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Enliven Therapeutics, Inc. (ELVN)

CIK: 0001672619. SIC: 2834 Pharmaceutical Preparations. Latest 10-K as of: 2026-03-03.

SIC breadcrumb: Manufacturing > Chemicals And Allied Products > SIC 2834 Pharmaceutical Preparations

SEC company page: https://www.sec.gov/edgar/browse/?CIK=1672619. Latest filing source: 0001193125-26-088232.

Selected Fundamentals

MetricValueUnitFYFiled
Net income-103,694,000USD20252026-03-03
Assets476,168,000USD20252026-03-03

Financials

Annual standardized facts from SEC companyfacts as of latest extracted filing date 2026-03-03. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001672619.json. Derived margins, ratios, and free cash flow are computed from the extracted annual SEC facts.

Flow metrics use full-year FY periods from 10-K/10-K/A filings; balance-sheet metrics use FY-end instants. Free cash flow = operating cash flow - capital expenditures. Missing metrics are omitted rather than fabricated.

Metric20182019202020212022202320242025
Net income-23,463,000-41,360,000-51,384,000-37,662,000-71,584,000-89,024,000-103,694,000
Operating income-24,116,000-41,698,000-51,442,000-38,791,000-83,529,000-104,554,000-119,658,000
Diluted EPS-2.37-12.05-2.01-1.89-1.83
Operating cash flow-21,877,000-37,398,000-46,771,000-32,077,000-61,269,000-73,192,000-70,301,000
Capital expenditures140,00018,00012,000612,000149,00044,000158,000
Assets33,298,00090,842,00093,646,00083,298,000271,867,000325,760,000476,168,000
Liabilities4,382,0006,407,0007,616,00010,374,00025,961,00015,915,00016,568,000
Stockholders' equity-26,316,000-48,848,00084,435,000-42,887,000-76,825,000245,906,000309,845,000459,600,000
Cash and cash equivalents4,936,00047,698,00048,309,00075,536,000100,141,000124,117,00098,896,000
Free cash flow-22,017,000-37,416,000-46,783,000-32,689,000-61,418,000-73,236,000-70,459,000

Ratios

ROE and ROA use period-end equity/assets. Liabilities / equity uses total liabilities divided by stockholders' equity. Current ratio uses current assets divided by current liabilities when both are reported.

Metric20182019202020212022202320242025
Return on equity-48.98%-29.11%-28.73%-22.56%
Return on assets-70.46%-45.53%-54.87%-45.21%-26.33%-27.33%-21.78%
Liabilities / equity0.080.110.050.04
Current ratio7.2914.4712.868.0010.2819.9928.66

Financial Charts

Quarterly

Quarterly standardized facts from SEC companyfacts as of latest extracted filing date 2026-05-07. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001672619.json.

Flow metrics use discrete quarter-length periods from 10-Q/10-Q/A filings. Q4 revenue and net income are derived only when annual FY and nine-month YTD facts exist for the same fiscal year; derived Q4 values are labeled. EPS Q4 is not derived.

QuarterEnd DateRevenueNet IncomeDiluted EPSMethod
2022-Q22022-06-30-0.44reported discrete quarter
2022-Q32022-09-30-0.44reported discrete quarter
2023-Q12023-03-31-0.80reported discrete quarter
2023-Q22023-03-31-14,724,000reported discrete quarter
2023-Q22023-06-30-0.41reported discrete quarter
2023-Q32023-06-30-16,721,000reported discrete quarter
2023-Q32023-09-30-0.51reported discrete quarter
2023-Q42023-12-31-19,370,000derived Q4 = FY annual - nine-month YTD
2024-Q12024-03-31-22,738,000-0.54reported discrete quarter
2024-Q22024-03-31-22,738,000reported discrete quarter
2024-Q22024-06-30-0.41reported discrete quarter
2024-Q32024-06-30-19,950,000reported discrete quarter
2024-Q32024-09-30-0.48reported discrete quarter
2024-Q42024-12-31-23,180,000derived Q4 = FY annual - nine-month YTD
2025-Q12025-03-31-28,544,000-0.57reported discrete quarter
2025-Q22025-03-31-28,544,000reported discrete quarter
2025-Q22025-06-30-0.49reported discrete quarter
2025-Q32025-06-30-25,335,000reported discrete quarter
2025-Q32025-09-30-0.32reported discrete quarter
2025-Q42025-12-31-29,667,000derived Q4 = FY annual - nine-month YTD
2026-Q12026-03-31-23,627,000-0.38reported discrete quarter

Quarterly Charts

Macro Cross-References

Latest quarter (10-Q)

Latest 10-Q source: 0001193125-26-211982.

Extracted structurally from real Item 2 body heading to real Item 3/4 boundary. Confidence: high. Filing date: 2026-05-07. Report date: 2026-03-31.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed consolidated financial statements and related notes included elsewhere in this quarterly report on Form 10-Q. This discussion contains forward-looking statements that involve risks and uncertainties, including those described in the section titled “Special Note Regarding Forward-Looking Statements.” Our actual results and the timing of selected events could differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below and those set forth under the section titled “Risk factors” included elsewhere in this quarterly report on Form 10-Q.

