IMARA(IMRA) - 2024 Q4 - Annual Report

PART I Item 1. Business Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on precision oncology, advancing ELVN-001 and ELVN-002 with promising early clinical data - Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on precision oncology, developing small molecule therapeutics to improve patient survival and well-being[15] - The company's team includes seasoned drug hunters, with chemists who have been primary or co-inventors of over 20 product candidates advanced to clinical trials, including four FDA-approved products: Koselugo, Mektovi, Tukysa, and Retevmo[15] Lead Product Candidates Summary | Program | Target | Differentiation | Disease | Regimen | Next Milestone | Milestone Expected | | :-------- | :------- | :------------------------------------------------------- | :------------------------ | :---------- | :--------------------- | :----------------- | | ELVN-001 | BCR-ABL | Highly selective active site inhibitor w/activity against asciminib emergent mutations | CML | Monotherapy | Phase 1 Safety/Efficacy | Mid-2025 | | ELVN-002 | HER2 & HER2 mutants | Irreversible, highly selective, CNS penetrant | NSCLC, other solid tumors, HER2+ MBC and CRC | Monotherapy / Combination | Phase 1 Safety/Efficacy | 2H 2025 | Overview This section provides an overview of Enliven Therapeutics, Inc., including its forward-looking statements Our Strategy The company's strategy focuses on validated biology, differentiated chemistry, and disciplined clinical trial design Our Team This section highlights the expertise and experience of the company's leadership team Our Development Approach The company's development approach emphasizes a disciplined and data-driven process for advancing product candidates Our Pipeline This section details the company's current product pipeline, including lead and additional programs BCR-ABL Program: ELVN-001 ELVN-001 is a lead product candidate targeting BCR-ABL for Chronic Myeloid Leukemia (CML) HER2 Program: ELVN-002 ELVN-002 is a lead product candidate targeting HER2 for HER2-altered solid tumors Additional Programs This section outlines other early-stage development programs in the company's pipeline Competition The company faces significant competition from other pharmaceutical and biotechnology companies in the oncology market Manufacturing The company relies on third-party contract manufacturing organizations for the production of its product candidates Intellectual Property The company's intellectual property strategy focuses on protecting its product candidates through patents and other proprietary rights Government Regulations The company's drug development and commercialization activities are subject to extensive government regulations in the U.S. and internationally U.S. Drug Development This section outlines the regulatory framework for drug development in the United States Preclinical Studies and IND This section describes the requirements for preclinical studies and the Investigational New Drug (IND) application process Clinical Trials This section details the phases and regulatory requirements for conducting clinical trials in the U.S. NDA Review Process This section explains the New Drug Application (NDA) review and approval process by the FDA Orphan Drugs This section discusses the designation and benefits associated with orphan drug status Expedited Development and Review Programs This section describes various FDA programs designed to expedite drug development and review Post-Approval Requirements This section outlines the regulatory obligations and surveillance required after drug approval Other U.S. Regulatory Matters This section covers additional U.S. regulatory considerations beyond the core drug approval process U.S. Patent-Term Restoration and Marketing Exclusivity This section details mechanisms for extending patent terms and granting market exclusivity in the U.S. European Union Drug Development This section outlines the regulatory framework for drug development within the European Union European Union Drug Review and Approval This section describes the drug review and approval processes in the European Union Coverage and Reimbursement This section addresses the complexities of obtaining coverage and reimbursement for approved drugs Healthcare Reform This section discusses the impact of healthcare reform initiatives on the company's business Employees and Human Capital This section provides information on the company's workforce and human capital management Corporate Information This section provides general corporate information about Enliven Therapeutics, Inc. Item 1A. Risk Factors The company faces substantial risks from early development, including significant losses, uncertain clinical trial outcomes, regulatory hurdles, intense competition, and the need for additional funding - The company is in early development, has no approved products, and has incurred significant net losses ($89.0 million in 2024) with an accumulated deficit of $243.5 million as of December 31, 2024[142][147][472] - Success is highly dependent on ELVN-001 and ELVN-002, and failure in clinical