Enliven Therapeutics(ELVN) - 2025 Q2 - Quarterly Results

Company Overview and Q2 2025 Highlights This section provides an executive summary of Enliven Therapeutics' positive Phase 1 ELVN-001 trial data, strong financial position, and CEO commentary on future plans Executive Summary Enliven Therapeutics reported positive Phase 1 clinical trial data for ELVN-001 in CML, showing a 47% cumulative Major Molecular Response (MMR) rate and a favorable safety profile. The company maintains a strong financial position with $491 million in cash, providing a runway into the first half of 2029 - Enliven Therapeutics, a clinical-stage biopharmaceutical company, reported positive data from the Phase 1 clinical trial of ELVN-001 in CML[1] - The ELVN-001 trial showed a cumulative MMR rate of 47%, with 32% of patients achieving MMR by 24 weeks, and demonstrated a favorable safety and tolerability profile across all dose levels[1] Cash Position and Runway | Metric | Value | | :------------------------------------ | :--------------------------------------------------- | | Cash, cash equivalents, and marketable securities | $491 million | | Expected cash runway | Into the first half of 2029 | CEO Commentary CEO Sam Kintz highlighted ELVN-001's differentiated efficacy and tolerability, positioning it as a potential best-in-class CML therapy, with a Phase 3 trial planned for 2026 and a strengthened balance sheet - CEO Sam Kintz stated that ELVN-001's differentiated efficacy, tolerability, and convenience position it to be a potential best-in-class therapy for CML[2] - The company expects to initiate its first Phase 3 pivotal trial for ELVN-001 in 2026[2] - Enliven strengthened its balance sheet through a recent public offering that generated approximately $230 million in gross proceeds, extending its cash runway into the first half of 2029[2] Pipeline Updates: ELVN-001 Program This section details the ELVN-001 program, including its mechanism of action, positive Phase 1 clinical trial results, and future development plans ELVN-001 Program Description ELVN-001 is a potent, highly selective, small molecule kinase inhibitor designed to target the BCR::ABL gene fusion, the oncogenic driver for chronic myeloid leukemia (CML) - ELVN-001 is a potent, highly selective, small molecule kinase inhibitor[3] - It is designed to specifically target the BCR::ABL gene fusion, the oncogenic driver for patients with chronic myeloid leukemia (CML)[3] ENABLE Phase 1 Clinical Trial Results Updated positive data from the ENABLE Phase 1 clinical trial for ELVN-001 in previously treated CML patients demonstrated a 47% cumulative Major Molecular Response (MMR) rate, favorable tolerability, and comparative efficacy - Positive updated data from the ongoing ENABLE Phase 1 clinical trial (NCT05304377) for ELVN-001 in previously treated CML patients were announced in June 2025[3] ELVN-001 ENABLE Phase 1 MMR Rates (as of April 28, 2025) | Metric | Rate | | :------------------------------------------------ | :--- | | Evaluated patients in Major Molecular Response (MMR) | 47% (25 of 53) | | Patients achieving MMR by 24 weeks | 32% (13 of 41) | | Patients maintaining MMR | 100% (12 of 12) | - ELVN-001 remained well-tolerated across all evaluated doses and its achieved MMR rate by 24 weeks (32%) compared favorably with historical data from asciminib (24-25%) in less heavily pretreated patients[3] Future Development Plans Following positive Phase 1 results, Enliven Therapeutics plans to initiate a Phase 3 pivotal trial for ELVN-001 in 2026 - The Company plans to initiate a Phase 3 pivotal trial for ELVN-001 in 2026[4] Second Quarter 2025 Financial Results This section presents Enliven Therapeutics' financial performance for Q2 2025, highlighting cash position, operating expenses, and net loss Key Financial Highlights Enliven Therapeutics reported a strong cash position of $490.5 million as of June 30, 2025, extending its cash runway into the first half of 2029, with increased operating expenses and net loss Cash Position (as of June 30, 2025) | Metric | Value | | :------------------------------------ | :------------ | | Cash, cash equivalents, and marketable securities | $490.5 million | | Expected cash runway | Into the first half of 2029 | Operating Expenses (Three Months Ended June 30) | Expense Category | Q2 2025 (Millions) | Q2 2024 (Millions) | YoY Change | | :----------------- | :----------------- | :----------------- | :--------- | | Research and development | $21.5 | $18.8 | +14.4% | | General and administrative | $7.1 | $5.8 | +22.4% | Net Loss (Three Months Ended June 30) | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | YoY Change | | :------- | :----------------- | :----------------- | :--------- | | Net Loss | $(25.3) | $(20.0) | +26.5% | Condensed Consolidated Financial Information The condensed consolidated financial statements detail Enliven's Q2 2025 performance, showing increased operating expenses, net losses, and a significant rise in cash and total assets due to recent financing Statements of Operations For Q2 2025, total operating expenses increased to $28.6 million, resulting in a net loss of $25.3 million, or $(0.49) per share, with similar trends for the six-month period Statements of Operations (in thousands, except per share data) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $21,491 | $18,826 | $46,386 | $38,796 | | General and administrative | $7,093 | $5,777 | $13,891 | $11,794 | | Total operating expenses | $28,584 | $24,603 | $60,277 | $50,590 | | Loss from operations | $(28,584) | $(24,603) | $(60,277) | $(50,590) | | Other income (expense), net | $3,249 | $4,653 | $6,398 | $7,902 | | Net loss | $(25,335) | $(19,950) | $(53,879) | $(42,688) | | Net loss per share, basic and diluted | $(0.49) | $(0.41) | $(1.05) | $(0.95) | | Weighted-average shares outstanding | 52,105 | 48,075 | 51,084 | 45,060 | Balance Sheets As of June 30, 2025, cash, cash equivalents, and marketable securities significantly increased to $490.5 million, driving total assets to $503.9 million, while liabilities remained stable and stockholders' equity grew Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :-------------- | :---------------- | | Cash, cash equivalents and marketable securities | $490,503 | $313,440 | | Total current assets | $495,622 | $318,127 | | Total assets | $503,887 | $325,760 | | Total current liabilities | $15,211 | $15,915 | | Total liabilities | $15,415 | $15,915 | | Stockholders' equity | $488,472 | $309,845 | | Total liabilities and stockholders' equity | $503,887 | $325,760 | About Enliven Therapeutics This section provides an overview of Enliven Therapeutics, detailing its focus on precision oncology and small molecule therapeutics Company Profile Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics with a precision oncology approach to address unmet medical needs - Enliven is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics[6] - The company aims to address existing and emerging unmet needs with a precision oncology approach to improve survival and enhance overall well-being[6] - Enliven's discovery process combines deep insights in clinically validated biological targets and differentiated chemistry to design potentially first-in-class or best-in-class therapies[6] Legal and Disclaimers This section outlines important legal considerations, including forward-looking statements and disclaimers regarding cross-trial comparisons Forward-Looking Statements This section outlines that the press release contains forward-looking statements regarding future plans, trends, and financial conditions, which are subject to substantial risks and uncertainties - The press release contains forward-looking statements concerning Enliven and other matters that involve substantial risks and uncertainties, including goals, intentions, and expectations for future plans, trends, events, results of operations, and financial condition[7] - Forward-looking statements are based on current beliefs and assumptions subject to risks and uncertainties, and actual results could differ materially due to factors such as limited operating history, ability to advance product candidates, regulatory approval, and intellectual property protection[7][9] - Enliven undertakes no obligation to revise or update any forward-looking statement, except as required by applicable law[9] Cross-Trial Comparison Disclaimer The company explicitly states that it has not performed any head-to-head trials for ELVN-001, thus cross-trial comparisons with data from different studies are not valid - The Company has not performed any head-to-head trials for ELVN-001[11] - Data referenced from different clinical trials at different points in time, with differences in trial design and patient populations, means conclusions from cross-trial comparisons cannot be made[11] Contact Information This section provides contact details for investor and media relations Investor and Media Relations Contact information for investor and media inquiries is provided - Investors can contact ir@enliventherapeutics.com[11] - Media can contact media@enliventtherapeutics.com[11]