UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
| QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the quarterly period ended
OR
| TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from ______________ to _______________
Commission
File Number:
(Exact Name of Registrant as Specified in its Charter)
(State or other jurisdiction of incorporation or organization) |
(I.R.S.
Employer Identification No.) | |
| (Address of principal executive offices) | (Zip Code) |
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address and fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days.
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer | ☐ | Accelerated filer | ☐ |
| ☒ | Smaller reporting company | ||
| Emerging growth company |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
As of August 11, 2025, the registrant had shares of common stock, $ par value per share, outstanding.
Table of Contents
| i |
CAUTIONARY NOTICE ABOUT FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements, which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). This Report contains a number of forward-looking statements that reflect management’s current views and expectations with respect to our business, strategies, products, future results and events, and financial performance. All statements other than statements of historical facts contained in this report, including statements regarding our future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. In some cases, forward-looking statements may be identified by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “expect,” “objective,” “plan,” “potential,” “seek,” “grow,” “target,” “if,”, variations of such words, the negative of these terms and similar expressions intended to identify forward-looking statements. Our actual results may differ materially from those currently anticipated and expressed in such forward-looking statements as a result of a number of factors, including those which we discuss under “Risk Factors,” elsewhere in this Quarterly Report on Form 10-Q and in our other filings with the Securities and Exchange Commission (the “SEC”).
Readers should not place undue reliance on these forward-looking statements, which are based on management’s current expectations and projections about future events, are not guarantees of future performance, are subject to risks, uncertainties and assumptions and apply only as of the date of this Report. Our actual results, performance or achievements could differ materially from historical results as well as from the results expressed in, anticipated or implied by these forward-looking statements. An occurrence of, or any material adverse change in, one or more of the risk factors or risks and uncertainties referred to in this Report or included in our other public disclosures or our other periodic reports or other documents or filings filed with or furnished to the U.S. Securities and Exchange Commission could materially and adversely affect our business, prospects, financial condition and results of operations. Except as required by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Any public statements or disclosures by us following this Report that modify or impact any of the forward-looking statements contained in this Report will be deemed to modify or supersede such statements in this Report.
For a discussion of some of the factors that may affect our business, results and prospects, see “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the Securities and Exchange Commission (“SEC”) on March 21, 2025 and in our other reports we file with the SEC, including our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Readers are also urged to carefully review and consider the various disclosures made by us in this Report and in our other reports we file with the SEC, including our Quarterly Reports on Forms 10-Q and Current Reports on Form 8-K, and those described from time to time in our press releases and other communications, which attempt to advise interested parties of the risks and factors that may affect our business, prospects and results of operations.
Unless the context indicates or otherwise requires, “the Company,” “our Company,” “we,” “us,” and “our” refer to MAIA Biotechnology, Inc., a Delaware corporation, and its consolidated subsidiaries.
| 1 |
PART I—FINANCIAL INFORMATION
Item 1. Financial Statements
MAIA Biotechnology, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
| June 30, 2025 | December 31, 2024 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash | $ | $ | ||||||
| Prepaid expenses and other current assets | ||||||||
| Australia research and development incentives receivable | ||||||||
| Total current assets | ||||||||
| Other assets | ||||||||
| Total assets | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued expenses | ||||||||
| Total current liabilities | ||||||||
| Long term liabilities: | ||||||||
| Warrant liability | ||||||||
| Total liabilities | ||||||||
| Commitments and contingencies (Note 7) | ||||||||
| Stockholders’ equity (deficit) | ||||||||
| Preferred stock, $ par value, shares authorized at June 30, 2025 and December 31, 2024, shares issued and outstanding | ||||||||
| Common stock, $ par value, shares and shares authorized at June 30, 2025 and at December 31, 2024, respectively, and shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Accumulated other comprehensive loss | ( | ) | ( | ) | ||||
| Total stockholders’ equity | ||||||||
| Total liabilities and stockholders’ equity | $ | $ | ||||||
See the accompanying notes to the unaudited condensed consolidated financial statements.
| 2 |
MAIA Biotechnology, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(Unaudited)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses | $ | $ | $ | $ | ||||||||||||
| General and administrative expenses | ||||||||||||||||
| Total operating expenses | ||||||||||||||||
| Loss from operations | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other (expense) income: | ||||||||||||||||
| Interest income | ||||||||||||||||
| Australian research and development incentives | ||||||||||||||||
| Change in fair value of warrant liability | ( | ) | ( | ) | ( | ) | ||||||||||
| Loss on fair value of warrants over proceeds | ( | ) | ( | ) | ||||||||||||
| Other (expense) income, net: | ( | ) | ( | ) | ( | ) | ||||||||||
| Net loss | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Net loss per share | ||||||||||||||||
| Basic and diluted | $ | ) | $ | ) | $ | ) | $ | ) | ||||||||
| Weighted average common shares outstanding basic and diluted | ||||||||||||||||
See the accompanying notes to the unaudited condensed consolidated financial statements.
| 3 |
MAIA Biotechnology, Inc. and Subsidiaries
Condensed Consolidated Statements of Comprehensive Loss
(Unaudited)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Foreign currency translation adjustment | ( | ) | ||||||||||||||
| Comprehensive loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
See the accompanying notes to the unaudited condensed consolidated financial statements.
