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. Ateganosine (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. 103 We are a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer. Ateganosine (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 ateganosine 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 ateganosine in patients with Non-Small Cell Lung Cancer (NSCLC). In the trial, patients with advanced NSCLC are treated first with ateganosine 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. In July 2025, we initiated an expansion of the THIO-101 trial focused on third-line NSCLC patients who are resistant to checkpoint inhibitors and chemotherapy. The expansion will enroll up to 48 patients with two arms: Arm 1, continuing the evaluation of ateganosine sequenced with Libtayo® (cemiplimab); and Arm 2, evaluating ateganosine as a monotherapy, to further gain experience of ateganosine in the contribution of components. Based on the clinical data generated by our THIO-101 trial, we plan to seek filing for an accelerated approval of ateganosine 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 initiated a Phase 3 pivotal trial in 2025, named THIO-104, to evaluate the efficacy of ateganosine administered in sequence with a checkpoint inhibitor (CPI) in third-line 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. 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 ateganosine administered in sequence with BeOne’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, 2025 and the first quarter of 2026: ● 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 ateganosine, 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 ateganosine and is free to develop the programs in combination with other agents and in other indications. Since May 2025, BeiGene has changed its company name to BeOne Medicines. ● On February 4, 2025, we announced positive updated data from THIO-101 Phase 2 clinical trial evaluating its lead clinical candidate, ateganosine, 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 ateganosine (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. 104 ● 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 five 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 ateganosine sequenced with Libtayo ® (cemiplimab); and Arm 2, evaluating ateganosine as a monotherapy, to further gain experience of ateganosine in the contribution of components. Treatment cycles for patients in both arms will administer ateganosine 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 ateganosine 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 five 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 ateganosine 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 ateganosine dimer in the peer-reviewed scientific journal Naunyn-Schmiedeberg’s Archives of Pharmacology. In a preclinical study, ateganosine 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 ateganosine 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. ● On May 8, 2025, we issued and sold 719,999 shares of our common stock and warrants to purchase 719,999 shares of our common stock in a non-brokered private placement to accredited investors and certain Company directors pursuant to securities purchase agreements dated May 5, 2025 at a price per share of $1.50 for which we received gross proceeds of approximately $1.08 million, prior to offering expenses payable by the Company. The warrants issued in the private placement have an exercise price of $2.05, are exercisable one year following issuance and have a term of six years from the issuance date The securities being sold to the Company directors participating in the offering are being issued pursuant to the Company’s 2021 Equity Incentive Plan. 105 ● On June 3, 2025, we issued and sold 463,332 shares of our common stock and warrants to purchase 463,332 shares of our common stock in a non-brokered private placement to accredited investors and a Company director pursuant to securities purchase agreements dated May 27, 2025 at a price per share of $1.50 for which we received gross proceeds of approximately $0.7 million, prior to offering expenses payable by the Company. The warrants issued in the private placement have an exercise price of $1.71, are exercisable six months following issuance and have a term of five years from the issuance date The securities being sold to the Company director participating in the offering are being issued pursuant to the Company’s 2021 Equity Incentive Plan. ● On June 5, 2025, we announced updated data from its THIO-101 pivotal Phase 2 clinical trial. As of May 15, 2025, third line (3L) data showed median overall survival (OS) of 17.8 months for the 22 NSCLC patients who received at least one dose of ateganosine (the intent-to-treat population) in parts A and B of the trial. The