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Item 1. Financial Statements

2025-08-11 compared with 2025-05-09 · 929 added, 413 removed, 148 unchanged (90% of the section changed)

Financial Statements

MAIA Biotechnology, Inc.

Biotechnology, Inc.

and Subsidiaries

Condensed Consolidated Balance Sheets

Consolidated Balance Sheets

Current assets:

12 unchanged sentences

Stockholders’ equity (deficit)

Preferred stock, $ 0.0001 par value, 30,000,000 shares

authorized at March 31, 2025 and December 31, 2024,

0 shares issued and outstanding

Common stock, $ 0.0001 par value, 70,000,000 shares authorized at

March 31, 2025 and December 31, 2024, 29,587,314 and 26,157,788

shares issued and outstanding at March 31, 2025 and December 31, 2024,

Preferred stock, $ 0.0001 par value, 30,000,000 shares authorized at June 30, 2025 and December 31, 2024, 0 shares issued and outstanding

Common stock, $ 0.0001 par value, 150,000,000 shares and 70,000,000 shares authorized at June 30, 2025 and at December 31, 2024, respectively, 31,818,480 and 26,157,788 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively

Additional paid-in capital

Accumulated deficit

( 97,099,055 )

( 87,234,833 )

Accumulated other comprehensive loss

1 unchanged sentence

Total liabilities and stockholders’ equity

See the accompanying notes to the unaudited condensed consolidated financial statements.

MAIA Biotechnology, Inc.

the accompanying notes to the unaudited condensed consolidated financial statements.

Biotechnology, Inc.

and Subsidiaries

Co ndensed Consolidated Statements of Operations

Consolidated Statements of Operations

Three Months Ended

Six Months Ended

Operating expenses:

3 unchanged sentences

Loss from operations

Other income (expense):

( 5,166,058 )

( 3,815,262 )

( 10,591,489 )

( 7,764,138 )

Other (expense) income:

Interest income

Australian research and development

Australian research and development incentives

Change in fair value of warrant liability

Other income (expense) net:

( 5,157,493 )

( 9,338,791 )

Loss on fair value of warrants over proceeds

Other (expense) income, net:

( 5,064,014 )

( 9,182,593 )

( 5,346,963 )

( 8,879,276 )

( 9,864,222 )

( 16,946,731 )

Net loss per share

Basic and diluted

Weighted average common shares

outstanding basic and diluted

See the accompanying notes to the unaudited condensed consolidated financial statements.

MAIA Biotechnology, Inc.

Weighted average common shares outstanding basic and diluted

the accompanying notes to the unaudited condensed consolidated financial statements.

Biotechnology, Inc.

and Subsidiaries

Condensed Consolidated State ments of Comprehensive Loss

Consolidated Statements of Comprehensive Loss

Three Months Ended

Six Months Ended

$ ( 5,346,963 )

$ ( 8,879,276 )

$ ( 9,864,222 )

$ ( 16,946,731 )

Foreign currency translation adjustment

Comprehensive loss

See the accompanying notes to the unaudited condensed consolidated financial statements.

MAIA Biotechnology, Inc.

$ ( 5,338,836 )

$ ( 8,871,408 )

$ ( 9,863,635 )

$ ( 16,952,649 )

the accompanying notes to the unaudited condensed consolidated financial statements.

Biotechnology, Inc.

and Subsidiaries

Condensed Consolidated Statements of Chan ges in Stockholders' Equity (Deficit) (Unaudited)

For the Three Months Ended March 31,

Preferred Stock

Additional Paid-In Capital

Accumulated Deficit

Accumulated Other Comprehensive Income (Loss)

Total Stockholders' Equity

Balance at December 31, 2024

Exercise of stock options

Stock-based compensation expense

Issuance of common shares in connection with At-The-Market financing, net of $ 130,220 of issuance costs

Issuance of common shares in connection with the Private Placement Offerings, net of $ 74,448 of issuance costs

Issuance of warrants in connection with the Private Placement Offerings

Foreign currency translation adjustment

Balance at March 31, 2025

See the accompanying notes to the unaudited condensed consolidated financial statements.

MAIA Biotechnology, Inc.

Consolidated Statements of Changes in Stockholders’ Equity (Deficit) (Unaudited)

the Three and Six Months Ended

Comprehensive

Stockholders’

at December 31, 2024

$ ( 87,234,833 )

of stock options

compensation expense

of common shares in connection with At-The-Market financing, net of $ 130,220 of issuance costs

of common shares in connection with the Private Placement Offerings, net of $ 74,448 of issuance costs

of warrants in connection with the Private Placement Offerings

currency translation adjustment

( 4,517,259 )

at March 31, 2025

$ ( 91,752,092 )

of restricted stock

compensation expense

of common shares in connection with At-The-Market financing, net of $ 61,132 of issuance costs

of common shares in connection with the Private Placement Offerings, net of $ 115,493 of issuance costs

of warrants in connection with the Private Placement Offerings

currency translation adjustment

( 5,346,963 )

at June 30, 2025

$ 101,002,585

$ ( 97,099,055 )

the accompanying notes to the unaudited condensed consolidated financial statements.

Biotechnology, Inc.

and Subsidiaries

Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit) (Unaudited)

For the Three Months Ended March 31,

Preferred Stock

Additional Paid-In Capital

Accumulated Deficit

Accumulated Other Comprehensive Income (Loss)

Total Stockholders' Equity

Balance at December 31, 2023

Issuance of restricted stock

Stock-based compensation expense

Issuance of common shares in connection with At-The-Market financing, net of $ 179,628 of issuance costs

Issuance of common shares in connection with the Private Placement Offering #1, net of $ 50,000 of issuance costs

Issuance of common shares in connection with the Private Placement Offering #2, net of $ 47,261 of issuance costs

Issuance of warrants in connection with the Private Placement Offering #1

Foreign currency translation adjustment

Balance at March 31, 2024

See the accompanying notes to the unaudited condensed consolidated financial statements.

MAIA Biotechnology, Inc.

Consolidated Statements of Changes in Stockholders’ Equity (Deficit) (Unaudited)

the Three and Six Months Ended

Comprehensive

Stockholders’

at December 31, 2023

$ ( 63,980,177 )

of restricted stock

compensation expense

of common shares in connection with At-The-Market financing, net of $ 179,628 of issuance costs

of common shares in connection with the Private Placement Offering #1, net of $ 50,000 of issuance costs

of common shares in connection with the Private Placement Offering #2, net of $ 47,261 of issuance costs

of warrants in connection with the Private Placement Offering #1

currency translation adjustment

( 8,067,455 )

at March 31, 2024

$ ( 72,047,632 )

$ ( 5,764,928 )

$ ( 72,047,632 )

$ ( 5,764,928 )

of stock options

compensation expense

of common shares in connection with At-The-Market financing, net of $ 315,314 of issuance costs

of common shares in connection with the Private Placement Offering #3, net of $ 5,030 of issuance costs

of warrants in connection with the Private Placement Offering #3

Reclassification

of liability classified warrants to equity

currency translation adjustment

( 8,879,276 )

at June 30, 2024

$ ( 80,926,908 )

the accompanying notes to the unaudited condensed consolidated financial statements.

Biotechnology, Inc.

and Subsidiaries

Condensed Consolidated S tatements of Cash Flows

Three Months Ended

Consolidated Statements of Cash Flows

Six Months Ended

Cash flows from operating activities:

$ ( 9,864,222 )

$ ( 16,946,731 )

Adjustments to reconcile net loss to net cash used in operating activities:

Stock-based compensation

Consulting expense for restricted shares issued

Consulting and research expense for restricted shares issued

Change in fair value of warrant liability

Loss on fair value of warrants over proceeds

Change in operating assets and liabilities:

1 unchanged sentence

Australia research and development incentives receivable

Other receivables

Accounts payable

Accrued expenses

( 1,050,758 )

Net cash used in operating activities

( 8,337,611 )

( 8,271,571 )

Cash flows from financing activities:

Proceeds from exercise of stock options

Proceeds from exercise of warrants

Proceeds from private placement round 1 2025

2 unchanged sentences

Proceeds from private placement round 4 2025

Proceeds from private placement round 1 2024

Proceeds from private placement round 2 2024

Proceeds from private placement round 3 2024

Proceeds from private placement

Proceeds from At-The-Market offering

2 unchanged sentences

Net effect of foreign currency exchange on cash

Net increase in cash

Net increase (decrease) in cash

Cash at beginning of period

5 unchanged sentences

Warrants issued in connection with private placement offering 4 2025

See the accompanying notes to the unaudited condensed consolidated financial statements.

