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].

Core Insights - Entera Bio Ltd. has achieved a significant milestone with the FDA agreeing to use Bone Mineral Density (BMD) as the primary endpoint for the Phase 3 study of EB613, an oral treatment for osteoporosis [5][2] - The company reported strong Phase 2 data showing EB613's efficacy in increasing BMD in younger post-menopausal women, highlighting its potential to address a significant unmet medical need in osteoporosis treatment [5][2] - Entera's pipeline includes promising programs for obesity and short bowel syndrome in collaboration with OPKO, with preclinical data showing favorable pharmacokinetics for these oral therapies [4][6] EB613 Developments - EB613 is positioned as the first oral PTH(1-34) anabolic tablet for osteoporosis, with a Phase 3 study designed to evaluate its impact on total hip BMD and vertebral fractures [5][3] - Phase 2 results presented at major medical conferences indicate significant increases in trabecular and cortical bone indices after six months of treatment, comparable to injectable alternatives [5] - New analyses show EB613's ability to drive consistent BMD gains in younger post-menopausal women, with less than 15% of women currently willing to use existing injectable treatments [5] Financial Performance - As of September 30, 2025, Entera reported cash and cash equivalents of $16.6 million, with $8.0 million in restricted cash for OPKO collaboration [8] - The company incurred a net loss of $3.2 million for the quarter, slightly higher than the $3.0 million loss in the same period of 2024, with R&D expenses increasing to $1.6 million [9][10] - Total operating expenses for the quarter were $3.3 million, reflecting ongoing regulatory and Phase 3 preparation activities for EB613 [10] Collaboration and Future Plans - Entera is collaborating with OPKO on the GLP-2 program for short bowel syndrome, with positive pharmacokinetic data indicating a significant improvement over existing therapies [4] - The company is also developing an oral dual GLP-1/glucagon OXM tablet for obesity, with an IND submission planned for H1 2026 [6] - Next-generation EB613 is on track for a Phase 1 trial initiation in late 2025, with preclinical data validating the N-Tab™ platform [5]

Core Insights - Entera Bio Ltd. has presented new clinical data supporting the efficacy of EB613, an oral anabolic treatment for postmenopausal women, at the 2025 NAMS Annual Meeting [1][2] - EB613 is positioned as a first-in-class oral therapy that could significantly improve patient access to bone-building treatments, addressing the limitations of injectable therapies [1][4] Clinical Data Summary - In a Phase 2 trial, EB613 demonstrated statistically significant increases in bone mineral density (BMD) in early postmenopausal women, with a 3.2% increase in femoral neck BMD (p=0.02) and a 2.5% increase in lumbar spine BMD (p=0.08) [3][6] - The trial involved 161 patients and met all primary and secondary endpoints, showing rapid increases in bone formation markers and reductions in bone resorption markers [5][7] Market Potential - EB613 aims to transform osteoporosis treatment by providing an oral option that can be introduced earlier in the treatment journey, potentially increasing patient compliance and access [2][4] - The oral formulation of EB613 addresses a significant barrier in osteoporosis care, as current anabolic therapies are primarily injectable and underutilized [2][5]

Core Insights - Entera Bio Ltd. has presented new clinical data for EB613, an oral anabolic treatment for osteoporosis, demonstrating significant efficacy in increasing bone mineral density (BMD) in postmenopausal women [1][2][4] Group 1: Clinical Findings - EB613 showed statistically significant BMD increases in early postmenopausal women (≤10 years since last menstrual period) compared to placebo, with a 3.2% increase in femoral neck BMD (p=0.02) and a 2.5% increase in lumbar spine BMD (p=0.08) [3][6] - The treatment produced a 3.1% increase in lumbar spine BMD (p=0.05) and a 2.3% increase in total hip BMD (p=0.03) at six months, indicating meaningful improvements in bone strength [6] Group 2: Treatment Potential - EB613 is positioned as the first oral anabolic therapy for osteoporosis, addressing a significant barrier in osteoporosis care by providing a convenient oral option instead of injectable therapies [2][4][5] - The consistency of BMD improvements across different stages of menopause suggests that EB613 could transform osteoporosis treatment by allowing earlier intervention [2][4] Group 3: Future Developments - Entera plans to initiate a global registrational Phase 3 study for EB613 following FDA concurrence in July 2025, aiming to expand patient access to this innovative treatment [1][4]

Core Insights - Entera Bio Ltd. will present new clinical data from its Phase 2 trial of EB613 at the North American Menopause Society (NAMS) 2025 Annual Meeting, marking its first presentation at this event [1][2] - The presentation will focus on bone mineral density outcomes in early postmenopausal women with low bone mass or osteoporosis, highlighting the potential role of EB613 in earlier treatment stages [2][3] Company Overview - Entera Bio is a clinical stage company developing oral peptide and protein replacement therapies, aiming to transform the standard of care for significant unmet medical needs [6] - The company's lead product candidate, EB613, is being developed as the first oral, once-daily anabolic tablet treatment for osteoporosis, specifically targeting postmenopausal women with low bone mass [5][6] Product Details - EB613 has shown efficacy in a Phase 2, 6-month, placebo-controlled study involving 161 patients, meeting all biomarker and bone mineral density endpoints without significant safety concerns [5] - The treatment produced rapid increases in biochemical markers of bone formation and reductions in markers of bone resorption, along with increased bone mineral density in key areas [5] Market Context - Anabolic therapies for osteoporosis are underutilized, primarily due to their availability only as injections, which limits access for many eligible patients [3][5] - Entera Bio's oral formulation of EB613 has the potential to broaden access for over 200 million women worldwide living with osteoporosis, addressing a critical gap in treatment options [3][5]

Core Insights - Entera Bio Ltd. (ENTX) has reported promising pharmacokinetic data for its oral GLP-2 analog therapy, OPK-8801003, aimed at treating short bowel syndrome (SBS) [1][4] - The therapy is being developed in collaboration with OPKO Health and could provide a significant alternative to the current treatment, Gattex, which requires daily injections [2][11] Group 1: Therapy Development - OPK-8801003 combines OPKO Health's long-acting GLP-2 analog with Entera's N-Tab oral peptide platform, potentially transforming treatment for approximately 30,000 SBS patients in the U.S. and Europe [2][12] - The therapy demonstrated a plasma half-life of about 15 hours, which is 18 times longer than the 0.85-hour half-life of the current injection option [9][10] - Entera's oral therapy achieved peak plasma concentrations of nearly 200 ng/ml, significantly higher than the 36.8 ng/ml for subcutaneous teduglutide [10] Group 2: Market Potential - The SBS market is valued at nearly $800 million annually, and Entera's oral GLP-2 candidate could capture a share of this market by addressing the limitations of existing treatments [5][13] - The positive pharmacokinetic results not only advance the SBS program but also validate Entera's broader N-Tab oral peptide platform, indicating strong commercial potential [4][13] Group 3: Stock Performance and Investor Sentiment - Year-to-date, Entera Bio's stock has decreased by 15.5%, contrasting with a 3.1% gain in the industry and a 13.4% increase in the S&P 500 [3] - The encouraging pharmacokinetic data is expected to improve investor sentiment, as it serves as a de-risking milestone for the company's pipeline [4][5]

Core Insights - Entera Bio Ltd. is developing an oral GLP-2 therapy, OPK-8801003, which shows a significantly longer biological half-life and comparable peak plasma levels to the only approved GLP-2 therapy, Gattex [1][2][3] Company Overview - Entera Bio is focused on oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ platform to address significant unmet medical needs [6] - The company is collaborating with OPKO Health, Inc. to develop oral peptide candidates for intestinal malabsorption syndromes [2][6] Product Development - OPK-8801003 demonstrated a plasma half-life of approximately 15 hours in preclinical studies, an 18-fold improvement over teduglutide, which has a half-life of only 0.85 hours [7] - Peak plasma concentrations of OPK-8801003 reached ~200 ng/ml, significantly exceeding the reported Cmax of 36.8 ng/ml for teduglutide [7] - The systemic exposure of OPK-8801003 was maintained for over 24 hours, supporting once-daily oral dosing [7] Market Context - Short Bowel Syndrome (SBS) affects approximately 30,000 patients in the U.S. and EU, with current annual sales of Gattex totaling around $800 million [5] - SBS is the most common cause of chronic intestinal failure, accounting for about 75% of cases in adults and 50% in children [5]