updated analysis continues to demonstrate a 95% confidence interval (CI) lower bound of 12.5 months and a 99% CI lower bound of 10.8 months. The Company also mentioned that treatment had been generally well-tolerated to date in this heavily pre-treated population. ● On June 5, 2025, we announced that a new partial response (PR) was identified in a patient after 20 months of treatment in our Phase 2 THIO-101 clinical trial. A partial response is defined as a decrease in tumor size of at least 30%. ● On June 18, 2025, we announced its entry into a clinical master supply agreement with Roche for future studies investigating the combination of MAIA’s telomere targeting agent ateganosine (THIO), sequenced with Roche’s checkpoint inhibitor (CPI), atezolizumab (Tecentriq®), for the treatment of multiple hard-to-treat cancers. ● On June 24, 2025, we announced the appointment of two prominent oncologists to its Scientific Advisory Board (SAB), Claudia Fulgenzi, MD, and David J. Pinato, MD, MRCP (UK), PhD. Both are specialists in hepatocellular carcinoma (HCC), a tumor type to be studied in future clinical trials of MAIA’s lead candidate ateganosine (THIO) sequenced with a checkpoint inhibitor. ● On July 9, 2025, we announced the dosing of the first patient in Taiwan in the expansion phase of our THIO-101 Phase 2 trial for advanced non-small cell lung cancer (NSCLC). The trial’s entry into another continent marks a key milestone for MAIA, opening a significantly larger patient pool for its evaluations of ateganosine (THIO). MAIA also announced that screening for the trial is ongoing in Europe and Asia. ● On July 17, 2025, we announced the publication of preclinical data from its second generation ateganosine prodrugs platform in Nucleic Acids Research (NAR), a leading open-access peer-reviewed scientific journal. The study, titled “Novel Telomere-Targeting Dual-Pharmacophore Dinucleotide Prodrugs for Anticancer Therapy,” details MAIA’s lead ateganosine (THIO)-derived second-generation prodrugs as promising new molecules in its strategy for enhancing cancer treatment and overcoming drug resistance. The manuscript with the data was published on June 26, 2025, in Volume 53, Issue 12 of the NAR journal. ● On July 28, 2025, we announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ateganosine (THIO, 6-thio-dG or 6-thio2’-deoxyguanosine) for the treatment of non-small cell lung cancer (NSCLC). Ateganosine is currently being evaluated in a pivotal Phase 2 THIO-101 clinical trial evaluating its anti-tumor activity when followed by a checkpoint inhibitor. ● On August 13, 2025, we announced that the European Patent Office granted a patent broadly covering a portfolio of ateganosine-based analogues for telomere targeting anticancer therapy and methods of using ateganosine (THIO) alone or before administration of checkpoint inhibitors (CPIs). The patent, titled “Mercaptopurine Ribonucleoside Analogues for Altering Telomerase Mediated Telomere,” was invented by MAIA’s Chief Scientific Officer Sergei M. Gryaznov, PhD and Scientific Advisory Board member Jerry W. Shay, PhD. MAIA’s global patent and patent-pending estate covers several areas including telomerase mediated telomere altering compounds and treatment of therapy-resistant cancers. Further, ateganosine’s immunogenic treatment strategy, which focuses on sequential combination with checkpoint inhibitors, has been filed worldwide. MAIA’s IP portfolio for ateganosine currently comprises 10 issued patents worldwide including Europe (validated in 19 countries) along with 24 pending patent applications. 106 ● On August 27, 2025, we announced that a manuscript detailing developments in its Phase 2 THIO-101 clinical trial was accepted and published in the international peer-reviewed open access scientific journal, Cells, in a special issue, “Cellular Mechanisms of Anti-Cancer Therapies”. The manuscript, titled “Perioperative Management of Non-Small Cell Lung Cancer in the Era of Immunotherapy,” was authored by a group of oncology researchers in Turkey and the U.S. including MAIA scientists Sergei Gryaznov, Ph.D., Chief Scientific Officer and Ilgen Mender, Director of Biology Research, along with MAIA Scientific Advisory Board members Z. Gunnur Dikmen, M.D., Ph.D. and Saadettin Kiliçkap, M.D., M.Sc. ● On September 11, 2025, we highlighted positive efficacy data from its Phase 2 clinical trial, THIO-101, including that as of June 30, 2025: (i) estimated median progression free survival (PFS) in third-line treatment (180 mg dose) was 5.6 months; (ii) Estimated median overall survival (OS) was 17.8 months, with a 95% confidence interval (CI) lower bound of 12.5 months and a 99% CI lower bound of 10.8 months, consistent with the prior data readout (May 15, 2025); (iii) Across patients of all treatment lines, 2 patients have