Enliven Therapeutics (NASDAQ: ELVN) narrows loss and targets Phase 3 trial
Rhea-AI Filing Summary
Enliven Therapeutics reported first quarter 2026 results, highlighting progress on its chronic myeloid leukemia candidate ELVN-001 and a strong cash position. ELVN-001 showed positive initial Phase 1b data, with additional Phase 1 results expected mid-2026 and initiation of the Phase 3 ENABLE-2 pivotal trial planned for the second half of 2026.
For the quarter ended March 31, 2026, Enliven posted a net loss of $23.6 million, improving from $28.5 million a year earlier. Research and development expenses were $20.7 million versus $24.9 million, while general and administrative costs were $7.1 million versus $6.8 million. Cash, cash equivalents and marketable securities totaled $452.4 million, expected to fund operations into the first half of 2029.
Positive
- None.
Negative
- None.
Insights
Enliven narrows losses, maintains long runway, and prepares ELVN-001 for Phase 3 in CML.
Enliven Therapeutics reported a Q1 2026 net loss of $23.6M, better than $28.5M a year earlier, mainly as R&D spending declined to $20.7M from $24.9M. G&A rose modestly to $7.1M. This pattern fits a clinical-stage company sharpening its development spend while building infrastructure.
The balance sheet shows $452.4M in cash, cash equivalents and marketable securities as of March 31, 2026, described as sufficient into the first half of 2029. That multi-year runway is important as Enliven advances ELVN-001 from Phase 1b into a planned Phase 3 ENABLE-2 trial in the second half of 2026, following positive initial Phase 1b data in CML.
Future value will hinge on upcoming catalysts: a mid-2026 Phase 1 data update from the ENABLE trial, regulatory interactions with FDA on dose selection and Phase 3 design, and successful initiation of ENABLE-2 in the second half of 2026. Subsequent company filings and data disclosures will show whether ELVN-001 can sustain its potentially best-in-class positioning.
8-K Event Classification
Key Figures
Key Terms
Phase 3 ENABLE-2 pivotal trial medical
BCR:ABL gene fusion medical
ATP-competitive inhibitor medical
chronic myeloid leukemia (CML) medical
cash runway financial
clinical-stage biopharmaceutical company financial
Earnings Snapshot
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): |
(Exact name of registrant as specified in its charter)
(State or other jurisdiction |
(Commission File Number) |
(IRS Employer |
||
|
|
|
|
|
|
||||
|
||||
(Address of principal executive offices) |
|
(Zip Code) |
||
Registrant’s telephone number, including area code: |
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
Securities registered pursuant to Section 12(b) of the Act:
|
|
Trading |
|
|
|
|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On May 7, 2026, Enliven Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 2026. The full text of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
All of the information furnished in this Item 2.02 and Item 9.01 (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit Number |
|
Exhibit Description |
99.1 |
|
Press Release issued on May 7, 2026 |
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
|
|
Enliven Therapeutics, Inc. |
|
|
|
|
Date: |
May 7, 2026 |
By: |
/s/ Richard Fair |
|
|
Name: |
Richard Fair |
|
|
Title: |
President and Chief Executive Officer |
Exhibit 99.1
Enliven Therapeutics Reports First Quarter Financial Results and Provides a Business Update
Phase 1 data update for ELVN-001 expected mid-2026
Initiation of the Phase 3 ENABLE-2 pivotal trial of ELVN-001 expected in the second half of 2026
Strong balance sheet with $452 million in cash, cash equivalents and marketable securities, which is expected to provide cash runway into the first half of 2029
BOULDER, Colo., May 7, 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 first quarter ended March 31, 2026, and provided a business update.
“Recent strategic momentum in CML validates a remaining unmet need and a compelling long-term opportunity. Against this backdrop, we remain focused on execution as we prepare to initiate the Phase 3 pivotal trial of ELVN-001 in the second half of 2026,” said Rick Fair, Chief Executive Officer of Enliven. “Based on the Phase 1 data generated to date, we believe ELVN-001 has the potential to be the best-in-class ATP-competitive inhibitor in CML and that it is positioned strongly to compete across all lines of therapy.”
ELVN-001 Program Highlights
ELVN-001 is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion, the oncogenic driver for patients with chronic myeloid leukemia (CML).
