What changed in this filing

/stocks — the workspaceLOADING

Item 9A. Controls and Procedures

2025-03-21 compared with 2024-03-21 · 279 added, 183 removed, 650 unchanged (42% of the section changed)

18 unchanged sentences

As of December 31, 2024, our principal executive officer and principal financial officer, conducted an evaluation of the effectiveness of our internal control over financial reporting based on the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated Framework – 2013 (1992 Framework).

Based on this assessment and implementation of our remediation plans, management concluded that, as of December 31, 2023, our internal controls over financial reporting were effective.

Based on this assessment, management concluded that, as of December 31, 2024, our internal controls over financial reporting were effective.

Changes in Internal Control over Financial Reporting

6 unchanged sentences

Directors, Executive Officers and Corporate Governance.

Code of Business Conduct and Ethics

We have adopted a code of business conduct and ethics that applies to all our employees, officers and directors, including those officers responsible for financial reporting.

Our code of business conduct and ethics is available on the investor relations section of our website.

We intend to disclose any amendments to the code, or any waivers of its requirements, on our website or in a Current Report on Form 8-K.

The information required by this Item will be set forth in our definitive proxy statement with respect to our 2025 annual

meeting of stockholders to be filed not later than 120 days after the end of the 2024 fiscal year and is incorporated herein by

We have adopted a code of business conduct and ethics that applies to all our employees, officers and directors, including those officers responsible for financial reporting.

Our code of business conduct and ethics is available on the investor relations section of our website.

We intend to satisfy the disclosure requirement under Item 5.05 of Form 8-K regarding amendment to, or waiver from, a provision of our Code of Conduct by posting such information on the website address and location specified above.

We have adopted an insider trading policy applicable to our directors, officers, employees, and other covered persons, and have implemented processes for the company, that we believe are reasonably designed to promote compliance with insider trading laws, rules and regulations, and the NYSE American listing standards.

Our insider trading policy is filed as Exhibit 19.1 to this Annual Report on Form 10-K.

Executive Compensation.

19 unchanged sentences

At The Market Offering Agreement dated February 14, 2024 between MAIA Biotechnology, Inc.

Wainwright & Co., LLC, filed as Exhibit 1.1 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on February 14, 2024 and incorporated herein by reference.

Wainwright & Co., LLC, filed as Exhibit 1.1 to the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 14, 2024 and incorporated herein by reference.

Amended and Restated Certificate of Incorporation of MAIA Biotechnology, Inc

4 unchanged sentences

Specimen certificate representing shares of common stock

Common Stock Purchase Warrant, filed as Exhibit 4.1 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on November 16, 2023 and incorporated herein by reference.

Form of Warrant, filed as Exhibit 4.1 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on November 17, 2023 and incorporated herein by reference.

Form of Wainwright Warrant, filed as Exhibit 4.2 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on November 17, 2023 and incorporated herein by reference.

Form of Investor Warrants, filed as Exhibit 4.1 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on March 13, 2024 and incorporated herein by reference.

Form of Director Warrants, filed as Exhibit 4.1 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on March 13, 2024 and incorporated herein by reference.

Common Stock Purchase Warrant, filed as Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on November 16, 2023 and incorporated herein by reference.

Form of Warrant, filed as Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on November 17, 2023 and incorporated herein by reference.

Form of Wainwright Warrant, filed as Exhibit 4.2 to the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on November 17, 2023 and incorporated herein by reference.

Form of Investor Warrants, filed as Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on March 13, 2024 and incorporated herein by reference.

Form of Director Warrants, filed as Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on March 13, 2024 and incorporated herein by reference.

Form of Warrant, filed as Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on March 25,2024 and incorporated herein by reference.

Form of Investor Warrant, filed as Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on April 23, 2024.

Form of Director Warrant, filed as Exhibit 4.2 to the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on April 23, 2024.

Form of Investor Warrant, filed as Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on October 29, 2024.

Form of Director Warrant, filed as Exhibit 4.2 to the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on October 29, 2024.

Form of Investor Warrant, filed as Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on December 10, 2024

Form of Director Warrant, filed as Exhibit 4.2 to the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on December 10, 2024.

Form of Investor Warrant, filed as Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 19, 2025

Form of Director Warrant, filed as Exhibit 4.2 to the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 19, 2025.

Form of Investor Warrant, filed as Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 25, 2025

Form of Director Warrant, filed as Exhibit 4.2 to the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 25, 2025.

Form of Indemnification Agreement.

Employment Agreement, dated as of September 16, 2022, between the Company and Vlad Vitoc.

Employment Agreement, dated as of September 16, 2022, between the Company and Mihail Obrocea.

Employment Agreement, dated as of September 16, 2022, between the Company and Sergei Gryaznov.

Employment Agreement, dated as of September 16, 2022, between the Company and Joseph McGuire.

Employment Agreement, dated as of February 1, 2025, between the Company and Vlad Vitoc., filed as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 6, 2025 and incorporated herein by reference.

Employment Agreement, dated as of February 1, 2025, between the Company and Sergei Gryaznov, filed as Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 6, 2025 and incorporated herein by reference.

Supply and Non-Exclusive License Agreement between the Company and Regeneron Pharmaceuticals, Inc.

8 unchanged sentences

2021 Equity Incentive Plan.

Amendment to the MAIA Biotechnology Inc 2021 Equity Incentive Plan, filed as Annex A to the Registrants Proxy Statement on Schedule 14A filed with the Securities and Exchange Commission on April 19, 2023 and incorporated herein by reference

Form of Director Stock Option Award under Amended & Restated 2020 Equity Incentive Plan.

11 unchanged sentences

Form of Lock-Up Agreement, filed as Exhibit 10.2 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on November 17, 2023 and incorporated herein by reference.

Form of Securities Purchase Agreement, incorporated by reference to Exhibit 10.1 of our Current Report on Form 8-K filed with the Securities and Exchange Commission on March 13, 2024 and incorporated herein by reference.

Letter from EisnerAmper LLP regarding the change in the Registrant’s certifying accountant, dated November 21, 2022.

List of Subsidiaries of the Registrant.

Form of Securities Purchase Agreement, incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on March 13, 2024 and incorporated herein by reference.

Form of Securities Purchase Agreement, incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on April 23, 2024 and incorporated herein by reference.

Form of Securities Purchase Agreement, incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on October 29, 2024 and incorporated herein by reference.

Form of Securities Purchase Agreement, incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on December 10, 2024 and incorporated herein by reference.

Form of Securities Purchase Agreement, incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 19, 2025 and incorporated herein by reference.

Form of Securities Purchase Agreement, incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 25, 2025 and incorporated herein by reference.

Insider Trading Policy

List of Subsidiaries of the Registrant, filed as Exhibit 21.1 to the Registrant’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 21, 2024 and incorporated herein by reference.

Consent of Grant Thornton LLP, Independent Registered Public Accounting Firm.

5 unchanged sentences

Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

Clawback Policy

Clawback Policy, filed as Exhibit 97.1 to the Registrant’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 21, 2024 and incorporated herein by reference .

Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document.

7 unchanged sentences

(1) Filed as an exhibit to the registrant’s Current Report on Form 8-K filed with the SEC on August 1, 2022.

(2) Filed as an exhibit to the registrant’s Current Report on Form 8-K filed with the SEC on September 21, 2022.

(2) Filed as an exhibit to the registrant’s Registration Statement on Form S-1 filed with the SEC on May 31, 2022.

3 unchanged sentences

(6) Filed as an exhibit to the registrant’s Quarterly Report on Form 10-Q filed with the SEC on August 22, 2022.

(8) Filed as an exhibit to the registrant’s Current Report on Form 8-K filed with the SEC on November 22, 2022.

+ Indicates management contract or compensatory plan.

43 unchanged sentences

We have audited the accompanying consolidated balance sheets of MAIA Biotechnology, Inc.

(a Delaware corporation) and subsidiaries (the “Company”) as of December 31, 2023 and 2022, the related consolidated statements of operations, comprehensive loss, changes in stockholders’ equity, and cash flows for each of the two years in the period ended December 31, 2023, and the related notes (collectively referred to as the “financial statements”).

In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2023, in conformity with accounting principles generally accepted in the United States of America.

