0001672619false00016726192023-08-102023-08-10

 

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): August 10, 2023

 

 

Enliven Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware			001-39247	81-1523849
(State or other jurisdiction of incorporation)			(Commission File Number)	(IRS Employer Identification No.)
6200 Lookout Road
Boulder, Colorado				80301
(Address of principal executive offices)				(Zip Code)

 

Registrant’s telephone number, including area code: 720 647-8519

 

Not Applicable

(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):

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.001 per share		ELVN		The Nasdaq Global Select Market

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 August 10, 2023, Enliven Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2023. 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 August 10, 2023
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:	August 10, 2023	By:	/s/ Samuel Kintz
		Name:	Samuel Kintz
		Title:	President and Chief Executive Officer

 

---

 

 

Enliven Therapeutics Reports Second Quarter 2023 Financial Results and Highlights Recent Company Progress

Continued progress of parallel lead programs, ELVN-001 and ELVN-002, through dose escalation in Phase 1 trials, with initial proof of concept data for both programs expected in 2024

Strong balance sheet, closing the quarter with $278 million in cash, cash equivalents and marketable securities

BOULDER, Colo., August 10, 2023 (GLOBE NEWSWIRE) -- Enliven Therapeutics, Inc. (Enliven) (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, 2023 and provided a business update.

“We are pleased with the continued progress this quarter across our parallel lead programs,” said Sam Kintz, MBA, Enliven’s Co-founder, President and Chief Executive Officer. “The Phase 1 trials of ELVN-001 and ELVN-002 are advancing through dose escalation, and we look forward to reporting initial proof of concept data for both programs in 2024. Our team is focused on executing these clinical trials and enthusiastic to show their potential to help patients with CML and HER2-driven cancers.”

 

Recent Business Highlights and Upcoming Milestones

 

Research and Development Highlights

 

 

---

 

Second Quarter 2023 Financial Results

 

 

 

About Enliven Therapeutics

Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule inhibitors to help patients with cancer not only live longer, but better. Enliven aims to address existing and emerging unmet needs with a precision oncology approach that improves survival and enhances overall patient 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 (Securities Act)) 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, ELVN-002, Enliven’s third program and its early-stage discovery programs; the expected timing of initial results for ELVN-001 and ELVN-002; the expected timing of disclosure of more information on Enliven’s third

 

Page 2

 

 

---

 

program; and statements by Enliven’s Co-founder, President 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 factors, including, without limitation: the limited operating history of Enliven; the significant net losses incurred since its inception; 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 for the results of clinical trials to differ from preclinical, preliminary, initial or expected results; the risk of significant adverse events, toxicities or other undesirable side effects; Enliven’s limited resources; Enliven’s ability to obtain additional capital to finance its operations; the decision to develop or seek strategic collaborations to develop Enliven’s current or future product candidates in combination with other therapies and the related costs associated with running combination trials; Enliven’s lack of experience in developing a product candidate through commercialization; the ability to attract, hire, and retain 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; developments relating to Enliven’s competitors and its industry, including competing product candidates and therapies; reliance on third parties, including contract manufacturing organizations and contract research organizations; general economic and market conditions; and other risks and uncertainties, including those more fully described in Enliven’s filings with the Securities and Exchange Commission (SEC), including additional risks which may be found in the section entitled “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.

Contact:

Enliven Investors & Media:

Argot Partners

Enliven@argotpartners.com

 

 

 

 

 

 

Page 3

 

 

---

 

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,
			2023				2022				2023				2022
Operating expenses:
Research and development			$	15,183			$	7,937			$	27,063			$	14,996
General and administrative				4,951				1,079				9,489				2,698
Total operating expenses				20,134				9,016				36,552				17,694
Loss from operations				(20,134	)			(9,016	)			(36,552	)			(17,694	)
Other income (expense), net				3,413				127				5,107				136
Net loss			$	(16,721	)		$	(8,889	)		$	(31,445	)		$	(17,558	)
Net loss per share, basic and diluted			$	(0.41	)		$	(2.86	)		$	(1.05	)		$	(5.87	)
Weighted-average shares outstanding,    basic and diluted				40,961				3,104				29,862				2,991
Balance Sheets											June 30,				December 31,
											2023				2022
Assets
Current assets:
Cash, cash equivalents and marketable securities											$	277,865			$	75,536
Prepaid expenses and other current assets												5,310				2,217
Total current assets												283,175				77,753
Property and equipment, net												867				890
Operating lease right-of-use assets												475				626
Deferred offering costs												524				3,975
Restricted cash												54				54
Other long-term assets												3,406				—
Total assets											$	288,501			$	83,298
Liabilities, Convertible Preferred Stock and Stockholders' Equity (Deficit)
Current liabilities:
Accounts payable											$	2,843			$	3,438
Accrued expenses and other current liabilities												6,304				6,277
Total current liabilities												9,147				9,715
Long-term liabilities												360				659
Total liabilities												9,507				10,374
Convertible preferred stock												—				149,749
Stockholders' equity (deficit)												278,994				(76,825	)
Total liabilities, convertible preferred stock and stockholders' equity (deficit)											$	288,501			$	83,298

 

 

 

Page 4

 

 

---