Closed an oversubscribed
Completed in-license agreement with
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
Phase 1/2 clinical trial of LX2020 (HEROIC-PKP2) currently recruiting patients; data update from Cohort 1 on track for 2H 2024
“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
Business and Program Updates
- LX2006 for the Treatment of FA Cardiomyopathy: In
April 2024 , Lexeo announced the license of intellectual property rights fromCornell University , including current and future clinical data from an ongoing Weill Cornell Medicine investigator-initiated trial of AAVrh.10hFXN (LX2006).- In
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. - Additionally, 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.
- In
- 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: InMarch 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
- Interim data readout in mid-2024
- LX2020 for the treatment of PKP2-ACM
- 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
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 endedMarch 31, 2024 , compared to$16.4 million for the three months endedMarch 31, 2023 . - G&A Expenses: G&A expenses were
$7.5 million for the three months endedMarch 31, 2024 , compared to$2.9 million for the three months endedMarch 31, 2023 . - Net Loss: Net loss was
$21.7 million or$0.77 per share (basic and diluted) for the three months endedMarch 31, 2024 , compared to$18.7 million or$11.58 per share (basic and diluted) for the three months endedMarch 31, 2023 .
About
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
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Selected Condensed Financial Information (unaudited, in thousands, except share and per share amounts) | |||||||||
Condensed Consolidated Statements of Operations | |||||||||
Three Months Ended | |||||||||
2024 | 2023 | ||||||||
Operating expenses | |||||||||
Research and development | 15,742 | 16,438 | |||||||
General and administrative | 7,549 | 2,852 | |||||||
Total operating expenses | 23,291 | 19,290 | |||||||
Operating loss | (23,291 | ) | (19,290 | ) | |||||
Other income and expense | |||||||||
Other income (expense), net | (5 | ) | (4 | ) | |||||
Interest expense | (37 | ) | (50 | ) | |||||
Interest income | 1,651 | 687 | |||||||
Total other income and expense | 1,609 | 633 | |||||||
Loss from operations before income taxes | (21,682 | ) | (18,657 | ) | |||||
Income taxes | - | - | |||||||
Net loss and comprehensive loss | $ | (21,682 | ) | $ | (18,657 | ) | |||
Net loss per common share, basic and diluted | $ | (0.77 | ) | $ | (11.58 | ) | |||
Weighted average number of shares outstanding used in computation of net loss per common share, basic and diluted | 27,979,838 | 1,610,793 |
Condensed Consolidated Balance Sheet Data | ||||||||
2024 | 2023 | |||||||
Cash, cash equivalents, and investments | $ | 195,060 | $ | 121,466 | ||||
Total assets | 213,205 | 139,807 | ||||||
Total liabilities | 30,255 | 26,272 | ||||||
Total stockholders' equity | 182,950 | 113,535 |
Source:
2024 GlobeNewswire, Inc., source