IMARA(IMRA) - 2024 Q4 - Annual Results

Company Overview and Business Update Enliven Therapeutics provided a business update, highlighting CEO statements, pipeline progress for ELVN-001 and ELVN-002, and its precision oncology focus Introduction and CEO Statement Enliven reported Q4 and FY2024 results, with the CEO highlighting pipeline progress and pivotal trial preparations for ELVN-001 in 2026 - Enliven Therapeutics, a clinical-stage biopharmaceutical company, reported financial results for Q4 and full year 2024 and provided a business update, including pipeline progress[1] - CEO Sam Kintz highlighted ongoing progress, significant investigator enthusiasm for both programs, and accelerated momentum for ELVN-001[2] - The company is focused on continued clinical execution and preparing for the potential start of a pivotal trial for ELVN-001 in 2026[2] Recent Research and Development Highlights and Upcoming Milestones Enliven updated on ELVN-001 and ELVN-002 clinical progress, regulatory designations, and data readouts expected mid-2025 and H2 2025 - ELVN-001 is a potent, highly selective, small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion[3] - ELVN-002 is a potent, highly selective, central nervous system (CNS) penetrant and irreversible HER2 inhibitor[3] - The U.S. Food and Drug Administration (FDA) granted orphan drug designation to ELVN-001 for the treatment of chronic myeloid leukemia (CML)[4] - Updated Phase 1 data for ELVN-001 is expected mid-2025[1][4] - Expected monotherapy and combination data from the ELVN-002 Phase 1 trials are anticipated in the second half of 2025[1][9] ELVN-001 Program Update ELVN-001, a BCR::ABL inhibitor, showed positive initial Phase 1 data, received FDA Orphan Drug Designation for CML, with further data expected mid-2025 - ELVN-001 is designed to specifically target the BCR::ABL gene fusion[3] - In 2024, the Company announced positive initial data from the ongoing Phase 1 clinical trial for ELVN-001 that compared favorably to precedent Phase 1 trials for approved BCR::ABL1 tyrosine kinase inhibitors (TKIs)[4] - The U.S. Food and Drug Administration (FDA) granted orphan drug designation to ELVN-001 for the treatment of chronic myeloid leukemia (CML)[4] - The first patient was dosed in the Phase 1 trial evaluating ELVN-001 in Japanese patients with CML[4] - The Company plans to report additional data from the ongoing Phase 1a/b trial in the middle of 2025[4] ELVN-002 Program Update ELVN-002, a HER2 inhibitor, continues Phase 1 enrollment for monotherapy and combination trials, with data expected in H2 2025 - ELVN-002 is a CNS penetrant and irreversible HER2 inhibitor with activity against wild type HER2 and various HER2 mutations[3] - Enliven continued to enroll patients in its Phase 1 trial evaluating ELVN-002 as a monotherapy agent in patients with HER2+ and HER2 mutant tumors[3] - ELVN-002 is being evaluated in combination with Kadcyla® in patients with HER2+ metastatic breast cancer (MBC)[5] - The Company continued to enroll patients in its Phase 1 trial evaluating ELVN-002 in combination with trastuzumab +/- chemotherapeutic agents in patients with HER2+ MBC and colorectal cancer (CRC) and began dosing patients in the Phase 1b trial specifically evaluating patients with CRC[9] - Enliven plans to report data from the ongoing Phase 1 trials in the second half of 2025[9] About Enliven Therapeutics Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on precision oncology, developing small molecule therapeutics to address unmet needs - Enliven is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics[7] - Enliven aims to address existing and emerging unmet needs with a precision oncology approach that improves survival and enhances overall well-being[7] - 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[7] Financial Results Enliven reported increased operating expenses and net losses for Q4 and FY2024, maintaining a strong cash position into mid-2027 Summary of Financial Performance Enliven reported increased R&D and G&A expenses for Q4 and FY2024, leading to higher net