Entera Bio(ENTX) - 2025 Q2 - Quarterly Report

PART I – FINANCIAL INFORMATION Item 1. Financial Statements 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][37] - 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][55][57] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 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 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] - 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][74] - 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][82][83] Results of Operations 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][127] Liquidity and Capital Resources 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] - Existing cash resources are projected to fund operations through mid-Q3 2026, excluding the capital required for the EB613 Phase 3 program[130][136] - 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][135] - Substantial doubt about going concern ability persists, necessitating additional capital for future R&D, especially the costly EB613 Phase 3 trial[140] Item 3. Quantitative and Qualitative Disclosures About Market Risk 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] Item 4. Controls and Procedures 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] - No material changes to internal control over financial reporting occurred during the last fiscal quarter[154] PART II – OTHER INFORMATION Item 1. Legal Proceedings The company is not currently involved in any material legal proceedings - The company is not currently involved in any material legal proceedings[157] Item 1A. Risk Factors 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][159] - While research and some management are in Israel, other core activities like clinical, regulatory, and supply chain are external[159] - 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][164] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds The company reports no unregistered sales of equity securities during the period - No unregistered sales of equity securities occurred during the period[166] Item 3. Defaults Upon Senior Securities The company reports no defaults upon senior securities - No defaults upon senior securities were reported[167] Item 4. Mine Safety Disclosures This item is not applicable to the company - This item is not applicable to the company[168] Item 5. Other Information 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] Item 6. Exhibits 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]