(a Delaware corporation) and subsidiaries (the “Company”) as of December 31, 2024 and 2023, the related consolidated statements of operations, comprehensive loss, changes in stockholders’ equity, and cash flows for each of the two years in the period ended December 31, 2024, and the related notes (collectively referred to as the “consolidated financial statements”).

In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2024, in conformity with accounting principles generally accepted in the United States of America.

Going concern

5 unchanged sentences

Basis for opinion

These financial statements are the responsibility of the Company’s management.

Our responsibility is to express an opinion on the Company’s financial statements based on our audits.

These consolidated financial statements are the responsibility of the Company’s management.

Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits.

We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S.

20 unchanged sentences

Total current assets

Deferred offering costs

LIABILITIES AND STOCKHOLDERS' EQUITY

27 unchanged sentences

General and administrative expenses

Ratchet share expense

Total operating expenses

5 unchanged sentences

Change in fair value of warrant liability

Loss on fair value of warrants over proceeds

Other income (expense) net:

Deemed dividend on warrant

Net loss attributable to MAIA

Biotechnology, Inc.

Net loss per share

2 unchanged sentences

outstanding basic and diluted

See accompanying notes to the consolidated financial statements.

See the accompanying notes to the consolidated financial statements.

MAIA Biotechnology, I nc.

4 unchanged sentences

Comprehensive loss

See accompanying notes to the consolidated financial statements.

See the accompanying notes to the consolidated financial statements.

MAIA Biote chnology, Inc.

7 unchanged sentences

Balance at December 31, 2023

Issuance of common shares upon exercise of stock options

Issuance of restricted stock

Exercise of stock options

Stock-based compensation expense

Issuance of common shares in connection with At-The-Market financing, net

of $ 428,396 of issuance costs

Issuance of common shares in connection with follow-on offering, net of

$ 1,593,016 of issuance costs

Issuance of warrants to underwriter in connection with follow-on offering

Issuance of stock options to satisfy accrued bonus

Issuance of common shares in connection with direct offering, net of

$ 702,202 of issuance costs

Issuance of common shares in connection with At-The-Market financing, net of $ 658,801 of issuance costs

Issuance of common shares in connection with the Private Placement Offerings, net of $ 136,456 of issuance costs

Issuance of warrants in connection with the Private Placement Offerings

Exercise of warrants

Reclassification of liability classified warrants to equity

Foreign currency translation adjustment

Balance at December 31, 2024

See accompanying notes to the consolidated financial statements.

See the accompanying notes to the consolidated financial statements.

MAIA Biotechnology, Inc.

8 unchanged sentences

Issuance of common shares upon exercise of stock options

Issuance of common shares upon exercise of warrants

Issuance of restricted stock

Stock-based compensation

Issuance of common shares in connection with equity

Issuance of common shares in connection with initial public

offering, net of $ 2,749,905 issuance cost

Issuance of ratchet shares

Modification of warrant in equity

Deemed dividend on modification of warrant

Issuance of common shares in connection with At-The-Market financing, net

of $ 428,396 of issuance costs

Issuance of common shares in connection with follow-on offering, net of

$ 1,593,016 of issuance costs

Issuance of warrants to underwriter in connection with follow-on offering

Issuance of stock options to satisfy accrued bonus

Issuance of common shares in connection with direct offering, net of

$ 702,202 of issuance costs

Foreign currency translation adjustment

Balance at December 31, 2023

See accompanying notes to the consolidated financial statements.

See the accompanying notes to the consolidated financial statements.

MAIA Biotechnology, Inc.

5 unchanged sentences

Stock-based compensation

Issuance of ratchet shares

Consulting expense for restricted shares issued

Change in fair value of warrant liability

Loss on fair value of warrants over proceeds

Change in operating assets and liabilities:

5 unchanged sentences

Cash flows from financing activities:

Proceeds from issuance of common stock, net of transaction costs

Deferred offering costs

Proceeds from exercise of stock options

Proceeds from exercise of warrants

Proceeds from sale of common stock in initial public offering

Payment of initial public offering transaction costs

Proceeds from sale of common stock in follow-on offering

Proceeds from direct offering

Proceeds from private placement round 1

Proceeds from private placement round 2

Proceeds from private placement round 3

Proceeds from private placement round 4

Proceeds from private placement round 5

Proceeds from At-The-Market offering

2 unchanged sentences

Net effect of foreign currency exchange on cash

Net decrease in cash

Net increase (decrease) in cash

Cash at beginning of period

1 unchanged sentence

Supplemental disclosure of cash flow information:

Previously paid issuance costs in connection with the initial public offering

Warrants issued to underwriters in connection with the initial public offering

Options issued for accrued bonus

3 unchanged sentences

Warrants issued to underwriters in connection with the direct offering

See accompanying notes to the consolidated financial statements.

Warrants issued with private placement 1 offering

Warrants issued with private placement 2 offering

Warrants issued with private placement 3 offering

Warrants issued with private placement 4 offering

Warrants issued with private placement 5 offering

See the accompanying notes to the consolidated financial statements.

MAIA Biotechnology, In c.

20 unchanged sentences

The Company is dependent on its ability to continue to raise equity and/or debt financing to continue operations, and the attainment of profitable operations.

On April 27, 2023, the Company sold 2,555,500 shares of common stock at $ 2.25 per share in an underwritten public offering.

The aggregate net proceeds of the offering were approximately $ 4.2 million, after deducting underwriting discounts and expenses.

During October and November 2023, the Company sold an aggregate of 758,388 shares of common stock pursuant to the terms of an “at-the-market" Sales Agreement.

The aggregate net proceeds of the combined sales were approximately $ 1.2 million, after deducting sales commissions.

On November 17, 2023, the Company sold an aggregate of 2,424,243 shares of common stock in a registered direct offering pursuant to securities purchase agreements.

The aggregate net proceeds from the sale were $ 1.4 million, after deducting underwriting discounts, expenses, and warrants issued as a liability of $ 1.9 million.

Going Concern Considerations

2 unchanged sentences

To date the Company has incurred recurring losses, negative cash flow from operations and has accumulated a deficit of $ 87,234,833 from the Company’s inception through December 31, 2024.

As of December 31, 2023 , the Company had $ 7,150,695 in cash and cash equivalents.

As of December 31, 2024 , the Company had $ 9,601,298 in cash.

To meet the Company’s future working capital needs, the Company will need to raise additional equity or enter into debt financing.

14 unchanged sentences

Segment Information

Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision-maker in deciding how to allocate resources and assess performance.

The Company and the Company’s chief operating decision-maker, the Company’s Chief Executive Officer, views the Company’s operations and manages its business as a single operating segment, which is the business of discovering and developing products for the treatment of immunotherapies for cancer.

Operating segments are def ined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision-maker ("CODM") in deciding how to allocate resources and assess performance.

The Company and the Company’s chief operating decision-maker, the Company’s Chief Executive Officer, view the Company’s operations and manage its business as a single operating segment, which is the business of discovering and developing products for the treatment of immunotherapies for cancer.

Management has determined that the Company operates in one segment, given the common nature of its operations.

For additional information, see Note 9 - Segment Information.

Use of Estimates

15 unchanged sentences

At December 31, 2024 and 2023 , substantially all of the Company’s cash was deposited in accounts at two financial institutions.

The Company maintains its cash deposits, which at times may exceed the federally insured limits, with a reputable financial institutions and, accordingly, the Company believes such funds are subject to minimal credit risk.

The Company maintains its cash deposits, which at times may exceed the federally insured limits of $ 250,000 per financial institution, with a reputable financial institutions.

The Company believes such funds are subject to minimal credit risk.

Cash and Cash Equivalents

5 unchanged sentences

Under this accounting guidance, fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.

As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability.

As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a

To increase the comparability of fair value measures, the following hierarchy prioritizes the inputs to valuation methodologies used to measure fair value:

12 unchanged sentences

Research and development costs are expensed as incurred.

Advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received.

Advance payments for goods and services that will be used in future research and development activities are recorded in prepaid expenses and other current assets in the consolidated balance sheets and are expensed when the activity has been performed or when the goods have been received.

As part of the process of preparing the consolidated financial statements, the Company is required to estimate its prepaid or accrued expenses.

