UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended June 30, 2026
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: 001-41455
MAIA
BIOTECHNOLOGY, INC.
(Exact
Name of Registrant as Specified in its Charter)
Delaware
83-1495913
(State
or other jurisdiction of
incorporation
or organization)
(I.R.S.
Employer
Identification
No.)
444
West Lake Street , Suite 1700
Chicago ,
IL
60606
(Address
of principal executive offices)
(Zip
Code)
(312)
416-8592
(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
Common
Stock, $0.0001 par value per share
MAIA
NYSE
American
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. Yes ☒ No ☐
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). Yes ☒ No ☐
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
☐
Non-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 10, 2026, the registrant had 60,825,844 shares of common stock, $ 0.0001 par value per share, outstanding.
Table
of Contents
Page
Note
About Forward-Looking Statements
1
PART
I—FINANCIAL INFORMATION
2
Item
1.
Financial
Statements
2
Condensed
Consolidated Balance Sheets as of June 30, 2026 (Unaudited) and December 31, 2025
2
Condensed
Consolidated Statements of Operations (Unaudited) for the three and six months ended June 30, 2026 and 2025
3
Condensed
Consolidated Statements of Comprehensive Loss (Unaudited) for the three and six months ended June 30, 2026 and 2025
4
Condensed
Consolidated Statements of Changes in Stockholders’ Equity (Unaudited) for the three and six months ended June 30, 2026 and
2025
5
Condensed
Consolidated Statements of Cash Flows (Unaudited) for the six months ended June 30, 2026 and 2025
7
Notes
to Unaudited Condensed Consolidated Financial Statements
8
Item
2.
Management’s
Discussion and Analysis of Financial Condition and Results of Operations
23
Item
3.
Quantitative
and Qualitative Disclosures About Market Risk
29
Item
4.
Controls
and Procedures
29
PART
II—OTHER INFORMATION
30
Item
1.
Legal
Proceedings
30
Item
1A.
Risk
Factors
30
Item
2.
Unregistered
Sales of Equity Securities and Use of Proceeds
30
Item
3.
Defaults
Upon Senior Securities
30
Item
4.
Mine
Safety Disclosures
30
Item
5.
Other
Information
31
Item
6.
Exhibits
31
Signatures
32
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 within the meaning of the Private
Securities Litigation Reform Act of 1995 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 SEC 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, 2025 filed with the SEC on March 23, 2026 and in the 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, 2026
December
31, 2025
(Unaudited)
ASSETS
Current assets:
Cash
$ 27,595,831
$ 8,658,031
Prepaid
expenses and other current assets
641,540
1,043,825
Total current assets
28,237,371
9,701,856
Other
assets
2,800
2,800
Total
assets
$ 28,240,171
$ 9,704,656
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable
$ 2,838,652
$ 2,038,803
Accrued
expenses
3,419,240
3,797,595
Total
current liabilities
6,257,892
5,836,398
Long term liabilities:
Warrant
liability
1,307,269
1,492,395
Total
liabilities
7,565,161
7,328,793
Commitments and contingencies (Note 7)
-
-
Stockholders’ equity (deficit)
Preferred stock, $ 0.0001
par value, 30,000,000 shares authorized at June 30, 2026 and December 31, 2025, 0 shares issued and outstanding
—
—
Common stock, $ 0.0001
par value, 150,000,000
shares authorized at June 30, 2026 and at December 31, 2025, respectively, 60,817,482
and 38,624,289
shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively
6,082
3,863
Additional paid-in capital
144,654,861
112,053,233
Accumulated deficit
( 123,944,244 )
( 109,631,005 )
Accumulated
other comprehensive loss
( 41,689 )
( 50,228 )
Total
stockholders’ equity
20,675,010
2,375,863
Total
liabilities and stockholders’ equity
$ 28,240,171
$ 9,704,656
See
the accompanying notes to the unaudited condensed consolidated financial statements.
2
MAIA
Biotechnology, Inc. and Subsidiaries
Condensed
Consolidated Statements of Operations
(Unaudited)
2026
2025
2026
2025
Three
Months Ended June 30,
Six
Months Ended June 30,
2026
2025
2026
2025
Operating expenses:
Research
and development expenses
$ 5,639,660
$ 3,110,867
$ 9,164,757
$ 6,308,399
General
and administrative expenses
2,677,591
2,055,191
6,102,423
4,283,090
Total
operating expenses
8,317,251
5,166,058
15,267,180
10,591,489
Loss from operations
( 8,317,251 )
( 5,166,058 )
( 15,267,180 )
( 10,591,489 )
Other income (expense):
Interest income
236,320
79,697
348,077
161,880
Grant income
207,173
—
420,738
—
Change
in fair value of warrant liability
( 69,829 )
( 260,602 )
185,126
565,387
Other income (expense)
net:
373,664
( 180,905 )
953,941
727,267
Net loss
$ ( 7,943,587 )
$ ( 5,346,963 )
$ ( 14,313,239 )
$ ( 9,864,222 )
Net loss per share:
Basic and diluted
$ ( 0.13 )
$ ( 0.18 )
$ ( 0.27 )
$ ( 0.34 )
Weighted average
common shares outstanding basic and diluted
60,794,335
30,300,339
53,089,104
29,008,949
See
the accompanying notes to the unaudited condensed consolidated financial statements.
3
MAIA
Biotechnology, Inc. and Subsidiaries
Condensed
Consolidated Statements of Comprehensive Loss
(Unaudited)
2026
2025
2026
2025
Three
Months Ended June 30,
Six
Months Ended June 30,
2026
2025
2026
2025
Net loss
$ ( 7,943,587 )
$ ( 5,346,963 )
$ ( 14,313,239 )
$ ( 9,864,222 )
Foreign currency translation
adjustment
( 2,022 )
8,127
8,539
587
Comprehensive loss
$ ( 7,945,609 )
$ ( 5,338,836 )
$ ( 14,304,700 )
$ ( 9,863,635 )
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)
Shares
Amount
Shares
Amount
Capital
Deficit
Income
(Loss)
Equity
For the Three
and Six Months Ended
June 30,
2026
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, 2025
—
$ —
38,624,289
$ 3,863
$ 112,053,233
$ ( 109,631,005 )
$ ( 50,228 )
$ 2,375,863
Exercise of stock options
—
—
21,479
2
38,547
—
—
38,549
Stock-based compensation
expense
—
—
—
—
650,024
—
—
650,024
Issuance of restricted
stock
—
—
19,848
2
43,649
—
—
43,651
Issuance of common shares
in connection with the confidentially marketed public offering, net of $ 1,995,041 of issuance costs
—
—
22,005,875
2,201
31,011,571
—
—
31,013,772
Foreign currency translation
adjustment
—
—
—
—
—
—
10,561
10,561
Net
loss
—
—
—
—
—
( 6,369,652 )
—
( 6,369,652 )
Balance at March 31, 2026
—
$ —
60,671,491
$ 6,068
$ 143,797,024
$ ( 116,000,657 )
$ ( 39,667 )
$ 27,762,768
Stock-based compensation
expense
—
—
—
—
723,915
—
—
723,915
Issuance of restricted
stock
—
—
145,991
14
198,922
—
—
198,936
Other
—
—
—
—
( 65,000 )
—
—
( 65,000 )
Foreign currency translation
adjustment
—
—
—
—
—
—
( 2,022 )
( 2,022 )
Net
loss
—
—
—
—
—
( 7,943,587 )
—
( 7,943,587 )
Balance at June 30,
2026
—
$ —
60,817,482
$ 6,082
$ 144,654,861
$ ( 123,944,244 )
$ ( 41,689 )
$ 20,675,010
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,
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
—
$ —
26,157,788
$ 2,616
$ 90,897,468
$ ( 87,234,833 )
$ ( 30,615 )
$ 3,634,636
Exercise of stock options
—
—
570
—
844
—
—
844
Stock-based compensation
expense
—
—
—
—
371,472
—
—
371,472
Issuance of common shares
in connection with At-The-Market financing, net of $ 130,220 of issuance costs
—
—
666,323
67
1,390,804
—
—
1,390,871
Issuance of common shares
in connection with the Private Placement Offerings, net of $ 74,448 of issuance costs
—
—
2,762,633
276
2,390,457
—
—
2,390,733
Issuance of warrants in
connection with the Private Placement Offerings
—
—
—
—
1,678,768
—
—
1,678,768
Foreign currency translation
adjustment
—
—
—
—
—
—
( 7,540 )
( 7,540 )
Net
loss
—
—
—
—
—
( 4,517,259 )
—
( 4,517,259 )
Balance at March 31, 2025
—
$ —
29,587,314
$ 2,959
$ 96,729,813
$ ( 91,752,092 )
$ ( 38,155 )
$ 4,942,525
Issuance of restricted
stock
—
—
35,123
4
62,317
—
—
62,321
Exercise of warrants
—
—
219,283
22
328,902
—
—
328,924
Stock-based compensation
expense
—
—
—
—
802,484
—
—
802,484
Issuance of common shares
in connection with At-The-Market financing, net of $ 61,132 of issuance costs
—
—
793,429
79
1,419,683
—
—
1,419,762
Issuance of common shares
in connection with At-The-Market financing, net of issuance costs
—
—
793,429
79
1,419,683
—
—
1,419,762
Issuance of common shares
in connection with the Private Placement Offerings, net of $ 115,493 of issuance costs
—
—
1,183,331
118
896,549
—
—
896,667
Issuance of common shares
in connection with the Private Placement Offerings, net of issuance costs
—
—
1,183,331
118
896,549
—
—
896,667
Issuance of warrants in
connection with the Private Placement Offerings
—
—
—
—
762,837
—
—
762,837
Foreign currency translation
adjustment
—
—
—
—
—
—
8,127
8,127
Net
loss
—
—
—
—
—
( 5,346,963 )
—
( 5,346,963 )
Balance at June 30,
2025
—
$ —
31,818,480
$ 3,182
$ 101,002,585
$ ( 97,099,055 )
$ ( 30,028 )
$ 3,876,684
See
the accompanying notes to the unaudited condensed consolidated financial statements.
