Enliven Therapeutics Reports Second Quarter Financial Results and Provides a Business Update

Rhea-AI Summary

Enliven Therapeutics (Nasdaq: ELVN) reported Q2 2024 financial results and provided a business update. Key highlights include:

1. Dosing of first patients in Phase 1b arm for ELVN-001 in CML and Phase 1a trial for ELVN-002 in HER2+ MBC and CRC.

2. Strong financial position with $312.4 million in cash, providing runway into late 2026.

3. R&D expenses increased to $18.8 million in Q2 2024 from $15.2 million in Q2 2023.

4. Net loss widened to $20.0 million in Q2 2024 from $16.7 million in Q2 2023.

5. Upcoming presentation of updated ELVN-001 Phase 1a data at ESH-iCMLf Conference in September 2024.

Positive

• Dosed first patients in Phase 1b for ELVN-001 and Phase 1a for ELVN-002, advancing clinical trials
• Strong cash position of $312.4 million, providing runway into late 2026
• Acceptance of ELVN-001 Phase 1a data abstract for presentation at ESH-iCMLf Conference
• Received $10 million milestone payment from Cardurion

Negative

• Increased R&D expenses from $15.2 million in Q2 2023 to $18.8 million in Q2 2024
• Widened net loss from $16.7 million in Q2 2023 to $20.0 million in Q2 2024
• Increased G&A expenses from $5.0 million in Q2 2023 to $5.8 million in Q2 2024

Insights

Financial Analyst

Enliven Therapeutics' Q2 results show a strong financial position with $312.4 million in cash and equivalents, providing runway into late 2026. This is a significant cushion for a clinical-stage biotech. R&D expenses increased to $18.8 million, up 23.7% year-over-year, reflecting intensified clinical activities. The net loss widened to $20 million, a 19.8% increase, primarily due to higher R&D spending. While the burn rate has increased, it's aligned with the company's pipeline advancement. The strong cash position mitigates near-term financing risks, allowing Enliven to focus on clinical development without immediate capital concerns.

Oncology Research Analyst

Enliven's progress with ELVN-001 and ELVN-002 is noteworthy. The initiation of the Phase 1b trial for ELVN-001 in relapsed/refractory CML patients marks a important step towards addressing unmet needs in this population. The acceptance of updated Phase 1a data for presentation at a major conference suggests promising results. For ELVN-002, the commencement of combination trials with established therapies like trastuzumab and Kadcyla in HER2+ cancers demonstrates a strategic approach to enhance efficacy. The planned extensive patient enrollment (60-100) across various therapy lines for ELVN-001 will provide robust data to guide future development. These advancements position Enliven as a potential key player in precision oncology.

Market Research Analyst

Enliven's focus on precision oncology, particularly in CML and HER2+ cancers, aligns with the growing trend towards targeted therapies. The potential "best-in-class" status of ELVN-001 for CML could disrupt the current treatment landscape dominated by established TKIs. For ELVN-002, targeting both wild-type and mutant HER2 with CNS penetration addresses critical unmet needs in HER2+ cancers, especially in brain metastases. The combination strategies being explored could potentially position ELVN-002 as a versatile partner in various HER2-targeted regimens. With data readouts expected in 2025 for both programs, Enliven is approaching critical value-inflection points that could significantly impact its market position in the competitive oncology space.

Dosed the first patient in the Phase 1b arm of the clinical trial evaluating ELVN-001 in patients with CML that is relapsed, refractory or intolerant to available TKIs

Dosed the first patient in the Phase 1a clinical trial evaluating ELVN-002 in combination with trastuzumab +/- chemotherapeutic agents in HER2+ MBC and CRC

Strong balance sheet with $312 million in cash, cash equivalents and marketable securities, which is expected to provide cash runway into late 2026

BOULDER, Colo., Aug. 13, 2024 (GLOBE NEWSWIRE) -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage precision oncology company focused on the discovery and development of next-generation small molecule kinase inhibitors, today reported financial results for the second quarter ended June 30, 2024, and provided a business update, including highlights of pipeline progress.

“The second quarter of 2024 marked another period of significant progress for both of our parallel lead programs, ELVN-001 and ELVN-002,” said Sam Kintz, MBA, Enliven’s Co-founder and Chief Executive Officer. “We began dosing patients in the Phase 1b arm for ELVN-001 and in two combination trials for ELVN-002. Additionally, an abstract updating the data from the ongoing Phase 1a trial for ELVN-001 has been accepted for presentation at the upcoming ESH-iCMLf Conference in September.”

Pipeline Updates

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).

• The first patient was dosed in the Phase 1b arm of the clinical trial evaluating ELVN-001 in patients with CML that is relapsed, refractory or intolerant to available tyrosine kinase inhibitors (TKIs).
• The Company announced positive proof of concept data from the Phase 1a clinical trial in April of this year, and an abstract with updated Phase 1a data was accepted for presentation at the European Society of Hematology International CML Foundation 26^th Annual John Goldman Conference on CML taking place September 27-29 in Prague, Czech Republic.
• Additional Phase 1 data is expected in 2025 and is planned to include approximately 60-100 patients across various lines of therapy with significant follow-up.
  