development, regulatory approval, or commercialization would materially harm the business[142][154] - The company will need substantial additional funding to complete product development, and inability to secure capital on favorable terms could delay or eliminate programs[142][413][415] Risk Factor Summary This section provides a concise overview of the principal risks and uncertainties facing the company Risks Related to Our Limited Operating History, Financial Position and Need for Additional Capital The company's limited operating history, current financial position, and ongoing need for substantial additional capital pose significant risks Risks Related to the Discovery, Development and Commercialization of Our Product Candidates The discovery, development, and commercialization of product candidates are inherently risky, with no guarantee of success Risks Related to Regulatory Approval and Other Legal Compliance Matters The company faces significant risks related to obtaining and maintaining regulatory approvals and complying with various legal requirements Risks Related to Employee Matters, Managing Our Growth and Other Risks Related to Our Business Risks include challenges in attracting and retaining employees, managing organizational growth, and other operational aspects of the business Risks Related to Our Intellectual Property The company's ability to protect its intellectual property is crucial, and any failure could materially harm its business Risks Related to Our Dependence on Third Parties The company relies heavily on third parties for manufacturing, clinical trials, and other critical functions, introducing significant risks Risks Related to Our Common Stock Risks associated with the company's common stock include market volatility, liquidity, and potential dilution General Risk Factors This section outlines general risks that could affect the company's business, financial condition, and results of operations Item 1B. Unresolved Staff Comments. The company has no unresolved staff comments from the SEC - No unresolved staff comments are applicable to the company[445] Item 1C. Cybersecurity. The company maintains a cybersecurity risk management framework with board oversight, covering threat identification, assessment, management, and employee training - The company has a cybersecurity risk management framework for identifying, assessing, managing, and monitoring threats, including those from third-party vendors[446][447][448] - Cybersecurity risk oversight is provided by the board of directors, with the audit committee having primary strategic oversight, and the Chief Legal Officer and Head of IT managing day-to-day implementation[452][453][454] - Employees receive periodic cybersecurity training, and external consultants assist in designing and implementing cybersecurity policies[449][450] Risk Management and Strategy This section details the company's approach to managing cybersecurity risks and its strategic considerations Governance This section outlines the governance structure and oversight mechanisms for cybersecurity within the company Item 2. Properties. Corporate headquarters are in Boulder, Colorado, with a new 20,011 sq ft office and lab lease effective January 1, 2025 - Corporate headquarters are in Boulder, Colorado[455] - New lease for 20,011 sq ft of office and lab space from Jan 1, 2025, to Dec 31, 2026, with a five-year renewal option, replacing the existing sublease[455] Item 3. Legal Proceedings. The company is not currently involved in material litigation, though future proceedings could be costly and divert resources - The company is not currently involved in any material litigation or legal proceedings[456] - Future litigation, regardless of outcome, could incur significant defense and settlement costs, divert management attention, and harm reputation[456] Item 4. Mine Safety Disclosures. This item is not applicable to the company - Mine Safety Disclosures are not applicable[457] PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Common stock trades on Nasdaq under 'ELVN' since February 2023, with approximately 20 stockholders of record and no cash dividends paid or anticipated - Common stock began trading on Nasdaq Global Select Market under 'ELVN' on February 24, 2023, after a merger and 1-for-4 reverse stock split[459] - As of December 31, 2024, there were approximately 20 stockholders of record[460] - The company has not declared or paid cash dividends and plans to retain future earnings for business growth[461] Market Information for Our Common Stock This section provides details on the trading market for the company's common stock Holders of Record This section reports the approximate number of holders of record for the company's common stock Dividend Policy This section outlines the company's policy regarding cash dividends on its common stock Recent Sales of Unregistered Securities This section discloses information about recent sales of securities not registered under the Securities Act Use of Proceeds This section details the application of proceeds from recent securities offerings Purchases of Equity Securities by the Issuer and Affiliated Purchasers This section reports any purchases of the company's equity securities by the issuer or its affiliates Item 6. Reserved This item is reserved and contains no information Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations The clinical-stage company incurred an $89.0 million net loss in 2024, driven by R&D, and expects current capital of $313.4 million to fund operations into mid-2027, requiring more for future development - The company is a clinical-stage biopharmaceutical company with no product revenue to date, focused on small molecule therapeutics for precision oncology[467][480] Key Financial Highlights (in thousands) | Metric | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | Change (YoY) | | :-------------------------- | :---------------------- | :---------------------- | :------------- | | Net Loss | $(89,024) | $(71,584) | $(17,440) | | Research and Development | $80,778 | $64,574 | $16,204 | | General and Administrative | $23,776 | $18,955 | $4,821 | | Total Operating Expenses | $104,554 | $83,529 | $21,025 | | Other Income (Expense), Net | $15,530 | $11,945 | $3,585 | | Cash, Cash Equivalents & Marketable Securities | $313,440 | $253,148 | $60,292 | - Existing cash, cash equivalents, and marketable securities ($313.4 million as of Dec 31, 2024) are expected to fund operations into mid-2027, but substantial additional capital will be required[471][498][501] Overview This section provides a general overview of the company's financial condition and results of operations The Merger and Financing Transaction This section describes the details and financial impact of the company's merger and associated financing transaction Macroeconomic and Geopolitical Developments This section discusses the potential effects of broader macroeconomic and geopolitical factors on the company's business Components of Our Results of Operations This section breaks down the key components that contribute to the company's financial results Revenue This section explains the sources and recognition policies for the company's revenue Operating Expenses This section details the various categories of operating expenses incurred by the company Research and Development This section describes the nature and magnitude of the company's research and development expenses General and Administrative This section outlines the general and administrative expenses necessary for the company's operations Other Income (Expense), Net This section covers non-operating income and expenses, such as interest income and other financial items Results of Operations This section provides a comparative analysis of the company's financial performance over different periods Comparison of the years ended December 31, 2024 and 2023 This section offers a detailed comparison of financial results between the fiscal years 2024 and 2023 Research and Development Expenses This section analyzes the changes and drivers of research and development expenses between 2024 and 2023 General and Administrative Expenses This section examines the variations in general and administrative expenses between 2024 and 2023 Other Income (Expense), Net This section discusses the changes in other income and expenses, net, between the two fiscal years Liquidity and Capital Resources This section assesses the company's ability to meet its short-term and long-term financial obligations and funding needs Sources of Liquidity This section identifies the primary sources of cash and funding available to the company Future Capital Requirements This section outlines the company's anticipated capital needs for ongoing operations and future development Cash Flows This section provides an analysis of the company's cash inflows and outflows from operating, investing, and financing activities Cash Flows from Operating Activities This section details the cash generated or used by the company's core business operations Cash Flows from Investing Activities This section reports cash flows related to the purchase and sale of long-term assets and investments Cash Flows from Financing Activities This section describes cash flows associated with debt, equity, and dividend transactions Contractual Obligations and Commitments This section discloses the company's significant contractual obligations and future commitments Off-Balance Sheet Arrangements This section describes any off-balance sheet transactions or arrangements that could impact the company's financial position Critical Accounting Policies and Significant Judgments and Estimates This section discusses the accounting policies that require significant judgment and estimates by management Accrued Research and Development Expense This section explains the accounting policy and estimates related to accrued research and development expenses Stock-Based Compensation This section details the accounting treatment and valuation methods for stock-based compensation Recently Issued Accounting Pronouncements This section discusses the impact of new accounting standards and pronouncements on the company's financial statements Item 7A. Quantitative