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

Rhea-AI Summary

Enliven Therapeutics announced positive results from its Phase 1 trial of ELVN-001 for chronic myeloid leukemia, showing a 44% major molecular response (MMR) rate by 12 weeks. The company has $321 million in cash, extending its runway to late 2026. A $90 million PIPE financing and board appointment of Lori Kunkel were highlighted. Enliven also advanced its ELVN-002 trial for HER2+ cancers, with the first site activated and patient dosing expected in Q2 2024. Financial results showed increased R&D and G&A expenses, leading to a net loss of $22.7 million for Q1 2024, compared to $14.7 million in Q1 2023.

Positive

• Positive Phase 1 trial data for ELVN-001 with 44% MMR rate by 12 weeks.
• Strong financial position with $321 million in cash, extending the runway to late 2026.
• $90 million raised through PIPE financing.
• Advancement of ELVN-002 trial with first site activated.
• ELVN-002 showing promising initial data in HER2+ cancers.

Negative

• Increased R&D expenses from $11.9 million to $20 million year-over-year.
• Increased G&A expenses from $4.5 million to $6 million year-over-year.
• Net loss increased from $14.7 million to $22.7 million year-over-year.

Financial Analyst

Financial Performance: Enliven Therapeutics reported a net loss of $22.7 million for Q1 2024, a noticeable increase from the $14.7 million net loss in the same period last year. This uptick in losses can be attributed to heightened R&D expenses, which rose from $11.9 million to $20 million, indicating increased investment in their clinical trials. G&A expenses also saw an increase, signaling expanded operational activities.

Cash Position: The company's strong cash position of $320.5 million is a positive sign, providing a cash runway into late 2026. The recent PIPE financing, generating $90 million in gross proceeds, further strengthens their balance sheet. This financial stability is critical for continuing the development of ELVN-001 and ELVN-002 without immediate funding concerns.

Investor Implications: While the increased expenses and net losses may be a concern, the strong cash position and extended runway mitigate immediate financial risks. Investors should monitor future developments and data from ongoing trials as these will significantly impact the company's financial health and stock performance.

Medical Research Analyst

ELVN-001 Phase 1 Data: Achieving a 44% MMR rate in heavily pre-treated CML patients is impressive. This is especially noteworthy given the inclusion of asciminib-resistant patients, highlighting the potential of ELVN-001 as a novel treatment option. The tolerability profile, with no Grade 3 or higher non-hematologic treatment-related adverse events, adds to its attractiveness.

ELVN-002 Trials: The initiation of trials evaluating ELVN-002 combined with trastuzumab in HER2+ cancers extends the pipeline into other significant areas of need. Early responses in both HER2+ and mutant tumors, even in patients with brain metastases, are promising. The >10x target coverage compared to tucatinib at optimal doses is particularly encouraging.

Clinical Implications: The progress of these trials, especially with anticipated data in 2025, could significantly enhance the company's value proposition. Positive outcomes could lead to accelerated paths toward regulatory approval and market entry.

Market Research Analyst

Market Potential: Both ELVN-001 and ELVN-002 target areas with significant unmet medical needs. For ELVN-001, CML represents a lucrative market with limited effective treatments for heavily pre-treated patients. ELVN-002 extends the potential market to HER2+ cancers, including breast and colorectal cancers, which are substantial segments within oncology.

Competitive Landscape: The positive initial data positions Enliven well against existing BCR-ABL TKIs and HER2 inhibitors. However, competition remains fierce in oncology and sustained positive results will be important to differentiate their offerings.

Investor Perspective: Enliven's advancements position it favorably for long-term growth in the oncology market. Investors should keep an eye on upcoming data releases and trial progress, as these milestones will be pivotal in driving stock value and market sentiment.

Announced positive proof of concept data from Phase 1 clinical trial of ELVN-001 in CML, achieving an initial cumulative MMR rate of 44% (7/16) by 12 weeks in response-evaluable patients

Strong balance sheet with $321 million in cash, cash equivalents and marketable securities, which is expected to provide cash runway into late 2026

BOULDER, Colo., May 14, 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 first quarter ended March 31, 2024, and provided a business update, including highlights of pipeline progress.

“The first quarter of 2024 was a pivotal quarter for Enliven. We released positive proof of concept data from our Phase 1 clinical trial of ELVN-001, which was a significant milestone for the Company,” said Sam Kintz, MBA, Enliven’s Co-founder and Chief Executive Officer. “We are thrilled by the initial ELVN-001 data, particularly the tolerability profile and evidence of activity in heavily pre-treated patients, including in patients with asciminib-resistant chronic myeloid leukemia. We also continued to advance our trials of ELVN-002, including the activation of the first site to evaluate ELVN-002 in combination with trastuzumab in patients with HER2+ cancers, which we believe is an area of significant unmet need for patients. Additionally, we extended our cash runway into late 2026 thanks to the support of new and existing investors.”

Corporate Updates

• Entered into a securities purchase agreement for a private investment in public equity (PIPE) financing resulting in gross proceeds of $90 million. The financing, from both new and existing investors, is expected to extend the Company’s cash runway into late 2026 and through multiple key milestones for ELVN-001 and ELVN-002.
• Appointed to the Board of Directors, Lori Kunkel, MD, an accomplished industry executive and board member with a track record of success in corporate strategy, clinical development and commercialization.

