3 unchanged sentences
Condensed Consolidated Balance Sheets
−Removed: September 30,
Current assets:
14 unchanged sentences
Preferred stock, $ 0.0001 par value, 30,000,000 shares
−Removed: authorized at September 30, 2023 and December 31, 2022,
+Added: authorized at March 31, 2024 and December 31, 2023,
0 shares issued and outstanding
Common stock, $ 0.0001 par value, 70,000,000 shares authorized at
−Removed: September 30, 2023 and December 31, 2022, 13,761,123 and 10,955,904
−Removed: shares issued and outstanding at September 30, 2023 and December 31, 2022,
+Added: March 31, 2024 and December 31, 2023, 20,581,469 and 16,986,254
+Added: shares issued and outstanding at March 31, 2024 and December 31, 2023,
Additional paid-in capital
1 unchanged sentence
Accumulated other comprehensive loss
−Removed: Total stockholders' equity
−Removed: Total liabilities and stockholders' equity
+Added: Total stockholders' equity (deficit)
+Added: Total liabilities and stockholders' equity (deficit)
See the accompanying notes to the unaudited condensed consolidated financial statements.
2 unchanged sentences
Co ndensed Consolidated Statements of Operations
−Removed: For the Three Months Ended September 30,
−Removed: Nine Months Ended
−Removed: September 30,
+Added: Three Months Ended March 31,
Operating expenses:
1 unchanged sentence
General and administrative expenses
−Removed: Ratchet share expense
Total operating expenses
6 unchanged sentences
Other income, net
−Removed: Deemed dividend on warrant
Net loss attributable to MAIA
9 unchanged sentences
Three Months Ended
−Removed: September 30,
−Removed: Nine Months Ended
−Removed: September 30,
Foreign currency translation adjustment
3 unchanged sentences
and Subsidiaries
−Removed: Condensed Consolidated Statements of Chan ges in Stockholders' Equity (Unaudited)
−Removed: For the Three and Nine Months Ended
−Removed: September 30, 2023
+Added: Condensed Consolidated Statements of Chan ges in Stockholders' Equity (Deficit) (Unaudited)
+Added: For the Three Months Ended March 31,
+Added: Preferred Stock
Additional Paid-In Capital
Accumulated Deficit
−Removed: Accumulated Other Comprehensive Loss
−Removed: Total Stockholders' Equity
+Added: Accumulated Other Comprehensive Income (Loss)
+Added: Total Stockholders' Equity (Deficit)
Balance at December 31, 2023
1 unchanged sentence
Stock-based compensation expense
+Added: Issuance of common shares in connection with At-The-Market financing, net of $ 179,628 of issuance costs
+Added: Issuance of common shares in connection with the Private Placement Offering #1, net of $ 50,000 of issuance costs
+Added: Issuance of common shares in connection with the Private Placement Offering #2, net of $ 47,261 of issuance costs
+Added: Issuance of warrants in connection with the Private Placement Offering #1
Foreign currency translation adjustment
Balance at March 31, 2024
−Removed: Issuance of restricted stock
−Removed: Issuance of common shares in connection with follow-on offering, net of $ 1,593,016 of issuance costs
−Removed: Issuance of warrants to underwriter in connection with follow-on offering
−Removed: Stock-based compensation expense
−Removed: Issuance of stock options to satisfy accrued bonus
−Removed: Foreign currency translation adjustment
−Removed: Balance at June 30, 2023
−Removed: Issuance of common shares upon exercise of stock options
−Removed: Issuance of restricted stock
−Removed: Stock-based compensation expense
−Removed: Foreign currency translation adjustment
−Removed: Balance at September 30, 2023
See the accompanying notes to the unaudited condensed consolidated financial statements.
2 unchanged sentences
Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited)
−Removed: For the Three and Nine Months Ended
−Removed: September 30, 2022
+Added: For the Three Months Ended March 31,
+Added: Preferred Stock
Additional Paid-In Capital
3 unchanged sentences
Balance at December 31, 2022
−Removed: Issuance of common shares upon exercise of stock options
−Removed: Issuance of common shares upon exercise of warrants
−Removed: Issuance of common shares in connection with Equity Financing
+Added: Issuance of restricted stock
Stock-based compensation expense
−Removed: Modification of warrant in equity
−Removed: Deemed dividend on modification of warrant
Foreign currency translation adjustment
Balance at March 31, 2023
−Removed: Issuance of common shares upon exercise of warrants
−Removed: Issuance of common shares in connection with Equity Financing
−Removed: Stock-based compensation expense
−Removed: Foreign currency translation adjustment
−Removed: Balance at June 30, 2022
−Removed: Issuance of common shares upon exercise of stock options
−Removed: Issuance of common shares in connection with initial public offering, net of $ 2,749,905 issuance cost
−Removed: Issuance of ratchet share
−Removed: Stock-based compensation expense
−Removed: Foreign currency translation adjustment
−Removed: Balance at September 30, 2022
See the accompanying notes to the unaudited condensed consolidated financial statements.
2 unchanged sentences
Condensed Consolidated S tatements of Cash Flows
−Removed: Nine Months Ended
−Removed: September 30,
+Added: Three Months Ended
Cash flows from operating activities:
1 unchanged sentence
Stock-based compensation
−Removed: Issuance of ratchet shares
Consulting expense for restricted shares issued
3 unchanged sentences
Australia research and development incentives receivable
+Added: Other receivables
Accounts payable
2 unchanged sentences
Cash flows from financing activities:
−Removed: Proceeds from issuance of common stock, net of transaction costs
−Removed: Deferred offering costs
−Removed: Proceeds from exercise of stock options
−Removed: Proceeds from exercise of warrants
−Removed: Proceeds from sale of common stock in initial public offering
−Removed: Payment of initial public offering transaction costs
−Removed: Proceeds from sale of common stock in follow-on offering
−Removed: Payment of follow-on offering transactions costs
+Added: Proceeds from sale of common stock in private placement offering #1
+Added: Proceeds from sale of common stock in private placement offering #2
+Added: Proceeds from At-The-Market offering
+Added: Payment of offering transactions costs
Net cash provided by financing activities
Net effect of foreign currency exchange on cash
−Removed: Net decrease in cash
+Added: Net increase (decrease) in cash
Cash at beginning of period
1 unchanged sentence
Supplemental disclosure of cash flow information:
−Removed: Previously paid issuance costs in connection with the initial public offering
−Removed: Warrants issued to underwriters in connection with the initial public offering
−Removed: Options issued for accrued bonus
−Removed: Warrants issued to underwriters in connection with the follow-on offering
+Added: Warrants issued in connection with private placement offering #1
+Added: Warrants issued in connection with private placement offering #2
See the accompanying notes to the unaudited condensed consolidated financial statements.
24 unchanged sentences
The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
−Removed: To date, the Company has incurred recurring losses, negative cash flow from operations and has accumulated a deficit of $ 57,723,515 from the Company’s inception through September 30, 2023.
−Removed: As of September 30, 2023, the Company had $ 6,104,587 in cash and cash equivalents and working capital of approximately $ 2,483,179 .
−Removed: To meet the Company’s future working capital needs, the Company will need to raise additional equity or enter into debt financing.
+Added: To date, the Company has incurred recurring losses, negative cash flow from operations and has accumulated a deficit of $ 72,047,632 from the Company’s inception through March 31, 2024.
+Added: As of March 31, 2024, the Company had $ 8,271,449 in cash and cash equivalents and working capital of approximately $ 3,792,234 .
+Added: 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.
−Removed: 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.
+Added: 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
Basis of presentation and consolidation principles
−Removed: 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”).
+Added: 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.
−Removed: generally accepted accounting principles (“GAAP”) have been condensed or omitted pursuant to such rules and regulations.
+Added: 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.
−Removed: 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, 2022 included in the Company’s Annual Report on Form 10-K filed on March 24, 2023.
+Added: 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, 2023 included in the Company’s Annual Report on Form 10-K filed on March 21, 2024.
The condensed consolidated balance sheet as of December 31, 2023 was derived from the audited financial statements.
6 unchanged sentences
Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision-maker in deciding how to allocate resources and assess performance.
−Removed: 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.
+Added: 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.
Use of Estimates
−Removed: 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.
−Removed: The most significant estimates in the Company’s financial statements relate to the valuation of common stock, stock options and warrants, the embedded features in convertible notes, and accruals for outsourced research and development activities.
+Added: 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.
+Added: The most significant estimates in the Company’s financial statements relate to the valuation of 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.
−Removed: To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected.
+Added: 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
−Removed: 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.
+Added: 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, 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
−Removed: 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.
−Removed: The resulting foreign currency translation adjustment is included in stockholders’
−Removed: equity as accumulated other comprehensive loss.
+Added: 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.
+Added: 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
1 unchanged sentence
Cash accounts are maintained at financial institutions that potentially subject the Company to concentrations of credit risk.
−Removed: At September 30, 2023 and December 31, 2022 , substantially all of the Company’s cash was deposited in accounts at one financial institution.
+Added: At March 31, 2024 and December 31, 2023 , substantially all of the Company’s cash was deposited in accounts at two financial institutions.
