Core Viewpoint - MAIA Biotechnology, Inc. demonstrates strong confidence in the commercial potential of ateganosine, a first-in-class anticancer treatment, as evidenced by recent stock purchases by independent directors [1][3]. Group 1: Director Investments - Three directors purchased a total of 179,737 shares and 179,737 warrants at an average price of $1.224, raising approximately $1.51 million in gross proceeds from the private placement offering [2]. - Directors and officers currently hold 5,019,857 shares, representing 13.43% of MAIA [2]. Group 2: Product Development and Trials - The initiation of a pivotal Phase 3 international trial for ateganosine has begun, with first patient dosing occurring this month [3]. - The FDA has granted Fast Track designation for ateganosine for the treatment of non-small cell lung cancer (NSCLC), indicating a high probability of regulatory approval based on statistical assessments of the trial [3]. Group 3: Mechanism of Action - Ateganosine is a telomere-targeting agent that induces telomerase-dependent DNA modification and selective cancer cell death, showing promise in advanced NSCLC treatment [4]. - The sequential treatment of ateganosine followed by PD-(L)1 inhibitors has resulted in significant tumor regression in advanced cancer models, suggesting its potential effectiveness [4]. Group 4: Company Overview - MAIA Biotechnology focuses on developing targeted immunotherapies for cancer, with ateganosine as its lead program aimed at improving treatment outcomes for patients with telomerase-positive cancer cells [5].

CHICAGO, IL, Dec. 16, 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 1,233,488 shares of common stock at a purchase price of $1.224 per share, in a private placement to accredited investors and a Company director. Each share of common stock is being offered toge ...

CHICAGO, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Ateganosine (THIO, 6-thio-2'-deoxyguanosine), a first-in-class telomere-targeting therapy under development by MAIA Biotechnology (NYSE American: MAIA), appears to be gaining increasing attention in the oncology community as emerging clinical results continue to surpass expectations in advanced non-small cell lung cancer (NSCLC). With the therapy’s Phase 2 trial ongoing and a pivotal Phase 3 program initiated this week, ateganosine is being closely watched as one o ...

Core Insights - MAIA Biotechnology has initiated the first patient dosing in the THIO-104 Phase 3 pivotal trial for ateganosine, a treatment for advanced non-small cell lung cancer (NSCLC) [1][3] - The trial aims to compare the overall survival of ateganosine sequenced with a checkpoint inhibitor against chemotherapy in patients resistant to previous treatments [2][6] - The FDA has granted Fast Track designation for ateganosine, indicating its potential significance in treating NSCLC [4] Company Overview - MAIA Biotechnology is focused on developing targeted immunotherapies for cancer, with ateganosine as its lead program targeting telomeres in cancer cells [5][8] - The company aims to improve survival rates for NSCLC patients, with Phase 2 data showing a median survival of 17.8 months for ateganosine compared to approximately six months for chemotherapy [3][5] Clinical Trial Details - The THIO-104 trial is a multicenter, open-label study designed to enroll up to 300 patients, assessing the efficacy and safety of ateganosine in combination with a checkpoint inhibitor [2][6] - The primary endpoint of the trial is median overall survival, with safety and tolerability also being evaluated [6]

Core Insights - MAIA Biotechnology, Inc. is demonstrating strong insider confidence through recent share purchases by CEO Dr. Vlad Vitoc and board members, acquiring approximately 182,445 shares between November 21 and 28, 2025, signaling belief in the long-term value of the ateganosine platform [1][2][3] Group 1: Insider Activity - The recent insider buying reflects a unified stance from MAIA's leadership, showcasing confidence in the company's strategy and the clinical evidence supporting ateganosine as a potential therapeutic pathway for advanced non-small cell lung cancer (NSCLC) [2][3] - Directors and Officers currently hold 4,480,120 shares, representing 12.95% of the company, indicating significant insider ownership and commitment [3] Group 2: Clinical Development - Ateganosine, MAIA's lead program, is in mid- to late-stage clinical development and has shown encouraging results, enhancing both internal and external confidence in its potential as a first-in-class cancer therapy targeting telomerase-positive cancer cells [2][4] - The company's approach is positioned as a meaningful new therapeutic pathway for patients with advanced NSCLC, highlighting the innovative nature of its drug development strategy [2][4]

