secwatch.observer — SEC 8-K summary
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Issuer:     MAIA Biotechnology, Inc. (MAIA)
CIK:        0001878313
Form:       8-K
Filed at:   2025-12-11T23:59:59+00:00
Accession:  0001493152-25-027244
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

MAIA dosed first patient in THIO-104 Phase 3 trial of ateganosine for third-line NSCLC
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- First patient dosed in THIO-104 Phase 3 pivotal trial evaluating ateganosine + CPI vs chemo in third-line NSCLC.
- Trial targets up to 300 patients with primary endpoint of overall survival; screening underway in Taiwan, Turkey, EMA countries, Georgia.
- CEO Vitoc and board purchased ~182,445 shares on open market Nov 21–28, 2025; insiders now hold 12.95% of company.
- Phase 2 data showed median OS 17.8 months vs ~6 months for chemo; FDA granted Fast Track designation for ateganosine.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1878313/000149315225027244/0001493152-25-027244-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1878313/000149315225027244/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-25-027244

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer