Company confirms 12 patients enrolled in Phase 2 THIO-101 to date as expansion trial adds new countries Posters for Phase 2 and Phase 3 clinical trials available CHICAGO , Nov. 21, 2025 (GLOBE NEWSWIRE) -- MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced highlights from two poster presentations delivered at SITC 2025, an annual conference hosted by the Society for Immu ...

Core Insights - MAIA Biotechnology has initiated patient enrollment in Romania for the Phase 2 THIO-101 Part C study, focusing on ateganosine as a treatment for advanced non-small cell lung cancer (NSCLC) patients [1][2] - The company aims to provide a promising alternative for NSCLC patients who have limited treatment options, with ateganosine showing a 38% response rate compared to current treatments with response rates of up to 6% [2][3] - The expansion of the study in Romania is part of MAIA's strategy to accelerate patient access to innovative therapies and pursue accelerated approval in the U.S. [2] Company Overview - MAIA Biotechnology is a clinical-stage biopharmaceutical company dedicated to developing targeted immunotherapies for cancer, with a focus on ateganosine as a potential first-in-class telomere-targeting agent for NSCLC [1][7] - The company received FDA's Fast Track Designation for ateganosine in July, which supports its goal of expedited development and review [2] Clinical Trial Details - The THIO-101 Phase 2 clinical trial is a multicenter, open-label study designed to evaluate the anti-tumor activity of ateganosine followed by PD-(L)1 inhibitors in advanced NSCLC patients who have previously shown resistance to other treatments [5][6] - The trial has two primary objectives: assessing the safety and tolerability of ateganosine and evaluating its clinical efficacy using Overall Response Rate (ORR) as the primary endpoint [5][6] Treatment Mechanism - Ateganosine works by inducing telomerase-dependent telomeric DNA modification, leading to selective cancer cell death and activation of immune responses [4] - The treatment aims to enhance and prolong immune response in patients with advanced NSCLC who have not responded to prior therapies [5]

