Entera Bio's N-Tab Platform and Pipeline - Entera Bio's proprietary N-Tab platform transforms peptides into orally bioavailable tablets, potentially unlocking patient acceptance and driving superior health outcomes[7, 19] - The company's lead asset, EB613, is a differentiated Phase 3 asset poised for blockbuster sales as a first-in-class oral PTH(1-34) anabolic tablet treatment for osteoporosis, a condition affecting over 200 million people worldwide[7, 27] - Entera has a rich pipeline with multiple blockbuster opportunities in high-impact therapeutic areas, including EB612 for hypoparathyroidism, OXM for obesity/metabolic disorders, and GLP-2 for GI inflammatory disorders and short bowel syndrome[7, 8] - The company's cash runway extends into H2 2026, with multiple catalysts expected in the next 12 months[8] EB613 for Osteoporosis - EB613 is positioned as the first oral anabolic treatment to support earlier intervention in osteoporosis, addressing a substantial treatment gap[7, 28] - A Phase 2 study of EB613 in post-menopausal women with low bone mass or osteoporosis demonstrated a faster onset of action and higher increases in BMD at the cortical bone (femoral neck and hip region)[23] - EB613's Phase 2 results showed a distinct dual mechanism of increased bone formation (P1NP) and reduced bone resorption (CTX)[44] - Phase 2 data indicated that EB613 increased BMD at all major skeletal sites, with placebo-adjusted BMD change of EB613 2.5mg from Baseline to Month 6 as Compared with Published Forteo® Data[56, 57] GLP-1/Glucagon and GLP-2 Programs - Entera is developing an oral GLP-1/Glucagon (OXM) dual agonist tablet for metabolic disorders and obesity in partnership with OPKO, with an IND filing expected late 2025/early 2026[8, 104, 116] - Pre-clinical data supports the development of once-daily oral GLP-2 analog tablets for short bowel syndrome (SBS), a rare disease affecting approximately 30,000 patients across the US and EU[8, 106, 108]

Core Insights - Entera Bio Ltd. is advancing EB613, an oral anabolic treatment for postmenopausal women with osteoporosis, which has been selected for presentation at the ASBMR 2025 Annual Meeting [1][4] - EB613 is designed to be the first once-daily oral PTH(1-34) tablet, aiming to provide a viable treatment option for patients at high risk of fractures [2][4] - The Phase 2 study demonstrated significant increases in bone mineral density (BMD) across all measured skeletal sites compared to baseline and placebo [2][4] Company Overview - Entera Bio is focused on developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ technology platform [5] - The company is preparing to initiate a Phase 3 registrational study for EB613 following FDA qualification of a quantitative BMD endpoint [5] - Entera's pipeline includes other innovative oral therapies targeting conditions such as hypoparathyroidism and obesity [5] Industry Context - Osteoporosis is a significant health concern, affecting approximately 200 million women globally, with a high risk of fragility fractures in older adults [3] - The current injectable anabolic treatments are not suitable for many patients, highlighting the need for oral alternatives like EB613 [4]

Core Viewpoint - OPKO Health and Entera Bio are advancing the development of an oral treatment, OPK-88006, for obesity and metabolic disorders, with new pharmacologic data to be presented at the ENDO 2025 annual meeting [1][2]. Company Overview - OPKO Health is a multinational biopharmaceutical and diagnostics company focused on establishing leading positions in rapidly growing markets through its discovery, development, and commercialization expertise [5]. - Entera Bio is a clinical-stage company developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ technology to address significant unmet medical needs [4]. Product Development - OPK-88006 is a dual agonist GLP-1/glucagon peptide being developed as both a once-daily oral tablet and a weekly injectable treatment [2][3]. - The oral formulation aims to provide a simpler titration process and improved tolerability for patients, with a focus on sustainable weight loss to mitigate comorbidities like severe fatty liver and sleep apnea [3]. - Both companies plan to file an Investigational New Drug application with the U.S. FDA for OPK-88006 later this year, with Phase 1 clinical studies in preparation [3]. Clinical Trials and Research - The upcoming presentation at the ENDO 2025 meeting will showcase in vivo pharmacokinetic and pharmacodynamic results for OPK-88006 [4]. - Entera's advanced product candidate, EB613, is also in development as the first oral treatment for post-menopausal women with low bone mineral density and high-risk osteoporosis, with a Phase 2 study already meeting its endpoints [4].

