Item 1. Financial Statements
Item 1. Financial Statements
MAIA Biotechnology, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(Unaudited)
March 31,
2025
December 31,
2024
ASSETS
Current assets:
Cash
$
10,863,296
$
9,601,298
Prepaid expenses and other current assets
920,472
473,834
Australia research and development incentives receivable
78,084
77,347
Total current assets
11,861,852
10,152,479
Other assets
2,800
2,800
Total assets
$
11,864,652
$
10,155,279
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable
$
1,841,369
$
1,512,436
Accrued expenses
3,216,142
2,317,602
Total current liabilities
5,057,511
3,830,038
Long term liabilities:
Warrant liability
1,864,616
2,690,605
Total liabilities
6,922,127
6,520,643
Commitments and contingencies (Note 7)
Stockholders' equity (deficit)
Preferred stock, $ 0.0001 par value, 30,000,000 shares
authorized at March 31, 2025 and December 31, 2024,
0 shares issued and outstanding
—
—
Common stock, $ 0.0001 par value, 70,000,000 shares authorized at
March 31, 2025 and December 31, 2024, 29,587,314 and 26,157,788
shares issued and outstanding at March 31, 2025 and December 31, 2024,
respectively
2,959
2,616
Additional paid-in capital
96,729,813
90,897,468
Accumulated deficit
( 91,752,092
)
( 87,234,833
)
Accumulated other comprehensive loss
( 38,155
)
( 30,615
)
Total stockholders' equity
4,942,525
3,634,636
Total liabilities and stockholders' equity
$
11,864,652
$
10,155,279
See the accompanying notes to the unaudited condensed consolidated financial statements.
2
MAIA Biotechnology, Inc. and Subsidiaries
Co ndensed Consolidated Statements of Operations
(Unaudited)
Three Months Ended
March 31,
2025
2024
Operating expenses:
Research and development expenses
$
3,197,532
$
2,320,742
General and administrative expenses
2,227,899
1,628,134
Total operating expenses
5,425,431
3,948,876
Loss from operations
( 5,425,431
)
( 3,948,876
)
Other income (expense):
Interest income
82,183
44,118
Australian research and development
incentives
—
18,601
Change in fair value of warrant liability
825,989
( 4,181,298
)
Other income (expense) net:
908,172
( 4,118,579
)
Net loss
$
( 4,517,259
)
$
( 8,067,455
)
Net loss per share
Basic and diluted
$
( 0.16
)
$
( 0.46
)
Weighted average common shares
outstanding basic and diluted
27,696,550
17,601,407
See the accompanying notes to the unaudited condensed consolidated financial statements.
3
MAIA Biotechnology, Inc. and Subsidiaries
Condensed Consolidated State ments of Comprehensive Loss
(Unaudited)
Three Months Ended
March 31,
2025
2024
Net loss
$
( 4,517,259
)
$
( 8,067,455
)
Foreign currency translation adjustment
( 7,540
)
( 13,786
)
Comprehensive loss
$
( 4,524,799
)
$
( 8,081,241
)
See the accompanying notes to the unaudited condensed consolidated financial statements.
4
MAIA Biotechnology, Inc. and Subsidiaries
Condensed Consolidated Statements of Chan ges in Stockholders' Equity (Deficit) (Unaudited)
For the Three Months Ended March 31,
2025
Preferred Stock
Common Stock
Shares
Amount
Shares
Amount
Additional Paid-In Capital
Accumulated Deficit
Accumulated Other Comprehensive Income (Loss)
Total Stockholders' Equity
Balance at December 31, 2024
—
$
—
26,157,788
$
2,616
$
90,897,468
$
( 87,234,833
)
$
( 30,615
)
$
3,634,636
Exercise of stock options
—
—
570
—
844
—
—
844
Stock-based compensation expense
—
—
—
—
371,472
—
—
371,472
Issuance of common shares in connection with At-The-Market financing, net of $ 130,220 of issuance costs
—
—
666,323
67
1,390,804
—
—
1,390,871
Issuance of common shares in connection with the Private Placement Offerings, net of $ 74,448 of issuance costs
—
—
2,762,633
276
2,390,457
—
—
2,390,733
Issuance of warrants in connection with the Private Placement Offerings
—
—
—
—
1,678,768
—
—
1,678,768
Foreign currency translation adjustment
—
—
—
—
—
—
( 7,540
)
( 7,540
)
Net loss
—
—
—
—
—
( 4,517,259
)
—
( 4,517,259
)
Balance at March 31, 2025
—
$
—
29,587,314
$
2,959
$
96,729,813
$
( 91,752,092
)
$
( 38,155
)
$
4,942,525
See the accompanying notes to the unaudited condensed consolidated financial statements.