7 unchanged sentences

There may be instances in which payments made to the Company’s vendors will exceed the level of services provided and result in a prepayment of the applicable research and development or manufacturing expense.

In accruing service fees, the Company estimates the time period over which services will be performed and

the level of effort to be expended in each period.

In accruing service fees, the Company estimates 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 its estimate, the Company adjusts the accrual or prepaid expense accordingly.

12 unchanged sentences

The assessment of the conditions surrounding the bifurcation of embedded derivatives depends on the nature of the host contract.

Bifurcated embedded derivatives are recognized at fair value, with changes in fair value recognized in the statement of operations and there were no derivative instruments for the years ended December 31, 2023 and December 31, 2022.

Bifurcated embedded derivatives are recognized at fair value, with changes in fair value recognized in the statement of operations.

The Company has warrant liabilities deemed derivative instruments.

Total warrant liabilities for the years ended December 31, 2024 and December 31, 2023 was $ 2,690,605 and $ 2,152,188 , respectively.

Stock-Based Compensation

11 unchanged sentences

The Company has not paid, and does not anticipate paying, cash dividends on shares of its Common Stock.

Prior to the offering, in order to estimate the fair value of shares of the common stock, the Company's board of directors considered, among other things, sales of common stock to third party investors and valuations of common stock, business, financial condition and results of operations, including related industry trends affecting operations;

the likelihood of achieving a liquidity event, such as an offering, or sale, given prevailing market conditions;

the lack of marketability of our common stock;

the market performance of comparable publicly traded companies;

and global economic and capital market conditions.

All stock-based compensation costs are recorded in general and administrative or research and development costs in the consolidated statements of operations based upon the underlying individual’s role at the Company.

10 unchanged sentences

When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit would more likely than not be realized assuming examination by the taxing authority.

The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances.

determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances.

The Company recognizes any interest and penalties accrued related to unrecognized tax benefits as income tax expense.

1 unchanged sentence

Deferred offering costs consists of legal, accounting, underwriting fees and other costs that are directly related to a planned follow on offering and will be charged to additional paid-in capital upon the completion of the follow on offering.

The Company had $ 211,203 costs as of December 31, 2022 and no costs as of December 31, 2023.

The Company had no offering costs as of December 31, 2024 and December 31, 2023, respectively .

Net Loss Per Share

Basic loss per share of common stock is computed by dividing net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding for the period.

Basic loss per share of Common Stock is computed by dividing net loss by the weighted average number of shares of Common Stock outstanding for the period.

Diluted net loss per share is calculated by adjusting the weighted-average number of shares outstanding for the dilutive effect of Common Stock equivalents outstanding for the period, determined using the treasury-stock method.

6 unchanged sentences

Shares issuable upon exercise of warrants

In February 2016, the FASB issued ASU No.

In February 2016, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update (" ASU") No.

2016-02 , as amended, Leases (“Topic 842”), which applies to all leases.

2 unchanged sentences

All leases with a term greater than one year are recognized on the condensed consolidated balance sheet as right-of-use assets, lease liabilities and, if applicable, long-term lease liabilities.

The Company has elected not to recognize on the consolidated balance sheet leases with terms of one-year or less if entered into.

The Company has elected not to recognize on the consolidated balance sheet leases with terms of one-year or less.

Lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected lease term.

The interest rate implicit in lease contracts is typically not readily determinable.

As such, the Company utilizes the appropriate incremental borrowing rate, which is the rate incurred to borrow

on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment.

As such, the Company utilizes the appropriate incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment.

Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or incentives received.

At the inception of an arrangement the Company determines whether the arrangement is or contains a lease based on the circumstances present.

Currently none of the Company’s operating lease commitments are subject to the new standard as its leases are short-term in nature (i.e., less than twelve months).

Currently none of the Company’s operating lease commitments are subject to the standard as its leases are short-term in nature (i.e., less than twelve months).

Recent Accounting Standards

In June 2016, the FASB issued ASU No.

2016-13, Financial Instruments - Credit Losses (Topic 326):

Measurement of Credit Losses on Financial Instruments.

Subsequently, in November 2018, the FASB issued ASU 2018-19, Codification Improvements to Topic 326, Financial Instruments-Credit Losses.

ASU 2016-13 requires entities to measure all expected credit losses for most financial assets held at the reporting date based on an expected loss model which includes historical experience, current conditions, and reasonable and supportable forecasts.

ASU 2016-13 also requires enhanced disclosures to help financial statement users better understand significant estimates and judgments used in estimating credit losses.

This ASU is effective for smaller reporting companies for fiscal years beginning after December 15, 2022, with early adoption permitted.

The adoption of this guidance had no impact on our financial statements and disclosures.

In November 2023, the FASB issued ASU No.

2023-07, Segment Reporting – Improvements to Reportable Segment Disclosures, which provides updates to qualitative and quantitative reportable segment disclosure requirements, including enhanced disclosures about significant segment expenses and increased interim disclosure requirements, among others.

2023-07 is effective for fiscal years beginning after December 15, 2023, and interim periods in fiscal years beginning after December 15, 2024.

Early adoption is permitted, and the amendments should be applied retrospectively.

We do not expect the amendments in this ASU to have a material impact on our consolidated financial statements.

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280):

Improvements to Reportable Segment Disclosures to improve the disclosures about reportable segments and include more detailed information about a reportable segment’s expenses.

ASU 2023-07 also requires that a public entity with a single reportable segment provide all of the disclosures required as part of the amendments and all existing disclosures required by Topic 280.

The ASU should be applied retrospectively to all prior periods presented in the financial statements and is effective for fiscal years beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15, 2024.

The adoption did not have an impact on the Company’s financial condition or results of operations.

See Note 9 - Segment Information.

In December 2023, the FASB issued ASU No.

3 unchanged sentences

We do not expect the amendments in this ASU to have a material impact on our consolidated financial statements.

In March 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses, which requires detailed disclosure of significant expense components and additional clarity when expenses are classified by function.

2024-03 is effective for fiscal years beginning after December 15, 2026 and allows for adoption on a prospective basis, with a retrospective option.

Early adoption is permitted.

We do not expect the amendments in this ASU to have a material impact on our consolidated financial statements.

From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and are adopted by the Company as of the specified effective date.

2 unchanged sentences

Consulting Services

Radu Vitoc, a shareholder and brother of the CEO, provided consulting services to the Company through July 2022 for which the Company incurred $ 39,900 for such services.

The Company paid Mr.

Vitoc $ 19,950 in cash and issued him options to purchase 4,690 shares of common stock with a total fair value of $ 19,950 .

In August 2022, Mr.

Vitoc became an employee of the Company.

The consulting firm FGMK, LLC and its affiliate FGMK Business Holdings, LLC beneficially owned more than 5 % of the stock of the Company and is therefore a related party.

On November 13, 2024, the Company expensed $ 67,990 related to the grant of 28,448 restricted shares of Common Stock for payment of their accounting, tax and valuation services.

In addition, FGMK Business Holdings, LLC participated in the December 2024 private placement and purchased 243,470 shares of the Company's Common Stock and warrants to purchase 243,470 shares of the Company's Common Stock for an aggregate purchase price of approximately $ 550,000 .

Certain of our directors and executive officers previously adopted written plans, known as Rule 10b5-1 plans, in which they contracted with a broker to buy shares of our Common Stock on a periodic basis.

Each of these plans have expired as of the date of the accompanying consolidated financial statements.

Our directors and executive officers may, in the future, adopt Rule 10b5-1 plans in which they contract with a broker to buy or sell shares of our Common Stock on a periodic basis.

Under a Rule 10b5-1 plan, a broker executes trades pursuant to parameters established by the director or officer at the time was entered into, without further direction from the director or officer.

The director or officer may amend or terminate the plan in limited circumstances.

Our directors and executive officers may also buy or sell additional shares of our Common Stock outside of a Rule 10b5-1 plan when they are not in possession of material nonpublic information.

