Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You should read the following discussion together with our consolidated financial statements and the related notes included elsewhere in this Annual Report on Form 10-K. This discussion contains forward-looking statements that are based on our current expectations, estimates and projections about our business and operations. Our actual results may differ materially from those currently anticipated and expressed in such forward-looking statements as a result of a number of factors, including those which we discuss under “Risk Factors” and elsewhere in this Annual Report on Form 10-K.

Overview

We are a clinical stage biotechnology company engaged in the discovery, development and commercialization of therapies targeting cancer. Our initial disease target is lung cancer, a serious medical condition with an incidence of over 236,000 new cases in the US in 2022, representing 12.3% of all cancers, and over 130,000 deaths, or 21.4% of all cancers. Worldwide, lung cancer incidence is over 2,200,000 per year (ranking second only after breast cancer), and mortality over 1,800,000 (ranking first). Specifically, we are targeting Non-Small Cell Lung Cancer (“NSCLC”), which represents 85% of all lung cancers. THIO (6-thio-dG or 6-thio-2 ‘-deoxyguanosine), our lead asset, is an investigational dual mechanism of action drug candidate incorporating telomere targeting and immunogenicity.

We are a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer. THIO (6-thio-dG or 6-thio-2 ‘-deoxyguanosine), our lead asset, is an investigational dual mechanism of action drug candidate incorporating telomere targeting and immunogenicity. In July 2022, the first patient was administered with THIO in our Phase 2 human trial (THIO-101) in Australia. In December 2022, regulatory authorities in three European countries, Hungary, Poland, and Bulgaria, approved the implementation of THIO-101, Phase 2 clinical trial evaluating THIO in patients with Non-Small Cell Lung Cancer (NSCLC). Patients with advanced NSCLC will be treated first with THIO followed a few days later by the immune checkpoint inhibitor Libtayo® (cemiplimab), manufactured and commercialized by Regeneron. Cemiplimab is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. Cemiplimab has been approved in the United States and the rest of the world for multiple cancer indications, including NSCLC. In February 2021, we signed a clinical supply agreement with Regeneron to receive cemiplimab at no cost, which represents a significant cost-savings for the study. In return, we have granted Regeneron exclusive development rights in combination with PD-1 inhibitors for NSCLC for the study period. Based on the clinical data generated by our THIO-101 trial, we plan to seek filing for an accelerated approval of THIO in the United States for the treatment of patients with advanced NSCLC in 2026, but even if granted, accelerated approval status does not guarantee an accelerated review or marketing approval by the Food and Drug Administration (FDA). We plan to initiate a Phase 3 pivotal trial in 2025, named THIO-104, to evaluate the efficacy of THIO administered in sequence with a checkpoint inhibitor (CPI) in third-line non-small cell lung cancer (NSCLC) patients who are resistant to checkpoint inhibitors and chemotherapy which could lead filing for early full commercial approval in 2026 and final analysis could lead to filing for full commercial approval in 2027. The multicenter, open-label, pivotal Phase 3 trial is designed to provide a direct comparison to chemotherapy in a 1:1 randomization of up to 300 patients. In addition, the originally planned Phase 2 clinical trial in multiple tumor indications (THIO-102) is now divided into different trials for one tumor indication each: hepatocellular carcinoma (HCC), colorectal cancer (CRC) and small cell lung cancer (SCLC). Phase 2 clinical trials in HCC, CRC and SCLC are planned to be initiated in 2026, evaluating treatment with THIO administered in sequence with BeiGene's immune checkpoint inhibitor, tislelizumab. Clinical trials with other solid tumors (ST), such as breast, prostate, gastric, pancreatic and ovarian, may still be considered for potential future trials.

We were incorporated in Delaware in August 2018, and have operations in Chicago, Illinois, with some of our team members setup virtually and working remotely in California, North Carolina, and New Jersey, among others. Our principal executive office is located at 444 West Lake Street, Suite 1700, Chicago, IL 60606, and our phone number is (312) 416-8592. In July 2021, we established a wholly-owned Australian subsidiary, MAIA Biotechnology Australia Pty Ltd., to conduct various preclinical and clinical activities for the development of our product candidates. ln April 2022, we established a wholly owned Romanian subsidiary, MAIA Biotechnology Romania S.R.L. to conduct various preclinical and clinical activities for the development of our product candidates. Our website address is www.MAIABiotech.com. The information contained on our website is not incorporated by reference into this prospectus supplement, and you should not consider any information contained on, or that can be accessed through, our website as part of this prospectus supplement or in deciding whether to purchase our securities.

We accomplished the following key milestones in the fiscal year ended December 31, 2024 and the first quarter of 2025:

•

On January 17, 2024, we announced new interim data for our ongoing THIO-101 Phase 2 trial in non-small cell lung cancer (NSCLC). In the latest available data from THIO-101 (November 13, 2023), 60 patients had been dosed with THIO in sequential combination with Libtayo®. The patients received either 60mg, 180mg, or 360mg of THIO per dose, and 42 had at least one post baseline assessment completed. The observed disease control was well sustained compared to previous scans.

•

On February 7, 2024, we announced publication of international Patent Cooperation Treaty (“PCT”) application titled “Dinucleotides and Their Use in Treating Cancer.” The new dinucleotides disclosed in the patent application are telomere-targeting molecules, such as THIO fragments or other THIO analogues. These compounds are key next-generation telomere-targeting agents, an important extension of MAIA’s innovative cancer treatment platform. The PCT system streamlines the process for obtaining patent protection globally. Under the PCT, applicants can seek patent protection in a large number of countries.

•

On February 14, 2024, we entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”), to sell shares of our Common Stock having an aggregate sales price of up to $1,445,000, from time to time, through an “at-the-market offering” program under which Wainwright will act as sales agent. Effective March 25, 2024, the Company filed a prospectus supplement to amend, supplement and supersede certain information contained in the earlier prospectus and prospectus supplement, which increased the number of shares of Common Stock the Company may offer and sell under the ATM Agreement to an aggregate offering price of up to $4,950,000 from time to time. Effective May 15, 2024, the Company filed a prospectus supplement to amend, supplement and supersede certain information contained in the earlier prospectus and prospectus supplement, which increased the number of Shares the Company may offer and sell under the ATM Agreement to an aggregate offering price of up to $11,280,000 from time to time. Effective December 23, 2024, the Company filed a prospectus supplement to amend, supplement and supersede certain information contained in the earlier prospectus and prospectus supplement, which increased the number of Shares the Company may offer and sell under the ATM Agreement to an aggregate offering price of up to $30,000,000 from time to time. As of the date of this Annual Report, we have sold 3,940,683 shares of our Common Stock under the ATM Agreement at an average price of $2.95 per share, resulting in aggregate gross proceeds of approximately $11,633,086, for which we paid Wainwright $348,993 in commissions resulting in net proceeds to us of approximately $11,284,093.

•

On February 22, 2024, we announced completion of enrollment in Phase 2 THIO-101 go-to-market clinical trial. The trial reached the enrollment target of 41 patients for the 180mg/dose on February 19, 2024. As of the latest data available for the trial, 79 patients had received either 60mg (24 patients), 180mg (41 patients) or 360mg (14 patients). The original trial design targeted up to 182 patients, including all patients in the safety lead-in and 41 patients in each of the 3 tested doses (60mg, 180mg, and 360mg). Following the selection of 180 mg/cycle as the optimal dose in December 2023, all patients were subsequently enrolled at the 180mg/cycle dose and trial enrollment was completed ahead of schedule.

•

On March 6, 2024, we announced interim efficacy data for THIO-101 Phase 2 trial in NSCLC. In the latest data available (January 8, 2024), the overall response rate (ORR), characterized as partial or complete response to therapy, was 38% (3 out of 8 patients) in the efficacy evaluable population for combination THIO 180mg + cemiplimab in third-line treatment for NSCLC patients who failed treatment with immune checkpoint inhibitors in prior lines of therapy, with or without chemotherapy.

•

On March 28, 2024, we issued and sold 578,643 shares of our Common Stock and warrants to purchase 578,643 shares of our Common Stock in a private placement to certain accredited investors pursuant to securities purchase agreements dated March 25, 2024 at a price per share of $2.295 for which we received gross proceeds of approximately $1.33 million. The warrants issued in the private placement have an exercise price of $2.55, are exercisable six months after issuance and expire 5-years after the initial exercise date.

•

On March 27, 2024, we evaluated additional clinical data from its Phase 2 clinical trial, THIO-101. At such time, a total of 68 patients have been dosed and had a post-baseline scan in MAIA’s Phase 2 clinical trial, THIO-101, evaluating THIO in sequential combination with an immune checkpoint inhibitor in patients with advanced NSCLC. Preliminary efficacy across all lines of therapy in this March 2024 data cut were consistent with previous reports including: (i) 75% of patients receiving THIO 180mg as third-line therapy for NSCLC have surpassed the overall survival (“OS”) threshold of 5.8 months; (ii) 88% of patients in the same setting (3L, 180mg) also crossed the 2.5 months progression free survival (“PFS”) threshold and have shown ORR of 38%, greatly improving on current chemo treatment that have ORRs of around 6-10%; and (iii) across all third-line patients, DCR of 85% remained superior to current chemotherapy options, which ranges from 25-35% DCR.

•

issuance and expire 5-years after the initial exercise date. The securities sold to our directors participating in the April 25, 2024 private placement were issued pursuant to the MAIA 2021 Plan.

•

On June 4, 2024, we announced new preliminary efficacy data from the Phase 2 THIO-101 clinical trial. The updated included that as of April 30, 2024: (i) all evaluable patients had completed ≥1 post-baseline assessment; (ii) third-line treatment across all doses had shown DCR of 85% for THIO, 65% of patients crossed the 5.8-month OS threshold identified in literature, 85% of patients crossed the 2.5-month PFS threshold, median survival follow-up time was 9.1 months; and (iii) third-line treatment with THIO 180mg had shown median PFS of 5.5 months, 78% OS rate at 6 months, 38% ORR, 75% of patients crossed the 5.8-month OS threshold, 88% of patients crossed the 2.5-month PFS threshold and median survival follow-up time observed was 9.1 months.

•

On June 6, 2024, we announced highlights and key achievements year-to-date, including: (i) exceptional measures of efficacy by lead drug THIO in Phase 2 clinical trial, with 38% ORR in third-line (3L) setting (THIO 180mg) compared to ~6% for currently available treatments in a similar population and 5.5 months median progression-free survival (PFS) (3L, THIO 180mg); and (ii) secured continued insider investment through independent board members’ participation in private placement equity financings, with funding of more than $12M year-to-date.

•

On June 7, 2024, we announced the validation of clinical and regulatory pathways for viable therapies leveraging the cell’s telomeric functions as evidenced by the FDA approval of imetelstat, a treatment for low- to intermediate-risk hematologic malignancies (myelodysplastic syndromes) from Geron Corporation, illuminating the role of telomere targeting as a viable therapeutic strategy for cancer treatment.

•

On July 23, 2024, we announced treatment updates from our Phase 2 clinical trial of THIO. As of June 12, the latest clinical cut-off date: (i) 6 patients remain on treatment following at least 12 months of therapy; (ii) treatment with THIO followed by cemiplimab has been well tolerated throughout the trial, with lower toxicity compared to standard-of-care treatments; and (iii) the longest-treated patients have completed 21 cycles of THIO sequenced with cemiplimab.

•

On September 10, 2024, we announced updates from our lead clinical candidate THIO, in our Phase 2 clinical trial, THIO-101. The updates included: (i) As of August 1, 2024, 16 patients had survival follow-up surpassing 12 months, including 9 in third line treatment (3L); (ii) Interim median survival follow-up in 3L was 10.6 months.; and (iii) THIO's substantial survival benefit in third line surpasses comparable standard-of-care overall survival of 5.8 months.

•

On November 1, 2024, we issued and sold 1,079,784 shares of our common stock and warrants to purchase 1,079,784 shares of our common stock in a private placement to certain accredited investors and Company directors pursuant to securities purchase agreements dated October 28, 2024 at a price per share of $2.259 for which we received gross proceeds of approximately $2.44 million. The warrants issued in the private placement have an exercise price of $2.51, are exercisable six months after issuance and expire 5-years after the initial exercise date. The securities sold to our directors participating in the private placement were issued pursuant to our 2021 Equity Incentive Plan.

•

On December 3, 2024, we announced the amendment of the 2021 clinical supply agreement with Regeneron for the expansion portion of THIO-101, its Phase 2 clinical trial evaluating THIO in sequential administration with cemiplimab (Libtayo®). The new expansion will further assess the efficacy of MAIA’s lead asset, THIO, sequenced with immune checkpoint inhibitor (CPI) Libtayo® (cemiplimab) for advanced non-small cell lung cancer (NSCLC) patients receiving third-line therapy who were resistant to previous checkpoint inhibitor treatments and chemotherapy. The original 2021 agreement between MAIA and Regeneron was designed to supply the original THIO-101 trial through the dose selection and safety evaluation process.

•

On December 13, 2024, we issued and sold 507,364 shares of our common stock and warrants to purchase 507,364 shares of our common stock in a private placement to certain accredited investors and Company directors pursuant to securities purchase agreements dated December 9, 2024 at a price per share of $1.872 for which we received gross proceeds of approximately $950,000. The warrants issued in the private placement have an exercise price of $2.08, are exercisable six months after issuance and expire 5-years after the initial exercise date. The securities sold to our directors participating in the private placement were issued pursuant to our 2021 Equity Incentive Plan.

•

On December 16, 2024, we announced that the FDA has designated THIO for the treatment of pediatric-type diffuse high-grade gliomas (PDHGG) as a drug for a “rare pediatric disease” (RPDD). Upon FDA approval of a future new drug application in PDHGG, MAIA would be eligible to receive a priority review voucher that can be redeemed by drug developers for FDA priority review of a different product or transferred or sold to another sponsor.