and Qualitative Disclosures About Market Risk Primary market risk is interest income sensitivity from short-term investments, with no material impact expected from interest rate changes and immaterial foreign currency risk - Primary market risk is interest income sensitivity from cash, cash equivalents, and marketable securities (U.S. Treasury securities and money market funds)[526] - A hypothetical 100 basis point change in interest rates is not expected to materially impact financial results due to short-term maturities[526] - No debt outstanding, thus no interest rate risk related to debt. Foreign currency exchange risk is currently not hedged and deemed immaterial[527][528] Interest Rate Risk This section analyzes the company's exposure to fluctuations in interest rates and their potential impact Foreign Currency Exchange Risk This section discusses the company's exposure to foreign currency exchange rate fluctuations Item 8. Financial Statements and Supplementary Data This section presents the audited consolidated financial statements for 2024 and 2023, prepared under U.S. GAAP and audited by Deloitte & Touche LLP - The financial statements for December 31, 2024 and 2023 were audited by Deloitte & Touche LLP and present fairly the financial position and results of operations in conformity with U.S. GAAP[533][536] Consolidated Balance Sheet Highlights (in thousands) | Asset/Liability | As of Dec 31, 2024 | As of Dec 31, 2023 | | :---------------------------------- | :----------------- | :----------------- | | Cash and cash equivalents | $124,117 | $100,141 | | Marketable securities | $189,323 | $153,007 | | Total current assets | $318,127 | $266,151 | | Total assets | $325,760 | $271,867 | | Total current liabilities | $15,915 | $25,894 | | Total liabilities | $15,915 | $25,961 | | Total stockholders' equity | $309,845 | $245,906 | | Accumulated deficit | $(243,472) | $(154,448) | Consolidated Statements of Operations Highlights (in thousands) | Metric | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | | :-------------------------------------- | :---------------------- | :---------------------- | | Research and development expenses | $80,778 | $64,574 | | General and administrative expenses | $23,776 | $18,955 | | Total operating expenses | $104,554 | $83,529 | | Loss from operations | $(104,554) | $(83,529) | | Interest income | $14,891 | $11,967 | | Net loss | $(89,024) | $(71,584) | | Net loss per share, basic and diluted | $(1.89) | $(2.01) | | Weighted-average shares outstanding | 47,072,532 | 35,546,215 | Report of Independent Registered Public Accounting Firm This section contains the audit report from the independent registered public accounting firm Consolidated Balance Sheets This section presents the company's consolidated financial position at specific points in time Consolidated Statements of Operations and Comprehensive Loss This section provides the company's consolidated financial performance over specified periods Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) This section details changes in the company's convertible preferred stock and stockholders' equity (deficit) Consolidated Statements of Cash Flows This section presents the company's cash inflows and outflows from operating, investing, and financing activities Notes to Consolidated Financial Statements This section provides additional information and explanations for the figures presented in the financial statements 1. Organization, Description of Business and Liquidity This note describes the company's organization, business, and liquidity position 2. Summary of Significant Accounting Policies This note outlines the key accounting principles and methods used in preparing the financial statements 3. The Merger This note provides details about the company's merger transaction and its accounting treatment 4. Fair Value Measurements This note explains the fair value measurements of financial instruments and assets 5. Marketable Securities This note provides information on the company's marketable securities portfolio 6. Leases This note details the company's lease arrangements and related accounting 7. Property and Equipment, Net This note presents information on the company's property and equipment, net of accumulated depreciation 8. Accrued Expenses and Other Current Liabilities This note provides a breakdown of accrued expenses and other current liabilities 9. Commitments and Contingencies This note discloses the company's significant commitments and potential contingent liabilities 10. Common Stock This note provides details regarding the company's common stock, including shares authorized and outstanding 11. Preferred Stock and Convertible Preferred Stock This note describes the company's preferred stock and convertible preferred stock arrangements 12. Stock-Based Compensation This note explains the company's stock-based compensation plans and related expenses 13. Income Taxes This note provides information on the company's income tax provisions and deferred tax assets/liabilities 14. 