Core Viewpoint - Entera Bio Ltd. is advancing its oral peptide therapy EB613 for osteoporosis, with two abstracts accepted for presentation at the upcoming WCO-IOF-ESCEO congress in April 2025, highlighting the company's commitment to addressing significant health concerns in osteoporosis treatment [1][4]. Group 1: Product Development - EB613 is being developed as the first once-daily oral anabolic PTH(1-34) tablet treatment aimed at high-risk post-menopausal women with osteoporosis [2][6]. - A Phase 2 study of EB613 showed a fast onset of action and significant increases in bone mineral density (BMD) across all skeletal sites, along with increased bone formation and reduced bone resorption [2][6]. - The company plans to initiate a Phase 3 registrational study for EB613 following FDA qualification of a quantitative BMD endpoint [7]. Group 2: Market Need and Impact - Osteoporosis poses a serious health risk, with an estimated 200 million women affected globally, and 50% of women and 20% of men over 50 at risk of fragility fractures [5]. - EB613 aims to provide a simple oral treatment option to address the treatment gap in current osteoporosis care, which often relies on injectable therapies [6]. Group 3: Presentation Details - The presentation titled "Effects of EB613 Tablets [Oral PTH(1-34)] on Trabecular and Cortical Bone Using 3D-DXA: Post-Hoc Results from Phase 2 Study" will be delivered as an oral presentation on April 11, 2025 [3]. - Another presentation, "EB613 Tablet Treatment [Oral PTH(1-34)] – Does PK Drive Bone Modeling Versus Bone Remodeling?" will be showcased as a poster from April 11 to April 13, 2025 [3].

Core Insights - Entera Bio Ltd. is advancing EB613, an oral anabolic PTH(1-34) tablet treatment aimed at high-risk post-menopausal women with osteoporosis, with abstracts accepted for presentation at the WCO-IOF-ESCEO congress in April 2025 [1][2][4] 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 [7] - The company's pipeline includes five first-in-class oral peptide programs targeting PTH(1-34), GLP-1, and GLP-2, with EB613 being the most advanced candidate [7] Product Development - EB613 is designed to provide an anabolic boost to strengthen skeletal microarchitecture and induce rapid bone mineral density (BMD) gains, followed by consolidation with an antiresorptive agent [6] - A placebo-controlled Phase 2 study of EB613 demonstrated significant increases in BMD at all skeletal sites and improvements in bone formation and resorption markers [2][6] Market Need - Osteoporosis is a significant health concern, affecting approximately 200 million women globally, with a high risk of fragility fractures among individuals over 50 [5] - Current injectable anabolic treatments are not viable for most patients, highlighting the need for a simple oral treatment like EB613 [6] Upcoming Presentations - Two abstracts related to EB613 will be presented at the WCO-IOF-ESCEO congress, including an oral presentation on the effects of EB613 on trabecular and cortical bone and a poster presentation on pharmacokinetics [3]

Core Viewpoint - Entera Bio Ltd. is actively participating in the Oppenheimer 35th Annual Healthcare Life Sciences Conference, showcasing its advancements in orally delivered peptides and therapeutic proteins [1][2]. Company Overview - Entera Bio is a clinical-stage company focused on developing tablet treatments for peptide and small protein replacement therapies, addressing significant unmet medical needs [3]. - The company utilizes a proprietary technology platform (N-Tab™) and has a pipeline that includes five first-in-class oral peptide programs [3]. - The most advanced product candidate, EB613, is being developed as the first oral osteoanabolic treatment for post-menopausal women with low bone mineral density (BMD) and high-risk osteoporosis [3]. - A Phase 2 study of EB613 met primary and secondary endpoints, with results published in the Journal for Bone and Mineral Research [3]. - Entera is preparing to initiate a Phase 3 registrational study for EB613 in the second half of 2025, pending FDA qualification of a quantitative treat-to-target BMD endpoint [3]. - Other programs include EB612 for hypoparathyroidism and collaborations with OPKO Health for oral treatments targeting obesity and gastrointestinal conditions [3].

Core Insights - Entera Bio Ltd. reported a quarterly loss of $0.08 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.05, marking a 60% earnings surprise [1] - The company generated revenues of $0.04 million for the quarter ended September 2024, exceeding the Zacks Consensus Estimate by 5%, compared to zero revenues a year ago [2] - Entera Bio's stock has increased by approximately 191.7% since the beginning of the year, significantly outperforming the S&P 500's gain of 25.2% [3] Earnings Outlook - The earnings outlook for Entera Bio is mixed, with the current consensus EPS estimate for the upcoming quarter at -$0.06 on revenues of $0.04 million, and -$0.23 on revenues of $0.14 million for the current fiscal year [7] - The company's Zacks Rank is currently 3 (Hold), indicating that shares are expected to perform in line with the market in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Entera Bio belongs, is currently ranked in the top 35% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - Another company in the same industry, Orchestra BioMed Holdings, Inc., is expected to report a quarterly loss of $0.44 per share, with revenues projected to be $0.81 million, reflecting a year-over-year increase of 92.9% [9]