| 4 |
MAIA Biotechnology, Inc. and Subsidiaries
Condensed Consolidated Statements of Changes in Stockholders’ Equity (Deficit) (Unaudited)
| For the Three and Six Months Ended | ||||||||||||||||||||||||||||||||
| June 30, 2025 | ||||||||||||||||||||||||||||||||
| Preferred Stock | Common Stock | Additional Paid-In | Accumulated | Accumulated Other Comprehensive | Total Stockholders’ | |||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Capital | Deficit | Income (Loss) | Equity | |||||||||||||||||||||||||
| Balance at December 31, 2024 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||||||||||||||||
| Exercise of stock options | — | |||||||||||||||||||||||||||||||
| Stock-based compensation expense | — | — | ||||||||||||||||||||||||||||||
| Issuance
of common shares in connection with At-The-Market financing, net of $ | — | |||||||||||||||||||||||||||||||
| Issuance
of common shares in connection with the Private Placement Offerings, net of $ | — | |||||||||||||||||||||||||||||||
| Issuance of warrants in connection with the Private Placement Offerings | — | — | ||||||||||||||||||||||||||||||
| Foreign currency translation adjustment | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Net loss | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Balance at March 31, 2025 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||||||||||||||||
| Issuance of restricted stock | — | |||||||||||||||||||||||||||||||
| Exercise of warrants | — | |||||||||||||||||||||||||||||||
| Stock-based compensation expense | — | — | ||||||||||||||||||||||||||||||
| Issuance
of common shares in connection with At-The-Market financing, net of $ | — | |||||||||||||||||||||||||||||||
| Issuance
of common shares in connection with the Private Placement Offerings, net of $ | — | |||||||||||||||||||||||||||||||
| Issuance of warrants in connection with the Private Placement Offerings | — | — | ||||||||||||||||||||||||||||||
| Foreign currency translation adjustment | — | — | ||||||||||||||||||||||||||||||
| Net loss | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Balance at June 30, 2025 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||||||||||||||||
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 and Six Months Ended | ||||||||||||||||||||||||||||||||
| June 30, 2024 | ||||||||||||||||||||||||||||||||
| Preferred Stock | Common Stock | Additional Paid-In | Accumulated | Accumulated Other Comprehensive | Total Stockholders’ Equity | |||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Capital | Deficit | Income (Loss) | (Deficit) | |||||||||||||||||||||||||
| Balance at December 31, 2023 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||||||||||||||||
| Issuance of restricted stock | — | |||||||||||||||||||||||||||||||
| Stock-based compensation expense | — | — | ||||||||||||||||||||||||||||||
| Issuance
of common shares in connection with At-The-Market financing, net of $ | — | |||||||||||||||||||||||||||||||
| Issuance
of common shares in connection with the Private Placement Offering #1, net of $ | — | |||||||||||||||||||||||||||||||
| Issuance
of common shares in connection with the Private Placement Offering #2, net of $ | — | |||||||||||||||||||||||||||||||
| Issuance of warrants in connection with the Private Placement Offering #1 | — | — | ||||||||||||||||||||||||||||||
| Foreign currency translation adjustment | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Net loss | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Balance at March 31, 2024 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||||||||||||||||||
| Exercise of stock options | — | |||||||||||||||||||||||||||||||
| Stock-based compensation expense | — | — | ||||||||||||||||||||||||||||||
| Issuance
of common shares in connection with At-The-Market financing, net of $ | — | |||||||||||||||||||||||||||||||
| Issuance
of common shares in connection with the Private Placement Offering #3, net of $ | — | |||||||||||||||||||||||||||||||
| Issuance of warrants in connection with the Private Placement Offering #3 | — | — | ||||||||||||||||||||||||||||||
| Exercise of warrants | — | |||||||||||||||||||||||||||||||
| Reclassification of liability classified warrants to equity | — | — | ||||||||||||||||||||||||||||||
| Foreign currency translation adjustment | — | — | ||||||||||||||||||||||||||||||
| Net loss | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Balance at June 30, 2024 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||||||||||||||||
See the accompanying notes to the unaudited condensed consolidated financial statements.
| 6 |
MAIA Biotechnology, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows
(Unaudited)
| Six Months Ended June 30, | ||||||||
| 2025 | 2024 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | ||||||||
| Consulting and research 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: | ||||||||
| Prepaid expenses and other current assets | ( | ) | ||||||
| Australia research and development incentives receivable | ( | ) | ||||||
| Accounts payable | ( | ) | ||||||
| Accrued expenses | ( | ) | ||||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash flows from financing activities: | ||||||||
| Proceeds from exercise of stock options | ||||||||
| Proceeds from exercise of warrants | ||||||||
| Proceeds from private placement round 1 2025 | ||||||||
| Proceeds from private placement round 2 2025 | ||||||||
| Proceeds from private placement round 3 2025 | ||||||||
| Proceeds from private placement round 4 2025 | ||||||||
| Proceeds from private placement round 1 2024 | ||||||||
| Proceeds from private placement round 2 2024 | ||||||||
| Proceeds from private placement round 3 2024 | ||||||||
| Proceeds from At-The-Market offering | ||||||||
| Payment of offering transactions costs | ( | ) | ( | ) | ||||
| Net cash provided by financing activities | ||||||||
| Net effect of foreign currency exchange on cash | ( | ) | ||||||
| Net increase (decrease) in cash | ||||||||
| Cash at beginning of period | ||||||||
| Cash at end of period | $ | $ | ||||||
| Supplemental disclosure of cash flow information: | ||||||||
| Warrants issued in connection with private placement offering 1 2025 | $ | $ | ||||||
| Warrants issued in connection with private placement offering 2 2025 | $ | $ | ||||||
| Warrants issued in connection with private placement offering 3 2025 | $ | $ | ||||||
| Warrants issued in connection with private placement offering 4 2025 | $ | $ | ||||||
| Warrants issued in connection with private placement offering 1 2024 | $ | $ | ||||||
| Warrants issued in connection with private placement offering 2 2024 | $ | $ | ||||||
| Warrants issued in connection with private placement offering 3 2024 | $ | $ | ||||||
See the accompanying notes to the unaudited condensed consolidated financial statements.
| 7 |
MAIA Biotechnology, Inc. and Subsidiaries
Notes to Unaudited Condensed Consolidated 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
| ● | 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 $
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 $ 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 June 30, 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.
| 9 |
Cash and Cash Equivalents
The
Company considers all highly liquid investments purchased with maturities of three months or less to be cash equivalents. As of June
30, 2025, and December 31, 2024, cash includes cash in depository bank accounts. The Company had
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 six months ended June 30, 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 six months ended June 30, 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.
| 10 |
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 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.
| 11 |
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 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 six months ended June 30, 2025, restricted shares of Common Stock were issued for consulting and research services. During the six months ended June 30, 2024, 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.
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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.
On July 4, 2025, the “One big Beautiful Bill Act (OBBBA) was signed into law. This legislation introduces a number of new changes to the Internal Revenue Code. As a pre-revenue company that does not currently generate taxable income, we do not expect the legislation to have a material impact on our tax posture. The Company will continue to maintain a full valuation allowance against its net deferred tax assets.
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 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.
| Six Months Ended June 30, | ||||||||
| 2025 | 2024 | |||||||
| Shares issuable upon exercise of stock options | ||||||||
| Shares issuable upon exercise of warrants | ||||||||
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.
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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 and Private Placement
The
consulting firm FGMK, LLC and its affiliate FGMK Business Holdings, LLC beneficially owns more than
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.
