UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Date of Report (Date of earliest event reported): May 09, 2024 |
Lexeo Therapeutics, Inc.
(Exact name of Registrant as Specified in Its Charter)
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Delaware |
001-41855 |
85-4012572 |
(State or Other Jurisdiction
of Incorporation) |
(Commission File Number) |
(IRS Employer
Identification No.) |
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345 Park Avenue South, Floor 6 |
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New York, New York |
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10010 |
(Address of Principal Executive Offices) |
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(Zip Code) |
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Registrant’s Telephone Number, Including Area Code: 212 547-9879 |
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading
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Name of each exchange on which registered
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Common Stock, $0.0001 par value per share |
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LXEO |
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Nasdaq Global Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On May 9, 2024, Lexeo Therapeutics, Inc. (the “Registrant”) issued a press release announcing business highlights and its financial results for the three months ended March 31, 2024. A copy of this press release is furnished herewith as Exhibit 99.1 to this Current Report and is incorporated herein by reference.
The information in this Item 2.02, and Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any of the Registrant’s filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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Exhibit Number |
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Description |
99.1 |
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Press Release |
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Lexeo Therapeutics, Inc. |
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Date: |
May 9, 2024 |
By: |
/s/ R. Nolan Townsend |
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R. Nolan Townsend, Chief Executive Officer |
Exhibit 99.1
Lexeo Therapeutics Reports First Quarter 2024 Financial Results and Operational Highlights
Closed an oversubscribed $95 million equity financing in March with Q1 2024 cash balance of $195.1 million at quarter-end, expected to provide runway into 2027
Completed in-license agreement with Cornell University for intellectual property rights, including current and future clinical data from an ongoing investigator-initiated trial of AAVrh.10hFXN (LX2006) to support regulatory discussions
Interim readout of combined data set of LX2006 at multiple doses anticipated in mid-2024; Lexeo expects to provide analysis of natural history data and baseline characteristics of these study participants in advance of interim readout
Phase1/2 clinical trial of LX2020 (HEROIC-PKP2) currently recruiting patients; data update from Cohort 1 on track for 2H 2024
NEW YORK – May 9, 2024 (GLOBE NEWSWIRE) – 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).
oIn 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.
oAdditionally, 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
oInterim data readout in mid-2024
•LX2020 for the treatment of PKP2-ACM
oInterim data readout (Cohort 1) in 2H 2024
•LX1001 for the treatment of APOE4-associated Alzheimer’s disease
oInterim Phase 1/2 data readout (all cohorts) in 2H 2024
•LX2021 for the treatment of DSP cardiomyopathy
oInitiate 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 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, 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) 245-6838
janine.bogris@inizioevoke.com
Investor Response:
Stephen Jasper
(858) 525-2047
stephen@gilmartinir.com
Lexeo Therapeutics, Inc.
Selected Condensed Financial Information
(unaudited, in thousands, except share and per share amounts)
Condensed Consolidated Statements of Operations
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Three Months Ended March 31, |
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2024 |
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2023 |
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Operating expenses |
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Research and development |
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15,742 |
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16,438 |
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General and administrative |
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7,549 |
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2,852 |
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Total operating expenses |
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23,291 |
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19,290 |
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Operating loss |
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(23,291 |
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(19,290 |
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Other income and expense |
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Other income (expense), net |
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(5 |
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(4 |
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Interest expense |
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(37 |
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(50 |
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Interest income |
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1,651 |
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687 |
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Total other income and expense |
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1,609 |
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633 |
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Loss from operations before income taxes |
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(21,682 |
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(18,657 |
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Income taxes |
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- |
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- |
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Net loss and comprehensive loss |
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$ |
(21,682 |
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$ |
(18,657 |
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Net loss per common share, basic and diluted |
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$ |
(0.77 |
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$ |
(11.58 |
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Weighted average number of shares outstanding used in computation of net loss per common share, basic and diluted |
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27,979,838 |
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1,610,793 |
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Condensed Consolidated Balance Sheet Data
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March 31, |
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December 31, |
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2024 |
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2023 |
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Cash, cash equivalents, and investments |
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$ |
195,060 |
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$ |
121,466 |
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Total assets |
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213,205 |
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139,807 |
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Total liabilities |
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30,255 |
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26,272 |
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Total stockholders' equity |
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182,950 |
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113,535 |
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