Private Placement

The following Company directors participated in the March 2024 private placement as follows:

(i) Stan Smith purchased 170,940 shares of our Common Stock and warrants to purchase up to 170,940 shares of our Common Stock for an aggregate purchase price of approximately $ 200,000 ;

(ii) Louie Ngar Yee purchased 170,940 shares of our Common Stock and warrants to purchase up to 170,940 shares of our Common Stock for an aggregate purchase price of approximately $ 200,000 ;

(iii) Cristian Luput purchased 69,282 shares of our Common Stock and warrants to purchase up to 69,282 shares of our Common Stock for an aggregate purchase price of approximately $ 81,060 ;

(iv) Steven Chaouki purchased 34,641 shares of our Common Stock and warrants to purchase up to 34,641 shares of our Common Stock for an aggregate purchase price of approximately $ 40,530 ;

and (v) Ramiro Guerrero purchased 6,928 shares of our Common Stock and warrants to purchase up to 6,928 shares of our Common Stock for an aggregate purchase price of approximately $ 8,106 .

The following Company directors participated in the April 2024 private placement as follows:

(i) Stan Smith purchased 147,492 shares of our Common Stock and warrants to purchase up to 147,492 shares of our Common Stock for an aggregate purchase price of approximately $ 300,000 ;

and (ii) Louie Ngar Yee purchased 19,665 shares of our Common Stock and warrants to purchase up to 19,665 shares of our Common Stock for an aggregate purchase price of approximately $ 40,000 .

The following Company directors participated in the November 2024 private placement as follows:

(i) Stan Smith purchased 100,000 shares of our Common Stock and warrants to purchase up to 100,000 shares of our Common Stock for an aggregate purchase price of approximately $ 225,900 ;

(ii) Ramiro Guerrero purchased 88,534 shares of our Common Stock and warrants to purchase up to 88,534 shares of our Common Stock for an aggregate purchase price of approximately $ 200,000 ;

(iii) Cristian Luput purchased 22,133 shares of our Common Stock and warrants to purchase up to 22,133 shares of our Common Stock for an aggregate purchase price of approximately $ 50,000 ;

and (iv) Steven Chaouki purchased 22,133 shares of our Common Stock and warrants to purchase up to 22,133 shares of our Common Stock 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 5 % stockholder FGMK Business Holdings, LLC purchased 243,470 shares and 243,470 warrants for a purchase price of approximately $ 550,000 .

The following Company directors participated in the December 2024 private placement as follows:

(i) Stan Smith purchased 25,000 shares of our Common Stock and warrants to purchase up to 25,000 shares of our Common Stock for an aggregate purchase price of approximately $ 46,800 ;

and (ii) Ramiro Guerrero purchased 54,518 shares of our Common Stock and warrants to purchase up to 53,418 shares of our Common Stock 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 .

ACCRUED EXPENSES

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During the years ended December 31, 2024 and 2023 , the Company accrued $ 941,098 and $ 786,999 , respectively, in bonus expense relating to employees and officers of the Company.

On May 31, 2023, the 2022 accrued bonus balance was settled by issuance of 974,046 stock options with a total fair value of $ 977,123 .

The fair value of the options issued was less than the accrued bonus balance by $ 117,459 due to payroll taxes accrued for related to the 2022 bonuses and not payable with the issuance of the stock options and for employees who were terminated after December 31, 2022 and not eligible for the bonus payout.

This difference was recorded against payroll expense and is presented within general and administrative expenses and research and development expenses on the statement of operations for the year ended December 31, 2023.

In April 2024, the Compensation Committee determined that bonuses relating to 2023 would not be paid to all executive and non-executive employees.

This change in estimated bonuses was recorded against the same general ledger accounts that the original estimate was recorded to and is reflected within the general and administrative expenses and research and development expenses on the statement of operations for the year ended December 31, 2024.

Accrued Severance

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Obrocea’s terminations were not based on any disagreement with the Company’s operations, policies or practices.

As of December 31, 2023, the Company has accrued severance balance of $ 824,435 .

The accrued severance included in accrued expense was $ 824,435 as of December 31 ,2023.

The accrued severance was paid in 2024.

There was no accrued severance as of December 31, 2024 .

FAIR VALUE OF FINANCIAL LIABILITIES

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Issuance of warrants

Gain on fair value of warrant liability

Exercise of warrants

Amendment of warrants

Loss (gain) on fair value of warrant liability

Balance, end of period

STOCKHOLDERS’ EQUITY

Upon the closing of the Company’s initial public offering, the Company’s shareholders agreement terminated pursuant to its terms.

In connection with the closing of the Company’s initial public offering, the Company amended and restated its Amended and Restated Certificate of Incorporation (the “Amended and Restated Certificate of Incorporation”) and amended and restated its Bylaws (the “Amended and Restated Bylaws”).

The Amended and Restated Certificate of Incorporation was filed with the Secretary of State of the State of Delaware on August 1, 2022 and became effective on that date, and among other things, increased the authorized number of common stock to 70,000,000 shares and decreased the authorized number of preferred stock to 30,000,000 shares.

Sales of MAIA Common Stock

During January and February 2022, the Company sold 263,729 shares of common stock at $ 9.00 per share for gross proceeds of $ 2,373,561 with no transaction costs.

During May 2022, the Company sold 11,111 shares of common stock at $ 9 per share for gross proceeds of $ 99,999 with no transaction costs.

The Company issued these shareholders additional shares upon the closing of the Company's initial public offering such that the $ 9.00 price per share they paid was equal to the price per share in the Company's initial public offering of $ 5.00 .

The number of ratchet shares were calculated using the $ 5.00 per share price in the Company's initial public offering and 219,872 shares of common stock were issued on August 1, 2022 to the investors in the recent private rounds.

The ratchet shares were determined to be a freestanding instrument that was classified as a liability when the right was granted and subsequently reclassified to equity when shares were issued.

The ratchet shares were valued at $ 1,099,360 , based on the $ 5.00 price of the initial public offering and were recorded as expense included in operating expenses.

Initial Public Offering

On July 28, 2022 the Company’s shares of common stock began trading on the NYSE American under the symbol MAIA.

On August 1, 2022, the Company sold 2,000,000 shares of common stock at $ 5.00 per share for gross proceeds of $ 10,000,000 in an initial public offering prior to deducting underwriting discounts, commissions, and other offering expenses.

On August 3, 2022, the Company sold an additional 300,000 shares of common stock at $ 5.00 per share when the underwriter exercised the overallotment for gross proceeds of $ 1,500,000 prior to deducting underwriting discounts, commissions, and other offering expenses.

After deducting the underwriting discount and other offering expenses payable by the Company, the total net proceeds for the initial public offering and the overallotment were approximately $ 9,100,000 .

Follow-on Offering

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The total net proceeds of $ 4,156,859 after deducting underwriting discounts and other offering expenses payable by the Company.

At-the-Market Equity Offering

At-the-Market Equity Offering (ThinkEquity)

On September 1, 2023, the Company entered into an “at-the-market" Sales Agreement (the “Sales Agreement”) with ThinkEquity LLC (the “Sales Agent”), pursuant to which the Company may offer and sell, from time to time, through the Sales Agent, shares (the “Shares”) of the Company’s Common Stock, par value $ 0.0001 per share (the “Common Stock”), having an aggregate offering price of up to $ 7,000,000 , subject to the terms and conditions of the Sales Agreement.

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Of the $ 3.4 million, $ 2.0 million was allocated and classified as warrant liability.

At-the-Market Offering (H.C.

On February 14, 2024, the Comany entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C.

Wainwright & Co., LLC (“Wainwright”), to sell shares of its Common Stock having an aggregate sales price of up to $ 1,445,000 , from time to time, through an “at-the-market offering” program under which Wainwright will act as sales agent.

Effective March 25, 2024, the Company filed a prospectus supplement to amend, supplement and supersede certain information contained in the earlier prospectus and prospectus supplement, which increased the number of shares of Common Stock the Company may offer and sell under the ATM Agreement to an aggregate offering price of up to $ 4,950,000 from time to time.

Effective May 15, 2024, the Company filed a prospectus supplement to amend, supplement and supersede certain information contained in the earlier prospectus and prospectus supplement, which increased the number of Shares the Company may offer and sell under the ATM Agreement to an aggregate offering price of up to $ 11,280,000 from time to time.