First Quarter 2026 Financial Results
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 Boulder, Colorado. 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 the management of Enliven, as well as assumptions made by, and information currently available to, management of Enliven. 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 of, and plans regarding, market opportunities, and expectations regarding Enliven's ELVN-001 program; statements regarding the potential long-term opportunity in CML; expected milestones for ELVN-001, including the potential timing for the presentation of additional Phase 1 data from the ongoing ENABLE trial, the potential timing of regulatory interactions with the FDA on dose selection and Phase 3 trial design, and potential timing of the initiation of Phase 3 ENABLE-2; Enliven's expected cash runway; statements regarding ELVN-001's positioning as the potentially best-in-class ATP-competitive inhibitor in CML, and its positioning to strongly compete across all lines of therapy; and statements by Enliven's
Page 2
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 the results of the ongoing or any future clinical trial of ELVN-001 to differ from the results from earlier trials of ELVN-001; the risk of delays in completing the ongoing ENABLE trial or initiation of a Phase 3 trial of ELVN-001; risks associated with unexpected events during the remainder of the ongoing ENABLE trial, including adverse events, toxicities or other undesirable side effects; the risk of difficulties in recruiting, enrolling or maintaining patients in clinical trials of ELVN-001; the limited operating history of Enliven; the ability to advance product candidates through preclinical and clinical development; the ability to obtain regulatory approval for, and ultimately commercialize or license, product candidates; the outcome of preclinical testing and early clinical trials for product candidates and the potential that the outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, including extrapolations or predictions regarding the safety and efficacy of ELVN-001 based on comparisons to published results of trials of other products, which may be different when evaluated in head-to-head studies; Enliven's limited resources; the risk of failing to demonstrate safety and efficacy of product candidates; the risk that FDA disagrees with Enliven's clinical trial design or Enliven's interpretation of the data; the risk that regulatory authorities may require Enliven to develop and obtain approval for a companion diagnostic in connection with the approval of a product candidate; Enliven's limited experience as a company in designing and conducting clinical trials; the potential for interim, topline, and preliminary data from Enliven's preclinical studies and clinical trials to materially change in the final data; developments relating to Enliven's competitors and its industry, including competing product candidates and therapies; the potential market opportunity for any of Enliven's programs; the decision to develop or seek strategic collaborations to develop Enliven's current or future product candidates in combination with other therapies and the cost of combination therapies; 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; geo-political developments, general market or macroeconomic conditions; 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, including those more fully described in Enliven's filings with the Securities and Exchange Commission (SEC), which may be found in the section titled "Risk Factors" in Enliven's Annual and Quarterly Reports on Form 10-K and 10-Q filed with the SEC and in Enliven's future reports to be filed with the SEC. 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.
Page 3
Contact
Investors
ir@enliventherapeutics.com
Media
media@enliventherapeutics.com
Page 4
Enliven Therapeutics, Inc.
Selected Condensed Consolidated Financial Information
(in thousands, except per share data)
(unaudited)
Statements of Operations |
|
|
Three Months Ended March 31, |
|
|||||
|
|
|
2026 |
|
|
2025 |
|
||
Operating expenses: |
|
|
|
|
|
|
|
||
Research and development |
|
|
$ |
20,687 |
|
|
$ |
24,895 |
|
General and administrative |
|
|
|
7,136 |
|
|
|
6,798 |
|
Total operating expenses |
|
|
|
27,823 |
|
|
|
31,693 |
|
Loss from operations |
|
|
|
(27,823 |
) |
|
|
(31,693 |
) |
Other income (expense), net |
|
|
|
4,196 |
|
|
|
3,149 |
|
Net loss |
|
|
$ |
(23,627 |
) |
|
$ |
(28,544 |
) |
Net loss per share, basic and diluted |
|
|
$ |
(0.38 |
) |
|
$ |
(0.57 |
) |
Weighted-average shares outstanding, |
|
|
|
62,799 |
|
|
|
50,051 |
|
|
|
|
|
|
|
|
|
||
Balance Sheets |
March 31, |
|
|
December 31, |
|
||||
|
2026 |
|
|
2025 |
|
||||
Assets |
|
|
|
|
|
||||
Current assets: |
|
|
|
|
|
||||
Cash, cash equivalents and marketable securities |
$ |
452,401 |
|
|
$ |
462,621 |
|
||
Prepaid expenses and other current assets |
|
10,736 |
|
|
|
12,257 |
|
||
Total current assets |
|
463,137 |
|
|
|
474,878 |
|
||
Property and equipment, net |
|
20 |
|
|
|
34 |
|
||
Operating lease right-of-use assets |
|
290 |
|
|
|
383 |
|
||
Deferred offering costs |
|
217 |
|
|
|
217 |
|
||
Other long-term assets |
|
1,188 |
|
|
|
656 |
|
||
Total assets |
$ |
464,852 |
|
|
$ |
476,168 |
|
||
Liabilities and Stockholders' Equity |
|
|
|
|
|
||||
Current liabilities: |
|
|
|
|
|
||||
Accounts payable |
$ |
1,640 |
|
|
$ |
2,159 |
|
||
Accrued expenses and other current liabilities |
|
9,847 |
|
|
|
14,409 |
|
||
Total current liabilities |
|
11,487 |
|
|
|
16,568 |
|
||
Total liabilities |
|
11,487 |
|
|
|
16,568 |
|
||
Stockholders' equity |
|
453,365 |
|
|
|
459,600 |
|
||
Total liabilities and stockholders' equity |
$ |
464,852 |
|
|
$ |
476,168 |
|
||
Page 5