MAIA Biotechnology, Inc. (NYSE:MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today provided a corporate update on 2025 achievements and highlighted key targeted milestones and growth catalysts for 2026.

"MAIA's strong clinical execution in 2025 delivered exceptional efficacy data for ateganosine sequenced with a checkpoint inhibitor, including disease control, response rates, and survival data well above standard of care benchmarks," said MAIA founder and CEO Vlad Vitoc, M.D. "The results clearly differentiate our novel telomere-targeting science and support the U.S. FDA's Fast Track designation granted in 2025, positioning ateganosine for potential eligibility under the Accelerated Approval and Priority Review regulatory pathways.

"Our statistical assessments of ateganosine imply a high probability of technical success in our concurrent Phase 3 and Phase 2 trials. As our first-in-class small molecule advances toward potential early commercial approval—possibly within 18 to 24 months—we believe our strong execution is driving a clear value-creation inflection point, with meaningful long-term benefits for stockholders."

2025 Achievements

• Secured FDA Fast Track designation for ateganosine as a treatment for NSCLC. Fast Track expedites the review of investigational drugs that treat serious conditions and fill an unmet medical need.
  
  
  
   
• Marked a major clinical milestone by initiating a full approval THIO-104 Phase 3 trial in third-line (3L) NSCLC patients resistant to immunotherapy and chemotherapy.
  
  
  
   
• Advanced the THIO-101 Phase 2 clinical trial to the Part C expansion phase, substantially increasing the patient pool to include countries in Asia and Europe. The expansion trial positions the ateganosine program for broader regulatory and commercial relevance.
  
  
  
   
• Awarded $2.3 million grant from the National Institutes of Health (NIH) for the expansion of Phase 2 trial. The grant is intended to support expenses related to the enrollment of U.S. patients who are resistant to chemo and immunotherapy.
  
  
  
   
• Validated telomere-targeting as a differentiated therapeutic approach with applicability to multiple high mortality cancers. To our knowledge, ateganosine remains the only direct telomere-targeting anticancer agent in clinical development anywhere.
  
  
  
   
• Established checkpoint inhibitor combination partnerships through a master agreement with Roche for atezolizumab and a clinical supply agreement with BeOne Medicines for tislelizumab, enabling multiple future combination trials.
  
  
  
   
• Raised approximately $17.6 million from capital raises throughout 2025, with participation by members of the Board in nearly all transactions. This signals strong conviction and confidence in the long-term value creation potential of the ateganosine platform. As of December 31,2025, MAIA's directors and officers hold more than 5 million shares or approximately 13% of the Company.
  
  
  
   

Targeted 2026 Milestones

• Initial measures of efficacy from Phase 3 study. Interim disease control rates (DCR), overall response rates (ORR) and progression free survival (PFS) analysis of ateganosine compared to the control arm will support regulatory discussions. Strong interim data could lead to early full commercial approval.
  
  
  
   
• Conclusion of Part C of Phase 2 study. Expansion of the trial provides additional clinical efficacy data to support regulatory review for commercial approval.
  
  
  
   
• Engage in regulatory interactions with the FDA. Expand ongoing FDA dialogue under the Fast Track designation, including discussions around trial enhancements and prospects for Accelerated Approval and Priority Review.
  
  
  
   
• Clinical development of second-generation molecules to start in Phase 1 trials. Additional small molecules fully developed in-house with better expected efficacy compared to ateganosine.