Private Placement
The
following Company directors participated in the February 2025 private placement as follows: (i) Stan Smith purchased shares of
our Common Stock and warrants to purchase up to
The
following Company directors participated in the March 2025 private placement as follows: (i) Stan Smith purchased shares of our
Common Stock and warrants to purchase up to
The
following Company directors participated in the May 2025 private placement as follows: (i) Stan Smith purchased shares of our
Common Stock and warrants to purchase up to
The
following Company director participated in the June 2025 private placement as follows: Stan Smith purchased shares of our Common
Stock and warrants to purchase up to
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3. ACCRUED EXPENSES
As of June 30, 2025 and December 31, 2024 accrued expenses consisted of the following:
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Bonus | $ | $ | ||||||
| Professional fees | ||||||||
| Research and development costs | ||||||||
| Other | ||||||||
| Total accrued expenses | $ | $ | ||||||
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 June 30, 2025 | ||||||||||||||||
| Total | Level 1 | Level 2 | Level 3 | |||||||||||||
| Liabilities: | ||||||||||||||||
| Warrant liability | $ | $ | $ | $ | ||||||||||||
| Total liabilities | $ | $ | $ | $ | ||||||||||||
| Fair value at December 31, 2024 | ||||||||||||||||
| Total | Level 1 | Level 2 | Level 3 | |||||||||||||
| Liabilities: | ||||||||||||||||
| Warrant liability | $ | $ | $ | $ | ||||||||||||
| Total liabilities | $ | $ | $ | $ | ||||||||||||
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 June 30, | Six Months Ended June 30, | |||||||||||||||
| Warrant liabilities: | 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Balance, beginning of period | $ | $ | $ | $ | ||||||||||||
| Issuance of warrants | ||||||||||||||||
| Exercises of warrants | ( | ) | ( | ) | ||||||||||||
| Amendments of warrants | ( | ) | ( | ) | ||||||||||||
| Loss (gain) on fair value of warrant liability | ( | ) | ||||||||||||||
| Balance, end of period | $ | $ | $ | $ | ||||||||||||
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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 shares and decreased the authorized number of Preferred Stock to shares. On May 22, 2025 the Company’s shareholders approved an amendment (the “Certificate of Amendment”) to the Company’s Amended and Restated Certificate of Incorporation to increase the number of authorized shares of Common Stock from to . The Certificate of Amendment was filed with the Secretary of State of the State of Delaware on May 22, 2025, and became effective on that date, increasing the authorized number of shares of Common Stock to . The number of shares of Preferred Stock authorized remains 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 $ per share, (the “Shares”)
having an aggregate sales price of up to $
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 $
Private Placement
On
February 24, 2025, the Company issued and sold shares of its Common Stock and warrants to purchase 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 $ for which the Company received gross proceeds of approximately $
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On
March 3, 2025, the Company issued and sold shares of its Common Stock and warrants to purchase 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 $ for which the Company received gross proceeds of approximately $
On
May 8, 2025, the Company issued and sold shares of its Common Stock and warrants to purchase 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 $ for which the Company received gross proceeds of approximately $
On
June 3, 2025, the Company issued and sold shares of its Common Stock and warrants to purchase shares of its Common Stock
in a private placement to certain accredited investors and Company directors pursuant to securities purchase agreements dated May 27,
2025 at a price per share of $ for which the Company received gross proceeds of approximately $
MAIA Biotechnology, Inc. Restricted Stock Awards
During
the six months ended June 30, 2025, the Company expensed $
During
the six months ended June 30, 2024, the Company expensed $
MAIA Stock Warrants
Concurrently
with the closing of the IPO, the Company issued warrants to purchase an aggregate of up to
| 17 |
On
November 9, 2023, the Company issued warrants to purchase an aggregate of up to
On
November 17, 2023, the Company issued warrants concurrently with the Company’s registered direct offering to purchase an aggregate
of up to
On
November 17, 2023, concurrently with the closing of the Company’s registered direct offering, the Company issued warrants to purchase
an aggregate of
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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 shares of its Common Stock to the investors in the private placement, at an exercise price of $
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 shares of its Common Stock to the investors in the private placement at an exercise price of $ per share. The warrants
are exercisable beginning on
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 shares of its Common Stock to the investors
in the private placement at an exercise price of $ per share. The warrants are exercisable beginning on
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
shares of its Common Stock to the investors in the private
placement at an exercise price of $
per share. The warrants are exercisable beginning on
| 19 |
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
shares of its Common Stock to the investors in the private placement at an exercise price of $
per share. The warrants are exercisable beginning on
Concurrently
with the closing of the Company’s private placement offering on May 8, 2025, the Company issued warrants to purchase an
aggregate of up to
shares of its Common Stock to the investors in the private placement at an exercise price of $per
share. The warrants are exercisable beginning on
Concurrently
with the closing of the Company’s private placement offering on June 3, 2025, the Company issued warrants to purchase an
aggregate of up to
shares of its Common Stock to the investors in the private placement at an exercise price of $
per share. The warrants are exercisable beginning on
On
June 17, 2025, the Company executed a Warrant Inducement Offer to select warrant holders allowing them to exercise their warrants held
at a reduction of the exercise price for cash. The warrant’s exercise price was reduced to $
| Warrants Outstanding | Weighted Average Exercise Price | Weighted Average Remaining Contractual Term in Years | ||||||||||
| Balance at January 1, 2025 | $ | |||||||||||
| Issued | — | |||||||||||
| Exercised | ( | ) | ( | ) | — | |||||||
| Expired | — | |||||||||||
| Balance at June 30, 2025 | $ | |||||||||||
| 20 |
| Warrants Outstanding | Weighted Average Exercise Price | Weighted Average Remaining Contractual Term in Years | ||||||||||
| Balance at January 1, 2024 | $ | |||||||||||
| Issued | ||||||||||||
| Exercised | ( | ) | ( | ) | ||||||||
| Expired | ||||||||||||
| Balance at June 30, 2024 | $ | |||||||||||
| 2025 | 2024 | |||||||
| Risk-free interest rate | %- | % | %- | % | ||||
| Expected term (in years) | - | |||||||
| Expected volatility | % | % | ||||||
| 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 the options outstanding under the plan as of June 30, 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 options outstanding in the plan as of June 30, 2025. There are 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 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 % 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 based on the fully diluted shares outstanding as of December 31, 2022. The amount reserved for issuance under the MAIA 2021 Plan increased by 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 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 % of such amount). As of June 30, 2025, there are shares of Common Stock available for future issuance under the MAIA 2021 Plan and options are outstanding under the MAIA 2021 Plan.
| 21 |
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 from the date of grant. In the case of an option granted to a % stockholder, the exercise price shall be generally no less than % of the fair market value per share on the date of grant, and the contractual term shall be . 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.
As of June 30, 2025, only stock options have been awarded pursuant to the MAIA stock option and equity incentive plans.
| Options Outstanding | Weighted Average Exercise Price | Weighted Average Remaining Contractual Term in Years | Aggregate Intrinsic Value | |||||||||||||
| Balance at January 1, 2025 | $ | |||||||||||||||
| Granted | ||||||||||||||||
| Exercised | ( | ) | ( | ) | ||||||||||||
| Cancelled/forfeited | ( | ) | ( | ) | ||||||||||||
| Balance at June 30, 2025 | $ | $ | ||||||||||||||
| Options exercisable at June 30, 2025 | $ | $ | ||||||||||||||
| 2025 | 2024 | |||||||
| Risk-free interest rate | % - | % | % - | % | ||||
| Expected term (in years) | – | - | ||||||
| Expected volatility | % - | % | % - | % | ||||
| Expected dividend yield | — | % | — | % |
The weighted-average grant date fair value of stock options issued during the six months ended June 30, 2025 and 2024 was $ and $, respectively. As of June 30, 2025, the total unrecognized compensation related to unvested employee and non-employee stock option awards granted was $, which the Company expects to recognize over a weighted average period of approximately years.
| For the Three Months Ended June 30, | For the Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| General and administrative | $ | $ | $ | $ | ||||||||||||
| Research and development | ||||||||||||||||
| Total stock-based compensation | $ | $ | $ | $ | ||||||||||||
| 22 |
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)
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
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
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.