Overview

We are a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics to help people not only live longer, but live better. We aim to address existing and emerging unmet needs with a precision medicine approach that improves survival and enhances overall well-being. Our discovery process combines deep insights into 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 that address unmet needs with an increased probability of clinical and commercial success. Validated targets are those whose role in disease pathology have been demonstrated by mechanistic and clinical studies. We are currently advancing ELVN-001, as well as pursuing multiple additional research-stage opportunities that align with our small molecule development approach. To prioritize the advancement of ELVN-001 and its upcoming pivotal trial, we are exploring strategic alternatives for the ELVN-002 program and are no longer pursuing its development.

The following table summarizes our clinical programs:

Enliven Inc. (formerly, Enliven Therapeutics, Inc.) (“Former Enliven”) was incorporated in the State of Delaware in June 2019, and we are headquartered in Boulder, Colorado. We devote substantially all of our resources to research and development activities of our breakpoint cluster region – Abelson (“BCR-ABL”) program and our other programs, business planning, establishing and maintaining our intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these activities.

We do not own or operate, and currently have no plans to establish, any manufacturing facilities. We rely, and expect to continue to rely, on third parties for the manufacture of our product candidates for clinical and preclinical testing, as well as for commercial manufacturing, should any of our product candidates obtain marketing approval. We believe that this strategy allows us to maintain a more efficient infrastructure by eliminating the need for us to invest in our own manufacturing facilities, equipment and personnel, while also enabling us to focus our expertise and resources on the development of our product candidates.

Former Enliven funded its operations primarily through private placements of its convertible preferred stock and sale of common stock, raising aggregate gross proceeds of $140.5 million from these private placements and an aggregate of $164.5 million in gross proceeds from the sale of common stock in the Former Enliven pre-closing financing (the “Financing Transaction”). In March 2024, we sold in a private placement (the "Private Placement") common stock and pre-funded warrants to purchase shares of our common stock, resulting in aggregate gross proceeds of $90.0 million, and in June 2025, we completed an underwritten public offering (the "Public Offering") where we sold common stock and pre-funded warrants to purchase shares of our common stock, resulting in aggregate gross proceeds of $230.0 million. Through March 31, 2026, we have sold shares of our common stock pursuant to the Sales Agreement (as defined below) and received gross proceeds of $40.0 million. As of March 31, 2026, we had cash, cash equivalents and marketable securities of $452.4 million. Based on our current operating plan, our existing cash, cash

24

equivalents and marketable securities will be sufficient to fund our planned operating expenses and capital expenditure requirements for at least the next 12 months from the date of the filing of this Form 10-Q.

As of March 31, 2026, we had an accumulated deficit of $370.8 million. We have incurred significant losses and negative cash flows from operations since inception, including net losses of $103.7 million and $89.0 million for the years ended December 31, 2025 and 2024, respectively, and $23.6 million for the three months ended March 31, 2026. We expect that our operating losses and negative operating cash flows will continue for the foreseeable future as we continue to develop our product candidates.

Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on a variety of factors including the timing and scope of our research and development activities. We expect our expenses and capital requirements will increase substantially in connection with our ongoing activities, if and as we:

•
advance our BCR-ABL program through clinical development;

•
make changes to our clinical development plan for ELVN-001;

•
advance any other product candidates through preclinical and clinical development;

•
advance the development of our other small molecule research programs;

•
expand our pipeline of product candidates through our own research and development efforts;

•
seek to discover and develop additional product candidates;

•
seek regulatory approvals for any product candidates that successfully complete clinical trials;

•
incur costs related to our decision not to develop the HER2 program beyond 2025;

•
develop any required companion diagnostic;

•
establish a sales, marketing, medical and distribution infrastructure to commercialize any approved product candidates;

•
contract to manufacture any clinical product candidates as well as approved product candidates; for example, we expect to manufacture certain of our product candidates in additional countries including countries in Europe, which may increase the cost of manufacturing our product candidates;

•
contract for supplies and drug product for use in potential combination studies or in comparator arms of clinical trials;

•
expand our clinical, scientific, management and administrative teams;

•
maintain, expand, protect and enforce our intellectual property portfolio, including patents, trade secrets and know-how;

•
implement operational, financial and management systems; and

•
operate as a public company.

We do not have any products approved for commercial sale, and we have not generated any revenue from product sales or other sources. Our ability to generate product revenue sufficient to achieve and maintain profitability will depend upon the successful development and eventual commercialization of one or more of our product candidates, which we expect, if it ever occurs, will take many years. We will therefore require substantial additional capital to develop our product candidates and support our continuing operations. Accordingly, until such time that we can generate a sufficient amount of revenue from product sales, companion diagnostics or other sources, if ever, we expect to finance our operations through equity or debt financings, loans or other capital sources, which could include income from collaborations, partnerships or other marketing, distribution, licensing or other strategic arrangements with third parties, or from grants. However, we may be unable to raise additional capital from these sources on favorable terms, or at all. Our failure to obtain sufficient capital on acceptable terms when needed could have a material adverse effect on our business, results of operations or financial condition, including requiring us to delay, reduce or curtail our research, product development or future commercialization efforts. We may also be required to license rights to product candidates at an earlier stage of development or on less favorable terms than we would otherwise choose. We cannot provide assurance that we will ever generate positive cash flow from operating activities.

25

The Merger

On October 13, 2022, we entered into an agreement and plan of merger ("Merger Agreement" and such transactions considered by the Merger Agreement, the "Merger") with Former Enliven and Iguana Merger Sub, Inc. ("Merger Sub"). Pursuant to the Merger Agreement, Merger Sub merged with and into Former Enliven, with Former Enliven continuing as our wholly owned subsidiary and the surviving corporation of the Merger. Immediately following the Merger, we changed our name to Enliven Therapeutics, Inc.

