MAIA News & Events

MAIA Biotechnology announced that it has commenced an underwritten public offering of shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of its common stock. All of the shares of common stock and pre-funded warrants to be sold in this offering are being offered by the company. MAIA intends to use the net proceeds from the offering to conduct clinical trials and for working capital and general corporate purposes. Konik Capital Partners, a division of T.R. Winston & Company, is acting as the sole book-running manager for the offering.

MAIA Biotechnology published a 2026 Letter to Shareholders by Founder and CEO Vlad Vitoc, M.D. featuring the Company's strong momentum in clinical trials of its lead molecule, ateganosine, as a treatment for non-small cell lung cancer. As stated in the Letter, Dr. Vitoc wrote, "Our development strategy intentionally targets the third-line NSCLC population, where the unmet need is urgent. No established standard of care exists in 3L treatment, with most oncologists currently treating 3L patients with chemotherapy, leading to particularly poor clinical outcomes. In clinical studies, ateganosine sequenced with an immune checkpoint inhibitor has demonstrated outcomes that exceed those historically achieved with either CPI-based therapy or chemotherapy alone. These findings position ateganosine not as a competitor to CPIs, but as the foundation of a new treatment category designed specifically for advanced NSCLC following CPI and chemotherapy failure. By focusing on a third-line population with no defined standard of care, we are addressing an underserved group of approximately 50,000 patients annually in the United States and creating a differentiated, incremental revenue opportunity outside of the CPI market."

Targeted 2026 Milestones: Initial measures of efficacy from Phase 3 study. Interim disease control rates, overall response rates and progression free survival 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. "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 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."