The Company maintains its cash deposits, which at times may exceed the federally insured limits, with a reputable financial institution, and accordingly, the Company believes such funds are subject to minimal credit risk.
1 unchanged sentence
The Company considers all highly liquid investments purchased with maturities of three months or less to be cash equivalents.
−Removed: As of September 30, 2023 and December 31, 2022 , cash includes cash in a depository bank account;
−Removed: the Company had no cash equivalents as of September 30, 2023 or December 31, 2022 .
+Added: As of March 31, 2024 and December 31, 2023 cash includes cash in a depository bank accounts.
+Added: The Company had no cash equivalents as of March 31, 2024 or December 31, 2023 .
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.
−Removed: 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.
+Added: 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.
5 unchanged sentences
These valuations require significant judgment.
−Removed: Fair value measurements discussed herein are based upon certain market assumptions and pertinent information available to management as of and during the nine months ended September 30, 2023, and as of and during the twelve months ended December 31, 2022.
+Added: 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, 2024, and as of and during the twelve months ended December 31, 2023.
The carrying amount of accounts payable approximated fair value as they are short term in nature.
−Removed: The fair value of warrants issued for services is estimated based on the Black-Scholes-Merton model during the nine months ended September 30, 2023 .
−Removed: The estimated fair value of warrants issued to underwriters and embedded features, represented Level 3 measurements.
+Added: The fair value of warrants issued for services is estimated based on the Black-Scholes-Merton model during the three months ended March 31, 2024 .
+Added: The estimated fair value of warrants issued to underwriters represented Level 3 measurements.
General and Administrative
1 unchanged sentence
Research and Development
−Removed: 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.
+Added: The Company’s research and development expenses consist primarily of costs associated with the Company’s clinical trials, salaries, payroll taxes, employee benefits, and stock-based compensation charges for those individuals involved in ongoing research and development efforts.
Research and development costs are expensed as incurred.
1 unchanged sentence
As part of the process of preparing the condensed consolidated financial statements, the Company is required to estimate its accrued expenses.
−Removed: 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.
−Removed: The majority of the Company’s service providers invoice the Company monthly in arrears for services performed or when contractual milestones are met.
+Added: 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.
+Added: 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 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.
−Removed: The estimates in the Company’s accrued research and development expenses are related to expenses incurred with respect to CROs, CMOs and other vendors in connection with research and development and manufacturing activities.
−Removed: 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.
+Added: The estimates in the Company’s accrued research and development expenses are related to expenses incurred with respect to CROs, CMOs and other vendors in connection with research and development and manufacturing activities.
+Added: 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.
−Removed: 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.
+Added: 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.
−Removed: 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.
+Added: 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.
1 unchanged sentence
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.
−Removed: 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.
+Added: 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.
−Removed: 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.
+Added: 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.
14 unchanged sentences
For these analyses, companies with comparable characteristics are selected, 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.
−Removed: The Company computes the historical volatility data using the daily closing prices for the selected companies’
−Removed: shares during the equivalent period of the calculated expected term of its share-based awards.
+Added: 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.
6 unchanged sentences
and global economic and capital market conditions.
−Removed: During the nine months ended September 30, 2023 , 248,969 restricted shares of common stock were issued for consulting services.
−Removed: There were no issuances o f restricted stock awards during the nine months ended September 30, 2022.
+Added: During the three months ended March 31, 2024 , 12,500 restricted shares of common stock were issued for consulting services.
+Added: There were no issuances of restricted stock awards during the three months ended March 31, 2023.
The fair value of restricted stock awards is based on the common stock price.
−Removed: 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.
+Added: All stock-based compensation costs are recorded in general and administrative or resear ch and development costs in the condensed consolidated statements of operations based upon the underlying individual’s role at the Company.
Common Stock Warrants
−Removed: 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.
−Removed: When warrants are issued for services provided by non-employees, under ASC 718, Compensation –
−Removed: Stock Compensation (“ASC 718”), the warrants shall be classified as a liability if 1) the underlying shares are classified as liabilities or 2) the entity can be required under any circumstances to settle the warrant by transferring cash or other assets.
+Added: 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.
+Added: 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 1) the underlying shares are classified as liabilities or 2) 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.
−Removed: Income taxes are recorded in accordance with ASC 740, Income Taxes (“ASC 740”), which provides for deferred taxes using an asset and liability approach.
+Added: 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.
7 unchanged sentences
Deferred offering costs are included in other assets and consist of legal, accounting, underwriting fees and other costs.
−Removed: Deferred offering costs as of the December 31, 2022 balance sheet date are directly related to the follow-on offering and were charged to additional paid-in capital upon the completion of the follow-on offering on April 27, 202 3.
−Removed: Deferred offering costs incurred through the September 30, 2023 balance sheet are directly related to a proposed follow-on offerings that will be charged to additional paid-in capital upon the completion of the offering.
+Added: There are no deferred offering costs as of the December 31, 2023 balance sheet date.
+Added: Deferred offering costs incurred through the March 31, 2024 balance sheet are directly related to at-the-market offering and will be charged to additional paid-in capital upon the completion of the offering.
Net Loss Per Share
4 unchanged sentences
Since the Company had a net loss in each of the periods presented, basic and diluted net loss per common share are the same.
−Removed: 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:
−Removed: Nine Months Ended
−Removed: September 30,
+Added: 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:
+Added: Three Months Ended
Shares issuable upon exercise of stock options
1 unchanged sentence
Recent Accounting Standards
+Added: In November 2023, the FASB issued ASU No.
+Added: 2023-07, Segment Reporting – Improvements to Reportable Segment Disclosures, which provides updates to qualitative and quantitative reportable segment disclosure requirements, including enhanced disclosures about significant segment expenses and increased interim disclosure requirements, among others.
+Added: 2023-07 is effective for fiscal years beginning after December 15, 2023, and interim periods in fiscal years beginning after December 15, 2024.
+Added: Early adoption is permitted, and the amendments should be
+Added: applied retrospectively.
+Added: We do not expect the amendments in this ASU to have a material impact on our consolidated financial statements.
+Added: In December 2023, the FASB issued ASU No.
+Added: 2023-09, Improvements to Income Tax Disclosures, 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.
+Added: 2023-09 is effective for fiscal years beginning after December 15, 2024 and allows for adoption on a prospective basis, with a retrospective option.
+Added: Early adoption is permitted.
+Added: 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 Financial Accounting Standards Board 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.
+Added: Reclassification of Prior Year Presentation
+Added: Certain prior year amounts have been reclassified for consistency with the current year presentation.
+Added: These reclassifications had no effect on the reported statement of cash flows.
RELATED PARTY TRANSACTIONS
5 unchanged sentences
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.
+Added: Private Placement
+Added: The following Company directors participated in the March 2024 private placement as follows:
+Added: (i) Stan Smith purchased 170,940 shares of our common stock and warrants to purchase up to 170,940 shares of our common stock for an aggregate purchase price of $ 200,000 ;
+Added: (ii) Louie Ngar Yee purchased 170,940 shares of our common stock and warrants to purchase up to 170,940 shares of our common stock for an aggregate purchase price of $ 200,000 ;
+Added: (iii) Cristian Luput purchased 69,282 shares of our common stock and warrants to purchase up to 69,282 shares of our common stock for an aggregate purchase price of $ 81,060 ;
+Added: (iv) Steven Chaouki purchased 34,641 shares of our common stock and warrants to purchase up to 34,641 shares of our common stock for an aggregate purchase price of $ 40,530 and (v) Ramiro Guerrero purchased 6,928 shares of our common stock and warrants to purchase up to 6,928 shares of our common stock for an aggregate purchase price of $ 8,106 .
ACCRUED EXPENSES
−Removed: As of September 30, 2023 and December 31, 2022, accrued expenses consisted of the following:
−Removed: September 30,
+Added: As of March 31, 2024 and December 31, 2023 accrued expenses consisted of the following:
Professional fees
Research and development costs
+Added: Accrued severance
Total accrued expenses
−Removed: Accrued Bonus
−Removed: On May 31, 2023, the 2022 accrued bonus for current employees and officers was settled by the issuance of 511,225 stock options with a total fair value of $ 974,224 .
FAIR VALUE OF FINANCIAL LIABILITIES
2 unchanged sentences
The fair value of the warrant liabilities recorded are as follows:
−Removed: Fair value at September 30, 2023
+Added: Fair value at December 31, 2023
Warrant liability
Total liabilities
+Added: Fair value at March 31, 2024
+Added: Warrant liability
+Added: Total liabilities
The table below provides a summary of the changes in fair value of the warrant liabilities measured on a recurring basis using significant unobservable inputs (Level 3):
Three Months Ended
−Removed: September 30,
−Removed: Nine Months Ended
−Removed: September 30,
Warrant liabilities:
Balance, beginning of period
−Removed: Gain on fair value of warrant liability
+Added: Issuance of warrants
+Added: Loss (Gain) on fair value of warrant liability
Balance, end of period
−Removed: STOCKHOLDERS’
−Removed: Upon the closing of the Company’s initial public offering, the Company’s shareholders agreement terminated pursuant to its terms.
−Removed: In connection with the closing of the Company’s initial public offering, the Company amended and restated its Amended and Restated Certificate of Incorporation (the “Amended and Restated Certificate of Incorporation”) and amended and restated its Bylaws (the “Amended and Restated Bylaws”).
+Added: STOCKHOLDERS’ EQUITY
+Added: Upon the closing of the Company’s initial public offering, the Company’s shareholders agreement terminated pursuant to its terms.
+Added: In connection with the closing of the Company’s initial public offering, the Company amended and restated its Amended and Restated Certificate of Incorporation (the “Amended and Restated Certificate of Incorporation”) and amended and restated its Bylaws (the “Amended and Restated Bylaws”).
The Amended and Restated Certificate of Incorporation was filed with the Secretary of State of the State of Delaware on August 1, 2022 and became effective on that date, and among other things, increased the authorized number of common stock to 70,000,000 shares and decreased the authorized number of preferred stock to 30,000,000 shares.
−Removed: Sales of MAIA Common Stock
−Removed: During January and February 2022, the Company sold 263,729 shares of common stock at $ 9.00 per share for gross proceeds of $ 2,373,561 with no transaction costs.
−Removed: During May 2022, the Company sold 11,111 shares of common stock at $ 9 per share for gross proceeds of $ 99,999 with no transaction costs.
−Removed: The Company issued these shareholders additional shares (“Ratchet Shares”) upon the closing of the Company's initial public offering such that the $ 9.00 price per share they paid was equal to the price per share in the Company's initial public offering of $ 5.00 .
−Removed: The number of Ratchet Shares were calculated using the $ 5.00 per share price in the Company's initial public offering and 219,872 shares of common stock were issued on August 1, 2022 to the investors in the Recent Private Rounds.
−Removed: The Ratchet shares were determined to be a freestanding instrument that was classified as a liability when the right was granted and subsequently reclassified to equity when shares were issued.
−Removed: The Ratchet Shares were valued at $ 1,099,360 , based on the $ 5 price of the initial public offering and were recorded as expense included in operating expense in the 2022 Consolidated Statement of Operations.
−Removed: Initial Public Offering
−Removed: On July 28, 2022 the Company’s shares of common stock began trading on the NYSE American under the symbol MAIA.
−Removed: On August 1, 2022, the Company sold 2,000,000 shares of common stock at $ 5.00 per share for gross proceeds of $ 10,000,000 in an initial public offering prior to deducting underwriting discounts, commissions, and other offering expenses.
−Removed: ThinkEquity LLC (“ThinkEquity”) served as underwriter in the offering.
−Removed: On August 3, 2022, the Company sold an additional 300,000 shares of common stock at $ 5.00 per share when ThinkEquity exercised its over-allotment option in full for gross proceeds of $ 1,500,000 prior to deducting underwriting discounts, commissions, and other offering expenses.
−Removed: After deducting the underwriting discount and other offering expenses payable by the Company, the total net proceeds for the initial public offering and the over-allotment were $ 9,093,830 .
−Removed: Follow-on Offering
−Removed: On April 27, 2023, the Company sold 2,555,500 shares of the Company’s common stock at a price of $ 2.25 per share in an underwritten public offering, including the full exercise by the underwriter of its overallotment option.
−Removed: ThinkEquity LLC served as underwriter in the offering.
−Removed: The total net proceeds of the offering were approximately $ 4,398,000 , after deducting underwriting discounts, commissions, and other offering expenses.
At-the-Market Equity Offering
−Removed: On September 1, 2023, the Company entered into an “at-the-market”
−Removed: Sales Agreement (the “Sales Agreement”) with ThinkEquity LLC (the “Sales Agent”), pursuant to which the Company may offer and sell, from time to time, through the Sales Agent, shares (the “Shares”) of the Company’s common stock, par value $ 0.0001 per share (the “Common Stock”), having an aggregate offering price of up to $ 7,000,000 , subject to the terms and conditions of the Sales Agreement.
−Removed: The Shares will be offered and sold pursuant to the Company’s prospectus supplement (the “Prospectus Supplement”), filed September 1, 2023 with the Securities and Exchange Commission (the “SEC”), to the prospectus forming a part of the Company’s shelf Registration Statement on Form S-3 (File No.
−Removed: 333-273984) filed by the Company with the SEC on August 15, 2023 and declared effective by the SEC on August 23, 2023.
−Removed: As of September 30, 2023, no sales have been executed.
+Added: On February 14, 2024, the Company entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C.
+Added: 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.
+Added: 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.
+Added: The Company will pay Wainwright a commission rate equal to 3.0 % of the aggregate gross proceeds from each sale of Shares.
+Added: As of March 24, 2024, the Company has sold 507,754 shares of common stock at an average price of $ 1.47 per share, resulting in aggregate gross proceeds of approximately $ 745,251 .
+Added: The Company anticipates that the at-the-market offering will continue throughout the next reporting period.
+Added: 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.
Share Repurchase Program
−Removed: On September 28, 2023, the Company announced that its board of directors approved a share repurchase program pursuant to which the Company may repurchase up to $ 800,000 of the Company’s issued and outstanding shares of common stock, par value $ 0.0001 per share, through September 2024 .
+Added: On September 28, 2023, the Company announced that its board of directors approved a share repurchase program pursuant to which the Company may repurchase up to $ 800,000 of the Company’s issued and outstanding shares of common stock, par value $ 0.0001 per share, through September 2024 .
The Company expects to fund repurchases by using cash on hand and expected cash flow to be generated in the future.
−Removed: As of September 30, 2023 no shares have been repurchased.
+Added: As of March 31, 2024 no shares have been repurchased.
+Added: Private Placement
+Added: On March 14, 2024, the Company issued and sold 2,496,318 shares of its common stock and warrants to purchase 2,496,318 shares of its common stock in a private placement to certain accredited investors and Company directors pursuant to securities purchase agreements dated March 25, 2024 at a price per share of $ 1.17 for which the Company received gross proceeds of approximately $ 2.92 million.
+Added: The warrants are exercisable at a price per share of $ 1.30 , are exercisable commencing six months following issuance, and have a term of five year from the initial exercise date.
+Added: The securities sold to Company directors participating in the private placement were issued pursuant to the Company’s 2021 Equity Incentive Plan.
+Added: On March 28, 2024, the Company issued and sold (i) 578,643 shares of its common stock, and (ii) warrants to purchase up to 578,643 shares of its common stock, to accredited investors pursuant to securities purchase agreements dated March 25, 20241 at a price per share of $ 2.295 for which the Company received gross proceeds of approximately $ 1.33 million.
+Added: The warrants are exercisable at a price per share of $ 2.55 , are exercisable commencing six months following issuance, and have a term of five years from the initial exercise date.
MAIA Biotechnology, Inc.
Restricted Stock Awards
−Removed: During the nine months ended September 30, 2022, MAIA recognized $ 52,500 of stock compensation expense related to 29,168 of MAIA’s restricted shares granted to the founders.
−Removed: During the nine months ended September 30, 2023 , the company expensed $ 682,962 for investor relation services related to the grant of 248,969 restricted shares of common stock.
−Removed: There are no unvested restricted shares as of September 30, 2023.
+Added: During the three months ended March 31, 2023 , the company expensed $ 164,070 to consulting for investor relations related to the grant of 40,500 restricted shares of common stock.
+Added: There were no unvested restricted shares as of March 31, 2023.
+Added: 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.
+Added: There are no unvested restricted shares as of March 31, 2024.
MAIA Stock Warrants
−Removed: In January 2022, the Company and certain warrant holders executed waivers related to the acceptance and approval of an amendment to the holders’
−Removed: warrant agreements originally issued between May 6, 2020 and February 26, 2021 in connection with the Company’s issuance of convertible notes.
−Removed: The amendment removed the IPO expiration provision from the warrant agreements, and the warrants are now only to be exercisable, in whole or in part, during the exercise period ending on the earliest to occur of:
−Removed: (a) various dates in 2028 as stated within the warrant agreements;
−Removed: or (b) immediately prior to the closing of a change of control.
−Removed: The value of the warrant modification to th e 144,497 warrants was calculated using the Black-Scholes-Merton option pricing model.
−Removed: The incremental fair value attributable to the modified awards compared to the original awards immediately prior to the modification was calculated at $ 450,578 and was treated as a deemed dividend for the nine months ended September 30, 2022 and is reflected as “Deemed dividend on warrant modification”
−Removed: in the accompanying statement of operations.
−Removed: During January 2022, warrants were exercised, resulting in the issuance of 61,111 shares of MAIA common stock for proceeds of $ 110,000 .
−Removed: During May 2022, warrants were exercised, resulting in the issuance of 153,000 shares of common stock for proceeds of approximately $ 275,400 .
−Removed: Another 394,501 warrants were exercised with a cashless exercise assuming the fair market value of $ 9.00 per share resulting in the issuance of 315,601 shares of common stock.
−Removed: On August 1, 2022 at the closing of the initial public offering, 20,520 warrants with an exercise price of $ 5.00 per share expired.
−Removed: Concurrently with the closing of the Company’s initial public offering, 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”).
−Removed: The Representative’s Warrants are exercisable beginning on January 23, 2023 , and expire on July 27, 2027 , pursuant to the terms and conditions of the Representative’s Warrants.
