MAIA Biotechnology(MAIA) - 2023 Q4 - Annual Report

PART I Business 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] - 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][125] - 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] - THIO's mechanism involves targeting telomeres in cancer cells, causing DNA damage and inducing an immune response to enhance checkpoint inhibitor responsiveness[37] - 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][98] Our Lead Product Candidate and Clinical Development 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][22] - 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][35] 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] Our Pipeline and Strategy 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][47] - 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] Market Opportunity 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][51] 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 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] - 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][60][127][129] - 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][140][149] Government Regulation 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] - 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][169] - 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][181] - 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][206][208] Corporate and Human Capital 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][224] - MAIA was incorporated in Delaware in August 2018, operates in Chicago, and has subsidiaries in Australia and Romania for clinical activities[226] - 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][231] Risk Factors 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] - 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][242] - 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] - 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][351] - 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] Unresolved Staff Comments The company reports that it has no unresolved staff comments from the SEC - None[449] Cybersecurity 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] - The company has an incident response playbook and engages third-party services for penetration testing and independent audits to evaluate security controls[451][452] Properties 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] Legal Proceedings 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] Mine Safety Disclosures This item is not applicable to the company - Not applicable[456] PART II Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 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] - The company has never declared or paid cash dividends and does not plan to in the foreseeable future, retaining earnings for business operations[459] - In 2023, the company issued unregistered restricted common stock to various firms for investor relations, media, and consulting services[460][461][462][463] [Reserved] This item is reserved Management's Discussion and Analysis of Financial Condition and Results of Operations 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] - 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] - 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][482][493] - 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] Quantitative and Qualitative Disclosures About Market Risk 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] Financial Statements and Supplementary Data 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][540] 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 The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None[504] Controls and Procedures 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] - 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] - No material changes to the internal control over financial reporting occurred during the quarter ended December 31, 2023[508] Other Information The company reports no other information for this item - None[510] Disclosure Regarding Foreign Jurisdictions that Prevent Inspections This item is not applicable to the company - Not applicable[511] PART III Directors, Executive Officers and Corporate Governance 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] Executive Compensation 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] Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 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] Certain Relationships and Related Transactions, and Director Independence 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] Principal Accounting Fees and Services 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] PART IV Exhibits, Financial Statement Schedules 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] - An index of exhibits filed with the Form 10-K is provided and incorporated by reference[523] Form 10-K Summary The company did not provide a summary for this item - None[524]