[PART I – FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) Presents unaudited condensed consolidated financial statements, detailing financial position, performance, and cash flows, with a net loss of **$2.7 million** for Q2 2025 and a going concern warning Condensed Consolidated Balance Sheet Highlights (in thousands USD) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $10,858 | $8,660 | | Restricted cash | $8,015 | $0 | | Total current assets | $19,311 | $8,972 | | Total assets | $19,667 | $9,390 | | **Liabilities & Equity** | | | | Total current liabilities | $1,844 | $1,176 | | Total liabilities | $2,411 | $1,310 | | Total shareholders' equity | $17,256 | $8,080 | Condensed Consolidated Statements of Operations (in thousands USD, except per share data) | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Revenues | $0 | $57 | $42 | $57 | | Research and development, net | $1,520 | $1,086 | $2,643 | $1,821 | | General and administrative | $1,148 | $1,088 | $2,588 | $2,415 | | Operating Loss | $2,668 | $2,165 | $5,231 | $4,227 | | Net Loss | $2,656 | $2,145 | $5,223 | $4,162 | | Loss Per Share (Basic & Diluted) | $0.06 | $0.06 | $0.12 | $0.11 | Condensed Consolidated Statements of Cash Flows Highlights (in thousands USD) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($3,035) | ($3,197) | | Net cash used in investing activities | ($37) | $0 | | Net cash provided by financing activities | $13,286 | $1,246 | | **Net Change in Cash** | **$10,214** | **($1,951)** | - The company's accumulated deficit of **$119.2 million** as of June 30, 2025, raises substantial doubt about its going concern ability due to insufficient funds for the EB613 Phase 3 program[36](index=36&type=chunk)[37](index=37&type=chunk) - A collaboration with OPKO Health, Inc. in March 2025 included an **$8.0 million** equity investment for an oral GLP-1/glucagon dual agonist program, with proceeds held in escrow[53](index=53&type=chunk)[55](index=55&type=chunk)[57](index=57&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses clinical-stage focus, EB613 Phase 3 progress, increased operating losses from R&D, and liquidity challenges for future trials, reinforcing going concern uncertainty [Overview](index=19&type=section&id=Overview) Entera, a clinical-stage company, develops oral peptide therapies, with lead candidate EB613 for osteoporosis receiving positive FDA feedback on its Phase 3 study design - EB613 is the company's most advanced product, developed as the first oral, once-daily bone-building treatment for post-menopausal osteoporosis[71](index=71&type=chunk) - The FDA agreed in July 2025 to a single Phase 3 study design for EB613, using total hip Bone Mineral Density (BMD) as the primary endpoint, enabling program advancement[73](index=73&type=chunk)[74](index=74&type=chunk) - Collaboration with OPKO aims to develop an oral dual agonist GLP-1/Glucagon (OXM) peptide for obesity, with an IND filing planned later this year[81](index=81&type=chunk)[82](index=82&type=chunk)[83](index=83&type=chunk) [Results of Operations](index=26&type=section&id=Results%20of%20Operations) Operating losses increased in Q2 and H1 2025, primarily driven by a **40%** and **45%** rise in R&D expenses respectively, due to preparations for the EB613 Phase 3 program Comparison of Operating Results (in thousands USD) | Metric | Q2 2025 | Q2 2024 | Change (%) | H1 2025 | H1 2024 | Change (%) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Operating Loss | $2,668 | $2,165 | 23% | $5,231 | $4,227 | 24% | | R&D Expenses | $1,520 | $1,086 | 40% | $2,643 | $1,821 | 45% | | G&A Expenses | $1,148 | $1,088 | 6% | $2,588 | $2,415 | 7% | - Increased R&D expenses in Q2 and H1 2025 were primarily due to higher consulting and regulatory fees for EB613 Phase 3 program preparations[120](index=120&type=chunk)[127](index=127&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company had **$18.9 million** in cash, sufficient for operations through mid-Q3 2026, but additional capital is needed for the EB613 Phase 3 trial, reinforcing going concern doubts - As of June 30, 2025, cash, cash equivalents, and restricted cash totaled **$18.9 million**, with **$8.0 million** designated for the OPKO collaboration agreement[132](index=132&type=chunk) - Existing cash resources are projected to fund operations through mid-Q3 2026, excluding the capital required