MAIA Biotechnology, Inc. 10-K

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. 86 • 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 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 certain of our directors pursuant to securities purchase agreements dated March 11, 2024 at a price per share of $1.17 for which we received gross proceeds of approximately $2.92 million. The warrants issued in the private placement have an exercise price of $1.30, are exercisable six months after issuance and expire 5-years after the initial exercise date. The securities sold to our directors participating in the March 14, 2024 private placement were issued pursuant to the MAIA Biotechnology, Inc. 2021 Equity Incentive Plan (the “MAIA 2021 Plan”). • 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. • 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 Company directors pursuant to securities purchase agreements dated April 22, 2024 at a price per share of $2.034, for which we received gross proceeds of approximately $1.0 million. The warrants issued in the private placement have an exercise price of $2.26, are exercisable six months after 87 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 88 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 89 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 2024 2023 Dollars Percentage Operating expenses: Research and development expenses $ 10,009,229 $ 11,112,257 $ (1,103,028 ) (10)% General and administrative expenses 6,947,981 9,070,124 (2,122,143 ) (23)% Total operating costs and expenses 16,957,210 20,182,381 (3,225,171 ) (16)% Loss from operations (16,957,210 ) (20,182,381 ) 3,225,171 (16)% Other income (expense): Interest expense (57 ) (6,863 ) 6,806 (99)% Interest income 318,367 34,490 283,877 823% Australian research and development incentives 79,954 176,719 (96,765 ) (55)% Change in fair value of warrant liability (6,682,758 ) 205,130 (6,887,888 ) (3358)% Loss on fair value of warrants over proceeds (12,952 ) — (12,952 ) (100)% Other income (expense), net (6,297,446 ) 409,476 (6,706,922 ) (1638)% Net loss $ (23,254,656 ) $ (19,772,905 ) $ (3,481,751 ) 18% 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 90 $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, 2024 2023 Balance Sheet Data: Cash $ 9,601,298 $ 7,150,695 Working capital (1) 6,322,441 2,626,899 Total assets 10,155,279 7,566,852 Accrued bonus 941,098 786,999 Total stockholders' equity 3,634,636 477,511 (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, 91 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 92 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, 2024 2023 Net cash flows used in operating activities $ (15,704,461 ) $ (13,071,016 ) Net cash flows provided by financing activities 18,176,609 9,270,901 Effect of foreign currency exchange rate changes on cash (21,545 ) (117 ) Net increase (decrease) in cash $ 2,450,603 $ (3,800,232 ) 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 93 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. 94 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.