UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM 10-K Washington, D.C. 20549 (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39247 ENLIVEN THERAPEUTICS, INC. | Large accelerated filer | ☐ | Accelerated filer | ☐ | | --- | --- | --- | --- | | Non-accelerated ...

Enliven Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides a Business Update Reported positive initial Phase 1b data for ELVN-001 in CML Exhibit 99.1 Initiation of the Phase 3 ENABLE-2 pivotal trial of ELVN-001 expected in the second half of 2026 Key data readout, regulatory interactions, and operational catalysts throughout 2026 Strong balance sheet with $463 million in cash, cash equivalents and marketable securities, which is expected to provide cash runway into the fir ...

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Financial Performance - The company reported a net loss of $20.1 million for the three months ended September 30, 2025, compared to a net loss of $23.2 million for the same period in 2024, reflecting a decrease of approximately 13.4%[145]. - The net loss for the nine months ended September 30, 2025, was $74.0 million, compared to a net loss of $65.8 million in the same period of 2024[150]. - The company has not generated any revenue from product sales and does not expect to do so in the foreseeable future[135]. Operating Expenses - Total operating expenses for the three months ended September 30, 2025, were $25.1 million, down from $27.1 million in the same period in 2024, indicating a reduction of about 7.3%[145]. - General and administrative expenses increased to $6.9 million in Q3 2025 from $5.8 million in Q3 2024, reflecting a rise of approximately 19.0%[145]. - Total operating expenses for the nine months ended September 30, 2025, were $85.4 million, compared to $77.7 million for the same period in 2024, reflecting an increase of $7.7 million[150]. Research and Development - Research and development expenses decreased to $18.2 million in Q3 2025 from $21.3 million in Q3 2024, a decline of approximately 14.3%[145]. - Research and development expenses for Q3 2025 were $18.2 million, a decrease of $3.1 million from $21.3 million in Q3 2024, primarily due to a reduction in external costs related to ELVN-002[147]. - The company is advancing its ELVN-001 program into Phase 3 initiation expected in 2026, while exploring strategic alternatives for the ELVN-002 program[124]. Cash and Liquidity - The company had cash, cash equivalents, and marketable securities totaling $477.6 million as of September 30, 2025, which is expected to fund operations for at least the next 12 months[128]. - Cash, cash equivalents, and marketable securities as of September 30, 2025, totaled $477.6 million, providing liquidity for ongoing operations[159]. - The company raised aggregate gross proceeds of $90.0 million from a private placement in March 2024 and $230.0 million from a public offering in June 2025[127]. Capital Requirements - The company expects to require substantial additional capital to fund ongoing operations and product development, with no revenue generated to date[160]. - The company plans to continue financing operations through equity or debt financings, as it does not have any products approved for commercial sale[130]. Cash Flow - Net cash used in operating activities for the nine months ended September 30, 2025 was $54.5 million, compared to $56.0 million for the same period in 2024, reflecting a decrease of 2.7%[167][168]. - Net cash used in investing activities increased significantly to $186.2 million in 2025 from $36.7 million in 2024, primarily due to cash used for purchasing marketable securities[169][170]. - Net cash provided by financing activities rose to $218.2 million in 2025, up from $93.2 million in 2024, driven mainly by proceeds from the sale of common stock and pre-funded warrants[171][172]. Debt and Lease Obligations - As of September 30, 2025, the company had no debt outstanding, eliminating exposure to interest rate risk related to debt[179]. - The company entered into a non-cancellable operating lease for approximately 20,011 rentable square feet of office and laboratory space, with total lease obligations of $514,000 due by the end of 2026[174]. Other Financial Considerations - The accumulated deficit as of September 30, 2025, was $317.5 million, with significant losses reported since inception[129]. - The company does not currently hedge against foreign currency risks, although it may consider doing so in the future[180]. - The company anticipates potential impacts from recently issued accounting pronouncements on its financial condition and results of operations[177].