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).

• Announced positive proof of concept data from the Phase 1 clinical trial evaluating ELVN-001 in patients with CML who are relapsed, refractory or intolerant to available tyrosine kinase inhibitors (TKIs).
  • As of the cutoff date of March 18, 2024, 44% (7/16) of response-evaluable patients achieved a cumulative major molecular response (MMR) rate by week 12, and patients with prior exposure to asciminib and/or who were TKI-resistant also demonstrated responses, with a 44% and 40% cumulative MMR rate, respectively. Among response-evaluable patients, all had improved or stable BCR::ABL1 transcript levels by 12 weeks. ELVN-001 was well tolerated with no Grade 3 or higher non-hematologic treatment-related adverse events and no dose reductions reported.
  • These data compare favorably to precedent Phase 1 cumulative MMR rates for approved BCR::ABL1 TKIs, particularly given the more heavily pre-treated patient population. Further details can be found here.
  • Phase 1b data is expected in 2025 and is expected to include between 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.

• Following U.S. Food and Drug Administration approval of its Investigational New Drug application, the Company activated the first site to evaluate ELVN-002 in combination with trastuzumab +/- chemotherapeutic agents in HER2+ metastatic breast cancer (MBC) and colorectal cancer (CRC). First patient dosing for the combination trial is expected in Q2 2024.
• The combination trial in patients with HER2+ cancers is supported by the initial data from the ongoing monotherapy trial, which includes:
  • Investigator reported responses (including unconfirmed) in both HER2+ and HER2 mutant tumors, including in patients who have progressed on Enhertu and patients with brain metastases, at doses that have been well tolerated.
  • Importantly, at the clinically predicted optimal monotherapy dose, ELVN-002 had >10x target coverage based on pharmacokinetics in cancer patients and preclinical HER2+ efficacy compared to tucatinib.
• Phase 1 monotherapy data, Phase 1a/b Herceptin combination data in HER2+ CRC, and initial Phase 1a combination data in HER2+ MBC are expected in 2025.
  

First Quarter 2024 Financial Results

• Cash Position: As of March 31, 2024, the Company had cash, cash equivalents and marketable securities totaling $320.5 million, which is expected to provide cash runway into late 2026.
• Research and development (R&D) expenses: R&D expenses were $20.0 million for the first quarter of 2024, compared to $11.9 million for the first quarter of 2023.
• General and administrative (G&A) expenses: G&A expenses for the first quarter of 2024 were $6.0 million, compared to $4.5 million for the first quarter of 2023.
• Net Loss: Enliven reported a net loss of $22.7 million for the first quarter of 2024, compared to a net loss of $14.7 million for the first 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 dosing of ELVN-002 for the combination trial and of data from the clinical trials of ELVN-001 and ELVN-002; statements relating to Enliven’s expected cash runway; and the anticipated use of proceeds from the PIPE financing; 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.

Head-to-Head Comparisons
The Company has not performed any head-to-head trials for ELVN-001. As a result, the data referenced in this press release is derived from different clinical trials at different points in time, with differences in trial design and patient populations. As a result, conclusions from cross-trial comparisons cannot be made.

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 March 31,
		2024				2023
Operating expenses:
Research and development	$	19,970			$	11,880
General and administrative		6,017				4,538
Total operating expenses		25,987				16,418
Loss from operations		(25,987	)			(16,418	)
Other income (expense), net		3,249				1,694
Net loss	$	(22,738	)		$	(14,724	)
Net loss per share, basic and diluted	$	(0.54	)		$	(0.80	)
Weighted-average shares outstanding, basic and diluted		42,046				18,515
Balance Sheets	March 31,				December 31,
		2024				2023
Assets
Current assets:
Cash, cash equivalents and marketable securities	$	320,504			$	253,148
Restricted cash		54				54
Prepaid expenses and other current assets		6,641				2,949
Contingent value right asset		10,000				10,000
Total current assets		337,199				266,151
Property and equipment, net		683				742
Operating lease right-of-use assets		241				320
Deferred offering costs		563				563
Other long-term assets		4,091				4,091
Total assets	$	342,777			$	271,867
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable	$	2,727			$	532
Accrued expenses and other current liabilities		12,304				15,362
Contingent value right liability		10,000				10,000
Total current liabilities		25,031				25,894
Long-term liabilities		34				67
Total liabilities		25,065				25,961
Stockholders' equity		317,712				245,906
Total liabilities and stockholders' equity	$	342,777			$	271,867

 

 

FAQ

What were the results of Enliven Therapeutics' Phase 1 trial of ELVN-001?

The Phase 1 trial of ELVN-001 showed a 44% major molecular response (MMR) rate by 12 weeks.

What is Enliven Therapeutics' cash position as of Q1 2024?

Enliven Therapeutics has $321 million in cash, cash equivalents, and marketable securities as of Q1 2024.

How much did Enliven Therapeutics raise through PIPE financing?

Enliven Therapeutics raised $90 million through PIPE financing.

What are the future plans for ELVN-002?

ELVN-002 is being evaluated in a combination trial for HER2+ cancers, with patient dosing expected in Q2 2024.

How did Enliven Therapeutics' financial performance change year-over-year?

Enliven Therapeutics' net loss increased from $14.7 million to $22.7 million year-over-year.