Lexeo Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Operational Highlights
March 11 2024 - 7:42AM
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 fourth quarter and full year 2023 financial
results and provided operational highlights.
“The past year has been transformative for Lexeo
as we successfully completed our initial public offering and
continued to advance our pipeline of genetic medicines,” stated R.
Nolan Townsend, Chief Executive Officer of Lexeo Therapeutics.
“Building on our success in 2023, we are pleased to report that we
have observed a positive change in frataxin levels now in Cohort 2
of the SUNRISE-FA trial. The low baseline protein levels observed
in these patients provide unique insights into the biology of FA
and we believe the increases in post treatment protein expression
mediated by LX2006 may be sufficient to restore mitochondrial
function with physiological improvement. These data, combined with
our recent financing and progress across our pipeline, reflect
exciting developments and add to our track record of clinical
execution.”
SUNRISE-FA Liquid Chromatography Mass
Spectrometry (LCMS) Assay Protein Expression Data
Subject |
Pre-Treatment FXN Levels (ng/mg protein) |
Post-Treatment FXNLevels (ng/mg protein) |
Change fromBaseline (ng/mg protein) |
Cohort 1 Subject 1 (1.8x1011 vg/kg) |
0.75 |
0.97 |
0.22 |
Cohort 2 Subject 1 (5.6x1011 vg/kg) |
0.97 |
2.77 |
1.81 |
Cohort 2 Subject 2 (5.6x1011 vg/kg) |
1.83 |
2.23 |
0.40 |
Note: Only one patient in Cohort 1 underwent pre
and post treatment cardiac biopsy.
- Average pre-treatment FXN level across three subjects was
1.18ng/mg. Compared to FXN levels observed in 29 cadaver tissue
samples from 16 individuals without heart disease, we believe the
average pre-treatment FXN level represents approximately two
percent of healthy individual frataxin levels in the heart.
- To our knowledge, SUNRISE-FA is the first clinical trial to
evaluate frataxin levels in the target organ of FA cardiomyopathy
patients via cardiac biopsy. Data to date suggest that FA patients
may have lower FXN levels in the heart versus peripheral
tissues.
- Across all three cardiac biopsies, we observed an increase in
FXN levels as measured by liquid chromatography mass spectrometry
relative to pre-treatment baseline levels.
- We observed an approximately five-fold increase in protein on
average in the second cohort (5.6x1011 vg/kg) to date, relative to
the first cohort (1.8x1011 vg/kg). A dose-dependent response was
also seen in our IND-enabling preclinical studies, where a
non-linear relationship was observed between dose delivered and
frataxin protein expression.
Lexeo expects to present additional interim data
from SUNRISE-FA Cohorts 1 and 2 in mid-2024, including measures of
hypertrophy and other cardiac biomarkers at multiple timepoints(1).
Ahead of this interim readout, Lexeo expects to provide an analysis
of baseline characteristics from LX2006-treated patients to
characterize the cardiovascular disease phenotype seen in FA as
well as baseline levels of hypertrophy and other cardiac biomarkers
that will be reported at mid-year.
____________(1) Trial participants receive
immune suppression with prednisone beginning on the day prior to
treatment/infusion through 14 weeks following LX2006
administration. Given the potential impact of corticosteroids on
systemic status and cardiac biomarkers, efficacy data in the
mid-2024 data readout will be presented for timepoints following
cessation of corticosteroid administration.
Business and Program Updates
- LX2006 for the Treatment of FA Cardiomyopathy:
Announced preliminary frataxin protein expression data from the
second dose cohort of SUNRISE-FA showing positive change in
post-treatment frataxin levels three months following
administration of LX2006. Lexeo expects to report additional
interim data from the SUNRISE-FA Phase 1/2 clinical trial in
mid-2024 with follow-up out to one year from the low-dose and
multiple timepoints of follow-up expected from at least three
patients treated at the mid-dose.
- LX2020 for the Treatment of PKP2-ACM: In
December 2023, the FDA granted Fast Track designation (FTD) and
Orphan Drug designation (ODD) to LX2020, which allows more frequent
interactions with FDA to facilitate development and expedite review
processes. The ODD also provides additional benefits to Lexeo, such
as market exclusivity upon regulatory approval. Clinical trial
start-up activities are underway and Lexeo expects to dose the
first patient in the HEROIC-PKP2 Phase 1/2 clinical trial of LX2020
in 1H 2024, with an interim data readout from Cohort 1 expected in
2H 2024. Lexeo has also initiated SNAPSHOT-PKP2, a natural history
study designed to evaluate PKP2-ACM disease progression up to two
years retrospectively and over twelve months prospectively in up to
20 patients in the United States.
- APOE4-associated Alzheimer’s Disease Programs:
Lexeo completed enrollment of all four cohorts in the LEAD Phase
1/2 clinical trial of LX1001 for the treatment of APOE4-associated
Alzheimer’s disease in Q4 2023. The Company expects to provide an
interim data readout of all cohorts in 2H 2024.
- Pricing of $95 Million Equity Financing: Lexeo
today announced that it has entered into a common stock purchase
agreement with certain new and existing investors to issue and sell
an aggregate of 6,278,905 shares of its common stock at a price of
$15.13 per share, through a private placement. Lexeo anticipates
the gross proceeds from the private placement to be approximately
$95.0 million, before deducting any offering related expenses. The
financing is expected to close on or about March 13, 2024, subject
to customary closing conditions. The proceeds from this financing,
combined with current cash, cash equivalents and marketable
securities, are expected to fund operating and capital expenditures
into 2027.
