MAIA Biotechnology, Inc.
For the period ended Sep 30, 2026. Filed Nov 9, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 9, 2026
MAIA$1.09+2.8%Stored close · as of Nov 9, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-10.
0001493152-26-036764
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-09.
0001493152-26-050757
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 53 previous paragraphs and 58 current paragraphs.
35 unchanged; 17 reworded; 6 added; 1 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 4 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (6)
Current report
Comparison of Nine Months Ended September 30, 2026 and 2025
Current report
From July 1, 2025 through September 30, 2025, we sold 2,086,312 shares of Common Stock through Wainwright under the ATM Agreement at an average price of approximately $1.81 per share, resulting in aggregate gross proceeds of approximately $3,779,251, for which we paid Wainwright approximately $113,378 in commissions and other issuance costs of $3,758, resulting in net proceeds to us of approximately $3,662,115.
Current report
On June 17, 2025, the Company executed a Warrant Inducement Offer to select warrant holders allowing them to exercise their warrants held at a reduction of the exercise price for cash. The warrant’s exercise price was reduced to $1.50 per share. Certain warrant holders accepted the offer and warrants were exercised, resulting in the issuance of 219,283 shares of MAIA Common Stock for proceeds of approximately $328,924. The fair value of the modified warrants was greater than the fair value of the original warrants at the modification date by $105,154; therefore, the incremental cost was recognized as an increase to warrant additional paid in capital and a decrease to additional paid in capital, there was no net equity difference.
Current report
On September 18, 2025, the Company executed a Warrant Inducement Offer to select warrant holders allowing them to exercise their warrants held at a reduction of the exercise price for cash. The warrant’s exercise price was reduced to $1.30 per share. Certain warrant holders accepted the offer and warrants were exercised, resulting in the issuance of 440,503 shares of MAIA Common Stock for proceeds of approximately $572,654. The fair value of the modified warrants was greater than the fair value of the original warrants at the modification date by $60,275; therefore, the incremental cost was recognized as an increase to warrant additional paid in capital and a decrease to additional paid in capital, there was no net equity difference.
Current report
Non-Cash Financing Activities
Current report
Issuance of common stock in exchange for clinical trial subscription receivable of $1,000,000.
Removed paragraphs (1)
Previous report
Comparison of Six Months Ended June 30, 2026 and 2025
Reworded paragraphs (17)
Previous wording
We are a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer. Ateganosine (also known as 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. Our initial disease target is lung cancer, a serious medical condition with an incidence of over 235,000 new cases in the US in 2024, representing 12% of all cancers, and over 125,000 deaths, or 20% 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. 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 NSCLC. Patients with advanced NSCLC will be 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. 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 which could lead filing for early full commercial approval in 2027 and final analysis could lead to filing for full commercial approval in 2028. 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 (…
Excerpt shortened here; the source contains the full paragraph.
Current wording
We are a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer. Ateganosine (also known as 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. Our initial disease target is lung cancer, a serious medical condition with an incidence of over 235,000 new cases in the US in 2024, representing 12% of all cancers, and over 125,000 deaths, or 20% 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. 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 NSCLC. Patients with advanced NSCLC will be 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. 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 which could lead to filing for early full commercial approval in 2027 and final analysis could lead to filing for full commercial approval in 2028. 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 cance…
Excerpt shortened here; the source contains the full paragraph.
Previous wording
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.
Current wording
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.
Previous wording
We accomplished the key milestones set forth below in the six months ended June 30, 2026 and the third quarter of 2026: Please note that on March 18, 2025, the company announced “ateganosine” as the nonproprietary (generic) name for THIO, and its intent to use the generic name to support clear communication, while keeping the name THIO in the Company’s clinical trial designations (THIO-101, THIO-102, THIO-104).
Current wording
We accomplished the key milestones set forth below in the nine months ended September 30, 2026, and subsequent to quarter-end through the date of the Quarterly Report: Please note that on March 18, 2025, the company announced “ateganosine” as the nonproprietary (generic) name for THIO, and its intent to use the generic name to support clear communication, while keeping the name THIO in the Company’s clinical trial designations (THIO-101, THIO-102, THIO-104).
Previous wording
Results of Operations for the Three and Six Months Ended June 30, 2026 and 2025
Current wording
Results of Operations for the Three and Nine Months Ended September 30, 2026 and 2025
Previous wording
Research and development expenses increased by approximately $2,529,000 (or approximately 81%), from approximately $3,111,000 for the three months ended June 30, 2025, compared to approximately $5,640,000 for the three months ended June 30, 2026. The increase was primarily related to an increase in scientific research and clinical research of approximately $2,354,000, an increase in payroll expense of approximately $154,000, an increase in other expenses of approximately $25,000, offset by a decrease in stock-based compensation cost of approximately $3,000, and a decrease in professional fees of approximately $1,000.