Financial Performance - As of March 31, 2025, the total assets of Entera Bio Ltd. increased to $21.6 million from $9.39 million as of December 31, 2024, representing a growth of 130%[24] - The company reported revenues of $42,000 for the three months ended March 31, 2025, compared to no revenues in the same period of 2024[27] - Operating expenses for the first quarter of 2025 were $2.56 million, up from $2.06 million in the same period of 2024, reflecting an increase of 24%[27] - The net loss for the three months ended March 31, 2025, was $2.57 million, compared to a net loss of $2.02 million for the same period in 2024, indicating a 27% increase in losses[27] - Cash and cash equivalents at the end of the period were $12.57 million, up from $8.66 million at the beginning of the quarter, marking a 45% increase[24] - The company has an accumulated deficit of $116.5 million as of March 31, 2025, which has increased from $113.93 million at the end of 2024[24] - For the three months ended March 31, 2025, the company recognized total revenues of $42 thousand from a research services agreement[56] - The company’s basic loss per share is calculated based on the net loss for the period divided by the weighted average number of outstanding shares[44] - As of March 31, 2025, the company reported accrued expenses and other payables totaling $1,320 thousand, compared to $874 thousand as of December 31, 2024[52] Strategic Initiatives - Entera Bio Ltd. is preparing to initiate a Phase 3 registrational study for its product candidate EB613, aimed at treating post-menopausal women with low bone mineral density[37] - The company intends to license its N-Tab™ technology to biopharmaceutical companies for use with their proprietary compounds, indicating a strategy for market expansion[38] - The company is evaluating various financing alternatives and strategic collaborations to support its ongoing operations and future research and clinical development[38] - The company entered into a collaboration agreement with OPKO, granting an exclusive license for the development of a GLP-1/glucagon dual agonist, with the company retaining 40% of the proceeds and development costs[57] - 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[58] Shareholder Information - Entera Bio Ltd. does not anticipate paying any cash dividends in the foreseeable future, focusing instead on capital appreciation for shareholders[18] - The company issued 2,700,000 ordinary shares under the Leerink ATM Program for net proceeds of $5,997 thousand at a weighted average price of $2.29 per share[49] - The company granted 142,545 options to purchase ordinary shares to non-executive board members with an exercise price of $2.28 per share[51] Operational Context - The company’s research personnel and some management personnel are located in Israel, but core activities remain largely unaffected by ongoing hostilities[39] - The company recognized revenue over the contract term using the input model method for the research services agreement due to the unique nature of the services provided[54] - The company is evaluating the impact of recently issued accounting pronouncements on its financial statement disclosures[47]

Financial Performance - The net loss for Q1 2025 was $2.6 million, or $0.06 per ordinary share, compared to a net loss of $2.0 million, or $0.05 per ordinary share, for Q1 2024[10]. - Total revenues for the three months ended March 31, 2025, were $42,000, compared to $0 for the same period in 2024[18]. - The net loss for the three months ended March 31, 2025, was $2,567,000, compared to a net loss of $2,017,000 in the same period last year, indicating a 27.3% increase in losses[18]. - Loss per share for Q1 2025 was $0.06, compared to $0.05 for Q1 2024[18]. Expenses - Research and development expenses increased to $1.1 million in Q1 2025 from $0.7 million in Q1 2024, primarily due to consulting fees and collaboration costs[12]. - General and administrative expenses rose to $1.4 million in Q1 2025 from $1.3 million in Q1 2024, mainly due to increased IP costs and legal fees related to the OPKO collaboration[12]. - Total operating expenses for Q1 2025 were $2,563,000, compared to $2,062,000 in Q1 2024, marking a 24.3% increase[18]. - Research and development expenses increased to $1,123,000, up from $735,000 year-over-year, representing a 52.7% increase[18]. - General and administrative expenses rose to $1,440,000, compared to $1,327,000 in the prior year, reflecting an 8.5% increase[18]. Assets and Equity - Total assets as of March 31, 2025, were $21,600,000, significantly up from $9,390,000 as of December 31, 2024, representing a 130.5% increase[16]. - Total shareholders' equity increased to $19,379,000 from $8,080,000, reflecting a growth of 140.0%[16]. - Total liabilities rose to $2,221,000 from $1,310,000, indicating a 69.3% increase[16]. Collaboration and Development - Entera is preparing to initiate a Phase 3 registrational study for EB613, the first oral anabolic treatment for osteoporosis, pending FDA qualification of a quantitative BMD endpoint[11]. - The company plans to submit an Investigational New Drug application for the Oral OXM program later in 2025 or early 2026, with OPKO holding a 60% stake in the program[7]. - Entera's collaboration with OPKO includes the development of the first oral GLP-1/glucagon peptide tablet for obesity and the first oral GLP-2 peptide tablet for short bowel syndrome[4]. Team and Market Focus - Entera has strengthened its core team with key appointments, including Leslie Gautam as Chief Business Officer and Cherin Smith as Head of Clinical Operations, both bringing extensive experience in women's health[8]. - The company aims to address significant unmet needs in osteoporosis treatment, with over 54 million individuals in the U.S. at risk for bone health issues[2]. - EB613 has shown promising results in increasing bone mineral density and fracture resistance in postmenopausal women, with data consistent with subcutaneous teriparatide[7]. Cash Position - As of March 31, 2025, Entera had cash and cash equivalents of $20.6 million, with $8 million allocated for collaboration activities with OPKO, expected to support operations through mid-Q3 2026[9].

