NEW YORK, May 09, 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).
- 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.
- 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
- 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 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.
