Enliven Therapeutics, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Enliven Therapeutics, Inc. has submitted its 2023 10-K filing, detailing financial data and equity plans.</b>

AI Summary

Enliven Therapeutics, Inc. (ELVN) filed a Annual Report (10-K) with the SEC on March 14, 2024. Enliven Therapeutics, Inc. filed its annual report for the fiscal year ended December 31, 2023. The company's principal executive offices are located at 6200 Lookout Road, Boulder, CO 80301. The filing includes information on various equity incentive plans, including the TwoThousandAndNineteenEquityIncentivePlan and TwoThousandAndTwentyEquityIncentivePlan. Financial data points such as Common Stock, Restricted Stock Units (RSUs), and Accumulated Other Comprehensive Income are detailed as of December 31, 2023. The report references former company name IMARA Inc., with a date of name change on April 19, 2016.

Why It Matters

For investors and stakeholders tracking Enliven Therapeutics, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Enliven Therapeutics' financial position and operational activities for the fiscal year 2023, crucial for investors assessing the company's performance and future prospects. The detailed breakdown of equity incentive plans and stock-related data offers insight into the company's compensation structure and potential dilution effects for shareholders.

Risk Assessment

Risk Level: medium — Enliven Therapeutics, Inc. shows moderate risk based on this filing. The company is in the pharmaceutical preparations industry (SIC 2834), which is subject to significant regulatory oversight, lengthy development cycles, and high R&D costs, as indicated by the filing's focus on equity incentive plans and financial data points.

Analyst Insight

Investors should review the detailed financial statements and risk factors within the 10-K to understand Enliven Therapeutics' current financial health and strategic direction.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reported period)
• 2016-04-19 — Date of Name Change (From IMARA Inc. to Enliven Therapeutics, Inc.)
• 2834 — SIC Code (Pharmaceutical Preparations)
• 001-39247 — SEC File Number (Associated SEC filing number)

Key Players & Entities

• Enliven Therapeutics, Inc. (company) — Filer name
• IMARA Inc. (company) — Former company name
• 2023-12-31 (date) — Fiscal year end
• 6200 Lookout Road, Boulder, CO 80301 (address) — Business address
• 0000950170-24-031495 (filing_id) — Accession number
• 2834 (sic_code) — Standard Industrial Classification
• Helen Collins MD (person) — Mentioned in context of a date range
• 001-39247 (filing_id) — SEC file number

FAQ

Risk Factors

• Regulatory Environment [high — regulatory]: The pharmaceutical industry is subject to extensive regulation by government authorities, impacting product development, manufacturing, and marketing.
• Funding and Liquidity [high — financial]: The company's ability to fund its operations and development programs depends on its access to capital and its cash reserves.
• Research and Development [high — operational]: Success in developing new pharmaceutical products is uncertain and requires significant investment in research and development.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K filing.
• 2024-03-14: Filing Date — Date the 10-K was officially filed with the SEC.

Key Financial Figures

• $0.001 — nge on which registered Common Stock, $0.001 par value per share ELVN The Nasdaq
• $6.0 billion — ultiple blockbuster products, exceeding $6.0 billion of sales in 2022, and why there remains
• $3.0 billion — ny cancers and are projected to achieve $3.0 billion in collective commercial sales in 2028.

Filing Documents

• elvn-20231231.htm (10-K) — 2916KB
• elvn-ex4_2.htm (EX-4.2) — 19KB
• elvn-ex10_3.htm (EX-10.3) — 74KB
• elvn-ex10_6.htm (EX-10.6) — 42KB
• elvn-ex10_7.htm (EX-10.7) — 42KB
• elvn-ex10_8.htm (EX-10.8) — 42KB
• elvn-ex10_9.htm (EX-10.9) — 43KB
• elvn-ex10_10.htm (EX-10.10) — 43KB
• elvn-ex10_11.htm (EX-10.11) — 101KB
• elvn-ex10_12.htm (EX-10.12) — 101KB
• elvn-ex10_13.htm (EX-10.13) — 101KB
• elvn-ex10_14.htm (EX-10.14) — 101KB
• elvn-ex10_15.htm (EX-10.15) — 101KB
• elvn-ex10_16.htm (EX-10.16) — 47KB
• elvn-ex21_1.htm (EX-21.1) — 4KB
• elvn-ex23_1.htm (EX-23.1) — 3KB
• elvn-ex31_1.htm (EX-31.1) — 14KB
• elvn-ex31_2.htm (EX-31.2) — 14KB
• elvn-ex32_1.htm (EX-32.1) — 9KB
• elvn-ex32_2.htm (EX-32.2) — 9KB
• elvn-ex97_1.htm (EX-97.1) — 45KB
• img251772460_0.jpg (GRAPHIC) — 85KB
• img251772460_1.jpg (GRAPHIC) — 85KB
• img251772460_2.jpg (GRAPHIC) — 85KB
• 0000950170-24-031495.txt (&nbsp;) — 11843KB
• elvn-20231231.xsd (EX-101.SCH) — 1321KB
• elvn-20231231_htm.xml (XML) — 1591KB