−Removed: On August 3, concurrently with the full exercise of the Underwriter’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.
−Removed: The Representative’s Warrants are not
−Removed: indexed to the Company’s own stock and therefore meet the definition of a derivative liability.
−Removed: The Representative’s Warrants are liability classified instruments and were initially recorded as $ 343,735 , which was the value determined using the Black-Scholes-Merton method using a term of five years , risk free interest rate of 2.82 % and volatility of 77.5 %.
−Removed: As of September 30, 2023 and December 31, 2022 the Company remeasured the warrant liability resulting in a value of $ 103,407 and $ 245,341 respectively.
−Removed: The gain on remeasurement of the warrant liability in the amount o f $ 141,934 w as included in other income for the nine months ended September 30, 2023.
−Removed: Concurrently with the closing of the Company’s follow-on offering, the Company issued warrants to purchase an aggregate of up to 127,775 shares of its common stock to the Representative or its designees, at an exercise price of $ 2.81 per share (the “Follow-On Representative’s Warrants”).
−Removed: The Follow-On Representative’s Warrants are exercisable beginning on October 24, 2023 , and expire on April 24, 2028 , pursuant to the terms and conditions of the Follow-On Representative’s Warrants.
−Removed: The Follow-On Representative’s Warrants are equity classified instruments and the value of the Follow-On Representative’s Warrants determined using the Black-Scholes-Merton method was $ 241,009 using a term of five years , risk free interest rate of 4.09 % and volatility of 86.3 %.
+Added: Concurrently with the closing of the Company’s initial public offering, 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”).
+Added: The Representative’s Warrants are exercisable beginning on January 23, 2023 , and expire on July 27, 2027 , pursuant to the terms and conditions of the Representative’s Warrants.
+Added: On August 3, concurrently with the full exercise of the Underwriter’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.
+Added: The Representative’s Warrants are not indexed to the Company’s own stock and therefore meet the definition of a derivative liability.
+Added: The Representative’s Warrants are liability classified instruments and were initially recorded as $ 343,735 , which was the value determined using the Black-Scholes-Merton method using a term of five years , risk free interest rate of 2.82 % and volatility of 77.5 %.
+Added: As of March 31, 2024 and December 31, 2023 the Company remeasured the warrant liability resulting in a value of $ 112,878 and $ 40,211 respectively.
+Added: The loss on remeasurement of the warrant liability in the amount of $ 72,666 was included in other expense for the three months ended March 31, 2024.
+Added: On November 9, 2023, the Company issued warrants to purchase an aggregate of up to 239,234 shares of its common stock to Alumni Capital LP, at an exercise price of $ 2.09 per share.
+Added: The warrants were exercisable beginning on November 10, 2023 , and expire on November 10, 2027 , pursuant to the terms and conditions of the warrants.
+Added: The warrants are not indexed to the Company’s own stock and therefore meet the definition of a derivative liability.
+Added: On November 13, 2023, 131,578 warrant shares vested in accordance with the terms.
+Added: The warrants are liability classified instruments and were initially recorded as $ 84,251 , which was the value 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 %.
+Added: Laidlaw & Company Ltd.
+Added: acted as the financial advisor to the Company in connection with the warrant and were paid a cash fee of $ 13,750 .
+Added: As of March 31, 2024 and December 31, 2023 the Company remeasured the warrant liability resulting in a value of $ 199,902 and $ 84,251 respectively.
+Added: The loss on remeasurement of the warrant liability in the amount of $ 115,651 is included in other expense for the three months ended March 31, 2024.
+Added: 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), are exercisable six months following issuance and will have a term of five years from the initial exercise date.
+Added: The Warrants contain customary anti-dilution adjustments to the exercise price, including for share splits, share dividends, rights offerings and pro rata distributions.
+Added: The warrants are not indexed to the Company’s own stock and therefore meet the definition of a derivative liability.
+Added: The warrants are liability classified instruments and were initially recorded as $ 1,903,915 , which was the value determined using the Black-Scholes-Merton method using a term of 5.38 years, risk free interest rate of 3.85 % and volatility of 90.0 %.
+Added: As of March 31, 2024 and December 31, 2023 the Company remeasured the warrant liability resulting in a value of $ 4,211,746 and $ 1,903,915 respectively.
+Added: The loss on remeasurement of the warrant liability in the amount of $ 2,307,832 is included in other expense for the three months ended March 31, 2024.
+Added: 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.
+Added: The Representative’s Warrants are exercisable beginning November 15, 2023 , and expire on November 15, 2028 , pursuant to the terms and conditions of the Representative’s Warrants.
+Added: The warrants are not indexed to the Company’s own stock and therefore meet the definition of a derivative liability.
+Added: The warrants are liability classified instruments and were initially recorded as $ 123,811 , which was determined using the Black-Scholes-Merton method using a term of 4.88 years, risk free interest rate of 3.84 % and volatility of 90.0 %.
+Added: As of March 31, 2024 and December 31, 2023 the Company remeasured the warrant liability resulting in a value of $ 280,770 and $ 123,811 respectively.
+Added: The loss on remeasurement of the warrant liability in the amount of $ 156,959 is included in other expense for the three months ended March 31, 2024.
+Added: 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 .
+Added: The warrants issued were divided into two groups, warrants issued to outside investors and warrants issued to directors.
+Added: The warrants issued to outside investors of 2,043,587 are not indexed to the Company’s own stock and therefore meet the definition of a derivative liability.
+Added: The warrants are liability classified instruments and were initially recorded as $ 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 %.
+Added: As of March 31, 2024, the Company
+Added: remeasured the warrant liability resulting in a valu e of $ 3,793,921 .
+Added: The loss on remeasurement of the warrant liability in the amount of $ 1,744,321 is included in other expense for the three months ended March 31, 2024.
+Added: The warrants issued to directors of 452,731 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 %.
+Added: 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.
+Added: The warrants are exercisable beginning on September 28, 2024 , and expire on September 28, 2029 .
+Added: The warrants are not indexed to the Company’s own stock and therefore meet the definition of a derivative liability.
+Added: The warrants are liability classified instruments and were initially recorded as $ 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 %.
+Added: As of March 31, 2024, the Company remeasured the warrant liability resulting in a value of $ 973,980 .
+Added: The gain on remeasurement of the warrant liability in the amount of $ 216,131 is included in other expense for the three months ended March 31, 2024.
Balance at January 1, 2024
−Removed: Balance at September 30, 2023
+Added: Balance at March 31, 2024
MAIA Biotechnology, Inc.
1 unchanged sentence
In 2018, the Company adopted the MAIA Biotechnology, Inc.
−Removed: 2018 Stock Option Plan (the “MAIA 2018 Plan”).
+Added: 2018 Stock Option Plan (the “MAIA 2018 Plan”).
MAIAs board of directors administers the MAIA Plan for the purposes of attracting, retaining, and motivating key employees, directors, and consultants of MAIA.
−Removed: The terms of the MAIA 2018 Plan continue to govern th e 1,924,500 options outstanding in the plan as of September 30, 2023.
+Added: The terms of the MAIA 2018 Plan continue to govern th e 1,924,500 options outstanding in the plan as of March 31, 2024.
In 2020, the Company adopted the MAIA Biotechnology, Inc.
−Removed: Amended and Restated 2020 Equity Incentive Plan (the “MAIA 2020 Plan’’), also administered by the board of directors.
+Added: 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.
−Removed: The terms of the MAIA 2020 Plan continue to govern the 3,935,000 o ptions outstanding in the plan as of September 30, 2023 .
+Added: The terms of the MAIA 2020 Plan continue to govern the 3,532,125 o ptions outstanding in the plan as of March 31, 2024 .
There are no shares reserved for future issuance in the MAIA 2018 Plan or the MAIA 2020 Plan.
On August 1, 2022 the Company approved the MAIA Biotechnology, Inc.
−Removed: 2021 Equity Incentive Plan (the “MAIA 2021 Plan’’) with 1,909,518 shares of common stock reserved for issuance.
−Removed: On May 25, 2023 the MAIA 2021 Plan was amended to include and automatic increase to the plan in the amount equal to ten percent ( 10 %) of the total number of shares of stock outstanding on a fully diluted basis on December 31 of the preceding calendar year (the “Increase Date”);
+Added: 2021 Equity Incentive Plan (the “MAIA 2021 Plan’’) with 1,909,518 shares of common stock reserved for issuance.
+Added: On May 25, 2023 the MAIA 2021 Plan was amended to include an automatic increase to the plan in the amount equal to ten percent ( 10 %) of the total number of shares of stock outstanding on a fully diluted basis on December 31 of the preceding calendar year (the “Increase Date”);
provided that, the board of directors may act prior to any Increase Date to provide that there will be no increase for such year or that the increase for such year will be a lesser number of shares of stock.
The amount reserved for issuance under the MAIA 2021 Plan increased by 1,956,993 b ased on the fully diluted shares outstanding as of December 31, 2022.
−Removed: As of September 30, 2023 there are 1,912,548 shares of common stock available for future issuance under the MAIA 2021 Plan and 2,001,236 options are outstanding in the MAIA 2021 Plan.
−Removed: 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.
−Removed: 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 .
