MAIA

Company Overview — What Does MAIA Biotechnology, Inc. Do?

We are a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer. THIO, our lead asset, is an investigational dual mechanism of action drug candidate incorporating telomere targeting and immunogenicity. In July 2022, the first patient was administered with THIO in our Phase 2 human trial (THIO-101) in Australia. We have also submitted a similar application to conduct the same Phase 2 study in Europe. Patients with advanced Non-Small Cell Lung Cancer (NSCLC) will be treated first with THIO followed a few days later by the immune checkpoint inhibitor Libtayo® (cemiplimab) manufactured and commercialized by Regeneron. Cemiplimab is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. Cemiplimab has been approved in the United States and the rest of the world for multiple cancer indications, including NSCLC. In February 2021, we signed a clinical supply agreement with Regeneron to receive cemiplimab at no cost, which represents a significant cost-savings for the study. In return, we have granted Regeneron exclusive development rights in combination with PD-1 inhibitors for NSCLC for the study period. Based on the clinical data generated by our THIO-101 trial, in late 2024 we plan to seek an accelerated approval of THIO in the United States for the treatment of patients with advanced NSCLC, but even if granted, accelerated approval status does not guarantee an accelerated review or marketing approval by the FDA. In addition, in the First Quarter of 2023, we plan to initiate a pivotal Phase 2 clinical trial in patients with advanced colorectal cancer, hepatocellular carcinoma, and small cell lung cancer, of THIO administered in sequence with Anti-PD-1 or Anti-PD-L1 by end of 2023. Our Lead Product Candidate THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a telomere-targeting agent currently in clinical development to evaluate its activity in NSCLC. Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. THIO is being developed as a second- or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors. In 2019, our research team discovered that THIO produced telomere modifications and disruption, which ultimately induced cancer-specific innate and adaptive immune responses against immunologically “cold” or tumor types that were unresponsive to immune checkpoint inhibitors. This hypothesis was tested and demonstrated in syngeneic and humanized mouse models. THIO administered to mice in low doses and followed by an immune-checkpoint inhibiting agent, such as an anti-PD-1 or anti-PD-L1 compound, induced complete tumor regression with no tumor recurrence during the 14 weeks of observation. Further, no toxicities were reported in the tumor-free mice. These new findings were published in the peer-reviewed research scientific journal, Cancer Cell in July 2020. Based on these recent discoveries, a new therapeutic approach has been designed to advance THIO into a Phase 2 clinical trial (THIO-101) in patients with advanced NSCLC. Our regulatory strategy includes a planned filing of an Investigational New Drug application (IND) with the U.S. FDA. This would allow U.S. sites to participate in the THIO-101 NSCLC trial. The human safety data generated in Australia and Europe would constitute the basis of the IND application. Although we plan to rely solely on the safety and efficacy data we generate in our own clinical trials in support of our planned NDA filing, and do not plan to rely on clinical data generated by unaffiliated third parties, we take added confidence in the potential tolerability of THIO in light of the fact that the THIO doses we plan to test represent a range 4 to 40 times lower than the maximum tolerated dose tested in the earlier clinical trials sponsored by the National Cancer Institute in the 1970s. As part of the existing data base of clinical experience with the drug, we expect to reference the older NCI studies in the public domain as well as reference NCI’s original IND filing in support of an IND filing, pursuant to FDA regulations, and we are currently working with experts to evaluate the extent and quality of the existing data supporting THIO. We expect to request a pre-IND meeting with the FDA for guidance in 2022. The planned THIO-101 phase 2 trial is intended to be a proof-of-concept study that may be modified depending on interim results to include both primary and secondary endpoints and be consistent with previously approved cancer treatments. Based on the clinical data generated in the THIO-101 study and assuming THIO achieves its intended clinical effect with a manageable safety profile at one of the doses tested in the study, we expect to seek early FDA guidance on the possibility of utilizing one or more of FDA’s expedited programs for serious conditions, such as fast track designation, breakthrough therapy designation, priority review and/or accelerated approval designation. Even if granted, accelerated approval status does not guarantee an accelerated review or marketing approval by the FDA. The THIO-101 study protocol may need to be amended to increase the number of patients enrolled, undergo modification of the statistical analysis, or change in the trial design and/or primary endpoints. Our Science--Driven Telomere Targeting Approach Telomeres are regions of repetitive DNA nucleotide sequences that are associated with specialized proteins at the ends of linear chromosomes in cells. THIO’s mechanism of action comprises telomere targeting and induction of anti-cancer immunogenicity. The enzyme telomerase recognizes THIO’s metabolite formed in situ and incorporates it into the structure of the cancer cell’s telomeres, creating a faulty structure, which breaks apart the telomere spatial structure. As a result, the telomeric structure unwinds and the cancer cells die. We believe THIO transforms “cold” tumors into “hot” tumors