6
MAIA
Biotechnology, Inc. and Subsidiaries
Condensed
Consolidated Statements of Cash Flows
(Unaudited)
2026
2025
Six
Months Ended June 30,
2026
2025
Cash flows from operating
activities:
Net loss
$ ( 14,313,239 )
$ ( 9,864,222 )
Adjustments to reconcile net loss to net
cash used in operating activities:
Stock-based compensation
1,373,939
1,173,956
Restricted stock issued
for consulting expense
242,587
62,321
Change in fair value
of warrant liability
( 185,126 )
( 565,387 )
Change in operating assets and liabilities:
Prepaid expenses and
other current assets
401,990
( 352,257 )
Accounts payable
796,104
206,031
Accrued
expenses
( 377,638 )
1,001,947
Net
cash used in operating activities
( 12,061,383 )
( 8,337,611 )
Cash flows from financing
activities:
Proceeds from exercise of stock options
38,549
844
Proceeds from exercise of warrants
—
328,924
Proceeds from private placement round 1
2025
—
2,715,000
Proceeds from private placement round 2
2025
—
1,428,949
Proceeds from private placement round 3
2025
—
1,079,998
Proceeds from private placement round 4
2025
—
694,999
Proceeds from private placement
—
694,999
Proceeds from confidentially marketed public
offering
33,008,813
—
Proceeds from At-The-Market offering
—
3,001,985
Payment of offering
transactions costs
( 2,060,041 )
( 381,293 )
Net cash provided by
financing activities
30,987,321
8,869,406
Net effect of foreign
currency exchange on cash
11,862
11,429
Net increase in cash
18,937,800
543,224
Cash at beginning of
period
8,658,031
9,601,298
Cash at end of period
$ 27,595,831
$ 10,144,522
Supplemental disclosure
of cash flow information:
Warrants issued in
connection with private placement offering 1 2025
$ —
$ 1,107,202
Warrants issued in
connection with private placement offering 2 2025
$ —
$ 571,566
Warrants issued in
connection with private placement offering 3 2025
$ —
$ 462,592
Warrants issued in
connection with private placement offering 4 2025
$ —
$ 300,245
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 Delaware on August 3, 2018 . These condensed consolidated financial statements include the accounts of MAIA and its subsidiaries,
as follows:
●
In
July 2021, the Company established a wholly owned Australian subsidiary, MAIA Biotechnology Australia Pty Ltd., to conduct various
pre-clinical and clinical activities for the development of the Company’s product candidates.
●
In
April 2022, the Company established a wholly owned Romanian subsidiary, MAIA Biotechnology Romania S.R.L., to conduct various pre-clinical
and clinical activities for the development of the Company’s product candidates.
Liquidity
At
June 30, 2026, the Company had working capital of $ 21,979,479 , an accumulated deficit of $ 123,944,244 , cash of $ 27,595,831 and
current liabilities of $ 6,257,892 . Since its inception the Company has experienced net losses and negative cash flows from operations
each fiscal year. The Company has no revenue and expects to continue to incur operating losses for the foreseeable future and may never
become profitable. The Company is dependent on its ability to continue to raise equity and/or debt financing to continue operations,
and the attainment of profitable operations.
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, 2025, included in the Company’s Annual Report on Form 10-K filed with the SEC on March 23, 2026. The condensed consolidated
balance sheet as of December 31, 2025, 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.
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
CODM, the 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.
8
Use
of Estimates
The
preparation of the Company’s unaudited interim condensed consolidated financial statements in conformity with GAAP requires management
to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The most significant
estimates in the Company’s financial statements relate to the valuation of the Company’s common stock, par value $ 0.0001
per share (the “Common Stock”), stock options and warrants, the embedded features in convertible notes, and accruals for
outsourced research and development activities. These estimates and assumptions are based on current facts, historical experience and
various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about
the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual
results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates
and actual results, the Company’s future results of operations will be affected.
Certain
Risks and Uncertainties
The
Company’s activities are subject to significant risks and uncertainties, including the risk of failure to secure additional funding
to properly execute the Company’s business plan. The Company is subject to risks that are common to companies in the pharmaceutical
industry, including, but not limited to, the development by the Company or its competitors of new technological innovations, dependence
on key personnel, reliance on third party manufacturers, protection of proprietary technology, and compliance with regulatory requirements.
Foreign
Currency Translation
The
financial statements of the Company’s foreign subsidiaries, where the local currency is the functional currency, are translated
using exchange rates in effect as of the applicable balance sheet dates for assets and liabilities and average exchange rates during
the period for results of operations. The resulting foreign currency translation adjustment is included in stockholders’ equity
as accumulated other comprehensive loss.
Off-Balance
Sheet Risk and Concentrations of Credit Risk
The
Company has no significant off-balance sheet risks, such as foreign exchange contracts, option contracts, or other foreign hedging arrangements.
Cash accounts are maintained at financial institutions that potentially subject the Company to concentrations of credit risk. As of June
30, 2026 and December 31, 2025, substantially all of the Company’s cash was deposited in accounts at two financial institutions.
The Company maintains its cash deposits, which at times may exceed the federally insured limits, with a reputable financial institution,
and accordingly, the Company believes such funds are subject to minimal credit risk.
Cash
and Cash Equivalents
The
Company considers all highly liquid investments purchased with maturities of three months or less to be cash equivalents. As of June
30, 2026 and December 31, 2025, the Company had no cash equivalents.
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 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.
9
●
Level
2 - Valuations based on observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets
and liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active,
or other inputs that are observable or can be corroborated by observable market data.
●
Level
3 - Valuations based on unobservable inputs reflecting our own assumptions, consistent with reasonably available assumptions made
by other market participants. These valuations require significant judgment.
Fair
value measurements discussed herein are based upon certain market assumptions and pertinent information available to management as
of and during the three and six months ended June 30, 2026, and 2025 and as of December 31, 2025.
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, 2026 and the twelve months ended December 31, 2025. The estimated fair
value of warrants issued to underwriters represented Level 3 measurements.
General
and Administrative
General
and administrative expenses primarily consist of costs for corporate functions, including payroll and related expenses, rent, outside
legal expenses, insurance costs, and other general and administrative costs.
Research
and Development
The
Company’s research and development expenses consist primarily of costs associated with the Company’s clinical trials, salaries,
payroll taxes, employee benefits, and stock-based compensation charges for those individuals involved in ongoing research and development
efforts. Research and development costs are expensed as incurred. Advance payments for goods and services that will be used in future
research and development activities are expensed when the activity has been performed or when the goods have been received.
As
part of the process of preparing the condensed consolidated financial statements, the Company is required to estimate its accrued expenses.
This process involves reviewing quotations and contracts, identifying services that have been performed on the Company’s behalf
and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced
or otherwise notified of the actual cost. The majority of the Company’s service providers invoice the Company monthly in arrears
for services performed or when contractual milestones are met. The Company makes estimates of its accrued expenses as of each balance
sheet date in our condensed consolidated financial statements based on facts and circumstances known to the Company at that time. The
Company periodically confirms the accuracy of its estimates with the service providers and makes adjustments if necessary. The estimates
in the Company’s accrued research and development expenses are related to expenses incurred with respect to contract research organizations
(“CROs”), contract manufacturing 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.
10
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
National
Institute of Health (NIH) Grant
The
Company entered into an agreement with the National Cancer Institute for SBIR grant. Under the terms of the agreement, the National Cancer
Institute has committed to reimburse the Company up to $ 2,297,863 of qualifying research and development expenses over the term of the
grant. The Company’s ability to receive these funds is contingent upon incurring eligible costs and achieving certain performance
objectives.
Derivative
Financial Instruments
The
Company does not use derivative instruments to hedge exposures to cash flow, market, or foreign currency risks. The Company evaluates
all of its financial instruments to determine if such instruments contain features that qualify as embedded derivatives.
Embedded
derivatives must be separately measured from the host contract if all the requirements for bifurcation are met. The assessment of the
conditions surrounding the bifurcation of embedded derivatives depends on the nature of the host contract. Bifurcated embedded derivatives
are recognized at fair value, with changes in fair value recognized in the statement of operations each period.
Stock-Based
Compensation
The
Company records share-based compensation for awards granted to employees, non-employees, and to members of the board of directors based
on the grant date fair value of awards issued, and the expense is recorded on a straight-line basis over the requisite service period.
Forfeitures are recognized when they occur.
The
Company uses the Black-Scholes-Merton option pricing model to determine the fair value of stock options and warrants. The use of the
Black-Scholes-Merton option-pricing model requires management to make assumptions with respect to the expected term of the option, the
expected volatility of the Common Stock consistent with the expected life of the option, risk-free interest rates and expected dividend
yields of the Common Stock. The Company has concluded that its historical share option exercise experience does not provide a reasonable
basis upon which to estimate expected term. Therefore, the expected term was determined according to the simplified method, which is
the average of the vesting tranche dates and the contractual term. Due to the lack of company specific 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.
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 , 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.
11
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.
In
July 2025, the One Big Beautiful Bill Act (Public Law 119-21) was enacted. The Company recognized the income tax effects of the
legislation in the period of enactment in accordance with ASC 740. The legislation did not have a material impact on the
Company’s condensed consolidated financial statements for the quarter ended June 30, 2026. The Company will continue to
evaluate the impact of the legislation on future periods.