Current wording
Research and development expenses decreased by approximately $1,021,000 (or approximately 16%), from approximately $6,357,000 for the three months ended September 30, 2025, compared to approximately $5,336,000 for the three months ended September 30, 2026. The decrease was primarily related to a decrease in scientific research and clinical research of approximately $1,174,000, a decrease in professional fees of approximately $37,000 offset by an increase in payroll expense of approximately $96,000, an increase in other expenses of approximately $10,000, and an increase in stock-based compensation cost of approximately $84,000.
Previous wording
General and administrative expenses increased by approximately $622,000 (or approximately 30%) from approximately $2,055,000 for the three months ended June 30, 2025, compared to approximately $2,677,000 for the three months ended June 30, 2026. The increase was primarily related to an increase in investor relations of approximately $331,000, an increase in other expenses of approximately $187,000, an increase in payroll of approximately $135,000, and an increase in professional fees of approximately $45,000, offset by a decrease in stock-based compensation of approximately $76,000.
Current wording
General and administrative expenses decreased by approximately $315,000 (or approximately 10%) from approximately $3,003,000 for the three months ended September 30, 2025, compared to approximately $2,688,000 for the three months ended September 30, 2026. The decrease was primarily related to a decrease in investor relations of approximately $374,000, a decrease in other expenses of approximately $255,000, offset by an increase in payroll of approximately $46,000, an increase in professional fees of approximately $117,000, and an increase in stock-based compensation of approximately $151,000.
Previous wording
Other income (expense), net increased by approximately $555,000 (or approximately 307%) from other expense, net of approximately $181,000 for the three months ended June 30, 2025, compared to other income, net of approximately $374,000 for the three months ended June 30, 2026. The increase was primarily related an increase in grant income of $207,000, an increase in the change in the fair value of the warrant liability of approximately $191,000, and a net increase in interest income of approximately $157,000.
Current wording
Other income (expense), net increased by approximately $389,000 (or approximately 85%) from other income (expense), net of approximately $458,000 for the three months ended September 30, 2025, compared to other income (expense), net of approximately $847,000 for the three months ended September 30, 2026. The increase was primarily related to an increase in grant income of $310,000, a net increase in interest income of approximately $108,000 offset by a decrease in the change in the fair value of the warrant liability of approximately $29,000.
Previous wording
Research and development expenses increased by approximately $2,856,000 (or approximately 45%), from approximately $6,308,000 for the six months ended June 30, 2025, to approximately $9,164,000 for the six months ended June 30, 2026. The increase was primarily related to an increase in scientific research and clinical research of approximately $2,407,000, an increase in payroll expense of approximately $383,000, an increase in stock-based compensation cost of approximately $34,000, an increase in other expense of approximately $30,000, and an increase in professional fees of approximately $2,000.
Current wording
Research and development expenses increased by approximately $1,836,000 (or approximately 14%), from approximately $12,665,000 for the nine months ended September 30, 2025, to approximately $14,501,000 for the nine months ended September 30, 2026. The increase was primarily related to an increase in scientific research and clinical research of approximately $1,233,000, an increase in payroll expense of approximately $479,000, an increase in stock-based compensation cost of approximately $118,000, and an increase in other expense of approximately $9,000, offset by a decrease in professional fees of approximately $3,000.
Previous wording
General and administrative expenses increased by approximately $1,819,000 (or approximately 42%) from approximately $4,283,000 for the six months ended June 30, 2025, to approximately $6,102,000 for the six months ended June 30, 2026. The increase was primarily related to an increase in professional fees of approximately $343,000, an increase of investor relations of approximately $499,000, an increase in stock-based compensation of approximately $166,000, an increase of approximately $764,000 payroll expense and an increase in other expense of approximately $47,000.
Current wording
General and administrative expenses increased by approximately $1,504,000 (or approximately 21%) from approximately $7,287,000 for the nine months ended September 30, 2025, to approximately $8,791,000 for the nine months ended September 30, 2026. The increase was primarily related to an increase in professional fees of approximately $461,000, an increase in investor relations of approximately $124,000, an increase in stock-based compensation of approximately $317,000, an increase in payroll expense of approximately $811,000 offset by a decrease in other expense of approximately $209,000.
Previous wording
Other income (expense), net increased by approximately $227,000 (or approximately 31%) from other income, net of approximately $727,000 for the six months ended June 30, 2025, to other income, net of approximately $954,000 for the six months ended June 30, 2026. The increase was primarily related to an increase in grant income of approximately $421,000, a decrease in the change in the fair value of the warrant liability of approximately $380,000, and a net increase in interest income of approximately $186,000.
Current wording
Other income (expense), net increased by approximately $616,000 (or approximately 52%) from other income (expense), net of approximately $1,185,000 for the nine months ended September 30, 2025, to other income (expense), net of approximately $1,801,000 for the nine months ended September 30, 2026. The increase was primarily related to an increase in grant income of approximately $731,000, a net increase in interest income of approximately $294,000 offset by a decrease in the change in the fair value of the warrant liability of approximately $409,000.