Effective December 23, 2024, the Company filed a prospectus supplement to amend, supplement and supersede certain information contained in the earlier prospectus and prospectus supplement, which increased the number of Shares the Company may offer and sell under the ATM Agreement to an aggregate offering price of up

to $ 30,000,000 from time to time.

As of the date of this Annual Report, the Company has sold 3,940,683 shares of its Common Stock under the ATM Agreement at an average price of $ 2.95 per share, resulting in aggregate gross proceeds of approximately $ 11,633,086 , for which we paid Wainwright $ 348,993 in commissions resulting in net proceeds to us of approximately $ 11,284,093 .

Private Placements

On March 14, 2024, the Company issued and sold 2,496,318 shares of our Common Stock and warrants to purchase 2,496,318 shares of its 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 the Company's directors participating in the March 14, 2024 private placement were issued pursuant to the MAIA 2021 Plan.

On March 28, 2024, the Company issued and sold 578,643 shares of our Common Stock and warrants to purchase 578,643 shares of its 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, the Company issued and sold 494,096 shares of its 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 the Company's directors participating in the April 25, 2024 private placement were issued pursuant to the MAIA 2021 Plan.

On November 1, 2024, the Company issued and sold 1,079,784 shares of its 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 the Company's directors participating in the November 1, 2024 private placement were issued pursuant to the MAIA 2021 Plan.

On December 13, 2024, the Company issued and sold 507,364 shares of its 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 the Company's directors participating in the December 13, 2024 private placement were issued pursuant to the MAIA 2021 Plan.

MAIA Biotechnology, Inc.

Restricted Stock Awards

During the year ended December 31, 2022, MAIA recognized $ 52,500 of stock compensation related to 29,168 of MAIA’s restricted shares granted to the founders.

During the year ended December 31, 2023, the Company expensed $ 731,661 for investor and media relation services related to the grant of 291,469 restricted shares of Common Stock.

There are no unvested restricted shares as of December 31, 2023.

During the year ended December 31, 2024, the Company expensed $ 179,490 for investor services and accounting, tax and valuation services related to the grant of 75,550 restricted shares of Common Stock.

There are no unvested restricted shares as of December 31, 2024.

MAIA Stock Warrants

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or (b) immediately prior to the closing of a change of control.

The value of the warrant modification to the 144,497 warrants was calculated using the Black-Scholes-Merton option pricing model.

The value of the warrant

modification to the 144,497 warrants was calculated using the Black-Scholes-Merton option pricing model.

The incremental fair value attributable to the modified awards compared to the original awards immediately prior to the modification was calculated at $ 450,578 and was treated as a deemed dividend and is reflected as “Deemed dividend on warrant modification” in the accompanying statement of operations.

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The warrants are liability classified instruments and were initially recorded as $ 343,735 , which was the value determined using the Black-Scholes-Merton method using a term of five years , risk free interest rate of 2.82 % and volatility of 77.5 %.

As of December 31, 2023 the Company remeasured the warrant liability resulting in a value of $ 40,211 .

The loss on remeasurement of the warrant liability in the amount of $ 205,130 was included in other (expense) income.

As of December 31, 2024 and December 31, 2023 the Company remeasured the warrant liability resulting in a value of $ 71,672 and $ 40,211 , respectively.

The loss on remeasurement of the warrant liability in the amount of $ 31,461 and $ 205,130 was included in other (expense) income for the years ended December 31, 2024 and December 31, 2023, respectively.

Concurrently with the closing of the Company’s follow-on offering, the Company issued warrants to purchase an aggregate of up to 127,775 shares of its Common Stock to the Representative or its designees, at an exercise price of $ 2.81 per share (the “Follow-On Representative’s Warrants”).

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The Follow-On Representative’s Warrants are equity classified instruments and the value of the Follow-On Representative’s Warrants determined using the Black-Scholes-Merton method was $ 241,109 using the term of five years , risk free interest rate of 4.09 % and volatility of 86.3 %.

During 2024, 116,532 warrants were exercised on various dates in cashless exercises and the investors were issued 22,869 shares of Common Stock.

As of December 31, 2024, there are 11,243 warrants exercisable through April 24, 2028.

On November 9, 2023, the Company issued warrants to purchase an aggregate of up to 239,234 shares of its Common Stock to Alumni Capital LP, at an exercise price of $ 2.09 per share.

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acted as the financial advisor to the Company in connection with the warrant and were paid a cash fee of $ 13,750 .

Concurrently with the Company’s registered direct offering, the Company issued warrants to purchase an aggregate of up to 2,424,243 shares of its common stock to the Representative or its designees, at an exercise price of $ 1.86 per share (the “Representative’s Warrants”).

The Representative’s Warrants are exercisable beginning on November 15, 2023 , and expire on May 17, 2029 , pursuant to the terms and conditions of the Representative’s Warrants.

The warrants were exercised on May 22, 2024 in a cashless exercise and Alumni was issued 54,976 shares of Common Stock.

The Company remeasured the warrant liability at the time of the exercise resulting in a value of $ 375,705 .

The loss on remeasurement of the warrant liability in the amount of $ 291,454 and $ 0 was included in other (expense) income for the years ended December 31, 2024 and December 31, 2023, respectively.

On November 17, 2023, the Company issued warrants concurrently with the Company’s registered direct offering to purchase an aggregate of up to 2,424,243 shares of its Common Stock to the investors in a registered direct offering at an exercise price of $ 1.86 per share (subject to customary adjustments set forth in the warrants).

The warrants are exercisable six months following issuance and have a term of five years from the initial exercise date.

The warrants contain customary anti-dilution adjustments to the exercise price, including share splits, share dividends, rights offerings and pro rata distributions.

The warrants are not indexed to the Company’s own stock and therefore meet the definition of a derivative liability.

The warrants are liability classified instruments and were initially recorded as $ 1,903,915 , which was the value determined using the Black-Scholes-Merton method using a term of 5.38 years, risk free interest rate of 3.85 % and volatility of 90.0 %.

On November 15, 2023, concurrently with the closing of the offering, the Company issued warrants to purchase an aggregate of 169,697 shares of its common stock to the Representative or its designees, at an exercise price of $ 2.06 per share.

The Representative’s Warrants are exercisable beginning November 15, 2023 , and expire on November 15, 2028 , pursuant to the terms and conditions of the Representative’s Warrants.

The warrants are not indexed to the Company’s own stock and therefore meet the definition of a derivative liability.

The warrants are liability classified instruments and were initially recorded as $ 123,811 ,

In 2024, 909,091 warrants were exercised on various dates in cashless exercises and the investor was issued 458,726 shares of Common Stock.

The Company remeasured the warrant liability of the exercised warrants at the time of exercise resulting in a value of $ 2,815,970 .

The loss on remeasurement of the warrant liability $ 3,101,533 and $ 0 was included in other (expense) income for the years ended December 31, 2024 and December 31, 2023, respectively.

On November 17, 2023, concurrently with the closing of the Company’s registered direct offering, the Company issued warrants to purchase an aggregate of 169,697 shares of its Common Stock to the Representative or its designees, at an exercise price of $ 2.06 per share.

These representative’s warrants were exercisable beginning November 15, 2023 , and expire on November 15, 2028 , pursuant to their terms and conditions.

The representative’s warrants are not indexed to the Company’s own stock and therefore meet the definition of a derivative liability.

The representative’s warrants are liability classified instruments and were initially recorded as

$ 123,811 , which was determined using the Black-Scholes-Merton method using a term of 4.88 years, risk free interest rate of 3.84 % and volatility of 90.0 %.

As of December 31, 2024 and December 31, 2023, the Company remeasured the warrant liability resulting in a value of $ 230,038 and $ 123,811 , respectively.

The loss on remeasurement of the warrant liability in the amount of $ 106,227 and $ 0 is included in other (expense) income for the years ended December 31, 2024 and December 31, 2023, respectively.

Concurrently with the closing of the Company’s private placement on March 14, 2024, the Company issued warrants to purchase an aggregate of up to 2,496,318 shares of its Common Stock to the investors in the private placement, at an exercise price of $ 1.30 per share are exercisable beginning on September 14, 2024 , and expire on September 14, 2029 .

