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 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 reported positive efficacy data from its Phase 2 clinical trial, THIO-101, which evaluates ateganosine (THIO) in combination with cemiplimab for advanced non-small cell lung cancer (NSCLC) patients who have failed multiple standard therapies [1][2] Group 1: Efficacy Data - The Phase 2 trial THIO-101 shows a progression-free survival (PFS) of 5.6 months, which is more than double the standard of care PFS of 2.5 months [2][6] - The estimated median overall survival (OS) is reported at 17.8 months, with a 95% confidence interval lower bound of 12.5 months [6] Group 2: Drug Mechanism and Development - Ateganosine is a first-in-class investigational telomere-targeting agent that induces telomerase-dependent telomeric DNA modification and selective cancer cell death [3] - The drug activates both innate and adaptive immune responses, leading to significant tumor regression in advanced cancer models [3] Group 3: Clinical Trial Design - THIO-101 is a multicenter, open-label, dose-finding Phase 2 clinical trial designed to evaluate ateganosine's anti-tumor activity when followed by PD-(L)1 inhibition [4] - 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 [4] Group 4: Company Overview - MAIA Biotechnology focuses on developing targeted immunotherapies for cancer, with ateganosine being its lead program aimed at treating NSCLC patients with telomerase-positive cancer cells [7]

Core Insights - MAIA Biotechnology, Inc. announced the presentation of ateganosine (THIO) data at the 2025 IASLC World Conference on Lung Cancer, highlighting its potential in treating non-small cell lung cancer (NSCLC) [1][2] - The ongoing THIO-101 trial shows a median overall survival (OS) of 17.8 months, indicating substantial efficacy of ateganosine in late-stage NSCLC patients [3] - The FDA granted Fast Track designation for ateganosine, allowing for expedited regulatory processes and potential accelerated approval [4] Company Overview - MAIA Biotechnology is focused on developing targeted immunotherapies for cancer, with ateganosine as its lead program aimed at treating NSCLC patients with telomerase-positive cancer cells [10] - The company aims to improve and extend the lives of cancer patients through innovative therapies [10] Clinical Trial Details - The THIO-101 Phase 2 clinical trial is designed to evaluate the anti-tumor activity of ateganosine followed by PD-(L)1 inhibitors in advanced NSCLC patients who have shown resistance to previous treatments [9] - 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 [9] Conference Information - The IASLC World Conference on Lung Cancer serves as a platform for sharing cutting-edge research and fostering collaboration among industry leaders and experts [6] - MAIA's poster presentation is scheduled for September 7, 2025, focusing on metastatic non-small cell lung cancer and immunotherapy [8]

Company Overview - MAIA Biotechnology, Inc. is a biotechnology company founded in 2018 and headquartered in Chicago, Illinois, focused on discovering, developing, and commercializing novel cancer therapies addressing high unmet medical needs [2]. Recent Developments - MAIA Biotechnology advanced its lead candidate, ateganosine (THIO), with significant progress in clinical, regulatory, and pipeline fronts during Q2 2025 [4]. - The pivotal Phase 2 THIO-101 study in advanced non-small cell lung cancer (NSCLC) reported a median overall survival of 17.8 months among 22 third-line patients, with treatment being generally well tolerated [4]. - A new partial response was confirmed after 20 months of therapy, indicating the potential effectiveness of the treatment [4]. - The trial has expanded into Asia, with first dosing in Taiwan and ongoing screening in Europe and Asia [4]. - MAIA entered a master clinical supply agreement with Roche to evaluate ateganosine in combination with atezolizumab (Tecentriq®) across multiple hard-to-treat cancers [4]. - The FDA granted Fast Track designation for ateganosine in the treatment of NSCLC, enhancing the regulatory path for the drug [4]. Future Plans - MAIA plans to initiate studies in various cancers beyond NSCLC, including hepatocellular carcinoma (HCC), small cell lung cancer (SCLC), colorectal cancer (CRC), breast, prostate, gastric, pancreatic, and ovarian cancers [4]. - The company aims to evaluate THIO-103 for first-line NSCLC and SCLC [4]. Valuation Insights - Recent updates have de-risked the THIO program in third-line NSCLC, with the Phase 2 THIO-101 dataset supporting a generally tolerable safety profile and durability of response [4]. - The valuation model has been revised to reflect recent financial results and share count, yielding a valuation of $10.27 per share, contingent on successful execution by the company [4].

Core Insights - MAIA Biotechnology, Inc. has released updated data from its pivotal Phase 2 clinical trial for ateganosine (THIO) in combination with Regeneron's cemiplimab for advanced non-small cell lung cancer (NSCLC) patients resistant to immune therapy and chemotherapy [1][4]. Group 1: Clinical Trial Results - The trial's third line (3L) data indicates a median overall survival (OS) of 17.8 months for 22 NSCLC patients who received at least one dose of ateganosine, with a 95% confidence interval lower bound of 12.5 months [2][3]. - The treatment has shown to be generally well-tolerated in a heavily pretreated patient population, with one patient completing 32 cycles of therapy and achieving 24.3 months of survival [3]. Group 2: Comparison with Standard Treatments - The median OS of 17.8 months for ateganosine is nearly triple the OS of 5 to 6 months reported for standard-of-care chemotherapy treatments in similar NSCLC settings [3][4]. Group 3: Regulatory and Market Implications - MAIA's potential regulatory pathways for ateganosine could lead to accelerated FDA approval and robust exclusivity in NSCLC, with a possible FDA decision as early as next year [4]. - A new partial response was identified in a patient after 20 months of treatment, defined as a decrease in tumor size of at least 30%, indicating the treatment's efficacy and low toxicity [5]. Group 4: Market Reaction - Following the announcement, MAIA's stock price increased by 11.7%, reaching $1.97 [5].