Financial Position - As of September 30, 2024, Entera Bio had cash and cash equivalents of $6.9 million, sufficient to meet projected operating requirements into Q3 2025[8]. - The company’s total assets decreased from $11.8 million as of December 31, 2023, to $7.7 million as of September 30, 2024[15]. Operating Expenses - Research and development expenses for Q3 2024 were $1.5 million, an increase of $0.1 million from $1.4 million in Q3 2023, primarily due to a $0.5 million increase in materials for EB613 phase 3 study preparation[9]. - General and administrative expenses for Q3 2024 were $1.5 million, up from $1.0 million in Q3 2023, mainly due to higher intellectual property expenses and consultancy fees[10]. - Total operating expenses for Q3 2024 were $3.0 million, compared to $2.4 million in Q3 2023[10]. Net Loss - The net loss for Q3 2024 was $3.0 million, or $0.08 per ordinary share, consistent with the net loss of $2.4 million, or $0.08 per share, in Q3 2023[11]. Product Development - Entera is developing EB613, the first oral PTH(1-34) tablet treatment for post-menopausal women with high-risk osteoporosis, with a pivotal program expected to leverage new FDA regulatory pathways[3]. - The company presented new pharmacological data for EB613 at the ASBMR 2024 Annual Meeting, highlighting its commitment to advancing osteoporosis therapy[4]. - Entera and OPKO Health announced positive topline results for the oral oxyntomodulin tablet program, showing significant systemic exposure and a statistically significant reduction in plasma glucose levels[5]. - Entera is also validating its oral GLP-2 tablet for Short Bowel Syndrome, with final in vivo data expected in the second half of 2024[6].

Core Insights - Entera Bio Ltd. reported financial results and key business updates for Q3 2024, highlighting advancements in its oral peptide and therapeutic protein development pipeline [1] Business Updates - The company is focusing on its pivotal clinical asset, EB613, an oral PTH(1-34) tablet for post-menopausal women with high-risk osteoporosis, and anticipates a significant FDA ruling in January 2025 regarding regulatory endpoints for osteoporosis drugs [2][3] - Entera's proprietary N-Tab™ platform has shown consistent results across various oral therapies, including GLP-2 and GLP-1/Glucagon tablets, with promising data presented at recent conferences [2][4][5] - The company is also developing an oral GLP-2 tablet for Short Bowel Syndrome and collaborating on an oral PTH replacement therapy for hypoparathyroidism [6][7] Financial Performance - As of September 30, 2024, Entera had cash and cash equivalents of $6.9 million, sufficient to meet projected operating requirements into Q3 2025 [7] - Research and development expenses for Q3 2024 were $1.5 million, up from $1.4 million in Q3 2023, primarily due to increased material costs for the EB613 phase 3 study [8] - General and administrative expenses rose to $1.5 million in Q3 2024 from $1.0 million in Q3 2023, driven by higher intellectual property expenses and consultancy fees [9] - The net loss for Q3 2024 was $3.0 million, consistent with the loss per share of $0.08, compared to a net loss of $2.4 million in Q3 2023 [10][16]

Core Insights - Entera Bio Ltd. and OPKO Health, Inc. announced positive topline pharmacokinetic/pharmacodynamic results from their collaboration on a long-acting oxyntomodulin analog combined with Entera's N-Tab technology [1][5] - The program aims to develop the first oral dual agonist GLP-1/glucagon peptide for treating obesity and metabolic disorders [2] Company Developments - Entera and OPKO have completed in vivo proof-of-concept studies in rodent and pig models, showing significant systemic exposure and favorable pharmacokinetic profiles for oral OXM [6] - The oral OXM demonstrated a significant decrease in plasma glucose levels in a glucose tolerance test compared to a placebo [7] - OPKO's previous studies indicated that pegylated OXM led to significant weight loss and reductions in HbA1, triglycerides, and cholesterol levels in obese and diabetic patients [8] Market Context - The global weight management market was valued at $142.58 billion in 2022, with an expected CAGR of 9.94% from 2023 to 2030, indicating a growing opportunity for obesity treatments [4] - Entera and OPKO's market capitalizations are currently $70.14 million and $1.03 billion, respectively [4] Stock Performance - Following the announcement, ENTX shares fell by 1.5% to $1.93, while OPK shares remained nearly flat at $1.48 [3] - Over the past six months, ENTX and OPK shares have increased by 24.6% and 46.6%, respectively, contrasting with a 0.9% decline in the industry [9]

For those looking to find strong Medical stocks, it is prudent to search for companies in the group that are outperforming their peers. Has Entera Bio Ltd. (ENTX) been one of those stocks this year? A quick glance at the company's year-to-date performance in comparison to the rest of the Medical sector should help us answer this question. Entera Bio Ltd. is one of 1017 individual stocks in the Medical sector. Collectively, these companies sit at #5 in the Zacks Sector Rank. The Zacks Sector Rank considers 1 ...

JERUSALEM, Aug. 20, 2024 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), ("Entera" or the "Company") a leader in the development of orally delivered peptides and small therapeutic proteins, today announced that management will be participating in the following investor and scientific conferences: H.C. Wainwright 26th Annual Global Investment Conference (Presentation and 1x1) Date and Time: September 9, 2024 at 7am ET Location: Virtual, September 9-11, 2024 American Society for Bone and Mineral Research ...

Entera Bio Ltd. (ENTX) could be a solid addition to your portfolio given its recent upgrade to a Zacks Rank #2 (Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices. The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate. Since a changing ...