losses, but maintains a strong $313.4 million cash position into mid-2027 - As of December 31, 2024, the Company had cash, cash equivalents and marketable securities totaling $313.4 million, which is expected to provide cash runway into mid-2027[1][9] Key Financial Highlights (Q4 and Full Year 2024 vs 2023) | Metric | Q4 2024 (in millions) | Q4 2023 (in millions) | YoY Change (Q4) | FY 2024 (in millions) | FY 2023 (in millions) | YoY Change (FY) | | :---------------------- | :-------------------- | :-------------------- | :---------------- | :-------------------- | :-------------------- | :---------------- | | R&D Expenses | $20.7 | $17.9 | +15.6% | $80.8 | $64.6 | +25.1% | | G&A Expenses | $6.2 | $4.8 | +29.2% | $23.8 | $19.0 | +25.3% | | Net Loss | $(23.2) | $(19.4) | +19.6% | $(89.0) | $(71.6) | +24.3% | Statements of Operations Enliven's Q4 2024 total operating expenses increased to $26.9 million, resulting in a $23.2 million net loss, with FY2024 net loss at $89.0 million Statements of Operations (in thousands, except per share data) | Metric | Three Months Ended Dec 31, 2024 (in thousands) | Three Months Ended Dec 31, 2023 (in thousands) | Year Ended Dec 31, 2024 (in thousands) | Year Ended Dec 31, 2023 (in thousands) | | :-------------------------------- | :--------------------------------------------- | :--------------------------------------------- | :------------------------------------- | :------------------------------------- | | Research and development | $20,724 | $17,905 | $80,778 | $64,574 | | General and administrative | $6,172 | $4,824 | $23,776 | $18,955 | | Total operating expenses | $26,896 | $22,729 | $104,554 | $83,529 | | Loss from operations | $(26,896) | $(22,729) | $(104,554) | $(83,529) | | Other income (expense), net | $3,716 | $3,359 | $15,530 | $11,945 | | Net loss | $(23,180) | $(19,370) | $(89,024) | $(71,584) | | Net loss per share, basic and diluted | $(0.46) | $(0.47) | $(1.89) | $(2.01) | | Weighted-average shares outstanding | 49,858 | 41,128 | 47,073 | 35,546 | Balance Sheets As of December 31, 2024, total assets increased to $325.8 million, driven by $313.4 million in cash, while liabilities decreased and equity rose significantly Balance Sheets (in thousands) | Asset/Liability/Equity | December 31, 2024 (in thousands) | December 31, 2023 (in thousands) | | :-------------------------------- | :------------------------------- | :------------------------------- | | Cash, cash equivalents and marketable securities | $313,440 | $253,148 | | Total current assets | $318,127 | $266,151 | | Total assets | $325,760 | $271,867 | | Accounts payable | $1,342 | $532 | | Accrued expenses and other current liabilities | $14,573 | $15,362 | | Contingent value right liability | — | $10,000 | | Total current liabilities | $15,915 | $25,894 | | Total liabilities | $15,915 | $25,961 | | Stockholders' equity | $309,845 | $245,906 | | Total liabilities and stockholders' equity | $325,760 | $271,867 | Forward-Looking Statements This section outlines forward-looking statements regarding Enliven's future plans and financial position, emphasizing inherent risks and uncertainties that could materially alter actual results - The press release contains forward-looking statements concerning Enliven's future plans, trends, events, results of operations, and financial position[8] - These statements include expectations regarding Enliven's programs (ELVN-001 and ELVN-002), potential timing for a pivotal trial, and expected data from clinical trials[10] - Forward-looking statements are subject to substantial risks and uncertainties, including limited operating history, ability to advance product candidates, regulatory approval, and reliance on third parties[10] - Enliven undertakes no obligation to revise or update any forward-looking statement, except as required by applicable law[10] Contact Information This section provides contact information for Enliven Therapeutics' investor relations and media inquiries - Investors can contact ir@enliventherapeutics.com[11] - Media can contact media@enliventherapeutics.com[11]