Net
Loss Per Share
Basic
loss per share of Common Stock is computed by dividing net loss attributable to common stockholders by the weighted average number of
shares of Common Stock outstanding for the period. Diluted net loss per share is calculated by adjusting the weighted-average number
of shares outstanding for the dilutive effect of Common Stock equivalents outstanding for the period, determined using the treasury-stock
method. Diluted loss per share excludes, when applicable, the potential impact of stock options, unvested shares of restricted stock
awards, and common stock warrants because their effect would be anti-dilutive due to our net loss. Gains on warrant liabilities are only
considered dilutive when the average market price of the Common Stock during the period exceeds the exercise price of the warrants. Since
the Company had a net loss in each of the periods presented, basic and diluted net loss per common share are the same.
The
following table summarizes the Company’s potentially dilutive securities, in common share equivalents, which have been excluded
from the calculation of dilutive loss per share as their effect would be anti-dilutive:
SCHEDULE OF ANTIDILUTIVE SHARES EXCLUDED FROM CALCULATION OF DILUTIVE LOSS PER SHARE
2026
2025
Six
Months Ended June 30,
2026
2025
Shares issuable upon exercise
of stock options
16,680,425
11,952,412
Shares issuable upon exercise of warrants
13,086,220
10,143,192
Leases
In
February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No.
2016-02, as amended, Leases (“Topic 842”), which applies to all leases. Under Topic 842, a right-of-use asset and lease obligation
will be recorded for all leases, whether operating or financing leases, while the statement of operations will reflect lease expense
for operating leases and amortization and interest expense for financing leases. At the inception of an arrangement the Company determines
whether the arrangement is or contains a lease based on the circumstances present. All leases with a term greater than one year are recognized
on the consolidated balance sheet as right-of-use assets, lease liabilities and, if applicable, long-term lease liabilities. The Company
has elected not to recognize on the consolidated balance sheet leases with terms of one year or less. Lease liabilities and their corresponding
right-of-use assets are recorded based on the present value of lease payments over the expected lease term. The interest rate implicit
in lease contracts is typically not readily determinable. As such, the Company utilizes the appropriate incremental borrowing rate, which
is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic
environment. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or incentives
received. At the inception of an arrangement the Company determines whether the arrangement is or contains a lease based on the circumstances
present. Currently none of the Company’s operating lease commitments are subject to the standard as its leases are short-term in
nature (i.e., less than twelve months).
12
Recent
Accounting Standards
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.
In
December 2025, the FASB issued ASU 2025-10, Government Grants (Topic 832): Accounting for Government Grants Received by Business
Entities, which requires recognizing grants when compliance with conditions is probable. ASU 2025-10 is effective for fiscal years
beginning after December 15, 2028 and allows for adoption on a prospective basis, with a retrospective option. Early adoption is
permitted. The Company has elected earlier adoption, which did not have a material impact on our consolidated financial statements.
See Note 9 – Government Grants.
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 own more than 5 % of the stock of the Company and
are therefore related parties. The Company expensed $ 19,830 and $ 31,570 during the six-month period ended June 30, 2026 and June 30,
2025, respectively, related to accounting, tax and valuation services provided by these parties. In addition, FGMK Business Holdings,
LLC participated in the February 2025 private placement and purchased 1,350,000 shares of the Company’s Common Stock and warrants
to purchase 1,350,000 shares of the Company’s Common Stock for an aggregate purchase price of approximately $ 2,025,000 .
10b5-1
Plan
Certain
of our directors and executive officers previously adopted written plans, known as Rule 10b5-1 plans, in which they contracted with a
broker to buy shares of our Common Stock on a periodic basis. Each of these plans have expired as of the date of this Quarterly Report.
Our directors and executive officers may, in the future, adopt Rule 10b5-1 plans in which they contract with a broker to buy or sell
shares of our Common Stock on a periodic basis. Under a Rule 10b5-1 plan, a broker executes trades pursuant to parameters established
by the director or officer at the time it 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 non-public information.
Private
Placement
The
following Company directors participated in the February 2025 private placement as follows: (i) Stan Smith purchased 50,000 shares of
our Common Stock and warrants to purchase up to 50,000 shares of our Common Stock for an aggregate purchase price of $ 75,000 ; (ii) Ramiro
Guerrero purchased 73,333 shares of our Common Stock and warrants to purchase up to 73,333 shares of our Common Stock for an aggregate
purchase price of approximately $ 110,000 .
The
following Company directors participated in the March 2025 private placement as follows: (i) Stan Smith purchased 25,000 shares of our
Common Stock and warrants to purchase up to 25,000 shares of our Common Stock for an aggregate purchase price of $ 37,500 ; (ii) Ramiro
Guerrero purchased 33,333 shares of our Common Stock and warrants to purchase up to 33,333 shares of our Common Stock for an aggregate
purchase price of approximately $ 50,000 .
The
following Company directors participated in the May 2025 private placement as follows: (i) Stan Smith purchased 66,666 shares of our
Common Stock and warrants to purchase up to 66,666 shares of our Common Stock for an aggregate purchase price of $ 99,999 ; (ii) Ramiro
Guerrero purchased 20,000 shares of our Common Stock and warrants to purchase up to 20.000 shares of our Common Stock for an aggregate
purchase price of approximately $ 30,000 .
The following Company director participated in
the June 2025 private placement as follows: Stan Smith purchased 33,333 shares of our Common Stock and warrants to purchase up to 33,333
shares of our Common Stock for an aggregate purchase price of approximately $ 50,000 .
There
were no private placements in the six months ended June 30, 2026.
13
3.
ACCRUED EXPENSES
As
of June 30, 2026 and December 31, 2025 accrued expenses consisted of the following:
SCHEDULE OF ACCRUED EXPENSES
June 30, 2026
December 31, 2025
Bonus
$ 649,590
$ 1,199,955
Professional fees
117,803
288,077
Research and development costs
2,285,803
2,061,497
Other
366,044
248,066
Total accrued expenses
$ 3,419,240
$ 3,797,595
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:
SCHEDULE OF FAIR VALUE MEASUREMENT OF EMBEDDED DERIVATIVE LIABILITIES AND WARRANT LIABILITIES
Fair
value at June 30, 2026
Total
Level
1
Level
2
Level
3
Liabilities:
Warrant
liability
$ 1,307,269
$ —
$ —
$ 1,307,269
Total liabilities
$ 1,307,269
$ —
$ —
$ 1,307,269
Fair
value at December 31, 2025
Total
Level
1
Level
2
Level
3
Liabilities:
Warrant
liability
$ 1,492,395
$ —
$ —
$ 1,492,395
Total liabilities
$ 1,492,395
$ —
$ —
$ 1,492,395
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):
SCHEDULE OF CHANGES IN FAIR VALUE OF THE DERIVATIVE LIABILITIES AND WARRANT LIABILITIES
Warrant
liabilities:
2026
2025
2026
2025
Three
Months Ended June 30,
Six
Months Ended June 30,
Warrant
liabilities:
2026
2025
2026
2025
Balance, beginning of period
$ 1,237,440
$ 1,864,616
$ 1,492,395
$ 2,690,605
Issuance of warrants
—
—
—
—
Exercises of warrants
—
—
—
—
Amendments of warrants
—
—
—
—
Loss (gain) on fair
value of warrant liability
69,829
260,602
( 185,126 )
( 565,387 )
Balance, end of period
$ 1,307,269
$ 2,125,218
$ 1,307,269
$ 2,125,218
14
5.
STOCKHOLDERS’ EQUITY
Upon
the closing of the Company’s July 2022 initial public offering (“IPO”), the Company’s shareholders agreement
terminated pursuant to its terms. In connection with the closing of the IPO, the Company amended and restated its Amended and Restated
Certificate of Incorporation (the “Amended and Restated Certificate of Incorporation”) and amended and restated its Bylaws
(the “Amended and Restated Bylaws”). The Amended and Restated Certificate of Incorporation was filed with the Secretary of
State of the State of Delaware on August 1, 2022, and became effective on that date, and among other things, increased the authorized
number of Common Stock to 70,000,000 shares and decreased the authorized number of Preferred Stock to 30,000,000 shares. 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 70,000,000 to 150,000,000 . 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 150,000,000 . The number of shares of Preferred Stock authorized remains
30,000,000 shares.
At-the-Market
Equity Offering
On
February 14, 2024, the Company entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright
& Co., LLC (“Wainwright”), to sell shares of its Common Stock, par value $ 0.0001 per share, (the “Shares”)
having an aggregate sales price of up to $ 1,445,000 , from time to time, through an at-the-market offering program under which Wainwright
will act as sales agent. The sales, if any, of the Shares made under the ATM Agreement will be made by any method permitted by law deemed
to be an “at-the-market offering” as defined in Rule 415 promulgated under the Securities Act. Effective March 25, 2024,
the Company filed a prospectus supplement to amend, supplement and supersede certain information contained in the earlier prospectus
and prospectus supplement, which increased the number of Shares the Company may offer and sell under the ATM Agreement to an aggregate
offering price of up to $ 4,950,000 , from time to time, which did not include any sales made previously under the ATM Agreement.
Effective
December 23, 2024, the Company filed a prospectus supplement to amend, supplement and supersede certain information contained in the
earlier prospectus and prospectus supplement, which increased the number of Shares the Company may offer and sell under the ATM Agreement
to an aggregate offering price of up to $ 30,000,000 from time to time. Effective March 22, 2025, the Company filed a prospectus supplement
to amend, supplement and supersede certain information contained in the earlier prospectus and prospectus supplement, which decreased
the number of Shares the Company may offer and sell under the ATM Agreement to an aggregate offering price of up to $ 11,200,000 from
time to time, which did not include any sales made previously under the ATM Agreement. During the quarter ended March 31, 2025, the Company
sold 666,323 shares of Common Stock at an average price of approximately $ 2.28 per share, resulting in aggregate gross proceeds of approximately
$ 1,521,091 , for which it paid Wainwright approximately $ 45,633 in commissions and other issuance costs of $ 84,587 , resulting in net proceeds
to the Company of approximately $ 1,390,871 . Effective May 14, 2026, the Company filed a prospectus supplement, which terminated the ATM
Agreement. Termination will be effective 7-business days after May 14, 2026, in accordance with the terms of the agreement. During the
quarter ended June 30, 2026, the Company did not sell shares of Common Stock under the ATM agreement. On May 14, 2026, we terminated
our ATM Agreement with Wainwright, which termination was effective on May 21, 2026.