MAIA Biotechnology, Inc.

Warrants issued in connection with private placement offering 1 2024

Warrants issued in connection with private placement offering 2 2024

Warrants issued in connection with private placement offering 3 2024

the accompanying notes to the unaudited condensed consolidated financial statements.

Biotechnology, Inc.

and Subsidiaries

Notes to Unaudited Condensed Con solidated Financial Statements

to Unaudited Condensed Consolidated Financial Statements

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.

of Business, Organization, and Principles of Consolidation

Biotechnology, Inc.

and subsidiaries (collectively, “the Company”) is a biopharmaceutical company that develops oncology

drug candidates to improve and extend the lives of people with cancer.

MAIA Biotechnology, Inc.

(“MAIA”) was incorporated in the state of Delaware on August 3, 2018 .

These condensed consolidated financial statements include the accounts of MAIA and its subsidiaries, as follows:

• In July 2021, the Company established a wholly owned Australian subsidiary, MAIA Biotechnology Australia Pty Ltd., to conduct various pre-clinical and clinical activities for the development of the Company's product candidates.

• In April 2022, the Company established a wholly owned Romanian subsidiary, MAIA Biotechnology Romania S.R.L., to conduct various pre-clinical and clinical activities for the development of the Company's product candidates.

Going Concern Considerations

The accompanying unaudited condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.

The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

To date, the Company has incurred recurring losses, negative cash flow from operations and has accumulated a deficit of $ 91,752,092 from the Company’s inception through March 31, 2025.

As of March 31, 2025, the Company had $ 10,863,296 in cash and working capital of approximately $ 6,804,341 .

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

While the Company has historically been able to raise additional capital through issuance of equity and/or debt financing, and while the Company has implemented a plan to control its expenses in order to satisfy its obligations due within one year from the date of issuance of these financial statements, the Company cannot guarantee that it will be able to raise additional equity, raise debt, or contain expenses.

Accordingly, there is substantial doubt about the Company’s ability to continue as a going concern within one year after these financial statements are issued.

Basis of Presentation and Consolidation Principles

The accompanying condensed consolidated financial statements have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”).

Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with U.S.

generally accepted accounting principles (“GAAP”) have been condensed or omitted pursuant to such rules and regulations.

(“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,

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.

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.

Concern Considerations

accompanying unaudited condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the

realization of assets and the satisfaction of liabilities in the normal course of business.

The consolidated financial statements do

not include any adjustments that might result from the outcome of this uncertainty.

date, the Company has incurred recurring losses, negative cash flow from operations and has accumulated a deficit of $ 97,099,055 from

the Company’s inception through June 30, 2025.

As of June 30, 2025, the Company had $ 10,144,522 in cash and working capital of

approximately $ 5,999,102 .

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

While the Company has historically been able to raise additional capital through issuance of equity and/or debt financing, and while

the Company has implemented a plan to control its expenses in order to satisfy its obligations due within one year from the date of issuance

of these financial statements, the Company cannot guarantee that it will be able to raise additional equity, raise debt, or contain expenses.

Accordingly, there is substantial doubt about the Company’s ability to continue as a going concern within one year after these

financial statements are issued.

of Presentation and Consolidation Principles

accompanying condensed consolidated financial statements have been prepared by the Company pursuant to the rules and regulations of the

Securities and Exchange Commission (“SEC”).

Certain information and footnote disclosures normally included in annual financial

statements prepared in accordance with U.S.

generally accepted accounting principles (“GAAP”) have been condensed or omitted

pursuant to such rules and regulations.

The condensed consolidated financial statements may not include all disclosures required by GAAP;

however, the Company believes that the disclosures are adequate to make the information presented not misleading.

These unaudited condensed financial statements should be read in conjunction with the audited financial statements and the notes thereto for the fiscal year ended December 31, 2024 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 21, 2025.

The condensed consolidated balance sheet as of December 31, 2024 was derived from such audited financial statements.

In the opinion of management, all adjustments, consisting of only normal recurring adjustments that are necessary to present fairly the financial position, results of operations, and cash flows for the interim periods, have been made.

The results of operations for the interim periods are not necessarily indicative of the operating results for the full fiscal year or any future periods.

The unaudited interim condensed consolidated financial statements include the accounts of the Company's wholly owned subsidiaries.

These unaudited condensed

financial statements should be read in conjunction with the audited financial statements and the notes thereto for the fiscal year ended

December 31, 2024, included in the Company’s Annual Report on Form 10-K filed with the SEC on March 21, 2025.

The condensed consolidated

balance sheet as of December 31, 2024, was derived from such audited financial statements.

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.

unaudited interim condensed consolidated financial statements include the accounts of the Company’s wholly owned subsidiaries.

All transactions and accounts between and among its subsidiaries have been eliminated.

All adjustments and disclosures necessary for a fair presentation of these unaudited interim condensed consolidated financial statements have been included.

Segment Information

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

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

All adjustments and disclosures necessary for

a fair presentation of these unaudited interim condensed consolidated financial statements have been included.

segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief

operating decision-maker (“CODM”) in deciding how to allocate resources and assess performance.

The Company and the Company’s

chief operating decision-maker, the Company’s Chief Executive Officer, view the Company’s operations and manage its business

as a single operating segment, which is the business of discovering and developing products for the treatment of immunotherapies for

Management has determined that the Company operates in one 1 segment, given the common nature of its operations.

For additional information, see Note 8 - Segment Information.

Use of Estimates

The preparation of the Company’s unaudited interim condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes.

The most significant estimates in the Company’s financial statements relate to the valuation of the Company’s common stock, par value $ 0.0001 per share (the “Common Stock”), stock options and warrants, the embedded features in convertible notes, and accruals for outsourced research and development activities.

These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources.

Actual results may differ materially and adversely from these estimates.

To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected.

Certain Risks and Uncertainties

The Company’s activities are subject to significant risks and uncertainties including the risk of failure to secure additional funding to properly execute the Company’s business plan.

The Company is subject to risks that are common to companies in the pharmaceutical industry, including, but not limited to, the development by the Company or its competitors of new technological innovations, dependence on key personnel, reliance on third party manufacturers, protection of proprietary technology, and compliance with regulatory requirements.

Foreign Currency Translation

The financial statements of the Company’s foreign subsidiaries, where the local currency is the functional currency, are translated using exchange rates in effect as of the applicable balance sheet dates for assets and liabilities and average exchange rates during the period for results of operations.

The resulting foreign currency translation adjustment is included in stockholders’ equity as accumulated other comprehensive loss.

Off-Balance Sheet Risk and Concentrations of Credit Risk

The Company has no significant off-balance sheet risks, such as foreign exchange contracts, option contracts, or other foreign hedging arrangements.

For additional

information, see Note 8 - Segment Information.

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.

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.

Risks and Uncertainties

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.

Currency Translation

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.

Sheet Risk and Concentrations of Credit Risk

Company has no significant off-balance sheet risks, such as foreign exchange contracts, option contracts, or other foreign hedging arrangements.

Cash accounts are maintained at financial institutions that potentially subject the Company to concentrations of credit risk.

As of March 31, 2025 and December 31, 2024 , substantially all of the Company’s cash was deposited in accounts at two financial institutions.

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

Cash and Cash Equivalents

The Company considers all highly liquid investments purchased with maturities of three months or less to be cash equivalents.

As of March 31, 2025 and December 31, 2024 , cash includes cash in depository bank accounts.

The Company had no cash equivalents as of March 31, 2025 or December 31, 2024 .

Fair Value Measurements

The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values.

Accounting Standards Codification (“ASC”) Topic 820, Fair Value Measurements and Disclosures (“ASC 820”) establishes a hierarchy of inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the observable inputs be used when available.

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

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

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

• Level 1 - Valuations based on quoted prices for identical assets and liabilities in active markets.

• Level 2 - Valuations based on observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data.

• Level 3 - Valuations based on unobservable inputs reflecting our own assumptions, consistent with reasonably available assumptions made by other market participants.

30, 2025 and December 31, 2024, substantially all of the Company’s cash was deposited in accounts at two financial institutions.