5
MAIA Biotechnology, Inc. and Subsidiaries
Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit) (Unaudited)
For the Three Months Ended March 31,
2024
Preferred Stock
Common Stock
Shares
Amount
Shares
Amount
Additional Paid-In Capital
Accumulated Deficit
Accumulated Other Comprehensive Income (Loss)
Total Stockholders' Equity
Balance at December 31, 2023
—
$
—
16,986,254
$
1,699
$
64,472,249
$
( 63,980,177
)
$
( 16,260
)
$
477,511
Issuance of restricted stock
—
—
12,500
1
11,499
—
—
11,500
Stock-based compensation expense
—
—
—
—
349,965
—
—
349,965
Issuance of common shares in connection with At-The-Market financing, net of $ 179,628 of issuance costs
—
—
507,754
51
565,572
—
—
565,623
Issuance of common shares in connection with the Private Placement Offering #1, net of $ 50,000 of issuance costs
—
—
2,496,318
250
590,161
—
—
590,411
Issuance of common shares in connection with the Private Placement Offering #2, net of $ 47,261 of issuance costs
—
—
578,643
58
90,560
—
—
90,618
Issuance of warrants in connection with the Private Placement Offering #1
—
—
—
—
230,685
—
—
230,685
Foreign currency translation adjustment
—
—
—
—
—
—
( 13,786
)
( 13,786
)
Net loss
—
—
—
—
—
( 8,067,455
)
—
( 8,067,455
)
Balance at March 31, 2024
—
$
—
20,581,469
$
2,059
$
66,310,691
$
( 72,047,632
)
$
( 30,046
)
$
( 5,764,928
)
See the accompanying notes to the unaudited condensed consolidated financial statements.
6
MAIA Biotechnology, Inc. and Subsidiaries
Condensed Consolidated S tatements of Cash Flows
(Unaudited)
Three Months Ended
March 31,
2025
2024
Cash flows from operating activities:
Net loss
$
( 4,517,259
)
$
( 8,067,455
)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation
371,472
349,965
Consulting expense for restricted shares issued
—
11,500
Change in fair value of warrant liability
( 825,989
)
4,181,298
Change in operating assets and liabilities:
Prepaid expenses and other current assets
( 456,752
)
67,091
Australia research and development incentives receivable
—
( 18,602
)
Other receivables
—
( 71,856
)
Accounts payable
359,070
237,018
Accrued expenses
867,184
( 275,759
)
Net cash used in operating activities
( 4,202,274
)
( 3,586,800
)
Cash flows from financing activities:
Proceeds from exercise of stock options
844
—
Proceeds from private placement round 1 2024
—
2,920,696
Proceeds from private placement round 2 2024
—
1,327,990
Proceeds from private placement round 1 2025
2,715,000
—
Proceeds from private placement round 2 2025
1,428,949
—
Proceeds from At-The-Market offering
1,521,091
745,251
Payment of offering transactions costs
( 204,668
)
( 276,889
)
Net cash provided by financing activities
5,461,216
4,717,048
Net effect of foreign currency exchange on cash
3,056
( 9,494
)
Net increase in cash
1,261,998
1,120,754
Cash at beginning of period
9,601,298
7,150,695
Cash at end of period
$
10,863,296
$
8,271,449
Supplemental disclosure of cash flow information:
Warrants issued in connection with private placement offering 1 2024
$
—
$
2,049,600
Warrants issued in connection with private placement offering 2 2024
$
—
$
1,190,111
Warrants issued in connection with private placement offering 1 2025
$
2,416,223
$
—
Warrants issued in connection with private placement offering 2 2025
$
1,240,185
$
—
See the accompanying notes to the unaudited condensed consolidated financial statements.
7
MAIA Biotechnology, Inc. and Subsidiaries
Notes to Unaudited Condensed Con solidated Financial Statements
1. NATURE OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Description of Business, Organization, and Principles of Consolidation
MAIA Biotechnology, Inc. and subsidiaries (collectively, “the Company”) is a biopharmaceutical company that develops oncology drug candidates to improve and extend the lives of people with cancer. MAIA Biotechnology, Inc. (“MAIA”) was incorporated in the state of Delaware on August 3, 2018 . These condensed consolidated financial statements include the accounts of MAIA and its subsidiaries, as follows:
• In July 2021, the Company established a wholly owned Australian subsidiary, MAIA Biotechnology Australia Pty Ltd., to conduct various pre-clinical and clinical activities for the development of the Company's product candidates.
• In April 2022, the Company established a wholly owned Romanian subsidiary, MAIA Biotechnology Romania S.R.L., to conduct various pre-clinical and clinical activities for the development of the Company's product candidates.
Going Concern Considerations
The accompanying unaudited 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 consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
To date, the Company has incurred recurring losses, negative cash flow from operations and has accumulated a deficit of $ 91,752,092 from the Company’s inception through March 31, 2025. As of March 31, 2025, the Company had $ 10,863,296 in cash and working capital of approximately $ 6,804,341 .
To meet the Company’s future working capital needs, the Company will need to raise additional equity or enter into debt financing. While the Company has historically been able to raise additional capital through issuance of equity and/or debt financing, and while the Company has implemented a plan to control its expenses in order to satisfy its obligations due within one year from the date of issuance of these financial statements, the Company cannot guarantee that it will be able to raise additional equity, raise debt, or contain expenses. Accordingly, there is substantial doubt about the Company’s ability to continue as a going concern within one year after these financial statements are issued.
Basis of Presentation and Consolidation Principles
The accompanying condensed consolidated financial statements have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) have been condensed or omitted pursuant to such rules and regulations. The condensed consolidated financial statements may not include all disclosures required by GAAP; however, the Company believes that the disclosures are adequate to make the information presented not misleading. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and the notes thereto for the fiscal year ended December 31, 2024 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 21, 2025. The condensed consolidated balance sheet as of December 31, 2024 was derived from such audited financial statements.
In the opinion of management, all adjustments, consisting of only normal recurring adjustments that are necessary to present fairly the financial position, results of operations, and cash flows for the interim periods, have been made. The results of operations for the interim periods are not necessarily indicative of the operating results for the full fiscal year or any future periods.
