oral anabolic treatment for osteoporosis, with a streamlined Phase 3 protocol and anticipates feedback within 60 days [1][2][5] - The Phase 3 trial will evaluate the efficacy of EB613 in increasing total hip bone mineral density (BMD) over 12 months, with a target enrollment of 750 postmenopausal women [3][5] - The company expects topline data in the second half of 2028, one year earlier than previously anticipated, and plans to conduct a 12-month open-label extension study in parallel with the NDA review [1][5] Company Overview - Entera Bio is focused on developing oral peptide and protein replacement therapies, with EB613 being the first oral anabolic tablet for osteoporosis [9] - The company utilizes a proprietary technology platform (N-Tab) to create innovative oral therapies, aiming to transform the standard of care in various medical fields [9] - Entera's pipeline includes other oral therapies for conditions such as hypoparathyroidism, obesity, and metabolic syndromes, indicating a broad focus on unmet medical needs [9] Industry Context - Osteoporosis is a significant public health issue, leading to over 2 million fractures annually in the US, with a projected increase in medical costs from $57 billion in 2018 to $95 billion by 2040 [8] - The disease predominantly affects postmenopausal women, with one in three women and one in five men likely to suffer an osteoporosis-related fracture after age 50 [8] - Current anabolic therapies for osteoporosis are administered via injection, limiting patient access; Entera's oral formulation aims to democratize treatment and improve patient compliance [6][8]

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]