MAIA Biotechnology, Inc.

MAIA Biotechnology announced the completion of international enrollment for Part C of its Phase 2 THIO-101 expansion trial, evaluating ateganosine in advanced non-small cell lung cancer (NSCLC) patients. Forty-one patients were enrolled across six international sites, while domestic enrollment is now underway at three U.S. clinical sites. The company highlighted promising previous data from Parts A and B, showing a median survival of 17.8 months compared to an expected 5.8 months, and noted ateganosine's FDA Fast Track designation.

MAIA Biotechnology announced the activation of Winship Cancer Institute of Emory University as the third U.S. clinical site for its Phase 2 THIO-101 expansion trial, which is now enrolling patients. The trial evaluates ateganosine as a third-line treatment for non-small cell lung cancer (NSCLC) in patients resistant to checkpoint inhibitors and chemotherapy. Winship is Georgia's only NCI-designated Comprehensive Cancer Center, and early efficacy data from Parts A and B of the trial have shown promising results, with some patients surviving over two years.

MAIA Biotechnology provided an update on its pivotal Phase 3 THIO-104 trial for ateganosine, a novel telomere-targeting therapy for advanced non-small cell lung cancer (NSCLC). The trial has dosed 29 patients across 34 sites in 6 countries, with a target of up to 100 patients by year-end and an interim analysis expected in 2027. Ateganosine, which has US FDA Fast Track designation, showed a median overall survival of 17.8 months in Phase 2, significantly higher than the 5.8 months for standard chemotherapy, and targets a projected $70 billion global NSCLC market by 2030.

MAIA Biotechnology announced that the FDA has cleared an amendment to its investigational new drug (IND) application, allowing the company to expand U.S. enrollment for the Phase 2 THIO-101 trial of ateganosine for advanced non-small cell lung cancer (NSCLC). This clearance, along with the Fast Track designation granted in July 2025, may support a potential Accelerated Approval filing. The company also highlighted positive overall survival data from earlier parts of the THIO-101 trial and confirmed ongoing enrollment for its pivotal Phase 3 THIO-104 study.

MAIA Biotechnology, Inc. announced that its founder and CEO, Vlad Vitoc, M.D., and Director Stan V. Smith, Ph.D., increased their ownership positions through open market purchases. Dr. Vitoc acquired approximately 72,700 shares at an average price of $1.3877, while Dr. Smith purchased approximately 75,000 shares at an average price of $1.336. These investments reflect strong confidence in the company's telomere-targeting immuno-oncology platform and the ateganosine program, which is advancing toward later-stage development for non-small cell lung cancer. Directors and officers now collectively hold a 20.46% stake in MAIA.

MAIA Biotechnology, Inc. has terminated its At The Market Offering Agreement with H.C. Wainwright & Co., LLC, effective 7 business days after May 14, 2026. Since March 28, 2025, the company sold 3,116,012 shares of common stock under this agreement, generating gross proceeds of approximately $5,680,924.

MAIA Biotechnology reported a net loss of $6.37 million for the first quarter of 2026, an increase from $4.52 million in the prior year, though net loss per share improved to $(0.14) from $(0.16). The company significantly strengthened its liquidity, with cash increasing to $34.41 million at March 31, 2026, from $8.66 million at December 31, 2025, primarily driven by $33.01 million in proceeds from a confidentially marketed public offering. Operating expenses continued to rise, reflecting increased research and development and general and administrative costs.

MAIA Biotechnology has activated its first U.S. clinical site for the Phase 2 THIO-101 expansion trial, evaluating its lead investigational therapy for third-line non-small cell lung cancer (NSCLC). This expansion aims to reach an estimated 50,000 U.S. patients annually who are resistant to current treatments. The U.S. trial is supported by a $2.3 million NIH grant, building on previous positive efficacy data from 2025, which showed overall survival beyond two years for eight patients.