Macroeconomic and Geopolitical Developments

We are monitoring macroeconomic and geopolitical developments, such as conditions and risks related to government shutdowns, inflation, instability in the banking and financial sector, tightening of the credit markets, the Russia-Ukraine conflict, conflicts in the Middle East (including the Iran conflict), the imposition of various sanctions and tariffs by the United States or other countries, public health emergencies/epidemics, and changes in government administration policy positions, so that we may be prepared to react to new developments as they arise.

The extent of the impact of these developments on our business, operations and research and development timelines and plans remains uncertain and will depend on numerous factors, including the impact, if any, on our personnel, the responses of governmental entities, and the responses of third parties, such as contract research organizations (“CROs”), contract manufacturing organizations (“CMOs”) and other third parties with whom we do business. Any prolonged material disruption to our employees or suppliers could adversely impact our development activities, financial condition and results of operations, including our ability to obtain financing. For more information regarding the risks related to macroeconomic and geopolitical developments, see the section titled “Risk Factors” found elsewhere in this quarterly report on Form 10-Q.

Components of Our Results of Operations

Revenue

To date, we have not generated any revenue and we do not expect to generate any revenue from the sale of products or from other sources in the foreseeable future.

Operating Expenses

Research and Development

Research and development expenses account for a significant portion of our operating expenses and consist primarily of external and internal expenses incurred in connection with the discovery and development of our product candidates.

External expenses include:

•
payments to third parties in connection with the development of our product candidates, including agreements with third parties such as CROs, CMOs and consultants;

•
the cost of manufacturing products for use in our clinical trials and preclinical studies, including payments to CMOs and consultants;

•
the cost to acquire drug product for use in combination studies and for comparator arms of clinical trials; and

•
payments to third parties in connection with the preclinical development of our product candidates and any required companion diagnostic, including for outsourced professional scientific development services, consulting research and sponsored research.

Internal expenses include:

•
personnel-related costs, including salaries, bonuses, related benefits and stock-based compensation expenses for employees engaged in research and developm

[Excerpt truncated for page length; source filing is linked above.]

Latest 10-K MD&A

Extracted structurally from real Item 7 body heading to real Item 7A/8 boundary. Confidence: high. Filing date: 2026-03-03. Report date: 2025-12-31.

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You should read the following discussion and analysis of our financial condition and results of operations together with our consolidated financial statements and related notes included elsewhere in this Annual Report on Form 10-K. This discussion contains forward-looking statements that involve risks and uncertainties, including those described in the section titled “Special Note Regarding Forward-Looking Statements.” Our actual results and the timing of selected events could differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below and those set forth under the section titled “Risk factors” included elsewhere in this Annual Report on Form 10-K.

Overview

We are a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics to help people not only live longer, but live better. We aim to address existing and emerging unmet needs with a precision medicine approach that improves survival and enhances overall well-being. Our discovery process combines deep insights into 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 that address unmet needs with an increased probability of clinical and commercial success. Validated targets are those whose role in disease pathology have been demonstrated by mechanistic and clinical studies. We are currently advancing ELVN-001, as well as pursuing multiple additional research-stage opportunities that align with our small molecule development approach. To prioritize the advancement of ELVN-001 and its upcoming pivotal trial, we are exploring strategic alternatives for the ELVN-002 program and are no longer pursuing its development. To prioritize the advancement of ELVN-001 and its upcoming pivotal trial, we are exploring strategic alternatives for the ELVN-002 program and are no longer pursuing its development.

The following table summarizes our clinical programs:

Enliven Inc. (formerly, Enliven Therapeutics, Inc.) (“Former Enliven”) was incorporated in the State of Delaware in June 2019, and we are headquartered in Boulder, Colorado. We devote substantially all of our resources to research and development activities of our BCR-ABL program and our other programs, business planning, establishing and maintaining our intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these activities.

We do not own or operate, and currently have no plans to establish, any manufacturing facilities. We rely, and expect to continue to rely, on third parties for the manufacture of our product candidates for clinical and preclinical testing, as well as for commercial manufacturing, should any of our product candidates obtain marketing approval. We believe that this strategy allows us to maintain a more efficient infrastructure by eliminating the need for us to invest in our own manufacturing facilities, equipment and personnel, while also enabling us to focus our expertise and resources on the development of our product candidates.

Former Enliven funded its operations primarily through private placements of its convertible preferred stock and sale of common stock, raising aggregate gross proceeds of $140.5 million from these private placements and an aggregate of $164.5 million in gross proceeds from the sale of common stock in the Former Enliven pre-closing financing (the “Financing Transaction”). In March 2024, we sold in the Private Placement common stock and pre-funded warrants to purchase shares of our common stock, resulting in aggregate gross proceeds of $90.0 million, and in June 2025, we completed the Public Offering where we sold common stock and pre-funded warrants to purchase shares of our common stock, resulting in aggregate gross proceeds of $230.0 million. Through December 31, 2025, we have sold shares of our common stock pursuant to the Sales Agreement and received gross proceeds of $40.0 million. As of December 31, 2025, we had cash, cash equivalents and marketable securities of $462.6 million. Based on our current operating plan, our existing cash, cash equivalents and marketable securities will be sufficient to fund our planned operating expenses and capital expenditure requirements for at least the next 12 months from the date of the filing of this Form 10-K.

