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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
Date of Report (Date of earliest event reported): December 11, 2023 |
Lexeo Therapeutics, Inc.
(Exact name of Registrant as Specified in Its Charter)
Delaware |
001-41855 |
85-4012572 |
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(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
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345 Park Avenue South, Floor 6 |
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New York, New York |
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10010 |
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(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 |
N/A |
(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:
Securities registered pursuant to Section 12(b) of the Act:
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Trading |
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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 December 11, 2023, Lexeo Therapeutics, Inc. (the “Registrant”) issued a press release announcing business highlights and its financial results for the three and nine-months ended September 30, 2023. 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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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: |
December 11, 2023 |
By: |
/s/ R. Nolan Townsend |
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R. Nolan Townsend, Chief Executive Officer |
Exhibit 99.1
Lexeo Therapeutics Reports Third Quarter 2023 Financial Results and Operational Highlights
Completed enrollment of the LEAD Phase 1/2 clinical trial of LX1001 for the treatment of APOE4-associated Alzheimer’s disease
Received clearance of LX2006 Clinical Trial Application (CTA) in Canada for the treatment of FA cardiomyopathy; activated first clinical trial site outside of the United States
Presented additional preclinical data on LX2020 for the treatment of PKP2-ACM at the 2023 American Heart Association Scientific Sessions
Completed initial public offering (IPO) of common stock in November 2023, raising $111.5 million in gross proceeds and supporting operational runway into Q4 2025
NEW YORK – December 11, 2023 (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 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
Expected Upcoming Milestones
Third Quarter Financial Results
Pro Forma Cash Position for Initial Public Offering
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 |
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2023 |
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2022 |
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2023 |
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2022 |
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Revenue |
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Grant revenue |
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$ |
- |
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$ |
531 |
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$ |
- |
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$ |
654 |
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Total revenue |
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- |
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531 |
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- |
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654 |
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Operating expenses |
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Research and development |
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17,246 |
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15,362 |
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44,920 |
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37,775 |
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General and administrative |
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3,027 |
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2,651 |
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8,619 |
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8,191 |
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Total operating expenses |
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20,273 |
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18,013 |
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53,539 |
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45,966 |
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Operating loss |
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(20,273 |
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(17,482 |
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(53,539 |
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(45,312 |
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Other income and expense |
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Gain (loss) on fair value adjustment to convertible SAFE note |
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(272 |
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- |
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(272 |
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- |
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Other income (expense) |
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1 |
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- |
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(6 |
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- |
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Interest expense |
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(52 |
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(29 |
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(155 |
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(37 |
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Interest income |
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488 |
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456 |
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1,765 |
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649 |
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Total other income and expense |
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165 |
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427 |
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1,332 |
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612 |
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Loss from operations before income taxes |
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(20,108 |
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(17,055 |
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(52,207 |
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(44,700 |
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Income taxes |
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- |
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- |
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- |
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- |
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Net loss and comprehensive loss |
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$ |
(20,108 |
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$ |
(17,055 |
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$ |
(52,207 |
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$ |
(44,700 |
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Net loss per common share, basic and diluted |
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$ |
(12.36 |
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$ |
(10.38 |
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$ |
(32.24 |
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$ |
(27.50 |
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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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1,626,734 |
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1,643,122 |
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1,619,152 |
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1,625,611 |
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Condensed Consolidated Balance Sheet Data |
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September 30, |
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December 31, |
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2023 |
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2022 |
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Cash and cash equivalents |
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$ |
35,449 |
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$ |
77,335 |
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Total assets |
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54,724 |
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97,076 |
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Total liabilities |
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32,499 |
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24,997 |
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Total convertible preferred stock |
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185,033 |
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185,033 |
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Total stockholders' deficit |
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(162,808 |
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(112,954 |
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