The warrants issued were divided into two groups:

warrants issued to directors and warrants issued to non-affiliated investors.

The warrants to purchase 452,731 shares of the Company’s Common Stock issued to directors were deemed options issued under the MAIA 2021 Plan and are equity classified instruments, and the value of these warrants determined using the Black-Scholes-Merton method was $ 230,685 using a term of 5.5 years, risk free interest rate of 4.20 % and volatility of 95 %.

The warrants to purchase 2,043,587 share of the Company’s Common Stock issued to non-affiliated investors were not indexed to the Company’s own stock and therefore met the definition of a derivative liability.

The warrants issued to non-affiliated investors were liability classified instruments when issued and were initially recorded at a value of $ 2,049,600 , which was determined using the Black-Scholes-Merton method using a term of 5.5 years, risk free interest rate of 4.20 % and volatility of 95.0 %.

In May 2024, the Company amended the warrant agreements to adjust them to be indexed to the Company’s own stock, and they were therefore reclassed to equity classified instruments in a non-cash transaction.

When the warrant agreements were amended, the Company remeasured the warrant liability resulting in a final warrant value of $ 5,089,063 .

The warrant liability for these warrants was removed and equity was increased by $ 5,089,063 to account for the equity classification.

The loss on the remeasurement of the warrant liability in the amount of $ 3,039,463 and $ 0 is included in other (expense) income for the years ended December 31, 2024 and December 31, 2023, respectively.

Concurrently with the closing of the Company’s private placement offering on March 28, 2024, the Company issued warrants to purchase an aggregate of up to 578,643 shares of its Common Stock to the investors in the private placement at an exercise price of $ 2.55 per share.

The warrants are exercisable beginning on September 28, 2024 , and expire on September 28, 2029 .

The warrants were not indexed to the Company’s own stock and therefore meet the definition of a derivative liability.

The warrants were liability classified instruments when issued and were initially recorded at a value of $ 1,190,111 , which was determined using the Black-Scholes-Merton method using a term of 5.5 years, risk free interest rate of 4.20 % and volatility of 95.0 %.

In May 2024, the Company amended the warrant agreements related to 437,031 warrants to adjust them to be indexed to the Company’s own stock, and they were therefore reclassed to equity classified instruments in a non-cash transaction.

When the warrants agreements were amended, the Company remeasured the warrant liability resulting in a final warrant value of $ 1,011,562 .

The warrant liability for these 437,031 warrants was removed and equity was increased by $ 1,011,562 to account for the equity classification.

The loss on the remeasurement of the warrant liability in the amount of $ 112,708 and $ 0 is included in other (expense) income for the years ended December 31, 2024 and December 31, 2023, respectively.

The remaining 141,612 warrants remain liability classified instruments.

As of December 31, 2024 and December 31, 2023, the Company remeasured the warrant liability, resulting in a value of $ 199,417 and $ 0 , respectively.

The gain on remeasurement of the warrant liability in the amount of $ 91,840 and $ 0 is included in other (expense) income for the years ended December 31, 2024 and December 31, 2023, respectively.

Concurrently with the closing of the Company’s private placement offering on April 25, 2024, the Company issued warrants to purchase an aggregate of up to 494,096 shares of its Common Stock to the investors in the private placement at an exercise price of $ 2.26 per share.

The warrants are exercisable beginning on October 25, 2024 , and expire on October 25, 2029 .

The warrants issued were divided into two groups:

warrants issued to directors and warrants issued to non-affiliated investors.

The warrants to purchase 167,157 shares of the Company’s Common Stock issued to directors were deemed options issued under the MAIA 2021 Plan (as defined below) and are equity classified instruments and the value of these warrants determined using the Black-Scholes-Merton method was $ 346,606 using a term of 5.5 years, risk free interest rate of 4.70 % and volatility of 95 %.

The warrants to purchase 326,939 shares of the Company’s Common Stock issued to non-affiliated investors were not indexed to the Company’s own stock and therefore met the definition of a derivative liability.

The warrants were liability classified instruments when issued and were initially recorded at a value of $ 677,919 , which was determined using the Black-Scholes-Merton method using a term of 5.5 years, risk free interest rate of 4.70 % and volatility of 95.0 %.

In May 2024, the Company amended these warrant agreements to adjust them to be indexed to the Company’s own stock, and they were therefore reclassed to equity classified instruments in a non-cash transaction.

When the warrant agreements were amended, the Company remeasured the warrant liability resulting in a final warrant value of $ 769,671 .

The warrant liability for these warrants were removed and equity was increased by $ 769,671 to account for the equity classification.

The loss on the remeasurement of the warrant liability in the amount of $ 91,572 and $ 0 is included in other (expense) income for the years ended December 31, 2024 and December 31, 2023, respectively.

Concurrently with the closing of the Company’s private placement offering on November 1, 2024, the Company issued warrants to purchase an aggregate of up to 1,079,784 shares of its Common Stock to the investors in the private placement at an exercise price of $ 2.51 per share.

The warrants are exercisable beginning on May 1, 2025 , and expire on May 1, 2030 .

The warrants issued were divided into two groups:

warrants issued to directors and warrants issued to non-affiliated investors.

The warrants to purchase 232,800 shares of the Company’s Common Stock issued to directors were deemed options issued under the MAIA 2021 Plan (as defined below) and are equity classified instruments and the value of these warrants determined using the Black-Scholes-Merton method was $ 494,851 using a term of 5.5 years, risk free interest rate of 4.22 % and volatility of 95 %.

The warrants to purchase 846,984 shares of the Company’s Common Stock issued to non-affiliated investors are indexed to the Company’s own stock, and they

were therefore equity classified instruments and the value of these warrants determined using the Black-Scholes-Merton method was $ 1,800,389 using a term of 5.5 years, risk free interest rate of 4.22 % and volatility of 95 %.

Concurrently with the closing of the Company’s private placement offering on December 13, 2024, the Company issued warrants to purchase an aggregate of up to 507,364 shares of its Common Stock to the investors in the private placement at an exercise price of $ 2.08 per share.

The warrants are exercisable beginning on June 13, 2025 , and expire on June 13, 2030 .

The warrants issued were divided into two groups:

warrants issued to directors and warrants issued to non-affiliated investors.

The warrants to purchase 78,418 shares of the Company’s Common Stock issued to directors were deemed options issued under the MAIA 2021 Plan (as defined below) and are equity classified instruments and the value of these warrants determined using the Black-Scholes-Merton method was $ 116,151 using a term of 5.5 years, risk free interest rate of 4.25 % and volatility of 95 %.

The warrants to purchase 428,946 shares of the Company’s Common Stock issued to non-affiliated investors are indexed to the Company’s own stock and they were therefore equity classified instruments and the value of these warrants determined using the Black-Scholes-Merton method was $ 635,345 using a term of 5.5 years, risk free interest rate of 4.25 % and volatility of 95 %.

Balance at January 1, 2024

Balance at December 31, 2024

The value of the warrants are calculated using the Black-Scholes-Merton option pricing model with the following assumptions for warrants granted during the years ended December 31, 2023 and 2022:

Balance at January 1, 2023

Balance at December 31, 2023

The Company's warrant liability, which relates to warrants to purchase shares of common stock, is measured at fair value at each reporting period and changes in fair value are recorded in other income (expense) within the statement of operations until the warrants are exercised, expire, or are reclassified to stockholders' equity.

The weighted-average fair values of warrants issued during the years ended December 31, 2024 and 2023 were $ 1.87 and $ 1.93 , respectively.

The warrants vested as of December 31, 2024 and 2023 were 5,442,246 and 3,650,278 , respectively.

Risk-free interest rate

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2021 Equity Incentive Plan (the “MAIA 2021 Plan’’) with 1,909,518 shares of Common Stock reserved for issuance.

On May 25, 2023, after receiving shareholder approval, the MAIA 2021 Plan was amended to include an automatic increase in the aggregate number of shares reserved for awards under the 2021 Plan, commencing on the date of shareholder approval of the amendment, and then each January 1 following thereafter, and ending on (and including) January 1, 2032 (each an “Increase Date”) in an amount equal to ten percent ( 10 %) of the total number of shares of stock outstanding on a fully diluted basis on December 31 of the preceding calendar year (the “Increase Date”);

On May 25, 2023, the MAIA 2021 Plan was amended to include an automatic increase to the plan in an amount equal to ten percent ( 10 %) of the total number of shares of stock outstanding on a fully diluted basis on December 31 of the preceding calendar year (the “Increase Date”);

provided that, the board of directors may act prior to any Increase Date to provide that there will be no increase for such year or that the increase for such year will be a lesser number of shares of stock.