8
The unaudited interim condensed consolidated financial statements include the accounts of the Company's wholly owned subsidiaries. All transactions and accounts between and among its subsidiaries have been eliminated. All adjustments and disclosures necessary for a fair presentation of these unaudited interim condensed consolidated financial statements have been included.
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 ("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 8 - Segment Information.
Use of Estimates
The preparation of the Company’s unaudited interim condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The most significant estimates in the Company’s financial statements relate to the valuation of the Company’s common stock, par value $ 0.0001 per share (the “Common Stock”), stock options and warrants, the embedded features in convertible notes, and accruals for outsourced research and development activities. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected.
Certain Risks and Uncertainties
The Company’s activities are subject to significant risks and uncertainties including the risk of failure to secure additional funding to properly execute the Company’s business plan. The Company is subject to risks that are common to companies in the pharmaceutical industry, including, but not limited to, the development by the Company or its competitors of new technological innovations, dependence on key personnel, reliance on third party manufacturers, protection of proprietary technology, and compliance with regulatory requirements.
Foreign Currency Translation
The financial statements of the Company’s foreign subsidiaries, where the local currency is the functional currency, are translated using exchange rates in effect as of the applicable balance sheet dates for assets and liabilities and average exchange rates during the period for results of operations. The resulting foreign currency translation adjustment is included in stockholders’ equity as accumulated other comprehensive loss.
Off-Balance Sheet Risk and Concentrations of Credit Risk
The Company has no significant off-balance sheet risks, such as foreign exchange contracts, option contracts, or other foreign hedging arrangements. Cash accounts are maintained at financial institutions that potentially subject the Company to concentrations of credit risk. As of March 31, 2025 and December 31, 2024 , 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 institution, and accordingly, the Company believes such funds are subject to minimal credit risk.
Cash and Cash Equivalents
9
The Company considers all highly liquid investments purchased with maturities of three months or less to be cash equivalents. As of March 31, 2025 and December 31, 2024 , cash includes cash in depository bank accounts. The Company had no cash equivalents as of March 31, 2025 or December 31, 2024 .
Fair Value Measurements
The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. Accounting Standards Codification (“ASC”) Topic 820, Fair Value Measurements and Disclosures (“ASC 820”) establishes a hierarchy of inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the observable inputs be used when available.
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. To increase the comparability of fair value measures, the following hierarchy prioritizes the inputs to valuation methodologies used to measure fair value:
• Level 1 - Valuations based on quoted prices for identical assets and liabilities in active markets.
• Level 2 - Valuations based on observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data.
• Level 3 - Valuations based on unobservable inputs reflecting our own assumptions, consistent with reasonably available assumptions made by other market participants. These valuations require significant judgment.
Fair value measurements discussed herein are based upon certain market assumptions and pertinent information available to management as of and during the three months ended March 31, 2025, and as of and during the twelve months ended December 31, 2024. The carrying amount of accounts payable approximated fair value, as they are short term in nature. The fair value of warrants issued for services is estimated based on the Black-Scholes-Merton model during the three months ended March 31, 2025 . The estimated fair value of warrants issued to underwriters represented Level 3 measurements.
General and Administrative
General and administrative expenses primarily consist of costs for corporate functions, including payroll and related expenses, rent, outside legal expenses, insurance costs, and other general and administrative costs.
Research and Development
The Company’s research and development expenses consist primarily of costs associated with the Company’s clinical trials, salaries, payroll taxes, employee benefits, and stock-based compensation charges for those individuals involved in ongoing research and development efforts. 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.
As part of the process of preparing the condensed consolidated financial statements, the Company is required to estimate its accrued expenses. This process involves reviewing quotations and contracts, identifying services that have been performed on the Company’s behalf and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of the actual cost. The majority of the Company’s service providers invoice the Company monthly in arrears for services performed or when contractual milestones are met. The Company makes estimates of its accrued expenses as of each balance sheet date in our condensed consolidated financial statements based on facts and circumstances known to the Company at that time. The Company periodically confirms the accuracy of its estimates with the service providers and makes adjustments if necessary. The estimates in the Company’s accrued research and development expenses are related to expenses incurred with respect to contract research organizations (“CROs”), contract manufacturing
10
organizations (“CMOs”), and other vendors in connection with research and development and manufacturing activities.
The Company bases its expense related to CROs and CMOs on its estimates of the services received and efforts expended pursuant to quotations and contracts with such vendors that conduct research and development and manufacturing activities on the Company’s behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. 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. 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. Although the Company does not expect its estimates to be materially different from amounts actually incurred, the Company’s understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and could result in us reporting amounts that are too high or too low in any particular period. There have been no material changes in estimates for the periods presented.
Research and Development Incentive
The Company recognizes other income from Australian research and development incentives when there is reasonable assurance that the income will be received, the relevant expenditure has been incurred, and the consideration can be reliably measured. The research and development incentive is one of the key elements of the Australian government’s support for Australia’s innovation system and is supported by legislative law primarily in the form of the Australian Income Tax Assessment Act 1997, as long as eligibility criteria are met. Under the program, a percentage of eligible research and development expenses incurred by the Company through its subsidiary in Australia are reimbursed.
