MAIA Biotechnology(MAIA) - 2025 Q2 - Quarterly Report

Cautionary Notice About Forward-Looking Statements 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] - 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][11][12] - The company undertakes no obligation to publicly update or revise any forward-looking statements unless required by law[11] PART I—FINANCIAL INFORMATION 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 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 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] - Total current assets increased by $890,575, and total liabilities increased by $648,527[17] Condensed Consolidated Statements of Operations This statement details the company's revenues, expenses, and net loss over specific reporting periods Three Months Ended June 30 | Metric | June 30, 2025 ($) | 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) | $(0.85) | - Net loss decreased by 40% for the three months ended June 30, 2025, and by 42% for the six months ended June 30, 2025, compared to the prior year periods[20] Condensed Consolidated Statements of Comprehensive Loss This statement presents the net loss and other comprehensive income or loss components for the reporting periods Three Months Ended June 30 | Metric | June 30, 2025 ($) | 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) 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] - Additional paid-in capital increased significantly due to common stock issuances from At-The-Market (ATM) financing and private placement offerings[25] - The accumulated deficit increased from $(87,234,833) at December 31, 2024, to $(97,099,055) at June 30, 2025, primarily due to net losses[25] Condensed Consolidated Statements of Cash Flows This statement categorizes cash inflows and outflows from operating, investing, and financing activities for the reporting periods Six Months Ended June 30 | Metric | June 30, 2025 ($) | 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] - Cash at the end of the period decreased from $11,579,391 in 2024 to $10,144,522 in 2025[32] Notes to Unaudited Condensed Consolidated Financial Statements 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 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][41] - 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][38] - The company operates as a single operating segment, dedicated to discovering and developing immunotherapies for cancer[43] 2. Related Party Transactions 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 $31,570 in common stock for accounting, tax, and valuation services and participated in the February 2025 private placement[75] - Company directors (Stan Smith, Ramiro Guerrero) participated in multiple private placements in February, March, May, and June 2025, purchasing common stock and warrants[77][78][79][80] 3. Accrued Expenses This note provides a breakdown of accrued expenses, including bonuses, professional fees, and research and development costs Accrued Expenses | Accrued Expense Category | June 30, 2025 ($) | 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 $1.2 million[81] 4. Fair Value of Financial Liabilities This note outlines the fair value measurement of financial liabilities, specifically warrant liabilities, and changes over the reporting period Fair Value of Warrant Liabilities | Liability | June 30, 2025 ($) | 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] 5. Stockholders' Equity 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] - The company raised approximately $1.42 million in net proceeds from At-The-Market (ATM) offerings and approximately $5.92 million in gross proceeds from private placements during the first half of 2025[85][86][87][88][89] Stock Warrants Activity (Six Months Ended June 30) | Metric | June 30, 2025 (Units) | June 30, 2024 (Units) | | :----------------------- | :------------------ | :------------------ | | Warrants Outstanding (beginning) | 6,718,176 | 3,650,278 | | Issued | 3,644,299 | 2,949,169 | | Exercised | (219,283) | (1,157,201) | | Warrants Outstanding (end) | 10,143,192 | 5,442,246 | | Weighted Average Exercise Price (end) ($) | $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] 6. Commitments and Contingencies 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][115][116] - 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][118][119] 7. Income Taxes 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][121] - No income tax expense was recorded for the six months ended June 30, 2025, and 2024[121] 8. Segment Information 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] 9. Subsequent Events 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] - Since July 1, 2025, the company sold 1,174,740 shares of common stock through the ATM Agreement, generating net proceeds of approximately $2.19 million[124] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's analysis of the company's financial condition and results, focusing on ateganosine development, clinical milestones, liquidity, and changes in operating expenses and financing activities Overview This overview introduces MAIA Biotechnology as a clinical-stage biopharmaceutical company focused on developing ateganosine for cancer, highlighting key clinical milestones and future trial plans - MAIA Biotechnology is a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, with ateganosine (THIO) as its lead asset, primarily targeting Non-Small Cell Lung Cancer (NSCLC)[126] - Key milestones in the first half of 2025 include positive updated data from the THIO-101 Phase 2 trial (median overall survival of 16.9 months in 3L NSCLC patients), new clinical supply agreements with BeiGene and Roche, and Fast Track designation for ateganosine for NSCLC by the FDA[128][129][131] - The company plans to initiate a Phase 3 pivotal trial (THIO-104) in 2025 for NSCLC and Phase 2 trials in hepatocellular carcinoma (HCC), small cell lung cancer (SCLC), and colorectal cancer (CRC) in 2026[126][128] Results of Operations for the Three and Six Months Ended June 30, 2025 and 2024 This section analyzes the financial performance for the three and six months ended June 30, 2025, compared to 2024, focusing on changes in expenses and net loss Comparison of Three Months ended June 30, 2025 and 2024 This comparison highlights significant changes in research and development, general and administrative expenses, and net loss for the three months ended June 30 Key Financial Changes (Three Months Ended June 30) | Metric | 2025 ($) | 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] - Other income (expense), net, improved by approximately $4.88 million (96%) primarily due to a favorable change in the fair value of warrant liability[135] Comparison of Six Months Ended June 30, 2025 and 2024 This comparison highlights significant changes in research and development, general and administrative expenses, and net loss for the six months ended June 30 Key Financial Changes (Six Months Ended June 30) | Metric | 2025 ($) | 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] - 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] Liquidity and Capital Resources 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 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] - 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][141] Sales of Common Stock 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][146][149][150] - The company also received approximately $3.00 million in gross proceeds from At-The-Market (ATM) offerings during the first half of 2025[147][148] - Additional capital will be required to fund operations, develop ateganosine, and pursue other product development, with no assurance of availability or acceptable terms[151] Cash Flows This subsection analyzes the cash generated from or used in operating, investing, and financing activities for the reporting periods Cash Flow Summary (Six Months Ended June 30) | Activity | 2025 ($) | 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] - 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] - There were no cash flows from investing activities for the six months ended June 30, 2025, and 2024[156] Off-Balance Sheet Arrangements 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] Critical Accounting Policies and Significant Judgments and Estimates 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] Item 3. Quantitative and Qualitative Disclosures About Market Risk 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] Item 4. Controls and Procedures 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] - No material changes in internal control over financial reporting were identified during the period covered by this Quarterly Report[164] PART II—OTHER INFORMATION 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 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] Item 1A. Risk Factors 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] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 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] - On June 18, 2025, 17,083 shares of common stock (valued at $30,751) were issued to a service provider for services rendered[170] Item 3. Defaults Upon Senior Securities The company reports no defaults upon senior securities during the period - No defaults upon senior securities were reported[172] Item 4. Mine Safety Disclosures This item is not applicable to MAIA Biotechnology, Inc. - This item is not applicable to the company[173] Item 5. Other Information 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] Item 6. Exhibits 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] 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]