Enliven Therapeutics Reports Second Quarter Financial Results and Provides a Business Update
2024年8月14日 - 5:05AM
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 26th 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 StatementsThis 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.
ContactInvestorsir@enliventherapeutics.com
Mediamedia@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 |
|
|
|
|
|
|
|
|
|
Enliven Therapeutics (NASDAQ:ELVN)
過去 株価チャート
から 7 2024 まで 8 2024
Enliven Therapeutics (NASDAQ:ELVN)
過去 株価チャート
から 8 2023 まで 8 2024