rendering them responsive to immunotherapy (checkpoint inhibitors) and this process takes place promptly within 24 to 72 hours. We believe we can improve the immunotherapy efficacy and we can restore the immunotherapy efficacy in patients who have progressed or developed resistance to prior immunotherapy. Telomere maintenance is essential for cell proliferation and resilience in cancer cells, and thus represents one of the key therapeutic targets for cancer treatment. Telomerase is an enzyme that is present in a majority of human cancer cells (over 85% in the aggregate), across various tumor types. In contrast, its activity is detected in less than 1% of normal cells. THIO has only been shown to be active in cancer cells that are telomerase positive (TERT+). Cancer cells are constantly telomerase positive due to an uncontrolled division process, while a relatively small number of normal cells are telomerase positive only transiently. Therefore, THIO activity is expected to be highly specific to cancer cells versus normal cells. Cancer-specific disturbance of telomeric structure, mediated by telomerase, is likely to lead to disruption in the cell cycle, followed by a very rapid and telomere-length independent cell death. THIO was observed to induce cancer-specific telomere disruption, by using the enzyme telomerase, which differentiates THIO from all other available cancer therapies currently in clinical use. We are also currently developing potential next generation small molecule telomere modifying agents with the goal of identifying additional proprietary drug candidates, across multiple cancer types. We have generated 82 new telomere-targeting compounds of which 60 compounds have been evaluated in vitro. Currently, five molecules have been selected for further evaluation in additional in vitro and in vivo models. Human clinical trials prior to approval are typically conducted in three sequential Phases that may overlap or be combined. In Phase 1, the drug or biologic is initially introduced into healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion. In Phase 2, the drug or biologic is evaluated in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance, optimal dosage and dosing schedule for patients having the specific disease. In Phase 3, larger-scale clinical trials are undertaken to evaluate clinical efficacy and safety and the overall risk/benefit ratio of the product. Post-approval studies, or Phase 4 clinical trials, may be conducted voluntarily, or as a condition of FDA’s approval of a drug. These studies may be used to confirm preliminary efficacy results, gain additional experience from the treatment of certain patient populations, or to support additional indications or labeling changes. We completed our selection process for the clinical sites for our Phase 2 study in Australia and Europe and our application to start the Phase 2 study in Australia has been approved. In July 2022, the first patient was administered with THIO in our Phase 2 human trial (THIO-101) in Australia. We have also submitted a similar application to conduct the same Phase 2 study in Europe. In March 2022, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to THIO for the treatment of hepatocellular carcinoma and in May 2022, the FDA granted the second ODD to THIO for the treatment of small cell lung cancer. The FDA’s Office of Orphan Products Development may grant orphan designation status to drugs and biologics that are intended for the treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides certain benefits, including financial incentives, to support clinical development and the potential for up to seven years of market exclusivity for the drug for the designated orphan indication in the U.S. if the drug is ultimately approved for its designated indication. --- Our Second Generation Target Candidates Our THIO program drives our development pipeline of second-generation telomere targeting agents. We have initiated an early-stage research and discovery program aimed at identifying new compounds capable of acting through similar mechanisms of activity as THIO, such as the targeting and modifying telomeric structures of cancer cells through cancer-cell intrinsic telomerase activity. The main objective for this program is to discover new compounds with potentially improved specificity towards cancer cells relative to normal cells and with potentially increased anticancer activity. This program may also allow us to strengthen our patent portfolio. Although the program is in early stages and we may not be able to identify suitable compounds, we believe we will be able to create a second generation of THIO-like compounds. Our current 2nd-generation pipeline of potential telomere-targeting agents includes five compounds that have successfully undergone in vitro inhibitory testing in five cancer models. The data from those studies showed a significantly lower 50% inhibitory concentration (IC50) for those compounds compared to THIO. Based on those data, we have progressed those five compounds to in vivo testing and with proceeds from the IPO, we plan to initiate pre- clinical testing for at least two of them in mid-2022, with the goal of advancing at least one compound to clinical trials by the end of 2024. We were incorporated in Delaware in August 2018, and we have operations in Chicago, Illinois, with some of our team members setup virtually and working remotely in California, Nevada and Florida. Our principal executive office is located at 444 West Lake Street, Suite 1700, Chicago, IL. MAIA Biotechnology, Inc. (MAIA) is classified as a micro-cap stock in the Healthcare sector, specifically within the Pharmaceutical Products industry. The company is led by CEO Vlad Vitoc and employs approximately 9 people. With a market capitalization of $81M, MAIA is one of the notable companies in the Healthcare sector.

