Enliven Therapeutics Reports Third Quarter 2026 Financial Results and Provides a Business Update

Enliven expects its cash runway to extend into 2030 as it prepares to begin its first pivotal trial.

Rhea-AI Summary

Enliven Therapeutics (Nasdaq: ELVN) reached FDA alignment on the final design of its pivotal Phase 3 ENABLE-2 trial of relcobatinib. The company expects to initiate the trial before year-end 2026 in previously treated chronic myeloid leukemia. Planned enrollment is approximately 450 patients, randomized between relcobatinib and an investigator-selected therapy. The primary endpoint is major molecular response, a measure of treatment response, at Week 24; Week 96 response is the key secondary endpoint.

Cash, cash equivalents and marketable securities totaled $884.4 million at September 30, 2026, with Enliven expecting funding to last into 2030. Third-quarter net loss widened to $27.703 million from $20.148 million a year earlier. Research and development expenses rose to $28.024 million from $18.225 million, while general and administrative expenses increased to $8.021 million from $6.871 million.

8 points · 0 major

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0 major · 9 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointENABLE-2 achieved FDA alignment on final trial design for previously treated chronic myeloid leukemia.
• Moderate point. Forward-looking: it has not happened yet and may not happen.ENABLE-2 remains on track to initiate before year-end 2026, according to Enliven.
• Moderate pointCash, cash equivalents and marketable securities increased to $884.351 million from $462.621 million at December 31, 2025.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Enliven expects its cash position to provide runway into 2030.
• Minor pointRelcobatinib preclinical data demonstrated activity against treatment-resistant mutations in research published in Leukemia.

3 minor points

• Minor pointOther income, net increased to $8.342 million in Q3 2026 from $4.948 million a year earlier.
• Minor pointNine-month other income, net increased to $17.262 million in 2026 from $11.346 million in 2025.
• Minor pointNine-month loss per share narrowed to $1.21 in 2026 from $1.35 in 2025.

Negative

• Moderate pointQ3 net loss widened to $27.703 million in 2026 from $20.148 million in 2025.
• Moderate pointNine-month weighted-average shares outstanding increased to 69.040 million in 2026 from 54.794 million in 2025.
• Minor pointQ3 loss per share widened to $0.36 in 2026 from $0.32 in 2025.
• Minor pointQ3 research and development expenses rose to $28.024 million in 2026 from $18.225 million in 2025.
• Minor pointQ3 general and administrative expenses rose to $8.021 million in 2026 from $6.871 million in 2025.

4 minor points

• Minor pointNine-month net loss widened to $83.815 million in 2026 from $74.027 million in 2025.
• Minor pointNine-month research and development expenses rose to $77.707 million in 2026 from $64.611 million in 2025.
• Minor pointNine-month general and administrative expenses rose to $23.370 million in 2026 from $20.762 million in 2025.
• Minor pointQ3 weighted-average shares outstanding increased to 77.982 million in 2026 from 62.094 million in 2025.

News Explained

The release reports weighted-average shares outstanding of 77,982 thousand in Q3 2026 versus 62,094 thousand a year earlier; if the higher average reflects additional shares issued, existing holders’ percentage ownership would be reduced.

Key Figures

Cash, cash equivalents and marketable securities: $884.4 million Cash runway: Into 2030 R&D expenses: $28.0 million vs. $18.2 million +5 more

Cash, cash equivalents and marketable securities

$884.4 million

As of September 30, 2026

Cash runway

Into 2030

Company expectation

R&D expenses

$28.0 million vs. $18.2 million

Third quarter 2026 vs. third quarter 2025

G&A expenses

$8.0 million vs. $6.9 million

Third quarter 2026 vs. third quarter 2025

Net loss

$27.7 million vs. $20.1 million

Third quarter 2026 vs. third quarter 2025

ENABLE-2 initiation

Before year-end 2026

Pivotal Phase 3 trial; company remains on track

Trial enrollment

Approximately 450 patients

Planned randomized ENABLE-2 Phase 3 trial

Primary endpoint

Major molecular response at Week 24

ENABLE-2 trial; could support accelerated approval

Previous Earnings Reports

2 past events · Latest: Aug 05

Same Type 2 events

1. Aug 05

   Q2 earnings

   24h Move

   +0.9%

   Reported $895.2M in cash and runway into 2030, establishing prior-quarter funding capacity.

