MAIA Biotechnology Reports $22.4 Million Net Loss, Highlights Clinical Advancements for Ateganosine

MAIA Biotechnology, Inc., a clinical-stage biopharmaceutical company, released its 10-K filing, outlining its financial performance and operational developments. The company, focused on developing targeted immunotherapies for cancer, reported a net loss of $22.4 million for the year ended December 31, 2025, compared to a net loss of $23.3 million in 2024. Research and development expenses increased significantly, rising by 45% to $14.5 million, driven by increased payroll, pre-clinical research, and clinical trial expenses related to its lead asset, ateganosine. General and administrative expenses also saw a substantial increase of 40%, reaching $9.7 million, primarily due to higher investor relations expenses, increased payroll, stock-based compensation, and professional fees.

Despite the losses, MAIA Biotechnology highlighted key operational advancements. The company is currently focused on ateganosine, a dual mechanism of action drug candidate, and its Phase 2 clinical trial (THIO-101) in Non-Small Cell Lung Cancer (NSCLC). The trial is evaluating ateganosine in sequence with Regeneron's Libtayo. In July 2025, the company initiated an expansion of the THIO-101 trial, focusing on third-line NSCLC patients resistant to checkpoint inhibitors and chemotherapy. The expansion will enroll up to 48 patients with two arms: one evaluating ateganosine sequenced with Libtayo, and the other evaluating ateganosine as a monotherapy. The company also initiated a Phase 3 pivotal trial in 2025, named THIO-104, to evaluate the efficacy of ateganosine administered in sequence with a checkpoint inhibitor (CPI) in third-line NSCLC patients who are resistant to checkpoint inhibitors and chemotherapy.

Strategic collaborations and agreements were also a key focus for MAIA Biotechnology. In January 2025, the company entered into a clinical supply agreement with BeOne Medicines to assess ateganosine in combination with tislelizumab in HCC, SCLC, and CRC. In June 2025, MAIA entered into a clinical master supply agreement with Roche for future studies investigating the combination of ateganosine sequenced with Roche’s checkpoint inhibitor, atezolizumab, for the treatment of multiple hard-to-treat cancers. These collaborations aim to expand the clinical development of ateganosine and explore its potential in various cancer indications.

Looking ahead, MAIA Biotechnology plans to seek accelerated approval for ateganosine in the United States for advanced NSCLC in 2026, based on clinical data from the THIO-101 trial. The company also intends to initiate Phase 2 clinical trials in HCC, CRC, and SCLC in 2026, evaluating treatment with ateganosine administered in sequence with BeOne Medicines’s immune checkpoint inhibitor, tislelizumab. The company's cash position as of December 31, 2025, was $8.7 million, with working capital of $3.9 million. The company acknowledges the need for additional capital to fund its operations and advance its clinical programs.