Core Insights - Entera Bio Ltd. reported financial results and business updates for Q1 2025, highlighting progress in its oral peptide and protein replacement therapies, particularly EB613 for osteoporosis and Oral OPK-88006 for metabolic diseases [1][2][12]. Financial Performance - As of March 31, 2025, Entera had cash and cash equivalents of $20.6 million, with $8 million allocated for collaboration with OPKO, expected to sustain operations through mid-Q3 2026 [12]. - The net loss for Q1 2025 was $2.6 million, or $0.06 per share, compared to a net loss of $2.0 million, or $0.05 per share, in Q1 2024 [13][21]. Product Development - EB613 is the first oral anabolic treatment for postmenopausal women with osteoporosis, with plans to initiate a Phase 1 study in H2 2025 [2][3]. - The company is preparing for a pivotal program for EB613, which has shown promising results in increasing bone mineral density (BMD) [3][4]. - Entera is also developing Oral OPK-88006, a dual-acting GLP1/Glucagon tablet for metabolic diseases, with a 40% stake in its economics [2][10]. Clinical Advancements - EB613's early mechanistic effects were selected for oral presentation at the 2025 World Congress on Osteoporosis, indicating strong interest in its clinical potential [2]. - The SABRE initiative is advocating for regulatory reform to qualify BMD as a surrogate endpoint for fracture risk, which could facilitate the approval of new osteoporosis treatments [3]. Team Expansion - Entera has strengthened its core team with the appointment of Leslie Gautam as Chief Business Officer and Cherin Smith as Head of Clinical Operations, both bringing extensive experience in women's health and clinical operations [8][11].

Core Insights - Entera Bio Ltd. is developing EB613, the first once-daily oral anabolic PTH(1-34) tablet for postmenopausal women with osteoporosis at high risk for fracture [1][4] - The Phase 2 study showed significant increases in bone mineral density (BMD) at various skeletal sites compared to placebo, indicating a dual effect of stimulating bone formation and inhibiting resorption [1][2] - The company plans to initiate a Phase 3 registrational study for EB613 following positive Phase 2 results [5] Company Overview - Entera Bio is a clinical-stage company focused on oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ technology [5] - The company's pipeline includes five differentiated oral peptide programs targeting conditions such as osteoporosis, hypoparathyroidism, and obesity [5] - EB613 is positioned as a solution for the treatment gap in osteoporosis care, aiming to provide a simple daily tablet for patients who currently lack effective treatment options [4][5] Clinical Study Findings - The Phase 2 study randomized 161 postmenopausal women and demonstrated early effects on trabecular and cortical bone, suggesting rapid bone strengthening and fracture resistance [2][3] - 3D-DXA analysis revealed substantial improvements in areal BMD at the total hip and femoral neck, consistent with results from subcutaneous teriparatide [3] - The study's findings indicate a broad distribution of bone loss with placebo and a similar distribution of bone gain with EB613 in the femur [2] Market Context - Osteoporosis affects approximately 200 million women globally, with a significant risk of fragility fractures, particularly in postmenopausal women [4] - Current injectable anabolic treatments are not viable for many patients, highlighting the need for an effective oral treatment like EB613 [4]

Core Insights - Entera Bio Ltd. announced positive results from a Phase 2 study of EB613, an oral PTH(1-34) tablet aimed at treating postmenopausal women with osteoporosis at high risk for fractures [1][2][4] - The study demonstrated significant increases in bone mineral density (BMD) across various skeletal sites compared to placebo, indicating the potential for rapid bone strengthening and fracture resistance [2][3] Company Overview - Entera Bio is focused on developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ technology platform [5] - The company's lead product, EB613, is positioned as the first oral anabolic treatment for postmenopausal women with low BMD and high-risk osteoporosis [5] - Entera is preparing to initiate a Phase 3 registrational study for EB613 following FDA qualification of a quantitative BMD endpoint [5] Study Details - The Phase 2 study involved 161 postmenopausal women and assessed the effects of EB613 over 6 months, showing improvements in integral volumetric BMD, trabecular volumetric BMD, cortical thickness, and cortical surface BMD compared to placebo [2][3] - 3D-DXA analysis indicated a dual effect of EB613, stimulating bone formation while inhibiting resorption, with significant improvements noted in both trabecular and cortical bone [1][2] Market Context - Osteoporosis is a significant health concern, affecting approximately 200 million women globally, with a high risk of fragility fractures [4] - Current injectable anabolic treatments are not viable for many patients, highlighting the need for an effective oral treatment option like EB613 [4]

Financial Performance - Entera Bio Ltd. reported revenues of $181,000 for the year ended December 31, 2024, compared to no revenues in 2023[500]. - The company incurred a net loss of $9,541,000 in 2024, an increase from a net loss of $8,889,000 in 2023, reflecting a 7.3% increase in losses year-over-year[500]. - Total operating expenses for 2024 were $9,594,000, up from $8,891,000 in 2023, indicating an increase of approximately 7.9%[500]. - The net loss for the year ended December 31, 2024, was $9,541,000, compared to a net loss of $8,889,000 in 2023, representing an increase of approximately 7.3%[508]. - The company reported a total loss before taxes of $9,527 for the year ended December 31, 2024, compared to $8,860 in 2023[625]. Cash and Assets - Cash and cash equivalents decreased to $8,660,000 as of December 31, 2024, down from $11,019,000 in 2023, representing a decline of 21.4%[497]. - The total assets of Entera Bio Ltd. decreased to $9,390,000 in 2024 from $11,765,000 in 2023, a reduction of 20.2%[497]. - The company’s accumulated deficit increased to $113,927,000 in 2024 from $104,386,000 in 2023, reflecting a rise of 9.8%[497]. - Cash flows used in operating activities decreased to $6,818,000 in 2024 from $7,310,000 in 2023, indicating improved cash management[508]. - The company expects its available funds to support operations into the third quarter of 2026, excluding the initiation of the Phase 3 study for EB613[513]. Shareholder Equity and Capital Raising - The number of shares outstanding increased to 38,837,220 as of December 31, 2024, from 35,476,341 in 2023, marking an increase of 6.7%[497]. - The company raised $3,960,000 through ATM programs in 2024, a significant increase from $5,000 in 2023, indicating enhanced financing activities[508]. - An aggregate of 2,236,126 ordinary shares were issued under the Leerink ATM Program for net proceeds of $3,840 at a weighted average price of $1.77 per share during the year ended December 31, 2024[589]. - The Company raised approximately $6.6 million from a private offering (2023 PIPE) by issuing 6,662,389 ordinary shares at a purchase price of $0.835 per unit[592]. - The Company issued 143,049 ordinary shares to non-executive board members in lieu of cash board fees, valued at $263 based on the market price at the grant date[600]. Operational Developments - The company is preparing 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[511]. - The ongoing conflict in Israel has had an immaterial impact on the company's operations and financial condition during 2024 and 2023[515]. - The Company entered into a collaboration agreement with OPKO, granting an exclusive license for developing a GLP-1/glucagon dual agonist, with a revenue sharing of 40% for Entera Bio and 60% for OPKO[637]. - The Company has entered into a research collaboration agreement with OPKO Biologics, Inc., recognizing total expenses of $71 for the year ended December 31, 2024[580]. Compensation and Expenses - The company incurred share-based compensation expenses of $2,556,000 in 2024, up from $1,689,000 in 2023, reflecting increased employee compensation costs[508]. - The Company has not paid any cash dividends and does not anticipate doing so in the foreseeable future[549]. - The Company incurred transaction costs of approximately $1,000 related to the issuance of Broker Warrants and Finder Warrants[599]. Lease and Tax Information - The Company has a total lease liability of $272 as of December 31, 2024, with future minimum lease payments totaling $301[574]. - As of December 31, 2024, the deferred tax assets were $20,873, with a valuation allowance of the same amount, indicating uncertainty in realization[630]. - The Company has a weighted-average remaining lease term of 1.54 years and a weighted-average discount rate of 14% for its operating leases as of December 31, 2024[573]. Stock Options and Warrants - As of December 31, 2024, Entera Bio Ltd. had a total of 7,652,654 outstanding options with a weighted average exercise price of $2.32, compared to 7,105,414 options at $2.57 in 2023[615]. - The aggregate intrinsic value of outstanding options as of December 31, 2024, was $3,632, while the intrinsic value of exercisable options was $2,255[615]. - The company granted 2,116,331 options in 2024 at an average exercise price of $1.49, compared to 1,798,884 options at $0.78 in 2023[615]. - The exercise price for Investor Warrants is set at $1.00 per share, which are immediately exercisable and expire five years from the date of issuance[594].