2. Nov 12

   Q3 earnings

   24h Move

   -0.1%

   Reported Q3 2025 R&D, G&A and net loss, providing direct year-over-year financial comparators.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

nonproprietary name, tyrosine kinase inhibitor, accelerated approval

3 terms

nonproprietary name regulatory

"adopted relcobatinib as the nonproprietary name for ELVN-001"

A nonproprietary name is the official, generic name given to a pharmaceutical substance that is not a brand or trademark; it identifies the active drug ingredient by a standardized, descriptive term (for example an International Nonproprietary Name or a United States Adopted Name). It is used in prescribing, labeling, regulatory filings, and scientific communication to unambiguously refer to the substance regardless of the manufacturer, and it may differ slightly between naming bodies or countries even though it denotes the same active ingredient.

tyrosine kinase inhibitor medical

"activity against a broad range of clinically relevant tyrosine kinase inhibitor"

A tyrosine kinase inhibitor is a type of drug that blocks specific proteins in cells that act like on/off switches for growth and survival signals, often used to stop cancer cells from multiplying. For investors, these drugs matter because their clinical trial results, regulatory approvals, safety profiles, and patent status drive sales potential and company valuation—think of them as precision tools whose effectiveness and market exclusivity determine commercial success.

accelerated approval regulatory

"which could support accelerated approval"

Accelerated approval is a process that allows new medical treatments to be approved more quickly than usual if they address serious or life-threatening conditions and show promising early results. For investors, it signals that a treatment may reach the market sooner, potentially boosting a company's prospects, but it also involves some uncertainty since full evidence of effectiveness is still being gathered.

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Reached alignment with the FDA on the final design of the ENABLE-2 pivotal Phase 3 trial 

On track to initiate ENABLE-2 before year-end 2026

Strong balance sheet with $884 million in cash, cash equivalents and marketable securities, which is expected to provide cash runway into 2030

BURLINGAME, Calif., Nov. 5, 2026 /PRNewswire/ -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, today reported financial results for the third quarter ended September 30, 2026, and provided a business update.

"This quarter marked an important milestone for Enliven as we reached alignment with the FDA on the final design of ENABLE-2, providing a clear path to initiate our first pivotal trial," said Rick Fair, Chief Executive Officer of Enliven. "The compelling ENABLE data presented at EHA in June generated strong engagement across the medical community, and we are encouraged by the enthusiasm from physicians and investigators as we prepare to initiate ENABLE-2. As we approach year-end, we remain confident in relcobatinib's potential to become a best-in-class therapy for patients with CML and are focused on executing our Phase 3 development program."

Relcobatinib Updates

• The United States Adopted Names (USAN) Council adopted relcobatinib as the nonproprietary name for ELVN-001.
• The Company announced that it reached alignment with the U.S. Food and Drug Administration (FDA) on the final design of the ENABLE-2 pivotal trial of relcobatinib in patients with previously treated chronic myeloid leukemia (CML).
• Clinical data for relcobatinib from the Phase 1 ENABLE trial were featured in encore oral presentations at the meetings of the Society of Hematologic Oncology (SOHO), the International CML Foundation (ESH-iCMLf), the Japanese Society of Hematology (JSH) and the German Society for Hematology and Medical Oncology (DGHO), reflecting continued enthusiasm for its clinical profile.
• Preclinical data published in the peer-reviewed journal Leukemia demonstrated relcobatinib's unique binding mode, high selectivity for BCR::ABL1 and activity against a broad range of clinically relevant tyrosine kinase inhibitor (TKI)-resistant mutations, supporting its potential as a best-in-class TKI for CML.
• The Company remains on track to initiate ENABLE-2 before year-end 2026.

Additional Company Updates

• Enliven appointed Kristine Ball, an accomplished biopharmaceutical executive, to its Board of Directors.
• Management will participate at the following investor conferences:
  • Guggenheim Healthcare Innovation Conference, November 9-11, Boston, MA (Fireside Chat and 1x1 Meetings)
  • Stifel Healthcare Conference, November 10-12, New York, NY (1x1 Meetings)
  • Jefferies Global Healthcare Conference, November 16-19, London, UK (Fireside Chat and 1x1 Meetings)
    • The fireside chat will be webcast live and can be accessed by visiting the investor relations section of the Company's website at https://ir.enliventherapeutics.com/. The webcast will be archived for a period of 90 days following the conclusion of the live event.