401(k) Savings Plan This note describes the company's 401(k) savings plan for employees 15. Segment Information This note provides financial information about the company's operating segments 16. Net Loss Per Share This note details the calculation of basic and diluted net loss per share Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure. There have been no changes in or disagreements with the company's accountants on accounting or financial disclosure - No changes in or disagreements with accountants on accounting and financial disclosure[665] Item 9A. Controls and Procedures. Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2024, with no material changes during the quarter - Disclosure controls and procedures were effective at a reasonable assurance level as of December 31, 2024[666] - Management concluded that internal control over financial reporting was effective as of December 31, 2024, based on the COSO framework[667] - No material changes in internal control over financial reporting occurred during the quarter ended December 31, 2024[668] Evaluation of Disclosure Controls and Procedures This section presents management's evaluation of the effectiveness of the company's disclosure controls and procedures Management's Report on Internal Control Over Financial Reporting This section contains management's assessment of the effectiveness of the company's internal control over financial reporting Changes in Internal Control over Financial Reporting This section reports any material changes in the company's internal control over financial reporting Inherent Limitations on Effectiveness of Controls This section acknowledges the inherent limitations that may affect the effectiveness of any control system Item 9B. Other Information. Executive officers and a director adopted Rule 10b5-1 trading arrangements for common stock sales on November 15, 2024, effective until March 2026 - Samuel Kintz (President and CEO) adopted a Rule 10b5-1 trading arrangement on November 15, 2024, for the sale of up to 400,000 shares of common stock, effective until March 13, 2026[670] - Joseph P. Lyssikatos (Chief Scientific Officer) adopted a Rule 10b5-1 trading arrangement on November 15, 2024, for the sale of up to 400,000 shares of common stock, effective until March 17, 2026[671][672] - Richard Heyman (Director) adopted a Rule 10b5-1 trading arrangement on November 15, 2024, for the sale of up to 49,160 shares of common stock, effective until March 13, 2026[673] Item 9C. Disclosure Regarding Foreign Jurisdictions That Prevent Inspections. This item is not applicable to the company - Disclosure regarding foreign jurisdictions that prevent inspections is not applicable[676] PART III Item 10. Directors, Executive Officers and Corporate Governance. Information on directors, executive officers, and corporate governance will be provided in the definitive proxy statement - Information on directors, executive officers, and corporate governance is incorporated by reference from the definitive proxy statement to be filed within 120 days after December 31, 2024[679] Item 11. Executive Compensation. Information on executive compensation will be provided in the definitive proxy statement - Information on executive compensation is incorporated by reference from the definitive proxy statement to be filed within 120 days after December 31, 2024[680] Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters. Information on security ownership and related stockholder matters will be provided in the definitive proxy statement - Information on security ownership and related stockholder matters is incorporated by reference from the definitive proxy statement to be filed within 120 days after December 31, 2024[681] Item 13. Certain Relationships and Related Transactions, and Director Independence. Information on certain relationships, related transactions, and director independence will be provided in the definitive proxy statement - Information on certain relationships, related transactions, and director independence is incorporated by reference from the definitive proxy statement to be filed within 120 days after December 31, 2024[682] Item 14. Principal Accounting Fees and Services. Information on principal accounting fees and services will be provided in the definitive proxy statement - Information on principal accounting fees and services is incorporated by reference from the definitive proxy statement to be filed within 120 days after December 31, 2024[683] PART IV Item 15. Exhibit and Financial Statement Schedules. This section lists financial statements and supplementary data, along with an exhibit index of required documents - Financial statements are filed under Item 8 of this report[686] - An Exhibit Index lists documents incorporated by reference or filed with the report, numbered according to Regulation S-K Item 601[687] Item 16. Form 10-K Summary. No Form 10-K Summary is provided - No Form 10-K Summary is provided[688] SIGNATURES The report is duly signed by the President and CEO, Samuel Kintz, and CFO, Benjamin Hohl, along with other directors - The report is signed by Samuel Kintz (President and CEO) and Benjamin Hohl (CFO) on March 13, 2025[698][701]