- The FDA has recommended that IO Biotech **not submit a Biologics License Application (BLA)** for Cylembio based on data from the IOB-013 clinical trial, where results narrowly missed statistical significance.  **[1865494_0001193125-25-221704_d940102dex991.htm:0]** **[1865494_0001193125-25-221704_d940102d8k.htm:3]** 
- IO Biotech plans to **design a new registrational study** for Cylembio for the treatment of first-line patients with advanced melanoma and will continue discussions with the FDA and European regulators.  **[1865494_0001193125-25-221704_d940102dex991.htm:0]** **[1865494_0001193125-25-221704_d940102d8k.htm:3]** 
- The company is implementing a restructuring plan, including an **approximate 50% reduction in its workforce**, to conserve capital.  **[1865494_0001193125-25-221704_d940102dex991.htm:0]** **[1865494_0001193125-25-221704_d940102d8k.htm:1]** 
- This restructuring is expected to result in a non-recurring charge of between **$1.0 million and $1.5 million** in the third quarter of 2025.  **[1865494_0001193125-25-221704_d940102dex991.htm:0]** **[1865494_0001193125-25-221704_d940102d8k.htm:1]** 
- IO Biotech currently has capital to fund its operations into the **first quarter of 2026**.  **[1865494_0001193125-25-221704_d940102dex991.htm:0]**

IO Biotech (IOBT)