Pursuant to the automatic increase provision, on May 25, 2023, the amount reserved for issuance under the MAIA 2021 Plan increased by 1,956,993 based on the fully diluted shares outstanding as of December 31, 2022.

Pursuant to the automatic increase provision, on April 23, 2024, the amount reserved for issuance under the MAIA 2021 Plan increased by 2,838,668 based on the fully diluted shares outstanding as of December 31, 2023.

As of December 31, 2024, there were 1,790,744 shares of Common Stock available for future issuance under the MAIA 2021 Plan and 4,492,491 options outstanding in the MAIA 2021 Plan.

In addition, pursuant to the automatic increase provision, on January 1, 2024, the amount reserved for issuance under the MAIA 2021 Plan increased by 2,838,668 shares based on the fully diluted shares outstanding as of December 31, 2023.

On December 31, 2024, the Company’s board of directors increased the amount of shares available under the 2021 Plan by 2,250,000 shares effective January 1, 2025 pursuant to the annual increase provision, based on the fully diluted shares outstanding as of December 31, 2024 (and the discretion of the board to authorize less than 10 % of such amount).

Stock options are to be granted with an exercise price which is at least equal to the stock’s estimated fair value at the date of grant, and with a contractual term of no more than ten years from the date of grant.

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Options exercisable at December 31, 2024

During the year ended December 31, 2023, the fair value of the Company’s common stock is based on the closing price of the common stock in the public market.

During the year ended December 31, 2022, the fair value of the Company’s common stock was estimated for financial reporting purposes from January 1 to January 26, 2022 based on valuations of $ 8.87 per share as of December 31, 2022 .

For our valuations of common stock performed, we used a hybrid method of the Option Pricing Method (“OPM”) and the Probability-Weighted Expected Return Method (“PWERM”).

PWERM considers various potential liquidity outcomes.

Our approach included the use of an initial public offering scenario, a scenario assuming continued operation as a private entity, and a dissolution scenario.

Under the hybrid OPM and PWERM, the per share values calculated under the OPM and PWERM are weighted based on expected exit outcomes and the quality of the information specific to each allocation methodology to arrive at a final estimated fair value per share

of the common stock before a discount for lack of marketability is applied.

From January 27 to May 31, 2022 the fair value of the Company’s common stock was estimated for financial reporting purposes at $ 9 per share based on the sale of common stock from January 27, 2022 to May 19, 2022.

From June 1, 2022 to August 1, 2022 the fair value of the Company's common stock was estimated for financial reporting purpose at $ 5 per share based on the price paid in the initial public offering.

Following the initial public offering, the fair value of common stock, is based on the closing price of the common stock in the public market.

The value of option grants are calculated using the Black-Scholes-Merton option pricing model with the following assumptions for options granted during the years ended December 31, 2024 and 2023.

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Expected dividend yield

The weighted-average grant date fair values of stock options issued during the years ended December 31, 2023 and 2022 w ere $ 2.55 and $ 3.75 , respectively.

As of December 31, 2023 , the total unrecognized compensation related to unvested employee and non-employee stock option awards granted was $ 1,790,683 which the Company expects to recognize over a weighted average period of approximately 2.98 years.

The weighted-average fair values of stock options issued during the years ended December 31, 2024 and 2023 w ere $ 2.41 and $ 2.55 , respectively.

As of December 31, 2024 , the total unrecognized compensation related to unvested employee and non-employee stock

option awards granted was $ 2,667,623 which the Company expects to recognize over a weighted average period of approximately 2.20 years.

Stock based compensation related to the Company’s stock plans are as follows:

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The Company will also pay UTSW running royalties on a yearly basis as a percentage of Net Sales of the Company or its sublicensee.

There are single digit royalty rates for licensed products and licensed services covered by a Valid Claim (as defined in the agreement) and dependent on whether Net Sales are greater than or less than/equal to $1,000,000,000, with Net Sales above that amount commanding a slightly higher percentage.

There are single digit royalty rates for licensed products and licensed services covered by a Valid Claim (as defined in the agreement)

and dependent on whether Net Sales are greater than or less than/equal to $1,000,000,000, with Net Sales above that amount commanding a slightly higher percentage.

In each case, the royalty percentage is lower before patent issuance in each jurisdiction.

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("Regeneron") to perform one clinical trial for the treatment of patients with Non-Small Cell Lung Cancer (NSCLC) involving a Regeneron drug candidate that utilizes one of the Company's compounds/agents.

The Company is responsible for all costs of the study with Regeneron supplying their drug cemiplimab representing a cost savings for the Company, the first phase of which is expected to take approximately two years.

The Company is responsible for all costs of the study with Regeneron supplying their drug cemiplimab representing a cost savings for the Company.

The overall term of the agreement is for five years unless earlier terminated for certain reasons as defined in the agreement.

Either party may terminate a study plan in the event that patient screening for the clinical study does not commence within twelve (12) months after (a) the Effective Date, with respect to the initial study, or (b) the execution of the applicable study plan, with respect to each other study.

If either party terminates a study plan, the Company shall reimburse Regeneron for the Regeneron product it

received in connection with such study plan based on the actual out-of-pocket cost to Regeneron of such Regeneron product.

If either party terminates a study plan, the Company shall reimburse Regeneron for the Regeneron product it received in connection with such study plan based on the actual out-of-pocket cost to Regeneron of such Regeneron product.

The THIO-101 study protocol was amended in December 2024 to increase the number of patients enrolled in an expansion arm to further evaluate efficacy of the treatment in third-line NSCLC patients resistant to checkpoint inhibitor and chemotherapy.

As of December 31, 2024 neither party has terminated the agreement.

BeiGene - In December 2024, the Company reached an agreement with BeiGene Swizerland GmbH, ("BeiGene") to perform certain clinical trials for the treatment of patients with small cell lung cancer (SCLC), liver cancer (HCC), and colorectal cancer (CRC) involving a BeiGene drug candidate that utilizes one of the Company's compounds/agents.

The Company is responsible for all costs of the study with BeiGene supplying their drug tislelizumab representing a cost savings for the Company.

The overall term of the agreement is for seven years unless earlier terminated for certain reasons as defined in the agreement.

As of December 31, 2024 neither party has terminated the agreement.

The Company's net deferred tax assets consist of the following components:

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The Company has unused U.S.

federal research and experimentation (“R & E”) tax credits of $ 0.5 million that begin to expire in 2041 .

The use of the Company’s NOL and R & E credit carryforwards may, however, be subject to limitations as a result of an ownership change.

federal research and development (“R & D”) tax credits of $ 0.5 million that begin to expire in 2041 .

The use of the Company’s NOL and R & D credit carryforwards may, however, be subject to limitations as a result of an ownership change.

A corporation undergoes an “ownership change,” in general, if a greater than 50% change (by value) in its equity ownership by one or more five‑percent stockholders (or certain groups of non-five-percent stockholders) over a three-year period occurs.

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federal and taxable income would be subject to these limitations, which could potentially result in increased future tax liability compared to the tax liability the Company would incur if its use of NOL carryforwards were not so limited.

In addition, for state income, franchise and similar tax purposes, there may be periods during which the use of NOL carryforwards is suspended or otherwise limited, which could accelerate or permanently increase the Company’s state income, franchise, or similar taxes.

In addition, for

state income, franchise and similar tax purposes, there may be periods during which the use of NOL carryforwards is suspended or otherwise limited, which could accelerate or permanently increase the Company’s state income, franchise, or similar taxes.

In accordance with ASC 740, “Income Taxes,” the Company recorded a valuation allowance to fully offset its deferred tax assets, because it is not more likely than not that the Company will realize future benefits associated with these deferred tax assets at December 31, 2024 and 2023 .The valuation allowance increased by approximately $ 4.8 million and $ 4.1 million during the years ended December 31, 2024 and 2023, respectively, mainly due to increases in the NOL carryforward and other deferred tax assets.