Private
Placement
On
February 24, 2025, the Company issued and sold 1,810,000 shares of its Common Stock and warrants to purchase 1,810,000 shares of its
Common Stock in a private placement to certain accredited investors and Company directors pursuant to securities purchase agreements
dated February 18, 2025 at a price per share of $ 1.50 for which the Company received gross proceeds of approximately $ 2.7 million. The
warrants are exercisable at a price per share of $ 1.87 , commencing one year following issuance, have a term of six years from the issuance
date, and expire on February 24, 2031 . The securities sold to Company directors participating in the private placement were issued pursuant
to the MAIA Biotechnology, Inc. 2021 Equity Incentive Plan (the “MAIA 2021 Plan”).
On
March 3, 2025, the Company issued and sold 952,633 shares of its Common Stock and warrants to purchase 952,633 shares of its Common Stock
in a private placement to certain accredited investors and Company directors pursuant to securities purchase agreements dated February
25, 2025 at a price per share of $ 1.50 for which the Company received gross proceeds of approximately $ 1.4 million. The warrants are
exercisable at a price per share of $ 1.85 , commencing one year following issuance, have a term of six years from the issuance date, and
expire on March 3, 2031 . The securities sold to Company directors participating in the private placement were issued pursuant to the
MAIA 2021 Plan.
15
On
May 8, 2025, the Company issued and sold 719,999 shares of its Common Stock and warrants to purchase 719,999 shares of its Common Stock
in a private placement to certain accredited investors and Company directors pursuant to securities purchase agreements dated May 5,
2025 at a price per share of $ 1.50 for which the Company received gross proceeds of approximately $ 1.08 million. The warrants are exercisable
at a price per share of $ 2.05 , commencing one year following issuance, have a term of six years from the issuance date, and expire on
May 8, 2031 . The securities sold to Company directors participating in the private placement were issued pursuant to the MAIA 2021 Plan.
On
June 3, 2025, the Company issued and sold 463,332 shares of its Common Stock and warrants to purchase 463,332 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 $ 1.50 for which the Company received gross proceeds of approximately $ 0.7 million. The warrants are exercisable
at a price per share of $ 1.71 , commencing six months following issuance, have a term of five years from the issuance date, and expire
on June 3, 2030 . The securities sold to Company directors participating in the private placement were issued pursuant to the MAIA 2021
Plan.
There
were no private placements in the six months ended June 30, 2026.
Confidentially
Marketed Public Offering
On
March 4, 2026, the Company issued and sold 20,000,000 shares of its Common Stock to certain accredited investors pursuant to a confidentially
marketed public offering with Konik Capital Partners, LLC. (“Konik Capital”) at a price per share of $ 1.50 for which the
Company received gross proceeds of approximately $ 30,000,000 . The Company paid Konik Capital approximately $ 1,500,000 in commissions
and other issuance costs of approximately $ 329,000 , resulting in net proceeds to the Company of approximately $ 28,171,000 .
On
March 9, 2026, the Company issued and sold 2,005,875 shares of its Common Stock to certain accredited investors pursuant to a confidentially
marketed follow-on public offering with Konik Capital at a price per share of $ 1.50 for which the Company received gross proceeds of
approximately $ 3,009,000 . The Company paid Konik Capital approximately $ 150,000 in commissions and other issuance costs of approximately
$ 16,000 , resulting in net proceeds to the Company of approximately $ 2,843,000 .
MAIA
Biotechnology, Inc. Restricted Stock Awards
During
the six months ended June 30, 2026, the Company recorded $ 19,830 to consulting expense for accounting services and $ 222,758 to research
and development expense for research services related to the issuance of 15,492 and 150,348 restricted shares of Common Stock, respectively.
There were no unvested restricted shares as of June 30, 2026.
During
the six months ended June 30, 2025, the Company recorded $ 31,570 to consulting expense for accounting services and $ 30,751 to research
and development expense for research fees related to the issuance of 18,040 and 17,083 restricted shares of Common Stock, respectively.
There were no unvested restricted shares as of June 30, 2025.
MAIA
Stock Warrants
Concurrently
with the closing of the IPO, the Company issued warrants to purchase an aggregate of up to 100,000 shares of its Common Stock to the
representative or its designees, at an exercise price of $ 6.25 per share (the “Representative’s Warrants”). The Representative’s
Warrants were exercisable beginning on January 23, 2023 , and expire on July 27, 2027 , pursuant to their terms and conditions. On August
3, 2023, concurrently with the full exercise of the representative’s over-allotment option, the Company issued additional Representative’s
Warrants to purchase an aggregate of up to 15,000 shares of its Common Stock to the representative or its designees on the same terms.
The Representative’s Warrants are not indexed to the Company’s own stock and therefore meet the definition of a derivative
liability. The Representative’s Warrants are liability classified instruments and were initially recorded at a value of $ 343,735 ,
which was determined using the Black-Scholes-Merton method using a term of five years , risk free interest rate of 2.82 % and volatility
of 77.5 %. As of June 30, 2026 and December 31, 2025, the Company remeasured the warrant liability resulting in a value of $ 5,278 and
$ 27,455 respectively. The loss on remeasurement of the warrant liability in the amount of $ 954 and the gain on the loss remeasurement
of the warrant liability in the amount of $ 22,177 was included in other income (expense) for the three and six months ended June 30,
2026 respectively. The gain on remeasurement of the warrant liability in the amount of $ 5,808 and $ 32,076 was included in other income
(expense) for the three and six months ended June 30, 2025, respectively.
16
On
November 17, 2023, the Company issued warrants concurrently with the Company’s registered direct offering to purchase an aggregate
of up to 2,424,243 shares of its Common Stock to the investors in the registered direct offering at an exercise price of $ 1.86 per share
(subject to customary adjustments as set forth in the warrants). The warrants are exercisable six months following issuance and will
have a term of five years from the initial exercise date. The warrants contain customary anti-dilution adjustments to the exercise price,
including for share splits, share dividends, rights offerings and pro rata distributions. The warrants were not indexed to the Company’s
own stock and therefore met the definition of a derivative liability. The warrants were liability classified instruments and were initially
recorded at a value of $ 1,903,915 , which was determined using the Black-Scholes-Merton method using a term of 5.38 years, risk free interest
rate of 3.85 % and volatility of 90.0 %. During the nine months ended September 30, 2024, 909,091 warrants were exercised on various dates
in cashless exercises and the investor was issued 458,726 shares of Common Stock. The Company remeasured the warrant liability of the
exercised warrants at the time of the exercise resulting in a value of $ 2,815,970 . The warrant liability for the exercised warrants was
removed and equity was increased by the value of $ 2,815,970 . As of June 30, 2026 and December 31, 2025, the warrant liability resulted
in a value of $ 1,119,226 and $ 1,216,774 , respectively. The loss on remeasurement of the warrant liability in the amount of $ 94,219 and
the gain on remeasurement of the warrant liability in the amount of $ 97,548 was included in other income (expense) for the three and
six months ended June 30, 2026, respectively. The loss on remeasurement of the warrant liability in the amount of $ 246,105 and the gain
on the remeasurement of the warrant liability in the amount of $ 433,443 was included in other income (expense) for the three and six
months ended June 30, 2025, respectively.
On
November 17, 2023, concurrently with the closing of the Company’s registered direct offering, the Company issued warrants to purchase
an aggregate of 169,697 shares of its Common Stock to the representative or its designees, at an exercise price of $ 2.06 per share. These
representative’s warrants were exercisable beginning November 15, 2023 , and expire on November 15, 2028 , pursuant to their terms
and conditions. The representative’s warrants are not indexed to the Company’s own stock and therefore meet the definition
of a derivative liability. The representative’s warrants are liability classified instruments and were initially recorded at a
value of $ 123,811 , which was determined using the Black-Scholes-Merton method using a term of 4.88 years, risk free interest rate of
3.84 % and volatility of 90.0 %. As of June 30, 2026 and December 31, 2025, the Company remeasured the warrant liability resulting in a
value of $ 93,320 and $ 130,553 respectively. The gain on remeasurement of the warrant liability in the amount of $ 15,919 and $ 37,233 was
included in other income (expense) for the three and six months ended June 30, 2026, respectively. The gain on remeasurement of the warrant
liability in the amount of $ 65,546 and the loss on remeasurement of the warrant liability in the amount of $ 15,741 was included in other
income (expense) for the three and six months ended June 30, 2025, respectively.
Concurrently
with the closing of the Company’s private placement offering on March 28, 2024, the Company issued warrants to purchase an aggregate
of up to 578,643 shares of its Common Stock to the investors in the private placement at an exercise price of $ 2.55 per share. The warrants
are exercisable beginning on September 28, 2024 , and expire on September 28, 2029 . The warrants were not indexed to the Company’s
own stock and therefore meet the definition of a derivative liability. The warrants were liability classified instruments when issued
and were initially recorded at a value of $ 1,190,111 , which was determined using the Black-Scholes-Merton method using a term of 5.5
years, risk free interest rate of 4.20 % and volatility of 95.0 In May 2024, the Company amended the warrant agreements related to 437,031
warrants to adjust them to be indexed to the Company’s own stock, and they were therefore reclassed to equity classified instruments
in a non-cash transaction. When the warrants agreements were amended, the Company remeasured the warrant liability resulting in a final
warrant value of $ 1,011,562 . The warrant liability for these 437,031 warrants was removed and equity was increased by $ 1,011,562 to account
for the equity classification. The remaining 141,612 warrants remain liability classified instruments. As of June 30, 2026 and December
31, 2025, the Company remeasured the warrant liability, resulting in a value of $ 89,445 and $ 117,613 , respectively. The gain on remeasurement
of the warrant liability in the amount of $ 9,425 and $ 28,168 was included in other income (expense) for the three and six months ended
June 30, 2026, respectively. The loss on remeasurement of the warrant liability in the amount of $ 4,564 and the gain on remeasurement
of the warrant liability in the amount of $ 50,063 was included in other income (expense) for the three and six months ended June 30,
2025, respectively.