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
BeOne
In
December 2024, the Company reached an agreement with BeOne Medicines, Ltd., (“BeOne”) 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 BeOne drug
candidate that utilizes one of the Company’s compounds/agents. The Company is responsible for all costs of the study with BeOne
supplying their drug tislelizumab representing a cost savings for the Company. The overall term of the agreement is for
| 23 |
Roche
In
June 2025, the Company reached an agreement with F. Hoffman-La Roche Ltd, (“Roche”) to perform certain clinical trials for
the treatment of patients with hard-to-treat cancers involving Roche’s checkpoint inhibitor, atezolizumab (Tecentriq®). The
Company is responsible for all costs of the study with Roche supplying their drug atezolizumab representing a cost savings for the Company.
The overall term of the agreement is for
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 June 30, 2025, and December 31, 2024, the Company had a full valuation allowance against its deferred tax assets.
For
the six months ended June 30, 2025 and 2024, the Company recorded
8. SEGMENT INFORMATION
The
Company operates in
9. SUBSEQUENT EVENTS
Issuance of Options
From
July 1 to August 11, 2025, the Company issued
At-The-Market Offering with H.C. Wainwright
Since
July 1, 2025, the Company has sold
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion together with our financial statements and the related notes included elsewhere in this Quarterly Report on Form 10-Q. This discussion contains forward-looking statements that are based on our current expectations, estimates and projections about our business and operations. Our actual results may differ materially from those currently anticipated and expressed in such forward-looking statements as a result of a number of factors, including those which we discuss under “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q.
Overview
We are a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer. Ateganosine (also known as THIO, 6-thio-dG or 6-thio-2 ‘-deoxyguanosine), our lead asset, is an investigational dual mechanism of action drug candidate incorporating telomere targeting and immunogenicity. Our initial disease target is lung cancer, a serious medical condition with an incidence of over 235,000 new cases in the US in 2024, representing 12% of all cancers, and over 125,000 deaths, or 20% of all cancers. Worldwide, lung cancer incidence is over 2,200,000 per year (ranking second only after breast cancer), and mortality over 1,800,000 (ranking first). Specifically, we are targeting Non-Small Cell Lung Cancer (“NSCLC”), which represents 85% of all lung cancers. In July 2022, the first patient was administered with ateganosine in our Phase 2 human trial (THIO-101) in Australia. In December 2022, regulatory authorities in three European countries, Hungary, Poland, and Bulgaria, approved the implementation of THIO-101, Phase 2 clinical trial evaluating ateganosine in patients with NSCLC. Patients with advanced NSCLC will be treated first with ateganosine followed a few days later by the immune checkpoint inhibitor Libtayo® (cemiplimab), manufactured and commercialized by Regeneron. Cemiplimab is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. Cemiplimab has been approved in the United States and the rest of the world for multiple cancer indications, including NSCLC. In February 2021, we signed a clinical supply agreement with Regeneron to receive cemiplimab at no cost, which represents a significant cost-savings for the study. In return, we have granted Regeneron exclusive development rights in combination with PD-1 inhibitors for NSCLC for the study period. Based on the clinical data generated by our THIO-101 trial, we plan to seek filing for an accelerated approval of ateganosine in the United States for the treatment of patients with advanced NSCLC in 2026, but even if granted, accelerated approval status does not guarantee an accelerated review or marketing approval by the Food and Drug Administration (FDA). We plan to initiate a Phase 3 pivotal trial in 2025, named THIO-104, to evaluate the efficacy of ateganosine administered in sequence with a checkpoint inhibitor (CPI) in third-line NSCLC patients who are resistant to checkpoint inhibitors and chemotherapy which could lead filing for early full commercial approval in 2026 and final analysis could lead to filing for full commercial approval in 2027. The multicenter, open-label, pivotal Phase 3 trial is designed to provide a direct comparison to chemotherapy in a 1:1 randomization of up to 300 patients. In addition, the originally planned Phase 2 clinical trial in multiple tumor indications (THIO-102) is now divided into different trials for one tumor indication each: hepatocellular carcinoma (HCC), colorectal cancer (CRC) and small cell lung cancer (SCLC). In January 2025, we entered into a clinical supply agreement with global oncology company BeOne Medicines to assess the efficacy of ateganosine in combination with BeOne’s immune checkpoint inhibitor (CPI) tislelizumab in three cancer indications across different trials to study the drug combination in HCC, SCLC and CRC. Phase 2 clinical trials in HCC, CRC and SCLC are planned to be initiated in 2026, evaluating treatment with ateganosine administered in sequence with BeOne’s immune checkpoint inhibitor, tislelizumab. In June, 2025, MAIA announced its entry into a clinical master supply agreement with Roche for future studies investigating the combination of ateganosine sequenced with Roche’s checkpoint inhibitor (CPI), atezolizumab (Tecentriq®), for the treatment of multiple cancers indications. Clinical trials with other solid tumors (ST), such as breast, prostate, gastric, pancreatic and ovarian, may still be considered for potential future trials.
We were incorporated in Delaware in August 2018, and have operations in Chicago, Illinois, with some of our team members setup virtually and working remotely in California, North Carolina, and New Jersey, among others. Our principal executive office is located at 444 West Lake Street, Suite 1700, Chicago, IL 60606, and our phone number is (312) 416-8592. In July 2021, we established a wholly-owned Australian subsidiary, MAIA Biotechnology Australia Pty Ltd., to conduct various preclinical and clinical activities for the development of our product candidates. ln April 2022, we established a wholly owned Romanian subsidiary, MAIA Biotechnology Romania S.R.L. to conduct various preclinical and clinical activities for the development of our product candidates. Our website address is www.MAIABiotech.com. The information contained on our website is not incorporated by reference into this prospectus supplement, and you should not consider any information contained on, or that can be accessed through, our website as part of this prospectus supplement or in deciding whether to purchase our securities.
| 25 |
We accomplished the key milestones set forth below in the six months ended June 30, 2025 and the second quarter of 2025: Please note that for consistency of the announcements at the time of their releases, the milestones from January 1, 2025 to March 17, 2025, refer to the molecule “ateganosine” as “THIO” only. On March 18, 2025, the company announced “ateganosine” as the nonproprietary (generic) name for THIO, and its intent to use the generic name to support clear communication, while keeping the name THIO in the Company’s clinical trial designations (THIO-101, THIO-102, THIO-103, THIO-104).