for the EB613 Phase 3 program[130](index=130&type=chunk)[136](index=136&type=chunk) - The company raised **$6.0 million** net from its ATM program in January 2025 and received an **$8.0 million** investment from OPKO in March 2025 for their collaboration[134](index=134&type=chunk)[135](index=135&type=chunk) - Substantial doubt about going concern ability persists, necessitating additional capital for future R&D, especially the costly EB613 Phase 3 trial[140](index=140&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Entera Bio Ltd. is not required to provide market risk disclosures - As a smaller reporting company, Entera Bio Ltd. is not required to provide quantitative and qualitative disclosures about market risk[152](index=152&type=chunk) [Item 4. Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting - Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025[153](index=153&type=chunk) - No material changes to internal control over financial reporting occurred during the last fiscal quarter[154](index=154&type=chunk) [PART II – OTHER INFORMATION](index=32&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings - The company is not currently involved in any material legal proceedings[157](index=157&type=chunk) [Item 1A. Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) Updates risk factors, focusing on the potential impact of the ongoing multi-front war in Israel, which could adversely affect operations, capital raising, and stock price if it escalates - A new risk factor addresses Israel's multi-front war with terrorist groups and state actors[158](index=158&type=chunk)[159](index=159&type=chunk) - While research and some management are in Israel, other core activities like clinical, regulatory, and supply chain are external[159](index=159&type=chunk) - The conflict has not materially impacted business to date, but escalation could lead to operational disruptions, capital raising difficulties, and negative share price impact[161](index=161&type=chunk)[164](index=164&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=33&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities during the period - No unregistered sales of equity securities occurred during the period[166](index=166&type=chunk) [Item 3. Defaults Upon Senior Securities](index=33&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - No defaults upon senior securities were reported[167](index=167&type=chunk) [Item 4. Mine Safety Disclosures](index=33&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - This item is not applicable to the company[168](index=168&type=chunk) [Item 5. Other Information](index=33&type=section&id=Item%205.%20Other%20Information) No officers or directors adopted or terminated Rule 10b5-1 trading plans during the quarter ended June 30, 2025 - No officers or directors adopted or terminated any Rule 10b5-1(c) trading plans during the quarter[169](index=169&type=chunk) [Item 6. Exhibits](index=33&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including officer certifications, an amendment to the sales agreement, and XBRL data files - Exhibits include officer certifications, an amendment to the Sales Agreement with Leerink Partners LLC, and XBRL interactive data files[170](index=170&type=chunk)

[Entera Bio Second Quarter 2025 Results](index=1&type=section&id=Entera%20Bio%20Second%20Quarter%202025%20Results) Entera Bio reported its second quarter 2025 results, highlighting a pivotal FDA agreement for EB613's Phase 3 trial, significant pipeline advancements, and a strengthened financial position [CEO Statement & Key Highlights](index=1&type=section&id=CEO%20Statement%20%26%20Key%20Highlights) Entera Bio secured FDA agreement on EB613's Phase 3 trial design, validating BMD as the primary endpoint, and strengthened its cash position to **$18.9 million**, extending operational runway through mid-Q3 2026 - The FDA agreed to use **Bone Mineral Density (BMD)** as the primary endpoint for the EB613 Phase 3 program, creating a streamlined pathway for the first oral anabolic osteoporosis treatment[3](index=3&type=chunk)[5](index=5&type=chunk)[6](index=6&type=chunk) - The company's cash position is **$18.9 million** as of June 30, 2025, which is expected to fund operations through the **middle of the third quarter of 2026**[3](index=3&type=chunk)[5](index=5&type=chunk)[9](index=9&type=chunk) - Promising