UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 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. Delaware 83-1495913 (State or other jurisdiction of incorporation or ...

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].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 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- ...

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].

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, 2024 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) (State or other jurisdiction of incorporation o ...

Summary of MAIA Biotechnology Inc (MAIA) 2025 Conference Call Company Overview - **Company**: MAIA Biotechnology Inc (MAIA) - **Focus**: Development of telomere targeting immunotherapies for cancer, specifically the lead molecule "thio" [2][10] Key Points and Arguments Clinical Trials and Efficacy - **Current Trials**: - THIO-101 is a pivotal phase two trial targeting non-small cell lung cancer (NSCLC) in combination with Regeneron's checkpoint inhibitor Libtayo, expected to enroll patients in 2025 [3][5] - THIO-102 will focus on colorectal cancer, hepatocellular carcinoma (HCC), and small cell lung cancer, with plans for separate trials [7][27] - THIO-103 is a planned phase two/three trial for first-line therapy, likely starting in 2026 [8][30] - **Efficacy Results**: - THIO-101 has shown over 80% disease control rates and response rates significantly higher than standard chemotherapy [4][25] - In preclinical studies, THIO combined with checkpoint inhibitors demonstrated a 60% complete response rate, compared to 2-5% with existing therapies [18][20] Market Opportunity - **Market Size**: The NSCLC market generated over $34 billion in sales last year, with significant opportunities in other hard-to-treat cancers [5][33] - **FDA Designations**: THIO has received three orphan drug designations and one rare pediatric disease designation, indicating high unmet medical need [5][6] Pipeline Development - **Second Generation Agents**: MAIA is developing a franchise of telomere targeting agents, with 84 new molecules in development, seven of which show superior efficacy [8][10] - **Intellectual Property**: The company holds a robust patent portfolio with over 30 patents, ensuring market exclusivity until at least 2041 [31] Financial Projections - **Sales Expectations**: The checkpoint inhibitor market was valued at $46 billion in early 2023, with expectations to exceed $50 billion in 2024 [33] - **Investment Potential**: The company anticipates significant revenue potential across multiple tumor types, with comparable companies valued between $1 billion and $4 billion at similar stages [35] Additional Important Information - **Safety Profile**: THIO has demonstrated a safety profile far superior to traditional chemotherapy, making it a promising alternative for patients [4][21] - **Management Experience**: The management team has extensive experience in oncology and drug development, enhancing investor confidence [32] Upcoming Milestones - **Data Releases**: - Full efficacy data from THIO-101 expected mid-2025, with median survival data anticipated in Q2 2025 [36][38] - **Regulatory Filings**: Plans for filing for US approval with potential accelerated approval in 2026 [37]

MAIA Biotechnology Inc (MAIA) FY 2024 Annual General Meeting May 23, 2024 06:00 PM ET Speaker0 Welcome to the twenty twenty four Myo Biotechnology, Inc. Annual Meeting. I will now turn the meeting over to Vlad Vittok. You may begin. Speaker1 Good morning, ladies and gentlemen. I am Vlad Vittok, Chief Executive Officer of Maya Biotechnology, Chairman of the company's Board of Directors and Chairman of this Annual Meeting. I hereby call this annual meeting of stockholders to order. On behalf of my fellow offi ...