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

• The first patient was dosed in the Phase 1a trial evaluating ELVN-002 in combination with trastuzumab +/- chemotherapeutic agents in patients with HER2+ metastatic breast cancer (MBC) and colorectal cancer (CRC).
• Additionally, the first patient with HER2+ MBC was dosed in the exploratory Phase 1a arm evaluating ELVN-002 in combination with ado-trastuzumab emtansine (Kadcyla^®), an approved HER2 antibody drug conjugate.
• Phase 1 monotherapy data and initial Phase 1a combination data are expected in 2025.
  

Second Quarter 2024 Financial Results

• Cash Position: As of June 30, 2024, the Company had cash, cash equivalents and marketable securities totaling $312.4 million, which is expected to provide cash runway into late 2026. The cash balance includes $10 million that was received from Cardurion for the achievement of a milestone pursuant to an asset purchase agreement entered into prior to the merger between Imara Inc. and Enliven Inc. In August 2024, Enliven remitted the milestone payment, less permitted deductions, to the stockholders of Enliven (formerly Imara) prior to the merger.
• Research and development (R&D) expenses: R&D expenses were $18.8 million for the second quarter of 2024, compared to $15.2 million for the second quarter of 2023.
• General and administrative (G&A) expenses: G&A expenses were $5.8 million for the second quarter of 2024, compared to $5.0 million for the second quarter of 2023.
• Net Loss: Net loss was $20.0 million for the second quarter of 2024, compared to $16.7 million for the second quarter of 2023.

About Enliven Therapeutics
Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule inhibitors to help people with cancer 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. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or 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 and expectations regarding Enliven’s programs, including ELVN-001 and ELVN-002; Enliven’s pipeline of product candidates; expected milestones for ELVN-001 and ELVN-002, including the expected timing of data from the clinical trials of ELVN-001 and ELVN-002 and the number of patients included in such data; 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 preclinical and clinical development; the ability to obtain regulatory approval for, and ultimately commercialize, 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 contract manufacturing organizations, contract research organizations and strategic partners; 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.

Contact
Investors
ir@enliventherapeutics.com

Media
media@enliventherapeutics.com

Enliven Therapeutics, Inc.
Selected Condensed Consolidated Financial Information
(in thousands, except per share data)
(unaudited)
Statements of Operations	Three Months Ended June 30,								Six Months Ended June 30,
	2024				2023				2024				2023
Operating expenses:
Research and development	$	18,826			$	15,183			$	38,796			$	27,063
General and administrative		5,777				4,951				11,794				9,489
Total operating expenses		24,603				20,134				50,590				36,552
Loss from operations		(24,603	)			(20,134	)			(50,590	)			(36,552	)
Other income (expense), net		4,653				3,413				7,902				5,107
Net loss	$	(19,950	)		$	(16,721	)		$	(42,688	)		$	(31,445	)
Net loss per share, basic and diluted	$	(0.41	)		$	(0.41	)		$	(0.95	)		$	(1.05	)
Weighted-average shares outstanding, basic and diluted		48,075				40,961				45,060				29,862
Balance Sheets									June 30,				December 31,
									2024				2023
Assets
Current assets:
Cash, cash equivalents and marketable securities									$	312,390			$	253,148
Restricted cash										54				54
Prepaid expenses and other current assets										5,683				2,949
Contingent value right asset										—				10,000
Total current assets										318,127				266,151
Property and equipment, net										630				742
Operating lease right-of-use assets										161				320
Deferred offering costs										563				563
Other long-term assets										7,562				4,091
Total assets									$	327,043			$	271,867
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable									$	1,083			$	532
Accrued expenses and other current liabilities										11,822				15,362
Contingent value right liability										9,200				10,000
Total current liabilities										22,105				25,894
Long-term liabilities										6				67
Total liabilities										22,111				25,961
Stockholders' equity										304,932				245,906
Total liabilities and stockholders' equity									$	327,043			$	271,867

FAQ

What were Enliven Therapeutics' (ELVN) key financial results for Q2 2024?

Enliven reported a net loss of $20.0 million, R&D expenses of $18.8 million, and G&A expenses of $5.8 million. The company had $312.4 million in cash, cash equivalents, and marketable securities as of June 30, 2024.

What progress did Enliven Therapeutics (ELVN) make with its ELVN-001 clinical trials in Q2 2024?

Enliven dosed the first patient in the Phase 1b arm of the clinical trial evaluating ELVN-001 in patients with CML that is relapsed, refractory, or intolerant to available TKIs. An abstract with updated Phase 1a data was accepted for presentation at the ESH-iCMLf Conference in September 2024.

What advancements did Enliven Therapeutics (ELVN) make with ELVN-002 in Q2 2024?

Enliven dosed the first patient in the Phase 1a trial evaluating ELVN-002 in combination with trastuzumab +/- chemotherapeutic agents in HER2+ metastatic breast cancer and colorectal cancer. They also dosed the first patient in an exploratory Phase 1a arm evaluating ELVN-002 in combination with Kadcyla.

What is Enliven Therapeutics' (ELVN) cash runway projection as of Q2 2024?

Based on their current cash, cash equivalents, and marketable securities totaling $312.4 million, Enliven expects to have a cash runway into late 2026.