Financial Position - As of September 30, 2025, Enliven Therapeutics had cash, cash equivalents, and marketable securities totaling $477.6 million, providing a cash runway into the first half of 2029[9]. Research and Development - Research and development (R&D) expenses for Q3 2025 were $18.2 million, a decrease from $21.3 million in Q3 2024, representing a reduction of approximately 14.5%[9]. - The company completed enrollment of the randomized Phase 1b cohorts of the ENABLE trial for ELVN-001 in chronic myeloid leukemia (CML) and is on track to initiate a Phase 3 pivotal trial in 2026[1][3]. - ELVN-001 is designed to specifically target the BCR::ABL gene fusion, the oncogenic driver for CML patients, and has shown potential as a selective active-site inhibitor[4][10]. - Enliven presented data from the ENABLE Phase 1a/1b clinical trial at multiple medical meetings, highlighting the strength of the data and community support for ELVN-001[3][4]. - The company plans to present additional data from the ENABLE trial at the 67th Annual American Society of Hematology (ASH) meeting in December 2025[5]. Operating Expenses - General and administrative (G&A) expenses for Q3 2025 were $6.9 million, an increase from $5.8 million in Q3 2024, reflecting a rise of approximately 19%[9]. - Total operating expenses for Q3 2025 were $25.1 million, down from $27.1 million in Q3 2024, marking a decrease of approximately 7.3%[17]. Net Loss - Enliven reported a net loss of $20.1 million for Q3 2025, compared to a net loss of $23.2 million for Q3 2024, indicating an improvement of about 13.4%[9]. Share Information - The weighted-average shares outstanding for Q3 2025 were 62,094, compared to 48,267 for Q3 2024, indicating an increase in shares[17].

Financial Performance - Total operating expenses for Q2 2025 were $28.6 million, an increase of 16.1% from $24.6 million in Q2 2024[142]. - The net loss for Q2 2025 was $25.3 million, up from a net loss of $20.0 million in Q2 2024, representing a 26.2% increase[142]. - Net loss for the six months ended June 30, 2025, was $53.9 million, compared to a net loss of $42.7 million in 2024, indicating an increase in losses of 26.1%[147]. - Other income decreased to $3.2 million for the three months ended June 30, 2025, down from $4.7 million in 2024, a decline of 31.9%[146]. Operating Expenses - Research and development expenses rose to $21.5 million in Q2 2025, compared to $18.8 million in Q2 2024, reflecting a 14.2% increase[142]. - General and administrative expenses increased to $7.1 million in Q2 2025 from $5.8 million in Q2 2024, marking a 22.7% rise[142]. - Total operating expenses for the six months ended June 30, 2025, were $60.3 million, compared to $50.6 million in 2024, reflecting a 19.0% increase[147]. - General and administrative expenses rose to $7.1 million for the three months ended June 30, 2025, compared to $5.8 million in 2024, a 22.4% increase[145]. Cash and Securities - As of June 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $490.5 million, sufficient to fund operations for at least the next 12 months[125]. - Cash, cash equivalents, and marketable securities totaled $490.5 million as of June 30, 2025[154]. - The company raised gross proceeds of $230.0 million from a public offering completed in June 2025[151]. - The company’s cash, cash equivalents, and marketable securities primarily consist of U.S. Treasury securities, with no material impact expected from interest rate fluctuations[173]. Funding and Capital - The company has raised a total of $140.5 million from private placements and $164.5 million from common stock sales, with an additional $90.0 million raised in March 2024[124]. - Net cash provided by financing activities rose to $218.6 million in the first half of 2025, up from $92.1 million in 2024, driven by proceeds from the sale of common stock and pre-funded warrants[167][168]. - Future capital requirements will depend on various factors, including the costs associated with research, development, and regulatory review of product candidates[160]. Research and Development - The company is advancing the ELVN-001 program into Phase 3 trials, with initiation expected in 2026[121]. - The HER2 program (ELVN-002) is being deprioritized, with no further development planned beyond 2025[120]. - The company intends to expand its pipeline of product candidates through ongoing research and development efforts[157]. - The company does not expect to generate any revenue in the foreseeable future as it has no products approved for commercial sale[132]. Cash Flow Activities - Net cash used in operating activities for the six months ended June 30, 2025 was $41.2 million, compared to $43.8 million for the same period in 2024, reflecting a decrease of 6%[163][164]. - Net cash used in investing activities increased significantly to $182.2 million in the first half of 2025 from $51.6 million in 2024, primarily due to cash used for purchasing marketable securities[165][166]. Debt and Obligations - As of June 30, 2025, the company had no debt outstanding, eliminating exposure to interest rate risk related to debt[174]. - The company has a total operating lease obligation of $614,000, with $200,000 due in 2025 and $414,000 due thereafter[169]. Accounting Policies - There have been no material changes to the company's critical accounting policies and estimates as of June 30, 2025[171]. - Non-cash charges for stock-based compensation amounted to $14.5 million in the first half of 2025, compared to $9.7 million in 2024[163][164].