completed 33 cycles of therapy, highlighting ateganosine’ potential for extended dosing, which usually translates into longer patient survival. ● On September 24, 2025, announced today that the National Institutes of Health (NIH) has awarded a $2.3 million grant for the expansion of its THIO-101 Phase 2 clinical trial evaluating ateganosine as a third-line treatment for patients with advanced non-small cell lung cancer (NSCLC). ● On October 1, 2025, we issued and sold 1,733,766 shares of our common stock and warrants to purchase 1,733,766 shares of our common stock in a non-brokered private placement to accredited investors and certain Company directors pursuant to securities purchase agreements dated September 29, 2025 at a price per share of $1.30 for which we received gross proceeds of approximately $2.25 million, prior to offering expenses payable by the Company. The warrants issued in the private placement have an exercise price of $1.57, are exercisable six months following issuance and have a term of three 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 October 7, 2025 we announced our launch of a new digital asset treasury strategy focused on top-tier cryptocurrency asset. Due to cryptocurrency volatility, the Company’s digital asset strategy is currently on hold. As of the date of this report, the Company holds approximately $0 in digital assets. ● On October 16, 2025, we issued and sold 603,769 shares of our common stock and warrants to purchase 603,769 shares of our common stock in a non-brokered private placement to accredited investors pursuant to securities purchase agreements dated October 13, 2025 at a price per share of $1.22 for which we received gross proceeds of approximately $736,600, prior to offering expenses payable by the Company. The warrants issued in the private placement have an exercise price of $1.52, are exercisable six months following issuance and have a term of three years from the issuance date. ● On October 23, 2025, we announced that as of September 17, 2025, a patient that began therapy in March 2023 has shown survival of 30 months, or 912 days, an outstanding measure relative to many of the high-risk cancers. The patient with thirty month survival received therapy every three weeks, and concluded treatment upon reaching the maximum treatment duration of 2 years based on protocol requirements. ● On October 27, 2025, we announced that we have enrolled five patients from Taiwan and Turkey in the expansion phase of its THIO-101 Phase 2 trial. ● On November 20, 2025, we announced Romania as an additional country to begin screening patients for the expansion phase of its THIO-101 Phase 2 clinical trial which evaluates ateganosine sequenced with an immune checkpoint inhibitor as a third-line treatment for non-small cell lung cancer (NSCLC). ● On November 21, 2025, we announced that we have enrolled twelve patients from Taiwan, Turkey, Hungary and Poland in the expansion phase of its THIO-101 Phase 2 trial. 107 ● On December 11, 2025, we announced that the first patient has been dosed in THIO-104 Phase 3 pivotal trial evaluating the efficacy of ateganosine administered in sequence with a checkpoint inhibitor (CPI) as a third-line treatment for advanced non-small cell lung cancer (NSCLC). The multicenter, open-label trial is designed to assess overall survival for ateganosine sequenced with a CPI compared to investigator’s choice of chemotherapy in a 1:1 randomization of up to 300 patients. MAIA has received regulatory approval to screen patients in Taiwan, Turkey, select European Medicines Agency (EMA) countries, and Georgia. Screening and enrollment are now underway. ● On December 22, 2025, we issued and sold 1,233,488 shares of our common stock and warrants to purchase 1,233,488 shares of our common stock in a non-brokered private placement to accredited investors and certain Company directors pursuant to securities purchase agreements dated December 16, 2025 at a price per share of $1.224 for which we received gross proceeds of approximately $1.51 million, prior to offering expenses payable by the Company. The warrants issued in the private placement have an exercise price of $1.36, are exercisable six months following issuance and have a term of three 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 January 20, 2026, we provided a corporate update on 2025 achievements and highlighted key targeted milestones and growth catalysts for 2026. The targeted milestones include: (i) initial measures of efficacy from Phase 3 study, with interim disease control rates (DCR), overall response rates (ORR) and progression free survival (PFS) analysis of ateganosine compared to the control arm will support regulatory discussions; (ii) expected conclusion of Part C of Phase 2 study, which will provide additional clinical efficacy