| ● | On January 7, 2025, we announced that we had entered into a clinical supply agreement with global oncology company BeiGene to assess the efficacy of THIO, its small molecule telomere-targeting anticancer agent, in combination with BeiGene’s immune checkpoint inhibitor (CPI) tislelizumab in three cancer indications. The single arm pivotal Phase 2 trials will study the drug combination in hepatocellular carcinoma (HCC), small cell lung cancer (SCLC) and colorectal cancer (CRC). Under the terms of the collaboration, MAIA will sponsor and fund the planned clinical trials and BeiGene will provide tislelizumab. MAIA maintains global development and commercial rights to THIO and is free to develop the programs in combination with other agents and in other indications. |
| ● | On February 4, 2025, we announced positive updated data from THIO-101 Phase 2 clinical trial evaluating its lead clinical candidate, THIO, sequenced with Regeneron’s immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who failed two or more standard-of-care therapy regimens. As of January 15, 2025, third line (3L) data updates showed that: (i) median overall survival (OS) of 16.9 months for the 22 NSCLC patients who received at least one dose of THIO (the intent-to-treat population) in parts A and B of the trial. (ii) The analysis demonstrated a 95% confidence interval (CI) lower bound of 12.5 months and a 99% CI lower bound of 10.8 months. (iii) The treatment has been generally well-tolerated to date in this heavily pre-treated population. |
| ● | 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 Company directors pursuant to securities purchase agreements dated February 18, 2025 at a price per share of $1.50 for which we received gross proceeds of approximately $2.72 million. The warrants issued in the private placement have an exercise price of $1.87, are exercisable one year after issuance and expire 5-years after the initial exercise date. The securities sold to our directors participating in the private placement were issued pursuant to our 2021 Equity Incentive Plan. |
| ● | On February 26, 2025, we announced the trial design for the expansion of its THIO-101 pivotal Phase 2 trial in non-small cell lung cancer (NSCLC). The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. The THIO-101 study in 3L will enroll up to 48 patients with two arms: Arm 1, continuing the evaluation of THIO sequenced with Libtayo® (cemiplimab); and Arm 2, evaluating THIO as a monotherapy, to further gain experience of THIO in the contribution of components. Treatment cycles for patients in both arms will administer THIO on 3 consecutive days, followed by immune activation on day 4. Arm 1 will administer Libtayo on day 5. The Company plans to enroll an additional 100 patients for the registration phase of the trial. MAIA expects to conduct the trials in the U.S. and select countries in Europe and Asia. |
| ● | On February 27, 2025, we announced plans to initiate a Phase 3 pivotal trial in 2025, named THIO-104, to evaluate the efficacy of THIO administered in sequence with a checkpoint inhibitor (CPI) in third-line non-small cell lung cancer (NSCLC) patients who are resistant to checkpoint inhibitors and chemotherapy. The multicenter, open-label, pivotal Phase 3 trial is designed to provide a direct comparison to chemotherapy in a 1:1 randomization of up to 300 patients. | |
| ● | 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 non-brokered private placement to accredited investors and certain Company directors pursuant to securities purchase agreements dated February 24, 2025 at a price per share of $1.50 for which we received gross proceeds of approximately $1.43 million, prior to offering expenses payable by the Company. The warrants issued in the private placement have an exercise price of $1.85, are exercisable one year after issuance and expire 5-years after the initial exercise date. The securities sold to our directors participating in the private placement were issued pursuant to our 2021 Equity Incentive Plan. |
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| ● | On March 18, 2025, MAIA announced that the United States Adopted Names (USAN) Council had approved “ateganosine” as the nonproprietary (generic) name for its lead molecule THIO, a telomere-targeting anticancer agent in clinical development as a first-in-class treatment for advanced non-small cell lung cancer (NSCLC). The company chose a name inspired by the mechanism of action of THIO: altering telomeric guanosine of the cancer cells. The generic name ateganosine is a unique and consistent identity that aims to support clear communication between healthcare providers, patients and researchers. MAIA will retain the name THIO in its clinical trial designations (THIO-101, THIO-102, THIO-103, THIO-104). |
| ● | On March 20, 2025, we announced the publication of preclinical data for our lead proprietary telomere-targeting THIO dimer in the peer-reviewed scientific journal Naunyn-Schmiedeberg’s Archives of Pharmacology. In a preclinical study, ateganosine (THIO) and its new described dimer form were found to be potent inhibitors of Glutathione S-transferase Pi (GSTP1), a key enzyme implicated in cancer progression and chemoresistance and a highly important factor for the detoxification of cancer cells. The findings suggest that the dimerized form of ateganosine could enhance chemotherapeutic efficacy by effectively targeting GSTP1 and reducing drug resistance. The article, titled “Investigation of the inhibitory effects of the telomere-targeted compounds on glutathione S-transferase P1,” was published on February 15, 2025. |
| ● | Effective March 26, 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 of the Company’s common stock, par value $0.0001 per share that the Company may offer and sell under the At The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”), through an “at-the-market offering” program under which Wainwright will act as sales agent the ATM. During the quarter ended June 30, 2025, the Company sold 793,429 shares of Common Stock through Wainwright under the ATM Agreement at an average price of approximately $1.87 per share, resulting in aggregate gross proceeds of approximately $1,480,894, for which it paid Wainwright approximately $44,427 in commissions and other issuance costs of $16,705, resulting in net proceeds to the Company of approximately $1,419,762. As of the date of this Quarterly Report, the Company has sold 2,634,492 shares of our Common Stock through Wainwright under the ATM Agreement at an average price of $2.00 per share, resulting in aggregate gross proceeds of approximately $5,259,024, for which we paid Wainwright $157,771 in commissions resulting in net proceeds to us of approximately $5,101,253. |
| ● | On May 8, 2025, we issued and sold 719,999 shares of our common stock and warrants to purchase 719,999 shares of our common stock in a non-brokered private placement to accredited investors and certain Company directors pursuant to securities purchase agreements dated May 5, 2025 at a price per share of $1.50 for which we received gross proceeds of approximately $1.08 million, prior to offering expenses payable by the Company. The warrants issued in the private placement have an exercise price of $2.05, are exercisable one year after issuance and expire 5-years after the initial exercise date. The securities sold to our directors participating in the private placement were issued pursuant to our 2021 Equity Incentive Plan. |