Management has assessed the Company’s research and development activities and expenditures to determine which activities and expenditures are likely to be eligible under the research and development incentive regime described above. At each period end, management estimates the refundable tax offset available to the Company based on available information at the time, and it is included in Australian research and development incentives in the condensed consolidated statements of operations.
Derivative Financial Instruments
The Company does not use derivative instruments to hedge exposures to cash flow, market, or foreign currency risks. The Company evaluates all of its financial instruments to determine if such instruments contain features that qualify as embedded derivatives.
Embedded derivatives must be separately measured from the host contract if all the requirements for bifurcation are met. 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 each period.
Stock-Based Compensation
The Company records share-based compensation for awards granted to employees, non-employees, and to members of the board of directors based on the grant date fair value of awards issued, and the expense is recorded on a straight-line basis over the requisite service period. Forfeitures are recognized when they occur.
The Company uses the Black-Scholes-Merton option pricing model to determine the fair value of stock options and warrants. The use of the Black-Scholes-Merton option-pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the Common Stock consistent with the expected life of the option, risk-free interest rates and expected dividend yields of the Common Stock. The Company has concluded that its historical share option exercise experience does not provide a reasonable basis upon which to estimate expected term. Therefore, the expected term was determined according to the simplified method, which is the average of the vesting tranche dates and the contractual term. Due to the lack of company specific
11
historical and implied volatility data, the estimate of expected volatility is primarily based on the historical volatility of a group of similar companies that are publicly traded. For these analyses, companies with comparable characteristics, including enterprise value and position within the industry, and with historical share price information sufficient to meet the expected life of the share-based awards, are selected. The Company computes the historical volatility data using the daily closing prices for the selected companies’ shares during the equivalent period of the calculated expected term of its share-based awards. The risk-free interest rate is determined by reference to U.S. Treasury zero-coupon issues with remaining maturities similar to the expected term of the options. The Company has not paid, and does not anticipate paying, cash dividends on shares of its Common Stock.
Prior to the Company’s initial public offering (“IPO”) 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 initial public offering, or sale, given prevailing market conditions; the lack of marketability of our Common Stock; the market performance of comparable publicly traded companies; and U.S. and global economic and capital market conditions.
During the three months ended March 31, 2025 , there were no issuance of restricted shares of Common Stock. During the three months ended March 31, 2024 , 12,500 restricted shares of Common Stock were issued for consulting services. The fair value of restricted stock awards is based on the Common Stock price.
All stock-based compensation costs are recorded in general and administrative or research and development costs in the condensed consolidated statements of operations based upon the underlying individual’s role at the Company.
Common Stock Warrants
The Company accounts for Common Stock warrants as either equity instruments or as liabilities in accordance with ASC 480, Distinguishing Liabilities from Equity (“ASC 480”), depending on the specific terms of the warrant agreement.
When warrants are issued for services provided by non-employees, under ASC 718, Compensation – Stock Compensation (“ASC 718”), the warrants shall be classified as a liability if: (i) the underlying shares are classified as liabilities; or (ii) the entity can be required under any circumstances to settle the warrant by transferring cash or other assets. The measurement of equity-classified non-employee share-based payments is generally fixed on the grant date and are considered compensatory, as defined by ASC 718.
Income Taxes
Income taxes are recorded in accordance with ASC 740, Income Taxes (“ASC 740”), which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Valuation allowances are provided, if based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. 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. The Company recognizes any interest and penalties accrued related to unrecognized tax benefits as income tax expense.
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. 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. Diluted loss per share excludes, when applicable, the potential impact of stock options, unvested shares of restricted stock awards, and common
12
stock warrants because their effect would be anti-dilutive due to our net loss. Gains on warrant liabilities are only considered dilutive when the average market price of the Common Stock during the period exceeds the exercise price of the warrants. Since the Company had a net loss in each of the periods presented, basic and diluted net loss per common share are the same.
The following table summarizes the Company’s potentially dilutive securities, in common share equivalents, which have been excluded from the calculation of dilutive loss per share as their effect would be anti-dilutive:
Three Months Ended
March 31,
2025
2024
Shares issuable upon exercise of stock options
10,904,814
8,060,978
Shares issuable upon exercise of warrants
9,299,143
6,272,508
Recent Accounting Standards
In December 2023, the FASB issued ASU No. 2023-09, Improvements to Income Tax Disclosures (“ASU No. 2023-09”), which requires disclosure of disaggregated income taxes paid, prescribes standard categories for the components of the effective tax rate reconciliation, and modifies other income tax-related disclosures. ASU No. 2023-09 is effective for fiscal years beginning after December 15, 2024 and allows for adoption on a prospective basis, with a retrospective option. Early adoption is permitted. We do not expect the amendments in ASU No. 2023-09 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. ASU No. 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. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption.
2. RELATED PARTY TRANSACTIONS
Consulting Services
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. The Company expensed $ 11,445 as of March 31, 2025 related to accounting, tax and valuation services. In addition, FGMK Business Holdings, LLC participated in the February 2025 private placement and purchased 1,350,000 shares of the Company’s Common Stock and warrants to purchase 1,350,000 shares of the Company’s Common Stock for an aggregate purchase price of approximately $ 2,025,000 .
10b5-1 Plan
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 this Quarterly Report. 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.
13
Private Placement
The following Company directors participated in the February 2025 private placement as follows: (i) Stan Smith purchased 50,000 shares of our Common Stock and warrants to purchase up to 50,000 shares of our Common Stock for an aggregate purchase price of $ 75,000 ; (ii) Ramiro Guerrero purchased 73,333 shares of our Common Stock and warrants to purchase up to 73,333 shares of our Common Stock for an aggregate purchase price of $ 110,000 .