The Company maintains its cash deposits, which at times may exceed the federally insured limits, with a reputable financial institution,

and accordingly, the Company believes such funds are subject to minimal credit risk.

and Cash Equivalents

Company considers all highly liquid investments purchased with maturities of three months or less to be cash equivalents.

30, 2025, and December 31, 2024, cash includes cash in depository bank accounts.

The Company had no cash equivalents as of June 30, 2025,

or December 31, 2024.

Value Measurements

Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs

used in determining the reported fair values.

Accounting Standards Codification (“ASC”) Topic 820, Fair Value Measurements

and Disclosures (“ASC 820”) establishes a hierarchy of inputs used in measuring fair value that maximizes the use of

observable inputs and minimizes the use of unobservable inputs by requiring that the observable inputs be used when available.

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:

1 - Valuations based on quoted prices for identical assets and liabilities in active markets.

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.

3 - Valuations based on unobservable inputs reflecting our own assumptions, consistent with reasonably available assumptions made

by other market participants.

These valuations require significant judgment.

Fair value measurements discussed herein are based upon certain market assumptions and pertinent information available to management as of and during the three months ended March 31, 2025, and as of and during the twelve months ended December 31, 2024.

The carrying amount of accounts payable approximated fair value, as they are short term in nature.

The fair value of warrants issued for services is estimated based on the Black-Scholes-Merton model during the three months ended March 31, 2025 .

The estimated fair value of warrants issued to underwriters represented Level 3 measurements.

General and Administrative

General and administrative expenses primarily consist of costs for corporate functions, including payroll and related expenses, rent, outside legal expenses, insurance costs, and other general and administrative costs.

Research and Development

The Company’s research and development expenses consist primarily of costs associated with the Company’s clinical trials, salaries, payroll taxes, employee benefits, and stock-based compensation charges for those individuals involved in ongoing research and development efforts.

value measurements discussed herein are based upon certain market assumptions and pertinent information available to management as of

and during the six months ended June 30, 2025, and as of and during the twelve months ended December 31, 2024.

The carrying amount of

accounts payable approximated fair value, as they are short term in nature.

The fair value of warrants issued for services is estimated

based on the Black-Scholes-Merton model during the six months ended June 30, 2025.

The estimated fair value of warrants issued to underwriters

represented Level 3 measurements.

and Administrative

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.

and Development

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

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.

Management has assessed the Company’s research and development activities and expenditures to determine which activities and expenditures are likely to be eligible under the research and development incentive regime described above.

At each period end, management estimates the refundable tax offset available to the Company based on available information at the time, and it is included in Australian research and development incentives in the condensed consolidated statements of operations.

Derivative Financial Instruments

The Company does not use derivative instruments to hedge exposures to cash flow, market, or foreign currency risks.

The Company evaluates all of its financial instruments to determine if such instruments contain features that qualify as embedded derivatives.

Embedded derivatives must be separately measured from the host contract if all the requirements for bifurcation are met.

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

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

Stock-Based Compensation

The Company records share-based compensation for awards granted to employees, non-employees, and to members of the board of directors based on the grant date fair value of awards issued, and the expense is recorded on a straight-line basis over the requisite service period.

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.

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.

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.

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.

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.

and Development Incentive

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.

the program, a percentage of eligible research and development expenses incurred by the Company through its subsidiary in Australia are

has assessed the Company’s research and development activities and expenditures to determine which activities and expenditures

are likely to be eligible under the research and development incentive regime described above.

At each period end, management estimates

the refundable tax offset available to the Company based on available information at the time, and it is included in Australian research

and development incentives in the condensed consolidated statements of operations.

Financial Instruments

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.

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.

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.

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

For these analyses, companies with comparable characteristics, including enterprise value and position within the industry, and

with historical share price information sufficient to meet the expected life of the share-based awards, are selected.

The Company computes

the historical volatility data using the daily closing prices for the selected companies’ shares during the equivalent period of

the calculated expected term of its share-based awards.

The risk-free interest rate is determined by reference to U.S.

Treasury zero-coupon issues with remaining maturities similar to the expected term of the options.

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

Prior to the Company’s initial public offering (“IPO”) in order to estimate the fair value of shares of the Common Stock, the Company's board of directors considered, among other things, sales of Common Stock to third party investors and valuations of Common Stock, business, financial condition and results of operations, including related industry trends affecting operations;

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

the lack of marketability of our Common Stock;

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.

to the Company’s initial public offering (“IPO”) in order to estimate the fair value of shares of the Common Stock,

the Company’s board of directors considered, among other things, sales of Common Stock to third party investors and valuations

of Common Stock, business, financial condition and results of operations, including related industry trends affecting operations;

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

of marketability of our Common Stock;

the market performance of comparable publicly traded companies;

and global economic and capital market conditions.

During the three months ended March 31, 2025 , there were no issuance of restricted shares of Common Stock.

During the three months ended March 31, 2024 , 12,500 restricted shares of Common Stock were issued for consulting services.

The fair value of restricted stock awards is based on the Common Stock price.

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

Common Stock Warrants

The Company accounts for Common Stock warrants as either equity instruments or as liabilities in accordance with ASC 480, Distinguishing Liabilities from Equity (“ASC 480”), depending on the specific terms of the warrant agreement.

When warrants are issued for services provided by non-employees, under ASC 718, Compensation – Stock Compensation (“ASC 718”), the warrants shall be classified as a liability if:

and global economic and

capital market conditions.

the six months ended June 30, 2025, 35,123 restricted shares of Common Stock were issued for consulting and research services.

the six months ended June 30, 2024, 12,500 restricted shares of Common Stock were issued for consulting services.

The fair value of restricted

stock awards is based on the Common Stock price.

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.

Stock Warrants

Company accounts for Common Stock warrants as either equity instruments or as liabilities in accordance with ASC 480, Distinguishing

Liabilities from Equity (“ASC 480”), depending on the specific terms of the warrant agreement.

warrants are issued for services provided by non-employees, under ASC 718, Compensation – Stock Compensation (“ASC

718”), the warrants shall be classified as a liability if:

(i) the underlying shares are classified as liabilities;

or (ii) the entity can be required under any circumstances to settle the warrant by transferring cash or other assets.

The measurement of equity-classified non-employee share-based payments is generally fixed on the grant date and are considered compensatory, as defined by ASC 718.

Income taxes are recorded in accordance with ASC 740, Income Taxes (“ASC 740”), which provides for deferred taxes using an asset and liability approach.

The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns.

Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse.

Valuation allowances are provided, if based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.

The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740.

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

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

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

Net Loss Per Share

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

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

Diluted loss per share excludes, when applicable, the potential impact of stock options, unvested shares of restricted stock awards, and common

stock warrants because their effect would be anti-dilutive due to our net loss.

Gains on warrant liabilities are only considered dilutive when the average market price of the Common Stock during the period exceeds the exercise price of the warrants.

Since the Company had a net loss in each of the periods presented, basic and diluted net loss per common share are the same.

The following table summarizes the Company’s potentially dilutive securities, in common share equivalents, which have been excluded from the calculation of dilutive loss per share as their effect would be anti-dilutive:

Three Months Ended

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.

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.

July 4, 2025, the “One big Beautiful Bill Act (OBBBA) was signed into law.

This legislation introduces a number of new changes

to the Internal Revenue Code.

As a pre-revenue company that does not currently generate taxable income, we do not expect the legislation

to have a material impact on our tax posture.

The Company will continue to maintain a full valuation allowance against its net deferred

Loss Per Share

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

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.

the Company had a net loss in each of the periods presented, basic and diluted net loss per common share are the same.

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

Six Months Ended

Shares issuable upon exercise of stock options

Shares issuable upon exercise of warrants

Recent Accounting Standards

In December 2023, the FASB issued ASU No.

Accounting Standards

December 2023, the FASB issued ASU No.

2023-09, Improvements to Income Tax Disclosures (“ASU No.

2023-09”), which requires disclosure of disaggregated income taxes paid, prescribes standard categories for the components of the effective tax rate reconciliation, and modifies other income tax-related disclosures.

2023-09 is effective for fiscal years beginning after December 15, 2024 and allows for adoption on a prospective basis, with a retrospective option.

2023-09”), which

requires disclosure of disaggregated income taxes paid, prescribes standard categories for the components of the effective tax rate reconciliation,

and modifies other income tax-related disclosures.

