Lexeo Therapeutics Reports First Quarter 2024 Financial Results and Operational Highlights
May 09 2024 - 7:00AM
Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic
medicine company dedicated to pioneering treatments for genetically
defined cardiovascular diseases and APOE4-associated Alzheimer’s
disease, today reported first quarter 2024 financial results and
provided operational highlights.
“We continue to make great progress in advancing our suite of
gene therapy candidates. We are pleased by the potential to
strengthen our FA cardiomyopathy data package through our recent
agreement with Cornell University, which we believe will enable us
to generate a more robust safety data package and potentially
facilitate an accelerated path to regulatory engagements for
LX2006,” said R. Nolan Townsend, Chief Executive Officer of Lexeo
Therapeutics. “We also are proud to have initiated our Phase 1/2
clinical trial for patients with PKP2-ACM, a devastating disease
with limited therapeutic options, and we look forward to sharing
interim clinical results in the second half of the year.”
Business and Program Updates
- LX2006 for the Treatment of FA Cardiomyopathy:
In April 2024, Lexeo announced the license of intellectual property
rights from Cornell University, including current and future
clinical data from an ongoing Weill Cornell Medicine
investigator-initiated trial of AAVrh.10hFXN (LX2006).
- In March 2024, Lexeo announced preliminary frataxin protein
expression data from Cohort 2 of the SUNRISE-FA Phase 1/2 clinical
trial, demonstrating an increase in post-administration frataxin
protein levels, as measured by liquid chromatography mass
spectrometry compared to pre-treatment baseline levels.
- Additionally, in April 2024, the FDA granted Fast Track
designation (FTD) to LX2006, which Lexeo expects will facilitate
its clinical development. The FDA has previously granted Rare
Pediatric Disease designation and Orphan Drug designation to
LX2006.
- LX2020 for the Treatment of PKP2-ACM: All
previously reported milestones on track with HEROIC-PKP2 Phase 1/2
clinical trial currently recruiting patients.
- Closed $95 Million PIPE Financing: In March
2024, Lexeo announced the closing of an oversubscribed $95 million
equity financing. Lexeo anticipates that current cash, cash
equivalents and marketable securities will be sufficient to fund
operating and capital expenditures into 2027.
Expected Upcoming Milestones
- LX2006 for the treatment of Friedreich ataxia
cardiomyopathy
- Interim data readout in mid-2024
- LX2020 for the treatment of PKP2-ACM
- Interim data readout (Cohort 1) in 2H 2024
- LX1001 for the treatment of APOE4-associated
Alzheimer’s disease
- Interim Phase 1/2 data readout (all cohorts) in 2H 2024
- LX2021 for the treatment of DSP cardiomyopathy
- Initiate IND-enabling studies in 2024
First Quarter Financial Results
- Cash Position: As of March 31, 2024, cash and
cash equivalents were $195.1 million, which we believe will be
sufficient to fund operations into 2027.
- R&D Expenses: R&D expenses were $15.7
million for the three months ended March 31, 2024, compared to
$16.4 million for the three months ended March 31, 2023.
- G&A Expenses: G&A expenses were $7.5
million for the three months ended March 31, 2024, compared to $2.9
million for the three months ended March 31, 2023.
- Net Loss: Net loss was $21.7 million or $0.77
per share (basic and diluted) for the three months ended March 31,
2024, compared to $18.7 million or $11.58 per share (basic and
diluted) for the three months ended March 31, 2023.
About Lexeo TherapeuticsLexeo Therapeutics is a
New York City-based, clinical stage genetic medicine company
dedicated to transforming healthcare by applying pioneering science
to fundamentally change how genetically defined cardiovascular
diseases and APOE4-associated Alzheimer’s disease are treated.
Using a stepwise development approach, Lexeo is leveraging early
proof-of-concept functional and biomarker data to advance a
pipeline of cardiovascular and APOE4-associated Alzheimer’s disease
programs.
Forward looking StatementsCertain statements in
this press release may constitute “forward-looking statements”
within the meaning of the federal securities laws, including, but
not limited to, Lexeo’s expectations and plans regarding its
current product candidates and programs, including statements
regarding the anticipated benefits of the license agreement between
Lexeo Therapeutics and Cornell University and the data to be
provided thereunder and the timing of the initiation of and results
from Lexeo’s clinical trials, expectations regarding the time
period over which Lexeo’s capital resources will be sufficient to
fund its anticipated operations and estimates regarding Lexeo’s
financial condition. Words such as “may,” “might,” “will,”
“objective,” “intend,” “should,” “could,” “can,” “would,” “expect,”
“believe,” “design,” “estimate,” “predict,” “potential,” “develop,”
“plan” or the negative of these terms, and similar expressions, or
statements regarding intent, belief, or current expectations, are
forward-looking statements. While Lexeo believes these
forward-looking statements are reasonable, undue reliance should
not be placed on any such forward-looking statements. These
forward-looking statements are based upon current information
available to the company as well as certain estimates and
assumptions and are subject to various risks and uncertainties
(including, without limitation, those set forth in Lexeo’s filings
with the U.S. Securities and Exchange Commission (SEC)), many of
which are beyond the company’s control and subject to change.
Actual results could be materially different from those indicated
by such forward looking statements as a result of many factors,
including but not limited to: risks and uncertainties related to
global macroeconomic conditions and related volatility;
expectations regarding the initiation, progress, and expected
results of Lexeo’s preclinical studies, clinical trials and
research and development programs; the unpredictable relationship
between preclinical study results and clinical study results;
delays in submission of regulatory filings or failure to receive
regulatory approval; liquidity and capital resources; and other
risks and uncertainties identified in Lexeo’s Annual Report on Form
10-K for the annual period ended December 31, 2023, filed with the
SEC on March 11, 2024, and subsequent future filings Lexeo may make
with the SEC. New risks and uncertainties may emerge from time to
time, and it is not possible to predict all risks and
uncertainties. Lexeo claims the protection of the Safe Harbor
contained in the Private Securities Litigation Reform Act of 1995
for forward-looking statements. Lexeo expressly disclaims any
obligation to update or alter any statements whether as a result of
new information, future events or otherwise, except as required by
law.
Media Response:Janine Bogris(201)
245-6838Janine.Bogris@inizioevoke.com
Investor Response:Stephen Jasper(858)
525-2047stephen@gilmartinir.com
Lexeo Therapeutics, Inc.Selected Condensed
Financial Information(unaudited, in thousands, except
share and per share amounts) |
|
|
|
|
|
Condensed Consolidated
Statements of Operations |
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
2024 |
|
|
2023 |
|
Operating expenses |
|
|
|
|
|
|
|
Research and development |
|
|
|
15,742 |
|
|
|
16,438 |
|
General and administrative |
|
|
|
7,549 |
|
|
|
2,852 |
|
Total operating expenses |
|
|
|
23,291 |
|
|
|
19,290 |
|
Operating loss |
|
|
|
(23,291 |
) |
|
|
(19,290 |
) |
Other income and expense |
|
|
|
|
|
|
|
Other income (expense), net |
|
|
|
(5 |
) |
|
|
(4 |
) |
Interest expense |
|
|
|
(37 |
) |
|
|
(50 |
) |
Interest income |
|
|
|
1,651 |
|
|
|
687 |
|
Total other income and expense |
|
|
|
1,609 |
|
|
|
633 |
|
Loss from operations before
income taxes |
|
|
|
(21,682 |
) |
|
|
(18,657 |
) |
Income taxes |
|
|
|
- |
|
|
|
- |
|
Net loss and comprehensive
loss |
|
|
$ |
(21,682 |
) |
|
$ |
(18,657 |
) |
Net loss per common share,
basic and diluted |
|
|
$ |
(0.77 |
) |
|
$ |
(11.58 |
) |
Weighted average number of
shares outstanding used in computation of net loss per common
share, basic and diluted |
|
|
|
27,979,838 |
|
|
|
1,610,793 |
|
Condensed Consolidated
Balance Sheet Data |
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2024 |
|
|
2023 |
|
Cash, cash equivalents, and investments |
|
$ |
195,060 |
|
|
$ |
121,466 |
|
Total assets |
|
|
213,205 |
|
|
|
139,807 |
|
Total liabilities |
|
|
30,255 |
|
|
|
26,272 |
|
Total stockholders' equity |
|
|
182,950 |
|
|
|
113,535 |
|
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