Enliven Therapeutics Highlights Business Achievements and Reports First Quarter 2023 Financial Results
11 Mayo 2023 - 3:05PM
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 first quarter
ended March 31, 2023 and provided a business update.
“2023 is off to a strong start with the
successful completion of our merger with Imara Inc. and the
concurrent private financing, dosing of the first patient in the
Phase 1 study of ELVN-002, continued progression of enrollment in
our Phase 1 trial for ELVN-001, and good progress on our discovery
pipeline,” said Sam Kintz, MBA, Enliven’s Co-founder and President
and Chief Executive Officer. “2023 is a critical year of execution
for us as our parallel lead programs advance ahead of expected
Phase 1a data for both programs in 2024.”
Recent Business Highlights and Upcoming
Milestones
Research and Development Highlights
- ELVN-002: Dosed the first patient in the Phase
1 clinical trial evaluating ELVN-002 in people with cancers
harboring an abnormal HER2 gene (NCT05650879). ELVN-002 is a CNS
penetrant, selective and irreversible HER2 inhibitor with activity
against various HER2 mutations, including Exon 20 insertion
mutations (E20IMs) in NSCLC, for which there are currently no
approved small molecule inhibitors. The Company expects to share
initial safety and efficacy data from the Phase 1a study in
2024.
- ELVN-001: Continued progress in the dose
escalation portion of the Phase 1 clinical trial evaluating
ELVN-001 in adults with CML (NCT05304377). The Company expects to
share initial safety and efficacy data from the Phase 1a study in
2024.
- Pipeline: Progress toward nominating a product
candidate for a third program, which is expected in the second
quarter of this year. Enliven is also actively pursuing multiple
additional early-stage discovery programs.
Corporate and Business Highlights
- In February 2023, Enliven
successfully completed the merger with Imara Inc. and concurrent
private financing, and the combined company’s shares commenced
trading under the new ticker “ELVN” on February 24, 2023. The
Company's cash and cash equivalents, including proceeds from the
merger and the concurrent private financing, are expected to fund
the Company’s planned operations into early 2026.
First Quarter 2023 Financial
Results
- Cash Position: As
of March 31, 2023, the Company had cash and cash equivalents
totaling $292.1 million.
- Research and development
(R&D) expenses: R&D expenses were $11.9
million for the first quarter of 2023, compared to $7.1
million for the first quarter of 2022.
- General and administrative
(G&A) expenses: G&A expenses for the first quarter
of 2023 were $4.5 million, compared to $1.6 million for the first
quarter of 2022.
- Net Loss: Enliven
reported a net loss of $14.7 million for the first quarter of
2023, compared to a net loss of $8.7 million for the first quarter
of 2022.
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 and its early-stage
discovery programs; the expected timing of Phase 1a data for
ELVN-001 and ELVN-002 and timing for making a product candidate
nomination for Enliven’s third program; expectations regarding the
sufficiency of Enliven’s capital resources and cash runway; 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; Enliven’s lack of experience in commercializing a
product candidate; 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 Enliven’s Quarterly Report on Form
10-Q filed with the SEC on May 11, 2023 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
PartnersEnliven@argotpartners.com
Enliven Therapeutics,
Inc.Selected Condensed Consolidated Financial
Information(in thousands, except per share data)(unaudited)
|
|
|
|
|
|
|
Statements of Operations |
|
|
Three Months Ended March 31, |
|
|
|
|
|
2023 |
|
|
|
2022 |
|
|
Operating
expenses: |
|
|
|
|
|
|
Research and development |
|
|
$ |
11,880 |
|
|
$ |
7,059 |
|
|
General and administrative |
|
|
|
4,538 |
|
|
|
1,619 |
|
|
Total
operating expenses |
|
|
|
16,418 |
|
|
|
8,678 |
|
|
Loss from
operations |
|
|
|
(16,418 |
) |
|
|
(8,678 |
) |
|
Other income
(expense), net |
|
|
|
1,694 |
|
|
|
9 |
|
|
Net
loss |
|
|
$ |
(14,724 |
) |
|
$ |
(8,669 |
) |
|
Net loss per
share, basic and diluted |
|
|
$ |
(0.80 |
) |
|
$ |
(3.01 |
) |
|
Weighted-average shares outstanding, basic and diluted |
|
|
|
18,515 |
|
|
|
2,877 |
|
|
|
|
|
|
|
|
|
Balance Sheets |
|
March
31, |
|
December
31, |
|
|
|
|
2023 |
|
|
|
2022 |
|
|
Assets |
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
292,102 |
|
|
$ |
75,536 |
|
|
Prepaid expenses and other current
assets |
|
|
|
5,901 |
|
|
|
2,217 |
|
|
Total
current assets |
|
|
|
298,003 |
|
|
|
77,753 |
|
|
Property and
equipment, net |
|
|
|
853 |
|
|
|
890 |
|
|
Right-of-use
asset |
|
|
|
551 |
|
|
|
626 |
|
|
Deferred
offering costs |
|
|
|
— |
|
|
|
3,975 |
|
|
Restricted
cash |
|
|
|
54 |
|
|
|
54 |
|
|
Other
long-term assets |
|
|
|
3,405 |
|
|
|
— |
|
|
Total
assets |
|
|
$ |
302,866 |
|
|
$ |
83,298 |
|
|
Liabilities, Convertible Preferred Stock and Stockholders'
Equity (Deficit) |
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts payable |
|
|
$ |
5,860 |
|
|
$ |
3,438 |
|
|
Accrued expenses and other current
liabilities |
|
|
|
5,082 |
|
|
|
6,277 |
|
|
Total
current liabilities |
|
|
|
10,942 |
|
|
|
9,715 |
|
|
Long-term
liabilities |
|
|
|
508 |
|
|
|
659 |
|
|
Total
liabilities |
|
|
|
11,450 |
|
|
|
10,374 |
|
|
Convertible
preferred stock |
|
|
|
— |
|
|
|
149,749 |
|
|
Stockholders' equity (deficit) |
|
|
|
291,416 |
|
|
|
(76,825 |
) |
|
Total
liabilities, convertible preferred stock and stockholders' equity
(deficit) |
|
|
$ |
302,866 |
|
|
$ |
83,298 |
|
|
|
|
|
|
|
|
|
Enliven Therapeutics (NASDAQ:ELVN)
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Enliven Therapeutics (NASDAQ:ELVN)
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