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 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 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 Performance - Total revenues for the nine months ended September 30, 2024, were $99 million, compared to $0 for the same period in 2023[16] - Gross profit for the nine months ended September 30, 2024, was $9 million, with a gross margin of approximately 9.1%[16] - Operating loss for the nine months ended September 30, 2024, was $7.248 million, compared to $6.928 million for the same period in 2023[16] - Net loss for the nine months ended September 30, 2024, was $7.183 million, compared to $6.894 million for the same period in 2023[16] - Revenue for the three months ended September 30, 2024, was $42 thousand, a 100% increase from $0 in the same period in 2023, attributed to a research services agreement[109][115] - For the nine months ended September 30, 2024, the company reported revenues of $99 thousand, a 100% increase from $0 in the same period in 2023[115] Cash and Assets - Cash and cash equivalents decreased to $6.915 million as of September 30, 2024, from $11.019 million as of December 31, 2023[13] - Total current assets decreased to $7.340 million as of September 30, 2024, from $11.257 million as of December 31, 2023[13] - As of September 30, 2024, the company had cash and cash equivalents of $6.9 million, which is expected to meet projected operating requirements into the third quarter of 2025[92] - As of September 30, 2024, other current assets increased to $383,000 from $238,000 as of December 31, 2023, representing a 60.5% increase[56] - Cash and cash equivalents stood at $6.9 million as of September 30, 2024, with primary cash uses being research and development, general and administrative expenses, and working capital[124] Liabilities and Equity - Total liabilities decreased to $1.289 million as of September 30, 2024, from $1.379 million as of December 31, 2023[13] - Shareholders' equity decreased to $6.452 million as of September 30, 2024, from $10.386 million as of December 31, 2023[13] - Accrued expenses and other payables decreased to $765,000 as of September 30, 2024, down from $874,000 as of December 31, 2023, a reduction of 12.5%[56] Research and Development - Research and development expenses for the nine months ended September 30, 2024, were $3.298 million, compared to $3.510 million for the same period in 2023[16] - The company has incurred significant expenses related to research and development, which are expected to continue impacting its financial position[27] - Research and development expenses for the three months ended September 30, 2024, were $1.5 million, an 8% increase from $1.4 million in the same period in 2023[102][111] - Research and development expenses for the nine months ended September 30, 2024, were $3.3 million, a 6% decrease from $3.5 million in the same period in 2023[117] Future Plans and Financing - The company plans to initiate a Phase 3 registrational study for its product candidate EB613, which is aimed at treating post-menopausal women with low bone mineral density and high-risk osteoporosis[25] - Entera Bio Ltd. is evaluating various financing alternatives to support future research and development activities, with no certainty of obtaining necessary funding[27] - The company anticipates needing to raise additional capital to fund further operations, which may not be available on favorable terms[93] - The company plans to finance future research and development activities through public or private equity markets or collaborations, but there is no certainty about obtaining such funding[129] Operational Viability - As of September 30, 2024, Entera Bio Ltd. has an accumulated deficit of $111.6 million and negative cash flows from operating activities[27] - There is substantial doubt regarding the company's ability to continue as a going concern due to recurring losses and negative cash flows[122] - The company has not derived significant income from its activities and has incurred an accumulated deficit since inception, raising concerns about its operational viability[131] Product Development - The company is developing EB612 as the first oral PTH(1-34) tablet peptide replacement therapy for hypoparathyroidism[26] - The company’s most advanced product candidate, EB613, is being developed as the first oral, osteoanabolic tablet treatment for post-menopausal women with low bone mineral density and high-risk osteoporosis[70] - The FDA has concurred that a 2-year, placebo-controlled phase 3 study with Total Hip BMD as the primary endpoint could support a new drug application for EB613[70] - The company has safely administered its proprietary PTH tablets to a total of 255 subjects across Phase 1 and Phase 2 studies[73] Impact of External Factors - The company has not experienced material impacts on its business operations due to ongoing regional conflicts, and it does not expect delays in its programs[31] - The ongoing geopolitical situation in Israel has not materially impacted the company's business or operations to date[87] Stock and Securities - Entera Bio Ltd. has issued a total of 236,126 ordinary shares under the Leerink ATM Program for net proceeds of $601 at a weighted average price of $2.54 per share during the nine months ended September 30, 2024[43] - The company issued 143,049 ordinary shares to non-executive members of the Board in lieu of cash board fees, with a fair value of $263 based on the market price at the grant date[53] - The board of directors granted 25,000 restricted stock units (RSUs) to a consulting firm for services rendered, with vesting occurring in four monthly installments starting August 31, 2024[158] - The RSUs were not registered under the Securities Act and were offered in reliance on exemptions from registration requirements[159] - There were no defaults upon senior securities during the reporting period[160] - No officers or directors adopted or terminated any trading plans intended to satisfy Rule 10b5-1(c) during the quarter ended September 30, 2024[162] Compliance and Certifications - The report includes certifications from the Principal Executive Officer and Principal Financial Officer as required under the Sarbanes-Oxley Act[163]

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]

Entera Bio Ltd. (ENTX) and OPKO Health, Inc. (OPK) recently announced positive topline pharmacokinetic/pharmacodynamic (PK/PD) results from their ongoing collaborative research combining a proprietary long-acting oxyntomodulin (OXM) analog developed by OPKO and Entera's proprietary N-Tab technology. The program is focused on developing the first oral dual agonist GLP-1/glucagon peptide as a potential oncedaily treatment for patients with obesity and metabolic and fibrotic disorders. OXM is a naturally occur ...

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 ...