| ● | On June 3, 2025, we issued and sold 463,332 shares of our common stock and warrants to purchase 463,332 shares of our common stock in a non-brokered private placement to accredited investors and certain Company directors pursuant to securities purchase agreements dated May 27, 2025 at a price per share of $1.50 for which we received gross proceeds of approximately $0.7 million, prior to offering expenses payable by the Company. The warrants issued in the private placement have an exercise price of $1.71, are exercisable six months after issuance and expire 5-years after the issued date. The securities sold to our directors participating in the private placement were issued pursuant to our 2021 Equity Incentive Plan. | |
| ● | On June 5, 2025, MAIA announced updated data from its THIO-101 pivotal Phase 2 clinical trial. As of May 15, 2025, third line (3L) data showed median overall survival (OS) of 17.8 months for the 22 NSCLC patients who received at least one dose of ateganosine (the intent-to-treat population) in parts A and B of the trial. The updated analysis continues to demonstrate a 95% confidence interval (CI) lower bound of 12.5 months and a 99% CI lower bound of 10.8 months. The Company also mentioned that treatment had been generally well-tolerated to date in this heavily pre-treated population. |
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| ● | On June 5, 2025, we announced that a new partial response (PR) was identified in a patient after 20 months of treatment in our Phase 2 THIO-101 clinical trial. A partial response is defined as a decrease in tumor size of at least 30%. | |
| ● | On June 18, 2025, MAIA announced its entry into a clinical master supply agreement with Roche for future studies investigating the combination of MAIA’s telomere-targeting agent ateganosine (THIO), sequenced with Roche’s checkpoint inhibitor (CPI), atezolizumab (Tecentriq®), for the treatment of multiple hard-to-treat cancers. | |
| ● | On June 24, 2025, we announced the appointment of two prominent oncologists to its Scientific Advisory Board (SAB), Claudia Fulgenzi, MD, and David J. Pinato, MD, MRCP (UK), PhD. Both are specialists in hepatocellular carcinoma (HCC), a tumor type to be studied in future clinical trials of MAIA’s lead candidate ateganosine (THIO) sequenced with a checkpoint inhibitor. | |
| ● | On July 9, 2025, we announced the dosing of the first patient in Taiwan in the expansion phase of our THIO-101 Phase 2 trial for advanced non-small cell lung cancer (NSCLC). The trial’s entry into another continent marks a key milestone for MAIA, opening a significantly larger patient pool for its evaluations of ateganosine (THIO). MAIA also announced that screening for the trial is ongoing in Europe and Asia. | |
| ● | On July 17, 2025, MAIA announced the publication of preclinical data from its second generation ateganosine prodrugs platform in Nucleic Acids Research (NAR), a leading open-access peer-reviewed scientific journal. The study, titled “Novel Telomere-Targeting Dual-Pharmacophore Dinucleotide Prodrugs for Anticancer Therapy,” details MAIA’s lead ateganosine (THIO)-derived second-generation prodrugs as promising new molecules in its strategy for enhancing cancer treatment and overcoming drug resistance. The manuscript with the data was published on June 26, 2025, in Volume 53, Issue 12 of the NAR journal. | |
| ● | On July 28, 2025, we announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) for the treatment of non-small cell lung cancer (NSCLC). Ateganosine is currently being evaluated in a pivotal Phase 2 THIO-101 clinical trial evaluating its anti-tumor activity when followed by a checkpoint inhibitor. | |
| ● | In addition to NSCLC, HCC, SCLC and CRC we plan to conduct clinical trials evaluating ateganosine (THIO) in sequential combination with an immune checkpoint inhibitor in several other cancer indications, including solid tumors, such as breast, prostate, gastric, pancreatic and ovarian cancers. THIO-103 is a Phase 2 clinical trial planned to evaluate treatment with ateganosine in first-line patients for both NSCLC and SCLC. |
Impact of the War in Ukraine and War in Israel on Our Operations
The short and long-term implications of war in Ukraine and war in Israel are difficult to predict at this time. The imposition of sanctions and counter sanctions may have an adverse effect on the economic markets generally and could impact our business, financial condition, and results of operations. Because of the highly uncertain and dynamic nature of these events, the Company terminated any planned research activities in the impacted areas.
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Results of Operations for the Three and Six Months Ended June 30, 2025 and 2024
Comparison of Three Months ended June 30, 2025 and 2024
Three Months Ended June 30, | Change | |||||||||||||||
| 2025 | 2024 | Dollars | Percentage | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses | $ | 3,110,867 | $ | 2,052,233 | $ | 1,058,634 | 52 | % | ||||||||
| General and administrative expenses | 2,055,191 | 1,763,029 | 292,162 | 17 | % | |||||||||||
| Total operating costs and expenses | 5,166,058 | 3,815,262 | 1,350,796 | 35 | % | |||||||||||
| Loss from operations | (5,166,058 | (3,815,262 | ) | (1,350,796 | ) | 35 | % | |||||||||
| Other (expense) income: | ||||||||||||||||
| Interest income | 79,697 | 88,383 | (8,686 | ) | (10 | )% | ||||||||||
| Australian research and development incentives | — | 18,048 | (18,048 | ) | (100 | )% | ||||||||||
| Change in fair value of warrant liability | (260,602 | ) | (5,157,493 | ) | 4,896,891 | (95 | )% | |||||||||
| Loss on fair value of warrants over proceeds | — | (12,952 | ) | 12,952 | (100 | )% | ||||||||||
| Other expense, net | (180,905 | ) | (5,064,014 | ) | 4,883,109 | (96 | )% | |||||||||
| Net loss | (5,346,963 | ) | (8,879,276 | ) | 3,532,313 | (40 | )% | |||||||||
| Net loss attributable to MAIA Biotechnology, Inc. shareholders | $ | (5,346,963 | ) | $ | (8,879,276 | ) | $ | 3,532,313 | (40 | )% | ||||||
Operating Costs and Expenses
Research and development expenses
Research and development expenses increased by approximately $1,059,000 (or approximately 52%), from approximately $2,052,000 for the three months ended June 30, 2024, compared to approximately $3,111,000 for the three months ended June 30, 2025. The increase was primarily related to an increase in scientific research and clinical research of approximately $850,000, an increase in stock-based compensation cost of approximately $76,000, an increase in payroll expense of approximately $120,000, and an increase in other expenses of $13,000.
General and administrative expenses
General and administrative expenses increased by approximately $292,000 (or approximately 17%) from approximately $1,763,000 for the three months ended June 30, 2024, compared to approximately $2,055,000 for the three months ended June 30, 2025. The increase was primarily related to an increase in professional fees of approximately $220,000, an increase in stock-based compensation of approximately $313,000, and an increase of approximately $44,000 payroll expense, offset by a decrease in investor relations of approximately $285,000.
Other income (expense), net
Other
income (expense), net increased by approximately $4,883,000 (or approximately 96%) from other expense, net of approximately $5,064,000
for the three months ended June 30, 2024, compared to other expense, net of approximately $181,000 for the three months ended June 30,
2025. The increase was primarily related to the change in the fair value of the warrant liability of approximately $4,910,000, offset
by a reduction in the Australian research and development incentives of approximately $18,000 and a net decrease of interest income of
approximately $9,000.
