MAIA Biotechnology, Inc.

Previous wording

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

Current wording

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

Previous wording

We are a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer. Ateganosine (also know 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 2026 and final analysis could lead to filing for full commercial approval in 2027. The multicenter, open-label, pivotal Phase 3 trial is designed to provide a direct comparison to chemotherapy in a 1:1 randomization of up to 300 patients. In addition, the originally planned Phase 2 clinical trial in multiple tumor indications (THIO-102) is now divided into different trials for one tumor indication each: hepatocellular carcinoma (HCC), colorectal cancer (CRC) and small cell lung ca…

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 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 2026 and final analysis could lead to filing for full commercial approval in 2027. The multicenter, open-label, pivotal Phase 3 trial is designed to provide a direct comparison to chemotherapy in a 1:1 randomization of up to 300 patients. In addition, the originally planned Phase 2 clinical trial in multiple tumor indications (THIO-102) is now divided into different trials for one tumor indication each: hepatocellular carcinoma (HCC), colorectal cancer (CRC) and small cell lung c…

Excerpt shortened here; the source contains the full paragraph.

Previous wording

We accomplished the key milestones set forth below in the three months ended March 31, 2025 and the second 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 six months ended June 30, 2025 and the second 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).

Previous wording

Results of Operations for the Three Months Ended March 31, 2025 and 2024

Current wording

Results of Operations for the Three and Six Months Ended June 30, 2025 and 2024

Previous wording

General and administrative expenses increased by approximately $600,000 (or approximately 37%) from approximately $1,628,000 for the three months ended March 31, 2024, to approximately $2,228,000 for the three months ended March 31, 2025. The increase was primarily related to an increase in professional fees and investor relations of approximately $649,000, offset by a decrease in stock-based compensation of approximately $32,000, and a decrease of approximately $17,000 payroll expense.

Current wording

General and administrative expenses increased by approximately $292,000 (or approximately 17%) from approximately $1,763,000 for the three months ended June 30, 2024, compared to approximately $2,055,000 for the three months ended June 30, 2025. The increase was primarily related to an increase in professional fees of approximately $220,000, an increase in stock-based compensation of approximately $313,000, and an increase of approximately $44,000 payroll expense, offset by a decrease in investor relations of approximately $285,000.

Previous wording

Research and development expenses increased by approximately $877,000 (or approximately 38%), from approximately $2,321,000 for the three months ended March 31, 2024 to approximately $3,198,000 for the three months ended March 31, 2025. The increase was primarily related to an increase in scientific research and clinical research of approximately $873,000, an increase in stock-based compensation cost of approximately $54,000 offset by a decrease in payroll expense of approximately $37,000 and a decrease in other expense of $13,000.

Current wording

Research and development expenses increased by approximately $1,935,000 (or approximately 44%), from approximately $4,373,000 for the six months ended June 30, 2024, to approximately $6,308,000 for the six months ended June 30, 2025. The increase was primarily related to an increase in scientific research and clinical research of approximately $1,728,000, an increase in stock-based compensation cost of approximately $129,000, an increase in payroll expense of approximately $83,000, offset by decrease in other expense of $5,000.

Previous wording

Other income (expense), net increased by approximately $5,027,000 (or approximately 122%) from other (expense), net of approximately $4,119,000 for the three months ended March 31, 2024, to other income, net of approximately $908,000 for the three months ended March 31, 2025. The increase was primarily related to the change in the fair value of the warrant liability of approximately $5,007,000, a net increase in interest income of approximately $38,000, and a reduction in the Australian research and development incentives of approximately $18,000.

Current wording

Other income (expense), net increased by approximately $9,910,000 (or approximately 108%) from other (expense), net of approximately $ 9,183,000 for the six months ended June 30, 2024, to other income, net of approximately $727,000 for the six months ended June 30, 2025. The increase was primarily related to the change in the fair value of the warrant liability of approximately $9,918,000, a net increase in interest income of approximately $29,000, and a reduction in the Australian research and development incentives of approximately $37,000.

Previous wording

As of March 31, 2025, our cash totaled approximately $10,863,000 which represented an increase of approximately $1,262,000 compared to December 31, 2024. As of March 31, 2025, we had working capital of approximately $6,804,000 which represents an increase of approximately $482,000 compared to December 31, 2024. We have generated no revenues as of March 31, 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 March 31, 2025 of $10,863,000 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.