2023-09 is effective for fiscal years beginning after December 15, 2024 and

allows for adoption on a prospective basis, with a retrospective option.

Early adoption is permitted.

We do not expect the amendments in ASU No.

We do not expect the amendments

2023-09 to have a material impact on our consolidated financial statements.

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

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

March 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses , which requires detailed disclosure of significant

expense components and additional clarity when expenses are classified by function.

2024-03 is effective for fiscal years beginning

after December 15, 2026 and allows for adoption on a prospective basis, with a retrospective option.

Early adoption is permitted.

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

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

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.

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

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.

RELATED PARTY TRANSACTIONS

Consulting Services

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

The Company expensed $ 11,445 as of March 31, 2025 related to accounting, tax and valuation services.

In addition, FGMK Business Holdings, LLC participated in the February 2025 private placement and purchased 1,350,000 shares of the Company’s Common Stock and warrants to purchase 1,350,000 shares of the Company’s Common Stock for an aggregate purchase price of approximately $ 2,025,000 .

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.

Services and Private Placement

consulting firm FGMK, LLC and its affiliate FGMK Business Holdings, LLC beneficially owns more than 5 % of the stock of the Company and

is therefore a related party.

The Company expensed $ 31,570 with the issuance of 18,040 shares of common stock as of June 30, 2025, related

to accounting, tax and valuation services.

In addition, FGMK Business Holdings, LLC participated in the February 2025 private placement

and purchased 1,350,000 shares of the Company’s Common Stock and warrants to purchase 1,350,000 shares of the Company’s Common

Stock for an aggregate purchase price of approximately $ 2,025,000 .

of our directors and executive officers previously adopted written plans, known as Rule 10b5-1 plans, in which they contracted with a

broker to buy shares of our Common Stock on a periodic basis.

Each of these plans have expired as of the date of this Quarterly Report.

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

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

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

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

Private Placement

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

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

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

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

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

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

Our directors and executive officers may, in the future, adopt Rule 10b5-1 plans in which they contract with a broker to buy or sell

shares of our Common Stock on a periodic basis.

Under a Rule 10b5-1 plan, a broker executes trades pursuant to parameters established

by the director or officer at the time was entered into, without further direction from the director or officer.

The director or officer

may amend or terminate the plan in limited circumstances.

Our directors and executive officers may also buy or sell additional shares

of our Common Stock outside of a Rule 10b5-1 plan when they are not in possession of material nonpublic information.

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 ;

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 .

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 ;

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 .

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 ;

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 $ 30,000 .

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 .

ACCRUED EXPENSES

As of March 31, 2025 and December 31, 2024 accrued expenses consisted of the following:

of June 30, 2025 and December 31, 2024 accrued expenses consisted of the following:

OF ACCRUED EXPENSES

Professional fees

2 unchanged sentences

FAIR VALUE OF FINANCIAL LIABILITIES

Derivative Liability

Financial liabilities consisting of warrant liabilities measured at fair value on a recurring basis are summarized below.

The fair value of the warrant liabilities recorded are as follows:

Fair value at March 31, 2025

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 MEASUREMENTS OF EMBEDDED DERIVATIVE LIABILITIES AND WARRANT LIABILITIES

Fair value at June 30, 2025

Warrant liability

3 unchanged sentences

Total liabilities

The table below provides a summary of the changes in fair value of the warrant liabilities measured on a recurring basis using significant unobservable inputs (Level 3):

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

Three Months Ended

Six Months Ended

Warrant liabilities:

1 unchanged sentence

Issuance of warrants

Exercise of warrants

Amendment of warrants

(Gain) loss on fair value of warrant liability

Exercises of warrants

( 3,191,675 )

Amendments of warrants

( 6,870,296 )

Loss (gain) on fair value of warrant liability

Balance, end of period

STOCKHOLDERS’ EQUITY

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

In connection with the closing of the IPO, the Company amended and restated its Amended and Restated Certificate of Incorporation (the “Amended and Restated Certificate of Incorporation”) and amended and restated its Bylaws (the “Amended and Restated Bylaws”).

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

At-the-Market Equity Offering

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

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

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

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

During the quarter ended March 31, 2024, the Company sold 507,754 shares of Common Stock at an average price of approximately $ 1.47 per share, resulting in aggregate gross proceeds of approximately $ 745,251 , for which it paid Wainwright approximately $ 22,357 in commissions and other issuance costs of $ 157,271 , resulting in net proceeds to the Company of approximately $ 565,623 .

Effective December 23, 2024, the Company filed a prospectus supplement to amend, supplement and supersede certain information contained in the earlier prospectus and prospectus supplement, which increased the number of Shares the Company may offer and sell under the ATM Agreement to an aggregate offering price of up to $ 30,000,000 from time to time.

Effective March 22, 2025, the Company filed a prospectus supplement to amend, supplement and supersede certain information contained in the earlier prospectus and prospectus supplement, which decreased the number of Shares the Company may offer and sell under the ATM Agreement to an aggregate offering price of up to $ 11,200,000 from time to time.

During the quarter ended March 31, 2025, the Company sold 666,323 shares of Common Stock at an average price of approximately $ 2.28 per share, resulting in aggregate gross proceeds of approximately $ 1,521,091 , for which it paid Wainwright approximately $ 45,633 in commissions and other issuance costs of $ 84,587 , resulting in net proceeds to the Company of approximately $ 1,390,871 .

Private Placement

On February 24, 2025, the Company issued and sold 1,810,000 shares of its Common Stock and warrants to purchase 1,810,000 shares of its Common Stock in a private placement to certain accredited investors and Company directors pursuant to securities purchase agreements dated February 18, 2025 at a price per share of $ 1.50 for which the Company received gross proceeds of approximately $ 2.7 million.

The warrants are exercisable at a price per

share of $ 1.87 , are exercisable commencing one year following issuance, have a term of six years from the issuance date, and expiring on February 24, 2031 .

The securities sold to Company directors participating in the private placement were issued pursuant to the MAIA Biotechnology, Inc.

the closing of the Company’s IPO, the Company’s shareholders agreement terminated pursuant to its terms.

In connection with

the closing of the IPO, the Company amended and restated its Amended and Restated Certificate of Incorporation (the “Amended and

Restated Certificate of Incorporation”) and amended and restated its Bylaws (the “Amended and Restated Bylaws”).

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

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

& Co., LLC (“Wainwright”), to sell shares of its Common Stock, par value $ 0.0001 per share, (the “Shares”)

having an aggregate sales price of up to $ 1,445,000 , from time to time, through an at-the-market offering program under which Wainwright

will act as sales agent.

The sales, if any, of the Shares made under the ATM Agreement will be made by any method permitted by law deemed

to be an “at-the-market offering” as defined in Rule 415 promulgated under the Securities Act of 1933, as amended (the “Securities

Effective March 25, 2024, the Company filed a prospectus supplement to amend, supplement and supersede certain information

contained in the earlier prospectus and prospectus supplement, which increased the number of Shares the Company may offer and sell under

the ATM Agreement to an aggregate offering price of up to $ 4,950,000 , from time to time.

During the quarter ended June 30, 2024, the

Company sold 2,015,122 shares of Common Stock at an average price of approximately $ 3.53 per share, resulting in aggregate gross proceeds

of approximately $ 7,116,978 , for which it paid Wainwright approximately $ 213,509 in commissions and other issuance costs of $ 101,805 ,

resulting in net proceeds to the Company of approximately $ 6,801,664 .

December 23, 2024, the Company filed a prospectus supplement to amend, supplement and supersede certain information contained in the

earlier prospectus and prospectus supplement, which increased the number of Shares the Company may offer and sell under the ATM Agreement

to an aggregate offering price of up to $ 30,000,000 from time to time.

Effective March 22, 2025, the Company filed a prospectus supplement

to amend, supplement and supersede certain information contained in the earlier prospectus and prospectus supplement, which decreased

the number of Shares the Company may offer and sell under the ATM Agreement to an aggregate offering price of up to $ 11,200,000 from

time to time.

During the quarter ended June 30, 2025, the Company sold 793,429 shares of Common Stock through Wainwright under the ATM

Agreement at an average price of approximately $ 1.87 per share, resulting in aggregate gross proceeds of approximately $ 1,480,894 , for

which it paid Wainwright approximately $ 44,427 in commissions and other issuance costs of $ 16,705 , resulting in net proceeds to the Company

of approximately $ 1,419,762 .

