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]

Core Insights - MAIA Biotechnology, Inc. has published a manuscript on its Phase 2 THIO-101 clinical trial in the journal Cells, focusing on the management of non-small cell lung cancer (NSCLC) in the context of immunotherapy [1][2] - The company emphasizes the significance of its novel combination strategy using ateganosine with a checkpoint inhibitor, which shows promising results for patients with high unmet medical needs [2] Company Overview - MAIA Biotechnology is a clinical-stage biopharmaceutical company dedicated to developing targeted immunotherapies for cancer, with a focus on first-in-class drugs that aim to improve and extend the lives of cancer patients [4] - The lead program, ateganosine (THIO), is a telomere-targeting agent currently in clinical development for NSCLC patients with telomerase-positive cancer cells [4] Product Details - Ateganosine is a first-in-class investigational agent that targets telomeres, playing a crucial role in cancer cell survival and resistance to therapies [3] - The treatment has shown to induce significant tumor regression in advanced cancer models by activating both innate and adaptive immune responses [3]

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 Viewpoint - MAIA Biotechnology has received a patent from the European Patent Office for ateganosine-based analogues aimed at telomere-targeting anticancer therapy, which may enhance cancer treatment efficacy [1][4]. Group 1: Patent and Intellectual Property - The European Patent Office granted a patent for a portfolio of ateganosine-based analogues, which are designed for telomere-targeting anticancer therapy [1]. - MAIA's intellectual property (IP) portfolio includes 10 issued patents worldwide and 24 pending applications, covering various aspects of telomerase-mediated telomere altering compounds and treatment of therapy-resistant cancers [4]. - The new patent is expected to enhance the value of MAIA's telomere-targeting compounds within the European scientific community [3]. Group 2: Mechanism and Efficacy of Ateganosine - Mercaptopurine nucleoside analogues, including ateganosine, disrupt telomere structure and function, leading to reduced immune activity and programmed cancer cell death [2]. - Ateganosine is currently in clinical development for non-small cell lung cancer (NSCLC) and is designed to induce telomerase-dependent telomeric DNA modification, resulting in selective cancer cell death [5]. - The sequential treatment of ateganosine followed by PD-(L)1 inhibitors has shown significant tumor regression in advanced cancer models, indicating its potential for inducing cancer-specific immune memory [5]. Group 3: Company Overview - MAIA Biotechnology focuses on developing targeted immunotherapies for cancer, with ateganosine as its lead program aimed at treating NSCLC patients with telomerase-positive cancer cells [6]. - The company aims to create first-in-class drugs with novel mechanisms of action to improve and extend the lives of cancer patients [6].

[Cautionary Notice About Forward-Looking Statements](index=4&type=section&id=CAUTIONARY%20NOTICE%20ABOUT%20FORWARD-LOOKING%20STATEMENTS) This section advises readers on the inherent risks and uncertainties associated with forward-looking statements and the company's non-obligation to update them - This report contains forward-looking statements regarding the company's business, strategies, products, future results, and financial performance, which are subject to various risks and uncertainties[10](index=10&type=chunk) - Readers are advised not to place undue reliance on these statements, as actual results may differ materially from current expectations due to factors discussed under 'Risk Factors' and in other SEC filings[10](index=10&type=chunk)[11](index=11&type=chunk)[12](index=12&type=chunk) - The company undertakes no obligation to publicly update or revise any forward-looking statements unless required by law[11](index=11&type=chunk) [PART I—FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%E2%80%94FINANCIAL%20INFORMATION) This part presents the company's unaudited condensed consolidated financial statements and management's discussion and analysis for the reporting period [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents MAIA Biotechnology, Inc.'s unaudited condensed consolidated financial statements, including balance sheets, statements of operations, comprehensive loss, equity changes, and cash flows, with detailed accounting notes [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This statement provides a snapshot of the company's assets, liabilities, and stockholders' equity at specific points in time | Metric | June 30, 2025 (Unaudited) ($) | December 31, 2024 ($) | | :--------------------------------- | :------------------------ | :------------------ | | **ASSETS** | | | | Cash | $10,144,522 | $9,601,298 | | Total current assets | $11,043,054 | $10,152,479 | | Total assets | $11,045,854 | $10,155,279 | | **LIABILITIES AND STOCKHOLDERS' EQUITY** | | | | Total current liabilities | $5,043,952 | $3,830,038 | | Warrant liability | $2,125,218 | $2,690,605 | | Total liabilities | $7,169,170 | $6,520,643 | | Total stockholders' equity | $3,876,684 | $3,634,636 | - Cash increased by **$543,224** from December 31, 2024, to June 30, 2025[17](index=17&type=chunk) - Total current assets increased by **$890,575**, and total liabilities increased by **$648,527**[17](index=17&type=chunk) [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This statement details the company's revenues, expenses, and net loss over specific reporting periods Three Months Ended June 30 | Metric | June 30, 2025 ($) | June 30, 2024 ($) | | :--------------------------------- | :------------ | :------------ | | Research and development expenses | $3,110,867 | $2,052,233 | | General and administrative expenses | $2,055,191 | $1,763,029 | | Total operating expenses | $5,166,058 | $3,815,262 | | Net loss | $(5,346,963) | $(8,879,276) | | Net loss per share (Basic and diluted) | $(0.18) | $(0.40) | Six Months Ended June 30 | Metric | June 30, 2025 ($) | June 30, 2024 ($) | | :--------------------------------- | :------------ | :------------ | | Research and development expenses | $6,308,399 | $4,372,975 | | General and administrative expenses | $4,283,090 | $3,391,163 | | Total operating expenses | $10,591,489 | $7,764,138 | | Net loss | $(9,864,222) | $(16,946,731) | | Net loss per share (Basic and diluted) | $(0.34) | $(0.85) | - Net loss decreased by **40%** for the three months ended June 30, 2025, and by **42%** for the six months ended June 30, 2025, compared to the prior year periods[20](index=20&type=chunk) [Condensed Consolidated Statements of Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) This statement presents the net loss and other comprehensive income or loss components for the reporting periods Three Months Ended June 30 | Metric | June 30, 2025 ($) | June 30, 2024 ($) | | :--------------------------------- | :------------ | :------------ | | Net loss | $(5,346,963) | $(8,879,276) | | Foreign currency translation adjustment | $8,127 | $7,868 | | Comprehensive loss | $(5,338,836) | $(8,871,408) | Six Months Ended June 30 | Metric | June 30, 2025 ($) | June 30, 2024 ($) | | :--------------------------------- | :------------ | :------------ | | Net loss | $(9,864,222) | $(16,946,731) | | Foreign currency translation adjustment | $587 | $(5,918) | | Comprehensive loss | $(9,863,635) | $(16,952,649) | [Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit)](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity%20%28Deficit%29) This statement outlines the changes in the company's equity accounts, including stock issuances and accumulated deficit, over the reporting period - Total stockholders' equity increased from **$3,634,636** at December 31, 2024, to **$3,876,684** at June 30, 2025[25](index=25&type=chunk) - Additional paid-in capital increased significantly due to common stock issuances from At-The-Market (ATM) financing and private placement offerings[25](index=25&type=chunk) - The accumulated deficit increased from **$(87,234,833)** at December 31, 2024, to **$(97,099,055)** at June 30, 2025, primarily due to net losses[25](index=25&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This statement categorizes cash inflows and outflows from operating, investing, and financing activities for the reporting periods Six Months Ended June 30 | Metric | June 30, 2025 ($) | June 30, 2024 ($) | | :--------------------------------- | :------------ | :------------ | | Net cash used in operating activities | $(8,337,611) | $(8,271,571) | | Net cash provided by financing activities | $8,869,406 | $12,704,327 | | Net increase (decrease) in cash | $543,224 | $4,428,696 | | Cash at end of period | $10,144,522 | $11,579,391 | - Net cash provided by financing activities decreased by approximately **$3.8 million** from the six months ended June 30, 2024, to the same period in 2025[32](index=32&type=chunk) - Cash at the end of the period decreased from **$11,579,391** in 2024 to **$10,144,522** in 2025[32](index=32&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and additional information regarding the figures presented in the financial statements [1. Nature of Business and Summary of Significant Accounting Policies](index=11&type=section&id=1.%20NATURE%20OF%20BUSINESS%20AND%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) This note describes the company's operations, its biopharmaceutical focus, and the key accounting principles applied in preparing the financial statements - MAIA Biotechnology, Inc. is a biopharmaceutical company focused on developing oncology drug candidates, incorporated in Delaware in 2018, with subsidiaries in Australia and Romania[35](index=35&type=chunk)[41](index=41&type=chunk) - The company has incurred recurring losses and negative cash flow from operations, with an accumulated deficit of **$97,099,055** as of June 30, 2025, raising substantial doubt about its ability to continue as a going concern without additional financing[37](index=37&type=chunk)[38](index=38&type=chunk) - The company operates as a single operating segment, dedicated to discovering and developing immunotherapies for cancer[43](index=43&type=chunk) [2. Related Party Transactions](index=17&type=section&id=2.%20RELATED%20PARTY%20TRANSACTIONS) This note details transactions between the company and its related parties, including common stock issuances and private placement participations - FGMK, LLC, a related party, received **$31,570** in common stock for accounting, tax, and valuation services and participated in the February 2025 private placement[75](index=75&type=chunk) - Company directors (Stan Smith, Ramiro Guerrero) participated in multiple private placements in February, March, May, and June 2025, purchasing common stock and warrants[77](index=77&type=chunk)[78](index=78&type=chunk)[79](index=79&type=chunk)[80](index=80&type=chunk) [3. Accrued Expenses](index=18&type=section&id=3.%20ACCRUED%20EXPENSES) This note provides a breakdown of accrued expenses, including bonuses, professional fees, and research and development costs Accrued Expenses | Accrued Expense Category | June 30, 2025 ($) | December 31, 2024 ($) | | :----------------------- | :------------ | :---------------- | | Bonus | $595,506 | $941,098 | | Professional fees | $69,901 | $123,317 | | Research and development costs | $2,308,844 | $1,035,355 | | Other | $346,538 | $217,832 | | Total accrued expenses | $3,320,789 | $2,317,602 | - Research and development costs within accrued expenses more than doubled from December 31, 2024, to June 30, 2025, increasing by over **$1.2 million**[81](index=81&type=chunk) [4. Fair Value of Financial Liabilities](index=18&type=section&id=4.%20FAIR%20VALUE%20OF%20FINANCIAL%20LIABILITIES) This note outlines the fair value measurement of financial liabilities, specifically warrant liabilities, and changes over the reporting period Fair Value of Warrant Liabilities | Liability | June 30, 2025 ($) | December 31, 2024 ($) | | :---------------- | :------------ | :---------------- | | Warrant liability | $2,125,218 | $2,690,605 | Changes in Fair Value of Warrant Liabilities (Six Months Ended June 30) | Metric | June 30, 2025 ($) | June 30, 2024 ($) | | :--------------------------------- | :------------ | :------------ | | Balance, beginning of period | $2,690,605 | $2,152,188 | | Loss (gain) on fair value of warrant liability | $(565,387) | $9,338,791 | | Balance, end of period | $2,125,218 | $5,346,638 | - The company recognized a gain of **$565,387** on the fair value of warrant liability for the six months ended June 30, 2025, a significant improvement from a loss of **$9,338,791** in the prior year[82](index=82&type=chunk) [5. Stockholders' Equity](index=19&type=section&id=5.%20STOCKHOLDERS%27%20EQUITY) This note details changes in stockholders' equity, including authorized shares, stock issuances, warrant activity, and stock option awards - The number of authorized shares of Common Stock increased from **70,000,000** to **150,000,000** on May 22, 2025[83](index=83&type=chunk) - The company raised approximately **$1.42 million** in net proceeds from At-The-Market (ATM) offerings and approximately **$5.92 million** in gross proceeds from private placements during the first half of 2025[85](index=85&type=chunk)[86](index=86&type=chunk)[87](index=87&type=chunk)[88](index=88&type=chunk)[89](index=89&type=chunk) Stock Warrants Activity (Six Months Ended June 30) | Metric | June 30, 2025 (Units) | June 30, 2024 (Units) | | :----------------------- | :------------------ | :------------------ | | Warrants Outstanding (beginning) | 6,718,176 | 3,650,278 | | Issued | 3,644,299 | 2,949,169 | | Exercised | (219,283) | (1,157,201) | | Warrants Outstanding (end) | 10,143,192 | 5,442,246 | | Weighted Average Exercise Price (end) ($) | $2.17 | $2.37 | Stock Option Activity (Six Months Ended June 30, 2025) | Metric | Options Outstanding (Units) | Weighted Average Exercise Price ($) | Aggregate Intrinsic Value ($) | | :----------------------- | :------------------ | :------------------------------ | :------------------------ | | Balance at January 1, 2025 | 9,769,992 | $2.43 | — | | Granted | 2,591,991 | $1.80 | | | Exercised | (570) | $1.48 | | | Cancelled/forfeited | (409,001) | $3.60 | | | Balance at June 30, 2025 | 11,952,412 | $2.25 | $627,620 | | Options exercisable at June 30, 2025 | 8,772,024 | $2.29 | $474,995 | - Total unrecognized compensation related to unvested stock option awards was **$4,339,230** as of June 30, 2025, expected to be recognized over approximately **2.94 years**[111](index=111&type=chunk) [6. Commitments and Contingencies](index=27&type=section&id=6.