Current wording

As of June 30, 2025, our cash totaled approximately $10,145,000 which represented an increase of approximately $543,000 compared to December 31, 2024. As of June 30, 2025, we had working capital of approximately $5,999,000 which represents a decrease of approximately $323,000 compared to December 31, 2024. We have generated no revenue as of June 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 June 30, 2025, of $10,144,522 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 wording

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 25,2025 at a price of $1.50 per share, for which we received gross proceeds of approximately $1.4 million. The securities sold to our directors participating in the March 3, 2025 private placement were issued pursuant to the MAIA 2021 Plan.

Current wording

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 25, 2025 at a price of $1.50 per share, for which we received gross proceeds of approximately $1.4 million. The securities sold to our directors participating in the March 3, 2025, private placement were issued pursuant to the MAIA 2021 Plan.

Previous wording

From January 1, 2025 through March 31, 2025, we sold 666,323 shares of Common Stock 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.

Previous wording

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 after issuance and expire 5-years after the initial exercise date. The securities sold to our directors participating in the private placement were issued pursuant to our 2021 Equity Incentive Plan.

Current wording

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 wording

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.

Current wording

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 financing, as well as other sources. We cannot make any assurances that additional financing 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.

Previous wording

Cash Flows for the Three Months ended March 31, 2025 and 2024

Current wording

Cash Flows for the Six Months ended June 30, 2025 and 2024

Previous wording

For the three months ended March 31, 2024, net cash used in operating activities was approximately $3,587,000, which consisted of a net loss of approximately $8,067,000 offset by non-cash charges of approximately $350,000 in stock-based compensation, approximately $12,000 of non-cash expense to issue stock to consultants, and the remeasurement of the warrant liability of approximately $4,181,000. Total changes in operating assets and liabilities of approximately $463,000 were driven by an approximate $39,000 net decrease in accounts payable and accrued liabilities, an approximate $5,000 decrease in prepaid expenses and other assets and an approximate decrease of $19,000 in Australia research and development incentives receivables.

Current 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, approximately $62,000 of non-cash expense to issue stock to consultants and vendors, and the decrease in 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.

Previous 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.

Current wording

For the six months ended June 30, 2024, net cash used in operating activities was approximately $8,272,000, which consisted of a consolidated net loss of approximately $16,947,000 offset by non-cash charges of approximately $764,000 in stock-based compensation, approximately $12,000 of non-cash expense to issue stock to consultants, the remeasurement of the warrant liability of approximately $9,339,000, and the loss on fair value of warrants over proceeds of approximately $13,000. Total changes in operating assets and liabilities of approximately $1,452,000 were driven by an approximate $1,423,000 net decrease in accounts payable and accrued expenses, an approximate $37,000 decrease in the Australia research and development incentives receivable, an approximate $73,000 decrease in other receivables, and an approximate $81,000 increase in prepaid expense and other assets.

Previous wording

For the three months ended March 31, 2025 the effect of foreign currency exchange rate changes on cash increased the cash balance as of March 31, 2025 by approximately $3,000 versus a decrease of approximately $9,000 for the three months ended March 31, 2024.

Current wording

For the six months ended June 30, 2025, the effect of foreign currency exchange rate changes on cash increased the cash balance as of June 30, 2025 by approximately $11,000 versus a decrease of approximately $4,000 for the six months ended June 30, 2024.

Previous wording

For the three months ended March 31, 2025 and 2024, we did not have any cash provided by or used in investing activities.

Current wording

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

Previous wording

Net cash provided by financing activities was approximately $5,461,000 and $4,717,000 for the three months ended March 31, 2025 and 2024, respectively. Total 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, proceeds from the exercise of stock options of $1,000, and were offset by an approximate $205,000 of offering costs.

Current wording

Net cash provided by financing activities was approximately $8,869,000 and $12,704,000 for the six months ended June 30, 2025 and 2024, respectively. Total 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.

Previous wording

Net cash provided by financing activities for the three months ended March 31, 2024 consisted primarily of approximately $4,249,000 gross proceeds from private placement offerings, proceeds from the at-the-market offering of approximately $745,000, and offset by an approximate $277,000 of offering costs.

Current wording

Net cash provided by financing activities for the six months ended June 30, 2024, consisted primarily of approximately $5,254,000 gross proceeds from private placement offerings, proceeds from the at-the-market offering of approximately $7,862,000, proceeds from the exercise of stock options of $185,000, and offset by approximately $597,000 of offering costs.