The following Company directors participated in the March 2025 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 $ 37,500 ; (ii) Ramiro Guerrero purchased 33,333 shares of our Common Stock and warrants to purchase up to 33,333 shares of our Common Stock for an aggregate purchase price of $ 50,000 .
3. ACCRUED EXPENSES
As of March 31, 2025 and December 31, 2024 accrued expenses consisted of the following:
March 31,
December 31,
2025
2024
Bonus
$
1,227,667
$
941,098
Professional fees
287,606
123,317
Research and development costs
1,391,612
1,035,355
Other
309,257
217,832
Total accrued expenses
$
3,216,142
$
2,317,602
4. FAIR VALUE OF FINANCIAL LIABILITIES
Derivative Liability
Financial liabilities consisting of warrant liabilities measured at fair value on a recurring basis are summarized below. The fair value of the warrant liabilities recorded are as follows:
Fair value at March 31, 2025
Total
Level 1
Level 2
Level 3
Liabilities:
Warrant liability
1,864,616
—
—
1,864,616
Total liabilities
$
1,864,616
$
—
$
—
$
1,864,616
Fair value at December 31, 2024
Total
Level 1
Level 2
Level 3
Liabilities:
Warrant liability
2,690,605
—
—
2,690,605
Total liabilities
$
2,690,605
$
—
$
—
$
2,690,605
14
The table below provides a summary of the changes in fair value of the warrant liabilities measured on a recurring basis using significant unobservable inputs (Level 3):
Three Months Ended
March 31,
Warrant liabilities:
2025
2024
Balance, beginning of period
$
2,690,605
$
2,152,188
Issuance of warrants
—
3,239,711
Exercise of warrants
—
—
Amendment of warrants
—
—
(Gain) loss on fair value of warrant liability
( 825,989
)
4,181,298
Balance, end of period
$
1,864,616
$
9,573,197
5. STOCKHOLDERS’ EQUITY
Upon the closing of the Company’s IPO, the Company’s shareholders agreement terminated pursuant to its terms. In connection with the closing of the IPO, 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.
At-the-Market Equity Offering
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 “Securities Act”). 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 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. During the quarter ended March 31, 2024, the Company sold 507,754 shares of Common Stock at an average price of approximately $ 1.47 per share, resulting in aggregate gross proceeds of approximately $ 745,251 , for which it paid Wainwright approximately $ 22,357 in commissions and other issuance costs of $ 157,271 , resulting in net proceeds to the Company of approximately $ 565,623 .
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. Effective March 22, 2025, the Company filed a prospectus supplement to amend, supplement and supersede certain information contained in the earlier prospectus and prospectus supplement, which decreased the number of Shares the Company may offer and sell under the ATM Agreement to an aggregate offering price of up to $ 11,200,000 from time to time. During the quarter ended March 31, 2025, the Company 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 it paid Wainwright approximately $ 45,633 in commissions and other issuance costs of $ 84,587 , resulting in net proceeds to the Company of approximately $ 1,390,871 .
Private Placement
On February 24, 2025, the Company issued and sold 1,810,000 shares of its Common Stock and warrants to purchase 1,810,000 shares of its Common Stock in a private placement to certain accredited investors and Company directors pursuant to securities purchase agreements dated February 18, 2025 at a price per share of $ 1.50 for which the Company received gross proceeds of approximately $ 2.7 million. The warrants are exercisable at a price per
15
share of $ 1.87 , are exercisable commencing one year following issuance, have a term of six years from the issuance date, and expiring on February 24, 2031 . The securities sold to Company directors participating in the private placement were issued pursuant to the MAIA Biotechnology, Inc. 2021 Equity Incentive Plan (the “MAIA 2021 Plan”).
On March 3, 2025, the Company issued and sold 952,633 shares of its Common Stock and warrants to purchase 952,633 shares of its Common Stock in a private placement to certain accredited investors and Company directors pursuant to securities purchase agreements dated February 25, 2025 at a price per share of $ 1.50 for which the Company received gross proceeds of approximately $ 1.4 million. The warrants are exercisable at a price per share of $ 1.85 , are exercisable commencing one year following issuance, have a term of six years from the issuance date, and expiring on March 3, 2031 . The securities sold to Company directors participating in the private placement were issued pursuant to the MAIA Biotechnology, Inc. 2021 Equity Incentive Plan (the “MAIA 2021 Plan”).
MAIA Biotechnology, Inc. Restricted Stock Awards
During the three months ended March 31, 2025 , the Company had no expense related to restricted shares of Common Stock. There are no unvested restricted shares as of March 31, 2025.
During the three months ended March 31, 2024 , the Company expensed $ 11,500 to consulting expense related to the grant of 12,500 restricted shares of Common Stock. There were no unvested restricted shares March 31, 2024.