[PART I—FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%E2%80%94FINANCIAL%20INFORMATION) This section provides the company's unaudited condensed consolidated financial statements and management's discussion and analysis for the quarter ended March 31, 2024 [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for the quarter ended March 31, 2024, highlighting a significant increase in net loss and a substantial rise in total liabilities leading to a stockholders' deficit Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash | $8,271,449 | $7,150,695 | | Total Current Assets | $8,700,001 | $7,564,052 | | Total Assets | $8,716,036 | $7,566,852 | | Total Current Liabilities | $4,907,767 | $4,937,153 | | Warrant Liability | $9,573,197 | $2,152,188 | | Total Liabilities | $14,480,964 | $7,089,341 | | Total Stockholders' Equity (Deficit) | ($5,764,928) | $477,511 | Condensed Consolidated Statements of Operations (Unaudited) | Account | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Research and development expenses | $2,320,742 | $2,195,991 | | General and administrative expenses | $1,628,134 | $1,988,259 | | Loss from operations | ($3,948,876) | ($4,184,250) | | Change in fair value of warrant liability | ($4,181,298) | $20,942 | | Net loss | ($8,067,455) | ($4,116,876) | | Net loss per share (Basic and diluted) | ($0.46) | ($0.38) | Condensed Consolidated Statements of Cash Flows Highlights (Unaudited) | Account | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | ($3,586,800) | ($3,360,649) | | Net cash provided by financing activities | $4,717,048 | $0 | | Net increase (decrease) in cash | $1,120,754 | ($3,364,615) | | Cash at end of period | $8,271,449 | $7,586,312 | - The company has incurred recurring losses and has an accumulated deficit of **$72.0 million** as of March 31, 2024, leading management to conclude there is substantial doubt about its ability to continue as a going concern within one year[34](index=34&type=chunk)[35](index=35&type=chunk) - The fair value of warrant liabilities increased significantly from **$2.15 million** at the end of 2023 to **$9.57 million** at March 31, 2024, resulting in a **$4.18 million** loss recognized in the statement of operations[75](index=75&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's position as a clinical-stage biotech focusing on THIO for Non-Small Cell Lung Cancer (NSCLC), detailing Q1 2024 operational results, capital raising efforts, and ongoing going concern doubts - The company is a clinical-stage biotechnology firm with its lead asset, THIO, being developed for Non-Small Cell Lung Cancer (NSCLC)[118](index=118&type=chunk) - Key recent milestones include completing enrollment for the Phase 2 THIO-101 trial, reporting a **38% overall response rate (ORR)** in third-line NSCLC patients, and receiving FDA clearance for the IND application for THIO in the U.S[122](index=122&type=chunk)[123](index=123&type=chunk)[124](index=124&type=chunk) Comparison of Operating Expenses (Q1 2024 vs Q1 2023) | Expense Category | Q1 2024 | Q1 2023 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $2,320,742 | $2,195,991 | $124,751 | 6% | | General and administrative | $1,628,134 | $1,988,259 | ($360,125) | (18)% | | **Total operating expenses** | **$3,948,876** | **$4,184,250** | **($235,374)** | **(6)%** | - The increase in net loss for Q1 2024 was primarily driven by a **$4.2 million** non-cash expense related to the change in the fair value of warrant liability[132](index=132&type=chunk) - The company raised capital through multiple financing activities in Q1 2024: - At-The-Market (ATM) Offering: Gross proceeds of approximately **$745,000**[135](index=135&type=chunk) - March 14 Private Placement: Gross proceeds of approximately **$2.92 million**[136](index=136&type=chunk) - March 28 Private Placement: Gross proceeds of approximately **$1.33 million**[137](index=137&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is classified as a smaller reporting company and, as such, is not required to provide the information typically disclosed under this item - As a smaller reporting company, MAIA Biotechnology is not required to provide quantitative and qualitative disclosures about market risk[146](index=146&type=chunk) [Item 4. Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures) Based on an evaluation conducted by management, the company's disclosure controls and procedures were deemed effective at a reasonable assurance level as of March 31, 2024, with no material changes to internal control over financial reporting during the quarter - Management, including the CEO and Head of Finance, concluded that the company's disclosure controls and procedures were effective as of March 31, 2024[147](index=147&type=chunk) - No changes in internal control over financial reporting that materially affected, or are reasonably likely to materially affect, internal controls were identified during the quarter[148](index=148&type=chunk) [PART II—OTHER INFORMATION](index=37&type=section&id=PART%20II%E2%80%94OTHER%20INFORMATION) This section covers other important information including legal proceedings, risk factors, equity sales, and recent corporate actions [Item 1. Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently a party to any material legal proceedings - The company is not involved in any material legal proceedings[151](index=151&type=chunk) [Item 1A. Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) This section highlights a new risk factor concerning the potential delisting of the company's common stock from the NYSE American due to its stockholders' deficit - A new risk factor was added regarding the potential delisting from the NYSE American if the company fails to comply with continued listing requirements[153](index=153&type=chunk) - As of March 31, 2024, the company had a stockholders' deficit of approximately **$5.76 million** and had incurred net losses in the last three fiscal years, but it currently satisfies alternate compliance standards for listing[154](index=154&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=38&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company discloses two recent unregistered sales of equity securities, including restricted common stock for investor services and shares issued upon warrant exercise - On March 18, 2024, the company issued **12,500 shares** of restricted common stock for investor services[156](index=156&type=chunk) - On May 10, 2024, **4,678 shares** of Common Stock were issued upon the net-exercise of an existing warrant[157](index=157&type=chunk) [Item 3. Defaults Upon Senior Securities](index=38&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None[160](index=160&type=chunk) [Item 4. Mine Safety Disclosures](index=38&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[160](index=160&type=chunk) [Item 5. Other Information](index=38&type=section&id=Item%205.%20Other%20Information) The company discloses that on May 11, 2024, it amended certain common stock purchase warrants to change their accounting treatment from a liability to equity in future periods - On May 11, 2024, the company amended certain common stock purchase warrants issued on March 14, March 28, and April 25, 2024[162](index=162&type=chunk)[163](index=163&type=chunk)[164](index=164&type=chunk) - The amendments to the 'Fundamental Transaction' provision are intended to facilitate the warrants being accounted for as equity rather than a warrant liability in the future[162](index=162&type=chunk)[163](index=163&type=chunk)[164](index=164&type=chunk) [Item 6. Exhibits](index=40&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including forms of amendment to common stock purchase warrants and officer certifications - The exhibits filed with this report include amendments to common stock purchase warrants and required officer certifications under the Sarbanes-Oxley Act[168](index=168&type=chunk)

PART I [Business](index=6&type=section&id=Item%201.%20Business) MAIA Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, with its lead product THIO in a Phase 2 trial for NSCLC - MAIA is a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, with its lead asset, **THIO**, in a Phase 2 trial (**THIO-101**) for Non-Small Cell Lung Cancer (**NSCLC**)[19](index=19&type=chunk) - The company has a clinical supply agreement with Regeneron, receiving cemiplimab (**Libtayo®**) at no cost for the **THIO-101** trial, representing significant cost savings[19](index=19&type=chunk)[125](index=125&type=chunk) - MAIA plans to seek accelerated approval for **THIO** in the U.S. for advanced **NSCLC** based on **THIO-101** trial data, targeting late 2024[19](index=19&type=chunk) - **THIO's** mechanism involves targeting telomeres in cancer cells, causing DNA damage and inducing an immune response to enhance checkpoint inhibitor responsiveness[37](index=37&type=chunk) - The FDA has granted **THIO** three Orphan Drug Designations (**ODD**) for Hepatocellular Carcinoma (**HCC**), small cell lung cancer, and Malignant Gliomas Brain Cancer, offering potential for seven years of market exclusivity if approved[41](index=41&type=chunk)[98](index=98&type=chunk) [Our Lead Product Candidate and Clinical Development](index=6&type=section&id=Our%20Lead%20Product%20Candidate%20and%20Clinical%20Development) The company's lead product, THIO, is undergoing Phase 2 clinical development for advanced Non-Small Cell Lung Cancer - The lead product, **THIO**, a telomere-targeting agent, is in the **THIO-101** Phase 2 trial for advanced **NSCLC** patients who progressed after checkpoint inhibitors[21](index=21&type=chunk)[22](index=22&type=chunk) - The **THIO-101** trial completed enrollment ahead of schedule in February 2024, with the optimal dose of **180 mg/cycle** selected in December 2023[32](index=32&type=chunk)[35](index=35&type=chunk) THIO-101 Interim Efficacy Data (as of Jan 8, 2024) | Metric | Result | Population | | :--- | :--- | :--- | | Overall Response Rate (ORR) | 38% (3 out of 8 patients) | Efficacy evaluable, third-line treatment for NSCLC | - Interim **THIO-101** trial data showed a **100% Disease Control Rate (DCR)** in second-line treatment, significantly exceeding the standard of care **DCR of 53-64%**[31](index=31&type=chunk) [Our Pipeline and