−Removed: Outstanding options awarded under the MAIA 2021 Plan may, but need not, vest and therefore become exercisable in periodic installments that may, but
−Removed: need not, be equal.
+Added: The amount reserved for issuance under the MAIA 2021 Plan increased by 2,838,668 based on the fully diluted shares outstanding as of December 31, 2023.
+Added: As of March 31, 2024 there are 4,098,243 shares of common stock available for future issuance under the MAIA 2021 Plan and 2,604,353 options are outstanding in the MAIA 2021 Plan.
+Added: 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.
+Added: 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
+Added: share on the date of grant, and the contractual term shall be seven years .
+Added: 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.
2 unchanged sentences
under certain other circumstances, the period to cancellation may differ as described in the respective plan documents.
−Removed: Certain clauses in the Plans also govern the Company’s exercise repurchase rights and various other features of awards granted under the plans.
−Removed: As of September 30, 2023, only stock options have been awarded pursuant to the MAIA stock award plans.
−Removed: The following table summarizes the activity and information regarding MAIA’s outstanding and exercisable options for the nine months ended September 30, 2023:
+Added: Certain clauses in the Plans also govern the Company’s exercise repurchase rights and various other features of awards granted under the plans.
+Added: As of March 31, 2024, only stock options have been awarded pursuant to the MAIA stock award plans.
+Added: The following table summarizes the activity and information regarding MAIA’s outstanding and exercisable options for the three months ended March 31, 2024:
Options Outstanding
1 unchanged sentence
Cancelled/forfeited
−Removed: Balance at September 30, 2023
−Removed: Options exercisable at September 30, 2023
−Removed: During the nine months ended September 30, 2023, the fair value of our common stock is based on the closing price of the common stock in the public market.
−Removed: During the nine months ended September 30, 2022 , the fair value of the Company’s common stock was estimated for financial reporting purposes from January 1 to January 26, 2022 based on valuations of $ 8.87 per share as of December 31, 2021.
−Removed: For our valuations of common stock performed, we used a hybrid method of the Option Pricing Method (“OPM”) and the Probability-Weighted Expected Return Method (“PWERM”).
−Removed: PWERM considers various potential liquidity outcomes.
−Removed: Our approach included the use of an initial public offering scenario, a scenario assuming continued operation as a private entity, and a dissolution scenario.
−Removed: Under the hybrid OPM and PWERM, the per share values calculated under the OPM and PWERM are weighted based on expected exit outcomes and the quality of the information specific to each allocation methodology to arrive at a final estimated fair value per share of the common stock before a discount for lack of marketability is applied.
−Removed: From January 27 to May 31, 2022 the fair value of the Company’s common stock was estimated for financial reporting purposes at $ 9 per share based on the sale of common stock from January 27, 2022 to May 31, 2022.
−Removed: From June 1 to September 30, 2022 the fair value of the Company’s common stock was estimated for financial reporting purposes at $ 5 per share based on the price paid in the initial public offering.
−Removed: The value of option grants is calculated using the Black-Scholes-Merton option pricing model with the following assumptions for options granted during the nine months ended September 30, 2023 and 2022:
+Added: Balance at March 31, 2024
+Added: Options exercisable at March 31, 2024
+Added: 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, 2024 and 2023:
Risk-free interest rate
6 unchanged sentences
Expected dividend yield
−Removed: The weighted-average grant date fair value of stock options issued during the nine months ended September 30, 2023 and 2022 was $ 3.12 and $ 5.97 , respectively.
−Removed: As of September 30, 2023, the total unrecognized compensation
−Removed: related to unvested employee and non-employee stock option awards granted was $ 3,995,070 , which the Company expects to recognize over a weighted average period of approximately 2.9 years.
−Removed: Stock based compensation related to the Company’s stock plans are as follows:
+Added: The weighted-average grant date fair value of stock options issued during the three months ended March 31, 2024 and 2023 was $ 1.42 and $ 3.27 , respectively.
+Added: As of March 31, 2024, the total unrecognized compensation related to unvested employee and non-employee stock option awards granted was $ 2,080,928 , which the Company expects to recognize over a weighted average period of approximately 3.2 years.
+Added: Stock based compensation related to the Company’s stock plans are as follows:
Three Months Ended
−Removed: Nine Months Ended
−Removed: September 30,
−Removed: September 30,
General and administrative
5 unchanged sentences
Patent Licensing, Sponsored Research, and Patent & Technology Agreements
−Removed: THIO –
−Removed: 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.
−Removed: L2264 –
−Removed: MAIA Biotechnology”
−Removed: with the University of Texas Southwestern (“UTSW”) to license patent families for a specific compound (“THIO”) from UTSW to MAIA.
+Added: 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.
+Added: L2264 – MAIA Biotechnology” with the University of Texas Southwestern (“UTSW”) to license patent families for a specific compound (“THIO”) from UTSW to MAIA.
The agreement, as amended, has a term of 20 years.
1 unchanged sentence
The 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 .
−Removed: As of September 30, 2023, 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.
+Added: As of March 31, 2024, 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 royalties of 2 - 4 % (depending on THIO reaching specified sales levels in the respective jurisdictions) royalty payments on net sales up to $1,000,000,000, and 2.5 - 5 % on net sales above $1,000,000,000.
−Removed: Also in December 2020, the Company entered into a second license agreement with UTSW titled “Patent and Technology License Agreement AGT.
−Removed: L3648 —
−Removed: MAIA Biotechnology”
−Removed: pursuant to which UTSW is licensing an additional compound to MAIA.
+Added: Also in December 2020, the Company entered into a second license agreement with UTSW titled “Patent and Technology License Agreement AGT.
+Added: L3648 — MAIA Biotechnology” pursuant to which UTSW is licensing an additional compound to MAIA.
The agreement has a term of 20 years and requires the Company to reimburse UTSW for certain agreed-upon expenses.
The 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 .
−Removed: As of September 30, 2023, 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.
+Added: As of March 31, 2024, 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 agreement requires royalties of 2 - 4 % (depending on THIO reaching specified sales levels in the respective jurisdictions) royalty payments on net sales up to $1,000,000,000, and 2.5 - 5 % on net sales above $1,000,000,000.
4 unchanged sentences
The royalty obligations continue on a country-by-country basis until the later of expiration of the last Valid Claim in each country or ten ( 10 ) years after the First Commercial Sale (as defined in UTSW2 Agreement) in each country.
−Removed: Regeneron –
−Removed: In February 2021, the Company reached an agreement with Regeneron Pharmaceuticals, Inc.
−Removed: (“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.
+Added: Regeneron – In February 2021, the Company reached an agreement with Regeneron Pharmaceuticals, Inc.
+Added: (“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.
2 unchanged sentences
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.
−Removed: As of September 30, 2023 neither party has terminated the agreement.
+Added: As of March 31, 2024 neither party has terminated the agreement.
The Company provides for income taxes using the asset and liability approach.
1 unchanged sentence
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.
−Removed: 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.
−Removed: As of September 30, 2023, and December 31, 2022, the Company had a full valuation allowance against its deferred tax assets.
−Removed: For the nine months ended September 30, 2023 and 2022 , the Company recorded zero income tax expense.
−Removed: No tax benefit has been recorded in relation to the pre-tax losses for the nine months ended September 30, 2023 , due to full valuation allowance to offset any deferred tax assets.
−Removed: SUBSEQUENT EVENT
−Removed: Subsequent to the end of the reporting period September 30, 2023, the Company initiated an at-the-market offering of common stock, pursuant to a previously established equity distribution agreement with ThinkEquity LLC.
−Removed: As of the date of this filing, the Company has sold 452,388 sh ares of common stock at an average price o f $ 2.32 per share, resulting in aggregate gross proceeds of approximatel y $ 1,051,000 .
−Removed: The C ompany anticipates that the at-the-market offering will continue throughout the next reporting period.
−Removed: These subsequent events may have a material impact on the Company’s financial position, results of operations, and cash flows in future periods, and they are disclosed here for informational purposes.
−Removed: Investors should consider the potential impact of these events on their assessments of the Company’s financial condition and performance .
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations .
−Removed: You should read the following discussion together with our financial statements and the related notes included elsewhere in this Quarterly Report on Form 10-Q.
−Removed: This discussion contains forward-looking statements that are based on our current expectations, estimates and projections about our business and operations.
−Removed: Our actual results may differ materially from those currently anticipated and expressed in such forward-looking statements as a result of a number of factors, including those which we discuss under “Risk Factors”
−Removed: and elsewhere in this Quarterly Report on Form 10-Q.
−Removed: We are a clinical stage biotechnology company engaged in the discovery, development and commercialization of therapies targeting cancer.
−Removed: Our initial disease target is lung cancer, a serious medical condition with an incidence of over 236,000 new cases in the US in 2022, representing 12.3% of all cancers, and over 130,000 deaths, or 21.4% of all cancers.
−Removed: Worldwide, lung cancer incidence is over 2,200,000 per year (ranking second only after breast cancer), and mortality over 1,800,000 (ranking first).
−Removed: Specifically, we are targeting NSCLC, which represents 85% of all lung cancers.
−Removed: We accomplished the following key milestones:
−Removed: In November 2018, we in-licensed THIO from University of Texas Southwestern, in Dallas.
