On December 11, 2025, MAIA Biotechnology, Inc. (MAIA) disclosed two key developments for its lead oncology candidate. The company filed an 8-K form with the SEC announcing the initiation of a Phase 3 clinical trial for Ateganosine, a drug candidate for advanced non-small cell lung cancer (NSCLC). According to the filing, management indicated a high probability of technical success for regulatory approval of the therapy.

The same filing confirmed that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Ateganosine for the treatment of NSCLC. This regulatory status is designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need. The company stated both developments in a press release attached as Exhibit 99.1 to the SEC filing.

MAIA Biotechnology's 8-K filing, submitted on December 11, 2025, contains Item 9.01, which covers financial statements and exhibits. The attached press release forms the basis for the disclosed clinical and regulatory updates. No specific primary endpoint results, response rates, or overall survival data from the newly initiated Phase 3 trial were detailed in the filing summary.