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.

warrants are exercisable at a price per share of $ 1.87 , are exercisable commencing one year following issuance, have a term of six years

from the issuance date, and expiring on February 24, 2031 .

The securities sold to Company directors participating in the private placement

were issued pursuant to the MAIA Biotechnology, Inc.

2021 Equity Incentive Plan (the “MAIA 2021 Plan”).

On March 3, 2025, the Company issued and sold 952,633 shares of its Common Stock and warrants to purchase 952,633 shares of its Common Stock in a private placement to certain accredited investors and Company directors pursuant to securities purchase agreements dated February 25, 2025 at a price per share of $ 1.50 for which the Company received gross proceeds of approximately $ 1.4 million.

The warrants are exercisable at a price per share of $ 1.85 , are exercisable commencing one year following issuance, have a term of six years from the issuance date, and expiring on March 3, 2031 .

The securities sold to Company directors participating in the private placement were issued pursuant to the MAIA Biotechnology, Inc.

March 3, 2025, the Company issued and sold 952,633 shares of its Common Stock and warrants to purchase 952,633 shares of its Common Stock

in a private placement to certain accredited investors and Company directors pursuant to securities purchase agreements dated February

25, 2025 at a price per share of $ 1.50 for which the Company received gross proceeds of approximately $ 1.4 million.

The warrants are

exercisable at a price per share of $ 1.85 , are exercisable commencing one year following issuance, have a term of six years from the

issuance date, and expiring on March 3, 2031 .

The securities sold to Company directors participating in the private placement were issued

pursuant to the MAIA Biotechnology, Inc.

2021 Equity Incentive Plan (the “MAIA 2021 Plan”).

MAIA Biotechnology, Inc.

May 8, 2025, the Company issued and sold 719,999 shares of its Common Stock and warrants to purchase 719,999 shares of its Common Stock

in a private placement to certain accredited investors and Company directors pursuant to securities purchase agreements dated May 5,

2025 at a price per share of $ 1.50 for which the Company received gross proceeds of approximately $ 1.08 million.

The warrants are exercisable

at a price per share of $ 2.05 , are exercisable commencing one year following issuance, have a term of six years from the issuance date,

and expiring on May 8, 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”).

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 , are exercisable commencing six months following issuance, have a term of five years from the issuance

date, and expiring on June 3, 2030 .

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”).

Biotechnology, Inc.

Restricted Stock Awards

During the three months ended March 31, 2025 , the Company had no expense related to restricted shares of Common Stock.

There are no unvested restricted shares as of March 31, 2025.

During the three months ended March 31, 2024 , the Company expensed $ 11,500 to consulting expense related to the grant of 12,500 restricted shares of Common Stock.

There were no unvested restricted shares March 31, 2024.

MAIA Stock Warrants

Concurrently with the closing of the IPO, the Company issued warrants to purchase an aggregate of up to 100,000 shares of its Common Stock to the representative or its designees, at an exercise price of $ 6.25 per share (the “Representative’s Warrants”).

The Representative’s Warrants were exercisable beginning on January 23, 2023 , and expire on July 27, 2027 , pursuant to their terms and conditions.

On August 3, 2023, concurrently with the full exercise of the representative’s over-allotment option, the Company issued additional Representative’s Warrants to purchase an aggregate of up to 15,000 shares of its Common Stock to the representative or its designees on the same terms.

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

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

As of March 31, 2025 and December 31, 2024, the Company remeasured the warrant liability resulting in a value of $ 45,404 and $ 71,672 respectively.

The gain on remeasurement of the warrant liability in the amount of $ 26,268 and the loss on remeasurement of the warrant liability in the amount of $ 72,666 was included in other income (expense) for the three months ended March 31, 2025 and March 31, 2024, respectively.

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

The warrants were exercisable beginning on November 10, 2023 , and expire on November 10, 2027 , pursuant to their terms and conditions.

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

the six months ended June 30, 2025, the Company expensed $ 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 are no unvested restricted shares as of June 30, 2025.

the six months ended June 30, 2024, the Company expensed $ 11,500 to consulting expense for investor relations related to the grant of

12,500 restricted shares of Common Stock.

There are no unvested restricted shares as of June 30, 2024.

Stock Warrants

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.

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

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

As of June 30, 2025 and December 31, 2024, the Company remeasured the warrant liability resulting in a value of $ 39,596 and

$ 71,672 respectively.

The gain on remeasurement of the warrant liability in the amount of $5,808 and the gain on remeasurement of the

warrant liability in the amount of $ 32,076 was included in other income (expense) for the three and six months ended June 30, 2025, respectively.

The loss on remeasurement of the warrant liability in the amount of $ 96,732 and $ 169,398 was included in other income (expense) for the

three and six months ended June 30, 2024, respectively.

November 9, 2023, the Company issued warrants to purchase an aggregate of up to 239,234 shares of its Common Stock to Alumni Capital

LP (“Alumni”), at an exercise price of $ 2.09 per share.

The warrants were exercisable beginning on November 10, 2023 , and

expire on November 10, 2027 , pursuant to their terms and conditions.

The warrants are not indexed to the Company’s own stock and

therefore meet the definition of a derivative liability.

On November 13, 2023, 131,578 warrant shares vested in accordance with the terms.

The warrants are liability classified instruments and were initially recorded at a value of $ 84,251 , which was determined using the Black-Scholes-Merton method using a term of 3.87 years, risk free interest rate of 3.93 % and volatility of 90.0 %.

The warrants are liability classified instruments and were initially recorded at a value of $ 84,251 , which was determined using the Black-Scholes-Merton

method using a term of 3.87 years, risk free interest rate of 3.93 % and volatility of 90.0 %.

Laidlaw & Company Ltd.

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

As of March 31, 2024, the Company remeasured the warrant liability resulting in a value of $ 199,902 .

The loss on remeasurement of the warrant liability in the amount of $ 115,651 is included in other income(expense) for the three months ended March 31, 2024.

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

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

The warrant liability was removed to reflect the warrants being exercised and equity was increased by the value of $ 375,705 .

As of March 31, 2025 and December 31, 2024, the warrant liability resulted in a value of $ 0 and $ 0 , respectively.

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

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

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

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

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

During the nine months ended September 30, 2024, 909,091 warrants were exercised on various dates in cashless exercises and the investor was issued 458,726 shares of Common Stock.

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

The warrant liability for the exercised warrants was removed and equity was increased by the value of $ 2,815,970 .

As of March 31, 2025 and December 31, 2024, the warrant liability resulted in a value of $ 1,509,930 and $ 2,189,478 , respectively.

The gain on remeasurement in the amount of $ 679,548 and the loss on remeasurement in the amount of $ 2,307,832 was included in other income (expense) for the three months ended March 31, 2025 and Mach 31, 2024, respectively.

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

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

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

The representative’s warrants are liability classified instruments and were initially recorded at a value of $ 123,811 , which was determined using the Black-Scholes-Merton method using a term of 4.88 years, risk free interest rate of 3.84 % and volatility of 90.0 %.

As of March 31, 2025 and December 31, 2024 the Company remeasured the warrant liability resulting in a value of $ 164,492 and $ 230,038 respectively.

The gain on remeasurement of the warrant liability in the amount of $ 65,546 and the loss on remeasurement of $ 156,959 is included in other income (expense) for the three months ended March 31, 2025 and March 31, 2024, respectively.

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

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

The warrants were exercised on May

22, 2024 in a cashless exercise and Alumni was issued 54,976 shares of Common Stock.

The Company remeasured the warrant liability at

the time of the exercise resulting in a value of $ 375,705 .

The warrant liability was removed to reflect the warrants being exercised

and equity was increased by the value of $ 375,705 .

As of June 30, 2025 and December 31, 2024, the warrant liability resulted in a value

of $ 0 , respectively.

The loss on remeasurement at the time of exercise of the warrant liability in the amount of $ 175,803 and $ 291,454

was included in other expense for the three and six months ended June 30, 2024, respectively.

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 %.

In 2024, 909,091 warrants were exercised on various dates in cashless exercises and the investor

was issued 458,726 shares of Common Stock.

The Company remeasured the warrant liability of the exercised warrants at the time of 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, 2025 and December 31, 2024, the warrant liability resulted in a value of $ 1,756,035 and $ 2,189,478 ,

respectively.

