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MAIA Biotechnology, Inc.

For the period ended Mar 31, 2026. Filed May 11, 2026.

View on SEC.gov

About 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.

Mar 31, 2026 · Filed May 11, 2026

MAIA$1.06+1.9%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-09-30; filed 2025-11-07.

0001493152-25-021272

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-03-31; filed 2026-05-11.

0001493152-26-022154

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The 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 61 previous paragraphs and 42 current paragraphs.

25 unchanged; 15 reworded; 2 added; 21 removed; 0 previous and 0 current paragraphs rearranged.

Tables are not compared: 14 previous and 3 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 (2)

Current report

On March 4, 2026, the Company issued and sold 20,000,000 shares of its Common Stock to certain accredited investors pursuant to a confidentially marketed public offering with Konik Capital Partners, LLC. (“Konik Capital”) at a price per share of $1.50 for which the Company received gross proceeds of approximately $30,000,000. The Company paid Konik Capital approximately $1,500,000 in commissions and other issuance costs of approximately $329,000, resulting in net proceeds to the Company of approximately $28,171,000.

Current report

On March 9, 2026, the Company issued and sold 2,005,875 shares of its Common Stock to certain accredited investors pursuant to a confidentially marketed follow-on public offering with Konik Capital at a price per share of $1.50 for which the Company received gross proceeds of approximately $3,009,000. The Company paid Konik Capital approximately $150,000 in commissions and other issuance costs of approximately $16,000, resulting in net proceeds to the Company of approximately $2,843,000.
Removed paragraphs (21)

Previous report

Comparison of Nine Months Ended September 30, 2025 and 2024

Previous report

Research and development expenses increased by approximately $5,625,000 (or approximately 80%), from approximately $7,040,000 for the nine months ended September 30, 2024, to approximately $12,665,000 for the nine months ended September 30, 2025. The increase was primarily related to an increase in scientific research and clinical research of approximately $5,096,000, an increase in stock-based compensation cost of approximately $161,000, an increase in payroll expense of approximately $241,000, and an increase in professional fees of approximately $137,000, offset by decrease in other expense of $10,000.

Previous report

General and administrative expenses increased by approximately $2,374,000 (or approximately 48%) from approximately $4,912,000 for the nine months ended September 30, 2024, to approximately $7,286,000 for the nine months ended September 30, 2025. The increase was primarily related to an increase in professional fees of approximately $368,000, an increase of investor relations of approximately $1,025,000, an increase in stock-based compensation of approximately $440,000, an increase of approximately $167,000 payroll expense, and an increase in other expense of approximately $374,000.

Previous report

Other income (expense), net increased by approximately $8,915,000 (or approximately 115%) from other (expense), net of approximately $7,730,000 for the nine months ended September 30, 2024, to other income, net of approximately $1,185,000 for the nine months ended September 30, 2025. The increase was primarily related to the change in the fair value of the warrant liability of approximately $8,965,000, a net increase in interest income of approximately $2,000, and a reduction in the Australian research and development incentives of approximately $52,000.

Previous report

As of September 30, 2025, our cash totaled approximately $10,892,000 which represented an increase of approximately $1,290,000 compared to December 31, 2024. As of September 30, 2025, we had working capital of approximately $1,761,000 which represents a decrease of approximately $4,561,000 compared to December 31, 2024. We have generated no revenue as of September 30, 2025. Our current operating plan indicates that we 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 our lack of revenue generating activities. Based on our cash reserves as of September 30, 2025, of $10,891,736 and current financial condition as of the date of this Quarterly Report, the accompanying condensed 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 condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Previous report

To meet the Company’s future working capital needs, we will need to raise additional equity or enter into debt financing. While we have historically been able to raise additional capital through issuance of equity and/or debt financing, and we have 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, we cannot guarantee that it will be able to raise additional equity, raise debt, or contain expenses. Accordingly, there is substantial doubt about our ability to continue as a going concern within one year after these financial statements are issued.

Previous report

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 securities sold to our directors participating in the March 14, 2024 private placement were issued pursuant to the MAIA 2021 Plan.

Previous report

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.

Previous report

Between February 14, 2024 and March 31, 2024, we sold 507,754 shares of Common Stock at an average price of approximately $1.47 per share, resulting in aggregate gross proceeds of approximately $745,251 under the ATM Agreement dated February 14, 2024, for which we paid Wainwright approximately $22,357 in commissions resulting in net proceeds to us of approximately $722,894.

Previous report

Between October 1, 2024 and December 31, 2024, 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.

Previous report

From April 1, 2025 through June 30, 2025, we sold 793,429 shares of Common Stock through Wainwright under the ATM Agreement at an average price of approximately $1.87 per share, resulting in aggregate gross proceeds of approximately $1,480,894, for which we paid Wainwright approximately $44,427 in commissions and other issuance costs of $16,705, resulting in net proceeds to us of approximately $1,419,762.