Financial Performance - Enliven reported a net loss of $25.3 million for Q2 2025, up from a net loss of $20.0 million in Q2 2024[8][13]. - General and administrative (G&A) expenses for Q2 2025 were $7.1 million, compared to $5.8 million in Q2 2024[8][13]. - Research and development (R&D) expenses for Q2 2025 were $21.5 million, an increase from $18.8 million in Q2 2024[8][13]. - Total operating expenses for Q2 2025 were $28.6 million, compared to $24.6 million in Q2 2024[8][13]. Cash Position - The company has a strong cash position of $491 million, expected to provide a cash runway into the first half of 2029[1][8]. - The recent public offering generated gross proceeds of approximately $230 million, strengthening the company's balance sheet[2]. Clinical Development - Enliven Therapeutics reported a cumulative major molecular response (MMR) rate of 47% for ELVN-001, with 32% of patients achieving MMR by 24 weeks[1][3]. - The achieved MMR rate of 32% for ELVN-001 compares favorably to historical data from less heavily pretreated patients receiving asciminib, which showed MMR rates of 24%[3]. - ELVN-001 demonstrated a favorable safety and tolerability profile across all dose levels[1][3]. - The company plans to initiate a Phase 3 pivotal trial for ELVN-001 in 2026[4].

Financial Performance - For the three months ended March 31, 2025, total operating expenses were $31.7 million, an increase of 22% from $26.0 million in the same period in 2024[132]. - The net loss for Q1 2025 was $28.5 million, compared to a net loss of $22.7 million for Q1 2024, representing a 25% increase in losses[132]. - General and administrative expenses rose to $6.8 million for the three months ended March 31, 2025, compared to $6.0 million in the same period of 2024, an increase of 13.3%[135]. - Net cash used in operating activities was $24.1 million for the three months ended March 31, 2025, compared to $23.4 million for the same period in 2024, reflecting a 3.0% increase[148][149]. Research and Development - Research and development expenses for Q1 2025 were $24.9 million, up from $20.0 million in Q1 2024, reflecting a 25% increase[132]. - The company plans to advance the ELVN-001 program into Phase 1 safety/efficacy trials by mid-2025, focusing on a highly selective active site inhibitor for CML[111]. - The company intends to explore strategic alternatives for the ELVN-002 program and does not plan to pursue its development beyond 2025[110]. Cash and Funding - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $289.6 million, sufficient to fund operations for at least the next 12 months[115]. - The company raised $90.0 million in a private placement in March 2024, contributing to its funding strategy[115]. - The company has $200.0 million available for use under its shelf registration statement on Form S-3 as of March 31, 2025[138]. - The company expects to require substantial additional capital to fund operations and product development in the foreseeable future[140][141]. Revenue Generation - The company has not generated any revenue to date and does not expect to do so in the foreseeable future[122]. - The company has not generated any revenue from product sales to date and does not expect to do so until regulatory approval is obtained for its product candidates[140]. Debt and Financial Risk - As of March 31, 2025, the company had no debt outstanding, eliminating exposure to interest rate risk related to debt[160]. - A hypothetical 100 basis point increase or decrease in interest rates would not have a material impact on the company's financial results due to the short-term maturities of investments[159]. Foreign Currency Exposure - The company has limited contracts with vendors for research and development services denominated in foreign currencies, exposing it to potential foreign currency transaction gains or losses[161]. - The company does not currently engage in hedging activities to mitigate foreign currency exposure but may consider it in the future[161]. - The company believes that fluctuations in foreign exchange rates would not have a material impact on its financial condition or results of operations[161]. Accounting Policies - As of March 31, 2025, the company has not experienced material changes to its critical accounting policies and estimates since the last annual report[157]. - The company evaluates its estimates and assumptions periodically, acknowledging that actual results may differ from these estimates[157]. - Recent accounting pronouncements that may impact the company's financial condition are disclosed in the quarterly report[158]. - The company bases its estimates on historical experience, known trends, and various other factors deemed reasonable under the circumstances[157].