The loss on remeasurement in the amount of $ 246,105 and the gain on remeasurement in the amount of $ 433,443 was included

in other income (expense) for the three and six months ended June 30, 2025, respectively.

The loss on remeasurement of the warrant liability

in the amount of $ 805,104 and $ 3,112,936 was included in other income (expense) for the three and six months ended June 30, 2024, respectively.

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.

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, 2025 and December 31, 2024 the Company remeasured the warrant liability resulting in a

value of $ 180,233 and $ 230,038 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 value of $ 15,741 was included in other income (expense) for the three and six months

ended June 30, 2025, respectively.

The loss on remeasurement of the warrant liability in the amount of $ 181,705 and $ 338,664 is included

in other expense for the three and six months ended June 30, 2024, respectively.

with the closing of the Company’s private placement on March 14, 2024, the Company issued warrants to purchase an aggregate of

up to 2,496,318 shares of its Common Stock to the investors in the private placement, at an exercise price of $ 1.30 per share are exercisable

beginning on September 14, 2024 , and expire on September 14, 2029 .

The warrants issued were divided into two groups:

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

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

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

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

As of March 31, 2024, the Company remeasured the warrant liability resulting in a value of $ 3,793,921 .

The loss on remeasurement of the warrant liability in the amount of $ 1,744,321 is included in other income (expense) for the three months ended March 31, 2024.

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

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

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

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

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

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

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

As of March 31, 2024, the Company remeasured the warrant liability resulting in a value of $ 973,980 .

The gain on remeasurement of the warrant liability in the amount of $ 216,131 is included in other income (expense) for the three months ended March 31, 2024.

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

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

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

The remaining 141,612 warrants remain

liability classified instruments.

As of March 31, 2025 and December 31, 2024, the Company remeasured the warrant liability, resulting in a value of $ 144,790 and $ 199,417 , respectively.

The gain on remeasurement of the warrant liability in the amount of $ 54,627 is included in other income (expense) for the three months ended March 31, 2025.

Concurrently with the closing of the Company’s private placement offering on February 24, 2025, the Company issued warrants to purchase an aggregate of up to 1,686,667 shares of its Common Stock to the investors in the private placement at an exercise price of $ 1.87 per share.

The warrants are exercisable beginning on February 24, 2026 , and expire on February 24, 2031 .

warrants issued

to directors and warrants issued to non-affiliated investors.

The warrants to purchase 452,731 shares of the Company’s Common Stock

issued to directors were deemed options issued under the MAIA 2021 Plan and are equity classified instruments, and the value of these

warrants determined using the Black-Scholes-Merton method was $ 230,685 using a term of 5.5 years, risk free interest rate of 4.20 % and

volatility of 95 %.

The warrants to purchase 2,043,587 share of the Company’s Common Stock issued to non-affiliated investors were

not indexed to the Company’s own stock and therefore met the definition of a derivative liability.

The warrants issued to non-affiliated

investors were liability classified instruments when issued and were initially recorded at a value of $ 2,049,600 , which was determined

using the Black-Scholes-Merton method using a term of 5.5 years, risk free interest rate of 4.20 % and volatility of 95.0 %.

31, 2024, the Company remeasured the warrant liability resulting in a value of $ 3,793,921 .

The loss on remeasurement of the warrant liability

in the amount of $ 1,744,321 was included in other income (expense) for the six months ended June 30, 2024.

In May 2024, the Company amended

the warrant agreements to adjust them to be indexed to the Company’s own stock, and they were therefore reclassed to equity classified

instruments in a non-cash transaction.

When the warrant agreements were amended, the Company remeasured the warrant liability resulting

in a final warrant value of $ 5,089,063 .

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

account for the equity classification.

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.

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

The warrants were not indexed to the Company’s

own stock and therefore meet the definition of a derivative liability.

The warrants were liability classified instruments when issued

and were initially recorded at a value of $ 1,190,111 , which was determined using the Black-Scholes-Merton method using a term of 5.5

years, risk free interest rate of 4.20 % and volatility of 95.0 %.

As of March 31, 2024, the Company remeasured the warrant liability resulting

in a value of $ 973,980 .

The gain on remeasurement of the warrant liability in the amount of $ 216,131 was included in other income (expense)

for the six months ended June 30, 2024.

In May 2024, the Company amended the warrant agreements related to 437,031 warrants to adjust

them to be indexed to the Company’s own stock, and they were therefore reclassed to equity classified instruments in a non-cash

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, 2025 and December 31, 2024,

the Company remeasured the warrant liability, resulting in a value of $ 149,354 and $ 199,417 , 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.

Concurrently with the closing of the Company’s private placement

offering on April 25, 2024, the Company issued warrants to purchase an aggregate of up to 494,096 shares of its Common Stock to the investors

in the private placement at an exercise price of $ 2.26 per share.

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

on October 25, 2029 .

The warrants issued were divided into two groups:

warrants issued to directors and warrants issued to non-affiliated

The warrants to purchase 167,157 shares of the Company’s Common Stock issued to directors were deemed options issued

under the MAIA 2021 Plan (as defined below) and are equity classified instruments and the value of these warrants determined using the

Black-Scholes-Merton method was $ 346,606 using a term of 5.5 years, risk free interest rate of 4.70 % and volatility of 95 %.

to purchase 326,939 shares of the Company’s Common Stock issued to non-affiliated investors were not indexed to the Company’s

own stock and therefore met the definition of a derivative liability.

The warrants were liability classified instruments when issued and

were initially recorded at a value of $ 677,919 , which was determined using the Black-Scholes-Merton method using a term of 5.5 years,

risk free interest rate of 4.70 % and volatility of 95.0 %.

As of June 30, 2024, the Company amended these warrant agreements to adjust

them to be indexed to the Company’s own stock, and they were therefore reclassed to equity classified instruments.

When the warrant

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

The loss on the

remeasurement of the warrant liability in the amount of $ 91,752 is included in other expense for the three and six months ended June 30,

2024, respectively.

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

classification.

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

The warrants are exercisable beginning on February

24, 2026 , and expire on February

The warrants issued were divided into

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

The warrants to purchase 123,333 shares of the Company’s Common Stock issued to directors were deemed options issued under the MAIA 2021 Plan (as defined below) and are equity classified instruments and the value of these warrants determined using the Black-Scholes-Merton method was $ 176,680 using a term of 6 years, risk free interest rate of 4.23 % and volatility of 95 %.

The warrants to purchase 1,686,667 shares of the Company’s Common Stock issued to affiliated and non-affiliated investors are indexed to the Company’s own stock and they were therefore equity classified instruments and the value of these warrants determined using the Black-Scholes-Merton method was $ 2,416,223 using a term of 6 years, risk free interest rate of 4.23 % and volatility of 95 %.

Concurrently with the closing of the Company’s private placement offering on March 3, 2025, the Company issued warrants to purchase an aggregate of up to 952,633 shares of its Common Stock to the investors in the private placement at an exercise price of $ 1.85 per share.

The warrants are exercisable beginning on March 3, 2026 , and expire on March 3, 2031 .

The warrants to purchase 123,333

shares of the Company’s Common Stock issued to directors

were deemed options issued under the MAIA 2021 Plan (as defined below) and are equity classified instruments and the value of these warrants

determined using the Black-Scholes-Merton method was $ 176,680

using a term of 6

years, risk free interest rate of 4.23 %

and volatility of 95 %.

The warrants to purchase 1,686,667

shares of the Company’s Common Stock issued to affiliated

and non-affiliated investors are indexed to the Company’s own stock and they were therefore equity classified instruments and the

value of these warrants determined using the Black-Scholes-Merton method was $ 2,416,223

using a term of 6

years, risk free interest rate of 4.23 %

and volatility of 95 %.

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.

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

The warrants are exercisable beginning on March

3, 2026 , and expire on March

The warrants issued were divided into two groups:

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

The warrants to purchase 58,333 shares of the Company’s Common Stock issued to directors were deemed options issued under the MAIA 2021 Plan (as defined below) and are equity classified instruments and the value of these warrants determined using the Black-Scholes-Merton method was $ 80,894 using a term of 6 years, risk free interest rate of 3.97 % and volatility of 95 %.

