IO Biotech Advised Against Filing Biologics License Application for Cylembio; Plans to Cut 50% of Workforce
MT Newswires Live
Sep 29
IO Biotech (IOBT) said Monday the US Food and Drug Administration recommended it not submit a Biologics License Application for Cylembio based on results from the IOB-013 clinical trial, which failed to meet statistical significance.
The company said it will continue discussions with the FDA on the design of a potential new registrational study for Cylembio.
IO Biotech said it is implementing a plan to conserve capital, including a workforce reduction of about 50% in full-time employees, and anticipates a non-recurring charge of $1 million to $1.5 million in Q3 2025. The company expects its current capital to fund operations into Q1 2026.
IO Biotech shares were down more than 82% in recent Monday pre-bell activity.
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