MAIA Biotechnology (MAIA) Q2 2025 earnings summary

Executive summary

• Advanced clinical-stage immunotherapy pipeline, with lead asset ateganosine (THIO) in pivotal Phase 2 and planned Phase 3 trials for NSCLC, and expansion into HCC, SCLC, and CRC with global supply agreements.

• Achieved key milestones: positive Phase 2 data, FDA Fast Track designation for ateganosine in NSCLC, and new clinical supply agreements with Roche and BeiGene.

• Multiple private placements and at-the-market equity offerings raised over $5.9 million in the first half of 2025, supporting ongoing R&D and clinical activities.

• No material legal proceedings or new risk factors disclosed; operations impacted by global conflicts but mitigated by terminating research in affected regions.

Financial highlights

• Net loss for Q2 2025 was $5.3 million, a 40% improvement compared to $8.9 million in Q2 2024; six-month net loss was $9.9 million, down 42% year-over-year.

• Research and development expenses rose 52% year-over-year to $3.1 million for Q2 2025; general and administrative expenses increased 17% to $2.1 million.

• Other income (expense), net improved by $4.9 million in Q2 2025, mainly due to changes in fair value of warrant liabilities.

• Cash balance as of June 30, 2025 was $10.1 million, up $543,000 from December 31, 2024; working capital stood at $6.0 million.

• No revenue generated as of June 30, 2025; continued negative cash flow from operations.

Outlook and guidance

• Plans to initiate Phase 3 pivotal trial (THIO-104) in NSCLC in 2025, with potential accelerated approval filing in 2026 and full approval in 2027.

• Phase 2 trials in HCC, CRC, and SCLC planned for 2026, leveraging new supply agreements with BeOne and Roche.

• Ongoing at-the-market equity offering expected to continue to support liquidity needs.

• Substantial doubt remains about ability to continue as a going concern without additional capital raises.