Previous wording
Cash Flows for the Six Months ended June 30, 2026 and 2025
Current wording
Cash Flows for the Nine Months ended September 30, 2026 and 2025
Previous wording
For the six months ended June 30, 2026, net cash used in operating activities was approximately $12,061,000, which consisted of a consolidated net loss of approximately $14,313,000 offset by non-cash charges of approximately $1,374,000 in stock-based compensation, approximately $243,000 of non-cash expense to issue stock to vendors, and the decrease in the remeasurement of the warrant liability of approximately $185,000. Total changes in operating assets and liabilities of approximately $820,000 were driven by an approximate $1,198,000 net increase in accounts payable and prepaid expenses and other current assets, offset by an approximate $378,000 decrease in accrued expense.
Current wording
For the nine months ended September 30, 2026, net cash used in operating activities was approximately $18,372,000 which consisted of a consolidated net loss of approximately $21,491,000 offset by non-cash charges of approximately $2,255,000 in stock-based compensation, approximately $481,000 of non-cash expense to issue stock to vendors, and the decrease in the remeasurement of the warrant liability of approximately $535,000. Total changes in operating assets and liabilities of approximately $918,000 were driven by an approximate $2,362,000 net increase in accounts payable, prepaid expenses and other current assets, offset by an approximate $1,444,000 decrease in accrued expense.
Previous wording
For the six months ended June 30, 2025, net cash used in operating activities was approximately $8,338,000, which consisted of a consolidated net loss of approximately $9,864,000 offset by non-cash charges of approximately $1,173,000 in stock-based compensation, and the remeasurement of the warrant liability of approximately $565,000. Total changes in operating assets and liabilities of approximately $856,000 were driven by an approximate $1,208,000 net increase in accounts payable and accrued expenses, and an approximate $352,000 decrease in prepaid expense and other assets.
Current wording
For the nine months ended September 30, 2025, net cash used in operating activities was approximately $11,824,000, which consisted of a consolidated net loss of approximately $18,767,000 offset by non-cash charges of approximately $1,821,000 in stock-based compensation, approximately $250,000 of non-cash expense to issue stock to consultants and vendors, and the decrease in the remeasurement of the warrant liability of approximately $945,000. Total changes in operating assets and liabilities of approximately $5,817,000 were driven by an approximate $6,158,000 net increase in accounts payable and accrued expenses, and an approximate $341,000 decrease in prepaid expense and other assets.
Previous wording
For the six months ended June 30, 2026, the effect of foreign currency exchange rate changes on cash increased the cash balance as of June 30, 2026 by approximately $12,000 versus an increase of approximately $11,000 for the six months ended June 30, 2025.
Current wording
For the nine months ended September 30, 2026, the effect of foreign currency exchange rate changes on cash increased the cash balance as of September 30, 2026 by approximately $66,000 versus an increase of approximately $10,000 for the nine months ended September 30, 2025.
Previous wording
For the six months ended June 30, 2026 and 2025, we did not have any cash provided by or used in investing activities.
Current wording
For the nine months ended September 30, 2026 and 2025, we did not have any cash provided by or used in investing activities.
Previous wording
Net cash provided by financing activities was approximately $30,987,000 and $8,869,000 for the six months ended June 30, 2026 and 2025, respectively. Total net cash provided by financing activities for the six months ended June 30, 2026 consisted primarily of approximately $33,009,000 gross proceeds from public offerings, proceeds from the exercise of stock options of approximately $38,000, and were offset by an approximate $2,060.000 of offering costs.
Current wording
Net cash provided by financing activities was approximately $30,987,000 and $13,104,000 for the nine months ended September 30, 2026 and 2025, respectively. Total net cash provided by financing activities for the nine months ended September 30, 2026 consisted primarily of approximately $33,009,000 gross proceeds from public offerings, proceeds from the exercise of stock options of approximately $38,000, and were offset by an approximate $2,060,000 of offering costs.
Previous wording
Net cash provided by financing activities for the six months ended June 30, 2025, consisted primarily of approximately $5,919,000 gross proceeds from private placement offerings, proceeds from the at-the-market offering of approximately $3,002,000, proceeds from the exercise of stock options of $1,000, proceeds from the exercise of warrants of $328,000 and were offset by an approximate $381,000 of offering costs.
Current wording
Net cash provided by financing activities for the nine months ended September 30, 2025, consisted primarily of approximately $5,919,000 gross proceeds from private placement offerings, proceeds from the at-the-market offering of approximately $6,781,000, proceeds from the exercise of stock options of $1,000, proceeds from the exercise of warrants of $901,000 and were offset by an approximate $498,000 of offering costs.