Concurrently
with the closing of the Company’s private placement offering on February 24, 2025, the Company issued warrants to purchase an aggregate
of up to 1,810,000 shares of its Common Stock to the investors in the private placement at an exercise price of $ 1.87 per share. The
warrants are exercisable beginning on February 24, 2026 , and expire on February 24, 2031 . The warrants issued were divided into two groups:
warrants issued to directors and warrants issued to affiliated and non-affiliated investors. The warrants to purchase 123,333 shares
of the Company’s Common Stock issued to directors were deemed options issued under the MAIA 2021 Plan and are equity classified
instruments and the value of these warrants determined using the Black-Scholes-Merton method was $ 176,680 using a term of 6 years, risk
free interest rate of 4.23 % and volatility of 95 %. The warrants to purchase 1,686,667 shares of the Company’s Common Stock issued
to affiliated and non-affiliated investors are indexed to the Company’s own stock and they were therefore equity classified instruments
and the value of these warrants determined using the Black-Scholes-Merton method was $ 2,416,223 using a term of 6 years, risk free interest
rate of 4.23 % and volatility of 95 %. The total fair value ascribed to the warrants combined with the fair value of the common stock issued
in the private placement was then used for purposes of allocation of the equity classified warrant value within the condensed consolidated
statements of changes in the stockholders’ equity.
17
Concurrently
with the closing of the Company’s private placement offering on March 3, 2025, the Company issued warrants to purchase an aggregate
of up to 952,633 shares of its Common Stock to the investors in the private placement at an exercise price of $ 1.85 per share. The warrants
are exercisable beginning on March 3, 2026 , and expire on March 3, 2031 . The warrants issued were divided into two groups: warrants issued
to directors and warrants issued to non-affiliated investors. The warrants to purchase 58,333 shares of the Company’s Common Stock
issued to directors were deemed options issued under the MAIA 2021 Plan and are equity classified instruments and the value of these
warrants determined using the Black-Scholes-Merton method was $ 80,894 using a term of 6 years, risk free interest rate of 3.97 % and volatility
of 95 %. The warrants to purchase 894,300 shares of the Company’s Common Stock issued to non-affiliated investors are indexed to
the Company’s own stock and they were therefore equity classified instruments and the value of these warrants determined using
the Black-Scholes-Merton method was $ 1,240,185 using a term of 6 years, risk free interest rate of 3.97 % and volatility of 95 %. The total
fair value ascribed to the warrants combined with the fair value of the common stock issued in the private placement was then used for
purposes of allocation of the equity classified warrant value within the condensed consolidated statements of changes in the stockholders’
equity.
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 719,999 shares of its Common Stock to the investors in the private placement at an exercise price of $ 1.50 per share. The warrants
are exercisable beginning on May 8, 2026 , and expire on May 8, 2031 . The warrants issued were divided into two groups: warrants issued
to directors and warrants issued to non-affiliated investors. The warrants to purchase 86,666 shares of the Company’s Common Stock
issued to directors were deemed options issued under the MAIA 2021 Plan and are equity classified instruments and the value of these
warrants determined using the Black-Scholes-Merton method was $ 133,131 using a term of 6 years, risk free interest rate of 4.09 % and
volatility of 95 %. The warrants to purchase 633,333 shares of the Company’s Common Stock issued to non-affiliated investors are
indexed to the Company’s own stock and they were therefore equity classified instruments and the value of these warrants determined
using the Black-Scholes-Merton method was $ 972,890 using a term of 6 years, risk free interest rate of 4.09 % and volatility of 95 %. The
total fair value ascribed to the warrants combined with the fair value of the common stock issued in the private placement was then used
for purposes of allocation of the equity classified warrant value within the condensed consolidated statements of changes in the stockholders’
equity.
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 463,332 shares of its Common Stock to the investors in the private placement at an exercise price of $ 1.50 per share. The warrants
are exercisable beginning on December 3, 2025 , and expire on June 3, 2030 . The warrants issued were divided into two groups: warrants
issued to directors and warrants issued to non-affiliated investors. The warrants to purchase 33,333 shares of the Company’s Common
Stock issued to directors were deemed options issued under the MAIA 2021 Plan and are equity classified instruments and the value of
these warrants determined using the Black-Scholes-Merton method was $ 43,358 using a term of 5 years, risk free interest rate of 4.04 %
and volatility of 95 %. The warrants to purchase 429,999 shares of the Company’s Common Stock issued to non-affiliated investors
are indexed to the Company’s own stock and they were therefore equity classified instruments and the value of these warrants determined
using the Black-Scholes-Merton method was $ 559,324 using a term of 5 years, risk free interest rate of 4.04 % and volatility of 95 %. The
total fair value ascribed to the warrants combined with the fair value of the common stock issued in the private placement was then used
for purposes of allocation of the equity classified warrant value within the condensed consolidated statements of changes in the stockholders’
equity.
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 $ 1.50 per share. Certain warrant holders
accepted the offer and warrants were exercised, resulting in the issuance of 219,283 shares of MAIA Common Stock for proceeds of approximately
$ 328,924 . The fair value of the modified warrants was greater than the fair value of the original warrants at the modification date by
$ 105,154 ; therefore, the incremental cost was recognized as an increase to additional paid in capital and a decrease to warrant additional
paid in capital, there was no net equity difference.
SCHEDULE OF WARRANT ACTIVITY
Warrants
Outstanding
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contractual
Term
in
Years
Balance at January 1, 2026
13,086,220
$ 1.92
3.78
Issued
—
—
—
Exercised
—
—
—
Expired
—
—
—
Balance at June 30,
2026
13,086,220
$ 1.92
3.28
18
Warrants
Outstanding
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contractual
Term
in
Years
Balance at January 1, 2025
6,718,176
$ 2.37
4.56
Issued
3,644,299
4.04
—
Exercised
( 219,283 )
( 1.50 )
—
Expired
—
—
—
Balance at June 30,
2025
10,143,192
$ 2.17
4.62
The
value of warrant grants is calculated using the Warrant Black Scholes calculations with the following assumptions for warrants granted
during the six months ended June 30, 2026 and 2025:
SCHEDULE OF SHARE-BASED PAYMENT AWARD, WARRANTS, VALUATION ASSUMPTIONS
2026
2025
Risk-free interest rate
— %
- — %
4.04 %- 4.09 %
Expected term (in years)
—
5
- 6
Expected volatility
— %
95 %
Expected dividend yield
—
—
MAIA
Biotechnology, Inc. Stock Option and Equity Incentive Plans
In
2018, the Company adopted the MAIA Biotechnology, Inc. 2018 Stock Option Plan (the “MAIA 2018 Plan”). MAIAs board of directors
administers the MAIA 2018 Plan for the purposes of attracting, retaining, and motivating key employees, directors, and consultants of
MAIA. The terms of the MAIA 2018 Plan continue to govern the 1,752,945 options outstanding under the plan as of June 30, 2026.
In
2020, the Company adopted the MAIA Biotechnology, Inc. Amended and Restated 2020 Equity Incentive Plan (the “MAIA 2020 Plan”),
also administered by the board of directors. The MAIA 2020 Plan permitted awards to take the form of stock options, restricted stock
and restricted stock units. The terms of the MAIA 2020 Plan continue to govern the 3,503,589 options outstanding in the plan as of June
30, 2026. There are no shares reserved for future issuance under the MAIA 2018 Plan or the MAIA 2020 Plan.
On
August 1, 2022 the Company approved the MAIA 2021 Plan with 1,909,518 shares of Common Stock reserved for issuance. On May 25, 2023 the
MAIA 2021 Plan was amended to include an automatic increase to the plan in the amount equal to 10 % of the total number of shares of stock
outstanding on a fully diluted basis on December 31 of the preceding calendar year (the “Increase Date”); provided that,
the board of directors may act prior to any Increase Date to provide that there will be no increase for such year or that the increase
for such year will be a lesser number of shares of stock. The amount reserved for issuance under the MAIA 2021 Plan increased by 1,956,993
based on the fully diluted shares outstanding as of December 31, 2022. The amount reserved for issuance under the MAIA 2021 Plan increased
by 2,838,668 shares on January 1, 2024 based on the fully diluted shares outstanding as of December 31, 2023. The amount reserved for
issuance under the MAIA 2021 Plan increased by (i) 2,250,000 shares on January 1, 2025 based on the fully diluted shares outstanding
as of December 31, 2024 (and the discretion of the Company’s board of directors to authorize less than 10% of such amount) and
(ii) 6,458,889 shares on January 1, 2026, based on the fully diluted shares outstanding as of December 31, 2025. As of June 30, 2026,
there are 3,066,519 shares of Common Stock available for future issuance under the MAIA 2021 Plan and 11,423,891 options are outstanding
under the MAIA 2021 Plan.
Stock
options are to be granted with an exercise price which is at least equal to the stock’s estimated fair value at the date of grant,
and with a contractual term of no more than ten years from the date of grant. In the case of an option granted to a 10 % stockholder,
the exercise price shall be generally no less than 110 % of the fair market value per share on the date of grant, and the contractual
term shall be seven years . Outstanding options awarded under the MAIA 2021 Plan may, but need not, vest and therefore become exercisable
in periodic installments that may, but need not, be equal. The option may be subject to other terms and conditions as to the time or
times when it may be exercised (which may be based on performance or other criteria) as the board of directors may deem appropriate.
