UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-41455 MAIA BIOTECHNOLOGY, INC. (Exact name of Registrant as specified in its Charter) Delaware 83-1495913 (State or other jurisdictio ...

Core Viewpoint - MAIA Biotechnology, Inc. has successfully closed a public offering of 20 million shares at $1.50 per share, raising a total of $30 million for clinical trials and general corporate purposes [1][2]. Group 1: Offering Details - The public offering consisted of 20,000,000 shares priced at $1.50 each, resulting in gross proceeds of $30 million before expenses [1]. - The underwriters have a 30-day option to purchase an additional 3,000,000 shares at the same price to cover any overallotments [1]. - The offering was structured as a common stock-only investment with no warrant coverage, led by healthcare-dedicated investors [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for conducting clinical trials, working capital, and general corporate purposes [2]. Group 3: Company Background - MAIA Biotechnology is focused on developing targeted immunotherapies for cancer, with its lead program being ateganosine (THIO), aimed at treating NSCLC patients with telomerase-positive cancer cells [7].

Core Viewpoint - MAIA Biotechnology, Inc. has announced a public offering of 20 million shares at a price of $1.50 per share, aiming to raise $30 million for clinical trials and general corporate purposes [1][2]. Group 1: Offering Details - The public offering consists of 20,000,000 shares priced at $1.50 each, with expected gross proceeds of $30 million before expenses [1]. - The underwriters have a 45-day option to purchase an additional 3,000,000 shares at the same price to cover over-allotments [1]. - The offering is structured as a common stock-only investment with no warrant coverage [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for conducting clinical trials, working capital, and general corporate purposes [2]. Group 3: Regulatory Information - The securities are being offered under a "shelf" registration statement filed with the SEC, which became effective on August 23, 2023 [3]. - A prospectus supplement detailing the terms of the offering will be filed with the SEC [4]. Group 4: Company Overview - MAIA Biotechnology focuses on developing targeted immunotherapies for cancer, with its lead program being ateganosine (THIO), aimed at treating NSCLC patients with telomerase-positive cancer cells [7].

Core Viewpoint - MAIA Biotechnology, Inc. has initiated an underwritten public offering of its common stock and pre-funded warrants, with the intention to use the proceeds for clinical trials and general corporate purposes [1][2]. Group 1: Offering Details - The offering includes shares of common stock and pre-funded warrants, with a 30-day option for underwriters to purchase additional shares at the public offering price [1]. - The offering is subject to market conditions, and there is no assurance regarding its completion or the actual size and terms [1]. Group 2: Management and Use of Proceeds - Konik Capital Partners LLC is acting as the sole book-running manager for the offering [2]. - The net proceeds from the offering will be utilized for conducting clinical trials and for working capital and general corporate purposes [2]. Group 3: Regulatory Information - The securities are being offered under a "shelf" registration statement on Form S-3, which was filed with the SEC and declared effective in August 2023 [3]. - A preliminary prospectus supplement and accompanying prospectus will be filed with the SEC and will be available on its website [4].

Core Insights - MAIA Biotechnology is advancing ateganosine, a potential third-line therapy for non-small cell lung cancer (NSCLC), which has received FDA Fast Track designation, indicating a promising pathway for approval [2][4] - The global immunotherapy market is valued at $50 billion, presenting a substantial commercial opportunity for ateganosine as it targets an underserved patient population [2][3] - The development strategy focuses on the third-line NSCLC population, where no established standard of care exists, addressing approximately 50,000 patients annually in the U.S. [2][3] Company Overview - MAIA Biotechnology is a clinical-stage biopharmaceutical company dedicated to developing targeted immunotherapies for cancer, with ateganosine as its lead molecule [2][5] - The company aims to create first-in-class drugs with novel mechanisms of action to improve cancer treatment outcomes [5][6] Product Details - Ateganosine is a first-in-class investigational telomere-targeting agent that induces selective cancer cell death and activates immune responses, showing promise in clinical trials [4][5] - The drug is designed for patients with telomerase-positive cancer cells who have progressed beyond existing checkpoint inhibitor therapies [4][6]