−Removed: The patent license is global and exclusive for the duration of the patients’
−Removed: In 2019, we generated the first data for THIO demonstrating complete regression with no recurrence when administered in advance of atezolizumab (TecentriQ®;
−Removed: Genentech), in colorectal and lung cancer preclinical models.
−Removed: In the first quarter 2020, we filed a provisional patent application for THIO in sequential combination with checkpoint inhibitors, covering all tumor types.
−Removed: The patent has not been allowed to date, but if it is allowed will have an expiration date in 2041, excluding any patent term adjustment or patent extension.
−Removed: In the first quarter 2021, we entered into a Drug Supply Agreement with Regeneron Pharmaceuticals, Inc.
−Removed: Under this agreement, Regeneron will provide cemiplimab (Libtayo Ò
−Removed: anti-PD-1 checkpoint inhibitor) at no charge for the THIO-101 trials, testing THIO administration for immune activation followed by cemiplimab in NSCLC.
−Removed: This drug supply agreement replaces direct drug purchase expense that we would be otherwise required to incur.
−Removed: In exchange, Regeneron received development exclusivity in NSCLC for the duration of the trial meaning we cannot conduct trials in NSCLC with another checkpoint inhibitor during the time of the trial.
−Removed: All other areas of study and development in any other tumor types remain open.
−Removed: In the first quarter 2021, we initiated our clinical supply manufacturing under Good Manufacturing Practices conditions to provide clinical supply for THIO-101 and other development needs.
−Removed: In the first half of 2022, we completed a crossover round consisting of sales of 274,840 shares of our common stock at a price of $9.00 per shares for gross proceeds of approximately $2.5 million.
−Removed: In the first quarter 2022, THIO received approval by the Bellberry Human Research Ethics Committee (”HREC”) in Australia to initiate the THIO-101 Phase 2 clinical study.
−Removed: In March 2022, the U.S.
−Removed: Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to THIO for the treatment of hepatocellular carcinoma, and in May 2022, the FDA granted ODD to THIO for the treatment of small-cell lung cancer.
−Removed: The FDA’s Office of Orphan Products Development may grant orphan designation status to drugs and biologics that are intended for the treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the U.S.
−Removed: ODD provides certain
−Removed: benefits, including financial incentives, to support clinical development and the potential for up to seven years of market exclusivity for the drug for the designated orphan indication in the U.S.
−Removed: if the drug is ultimately approved for its designated indication.
−Removed: In May 2022, we entered into a research and collaboration agreement with the Nationwide Children’s Hospital to evaluate the potential of THIO in combination with current standard-of-care therapies for brain cancer.
−Removed: The organizations are conducting preclinical studies to assess the efficacy and safety of THIO in combination with radiotherapy and immune checkpoint inhibitors in vitro and in vivo models.
−Removed: In July 2022, we completed our selection process for the clinical sites for our Phase 2 study in Australia and Europe and our application to start the Phase 2 study in Australia has been approved.
−Removed: In July 2022, the first patient was administered with THIO in our Phase 2 human trial (THIO-101) in Australia.
−Removed: We have also submitted a similar application to conduct the same Phase 2 study in Europe.
−Removed: On July 28, 2022, the Company’s shares of common stock began trading on the NYSE American under the symbol MAIA.
−Removed: On August 1, 2022, the Company sold 2,000,000 shares of common stock at $5.00 per share for gross proceeds of $10,000,000 in an initial public offering prior to deducting underwriting discounts, commissions, and other offering expenses.
−Removed: On August 3, 2022, the Company sold an additional 300,000 shares of common stock at $5.00 per share when the underwriter exercised the overallotment for net proceeds of $1,500,000 prior to deducting underwriting discounts, commissions, and other offering expenses.
−Removed: We believe we have raised sufficient capital to fund the THIO-101 lead-in and preliminary efficacy of the phase 2 THIO-101 trial.
−Removed: In November 2022, we completed a pre-Investigational New Drug meeting with the FDA for the planned U.S.
−Removed: expansion of the THIO-101 Phase 2 trial evaluating THIO, an investigational telomere-targeting agent, in patients with advanced NSCLC.
−Removed: In December 2022, regulatory authorities in three European countries, Hungary, Poland, and Bulgaria, approved the implementation of THIO-101, MAIA’s Phase 2 clinical trial.
−Removed: THIO-101 is a critical component of THIO’s clinical development process and it is of the utmost importance that we collaborate with leading cancer institutes in Australia and now in Europe, for a target total of 30 clinical trial sites in six countries.
−Removed: In the first week of March 2023, the first two patients were dosed in Europe in MAIA’s Phase 2 clinical trial, THIO-101 evaluating THIO in patients with advanced Non-Small Cell Lung Cancer (NSCLC).
−Removed: Following regulatory clearances in Hungary, Poland, and Bulgaria, nine clinical sites have been activated in these three European countries.
−Removed: On April 11, 2023, we announced positive topline data related to the completion of Part A, safety lead-in portion of the THIO-101 trial which showed that administration of THIO, at the highest dose of 360 mg/cycle in sequential combination with Regeneron’s anti-PD-1 therapy, Libtayo Ò
−Removed: was well tolerated with no dose-limiting toxicities or significant treatment-related adverse events reported.
−Removed: On April 18, 2023, we published data in Hepatocellular Carcinoma (”HCC”) (liver cancer) models:
−Removed: as monotherapy, THIO achieved complete and durable responses in HCC, the dominant histology in primary liver cancer (90%), in in vivo models.
−Removed: When combined with Libtayo®, duration of response was further potentiated.
−Removed: Upon rechallenge with two times more cancer cells and no additional treatment, tumor growth was completely prevented.
−Removed: Administration of THIO alone and in combination with Libtayo® generated anti-cancer immune memory.
−Removed: On April 20, 2023, we announced preliminary survival data from Part A of THIO-101.
−Removed: The first two patients enrolled in Part A of the study continue to be alive, approximately 10 and 9 months respectively, from treatment initiation.
−Removed: Both patients have advanced Stage IV metastatic disease and are heavily pretreated, receiving third and fourth line of therapy respectively after previously failing treatment with an immune checkpoint inhibitor.
−Removed: They continue to be progression free following their last dose of THIO, 7 and 6 months respectively, with no new treatment.
−Removed: The current treatment options in patients with advanced relapsed or refractory NSCLC who failed two or more therapy regimens are limited and show minimal benefit.
−Removed: Furthermore, discontinuation of treatment is rapidly followed by physical decline and death, therefore seeing patients with such survival and no disease progression in this clinical setting, is noteworthy.
−Removed: In real-world clinical practice, observed survival in such heavily pretreated patients is 3-4 months.
−Removed: On April 27, 2023 we closed a follow-on offering and sold 2,555,500 shares of common stock at a public offering price of $2.25 per share, for gross proceeds of approximately $5.75 million, before deducting underwriting discounts and offering expenses.
−Removed: The shares sold in the offering include the exercise in full by the underwriter of its option to purchase an additional 333,300 shares of common stock, in addition to the 2,222,200 shares of common stock which the underwriters initially agreed to purchase.
−Removed: In July 2023 , MAIA announced that the first 2 patients dosed with THIO continue to be alive for approximately 12.2 and 11.5 months respectively, from treatment initiation.
−Removed: They have remained free of disease progression for 10.2 and 8.5 months, respectively, without requiring any additional therapy.
−Removed: We also highlighted that out of the first 11 patients with post-baseline scans, 82% (9 patients) met the disease control primary endpoint at first response assessment.
−Removed: For contrast, in similar heavily treated NSCLC patients, typical disease control rates are in the 25-35% range.
−Removed: On August 23, 2023, our universal shelf registration statement on Form S-3 (File No.
−Removed: 333-273984) (the “From S-3”) for possible future offerings was declared effective by the SEC.
−Removed: As of September 30, 2023, no securities have been issued pursuant to the Form S-3.
−Removed: On September 1, 2023, the Company entered into an “at-the-market”
−Removed: Sales Agreement (the “Sales Agreement”) with ThinkEquity LLC (the “Sales Agent”), pursuant to which the Company may offer and sell, from time to time, through the Sales Agent, shares of the Company’s common stock having an aggregate offering price of up to $7,000,000, subject to the terms and conditions of the Sales Agreement.
−Removed: The shares will be offered and sold pursuant to the Company’s prospectus supplement (the “Prospectus Supplement”), filed September 1, 2023 with the SEC to the prospectus forming a part of the Form S-3.
−Removed: As of September 30, 2023, no sales have been executed.
−Removed: On September 28, 2023, the Company announced that its board of directors approved a share repurchase program pursuant to which the Company may repurchase up to $800,000 of the Company’s issued and outstanding shares of common stock through September 2024.
−Removed: The Company expects to fund repurchases by using cash on hand and expected cash flow to be generated in the future.
−Removed: As of September 30, 2023, no repurchases have been executed.
−Removed: On October 3, 2023, the Company announced that the FDA has cleared its IND application for THIO to be evaluated in the U.S.
−Removed: as part of THIO-101, the Company’s ongoing global phase 2 clinical study in patients with advanced NSCLC.