Financial Performance - Entera Bio reported cash and cash equivalents of $8.7 million as of December 31, 2024, which increased to $21 million by March 28, 2025, primarily due to investments from institutional shareholders and OPKO[9]. - The net loss for 2024 was $9.5 million, or $0.25 per share, compared to a net loss of $8.9 million, or $0.31 per share, in 2023[10]. - Revenues for the year ended December 31, 2024, were $181 million, with no revenues reported for 2023[18]. - Gross profit for 2024 was $9 million, indicating a significant loss in revenue generation[18]. - Operating loss for 2024 was $9,585 million, compared to an operating loss of $8,891 million in 2023[18]. - Net loss for 2024 was $9,541 million, compared to a net loss of $8,889 million in 2023, reflecting a year-over-year increase of approximately 7.3%[18]. - Basic and diluted loss per share improved to $0.25 in 2024 from $0.31 in 2023[18]. - The weighted average number of shares outstanding increased to 37,650,179 in 2024 from 29,007,794 in 2023[18]. - Financial income, net, worsened to $(58) million in 2024 from $(31) million in 2023[18]. Expenses - Research and development expenses for 2024 were $4.5 million, consistent with 2023, while general and administrative expenses rose to $5.1 million from $4.4 million in 2023, reflecting an increase in intellectual property and advisor compensation[10]. - Total operating expenses increased to $9,594 million in 2024 from $8,891 million in 2023, representing an increase of approximately 7.9%[18]. - Research and development expenses slightly decreased to $4,499 million in 2024 from $4,510 million in 2023[18]. - General and administrative expenses rose to $5,095 million in 2024, up from $4,430 million in 2023, marking an increase of approximately 15%[18]. Assets and Liabilities - Entera's total assets decreased from $11.8 million in 2023 to $9.4 million in 2024, while total liabilities slightly decreased from $1.4 million to $1.3 million[16]. Product Development - Entera is developing EB613, the first oral PTH(1-34) tablet for osteoporosis, with a Phase 3 study expected to initiate following FDA's ruling on the SABRE project[4][3]. - The oral oxyntomodulin (OXM) program, in collaboration with OPKO, aims to create a once-daily treatment for obesity, with significant pharmacokinetic results indicating high plasma concentrations and prolonged exposure[7]. - Entera's oral GLP-2 tablets for short bowel syndrome showed plasma levels approximately 10-fold higher than therapeutic concentrations of subcutaneously administered teduglutide, indicating a potential for improved patient compliance[7]. - The FDA is expected to provide a ruling on the SABRE project within 10 months, which could qualify bone mineral density changes as a surrogate endpoint for future osteoporosis drug trials[4]. - Entera's collaboration with OPKO includes a 60% ownership interest for OPKO and 40% for Entera in the oral OXM program, with shared development costs[7]. - The company plans to continue its focus on execution and value addition in 2025, with ongoing work related to EB613 and other product candidates[3].