Core Insights - MAIA Biotechnology, Inc. is advancing its lead product, ateganosine, for the treatment of non-small cell lung cancer (NSCLC) with promising efficacy data and FDA Fast Track designation, positioning it for potential early commercial approval in the next 18 to 24 months [1][2][3] Group 1: Clinical Development and Achievements - The company reported exceptional efficacy data for ateganosine in combination with a checkpoint inhibitor, showing disease control and survival rates significantly above standard care benchmarks [2] - MAIA secured FDA Fast Track designation for ateganosine, which expedites the review process for drugs addressing serious conditions and unmet medical needs [3] - A major clinical milestone was achieved with the initiation of a Phase 3 trial for THIO-104 in NSCLC patients resistant to existing therapies [3] - The Phase 2 trial for THIO-101 has expanded to include more patients across Asia and Europe, enhancing the program's regulatory and commercial relevance [3] - A $2.3 million grant from the NIH was awarded to support the Phase 2 trial expansion, focusing on U.S. patients resistant to chemotherapy and immunotherapy [3] - The company validated its telomere-targeting approach as a unique therapeutic strategy applicable to multiple high-mortality cancers, with ateganosine being the only direct telomere-targeting agent in clinical development [3] Group 2: Financial and Strategic Positioning - MAIA raised approximately $17.6 million in capital throughout 2025, indicating strong confidence from board members in the long-term value of the ateganosine platform [3] - As of December 31, 2025, company directors and officers collectively hold over 5 million shares, representing about 13% of the company, reflecting their commitment to the company's future [3] Group 3: Future Directions - The company anticipates high probability of technical success in ongoing Phase 2 and Phase 3 trials, which could lead to significant value creation for shareholders [3] - Future plans include engaging in regulatory discussions with the FDA to enhance trial prospects and explore Accelerated Approval and Priority Review pathways [7] - Development of second-generation molecules is set to begin, with expectations of improved efficacy compared to ateganosine [7]

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].

Group 1 - MAIA Biotechnology, Inc. has entered into definitive agreements for the purchase and sale of 1,233,488 shares of common stock at a price of $1.224 per share in a private placement to accredited investors and a Company director [1] - Each share is offered with a warrant to purchase one additional share at an exercise price of $1.36, with the warrants exercisable six months after issuance and valid for three years [1] - The private placement is expected to close on or about December 18, 2025, subject to customary closing conditions [1] Group 2 - The gross proceeds from the offering are expected to be approximately $1.51 million before offering expenses [2] - The net proceeds will be used to fund Step 1 of Part C of the Phase II trial THIO-101 and for working capital [2] Group 3 - The securities are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933 and have not been registered under the Securities Act or applicable state securities laws [3] - The warrants and underlying shares may not be offered or sold in the United States except under an effective registration statement or applicable exemption [3] Group 4 - MAIA is focused on developing targeted immunotherapies for cancer, with its lead program being ateganosine (THIO), aimed at treating NSCLC patients with telomerase-positive cancer cells [5]

Core Insights - Ateganosine (THIO) is a first-in-class telomere-targeting therapy developed by MAIA Biotechnology, gaining attention in the oncology community due to promising clinical results in advanced non-small cell lung cancer (NSCLC) [1][2] - The therapy is currently in a Phase 2 trial, with a pivotal Phase 3 program initiated recently, indicating a significant step in its clinical development [1][7] Company Positioning - MAIA Biotechnology is positioned at the forefront of a new scientific category in oncology, with ateganosine being the only direct telomere-targeting anticancer agent in clinical development [2][8] - The company focuses on developing and commercializing first-in-class drugs with novel mechanisms intended to improve and extend the lives of cancer patients [9] Clinical Development - Statistical assessments from the Phase 3 trial suggest a high probability of technical success for regulatory approval of ateganosine, which has received Fast Track designation from the FDA for NSCLC treatment [3][4] - The dual mechanism of action of ateganosine differentiates it from existing therapies, as it selectively incorporates into cancer-cell telomeres and generates an immunogenic response that promotes tumor regression [4][5][6] Market Opportunity - The launch of the Phase 3 trial reflects growing confidence in the clinical profile of ateganosine, with NSCLC being one of the largest oncology markets globally, presenting substantial commercial opportunities for first-in-class therapies [7][8]

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]