MAIA Stock Warrants
Concurrently with the closing of the IPO, the Company issued warrants to purchase an aggregate of up to 100,000 shares of its Common Stock to the representative or its designees, at an exercise price of $ 6.25 per share (the “Representative’s Warrants”). The Representative’s Warrants were exercisable beginning on January 23, 2023 , and expire on July 27, 2027 , pursuant to their terms and conditions. On August 3, 2023, concurrently with the full exercise of the representative’s over-allotment option, the Company issued additional Representative’s Warrants to purchase an aggregate of up to 15,000 shares of its Common Stock to the representative or its designees on the same terms. 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 at a value of $ 343,735 , which was 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 March 31, 2025 and December 31, 2024, the Company remeasured the warrant liability resulting in a value of $ 45,404 and $ 71,672 respectively. The gain on remeasurement of the warrant liability in the amount of $ 26,268 and the loss on remeasurement of the warrant liability in the amount of $ 72,666 was included in other income (expense) for the three months ended March 31, 2025 and March 31, 2024, respectively.
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 (“Alumni”), at an exercise price of $ 2.09 per share. The warrants were exercisable beginning on November 10, 2023 , and expire on November 10, 2027 , pursuant to their terms and conditions. The warrants are not indexed to the Company’s own stock and therefore meet the definition of a derivative liability. On November 13, 2023, 131,578 warrant shares vested in accordance with the terms. The warrants are liability classified instruments and were initially recorded at a value of $ 84,251 , which was determined using the Black-Scholes-Merton method using a term of 3.87 years, risk free interest rate of 3.93 % and volatility of 90.0 %. Laidlaw & Company Ltd. acted as the financial advisor to the Company in connection with the warrant and were paid a cash fee of $ 13,750 . As of March 31, 2024, the Company remeasured the warrant liability resulting in a value of $ 199,902 . The loss on remeasurement of the warrant liability in the amount of $ 115,651 is included in other income(expense) for the three months ended March 31, 2024. 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 warrant liability was removed to reflect the warrants being exercised and equity was increased by the value of $ 375,705 . As of March 31, 2025 and December 31, 2024, the warrant liability resulted in a value of $ 0 and $ 0 , 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 the registered direct offering at an exercise price of $ 1.86 per share (subject to customary adjustments as set forth in the warrants). The warrants are exercisable six months following issuance and will have a term of five years from the initial exercise
16
date. The warrants contain customary anti-dilution adjustments to the exercise price, including for share splits, share dividends, rights offerings and pro rata distributions. The warrants were not indexed to the Company’s own stock and therefore met the definition of a derivative liability. The warrants were liability classified instruments and were initially recorded at a value of $ 1,903,915 , which was 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 %. During the nine months ended September 30, 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 the exercise resulting in a value of $ 2,815,970 . The warrant liability for the exercised warrants was removed and equity was increased by the value of $ 2,815,970 . As of March 31, 2025 and December 31, 2024, the warrant liability resulted in a value of $ 1,509,930 and $ 2,189,478 , respectively. The gain on remeasurement in the amount of $ 679,548 and the loss on remeasurement in the amount of $ 2,307,832 was included in other income (expense) for the three months ended March 31, 2025 and Mach 31, 2024, 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 at a value of $ 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 March 31, 2025 and December 31, 2024 the Company remeasured the warrant liability resulting in a value of $ 164,492 and $ 230,038 respectively. The gain on remeasurement of the warrant liability in the amount of $ 65,546 and the loss on remeasurement of $ 156,959 is included in other income (expense) for the three months ended March 31, 2025 and March 31, 2024, 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 %. As of March 31, 2024, the Company remeasured the warrant liability resulting in a value of $ 3,793,921 . The loss on remeasurement of the warrant liability in the amount of $ 1,744,321 is included in other income (expense) for the three months ended March 31, 2024. 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.
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 %. As of March 31, 2024, the Company remeasured the warrant liability resulting in a value of $ 973,980 . The gain on remeasurement of the warrant liability in the amount of $ 216,131 is included in other income (expense) for the three months ended March 31, 2024. 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 remaining 141,612 warrants remain
17
liability classified instruments. As of March 31, 2025 and December 31, 2024, the Company remeasured the warrant liability, resulting in a value of $ 144,790 and $ 199,417 , respectively. The gain on remeasurement of the warrant liability in the amount of $ 54,627 is included in other income (expense) for the three months ended March 31, 2025.
Concurrently with the closing of the Company’s private placement offering on February 24, 2025, the Company issued warrants to purchase an aggregate of up to 1,686,667 shares of its Common Stock to the investors in the private placement at an exercise price of $ 1.87 per share. The warrants are exercisable beginning on February 24, 2026 , and expire on February 24, 2031 . The warrants issued were divided into two groups: warrants issued to directors and warrants issued to affiliated and non-affiliated investors. The warrants to purchase 123,333 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 $ 176,680 using a term of 6 years, risk free interest rate of 4.23 % and volatility of 95 %. The warrants to purchase 1,686,667 shares of the Company’s Common Stock issued to affiliated and 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 $ 2,416,223 using a term of 6 years, risk free interest rate of 4.23 % and volatility of 95 %.
Concurrently with the closing of the Company’s private placement offering on March 3, 2025, the Company issued warrants to purchase an aggregate of up to 952,633 shares of its Common Stock to the investors in the private placement at an exercise price of $ 1.85 per share. The warrants are exercisable beginning on March 3, 2026 , and expire on March 3, 2031 . The warrants issued were divided into two groups: warrants issued to directors and warrants issued to non-affiliated investors. The warrants to purchase 58,333 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 $ 80,894 using a term of 6 years, risk free interest rate of 3.97 % and volatility of 95 %. The warrants to purchase 894,300 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 $ 1,240,185 using a term of 6 years, risk free interest rate of 3.97 % and volatility of 95 %.