data to support regulatory review for commercial approval; (iii) Plan to engage in regulatory interactions with the FDA to expand ongoing FDA dialogue under the Fast Track designation, including discussions around trial enhancements and prospects for Accelerated Approval and Priority Review; (iv) clinical development of second-generation molecules planned to start in Phase 1 trials, with additional small molecules fully developed in-house with better expected efficacy compared to ateganosine. ● On March 4, 2026, we issued and sold 20,000,000 shares of our common stock in a underwritten public offering at a price of $1.50 per share for aggregate gross proceeds of $30 million, prior to deducting underwriting discounts and other offering expenses. In addition, on March 9, 2026, the Company closed on the partial exercise of underwriter over-allotment option for the above referenced public offering for an additional 2,005,875 shares of common stock at the public offering price of $1.50 per share resulting in additional gross proceeds of approximately $3 million. After giving effect to the partial exercise of the over-allotment option, the total number of shares sold by Company in the public offering increased to 22,005,875 and gross proceeds increased to approximately $33 million ● In addition to NSCLC, HCC, SCLC and CRC we plan to conduct clinical trials evaluating ateganosine 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 ateganosine in first-line patients for both NSCLC and SCLC. Impact of the War in Ukraine and the conflict in Iran on Our Operations The short and long-term implications of Russia’s invasion of Ukraine and the conflict in Iran 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. 108 Financial Operations Overview and Analysis For the Years Ended December 31, 2025 and 2024 Comparison of the Years Ended December 31, 2025 and 2024 Years Ended December 31, Change 2025 2024 Dollars Percentage Operating expenses: Research and development expenses $ 14,547,332 $ 10,009,229 $ 4,538,103 45 % General and administrative expenses 9,722,354 6,947,981 2,774,373 40 % Total operating costs and expenses 24,269,686 16,957,210 7,301,585 43 % Loss from operations (24,269,686 ) (16,957,210 ) (7,312,476 ) 43 % Other income (expense): Interest expense — (57 ) 57 (100 )% Interest income 313,954 318,367 (4,413 ) (1 )% Australian research and development incentives — 79,954 (79,954 ) (100 )% Grant income 361,350 — 361,350 — % Change in fair value of warrant liability 1,198,210 (6,682,758 ) 7,880,968 (118 )% Loss on fair value of warrants over proceeds — (12,952 ) 12,952 (110 )% Other income (expense), net 1,873,514 (6,297,446 ) 8,170,960 (130 )% Net loss $ (22,396,172 ) $ (23,254,656 ) $ 858,484 (4 )% Operating Expenses Research and development expenses Research and development expenses increased by approximately $4,538,000 (or approximately 45%) from approximately $10,009,000 for the year ended December 31, 2024 to approximately $14,547,000 for the year ended December 31, 2025. The increase was primarily related to an increase in payroll expense of approximately $377,000 related to an increase in salaries of research and development employees, an increase in stock based compensation of approximately $204,000, an increase in Scientific pre-clinical research of approximately $1,699,000, an increase of other expenses related to research and development of approximately $47,000, an increase in clinical expenses related to the clinical trial of ateganosine of approximately $2,174,000, and an increase in professional fees of $37,000. General and administrative expenses General and administrative expenses increased by approximately $2,775,000 (or approximately 40%) from approximately $6,948,000 for the year ended December 31, 2024 to approximately $9,722,000 for the year ended December 31, 2025. The increase was primarily related to an increase in other expenses of approximately $1,548,000 related to higher investor relations expenses, an increase in payroll expense of approximately $281,000 relating to the increase in salaries of general and administrative employees, an increase in stock-based compensation of approximately $515,000, and an increase in professional fees of approximately $431,000, Other income (expense), net Other income (expense), net increased by approximately $8,171,000 (or approximately 130%) from other expense, net of approximately $6,297,000 for the year ended December 31, 2024 to other income, net of approximately $1,874,000 for the year ended December 31, 2025. The increase was primarily related to the change in the loss on fair value of the warrant liability of approximately $7,881,000, a change in the loss on fair value of warrants over proceeds of approximately $13,000, an increase for grant income of approximately $361,000, offset by a reduction in the Australia research and development incentives of approximately $80,000 and a reduction of interest income, net of approximately $4,000. 