%20COMMITMENTS%20AND%20CONTINGENCIES) This note describes the company's contractual obligations, including patent licensing agreements and drug supply agreements for clinical trials - The company has patent licensing agreements with the University of Texas Southwestern (UTSW) for its compounds, including THIO, requiring milestone payments up to **$112 million** and royalties of **2-5%** on net sales[114](index=114&type=chunk)[115](index=115&type=chunk)[116](index=116&type=chunk) - Drug supply agreements are in place with Regeneron, BeOne Medicines, and Roche, where these partners supply their respective drugs (cemiplimab, tislelizumab, atezolizumab) at no cost for MAIA's clinical trials, representing significant cost savings[117](index=117&type=chunk)[118](index=118&type=chunk)[119](index=119&type=chunk) [7. Income Taxes](index=29&type=section&id=7.%20INCOME%20TAXES) This note explains the company's income tax position, including its valuation allowance against deferred tax assets due to recurring losses - The company maintains a full valuation allowance against its net deferred tax assets due to recurring losses and no taxable income[120](index=120&type=chunk)[121](index=121&type=chunk) - No income tax expense was recorded for the six months ended June 30, 2025, and 2024[121](index=121&type=chunk) [8. Segment Information](index=29&type=section&id=8.%20SEGMENT%20INFORMATION) This note clarifies that the company operates as a single reportable segment focused on cancer immunotherapy development - MAIA Biotechnology operates as a single reportable segment, focused on discovering and developing immunotherapies for cancer[122](index=122&type=chunk) [9. Subsequent Events](index=29&type=section&id=9.%20SUBSEQUENT%20EVENTS) This note discloses significant events that occurred after the reporting period, including additional stock option grants and ATM offerings - From July 1 to August 11, 2025, the company issued **416,806** options at a weighted exercise price of **$1.91** to consultants[123](index=123&type=chunk) - Since July 1, 2025, the company sold **1,174,740** shares of common stock through the ATM Agreement, generating net proceeds of approximately **$2.19 million**[124](index=124&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's analysis of the company's financial condition and results, focusing on ateganosine development, clinical milestones, liquidity, and changes in operating expenses and financing activities [Overview](index=30&type=section&id=Overview) This overview introduces MAIA Biotechnology as a clinical-stage biopharmaceutical company focused on developing ateganosine for cancer, highlighting key clinical milestones and future trial plans - MAIA Biotechnology is a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, with ateganosine (THIO) as its lead asset, primarily targeting Non-Small Cell Lung Cancer (NSCLC)[126](index=126&type=chunk) - Key milestones in the first half of 2025 include positive updated data from the THIO-101 Phase 2 trial (median overall survival of **16.9 months** in 3L NSCLC patients), new clinical supply agreements with BeiGene and Roche, and Fast Track designation for ateganosine for NSCLC by the FDA[128](index=128&type=chunk)[129](index=129&type=chunk)[131](index=131&type=chunk) - The company plans to initiate a Phase 3 pivotal trial (THIO-104) in 2025 for NSCLC and Phase 2 trials in hepatocellular carcinoma (HCC), small cell lung cancer (SCLC), and colorectal cancer (CRC) in 2026[126](index=126&type=chunk)[128](index=128&type=chunk) [Results of Operations for the Three and Six Months Ended June 30, 2025 and 2024](index=34&type=section&id=Results%20of%20Operations%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) This section analyzes the financial performance for the three and six months ended June 30, 2025, compared to 2024, focusing on changes in expenses and net loss [Comparison of Three Months ended June 30, 2025 and 2024](index=34&type=section&id=Comparison%20of%20Three%20Months%20ended%20June%2030%2C%202025%20and%202024) This comparison highlights significant changes in research and development, general and administrative expenses, and net loss for the three months ended June 30 Key Financial Changes (Three Months Ended June 30) | Metric | 2025 ($) | 2024 ($) | Change (Dollars) ($) | Change (%) | | :--------------------------------- | :------------ | :------------ | :--------------- | :--------- | | Research and development expenses | $3,110,867 | $2,052,233 | $1,058,634 | 52% | | General and administrative expenses | $2,055,191 | $1,763,029 | $292,162 | 17% | | Net loss | $(5,346,963) | $(8,879,276) | $3,532,313 | (40)% | - Research and development expenses increased by **52%** (**$1.06 million**) due to higher scientific and clinical research, stock-based compensation, and payroll[133](index=133&type=chunk) - Other income (expense), net, improved by approximately **$4.88 million** (**96%**) primarily due to a favorable change in the fair value of warrant liability[135](index=135&type=chunk) [Comparison of Six Months Ended June 30, 2025 and 2024](index=35&type=section&id=Comparison%20of%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) This comparison highlights significant changes in research and development, general and administrative expenses, and net loss for the six months ended June 30 Key Financial Changes (Six Months Ended June 30) | Metric | 2025 ($) | 2024 ($) | Change (Dollars) ($) | Change (%) | | :--------------------------------- | :------------ | :------------ | :--------------- | :--------- | | Research and development expenses | $6,308,399 | $4,372,975 | $1,935,424 | 44% | | General and administrative expenses | $4,283,090 | $3,391,163 | $891,927 | 26% | | Net loss | $(9,864,222) | $(16,946,731) | $7,082,509 | (42)% | - Research and development expenses increased by **44%** (**$1.94 million**) due to higher scientific and clinical research, stock-based compensation, and payroll[137](index=137&type=chunk) - Other income (expense), net, improved by approximately **$9.91 million** (**108%**) primarily due to a favorable change in the fair value of warrant liability[139](index=139&type=chunk) [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's cash position, its ability to continue as a going concern, and its strategies for raising capital [Our Ability to Continue as a Going Concern](index=36&type=section&id=Our%20Ability%20to%20Continue%20as%20a%20Going%20Concern) This subsection addresses the company's financial viability given its recurring losses and negative cash flows, emphasizing the need for additional financing - As of June 30, 2025, cash totaled approximately **$10.145 million**, an increase of **$543,000** compared to December 31, 2024[140](index=140&type=chunk) - The company has generated no revenue and continues to incur losses and negative cash flows from operations, leading to substantial doubt about its ability to continue as a going concern without raising additional equity or debt financing[140](index=140&type=chunk)[141](index=141&type=chunk) [Sales of Common Stock](index=36&type=section&id=Sales%20of%20Common%20Stock) This subsection details the capital raised through private placements and At-The-Market offerings to fund ongoing operations and development - In the first half of 2025, the company received approximately **$5.92 million** in gross proceeds from multiple private placement offerings[145](index=145&type=chunk)[146](index=146&type=chunk)[149](index=149&type=chunk)[150](index=150&type=chunk) - The company also received approximately **$3.00 million** in gross proceeds from At-The-Market (ATM) offerings during the first half of 2025[147](index=147&type=chunk)[148](index=148&type=chunk) - Additional capital will be required to fund operations, develop ateganosine, and pursue other product development, with no assurance of availability or acceptable terms[151](index=151&type=chunk) [Cash Flows](index=37&type=section&id=Cash%20Flows) This subsection analyzes the cash generated from or used in operating, investing, and financing activities for the reporting periods Cash Flow Summary (Six Months Ended June 30) | Activity | 2025 ($) | 2024 ($) | | :--------------------------------- | :------------ | :------------ | | Net cash used in operating activities | $(8,337,611) | $(8,271,571) | | Net cash provided by financing activities | $8,869,406 | $12,704,327 | | Net increase in cash | $543,224 | $4,428,696 | - Operating activities consistently used cash, with approximately **$8.34 million** used in the first half of 2025[153](index=153&type=chunk) - Financing activities provided the majority of cash, totaling approximately **$8.87 million** in the first half of 2025, primarily from private placements and ATM offerings[157](index=157&type=chunk) - There were no cash flows from investing activities for the six months ended June 30, 2025, and 2024[156](index=156&type=chunk) [Off-Balance Sheet Arrangements](index=38&type=section&id=Off-Balance%20Sheet%20Arrangements) This section confirms the absence of any significant off-balance sheet arrangements that could materially impact the company's financial position - The company has no significant off-balance sheet arrangements[159](index=159&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=38&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) This section states that there have been no material changes to the critical accounting estimates previously disclosed in the annual report - There have been no material changes to the critical accounting estimates previously disclosed in the Annual Report on Form 10-K for the year ended December 31, 2024[160](index=160&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, MAIA Biotechnology, Inc. is not required to provide detailed quantitative and qualitative disclosures about market risk - The company is a smaller reporting company and is not required to provide detailed market risk disclosures[162](index=162&type=chunk) [Item 4. Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) Management evaluated the effectiveness of disclosure controls and procedures as of June 30, 2025, concluding they were effective, with no material changes in internal control over financial reporting identified - Disclosure controls and procedures were evaluated as effective at the reasonable assurance level as of June 30, 2025[163](index=163&type=chunk) - No material changes in internal control over financial reporting were identified during the period covered by this Quarterly Report[164](index=164&type=chunk) [PART II—OTHER INFORMATION](index=40&type=section&id=PART%20II%E2%80%94OTHER%20INFORMATION) This part provides additional information not covered in the financial statements, including legal proceedings, risk factors, equity sales, and other disclosures [Item 1. Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently party to any material legal proceedings, though it may be involved in routine claims incident to the ordinary course of business - The company is not party to any material legal proceedings[167](index=167&type=chunk) [Item 1A. Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) This section refers to the Annual Report on Form 10-K for a comprehensive discussion of risk factors and states that no additional risk factors have been added as of the date of this Quarterly Report - No additional risk factors have been added to those disclosed in the Annual Report on Form 10-K for the year ended December 31, 2024[168](index=168&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=40&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section details recent unregistered sales of common stock for consulting and service fees, which were exempt under Section 4(a)(2) of the Securities Act - On June 2, 2025, **18,040** shares of common stock (valued at **$31,570**) were issued to FGMK, LLC for accounting and tax services[169](index=169&type=chunk) - On June 18, 2025, **17,083** shares of common stock (valued at **$30,751**) were issued to a service provider for services rendered[170](index=170&type=chunk) [Item 3. Defaults Upon Senior Securities](index=40&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities during the period - No defaults upon senior securities were reported[172](index=172&type=chunk) [Item 4. Mine Safety Disclosures](index=40&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to MAIA Biotechnology, Inc. - This item is not applicable to the company[173](index=173&type=chunk) [Item 5. Other Information](index=40&type=section&id=Item%205.%20Other%20Information) The company reports that no Section 16 directors or officers adopted, modified, or terminated Rule 10b5-1 trading arrangements or non-Rule 10b5-1 trading arrangements during the fiscal quarter ended June 30, 2025 - No Rule 10b5-1 or non-Rule 10b5-1 trading arrangements were adopted, modified, or terminated by directors or Section 16 officers during the fiscal quarter ended June 30, 2025[174](index=174&type=chunk) [Item 6. Exhibits](index=41&type=section&id=Item%206.%20Exhibits) This section provides a list of exhibits filed with the Quarterly Report on Form 10-Q, including corporate governance documents, warrant forms, securities purchase agreements, and certifications - The report includes various exhibits such as the Amended and Restated Certificate of Incorporation, Bylaws, forms of investor and director warrants, securities purchase agreements, and certifications[175](index=175&type=chunk) [Signatures](index=42&type=section&id=SIGNATURES) This section contains the official signatures of the company's Chief Executive Officer and Head of Finance, certifying the report - The report is signed by Vlad Vitoc, Chief Executive Officer, and Jeffrey C. Himmelreich, Head of Finance, on August 11, 2025[179](index=179&type=chunk)

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].