88

As of December 31, 2025, we had an accumulated deficit of $347.2 million. We have incurred significant losses and negative cash flows from operations since inception, including net losses of $103.7 million and $89.0 million for the years ended December 31, 2025 and 2024, respectively. We expect that our operating losses and negative operating cash flows will continue for the foreseeable future as we continue to develop our product candidates.

Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on a variety of factors including the timing and scope of our research and development activities. We expect our expenses and capital requirements will increase substantially in connection with our ongoing activities, if and as we:

•
advance our BCR-ABL program through clinical development;

•
make changes to our clinical development plan for ELVN-001;

•
advance any other product candidates through preclinical and clinical development;

•
advance the development of our other small molecule research programs;

•
expand our pipeline of product candidates through our own research and development efforts;

•
seek to discover and develop additional product candidates;

•
seek regulatory approvals for any product candidates that successfully complete clinical trials;

•
incur costs related to our decision not to develop the HER2 program beyond 2025;

•
develop any required companion diagnostic;

•
establish a sales, marketing and distribution infrastructure to commercialize any approved product candidates;

•
contract to manufacture any clinical product candidates as well as approved product candidates; for example, we expect to manufacture certain of our product candidates in additional countries including countries in Europe, which may increase the cost of manufacturing our product candidates;

•
contract for supplies and drug product for use in potential combination studies or in comparator arms of clinical trials;

•
expand our clinical, scientific, management and administrative teams;

•
maintain, expand, protect and enforce our intellectual property portfolio, including patents, trade secrets and know-how;

•
implement operational, financial and management systems; and

•
operate as a public company.

We do not have any products approved for commercial sale, and we have not generated any revenue from product sales or other sources. Our ability to generate product revenue sufficient to achieve and maintain profitability will depend upon the successful development and eventual commercialization of one or more of our product candidates, which we expect, if it ever occurs, will take many years. We will therefore require substantial additional capital to develop our product candidates and support our continuing operations. Accordingly, until such time that we can generate a sufficient amount of revenue from product sales, companion diagnostics or other sources, if ever, we expect to finance our operations through equity or debt financings, loans or other capital sources, which could include income from collaborations, partnerships or other marketing, distribution, licensing or other strategic arrangements with third parties, or from grants. However, we may be unable to raise additional capital from these sources on favorable terms, or at all. Our failure to obtain sufficient capital on acceptable terms when needed could have a material adverse effect on our business, results of operations or financial condition, including requiring us to delay, reduce or curtail our research, product development or future commercialization efforts. We may also be required to license rights to product candidates at an earlier stage of development or on less favorable terms than we would otherwise choose. We cannot provide assurance that we will ever generate positive cash flow from operating activities.

89

The Merger

On October 13, 2022, we entered into the Merger Agreement with Former Enliven and Merger Sub. Pursuant to the Merger Agreement, Merger Sub merged with and into Former Enliven, with Former Enliven continuing as our wholly owned subsidiary and the surviving corporation of the Merger. Immediately following the Merger, we changed our name to Enliven Therapeutics, Inc.

Macroeconomic and Geopolitical Developments

We are monitoring macroeconomic and geopolitical developments, such as a potential government shutdown, inflation, instability in the banking and financial sector, tightening of the credit markets, the Russia-Ukraine conflict, conflict in the Middle East, including the Israel-Iran conflict, the imposition of various sanctions and tariffs by the United States and in other countries, public health emergencies/epidemics and the changes in government administration policy positions as a result of the current presidential administration, so that we may be prepared to react to new developments as they arise.

The extent of the impact of these developments on our business, operations and research and development timelines and plans remains uncertain and will depend on numerous factors, including the impact, if any, on our personnel, the responses of governmental entities, and the responses of third parties, such as CROs, CMOs and other third parties with whom we do business. Any prolonged material disruption to our employees or suppliers could adversely impact our development activities, financial condition and results of operations, including our ability to obtain financing. For more information regarding the risks related to macroeconomic and geopolitical developments, see the section titled “Risk Factors” found elsewhere in this Annual Report on Form 10-K.

Components of Our Results of Operations

Revenue

To date, we have not generated any revenue and we do not expect to generate any revenue from the sale of products or from other sources in the foreseeable future.

Operating Expenses

Research and Development

Research and development expenses account for a significant portion of our operating expenses and consist primarily of external and internal expenses incurred in connection with the discovery and development of our product candidates.

External expenses include:

•
payments to third parties in connection with the development of our product candidates, including agreements with third parties such as CROs, CMOs and consultants;

•
the cost of manufacturing products for use in our clinical trials and preclinical studies, including payments to CMOs and consultants;

•
the cost to acquire drug product for use in combination studies and for comparator arms of clinical trials; and

•
payments to third parties in connection with the preclinical development of our product candidates and any required companion diagnostic, including for outsourced professional scientific development services, consulting research and sponsored research.

Internal expenses include:

•
personnel-related costs, including salaries, bonuses, related benefits and stock-based compensation expenses for employees engaged in research and development functions; and

•
facilities-related expenses, depreciation, laboratory supplies, travel expenses and other allocated expenses.

We expense research and development expenses in the periods in which they are incurred. At any one time, we are working on multiple programs. Our internal resources, employees and infrastructure are not directly tied to any one research or drug discovery program and are typically deployed across multiple programs. External expenses are recognized based on an evaluation of the

90

progress to completion of specific tasks using information provided to us by our service providers or our estimate of the level of service that has been performed at each reporting date. We utilize CROs for our research and development activities and CMOs for our manufacturing activities, and we do not have our own manufacturing facilities.