Drug Development - The company is developing ateganosine, a dual mechanism drug candidate targeting lung cancer, with over 235,000 new cases expected in the US in 2024, representing 12% of all cancers [138]. - The Phase 2 trial (THIO-101) for ateganosine in advanced Non-Small Cell Lung Cancer (NSCLC) began in July 2022, with plans for accelerated approval filing in the US by 2026 [138]. - The company plans to initiate a Phase 3 pivotal trial (THIO-104) in 2025, comparing ateganosine with chemotherapy in up to 300 patients resistant to previous treatments [140]. - The company plans to initiate Phase 2 trials for ateganosine in hepatocellular carcinoma, colorectal cancer, and small cell lung cancer in 2026 [138]. - A clinical supply agreement with BeOne Medicines was established in January 2025 to assess ateganosine in combination with tislelizumab for three cancer indications [140]. - A new partial response was identified in a patient after 20 months of treatment in the Phase 2 THIO-101 clinical trial, defined as a decrease in tumor size of at least 30% [142]. - The median overall survival (OS) for patients in the THIO-101 trial was reported at 17.8 months as of May 15, 2025, with a 95% confidence interval lower bound of 12.5 months [141]. - The estimated median overall survival (OS) in the THIO-101 trial was 17.8 months, with a 95% confidence interval lower bound of 12.5 months [142]. Financial Performance - The company raised approximately $2.72 million from a private placement of 1,810,000 shares at $1.50 per share in February 2025 [140]. - Under the At The Market Offering Agreement, the company sold 2,086,312 shares at an average price of $1.81 per share, resulting in net proceeds of approximately $3.66 million [141]. - The company received gross proceeds of approximately $2.25 million from a private placement of 1,733,766 shares at a price of $1.30 per share [146]. - The net loss attributable to MAIA Biotechnology, Inc. shareholders for the three months ended September 30, 2025, was $8.90 million, a 225% increase from $2.74 million in the same period of 2024 [145]. - Research and development expenses increased by approximately $3.69 million (138%) from $2.67 million for the three months ended September 30, 2024, to $6.36 million for the same period in 2025 [145]. - General and administrative expenses rose by approximately $1.48 million (97%) from $1.52 million in Q3 2024 to $3.00 million in Q3 2025 [148]. - Total operating costs and expenses for the three months ended September 30, 2025, were $9.36 million, a 123% increase from $4.19 million in the same period of 2024 [145]. - Research and development expenses for the nine months ended September 30, 2025, were approximately $12.67 million, an increase of 80% from $7.04 million in the same period of 2024 [150]. - Other income (expense), net increased by approximately $8.92 million (115%) from a net loss of $7.73 million for the nine months ended September 30, 2024, to a net income of $1.19 million for the same period in 2025 [153]. Capital and Cash Management - As of September 30, 2025, the company's cash totaled approximately $10,892,000, an increase of approximately $1,290,000 compared to December 31, 2024 [154]. - The company reported a working capital of approximately $1,761,000, a decrease of approximately $4,561,000 compared to December 31, 2024 [154]. - For the nine months ended September 30, 2025, net cash used in operating activities was approximately $11,824,000, compared to $11,796,000 for the same period in 2024 [169]. - Net cash provided by financing activities was approximately $13,104,000 for the nine months ended September 30, 2025, compared to $13,331,000 for the same period in 2024 [174]. - The company issued and sold 2,496,318 shares of Common Stock at a price of $1.17 per share on March 14, 2024, generating gross proceeds of approximately $2.92 million [157]. - The company plans to allocate up to 90% of its corporate treasury reserves to acquire and hold Digital Assets, including Bitcoin and Ether, under the Digital Asset Treasury Plan adopted on October 6, 2025 [156]. - The company launched a new digital asset treasury strategy focused on top-tier cryptocurrency assets, with up to 90% of liquid assets authorized for investment in cryptocurrencies [146]. - For the nine months ended September 30, 2025, the effect of foreign currency exchange rate changes increased the cash balance by approximately $10,000 [172]. Going Concern and Capital Needs - The company has substantial doubt about its ability to continue as a going concern within one year after the issuance of its financial statements due to ongoing losses and lack of revenue [155]. - The company needs to raise additional capital to fund operations and develop new products, with no assurance that financing will be available on acceptable terms [168]. Corporate Structure - The company has established subsidiaries in Australia and Romania to conduct preclinical and clinical activities for its product candidates [139].

Core Insights - MAIA Biotechnology, Inc. is advancing its THIO-101 Phase 2 clinical trial, with the first five patients enrolled in the expansion phase in Taiwan and Turkey, indicating progress in its development of targeted immunotherapies for cancer [1][2][3] Company Overview - MAIA is a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, with its lead program being ateganosine (THIO), a potential first-in-class telomere-targeting agent for non-small cell lung cancer (NSCLC) [1][8] - The company aims to improve and extend the lives of cancer patients through innovative therapies [8] Clinical Trial Details - The THIO-101 trial is a multicenter, open-label, dose-finding Phase 2 study designed to evaluate the anti-tumor activity of ateganosine followed by PD-(L)1 inhibitors in patients with advanced NSCLC who have shown resistance to prior treatments [7] - The trial has two primary objectives: to assess the safety and tolerability of ateganosine and to evaluate its clinical efficacy using Overall Response Rate (ORR) as the primary endpoint [7] Scientific Insights - Ateganosine works by inducing telomerase-dependent telomeric DNA modification, leading to selective cancer cell death and activation of immune responses [6] - The treatment has shown promise in preclinical models, suggesting potential for profound tumor regression in advanced cancer cases [6] Market Context - Lung cancer, particularly NSCLC, remains a significant public health challenge, especially in regions like Turkey where smoking and air pollution are major contributors to the disease [3][4] - The high prevalence of smoking accounted for 89.6% of lung cancer cases in Turkey, highlighting the urgent need for effective treatment options [4]

Outstanding measure of efficacy relative to high-risk cancers with limited treatment options CHICAGO, Oct. 23, 2025 (GLOBE NEWSWIRE) -- MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced highlights from a recent presentation at the European Society for Medical Oncology (ESMO) Congress 2025 held in Berlin, Germany. Starting October 19, 2025, MAIA showcased two e-posters a ...