•

On January 7, 2025, we announced that we had entered into a clinical supply agreement with global oncology company BeiGene to assess the efficacy of THIO, its small molecule telomere-targeting anticancer agent, in combination with BeiGene’s immune checkpoint inhibitor (CPI) tislelizumab in three cancer indications. The single arm pivotal Phase 2 trials will study the drug combination in hepatocellular carcinoma (HCC), small cell lung cancer (SCLC) and colorectal cancer (CRC). Under the terms of the collaboration, MAIA will sponsor and fund the planned clinical trials and BeiGene will

provide tislelizumab. MAIA maintains global development and commercial rights to THIO and is free to develop the programs in combination with other agents and in other indications.

•

On February 4, 2025, we announced positive updated data from THIO-101 Phase 2 clinical trial evaluating its lead clinical candidate, THIO, sequenced with Regeneron’s immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who failed two or more standard-of-care therapy regimens. As of January 15, 2025, third line (3L) data updates showed that: (i) median overall survival (OS) of 16.9 months for the 22 NSCLC patients who received at least one dose of THIO (the intent-to-treat population) in parts A and B of the trial. (ii) The analysis demonstrated a 95% confidence interval (CI) lower bound of 12.5 months and a 99% CI lower bound of 10.8 months. (iii) The treatment has been generally well-tolerated to date in this heavily pre-treated population.

•

On February 24, 2025, we issued and sold 1,810,000 shares of our common stock and warrants to purchase 1,810,000 shares of our common stock in a private placement to certain accredited investors and Company directors pursuant to securities purchase agreements dated February 18, 2025 at a price per share of $1.50 for which we received gross proceeds of approximately $2,72 million. The warrants issued in the private placement have an exercise price of $1.87, are exercisable one year after issuance and expire 5-years after the initial exercise date. The securities sold to our directors participating in the private placement were issued pursuant to our 2021 Equity Incentive Plan.

•

On February 26, 2025, we announced the trial design for the expansion of its THIO-101 pivotal Phase 2 trial in non-small cell lung cancer (NSCLC). The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. The THIO-101 study in 3L will enroll up to 48 patients with two arms: Arm 1, continuing the evaluation of THIO sequenced with Libtayo® (cemiplimab); and Arm 2, evaluating THIO as a monotherapy, to further gain experience of THIO in the contribution of components. Treatment cycles for patients in both arms will administer THIO on 3 consecutive days, followed by immune activation on day 4. Arm 1 will administer Libtayo on day 5. The Company plans to enroll an additional 100 patients for the registration phase of the trial. MAIA expects to conduct the trials in the U.S. and select countries in Europe and Asia.

•

On February 27, 2025, we announced plans to initiate a Phase 3 pivotal trial in 2025, named THIO-104, to evaluate the efficacy of THIO administered in sequence with a checkpoint inhibitor (CPI) in third-line non-small cell lung cancer (NSCLC) patients who are resistant to checkpoint inhibitors and chemotherapy. The multicenter, open-label, pivotal Phase 3 trial is designed to provide a direct comparison to chemotherapy in a 1:1 randomization of up to 300 patients.

•

On March 3, 2025, we issued and sold 952,300 shares of our common stock and warrants to purchase 952,300 shares of our common stock in a non-brokered private placement to accredited investors and certain Company directors pursuant to securities purchase agreements dated February 24, 2025 at a price per share of $1.50 for which we received gross proceeds of approximately $1.43 million, prior to offering expenses payable by the Company. The warrants issued in the private placement have an exercise price of $1.85, are exercisable one year after issuance and expire 5-years after the initial exercise date. The securities sold to our directors participating in the private placement were issued pursuant to our 2021 Equity Incentive Plan.

•

On March 18, 2025, MAIA announced that the United States Adopted Names (USAN) Council had approved “ateganosine” as the nonproprietary (generic) name for its lead molecule THIO, a telomere-targeting anticancer agent in clinical development as a first-in-class treatment for advanced non-small cell lung cancer (NSCLC). The company chose a name inspired by the mechanism of action of THIO: altering telomeric guanosine of the cancer cells. The generic name ateganosine is a unique and consistent identity that aims to support clear communication between healthcare providers, patients and researchers. MAIA will retain the name THIO in its clinical trial designations (THIO-101, THIO-102, THIO-103, THIO-104).

•

On March 20, 2025, we announced the publication of preclinical data for its lead proprietary telomere-targeting THIO dimer in the peer-reviewed scientific journal Naunyn-Schmiedeberg's Archives of Pharmacology. In a preclinical study, THIO and its new described dimer form were found to be potent inhibitors of Glutathione S-transferase Pi (GSTP1), a key enzyme implicated in cancer progression and chemoresistance and a highly important factor for the detoxification of cancer cells. The findings suggest that the dimerized form of THIO could enhance chemotherapeutic efficacy by effectively targeting GSTP1 and reducing drug resistance. The article, titled “Investigation of the inhibitory effects of the telomere-targeted compounds on glutathione S-transferase P1,” was published on February 15, 2025.

•

In addition to NSCLC, HCC, SCLC and CRC we plan to conduct clinical trials evaluating THIO in sequential combination with an immune checkpoint inhibitor in several other cancer indications, including solid tumors, such as breast, prostate, gastric, pancreatic and ovarian cancers. THIO-103 is a Phase 2 clinical trial planned to evaluate treatment with THIO in first-line patients for both NSCLC and SCLC.

Impact of the War in Ukraine on Our Operations

The short and long-term implications of Russia’s invasion of Ukraine are difficult to predict at this time. The imposition of sanctions and counter sanctions may have an adverse effect on the economic markets generally and could impact our business, financial condition, and results of operations. Because of the highly uncertain and dynamic nature of these events, the Company terminated any planned research activities in Russia.

Financial Operations Overview and Analysis For the Years Ended December 31, 2024 and 2023

Comparison of the Years Ended December 31, 2024 and 2023

Years Ended December 31,

Change

Operating expenses:

Other income (expense):

Loss on fair value of warrants over proceeds (12,952 ) — (12,952 ) (100)%

Operating Expenses

Research and development expenses

Research and development expenses decreased by approximately $1,103,000 (or approximately 10%) from approximately $11,112,000 for the year ended December 31, 2023 to approximately $10,009,000 for the year ended December 31, 2024. The decrease was primarily related to a decrease in payroll expense of approximately $1,610,000 related to the decrease in the headcount of research and development employees and the reversal of the accrued bonus that was not paid, a decrease in stock based compensation of approximately $954,000 as no bonuses were paid in stock compensation in 2024, a decrease in Scientific pre-clinical research of approximately $630,000, a decrease of other expenses related to research and development of approximately $34,000, offset by the increase in clinical expenses related to the clinical trial of THIO of approximately $2,054,000, and the increase in professional fees of $71,000.

General and administrative expenses

General and administrative expenses decreased by approximately $2,122,000 (or approximately 23%) from approximately $9,070,000 for the year ended December 31, 2023 to approximately $6,948,000 for the year ended December 31, 2024. The decrease was primarily related to a decrease in other expenses of approximately $951,000 related to lower investor relations and insurance expenses, a decrease in payroll expense of approximately $795,000 relating to the decreased headcount of general and administrative employees and the reversal of the accrued bonus, a decrease in stock-based compensation of approximately $222,000, and a decrease in professional fees of approximately $154,000,

Other income (expense), net

Other income (expense), net increased by approximately $6,707,000 (or approximately 1638%) from other income, net of approximately $410,000 for the year ended December 31, 2023 to other expense, net of approximately $6,297,000 for the year ended December 31, 2024. The increase was primarily related to the change in the fair value of the warrant liability of approximately

$6,888,000, a loss on fair value of warrants over proceeds of approximately $13,000, a reduction in the Australia research and development incentives of approximately $97,000 and an increase of interest income, net of approximately $291,000.

Liquidity and Capital Resources

The following table presents selected financial information and statistics as of and for the years ended December 31, 2024 and 2023:

Years Ended December 31, 2024 and 2023

As of December 31,

Balance Sheet Data:

(1) We define working capital as current assets less current liabilities.

Capital Resources

Our Ability to Continue as a Going Concern

As of December 31, 2024, our available cash totaled approximately $9,601,000 which represented an increase of approximately $2,451,000 compared to December 31, 2023. As of December 31, 2024, we had working capital of approximately $6,322,000 which represents an increase of approximately $3,696,000 compared to December 31, 2023. We have generated no revenues as of December 31, 2024. The Company’s current operating plan indicates that it will continue to incur losses from operations and generate negative cash flows from operating activities given ongoing expenditures related to the completion of its ongoing clinical trials and the Company’s lack of revenue generating activities. Based on the Company’s cash reserves as December 31, 2024 of $9,601,298 and current financial condition as of the date of the Annual Report on Form 10-K, the accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

To meet the Company’s future working capital needs, the Company will need to raise additional equity or enter into debt financing. While the Company has historically been able to raise additional capital through issuance of equity and/or debt financing, and while the Company has implemented a plan to control its expenses in order to satisfy its obligations due within one year from the date of issuance of these financial statements, the Company cannot guarantee that it will be able to raise additional equity, raise debt, or contain expenses. Accordingly, there is substantial doubt about the Company’s ability to continue as a going concern within one year after these financial statements are issued.

Sale of Common Stock

On April 27, 2023, we sold 2,555,500 shares of the Company’s common stock at a price of $2.25 per share in an underwritten public offering. ThinkEquity served as the underwriter of the offering. The aggregate net proceeds of the offering were approximately $4.2 million, after deducting underwriting discounts and expenses. The shares of common stock were offered, issued and sold to the public pursuant to the Registration Statement on Form S-1, as amended from time to time (File No. 333-269606).

In October and November 2023, we issued and sold an aggregate of 758,388 shares of common stock through ThinkEquity LLC (“ThinkEquity”), pursuant to the terms of an “at-the-market" Sales Agreement, dated September 1, 2023 (the “Sales Agreement”), by and between the Company and ThinkEquity, the Company’s sale agent thereunder, for which the Company received aggregate gross proceeds of approximately $1.7 million.

On November 17, 2023, we issued and sold an aggregate of 2,424,243 shares of common stock in a registered direct offering pursuant to securities purchase agreements, for which the Company received aggregate gross proceeds of $4 million. H.C. Wainwright was the placement agent for the registered direct offering.

Between February 14, 2024 and March 31, 2024, we sold 507,754 shares of Common Stock at an average price of approximately $1.47 per share, resulting in aggregate gross proceeds of approximately $745,251 under the ATM Agreement dated February 14,

2024, for which we paid Wainwright approximately $22,357 in commissions resulting in net proceeds to us of approximately $722,894. Between April 1, 2024 and June 30, 2024, we sold 2,015,122 shares of our Common Stock at an average price of $3.53 per share, resulting in aggregate gross proceeds of approximately $7,116,978 under the ATM Agreement dated February 14, 2024 with Wainwright, for which we paid Wainwright $213,509 in commissions, resulting in net proceeds of approximately $6,903,469. Between July 1, 2024 and September 30, 2024, we sold 177,606 shares of Common Stock at an average price of approximately $3.72 per share, resulting in aggregate gross proceeds of approximately $660,437 under the ATM Agreement dated May 15, 2024, for which we paid Wainwright approximately $19,813 in commissions, resulting in net proceeds to us of approximately $640,624. Between October 1, 2024 and December 31, 2024, we sold we sold 573,878 shares of Common Stock at an average price of approximately $2.77 per share, resulting in aggregate gross proceeds of approximately $1,589,330 under the ATM Agreement dated May 15, 2024, for which we paid Wainwright approximately $47,680 in commissions, resulting in net proceeds to us of approximately $1,541,650.

On March 14, 2024, we issued and sold 2,496,318 shares of our Common Stock and warrants to purchase 2,496,318 shares of our Common Stock in a private placement to certain accredited investors and to our participating directors pursuant to securities purchase agreements dated March 11, 2024 at a price $1.17 per share, for which we received gross proceeds of approximately $2.92 million. The warrants are exercisable at a price per Share of $1.30, which price represents the greater of the book or market value of the stock on the date the purchase agreement was executed, are exercisable commencing six-months following issuance and have a term of five and a half years from the initial issuance date. The securities sold to our directors participating in the March 14, 2024 private placement were issued pursuant to the MAIA 2021 Plan.The following Company directors participated in the aforementioned private placement as follows: (i) Stan Smith purchased 170,940 shares and 170,940 warrants for an aggregate purchase price of $200,0000; (ii) Louie Ngar Yee purchased 170,940 shares and 170,940 warrants for an aggregate purchase price of $200,000; (iii) Cristian Luput purchased 69,282 shares and 69,282 warrants for an aggregate purchase price of $81,060 (iv) Steven Chaouki purchased 34,641 shares of common stock and 34,461 warrants for an aggregate purchase price of $40,530 and (v) Ramiro Guerrero purchased 6,928 shares and 6,928 warrants for an aggregate purchase price of $8,106.

On March 28, 2024, we issued and sold 578,643 shares of our Common Stock and warrants to purchase 578,643 shares of our Common Stock in a private placement to certain accredited investors pursuant to securities purchase agreements dated March 25, 2024 at a price of $2.295 per share, for which we received gross proceeds of approximately $1.33 million.The warrants are exercisable at a price per Share of $2.55, which price represents the greater of the book or market value of the stock on the date the purchase agreement was executed, are exercisable commencing six-months following issuance and have a term of five and a half years from the initial issuance date.

