MAIA Biotechnology (MAIA) Q3 2025 earnings summary

Executive summary

• Clinical-stage biopharma focused on immunotherapies for cancer, with lead asset ateganosine (THIO) in Phase 2/3 trials for NSCLC and other cancers.

• Key milestones include positive Phase 2 data, FDA Fast Track designation, and expansion into new geographies and indications.

• Entered clinical supply agreements with Regeneron, BeOne, and Roche for combination trials.

Financial highlights

• Net loss for Q3 2025 was $8.9M, up 225% year-over-year; nine-month net loss was $18.8M, a 5% improvement from prior year.

• Operating expenses for Q3 2025 rose 123% to $9.4M, driven by R&D and G&A increases.

• Cash balance as of September 30, 2025 was $10.9M, with working capital of $1.76M.

• No revenue generated; company remains pre-commercial.

Outlook and guidance

• Plans to initiate Phase 3 pivotal trial (THIO-104) in 2025 for NSCLC, with potential accelerated approval in 2026.

• Phase 2 trials in HCC, CRC, and SCLC planned for 2026.

• Ongoing need to raise additional capital to fund operations and clinical development.