Product candidates in later stages of development generally have higher development costs than those in earlier stages. As a result, we expect that our research and development expenses will increase substantially over the next several years as we advance our product candidates through preclinical studies into and through clinical trials, continue to discover and develop additional product candidates, expand, maintain, protect and enforce our intellectual property portfolio, and hire additional research and development personnel.

The successful development of our product candidates is highly uncertain, and we do not believe it is possible at this time to accurately project the nature, timing and estimated costs of the efforts necessary to complete the development of, and obtain regulatory approval for, any of our product candidates. To the extent our product candidates continue to advance into clinical trials, as well as advance into larger and later-stage clinical trials, our expenses will increase substantially and may become more variable. The duration, costs and timing of preclinical studies and clinical trials and development of our product candidates are subject to numerous uncertainties and will depend on a variety of factors, including:

•
the timing and progress of preclinical and clinical development activities;

•
the number and scope of preclinical and clinical programs we pursue;

•
our ability to establish a sufficient safety profile with IND-enabling toxicology studies to enable clinical trials;

•
successful patient enrollment in, and the initiation and completion of, clinical trials;

•
per subject trial costs;

•
the number and extent of trials required for regulatory approval;

•
whether clinical trials with combination drugs are pursued;

•
the comparator arms of our clinical trials;

•
the countries in which the trials are conducted;

•
the length of time required to enroll eligible subjects in clinical trials;

•
the number of subjects that participate in the trials;

•
the drop-out and discontinuation rate of subjects;

•
potential additional safety monitoring requested by regulatory agencies;

•
the duration of subject participation in the trials and follow-up;

•
the extent to which we encounter any serious adverse events in our clinical trials;

•
the timing of receipt of regulatory approvals from applicable regulatory authorities;

•
the timing, receipt and terms of any marketing approvals and post-marketing approval commitments from applicable regulatory authorities;

•
the extent to which we establish collaborations, strategic partnerships or other strategic arrangements with third parties, if any, and the performance of any such third party;

•
the timing and progress of development of any required companion diagnostic;

•
our ability to acquire drug supply for any products, the cost of such drug supply, and any delays in connection with obtaining such drug supply;

•
adverse effects of tariffs and trade restrictions, including increased supply chain costs or inability to obtain inputs;

•
hiring and retaining research and development and clinical operations personnel;

•
our arrangements with our CMOs and CROs, including transitioning from existing CMOs to CMOs in additional countries, including countries in Europe;

91

•
patient enrollment, which could be delayed due to the approval of new drugs for the same indications that may compete with our product candidates during clinical trials, for example, Scemblix (asciminib), which may lead to reduced market acceptance of our product candidates if our product candidates are approved;

•
development and timely delivery of commercial-grade drug formulations that can be used in our planned clinical trials and for commercial launch;

•
the impact of any business interruptions to our operations or to those of the third parties with whom we work, including due to any government shutdowns, public health emergency, health epidemic (including COVID-19) or other outbreaks, natural disasters, or other disruptions;

•
the impact of any supply chain disruptions resulting from macroeconomic or geopolitical situations, including due to any public health emergency, health epidemic (including COVID-19) or other outbreaks, the Russia-Ukraine conflict, conflict in the Middle East, including the Israel-Iran conflict, national security concerns and related legislation related to business operations in China and other countries and changes in government administration policy positions as a result of the current presidential administration; and

•
obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights.

Any of these factors could significantly impact the costs, timing and viability associated with the development of our product candidates.

General and Administrative

General and administrative expenses consist of salaries, bonuses, related benefits and stock-based compensation expense for personnel in executive, finance and administrative functions; professional fees for legal, consulting, accounting and audit services; and travel expenses, technology costs and other allocated expenses. We expense general and administrative expenses in the periods in which they are incurred.

We expect that our general and administrative expenses will increase substantially over the next several years as we hire additional personnel to support the growth of our business. In addition, we expect to continue to incur significant expenses associated with being a public company, including expenses related to accounting, audit, legal, regulatory, public company reporting and compliance, director and officer insurance, investor and public relations, and other administrative and professional services.

Other Income (Expense), Net

Other income (expense), net primarily consists of interest earned on our cash, cash equivalents and marketable securities, as well as gains and losses related to the change in fair value of the contingent value right (“CVR”) liability and income tax expense.

Results of Operations

Comparison of the years ended December 31, 2025 and 2024

The following table summarizes our results of operations for the periods indicated:

Year Ended December 31,

2025

2024

(in thousands)

Operating expenses:

Research and development

$

85,856

$

80,778

General and administrative

33,802

23,776

Total operating expenses

119,658

104,554

Loss from operations

(119,658

)

(104,554

)

Other income (expense), net

15,964

15,530

Net loss

$

(103,694

)

$

(89,024

)

92

Research and Development Expenses

The following table summarizes our research and development expenses for the periods indicated:

Year Ended December 31,

2025

2024

(in thousands)

External expenses:

ELVN-001

$

23,162

$

15,402

ELVN-002

15,713

28,488

Other

12,403

10,534

Total external expenses

51,278

54,424

Internal expenses:

Employee related expenses

31,764

23,882

Facilities, laboratory supplies and other

2,814

2,472

Total internal expenses

34,578

26,354

Total research and development expenses

$

85,856

$

80,778

Research and development expenses were $85.9 million for the year ended December 31, 2025 compared to $80.8 million for the year ended December 31, 2024, an increase of $5.1 million. The increase was primarily due to higher internal research and development costs, consisting of $4.3 million in stock-based compensation, $3.6 million in salaries and benefits, and $0.3 million in other internal costs. This increase was partially offset by lower external research and development costs, driven by a decrease of $12.8 million in ELVN-002 costs due to our intention not to pursue development beyond 2025 as we explore strategic alternatives for the program, partially offset by increases of $7.8 million in ELVN-001 costs due to clinical progression and $1.9 million in other external costs primarily related to higher research costs.