Core Viewpoint - The treatment landscape for advanced non-small cell lung cancer (NSCLC) is shifting towards a new class of therapies, specifically telomere-targeting agents, to address the unmet medical needs of patients without actionable mutations and those who are resistant to current therapies [1][4]. Industry Overview - Checkpoint inhibitors (CPIs) dominate the NSCLC treatment market, generating approximately $50 billion in global sales in 2024, with Merck's Keytruda accounting for $29.5 billion of that revenue [3][9]. - The NSCLC market is projected to grow from $34.1 billion to nearly $68.8 billion by 2033, indicating significant commercial opportunities for new therapies [7]. Company Insights - MAIA Biotechnology's ateganosine is positioned as a first-in-class telomere-targeting agent, designed to exploit telomerase activity found in over 80% of human tumors, offering a novel mechanism of action [5][12]. - The U.S. FDA has granted Fast Track Designation to ateganosine for treating NSCLC patients resistant to immunotherapy and chemotherapy, and a Phase 3 trial is set to begin [6]. Market Dynamics - The oncology market is expected to reward innovative therapies that fill existing treatment gaps, particularly in advanced NSCLC, which represents a significant unmet need [8][11]. - A significant portion of CPI sales, over 40%, is derived from NSCLC, highlighting the importance of this segment in the overall oncology market [9].

Core Insights - MAIA Biotechnology, Inc. announced that its CEO and certain board members purchased approximately 182,445 shares of the company's common stock at an average price of $1.06 between November 21 and 28, 2025 [1][2] Company Overview - MAIA is a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, specifically its lead program, ateganosine (THIO), which targets telomerase-positive cancer cells in non-small cell lung cancer (NSCLC) patients [4] Recent Developments - Vlad Vitoc, M.D., the Chairman and CEO, purchased 94,300 shares at an average price of $1.08, while other board members Cristian Luput and Stan V. Smith, Ph.D., purchased a combined total of 88,145 shares at an average price of $1.04 [2] - The company reported a 38% response rate and an overall survival of 17.8 months in its Phase 2 THIO-101 clinical trial, indicating the potential of ateganosine to improve patient outcomes [3] Management Confidence - The management expressed confidence in the ongoing clinical development of ateganosine, highlighting its potential to become a new standard of care for patients with non-small cell lung cancer [3] - Board members emphasized the strategic focus and scientific momentum of the company, suggesting it is well-positioned to deliver significant value for shareholders in the future [3]

Core Insights - MAIA Biotechnology is advancing its clinical trials for ateganosine, a novel telomere-targeting agent for non-small cell lung cancer (NSCLC), with 12 patients currently enrolled in the Phase 2 THIO-101 expansion trial [2][3][4] - The FDA has granted Fast Track designation for ateganosine, indicating potential for expedited approval based on promising early results [2][4] - The company is also initiating patient screening for the Phase 3 THIO-104 trial, which aims to evaluate ateganosine in a population with significant unmet medical needs [4][8] Clinical Trials Overview - The Phase 2 THIO-101 trial is designed to assess the safety and efficacy of ateganosine followed by the checkpoint inhibitor cemiplimab in advanced NSCLC patients resistant to prior treatments [8] - The trial has shown promising results, with a patient demonstrating a survival of 30 months, significantly exceeding the current overall survival of approximately 6 months for similar patient populations [4][8] - The Phase 3 THIO-104 trial will compare ateganosine with standard chemotherapy in third-line NSCLC patients resistant to previous therapies [6][8] Market Potential - Ateganoisne has the potential to enhance existing treatment strategies and improve outcomes for advanced NSCLC patients, addressing a critical gap in current cancer therapies [5][9] - The ongoing trials and positive early results position MAIA Biotechnology to potentially capture a significant share of the NSCLC treatment market, particularly for patients with telomerase-positive cancer cells [9]

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].