On April 25, 2024, we issued and sold 494,096 shares of our Common Stock and warrants to purchase 494,096 shares of our Common Stock in a private placement to certain accredited investors and to our participating directors pursuant to securities purchase agreements dated April 22, 2024 at a price of $2.034 per share, for which we received gross proceeds of approximately $1.0 million. The warrants are exercisable at a price per Share of $2.26, which price represents the greater of the book or market value of the stock on the date the purchase agreement was executed, are exercisable commencing six-months following issuance and have a term of five and a half years from the initial issuance date. The securities sold to our directors participating in the April 25, 2024 private placement were issued pursuant to the MAIA 2021 Plan. Company director Stan Smith purchased 147,492 shares and 147,492 warrants for an aggregate purchase price of approximately $300,000 and Company director Louie Ngar Yee purchased 19,665 shares and 19,665 warrants for an aggregate purchase price of approximately $40,000.

On November 1, 2024, we issued and sold 1,079,784 shares of our Common Stock and warrants to purchase 1,079,784 shares of our Common Stock in a private placement to certain accredited investors and to our participating directors pursuant to securities purchase agreements dated October 28, 2024 at a price of $2.259 per share, for which we received gross proceeds of approximately $2.44 million. The warrants are exercisable at a price per Share of $2.51, which price represents the greater of the book or market value of the stock on the date the purchase agreement was executed, are exercisable commencing six-months following issuance and have a term of five and a half years from the initial issuance date. The securities sold to our directors participating in the November 1, 2024 private placement were issued pursuant to the MAIA 2021 Plan. Company director Stan Smith purchased 100,000 shares and 100,000 warrants for an aggregate purchase price of approximately $225,900; Company director Ramiro Guerrero purchased 88,534 shares and 88,534 warrants for an aggregate purchase price of approximately $200,000; Company director Steven Chaouki purchased 22,133 shares and 22,133 warrants for an aggregate purchase price of approximately $50,000; and Company director Cristian Luput purchased 22,133 shares and 22,133 warrants for an aggregate purchase price of approximately $50,000. In addition, the son of Company director Stan Smith purchased 40,000 shares and 40,000 warrants for an aggregate purchase price of approximately $90,360 and related party 5% stockholder FGMK Business Holdings, LLC purchased 243,470 shares and 243,670 warrants for a purchase price of approximately $550,000.

On December 13, 2024, we issued and sold 507,364 shares of our Common Stock and warrants to purchase 507,364 shares of our Common Stock in a private placement to certain accredited investors and to our participating directors pursuant to securities purchase agreements dated December 9, 2024 at a price of $1.872 per share, for which we received gross proceeds of approximately $950,000. The warrants are exercisable at a price per Share of $2.08, which price represents the greater of the book or market value of the stock on the date the purchase agreement was executed, are exercisable commencing six-months following issuance and have a term of five

and a half years from the initial issuance date. The securities sold to our directors participating in the December 13, 2024 private placement were issued pursuant to the MAIA 2021 Plan. Company director Stan Smith purchased 25,000 shares and 25,000 warrants for an aggregate purchase price of approximately $46,800 and Company director Ramiro Guerrero purchased 53,418 shares and 53,418 warrants for an aggregate purchase price of approximately $100,000. In addition, Sylvia Guerrero, the sister of one of the Company directors purchased 5,341 shares and 5,341 warrants for an aggregate purchase price of approximately $10,000.

We will need to raise additional capital to fund our operations, to develop and commercialize THIO, and to develop, acquire or in-license other products. We may seek to fund our operations through public equity, private equity, or debt financings, as well as other sources. We cannot make any assurances that additional financings will be available to us and, if available, on acceptable terms or at all. This could negatively impact our business and operations and could also lead to the reduction of our operations.

Cash Flows

Cash Flows Years Ended December 31, 2024 and 2023

Years Ended December 31,

Effect of foreign currency exchange rate changes on cash (21,545 ) (117 )

Operating Activities

For the year ended December 31, 2024, net cash used in operating activities was approximately $15,704,000, which consisted of a consolidated net loss of approximately $23,255,000 offset by non-cash charges of approximately $7,550,000 which primarily includes approximately $1,913,000 in stock-based compensation, approximately $179,000 of expense related restricted shares issued for consulting services, and a loss of approximately $6,683,000 related to the changes in fair value of the warrant liability, and the loss on fair value of warrants over proceeds of approximately $13,000. Total changes in operating assets and liabilities of approximately $1,238,000 were primarily driven by an approximate $119,000 decrease in accounts payable, an approximate $980,000 decrease in an accrued expenses, an approximate decrease of $57,000 in Australian research and development incentives receivable, and an approximate $196,000 increase in prepaid expenses and other current assets.

For the year ended December 31, 2023, net cash used in operating activities was approximately $13,071,000, which consisted of a consolidated net loss of approximately $19,773,000 offset by non-cash charges of approximately $6,702,000 which primarily includes approximately $3,089,000 in stock-based compensation, approximately $732,000 of expense related restricted shares issued for consulting services, and a gain of approximately $205,000 related to the changes in fair value of the warrant liability. Total changes in operating assets and liabilities of approximately $3,086,000 were primarily driven by an approximate $472,000 increase in accounts payable, an approximate $2,170,000 increase in accrued expenses, an approximate decrease of $158,000 in Australian research and development incentives receivable, and an approximate $285,000 decrease in prepaid expenses and other current assets.

Financing Activities

Net cash provided by financing activities for the year ended December 31, 2024 was approximately $18,177,000 and consisted primarily of approximately $8,643,000 in gross proceeds from private placement offerings, proceeds from the at-the-market offering of approximately $10,112,000, proceeds from the exercise of stock options of $217,000, and were offset by approximately $795,000 of offering costs.

Net cash provided by financing activities for the year ended December 31, 2023 was approximately $9,271,000 and consisted primarily of gross proceeds from the sale of common stock of approximately $5,750,000 in a public offering, proceeds from issuance of common stock of approximately $4,000,000 in a registered direct offering, gross proceeds of approximately of $1,667,000 in an at-the-market offering facility through our sales agent for such facility, and approximately $1,000 from the proceeds from exercising of stock options, offset by approximately $2,147,000 of offering costs paid.

Critical Accounting Policies and Significant Judgments and Estimates

Management’s discussion and analysis of our financial condition and results of our operations is based on our consolidated financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The most significant estimates in the Company’s financial statements relate to the valuation of stock options and warrants and accruals for outsourced research and development activities. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments

about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected. We define our critical accounting policies as those accounting principles that require it to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. While our significant accounting policies are more fully described in Note 1 to our financial statements, we believe the following are the critical accounting policies used in the preparation of its financial statements that require significant estimates and judgments.

Stock-based compensation

Our stock-based awards are classified as equity (restricted stock awards and stock options). We recognize related stock-based compensation expense based on the grant date fair value of the awards. The fair value of restricted stock awards is based on the trading value of the Company's common stock. We estimate the fair value of stock options and warrants using the Black-Scholes-Merton valuation model which requires the use of subjective assumptions that could materially impact the estimation of fair value and related compensation expense to be recognized. One of these assumptions include the expected volatility of our stock price. Developing this assumption requires the use of judgment. The Company lacks sufficient company-specific historical and implied volatility information. Therefore, we estimate our expected stock volatility based on the historical volatility of a publicly traded set of peer companies, while corroborating these volatilities with our actual limited historical volatility information.

Two of the assumptions used in the Black-Scholes-Merton valuation model are historical volatility and fair value of common stock. Historical volatility is subject to uncertainty due to changes in the market over time. The fair value of our common stock is subject to uncertainty due to the possibility of changes in the results of our clinical trials, which could impact the fair value of our common stock. The total expense related to stock options is material to our financial statements on an annual basis, and significant fluctuations in the volatility assumption or the fair value of our common stock could result in material changes in related compensation expense to be recognized.

Prepaid and Accrued Research and Development Expenses

As part of the process of preparing our consolidated financial statements, we are required to estimate our prepaid and accrued research and development expenses. This process involves reviewing open contracts and purchase orders, communicating with our personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of the actual cost. We make estimates of our prepaid and accrued research and development expenses as of each balance sheet date in our financial statements based on facts and circumstances

known to us at the time. We confirm the accuracy of estimates with the service providers and make adjustments if necessary. Examples of estimated prepaid and accrued research and development expenses include expenses for:

•

Contract Research Organizations (CROs) in connection with clinical studies;

•

Investigative sites in connection with clinical studies;

•

Vendors in connection with preclinical development activities; and

•

Vendors related to product manufacturing, development and distribution of clinical materials.

We base our expenses related to clinical studies on our estimates of the services received and efforts expended pursuant to contracts with multiple CROs that conduct and manage clinical studies on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. The scope of services under these contracts can be modified and some of the agreements may be canceled by either party upon written notice. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the clinical expense. Payments under some of these contracts depend on factors such as the successful enrollment of subjects and the completion of clinical study

milestones. In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from our estimate, we adjust the accrual or prepaid accordingly. Although we do not expect our estimates to be materially different from amounts actually incurred, if our estimates of the status and timing of services performed differ from the actual status and timing of services performed we may report amounts that are too high or too low in any particular period. To date, there have been no material differences between our estimates and the amount actually incurred.

Item 7A. Quantitative and Qualitative Disclosures About Market Risk.

We are a smaller reporting company, as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required by this Item.

Item 8. Financial Statements and Supplementary Data.

Beginning on page F-2 are the consolidated financial statements with applicable notes and the related Report of Independent Registered Public Accounting Firm.

Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.

None.

Item 9A. Controls and Procedures.

Management’s Evaluation of our Disclosure Controls and Procedures

Under the supervision of and with the participation of our management, including our Chief Executive Officer, who is our principal executive officer, and our Head of Finance, who is our principal financial officer, we conducted an evaluation of the effectiveness of our disclosure controls and procedures as of December 31, 2024, the end of the period covered by this Annual Report. The term “disclosure controls and procedures,” as set forth in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, means controls and other procedures of a company that are designed to provide reasonable assurance that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the rules and forms promulgated by the SEC. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, management recognizes that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a control system, misstatements due to error or fraud may occur and not be detected. Based on the evaluation of our disclosure controls and procedures as of December 31, 2024, our Chief Executive

Officer and Head of Finance concluded that, as of such date, our disclosure controls and procedures were effective at the

reasonable assurance level.

Management’s Report on Internal Controls Over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over financial reporting as such term is defined in Exchange Act Rule 13a-15(f). Internal control over financial reporting is a process designed under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements for external purposes in accordance with U.S. GAAP. All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation.

As of December 31, 2024, our principal executive officer and principal financial officer, conducted an evaluation of the effectiveness of our internal control over financial reporting based on the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated Framework – 2013 (1992 Framework). Based on this assessment, management concluded that, as of December 31, 2024, our internal controls over financial reporting were effective.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting that occurred during the quarter ended December 31, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting

This Annual Report on Form 10-K does not include an attestation report of the Company’s registered public accounting firm regarding internal control over financial reporting. Management’s report was not subject to attestation by the company’s registered public accounting firm pursuant to rules of the SEC.

Item 9B. Other Information.

None.

Item 9C.Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.

Not applicable.

PART III

Item 10. Directors, Executive Officers and Corporate Governance.

The information required by this Item will be set forth in our definitive proxy statement with respect to our 2025 annual

meeting of stockholders to be filed not later than 120 days after the end of the 2024 fiscal year and is incorporated herein by

reference.

We have adopted a code of business conduct and ethics that applies to all our employees, officers and directors, including those officers responsible for financial reporting. Our code of business conduct and ethics is available on the investor relations section of our website. We intend to satisfy the disclosure requirement under Item 5.05 of Form 8-K regarding amendment to, or waiver from, a provision of our Code of Conduct by posting such information on the website address and location specified above.

We have adopted an insider trading policy applicable to our directors, officers, employees, and other covered persons, and have implemented processes for the company, that we believe are reasonably designed to promote compliance with insider trading laws, rules and regulations, and the NYSE American listing standards. Our insider trading policy is filed as Exhibit 19.1 to this Annual Report on Form 10-K.

Item 11. Executive Compensation.

The information required by this Item will be set forth in our definitive proxy statement with respect to our 2025 annual

meeting of stockholders to be filed not later than 120 days after the end of the 2024 fiscal year, and is incorporated herein by

reference.

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.

The information required by this Item will be set forth in our definitive proxy statement with respect to our 2025 annual

meeting of stockholders to be filed not later than 120 days after the end of the 2024 fiscal year, and is incorporated herein by

reference.

Item 13. Certain Relationships and Related Transactions, and Director Independence.

The information required by this Item will be set forth in our definitive proxy statement with respect to our 2025 annual

meeting of stockholders to be filed not later than 120 days after the end of the 2024 fiscal year, and is incorporated herein by

reference.

Item 14. Principal Accounting Fees and Services.

The information required by this Item will be set forth in our definitive proxy statement with respect to our 2025 annual

meeting of stockholders to be filed not later than 120 days after the end of the 2024 fiscal year, and is incorporated herein by

reference.

PART IV

Item 15. Exhibits, Financial Statement Schedules.

(a)(1) Financial Statements.

The consolidated financial statements required by this item are submitted in a separate section beginning on page F2 of this Annual Report on Form10-K.

(a)(2) Exhibits.

The exhibits filed as part of this Annual Report on Form 10-K are set forth on the Exhibit Index immediately preceding the signature page of this Annual Report on Form 10-K. The Exhibit Index is incorporated herein by reference.

Item 16. Form 10-K Summary

None.

Exhibit Index

ExhibitNumber Description

3.2(1) Amended and Restated Bylaws of MAIA Biotechnology, Inc.

4.1* Description of Registrant’s Securities.

4.2(1) Form of Representative’s Warrant (Included in Exhibit 10.19)

4.3(3) Form of Warrant

4.4(3) Specimen certificate representing shares of common stock

10.1(1) Form of Indemnification Agreement.

