Enliven Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides a Business Update
2024年3月15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 fourth quarter
and full year ended December 31, 2023, provided updated guidance on
parallel lead product candidates and highlighted pipeline progress.
“We are pleased with the ongoing momentum of our
clinical pipeline. Our Phase 1 trial of ELVN-001 is on track, and
we are excited to share our initial proof of concept data in the
second quarter of 2024,” said Sam Kintz, MBA, Enliven’s Co-founder
and Chief Executive Officer. “Furthermore, the FDA’s acceptance of
our second ELVN-002 IND application paves the way to evaluate
combination therapy in patients with HER2+ cancers, for which there
remains a significant unmet need, particularly in patients who
progress on or are intolerant to Enhertu. We are focused on getting
the trial up and running and dosing the first patient by
mid-2024.”
Recent Research and Development
Highlights and Upcoming Milestones
ELVN-001, a highly selective, small molecule
kinase inhibitor designed to specifically target the BCR-ABL gene
fusion
- Patient enrollment in the Phase 1
clinical trial in adults with CML (NCT05304377) remains ongoing,
and the Company has nearly completed the Phase 1a dose escalation
portion of the trial.
- The first clinical data disclosure
is expected in the second quarter of 2024. The Company expects this
data to include more than 20 patients enrolled at an efficacious
dose range, with 10 to 20 of those patients having been treated for
over three months at the time of disclosure.
ELVN-002, a potent, highly selective, central
nervous system (CNS) penetrant and irreversible HER2 inhibitor with
activity against wild type HER2 and various HER2 mutations
- The Company’s Investigational New
Drug (IND) application to evaluate ELVN-002 in combination with
trastuzumab +/- chemotherapeutic agents in adults with HER2+
metastatic breast cancer (MBC) and colorectal cancer (CRC) received
U.S. Food and Drug Administration (FDA) clearance. Dosing of the
first patient is expected by mid-2024.
- Precedent clinical evidence
suggests that dual HER2 targeting results in clinically meaningful
improvements in patients with HER2+ MBC and CRC.
- The ongoing Phase 1a dose
escalation (NCT05650879) is nearly complete, and the data from that
ongoing trial supports the additional Phase 1 combination trial.
The initial data disclosure for ELVN-002 is expected in 2024.
Full Year and Fourth Quarter 2023 Financial
Results
- Cash Position: As
of December 31, 2023, the Company had cash, cash equivalents and
marketable securities totaling $253.1 million, which is expected to
provide cash runway into early 2026.
- Research and development
(R&D) expenses: R&D expenses were $17.9 million
for the fourth quarter of 2023, compared to $8.2 million for the
fourth quarter of 2022. R&D expenses were $64.6 million for the
full year 2023, compared to $31.0 million for the full year
2022.
- General and administrative
(G&A) expenses: G&A expenses for the fourth
quarter of 2023 were $4.8 million, compared to $2.0 million for the
fourth quarter of 2022. G&A expenses were $19.0 million for the
full year 2023, compared to $7.8 million for the full year
2022.
- Net Loss: Enliven
reported a net loss of $19.4 million for the fourth quarter of
2023, compared to a net loss of $9.6 million for the fourth quarter
of 2022. Total net loss for the full year 2023 was $71.6 million,
compared to $37.7 million for the full year 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 live 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) 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; the expected timing of initial
data for the Phase 1a trials of ELVN-001 and ELVN-002; Enliven’s
pipeline of product candidates; the expected timing of dosing of
the first patient for the ELVN-002 combination trial; the expected
timing of the completion of the Phase 1a dose escalation for the
ELVN-002 monotherapy trial; the expected timing of disclosure of
more information on Enliven’s pipeline; the strength of Enliven’s
balance sheet and the sufficiency of cash, cash equivalents and
marketable securities to fund its current operating plan into early
2026; 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 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 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; 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), 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:Investorsir@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 December 31, |
|
Year Ended December 31, |
|
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
|
$ |
17,905 |
|
|
$ |
8,197 |
|
|
$ |
64,574 |
|
|
$ |
31,022 |
|
General and administrative |
|
|
|
4,824 |
|
|
|
1,966 |
|
|
|
18,955 |
|
|
|
7,769 |
|
Total operating expenses |
|
|
|
22,729 |
|
|
|
10,163 |
|
|
|
83,529 |
|
|
|
38,791 |
|
Loss from operations |
|
|
|
(22,729 |
) |
|
|
(10,163 |
) |
|
|
(83,529 |
) |
|
|
(38,791 |
) |
Other income (expense), net |
|
|
|
3,359 |
|
|
|
613 |
|
|
|
11,945 |
|
|
|
1,129 |
|
Net loss |
|
|
$ |
(19,370 |
) |
|
$ |
(9,550 |
) |
|
$ |
(71,584 |
) |
|
$ |
(37,662 |
) |
Net loss per share, basic and diluted |
|
|
$ |
(0.47 |
) |
|
$ |
(2.91 |
) |
|
$ |
(2.01 |
) |
|
$ |
(12.05 |
) |
Weighted-average shares outstanding, basic and diluted |
|
|
|
41,128 |
|
|
|
3,283 |
|
|
|
35,546 |
|
|
|
3,124 |
|
|
|
|
|
|
|
|
|
|
|
Balance Sheets |
|
|
|
|
December 31, |
|
|
|
|
|
|
2023 |
|
|
|
2022 |
|
Assets |
|
|
|
|
Current
assets: |
|
|
|
|
Cash, cash equivalents and marketable securities |
|
$ |
253,148 |
|
|
$ |
75,536 |
|
Restricted cash |
|
|
54 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
|
2,949 |
|
|
|
2,217 |
|
Contingent value right asset |
|
|
10,000 |
|
|
|
— |
|
Total current assets |
|
|
266,151 |
|
|
|
77,753 |
|
Property and equipment, net |
|
|
742 |
|
|
|
890 |
|
Operating lease right-of-use assets |
|
|
320 |
|
|
|
626 |
|
Deferred offering costs |
|
|
563 |
|
|
|
3,975 |
|
Restricted cash |
|
|
— |
|
|
|
54 |
|
Other long-term assets |
|
|
4,091 |
|
|
|
— |
|
Total assets |
|
$ |
271,867 |
|
|
$ |
83,298 |
|
Liabilities, Convertible Preferred Stock and Stockholders'
Equity (Deficit) |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
532 |
|
|
$ |
3,438 |
|
Accrued expenses and other current liabilities |
|
|
15,362 |
|
|
|
6,277 |
|
Contingent value right liability |
|
|
10,000 |
|
|
|
— |
|
Total current liabilities |
|
|
25,894 |
|
|
|
9,715 |
|
Long-term liabilities |
|
|
67 |
|
|
|
659 |
|
Total liabilities |
|
|
25,961 |
|
|
|
10,374 |
|
Convertible preferred stock |
|
|
— |
|
|
|
149,749 |
|
Stockholders' equity (deficit) |
|
|
245,906 |
|
|
|
(76,825 |
) |
Total liabilities, convertible preferred stock and stockholders'
equity (deficit) |
|
$ |
271,867 |
|
|
$ |
83,298 |
|
|
|
|
|
|
|
|
|
|
|
Enliven Therapeutics (NASDAQ:ELVN)
過去 株価チャート
から 8 2024 まで 9 2024
Enliven Therapeutics (NASDAQ:ELVN)
過去 株価チャート
から 9 2023 まで 9 2024