Previous 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.

Previous report

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 $1.08 million. The securities sold to our directors participating in the May 8, 2025 private placement were issued pursuant to the MAIA 2021 Plan.

Previous report

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 securities sold to our directors participating in the June 3, 2025 private placement were issued pursuant to the MAIA 2021 Plan.
Reworded paragraphs (15)

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 plan 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 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 c…

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 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.

Previous wording

We accomplished the key milestones set forth below in the nine months ended September 30, 2025 and the third quarter of 2025: Please note that for consistency of the announcements at the time of their releases, the milestones from January 1, 2025 to March 17, 2025, refer to the molecule “ateganosine” as “THIO” only. 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-103, THIO-104).

Current wording

We accomplished the key milestones set forth below in the three months ended March 31, 2026 and the second 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).

Previous wording

Results of Operations for the Three and Nine Months Ended September 30, 2025 and 2024

Current wording

Results of Operations for the Three Months Ended March 31, 2026 and 2025

Previous wording

Research and development expenses increased by approximately $3,690,000 (or approximately 138%), from approximately $2,667,000 for the three months ended September 30, 2024, compared to approximately $6,357,000 for the three months ended September 30, 2025. The increase was primarily related to an increase in scientific research and clinical research of approximately $3,369,000, an increase in stock-based compensation cost of approximately $32,000, an increase in payroll expense of approximately $158,000, and increase in professional fees of approximately $136,000, offset by a decrease in other expenses of $5,000.

Current wording

Research and development expenses increased by approximately $327,000 (or approximately 10%), from approximately $3,198,000 for the three months ended March 31, 2025, compared to approximately $3,525,000 for the three months ended March 31, 2026. The increase was primarily related to an increase in scientific research and clinical research of approximately $53,000, an increase in stock-based compensation cost of approximately $36,000, an increase in payroll expense of approximately $229,000, an increase in professional fees of approximately $3,000, and an increase in other expenses of $6,000.

Previous wording

General and administrative expenses increased by approximately $1,482,000 (or approximately 97%) from approximately $1,521,000 for the three months ended September 30, 2024, compared to approximately $3,003,000 for the three months ended September 30, 2025. The increase was primarily related to an increase in professional fees of approximately $89,000, an increase in stock-based compensation of approximately $159,000, increase in investor relations of approximately $1,026,000, an increase in other expenses of approximately $67,000 and an increase in payroll expense of approximately $141,000.

Current wording

General and administrative expenses increased by approximately $1,197,000 (or approximately 54%) from approximately $2,228,000 for the three months ended March 31, 2025, compared to approximately $3,425,000 for the three months ended March 31, 2026. The increase was primarily related to an increase in professional fees of approximately $298,000, an increase in stock-based compensation of approximately $242,000, an increase in payroll of approximately $630,000, and an increase in other expenses of approximately $27,000.

Previous wording

Other income (expense), net decreased by approximately $995,000 (or approximately 68%) from other income, net of approximately $1,452,000 for the three months ended September 30, 2024, compared to other income, net of approximately $457,000 for the three months ended September 30, 2025. The decrease was primarily related to the change in the fair value of the warrant liability of approximately $952,000, a decrease in the Australian research and development incentives of approximately $15,000, and a net decrease of interest income of approximately $28,000.

Current wording

Other income (expense), net decreased by approximately $328,000 (or approximately 36%) from other income, net of approximately $908,000 for the three months ended March 31, 2025, compared to other income, net of approximately $580,000 for the three months ended March 31, 2026. The decrease was primarily related to the change in the fair value of the warrant liability of approximately $571,000 offset by an increase in grant income of $213,000, and a net increase of interest income of approximately $30,000.

Previous wording

From January 1, 2025 through March 31, 2025, we sold 666,323 shares of Common Stock through Wainwright under the ATM Agreement at an average price of approximately $2.28 per share, resulting in aggregate gross proceeds of approximately $1,521,091, for which we paid Wainwright approximately $45,633 in commissions and other issuance costs of $84,587, resulting in net proceeds to us of approximately $1,390,871.

Current wording

From January 1, 2025 through March 31, 2025, we sold 666,323 shares of Common Stock through Wainwright under the ATM Agreement at an average price of approximately $2.28 per share, resulting in aggregate gross proceeds of approximately $1,521,091, for which we paid Wainwright approximately $45,633 in commissions and other issuance costs of $84,587, resulting in net proceeds to us of approximately $1,390,871. During the quarter ended March 31, 2026, the Company did not sell shares of Common Stock under the ATM agreement.

