MAIA Biotechnology, Inc.

What they do

MAIA is developing ateganosine, an investigational dual mechanism drug candidate combining telomere targeting and immunogenicity, as a second- or later-line treatment for NSCLC patients who have progressed beyond checkpoint inhibitors. Its Phase 2 THIO-101 trial in Australia and three European countries (Hungary, Poland, Bulgaria) sequences ateganosine followed by Regeneron's Libtayo (cemiplimab), supplied at no cost under a February 2021 clinical supply agreement. The company was incorporated in Delaware in August 2018 and operates from Chicago, Illinois, with subsidiaries in Australia (July 2021) and Romania (April 2022).

Revenue drivers

• Ateganosine (THIO) — lead asset — Pre-revenue; no product sales recorded in 2022, 2023 or 2024. Value depends on clinical success and potential regulatory approval in NSCLC.
• THIO-101 Phase 2 trial — Ongoing trial of ateganosine sequenced with Regeneron's cemiplimab in advanced NSCLC; enrollment in Australia and approved in Hungary, Poland and Bulgaria. A July 2025 expansion added up to 48 third-line patients across a cemiplimab combination arm and a monotherapy arm.
• THIO-104 Phase 3 pivotal trial — Initiated in 2025; multicenter, open-label, 1:1 randomized trial of up to 300 third-line NSCLC patients resistant to checkpoint inhibitors and chemotherapy, comparing ateganosine plus a checkpoint inhibitor against chemotherapy.
• Planned Phase 2 programs (HCC, CRC, SCLC) — The former THIO-102 multi-tumor plan was split into separate trials for hepatocellular carcinoma, colorectal cancer and small cell lung cancer, planned to start in 2026 with BeOne Medicines' tislelizumab.

Recent performance

MAIA has never reported revenue; annual revenue was $0.00 in 2022, 2023 and 2024. Net loss widened from $12.6M in 2021 to $23.3M in 2024, then narrowed slightly to $22.4M in 2025; diluted EPS improved from -$2.37 in 2021 to -$0.70 in 2025. Operating cash use rose from $4.1M in 2021 to $18.8M in 2025. At June 30, 2026, total assets were $28.2M, total liabilities $7.6M and shareholder equity $20.7M, with cash and equivalents reported at $0.00.

Strategy

MAIA's stated priority is advancing ateganosine in NSCLC, where it plans to seek accelerated FDA approval in 2026 based on THIO-101 data, while running the THIO-104 Phase 3 trial initiated in 2025. It intends to initiate separate Phase 2 trials in HCC, CRC and SCLC in 2026, evaluating ateganosine sequenced with BeOne Medicines' tislelizumab, and may consider other solid tumors such as breast, prostate, gastric, pancreatic and ovarian. The company relies on third-party manufacturers and clinical trial partners, including Regeneron for cemiplimab supply and exclusive development rights in combination with PD-1 inhibitors for NSCLC during the study period.

Risks

• No revenue and recurring losses — MAIA has reported $0.00 revenue in each of 2022, 2023 and 2024, with net losses of $23.3M in 2024 and $22.4M in 2025 and operating cash use of $18.8M in 2025.
• Clinical and regulatory uncertainty — Ateganosine remains investigational; the company plans to seek accelerated approval in 2026, but even if granted, accelerated approval status does not guarantee accelerated review or FDA marketing approval.
• Liquidity and financing need — The June 30, 2026 balance sheet showed $28.2M in total assets against $7.6M of liabilities, with cash and equivalents reported at $0.00, so operations depend on obtaining additional funding.
• Wainwright litigation — On April 22, 2026, H.C. Wainwright & Co. sued in New York Supreme Court for breach of a right of first refusal tied to a March 2026 securities offering, seeking $2,310,616.88 in cash and warrants for 1,540,411 shares at $1.875; MAIA filed a motion to dismiss on June 26, 2026.

Outlook

Management plans to seek accelerated FDA approval of ateganosine for advanced NSCLC in 2026 based on THIO-101 data, while continuing the Phase 3 THIO-104 trial and initiating Phase 2 trials in HCC, CRC and SCLC in 2026. The company disclosed it has no revenue and depends on external funding to develop and potentially commercialize its drug candidates. It also flagged that accelerated approval status, even if granted, does not guarantee accelerated review or marketing approval.