10.7+(4) MAIA Biotechnology, Inc. 2018 Stock Option Plan.

10.8+(4) MAIA Biotechnology, Inc. Amended & Restated 2020 Equity Incentive Plan.

10.9+(5) MAIA Biotechnology, Inc. 2021 Equity Incentive Plan.

10.15+(6) Form of Incentive Stock Option Award under 2021 Equity Incentive Plan.

19.1* Insider Trading Policy

100

101.SCH Inline XBRL Taxonomy Extension Schema Document

101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document

101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document

101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document

104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

* Filed herewith.

(1) Filed as an exhibit to the registrant’s Current Report on Form 8-K filed with the SEC on August 1, 2022.

(2) Filed as an exhibit to the registrant’s Registration Statement on Form S-1 filed with the SEC on May 31, 2022.

(3) Filed as an exhibit to the registrant’s Registration Statement on Form S-1 filed with the SEC on April 11, 2022.

(4) Filed as an exhibit to the registrant’s Registration Statement on Form S-8 filed with the SEC on August 1, 2022.

(5) Filed as an exhibit to the registrant’s Registration Statement on Form S-1 filed with the SEC on June 29, 2022.

(6) Filed as an exhibit to the registrant’s Quarterly Report on Form 10-Q filed with the SEC on August 22, 2022.

+ Indicates management contract or compensatory plan.

† Pursuant to Item 601(b)(10) of Regulation S-K, certain portions of this exhibit have been omitted (indicated by “[***]”) because the Registrant has determined that the information is not material and is the type that the Registrant treats as private or confidential.

101

SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Exchange Act of 1934, the registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

Dated: March 21, 2025.

MAIA BIOTECHNOLOGY, INC.

By: /s/ Vlad Vitoc

Name: Vlad Vitoc

Title: Chief Executive Officer and Chairman

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.

Name Title Date

/s/ Vlad Vitoc Chairman and Chief Executive Officer March 21, 2025

Vlad Vitoc (Principal Executive Officer)

/s/ Jeffrey C. Himmelreich Head of Finance March 21, 2025

Jeffrey C. Himmelreich (Principal Financial Officer)

/s/ Steven Chaouki Director March 21, 2025

Steven Chaouki

/s/ Ramiro Guerrero Director March 21, 2025

Ramiro Guerrero

/s/ Louie Ngar Yee Director March 21, 2025

Louie Ngar Yee

/s/ Cristian Luput Director March 21, 2025

Cristian Luput

/s/ Stan V. Smith Director March 21, 2025

Stan V. Smith

/s/ Jean-Manassé Theagène Director March 21, 2025

Jean-Manassé Theagène

102

INDEX TO CONSOLIDATED FINANCIAL STATEMENTS

Consolidated Balance Sheets F-3

Consolidated Statements of Operations F-4

Consolidated Statements of Comprehensive Loss F-5

Consolidated Statements of Changes in Stockholders’ Equity F-6

Consolidated Statements of Cash Flows F-8

Notes to Consolidated Financial Statements F-9

F-1

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

Board of Directors and Stockholders

MAIA Biotechnology, Inc.

Opinion on the financial statements

We have audited the accompanying consolidated balance sheets of MAIA Biotechnology, Inc. (a Delaware corporation) and subsidiaries (the “Company”) as of December 31, 2024 and 2023, the related consolidated statements of operations, comprehensive loss, changes in stockholders’ equity, and cash flows for each of the two years in the period ended December 31, 2024, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2024, in conformity with accounting principles generally accepted in the United States of America.

Going concern

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the financial statements, the Company has incurred recurring losses, has negative cash flows from operations, and has an accumulated deficit of $87,234,833 as of December 31, 2024. These conditions, along with other matters as set forth in Note 1, raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 1. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Basis for opinion

These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

/s/ GRANT THORNTON LLP

We have served as the Company’s auditor since 2022.

Charlotte, North Carolina

March 21, 2025

F-2

MAIA Biotechnology, Inc. and Subsidiaries

Consolidated Balance Sheets

ASSETS

Current assets:

Australia research and development incentives receivable 77,347 144,680

LIABILITIES AND STOCKHOLDERS' EQUITY

Current liabilities:

Long term liabilities:

Commitments and contingencies (Note 7)

Stockholders' equity (deficit)

Accumulated other comprehensive loss (30,615 ) (16,260 )

See the accompanying notes to the consolidated financial statements.

F-3

MAIA Biotechnology, Inc. and Subsidiaries

Consolidated Statements of Operations

Years Ended December 31,

Operating expenses:

Other income (expense):

Interest expense (57 ) (6,863 )

Australian research and development incentives 79,954 176,719

Loss on fair value of warrants over proceeds (12,952 ) —

Net loss per share

Basic and diluted $ (1.05 ) $ (1.49 )

See the accompanying notes to the consolidated financial statements.

F-4

MAIA Biotechnology, Inc. and Subsidiaries

Consolidated Statements of Comprehensive Loss

Years Ended December 31,

Foreign currency translation adjustment (14,355 ) (287 )

See the accompanying notes to the consolidated financial statements.

F-5

MAIA Biotechnology, Inc.

Consolidated Statements of Changes in Stockholders’ Equity

for the Year ended December 31, 2024

Preferred Stock Common Stock

Foreign currency translation adjustment — — — — — — (14,355 ) (14,355 )

See the accompanying notes to the consolidated financial statements.

F-6

MAIA Biotechnology, Inc.

Consolidated Statements of Changes in Stockholders’ Equity

for the Year ended December 31, 2023

Preferred Stock Common Stock

Issuance of stock options to satisfy accrued bonus — — — — 974,224 — — 974,224

Foreign currency translation adjustment — — — — — — (287 ) (287 )

See the accompanying notes to the consolidated financial statements.

F-7

MAIA Biotechnology, Inc. and Subsidiaries

Consolidated Statements of Cash Flows

Years Ended December 31,

Cash flows from operating activities:

Adjustments to reconcile net loss to net cash used in operating activities:

Consulting expense for restricted shares issued 179,490 731,661

Loss on fair value of warrants over proceeds 12,952 —

Change in operating assets and liabilities:

Australia research and development incentives receivable 56,805 158,405

Cash flows from financing activities:

Proceeds from exercise of stock options 217,158 1,432

Proceeds from sale of common stock in follow-on offering — 5,749,875

Proceeds from direct offering — 4,000,001

Proceeds from private placement round 1 2,920,696 —

Proceeds from private placement round 2 1,327,990 —

Proceeds from private placement round 3 1,004,999 —

Proceeds from private placement round 4 2,439,236 —

Proceeds from private placement round 5 949,791 —

Net effect of foreign currency exchange on cash (21,545 ) (117 )

Supplemental disclosure of cash flow information:

Options issued for accrued bonus $ — $ 974,224

Warrants issued in connection with the At-The-Market offering $ — $ 84,251

Warrants issued in connection with the direct offering $ — $ 1,903,915

Warrants issued with private placement 1 offering $ 2,049,600 $ —

Warrants issued with private placement 2 offering $ 1,190,111 $ —

Warrants issued with private placement 3 offering $ 677,919 $ —

Warrants issued with private placement 4 offering $ 1,800,389 $ —

Warrants issued with private placement 5 offering $ 635,345 $ —

See the accompanying notes to the consolidated financial statements.

F-8

MAIA Biotechnology, Inc. and Subsidiaries

Notes to Consolidated Financial Statements

For the Years Ended December 31, 2024 and 2023

NATURE OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Description of Business, Organization, and Principles of Consolidation

MAIA Biotechnology, Inc. and Subsidiaries (collectively, “the Company”) is a biopharmaceutical company that develops oncology drug candidates to improve and extend the lives of people with cancer. MAIA Biotechnology, Inc. (“MAIA”) was incorporated in the state of Delaware on August 3, 2018. These consolidated financial statements include the accounts of MAIA and its subsidiaries, as follows:

•

THIO Therapeutics, Inc. (“THIO”), incorporated in the state of Delaware on November 26, 2018. On August 13, 2021, MAIA and THIO completed a plan of reorganization in which THIO merged with and into MAIA. Prior to the merger, MAIA owned 93.3% of the outstanding shares of THIO Common Stock, which were canceled in connection with the merger. The remaining 6.7% minority stockholder of THIO received one share of MAIA Common Stock for each share of THIO Common Stock owned prior to the merger.

•

In July 2021, the Company established a wholly owned Australian subsidiary, MAIA Biotechnology Australia Pty Ltd, to conduct various pre-clinical and clinical activities for the development of the Company's product candidates.

•

In April 2022, the Company established a wholly owned Romanian subsidiary, MAIA Biotechnology Romania S.R.L., to conduct various pre-clinical and clinical activities for the development of the Company's product candidates.

Liquidity

At December 31, 2024, the Company had working capital of $6,322,441, an accumulated deficit of $87,234,833, cash of $9,601,298 and current liabilities of $3,830,038. Since its inception the Company has experienced net losses and negative cash flows from operations each fiscal year. The Company has no revenues and expects to continue to incur operating losses for the foreseeable future, and may never become profitable. The Company is dependent on its ability to continue to raise equity and/or debt financing to continue operations, and the attainment of profitable operations.

Going Concern Considerations

The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

To date the Company has incurred recurring losses, negative cash flow from operations and has accumulated a deficit of $87,234,833 from the Company’s inception through December 31, 2024. As of December 31, 2024, the Company had $9,601,298 in cash.

Impact of the War in Ukraine and War in Israel on Our Operations

The short and long-term implications of war in Ukraine and war in Israel are difficult to predict at this time. The imposition of sanctions and counter sanctions may have an adverse effect on the economic markets generally and could impact our business, financial condition, and results of operations. Because of the highly uncertain and dynamic nature of these events, the Company terminated any planned research activities in the impacted areas.

Basis of Presentation

The accompanying consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP” or “GAAP”). You should read the discussion and analysis together with such consolidated financial statements and the related notes thereto.

F-9

The consolidated financial statements include the accounts of the Company's wholly owned subsidiaries. All transactions and accounts between and among its subsidiaries have been eliminated. All adjustments and disclosures necessary for a fair presentation of these audited consolidated financial statements have been included.

Segment Information

Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision-maker ("CODM") in deciding how to allocate resources and assess performance. The Company and the Company’s chief operating decision-maker, the Company’s Chief Executive Officer, view the Company’s operations and manage its business as a single operating segment, which is the business of discovering and developing products for the treatment of immunotherapies for cancer. Management has determined that the Company operates in one segment, given the common nature of its operations. For additional information, see Note 9 - Segment Information.

Use of Estimates

The preparation of the Company’s audited consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The most significant estimates in the Company’s financial statements relate to the valuation of stock options and warrants, and prepaids or accruals for outsourced research and development activities. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected.

Certain Risks and Uncertainties

The Company’s activities are subject to significant risks and uncertainties including the risk of failure to secure additional funding to properly execute the Company’s business plan. The Company is subject to risks that are common to companies in the pharmaceutical industry, including, but not limited to, development by the Company or its competitors of new technological innovations, dependence on key personnel, reliance on third party manufacturers, protection of proprietary technology, and compliance with regulatory requirements.

Foreign Currency Translation

The financial statements of the Company’s foreign subsidiaries, where the local currency is the functional currency, are translated using exchange rates in effect as of the applicable balance sheet dates for assets and liabilities and average exchange rates during the period for results of operations. The resulting foreign currency translation adjustment is included in stockholders’ equity as accumulated other comprehensive loss.

Off-Balance Sheet Risk and Concentrations of Credit Risk

The Company has no significant off-balance sheet risks, such as foreign exchange contracts, option contracts, or other foreign hedging arrangements. Cash accounts are maintained at financial institutions that potentially subject the Company to concentrations of credit risk. At December 31, 2024 and 2023, substantially all of the Company’s cash was deposited in accounts at two financial institutions. The Company maintains its cash deposits, which at times may exceed the federally insured limits of $250,000 per financial institution, with a reputable financial institutions. The Company believes such funds are subject to minimal credit risk.

Cash and Cash Equivalents

The Company considers all highly liquid investments purchased with maturities of three months or less to be cash equivalents. As of December 31, 2024 and 2023, the Company has no cash equivalents as of December 31, 2024 and 2023.

Fair Value Measurements

The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. “Accounting Standards Codification (ASC) Topic 820”, Fair Value Measurements and Disclosures (“ASC 820”) establishes a hierarchy of inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the observable inputs be used when available.

Under this accounting guidance, fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a

F-10

liability. To increase the comparability of fair value measures, the following hierarchy prioritizes the inputs to valuation methodologies used to measure fair value:

•

Level 1 - Valuations based on quoted prices for identical assets and liabilities in active markets.

•

Level 2 - Valuations based on observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data.

•

Level 3 - Valuations based on unobservable inputs reflecting our own assumptions, consistent with reasonably available assumptions made by other market participants. These valuations require significant judgment.

Fair value measurements discussed herein are based upon certain market assumptions and pertinent information available to management as of and during the years ended December 31, 2024 and 2023. The carrying amount of accounts payable approximated fair value as they are short term in nature. The fair value of warrants issued for services is estimated based on the Black-Scholes model during the years ended December 31, 2024 and 2023. The estimated fair value of the warrants issued with the convertible notes, warrants issued to underwriters and embedded features, represented Level 3 measurements.

General and Administrative

General and administrative expenses primarily consist of costs for corporate functions, including payroll and related expenses, depreciation and amortization, rent, outside legal expenses, insurance costs, and other general and administrative costs.