pharmacokinetic data was presented for the **oral GLP-1/glucagon dual agonist program** for obesity, developed in collaboration with OPKO[3](index=3&type=chunk)[12](index=12&type=chunk) [Pipeline Updates](index=1&type=section&id=Pipeline%20Updates) Entera Bio reported significant pipeline progress, including a key regulatory agreement for EB613, advancements in hypoparathyroidism, and positive preclinical data from the OPKO collaboration [EB613 (Osteoporosis)](index=1&type=section&id=EB613%20(Osteoporosis)) Entera secured FDA agreement on **Bone Mineral Density (BMD)** as the primary endpoint for EB613's Phase 3 trial, reducing regulatory burden and advancing a next-generation tablet into Phase 1 by November 2025 - The FDA concurred on a single **24-month Phase 3 study** design using change in **total hip BMD** as the primary endpoint and vertebral fracture incidence as the key secondary endpoint[6](index=6&type=chunk) - The **regulatory burden was significantly reduced** as the FDA agreed that dedicated oral carcinogenicity and comprehensive DART studies are not warranted[6](index=6&type=chunk) - A **next-generation EB613 tablet**, utilizing the N-Tab™ technology, is expected to enter a **Phase 1 Safety and PK Study** in **November 2025**[5](index=5&type=chunk)[12](index=12&type=chunk) [Hypoparathyroidism Program](index=2&type=section&id=Hypoparathyroidism%20Program) Entera is developing EB612, an oral PTH(1-34) replacement for hypoparathyroidism, with initial preclinical PK/PD data for a long-acting PTH agonist expected by year-end - **First pre-clinical PK/PD data** for a once-daily tablet format for hypoparathyroidism is expected by the **end of the year**[7](index=7&type=chunk) [OPKO Health Collaboration Programs](index=2&type=section&id=OPKO%20Health%20Collaboration%20Programs) The OPKO Health collaboration shows promising preclinical PK data for oral obesity treatment OPK-88006, with an IND filing planned for H1 2026, and advances in the short bowel syndrome program - Obesity (**OPK-88006**): A mini-pig study showed **plasma levels consistent with the highest subcutaneous dose of Wegovy™**, supporting a **once-daily tablet regimen**. An **IND filing is expected in H1 2026**[12](index=12&type=chunk) - Short Bowel Syndrome (GLP-2): An abstract for the **first-in-class oral GLP-2 analog** was selected for a **poster presentation** at the 47th ESPEN Congress[12](index=12&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) Entera Bio reported a **$2.7 million net loss** for Q2 2025, driven by increased R&D for EB613, while maintaining a strong **$18.9 million cash position** with runway through mid-Q3 2026 [Financial Position (Balance Sheet)](index=2&type=section&id=Financial%20Position%20(Balance%20Sheet)) As of June 30, 2025, cash and cash equivalents, including restricted cash, significantly increased to **$18.9 million**, driving total assets to **$19.7 million** - Cash and cash equivalents were **$18.9 million** as of June 30, 2025, including **$8.0 million** in restricted cash designated for the OPKO collaboration[9](index=9&type=chunk) - The current cash on hand is expected to support operations through the **mid-third quarter of 2026**[9](index=9&type=chunk) Balance Sheet Summary (in thousands) | (in thousands) | June 30, 2025 (Unaudited) | December 31, 2024 (Audited) | | :--- | :--- | :--- | | Cash and cash equivalents | $10,858 | $8,660 | | Restricted cash | $8,015 | - | | **Total Assets** | **$19,667** | **$9,390** | | Total Liabilities | $2,411 | $1,310 | | **Total Shareholders' Equity** | **$17,256** | **$8,080** | [Financial Performance (Statement of Operations)](index=2&type=section&id=Financial%20Performance%20(Statement%20of%20Operations)) For Q2 2025, the company reported a **$2.7 million net loss**, or **$0.06 per share**, primarily due to a **$0.4 million increase in R&D expenses** for EB613 Phase 3 planning Statement of Operations Summary (in thousands, except per share data) | (in thousands, except per share data) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Research and development | $1,520 | $1,086 | | General and administrative | $1,148 | $1,088 | | **Total Operating Expenses** | **$2,668** | **$2,174** | | **Net Loss** | **$2,656** | **$2,145** | | Loss Per Share | $0.06 | $0.06 | - The increase in **R&D expenses by $0.4 million** year-over-year was primarily due to regulatory activities and Phase 3 planning for EB613[10](index=10&type=chunk)