109 Liquidity and Capital Resources The following table presents selected financial information and statistics as of and for the years ended December 31, 2025 and 2024: Years Ended December 31, 2025 and 2024 As of December 31, 2025 2024 Balance Sheet Data: Cash $ 8,658,031 $ 9,601,298 Working capital (1) 3,865,458 6,322,441 Total assets 9,704,656 10,155,279 Accrued bonus 1,199,955 941,098 Total stockholders’ equity 2,375,863 3,634,636 (1) We define working capital as current assets less current liabilities. Capital Resources Sale of Common Stock Between February 14, 2024 and December 31, 2024, we sold 3,274,360 shares of Common Stock at an average price of approximately $3.09 per share, resulting in aggregate gross proceeds of approximately $10,111,996 under the ATM Agreements dated February 14, 2024 and May 15, 2024, for which we paid Wainwright approximately $303,350 in commissions and $355,451 in other issuance costs resulting in net proceeds to us of approximately $9,453,195. 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. 110 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. 111 From October 1, 2025 thru December 31, 2025, we sold 236,271 shares of Common Stock through Wainwright under the ATM Agreement dated March 22, 2025 at an average price of approximately $1.78 per share, resulting in aggregate gross proceeds of approximately $420,780, for which we paid Wainwright approximately $12,623 in commissions and other issuance costs of 1,459, resulting in net proceeds to us of approximately $406,698. From January 1, 2025 through December 31, 2025, we sold 3,782,335 shares of Common Stock through Wainwright under the ATM Agreements dated December 19, 2024 and March 22, 2025 at an average price of approximately $1.90 per share, resulting in aggregate gross proceeds of approximately $7,202,016, for which we paid Wainwright approximately $216,060 in commissions and other issuance costs of $111,555, resulting in net proceeds to us of approximately $6,874,401. 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 $2.7 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. Company director Stan Smith purchased 50,000 shares and 50,000 warrants for an aggregate purchase price of approximately $75,000 and Company director Ramiro Guerrero purchased 73,333 shares and 73,333 warrants for an aggregate purchase price of approximately $110,000. In addition, related party 5% stockholder FGMK Business Holdings, LLC purchased 1,350,000 shares and 1,350,000 warrants for a purchase price of approximately $550,000. 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 $1.4 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. The securities sold to our directors participating in the March 3, 2025 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 $37,500 and Company director Ramiro Guerrero purchased 33,333 shares and 33,333 warrants for an aggregate purchase price of approximately $50,000. On May 8, 2025, we issued and sold 719,999 shares of our Common Stock and warrants to purchase 719,999 shares of our Common Stock in a private placement to certain accredited investors and to our participating directors pursuant to securities purchase agreements dated May 5, 2025 at a price of $1.50 per share, for which we received gross proceeds of approximately $1.1 million. The warrants are exercisable at a price per Share of $2.05, 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 May 8, 2025 private placement were issued pursuant to the MAIA 2021 Plan. Company director Stan Smith purchased 66,666 shares and 66,666 warrants for an aggregate purchase price of approximately $100,000 and Company director Ramiro Guerrero purchased 20,000 shares and 20,000 warrants for an aggregate purchase price of approximately $30,000. On June 3, 2025, we issued and sold 463,332 shares of our Common Stock and warrants to purchase 463,332 shares of our Common Stock in a private placement to certain accredited investors and to our participating directors pursuant to securities purchase agreements dated May 27, 2025 at a price of $1.50 per share, for which we received gross proceeds of approximately $0.7 million. The warrants are exercisable at a price per Share of $1.71, 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 years from the initial issuance date. The securities sold to our directors participating in the June 3, 2025 private placement were issued pursuant to the MAIA 2021 Plan. Company director Stan Smith purchased 33,333 shares and 33,333 warrants for an aggregate purchase price of approximately $50,000. 