Research and Development

The Company’s research and development expenses consist primarily of costs associated with the Company’s clinical trials, salaries, payroll taxes, employee benefits, and stock-based compensation charges for those individuals involved in ongoing research and development efforts. Research and development costs are expensed as incurred. Advance payments for goods and services that will be used in future research and development activities are recorded in prepaid expenses and other current assets in the consolidated balance sheets and are expensed when the activity has been performed or when the goods have been received.

As part of the process of preparing the consolidated financial statements, the Company is required to estimate its prepaid or accrued expenses. This process involves reviewing quotations and contracts, identifying services that have been performed on the Company’s behalf and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of the actual cost. The majority of the Company’s service providers invoice the Company monthly in arrears for services performed or when contractual milestones are met. The Company makes estimates of its prepaid or accrued expenses as of each balance sheet date in our consolidated financial statements based on facts and circumstances known to the Company at that time. The Company periodically confirms the accuracy of its estimates with the service providers and makes adjustments if necessary. The significant estimates in the Company’s prepaid or accrued research and development expenses are related to expenses incurred with respect to CROs and other vendors in connection with research and development and manufacturing activities.

The Company bases its expense related to CROs and Contract Manufacturing Organizations (CMOs) on its estimates of the services received and efforts expended pursuant to quotations and contracts with such vendors that conduct research and development and manufacturing activities on the Company’s behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to the Company’s vendors will exceed the level of services provided and result in a prepayment of the applicable research and development or manufacturing expense. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from its estimate, the Company adjusts the accrual or prepaid expense accordingly. Although the Company does not expect its estimates to be materially different from amounts actually incurred, the Company’s understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and could result in us reporting amounts that are too high or too low in any particular period. There have been no material changes in estimates for the periods presented.

Research and Development Incentive

The Company recognizes other income from Australian research and development incentives when there is reasonable assurance that the income will be received, the relevant expenditure has been incurred, and the consideration can be reliably measured. The research and development incentive is one of the key elements of the Australian Government’s support for Australia’s innovation system and is supported by legislative law primarily in the form of the Australian Income Tax Assessment Act 1997, as long as eligibility criteria are met. Under the program, a percentage of eligible research and development expenses incurred by the Company through its subsidiary in Australia are reimbursed.

F-11

Management has assessed the Company’s research and development activities and expenditures to determine which activities and expenditures are likely to be eligible under the research and development incentive regime described above. At each period end, management estimates the refundable tax offset available to the Company based on available information at the time and it is included in Australian research and development incentives in the consolidated statements of operations.

Derivative Financial Instruments

The Company does not use derivative instruments to hedge exposures to cash flow, market, or foreign currency risks. The Company evaluates all of its financial instruments, to determine if such instruments contain features that qualify as embedded derivatives.

Embedded derivatives must be separately measured from the host contract if all the requirements for bifurcation are met. The assessment of the conditions surrounding the bifurcation of embedded derivatives depends on the nature of the host contract. Bifurcated embedded derivatives are recognized at fair value, with changes in fair value recognized in the statement of operations. The Company has warrant liabilities deemed derivative instruments. Total warrant liabilities for the years ended December 31, 2024 and December 31, 2023 was $2,690,605 and $2,152,188, respectively.

Stock-Based Compensation

The Company records share-based compensation for awards granted to employees, non-employees, and to members of the board of directors based on the grant date fair value of awards issued, and the expense is recorded on a straight-line basis over the requisite service period. Forfeitures are recognized when they occur.

The Company uses the Black-Scholes-Merton option pricing model to determine the fair value of stock options. The use of the Black-Scholes-Merton option-pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the Common Stock consistent with the expected life of the option, risk-free interest rates and expected dividend yields of the Common Stock. The Company has concluded that its historical share option exercise experience does not provide a reasonable basis upon which to estimate expected term. Therefore, the expected term was determined according to the simplified method, which is the average of the vesting tranche dates and the contractual term. Due to the lack of company specific historical and implied volatility data, the estimate of expected volatility is primarily based on the historical volatility of a group of similar companies that are publicly traded. For these analyses, companies with comparable characteristics are selected, including enterprise value and position within the industry, and with historical share price information sufficient to meet the expected life of the share-based awards. The Company computes the historical volatility data using the daily closing prices for the selected companies’ shares during the equivalent period of the calculated expected term of its share-based awards. The risk-free interest rate is determined by reference to U.S. Treasury zero-coupon issues with remaining maturities similar to the expected term of the options. The Company has not paid, and does not anticipate paying, cash dividends on shares of its Common Stock.

All stock-based compensation costs are recorded in general and administrative or research and development costs in the consolidated statements of operations based upon the underlying individual’s role at the Company.

Common Stock Warrants

The Company accounts for Common Stock warrants as either equity instruments or liabilities in accordance with ASC 480, Distinguishing Liabilities from Equity (“ASC 480”), depending on the specific terms of the warrant agreement.

When warrants are issued for services to non-employees, under ASC 718, Compensation – Stock Compensation (“ASC 718”), the warrants shall be classified as a liability if 1) the underlying shares are classified as liabilities or 2) the entity can be required under any circumstances to settle the warrant by transferring cash or other assets. The measurement of equity-classified non-employee share-based payments is generally fixed on the grant date and are considered compensatory, as defined by ASC 718. The Company uses the Black-Scholes-Merton option pricing model to determine the fair value of the warrants.

Income Taxes

Income taxes are recorded in accordance with ASC 740, Income Taxes (“ASC 740”), which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Valuation allowances are provided, if based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit would more likely than not be realized assuming examination by the taxing authority. The

F-12

determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. The Company recognizes any interest and penalties accrued related to unrecognized tax benefits as income tax expense.

Deferred Offering Costs

Deferred offering costs consists of legal, accounting, underwriting fees and other costs that are directly related to a planned follow on offering and will be charged to additional paid-in capital upon the completion of the follow on offering. The Company had no offering costs as of December 31, 2024 and December 31, 2023, respectively.

Net Loss Per Share

Basic loss per share of Common Stock is computed by dividing net loss by the weighted average number of shares of Common Stock outstanding for the period. Diluted net loss per share is calculated by adjusting the weighted-average number of shares outstanding for the dilutive effect of Common Stock equivalents outstanding for the period, determined using the treasury-stock method. Diluted loss per share excludes, when applicable, the potential impact of stock options, unvested shares of restricted stock awards, and Common Stock warrants because their effect would be anti-dilutive due to our net loss. Gains on warrant liabilities are only considered dilutive when the average market price of the Common Stock during the period exceeds the exercise price of the warrants. Since the Company had a net loss in each of the periods presented, basic and diluted net loss per common share are the same.

The following table summarizes the Company’s potentially dilutive securities, in common share equivalents, which have been excluded from the calculation of dilutive loss per share as their effect would be anti-dilutive:

Years Ended December 31,

Leases

In February 2016, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") No. 2016-02, as amended, Leases (“Topic 842”), which applies to all leases. Under Topic 842, a right-of-use asset and lease obligation will be recorded for all leases, whether operating or financing leases, while the statement of operations will reflect lease expense for operating leases and amortization and interest expense for financing leases. At the inception of an arrangement the Company determines whether the arrangement is or contains a lease based on the circumstances present. All leases with a term greater than one year are recognized on the condensed consolidated balance sheet as right-of-use assets, lease liabilities and, if applicable, long-term lease liabilities. The Company has elected not to recognize on the consolidated balance sheet leases with terms of one-year or less. Lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable. As such, the Company utilizes the appropriate incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or incentives received. At the inception of an arrangement the Company determines whether the arrangement is or contains a lease based on the circumstances present. Currently none of the Company’s operating lease commitments are subject to the standard as its leases are short-term in nature (i.e., less than twelve months).

Recent Accounting Standards

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures to improve the disclosures about reportable segments and include more detailed information about a reportable segment’s expenses. ASU 2023-07 also requires that a public entity with a single reportable segment provide all of the disclosures required as part of the amendments and all existing disclosures required by Topic 280. The ASU should be applied retrospectively to all prior periods presented in the financial statements and is effective for fiscal years beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15, 2024. The adoptiondid not have an impact on the Company’s financial condition or results of operations. See Note 9 - Segment Information.

In December 2023, the FASB issued ASU No. 2023-09, Improvements to Income Tax Disclosures, which requires disclosure of disaggregated income taxes paid, prescribes standard categories for the components of the effective tax rate reconciliation, and modifies other income tax-related disclosures. ASU No. 2023-09 is effective for fiscal years beginning after December 15, 2024 and allows for adoption on a prospective basis, with a retrospective option. Early adoption is permitted. We do not expect the amendments in this ASU to have a material impact on our consolidated financial statements.

F-13

In March 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses, which requires detailed disclosure of significant expense components and additional clarity when expenses are classified by function. ASU No. 2024-03 is effective for fiscal years beginning after December 15, 2026 and allows for adoption on a prospective basis, with a retrospective option. Early adoption is permitted. We do not expect the amendments in this ASU to have a material impact on our consolidated financial statements.

From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption.

2. RELATED PARTY TRANSACTIONS

Consulting Services

The consulting firm FGMK, LLC and its affiliate FGMK Business Holdings, LLC beneficially owned more than 5% of the stock of the Company and is therefore a related party. On November 13, 2024, the Company expensed $67,990 related to the grant of 28,448 restricted shares of Common Stock for payment of their accounting, tax and valuation services. In addition, FGMK Business Holdings, LLC participated in the December 2024 private placement and purchased 243,470 shares of the Company's Common Stock and warrants to purchase 243,470 shares of the Company's Common Stock for an aggregate purchase price of approximately $550,000.

10b5-1 Plan

Certain of our directors and executive officers previously adopted written plans, known as Rule 10b5-1 plans, in which they contracted with a broker to buy shares of our Common Stock on a periodic basis. Each of these plans have expired as of the date of the accompanying consolidated financial statements. Our directors and executive officers may, in the future, adopt Rule 10b5-1 plans in which they contract with a broker to buy or sell shares of our Common Stock on a periodic basis. Under a Rule 10b5-1 plan, a broker executes trades pursuant to parameters established by the director or officer at the time was entered into, without further direction from the director or officer. The director or officer may amend or terminate the plan in limited circumstances. Our directors and executive officers may also buy or sell additional shares of our Common Stock outside of a Rule 10b5-1 plan when they are not in possession of material nonpublic information.

Private Placement

The following Company directors participated in the March 2024 private placement as follows: (i) Stan Smith purchased 170,940 shares of our Common Stock and warrants to purchase up to 170,940 shares of our Common Stock for an aggregate purchase price of approximately $200,000; (ii) Louie Ngar Yee purchased 170,940 shares of our Common Stock and warrants to purchase up to 170,940 shares of our Common Stock for an aggregate purchase price of approximately $200,000; (iii) Cristian Luput purchased 69,282 shares of our Common Stock and warrants to purchase up to 69,282 shares of our Common Stock for an aggregate purchase price of approximately $81,060; (iv) Steven Chaouki purchased 34,641 shares of our Common Stock and warrants to purchase up to 34,641 shares of our Common Stock for an aggregate purchase price of approximately $40,530; and (v) Ramiro Guerrero purchased 6,928 shares of our Common Stock and warrants to purchase up to 6,928 shares of our Common Stock for an aggregate purchase price of approximately $8,106.

The following Company directors participated in the April 2024 private placement as follows: (i) Stan Smith purchased 147,492 shares of our Common Stock and warrants to purchase up to 147,492 shares of our Common Stock for an aggregate purchase price of approximately $300,000; and (ii) Louie Ngar Yee purchased 19,665 shares of our Common Stock and warrants to purchase up to 19,665 shares of our Common Stock for an aggregate purchase price of approximately $40,000.

The following Company directors participated in the November 2024 private placement as follows: (i) Stan Smith purchased 100,000 shares of our Common Stock and warrants to purchase up to 100,000 shares of our Common Stock for an aggregate purchase price of approximately $225,900; (ii) Ramiro Guerrero purchased 88,534 shares of our Common Stock and warrants to purchase up to 88,534 shares of our Common Stock for an aggregate purchase price of approximately $200,000; (iii) Cristian Luput purchased 22,133 shares of our Common Stock and warrants to purchase up to 22,133 shares of our Common Stock for an aggregate purchase price of approximately $50,000; and (iv) Steven Chaouki purchased 22,133 shares of our Common Stock and warrants to purchase up to 22,133 shares of our Common Stock for an aggregate purchase price of approximately $50,000. In addition, the son of Company director Stan Smith purchased 40,000 shares and 40,000 warrants for an aggregate purchase price of approximately $90,360 and 5% stockholder FGMK Business Holdings, LLC purchased 243,470 shares and 243,470 warrants for a purchase price of approximately $550,000.

F-14

The following Company directors participated in the December 2024 private placement as follows: (i) Stan Smith purchased 25,000 shares of our Common Stock and warrants to purchase up to 25,000 shares of our Common Stock for an aggregate purchase price of approximately $46,800; and (ii) Ramiro Guerrero purchased 54,518 shares of our Common Stock and warrants to purchase up to 53,418 shares of our Common Stock for an aggregate purchase price of approximately $100,000. In addition, Sylvia Guerrero, the sister of one of the Company directors, purchased 5,341 shares and 5,341 warrants for an aggregate purchase price of approximately $10,000.

3. ACCRUED EXPENSES

As of December 31, 2024 and 2023, accrued expenses consisted of the following:

December 31, December 31,

Accrued Bonus

During the years ended December 31, 2024 and 2023, the Company accrued $941,098 and $786,999, respectively, in bonus expense relating to employees and officers of the Company. In April 2024, the Compensation Committee determined that bonuses relating to 2023 would not be paid to all executive and non-executive employees. This change in estimated bonuses was recorded against the same general ledger accounts that the original estimate was recorded to and is reflected within the general and administrative expenses and research and development expenses on the statement of operations for the year ended December 31, 2024.

