Iteos Therapeutics (ITOS) Q4 2024 earnings summary

Executive summary

• Advanced multiple clinical trials, including belrestotug + dostarlimab in collaboration with GSK, with key interim data from GALAXIES Lung-201 expected in 2Q25 and other major readouts anticipated in 2025.

• Completed enrollment of the second dose cohort for EOS-984 + pembrolizumab in Phase 1 and prepared for EOS-215 Phase 1 trial enrollment in 2Q25.

• Maintained a strong cash and investment position of $655.0 million as of December 31, 2024, providing operational runway through 2027.

Financial highlights

• Cash and investments totaled $655.0 million at year-end 2024, up from $632.5 million at year-end 2023.

• R&D expenses rose to $37.5 million for Q4 and $145.4 million for the year, up from $27.9 million and $113.3 million in the prior year, mainly due to increased activity in key programs.

• G&A expenses were $11.8 million for Q4 and $49.1 million for the year, slightly down from $12.4 million and $50.4 million in 2023.

• Net loss was $43.7 million ($1.01/share) for Q4 and $134.4 million ($3.32/share) for the year, compared to $30.6 million ($0.85/share) and $112.6 million ($3.15/share) in 2023.

Outlook and guidance

• Topline interim data from GALAXIES Lung-201 (>240 patients) expected in 2Q25, with additional interim datasets from GALAXIES H&N-202 and TIG-006 HNSCC anticipated in 2025.

• EOS-984 topline data as monotherapy and in combination with pembrolizumab expected in 2H25; EOS-215 Phase 1 enrollment to begin in 2Q25.

• Cash runway expected through 2027, supporting multiple Phase 3 trial initiations.