Lexeo Therapeutics Reports Third Quarter 2023 Financial Results and Operational Highlights
December 11 2023 - 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 third quarter 2023 financial results and
provided operational highlights.
“We have made significant progress to date in
2023, achieving several important clinical and corporate
milestones, as we continue to build a leading genetic medicine
company,” said R. Nolan Townsend, Chief Executive Officer of Lexeo.
“With the successful completion of our IPO, we are well positioned
to execute on our near-term corporate objectives. Importantly, as
we head into 2024, we expect to provide additional clinical data
readouts from our lead cardiovascular and APOE4-associated
Alzheimer’s disease programs, continuing our momentum into the new
year.”
Business and Program Updates
- APOE4-associated Alzheimer’s Disease Programs:
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. Additionally, Lexeo presented murine data on
LX1021, a preclinical gene therapy candidate designed to deliver a
Christchurch mutation modified APOE2 gene, at the 2023 Clinical
Trials in Alzheimer's Disease (CTAD) conference in October 2023.
The data demonstrated impact to both amyloid and tau pathology as
measured in two distinct murine models of Alzheimer’s disease and
suggest a potentially enhanced tau pathology treatment effect
compared to LX1001.
- LX2006 for the Treatment of FA Cardiomyopathy:
Received clearance of CTA in Canada for LX2006 for the treatment of
FA cardiomyopathy and activated the first clinical trial site for
the SUNRISE-FA Phase 1/2 clinical trial outside of the United
States.
- LX2020 for the Treatment of PKP2-ACM:
Presented additional preclinical data at the American Heart
Association Scientific Sessions in November 2023, including murine
and non-human primate data that supported the LX2020 IND, which was
cleared by the FDA in July 2023. 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 the first half of
2024.
- 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.
- Expanded Leadership Team: In October, Sandi
See Tai, M.D. joined Lexeo as Senior Vice President, Clinical
Development and Operations. Dr. See Tai has nearly twenty years of
biopharmaceutical experience in clinical development and medical
affairs and has led global clinical development efforts for
multiple cardiac precision medicine candidates, including achieving
global approvals for a product that treats ATTR
cardiomyopathy.
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
Third Quarter Financial
Results
- Cash Position: As of September 30, 2023, cash
and cash equivalents were $35.4 million; cash position pro forma
for the Company’s IPO is noted below.
- R&D Expenses: R&D expenses were $17.2
million for the three months ended September 30, 2023, compared to
$15.4 million for the three months ended September 30, 2022.
- G&A Expenses: G&A expenses were $3.0
million for the three months ended September 30, 2023, compared to
$2.7 million for the three months ended September 30, 2022.
- Net Loss: Net loss was $20.1 million or $12.36
per share (basic and diluted) for the three months ended September
30, 2023, compared to $17.1 million or $10.38 per share (basic and
diluted) for the three months ended September 30, 2022.
Pro Forma Cash Position for Initial Public
Offering
- Cash Position: As of September 30, 2023, cash
and cash equivalents were $136.4 million, pro forma for net
proceeds from the Company’s IPO in November 2023. Lexeo expects its
current cash and cash equivalents, including the net proceeds from
the IPO, will be sufficient to fund operations into Q4 2025.
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; and other risks and
uncertainties identified in our September 30, 2023 Quarterly Report
on Form 10-Q filed with the SEC and subsequent 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: Janine Bogris
(201) 245-6838 janine.bogris@canalecomm.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 EndedSeptember 30, |
|
|
Nine Months EndedSeptember 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
Grant revenue |
|
$ |
- |
|
|
$ |
531 |
|
|
$ |
- |
|
|
$ |
654 |
|
Total revenue |
|
|
- |
|
|
|
531 |
|
|
|
- |
|
|
|
654 |
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
17,246 |
|
|
|
15,362 |
|
|
|
44,920 |
|
|
|
37,775 |
|
General and administrative |
|
|
3,027 |
|
|
|
2,651 |
|
|
|
8,619 |
|
|
|
8,191 |
|
Total operating expenses |
|
|
20,273 |
|
|
|
18,013 |
|
|
|
53,539 |
|
|
|
45,966 |
|
Operating
loss |
|
|
(20,273 |
) |
|
|
(17,482 |
) |
|
|
(53,539 |
) |
|
|
(45,312 |
) |
Other income
and expense |
|
|
|
|
|
|
|
|
|
|
|
|
Gain (loss) on fair value adjustment to convertible SAFE note |
|
|
(272 |
) |
|
|
- |
|
|
|
(272 |
) |
|
|
- |
|
Other income (expense) |
|
|
1 |
|
|
|
- |
|
|
|
(6 |
) |
|
|
- |
|
Interest expense |
|
|
(52 |
) |
|
|
(29 |
) |
|
|
(155 |
) |
|
|
(37 |
) |
Interest income |
|
|
488 |
|
|
|
456 |
|
|
|
1,765 |
|
|
|
649 |
|
Total other income and expense |
|
|
165 |
|
|
|
427 |
|
|
|
1,332 |
|
|
|
612 |
|
Loss from
operations before income taxes |
|
|
(20,108 |
) |
|
|
(17,055 |
) |
|
|
(52,207 |
) |
|
|
(44,700 |
) |
Income taxes |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Net loss and
comprehensive loss |
|
$ |
(20,108 |
) |
|
$ |
(17,055 |
) |
|
$ |
(52,207 |
) |
|
$ |
(44,700 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
common share, basic and diluted |
|
$ |
(12.36 |
) |
|
$ |
(10.38 |
) |
|
$ |
(32.24 |
) |
|
$ |
(27.50 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average number of shares outstanding used in computation of net
loss per common share, basic and diluted |
|
|
1,626,734 |
|
|
|
1,643,122 |
|
|
|
1,619,152 |
|
|
|
1,625,611 |
|
Condensed Consolidated Balance Sheet Data |
|
September 30, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
Cash and cash equivalents |
|
$ |
35,449 |
|
|
$ |
77,335 |
|
Total
assets |
|
|
54,724 |
|
|
|
97,076 |
|
Total
liabilities |
|
|
32,499 |
|
|
|
24,997 |
|
Total
convertible preferred stock |
|
|
185,033 |
|
|
|
185,033 |
|
Total
stockholders' deficit |
|
|
(162,808 |
) |
|
|
(112,954 |
) |
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