Strategy](index=12&type=section&id=Our%20Pipeline%20and%20Strategy) The company's pipeline includes THIO for various solid tumors and second-generation telomere-targeting agents, with a strategy for accelerated approval and broader clinical development - The company's pipeline includes **THIO** for various solid tumors (e.g., **NSCLC**, Colorectal) and a second-generation program of telomere-targeting agents, with **seven compounds** advanced to in vivo testing[44](index=44&type=chunk)[47](index=47&type=chunk) - Key strategic elements include seeking accelerated approval for **THIO** in **NSCLC**, broadening its clinical development, developing a franchise of telomere-targeting treatments, and forming strategic collaborations[49](index=49&type=chunk) [Market Opportunity](index=14&type=section&id=Market%20Opportunity) THIO has broad therapeutic potential as telomerase is active in over 85% of human cancers, initially focusing on NSCLC, Colorectal, Liver, and Small Cell Lung Cancer - **THIO** has broad therapeutic potential as telomerase is active in over **85%** of human cancers, with initial focus on **NSCLC**, Colorectal Cancer (**CRC**), Hepatocellular Carcinoma (**HCC**), and Small Cell Lung Cancer (**SCLC**)[50](index=50&type=chunk)[51](index=51&type=chunk) Selected Cancer Market Sales Projections | Tumor Type | 2020 Annual Sales ($B) | 2028 Projected Sales ($B) | | :--- | :--- | :--- | | Non-Small Cell Lung Cancer | 21.0 | 32.7 | | Colorectal | 8.0 | 10.7 | | Liver | 1.0 | 5.0 | | Small Cell Lung Cancer | 0.9 | 2.3 | [Intellectual Property](index=15&type=section&id=Intellectual%20Property) The company's intellectual property portfolio includes 5 issued patents and 29 pending applications, primarily under exclusive license agreements with UTSW - The company's intellectual property portfolio includes **5 issued patents** and **29 pending applications** covering telomere altering compounds and their use with checkpoint inhibitors[57](index=57&type=chunk) - MAIA holds two exclusive, worldwide license agreements with The University of Texas Southwestern Medical Center (**UTSW**) for patent families related to **THIO** use, including with checkpoint inhibitors[59](index=59&type=chunk)[60](index=60&type=chunk)[127](index=127&type=chunk)[129](index=129&type=chunk) - Under the **UTSW** agreements, MAIA is obligated to pay milestone fees up to an aggregate of **$112 million** based on commercial sales and single-digit running royalties on net sales[139](index=139&type=chunk)[140](index=140&type=chunk)[149](index=149&type=chunk) [Government Regulation](index=47&type=section&id=Government%20Regulation) The company's products are subject to extensive regulation by the FDA and comparable authorities, involving lengthy approval processes and potential expedited programs - The company's products are subject to extensive regulation by the **FDA** in the U.S. and comparable authorities globally, covering research, development, testing, manufacturing, and marketing[162](index=162&type=chunk) - The **FDA** approval process is lengthy, involving preclinical testing, an Investigational New Drug (**IND**) application, and multiple phases of clinical trials (**Phase 1, 2, and 3**) to establish safety and efficacy[164](index=164&type=chunk)[169](index=169&type=chunk) - The company may utilize **FDA's** expedited programs, such as Fast Track, priority review, and accelerated approval, to potentially speed up **THIO's** development and review process[180](index=180&type=chunk)[181](index=181&type=chunk) - Sales of approved products depend on coverage and reimbursement from third-party payors like Medicare, Medicaid, and private insurers, subject to cost-containment pressures and healthcare reform[204](index=204&type=chunk)[206](index=206&type=chunk)[208](index=208&type=chunk) [Corporate and Human Capital](index=67&type=section&id=Corporate%20and%20Human%20Capital) The company had 13 full-time employees as of December 31, 2023, operates virtually with subsidiaries, and qualifies as an emerging growth and smaller reporting company - As of December 31, 2023, the company had **13 full-time employees**, focusing on attracting and retaining skilled personnel through competitive compensation and equity ownership[223](index=223&type=chunk)[224](index=224&type=chunk) - MAIA was incorporated in Delaware in August 2018, operates in Chicago, and has subsidiaries in Australia and Romania for clinical activities[226](index=226&type=chunk) - The company qualifies as an "emerging growth company" and a "smaller reporting company," benefiting from reduced disclosure obligations and an extended transition period for new accounting standards[227](index=227&type=chunk)[231](index=231&type=chunk) [Risk Factors](index=70&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks related to its financial position, clinical development, intellectual property, and ability to continue as a going concern - The company has a history of losses, with a net loss of **$19.8 million** in 2023 and an accumulated deficit of **$64.0 million** as of December 31, 2023[238](index=238&type=chunk) - Substantial doubt exists