Lexeo Therapeutics Reports Second Quarter 2024 Financial Results and Operational Highlights
12 August 2024 - 9:00PM
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 second quarter 2024 financial results and
provided operational highlights.
“We were proud to present the recent interim data of LX2006 for
the treatment of FA cardiomyopathy, the first ever to show promise
of treating this rare and fatal condition,” said R. Nolan Townsend,
Chief Executive Officer of Lexeo Therapeutics. “Based on the
favorable evidence to date, we have initiated engagements with FDA
on surrogate endpoints for a registrational study so we can work to
bring this potentially transformative gene therapy to patients as
quickly as possible.”
Business and Program Updates
- LX2006 for the Treatment of FA Cardiomyopathy:
In July 2024, Lexeo announced positive interim data of LX2006
across both the Lexeo SUNRISE-FA Phase 1/2 clinical trial
(NCT05445323) and the Weill Cornell Medicine investigator-initiated
Phase 1A trial (NCT05302271).
- Safety and Tolerability: Interim safety
results showed LX2006 was well tolerated with no treatment-related
serious adverse events in either study.
- Efficacy and Protein Expression: Sustained and
consistent improvements were observed across multiple cardiac
biomarkers associated with outcomes in FA cardiomyopathy, and
increased frataxin protein levels were observed in all SUNRISE-FA
participants post-treatment.
- Regulatory Plans: In light of the evidence of
treatment effect with improvements across multiple cardiac
measures, Lexeo recently initiated formal engagements with FDA to
discuss surrogate endpoints for a future registrational study and
expects to provide an update on ongoing regulatory engagements by
end of 2024. LX2006 was also granted Orphan Medicinal Product
designation for the treatment of Friedreich ataxia by the European
Commission in July 2024.
- Appointment of Tim Van Hauwermeiren to Board of
Directors: In July 2024, Lexeo announced the appointment
of Tim Van Hauwermeiren to its Board of Directors. Mr. Van
Hauwermeiren currently serves as the co-founder and CEO of argenx
SE, a global immunology company focused on severe autoimmune
diseases, and he brings over 20 years of life sciences business
development and general management experience to Lexeo.
Expected Upcoming Milestones
- LX2006 for the treatment of Friedreich ataxia
cardiomyopathy
- Previously disclosed data, and one additional cardiac biopsy
from Cohort 2, will be shared at a scientific conference in Fall
2024
- Update on ongoing regulatory engagements expected by end of
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
Second Quarter Financial Results
- Cash Position: As of June 30, 2024, cash and
cash equivalents were $175.0 million, which Lexeo believes will be
sufficient to fund operations into 2027.
- R&D Expenses: R&D expenses were $16.6
million for the three months ended June 30, 2024, compared to $11.2
million for the three months ended June 30, 2023.
- G&A Expenses: G&A expenses were $7.0
million for the three months ended June 30, 2024, compared to $2.7
million for the three months ended June 30, 2023.
- Net Loss: Net loss was $21.2 million or $0.64
per share (basic and diluted) for the three months ended June 30,
2024, compared to $13.4 million or $8.30 per share (basic and
diluted) for the three months ended June 30, 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.
Cautionary Note Regarding 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 potential benefits of
LX2006 for the treatment of Friedreich ataxia cardiomyopathy and
the timing for receipt and announcement of data from its clinical
trials, the timing and likelihood of potential regulatory approval,
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, Quarterly Report on Form 10-Q for the
quarterly period ended March 31, 2024, filed with the SEC on May 9,
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 Statements of Operations |
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
16,560 |
|
|
$ |
11,236 |
|
|
$ |
32,302 |
|
|
$ |
27,674 |
|
General and administrative |
|
|
6,990 |
|
|
|
2,739 |
|
|
|
14,539 |
|
|
|
5,592 |
|
Total operating expenses |
|
|
23,550 |
|
|
|
13,975 |
|
|
|
46,841 |
|
|
|
33,266 |
|
Operating loss |
|
|
(23,550 |
) |
|
|
(13,975 |
) |
|
|
(46,841 |
) |
|
|
(33,266 |
) |
Other income and expense |
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense), net |
|
|
(1 |
) |
|
|
(3 |
) |
|
|
(6 |
) |
|
|
(7 |
) |
Interest expense |
|
|
(35 |
) |
|
|
(53 |
) |
|
|
(72 |
) |
|
|
(103 |
) |
Interest income |
|
|
2,348 |
|
|
|
590 |
|
|
|
3,999 |
|
|
|
1,277 |
|
Total other income and expense |
|
|
2,312 |
|
|
|
534 |
|
|
|
3,921 |
|
|
|
1,167 |
|
Loss from operations before
income taxes |
|
|
(21,238 |
) |
|
|
(13,441 |
) |
|
|
(42,920 |
) |
|
|
(32,099 |
) |
Income taxes |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Net loss and comprehensive
loss |
|
$ |
(21,238 |
) |
|
$ |
(13,441 |
) |
|
$ |
(42,920 |
) |
|
$ |
(32,099 |
) |
Net loss per common share, basic
and diluted |
|
$ |
(0.64 |
) |
|
$ |
(8.30 |
) |
|
$ |
(1.41 |
) |
|
$ |
(19.87 |
) |
Weighted average number of shares
outstanding used in computation of net loss per common share, basic
and diluted |
|
|
33,001,946 |
|
|
|
1,619,547 |
|
|
|
30,490,892 |
|
|
|
1,615,194 |
|
Condensed Balance Sheet Data |
|
|
|
June 30 |
|
|
December 31, |
|
|
|
2024 |
|
|
2023 |
|
Cash and cash equivalents |
|
$ |
174,981 |
|
|
$ |
121,466 |
|
Total assets |
|
|
192,007 |
|
|
|
139,807 |
|
Total liabilities |
|
|
27,059 |
|
|
|
26,272 |
|
Total stockholders' equity |
|
|
164,948 |
|
|
|
113,535 |
|
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