Core Insights - The FDA is open to pooling data from ongoing Phase I/II studies of LX2006 with data from a pivotal trial to support a Biologics License Application (BLA) [1][3] - Interim clinical data for LX2006 show significant improvements in cardiac and neurologic measures for Friedreich ataxia, including an 18% mean improvement in left ventricular mass index (LVMI) at 6 months and a 23% improvement at 12 months [1][3] - Lexeo Therapeutics completed a $154 million equity financing to support LX2006 registrational activities and further development of its cardiac pipeline, with cash expected to fund operations into 2028 [1][5][7] Regulatory Progress - The FDA approved a comparability report between LX2006 HEK and Sf9 manufacturing processes, endorsing the use of the Sf9 process for commercial manufacturing [1][7] - Lexeo plans to submit enhanced manufacturing comparability data and additional nonclinical data to support the BLA submission [3] Clinical Data - Interim clinical data from LX2006 show a 2.0-point mean improvement in the modified Friedreich Ataxia Rating Scale (mFARS) across all participants with over 6 months of follow-up [3] - In the HEROIC-PKP2 Phase I/II trial, ten participants have been dosed, with interim data from the low-dose cohort reported and additional data expected in January 2026 [1][4] Financial Results - For Q3 2025, Lexeo reported a net loss of $20.3 million, or $0.33 per share, compared to a net loss of $29.5 million, or $0.89 per share, in Q3 2024 [5][10] - Research and Development expenses decreased to $15.7 million in Q3 2025 from $23.4 million in Q3 2024 [5][9] Cash Position - As of September 30, 2025, Lexeo had cash, cash equivalents, and investments totaling $122.8 million, which, along with the recent financing, is expected to fund operations into 2028 [5][11]
Lexeo Therapeutics Reports Third Quarter 2025 Financial Results and Operational Highlights