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Comparison of Six Months Ended June 30, 2025 and 2024
| Six Months Ended | ||||||||||||||||
| June 30, | Change | |||||||||||||||
| 2025 | 2024 | Dollars | Percentage | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses | $ | 6,308,399 | $ | 4,372,975 | $ | 1,935,424 | 44 | % | ||||||||
| General and administrative expenses | 4,283,090 | 3,391,163 | 891,927 | 26 | % | |||||||||||
| Total operating costs and expenses | 10,591,489 | 7,764,138 | 2,827,351 | 36 | % | |||||||||||
| Loss from operations | (10,591,489 | ) | (7,764,138 | ) | (2,827,351 | ) | 36 | % | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 161,880 | 132,501 | 29,379 | 22 | % | |||||||||||
| Australian research and development incentives | — | 36,649 | (36,649 | ) | (100 | )% | ||||||||||
| Loss on fair value of warrants over proceeds | — | (12,952 | ) | 12,952 | (100 | )% | ||||||||||
| Change in fair value of warrant liability | 565,387 | (9,338,791 | ) | 9,904,178 | (106 | )% | ||||||||||
| Other income (expense) net: | 727,267 | (9,182,593 | ) | 9,909,860 | (108 | )% | ||||||||||
| Net loss | $ | (9,864,222 | ) | $ | (16,946,731 | ) | $ | 7,082,509 | (42 | )% | ||||||
Operating Costs and Expenses
Research and development expenses
Research and development expenses increased by approximately $1,935,000 (or approximately 44%), from approximately $4,373,000 for the six months ended June 30, 2024, to approximately $6,308,000 for the six months ended June 30, 2025. The increase was primarily related to an increase in scientific research and clinical research of approximately $1,728,000, an increase in stock-based compensation cost of approximately $129,000, an increase in payroll expense of approximately $83,000, offset by decrease in other expense of $5,000.
General and administrative expenses
General and administrative expenses increased by approximately $892,000 (or approximately 26%) from approximately $3,391,000 for the six months ended June 30, 2024, to approximately $4,283,000 for the six months ended June 30, 2025. The increase was primarily related to an increase in professional fees of approximately $285,000, an increase of investor relations of approximately $306,000, an increase in stock-based compensation of approximately $275,000, and an increase of approximately $26,000 payroll expense.
Other income (expense), net
Other income (expense), net increased by approximately $9,910,000 (or approximately 108%) from other (expense), net of approximately $ 9,183,000 for the six months ended June 30, 2024, to other income, net of approximately $727,000 for the six months ended June 30, 2025. The increase was primarily related to the change in the fair value of the warrant liability of approximately $9,918,000, a net increase in interest income of approximately $29,000, and a reduction in the Australian research and development incentives of approximately $37,000.
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Liquidity and Capital Resources
Our Ability to Continue as a Going Concern
As of June 30, 2025, our cash totaled approximately $10,145,000 which represented an increase of approximately $543,000 compared to December 31, 2024. As of June 30, 2025, we had working capital of approximately $5,999,000 which represents a decrease of approximately $323,000 compared to December 31, 2024. We have generated no revenue as of June 30, 2025. Our current operating plan indicates that we will continue to incur losses from operations and generate negative cash flows from operating activities given ongoing expenditures related to the completion of its ongoing clinical trials and our lack of revenue generating activities. Based on our cash reserves as of June 30, 2025, of $10,144,522 and current financial condition as of the date of this Quarterly Report, the accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
To meet the Company’s future working capital needs, we will need to raise additional equity or enter into debt financing. While we have historically been able to raise additional capital through issuance of equity and/or debt financing, and we have implemented a plan to control its expenses in order to satisfy its obligations due within one year from the date of issuance of these financial statements, we cannot guarantee that it will be able to raise additional equity, raise debt, or contain expenses. Accordingly, there is substantial doubt about our ability to continue as a going concern within one year after these financial statements are issued.
Sales of Common Stock
On March 14, 2024, we issued and sold 2,496,318 shares of our Common Stock and warrants to purchase 2,496,318 shares of our Common Stock in a private placement to certain accredited investors and to our participating directors pursuant to securities purchase agreements dated March 11, 2024 at a price $1.17 per share, for which we received gross proceeds of approximately $2.92 million. The securities sold to our directors participating in the March 14, 2024 private placement were issued pursuant to the MAIA 2021 Plan.
On March 28, 2024, we issued and sold 578,643 shares of our Common Stock and warrants to purchase 578,643 shares of our Common Stock in a private placement to certain accredited investors pursuant to securities purchase agreements dated March 25, 2024 at a price of $2.295 per share, for which we received gross proceeds of approximately $1.33 million.
Between February 14, 2024 and March 31, 2024, we sold 507,754 shares of Common Stock at an average price of approximately $1.47 per share, resulting in aggregate gross proceeds of approximately $745,251 under the ATM Agreement dated February 14, 2024, for which we paid Wainwright approximately $22,357 in commissions resulting in net proceeds to us of approximately $722,894.
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 $2.7 million. 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 25, 2025 at a price of $1.50 per share, for which we received gross proceeds of approximately $1.4 million. The securities sold to our directors participating in the March 3, 2025, private placement were issued pursuant to the MAIA 2021 Plan.
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From January 1, 2025 through March 31, 2025, we sold 666,323 shares of Common Stock through Wainwright under the ATM Agreement at an average price of approximately $2.28 per share, resulting in aggregate gross proceeds of approximately $1,521,091, for which we paid Wainwright approximately $45,633 in commissions and other issuance costs of $84,587, resulting in net proceeds to us of approximately $1,390,871.
From April 1, 2025 through June 30, 2025, we sold 793,429 shares of Common Stock through Wainwright under the ATM Agreement at an average price of approximately $1.87 per share, resulting in aggregate gross proceeds of approximately $1,480,894, for which we paid Wainwright approximately $44,427 in commissions and other issuance costs of $16,705, resulting in net proceeds to us of approximately $1,419,762.
On May 8, 2025, we issued and sold 719,999 shares of our Common Stock and warrants to purchase 719,999 shares of our Common Stock in a private placement to certain accredited investors and to our participating directors pursuant to securities purchase agreements dated May 5, 2025, at a price of $1.50 per share, for which we received gross proceeds of approximately $1.08 million. The securities sold to our directors participating in the May 8, 2025 private placement were issued pursuant to the MAIA 2021 Plan.
On June 3, 2025, we issued and sold 463,332 shares of our Common Stock and warrants to purchase 463,332 shares of our Common Stock in a private placement to certain accredited investors and to our participating directors pursuant to securities purchase agreements dated May 27, 2025, at a price of $1.50 per share, for which we received gross proceeds of approximately $0.7 million. The securities sold to our directors participating in the June 3, 2025 private placement were issued pursuant to the MAIA 2021 Plan.
We will need to raise additional capital to fund our operations, to develop and commercialize ateganosine, and to develop, acquire or in-license other products. We may seek to fund our operations through public equity, private equity, or debt financing, as well as other sources. We cannot make any assurances that additional financing will be available to us and, if available, on acceptable terms or at all. This could negatively impact our business and operations and could also lead to the reduction of our operations.