MAIA Biotechnology, Inc. (MAIA) Stock Rating — Avoid (April 2026)

As of April 2026, MAIA Biotechnology, Inc. receives a Avoid rating with a composite score of 28.1/100 and 1 out of 5 stars from the Blank Capital Research quantitative model.MAIA ranks #4,193 out of 4,446 stocks in our coverage universe. Within the Healthcare sector, MAIA Biotechnology, Inc. ranks #749 of 838 stocks, placing it in the lower half of its Healthcare peers. The rating is generated by a multi-factor model that weighs quality (30%), momentum (25%), value (15%), investment (10%), stability (10%), and short interest (10%).

MAIA Stock Price and 52-Week Range

MAIA Biotechnology, Inc. (MAIA) currently trades at $1.19. The stock lost $0.01 (0.8%) in the most recent trading session. The 52-week high for MAIA is $3.19, which means the stock is currently trading -62.7% from its annual peak. The 52-week low is $0.87, putting the stock 36.8% above its annual trough. Recent trading volume was 0 shares, suggesting relatively thin trading activity.

Is MAIA Overvalued or Undervalued? — Valuation Analysis

MAIA Biotechnology, Inc. (MAIA) carries a value factor score of 17/100 in the Blank Capital model, signaling premium valuation that prices in significant future growth. The price-to-book ratio stands at 30.64x, versus the sector average of 2.75x.

At current multiples, MAIA Biotechnology, Inc. trades at a premium to most Healthcare peers. This elevated valuation may be justified if the company can sustain above-average growth rates and profitability, but it also creates downside risk if earnings disappoint expectations.

MAIA Biotechnology, Inc. Profitability — ROE, Margins, and Quality Score

MAIA Biotechnology, Inc. (MAIA) earns a quality factor score of 7/100, signaling below-average profitability metrics relative to the broader market. The return on equity (ROE) is -905.1%, compared to the Healthcare sector average of -43.5%, which is below typical expectations for high-quality companies. Return on assets (ROA) comes in at -221.6% versus the sector average of -33.1%.

Profitability is below benchmark levels, which may reflect industry headwinds, elevated reinvestment, or structural challenges.

MAIA Debt, Balance Sheet, and Financial Health

MAIA Biotechnology, Inc. has a debt-to-equity ratio of 308.0%, compared to the Healthcare sector average of 32.0%. This elevated leverage warrants close monitoring, as it increases the company's sensitivity to rising interest rates and economic downturns. The current ratio is 1.66x, suggesting adequate working capital coverage. Total debt on the balance sheet is $0. Cash and equivalents stand at $11M.

MAIA has a beta of 0.77, meaning it is less volatile than the S&P 500, making it a relatively defensive holding. The stability factor score for MAIA Biotechnology, Inc. is 37/100, suggesting elevated price swings that may be unsuitable for conservative portfolios.