CHICAGO, IL, Oct. 13, 2025 (GLOBE NEWSWIRE) -- MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 603,769 shares of common stock at a purchase price of $1.22 per share, in a private placement to accredited investors. Each share of common stock is being offered together with a warrant to pur ...

Core Viewpoint - MAIA Biotechnology has adopted a bold strategy by allocating up to 90% of its liquid assets into cryptocurrencies, marking a significant shift for a traditional biotech firm [1][4]. Company Overview - MAIA Biotechnology is a clinical-stage biopharma company based in Chicago, focusing on developing targeted immunotherapies for cancer, particularly its THIO therapy for telomerase-positive cancer cells [3][4]. Financial Impact - Following the announcement of the cryptocurrency allocation, MAIA's stock price increased over 8% intraday, rising from $1.74 to a high of $1.97 before settling in the mid-$1.70 range [2]. Investment Strategy - The company aims to diversify its investment portfolio by investing in leading cryptocurrencies such as Bitcoin, Ethereum, and USD Coin, while maintaining adequate working capital for business operations [5][6]. - MAIA's CEO emphasized a disciplined approach, targeting high-quality tokens to minimize risk and maximize potential returns for shareholders [6]. Governance and Oversight - MAIA plans to establish a Digital Assets Advisory Board to oversee its financial activities and ensure compliance with cybersecurity measures and accounting rules [6]. Industry Context - This move positions MAIA among a select group of non-tech, non-crypto public companies that are aggressively allocating treasury assets into digital currencies [7].

Core Insights - MAIA Biotechnology has authorized the allocation of up to 90% of its liquid assets in cryptocurrencies, specifically Bitcoin (BTC), Ethereum (ETH), and USD Coin (USDC) [1][2] - The company aims to diversify its investment portfolio through a new digital asset treasury strategy, focusing on high-quality cryptocurrency tokens to minimize risk while seeking strong returns [3] Group 1: Digital Asset Strategy - The Board of Directors has approved a strategy to hold a significant portion of liquid assets in cryptocurrencies, with corporate officers authorized to manage these transactions [2] - MAIA's CEO emphasized a disciplined approach to investing in cryptocurrencies, targeting only the highest-quality tokens to enhance shareholder value while maintaining adequate working capital [3] Group 2: Company Overview - MAIA Biotechnology is a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, with its lead program being ateganosine (THIO) for treating NSCLC patients [4]

CHICAGO, IL, Sept. 29, 2025 (GLOBE NEWSWIRE) -- MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 1,733,766 shares of common stock at a purchase price of $1.30 per share, in a private placement to accredited investors and a Company director. Each share of common stock is being offered toge ...

Core Insights - MAIA Biotechnology, Inc. has received a $2.3 million grant from the National Institutes of Health (NIH) to expand its THIO-101 Phase 2 clinical trial for advanced non-small cell lung cancer (NSCLC) [1][2][3] - The trial aims to enroll U.S. patients who are resistant to chemotherapy and immunotherapy, with the grant funding distributed over three years from 2025 to 2027 [2][3] - The median overall survival for patients in the third-line treatment of the trial was reported at 17.8 months, significantly higher than the 5 to 6 months observed with standard chemotherapy treatments [3][6] Company Overview - MAIA Biotechnology is focused on developing targeted immunotherapies for cancer, with its lead program being ateganosine, a first-in-class telomere-targeting agent for NSCLC [5][8] - The company aims to address the significant unmet clinical need in third-line NSCLC treatment, where no established standard of care currently exists [3][5] - The THIO-101 trial is designed to evaluate the safety and efficacy of ateganosine when followed by PD-(L)1 inhibitors, targeting patients who have progressed after previous treatments [6][7] Clinical Trial Details - THIO-101 is a multicenter, open-label, dose-finding Phase 2 clinical trial that tests the hypothesis that ateganosine can enhance immune response when administered before cemiplimab [6][7] - The trial has two primary objectives: to evaluate the safety and tolerability of ateganosine and to assess its clinical efficacy using Overall Response Rate (ORR) as the primary endpoint [6][7] - The expansion phase of the trial will allow access to a larger patient pool across multiple continents, enhancing the study's impact and relevance [3][6]