Financial Performance - Enliven Therapeutics reported a net loss of $28.5 million for Q1 2025, compared to a net loss of $22.7 million in Q1 2024, reflecting an increase of 25% year-over-year[7]. - General and administrative expenses for Q1 2025 were $6.8 million, compared to $6.0 million in Q1 2024, marking an increase of 13.3%[7]. - The company reported total operating expenses of $31.7 million for Q1 2025, compared to $26.0 million for Q1 2024, representing a 22% increase[7]. Research and Development - Research and development expenses for Q1 2025 were $24.9 million, up from $20.0 million in Q1 2024, indicating a 24.5% increase[7]. - In the Phase 1 ENABLE clinical trial of ELVN-001, 44% of evaluable patients achieved major molecular response (MMR) by 24 weeks[3]. - The trial enrolled 74 patients, with 82% remaining on study and a median treatment duration of approximately 26 weeks[3]. - Enliven plans to start a pivotal trial for ELVN-001 in 2026, focusing on clinical execution for the remainder of the year[2]. - The company intends to explore strategic alternatives for the ELVN-002 program and does not plan to pursue its development beyond 2025[7]. - Enliven will present updated data from the ENABLE trial at the EHA 2025 Congress in June 2025[3]. Cash Position - The company had cash, cash equivalents, and marketable securities totaling $289.6 million as of March 31, 2025, expected to provide a cash runway into late 2027[7].

PART I [Item 1. Business](index=5&type=section&id=Item%201.%20Business) 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](index=15&type=chunk) - 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](index=15&type=chunk) 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](index=5&type=section&id=Overview) This section provides an overview of Enliven Therapeutics, Inc., including its forward-looking statements [Our Strategy](index=6&type=section&id=Our%20Strategy) The company's strategy focuses on validated biology, differentiated chemistry, and disciplined clinical trial design [Our Team](index=8&type=section&id=Our%20Team) This section highlights the expertise and experience of the company's leadership team [Our Development Approach](index=8&type=section&id=Our%20Development%20Approach) The company's development approach emphasizes a disciplined and data-driven process for advancing product candidates [Our Pipeline](index=10&type=section&id=Our%20Pipeline) This section details the company's current product pipeline, including lead and additional programs [BCR-ABL Program: ELVN-001](index=10&type=section&id=BCR-ABL%20Program:%20ELVN-001) ELVN-001 is a lead product candidate targeting BCR-ABL for Chronic Myeloid Leukemia (CML) [HER2 Program: ELVN-002](index=12&type=section&id=HER2%20Program:%20ELVN-002) ELVN-002 is a lead product candidate targeting HER2 for HER2-altered solid tumors [Additional Programs](index=14&type=section&id=Additional%20Programs) This section outlines other early-stage development programs in the company's pipeline [Competition](index=14&type=section&id=Competition) The company faces significant competition from other pharmaceutical and biotechnology companies in the oncology market [Manufacturing](index=16&type=section&id=Manufacturing) The company relies on third-party contract manufacturing organizations for the production of its product candidates [Intellectual Property](index=16&type=section&id=Intellectual%20Property) The company's intellectual property strategy focuses on protecting its product candidates through patents and other proprietary rights [Government Regulations](index=20&type=section&id=Government%20Regulations) The company's drug development and commercialization activities are subject to extensive government regulations in the U.S. and internationally [U.S. Drug Development](index=20&type=section&id=U.S.%20Drug%20Development) This section outlines the regulatory framework for drug development in the United States [Preclinical Studies and IND](index=21&type=section&id=Preclinical%20Studies%20and%20IND) This section describes the requirements for preclinical studies and the Investigational New Drug (IND) application process [Clinical Trials](index=21&type=section&id=Clinical%20Trials) This section details the phases and regulatory requirements for conducting clinical trials in the U.S. [NDA Review Process](index=24&type=section&id=NDA%20Review%20Process) This section explains the New Drug Application (NDA) review and approval process by the FDA [Orphan Drugs](index=24&type=section&id=Orphan%20Drugs) This section discusses the designation and benefits associated with orphan drug status [Expedited Development and Review Programs](index=25&type=section&id=Expedited%20Development%20and%20Review%20Programs) This section describes various FDA programs designed to expedite drug development and review [Post-Approval Requirements](index=26&type=section&id=Post-Approval%20Requirements) This section outlines the regulatory obligations and surveillance required after drug approval [Other U.S. Regulatory Matters](index=27&type=section&id=Other%20U.S.%20Regulatory%20Matters) This section covers additional U.S. regulatory considerations beyond the core drug approval process [U.S. Patent-Term Restoration and Marketing Exclusivity](index=28&type=section&id=U.S.