Accrued Severance

On November 10, 2023, Joseph McGuire and Dr. Mihail Obrocea were terminated from their positions as Chief Financial Officer (and principal financial and accounting officer) and Chief Medical Officer, respectively, of the Company, effective immediately, as part of the Company’s effort to streamline operations. Mr. McGuire’s and Dr. Obrocea’s terminations were not based on any disagreement with the Company’s operations, policies or practices. The accrued severance included in accrued expense was $824,435 as of December 31 ,2023. The accrued severance was paid in 2024. There was no accrued severance as of December 31, 2024.

4. FAIR VALUE OF FINANCIAL LIABILITIES

Derivative Liability

Financial liabilities consisting of warrant liabilities measured at fair value on a recurring basis are summarized below. The fair value of the warrant liabilities recorded are as follows:

Fair value at December 31, 2024

Total Level 1 Level 2 Level 3

Liabilities:

Fair value at December 31, 2023

Total Level 1 Level 2 Level 3

Liabilities:

F-15

During the years ended December 31, 2024 and 2023, the Company had warrant liabilities of $2,690,605 and $2,152,188, respectively. The table below provides a summary of the changes in fair value of the warrant liabilities measured on a recurring basis using significant unobservable inputs (Level 3):

Years Ended December 31,

Amendment of warrants (6,870,296 ) —

Loss (gain) on fair value of warrant liability 6,682,758 (205,130 )

5. STOCKHOLDERS’ EQUITY

Follow-on Offering

On April 27, 2023 the Company sold 2,555,500 shares of the Company’s Common Stock at a public offering price of $2.25 per share in an underwritten public offering, including the full exercise of the overallotment option. ThinkEquity LLC served as the underwriter in the offering. The total net proceeds of $4,156,859 after deducting underwriting discounts and other offering expenses payable by the Company.

At-the-Market Equity Offering (ThinkEquity)

On September 1, 2023, the Company entered into an “at-the-market" Sales Agreement (the “Sales Agreement”) with ThinkEquity LLC (the “Sales Agent”), pursuant to which the Company may offer and sell, from time to time, through the Sales Agent, shares (the “Shares”) of the Company’s Common Stock, par value $0.0001 per share (the “Common Stock”), having an aggregate offering price of up to $7,000,000, subject to the terms and conditions of the Sales Agreement. The Shares will be offered and sold pursuant to the Company’s prospectus supplement (the “Prospectus Supplement”), filed September 1, 2023 with the Securities and Exchange Commission (the “SEC”), to the prospectus forming a part of the Company’s shelf Registration Statement on Form S-3 (File No. 333-273984) filed by the Company with the SEC on August 15, 2023 and declared effective by the SEC on August 23, 2023. In October and November 2023, the Company sold 758,388 shares of Common Stock through the Sales Agreement for net proceeds of $1,238,688 after deducting underwriting discounts and other offering expenses payable by the Company. The Sales Agreement was terminated on November 15, 2023. Of the $1,238,688, $84,251 was allocated and classified as a warrant liability.

Registered Direct Offering

On November 17, 2023, the Company entered into a registered direct offering pursuant to the Company’s prospectus supplement (the “Prospectus Supplement”), filed September 1, 2023 with the Securities and Exchange Commission (the “SEC”), to the prospectus forming part of the Company’s shelf Registration Statement on Form S-3 (File No. 333-273984) filed by the Company with the SEC on August 15, 2023 and declared effective by the SEC on August 23, 2023, and a prospectus supplement dated as of November 15, 2023, (the “Offering”) by the Company for an aggregate of 2,424,243 shares of Common Stock, par value $0.0001 per share (“the Common Stock”) pursuant to an Engagement Agreement dated as of November 4, 2023, by and between the Company and H.C. Wainwright & Co., LLC (“Wainwright”) for net proceeds of $3.4 million after deducting underwriting discounts and other offering expenses payable by the Company. Of the $3.4 million, $2.0 million was allocated and classified as warrant liability.

At-the-Market Offering (H.C. Wainwright)

On February 14, 2024, the Comany entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”), to sell shares of its Common Stock having an aggregate sales price of up to $1,445,000, from time to time, through an “at-the-market offering” program under which Wainwright will act as sales agent. Effective March 25, 2024, the Company filed a prospectus supplement to amend, supplement and supersede certain information contained in the earlier prospectus and prospectus supplement, which increased the number of shares of Common Stock the Company may offer and sell under the ATM Agreement to an aggregate offering price of up to $4,950,000 from time to time. Effective May 15, 2024, the Company filed a prospectus supplement to amend, supplement and supersede certain information contained in the earlier prospectus and prospectus supplement, which increased the number of Shares the Company may offer and sell under the ATM Agreement to an aggregate offering price of up to $11,280,000 from time to time. Effective December 23, 2024, the Company filed a prospectus supplement to amend, supplement and supersede certain information contained in the earlier prospectus and prospectus supplement, which increased the number of Shares the Company may offer and sell under the ATM Agreement to an aggregate offering price of up

F-16

to $30,000,000 from time to time. As of the date of this Annual Report, the Company has sold 3,940,683 shares of its Common Stock under the ATM Agreement at an average price of $2.95 per share, resulting in aggregate gross proceeds of approximately $11,633,086, for which we paid Wainwright $348,993 in commissions resulting in net proceeds to us of approximately $11,284,093.

Private Placements

On March 14, 2024, the Company issued and sold 2,496,318 shares of our Common Stock and warrants to purchase 2,496,318 shares of its Common Stock in a private placement to certain accredited investors and to our participating directors pursuant to securities purchase agreements dated March 11, 2024 at a price $1.17 per share, for which we received gross proceeds of approximately $2.92 million. The warrants are exercisable at a price per Share of $1.30, which price represents the greater of the book or market value of the stock on the date the purchase agreement was executed, are exercisable commencing six-months following issuance and have a term of five and a half years from the initial issuance date. The securities sold to the Company's directors participating in the March 14, 2024 private placement were issued pursuant to the MAIA 2021 Plan.

On March 28, 2024, the Company issued and sold 578,643 shares of our Common Stock and warrants to purchase 578,643 shares of its Common Stock in a private placement to certain accredited investors pursuant to securities purchase agreements dated March 25, 2024 at a price of $2.295 per share, for which we received gross proceeds of approximately $1.33 million.The warrants are exercisable at a price per Share of $2.55, which price represents the greater of the book or market value of the stock on the date the purchase agreement was executed, are exercisable commencing six-months following issuance and have a term of five and a half years from the initial issuance date.

On April 25, 2024, the Company issued and sold 494,096 shares of its Common Stock and warrants to purchase 494,096 shares of our Common Stock in a private placement to certain accredited investors and to our participating directors pursuant to securities purchase agreements dated April 22, 2024 at a price of $2.034 per share, for which we received gross proceeds of approximately $1.0 million. The warrants are exercisable at a price per Share of $2.26, which price represents the greater of the book or market value of the stock on the date the purchase agreement was executed, are exercisable commencing six-months following issuance and have a term of five and a half years from the initial issuance date. The securities sold to the Company's directors participating in the April 25, 2024 private placement were issued pursuant to the MAIA 2021 Plan.

On November 1, 2024, the Company issued and sold 1,079,784 shares of its Common Stock and warrants to purchase 1,079,784 shares of our Common Stock in a private placement to certain accredited investors and to our participating directors pursuant to securities purchase agreements dated October 28, 2024 at a price of $2.259 per share, for which we received gross proceeds of approximately $2.44 million. The warrants are exercisable at a price per Share of $2.51, which price represents the greater of the book or market value of the stock on the date the purchase agreement was executed, are exercisable commencing six-months following issuance and have a term of five and a half years from the initial issuance date. The securities sold to the Company's directors participating in the November 1, 2024 private placement were issued pursuant to the MAIA 2021 Plan.

On December 13, 2024, the Company issued and sold 507,364 shares of its Common Stock and warrants to purchase 507,364 shares of our Common Stock in a private placement to certain accredited investors and to our participating directors pursuant to securities purchase agreements dated December 9, 2024 at a price of $1.872 per share, for which we received gross proceeds of approximately $950,000. The warrants are exercisable at a price per Share of $2.08, which price represents the greater of the book or market value of the stock on the date the purchase agreement was executed, are exercisable commencing six-months following issuance and have a term of five and a half years from the initial issuance date. The securities sold to the Company's directors participating in the December 13, 2024 private placement were issued pursuant to the MAIA 2021 Plan.

MAIA Biotechnology, Inc. Restricted Stock Awards

During the year ended December 31, 2023, the Company expensed $731,661 for investor and media relation services related to the grant of 291,469 restricted shares of Common Stock. There are no unvested restricted shares as of December 31, 2023.

During the year ended December 31, 2024, the Company expensed $179,490 for investor services and accounting, tax and valuation services related to the grant of 75,550 restricted shares of Common Stock. There are no unvested restricted shares as of December 31, 2024.

MAIA Stock Warrants

In January 2022, the Company and certain warrant holders executed waivers related to the acceptance and approval of an amendment to the holders’ warrant agreements originally issued between May 6, 2020 and February 26, 2021 in connection with the Company’s issuance of convertible notes. The amendment removed the IPO expiration provision from the warrant agreements, and the warrants are now only to be exercisable, in whole or in part, during the exercise period ending on the earliest to occur of: (a) various dates in 2028 as stated within the warrant agreements; or (b) immediately prior to the closing of a change of control. The value of the warrant

F-17

modification to the 144,497 warrants was calculated using the Black-Scholes-Merton option pricing model. The incremental fair value attributable to the modified awards compared to the original awards immediately prior to the modification was calculated at $450,578 and was treated as a deemed dividend and is reflected as “Deemed dividend on warrant modification” in the accompanying statement of operations.

During January 2022, warrants were exercised, resulting in the issuance of 61,111 shares of MAIA Common Stock for proceeds of $110,000. During May 2022, warrants were exercised, resulting in the issuance of 153,000 shares of Common Stock for proceeds of approximately $275,400. Another 394,501 warrants were exercised with a cashless exercise assuming the fair market value of $9.00 per share resulting in the issuance of 315,601 shares of Common Stock.

At the closing of the initial public offering, 20,520 warrants with an exercise price of $5.00 per share expired.

Concurrently with the closing of the Company’s initial public offering, the Company issued warrants to purchase an aggregate of up to 100,000 shares of its Common Stock to the Representative or its designees, at an exercise price of $6.25 per share (the “Representative’s Warrants”). The Representative’s Warrants are exercisable beginning on January 23, 2023, and expire on July 27, 2027, pursuant to the terms and conditions of the Representative’s Warrants. On August 3, concurrently with the full exercise of the Underwriter’s over-allotment option, the Company issued additional warrants to purchase an aggregate of up to 15,000 shares of its Common Stock to the Representative or its designees on the same terms. The warrants are not indexed to the Company’s own stock and therefore meet the definition of a derivative liability. The warrants are liability classified instruments and were initially recorded as $343,735, which was the value determined using the Black-Scholes-Merton method using a term of five years, risk free interest rate of 2.82% and volatility of 77.5%. As of December 31, 2024 and December 31, 2023 the Company remeasured the warrant liability resulting in a value of $71,672 and $40,211, respectively. The loss on remeasurement of the warrant liability in the amount of $31,461 and $205,130 was included in other (expense) income for the years ended December 31, 2024 and December 31, 2023, respectively.

Concurrently with the closing of the Company’s follow-on offering, the Company issued warrants to purchase an aggregate of up to 127,775 shares of its Common Stock to the Representative or its designees, at an exercise price of $2.81 per share (the “Follow-On Representative’s Warrants”). The Follow-On Representative’s Warrants are exercisable beginning on October 24, 2023, and expire on April 24, 2028, pursuant to the terms and conditions of the Follow-On Representative’s Warrants. The Follow-On Representative’s Warrants are equity classified instruments and the value of the Follow-On Representative’s Warrants determined using the Black-Scholes-Merton method was $241,109 using the term of five years, risk free interest rate of 4.09% and volatility of 86.3%. During 2024, 116,532 warrants were exercised on various dates in cashless exercises and the investors were issued 22,869 shares of Common Stock. As of December 31, 2024, there are 11,243 warrants exercisable through April 24, 2028.

On November 9, 2023, the Company issued warrants to purchase an aggregate of up to 239,234 shares of its Common Stock to Alumni Capital LP, at an exercise price of $2.09 per share. The warrants are exercisable beginning on November 10, 2023, and expire on November 10, 2027, pursuant to the terms and conditions of the warrants. The warrants are not indexed to the Company’s own stock and therefore meet the definition of a derivative liability. On November 13, 2023, 131,578 warrant shares vested in accordance with the terms. The warrants are liability classified instruments and were initially recorded as $84,251, which was the value determined using the Black-Scholes-Merton method using a term of 3.87 years, risk free interest rate of 3.93% and volatility of 90.0%. Laidlaw & Company Ltd. acted as the financial advisor to the Company in connection with the warrant and were paid a cash fee of $13,750. The warrants were exercised on May 22, 2024 in a cashless exercise and Alumni was issued 54,976 shares of Common Stock. The Company remeasured the warrant liability at the time of the exercise resulting in a value of $375,705. The loss on remeasurement of the warrant liability in the amount of $291,454 and $0 was included in other (expense) income for the years ended December 31, 2024 and December 31, 2023, respectively.