about the company's ability to continue as a going concern due to cash reserves and the need for additional capital to fund operations and clinical development[241](index=241&type=chunk)[242](index=242&type=chunk) - The business is heavily dependent on the success of its single lead candidate, **THIO**; failure to gain regulatory approval or commercialize it would severely harm operations[249](index=249&type=chunk) - The company depends on license agreements with the University of Texas Southwestern (**UTSW**); termination or non-compliance could prevent product candidate development and commercialization[350](index=350&type=chunk)[351](index=351&type=chunk) - The company's common stock is at risk of delisting from **NYSE American** for failing to meet continued listing requirements, such as minimum stockholders' equity[416](index=416&type=chunk) [Unresolved Staff Comments](index=80&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports that it has no unresolved staff comments from the SEC - None[449](index=449&type=chunk) [Cybersecurity](index=81&type=section&id=Item%201C.%20Cybersecurity) The company has implemented a cybersecurity governance structure, with Board oversight, third-party evaluations, and an incident response plan to manage related risks - The Board of Directors retains oversight of cybersecurity, receiving regular briefings from senior leadership and a cybersecurity consultant[451](index=451&type=chunk) - The company has an incident response playbook and engages third-party services for penetration testing and independent audits to evaluate security controls[451](index=451&type=chunk)[452](index=452&type=chunk) [Properties](index=81&type=section&id=Item%202.%20Properties) The company's headquarters is a leased 124 square feet office in Chicago, IL, with a monthly rent of $3,000, reflecting its virtual business model - The company leases approximately **124 square feet** of office space in Chicago, IL for **$3,000 per month**[454](index=454&type=chunk) [Legal Proceedings](index=81&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[455](index=455&type=chunk) [Mine Safety Disclosures](index=81&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[456](index=456&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=82&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 NYSE American, with 20 million shares outstanding, no history of cash dividends, and recent unregistered issuances for services - As of March 21, 2024, there were **20,002,826 shares** of common stock outstanding[458](index=458&type=chunk) - The company has never declared or paid cash dividends and does not plan to in the foreseeable future, retaining earnings for business operations[459](index=459&type=chunk) - In 2023, the company issued unregistered restricted common stock to various firms for investor relations, media, and consulting services[460](index=460&type=chunk)[461](index=461&type=chunk)[462](index=462&type=chunk)[463](index=463&type=chunk) [[Reserved]](index=82&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=83&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company reported a net loss of $19.8 million in 2023, driven by increased R&D and G&A expenses, with cash decreasing to $7.15 million, raising going concern doubts Comparison of Operations (2023 vs. 2022) | Line Item | 2023 | 2022 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development expenses | $11,112,257 | $8,933,314 | $2,178,943 | 24% | | General and administrative expenses | $9,070,124 | $6,143,527 | $2,926,597 | 48% | | **Total operating expenses** | **$20,182,381** | **$16,176,201** | **$4,006,180** | **25%** | | **Net loss** | **($19,772,905)** | **($15,769,279)** | **($4,003,626)** | **25%** | - The increase in R&D expenses was primarily due to higher payroll (including severance), increased clinical trial expenses for **THIO**, and higher stock-based compensation[477](index=477&type=chunk) - The increase in G&A expenses was mainly attributable to higher payroll (including severance), professional fees, investor relations expenses, and Directors & Officers insurance costs[478](index=478&type=chunk) - The company's cash decreased from **$10.95 million** at year-end 2022 to **$7.15 million** at year-end 2023, with net cash used in operating activities at **$13.1 million** in 2023[481](index=481&type=chunk)[482](index=482&type=chunk)[493](index=493&type=chunk) - Management has concluded there is substantial doubt about the company's ability to continue as a going concern due to recurring losses, negative cash flows, and the need to raise additional capital[484](index=484&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=91&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, MAIA Biotechnology, Inc. is not required to provide the information for this item - The company is a smaller reporting company and is not required to provide this information[502](index=502&type=chunk) [Financial Statements and Supplementary Data](index=91&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the company's consolidated financial statements for 2023 and 2022, including auditor's report with