[PART I—FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%E2%80%94FINANCIAL%20INFORMATION) [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) For the quarter ended March 31, 2025, the company reported a net loss of $4.5 million, a decrease from the $8.1 million net loss in the same period of 2024, primarily due to a positive change in the fair value of warrant liability. Operating expenses increased to $5.4 million from $3.9 million year-over-year, driven by higher R&D and G&A costs. As of March 31, 2025, the company held $10.9 million in cash, an increase from year-end 2024, supported by $5.5 million in net cash from financing activities. However, with an accumulated deficit of $91.8 million and recurring losses, there is substantial doubt about the company's ability to continue as a going concern without raising additional capital [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, the company's total assets increased to $11.9 million from $10.2 million at the end of 2024, primarily due to a rise in cash. Total liabilities also grew to $6.9 million from $6.5 million, while total stockholders' equity improved to $4.9 million from $3.6 million, reflecting recent financing activities Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $10,863,296 | $9,601,298 | | Total current assets | $11,861,852 | $10,152,479 | | Total assets | $11,864,652 | $10,155,279 | | **Liabilities & Equity** | | | | Total current liabilities | $5,057,511 | $3,830,038 | | Warrant liability | $1,864,616 | $2,690,605 | | Total liabilities | $6,922,127 | $6,520,643 | | Accumulated deficit | $(91,752,092) | $(87,234,833) | | Total stockholders' equity | $4,942,525 | $3,634,636 | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three months ended March 31, 2025, the company reported a net loss of $4.5 million, or ($0.16) per share, compared to a net loss of $8.1 million, or ($0.46) per share, for the same period in 2024. The reduced net loss was primarily due to a $0.8 million gain from the change in fair value of warrant liability, compared to a $4.2 million loss in the prior year. Operating expenses increased by 37% year-over-year, driven by higher research and development and general and administrative costs Consolidated Statements of Operations (Unaudited) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development expenses | $3,197,532 | $2,320,742 | | General and administrative expenses | $2,227,899 | $1,628,134 | | Loss from operations | $(5,425,431) | $(3,948,876) | | Change in fair value of warrant liability | $825,989 | $(4,181,298) | | Net loss | $(4,517,259) | $(8,067,455) | | Net loss per share (Basic and diluted) | $(0.16) | $(0.46) | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the three months ended March 31, 2025, net cash used in operating activities was $4.2 million. Net cash provided by financing activities was $5.5 million, primarily from private placements and at-the-market offerings. This resulted in a net increase in cash of $1.3 million, bringing the cash balance to $10.9 million at the end of the period Cash Flow Summary (Unaudited) | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(4,202,274) | $(3,586,800) | | Net cash provided by financing activities | $5,461,216 | $4,717,048 | | Net increase in cash | $1,261,998 | $1,120,754 | | Cash at end of period | $10,863,296 | $8,271,449 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's accounting policies, including the significant risks and uncertainties related to its operations and need for future funding. Key disclosures include a going concern warning due to recurring losses and an accumulated deficit of $91.8 million. The company has engaged in multiple financing activities, including private placements and at-the-market offerings, raising significant capital. It has licensing agreements with potential milestone payments up to $112 million and clinical supply agreements with Regeneron and BeiGene. Subsequent to the quarter's end, the company conducted another private placement, raising approximately $1.08 million - The company has incurred recurring losses and has an accumulated deficit of **$91,752,092** as of March 31, 2025. Management has concluded there is substantial doubt about the Company's ability to continue as a going concern within one year[36](index=36&type=chunk)[37](index=37&type=chunk) - In February and March 2025, the company completed private placements, issuing a total of **2,762,633 shares** and associated warrants, raising gross proceeds of approximately **$4.1 million**[86](index=86&type=chunk)[88](index=88&type=chunk) - The company has patent licensing agreements with the University of Texas Southwestern (UTSW) that require potential milestone payments up to a combined total of **$112 million** for each of two agreements, plus royalties on net sales[111](index=111&type=chunk)[112](index=112&type=chunk) - Subsequent to the quarter end, on May 8, 2025, the company sold **719,999 shares** and warrants in a private placement for gross proceeds of approximately **$1.08 million**[120](index=120&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's position as a clinical-stage biopharmaceutical firm focused on its lead asset, ateganosine (THIO), for treating cancers, initially Non-Small Cell Lung Cancer (NSCLC). The company highlights recent progress, including positive data from the THIO-101 Phase 2 trial, a new clinical supply agreement with BeiGene, and plans for a pivotal Phase 3 trial (THIO-104) in 2025. Financially, operating expenses rose 37% year-over-year due to increased clinical research and professional fees. The company acknowledges substantial doubt about its ability to continue as a going concern and details its reliance on recent and future capital raises, including private placements and at-the-market offerings, to fund operations [Overview and Key Milestones](index=26&type=section&id=Overview%20and%20Key%20Milestones) MAIA is a clinical-stage biopharmaceutical company developing ateganosine (THIO), a targeted immunotherapy for cancer, with an initial focus on NSCLC. Key recent milestones include a clinical supply agreement with BeiGene for trials in three new cancer indications, positive updated data from the THIO-101 Phase 2 trial showing a median overall survival of 16.9 months in third-line NSCLC patients, and the official adoption of 'ateganosine' as the generic name for THIO. The company also announced plans for a pivotal Phase 3 trial (THIO-104) to begin in 2025 - The lead asset, ateganosine (THIO), is being evaluated in a Phase 2 trial (THIO-101) for Non-Small Cell Lung Cancer (NSCLC). The company plans to initiate a pivotal Phase 3 trial (THIO-104) in 2025[123](index=123&type=chunk) - Entered a clinical supply agreement with BeiGene to evaluate THIO in combination with tislelizumab for hepatocellular carcinoma (HCC), small cell lung cancer (SCLC), and colorectal cancer (CRC)[125](index=125&type=chunk) - Announced positive updated data from the THIO-101 Phase 2 trial, with a median overall survival (OS) of **16.9 months** for third-line NSCLC patients as of January 15, 2025[125](index=125&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) For the three months ended March 31, 2025, operating expenses increased by 37% to $5.4 million compared to the same period in 2024. Research and development expenses rose by 38% to $3.2 million due to increased scientific and clinical research activities. General and administrative expenses grew by 37% to $2.2 million, primarily from higher professional fees and investor relations costs. Other income, net, was approximately $0.9 million, a significant positive swing from an expense of $4.1 million in the prior year, mainly due to the change in fair value of warrant liability. This resulted in a reduced net loss of $4.5 million for the quarter Comparison of Operating Results | Expense Category | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development expenses | $3,197,532 | $2,320,742 | $876,790 | 38% | | General and administrative expenses | $2,227,899 | $1,628,134 | $599,765 | 37% | | Total operating costs and expenses | $5,425,431 | $3,948,876 | $1,476,555 | 37% | | Net loss | $(4,517,259) | $(8,067,455) | $3,550,196 | (44)% | - The increase in R&D expenses was primarily due to an **$873,000** increase in scientific and clinical research[130](index=130&type=chunk) - The increase in G&A expenses was primarily related to a **$649,000** increase in professional fees and investor relations[131](index=131&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company had approximately $10.9 million in cash and $6.8 million in working capital. Despite recent financing activities, including raising approximately $5.5 million net in Q1 2025 from private placements and at-the-market offerings, the company's history of losses and negative cash flows raises substantial