Warrants
Outstanding
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contractual
Term in
Years
Balance at January 1, 2025
6,718,176
$
2.37
4.56
Issued
2,580,967
3.01
—
Exercised
—
—
—
Expired
—
—
—
Balance at March 31, 2025
9,299,143
$
2.23
4.76
Warrants
Outstanding
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contractual
Term in
Years
Balance at January 1, 2024
3,650,278
$
2.82
5.00
Issued
2,622,230
1.58
—
Exercised
—
—
—
Expired
—
—
—
Balance at March 31, 2024
6,272,508
$
2.30
2.76
18
The value of warrant grants is calculated using the Warrant Black Scholes calculations with the following assumptions for warrants granted during the three months ended March 31, 2025 and 2024
2025
2024
Risk-free interest rate
3.97 %- 4.23 %
4.20 %
Expected term (in years)
6.0
5.5
Expected volatility
95 %
95 %
Expected dividend yield
—
—
MAIA Biotechnology, Inc. Stock Option and Equity Incentive Plans
In 2018, the Company adopted the MAIA Biotechnology, Inc. 2018 Stock Option Plan (the “MAIA 2018 Plan”). MAIAs board of directors administers the MAIA 2018 Plan for the purposes of attracting, retaining, and motivating key employees, directors, and consultants of MAIA. The terms of the MAIA 2018 Plan continue to govern th e 1,773,912 options outstanding under the plan as of March 31, 2025.
In 2020, the Company adopted the MAIA Biotechnology, Inc. Amended and Restated 2020 Equity Incentive Plan (the “MAIA 2020 Plan’’), also administered by the board of directors. The MAIA 2020 Plan permitted awards to take the form of stock options, restricted stock and restricted stock units. The terms of the MAIA 2020 Plan continue to govern the 3,503,589 options outstanding in the plan as of March 31, 2025 . There are no shares reserved for future issuance under the MAIA 2018 Plan or the MAIA 2020 Plan.
On August 1, 2022 the Company approved MAIA 2021 Plan with 1,909,518 shares of Common Stock reserved for issuance. On May 25, 2023 the MAIA 2021 Plan was amended to include an automatic increase to the plan in the amount equal to 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. 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. The amount reserved for issuance under the MAIA 2021 Plan increased by 2,838,668 shares on January 1, 2024 based on the fully diluted shares outstanding as of December 31, 2023. The amount reserved for issuance under the MAIA 2021 Plan increased by 2,250,000 shares on January 1, 2025 based on the fully diluted shares outstanding as of December 31, 2024 (and the discretion of the Company’s board of directors to authorized less than 10 % of such amount). As of March 31, 2025, there are 2,723,686 shares of Common Stock available for future issuance under the MAIA 2021 Plan and 5,627,313 options are outstanding under the MAIA 2021 Plan.
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. In the case of an option granted to a 10 % stockholder, the exercise price shall be generally no less than 110 % of the fair market value per share on the date of grant, and the contractual term shall be seven years . Outstanding options awarded under the MAIA 2021 Plan may, but need not, vest and therefore become exercisable in periodic installments that may, but need not, be equal. The option may be subject to other terms and conditions as to the time or times when it may be exercised (which may be based on performance or other criteria) as the board of directors may deem appropriate. Unexercised options are canceled ninety days after termination of an employee, director, founder, or consultant. Unexercised options are canceled immediately if an employee, director, founder, or consultant is terminated for cause; under certain other circumstances, the period to cancellation may differ as described in the respective plan documents. Certain clauses in the Plans also govern the Company’s exercise repurchase rights and various other features of awards granted under the plans.
19
As of March 31, 2025, only stock options have been awarded pursuant to the MAIA stock option and equity incentive plans.
The following table summarizes the activity and information regarding MAIA’s outstanding and exercisable options for the three months ended March 31, 2025:
Options Outstanding
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contractual
Term in
Years
Aggregate
Intrinsic
Value
Balance at January 1, 2025
9,769,992
$
2.43
6.68
—
Granted
1,135,392
1.85
Exercised
( 570
)
1.48
Cancelled/forfeited
—
—
Balance at March 31, 2025
10,904,814
$
2.36
6.73
$
236,183
Options exercisable at March 31, 2025
7,853,275
$
2.29
6.02
$
196,671
The value of option grants is calculated using the Black-Scholes-Merton option pricing model with the following assumptions for options granted during the three months ended March 31, 2025 and 2024:
2025
2024
Risk-free interest rate
4.22 % - 4.43 %
3.98 % - 4.49 %
Expected term (in years)
5 - 6.08
5 - 6.08
Expected volatility
95 %
95 % - 152.5 %
Expected dividend yield
—
—
The weighted-average grant date fair value of stock options issued during the three months ended March 31, 2025 and 2024 was $ 1.85 and $ 1.42 , respectively. As of March 31, 2025, the total unrecognized compensation related to unvested employee and non-employee stock option awards granted was $ 3,354,518 , which the Company expects to recognize over a weighted average period of approximately 2.58 years.
Stock based compensation related to the Company’s stock plans are as follows:
Three Months Ended
March 31,
2025
2024
General and administrative
$
198,858
$
230,989
Research and development
172,614
118,976
Total stock-based compensation
$
371,472
$
349,965
6. COMMITMENTS AND CONTINGENCIES
Legal
From time to time, the Company is involved in legal actions and claims arising in the normal course of business. Management believes there are no matters which will have a material adverse effect on the Company's financial position, operations or cash flows.