Cash Flows
Cash Flows for the Six Months ended June 30, 2025 and 2024
| Six Months Ended June 30, | ||||||||
| 2025 | 2024 | |||||||
| Net cash flows used in operating activities | $ | (8,337,611 | ) | $ | (8,271,571 | ) | ||
| Net cash flows provided by financing activities | 8,869,406 | 12,704,327 | ||||||
| Effect of foreign currency exchange rate changes on cash | 11,429 | (4,060 | ) | |||||
| Net increase in cash | $ | 543,224 | $ | 4,428,696 | ||||
Operating Activities
For the six months ended June 30, 2025, net cash used in operating activities was approximately $8,338,000, which consisted of a consolidated net loss of approximately $9,864.000 offset by non-cash charges of approximately $1,173,000 in stock-based compensation, approximately $62,000 of non-cash expense to issue stock to consultants and vendors, and the decrease in the remeasurement of the warrant liability of approximately $565,000. Total changes in operating assets and liabilities of approximately $856,000 were driven by an approximate $1,208,000 net increase in accounts payable and accrued expenses, and an approximate $352,000 decrease in prepaid expense and other assets.
For the six months ended June 30, 2024, net cash used in operating activities was approximately $8,272,000, which consisted of a consolidated net loss of approximately $16,947,000 offset by non-cash charges of approximately $764,000 in stock-based compensation, approximately $12,000 of non-cash expense to issue stock to consultants, the remeasurement of the warrant liability of approximately $9,339,000, and the loss on fair value of warrants over proceeds of approximately $13,000. Total changes in operating assets and liabilities of approximately $1,452,000 were driven by an approximate $1,423,000 net decrease in accounts payable and accrued expenses, an approximate $37,000 decrease in the Australia research and development incentives receivable, an approximate $73,000 decrease in other receivables, and an approximate $81,000 increase in prepaid expense and other assets.
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For the six months ended June 30, 2025, the effect of foreign currency exchange rate changes on cash increased the cash balance as of June 30, 2025 by approximately $11,000 versus a decrease of approximately $4,000 for the six months ended June 30, 2024.
Investing Activities
For the six months ended June 30, 2025 and 2024, we did not have any cash provided by or used in investing activities.
Financing Activities
Net cash provided by financing activities was approximately $8,869,000 and $12,704,000 for the six months ended June 30, 2025 and 2024, respectively. Total net cash provided by financing activities for the six months ended June 30, 2025 consisted primarily of approximately $5,919,000 gross proceeds from private placement offerings, proceeds from the at-the-market offering of approximately $3,002,000, proceeds from the exercise of stock options of $1,000, proceeds from the exercise of warrants of $328,000 and were offset by an approximate $381,000 of offering costs.
Net cash provided by financing activities for the six months ended June 30, 2024, consisted primarily of approximately $5,254,000 gross proceeds from private placement offerings, proceeds from the at-the-market offering of approximately $7,862,000, proceeds from the exercise of stock options of $185,000, and offset by approximately $597,000 of offering costs.
Off-Balance Sheet Arrangements
None.
Critical Accounting Policies and Significant Judgments and Estimates
Our condensed consolidated financial statements are prepared in accordance with GAAP. These accounting principles require us to make certain estimates, judgments and assumptions that affect the reported amounts of assets and liabilities as of the date of the financial statements. We believe that the estimates, judgments and assumptions are reasonable based upon information available to us at the time that these estimates, judgments and assumptions are made. To the extent there are material differences between these estimates, judgments or assumptions and actual results, our financial statements will be affected. For a discussion of our critical accounting estimates, please read Part II, Item 7 — Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 21, 2025. There have been no material changes to the critical accounting estimates previously disclosed in such report.
Recently Issued Accounting Standards Not Yet Effective or Adopted
Management does not believe that any recently issued, but not yet effective accounting pronouncements, if adopted, would have a material impact on the accompanying unaudited condensed consolidated financial statements.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
We are a smaller reporting company and are not required to provide the information otherwise required under this item.
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Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Under the supervision of and with the participation of our management, including our Chief Executive Officer, who is our principal executive officer, and our Head of Finance, who is our principal financial officer, we conducted an evaluation of the effectiveness of our disclosure controls and procedures as of June 30, 2025, the end of the period covered by this Quarterly Report. The term “disclosure controls and procedures,” as set forth in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, (the “Exchange Act”) means controls and other procedures of a company that are designed to provide reasonable assurance that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the rules and forms promulgated by the SEC. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, management recognizes that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a control system, misstatements due to error or fraud may occur and not be detected. Based on the evaluation of our disclosure controls and procedures as of June 30, 2025, our Chief Executive Officer and Head of Finance concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting identified in management’s evaluation pursuant to Rules 13a-15(d) or 15d-15(d) of the Exchange Act during the period covered by this Quarterly Report that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II—OTHER INFORMATION
Item 1. Legal Proceedings
We are not party to any material legal proceedings. From time to time, we may be involved in legal proceedings or subject to claims incident to the ordinary course of business. Regardless of the outcome, such proceedings or claims can have an adverse impact on us because of defense and settlement costs, diversion of resources and other factors, and there can be no assurances that favorable outcomes will be obtained.
Item 1A. Risk Factors.
Factors that could cause our actual results to differ materially from those in this Quarterly Report are any of the risks described in “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the Securities and Exchange Commission on March 21, 2025. Any of these factors could result in a significant or material adverse effect on our results of operations or financial condition. Additional risk factors not presently known to us or that we currently deem immaterial may also impair our business or results of operations. As of the date of this Quarterly Report, there are no additional risk factors added to the risk factors disclosed in our Annual Report on Form 10-K.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
(a) Recent sales of unregistered securities
On June 02, 2025, we issued 18,040 shares of our common stock with a value of $31,570 (based on the $1.75 closing price of our common stock on June 2, 2025) to FGMK, LLC, a greater than 5% holder of our common stock in consideration of accounting and tax assistance services. The issuance was exempt under Section 4(a)(2) of the Securities Act of 1933, as amended.
On June 18, 2025 we issued 17,083 shares of our common stock having a value of $30,751 (based on the $1.80 closing price of our common stock on June 18, 2025) to a service provider under a master services agreement in consideration of services rendered. The issuance was exempt under Section 4(a)(2) of the Securities Act of 1933, as amended.
(b) Purchases of equity securities by the issuer and affiliated purchasers.
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
10b5-1 Trading Plans
During
the fiscal quarter ended June 30, 2025, no Section 16 director or officer
There
were no “non-Rule 10b5-1 trading arrangements” (as defined in Item 408 of Regulation S-K of the Exchange Act)
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Item 6. Exhibits.
* Filed herewith.
**
Furnished herewith.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| MAIA BIOTECHNOLOGY INC. | ||
| Date: August 11, 2025 | By: | /s/ Vlad Vitoc |
| Vlad Vitoc | ||
| Chief Executive Officer | ||
| (Principal Executive Officer) | ||
| Date: August 11, 2025 | By: | /s/ Jeffrey C. Himmelreich |
| Jeffrey C. Himmelreich | ||
| Head of Finance | ||
| (Principal Financial and Accounting Officer) | ||
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