Core Insights - MAIA Biotechnology, Inc. has released updated data from its pivotal Phase 2 clinical trial for ateganosine (THIO) in combination with Regeneron's cemiplimab for advanced non-small cell lung cancer (NSCLC) patients resistant to immune therapy and chemotherapy [1][4]. Group 1: Clinical Trial Results - The trial's third line (3L) data indicates a median overall survival (OS) of 17.8 months for 22 NSCLC patients who received at least one dose of ateganosine, with a 95% confidence interval lower bound of 12.5 months [2][3]. - The treatment has shown to be generally well-tolerated in a heavily pretreated patient population, with one patient completing 32 cycles of therapy and achieving 24.3 months of survival [3]. Group 2: Comparison with Standard Treatments - The median OS of 17.8 months for ateganosine is nearly triple the OS of 5 to 6 months reported for standard-of-care chemotherapy treatments in similar NSCLC settings [3][4]. Group 3: Regulatory and Market Implications - MAIA's potential regulatory pathways for ateganosine could lead to accelerated FDA approval and robust exclusivity in NSCLC, with a possible FDA decision as early as next year [4]. - A new partial response was identified in a patient after 20 months of treatment, defined as a decrease in tumor size of at least 30%, indicating the treatment's efficacy and low toxicity [5]. Group 4: Market Reaction - Following the announcement, MAIA's stock price increased by 11.7%, reaching $1.97 [5].

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

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

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

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]

Financial Data and Key Metrics Changes - The company reported a total of 20,581,469 shares of common stock issued and outstanding as of the record date [6] - Approximately 70.93% of outstanding common stock was represented at the meeting, with 14,598,612 shares entitled to vote [22] Business Line Data and Key Metrics Changes - No specific business line data or key metrics were discussed in the provided content Market Data and Key Metrics Changes - No specific market data or key metrics were discussed in the provided content Company Strategy and Development Direction and Industry Competition - The company ratified the appointment of Grant Thornton as independent auditors for the fiscal year ending December 31, 2024, indicating a focus on maintaining strong governance and compliance [19][23] Management's Comments on Operating Environment and Future Outlook - Management did not provide specific comments on the operating environment or future outlook in the provided content Other Important Information - The election of directors was successfully conducted, with Christian Luputz, Ramiro Guerrero, and Vlad Vittok elected to serve for a three-year term [23] - The meeting was adjourned without any objections, and stockholders were invited to submit questions via email [24] Q&A Session Summary - There was no formal Q&A session during the meeting, but stockholders were encouraged to submit questions directly via email after the meeting [23]

[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)

