First-time presentation examining bone outcomes in early postmenopausal womenJERUSALEM, Oct. 16, 2025 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptide and protein replacement therapies, today announced that it will present new clinical data from its Phase 2 trial of EB613 at the upcoming North American Menopause Society (NAMS) 2025 Annual Meeting, taking place October 21–25, 2025, in Orlando, Florida. This will mark Entera’s first presentation at NAMS. The pres ...

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]

Core Viewpoint - Entera Bio Ltd. has presented promising preclinical data for its oral GLP-2 analog, OPK-8801003, which could significantly improve treatment for Short Bowel Syndrome (SBS) patients who currently rely on daily injections of the peptide [1][3]. 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 [6]. - The company is collaborating with OPKO Health, Inc. to develop oral peptide candidates for intestinal malabsorption syndromes, specifically targeting SBS [2][8]. Product Development - OPK-8801003 demonstrated a plasma half-life of approximately 15 hours in preclinical studies, an 18-fold improvement over the current treatment, teduglutide, which has a half-life of only 0.85 hours [7]. - The peak plasma concentration of OPK-8801003 reached ~200 ng/ml, significantly higher than the reported Cmax of 36.8 ng/ml for teduglutide [7]. - The systemic exposure (AUC) was maintained for over 24 hours, supporting the potential for once-daily oral dosing [7]. Market Context - Approximately 30,000 patients in the U.S. and EU suffer from SBS, with the only approved therapy, Gattex® (teduglutide), generating around $800 million in annual sales [5][2]. - SBS is a leading cause of chronic intestinal failure, accounting for about 75% of cases in adults and 50% in children [5]. Future Implications - The robust oral bioavailability and favorable safety profile of OPK-8801003 could fundamentally change the treatment landscape for SBS, offering a less invasive administration method and personalized dosing options [3][7].

Core Insights - Entera Bio Ltd. announced significant results from its Phase 2 study of EB613, an oral treatment for osteoporosis, showing improvements in both trabecular and cortical bone after just 6 months of treatment [1][2][4] - The company plans to initiate a global registrational Phase 3 study following FDA concurrence in July 2025 [1][4] - EB613 is positioned as a viable alternative to injectable anabolic treatments, which are currently underutilized due to accessibility issues [2][4] Company Overview - Entera Bio is focused on developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ technology [6] - The company's lead product, EB613, is the first oral anabolic treatment for post-menopausal women with osteoporosis, aiming to address significant unmet medical needs [6] - Entera is also developing other oral peptide therapies targeting conditions such as hypoparathyroidism and obesity [6] Clinical Study Results - The Phase 2 study of EB613 involved 161 patients and met all primary and secondary endpoints, demonstrating significant increases in bone mineral density (BMD) and favorable safety profiles [4][5] - Key findings included a 1.7% increase in integral volumetric BMD of the total hip and a 2.6% increase in the femoral neck compared to placebo [5] - Improvements in cortical thickness and surface BMD were also observed, indicating early strengthening effects of EB613 [3][5] Future Developments - Entera plans to begin a Phase 1 clinical trial for its Next-Gen EB613 tablet in late 2025, which has shown comparable pharmacokinetic properties to the current formulation [3][4] - The company aims to address the treatment gap in osteoporosis care with its oral formulation, which is expected to enhance patient compliance and accessibility [2][4]

