Enliven Therapeutics Reports Third Quarter 2023 Financial Results and Provides a Business Update
November 09 2023 - 4:05PM
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 third quarter
ended September 30, 2023, and provided a business update.
“We made significant progress this past
quarter,” said Sam Kintz, MBA, Enliven’s Co-founder and Chief
Executive Officer. “Both of our parallel lead programs are
advancing in their respective Phase 1 trials, and there continues
to be strong patient demand for both trials. Our team is
laser-focused on continuing to execute, and we look forward to
sharing initial data for these programs next year.”
Recent Business Highlights and Upcoming
Milestones
Research and Development Highlights
-
ELVN-001 and ELVN-002: Patient enrollment
continues to progress and Enliven expects to report initial proof
of concept data in 2024 for the Phase 1 clinical trials evaluating
ELVN-001 in adults with chronic myeloid leukemia (CML)
(NCT05304377) and ELVN-002 in patients with solid tumors with HER2
alterations (NCT05650879).
-
Pipeline: The Company continues to advance its
early-stage pipeline. It has completed IND enabling studies for its
third program, has an additional program in lead optimization and
has multiple efforts ongoing in target validation and lead
identification. In the near-term, the Company plans to remain
focused on progressing ELVN-001 and ELVN-002 and will prioritize
taking full advantage of the development opportunities related to
these programs before initiating a potential clinical trial for a
third program. The Company intends to provide additional detail and
guidance on its pipeline in the first half of 2024.
Third Quarter 2023 Financial
Results
- Cash Position: As
of September 30, 2023, the Company had cash, cash equivalents and
marketable securities totaling $263.5 million.
- Research and development
(R&D) expenses: R&D expenses were $19.6 million
for the third quarter of 2023, compared to $7.8 million for the
third quarter of 2022.
- General and administrative
(G&A) expenses: G&A expenses for the third quarter
of 2023 were $4.6 million, compared to $3.1 million for the third
quarter of 2022.
- Net Loss: Enliven
reported a net loss of $20.8 million for the third quarter of 2023,
compared to a net loss of $10.6 million for the third 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 )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; Enliven’s pipeline of product
candidates; the expected timing of initial results for ELVN-001 and
ELVN-002; statements relating to Enliven’s expected cash runway;
the expected timing of disclosure of more information on Enliven’s
pipeline; 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 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 adverse events, toxicities or other undesirable
side effects; potential delays or difficulties in the enrollment or
maintenance of patients in clinical trials; 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; Enliven’s limited experience as
a company in designing and conducting clinical trials; 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; developments relating to Enliven’s competitors and its
industry, including competing product candidates and therapies;
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: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 September 30, |
|
Nine Months Ended September 30, |
|
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
|
$ |
19,606 |
|
|
$ |
7,829 |
|
|
$ |
46,669 |
|
|
$ |
22,825 |
|
General and administrative |
|
|
|
4,642 |
|
|
|
3,105 |
|
|
|
14,131 |
|
|
|
5,803 |
|
Total
operating expenses |
|
|
|
24,248 |
|
|
|
10,934 |
|
|
|
60,800 |
|
|
|
28,628 |
|
Loss from
operations |
|
|
|
(24,248 |
) |
|
|
(10,934 |
) |
|
|
(60,800 |
) |
|
|
(28,628 |
) |
Other income
(expense), net |
|
|
|
3,479 |
|
|
|
380 |
|
|
|
8,586 |
|
|
|
516 |
|
Net
loss |
|
|
$ |
(20,769 |
) |
|
$ |
(10,554 |
) |
|
$ |
(52,214 |
) |
|
$ |
(28,112 |
) |
Net loss per
share, basic and diluted |
|
|
$ |
(0.51 |
) |
|
$ |
(3.27 |
) |
|
$ |
(1.55 |
) |
|
$ |
(9.15 |
) |
Weighted-average shares outstanding, basic and diluted |
|
|
|
41,031 |
|
|
|
3,229 |
|
|
|
33,665 |
|
|
|
3,071 |
|
|
|
|
|
|
|
|
|
|
|
Balance Sheets |
|
|
|
|
September
30, |
|
December
31, |
|
|
|
|
|
|
2023 |
|
|
|
2022 |
|
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash, cash equivalents and marketable securities |
|
$ |
263,478 |
|
|
$ |
75,536 |
|
Prepaid expenses and other current assets |
|
|
5,128 |
|
|
|
2,217 |
|
Total current
assets |
|
|
268,606 |
|
|
|
77,753 |
|
Property and
equipment, net |
|
|
806 |
|
|
|
890 |
|
Operating lease
right-of-use assets |
|
|
398 |
|
|
|
626 |
|
Deferred offering
costs |
|
|
563 |
|
|
|
3,975 |
|
Restricted cash |
|
|
54 |
|
|
|
54 |
|
Other long-term
assets |
|
|
3,614 |
|
|
|
— |
|
Total assets |
|
$ |
274,041 |
|
|
$ |
83,298 |
|
Liabilities,
Convertible Preferred Stock and Stockholders' Equity
(Deficit) |
|
|
|
|
Current
liabilities: |
|
|
|
|
Accounts payable |
|
$ |
1,493 |
|
|
$ |
3,438 |
|
Accrued expenses and other current liabilities |
|
|
10,586 |
|
|
|
6,277 |
|
Total current
liabilities |
|
|
12,079 |
|
|
|
9,715 |
|
Long-term
liabilities |
|
|
214 |
|
|
|
659 |
|
Total liabilities |
|
|
12,293 |
|
|
|
10,374 |
|
Convertible preferred
stock |
|
|
— |
|
|
|
149,749 |
|
Stockholders' equity
(deficit) |
|
|
261,748 |
|
|
|
(76,825 |
) |
Total liabilities,
convertible preferred stock and stockholders' equity (deficit) |
|
$ |
274,041 |
|
|
$ |
83,298 |
|
|
|
|
|
|
|
|
|
|
|
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