MAIA Biotechnology, Inc. Annual Review for Investors

This guide provides a simple overview of MAIA Biotechnology, Inc.'s performance for the year ending December 31, 2025. It uses their annual report. It shows you the company's business and financial health. This helps you decide if you want to invest.

How They're Funding Their Future

First, let's look at how MAIA Biotechnology funds its work. They raised money in many ways during 2025 and early 2026.

MAIA used 'private placements' and 'registered direct offerings'. These are ways the company gets money directly from specific investors. They do not sell shares to the public this way. They also issued 'investor warrants.' These are like coupons that let investors buy more shares later at a set price. They also issued 'restricted stock,' often for employees or directors as pay. In early 2026, they had an 'underwritten public offering.' This means they sold shares to the public through investment banks to raise money.

MAIA constantly raises money. Biotech companies need much funding for research, trials, and product launch. This is typical. For example, in June 2024, they secured over $12 million in insider investment. This means company insiders invested their own money. This shows they finance their goals. But watch out: issuing more shares or warrants can reduce your ownership percentage as a shareholder.

A Quick Look at MAIA

Here's a quick look at MAIA Biotechnology.

• Where they trade: MAIA's common stock trades on the NYSE American exchange. Its ticker symbol is MAIA.
• Company Size & Status: MAIA is a "smaller reporting company" and an "emerging growth company." What does this mean?
  • Smaller reporting company: This means they have less than $250 million in public shares. Or, they have less than $100 million in yearly sales. This allows them to report less, which saves money.
  • Emerging growth company: They had less than $1.235 billion in yearly sales last year. This gives them regulatory breaks for a few years. For example, they have fewer reporting rules, which helps them grow.
• Market Value: On June 30, 2025, shares held by the public were worth about $48.9 million. This shows the company's market size.
• Shares Outstanding: As of March 23, 2026, MAIA had about 60.7 million common shares. This number helps you understand the company's total ownership.
• When they started: MAIA began in Delaware in August 2018. They operate in Chicago, Illinois. Team members work remotely across the US. Subsidiaries in Australia and Romania help with research.

What MAIA Does (Their Main Focus)

MAIA Biotechnology develops new medicines. They focus on targeted immunotherapies for cancer. They help your body's immune system fight cancer better.

Their main focus is Ateganosine (also known as THIO). This drug works in two ways. It targets 'telomeres,' protective caps on our DNA ends. Telomeres often help cancer cells grow. It also boosts the immune system's cancer response. This approach got a big boost in June 2024. The FDA approved a similar drug from Geron Corporation. This confirms MAIA's strategy. They also plan for the future. In February 2024, they applied for a patent for new "dinucleotides." These are next-generation telomere-targeting agents. They could expand MAIA's treatment options. In March 2025, the USAN Council approved "ateganosine" as the generic name. This helps doctors and researchers communicate clearly.

MAIA develops Ateganosine for Non-Small Cell Lung Cancer (NSCLC). It targets patients who did not respond to other treatments. They plan to use Ateganosine as a "second- or later line of treatment."

In 2019, MAIA's research found Ateganosine affects telomeres. It also triggers the immune system to attack "cold" tumors. These tumors usually resist immune-boosting drugs. Mouse studies showed promising results. Ateganosine, followed by another immune drug, made tumors disappear. There were no harmful side effects. They published this research in 2020.

Beyond NSCLC, MAIA explores other uses. In April 2023, they shared preclinical data for Ateganosine. These studies, not yet in humans, focused on Hepatocellular Carcinoma (HCC), a liver cancer. In lab models, Ateganosine alone caused complete, lasting responses. Combined with another immune drug, effects were stronger. It even prevented tumor regrowth. This suggests Ateganosine has broader potential.

In March 2025, MAIA published new preclinical data. A dimer (double-molecule) of Ateganosine inhibited GSTP1. This enzyme helps cancer grow and resist drugs. This new Ateganosine form could boost chemotherapy. In July 2025, they published data on second-generation Ateganosine prodrugs. These drugs aim to improve cancer treatment and fight drug resistance. This expands their drug platform. In June 2025, MAIA partnered with Roche. They will study Ateganosine with Roche's atezolizumab (Tecentriq®). This combination targets various hard-to-treat cancers. It shows MAIA seeks more uses for its drug.

Looking Ahead: Second-Generation Drugs

MAIA also develops next-generation telomere-targeting agents. They found 82 new compounds. They tested 60 in labs. They chose 7 promising molecules for lab and animal tests. These new compounds showed better lab results than Ateganosine. This means they might work better at lower doses.

By January 2023, they picked two lead candidates: MAIA-2021-20 and MAIA-2022-12. In June 2023, they picked a third: MAIA-2021-029. They will move these into advanced preclinical studies. They hope to start human trials eventually. To protect these future drugs, MAIA filed three patent applications. These cover second-generation compounds in many countries. This includes the US, Europe, Australia, and Asia. More filings are planned for March 2026. This shows their long-term drug development and intellectual property strategy.

Building an Expert Team: Scientific Advisory Board

MAIA builds a strong Scientific Advisory Board (SAB). These external experts guide drug development and strategy. Top doctors and researchers bring specialized knowledge. They help MAIA with Ateganosine trials and approvals for various cancers.

For example, in June 2025, MAIA appointed HCC specialists. This supports their focus on Hepatocellular Carcinoma (HCC). These include Dr. David J. Pinato, a liver cancer expert. He is Director at Imperial College in London. Dr. Claudia A.M. Fulgenzi also joined. She specializes in liver and gastrointestinal cancers.

They added other key experts:

• Dr. Remus Vezan (BeOne Medicines) brings over 20 years of drug development experience. This includes cell and gene therapies. He helped approve major drugs like TECARTUS®, YESCARDA®, and IMBRUVICA®. He will help develop and approve ateganosine for many tumor types.
• Dr. Saadettin Kiliçkap (İstinye University, Türkiye) is a published researcher. He is an experienced clinical trial investigator. He will help develop ateganosine for solid tumors. These include lung, breast, melanoma, and gastrointestinal cancers.

MAIA brings in top talent. This strengthens development and expands reach into more cancer types.

Their Progress in Clinical Trials (Ateganosine's Journey)

MAIA tests Ateganosine in people. Here's their progress:

Ateganosine is not a new drug. The National Cancer Institute studied it in the 1970s and early 1980s. They ran at least 19 clinical trials. Over 600 cancer patients (adults and children) participated. They tested it alone and with other treatments. Back then, they often used the "maximum tolerated dose." This was the highest dose patients could handle. Results looked promising. But development stopped. Researchers likely didn't know how the drug fully worked.

Today's standards show these older studies have limits. They did not follow modern "Good Clinical Practices." These are strict rules for trials. So, they often lacked details. For example, they missed specific results, serious side effects, or statistical significance. Despite these gaps, MAIA believes Ateganosine has a well-established safety profile. They are now confirming this in modern studies. Interestingly, older studies focused on heavily pretreated patients. Their cancers resisted other therapies. This is very similar to MAIA's target patients today.