MAIA Biotechnology, Inc. Revenue and Earnings History — Quarterly Trend

In TTM 2026, MAIA Biotechnology, Inc. reported revenue of $0 and earnings per share (EPS) of $-0.70. Net income for the quarter was $-22M. Operating income came in at $-24M.

In FY 2025, MAIA Biotechnology, Inc. reported revenue of $0 and earnings per share (EPS) of $-0.70. Net income for the quarter was $-22M. Operating income came in at $-24M.

In Q3 2025, MAIA Biotechnology, Inc. reported revenue of $0 and earnings per share (EPS) of $-0.27. Net income for the quarter was $-9M. Operating income came in at $-9M.

In Q2 2025, MAIA Biotechnology, Inc. reported revenue of $0 and earnings per share (EPS) of $-0.18. Net income for the quarter was $-5M. Operating income came in at $-5M.

Over the past 8 quarters, MAIA Biotechnology, Inc. has experienced revenue contraction from $0 to $0. Investors analyzing MAIA stock should weigh these quarterly trends alongside the valuation and quality metrics discussed above.

MAIA Dividend Yield and Income Analysis

MAIA Biotechnology, Inc. (MAIA) does not currently pay a dividend. This is common among smaller companies in the Pharmaceutical Products industry that prefer to reinvest cash flows into business expansion rather than returning capital to shareholders. Income-focused investors looking for Healthcare dividend stocks may want to explore other Healthcare stocks or use the stock screener to filter by dividend yield.

MAIA Momentum and Technical Analysis Profile

MAIA Biotechnology, Inc. (MAIA) has a momentum factor score of 44/100, reflecting neutral trend characteristics. The stock is neither significantly outperforming nor underperforming the broader market on a momentum basis. The investment factor score is 25/100, which measures capital allocation efficiency and asset growth patterns. The short interest score of 64/100 reflects moderate short selling activity.

MAIA vs Competitors — Healthcare Sector Ranking and Peer Comparison

Within the Healthcare sector, MAIA Biotechnology, Inc. (MAIA) ranks #749 out of 838 stocks based on the Blank Capital composite score. This places MAIA in the lower half of all Healthcare stocks in our coverage universe. Key competitors and sector peers include ASTRAZENECA PLC (AZN) with a score of 61.4/100, Sol-Gel Technologies Ltd. (SLGL) with a score of 56.6/100, VIEMED HEALTHCARE, INC. (VMD) with a score of 53.4/100, Innoviva, Inc. (INVA) with a score of 52.7/100, and JOHNSON & JOHNSON (JNJ) with a score of 51.7/100.

Comparing MAIA against the S&P 500 benchmark is also instructive for understanding relative performance. Investors can view the full MAIA vs S&P 500 (SPY) comparison to assess how MAIA Biotechnology, Inc. stacks up against the broader market across all factor dimensions.

MAIA Next Earnings Date

No upcoming earnings date has been announced for MAIA Biotechnology, Inc. (MAIA) at this time. Check the earnings calendar for the latest scheduling updates across all stocks in our coverage universe.

Should You Buy MAIA? — Investment Thesis Summary

The quantitative profile for MAIA Biotechnology, Inc. suggests caution. The quality score of 7/100 flags below-average profitability. The value score of 17/100 indicates premium valuation. High volatility (stability score 37/100) increases portfolio risk.

In summary, MAIA Biotechnology, Inc. (MAIA) earns a Avoid rating with a composite score of 28.1/100 as of April 2026. The rating is derived from the Blank Capital Research methodology, which combines six factor dimensions into a single quantitative ranking. Investors should consider these quantitative signals alongside their own fundamental research, risk tolerance, and investment time horizon before making buy or sell decisions on MAIA stock.

Related Resources for MAIA Investors

Explore more research and tools: MAIA vs S&P 500 comparison, top Healthcare stocks, stock screener, our methodology, quality factor explained, value factor explained, momentum factor explained. Compare MAIA head-to-head with peers: MAIA vs AZN, MAIA vs SLGL, MAIA vs VMD.