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
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
“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
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 inOctober 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 ofthe 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 inJuly 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 endedSeptember 30, 2023 , compared to$15.4 million for the three months endedSeptember 30, 2022 . - G&A Expenses: G&A expenses were
$3.0 million for the three months endedSeptember 30, 2023 , compared to$2.7 million for the three months endedSeptember 30, 2022 . - Net Loss: Net loss was
$20.1 million or$12.36 per share (basic and diluted) for the three months endedSeptember 30, 2023 , compared to$17.1 million or$10.38 per share (basic and diluted) for the three months endedSeptember 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 inNovember 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
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
Media Response:
(201) 245-6838
janine.bogris@canalecomm.com
Investor Response:
(619) 916-7620
laurence@gilmartinir.com
Selected Condensed Financial Information (unaudited, in thousands, except share and per share amounts) | ||||||||||||||||
Condensed Consolidated Statements of Operations | Three Months Ended | Nine Months Ended | ||||||||||||||
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 | ||||||||
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 | ) |
Source: LEXEO Therapeutics
2023 GlobeNewswire, Inc., source