• Phase 2 Trial (THIO-101) for NSCLC: This trial began in Australia in July 2022. It expanded to Hungary, Poland, and Bulgaria in December 2022. The US FDA approved an Investigational New Drug (IND) application in 2023. This allowed US sites to join. Patients with advanced NSCLC first receive Ateganosine. A few days later, they get Libtayo® (cemiplimab). Regeneron makes this immune-boosting drug. MAIA gets Libtayo® free for the study. Regeneron gets rights to develop the combination.
  • Early Safety & Efficacy: In April 2023, MAIA announced positive early safety data. Ateganosine plus Libtayo® was well tolerated. Patients had no serious side effects. They also shared exciting survival data. Two heavily pretreated Stage IV cancer patients lived for 10 and 9 months. They were progression-free for 7 and 6 months. This is much longer than the typical 3-4 months for such patients.
  • Continued Positive Updates: These early results kept improving. In July 2023, the same two patients lived for 12.2 and 11.5 months. They remained progression-free for 10.2 and 8.5 months without more treatment. Also in July 2023, MAIA reported 82% of 11 patients achieved "disease control." This means their cancer shrank, partially shrank, or stayed stable. This is a strong early sign.
  • Impressive Disease Control Rate (DCR): In October 2023, MAIA reported a 100% interim DCR. This was for second-line treatment. It far surpassed the standard of care (SoC) DCR of 53-64%. DCR often predicts how long patients live.
  • Dose Selection & Enrollment Completion: In December 2023, MAIA chose 180mg/cycle as the best Ateganosine dose. This was based on safety and efficacy. By February 2024, they finished enrolling patients for this dose. They reached their target of 41 patients early. A total of 79 patients received Ateganosine across all tested doses.
  • Strong Efficacy Data in 2024 & 2025:
    • March 2024 data showed a 38% overall response rate (ORR). This means tumors shrank significantly. This was for the 180mg dose in third-line NSCLC patients. This is much better than the typical 6-10% ORR for chemotherapy. The disease control rate stayed high at 85%. Chemotherapy's DCR is 25-35%. They also reported 75% of patients lived longer than 5.8 months (overall survival). And 88% lived longer than 2.5 months without disease worsening (progression-free survival).
    • June 2024 updates confirmed these findings. The 180mg dose showed a median PFS of 5.5 months. It also showed a 78% OS rate at 6 months in third-line patients.
    • In February 2025, MAIA announced updated data. Median overall survival (OS) was 16.9 months for 22 NSCLC patients. The 95% confidence interval's lower bound was 12.5 months. This is impressive for heavily pretreated patients. This positive trend continued. In June 2025, median OS increased to 17.8 months for the same group. The strong confidence interval remained.
  • Long-Term Survival & Safety: By July 2024, 6 patients stayed on treatment for over 12 months. The longest-treated finished 21 cycles. The treatment showed lower toxicity than standard care. In September 2024, MAIA announced 16 patients survived over 12 months. Interim median survival for third-line patients reached 10.6 months. This far surpassed the standard-of-care OS of 5.8 months. In September 2025, two patients completed 33 cycles of therapy. This suggests Ateganosine could offer extended dosing and longer survival. In October 2025, one patient, starting therapy in March 2023, survived 30 months (912 days). This is outstanding for high-risk cancers. The treatment was generally well-tolerated in these pre-treated patients. In June 2025, one patient showed a new partial response. This means their tumor shrank significantly after 20 months of treatment.
  • Expansion & Latest Enrollment: In December 2024, MAIA changed its Regeneron agreement. They expanded the THIO-101 trial. It now focuses on NSCLC patients resistant to checkpoint inhibitors and chemotherapy. In February 2025, MAIA announced the expansion's detailed design. It will assess overall response rates in advanced NSCLC patients getting third-line therapy. This expansion has two groups. One continues Ateganosine + Libtayo®. The other tests Ateganosine alone (monotherapy). This helps understand its individual effect. The company plans to enroll 100 more patients for the trial's registration phase. They will conduct it in the U.S., Europe, and Asia. In July 2025, the first patient in Taiwan received a dose. This was a key milestone, opening a larger patient pool. By October 2025, five patients from Taiwan and Turkey enrolled. By November 2025, this grew to 12 patients. They came from Taiwan, Turkey, Hungary, and Poland. Romania also joined for screening.
• Aiming for Accelerated Approval: MAIA plans to seek accelerated approval for Ateganosine in the US. This is for advanced NSCLC in 2026. This plan uses THIO-101 trial data. In July 2025, the FDA granted Fast Track Designation. This speeds up development and review for serious conditions. It also helps drugs that meet unmet medical needs. Remember, "accelerated approval" does not guarantee faster review. It also does not guarantee final FDA approval. But it is a positive step.
• Phase 3 Trial (THIO-104): In February 2025, MAIA announced a larger Phase 3 trial. It is called THIO-104 and starts in 2025. This trial compares Ateganosine (with a checkpoint inhibitor) to standard chemotherapy. It will include up to 300 NSCLC patients resistant to prior treatments. This multicenter, open-label study means many locations will participate. Both patients and researchers will know the treatment given. Patients will randomly receive either Ateganosine with a checkpoint inhibitor or standard chemotherapy. In December 2025, the first patient received a dose in THIO-104. They secured approvals in Taiwan, Turkey, some European countries, and Georgia.
• New Trials on the Horizon: MAIA plans more.
  • They split their broad Phase 2 trial plans. Now they have separate studies for other cancers. These include liver cancer (HCC), colorectal cancer (CRC), and small cell lung cancer (SCLC). These Phase 2 trials start in 2026. They will test Ateganosine with tislelizumab from BeOne Medicines. MAIA announced this partnership in January 2025. MAIA sponsors the trials; BeOne Medicines provides its drug.
  • They also consider trials for other solid tumors. These include breast, prostate, and ovarian cancer later.
• Special Regulatory Designations:
  • In March 2022, the FDA gave Ateganosine Orphan Drug Designation (ODD). This was for treating Hepatocellular Carcinoma (HCC).
  • In May 2022, they granted a second ODD for Small Cell Lung Cancer (SCLC).
  • In late 2023, a third ODD was granted for Malignant Gliomas Brain Cancer.
  • What does Orphan Drug Designation mean? It is for drugs treating rare diseases. These affect fewer than 200,000 people in the U.S. This designation offers benefits. These include financial help for development. It also offers seven years of market exclusivity in the U.S. if approved. This applies to that specific rare condition.
  • In December 2024, the FDA named Ateganosine a "rare pediatric disease" drug (RPDD). This was for pediatric-type diffuse high-grade gliomas (PDHGG). If approved for this, MAIA could get a valuable priority review voucher (PRV). This voucher speeds up FDA review for another drug. Or, MAIA could sell it to another company. PRVs have sold for an average of $100 million. This makes them a significant potential asset.
  • In July 2025, the FDA granted Fast Track Designation for Ateganosine. This was for treating NSCLC. This designation speeds up drug development and review. It applies to serious conditions and unmet medical needs. If criteria are met, a Fast Track drug can get Accelerated Approval and Priority Review. This could get drugs to patients faster.
• Safety Notes: The US FDA approved MAIA to run trials in the US (IND approval). The current Ateganosine dose is 14 times lower than in 1970s trials. This suggests patients might tolerate it much better.

What They're Hoping For (Future Outlook & Risks)

Like all drug developers, MAIA has big future plans. Their main goal is to lead in cancer treatments. They target telomeres and similar small molecules. They want to position Ateganosine to "prime" the immune system. This helps it better respond to all immune-activating cancer drugs. They aim to:

• Secure enough funding for drug development. Their private placements and insider investments show this.
• Get FDA clearance for trials and drug approval. The July 2025 Fast Track Designation helps speed up review. They also explore Breakthrough Therapy Designation and Priority Review.
• Successfully complete clinical trials. They must show Ateganosine is safe and effective. THIO-101's positive survival data is encouraging. They set key milestones for 2026. These include early efficacy measures from their Phase 3 study. For example, disease control rates, overall response rates, and progression-free survival.
• Build teams and infrastructure to sell and market approved drugs.
• Protect their intellectual property. This means their unique discoveries and drugs. This is crucial for a biotech company. Their drugs are their main assets. MAIA actively protects them:
  • They hold 3 issued US patents and 9 issued foreign patents for Ateganosine. They also have 4 pending US patent applications and 11 pending foreign patent applications. This shows broad global protection for their lead drug.
  • They have a key agreement with UT Southwestern Medical Center (UTSW). They updated it in December 2020. MAIA secured an exclusive, worldwide license to develop and sell Ateganosine. This license uses key UTSW patent families. These patents cover important "methods of use" for Ateganosine. This means how doctors use the drug to treat diseases.
  • Key licensed patents include:
    • US patent no. 10,463,685. It protects how Ateganosine alters telomeres. It expires in April 2034.
    • US patent no. 12,070,472. It relates to treating drug-resistant cancers. It expires in March 2037.
    • A pending US application (No. 18/511,417). This is for treating pediatric brain tumors. If granted, it would expire earliest in March 2039.
  • They also have a non-exclusive license for other UTSW technologies. They protect their next-generation compounds too. Patent applications for these newer drugs show this. The August 2025 European Patent Office grant covers Ateganosine-based analogues. MAIA's full intellectual property for Ateganosine includes these. It also includes new filings for second-generation compounds. This broad approach gives them a strong competitive edge for years.

However, these are forward-looking statements. They are plans and expectations, not guarantees. Developing new drugs is long, expensive, and risky. Clinical trials might not go as planned. Regulatory approvals might not happen. They might face competition. MAIA itself states actual results could differ from expectations.