The Company will continue to assess the realizability of the deferred tax assets at each interim and annual balance sheet date based upon actual and forecasted operating results.

The Company incurred a pretax book loss of approximately $ 19.8 million for the year ended December 31, 2023, which consisted of a U.S.

loss of approximately $ 19.6 million and a foreign loss of approximately $ 0.2 million.

The Company incurred a pretax book loss of approximately $ 15.8 million for the year ended December 31, 2022, which consisted of a U.S.

loss of approximately $ 15.3 million and a foreign loss of approximately $ 0.5 million.

The Company incurred a pretax book loss of approximately $ 23.3 million for the year ended December 31, 2024 , and approximately $ 19.8 million for the year ended December 31, 2023.

No provision or benefit for U.S.

federal, state, or foreign income taxes has been recorded for the years ended December 31, 2023 and 2022, mainly due to net losses incurred by the Company in all jurisdictions other than Romania, which provides for a tax exemption.

federal, state, or foreign income taxes has been recorded for the years ended December 31, 2024 and 2023, mainly due to net losses incurred by the Company.

A provision of approximately $ 2 thousand for Romanian income tax was recorded for the year ended December 31, 2024.

No provision for Romanian income tax was recorded for the year ended December 31, 2023, due to a tax exemption.

The income tax benefit differs from the benefit that would result from applying federal statutory rates to loss before income taxes as follows:

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Stock-based compensation

Loss on extinguishment of debt

Warrant amendments

Other nondeductible expenses/(nontaxable income)

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The Company’s tax returns since inception remain open to examination by the taxing authorities.

SEGMENT INFORMATION

The Company operates in one reportable segment.

This determination is based on the Company's structure, the manner in which the chief operating decision maker ("CODM") reviews the operating results to assess performance and allocate resources, and the nature of the Company's operations.

The CODM, who is the Chief Executive Officer , regularly reviews consolidated financial information, such as consolidated net loss.

The CODM's review is for the purpose of assessing performance and making decisions about resource allocation.

See our consolidated financial statement in Part II, "Item 8, Financial Statements and Supplementary Data", and Note 1, "Description of Business, Organization, and Principles of Consolidation" for additional information about these line items and the related accounting policies.

SUBSEQUENT EVENTS

Issuance of Common Stock

On March 18, 2024, the Company issued 12,500 shares of common stock for investor relation services to Laidlaw & Company as part of the agreement signed on August 15, 2023.

Issuance of Options

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At-The-Market Offering with H.C.

On February 14, 2024, the Company entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C.

Wainwright & Co., LLC (“Wainwright”), to sell shares of its common stock, par value $ 0.0001 per share, (the “Shares”) having an aggregate sales price of up to $ 1,445,000 , from time to time, through an “at the market offering” program under which Wainwright will act as sales agent.

The sales, if any, of the Shares made under the ATM Agreement will be made by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415 promulgated under the Securities Act of 1933, as amended.

The Company will pay Wainwright a co mmission rate equal to 3.0 % of the aggregate gross proceeds from each sale of Shares.

As of the date of this filing, the Company has sold 507,754 shares of common stock at an average price of $ 1.47 per share, resulting in aggregate gross proceeds of approximately $ 745,250 .

Since January 1, 2025, the Company has sold 666,323 shares of Common Stock at an average price of $ 2.28 per share, resulting in aggregate gross proceeds of approximately $ 1,521,092 , for which it paid Wainwright approximately $ 45,633 in commissions, resulting in net proceeds to the Company of approximately $ 1,475,458 .

The Company anticipates that the at-the-market offering will continue throughout the next reporting period.

Private Placement

On March 11, 2024, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain accredited investors (the “Investors”) for the issuance and sale in a private placement (the “Private Placement”) of (i) 2,043,587 shares (the “Investor Shares”) of the Company’s common stock, par value $ 0.0001 per share (“Common Stock”), and (ii) warrants (the “Investor Warrants”) to purchase up to 2,043,587 shares of the Company’s Common Stock, at a price per share of $ 1.17 for an aggregate purchase price of approximately $ 2.4 million.

The Shares and the Warrants (and the shares of common stock underlying the Warrants) sold in the Private Placement are being issued as restricted securities as defined in Rule 144 of the Securities Act of 1933, as amended and do not contain any registration rights.

The Common 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 (subject to customary adjustments as set forth in the Investor Warrants, which do not include any provisions relating to price protection), are exercisable commencing six months following issuance and have a term of five years from the initial exercise date.

In addition, in recognition of the past and continued future services provided by members of the Company’s board of directors (the “Board”) and to further align the interests of directors with those of the Company’s stockholders, the Board has determined it advisable and in the best interests of the Company and its stockholders to allow members of the Board to participate in the Private Placement and directors of the Company executed the Purchase Agreement to subscribe for (i) 452,731 shares of Common Stock (the

“Director Shares,” together with the Investor Shares, the “Shares”) and (ii) common stock purchase warrants to purchase up to 452,731 shares of the Company’s Common Stock (the “Director Warrants,” together with the Investor Warrants, the “Warrants”) at a price per share of $ 1.17 for an aggregate purchase price of $ 529,695 The Director Warrants are exercisable at a price of $ 1.30 per share, which price represents the greater of the book or market value of the stock on the date the Purchase Agreement was executed (subject to customary adjustments as set forth in the Director Warrants), are exercisable commencing six months following issuance and will have a term of five years from the initial exercise date.

The Director Shares and Director Warrants (and any shares of Common Stock issuable upon exercise thereof) are being issued under the Company’s 2021 Equity Incentive Plan (the “Plan”) as an Unrestricted Stock Award (as defined in the Plan) and an Award of Options (as such terms are defined in the Plan), respectively.

The Private Placement closed on March 14, 2024 and the combined gross proceeds from the Private Placement was approximately $ 2.92 million, prior to deducting offering expenses payable by the Company.

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 $ 2.72 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.

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 $ 1.43 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.

Related Party Participation in Private Placement

The following Company directors participated in the aforementioned February 24, 2025 private placement as follows:

(i) Stan Smith purchased 50,000 shares of Common Stock and warrants to purchase up to 50,000 shares of Common Stock for an aggregate purchase price of approximately $ 75,000 ;

and (ii) Ramiro Guerrero purchased 73,333 shares of Common Stock and warrants to purchase up to 73,333 shares of Common Stock for an aggregate purchase price of approximately $ 110,000 .

In addition, FGMK Business Holdings, LLC, a 5 % stockholder purchased 1,350,000 shares of Common Stock and warrants to purchase up to 1,350,000 shares of the Company’s Common Stock for an aggregate purchase price of approximately $ 2.025 million.

The following Company directors participated in the aforementioned March 3, 2025 private placement as follows:

(i) Stan Smith purchased 170,940 shares of common stock and warrants to purchase up to 170,940 shares of common stock for an aggregate purchase price of $ 200,000 ;

(ii) Louie Ngar Yee purchased 170,940 shares of common stock and warrants to purchase up to 170,940 shares of common stock for an aggregate purchase price of $ 200,000 ;

(iii) Cristian Luput purchased 69,282 shares of common stock and warrants to purchase up to 69,282 shares of common stock for an aggregate purchase price of $ 81,060 ;

(iv) Steven Chaouki purchased 34,641 shares of common stock and warrants to purchase up to 34,641 shares of common stock for an aggregate purchase price of $ 40,530 and (v) Ramiro Guerrero purchased 6,928 shares of common stock and warrants to purchase up to 6,928 shares of common stock for an aggregate purchase price of $ 8,106 .

(i) Stan Smith purchased 25,000 shares of Common Stock and warrants to purchase up to 25,000 shares of Common Stock for an aggregate purchase price of approximately $ 37,500 ;

(ii) Ramiro Guerrero purchased 33,333 shares of Common Stock and warrants to purchase up to 33,333 shares of Common Stock for an aggregate purchase price of approximately $ 50,000 .

These subsequent events may have a material impact on the Company’s financial position, results of operations, and cash flows in future periods, and they are disclosed here for informational purposes.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures