Enliven Therapeutics Reports First Quarter Financial Results and Provides a Business Update
May 14 2024 - 4:05PM
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 first quarter
ended March 31, 2024, and provided a business update, including
highlights of pipeline progress.
“The first quarter of 2024 was a pivotal quarter
for Enliven. We released positive proof of concept data from our
Phase 1 clinical trial of ELVN-001, which was a significant
milestone for the Company,” said Sam Kintz, MBA, Enliven’s
Co-founder and Chief Executive Officer. “We are thrilled by the
initial ELVN-001 data, particularly the tolerability profile and
evidence of activity in heavily pre-treated patients, including in
patients with asciminib-resistant chronic myeloid leukemia. We also
continued to advance our trials of ELVN-002, including the
activation of the first site to evaluate ELVN-002 in combination
with trastuzumab in patients with HER2+ cancers, which we believe
is an area of significant unmet need for patients. Additionally, we
extended our cash runway into late 2026 thanks to the support of
new and existing investors.”
Corporate Updates
- Entered into a securities purchase
agreement for a private investment in public equity (PIPE)
financing resulting in gross proceeds of $90 million. The
financing, from both new and existing investors, is expected to
extend the Company’s cash runway into late 2026 and through
multiple key milestones for ELVN-001 and ELVN-002.
- Appointed to the Board of
Directors, Lori Kunkel, MD, an accomplished industry executive and
board member with a track record of success in corporate strategy,
clinical development and commercialization.
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).
- Announced positive proof of concept
data from the Phase 1 clinical trial evaluating ELVN-001 in
patients with CML who are relapsed, refractory or intolerant to
available tyrosine kinase inhibitors (TKIs).
- As of the cutoff date of March 18,
2024, 44% (7/16) of response-evaluable patients achieved a
cumulative major molecular response (MMR) rate by week 12, and
patients with prior exposure to asciminib and/or who were
TKI-resistant also demonstrated responses, with a 44% and 40%
cumulative MMR rate, respectively. Among response-evaluable
patients, all had improved or stable BCR::ABL1 transcript levels by
12 weeks. ELVN-001 was well tolerated with no Grade 3 or higher
non-hematologic treatment-related adverse events and no dose
reductions reported.
- These data compare favorably to
precedent Phase 1 cumulative MMR rates for approved BCR::ABL1 TKIs,
particularly given the more heavily pre-treated patient population.
Further details can be found here.
- Phase 1b data is expected in 2025
and is expected to include between 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.
- Following U.S. Food and Drug
Administration approval of its Investigational New Drug
application, the Company activated the first site to evaluate
ELVN-002 in combination with trastuzumab +/- chemotherapeutic
agents in HER2+ metastatic breast cancer (MBC) and colorectal
cancer (CRC). First patient dosing for the combination trial is
expected in Q2 2024.
- The combination trial in patients
with HER2+ cancers is supported by the initial data from the
ongoing monotherapy trial, which includes:
- Investigator reported responses
(including unconfirmed) in both HER2+ and HER2 mutant tumors,
including in patients who have progressed on Enhertu and patients
with brain metastases, at doses that have been well tolerated.
- Importantly, at the clinically
predicted optimal monotherapy dose, ELVN-002 had >10x target
coverage based on pharmacokinetics in cancer patients and
preclinical HER2+ efficacy compared to tucatinib.
- Phase 1 monotherapy data, Phase
1a/b Herceptin combination data in HER2+ CRC, and initial Phase 1a
combination data in HER2+ MBC are expected in 2025.
First Quarter 2024 Financial
Results
- Cash Position: As
of March 31, 2024, the Company had cash, cash equivalents and
marketable securities totaling $320.5 million, which is expected to
provide cash runway into late 2026.
- Research and development
(R&D) expenses: R&D expenses were $20.0 million
for the first quarter of 2024, compared to $11.9 million for the
first quarter of 2023.
- General and administrative
(G&A) expenses: G&A expenses for the first quarter
of 2024 were $6.0 million, compared to $4.5 million for the first
quarter of 2023.
- Net Loss: Enliven
reported a net loss of $22.7 million for the first quarter of 2024,
compared to a net loss of $14.7 million for the first quarter of
2023.
About Enliven
TherapeuticsEnliven 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 dosing of ELVN-002 for the
combination trial and of data from the clinical trials of ELVN-001
and ELVN-002; statements relating to Enliven’s expected cash
runway; and the anticipated use of proceeds from the PIPE
financing; 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.
Head-to-Head ComparisonsThe Company has not
performed any head-to-head trials for ELVN-001. As a result, the
data referenced in this press release is derived from different
clinical trials at different points in time, with differences in
trial design and patient populations. As a result, conclusions from
cross-trial comparisons cannot be made.
Contact: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 March 31, |
|
|
2024 |
|
|
|
2023 |
|
Operating
expenses: |
|
|
|
Research and development |
$ |
19,970 |
|
|
$ |
11,880 |
|
General and administrative |
|
6,017 |
|
|
|
4,538 |
|
Total
operating expenses |
|
25,987 |
|
|
|
16,418 |
|
Loss from
operations |
|
(25,987 |
) |
|
|
(16,418 |
) |
Other income
(expense), net |
|
3,249 |
|
|
|
1,694 |
|
Net
loss |
$ |
(22,738 |
) |
|
$ |
(14,724 |
) |
Net loss per
share, basic and diluted |
$ |
(0.54 |
) |
|
$ |
(0.80 |
) |
Weighted-average shares outstanding, basic and diluted |
|
42,046 |
|
|
|
18,515 |
|
|
|
|
|
Balance Sheets |
March
31, |
|
December
31, |
|
|
2024 |
|
|
|
2023 |
|
Assets |
|
|
|
Current
assets: |
|
|
|
Cash, cash equivalents and marketable securities |
$ |
320,504 |
|
|
$ |
253,148 |
|
Restricted cash |
|
54 |
|
|
|
54 |
|
Prepaid expenses and other current assets |
|
6,641 |
|
|
|
2,949 |
|
Contingent value right asset |
|
10,000 |
|
|
|
10,000 |
|
Total
current assets |
|
337,199 |
|
|
|
266,151 |
|
Property and
equipment, net |
|
683 |
|
|
|
742 |
|
Operating
lease right-of-use assets |
|
241 |
|
|
|
320 |
|
Deferred
offering costs |
|
563 |
|
|
|
563 |
|
Other
long-term assets |
|
4,091 |
|
|
|
4,091 |
|
Total
assets |
$ |
342,777 |
|
|
$ |
271,867 |
|
Liabilities and Stockholders' Equity |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable |
$ |
2,727 |
|
|
$ |
532 |
|
Accrued expenses and other current liabilities |
|
12,304 |
|
|
|
15,362 |
|
Contingent value right liability |
|
10,000 |
|
|
|
10,000 |
|
Total
current liabilities |
|
25,031 |
|
|
|
25,894 |
|
Long-term
liabilities |
|
34 |
|
|
|
67 |
|
Total
liabilities |
|
25,065 |
|
|
|
25,961 |
|
Stockholders' equity |
|
317,712 |
|
|
|
245,906 |
|
Total
liabilities and stockholders' equity |
$ |
342,777 |
|
|
$ |
271,867 |
|
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