Unexercised options are cancelled ninety days after termination of an employee, director, founder, or consultant. Unexercised options
are cancelled immediately if an employee, director, founder, or consultant is terminated for cause; under certain other circumstances,
the period to cancellation may differ as described in the respective plan documents. Certain clauses in the Plans also govern the Company’s
exercise repurchase rights and various other features of awards granted under the plans.
19
As
of June 30, 2026, only stock options have been awarded pursuant to the MAIA stock option and equity incentive plans.
The
following table summarizes the activity and information regarding MAIA’s outstanding and exercisable options for the six months
ended June 30, 2026:
SCHEDULE OF ACTIVITY AND INFORMATION OF OUTSTANDING AND EXERCISABLE OPTIONS
Options
Outstanding
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contractual
Term
in
Years
Aggregate
Intrinsic
Value
Balance at January 1, 2026
12,878,381
$ 2.19
6.68
-
Granted
4,223,523
1.37
Exercised
( 21,479 )
1.79
Cancelled/forfeited
( 400,000 )
1.44
Balance at June 30,
2026
16,680,425
$ 2.00
6.84
$ 513,032
Options exercisable
at June 30, 2026
11,219,197
$ 2.20
5.60
$ 176,297
The
value of option grants is calculated using the Black-Scholes-Merton option pricing model with the following assumptions for options granted
during the six months ended June 30, 2026 and 2025:
SCHEDULE OF SHARE-BASED PAYMENT AWARD, STOCK OPTIONS, VALUATION ASSUMPTIONS
2026
2025
Risk-free interest rate
3.94 %
- 4.04 %
3.78 %
- 4.43 %
Expected term (in years)
5
– 6.09
5
– 6.08
Expected volatility
85 %
90 %
- 95 %
Expected dividend yield
— %
— %
The
weighted-average grant date fair value of stock options issued during the six months ended June 30, 2026 and 2025 was $ 1.00 and $ 2.25 ,
respectively. As of June 30, 2026, the total unrecognized compensation related to unvested employee and non-employee stock option awards
granted was $ 5,887,064 , which the Company expects to recognize over a weighted average period of approximately 1.65 years.
During
the six months ended June 30, 2026, the Company granted performance-based stock options to a strategic advisor under the MAIA 2021 Plan.
The grant consists of 400,000 stock options, which represent the right to purchase shares of the Company’s common stock at $ 1.49
upon the achievement of specific performance milestones.
The
stock options are divided into two tranches, each subject to the following performance conditions:
●
Tranche
1: 100,000 stock options will be vested upon completion of a new or modification of an existing supply and non-exclusive license
agreement.
●
Tranche
2: 300,000 stock options will be vested upon the completion of any contractual agreement in which a third party gains license rights
to the Company’s patents or intellectual property or will be vested upon the completion of a transaction in which the Company
raises more than $ 10 million from an investor or group of investors in exchange for a royalty or equity representing more than 5 %
of the Company’s fully diluted shares outstanding.
The
Company estimates the fair value of these awards on the date of grant. For the performance-based milestones, expense is recognized over
the requisite service period only when it is deemed probable that the performance conditions will be met. As of June 30, 2026, the Company
determined that the achievement of Tranche 1 and Tranche 2 milestones were not probable. Consequently, the Company did not recognize
any stock-based compensation expense within General and Administrative expenses for the period.
20
Stock
based compensation related to the Company’s stock plans are as follows:
SCHEDULE OF STOCK BASED COMPENSATION EXPENSE
2026
2025
2026
2025
For
the Three Months Ended June 30,
For the six Months Ended June
30,
2026
2025
2026
2025
General and administrative
$ 494,221
$ 569,875
$ 934,957
$ 768,733
Research and development
229,694
232,609
438,982
405,223
Total stock-based
compensation
$ 723,915
$ 802,484
$ 1,373,939
$ 1,173,956
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 titled “Patent and
Technology License Agreement AGT. NO. L2264 – MAIA Biotechnology” with the University of Texas Southwestern (“UTSW”)
to license patent families for a specific compound (“THIO”) from UTSW to MAIA (the “UTSW Agreement”). The UTSW
Agreement, as amended, has a term of 20 years. The agreement requires MAIA to reimburse UTSW for agreed-upon expenses related to THIO.
The UTSW Agreement requires certain payments upon assignment of the license to a third party as well as upon reaching specific milestones,
ranging between $ 1,000,000 and $ 50,000,000 , not to exceed a combined milestone payment total of $ 112,000,000 . As of June 30, 2026, no
assignment has occurred and none of the defined milestones have been completed and therefore no payments are due to UTSW related to the
milestones. The UTSW Agreement requires MAIA to make royalty payments of: (i) 2 - 4 % (depending on THIO reaching specified sales levels
in the respective jurisdictions) on net sales up to $1,000,000,000; and (ii) 2.5 - 5 % on net sales above $1,000,000,000.
Also
in December 2020, the Company entered into a second license agreement with UTSW titled “Patent and Technology License Agreement
AGT. NO. L3648 — MAIA Biotechnology” pursuant to which UTSW is licensing an additional compound to MAIA (the “UTSW2
Agreement”). The UTSW2 Agreement has a term of 20 years and requires the Company to reimburse UTSW for certain agreed-upon expenses.
The UTSW2 Agreement requires certain payments upon assignment of the license to a third party as well as upon reaching specific milestones,
ranging between $ 1,000,000 and $ 50,000,000 , not to exceed a combined milestone payment total of $ 112,000,000 . As of June 30, 2026, no
assignment has occurred and none of the defined milestones have been completed and therefore no payments are due to UTSW related to the
milestones. The UTSW2 Agreement requires MAIA to make royalty payments of: (i) 2 - 4 % (depending on THIO reaching specified sales levels
in the respective jurisdictions) on net sales up to $1,000,000,000; (ii) and 2.5 - 5 % on net sales above $1,000,000,000.
The
Company will also pay UTSW running royalties on a yearly basis as a percentage of Net Sales (as defined in the UTSW2 Agreement) of the
Company or its sublicensee. There are single digit royalty rates for licensed products and licensed services covered by a Valid Claim
(as defined in the UTSW2 Agreement) and dependent on whether Net Sales are greater than or less than/equal to $1,000,000,000, with Net
Sales above that amount commanding a slightly higher percentage. In each case, the royalty percentage is lower before patent issuance
in each jurisdiction. In the event that the licensed product or licensed service is not covered by a Valid Claim, the running royalty
rates are reduced by 50%. The royalty obligations continue on a country-by-country basis until the later of expiration of the last Valid
Claim in each country or 10 years after the First Commercial Sale (as defined in UTSW2 Agreement) in each country.
Regeneron
In
February 2021, the Company entered into a Drug Supply Agreement (the “Drug Supply Agreement”) with Regeneron Pharmaceuticals,
Inc. (“Regeneron”) to perform one clinical trial for the treatment of patients with Non-Small Cell Lung Cancer (NSCLC) involving
a Regeneron drug candidate that utilizes one of the Company’s compounds/agents. The Company is responsible for all costs of the
study with Regeneron supplying their drug cemiplimab representing a cost savings for the Company, the first phase of which is expected
to take approximately two years. The overall term of the agreement is for five years unless earlier terminated for certain reasons as
defined in the agreement. Either party may terminate a study plan in the event that patient screening for the clinical study does not
commence within 12 months after: (i) the Effective Date (as defined in the Drug Supply Agreement), with respect to the initial study;
or (ii) the execution of the applicable study plan, with respect to each other study. If either party terminates a study plan, the Company
shall reimburse Regeneron for the Regeneron product it received in connection with such study plan based on the actual out-of-pocket
cost to Regeneron of such Regeneron product. As of June 30, 2026, neither party has terminated the agreement.
21
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 seven years unless
earlier terminated for certain reasons as defined in the agreement. As of June 30, 2026, neither party has terminated the agreement.
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 five years unless earlier terminated for certain reasons as defined in the agreement.
As of June 30, 2026, neither party has terminated the agreement.
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 IRC section 382. As of June 30, 2026, and December 31, 2025, the Company had a full valuation allowance against
its deferred tax assets.
No
provision or benefit for U.S. federal, state, Australian or Romanian income taxes has been recorded for the six months ended June 30,
2026 and 2025, mainly due to net losses incurred by the Company, and a full valuation allowance recorded against deferred tax assets.
8.
SEGMENT INFORMATION
The
Company operates in one reportable segment. This determination is based on the Company’s structure, the manner in which the CODM
reviews the operating results to assess performance and allocate resources, and the nature of the Company’s operations. Segment
assets are reported as total assets on the consolidated balance sheet. The CODM, who is the Chief Executive Officer, regularly reviews
consolidated financial information, such as consolidated net loss. The CODM’s review is for the purpose of assessing performance
and making decisions about resource allocation. See our consolidated financial statements in Part I, “Item 1, Financial Statements”,
and Note 1, “Description of Business, Organization, and Principles of Consolidation” for additional information about these
line items and the related accounting policies.
9 .
GOVERNMENT GRANTS
The
Company receives research grants from the National Institutes of Health (NIH) to support specific primary research and clinical development
projects. In accordance with ASU 2025-10, the Company accounts for these as government grants and has elected the income-related approach.
Grant proceeds are recognized in the consolidated statements of operations when there is reasonable assurance that the Company will comply
with the conditions attached to the grant and the grant will be received. The Company has elected to present these grant proceeds as
a component of Other income, net, rather than as a reduction of the related Research and Development (R&D) expenses.
During
the quarter ended June 30, 2026, the Company operated under one active NIH Small Business Innovation Research (SBIR) awards (Award #1R44CA309843-01).