Patent Licensing, Sponsored Research, and Patent & Technology Agreements
Ateganosine (THIO)
20
In November 2018 and as amended in December 2020, the Company entered into a Global Patent Licensing Agreement (“PLA”) titled “Patent and Technology License Agreement AGT. NO. L2264 – MAIA Biotechnology” with the University of Texas Southwestern (“UTSW”) to license patent families for a specific compound (“THIO”) from UTSW to MAIA (the “UTSW Agreement”). The UTSW Agreement, as amended, has a term of 20 years. The agreement requires MAIA to reimburse UTSW for agreed-upon expenses related to THIO. The UTSW Agreement requires certain payments upon assignment of the license to a third party as well as upon reaching specific milestones, ranging between $ 1,000,000 and $ 50,000,000 , not to exceed a combined milestone payment total of $ 112,000,000 . As of March 31, 2025, n o assignment has occurred and none of the defined milestones have been completed and therefore no payments a re due to UTSW related to the milestones. The UTSW Agreement requires royalties MAIA to make royalty payments of : (i) 2 - 4 % (depending on THIO reaching specified sales levels in the respective jurisdictions) on net sales up to $1,000,000,000; and (ii) 2.5 - 5 % on net sales above $1,000,000,000.
Also in December 2020, the Company entered into a second license agreement with UTSW titled “Patent and Technology License Agreement AGT. NO. L3648 — MAIA Biotechnology” pursuant to which UTSW is licensing an additional compound to MAIA (the “UTSW2 Agreement”). The UTSW2 Agreement has a term of 20 years and requires the Company to reimburse UTSW for certain agreed-upon expenses. The UTSW2 Agreement requires certain payments upon assignment of the license to a third party as well as upon reaching specific milestones, ranging between $ 1,000,000 and $ 50,000,000 , not to exceed a combined milestone payment total of $ 112,000,000 . As of March 31, 2025, no assignment has occurred and none of the defined milestones have been completed and therefore no payments are d ue to UTSW related to the milestones. The UTSW2 Agreement requires MAIA to make royalty payments of: (i) 2 - 4 % (depending on THIO reaching specified sales levels in the respective jurisdictions) on net sales up to $1,000,000,000; (ii) and 2.5 - 5 % on net sales above $1,000,000,000.
The Company will also pay UTSW running royalties on a yearly basis as a percentage of Net Sales (as defined in the UTSW2 Agreement) 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 UTSW2 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. In the event that the licensed product or licensed service is not covered by a Valid Claim, the running royalty rates are reduced by 50%. The royalty obligations continue on a country-by-country basis until the later of expiration of the last Valid Claim in each country or 10 years after the First Commercial Sale (as defined in UTSW2 Agreement) in each country.
Regeneron
In February 2021, the Company entered into a Drug Supply Agreement (the “Drug Supply Agreement”) with Regeneron Pharmaceuticals, Inc. (“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 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 12 months after: (i) the Effective Date (as defined in the Drug Supply Agreement), with respect to the initial study; or (ii) 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. As of March 31, 2025, 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 March 31, 2025 neither party has terminated the agreement.
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7. INCOME TAXES
The Company provides for income taxes using the asset and liability approach. Deferred tax assets and liabilities are recorded based on the differences between the financial statement and tax bases of assets and liabilities and the tax rates in effect when these differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance if, based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The issuance of shares in connection with the Company’s IPO, as well as prior share issuances, may result in limitations on the utilization of the Company’s net operating loss carryforwards under IRS section 382. As of March 31, 2025, and December 31, 2024, the Company had a full valuation allowance against its deferred tax assets.
For the three months ended March 31, 2025 and 2024 , the Company recorded zero income tax expense. No tax benefit has been recorded in relation to the pre-tax losses for the three months ended March 31, 2025 , due to full valuation allowance to offset any deferred tax assets.
8. 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 statements in Part I, "Item 1, Financial Statements", and Note 1, "Description of Business, Organization, and Principles of Consolidation" for additional information about these line items and the related accounting policies.
9. SUBSEQUENT EVENTS
Issuance of Options
From April 1 to May 9, 2025, the Company issued 162,833 options at a weighted exercise price of $1.51 to Board Members and consultants.
Private Placement
On May 8, 2025, the Company issued and sold 719,999 shares of its common stock and warrants to purchase 719,999 shares of its common stock in a private placement to certain accredited investors and Company directors pursuant to securities purchase agreements dated May 5, 2025 at a price per share of $ 1.50 for which the Company received gross proceeds of approximately $ 1.08 million. The warrants are exercisable at a price per share of $ 2.05 , are exercisable commencing one year following issuance, and have a term of five year from the initial exercise date. The securities sold to Company directors participating in the private placement were issued pursuant to the Company’s 2021 Equity Incentive Plan.
Related Party Participation in Private Placement
The following Company directors participated in the aforementioned May 8, 2025 private placement as follows: (i) Stan Smith purchased 66,666 shares of Common Stock and warrants to purchase up to 66,666 shares of Common Stock for an aggregate purchase price of approximately $ 99,999 ; (ii) Ramiro Guerrero purchased 20,000 shares of Common Stock and warrants to purchase up to 20,000 shares of Common Stock for an aggregate purchase price of approximately $ 30,000 .
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