doubt about its ability to continue as a going concern. Management states that additional capital will be necessary to fund operations and commercialize its products, and there is no guarantee that such financing will be available on acceptable terms - As of March 31, 2025, cash totaled approximately **$10.9 million**. The company has generated no revenues to date[134](index=134&type=chunk) - Management has concluded there is substantial doubt about the company's ability to continue as a going concern and will need to raise additional equity or debt financing[135](index=135&type=chunk) - In Q1 2025, the company raised gross proceeds of approximately **$4.1 million** from two private placements and **$1.5 million** from its At-The-Market (ATM) offering[139](index=139&type=chunk)[140](index=140&type=chunk)[141](index=141&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is a smaller reporting company and is not required to provide the information for this item - As a smaller reporting company, MAIA Biotechnology, Inc. is not required to provide quantitative and qualitative disclosures about market risk[155](index=155&type=chunk) [Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and Head of Finance, evaluated the company's disclosure controls and procedures as of March 31, 2025. They concluded that these controls were effective at a reasonable assurance level. There were no material changes to the company's internal control over financial reporting during the quarter - Based on an evaluation as of March 31, 2025, the Chief Executive Officer and Head of Finance concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level[156](index=156&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[157](index=157&type=chunk) [PART II—OTHER INFORMATION](index=35&type=section&id=PART%20II%E2%80%94OTHER%20INFORMATION) [Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings. It may, however, be involved in ordinary course of business claims from time to time - The company is not party to any material legal proceedings[159](index=159&type=chunk) [Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) The primary risk factor highlighted is the potential for the company's common stock to be delisted from the NYSE American. The company did not meet the exchange's minimum stockholders' equity requirement of $6 million as of December 31, 2024. While it currently complies with alternate listing standards related to market capitalization and public float, there is no assurance it can maintain compliance, and a delisting could severely limit liquidity and the ability to raise capital - A key risk is the potential delisting from the NYSE American for failing to meet the continued listing requirement of **$6 million** in stockholders' equity, as the company's equity was approximately **$3.6 million** as of December 31, 2024[161](index=161&type=chunk)[162](index=162&type=chunk) - The company is currently in compliance with alternate NYSE American listing standards based on market capitalization and public float, but there is no guarantee this will continue[162](index=162&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=36&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the period covered by this report - There were no unregistered sales of equity securities or purchases of equity securities by the issuer during the reporting period[164](index=164&type=chunk) [Other Information](index=36&type=section&id=Item%205.%20Other%20Information) During the fiscal quarter ended March 31, 2025, no director or Section 16 officer adopted, modified, or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement - No director or officer adopted, modified, or terminated a Rule 10b5-1 trading arrangement during the fiscal quarter ended March 31, 2025[166](index=166&type=chunk) [Exhibits](index=37&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including corporate governance documents, forms of warrants and securities purchase agreements from recent financing, and officer certifications

Core Viewpoint - MAIA Biotechnology, Inc. has been upgraded to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system emphasizes the importance of changing earnings estimates in determining near-term stock price movements, making it a valuable tool for investors [2][4]. - Rising earnings estimates for MAIA indicate an improvement in the company's underlying business, suggesting that investors may respond positively by driving the stock price higher [5]. Zacks Rank System - The Zacks Rank system classifies stocks based on earnings estimates into five groups, with Zacks Rank 1 (Strong Buy) stocks historically generating an average annual return of +25% since 1988 [7]. - MAIA's upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating strong potential for market-beating returns in the near term [10]. Earnings Estimate Revisions for MAIA - For the fiscal year ending December 2025, MAIA is expected to earn -$0.75 per share, with no year-over-year change; however, the Zacks Consensus Estimate has increased by 44.4% over the past three months [8].

PART I [Business](index=6&type=section&id=Item%201.%20Business) MAIA Biotechnology is a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer [Our Company](index=6&type=section&id=Our%20Company) MAIA is a clinical-stage biopharmaceutical company developing THIO for cancer, with its first Phase 2 trial for NSCLC initiated in July 2022 - MAIA is a clinical-stage biopharmaceutical company developing THIO, a dual-mechanism drug candidate for cancer, which targets telomeres and enhances immunogenicity. The first patient was dosed in its Phase 2 trial (THIO-101) for Non-Small Cell Lung Cancer (NSCLC) in July 2022[21](index=21&type=chunk) - The company has established wholly-owned subsidiaries in Australia (MAIA Biotechnology Australia Pty Ltd.) and Romania (MAIA Biotechnology Romania S.R.L.) to conduct preclinical and clinical development activities[22](index=22&type=chunk) [Our Lead Product Candidate](index=6&type=section&id=Our%20Lead%20Product%20Candidate) THIO is a telomere-targeting agent for NSCLC, showing promising interim Phase 2 data and a rare pediatric disease designation - THIO is a telomere-targeting agent being developed as a second- or later-line treatment for NSCLC patients who have progressed on existing checkpoint inhibitors[23](index=23&type=chunk) - The company has reported positive interim data from the THIO-101 trial, including a **100% disease control rate (DCR)** in second-line treatment and a **38% overall response rate (ORR)** in third-line treatment for NSCLC[33](index=33&type=chunk)[39](index=39&type=chunk) - As of January 15, 2025, data from the THIO-101 trial showed a median overall survival (OS) of **16.9 months** for third-line NSCLC patients, which significantly surpasses the standard-of-care OS of **5.8 months**[50](index=50&type=chunk)[46](index=46&type=chunk) - The FDA has granted THIO a "rare pediatric disease" designation (RPDD) for the treatment of pediatric-type diffuse high-grade gliomas (PDHGG), making MAIA eligible for a priority review voucher upon potential approval[48](index=48&type=chunk) [Our Science--Driven Telomere Targeting Approach](index=14&type=section&id=Our%20Science--Driven%20Telomere%20Targeting%20Approach) THIO's mechanism involves telomerase incorporation into cancer cell telomeres, disrupting them and making 'cold' tumors 'hot' for immunotherapy - THIO's mechanism of action involves the enzyme telomerase incorporating it into cancer cell telomeres, which disrupts their structure, leads to DNA damage, and causes cancer cell death. This process is believed to transform immunologically "cold" tumors into "hot" tumors, making them responsive to immunotherapy[55](index=55&type=chunk) - Telomerase is present in over **85%** of human cancer cells but in less than **1%** of normal cells, suggesting THIO's activity is highly specific to cancer cells[56](index=56&type=chunk) [Our Second Generation Molecule Candidates](index=15&type=section&id=Our%20Second%20Generation%20Molecule%20Candidates) The company is researching new telomere-targeting compounds, with one lead and two backup candidates in preclinical development - The company has an early-stage research program to identify new telomere-targeting compounds with potentially improved specificity and anticancer activity compared to THIO[61](index=61&type=chunk) - Seven second-generation compounds have progressed to in vivo testing, with one lead candidate (MAIA-2021-20) and two back-up candidates nominated for further preclinical development[62](index=62&type=chunk) [Our Strategy](index=16&type=section&id=Our%20Strategy) The company aims to advance THIO's clinical programs, broaden its development, expand intellectual property, and pursue strategic collaborations - Advance clinical programs and seek accelerated approval