%20Patent-Term%20Restoration%20and%20Marketing%20Exclusivity) This section details mechanisms for extending patent terms and granting market exclusivity in the U.S. [European Union Drug Development](index=28&type=section&id=European%20Union%20Drug%20Development) This section outlines the regulatory framework for drug development within the European Union [European Union Drug Review and Approval](index=29&type=section&id=European%20Union%20Drug%20Review%20and%20Approval) This section describes the drug review and approval processes in the European Union [Coverage and Reimbursement](index=29&type=section&id=Coverage%20and%20Reimbursement) This section addresses the complexities of obtaining coverage and reimbursement for approved drugs [Healthcare Reform](index=30&type=section&id=Healthcare%20Reform) This section discusses the impact of healthcare reform initiatives on the company's business [Employees and Human Capital](index=32&type=section&id=Employees%20and%20Human%20Capital) This section provides information on the company's workforce and human capital management [Corporate Information](index=33&type=section&id=Corporate%20Information) This section provides general corporate information about Enliven Therapeutics, Inc. [Item 1A. Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) 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](index=142&type=chunk)[147](index=147&type=chunk)[472](index=472&type=chunk) - 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](index=142&type=chunk)[154](index=154&type=chunk) - 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](index=142&type=chunk)[413](index=413&type=chunk)[415](index=415&type=chunk) [Risk Factor Summary](index=34&type=section&id=Risk%20Factor%20Summary) 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](index=35&type=section&id=Risks%20Related%20to%20Our%20Limited%20Operating%20History,%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) 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](index=37&type=section&id=Risks%20Related%20to%20the%20Discovery,%20Development%20and%20Commercialization%20of%20Our%20Product%20Candidates) 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](index=54&type=section&id=Risks%20Related%20to%20Regulatory%20Approval%20and%20Other%20Legal%20Compliance%20Matters) 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](index=74&type=section&id=Risks%20Related%20to%20Employee%20Matters,%20Managing%20Our%20Growth%20and%20Other%20Risks%20Related%20to%20Our%20Business) Risks include challenges in attracting and retaining employees, managing organizational growth, and other operational aspects of the business [Risks Related to Our Intellectual Property](index=81&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) 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](index=95&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) The company relies heavily on third parties for manufacturing, clinical trials, and other critical functions, introducing significant risks [Risks Related to Our Common Stock](index=102&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) Risks associated with the company's common stock include market volatility, liquidity, and potential dilution [General Risk Factors](index=111&type=section&id=General%20Risk%20Factors) This section outlines general risks that could affect the company's business, financial condition, and results of operations [Item 1B. Unresolved Staff Comments.](index=111&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments.) The company has no unresolved staff comments from the SEC - No unresolved staff comments are applicable to the company[445](index=445&type=chunk) [Item 1C. Cybersecurity.](index=111&type=section&id=Item%201C.%20Cybersecurity.) 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](index=446&type=chunk)[447](index=447&type=chunk)[448](index=448&type=chunk) - 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](index=452&type=chunk)[453](index=453&type=chunk)[454](index=454&type=chunk) - Employees receive periodic cybersecurity training, and external consultants assist in designing and implementing cybersecurity policies[449](index=449&type=chunk)[450](index=450&type=chunk) [Risk Management and Strategy](index=111&type=section&id=Risk%20Management%20and%20Strategy) This section details the company's approach to managing cybersecurity risks and its strategic considerations [Governance](index=112&type=section&id=Governance) This section outlines the governance structure and oversight mechanisms for cybersecurity within the company [Item 2. Properties.](index=112&type=section&id=Item%202.%20Properties.) 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](index=455&type=chunk) - 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](index=455&type=chunk) [Item 3. Legal Proceedings.](index=112&type=section&id=Item%203.%20Legal%20Proceedings.) 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](index=456&type=chunk) - Future litigation, regardless of outcome, could incur significant defense and settlement costs, divert management attention, and harm reputation[456](index=456&type=chunk) [Item 4. Mine Safety Disclosures.](index=112&type=section&id=Item%204.%20Mine%20Safety%20Disclosures.) This item is not applicable to the company - Mine Safety Disclosures are not applicable[457](index=457&type=chunk) PART II [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=113&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity,%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) 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](index=459&type=chunk) - As of December 31, 2024, there were approximately **20 stockholders** of record[460](index=460&type=chunk) - The company has not declared or paid cash dividends and plans to retain future earnings for business growth[461](index=461&type=chunk) [Market Information for Our Common Stock](index=113&type=section&id=Market%20Information%20for%20Our%20Common%20Stock) This section provides details on the trading market for the company's common stock [Holders of Record](index=113&type=section&id=Holders%20of%20Record) This section reports the approximate number of holders of record for the company's common stock [Dividend Policy](index=113&type=section&id=Dividend%20Policy) This section outlines the company's policy regarding cash dividends on its common stock [Recent Sales of Unregistered Securities](index=113&type=section&id=Recent%20Sales%20of%20Unregistered%20Securities) This section discloses information about recent sales of securities not registered under the Securities Act [Use of Proceeds](index=113&type=section&id=Use%20of%20Proceeds) This section details the application of proceeds from recent securities offerings [Purchases of Equity Securities by the Issuer and Affiliated Purchasers](index=113&type=section&id=Purchases%20of%20Equity%20Securities%20by%20the%20Issuer%20and%20Affiliated%20Purchasers) This section reports any purchases of the company's equity securities by the issuer or its affiliates [Item 6. Reserved](index=113&type=section&id=Item%206.%20Reserved) This item is reserved and contains no information [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=114&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) 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](index=467&type=chunk)[480](index=480&type=chunk) 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](index=471&type=chunk)[498](index=498&type=chunk)[501](index=501&type=chunk) [Overview](index=114&type=section&id=Overview) This section provides a general overview of the company's financial condition and results of operations [The Merger and Financing Transaction](index=116&type=section&id=The%20Merger%20and%20Financing%20Transaction) This section describes the details and financial impact of the company's merger and associated financing transaction [Macroeconomic and Geopolitical Developments](index=116&type=section&id=Macroeconomic%20and%20Geopolitical%20Developments) This section discusses the potential effects of broader macroeconomic and geopolitical factors on the company's business [Components of Our Results of Operations](index=116&type=section&id=Components%20of%20Our%20Results%20of%20Operations) This section breaks down the key components that contribute to the company's financial results [Revenue](index=116&type=section&id=Revenue) This section explains the sources and recognition policies for the company's revenue [Operating Expenses](index=116&type=section&id=Operating%20Expenses) This section details the various categories of operating expenses incurred by the company [Research and Development](index=116&type=section&id=Research%20and%20Development) This section describes the nature and magnitude of the company's research and development expenses [General and Administrative](index=118&type=section&id=General%20and%20Administrative) This section outlines the general and administrative expenses necessary for the company's operations [Other Income (Expense), Net](index=118&type=section&id=Other%20Income%20(Expense),%20Net) This section covers non-operating income and expenses, such as interest income and other financial items [Results of Operations](index=119&type=section&id=Results%20of%20Operations) 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](index=119&type=section&id=Comparison%20of%20the%20years%20ended%20December%2031,%202024%20and%202023) This section offers a detailed comparison of financial results between the fiscal years 2024 and 2023 [Research and Development Expenses](index=119&type=section&id=Research%20and%20Development%20Expenses) This section analyzes the changes and drivers of research and development expenses between 2024 and 2023 [General and Administrative Expenses](index=119&type=section&id=General%20and%20Administrative%20Expenses) This section examines the variations in general and administrative expenses between 2024 and 2023 [Other Income (Expense), Net](index=119&type=section&id=Other%20Income%20(Expense),%20Net) This section discusses the changes in other income and expenses, net, between the two fiscal years [Liquidity and Capital Resources](index=120&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's ability to meet its short-term and long-term financial obligations and funding needs [Sources of Liquidity](index=120&type=section&id=Sources%20of%20Liquidity) This section identifies the primary sources of cash and funding available to the company [Future Capital Requirements](index=120&type=section&id=Future%20Capital%20Requirements) This section outlines the company's anticipated capital needs for ongoing operations and future development [Cash Flows](index=122&type=section&id=Cash%20Flows) This section provides an analysis of the company's cash inflows and outflows from operating, investing, and financing activities [Cash Flows from Operating Activities](index=122&type=section&id=Cash%20Flows%20from%20Operating%20Activities) This