Third Quarter 2026 Financial Results

• Cash position: As of September 30, 2026, the Company had cash, cash equivalents and marketable securities totaling $884.4 million, which is expected to provide cash runway into 2030.
• Research and development (R&D) expenses: R&D expenses were $28.0 million for the third quarter of 2026, compared to $18.2 million for the third quarter of 2025.
• General and administrative (G&A) expenses: G&A expenses were $8.0 million for the third quarter of 2026, compared to $6.9 million for the third quarter of 2025.
• Net loss: Enliven reported a net loss of $27.7 million for the third quarter of 2026, compared to a net loss of $20.1 million for the third quarter of 2025.

About Relcobatinib (ELVN-001)
Relcobatinib (ELVN-001) is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL1 gene fusion, the oncogenic driver for patients living with CML. As a highly selective active-site TKI, relcobatinib has a mechanism of action that is complementary to allosteric BCR::ABL1 inhibitors, which may play an increasingly important role in the standard of care. Relcobatinib was also designed to have activity against the T315I mutation, the most common BCR::ABL1 mutation, which confers resistance to nearly all approved TKIs, as well as activity against mutations known to confer resistance to allosteric BCR::ABL1 inhibitors.

About the ENABLE-2 Trial
ENABLE-2 is a planned randomized Phase 3 trial of relcobatinib in adults with CML previously treated with one or more TKIs. The trial is expected to enroll approximately 450 patients, who will be randomized 1:1 to receive relcobatinib 80 mg once daily or an investigator-selected second-generation TKI (dasatinib, nilotinib, or bosutinib). The primary endpoint is major molecular response (MMR) at Week 24, which could support accelerated approval, with MMR at Week 96 serving as the key secondary endpoint that could support full approval.

About Enliven Therapeutics
Enliven is 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. Enliven aims to address existing and emerging unmet needs with a precision medicine approach that improves survival and enhances overall well-being. Enliven's discovery process combines deep insights into clinically validated biological targets and differentiated chemistry to design potentially first-in-class or best-in-class therapies. Enliven is based in Burlingame, California. To learn more, visit www.enliventherapeutics.com and connect with us on LinkedIn and X. 

Forward-Looking Statements
This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended) concerning Enliven and other matters that involve substantial risks and uncertainties. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations and financial condition, or otherwise, based on current beliefs of Enliven's management, as well as assumptions made by, and information currently available to, Enliven's management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "anticipate," "plan," "likely," "believe," "estimate," "project," "intend," and other similar expressions or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Statements that are not historical facts are forward-looking statements. Forward-looking statements in this press release include, but are not limited to: statements regarding the potential profile, activity, selectivity, safety, tolerability, efficacy, differentiated attributes, therapeutic benefit and potential best-in-class profile of relcobatinib; the interpretation of data from the ongoing ENABLE trial, including MMR rate, safety and tolerability data; the timing, content and availability of additional clinical data and presentation materials; the continued conduct, design, objectives, endpoints, dose selection and future clinical evaluation of relcobatinib, including the planned ENABLE-2 Phase 3 trial, the potential timing of initiation of ENABLE-2, the potential timing and outcome of the Phase 3 trial; Enliven's expected cash runway; and statements by Enliven's Chief Executive Officer. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various risks and uncertainties, including, without limitation: the potential for interim, topline and preliminary results from Enliven's clinical trials to materially change as additional patient data become available or following more comprehensive review; the potential for results from the ongoing or any future clinical trial of relcobatinib to differ from the results of earlier trials of relcobatinib; relcobatinib failing to demonstrate sufficient safety, efficacy, tolerability, durability, differentiated attributes or therapeutic benefit in current or future clinical trials; risks associated with unexpected events during the remainder of the ENABLE trial including serious adverse events, toxicities, dose reductions, discontinuations or other undesirable side effects; delays or difficulties in recruiting, enrolling or maintaining patients in relcobatinib clinical trials; the risks of delays in completing the ongoing ENABLE trial or initiating ENABLE-2; Enliven failing to complete the ongoing ENABLE trial, to present additional data, to initiate ENABLE-2 or to advance relcobatinib through clinical development; regulatory authorities disagreeing with Enliven's clinical trial design, dose selection, endpoints or interpretation of data, or requiring additional studies or diagnostics; developments relating to Enliven's competitors and industry which may affect the development or potential market opportunity for relcobatinib; the potential inability of Enliven to obtain regulatory approval for, or ultimately commercialize or license, relcobatinib or other product candidates; Enliven's limited resources; the ability to attract, hire, and retain highly skilled executive officers and employees; the ability of Enliven to protect its intellectual property and proprietary technologies; the scope of any patent protection Enliven obtains or the loss of any of Enliven's patent protection; reliance on third parties, including medical institutions, contract manufacturing organizations, contract research organizations and strategic partners; geopolitical developments, general market or macroeconomic conditions; the risk that Enliven's cash runway estimate is based on assumptions that may prove to be wrong and that Enliven may use its capital resources sooner than it expects; Enliven's ability to obtain additional capital to fund Enliven's general corporate activities and to fund Enliven's research and development; and other risks and uncertainties more fully described in Enliven's filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in Enliven's Annual and Quarterly Reports on Form 10-K and Form 10-Q filed with the SEC and in Enliven's future SEC filings. Except as required by applicable law, Enliven undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

This press release contains hyperlinks to information that is not deemed to be incorporated by reference into this press release.

Enliven Therapeutics, Inc.
Selected Condensed Consolidated Financial Information
(in thousands, except per share data)
(unaudited)
Statements of Operations			Three Months Ended September 30,				Nine Months Ended September 30,
			2026		2025		2026		2025
Operating expenses:
Research and development			$               28,024		$               18,225		$               77,707		$               64,611
General and administrative			8,021		6,871		23,370		20,762
Total operating expenses			36,045		25,096		101,077		85,373
Loss from operations			(36,045)		(25,096)		(101,077)		(85,373)
Other income (expense), net			8,342		4,948		17,262		11,346
Net loss			$             (27,703)		$             (20,148)		$             (83,815)		$             (74,027)
Net loss per share, basic and diluted			$                 (0.36)		$                 (0.32)		$                 (1.21)		$                 (1.35)
Weighted-average shares outstanding,    basic and diluted			77,982		62,094		69,040		54,794
Balance Sheets							September 30,		December 31,
							2026		2025
Assets
Current assets:
Cash, cash equivalents and marketable securities							$             884,351		$             462,621
Prepaid expenses and other current assets							10,405		12,257
Total current assets							894,756		474,878
Property and equipment, net							201		34
Operating lease right-of-use assets							1,306		383
Deferred offering costs							—		217
Other long-term assets							962		656
Total assets							$             897,225		$             476,168
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable							$                 2,730		$                 2,159
Accrued expenses and other current liabilities							16,743		14,409
Total current liabilities							19,473		16,568
Long-term liabilities							805		—
Total liabilities							20,278		16,568
Stockholders' equity							876,947		459,600
Total liabilities and stockholders' equity							$             897,225		$             476,168

 

 

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SOURCE Enliven Therapeutics, Inc.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

When will Enliven start the ENABLE-2 trial of relcobatinib?

Enliven remains on track to initiate ENABLE-2 before year-end 2026. The planned pivotal Phase 3 trial follows alignment with the FDA on its final design and will study adults with chronic myeloid leukemia previously treated with one or more tyrosine kinase inhibitors.

How long does Enliven expect its cash to last?

Enliven expects its cash, cash equivalents and marketable securities to provide cash runway into 2030. These holdings totaled $884.4 million at September 30, 2026.

What treatments will patients receive in Enliven's ENABLE-2 trial?

Patients will be randomized 1:1 to relcobatinib 80 mg once daily or an investigator-selected second-generation tyrosine kinase inhibitor. The comparator choices are dasatinib, nilotinib or bosutinib.

How could ENABLE-2 support approval of Enliven's relcobatinib?

The trial's primary endpoint, major molecular response at Week 24, could support accelerated approval. Major molecular response at Week 96, the key secondary endpoint, could support full approval.