On November 17, 2023, the Company issued warrants concurrently with the Company’s registered direct offering to purchase an aggregate of up to 2,424,243 shares of its Common Stock to the investors in a registered direct offering at an exercise price of $1.86 per share (subject to customary adjustments set forth in the warrants). The warrants are exercisable six months following issuance and have a term of five years from the initial exercise date. The warrants contain customary anti-dilution adjustments to the exercise price, including share splits, share dividends, rights offerings and pro rata distributions. The warrants are not indexed to the Company’s own stock and therefore meet the definition of a derivative liability. The warrants are liability classified instruments and were initially recorded as $1,903,915, which was the value determined using the Black-Scholes-Merton method using a term of 5.38 years, risk free interest rate of 3.85% and volatility of 90.0%. In 2024, 909,091 warrants were exercised on various dates in cashless exercises and the investor was issued 458,726 shares of Common Stock. The Company remeasured the warrant liability of the exercised warrants at the time of exercise resulting in a value of $2,815,970. The loss on remeasurement of the warrant liability $3,101,533 and $0 was included in other (expense) income for the years ended December 31, 2024 and December 31, 2023, respectively.

On November 17, 2023, concurrently with the closing of the Company’s registered direct offering, the Company issued warrants to purchase an aggregate of 169,697 shares of its Common Stock to the Representative or its designees, at an exercise price of $2.06 per share. These representative’s warrants were exercisable beginning November 15, 2023, and expire on November 15, 2028, pursuant to their terms and conditions. The representative’s warrants are not indexed to the Company’s own stock and therefore meet the definition of a derivative liability. The representative’s warrants are liability classified instruments and were initially recorded as

F-18

$123,811, which was determined using the Black-Scholes-Merton method using a term of 4.88 years, risk free interest rate of 3.84% and volatility of 90.0%. As of December 31, 2024 and December 31, 2023, the Company remeasured the warrant liability resulting in a value of $230,038 and $123,811, respectively. The loss on remeasurement of the warrant liability in the amount of $106,227 and $0 is included in other (expense) income for the years ended December 31, 2024 and December 31, 2023, respectively.

Concurrently with the closing of the Company’s private placement on March 14, 2024, the Company issued warrants to purchase an aggregate of up to 2,496,318 shares of its Common Stock to the investors in the private placement, at an exercise price of $1.30 per share are exercisable beginning on September 14, 2024, and expire on September 14, 2029. The warrants issued were divided into two groups: warrants issued to directors and warrants issued to non-affiliated investors. The warrants to purchase 452,731 shares of the Company’s Common Stock issued to directors were deemed options issued under the MAIA 2021 Plan and are equity classified instruments, and the value of these warrants determined using the Black-Scholes-Merton method was $230,685 using a term of 5.5 years, risk free interest rate of 4.20% and volatility of 95%. The warrants to purchase 2,043,587 share of the Company’s Common Stock issued to non-affiliated investors were not indexed to the Company’s own stock and therefore met the definition of a derivative liability. The warrants issued to non-affiliated investors were liability classified instruments when issued and were initially recorded at a value of $2,049,600, which was determined using the Black-Scholes-Merton method using a term of 5.5 years, risk free interest rate of 4.20% and volatility of 95.0%. In May 2024, the Company amended the warrant agreements to adjust them to be indexed to the Company’s own stock, and they were therefore reclassed to equity classified instruments in a non-cash transaction. When the warrant agreements were amended, the Company remeasured the warrant liability resulting in a final warrant value of $5,089,063. The warrant liability for these warrants was removed and equity was increased by $5,089,063 to account for the equity classification. The loss on the remeasurement of the warrant liability in the amount of $3,039,463 and $0 is included in other (expense) income for the years ended December 31, 2024 and December 31, 2023, respectively.

Concurrently with the closing of the Company’s private placement offering on March 28, 2024, the Company issued warrants to purchase an aggregate of up to 578,643 shares of its Common Stock to the investors in the private placement at an exercise price of $2.55 per share. The warrants are exercisable beginning on September 28, 2024, and expire on September 28, 2029. The warrants were not indexed to the Company’s own stock and therefore meet the definition of a derivative liability. The warrants were liability classified instruments when issued and were initially recorded at a value of $1,190,111, which was determined using the Black-Scholes-Merton method using a term of 5.5 years, risk free interest rate of 4.20% and volatility of 95.0%. In May 2024, the Company amended the warrant agreements related to 437,031 warrants to adjust them to be indexed to the Company’s own stock, and they were therefore reclassed to equity classified instruments in a non-cash transaction. When the warrants agreements were amended, the Company remeasured the warrant liability resulting in a final warrant value of $1,011,562. The warrant liability for these 437,031 warrants was removed and equity was increased by $1,011,562 to account for the equity classification. The loss on the remeasurement of the warrant liability in the amount of $112,708 and $0 is included in other (expense) income for the years ended December 31, 2024 and December 31, 2023, respectively. The remaining 141,612 warrants remain liability classified instruments. As of December 31, 2024 and December 31, 2023, the Company remeasured the warrant liability, resulting in a value of $199,417 and $0, respectively. The gain on remeasurement of the warrant liability in the amount of $91,840 and $0 is included in other (expense) income for the years ended December 31, 2024 and December 31, 2023, respectively.

Concurrently with the closing of the Company’s private placement offering on April 25, 2024, the Company issued warrants to purchase an aggregate of up to 494,096 shares of its Common Stock to the investors in the private placement at an exercise price of $2.26 per share. The warrants are exercisable beginning on October 25, 2024, and expire on October 25, 2029. The warrants issued were divided into two groups: warrants issued to directors and warrants issued to non-affiliated investors. The warrants to purchase 167,157 shares of the Company’s Common Stock issued to directors were deemed options issued under the MAIA 2021 Plan (as defined below) and are equity classified instruments and the value of these warrants determined using the Black-Scholes-Merton method was $346,606 using a term of 5.5 years, risk free interest rate of 4.70% and volatility of 95%. The warrants to purchase 326,939 shares of the Company’s Common Stock issued to non-affiliated investors were not indexed to the Company’s own stock and therefore met the definition of a derivative liability. The warrants were liability classified instruments when issued and were initially recorded at a value of $677,919, which was determined using the Black-Scholes-Merton method using a term of 5.5 years, risk free interest rate of 4.70% and volatility of 95.0%. In May 2024, the Company amended these warrant agreements to adjust them to be indexed to the Company’s own stock, and they were therefore reclassed to equity classified instruments in a non-cash transaction. When the warrant agreements were amended, the Company remeasured the warrant liability resulting in a final warrant value of $769,671. The warrant liability for these warrants were removed and equity was increased by $769,671 to account for the equity classification. The loss on the remeasurement of the warrant liability in the amount of $91,572 and $0 is included in other (expense) income for the years ended December 31, 2024 and December 31, 2023, respectively.

Concurrently with the closing of the Company’s private placement offering on November 1, 2024, the Company issued warrants to purchase an aggregate of up to 1,079,784 shares of its Common Stock to the investors in the private placement at an exercise price of $2.51 per share. The warrants are exercisable beginning on May 1, 2025, and expire on May 1, 2030. The warrants issued were divided into two groups: warrants issued to directors and warrants issued to non-affiliated investors. The warrants to purchase 232,800 shares of the Company’s Common Stock issued to directors were deemed options issued under the MAIA 2021 Plan (as defined below) and are equity classified instruments and the value of these warrants determined using the Black-Scholes-Merton method was $494,851 using a term of 5.5 years, risk free interest rate of 4.22% and volatility of 95%. The warrants to purchase 846,984 shares of the Company’s Common Stock issued to non-affiliated investors are indexed to the Company’s own stock, and they

F-19

were therefore equity classified instruments and the value of these warrants determined using the Black-Scholes-Merton method was $1,800,389 using a term of 5.5 years, risk free interest rate of 4.22% and volatility of 95%.

Concurrently with the closing of the Company’s private placement offering on December 13, 2024, the Company issued warrants to purchase an aggregate of up to 507,364 shares of its Common Stock to the investors in the private placement at an exercise price of $2.08 per share. The warrants are exercisable beginning on June 13, 2025, and expire on June 13, 2030. The warrants issued were divided into two groups: warrants issued to directors and warrants issued to non-affiliated investors. The warrants to purchase 78,418 shares of the Company’s Common Stock issued to directors were deemed options issued under the MAIA 2021 Plan (as defined below) and are equity classified instruments and the value of these warrants determined using the Black-Scholes-Merton method was $116,151 using a term of 5.5 years, risk free interest rate of 4.25% and volatility of 95%. The warrants to purchase 428,946 shares of the Company’s Common Stock issued to non-affiliated investors are indexed to the Company’s own stock and they were therefore equity classified instruments and the value of these warrants determined using the Black-Scholes-Merton method was $635,345 using a term of 5.5 years, risk free interest rate of 4.25% and volatility of 95%.

Expired — — —

Exercised — — —

Expired — — —

The Company's warrant liability, which relates to warrants to purchase shares of common stock, is measured at fair value at each reporting period and changes in fair value are recorded in other income (expense) within the statement of operations until the warrants are exercised, expire, or are reclassified to stockholders' equity. The weighted-average fair values of warrants issued during the years ended December 31, 2024 and 2023 were $1.87 and $1.93, respectively. The warrants vested as of December 31, 2024 and 2023 were 5,442,246 and 3,650,278, respectively.

Risk-free interest rate 4.2% - 4.7% 3.8% - 4.6%

Expected term (in years) 5.5 3.6 - 5.4

Expected volatility 95% 85% - 92%

Expected dividend yield —% —%

MAIA Biotechnology, Inc. Stock Award Plans

In 2018, the Company adopted the MAIA Biotechnology, Inc. 2018 Stock Option Plan (the “MAIA 2018 Plan”). MAIA’s board of directors administers the MAIA Plan for the purposes of attracting, retaining, and motivating key employees, directors, and consultants of MAIA. The terms of the MAIA 2018 Plan continue to govern the 1,773,912 options outstanding in the plan of December 31, 2024.

F-20

In 2020, the Company adopted the MAIA Biotechnology, Inc. Amended and Restated 2020 Equity Incentive Plan (the “MAIA 2020 Plan’’), also administered by the board of directors. The MAIA 2020 Plan permitted awards to take the form of stock options, restricted stock and restricted stock units. The terms of the MAIA 2020 Plan continue to govern the 3,503,589 options outstanding in the plan as of December 31, 2024. There are no shares reserved for future issuance in the MAIA 2018 Plan or the MAIA 2020 Plan.

On August 1, 2022 the Company approved the MAIA Biotechnology, Inc. 2021 Equity Incentive Plan (the “MAIA 2021 Plan’’) with 1,909,518 shares of Common Stock reserved for issuance. On May 25, 2023, the MAIA 2021 Plan was amended to include an automatic increase to the plan in an amount equal to ten percent (10%) of the total number of shares of stock outstanding on a fully diluted basis on December 31 of the preceding calendar year (the “Increase Date”); provided that, the board of directors may act prior to any Increase Date to provide that there will be no increase for such year or that the increase for such year will be a lesser number of shares of stock. Pursuant to the automatic increase provision, on May 25, 2023, the amount reserved for issuance under the MAIA 2021 Plan increased by 1,956,993 based on the fully diluted shares outstanding as of December 31, 2022. Pursuant to the automatic increase provision, on April 23, 2024, the amount reserved for issuance under the MAIA 2021 Plan increased by 2,838,668 based on the fully diluted shares outstanding as of December 31, 2023. As of December 31, 2024, there were 1,790,744 shares of Common Stock available for future issuance under the MAIA 2021 Plan and 4,492,491 options outstanding in the MAIA 2021 Plan. On December 31, 2024, the Company’s board of directors increased the amount of shares available under the 2021 Plan by 2,250,000 shares effective January 1, 2025 pursuant to the annual increase provision, based on the fully diluted shares outstanding as of December 31, 2024 (and the discretion of the board to authorize less than 10% of such amount).

Stock options are to be granted with an exercise price which is at least equal to the stock’s estimated fair value at the date of grant, and with a contractual term of no more than ten years from the date of grant. In the case of an option granted to a 10% stockholder, the exercise price shall be generally no less than 110% of the fair market value per share on the date of grant, and the contractual term shall be seven years. Outstanding options awarded under the MAIA 2021 Plan may, but need not, vest and therefore become exercisable in periodic installments that may, but need not, be equal. The option may be subject to other terms and conditions as to the time or times when it may be exercised (which may be based on performance or other criteria) as the board of directors may deem appropriate. Unexercised options are canceled ninety days after termination of an employee, director, founder, or consultant. Unexercised options are canceled immediately if an employee, director, founder, or consultant is terminated for cause; under certain other circumstances, the period to cancellation may differ as described in the respective plan documents. Certain clauses in the Plans also govern the Company’s exercise repurchase rights and various other features of awards granted under the plans.

As of December 31, 2024, stock options and restricted stock have been awarded pursuant to the MAIA stock award plans.

The following table summarizes the activity and information regarding MAIA's outstanding and exercisable options classified as equity awards as of December 31, 2024:

The value of option grants are calculated using the Black-Scholes-Merton option pricing model with the following assumptions for options granted during the years ended December 31, 2024 and 2023.

Expected term (in years) 5 - 6.25 5 - 6.25

Expected dividend yield — —

The weighted-average fair values of stock options issued during the years ended December 31, 2024 and 2023 were $2.41 and $2.55, respectively. As of December 31, 2024, the total unrecognized compensation related to unvested employee and non-employee stock

F-21

option awards granted was $2,667,623 which the Company expects to recognize over a weighted average period of approximately 2.20 years.

