PART I Business MAIA Biotechnology is a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer Our Company 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 202221 - 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 activities22 Our Lead Product Candidate 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 inhibitors23 - 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 NSCLC3339 - 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 months5046 - 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 approval48 Our Science--Driven Telomere Targeting Approach 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 immunotherapy55 - 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 cells56 Our Second Generation Molecule Candidates 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 THIO61 - 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 development62 Our Strategy 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 NSCLC69 - Broaden THIO's development by exploring combinations with other immunotherapies, including cell therapy69 - Develop a franchise of telomere-targeting cancer treatments and expand the intellectual property portfolio69 - Enter into strategic collaborations with other pharmaceutical and biotechnology companies69 THIO Market Opportunity and Unmet Medical Need 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 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 strategy78 - 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 inhibitors8082 Our Team 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 science89 - 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 team9091 Our Programs 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 therapy95 - 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 NSCLC136 - 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 patients52 - 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 Strategic Collaborations and Key Agreements 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 trial14647 - In December 2024, the company entered a Clinical Supply Agreement with BeiGene to supply tislelizumab for upcoming studies in HCC, CRC, and SCLC148 - 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 inhibitors150152 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 organizations181 - Current competitors in the NSCLC market include Merck, Regeneron, Eli Lilly, and Roche. Many competitors have significantly greater financial and operational resources than MAIA182185 Government Regulation 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 marketing186 - 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 efficacy188195 - 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 candidates205206 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 trials244 - All manufacturing partners are required to comply with the FDA's current Good Manufacturing Practice (cGMP) regulations245 Human Capital 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 opportunities247248 Risk Factors 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 funding258260263 - 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 process258275 - 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 execution259346352 - 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 competitors259378389 Unresolved Staff Comments The company reports that it has no unresolved staff comments from the SEC - None473 Cybersecurity 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 posture476 - 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 SEC476477 Properties 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 $3,200 per month under a twelve-month lease starting in April 2024479 Legal Proceedings As of the report date, the company is not a party to any material legal proceedings - The company is not currently party to any material legal proceedings480 Mine Safety Disclosures This item is not applicable to the company - Not applicable481 PART II Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities The company's common stock trades on the NYSE American under the symbol "MAIA" - The company's common stock is traded on the NYSE American under the symbol "MAIA"483 - As of March 21, 2025, there were 29,587,314 shares of common stock outstanding483 - The company has never declared or paid cash dividends and does not plan to in the foreseeable future484 Reserved This item is reserved Management's Discussion and Analysis of Financial Condition and Results of Operations The company is a clinical-stage biotech focused on its lead asset, THIO, for NSCLC Financial Performance Summary | Financial Metric | 2024 | 2023 | Change ($) | 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 THIO502 - The decrease in G&A expenses was mainly driven by lower investor relations, insurance, and payroll costs503 - 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 operations507508 Quantitative and Qualitative Disclosures About Market Risk 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 item532 Financial Statements and Supplementary Data 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 concern571 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 The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None534 Controls and Procedures 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 level535 - 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, 2024537 Other Information The company reports no other information for this item - None540 Disclosure Regarding Foreign Jurisdictions that Prevent Inspections This item is not applicable to the company - Not applicable541 PART III Directors, Executive Officers and Corporate Governance 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 stockholders543 Executive Compensation 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 stockholders546 Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 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 stockholders547 Certain Relationships and Related Transactions, and Director Independence 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 stockholders548 Principal Accounting Fees and Services 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 stockholders549 PART IV Exhibits, Financial Statement Schedules 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 report551 - An index of all exhibits filed as part of the Annual Report on Form 10-K is provided552 Form 10-K Summary The company reports no summary for this item - None553
MAIA Biotechnology(MAIA) - 2024 Q4 - Annual Report