Summary of Entera Bio Ltd. Conference Call Company Overview - **Company**: Entera Bio Ltd. - **Industry**: Biopharmaceuticals - **Focus**: Development of first-in-class oral peptide therapies for unmet medical needs - **Ticker Symbol**: ENTX (listed on NASDAQ) - **Cash Runway**: Expected to last until Q3 2026 [2][24] Core Technology and Pipeline - **Technology Platform**: NTAB technology platform enables the development of oral peptide therapies in tablet form, overcoming challenges such as proteolytic degradation and molecular polarity [2][3][4] - **Lead Asset**: EB613, the only oral peptide in development for osteoporosis, is set to enter a phase 3 registrational study [2][4][17] - **Other Pipeline Assets**: Include treatments for hypoparathyroidism, metabolic disorders, obesity, and gastrointestinal inflammation [2][4] EB613 Details - **Mechanism of Action**: EB613 is a PTH(1-34) teriparatide tablet that stimulates bone formation and suppresses bone resorption, aiming to provide a validated mechanism of action in a convenient oral format [6][10][12] - **Clinical Studies**: Phase 2 studies showed favorable outcomes in bone formation markers and bone mineral density (BMD) across skeletal sites [12][13][14] - **Comparison with Forteo**: EB613 has a similar amino acid sequence to Forteo but offers a more rapid onset of action and improved BMD outcomes, particularly at the hip [6][14][15] Osteoporosis Market Insights - **Prevalence**: Approximately 200 million women globally are affected by osteoporosis, with significant fracture risks [7][8] - **Current Treatment Landscape**: Most treatments are antiresorptive drugs, with bisphosphonates being the most commonly prescribed [9][10] - **Patient Access Issues**: Many patients do not receive adequate treatment due to the limitations of injectable therapies and the need for healthcare provider resources [11][19] Phase 3 Study Plans - **Study Design**: A double-blind, placebo-controlled, 24-month study focusing on total hip BMD as the primary endpoint, with secondary endpoints including vertebral fracture trends [17][18] - **Regulatory Alignment**: Recent agreement with the FDA allows the use of total hip BMD as a primary endpoint, a significant milestone for the company [18][23] Market Research and Patient Insights - **Clinician Feedback**: 30% of osteoporosis patients experience suboptimal responses to current treatments, highlighting a need for more effective solutions [19] - **Patient Interest**: 55% of surveyed patients expressed interest in oral bone-building treatments, indicating a potential market for EB613 [19] Future Developments - **Partnership with OPKO Health**: Development of an oral oxyntomodulin tablet is underway, with an IND filing expected in early 2026 [5][20] - **Additional Programs**: Plans to validate a different peptide for hypoparathyroidism and to present supplemental data at upcoming conferences [23] Conclusion - Entera Bio Ltd. is positioned to address significant unmet needs in osteoporosis treatment with its innovative oral peptide therapies, particularly EB613, which aims to enhance patient access and compliance compared to existing injectable options [2][19][24]

Osteoporosis Program: Phase 2 analysis exploring the dual actions of oral PTH(1-34) tablet treatment, EB613 on trabecular and cortical bone, and Next-Gen EB613 PK/PD data slated for oral and poster presentations at ASBMRShort Bowel Syndome and Rare GI Disorders: PK/PD of oral GLP-2 tablet candidate poster presentation at ESPENCorporate Overview at H.C. Wainwright Investor Conference JERUSALEM, Aug. 28, 2025 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptides and ...

Core Insights - Entera Bio reported a better-than-expected GAAP earnings per share of $0.06 for Q2 2025, contrasting with Wall Street's estimate of a loss of $(0.11) [1] - The company did not report any revenue for the quarter, down from $57,000 in Q2 2024, indicating a 100% year-over-year decline [2] - A significant regulatory breakthrough was achieved with the FDA's concurrence on the design for the Phase 3 trial of EB613, marking a key advancement in the company's product pipeline [5][6] Financial Performance - GAAP EPS for Q2 2025 was $(0.06), better than the estimated $(0.11) [2] - No revenue was reported for Q2 2025, compared to $57,000 in Q2 2024, reflecting a 100% decrease [2] - Research and Development expenses increased by 39.9% to $1.52 million from $1.09 million in Q2 2024 [2] - General & Administrative expenses rose by 5.5% to $1.15 million [2] - Cash and cash equivalents increased by 25.4% to $10.86 million compared to $8.66 million as of December 31, 2024 [2][8] Business Overview - Entera Bio focuses on oral delivery of protein and peptide drugs, utilizing its N-Tab™ technology to enhance stability and absorption of peptides [3] - The company aims to address challenges in pharmaceutical development by providing oral alternatives to injectable therapies [3][4] Key Developments - The FDA's agreement on using total hip bone mineral density as the primary measure of effectiveness for EB613's Phase 3 trial streamlines the regulatory process [5] - Positive results from a completed Phase 2 study of EB613 were presented, showing improvements in bone strength and mineralization compared to placebo [6] - The company is preparing to initiate a pivotal Phase 3 trial for EB613 with the new design [6] Future Outlook - Entera Bio plans to launch a Phase 1 trial for an updated version of EB613 in November 2025 [9] - Development of OPKO-partnered candidates, including an oral GLP-1/glucagon product, is expected to progress in H1 2026 [9] - Management did not provide specific revenue or earnings guidance but highlighted key operational milestones for the upcoming year [9][10]

[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)