for THIO in NSCLC[69](index=69&type=chunk) - Broaden THIO's development by exploring combinations with other immunotherapies, including cell therapy[69](index=69&type=chunk) - Develop a franchise of telomere-targeting cancer treatments and expand the intellectual property portfolio[69](index=69&type=chunk) - Enter into strategic collaborations with other pharmaceutical and biotechnology companies[69](index=69&type=chunk) [THIO Market Opportunity and Unmet Medical Need](index=17&type=section&id=THIO%20Market%20Opportunity%20and%20Unmet%20Medical%20Need) THIO targets cancers with high TERT presence, addressing significant market opportunities in NSCLC, colorectal, liver, and small cell lung cancers TERT Presence by Tumor Type | Tumor Type | TERT(+) Presence | | :--- | :--- | | Non-Small Cell Lung Cancer (NSCLC) | 78% | | Colorectal (CRC) | 82-89% | | Hepatocellular Carcinoma (HCC) | 79-86% | | Small Cell Lung Cancer (SCLC) | 100% | | Breast Cancer | 88% | | Prostate Cancer | 90% | Projected Annual Sales by Indication | Indication | Annual Sales 2024 ($B) | Annual Sales 2028 (projected, $B) | | :--- | :--- | :--- | | Non-Small Cell Lung Cancer | 28.3 | 43.3 | | Colorectal | 16.6 | 19.4 | | Liver | 2.6 | 5.0 | | Small Cell Lung Cancer | 1.6 | 2.3 | [Intellectual Property](index=19&type=section&id=Intellectual%20Property) The company maintains a global patent estate for telomere-altering compounds and THIO's immunogenic strategy, including exclusive licenses from UTSW - The company maintains a global patent estate with nine issued patents and twenty-two pending applications covering telomere altering compounds, treatment of therapy-resistant cancers, and THIO's immunogenic treatment strategy[78](index=78&type=chunk) - MAIA has exclusive, worldwide license agreements with The University of Texas Southwestern Medical Center (UTSW) for patent families related to methods of using THIO, including in combination with checkpoint inhibitors[80](index=80&type=chunk)[82](index=82&type=chunk) [Our Team](index=21&type=section&id=Our%20Team) The management team, led by CEO Vlad Vitoc and CSO Sergei Gryaznov, is supported by a Scientific Advisory Board of oncology experts - The management team is led by Co-founder and CEO Vlad Vitoc, M.D., M.B.A., with over **25 years** of experience in pharmaceuticals and biotechnology, and Chief Scientific Officer Sergei M. Gryaznov, Ph.D., an expert in drug discovery and telomerase science[89](index=89&type=chunk) - The company is supported by a Scientific Advisory Board (SAB) of internationally recognized experts in oncology, telomeres, and telomerase research, providing scientific advice to the management team[90](index=90&type=chunk)[91](index=91&type=chunk) [Our Programs](index=25&type=section&id=Our%20Programs) THIO targets cancer telomeric DNA and activates the immune system, with primary focus on the THIO-101 Phase 2 trial and future Phase 3 and basket trials - THIO targets two major cancer hallmarks: cancer cell telomeric DNA structure and activating the immune system to turn "cold" tumors into "hot" tumors responsive to therapy[95](index=95&type=chunk) - The primary clinical program is the THIO-101 Phase 2 trial, a dose-finding study evaluating the safety and efficacy of THIO sequenced with cemiplimab in patients with advanced NSCLC[136](index=136&type=chunk) - The company plans to initiate a Phase 3 pivotal trial (THIO-104) in 2025 to evaluate THIO with a checkpoint inhibitor in third-line NSCLC patients[52](index=52&type=chunk) - Future development plans include a "basket trial" to study THIO in multiple other cancer types such as colorectal cancer (CRC), hepatocellular carcinoma (HCC), and small-cell lung cancer (SCLC)[142](index=142&type=chunk) [Strategic Collaborations and Key Agreements](index=40&type=section&id=Strategic%20Collaborations%20and%20Key%20Agreements) MAIA has clinical supply agreements with Regeneron and BeiGene, and exclusive license agreements with UTSW for THIO-related patents - MAIA has a Clinical Supply Agreement with Regeneron Pharmaceuticals, which supplies cemiplimab (Libtayo®) at no cost for the THIO-101 study in NSCLC. This agreement was amended in December 2024 to support an expansion portion of the trial[146](index=146&type=chunk)[47](index=47&type=chunk) - In December 2024, the company entered a Clinical Supply Agreement with BeiGene to supply tislelizumab for upcoming studies in HCC, CRC, and SCLC[148](index=148&type=chunk) - The company holds two exclusive, worldwide license agreements with The University of Texas Southwestern Medical Center (UTSW) for patents covering methods of using THIO, including its sequential use with checkpoint inhibitors[150](index=150&type=chunk)[152](index=152&type=chunk) [Competition](index=48&type=section&id=Competition) The company faces intense competition from major pharmaceutical and biotech firms with significantly greater resources in the highly competitive industry - The biotechnology industry is highly competitive. MAIA faces competition from major pharmaceutical and biotech companies, academic institutions, and research organizations[181](index=181&type=chunk) - Current competitors in the NSCLC market include Merck, Regeneron, Eli Lilly, and Roche. Many competitors have significantly greater financial and operational resources than MAIA[182](index=182&type=chunk)[185](index=185&type=chunk) [Government Regulation](index=50&type=section&id=Government%20Regulation) The company's products are subject to extensive FDA and international regulations covering all stages from research to marketing, with potential for expedited programs - The company's products are subject to extensive regulation by the FDA in the United States and comparable authorities in other countries, covering research, development, testing, manufacturing, and marketing[186](index=186&type=chunk) - The FDA approval process is lengthy and involves preclinical studies, an Investigational New Drug (IND) application, and multiple phases of clinical trials (Phase 1, 2, and 3) to establish safety and efficacy[188](index=188&type=chunk)[195](index=195&type=chunk) - The company may utilize FDA's expedited programs such as Fast Track, priority review, and accelerated approval to potentially speed up the development and review process for its drug candidates[205](index=205&type=chunk)[206](index=206&type=chunk) [Manufacturing](index=71&type=section&id=Manufacturing) MAIA relies on third-party CMOs for all manufacturing, requiring compliance with FDA cGMP regulations for raw materials, API, and finished products - MAIA does not own or operate manufacturing facilities and relies on third-party contract manufacturing organizations (CMOs) for all raw materials, API, and finished products for its clinical trials[244](index=244&type=chunk) - All manufacturing partners are required to comply with the FDA's current Good Manufacturing Practice (cGMP) regulations[245](index=245&type=chunk) [Human Capital](index=71&type=section&id=Human%20Capital) The company has 13 full-time employees as of December 31, 2024, focusing on attracting and retaining talent through competitive compensation - As of December 31, 2024, the company had **13 full-time employees**. It focuses on attracting and retaining skilled employees through competitive compensation and equity ownership opportunities[247](index=247&type=chunk)[248](index=248&type=chunk) [Risk Factors](index=74&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks, including a history of financial losses, a "going concern" warning from its auditors, and the need for significant additional capital - The company has incurred significant losses since inception and its independent auditor has expressed substantial doubt about its ability to continue as a going concern without additional funding[258](index=258&type=chunk)[260](index=260&type=chunk)[263](index=263&type=chunk) - MAIA is heavily dependent on the success of its single lead candidate, THIO, which is still in clinical development and faces a lengthy, expensive, and unpredictable regulatory approval process[258](index=258&type=chunk)[275](index=275&type=chunk) - The company relies on third-party CMOs for manufacturing and CROs for clinical trials, creating risks related to quality control, supply chain disruptions, and trial execution[259](index=259&type=chunk)[346](index=346&type=chunk)[352](index=352&type=chunk) - Intellectual property risks include dependence on license agreements with UTSW, the possibility that licensed patent applications may not issue, and potential challenges to patent validity from competitors[259](index=259&type=chunk)[378](index=378&type=chunk)[389](index=389&type=chunk) [Unresolved Staff Comments](index=141&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports that it has no unresolved staff comments from the SEC - None[473](index=473&type=chunk) [Cybersecurity](index=141&type=section&id=Item%201C.