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.