General and Administrative Expenses

General and administrative expenses were $33.8 million for the year ended December 31, 2025 compared to $23.8 million for the year ended December 31, 2024, an increase of $10.0 million. The increase was primarily due to an increase of $9.6 million in stock-based compensation, largely attributable to modifications to certain equity awards and higher valuations on equity grants, as well as an increase of $0.4 million in professional fees and other costs.

Other Income (Expense), Net

Other income was $16.0 million for the year ended December 31, 2025 compared to $15.5 million for the year ended December 31, 2024, an increase of $0.5 million. The increase was primarily related to higher interest income of $1.1 million due to a higher investment balance net of lower interest rates and lower income tax expense of $0.2 million related to the CVR milestone payment in 2024, partially offset by a lower gain of $0.9 million related to the change in fair value of the CVR liability upon remeasurement in 2024.

Liquidity and Capital Resources

Sources of Liquidity

Since our inception, we have not generated any revenue from product sales or other sources and have incurred significant operating losses and negative cash flows from our operations. Former Enliven funded its operations primarily through private placements of its convertible preferred stock for gross proceeds of $140.5 million and sale of common stock in the Financing Transaction in February 2023 for gross proceeds of $164.5 million. In March 2024, we sold common stock and pre-funded warrants in the Private Placement and received aggregate gross proceeds of $90.0 million, and in June 2025, we completed the Public Offering where we sold common stock and pre-funded warrants, resulting in aggregate gross proceeds of $230.0 million.

On June 23, 2023, we entered into the Sales Agreement with the Sales Agent, pursuant to which we may offer and sell shares of our common stock, from time to time, through the Sales Agent, in such share amounts as we may specify by notice to the Sales Agent, in accordance with the terms and conditions set forth in the Sales Agreement. On August 13, 2025, we filed the Automatic Shelf Registration Statement with the SEC that allows us to undertake an indeterminate amount of equity and debt offerings. Concurrently with the filing of the Automatic Shelf Registration Statement, our prior shelf registration statement and prior

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prospectus supplement, which registered $200.0 million of common stock under our at-the-market program, were terminated, and we no longer had any common stock available for sale under the prior prospectus supplement.

On August 13, 2025, we filed a prospectus supplement to the Automatic Shelf Registration Statement that covers the offering, issuance and sale of up to $200.0 million of our common stock under the Sales Agreement. Following the filing of such prospectus supplement and the termination of our prior shelf registration statement and prior prospectus supplement, there was $200.0 million of common stock available for sale under the Sales Agreement.

Through December 31, 2025, we have sold shares of our common stock pursuant to the Sales Agreement and received gross proceeds of $40.0 million. As of December 31, 2025 and 2024, there was $200.0 million and $160.0 million, respectively, of our common stock available for sale under the Sales Agreement.

Our primary uses of cash to date have been to fund our research and development activities, including with respect to our BCR-ABL and HER2 programs and our other programs, business planning, establishing and maintaining our intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these activities. As of December 31, 2025, we had cash, cash equivalents and marketable securities of $462.6 million.

Future Capital Requirements

To date, we have not generated any revenue. We do not expect to generate any meaningful revenue unless and until we obtain regulatory approval of and commercialize any of our product candidates, and we do not know when, or if, that will occur. Until such time as we can generate significant revenue from product sales, if ever, we will continue to require substantial additional capital to develop our product candidates and fund operations for the foreseeable future. We expect our expenses to increase significantly in connection with our ongoing activities as described in greater detail below. We are subject to all the risks incident in the development of new biopharmaceutical products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may harm our business. We expect our expenses to increase significantly, if and as we:

•
advance our BCR-ABL program through clinical development;

•
advance any other product candidates through preclinical and clinical development;

•
advance the development of our other small molecule research programs;

•
expand our pipeline of product candidates through research and development efforts;

•
expand our pipeline of research programs;

•
seek to discover and develop additional product candidates;

•
seek regulatory approvals for any product candidates that successfully complete clinical trials;

•
develop any required companion diagnostic;

•
establish a sales, marketing and distribution infrastructure to commercialize any approved product candidates;

•
contract to manufacture any clinical product candidates or approved product candidates; for example, we expect to manufacture certain of our product candidates in additional countries, including countries in Europe, which may increase the cost of manufacturing our product candidates;

•
contract for supplies and drug product for use in potential combination trials;

•
expand our clinical, scientific, management and administrative teams;

•
maintain, expand, protect and enforce our intellectual property portfolio, including patents, trade secrets and know-how;

•
implement operational, financial and management systems; and

•
operate as a public company.

