Enliven Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides a Business Update

Rhea-AI Summary

Enliven Therapeutics (ELVN) has reported its Q4 and full year 2024 financial results, highlighting continued progress in its clinical programs. The company maintains a strong financial position with $313.4 million in cash and equivalents, providing runway into mid-2027.

Key pipeline updates include anticipated Phase 1 data for ELVN-001, their BCR::ABL kinase inhibitor for chronic myeloid leukemia (CML), expected mid-2025. Their second program, ELVN-002, a CNS-penetrant HER2 inhibitor, will report both monotherapy and combination trial data in H2 2025.

Financial highlights for FY2024 show R&D expenses of $80.8 million (up from $64.6M in 2023), G&A expenses of $23.8 million (up from $19.0M), and a net loss of $89.0 million (compared to $71.6M in 2023). The company is preparing for a potential pivotal trial of ELVN-001 in 2026.

Positive

• Strong cash position of $313.4M providing runway into mid-2027
• FDA granted orphan drug designation to ELVN-001 for CML treatment
• Positive initial Phase 1 data for ELVN-001 compared favorably to approved BCR::ABL1 TKIs
• Expansion of ELVN-002 clinical program with multiple ongoing trials

Negative

• Increased net loss to $89.0M in 2024 from $71.6M in 2023
• R&D expenses increased 25% to $80.8M in 2024
• G&A expenses rose 25% to $23.8M in 2024

Insights

Financial Analyst

Enliven's Q4 and full-year 2024 results demonstrate solid financial stewardship with $313.4 million in cash and equivalents, providing runway into mid-2027. This represents approximately 2.5 years of operational funding at current burn rates, positioning the company well for multiple clinical milestones without near-term financing pressure.

The financial fundamentals show expected increases in expenses as clinical programs advance. R&D expenses rose to $80.8 million for 2024 (25% increase from 2023), while G&A expenses grew to $23.8 million (25.3% increase). The full-year net loss of $89 million represents a 24.3% widening compared to 2023, aligning with the investment needed for a company with two active clinical programs.

With a market cap of approximately $1.02 billion, Enliven is trading at about 3.3x cash, relatively reasonable for a clinical-stage oncology company with multiple potential value inflection points in 2025. The cash runway extending into mid-2027 provides important operational flexibility through the anticipated pivotal trial for ELVN-001 planned for 2026, significantly de-risking the financial aspect of clinical execution.

What's particularly notable is that despite increasing expenses, the company has maintained disciplined cash management, extending runway while advancing multiple clinical programs simultaneously - a balance many biotech companies struggle to achieve.

Oncology Clinical Development Expert

Enliven's clinical progress demonstrates thoughtful pipeline advancement with differentiated assets. ELVN-001, their BCR::ABL inhibitor for CML, is progressing well with positive initial data that the company reports "compared favorably" to precedent Phase 1 trials for approved TKIs in this class. The FDA's orphan drug designation provides validation and potential regulatory benefits.

The expansion into Japanese patients represents smart global development strategy, especially important for CML where Asian markets have significant patient populations. The acceleration in enrollment momentum mentioned by management suggests growing investigator confidence in the program.

For ELVN-002, the company is pursuing a comprehensive development approach spanning HER2+ breast cancer, HER2-mutant tumors, and colorectal cancer. The multiple combination approaches (with Kadcyla and with trastuzumab +/- chemotherapy) demonstrate strategic thinking about potential approval pathways and differentiation in crowded HER2 therapeutic landscape.

The planned data readouts in 2025 (mid-year for ELVN-001 and second half for ELVN-002) will be critical value-driving events. Most significantly, management's mention of preparing for a potential pivotal trial for ELVN-001 in 2026 indicates confidence in their data and suggests the program may be progressing more rapidly than typical development timelines.

The CNS penetrance of ELVN-002 is a potentially important differentiator, as brain metastases remain a significant unmet need in HER2+ cancers.

i

Enliven's Q4 and full-year 2024 results reveal a remarkably strong financial foundation with $313.4 million cash position extending runway into mid-2027. This 2.5+ year runway significantly exceeds the industry median of 12-18 months for clinical-stage oncology companies, providing important operational flexibility through multiple data inflection points without dilution pressure.