The warrants to purchase 894,300 shares of the Company’s Common Stock issued to non-affiliated investors are indexed to the Company’s own stock and they were therefore equity classified instruments and the value of these warrants determined using the Black-Scholes-Merton method was $ 1,240,185 using a term of 6 years, risk free interest rate of 3.97 % and volatility of 95 %.

warrants issued to directors and warrants issued to non-affiliated

The warrants to purchase 58,333

shares of the Company’s Common Stock issued to directors were deemed options issued under the MAIA 2021 Plan (as defined

below) and are equity classified instruments and the value of these warrants determined using the Black-Scholes-Merton method was

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

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.

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

The warrants are exercisable beginning on May

8, 2026 , and expire on May

The warrants issued were divided into two groups:

warrants issued to directors and warrants issued to non-affiliated

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 (as defined

below) and are equity classified instruments and the value of these warrants determined using the Black-Scholes-Merton method was

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

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.

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

The warrants are exercisable beginning on December

3, 2025 , and expire on June

The warrants issued were divided into two groups:

warrants issued to directors and warrants issued to non-affiliated

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 (as defined

below) and are equity classified instruments and the value of these warrants determined using the Black-Scholes-Merton method was

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

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.

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

The fair value of the modified warrants was greater than the fair value of the original warrants at the modification date by

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 EXERCISED TABLE

Balance at January 1, 2025

Balance at March 31, 2025

Balance at June 30, 2025

Balance at January 1, 2024

Balance at March 31, 2024

The value of warrant grants is calculated using the Warrant Black Scholes calculations with the following assumptions for warrants granted during the three months ended March 31, 2025 and 2024

( 1,157,201 )

Balance at June 30, 2024

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, 2025 and 2024

SCHEDULE OF SHARE-BASED PAYMENT AWARD, WARRANTS, VALUATION ASSUMPTIONS

Risk-free interest rate

4.04 %- 4.09 %

4.20 %- 4.70 %

Expected term (in years)

1 unchanged sentence

Expected dividend yield

MAIA Biotechnology, Inc.

Biotechnology, Inc.

Stock Option and Equity Incentive Plans

In 2018, the Company adopted the MAIA Biotechnology, Inc.

2018, the Company adopted the MAIA Biotechnology, Inc.

2018 Stock Option Plan (the “MAIA 2018 Plan”).

MAIAs board of directors administers the MAIA 2018 Plan for the purposes of attracting, retaining, and motivating key employees, directors, and consultants of MAIA.

The terms of the MAIA 2018 Plan continue to govern th e 1,773,912 options outstanding under the plan as of March 31, 2025.

In 2020, the Company adopted the MAIA Biotechnology, Inc.

Amended and Restated 2020 Equity Incentive Plan (the “MAIA 2020 Plan’’), also administered by the board of directors.

The MAIA 2020 Plan permitted awards to take the form of stock options, restricted stock and restricted stock units.

The terms of the MAIA 2020 Plan continue to govern the 3,503,589 options outstanding in the plan as of March 31, 2025 .

MAIAs board of directors

administers the MAIA 2018 Plan for the purposes of attracting, retaining, and motivating key employees, directors, and consultants of

The terms of the MAIA 2018 Plan continue to govern the 1,773,912 options outstanding under the plan as of June 30, 2025.

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

There are no shares reserved for future issuance under the MAIA 2018 Plan or the MAIA 2020 Plan.

On August 1, 2022 the Company approved MAIA 2021 Plan with 1,909,518 shares of Common Stock reserved for issuance.

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

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

The amount reserved for issuance under the MAIA 2021 Plan increased by 1,956,993 based on the fully diluted shares outstanding as of December 31, 2022.

The amount reserved for issuance under the MAIA 2021 Plan increased by 2,838,668 shares on January 1, 2024 based on the fully diluted shares outstanding as of December 31, 2023.

The amount reserved for issuance under the MAIA 2021 Plan increased by 2,250,000 shares on January 1, 2025 based on the fully diluted shares outstanding as of December 31, 2024 (and the discretion of the Company’s board of directors to authorized less than 10 % of such amount).

As of March 31, 2025, there are 2,723,686 shares of Common Stock available for future issuance under the MAIA 2021 Plan and 5,627,313 options are outstanding under the MAIA 2021 Plan.

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

In the case of an option granted to a 10 % stockholder, the exercise price shall be generally no less than 110 % of the fair market value per share on the date of grant, and the contractual term shall be seven years .

Outstanding options awarded under the MAIA 2021 Plan may, but need not, vest and therefore become exercisable in periodic installments that may, but need not, be equal.

The option may be subject to other terms and conditions as to the time or times when it may be exercised (which may be based on performance or other criteria) as the board of directors may deem appropriate.

August 1, 2022 the Company approved MAIA 2021 Plan with 1,909,518 shares of Common Stock reserved for issuance.

On May 25, 2023 the MAIA

2021 Plan was amended to include an automatic increase to the plan in the amount equal to 10 % of the total number of shares of stock

outstanding on a fully diluted basis on December 31 of the preceding calendar year (the “Increase Date”);

provided that,

the board of directors may act prior to any Increase Date to provide that there will be no increase for such year or that the increase

for such year will be a lesser number of shares of stock.

The amount reserved for issuance under the MAIA 2021 Plan increased by 1,956,993

based on the fully diluted shares outstanding as of December 31, 2022.

The amount reserved for issuance under the MAIA 2021 Plan increased

by 2,838,668 shares on January 1, 2024 based on the fully diluted shares outstanding as of December 31, 2023.

The amount reserved for

issuance under the MAIA 2021 Plan increased by 2,250,000 shares on January 1, 2025 based on the fully diluted shares outstanding as of

December 31, 2024 (and the discretion of the Company’s board of directors to authorized less than 10 % of such amount).

30, 2025, there are 1,556,089 shares of Common Stock available for future issuance under the MAIA 2021 Plan and 6,674,911 options are

outstanding under the MAIA 2021 Plan.

options are to be granted with an exercise price which is at least equal to the stock’s estimated fair value at the date of grant,

and with a contractual term of no more than ten years from the date of grant.

In the case of an option granted to a 10 % stockholder,

the exercise price shall be generally no less than 110 % of the fair market value per share on the date of grant, and the contractual

term shall be seven years .

Outstanding options awarded under the MAIA 2021 Plan may, but need not, vest and therefore become exercisable

in periodic installments that may, but need not, be equal.

The option may be subject to other terms and conditions as to the time or

times when it may be exercised (which may be based on performance or other criteria) as the board of directors may deem appropriate.

Unexercised options are canceled ninety days after termination of an employee, director, founder, or consultant.

Unexercised options are canceled immediately if an employee, director, founder, or consultant is terminated for cause;

under certain other circumstances, the period to cancellation may differ as described in the respective plan documents.

Certain clauses in the Plans also govern the Company’s exercise repurchase rights and various other features of awards granted under the plans.

As of March 31, 2025, only stock options have been awarded pursuant to the MAIA stock option and equity incentive plans.

The following table summarizes the activity and information regarding MAIA’s outstanding and exercisable options for the three months ended March 31, 2025:

Unexercised options

are canceled immediately if an employee, director, founder, or consultant is terminated for cause;

under certain other circumstances,

the period to cancellation may differ as described in the respective plan documents.

Certain clauses in the Plans also govern the Company’s

exercise repurchase rights and various other features of awards granted under the plans.

of June 30, 2025, only stock options have been awarded pursuant to the MAIA stock option and equity incentive plans.

following table summarizes the activity and information regarding MAIA’s outstanding and exercisable options for the six months

ended June 30, 2025:

SCHEDULE OF ACTIVITY AND INFORMATION REGARDING OUTSTANDING AND EXERCISABLE OPTIONS

Options Outstanding

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Cancelled/forfeited

Balance at March 31, 2025

Options exercisable at March 31, 2025

The value of option grants is calculated using the Black-Scholes-Merton option pricing model with the following assumptions for options granted during the three months ended March 31, 2025 and 2024:

Balance at June 30, 2025

Options exercisable at June 30, 2025

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, 2025 and 2024:

SCHEDULE OF SHARE-BASED PAYMENT AWARD, STOCK OPTIONS, VALUATION ASSUMPTIONS

Risk-free interest rate

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Expected dividend yield

The weighted-average grant date fair value of stock options issued during the three months ended March 31, 2025 and 2024 was $ 1.85 and $ 1.42 , respectively.

As of March 31, 2025, the total unrecognized compensation related to unvested employee and non-employee stock option awards granted was $ 3,354,518 , which the Company expects to recognize over a weighted average period of approximately 2.58 years.