In order to complete the development of our product candidates and to build the sales, marketing and distribution infrastructure that we believe will be necessary to commercialize our product candidates, if approved, we will require substantial additional capital. Accordingly, until such time that we can generate a sufficient amount of revenue from product sales or other sources, if

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ever, we expect to seek to raise any necessary additional capital through equity or debt financings, loans or other capital sources, which could include income from collaborations, partnerships or other marketing, distribution, licensing or other strategic arrangements with third parties, or from grants. To the extent that we raise additional capital through equity financings or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, including restricting our operations and limiting our ability to incur liens, issue additional debt, pay dividends, repurchase our common stock, make certain investments or engage in merger, consolidation, licensing or asset sale transactions. If we raise capital through collaborations, partnerships and other similar arrangements with third parties, we may be required to grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. We may be unable to raise additional capital from these sources on favorable terms, or at all. Our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, the credit and financial markets in the United States. Our failure to obtain sufficient capital on acceptable terms when needed could have a material adverse effect on our business, results of operations or financial condition, including requiring us to delay, reduce or curtail our research, product development or future commercialization efforts. We may also be required to license rights to product candidates at an earlier stage of development or on less favorable terms than we would otherwise choose. We cannot provide assurance that we will ever generate positive cash flow from operating activities.

We expect that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements for at least the next 12 months from the date of this filing. We expect to continue to incur costs associated with operating as a public company. In addition, we anticipate that we will need substantial additional funding in connection with our continuing operations. We have based our projections of operating capital requirements on our current operating plan, which includes several assumptions that may prove to be incorrect, and we may use all of our available capital resources sooner than we expect.

Because of the numerous risks and uncertainties associated with research, development and commercialization of product candidates, we are unable to estimate the exact amount and timing of our capital requirements. Our future funding requirements will depend on many factors, including:

•
the scope, timing, progress, results and costs of researching and developing our product candidates, and conducting preclinical studies and clinical trials;

•
the scope, timing, progress, results and costs of researching and developing other product candidates that we may pursue;

•
the cost of research and development to expand our pipeline of research programs;

•
the costs, timing and outcome of regulatory review of our product candidates;

•
the cost of developing a companion diagnostic, if required for regulatory approval of any product;

•
the cost of acquiring drug product for any combination studies or comparator arms of clinical trials;

•
the cost of patient enrollment for existing clinical trials and any additional clinical trials;

•
the costs of future activities, including product sales, medical affairs, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval;

•
the costs of manufacturing commercial-grade products and sufficient inventory to support commercial launch;

•
the revenue, if any, received from commercial sale of our products, should any of our product candidates receive marketing approval;

•
the cost and timing of attracting, hiring and retaining skilled personnel to support our operations and continued growth;

•
the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;

•
our ability to establish, maintain, and derive value from collaborations, partnerships or other marketing, distribution, licensing or other strategic arrangements with third parties on favorable terms, if at all;

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•
the extent to which we acquire or in-license other product candidates and technologies, if any; and

•
the costs associated with operating as a public company.

A change in the outcome of any of these or other factors with respect to the development of any of our product candidates could significantly change the costs and timing associated with the development of that product candidate. Furthermore, our operating plans may change in the future, and we may need additional capital to meet the capital requirements associated with such operating plans.

Cash Flows

The following table summarizes our cash flows for the periods indicated:

Year Ended December 31,

2025

2024

(in thousands)

Net cash used in operating activities

$

(70,301

)

$

(73,192

)

Net cash used in investing activities

(173,841

)

(35,997

)

Net cash provided by financing activities

218,867

133,165

Net (decrease) increase in cash, cash equivalents and restricted cash

$

(25,275

)

$

23,976

Cash Flows from Operating Activities

Net cash used in operating activities during the year ended December 31, 2025 was $70.3 million. This consisted primarily of a net loss of $103.7 million and net cash outflows from changes in our operating assets and liabilities of $1.1 million (primarily due to an increase in prepaids and other assets), partially offset by non-cash charges for stock-based compensation of $34.0 million and other non-cash charges of $0.5 million.

Net cash used in operating activities during the year ended December 31, 2024 was $73.2 million. This consisted primarily of a net loss of $89.0 million, net cash outflows from changes in our operating assets and liabilities of $4.5 million (primarily due to an increase in prepaids and other assets, partially offset by a net increase in accounts payable and accrued expenses and other liabilities) and non-cash change in the fair value of the CVR liability of $0.9 million, partially offset by non-cash charges for stock-based compensation of $20.2 million, non-cash amortization of premiums and discounts on marketable securities of $0.4 million and other non-cash charges of $0.6 million.

Cash Flows from Investing Activities

Net cash used in investing activities during the year ended December 31, 2025 was $173.8 million. This consisted primarily of cash used to purchase marketable securities of $446.8 million, partially offset by proceeds from maturities of marketable securities of $272.9 million.

Net cash used in investing activities during the year ended December 31, 2024 was $36.0 million. This consisted primarily of cash used to purchase marketable securities of $350.7 million and payment of the CVR milestone (net of permitted deductions) of $9.1 million, partially offset by proceeds from maturities of marketable securities of $313.9 million and receipt of the CVR milestone of $10.0 million.

Cash Flows from Financing Activities

Net cash provided by financing activities during the year ended December 31, 2025 was $218.9 million. This consisted primarily of net proceeds from the sale of shares of our common stock and pre-funded warrants in the Public Offering of $216.2 million, proceeds from the exercise of stock options of $2.3 million and proceeds from the issuance of common stock under our employee stock purchase plan of $0.6 million, partially offset by the payment of deferred offering costs of $0.2 million.

