Enliven Therapeutics Reports Second Quarter 2023 Financial Results and Highlights Recent Company Progress
10 Agosto 2023 - 10:05PM
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 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
- ELVN-001 and ELVN-002: Patient enrollment and
dose escalation continue to progress in the Phase 1 clinical trial
evaluating ELVN-001 in adults with chronic myeloid leukemia (CML)
(NCT05304377) and the Phase 1 clinical trial evaluating ELVN-002 in
patients with solid tumors with HER2 alterations (NCT05650879).
Initial safety and efficacy data from the Phase 1a trials are
expected to be reported in 2024.
- Pipeline: Selected a product candidate for the
Company’s third program, with more information to be disclosed in
2024. Enliven continues to actively pursue multiple additional
early-stage discovery programs.
Second Quarter 2023 Financial
Results
- Cash Position: As
of June 30, 2023, the Company had cash, cash equivalents and
marketable securities totaling $277.9 million.
- Research and development
(R&D) expenses: R&D expenses were $15.2 million
for the second quarter of 2023, compared to $7.9 million for the
second quarter of 2022.
- General and administrative
(G&A) expenses: G&A expenses for the second
quarter of 2023 were $5.0 million, compared to $1.1 million for the
second quarter of 2022.
- Net Loss: Enliven
reported a net loss of $16.7 million for the second quarter of
2023, compared to a net loss of $8.9 million for the second 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, 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 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
PartnersEnliven@argotpartners.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, |
|
|
|
|
|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Grafico Azioni Enliven Therapeutics (NASDAQ:ELVN)
Storico
Da Mag 2024 a Giu 2024
Grafico Azioni Enliven Therapeutics (NASDAQ:ELVN)
Storico
Da Giu 2023 a Giu 2024