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

Three Months Ended

weighted-average grant date fair value of stock options issued during the six months ended June 30, 2025 and 2024 was $ 2.25 and $ 2.41 ,

respectively.

As of June 30, 2025, the total unrecognized compensation related to unvested employee and non-employee stock option awards

granted was $ 4,339,230 , which the Company expects to recognize over a weighted average period of approximately 2.94 years.

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

SCHEDULE OF STOCK BASED COMPENSATION EXPENSE

For the Three Months Ended

For the Six Months Ended

General and administrative

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COMMITMENTS AND CONTINGENCIES

From time to time, the Company is involved in legal actions and claims arising in the normal course of business.

Management believes there are no matters which will have a material adverse effect on the Company's financial position, operations or cash flows.

Patent Licensing, Sponsored Research, and Patent & Technology Agreements

Ateganosine (THIO)

In November 2018 and as amended in December 2020, the Company entered into a Global Patent Licensing Agreement (“PLA”) titled “Patent and Technology License Agreement AGT.

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”).

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.

Licensing, Sponsored Research, and Patent & Technology Agreements

November 2018 and as amended in December 2020, the Company entered into a Global Patent Licensing Agreement (“PLA”) titled

“Patent and Technology License Agreement AGT.

L2264 – MAIA Biotechnology” with the University of Texas Southwestern

(“UTSW”) to license patent families for a specific compound (“THIO”) from UTSW to MAIA (the “UTSW Agreement”).

The UTSW Agreement, as amended, has a term of 20 years.

The agreement requires MAIA to reimburse UTSW for agreed-upon expenses related to THIO.

The UTSW Agreement requires certain payments upon assignment of the license to a third party as well as upon reaching specific milestones, ranging between $ 1,000,000 and $ 50,000,000 , not to exceed a combined milestone payment total of $ 112,000,000 .

As of March 31, 2025, n o assignment has occurred and none of the defined milestones have been completed and therefore no payments a re due to UTSW related to the milestones.

The agreement requires MAIA to reimburse UTSW for agreed-upon expenses related

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 .

30, 2025, 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 royalties MAIA to make royalty payments of :

(i) 2 - 4 % (depending on THIO reaching specified sales levels in the respective jurisdictions) on net sales up to $1,000,000,000;

(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.

L3648 — MAIA Biotechnology” pursuant to which UTSW is licensing an additional compound to MAIA (the “UTSW2 Agreement”).

in December 2020, the Company entered into a second license agreement with UTSW titled “Patent and Technology License Agreement

L3648 — MAIA Biotechnology” pursuant to which UTSW is licensing an additional compound to MAIA (the “UTSW2

The UTSW2 Agreement has a term of 20 years and requires the Company to reimburse UTSW for certain agreed-upon expenses.

The UTSW2 Agreement requires certain payments upon assignment of the license to a third party as well as upon reaching specific milestones, ranging between $ 1,000,000 and $ 50,000,000 , not to exceed a combined milestone payment total of $ 112,000,000 .

As of March 31, 2025, no assignment has occurred and none of the defined milestones have been completed and therefore no payments are d ue to UTSW related to the milestones.

The UTSW2 Agreement requires 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, 2025, no

assignment has occurred and none of the defined milestones have been completed and therefore no payments are due to UTSW related to the

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;

(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.

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:

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.

February 2021, the Company entered into a Drug Supply Agreement (the “Drug Supply Agreement”) with Regeneron Pharmaceuticals,

(“Regeneron”) to perform one clinical trial for the treatment of patients with Non-Small Cell Lung Cancer (NSCLC) involving

a Regeneron drug candidate that utilizes one of the Company’s compounds/agents.

The Company is responsible for all costs of the

study with Regeneron supplying their drug cemiplimab representing a cost savings for the Company, the first phase of which is expected

to take approximately two years.

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

defined in the agreement.

Either party may terminate a study plan in the event that patient screening for the clinical study does not

commence within 12 months after:

(i) the Effective Date (as defined in the Drug Supply Agreement), with respect to the initial study;

or (ii) the execution of the applicable study plan, with respect to each other study.

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

As of March 31, 2025, neither party has terminated the agreement.

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

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

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

As of March 31, 2025 neither party has terminated the agreement.

The Company provides for income taxes using the asset and liability approach.

Deferred tax assets and liabilities are recorded based on the differences between the financial statement and tax bases of assets and liabilities and the tax rates in effect when these differences are expected to reverse.

Deferred tax assets are reduced by a valuation allowance if, based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.

The issuance of shares in connection with the Company’s IPO, as well as prior share issuances, may result in limitations on the utilization of the Company’s net operating loss carryforwards under IRS section 382.

As of March 31, 2025, and December 31, 2024, the Company had a full valuation allowance against its deferred tax assets.

For the three months ended March 31, 2025 and 2024 , the Company recorded zero income tax expense.

No tax benefit has been recorded in relation to the pre-tax losses for the three months ended March 31, 2025 , due to full valuation allowance to offset any deferred tax assets.

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, 2025, neither party has terminated the agreement.

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, 2025, neither party has terminated the agreement.

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®).

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.

June 30, 2025, neither party has terminated the agreement.

Company provides for income taxes using the asset and liability approach.

Deferred tax assets and liabilities are recorded based on the

differences between the financial statement and tax bases of assets and liabilities and the tax rates in effect when these differences

are expected to reverse.

Deferred tax assets are reduced by a valuation allowance if, based on the weight of available evidence, it is

more likely than not that some or all of the deferred tax assets will not be realized.

The issuance of shares in connection with the

Company’s IPO, as well as prior share issuances, may result in limitations on the utilization of the Company’s net operating

loss carryforwards under IRS section 382.

As of June 30, 2025, and December 31, 2024, the Company had a full valuation allowance against

its deferred tax assets.

the six months ended June 30, 2025 and 2024, the Company recorded zero income tax expense.

No tax benefit has been recorded in relation

to the pre-tax losses for the six months ended June 30, 2025, due to full valuation allowance to offset any deferred tax assets.

SEGMENT INFORMATION

The Company operates in one reportable segment.

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

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

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

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

Company operates in one reportable segment.

This determination is based on the Company’s structure, the manner in which the chief

operating decision maker (“CODM”) reviews the operating results to assess performance and allocate resources, and the nature

of the Company’s operations.

The CODM, who is the Chief Executive Officer, regularly reviews consolidated financial information,

such as consolidated net loss.

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

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

SUBSEQUENT EVENTS

Issuance of Options

From April 1 to May 9, 2025, the Company issued 162,833 options at a weighted exercise price of $1.51 to Board Members and consultants.

Private Placement

On May 8, 2025, the Company issued and sold 719,999 shares of its common stock and warrants to purchase 719,999 shares of its common stock in a private placement to certain accredited investors and Company directors pursuant to securities purchase agreements dated May 5, 2025 at a price per share of $ 1.50 for which the Company received gross proceeds of approximately $ 1.08 million.

The warrants are exercisable at a price per share of $ 2.05 , are exercisable commencing one year following issuance, and have a term of five year from the initial exercise date.

The securities sold to Company directors participating in the private placement were issued pursuant to the Company’s 2021 Equity Incentive Plan.

Related Party Participation in Private Placement

The following Company directors participated in the aforementioned May 8, 2025 private placement as follows:

(i) Stan Smith purchased 66,666 shares of Common Stock and warrants to purchase up to 66,666 shares of Common Stock for an aggregate purchase price of approximately $ 99,999 ;

(ii) Ramiro Guerrero purchased 20,000 shares of Common Stock and warrants to purchase up to 20,000 shares of Common Stock for an aggregate purchase price of approximately $ 30,000 .

July 1 to August 11, 2025, the Company issued 416,806 options at a weighted exercise price of $ 1.91 to consultants.

At-The-Market

Offering with H.C.

July 1, 2025, the Company has sold 1,174,740 shares of its Common Stock through Wainwright under the ATM Agreement at an average

price of approximately $ 1.92 per share, resulting in aggregate gross proceeds of approximately $ 2,257,039 , for which it paid Wainwright

approximately $ 67,711 in commissions, resulting in net proceeds to the Company of approximately $ 2,189,328 .

The Company anticipates that

the at-the-market offering will continue throughout the next reporting period.

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

What changed 10-Q

Item 1. Financial Statements