Net cash used in financing activities during the year ended December 31, 2024 was $133.2 million. This consisted primarily of net proceeds from the sale of shares of our common stock and pre-funded warrants in the Private Placement of $89.7 million, net proceeds from the sale of shares of our common stock pursuant to the Sales Agreement of $39.2 million, proceeds from the exercise of stock options of $3.6 million and proceeds from the issuance of common stock under our employee stock purchase plan of $0.7 million.

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Contractual Obligations and Commitments

In September 2024, we entered into the Lease, which is a non-cancellable operating lease. Under the terms of the Lease, we will lease approximately 20,011 rentable square feet of office and laboratory space from January 1, 2025 through December 31, 2026, with a renewal option for an additional term of five years.

The following table summarizes our contractual obligations and commitments as of December 31, 2025 (in thousands):

Payments Due by Period

Total

2026

Thereafter

Operating lease obligations - facility lease

$

414

$

414

$

—

We have also entered into agreements in the normal course of business with certain vendors for the provision of goods and services, which includes manufacturing services with CMOs and development services with CROs. These agreements may include certain provisions for purchase obligations and termination obligations that could require payments for the cancellation of committed purchase obligations or for early termination of the agreements. The amount of the cancellation or termination payments vary and are based on the timing of the cancellation or termination and the specific terms of the agreement. These obligations and commitments are not separately presented.

Off-Balance Sheet Arrangements

We currently do not have, and did not have during the periods presented, any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.

Critical Accounting Policies and Significant Judgments and Estimates

Our financial statements are prepared in accordance with generally accepted accounting principles in the United States. The preparation of our financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, costs and expenses, and the disclosure of contingent assets and liabilities in our financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on a periodic basis. Our actual results may differ from these estimates.

While our significant accounting policies are described in more detail in the notes to our audited consolidated financial statements appearing elsewhere in this Annual Report on Form 10-K, we believe that the following accounting policies are critical to understanding our historical and future performance, as the policies relate to the more significant areas involving management’s judgments and estimates used in the preparation of our consolidated financial statements.

Accrued Research and Development Expense

We are required to estimate our expenses resulting from obligations under contracts with vendors and consultants, in connection with conducting research and development activities. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided under such contracts. We reflect research and development expenses in our financial statements by matching those expenses with the period in which services and efforts are expended. We account for these expenses according to the progress of the preclinical studies, manufacturing activities and clinical trials, as measured by the timing of various aspects of the study or related activities. We determine accrual estimates through review of the underlying contracts along with preparation of financial models taking into account discussions with research and development and other key personnel as to the progress of studies, or other services being conducted. During the course of a study, we adjust our rate of expense recognition if actual results differ from our estimates.

Although we do not expect our estimates to be materially different from amounts actually incurred, if our estimates of the status and timing of services performed differ from the actual status and timing of services performed, it could result in us reporting amounts that are too high or too low in any particular period. To date, there have been no material differences between our estimates of such expenses and the amounts actually incurred.

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Stock-Based Compensation

We measure stock-based awards granted to employees, non-employee directors, consultants and independent advisors based on the estimated grant date fair value of the awards. For awards with only service conditions, including stock options, restricted stock awards and restricted stock units, compensation expense is recognized over the requisite service period using the straight-line method. We use the Black-Scholes option pricing model to estimate the fair value of our stock-based awards. The Black-Scholes option pricing model requires us to make assumptions and judgments about the variables used in the calculations, including the expected term, expected volatility of our common stock, risk-free interest rate and expected dividend yield. As the stock-based compensation is based on awards ultimately expected to vest, it is reduced by forfeitures, which we account for as they occur.

Estimating the fair value of equity-settled awards as of the grant date using the Black-Scholes option pricing model is affected by subjective assumptions. Changes in the assumptions can materially affect the fair value and ultimately how much stock-based compensation is recognized. These inputs are subjective and generally require significant analysis and judgment to develop. The inputs are as follows:

•
Expected Term—The expected term represents the period that our options are expected to be outstanding and is determined using the simplified method (based on the mid-point between the vesting date and the end of the contractual term) as we do not have sufficient historical information to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior for our stock option grants.

•
Expected Volatility—The expected stock price volatility is estimated based on the average volatility for comparable publicly-traded biopharmaceutical companies over a period equal to the expected term of the stock option grants as we do not have sufficient history of trading our common stock. The comparable companies are chosen based on their similarities to us, including life cycle stage, therapeutic focus and size.

•
Risk-Free Interest Rate—The risk-free interest rate is based on U.S. Treasury yields in effect at the grant date for notes with comparable terms as the awards.

•
Expected Dividend Yield—We have never paid dividends on our common stock and have no plans to do so in the future. Therefore, we used an expected dividend of zero.

We will continue to use judgment in evaluating the expected volatilities, expected terms, and risk-free interest rates utilized for our stock-based compensation calculations on a prospective basis. Assumptions we used in applying the Black-Scholes option pricing model to determine the estimated fair value of our stock-based awards involve inherent uncertainties and the application of significant judgment. As a result, if factors or expected outcomes change and we use significantly different assumptions or estimates, our stock-based compensation recognized in future periods could be materially different.

We expect to continue to grant stock options and other stock-based awards in the future, and to the extent that we do, our stock-based compensation expense recognized in future periods will likely increase.

See Note 10 to our audited consolidated financial statements appearing elsewhere in this Annual Report on Form 10-K for further details.

Recently Issued Accounting Pronouncements

A description of recently issued accounting pronouncements that may potentially impact our financial condition and results of operations is disclosed in Note 2 to our audited consolidated financial statements appearing elsewhere in this Annual Report on Form 10-K.

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