Stock based compensation related to the Company’s stock plans are as follows:

Years Ended

December 31,

6.EMPLOYEE RETIREMENT PLAN

Our eligible employees have been permitted to participate in our 401(k) beginning October 1, 2022. Participation in the 401(k) plan is offered for the benefit of our employees, including our named executive officers, who remain employed with us, and who satisfy certain eligibility requirements. We match employee contributions using a benchmark to industry standards. The Company will make a safe harbor matching contribution equal to 100% of employee salary deferrals that do not exceed 1% of their compensation plus 50% of their salary deferrals between 1% and 6% of their compensation.The 2024 Company match is immaterial. Under the 401(k) plan, eligible employees may elect to defer a portion of their compensation, within the limits prescribed by the Code, on a pre-tax or after-tax (Roth) basis, through contributions to the 401(k) plan. The 401(k) plan is intended to qualify under Sections 401(a) and 501(a) of the Code. As a tax-qualified retirement plan, pre-tax contributions to the 401(k) plan and earnings on those pre-tax contributions are not taxable to the employees until distributed from the 401(k) plan, and earnings on Roth contributions are not taxable when distributed from the 401(k) plan.

7. COMMITMENTS AND CONTINGENCIES

Legal

From time to time, the Company is involved in legal actions and claims arising in the normal course of business. Management believes there are no matters which will have a material adverse effect on the Company's financial position, operations or cash flows.

Patent Licensing, Sponsored Research, and Patent & Technology Agreements

THIO - In November 2018 and as amended in December 2020, the Company entered into a Global Patent Licensing Agreement (“PLA”) titled “Patent and Technology License Agreement AGT. NO. L2264 - MAIA Biotechnology” with the University of Texas Southwestern (“UTSW”) to license patent families for a specific compound (“THIO”) from UTSW to MAIA. The agreement, as amended, has a term of 20 years. The agreement requires MAIA to reimburse UTSW for agreed-upon expenses related to THIO. The agreement requires certain payments upon assignment of the license to a third party as well as upon reaching specific milestones, ranging between $1,000,000 and $50,000,000, not to exceed a combined milestone payment total of $112,000,000. As of December 31, 2024, no assignment has occurred and none of the defined milestones have been completed and therefore no payments are due to UTSW related to the milestones. The agreement requires royalties of 2-4% (depending on THIO reaching specified sales levels in the respective jurisdictions) royalty payments on net sales up to $1,000,000,000, and 2.5-5% on net sales above $1,000,000,000.

Also in December 2020, the Company entered into a second license agreement with UTSW titled “Patent and Technology License Agreement AGT. NO. L3648 — MAIA Biotechnology” pursuant to which UTSW is licensing an additional compound to MAIA. The agreement has a term of 20 years and requires the Company to reimburse UTSW for certain agreed-upon expenses. The agreement requires certain payments upon assignment of the license to a third party as well as upon reaching specific milestones, ranging between $1,000,000 and $50,000,000, not to exceed a combined milestone payment total of $112,000,000. As of December 31, 2024, no assignment has occurred and none of the defined milestones have been completed and therefore no payments are due to UTSW related to the milestones.

The agreement requires royalties of 2-4% (depending on THIO reaching specified sales levels in the respective jurisdictions) royalty payments on net sales up to $1,000,000, and 2.5-5% on net sales above $1,000,000,000.

The Company will also pay UTSW running royalties on a yearly basis as a percentage of Net Sales of the Company or its sublicensee. There are single digit royalty rates for licensed products and licensed services covered by a Valid Claim (as defined in the agreement)

F-22

and dependent on whether Net Sales are greater than or less than/equal to $1,000,000,000, with Net Sales above that amount commanding a slightly higher percentage. In each case, the royalty percentage is lower before patent issuance in each jurisdiction. In the event that the licensed product or licensed service is not covered by a Valid Claim, the running royalty rates are reduced by fifty percent (50%). The royalty obligations continue on a country-by-country basis until the later of expiration of the last Valid Claim in each country or ten (10) years after the First Commercial Sale (as defined in UTSW2 Agreement) in each country.

Regeneron - In February 2021, the Company reached an agreement with Regeneron Pharmaceuticals, Inc. ("Regeneron") to perform one clinical trial for the treatment of patients with Non-Small Cell Lung Cancer (NSCLC) involving a Regeneron drug candidate that utilizes one of the Company's compounds/agents. The Company is responsible for all costs of the study with Regeneron supplying their drug cemiplimab representing a cost savings for the Company. The overall term of the agreement is for five years unless earlier terminated for certain reasons as defined in the agreement. Either party may terminate a study plan in the event that patient screening for the clinical study does not commence within twelve (12) months after (a) the Effective Date, with respect to the initial study, or (b) the execution of the applicable study plan, with respect to each other study. If either party terminates a study plan, the Company shall reimburse Regeneron for the Regeneron product it received in connection with such study plan based on the actual out-of-pocket cost to Regeneron of such Regeneron product. The THIO-101 study protocol was amended in December 2024 to increase the number of patients enrolled in an expansion arm to further evaluate efficacy of the treatment in third-line NSCLC patients resistant to checkpoint inhibitor and chemotherapy. As of December 31, 2024 neither party has terminated the agreement.

BeiGene - In December 2024, the Company reached an agreement with BeiGene Swizerland GmbH, ("BeiGene") to perform certain clinical trials for the treatment of patients with small cell lung cancer (SCLC), liver cancer (HCC), and colorectal cancer (CRC) involving a BeiGene drug candidate that utilizes one of the Company's compounds/agents. The Company is responsible for all costs of the study with BeiGene supplying their drug tislelizumab representing a cost savings for the Company. The overall term of the agreement is for seven years unless earlier terminated for certain reasons as defined in the agreement. As of December 31, 2024 neither party has terminated the agreement.

8. INCOME TAXES

The Company's net deferred tax assets consist of the following components:

December 31,

Deferred tax assets:

Net deferred tax asset $ — $ —

At December 31, 2024, the Company has unused U.S. federal and state net operating loss (“NOL”) carryforwards of $35.5 million that may be applied against future taxable income. The state NOL carryforwards begin to expire in 2030. The U.S. federal NOL carryforwards may be carried forward indefinitely, however are limited to 80 percent of taxable income. The Company has unused Australian NOL carryforwards of $0.2 million that may be carried forward indefinitely. The Company has unused U.S. federal research and development (“R & D”) tax credits of $0.5 million that begin to expire in 2041.

The use of the Company’s NOL and R & D credit carryforwards may, however, be subject to limitations as a result of an ownership change. A corporation undergoes an “ownership change,” in general, if a greater than 50% change (by value) in its equity ownership by one or more five‐percent stockholders (or certain groups of non-five-percent stockholders) over a three-year period occurs. After such an ownership change, the corporation’s use of its pre-change NOL carryforwards and other pre‐change tax attributes to offset its post-change income is subject to an annual limitation determined by the equity value of the corporation on the date the ownership change occurs multiplied by a rate determined monthly by the Internal Revenue Service.

If an ownership change occurs and if the Company earns net taxable income, the Company’s ability to use its pre-change NOLs to offset U.S. federal and taxable income would be subject to these limitations, which could potentially result in increased future tax liability compared to the tax liability the Company would incur if its use of NOL carryforwards were not so limited. In addition, for

F-23

state income, franchise and similar tax purposes, there may be periods during which the use of NOL carryforwards is suspended or otherwise limited, which could accelerate or permanently increase the Company’s state income, franchise, or similar taxes.

In accordance with ASC 740, “Income Taxes,” the Company recorded a valuation allowance to fully offset its deferred tax assets, because it is not more likely than not that the Company will realize future benefits associated with these deferred tax assets at December 31, 2024 and 2023.The valuation allowance increased by approximately $4.8 million and $4.1 million during the years ended December 31, 2024 and 2023, respectively, mainly due to increases in the NOL carryforward and other deferred tax assets. The Company will continue to assess the realizability of the deferred tax assets at each interim and annual balance sheet date based upon actual and forecasted operating results.

The Company incurred a pretax book loss of approximately $23.3 million for the year ended December 31, 2024, and approximately $19.8 million for the year ended December 31, 2023.

No provision or benefit for U.S. federal, state, or foreign income taxes has been recorded for the years ended December 31, 2024 and 2023, mainly due to net losses incurred by the Company. A provision of approximately $2 thousand for Romanian income tax was recorded for the year ended December 31, 2024. No provision for Romanian income tax was recorded for the year ended December 31, 2023, due to a tax exemption.

The income tax benefit differs from the benefit that would result from applying federal statutory rates to loss before income taxes as follows:

December 31,

Statutory federal income tax rate 21.0 % 21.0 %

State taxes, net of federal tax benefit 6.3 % 1.1 %

Stock-based compensation (0.9 )% (2.2 )%

Warrant amendments (6.0 )% — %

Other nondeductible expenses/(nontaxable income) 0.3 % 1.0 %

Change in valuation allowance (20.7 )% (20.9 )%

Income tax benefit — % — %

The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit would more likely than not be realized assuming examination by the taxing authority. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. The Company recognizes any interest and penalties accrued related to unrecognized tax benefits as income tax expense. The Company did not have any significant unrecognized tax benefits during the years ended December 31, 2024 and 2023. The Company files income tax returns in the U.S. federal jurisdiction, several U.S. States, Australia, and Romania. The Company’s tax returns since inception remain open to examination by the taxing authorities.

9. SEGMENT INFORMATION

The Company operates in one reportable segment. This determination is based on the Company's structure, the manner in which the chief operating decision maker ("CODM") reviews the operating results to assess performance and allocate resources, and the nature of the Company's operations. The CODM, who is the Chief Executive Officer, regularly reviews consolidated financial information, such as consolidated net loss. The CODM's review is for the purpose of assessing performance and making decisions about resource allocation. See our consolidated financial statement in Part II, "Item 8, Financial Statements and Supplementary Data", and Note 1, "Description of Business, Organization, and Principles of Consolidation" for additional information about these line items and the related accounting policies.

10. SUBSEQUENT EVENTS

Issuance of Options

From January 1 to March 21, 2025, the Company issued 456,545 options at a weighted exercise price of $1.41 to employees and consultants.

At-The-Market Offering with H.C. Wainwright

F-24

Since January 1, 2025, the Company has sold 666,323 shares of Common Stock at an average price of $2.28 per share, resulting in aggregate gross proceeds of approximately $1,521,092, for which it paid Wainwright approximately $45,633 in commissions, resulting in net proceeds to the Company of approximately $1,475,458. The Company anticipates that the at-the-market offering will continue throughout the next reporting period.

Private Placement

On February 24, 2025, we issued and sold 1,810,000 shares of our Common Stock and warrants to purchase 1,810,000 shares of our Common Stock in a private placement to certain accredited investors and to our participating directors pursuant to securities purchase agreements dated February 18, 2025 at a price of $1.50 per share, for which we received gross proceeds of approximately $2.72 million. The warrants are exercisable at a price per Share of $1.87, which price represents the greater of the book or market value of the stock on the date the purchase agreement was executed, are exercisable commencing one-year following issuance and have a term of six years from the initial issuance date. The securities sold to our directors participating in the February 24, 2025 private placement were issued pursuant to the MAIA 2021 Plan.

On March 3, 2025, we issued and sold 952,633, shares of our Common Stock and warrants to purchase 952,633 shares of our Common Stock in a private placement to certain accredited investors and to our participating directors pursuant to securities purchase agreements dated February 24, 2025 at a price of $1.50 per share, for which we received gross proceeds of approximately $1.43 million. The warrants are exercisable at a price per Share of $1.85, which price represents the greater of the book or market value of the stock on the date the purchase agreement was executed, are exercisable commencing one-year following issuance and have a term of six years from the initial issuance date.

Related Party Participation in Private Placement

The following Company directors participated in the aforementioned February 24, 2025 private placement as follows: (i) Stan Smith purchased 50,000 shares of Common Stock and warrants to purchase up to 50,000 shares of Common Stock for an aggregate purchase price of approximately $75,000; and (ii) Ramiro Guerrero purchased 73,333 shares of Common Stock and warrants to purchase up to 73,333 shares of Common Stock for an aggregate purchase price of approximately $110,000. In addition, FGMK Business Holdings, LLC, a 5% stockholder purchased 1,350,000 shares of Common Stock and warrants to purchase up to 1,350,000 shares of the Company’s Common Stock for an aggregate purchase price of approximately $2.025 million.

The following Company directors participated in the aforementioned March 3, 2025 private placement as follows: (i) Stan Smith purchased 25,000 shares of Common Stock and warrants to purchase up to 25,000 shares of Common Stock for an aggregate purchase price of approximately $37,500; (ii) Ramiro Guerrero purchased 33,333 shares of Common Stock and warrants to purchase up to 33,333 shares of Common Stock for an aggregate purchase price of approximately $50,000.

These subsequent events may have a material impact on the Company’s financial position, results of operations, and cash flows in future periods, and they are disclosed here for informational purposes. Investors should consider the potential impact of these events on their assessments of the Company’s financial condition and performance.

F-25

MAIA US Equity

MAIA · 10-K · period ended 2024-12-31

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

Item 7A. Quantitative and Qualitative Disclosures About Market Risk.

Item 8. Financial Statements and Supplementary Data.

Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.

Item 9A. Controls and Procedures.

Item 9B. Other Information.

Item 9C.Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.

Item 10. Directors, Executive Officers and Corporate Governance.

Item 11. Executive Compensation.

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.

Item 13. Certain Relationships and Related Transactions, and Director Independence.

Item 14. Principal Accounting Fees and Services.

Item 15. Exhibits, Financial Statement Schedules.

Item 16. Form 10-K Summary

MAIA US Equity☆

MAIA · 10-K · period ended 2024-12-31

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

Item 7A. Quantitative and Qualitative Disclosures About Market Risk.

Item 8. Financial Statements and Supplementary Data.

Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.

Item 9A. Controls and Procedures.

Item 9B. Other Information.

Item 9C.Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.

Item 10. Directors, Executive Officers and Corporate Governance.

Item 11. Executive Compensation.

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.

Item 13. Certain Relationships and Related Transactions, and Director Independence.

Item 14. Principal Accounting Fees and Services.

Item 15. Exhibits, Financial Statement Schedules.

Item 16. Form 10-K Summary

MAIA US Equity