−Removed: THIO is being tested in sequential combination with Regeneron’s anti PD-1 monoclonal antibody cemiplimab (Libtayo®) to evaluate anti-tumor activity and immune response in NSCLC patients.
−Removed: On October 10, 2023, the Company announced that 49 patients have been dosed in MAIA’s Phase 2 clinical trial, THIO-101, evaluating THIO in sequential combination with an immune checkpoint inhibitor in patients with advanced NSCLC.
−Removed: Impact of the War in Ukraine and War in Israel on Our Operations
−Removed: The short and long-term implications of war in Ukraine and war in Israel are difficult to predict at this time.
−Removed: The imposition of sanctions and counter sanctions may have an adverse effect on the economic markets generally and could impact our business, financial condition, and results of operations.
−Removed: Because of the highly uncertain and dynamic nature of these events, the Company terminated any planned research activities in the impacted areas.
−Removed: Financial Operations Overview and Analysis for the Three and Nine Months Ended September 30, 2023 and 2022
−Removed: Comparison of three months ended September 30, 2023 and 2022
−Removed: Three Months Ended
−Removed: September 30,
−Removed: Operating expenses:
−Removed: Research and development
−Removed: General and administrative
−Removed: Ratchet share expense
−Removed: Total operating costs and expenses
−Removed: Loss from operations
−Removed: Other (expense) income:
−Removed: Interest expense
−Removed: Interest income
−Removed: Australian research and
−Removed: development incentives
−Removed: Change in fair value of warrant
−Removed: Other income, net
−Removed: Net loss attributable to MAIA
−Removed: Biotechnology, Inc.
−Removed: Operating Expenses
−Removed: Research and development expenses
−Removed: Research and development expenses increased by approximately $256,000 or 11%, from approximately $2,343,000 for the three months ended September 30, 2022 to approximately $2,600,000 for the three months ended September 30, 2023.
−Removed: The increase was primarily related to an increase in scientific research of approximately $519,000 and an increase in stock-based compensation costs of approximately $64,000, offset by a decrease in clinical expenses of approximately $126,000, a decrease in payroll and bonus expenses of approximately $120,000 related to the decreased headcount of additional research and development employees, a decrease in consulting of approximately $46,000, and a decrease of approximately $35,000 in other expenses.
−Removed: General and administrative expenses
−Removed: General and administrative expenses increased by approximately $703,000, or 43% from approximately $1,653,000 for the three months ended September 30, 2022 to approximately $2,356,000 for the three months ended September 30, 2023.
−Removed: The increase was primarily related to an increase in professional fees of approximately $522,000 relating to the write-off of deferred offering costs, an increase in other expenses of approximately $200,000 related to the new investor relation contract, and an increase in payroll expense of approximately $6,000, offset by a decrease in stock-based compensation of approximately $25,000.
−Removed: Ratchet Expense
−Removed: Ratchet expense decreased by approximately $1,099,000 or 100% from approximately $1,099,000 for the three months ended September 30, 2022 to $0 for the three months ended September 30, 2023.
−Removed: The decrease is due to the fact that the ratchet share issuance was a one-time event at the time of the IPO and thus no ratchet share issuance this quarter.
−Removed: Other expense, net
−Removed: Other income, net decreased by approximately 112,000 or 58% from other income of approximately $192,000 for the three months ended September 30, 2022 to other income of approximately $80,000 for the three months ended September 30, 2023.
−Removed: The decrease was primarily related to the change in the fair value of the warrant liability of approximately $110,000, a reduction in the Australia research and development incentives of approximately $7,000 and a net increase of interest income of approximately $5,000.
−Removed: Comparison of nine months ended September 30, 2023 and 2022
−Removed: Nine Months Ended
−Removed: September 30,
−Removed: Operating expenses:
−Removed: Research and development
−Removed: General and administrative
−Removed: Ratchet share expense
−Removed: Total operating costs and expenses
−Removed: Loss from operations
−Removed: Other (expense) income:
−Removed: Interest expense
−Removed: Interest income
−Removed: Australian research and
−Removed: development incentives
−Removed: Change in fair value of warrant
−Removed: Other income, net
−Removed: Deemed dividend on warrant
−Removed: modifications
−Removed: Net loss attributable to MAIA
−Removed: Biotechnology, Inc.
−Removed: Operating Expenses
−Removed: Research and development expenses
−Removed: Research and development expenses increased by approximately $855,000 or 13%, from approximately $6,540,000 for the nine months ended September 30, 2022 to approximately $7,395,000 for the nine months ended September 30, 2023.
−Removed: The increase was primarily related to an increase in scientific research of approximately $1,181,000, an increase in payroll related expenses and bonus expense of approximately $538,000 related to an increase in payroll, bonus expense and benefits due to an increased headcount of development employees, an increase in stock-based compensation of approximately $130,000, an increase of approximately $5,000 in other expenses, offset by decrease in other clinical expenses of approximately $778,000 and a decrease in professional fees of approximately $221,000.
−Removed: General and administrative expenses
−Removed: General and administrative expenses increased by approximately $2,068,000 or 48% from approximately $4,342,000 for the nine months ended September 30, 2022 to approximately $6,410,000 for the nine months ended September 30, 2023.
−Removed: The increase was primarily attributable to the increased costs to create additional infrastructure to support our operations as a public company.
−Removed: Increases included an increase in other expenses of approximately $1,508,000 primarily related to investor relations and insurance required to operate as a public company, an increase
−Removed: in payroll, bonus expenses and benefits due to an increase headcount of operational employees approximately $418,000, and an increase in professional fees of approximately $375,000, offset by a decrease in stock-based compensation expense of approximately $233,000 related to lower Board of Directors compensation.
−Removed: Ratchet Expense
−Removed: Ratchet expense decreased by approximately $1,099,000 or 100% from approximately $1,099,000 for the nine months ended September 30, 2022 to $0 for the nine months ended September 30, 2023.
−Removed: The decrease is due to the fact that the ratchet share issuance was a one-time event at the time of the IPO and thus no ratchet share issuance this quarter.
−Removed: Other expense, net
−Removed: Other income expense, decreased by approximately $69,000 or 19% from approximately $358,000 of other income for the nine months ended September 30, 2022 to approximately $288,000 of other income for the nine months ended September 30, 2023.
−Removed: The change in other income, net was primarily the result of approximately $81,000 decrease of income related to the Australian research and development incentive, a net increase in interest expense of approximately $2,000, offset by approximately $14,000 related to the change in fair value of the warrant liability for the nine months ended September 30, 2023.
−Removed: Liquidity and Capital Resources
−Removed: Our Ability to Continue as a Going Concern
−Removed: As of September 30, 2023, our cash totaled $6,104,587 which represented a decrease of approximately $4,846,000 compared to December 31, 2022.
−Removed: As of September 30, 2023, we had working capital of approximately $2,483,000 which represents a decrease of approximately $6,316,000 compared to December 31, 2022.
−Removed: We have generated no revenues as of September 30, 2023.
−Removed: The Company’s current operating plan indicates that it will continue to incur losses from operations and generate negative cash flows from operating activities given ongoing expenditures related to the completion of its ongoing clinical trials and the Company’s lack of revenue generating activities.
−Removed: Based on the Company’s cash reserves as of September 30, 2023 of $6,104,587 and current financial condition as of the date of the Quarterly Report on Form 10-Q, the accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.
−Removed: The condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
−Removed: To meet the Company’s future working capital needs, the Company will need to raise additional equity or enter into debt financing.
−Removed: 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.
−Removed: 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.
−Removed: Sales of Common Stock
−Removed: During January and February 2022, the Company sold 263,729 shares of common stock at $9.00 per share for gross proceeds of $2,373,561 before transaction costs and expenses.
−Removed: Between April 22, 2022 and May 3, 2022, warrant holders exercised warrants, resulting in the issuance of 153,000 shares of common stock for proceeds of approximately $275,400.
−Removed: On May 19, 2022, the Company sold 11,111 shares of common stock at $9.00 per share for gross proceeds of $99,999 with no transaction costs.
−Removed: On August 1, 2022, the Company sold 2,000,000 shares of common stock at $5 per share for gross proceeds of $10,000,000 in an initial public offering.
−Removed: On August 3, 2022, the Company sold an additional 300,000 shares of common stock at $5 per share for gross proceeds of $1,500,000 per the overallotment option for the underwriter.
−Removed: Concurrently with the closing of the Company’s initial public offering, 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.
−Removed: The warrants are exercisable beginning on January 23, 2023, and expire on July 27, 2027, pursuant to the terms and conditions of the warrants.
−Removed: On August 3, concurrently with the full exercise of the Underwriter’s over-allotment option, the Company issued additional 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.
−Removed: On April 27, 2023, the Company sold 2,555,500 shares of the Company’s common stock at a price of $2.25 per share in an underwritten public offering.
−Removed: ThinkEquity served as underwriter of the offering.
−Removed: The aggregate net proceeds of the offering were approximately $4.4 million, after deducting underwriting discounts and offering expenses.
−Removed: Concurrently with the closing of the public offering, the Company also issued warrants to purchase an aggregate of up to 127,775 shares of its common stock to ThinkEquity or its designees, at an exercise price of $2.8125 per share.