112 On October 1, 2025, we issued and sold 1,733,766 shares of our Common Stock and warrants to purchase 1,733,766 shares of our Common Stock in a private placement to certain accredited investors and to our participating directors pursuant to securities purchase agreements dated September 29, 2025 at a price of $1.30 per share, for which we received gross proceeds of approximately $2.3 million. The warrants are exercisable at a price per Share of $1.57, 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 three years from the initial issuance date. The securities sold to our directors participating in the October 1, 2025 private placement were issued pursuant to the MAIA 2021 Plan. Company director Stan Smith purchased 19,230 shares and 19,230 warrants for an aggregate purchase price of approximately $25,000. On October 16, 2025, we issued and sold 603,769 shares of our Common Stock and warrants to purchase 603,769 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 13, 2025 at a price of $1.22 per share, for which we received gross proceeds of approximately $0.7 million. The warrants are exercisable at a price per Share of $1.52, 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 three years from the initial issuance date. On December 22, 2025, we issued and sold 1,233,488 shares of our Common Stock and warrants to purchase 1,233,488 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 16, 2025 at a price of $1.224 per share, for which we received gross proceeds of approximately $1.5 million. The warrants are exercisable at a price per Share of $1.36, 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 three years from the initial issuance date. The securities sold to our directors participating in the December 22, 2025 private placement were issued pursuant to the MAIA 2021 Plan. Company director Louie Ngar Yee purchased 81,699 shares and 81,699 warrants for an aggregate purchase price of approximately $100,000, Company director Stan Smith purchased 57,189 shares and 57,189 warrants for an aggregate purchase price of approximately $70,000, and Company director Steven Chaouki purchased 40,849 shares and 40,849 warrants for an aggregate purchase price of approximately $50,000, National Institute of Health Grant On September 24, 2025, we announced that the National Institutes of Health (NIH) has awarded us a $2.3 million grant for the expansion of its THIO-101 Phase 2 clinical trial evaluating ateganosine as a third-line treatment for patients with advanced non-small cell lung cancer (NSCLC) We will need to raise additional capital to fund our operations, to develop and commercialize ateganosine, 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, 2025 and 2024 Years Ended December 31, 2025 2024 Net cash flows used in operating activities $ (18,844,598 ) $ (15,704,461 ) Net cash flows provided by financing activities 17,906,547 18,176,609 Effect of foreign currency exchange rate changes on cash (5,216 ) (21,545 ) Net (decrease) increase in cash $ (943,267 ) $ 2,450,603 113 Operating Activities For the year ended December 31, 2025, net cash used in operating activities was approximately $18,845,000, which consisted of a consolidated net loss of approximately $22,396,000 offset by non-cash charges of approximately $2,052,000 which primarily includes approximately $2,631,000 in stock-based compensation, approximately $619,000 of expense related restricted shares issued for consulting services, and a gain of approximately $1,198,000 related to the changes in fair value of the warrant liability. Total changes in operating assets and liabilities of approximately $1,499,000 were primarily driven by an approximate $520,000 increase in accounts payable, an approximate $1,479,000 increase in accrued expenses, an approximate increase of $80,000 in Australian research and development incentives receivable, and an approximate $580,000 decrease in prepaid expenses and other current assets. 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 $8,788,000 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 increase of $57,000 in Australian research and development incentives receivable, and an approximate $196,000 decrease in prepaid expenses and other current assets. Financing Activities Net cash provided by financing activities for the year ended December 31, 2025 was approximately $17,907,000 and consisted primarily of approximately $10,419,000 in gross proceeds from private placement offerings, proceeds from the at-the-market offering of approximately $7,202,000, proceeds from the exercise of stock options of approximately $1,000, proceeds from the exercise of warrants of approximately $902,000 and were offset by approximately $617,000 of offering costs. 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. 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. 114 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. 115 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.