section details the cash generated or used by the company's core business operations [Cash Flows from Investing Activities](index=122&type=section&id=Cash%20Flows%20from%20Investing%20Activities) This section reports cash flows related to the purchase and sale of long-term assets and investments [Cash Flows from Financing Activities](index=123&type=section&id=Cash%20Flows%20from%20Financing%20Activities) This section describes cash flows associated with debt, equity, and dividend transactions [Contractual Obligations and Commitments](index=123&type=section&id=Contractual%20Obligations%20and%20Commitments) This section discloses the company's significant contractual obligations and future commitments [Off-Balance Sheet Arrangements](index=123&type=section&id=Off-Balance%20Sheet%20Arrangements) 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](index=123&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) This section discusses the accounting policies that require significant judgment and estimates by management [Accrued Research and Development Expense](index=124&type=section&id=Accrued%20Research%20and%20Development%20Expense) This section explains the accounting policy and estimates related to accrued research and development expenses [Stock-Based Compensation](index=124&type=section&id=Stock-Based%20Compensation) This section details the accounting treatment and valuation methods for stock-based compensation [Recently Issued Accounting Pronouncements](index=125&type=section&id=Recently%20Issued%20Accounting%20Pronouncements) 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](index=126&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) 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](index=526&type=chunk) - A hypothetical **100 basis point** change in interest rates is not expected to materially impact financial results due to short-term maturities[526](index=526&type=chunk) - No debt outstanding, thus no interest rate risk related to debt. Foreign currency exchange risk is currently not hedged and deemed immaterial[527](index=527&type=chunk)[528](index=528&type=chunk) [Interest Rate Risk](index=126&type=section&id=Interest%20Rate%20Risk) This section analyzes the company's exposure to fluctuations in interest rates and their potential impact [Foreign Currency Exchange Risk](index=126&type=section&id=Foreign%20Currency%20Exchange%20Risk) This section discusses the company's exposure to foreign currency exchange rate fluctuations [Item 8. Financial Statements and Supplementary Data](index=127&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) 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](index=533&type=chunk)[536](index=536&type=chunk) 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](index=128&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) This section contains the audit report from the independent registered public accounting firm [Consolidated Balance Sheets](index=129&type=section&id=Consolidated%20Balance%20Sheets) This section presents the company's consolidated financial position at specific points in time [Consolidated Statements of Operations and Comprehensive Loss](index=130&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section provides the company's consolidated financial performance over specified periods [Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit)](index=131&type=section&id=Consolidated%20Statements%20of%20Convertible%20Preferred%20Stock%20and%20Stockholders'%20Equity%20(Deficit)) This section details changes in the company's convertible preferred stock and stockholders' equity (deficit) [Consolidated Statements of Cash Flows](index=132&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) This section presents the company's cash inflows and outflows from operating, investing, and financing activities [Notes to Consolidated Financial Statements](index=133&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) This section provides additional information and explanations for the figures presented in the financial statements [1. Organization, Description of Business and Liquidity](index=133&type=section&id=1.%20Organization,%20Description%20of%20Business%20and%20Liquidity) This note describes the company's organization, business, and liquidity position [2. Summary of Significant Accounting Policies](index=135&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the key accounting principles and methods used in preparing the financial statements [3. The Merger](index=143&type=section&id=3.%20The%20Merger) This note provides details about the company's merger transaction and its accounting treatment [4. Fair Value Measurements](index=144&type=section&id=4.%20Fair%20Value%20Measurements) This note explains the fair value measurements of financial instruments and assets [5. Marketable Securities](index=145&type=section&id=5.%20Marketable%20Securities) This note provides information on the company's marketable securities portfolio [6. Leases](index=145&type=section&id=6.%20Leases) This note details the company's lease arrangements and related accounting [7. Property and Equipment, Net](index=146&type=section&id=7.%20Property%20and%20Equipment,%20Net) This note presents information on the company's property and equipment, net of accumulated depreciation [8. Accrued Expenses and Other Current Liabilities](index=146&type=section&id=8.