−Removed: The warrants are exercisable beginning on October 24, 2023, and expire on April 24, 2028, pursuant to the terms and conditions of the warrants
−Removed: On September 1, 2023, the Company entered into an “at-the-market”
−Removed: Sales Agreement (the “Sales Agreement”) with ThinkEquity LLC (the “Sales Agent”), pursuant to which the Company may offer and sell, from time to time, through the Sales Agent, shares of the Company’s common stock having an aggregate offering price of up to $7,000,000, subject to the terms and conditions of the Sales Agreement.
−Removed: The shares will be offered and sold pursuant to the Company’s prospectus supplement (the “Prospectus Supplement”), filed September 1, 2023 with the SEC to the prospectus forming a part of the Form S-3.
−Removed: As of September 30, 2023, no sales have been executed.
−Removed: We will need to raise additional capital to fund our operations, to develop and commercialize THIO, and to develop, acquire or in-license other products.
−Removed: We may seek to fund our operations through public equity, private equity, or debt financings, as well as other sources.
−Removed: We cannot make any assurances that additional financings will be available to us and, if available, on acceptable terms or at all.
−Removed: This could negatively impact our business and operations and could also lead to the reduction of our operations.
−Removed: Cash Flows for nine months ended September 30, 2023 and 2022
−Removed: Nine Months Ended
−Removed: September 30,
−Removed: Net cash flows used in operating activities
−Removed: Net cash flows provided by financing activities
−Removed: Effect of foreign currency exchange rate changes on cash
−Removed: Net increase in cash and cash equivalents
−Removed: Operating Activities
−Removed: For the nine months ended September 30, 2023, net cash used in operating activities was approximately $9,079,000, which consisted of a consolidated net loss of approximately $13,516,000 offset by non-cash charges of approximately $1,727,000 in stock-based compensation, and approximately $683,000 of non-cash expense to issue stock to consultants, offset by the remeasurement of the warrant liability of approximately $142,000.
−Removed: Total changes in operating assets and liabilities of approximately $2,169,000 were driven by an approximate $1,861,000 net increase in accounts payable and accrued expenses, an approximate $175,000 increase in the Australia research and development incentives receivable, and an approximate $134,000 increase in prepaid expense and other assets.
−Removed: For the nine months ended September 30, 2022, net cash used in operating activities was approximately $9,146,000, which consisted of a net loss of approximately $11,624,000 offset by non-cash charges of approximately $1,831,000
−Removed: in stock-based compensation, approximately $1,099,00 non-cash charges for issuance of ratchet shares, offset by the remeasurement of the warrant liability of approximately $128,000.
−Removed: Total changes in operating assets and liabilities of approximately $325,000 were driven by an approximate $317,000 increase in accounts payable and accrued liabilities, offset by an approximate $412,000 decrease in prepaid expenses and other assets and an approximate decrease of $230,000 in Australia research and development incentives receivables.
−Removed: For the nine months ended September 30, 2023 the effect of foreign currency exchange rate changes on cash decreased the cash balance as of September 30, 2023 by approximately $13,000 versus approximately $34,000 for the nine months ended September 30, 2022.
−Removed: Financing Activities
−Removed: Net cash provided by financing activities was approximately $4,245,000 and $12,670,000 for the nine months ended September 30, 2023 and 2022, respectively.
−Removed: Total net cash provided by financing activities for the nine months ended September 30, 2023 consisted primarily of approximately $5,750,000 gross proceeds from the follow-on offering and proceeds from exercise of stock options of approximately $1,000, offset by an approximate $1,352,000 of follow-on offering costs and an approximate $154,000 decrease in deferred offering costs.
−Removed: Total net cash provided by financing activities for nine months ended September 30, 2022 consisted of proceeds from the sale of common stock in the initial public offering of approximately $11,500,000, proceeds from the issuance of common stock net of transactions costs totaling approximately $2,474,000, proceeds from the exercise of warrants of $385,000, proceeds from exercise of stock options of approximately $66,000, offset by an approximate $1,755,000 payment of initial public offering cost.
−Removed: Critical Accounting Policies and Significant Judgments and Estimates
−Removed: Our condensed consolidated financial statements are prepared in accordance with U.S.
−Removed: generally accepted accounting principles (U.S.
−Removed: These accounting principles require us to make certain estimates, judgments and assumptions that affect the reported amounts of assets and liabilities as of the date of the financial statements.
−Removed: We believe that the estimates, judgments and assumptions are reasonable based upon information available to us at the time that these estimates, judgments and assumptions are made.
−Removed: To the extent there are material differences between these estimates, judgments or assumptions and actual results, our financial statements will be affected.
−Removed: For a discussion of our critical accounting estimates, please read Part II, Item 7 —
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on March 24, 2023.
−Removed: There have been no material changes to the critical accounting estimates previously disclosed in such report.
−Removed: Quantitative and Qualitative Disclosures About Market Risk.
−Removed: We are a smaller reporting company and are not required to provide the information otherwise required under this item.
+Added: 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.
+Added: As of March 31, 2024, and December 31, 2023, the Company had a full valuation allowance against its deferred tax assets.
+Added: For the three months ended March 31, 2024 and 2023 , the Company recorded zero income tax expense.
+Added: No tax benefit has been recorded in relation to the pre-tax losses for the three months ended March 31, 2024 , due to full valuation allowance to offset any deferred tax assets.
+Added: SUBSEQUENT EVENTS
+Added: Issuance of Options
+Added: From April 1 to May 14, 2024, the Company issued 648,263 options at a weighted exercise price of $ 2.94 to employees and consultants.
+Added: On May 10, 2024, the Company issued 4,678 shares of Common Stock upon exercise of an existing warrant on a net-exercise basis.
+Added: These shares were issued pursuant to the exemption from registration provided by Section 4(a)(2) and/or 3(a)(9) of the Securities Act of 1933, as amended.
+Added: At-The-Market Offering with H.C.
+Added: On February 14, 2024, the Company entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C.
+Added: 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.
+Added: 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.
+Added: The Company will pay Wainwright a commission rate equal to 3.0 % of the aggregate gross proceeds from each sale of Shares.
+Added: 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 Agre ement to an aggregate offering price of up to $ 4,950,000 from time to time.
+Added: Since April 1, 2024, the Company has sold 748,808 shares of its common stock at an average price of $ 3.03 per share, resulting in aggregate gross proceeds of approximately $ 2,265,162 .
+Added: The Company anticipates that the at-the-market offering will continue throughout the next reporting period.
+Added: Private Placement
+Added: On April 25, 2024, the Company issued and sold 494,096 shares of its common stock and warrants to purchase 494,096 shares of its common stock in a private placement to certain accredited investors and Company directors pursuant to securities purchase agreements dated April 22, 2024 at a price per share of $ 2.034 for which the Company received gross proceeds of approximately $ 1.0 million.
+Added: The warrants are exercisable at a price per share of $ 2.26 , are exercisable commencing six months following issuance, and have a term of five year from the initial exercise date.
+Added: The securities sold to Company directors participating in the private placement were issued pursuant to the Company’s 2021 Equity Incentive Plan.
+Added: Related Party Participation in Private Placement
+Added: The following Company directors participated in the aforementioned April 2024 private placement as follows:
+Added: (i) Stan Smith purchased 147,492 shares of common stock and warrants to purchase up to 147,492 shares of common
+Added: stock for an aggregate purchase price of approximately $ 300,000 ;
+Added: (ii) Louie Ngar Yee purchased 19,665 shares of common stock and warrants to purchase up to 19,665 shares of common stock for an aggregate purchase price of approximately $ 40,000 .
+Added: Amendments to Common Stock Purchase Warrants
+Added: On May 11, 2024, the Company entered into amendments to certain of those common stock purchase warrants originally issued on March 14, 2024 with an exercise price of $ 1.30 per share with holders of such warrants to purchase 1,794,882 shares of common stock (out of warrants to purchase an aggregate of 2,043,587 shares of common stock issued to non-affiliated investors on March 14, 2024) to amend and restate the “Fundamental Transaction” adjustment provision in such warrants to facilitate such warrants being accounted for on the Company’s balance sheet as equity in future periods as opposed to a warrant liability.
+Added: On May 11, 2024, the Company entered into amendments to certain of those common stock purchase warrants originally issued on March 28, 2024 with an exercise price of $ 2.55 per share with holders of such warrants to purchase 349,886 shares of common stock (out of warrants to purchase an aggregate of 578,643 shares of common stock issued to non-affiliated investors on March 28, 2024) to amend and restate the “Fundamental Transaction” adjustment provision in such warrants to facilitate such warrants being accounted for on the Company’s balance sheet as equity in future periods as opposed to a warrant liability.
+Added: On May 11, 2024, the Company entered into amendments to certain of those common stock purchase warrants originally issued on April 25, 2024 with an exercise price of $ 2.26 per share with holders of such warrants to purchase 263,027 shares of common stock (out of warrants to purchase an aggregate of 326,939 shares of common stock issued to non-affiliated investors on April 25, 2024) to amend and restate the “Fundamental Transaction” adjustment provision in such warrants to facilitate such warrants being accounted for on the Company’s balance sheet as equity in future periods as opposed to a warrant liability.
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.