a 'going concern' paragraph - The Report of Independent Registered Public Accounting Firm includes an opinion on the financial statements and a paragraph highlighting substantial doubt about the Company's ability to continue as a going concern[539](index=539&type=chunk)[540](index=540&type=chunk) Key Balance Sheet Data (as of Dec 31) | Account | 2023 | 2022 | | :--- | :--- | :--- | | Cash | $7,150,695 | $10,950,927 | | Total Assets | $7,566,852 | $12,022,040 | | Total Liabilities | $7,089,341 | $3,514,247 | | Total Stockholders' Equity | $477,511 | $8,507,793 | Net Loss Per Share | Metric | 2023 | 2022 | | :--- | :--- | :--- | | Net Loss per Share (Basic and Diluted) | ($1.49) | ($1.75) | | Weighted Average Shares Outstanding | 13,261,572 | 9,276,761 | [Changes in and Disagreements With Accountants on Accounting and Financial Disclosure](index=91&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[504](index=504&type=chunk) [Controls and Procedures](index=91&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2023, with no material changes during Q4 2023 - Management concluded that as of December 31, 2023, the company's disclosure controls and procedures were effective at a reasonable assurance level[505](index=505&type=chunk) - Based on a COSO framework evaluation, management concluded that the company's internal controls over financial reporting were effective as of December 31, 2023[507](index=507&type=chunk) - No material changes to the internal control over financial reporting occurred during the quarter ended December 31, 2023[508](index=508&type=chunk) [Other Information](index=92&type=section&id=Item%209B.%20Other%20Information) The company reports no other information for this item - None[510](index=510&type=chunk) [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=92&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) This item is not applicable to the company - Not applicable[511](index=511&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=93&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information on directors, executive officers, and corporate governance is incorporated by reference from the 2024 definitive proxy statement - Information is incorporated by reference from the definitive proxy statement for the 2024 annual stockholder meeting[515](index=515&type=chunk) [Executive Compensation](index=93&type=section&id=Item%2011.%20Executive%20Compensation) The information regarding executive compensation is incorporated by reference from the company's definitive proxy statement for its 2024 annual meeting of stockholders - Information is incorporated by reference from the definitive proxy statement for the 2024 annual stockholder meeting[516](index=516&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=93&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Details concerning security ownership of certain beneficial owners, management, and related stockholder matters are incorporated by reference from the company's definitive proxy statement for its 2024 annual meeting of stockholders - Information is incorporated by reference from the definitive proxy statement for the 2024 annual stockholder meeting[517](index=517&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=93&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information regarding certain relationships, related party transactions, and director independence is incorporated by reference from the company's definitive proxy statement for its 2024 annual meeting of stockholders - Information is incorporated by reference from the definitive proxy statement for the 2024 annual stockholder meeting[518](index=518&type=chunk) [Principal Accounting Fees and Services](index=93&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Information concerning principal accounting fees and services is incorporated by reference from the company's definitive proxy statement for its 2024 annual meeting of stockholders - Information is incorporated by reference from the definitive proxy statement for the 2024 annual stockholder meeting[519](index=519&type=chunk) PART IV [Exhibits, Financial Statement Schedules](index=94&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section indicates consolidated financial statements begin on page F-2 and provides an index of all filed exhibits - The consolidated financial statements are located in a separate section starting on page **F-2**[522](index=522&type=chunk) - An index of exhibits filed with the Form 10-K is provided and incorporated by reference[523](index=523&type=chunk) [Form 10-K Summary](index=94&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company did not provide a summary for this item - None[524](index=524&type=chunk)