These grants are cost-reimbursable, meaning the Company is entitled to payment only after incurring allowable costs as defined by the
NIH Grants Policy Statement. As of June 30, 2026, the Company has recognized a receivable of approximately $ 0.05 million for qualified
R&D expenditures that have been incurred but not yet reimbursed by the NIH.
NIH
grants are subject to audit and retrospective adjustment by the granting agency to ensure compliance. While the Company believes it has
complied with all material terms of the grant agreements, any costs found to be unallowable upon audit could be subject to repayment.
As of June 30, 2026, no such repayment is deemed probable.
10.
SUBSEQUENT EVENTS
Issuance
of Options
From
July 1 to August 10, 2026, the Company issued 35,675 options at a weighted exercise price of $ 1.28 to consultants.
Issuance
of Stock
On
July 7, 2026, the Company issued 8,362 restricted shares of Common Stock having a value of $ 14,550 (based on the $ 1.73 price calculated
by using 120% of the dollar value weighted average price of our common stock on the New York Stock Exchange for the thirty (30) trading
days immediately preceding the date of the purchase payment) 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.
22
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 initiated a Phase 3 pivotal trial in 2025, named THIO-104, to evaluate the efficacy of
ateganosine administered in sequence with a checkpoint inhibitor (CPI) in third-line NSCLC patients who are resistant to checkpoint inhibitors
and chemotherapy which could lead filing for early full commercial approval in 2027 and final analysis could lead to filing for full
commercial approval in 2028. The multicenter, open-label, pivotal Phase 3 trial is designed to provide a direct comparison to chemotherapy
in a 1:1 randomization of up to 300 patients. In addition, the originally planned Phase 2 clinical trial in multiple tumor indications
(THIO-102) is now divided into different trials for one tumor indication each: hepatocellular carcinoma (HCC), colorectal cancer (CRC)
and small cell lung cancer (SCLC). In December 2024, 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.
23
We
accomplished the key milestones set forth below in the six months ended June 30, 2026 and the third quarter of 2026: Please note that
on March 18, 2025, the company announced “ateganosine” as the nonproprietary (generic) name for THIO, and its intent to use
the generic name to support clear communication, while keeping the name THIO in the Company’s clinical trial designations (THIO-101,
THIO-102, THIO-104).
●
On
January 20, 2026, we provided a corporate update on 2025 achievements and highlighted key targeted milestones and growth catalysts
for 2026. The targeted milestones include: (i) initial measures of efficacy from Phase 3 study, with interim disease control rates
(DCR), overall response rates (ORR) and progression free survival (PFS) analysis of ateganosine compared to the control arm will
support regulatory discussions; (ii) expected conclusion of Part C of Phase 2 study, which will provide additional clinical efficacy
data to support regulatory review for commercial approval; (iii) Plan to engage in regulatory interactions with the FDA to expand
ongoing FDA dialogue under the Fast Track designation, including discussions around trial enhancements and prospects for Accelerated
Approval and Priority Review; (iv) clinical development of second-generation molecules planned to start in Phase 1 trials, with additional
small molecules fully developed in-house with better expected efficacy compared to ateganosine.
●
On
March 4, 2026, we issued and sold 20,000,000 shares of our common stock in confidentially marketed public offering at a price of
$1.50 per share for aggregate gross proceeds of $30 million, prior to deducting underwriting discounts and other offering expenses.
In addition, on March 9, 2026, the Company closed on the partial exercise of underwriter over-allotment option for the above referenced
offering for an additional 2,005,875 shares of common stock at the offering price of $1.50 per share resulting in additional gross
proceeds of approximately $3 million. After giving effect to the partial exercise of the over-allotment option, the total number
of shares sold by Company in the offering increased to 22,005,875 and gross proceeds increased to approximately $33 million.
●
On
March 31, 2026, we announced overall survival (OS) beyond two years for eight patients treated with ateganosine sequenced with cemiplimab
in Parts A and B of its ongoing Phase 2 THIO-101 clinical trial in non-small cell lung cancer (NSCLC). The patients did not receive
subsequent lines of therapy. The highlights were presented in a poster on March 27, 2026, at the European Lung Cancer Congress 2026
(ELCC), in Copenhagen, Denmark.
●
On
April 8, 2026, we announced that net proceeds from the $33 million confidentially marketed public offering of common stock in March
2026 are expected to fully fund the Company’s ongoing pivotal Phase 3 clinical trial of its lead investigational therapy, ateganosine,
as a treatment for non-small cell lung cancer (NSCLC).
●
On
April 16, 2026, we announced the activation the first U.S. clinical site in its Phase 2 THIO-101 expansion trial of its lead investigational
therapy as a third-line (3L) treatment for non-small cell lung cancer (NSCLC). The trial’s expansion into the U.S. marks a
key milestone for MAIA, which is expected to open a significantly larger patient pool for evaluation of ateganosine, a novel dual
mechanism of action drug candidate incorporating telomere targeting and immunogenicity. In addition to the first location, Summit
Medical Group in New Jersey, MAIA intends to open four additional sites in U.S. in 2026. The trial is ongoing in Europe and Asia
with 44 active sites in 6 countries.
●
On
June 3, 2026, we announced that the U.S. Food and Drug Administration (“FDA”) cleared an amendment to the Investigational
New Drug (“IND”) application for ateganosine, enabling MAIA to initiate U.S. patient enrollment in the expansion of its
Phase 2 THIO-101 clinical trial evaluating ateganosine in patients with advanced third-line (“3L”) non-small cell lung
cancer (“NSCLC”). The amended IND also reflects updates to the Company’s manufacturing processes, including additional
manufacturers, formulation improvements and revised storage conditions for ateganosine.
●
On
June 4, 2026, we announced a patient enrollment update for the ongoing pivotal Phase 3 THIO-104 clinical trial evaluating ateganosine
as a treatment for advanced 3L NSCLC. As of the announcement date, 29 patients had been dosed across 34 activated clinical sites
in six countries outside the United States.
●
On
June 10, 2026, we announced the activation of Central Alabama Research in Homewood, Alabama, as the second U.S. clinical site participating
in the Phase 2 THIO-101 expansion trial.
●
On
June 18, 2026, we announced the activation of the Winship Cancer Institute of Emory University as the third U.S. clinical site participating
in the Phase 2 THIO-101 expansion trial.
●
On
June 25, 2026, we announced the completion of international patient enrollment in Part C of the Phase 2 THIO-101 expansion trial
evaluating ateganosine in patients with advanced 3L NSCLC. Patient screening continues at activated clinical sites in the United
States while the Company continues to monitor patient outcomes and data maturation from the international portion of the study.
●
On
July 8, 2026, we announced initial efficacy results from Part C of the Phase 2 THIO-101 clinical trial. As of July 6, 2026, among
the 21 efficacy-evaluable patients who had undergone at least one post-baseline tumor assessment, the study demonstrated a disease
control rate (“DCR”) of 90.5% (19 of 21 patients) following treatment with ateganosine administered sequentially with
cemiplimab (Libtayo®).
●
In
addition to NSCLC, HCC, SCLC and CRC we plan to conduct clinical trials evaluating ateganosine 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.
24
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.
Results
of Operations for the Three and Six Months Ended June 30, 2026 and 2025
Comparison
of Three Months ended June 30, 2026 and 2025
Three
Months Ended June 30,
Change
2026
2025
Dollars
Percentage
Operating expenses:
Research
and development expenses
$ 5,639,660
$ 3,110,867
$ 2,528,793
81 %
General
and administrative expenses
2,677,591
2,055,191
622,400
30 %
Total
operating costs and expenses
8,317,251
5,166,058
3,151,193
61 %
Loss
from operations
(8,317,251 )
(5,166,058 )
(3,151,193 )
61 %
Other (expense) income:
Interest income
236,320
79,697
156,623
197 %
Grant income
207,173
—
207,173
— %
Change in fair value
of warrant liability
(69,829 )
(260,602 )
190,773
(73 )%
Other income (expense)
net
373,664
(180,905 )
554,569
(307 )%
Net loss
$ (7,943,587 )
$ (5,346,963 )
$ (2,596,624 )
49 %
Operating
Costs and Expenses
Research
and development expenses
Research
and development expenses increased by approximately $2,529,000 (or approximately 81%), from approximately $3,111,000 for the three months
ended June 30, 2025, compared to approximately $5,640,000 for the three months ended June 30, 2026. The increase was primarily related
to an increase in scientific research and clinical research of approximately $2,354,000, an increase in payroll expense of approximately
$154,000, an increase in other expenses of approximately $25,000, offset by a decrease in stock-based compensation cost of approximately
$3,000, and a decrease in professional fees of approximately $1,000.
General
and administrative expenses
General
and administrative expenses increased by approximately $622,000 (or approximately 30%) from approximately $2,055,000 for the three
months ended June 30, 2025, compared to approximately $2,677,000 for the three months ended June 30, 2026. The increase was
primarily related to an increase in investor relations of approximately $331,000, an increase in other expenses of approximately
$187,000, an increase in payroll of approximately $135,000, and an increase in professional fees of approximately $45,000, offset by
a decrease in stock-based compensation of approximately $76,000.
Other
income (expense), net
Other
income (expense), net increased by approximately $555,000 (or approximately 307%) from other expense, net of approximately $181,000 for
the three months ended June 30, 2025, compared to other income, net of approximately $374,000 for the three months ended June 30, 2026.
The increase was primarily related an increase in grant income of $207,000, an increase in the change in the fair value of the warrant
liability of approximately $191,000, and a net increase in interest income of approximately $157,000.