Core Insights - Entera Bio Ltd. has achieved a significant milestone with the FDA's agreement to use Bone Mineral Density (BMD) as the primary endpoint for the Phase 3 program of EB613, marking a step towards the first oral anabolic osteoporosis treatment [2][4][5] - The company reported a cash position of $18.9 million as of June 30, 2025, which is expected to support operations through mid-Q3 2026 [9][10] - Entera is advancing multiple programs, including the oral GLP-1/glucagon dual agonist in collaboration with OPKO Health, and is preparing for a Phase 1 study of the next-generation EB613 [2][4][14] Financial Results - For the quarter ended June 30, 2025, Entera reported a net loss of $2.7 million, or $0.06 per share, compared to a net loss of $2.1 million, or $0.06 per share, for the same period in 2024 [10][19] - Research and development expenses increased to $1.5 million from $1.1 million year-over-year, primarily due to regulatory activities and Phase 3 planning for EB613 [10][11] - Total operating expenses for the quarter were $2.7 million, up from $2.2 million in the previous year [11][19] Business Updates - The FDA has waived additional safety studies for EB613, allowing for a streamlined pathway to market [4][5] - Entera's collaboration with OPKO Health is showing strong momentum, particularly in obesity and hypoparathyroidism programs [2][4][14] - The next-generation EB613 is expected to enter Phase 1 clinical trials in November 2025, utilizing Entera's proprietary N-TAB™ technology [4][12]

Core Viewpoint - Entera Bio Ltd. has received FDA agreement to support the NDA marketing application filing for EB613 based on a single 24-month phase 3 study, marking a significant regulatory milestone for the company and the osteoporosis community [1][2] 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 candidate, EB613, is an oral anabolic treatment for post-menopausal women with low bone mineral density (BMD) and high-risk osteoporosis [5] Product Development - EB613 is designed as the first oral, once-daily anabolic tablet treatment for osteoporosis, aiming to increase skeletal mass, improve bone microarchitecture, and reduce fracture risk [3][4] - A phase 2 study of EB613 demonstrated significant efficacy, meeting all biomarker and BMD endpoints without major safety concerns [4] Regulatory Context - The FDA's agreement allows Entera to advance its clinical development program without waiting for the qualification of the SABRE initiative, which aims to establish BMD as a regulatory endpoint [2][6] - The SABRE initiative has shown that treatment-related gains in total-hip BMD can predict fracture-risk reduction, with a correlation coefficient of 0.73 [6] Market Need - Osteoporosis affects over 200 million women globally, with a significant portion remaining undertreated despite available injectable treatments [3] - The lack of new FDA-approved osteoporosis drugs since 2019 highlights the urgent need for innovative treatments like EB613 [3]

Core Insights - OPKO Health and Entera Bio announced a first-in-class oral GLP-2 analog for treating Short Bowel Syndrome (SBS), selected for a poster presentation at the ESPEN Congress in September 2025 [1][2] Company Overview - OPKO Health is a multinational biopharmaceutical and diagnostics company focused on establishing industry-leading positions in rapidly growing markets through its discovery, development, and commercialization expertise [6] - Entera Bio is a clinical-stage company developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ technology for significant unmet medical needs [5] Product Development - The oral GLP-2 tablet program combines OPKO's long-acting GLP-2 agonist with Entera's N-Tab™ technology, aimed at patients with SBS and related gastrointestinal disorders [2] - Current approved therapy for SBS, GATTEX (teduglutide), generates approximately $800 million in annual sales and requires daily subcutaneous injections [4] Market Context - Short Bowel Syndrome affects around 30,000 patients in the US and EU, leading to malabsorption and increased risk of malnutrition [4] - The introduction of an oral tablet format for GLP-2 therapy may improve patient compliance and enable personalized treatment [3]

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].