%20Accrued%20Expenses%20and%20Other%20Current%20Liabilities) This note provides a breakdown of accrued expenses and other current liabilities [9. Commitments and Contingencies](index=146&type=section&id=9.%20Commitments%20and%20Contingencies) This note discloses the company's significant commitments and potential contingent liabilities [10. Common Stock](index=146&type=section&id=10.%20Common%20Stock) This note provides details regarding the company's common stock, including shares authorized and outstanding [11. Preferred Stock and Convertible Preferred Stock](index=147&type=section&id=11.%20Preferred%20Stock%20and%20Convertible%20Preferred%20Stock) This note describes the company's preferred stock and convertible preferred stock arrangements [12. Stock-Based Compensation](index=148&type=section&id=12.%20Stock-Based%20Compensation) This note explains the company's stock-based compensation plans and related expenses [13. Income Taxes](index=151&type=section&id=13.%20Income%20Taxes) This note provides information on the company's income tax provisions and deferred tax assets/liabilities [14. 401(k) Savings Plan](index=154&type=section&id=14.%20401(k)%20Savings%20Plan) This note describes the company's 401(k) savings plan for employees [15. Segment Information](index=154&type=section&id=15.%20Segment%20Information) This note provides financial information about the company's operating segments [16. Net Loss Per Share](index=155&type=section&id=16.%20Net%20Loss%20Per%20Share) 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.](index=156&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure.) 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](index=665&type=chunk) [Item 9A. Controls and Procedures.](index=156&type=section&id=Item%209A.%20Controls%20and%20Procedures.) 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](index=666&type=chunk) - Management concluded that internal control over financial reporting was effective as of December 31, 2024, based on the COSO framework[667](index=667&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter ended December 31, 2024[668](index=668&type=chunk) [Evaluation of Disclosure Controls and Procedures](index=156&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) 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](index=156&type=section&id=Management's%20Report%20on%20Internal%20Control%20Over%20Financial%20Reporting) 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](index=156&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) This section reports any material changes in the company's internal control over financial reporting [Inherent Limitations on Effectiveness of Controls](index=156&type=section&id=Inherent%20Limitations%20on%20Effectiveness%20of%20Controls) This section acknowledges the inherent limitations that may affect the effectiveness of any control system [Item 9B. Other Information.](index=156&type=section&id=Item%209B.%20Other%20Information.) 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](index=670&type=chunk) - 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](index=671&type=chunk)[672](index=672&type=chunk) - 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](index=673&type=chunk) [Item 9C. Disclosure Regarding Foreign Jurisdictions That Prevent Inspections.](index=158&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20That%20Prevent%20Inspections.) This item is not applicable to the company - Disclosure regarding foreign jurisdictions that prevent inspections is not applicable[676](index=676&type=chunk) PART III [Item 10. Directors, Executive Officers and Corporate Governance.](index=159&type=section&id=Item%2010.%20Directors,%20Executive%20Officers%20and%20Corporate%20Governance.) 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](index=679&type=chunk) [Item 11. Executive Compensation.](index=159&type=section&id=Item%2011.%20Executive%20Compensation.) 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](index=680&type=chunk) [Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.](index=159&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters.) 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](index=681&type=chunk) [Item 13. Certain Relationships and Related Transactions, and Director Independence.](index=159&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions,%20and%20Director%20Independence.) 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](index=682&type=chunk) [Item 14. Principal Accounting Fees and Services.](index=159&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services.) 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](index=683&type=chunk) PART IV [Item 15. Exhibit and Financial Statement Schedules.](index=160&type=section&id=Item%2015.%20Exhibit%20and%20Financial%20Statement%20Schedules.) 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](index=686&type=chunk) - An Exhibit Index lists documents incorporated by reference or filed with the report, numbered according to Regulation S-K Item 601[687](index=687&type=chunk) [Item 16. Form 10-K Summary.](index=160&type=section&id=Item%2016.%20Form%2010-K%20Summary.) No Form 10-K Summary is provided - No Form 10-K Summary is provided[688](index=688&type=chunk) [SIGNATURES](index=164&type=section&id=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](index=698&type=chunk)[701](index=701&type=chunk)