25
Comparison
of Six Months Ended June 30, 2026 and 2025
Six Months
Ended June
30,
Change
2026
2025
Dollars
Percentage
Operating expenses:
Research
and development expenses
$ 9,164,757
$ 6,308,399
$ 2,856,358
45 %
General
and administrative expenses
6,102,423
4,283,090
1,819,333
42 %
Total
operating costs and expenses
15,267,180
10,591,489
4,675,691
44 %
Loss
from operations
(15,267,180 )
(10,591,489 )
(4,675,691 )
44 %
Other income (expense):
Interest income
348,077
161,880
186,197
115 %
Grant income
420,738
—
420,738
— %
Change in fair value
of warrant liability
185,126
565,387
(380,261 )
(67 )%
Other income (expense)
net:
953,941
727,267
226,674
31 %
Net loss
$ (14,313,239 )
$ (9,864,222 )
$ (4,449,017 )
45 %
Operating
Costs and Expenses
Research
and development expenses
Research
and development expenses increased by approximately $2,856,000 (or approximately 45%), from approximately $6,308,000 for the six months
ended June 30, 2025, to approximately $9,164,000 for the six months ended June 30, 2026. The increase was primarily related to an increase
in scientific research and clinical research of approximately $2,407,000, an increase in payroll expense of approximately $383,000, an
increase in stock-based compensation cost of approximately $34,000, an increase in other expense of approximately $30,000, and an increase
in professional fees of approximately $2,000.
General
and administrative expenses
General
and administrative expenses increased by approximately $1,819,000 (or approximately 42%) from approximately $4,283,000 for the six months
ended June 30, 2025, to approximately $6,102,000 for the six months ended June 30, 2026. The increase was primarily related to an increase
in professional fees of approximately $343,000, an increase of investor relations of approximately $499,000, an increase in stock-based
compensation of approximately $166,000, an increase of approximately $764,000 payroll expense and an increase in other expense of approximately
$47,000.
Other
income (expense), net
Other
income (expense), net increased by approximately $227,000 (or approximately 31%) from other income, net of approximately $727,000
for the six months ended June 30, 2025, to other income, net of approximately $954,000 for the six months ended June 30, 2026. The
increase was primarily related to an increase in grant income of approximately $421,000, a decrease in the change in the fair value
of the warrant liability of approximately $380,000, and a net increase in interest income of approximately $186,000.
Liquidity
and Capital Resources
Sales
of Common Stock
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.
26
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.
From
January 1, 2025 through March 31, 2025, we sold 666,323 shares of Common Stock through Wainwright under the ATM Agreement at an average
price of approximately $2.28 per share, resulting in aggregate gross proceeds of approximately $1,521,091, for which we paid Wainwright
approximately $45,633 in commissions and other issuance costs of $84,587, resulting in net proceeds to us of approximately $1,390,871.
During the quarter ended June 30, 2026, the Company did not sell shares of Common Stock under the ATM agreement.
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.
On
March 4, 2026, the Company issued and sold 20,000,000 shares of its Common Stock to certain accredited investors pursuant to a confidentially
marketed public offering with Konik Capital Partners, LLC. (“Konik Capital”) at a price per share of $1.50 for which the
Company received gross proceeds of approximately $30,000,000. The Company paid Konik Capital approximately $1,500,000 in commissions
and other issuance costs of approximately $329,000, resulting in net proceeds to the Company of approximately $28,171,000.
On
March 9, 2026, the Company issued and sold 2,005,875 shares of its Common Stock to certain accredited investors pursuant to a confidentially
marketed follow-on public offering with Konik Capital at a price per share of $1.50 for which the Company received gross proceeds of
approximately $3,009,000. The Company paid Konik Capital approximately $150,000 in commissions and other issuance costs of approximately
$16,000, resulting in net proceeds to the Company of approximately $2,843,000.
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, 2026 and 2025
Six
Months Ended June 30,
2026
2025
Net cash flows used in operating
activities
$ (12,061,383 )
$ (8,337,611 )
Net cash flows provided by financing activities
30,987,321
8,869,406
Effect of foreign currency
exchange rate changes on cash
11,862
11,429
Net increase in cash
$ 18,937,800
$ 543,224
27
Operating
Activities
For
the six months ended June 30, 2026, net cash used in operating activities was approximately $12,061,000, which consisted of a consolidated
net loss of approximately $14,313,000 offset by non-cash charges of approximately $1,374,000 in stock-based compensation, approximately
$243,000 of non-cash expense to issue stock to vendors, and the decrease in the remeasurement of the warrant liability of approximately
$185,000. Total changes in operating assets and liabilities of approximately $820,000 were driven by an approximate $1,198,000 net increase
in accounts payable and prepaid expenses and other current assets, offset by an approximate $378,000 decrease in accrued expense.
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, and 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, 2026, the effect of foreign currency exchange rate changes on cash increased the cash balance as of June
30, 2026 by approximately $12,000 versus an increase of approximately $11,000 for the six months ended June 30, 2025.
Investing
Activities
For
the six months ended June 30, 2026 and 2025, we did not have any cash provided by or used in investing activities.
Financing
Activities
Net
cash provided by financing activities was approximately $30,987,000 and $8,869,000 for the six months ended June 30, 2026 and 2025, respectively.
Total net cash provided by financing activities for the six months ended June 30, 2026 consisted primarily of approximately $33,009,000
gross proceeds from public offerings, proceeds from the exercise of stock options of approximately $38,000, and were offset by an approximate
$2,060.000 of offering costs.
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.
Digital
Asset Treasury Plan (DATP)
On
October 6, 2025, our Board of Directors formally adopted a Digital Asset Treasury Plan. This plan permits the Company to allocate up
to 90% of its corporate treasury reserves to acquire and hold Bitcoin, Ether, and USD Coin as a long-term store of value. As of the date
of this Quarterly Report on Form 10-Q, the Company has not yet executed any purchases of Digital Assets under this plan. Due to cryptocurrency
volatility, the Company’s digital asset strategy is currently on hold. As of the date of this report, the Company holds no digital
assets.
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, 2025 filed with the SEC on March 23, 2026. There have been no material changes to the critical
accounting estimates previously disclosed in such report.
28
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.
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, 2026, 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,
2026, 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.
29
PART
II—OTHER INFORMATION
Item
1. Legal Proceedings
On
April 22, 2026, H.C. Wainwright & Co., LLC (“Wainwright”) filed complaint in the Supreme Court of the State of New
York, County of New York with respect to an action for damages under New York law for breach of contract arising from the
Company’s breach of a right of first refusal provision set forth in the parties’ engagement agreement, arising from a
March 2026 offering of securities by the Company (the “Wainwright Action”). Wainwright seeks the amount of compensation
they could have received as underwriter in the March 2026 offering being (i) $2,310,616.88 in cash and (ii) warrants to purchase
1,540,411 shares of our common stock as an exercise price of $1.875 per share. On June 26, 2026, the Company filed a notice of
motion for dismissal. At this early stage in the proceedings, the Company is unable to make any prediction regarding the outcome of
the Wainwright Action.
From
time to time, we may be involved in legal proceedings or subject to claims in 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, 2025 filed with the Securities and Exchange
Commission on March 23, 2026. 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, except as set forth below, 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 9, 2026, we issued 8,362 shares of common stock having a value of $14,550 (based on $1.74 price calculated by using 120% of the
dollar value weighted average price of our common stock on the New York Stock Exchange American for the thirty (30) trading days immediately
preceding the date of the purchase payment) to a service provider under a master services agreement in consideration of services rendered.
We did not receive any cash proceeds from this issuance. The issuance was exempt under Section 4(a)(2) of the Securities Act of 1933,
as amended (the “Securities Act”).
On
July 7, 2026, we issued 8,362 shares of common stock having a value of $14,550 (based on $1.74 price calculated by using 120% of the
dollar value weighted average price of our common stock on the New York Stock Exchange American for the thirty (30) trading days immediately
preceding the date of the purchase payment) to a service provider under a master services agreement in consideration of services rendered.
We did not receive any cash proceeds from this issuance. The issuance was exempt under Section 4(a)(2) of the Securities Act.
(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.
30
Item
5. Other Information.
10b5-1
Trading Plans
During
the fiscal quarter ended June 30, 2026, no Section 16 director or officer adopted , modified , or terminated a “Rule 10b5-1 trading
arrangement” (as defined in Item 408 of Regulation S-K of the Exchange Act).
There
were no “non-Rule 10b5-1 trading arrangements” (as defined in Item 408 of Regulation S-K of the Exchange Act) adopted , modified
or terminated during the fiscal quarter ended June 30, 2026 by our directors and Section 16 officers.
Item
6. Exhibits.
Exhibit
No.
Description
3.1
Amended and Restated Certificate of Incorporation of MAIA Biotechnology, Inc., filed as Exhibit 3.1 to the registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on August 1, 2022 and incorporated herein by reference.
3.2
Amended and Restated Bylaws of MAIA Biotechnology, Inc., filed as Exhibit 3.2 to the registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on August 1, 2022 and incorporated herein by reference.
3.3
Certificate of Amendment to Amended and Restated Certificate of Incorporation of MAIA Biotechnology, Inc., filed as Exhibit 3.1 to the registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on May 23, 2025 and incorporated herein by reference.
31.1*
Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*
Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1**
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2**
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS*
Inline
XBRL Instance Document
101.SCH*
Inline
XBRL Taxonomy Extension Schema Document
101.CAL*
Inline
XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF*
Inline
XBRL Taxonomy Extension Definition Linkbase Document
101.LAB*
Inline
XBRL Taxonomy Extension Label Linkbase Document
101.PRE*
Inline
XBRL Taxonomy Extension Presentation Linkbase Document
104*
Cover
Page Interactive Data File (the cover page from the registrant’s quarterly report on Form 10-Q for the quarter ended June 30,
2026 is formatted in Inline XBRL).
*
Filed herewith.
**
Furnished herewith.
31
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 10, 2026
By:
/s/
Vlad Vitoc
Vlad
Vitoc
Chief
Executive Officer
(Principal
Executive Officer)
Date:
August 10, 2026
By:
/s/
Jeffrey C. Himmelreich
Jeffrey
C. Himmelreich
Head
of Finance
(Principal
Financial and Accounting Officer)
32
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