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The company reported a net loss of $8.6 million for the six months ended June 30, 2023, an increase from the $6.7 million loss in the same period of 2022, driven by higher research and development and general administrative expenses. As of June 30, 2023, the company had $9.1 million in cash and an accumulated deficit of $52.8 million. The financial statements were prepared on a going concern basis, but substantial doubt exists about the company's ability to continue as a going concern due to recurring losses and negative cash flows - The company has incurred recurring losses and negative cash flows, resulting in an accumulated deficit of **$52.8 million** as of June 30, 2023. This raises substantial doubt about its ability to continue as a going concern[31](index=31&type=chunk)[119](index=119&type=chunk) [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2023, total assets were $10.3 million, a decrease from $12.0 million at year-end 2022, primarily due to a reduction in cash from $11.0 million to $9.1 million. Total liabilities remained stable at approximately $3.4 million, while total stockholders' equity decreased from $8.5 million to $6.9 million, reflecting the net loss for the period Condensed Consolidated Balance Sheet Highlights (Unaudited) | Balance Sheet Item | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $9,146,156 | $10,950,927 | | Total current assets | $9,776,314 | $11,808,037 | | Total assets | $10,268,763 | $12,022,040 | | **Liabilities & Equity** | | | | Total current liabilities | $3,272,829 | $3,268,906 | | Total liabilities | $3,394,429 | $3,514,247 | | Accumulated deficit | $(52,847,772) | $(44,207,272) | | Total stockholders' equity | $6,874,334 | $8,507,793 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the six months ended June 30, 2023, the company reported a net loss of $8.6 million, compared to a net loss of $6.7 million for the same period in 2022. The increased loss was driven by a 14% rise in R&D expenses to $4.8 million and a 51% rise in G&A expenses to $4.1 million. Net loss per share for the six-month period was $0.72, an improvement from $0.90 in the prior year period due to a higher number of weighted average shares outstanding Condensed Consolidated Statements of Operations (Unaudited) | Metric | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development expenses | $2,599,315 | $2,119,465 | $4,795,306 | $4,196,794 | | General and administrative expenses | $2,065,331 | $1,322,579 | $4,053,590 | $2,688,808 | | Loss from operations | $(4,664,646) | $(3,442,044) | $(8,848,896) | $(6,885,602) | | Net loss | $(4,523,624) | $(3,305,883) | $(8,640,500) | $(6,719,728) | | Net loss per share (Basic and diluted) | $(0.35) | $(0.40) | $(0.72) | $(0.90) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2023, net cash used in operating activities was $5.9 million, an increase from $4.8 million in the prior-year period. Net cash provided by financing activities was $4.1 million, primarily from a follow-on stock offering, compared to $2.4 million in the same period of 2022. This resulted in a net decrease in cash of $1.8 million, leaving a cash balance of $9.1 million at the end of the period Cash Flow Summary (Unaudited) | Cash Flow Activity | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(5,921,281) | $(4,827,231) | | Net cash provided by financing activities | $4,119,522 | $2,411,027 | | Net decrease in cash | $(1,804,771) | $(2,424,280) | | Cash at end of period | $9,146,156 | $8,150,012 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail significant accounting policies, including the basis for the going concern uncertainty. Key commitments include patent licensing agreements with UTSW for the THIO compound, which involve potential milestone payments up to $112 million and sales royalties. The company also has a clinical trial collaboration with Regeneron. Stockholders' equity changes were driven by a follow-on offering in April 2023, stock-based compensation, and warrant issuances - The company has a Global Patent Licensing Agreement with the University of Texas Southwestern (UTSW) for its THIO compound, which includes potential milestone payments up to a combined total of **$112 million** and sales-based royalties of **2-5%**[96](index=96&type=chunk)[97](index=97&type=chunk)[98](index=98&type=chunk) - A clinical trial agreement is in place with Regeneron Pharmaceuticals to supply its drug cemiplimab at no cost for the THIO-101 trial in Non-Small Cell Lung Cancer (NSCLC)[101](index=101&type=chunk) - On April 27, 2023, the company completed a follow-on offering, selling **2,555,500 shares** at **$2.25 per share**, raising net proceeds of approximately **$4.4 million**[76](index=76&type=chunk)[124](index=124&type=chunk) - As of June 30, 2023, the company had a full valuation allowance against its deferred tax assets due to uncertainty of their realization[102](index=102&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) MAIA Biotechnology is a clinical-stage company focused on developing cancer therapies, with its lead candidate THIO targeting Non-Small Cell Lung Cancer (NSCLC). The company highlighted positive initial data from its THIO-101 Phase 2 trial. Operating expenses increased significantly in the first half of 2023 due to expanded clinical activities and costs associated with being a public company. The company's cash of $9.1 million as of June 30, 2023, raises substantial doubt about its ability to continue as a going concern, necessitating future capital raises to fund operations - The company is a clinical-stage biotechnology firm focused on developing therapies for cancer, with its primary target being Non-Small Cell Lung Cancer (NSCLC), which constitutes **85% of all lung cancers**[106](index=106&type=chunk) - Positive topline data from the THIO-101 trial's safety lead-in portion (Part A) showed THIO was well tolerated. Preliminary survival data for the first two heavily pretreated patients showed they remained alive and progression-free for approximately **10 and 9 months**, respectively, which