PART I—FINANCIAL INFORMATION [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) For the nine months ended September 30, 2023, MAIA Biotechnology reported a net loss of **$13.5 million** and **$9.1 million** net cash used in operations, with cash decreasing to **$6.1 million**, leading to substantial doubt about its going concern ability without additional capital [Condensed Consolidated Financial Statements](index=5&type=section&id=Condensed%20Consolidated%20Financial%20Statements) The company's financial statements reflect a deteriorating financial position, with total assets decreasing to **$7.0 million** from **$12.0 million** at year-end 2022, and net loss widening to **$13.5 million** from **$11.6 million** due to increased operating expenses, while financing activities provided only **$4.2 million** in 2023 compared to **$12.7 million** in 2022 Condensed Consolidated Balance Sheet Data (Unaudited) | Metric | Sep 30, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Cash | $6,104,587 | $10,950,927 | | Total Current Assets | $6,633,133 | $11,808,037 | | Total Assets | $7,001,073 | $12,022,040 | | Total Current Liabilities | $4,149,954 | $3,268,906 | | Total Liabilities | $4,253,361 | $3,514,247 | | Total Stockholders' Equity | $2,747,712 | $8,507,793 | Condensed Consolidated Statements of Operations (Unaudited) | Metric | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | Research and development expenses | $7,394,884 | $6,539,948 | | General and administrative expenses | $6,409,655 | $4,341,880 | | Loss from operations | $(13,804,539) | $(11,981,188) | | Net loss | $(13,516,243) | $(11,623,541) | | Net loss per share (Basic and diluted) | $(1.08) | $(1.39) | Condensed Consolidated Statements of Cash Flows (Unaudited) | Metric | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(9,078,570) | $(9,146,390) | | Net cash provided by financing activities | $4,245,463 | $12,670,074 | | Net decrease/increase in cash | $(4,846,340) | $3,489,350 | | Cash at end of period | $6,104,587 | $14,063,642 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes highlight significant risks and corporate actions, including substantial doubt about going concern with an accumulated deficit of **$57.7 million**, a **$4.4 million** follow-on offering, establishment of an ATM program and share repurchase program, subsequent **$1.05 million** ATM proceeds, and potential **$112 million** milestone payments - The company has incurred recurring losses, with an accumulated deficit of **$57.7 million** as of September 30, 2023, and management has concluded there is substantial doubt about its ability to continue as a going concern[32](index=32&type=chunk)[33](index=33&type=chunk) - In April 2023, the company completed a follow-on offering, selling **2,555,500 shares** at **$2.25 per share** for net proceeds of approximately **$4.4 million**[74](index=74&type=chunk) - In September 2023, the company established an "at-the-market" (ATM) sales agreement to sell up to **$7.0 million** of common stock and a share repurchase program to buy back up to **$800,000** of its stock. No transactions occurred under these programs as of September 30, 2023[75](index=75&type=chunk)[76](index=76&type=chunk) - Subsequent to the quarter end, the company sold **452,388 shares** under its ATM program at an average price of **$2.32 per share**, raising gross proceeds of approximately **$1.05 million**[103](index=103&type=chunk) - The company has licensing agreements with UT Southwestern for its THIO compound that include potential future milestone payments up to **$112 million** and sales-based royalties[96](index=96&type=chunk)[97](index=97&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's focus on developing its lead cancer therapy, THIO, for NSCLC, highlighting positive safety and preliminary survival data from the THIO-101 Phase 2 trial and FDA clearance for U.S. expansion, while financially, the net loss increased to **$13.5 million** due to rising R&D and G&A expenses, reiterating substantial doubt about going concern with only **$6.1 million** in cash [Overview and Key Milestones](index=24&type=section&id=Overview%20and%20Key%20Milestones) MAIA, a clinical-stage biotech, focuses on its lead candidate THIO for NSCLC, achieving key milestones including FDA Orphan Drug Designation, positive topline safety data, encouraging preliminary survival data, FDA clearance for U.S. expansion of the THIO-101 Phase 2 trial, and dosing **49 patients** as of October 2023 - Announced positive topline safety data from Part A of the THIO-101 trial in April 2023, with the highest dose being well tolerated[110](index=110&type=chunk) - In July 2023, reported that the first two patients in the trial remained alive and progression-free for approximately **12.2/10.2 months** and **11.5/8.5 months**, respectively, without additional therapy[112](index=112&type=chunk) - In October 2023, the FDA cleared the company's IND application for THIO, allowing for the U.S. expansion of the THIO-101 Phase 2 trial[112](index=112&type=chunk) - As of October 10, 2023, **49 patients** have been dosed in the THIO-101 Phase 2 clinical trial[112](index=112&type=chunk) [Results of Operations](index=27&type=section&id=Results%20of%20Operations) Operating expenses increased by **15%** to **$13.8 million** for the nine months ended September 30, 2023, driven by a **13%** rise in R&D expenses to **$7.4 million** and a **48%** surge in G&A expenses to **$6.4 million**, resulting in a higher net loss of **$13.5 million** Comparison of