Core Viewpoint - OPKO Health and Entera Bio have entered into a collaboration and license agreement to develop the first oral dual agonist GLP-1/glucagon peptide for treating obesity and metabolic disorders, with plans to file an Investigational New Drug application with the FDA later this year [1][2]. Group 1: Collaboration Details - OPKO will hold a 60% ownership interest in the program, while Entera will hold 40%, and they will share development costs accordingly [2]. - OPKO purchased 3,685,226 ordinary shares of Entera at $2.17 per share to fund Entera's share of costs through Phase 1 of the development program [2]. - Entera has the option to continue funding its share post-Phase 1 to maintain its ownership interest; if it opts out, it will retain a 15% interest in the program [2]. Group 2: Product Information - The program combines OPKO's long-acting oxyntomodulin analog (OPK-88006) with Entera's N-Tab™ technology, which has shown favorable pharmacodynamic and pharmacokinetic data [1][5]. - Oxyntomodulin is a naturally occurring peptide hormone that suppresses appetite and induces weight loss, with additional cardioprotective and anti-fibrotic properties [5]. Group 3: Company Backgrounds - Entera Bio focuses on developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ technology, with a pipeline that includes five oral peptide programs [6]. - OPKO Health is a multinational biopharmaceutical and diagnostics company aiming to establish leading positions in rapidly growing markets through its discovery and commercialization expertise [7].

Company Overview - Entera Bio Ltd. is a clinical stage company focused on developing oral peptide and protein replacement therapies in tablet form, addressing significant unmet medical needs [2] - The company utilizes a proprietary technology platform known as N-Tab™ and has a pipeline that includes five differentiated, first-in-class oral peptide programs targeting PTH(1-34), GLP-1, and GLP-2 [2] Product Development - The most advanced product candidate, EB613, is being developed as the first oral osteoanabolic (bone building) once-daily tablet treatment for post-menopausal women with low bone mineral density (BMD) and high-risk osteoporosis [2] - A Phase 2 study of EB613 tablets (n=161) met primary and secondary endpoints related to bone turnover biomarkers and BMD [2] - Entera is preparing to initiate a Phase 3 registrational study for EB613 following FDA's qualification of a quantitative BMD endpoint [2] - The EB612 program is aimed at developing the first oral PTH(1-34) tablet for hypoparathyroidism [2] - The company is also developing the first oral oxyntomodulin for obesity treatment and the first oral GLP-2 peptide tablet for rare malabsorption conditions in collaboration with OPKO Health [2] Upcoming Conferences - Entera Bio will participate in several upcoming conferences, including: - Leerink Partners Global Healthcare Conference on March 12, 2025, in Miami, FL [2] - 2025 World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases with an oral presentation on April 11, 2025, and a poster presentation on April 13, 2025, in Rome [2] - 2025 BIO International Convention from June 16-19, 2025, in Boston, MA [2]

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]

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]