is noteworthy compared to the typical **3-4 month survival** in this population[108](index=108&type=chunk)[110](index=110&type=chunk) - The company acknowledges that its current cash reserves are insufficient to fund operations for the next year, leading to substantial doubt about its ability to continue as a going concern. Additional capital will need to be raised through equity or debt financing[120](index=120&type=chunk)[124](index=124&type=chunk) [Financial Operations Overview and Analysis](index=26&type=section&id=Financial%20Operations%20Overview%20and%20Analysis) For the six months ended June 30, 2023, R&D expenses rose 14% to $4.8 million due to increased pre-clinical activities and higher payroll. G&A expenses increased 51% to $4.1 million, driven by costs of operating as a public company and increased headcount. This resulted in a 29% increase in the operating loss to $8.8 million compared to the same period in 2022 Comparison of Operating Results (Six Months Ended June 30) | Metric | 2023 | 2022 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development expenses | $4,795,306 | $4,196,794 | $598,512 | 14% | | General and administrative expenses | $4,053,590 | $2,688,808 | $1,364,782 | 51% | | Loss from operations | $(8,848,896) | $(6,885,602) | $(1,963,294) | 29% | | Net loss | $(8,640,500) | $(6,719,728) | $(1,920,772) | 29% | - The increase in R&D expenses for the six months ended June 30, 2023 was primarily due to a **$662,000** increase in pre-clinical activities and a **$658,000** increase in payroll and bonus expenses from higher headcount[116](index=116&type=chunk) - The increase in G&A expenses was mainly attributable to increased costs for infrastructure to support operations as a public company, including a **$1.3 million** increase in other expenses (investor relations, insurance) and a **$412,000** increase in payroll and benefits[117](index=117&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2023, the company had cash of $9.1 million and working capital of $6.5 million. Operations are funded through equity financing, including an IPO in August 2022 and a follow-on offering in April 2023 that raised approximately $4.4 million in net proceeds. Despite these efforts, the company's current funds are not sufficient to cover operations for the next twelve months, reinforcing the going concern uncertainty and the need to raise additional capital - As of June 30, 2023, the company's cash totaled **$9,146,156**. Management has concluded there is substantial doubt about the company's ability to continue as a going concern[119](index=119&type=chunk)[120](index=120&type=chunk) - In August 2022, the company raised total net proceeds of **$9.1 million** from its Initial Public Offering (IPO) and over-allotment option[75](index=75&type=chunk) - On April 27, 2023, the company closed a follow-on offering, raising aggregate net proceeds of approximately **$4.4 million**[124](index=124&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, MAIA Biotechnology, Inc. is not required to provide this information - The company is a smaller reporting company and is not required to provide the information otherwise required under this item[132](index=132&type=chunk) [Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) Management evaluated the company's disclosure controls and procedures and concluded they were effective as of June 30, 2023. A material weakness previously identified as of December 31, 2022, related to insufficient segregation of duties and accounting for complex transactions, was remediated during the second quarter of 2023 by reassigning roles and engaging a third-party consultant - Management concluded that as of June 30, 2023, the company's disclosure controls and procedures were effective at a reasonable assurance level[133](index=133&type=chunk) - A material weakness identified for the year ended December 31, 2022, concerning insufficient segregation of duties and accounting for complex transactions, was remediated in the second quarter of 2023[134](index=134&type=chunk) - Remediation actions included reassigning roles and responsibilities in the accounting system and engaging a third-party consultant to assist with complex transactions[135](index=135&type=chunk) [PART II. OTHER INFORMATION](index=32&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is not party to any material legal proceedings[137](index=137&type=chunk) [Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2022 - As of the date of this Quarterly Report, there have been no material changes to the risk factors disclosed in the Annual Report on Form 10-K filed on March 24, 2023[138](index=138&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=32&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During the quarter, the company issued unregistered shares of common stock to several entities for media, professional relations, and investor services. The use of proceeds from the August 2022 IPO and the April 2023 follow-on offering has not materially changed from the plans described in the respective prospectuses - The company issued unregistered shares of common stock for services to The Money Channel NYC Inc., Acorn Management Partners, LLC, Outside the Box Capital Inc., and FON Consulting[139](index=139&type=chunk)[140](index=140&type=chunk)[141](index=141&type=chunk)[142](index=142&type=chunk) - There has been no material change in the planned use of proceeds from the initial public offering as described in the final prospectus filed on July 29, 2022[144](index=144&type=chunk) [Defaults Upon Senior Securities](index=33&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) None - None[147](index=147&type=chunk) [Mine Safety Disclosures](index=33&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable - Not applicable[147](index=147&type=chunk) [Other Information](index=33&type=section&id=Item%205.%20Other%20Information) None - None[148](index=148&type=chunk) [Exhibits](index=34&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate governance documents, underwriting agreements, certifications, and XBRL data files