Business

Business 3 Item 1A.

Risk Factors

Risk Factors 27 Item 1B. Unresolved Staff Comments 85 Item 1C. Cybersecurity 85 Item 2.

Properties

Properties 86 Item 3.

Legal Proceedings

Legal Proceedings 87 Item 4. Mine Safety Disclosures 87 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 88 Item 6. Reserved 88 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 89 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 101 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 102 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 128 Item 9A.

Controls and Procedures

Controls and Procedures 128 Item 9B. Other Information 128 Item 9C. Disclosure Regarding Foreign Jurisdictions That Prevent Inspections 129 PART III Item 10. Directors, Executive Officers and Corporate Governance 130 Item 11.

Executive Compensation

Executive Compensation 130 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 130 Item 13. Certain Relationships and Related Transactions, and Director Independence 130 Item 14. Principal Accounting Fees and Services 130 PART IV Item 15. Exhibit and Financial Statement Schedules 131 Item 16. Form 10-K Summary 131

SIGNATURES

SIGNATURES 134 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains forward-looking statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this Annual Report on Form 10-K, including statements regarding our future results of operations and financial position, business strategy, development plans, planned preclinical studies and clinical trials, future results of clinical trials, expected research and development costs, regulatory strategy, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "would," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. Forward-looking statements contained in this Annual Report on Form 10-K include, but are not limited to, statements about: the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; the timing, progress and results of clinical trials for ELVN-001 from our BCR-ABL (as defined below) program and ELVN-002 from our HER2 (as defined below) program, and other product candidates we have and may in the future develop, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the studies or trials will become available, and research and development programs; the timing, scope and likelihood of regulatory filings and approvals, including timing of INDs (as defined below) and final U.S. Food and Drug Administration ("FDA") approval of ELVN-001 from our BCR-ABL program and ELVN-002 from our HER2 program and a

Bu siness

Item 1. Bu siness. Overview We are a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule inhibitors to help patients with cancer not only live longer, but live better. We aim to address existing and emerging unmet needs with a precision oncology approach that improves survival and enhances overall patient well-being. Our discovery process combines deep insights in clinically validated biological targets and differentiated chemistry with the goal of designing therapies for unmet needs. By combining clinically validated targets and specific target product profiles with disciplined clinical trial design and regulatory strategy, we aim to develop drugs with an increased probability of clinical and commercial success. "Clinically validated targets" refers to biological targets that have demonstrated statistical significance on efficacy endpoints in published third-party clinical trials. We have assembled a team of seasoned drug hunters with significant expertise in discovery and development of small molecule kinase inhibitors. Our team includes leading chemists who have been the primary or co-inventor of over 20 product candidates that have been advanced to clinical trials, including four FDA approved products: Koselugo (selumetinib), Mektovi (binimetinib), Tukysa (tucatinib), and Retevmo (selpercatinib). We are currently advancing two parallel lead product candidates, ELVN-001 and ELVN-002, as well as pursuing several additional research stage opportunities that align with our development approach. The following table summarizes our parallel lead product candidates: Our first product candidate, ELVN-001, is a potent, highly selective, small molecule kinase inhibitor designed to specifically target the breakpoint cluster region – Abelson ("BCR-ABL") gene fusion, the oncogenic driver for patients with chronic myeloid leukemia ("CML"). Although the approval of BCR-ABL tyrosine kinase inhibitors ("TKIs") has significan

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View this 10-K filing on SEC EDGAR