- Completed Initial Public Offering: In November
2023, Lexeo completed its underwritten initial public offering of
10,139,656 shares of its common stock, including the exercise of
the underwriter’s option to purchase 1,048,746 additional shares of
its common stock. The aggregate gross proceeds from the offering
were $111.5 million, before deducting underwriting discounts and
commissions and offering expenses payable by Lexeo.
Expected Upcoming Milestones
- LX2006 for the treatment of Friedreich’s ataxia
cardiomyopathy
- Interim data readout in mid-2024
- LX2020 for the treatment of PKP2-ACM
- First patient dosed in 1H 2024
- 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
Fourth Quarter and Full Year Financial
Results
- Cash Position: As of December 31, 2023, cash
and cash equivalents were $121.5 million, excluding the $95.0
million gross proceeds expected to be raised in the private
placement announced today. Lexeo expects the additional funds
raised in the financing to extend its runway into 2027.
- R&D Expenses: R&D expenses were $8.2
million for the three months ended December 31, 2023, compared to
$11.4 million for the three months ended December 31, 2022.
Research and Development expenses were $53.1 million for the year
ended December 31, 2023, compared to $49.2 million for the same
period in 2022.
- G&A Expenses: G&A expenses were $6.8
million for the three months ended December 31, 2023, compared to
$3.8 million for the three months ended December 31, 2022. G&A
expenses were $15.4 million for the year ended December 31, 2023,
compared to $12.0 million for the same period in 2022.
- Net Loss: Net loss was $14.2 million or $0.86
per share (basic and diluted) for the three months ended December
31, 2023, compared to $14.6 million or $8.86 per share (basic and
diluted) for the three months ended December 31, 2022. Net loss was
$66.4 million or $12.40 per share (basic and diluted) for the year
ended December 31, 2023, compared to $59.3 million or $36.36 per
share (basic and diluted) for the year ended December 31,
2022.
About Lexeo Therapeutics Lexeo
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 Statements
Certain statements in this press release may constitute
“forward-looking statements” within the meaning of the federal
securities laws, including, but not limited to, our expectations
and plans regarding our current product candidates and programs,
including the anticipated timing of the initiation of and results
from our clinical trials, expectations regarding the time period
over which our capital resources will be sufficient to fund our
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 (the 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 our 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, including the
anticipated closing of the private placement and anticipated runway
extension; and other risks and uncertainties identified in our
Quarterly Report of 10-Q for the quarterly period ended September
30, 2023, filed with the SEC on December 11, 2023, and subsequent
future filings we 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: Carolyn Hawley
(619) 849-5382 Carolyn.hawley@inizioevoke.com
Investor Response: Laurence Watts
(619) 916-7620 laurence@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 December 31, |
|
|
Year Ended December 31, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
Grant revenue |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
654 |
|
Total revenue |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
654 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
8,210 |
|
|
|
11,437 |
|
|
|
53,130 |
|
|
|
49,162 |
|
General and administrative |
|
|
6,764 |
|
|
|
3,760 |
|
|
|
15,383 |
|
|
|
12,001 |
|
Total operating expenses |
|
|
14,974 |
|
|
|
15,197 |
|
|
|
68,513 |
|
|
|
61,163 |
|
Operating loss |
|
|
(14,974 |
) |
|
|
(15,197 |
) |
|
|
(68,513 |
) |
|
|
(60,509 |
) |
Other income and expense |
|
|
|
|
|
|
|
|
|
|
|
|
Loss on fair value adjustment to convertible SAFE Note |
|
|
(258 |
) |
|
|
- |
|
|
|
(530 |
) |
|
|
- |
|
Other income (expense), net |
|
|
(8 |
) |
|
|
(1 |
) |
|
|
(13 |
) |
|
|
(2 |
) |
Interest expense |
|
|
(51 |
) |
|
|
(54 |
) |
|
|
(205 |
) |
|
|
(91 |
) |
Interest income |
|
|
1,103 |
|
|
|
675 |
|
|
|
2,867 |
|
|
|
1,325 |
|
Total other income and expense |
|
|
786 |
|
|
|
620 |
|
|
|
2,119 |
|
|
|
1,232 |
|
Loss from operations before income taxes |
|
|
(14,188 |
) |
|
|
(14,577 |
) |
|
|
(66,394 |
) |
|
|
(59,277 |
) |
Income taxes |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Net loss and comprehensive loss |
|
$ |
(14,188 |
) |
|
$ |
(14,577 |
) |
|
$ |
(66,394 |
) |
|
$ |
(59,277 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share, basic and diluted |
|
$ |
(0.86 |
) |
|
$ |
(8.86 |
) |
|
$ |
(12.40 |
) |
|
$ |
(36.36 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of shares outstanding used in computation
of net loss per common share, basic and diluted |
|
|
16,438,237 |
|
|
|
1,644,403 |
|
|
|
5,354,368 |
|
|
|
1,630,348 |
|
Condensed Consolidated Balance Sheet Data |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
Cash, cash equivalents, and investments |
|
$ |
121,466 |
|
|
$ |
77,335 |
|
Total assets |
|
|
139,807 |
|
|
|
97,076 |
|
Total liabilities |
|
|
26,272 |
|
|
|
24,997 |
|
Total convertible preferred stock |
|
|
- |
|
|
|
185,033 |
|
Total stockholders' equity (deficit) |
|
|
113,535 |
|
|
|
(112,954 |
) |
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