The company's balanced pipeline progression shows methodical clinical execution. ELVN-001's orphan drug designation for CML provides tangible benefits including seven years of market exclusivity upon approval, tax credits for clinical trials, and waived FDA user fees. The expansion to Japanese patients demonstrates global strategic thinking, as Asian markets represent significant CML populations.

ELVN-002's CNS-penetrant profile addresses a critical unmet need in HER2+ cancers, where brain metastases affect 30-55% of patients. The parallel development in multiple indications (breast, colorectal) with various combination approaches maximizes potential approval pathways.

While expenses increased ($80.8 million R&D, $23.8 million G&A), the 25% year-over-year growth aligns appropriately with clinical expansion. The $89 million annual net loss reflects disciplined spending relative to pipeline stage.

Management's confidence in potentially initiating a pivotal trial for ELVN-001 in 2026 suggests the preliminary data may be exceeding internal benchmarks, potentially accelerating the typical development timeline for oncology assets.

Updated Phase 1 data for ELVN-001 expected mid-2025 as positive enrollment momentum continues

Expected monotherapy and combination data from the ELVN-002 Phase 1 trials in second half of 2025

Strong balance sheet with $313 million in cash, cash equivalents and marketable securities, which is expected to provide cash runway into mid-2027

BOULDER, Colo., Mar. 13, 2025 /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 fourth quarter and full year ended December 31, 2024, and provided a business update, including highlights of pipeline progress.

"We are very pleased with the ongoing progress we are making as a Company. We continue to hear significant enthusiasm and excitement from investigators on both of our programs. The momentum of ELVN-001 has accelerated since the data presentation at the ESH-iCMLf conference," said Sam Kintz, Co-founder and Chief Executive Officer of Enliven. "2025 is a big year for Enliven and we are excited for the upcoming program updates. We are focused on continued clinical execution and preparing for the potential start of a pivotal trial for ELVN-001 in 2026."

Recent Research and Development Highlights and Upcoming Milestones

ELVN-001 is a potent, highly selective, small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion

• In 2024, the Company announced positive initial data from the ongoing Phase 1 clinical trial that compared favorably to the precedent Phase 1 trials for the approved BCR::ABL1 tyrosine kinase inhibitors (TKIs).
• The U.S. Food and Drug Administration (FDA) granted orphan drug designation to ELVN-001 for the treatment of chronic myeloid leukemia (CML).
• The first patient was dosed in the Phase 1 trial evaluating ELVN-001 in Japanese patients with CML (NCT06787144).
• The Company plans to report additional data from the ongoing Phase 1a/b trial in the middle of 2025.

ELVN-002 is a potent, highly selective, central nervous system (CNS) penetrant and irreversible HER2 inhibitor with activity against wild type HER2 and various HER2 mutations

• Enliven continued to enroll patients in its Phase 1 trial evaluating ELVN-002 as a monotherapy agent in patients with HER2+ and HER2 mutant tumors and its exploratory cohort in combination with Kadcyla® (an approved HER2 antibody drug conjugate) in patients with HER2+ metastatic breast cancer (MBC) (NCT05650879).
• Additionally, the Company continued to enroll patients in its Phase 1 trial evaluating ELVN-002 in combination with trastuzumab +/- chemotherapeutic agents in patients with HER2+ MBC and colorectal cancer (CRC) and began dosing patients in the Phase 1b trial specifically evaluating patients with CRC (NCT06328738).
• Enliven plans to report data from the ongoing Phase 1 trials in the second half of 2025.

Fourth Quarter and Full Year 2024 Financial Results

• Cash Position: As of December 31, 2024, the Company had cash, cash equivalents and marketable securities totaling $313.4 million, which is expected to provide cash runway into mid-2027.
• Research and development (R&D) expenses: R&D expenses were $20.7 million for the fourth quarter of 2024, compared to $17.9 million for the fourth quarter of 2023. R&D expenses were $80.8 million for the full year 2024, compared to $64.6 million for the full year 2023.
• General and administrative (G&A) expenses: G&A expenses for the fourth quarter of 2024 were $6.2 million, compared to $4.8 million for the fourth quarter of 2023. G&A expenses were $23.8 million for the full year 2024, compared to $19.0 million for the full year 2023.
• Net Loss: Enliven reported a net loss of $23.2 million for the fourth quarter of 2024, compared to a net loss of $19.4 million for the fourth quarter of 2023. Total net loss for the full year 2024 was $89.0 million, compared to $71.6 million for the full year 2023.