%20Cybersecurity) The company acknowledges the criticality of cybersecurity and faces threats common to the biopharmaceutical industry - The Board of Directors retains oversight of cybersecurity, with senior leadership and a cybersecurity consultant regularly briefing the Board on the company's security posture[476](index=476&type=chunk) - The company has implemented a governance structure and an incident response playbook to assess, identify, manage, and report cybersecurity risks in compliance with regulations from bodies like the SEC[476](index=476&type=chunk)[477](index=477&type=chunk) [Properties](index=143&type=section&id=Item%202.%20Properties) The company's headquarters is located in leased office space in Chicago, Illinois - The company leases approximately **124 square feet** of office space in Chicago, Illinois, for **$3,200 per month** under a twelve-month lease starting in April 2024[479](index=479&type=chunk) [Legal Proceedings](index=143&type=section&id=Item%203.%20Legal%20Proceedings) As of the report date, the company is not a party to any material legal proceedings - The company is not currently party to any material legal proceedings[480](index=480&type=chunk) [Mine Safety Disclosures](index=143&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[481](index=481&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=144&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on the NYSE American under the symbol "MAIA" - The company's common stock is traded on the NYSE American under the symbol "MAIA"[483](index=483&type=chunk) - As of March 21, 2025, there were **29,587,314 shares** of common stock outstanding[483](index=483&type=chunk) - The company has never declared or paid cash dividends and does not plan to in the foreseeable future[484](index=484&type=chunk) [Reserved](index=144&type=section&id=Item%206.%20%5BReserved%5D) This item is reserved [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=145&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company is a clinical-stage biotech focused on its lead asset, THIO, for NSCLC Financial Performance Summary | Financial Metric | 2024 | 2023 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development expenses | $10,009,229 | $11,112,257 | $(1,103,028) | (10)% | | General and administrative expenses | $6,947,981 | $9,070,124 | $(2,122,143) | (23)% | | Loss from operations | $(16,957,210) | $(20,182,381) | $3,225,171 | (16)% | | Net loss | $(23,254,656) | $(19,772,905) | $(3,481,751) | 18% | - The decrease in R&D expenses was primarily due to lower payroll and stock-based compensation, partially offset by increased clinical trial expenses for THIO[502](index=502&type=chunk) - The decrease in G&A expenses was mainly driven by lower investor relations, insurance, and payroll costs[503](index=503&type=chunk) - The company has substantial doubt about its ability to continue as a going concern due to recurring losses, negative cash flows, and the need to raise additional capital to fund future operations[507](index=507&type=chunk)[508](index=508&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=161&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, MAIA Biotechnology is not required to provide this information - The company is a smaller reporting company and is not required to provide the information for this item[532](index=532&type=chunk) [Financial Statements and Supplementary Data](index=161&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) The consolidated financial statements for the years ended December 31, 2024 and 2023, are provided, along with the report from the independent registered public accounting firm, Grant Thornton LLP - The independent auditor's report from Grant Thornton LLP includes a "Going concern" paragraph, highlighting recurring losses, negative cash flows, and an accumulated deficit of **$87,234,833** as of December 31, 2024, which raise substantial doubt about the company's ability to continue as a going concern[571](index=571&type=chunk) Consolidated Balance Sheet Data | Consolidated Balance Sheet Data | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Cash | $9,601,298 | $7,150,695 | | Total Assets | $10,155,279 | $7,566,852 | | Total Liabilities | $6,520,643 | $7,089,341 | | Total Stockholders' Equity | $3,634,636 | $477,511 | Consolidated Statement of Operations Data | Consolidated Statement of Operations Data | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | | :--- | :--- | :--- | | Total Operating Expenses | $16,957,210 | $20,182,381 | | Net Loss | $(23,254,656) | $(19,772,905) | | Net Loss Per Share (Basic and Diluted) | $(1.05) | $(1.49) | [Changes in and Disagreements With Accountants on Accounting and Financial Disclosure](index=161&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None[534](index=534&type=chunk) [Controls and Procedures](index=161&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management, including the CEO and Head of Finance, evaluated the company's disclosure controls and procedures and concluded they were effective as of December 31, 2024 - Management concluded that as of December 31, 2024, the company's disclosure controls and procedures were effective at a reasonable assurance level[535](index=535&type=chunk) - Based on an evaluation using the COSO 2013 framework, management concluded that the company's internal controls over financial reporting were effective as of December 31, 2024[537](index=537&type=chunk) [Other Information](index=163&type=section&id=Item%209B.%20Other%20Information) The company reports no other information for this item - None[540](index=540&type=chunk) [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=163&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) This item is not applicable to the company - Not applicable[541](index=541&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=164&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information required for this item, including details on directors, executive officers, and corporate governance, will be incorporated by reference from the company's definitive proxy statement for its 2025 annual stockholder meeting - The required information will be incorporated by reference from the definitive proxy statement for the 2025 annual meeting of stockholders[543](index=543&type=chunk) [Executive Compensation](index=164&type=section&id=Item%2011.%20Executive%20Compensation) Information regarding executive compensation will be incorporated by reference from the company's definitive proxy statement for its 2025 annual stockholder meeting - The required information will be incorporated by reference from the definitive proxy statement for the 2025 annual meeting of stockholders[546](index=546&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=164&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information on security ownership by beneficial owners and management will be incorporated by reference from the company's definitive proxy statement for its 2025 annual stockholder meeting - The required information will be incorporated by reference from the definitive proxy statement for the 2025 annual meeting of stockholders[547](index=547&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=164&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information concerning related party transactions and director independence will be incorporated by reference from the company's definitive proxy statement for its 2025 annual stockholder meeting - The required information will be incorporated by reference from the definitive proxy statement for the 2025 annual meeting of stockholders[548](index=548&type=chunk) [Principal Accounting Fees and Services](index=164&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Information regarding principal accounting fees and services will be incorporated by reference from the company's definitive proxy statement for its 2025 annual stockholder meeting - The required information will be incorporated by reference from the definitive proxy statement for the 2025 annual meeting of stockholders[549](index=549&type=chunk) PART IV [Exhibits, Financial Statement Schedules](index=165&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section indicates that the consolidated financial statements are included beginning on page F-2 and provides an index of the exhibits filed with the Annual Report - The consolidated financial statements required by this item are located in a separate section beginning on page F-2 of the report[551](index=551&type=chunk) - An index of all exhibits filed as part of the Annual Report on Form 10-K is provided[552](index=552&type=chunk) [Form 10-K Summary](index=165&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company reports no summary for this item - None[553](index=553&type=chunk)