Previous wording

Cash Flows for the Nine Months ended September 30, 2025 and 2024

Current wording

Cash Flows for the three Months ended March 31, 2026 and 2025

Previous 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.

Current wording

For the three months ended March 31, 2026, net cash used in operating activities was approximately $5,311,000, which consisted of a consolidated net loss of approximately $6,370,000 offset by non-cash charges of approximately $650,000 in stock-based compensation, approximately $44,000 of non-cash expense to issue stock to vendors, and the decrease in the remeasurement of the warrant liability of approximately $255,000. Total changes in operating assets and liabilities of approximately $620,000 were driven by an approximate $1,078,000 net increase in accounts payable and prepaid expenses and other current assets, offset by an approximate $458,000 decrease in accrued expense.

Previous wording

For the nine months ended September 30, 2024, net cash used in operating activities was approximately $11,796,000, which consisted of a consolidated net loss of approximately $19,683,000 offset by non-cash charges of approximately $1,219,000 in stock-based compensation, approximately $112,000 of non-cash expense to issue stock to consultants, the remeasurement of the warrant liability of approximately $8,008,000, and the loss on fair value of warrants over proceeds of approximately $13,000. Total changes in operating assets and liabilities of approximately $1,465,000 were driven by an approximate $1,330,000 net decrease in accounts payable and accrued expenses, an approximate $93,000 increase in the Australia research and development incentives receivable, and an approximate $227,000 decrease in prepaid expense and other assets.

Current wording

For the three months ended March 31, 2025, net cash used in operating activities was approximately $4,202,000, which consisted of a consolidated net loss of approximately $4,517,000 offset by non-cash charges of approximately $371,000 in stock-based compensation, and the remeasurement of the warrant liability of approximately $826,000. Total changes in operating assets and liabilities of approximately $769,000 were driven by an approximate $1,226,000 net increase in accounts payable and accrued expenses, and an approximate $457,000 increase in prepaid expense and other assets.

Previous wording

For the nine months ended September 30, 2025, the effect of foreign currency exchange rate changes on cash increased the cash balance as of September 30, 2025 by approximately $10,000 versus an increase of approximately $5,000 for the nine months ended September 30, 2024.

Current wording

For the three months ended March 31, 2026, the effect of foreign currency exchange rate changes on cash increased the cash balance as of March 31, 2026 by approximately $14,000 versus an increase of approximately $3,000 for the three months ended March 31, 2025.

Previous wording

For the nine months ended September 30, 2025 and 2024, we did not have any cash provided by or used in investing activities.

Current wording

For the three months ended March 31, 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 13,104,000 and $13,331,000 for the nine months ended September 30, 2025 and 2024, respectively. Total 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, and proceeds from the exercise of warrants of $901,000 and were offset by an approximate $498,000 of offering costs.

Current wording

Net cash provided by financing activities was approximately $31,052,000 and $5,461,000 for the three months ended March 31, 2026 and 2025, respectively. Total net cash provided by financing activities for the three months ended March 31, 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 $1,995,000 of offering costs.

Previous wording

Net cash provided by financing activities for the nine months ended September 30, 2024, consisted primarily of approximately $5,254,000 gross proceeds from private placement offerings, proceeds from the at-the-market offering of approximately $8,523,000, proceeds from the exercise of stock options of $216,000, and offset by approximately $661,000 of offering costs.

Current wording

Net cash provided by financing activities for the three months ended March 31, 2025 consisted primarily of approximately $4,144,000 gross proceeds from private placement offerings, proceeds from the at-the-market offering of approximately $1,521,000, net proceeds from the exercise of stock options of $1,000, and were offset by an approximate $205,000 of offering costs.

Previous wording

On October 6, 2025, our Board of Directors formally adopted a Digital Asset Treasury Plan. This plan permits the Company to allocate up to 90% of its corporate treasury reserves to acquire and hold Bitcoin, Ether, and USD Coin as a long-term store of value. As of the date of this Quarterly Report on Form 10-Q, the Company has not yet executed any purchases of Digital Assets under this plan. The timing and amount of any future purchases will depend on various factors, including our ongoing liquidity needs, the market price of the Digital Asset, and general market and economic conditions. Future utilization of the DATP could subject our capital resources and liquidity to the significant market risks associated with Digital Assets.

Current wording

On October 6, 2025, our Board of Directors formally adopted a Digital Asset Treasury Plan. This plan permits the Company to allocate up to 90% of its corporate treasury reserves to acquire and hold Bitcoin, Ether, and USD Coin as a long-term store of value. As of the date of this Quarterly Report on Form 10-Q, the Company has not yet executed any purchases of Digital Assets under this plan. Due to cryptocurrency volatility, the Company’s digital asset strategy is currently on hold. As of the date of this report, the Company holds no digital assets.