Iteos Therapeutics (ITOS) Q3 2024 earnings summary

Executive summary

• Clinical-stage biopharma advancing three immuno-oncology programs, with belrestotug in Phase 3 and Phase 2 trials for NSCLC and HNSCC, and EMA clearance enabling EU site activation and first EU patient dosing in GALAXIES Lung-301.

• Completed EOS-984 Phase 1 monotherapy enrollment and initiated combination dosing with pembrolizumab.

• Interim and topline data from multiple trials, including GALAXIES Lung-201, GALAXIES H&N-202, TIG-006, and EOS-984, expected in 2025.

• Net loss of $45.4M for Q3 2024 and $90.7M for the nine months ended September 30, 2024.

• Pro forma cash and investments of $683.9M as of September 30, 2024, expected to fund operations through 2027.

Financial highlights

• License and collaboration revenue was $35.0M for the nine months ended September 30, 2024, driven by a $35M GSK milestone.

• R&D expenses rose to $107.9M for the nine months ended September 30, 2024, up $22.4M year-over-year.

• General and administrative expenses decreased slightly to $37.2M for the nine months ended September 30, 2024.

• Net loss for the nine months ended September 30, 2024 was $90.7M, compared to $82.1M in the prior year period.

• Net loss per share for Q3 2024 was $1.05; nine-month net loss per share was $2.29.

Outlook and guidance

• Cash and investments are expected to fund operations and capital expenditures through 2027.

• Interim and topline data from key trials anticipated in 2025, including GALAXIES Lung-201, GALAXIES H&N-202, TIG-006, and EOS-984.

• The company anticipates continued significant expenses as it advances clinical programs and initiates new trials.