MAIA Biotechnology Secures \$33 Million Capital Raise to Fully Fund Pivotal Phase 3 Trial of Ateganosine in NSCLC

Key Highlights for Investors

• MAIA Biotechnology, Inc. (NYSE American: MAIA) announces successful completion of a \$33 million public offering of common stock, expected to fully fund the ongoing pivotal Phase 3 clinical trial of its lead asset, ateganosine (THIO), in non-small cell lung cancer (NSCLC).
• Strong investor participation in the offering, including healthcare-dedicated investors and existing shareholders, underscores market confidence in MAIA’s late-stage clinical program and commercial potential.
• Ateganosine (THIO) is a first-in-class, dual-mechanism, telomere-targeting anticancer therapy with Fast Track designation from the U.S. FDA for third-line NSCLC treatment.
• Statistical assessments suggest a high probability of Phase 3 technical success if data is consistent with positive Phase 2 results, with interim data readout expected next year.
• Pivotal THIO-104 Phase 3 trial ongoing, aiming to compare ateganosine plus checkpoint inhibitor versus chemotherapy (the current standard in third-line NSCLC) in up to 300 patients worldwide.
• Potential for early full commercial approval in third-line NSCLC based on interim data, pending FDA discussions.

Detailed Report

MAIA Biotechnology, Inc., a clinical-stage biopharmaceutical company specializing in targeted immunotherapies for cancer, announced that the net proceeds from its recent \$33 million public offering are projected to fully finance the pivotal Phase 3 clinical trial for ateganosine (THIO) through to completion. The company highlighted robust participation from both new and existing shareholders in the March 2026 offering, reinforcing investor confidence in MAIA’s developmental and commercial trajectory.

Ateganosine is described as a dual-mechanism therapy that disrupts telomere structure and function in cancer cells while simultaneously inducing immune activation. The U.S. FDA has granted Fast Track designation to ateganosine for the treatment of third-line non-small cell lung cancer (NSCLC), a notable regulatory milestone that may provide opportunities for expedited development and review.

Dr. Vlad Vitoc, Founder and CEO of MAIA, emphasized that the successful capital raise is expected to cover all costs for the pivotal THIO-104 Phase 3 trial. He stated, “Statistical assessments point to a high probability of technical success in the third-line setting if Phase 3 data is consistent with our Phase 2 trial results.” Dr. Vitoc also noted that interim data, anticipated next year, could open the door for FDA discussions regarding early full commercial approval in this patient population.

About the THIO-104 Phase 3 Clinical Trial

The THIO-104 trial is a global, multicenter, open-label, randomized study evaluating ateganosine in combination with a checkpoint inhibitor (CPI) in third-line NSCLC patients who have failed prior checkpoint inhibitor and chemotherapy regimens. The trial will enroll up to 300 patients and randomize them 1:1 to receive either the ateganosine/CPI sequence or investigator’s choice of chemotherapy (the current standard for third-line NSCLC).

Primary objectives include:

• Assessing the clinical efficacy of ateganosine versus chemotherapy, using median Overall Survival (OS) as the primary endpoint.
• Evaluating the safety and tolerability of ateganosine followed by a checkpoint inhibitor.

More information on this trial is available on ClinicalTrials.gov (Identifier: NCT06908304).

Mechanism of Ateganosine (THIO)

Ateganosine (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class telomere-targeting agent. Telomeres and the enzyme telomerase are critical for the survival of cancer cells and their resistance to therapies. Ateganosine induces telomerase-dependent telomeric DNA modification, triggers DNA damage responses, and leads to selective cancer cell death. The therapy also generates telomeric DNA fragments that activate both innate (cGAS/STING) and adaptive (T-cell) immune responses. Preclinical models have shown that sequential ateganosine and PD-(L)1 inhibitor therapy can result in durable tumor regression and cancer-type specific immune memory.

Shareholder-Relevant & Price Sensitive Information

• The \$33 million capital raise is pivotal, ensuring MAIA does not require additional financing for its lead trial in the near term, which reduces dilution risk and reassures investors about the company’s financial position.
• The FDA Fast Track designation accelerates the path to approval and may lead to earlier market access if interim data are positive, making upcoming data readouts and regulatory interactions potentially significant share price catalysts.
• Positive interim Phase 3 data (expected next year) could support early regulatory approval discussions, which could be highly value-creating for shareholders.
• High technical success probability for Phase 3, as per company’s statistical assessments, increases the likelihood of a favorable outcome.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy and immuno-oncology company developing first-in-class drugs with novel mechanisms intended to improve and extend the lives of cancer patients. Ateganosine (THIO) is its lead program, targeting telomerase-positive NSCLC. For more information, visit www.maiabiotech.com.

Forward-Looking Statements Disclaimer

This article contains forward-looking statements that are subject to various risks and uncertainties. These statements are based on current expectations but are not guarantees of future performance. Actual results may differ materially due to market conditions, clinical trial outcomes, regulatory timelines, and other factors beyond the company’s control. Investors should review MAIA’s filings and consider all risks before making investment decisions.

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