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 oncology approach that improves survival and enhances overall well-being. Enliven's discovery process combines deep insights in clinically validated biological targets and differentiated chemistry to design potentially first-in-class or best-in-class therapies. Enliven is based in Boulder, Colorado.

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 position, 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 programs, including ELVN-001 and ELVN-002; expected milestones for ELVN-001 and ELVN-002, including the potential timing for a start of a potential pivotal trial and the expected timing of data from the clinical trials of ELVN-001 and ELVN-002, including updated data from the Phase 1 trial evaluating ELVN-001 in patients with CML and the Phase 1 trials in ELVN-002; statements relating to Enliven's expected cash runway; and statements by Enliven's Co-founder and 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 limited operating history of Enliven; the ability to advance product candidates through 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; Enliven's limited resources; the risk of failing to demonstrate safety and efficacy of product candidates; 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 from the final data; potential delays or difficulties in the enrollment or maintenance of patients in clinical trials; developments relating to Enliven's competitors and its industry, including competing product candidates and therapies; 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.

Enliven Therapeutics, Inc.
Selected Condensed Consolidated Financial Information
(in thousands, except per share data)
(unaudited)
Statements of Operations			Three Months Ended December 31,				Year Ended December 31,
			2024		2023		2024		2023
Operating expenses:
Research and development			$               20,724		$               17,905		$               80,778		$               64,574
General and administrative			6,172		4,824		23,776		18,955
Total operating expenses			26,896		22,729		104,554		83,529
Loss from operations			(26,896)		(22,729)		(104,554)		(83,529)
Other income (expense), net			3,716		3,359		15,530		11,945
Net loss			$             (23,180)		$             (19,370)		$             (89,024)		$             (71,584)
Net loss per share, basic and diluted			$                 (0.46)		$                 (0.47)		$                 (1.89)		$                 (2.01)
Weighted-average shares outstanding,    basic and diluted			49,858		41,128		47,073		35,546
Balance Sheets							December 31,
							2024		2023
Assets
Current assets:
Cash, cash equivalents and marketable securities							$             313,440		$             253,148
Restricted cash							54		54
Prepaid expenses and other current assets							4,633		2,949
Contingent value right asset							—		10,000
Total current assets							318,127		266,151
Property and equipment, net							458		742
Operating lease right-of-use assets							—		320
Deferred offering costs							—		563
Other long-term assets							7,175		4,091
Total assets							$             325,760		$             271,867
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable							$                 1,342		$                    532
Accrued expenses and other current liabilities							14,573		15,362
Contingent value right liability							—		10,000
Total current liabilities							15,915		25,894
Long-term liabilities							—		67
Total liabilities							15,915		25,961
Stockholders' equity							309,845		245,906
Total liabilities and stockholders' equity							$             325,760		$             271,867

 

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SOURCE Enliven Therapeutics, Inc.

FAQ

When will Enliven Therapeutics (ELVN) report updated Phase 1 data for ELVN-001?

Enliven will report additional Phase 1 data for ELVN-001 in mid-2025.

What is ELVN's cash runway based on their Q4 2024 financial results?

With $313.4 million in cash and equivalents, Enliven's cash runway extends into mid-2027.

How much did Enliven's (ELVN) R&D expenses increase in 2024 compared to 2023?

R&D expenses increased to $80.8 million in 2024 from $64.6 million in 2023, a $16.2 million increase.

When will Enliven (ELVN) report data from ELVN-002's Phase 1 trials?

Data from ELVN-002's ongoing Phase 1 trials will be reported in the second half of 2025.

What was Enliven's (ELVN) net loss for full year 2024?

Enliven reported a net loss of $89.0 million for the full year 2024.