Operating Expenses (Nine Months Ended Sep 30) | Expense Category | 2023 | 2022 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $7,394,884 | $6,539,948 | $854,936 | 13% | | General and administrative | $6,409,655 | $4,341,880 | $2,067,775 | 48% | | Total operating expenses | $13,804,539 | $11,981,188 | $1,823,351 | 15% | - The increase in R&D expenses was primarily due to a **$1.2 million** increase in scientific research and a **$538,000** increase in payroll and bonus expenses[119](index=119&type=chunk) - The increase in G&A expenses was driven by a **$1.5 million** increase in other expenses (investor relations, insurance) and a **$418,000** increase in payroll and benefits due to higher headcount[120](index=120&type=chunk)[121](index=121&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) The company's ability to continue as a going concern is in substantial doubt, with cash totaling **$6.1 million** as of September 30, 2023, a decrease of **$4.8 million** from year-end 2022, and net cash used in operating activities of **$9.1 million**, necessitating additional capital to fund operations and clinical development - As of September 30, 2023, the company had cash of **$6,104,587** and working capital of approximately **$2,483,000**[124](index=124&type=chunk) - Management reiterates that there is substantial doubt about the Company's ability to continue as a going concern and that it will need to raise additional equity or debt financing[125](index=125&type=chunk) Cash Flow Summary (Nine Months Ended Sep 30) | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(9,078,570) | $(9,146,390) | | Net cash provided by financing activities | $4,245,463 | $12,670,074 | [Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, MAIA Biotechnology is not required to provide the information for this item - The company is a smaller reporting company and is not required to provide the information otherwise required under this item[138](index=138&type=chunk) [Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) Based on an evaluation as of September 30, 2023, the company's management, including the CEO and CFO, concluded that its disclosure controls and procedures were effective at a reasonable assurance level, with no material changes to internal control over financial reporting during the quarter - The Chief Executive Officer and Chief Financial Officer concluded that as of September 30, 2023, the company's disclosure controls and procedures were effective at the reasonable assurance level[139](index=139&type=chunk) - No changes in internal control over financial reporting were identified during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[140](index=140&type=chunk) PART II—OTHER INFORMATION [Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently a party to any material legal proceedings - The company is not party to any material legal proceedings[142](index=142&type=chunk) [Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) The company directs investors to its Annual Report on Form 10-K for risk factors and adds a new risk concerning its recently authorized share repurchase program, highlighting that the program is not guaranteed to be fully utilized, may not enhance long-term stockholder value, and could increase stock price volatility or negatively impact cash balance - A new risk factor has been added regarding the company's share repurchase program, which was authorized for up to **$800,000** through September 2024[144](index=144&type=chunk) - The new risk states that the repurchase program is not obligatory, may not enhance stockholder value, and could increase stock price volatility or reduce available cash[144](index=144&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=33&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During the quarter, the company issued unregistered restricted common stock for investor relations services and confirmed no material change in the planned use of proceeds from its July 2022 IPO and April 2023 follow-on offering - In August and September 2023, the company issued shares of restricted common stock for investor services under an exemption from registration requirements[145](index=145&type=chunk)[146](index=146&type=chunk)[147](index=147&type=chunk) - There has been no material change in the planned use of proceeds from the company's initial public offering or its April 2023 underwritten public offering[148](index=148&type=chunk)[149](index=149&type=chunk) [Other Items (Items 3, 4, 5, 6)](index=34&type=section&id=Other%20Items%20(3,%204,%205,%206)) The company reports no defaults upon senior securities, no mine safety disclosures, and no other material information to disclose for the period, with a list of exhibits filed with the report - Item 3 (Defaults Upon Senior Securities), Item 5 (Other Information): None[151](index=151&type=chunk)[153](index=153&type=chunk) - Item 4 (Mine Safety Disclosures): Not applicable[151](index=151&type=chunk) - Item 6 (Exhibits): A list of exhibits filed with the Form 10-Q is provided, including certifications and an at-the-market sales agreement[155](index=155&type=chunk)