What changed in this filing

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Item 1. Financial Statements

2023-08-08 compared with 2023-05-08 · 180 added, 139 removed, 490 unchanged (39% of the section changed)

19 unchanged sentences

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

authorized at March 31, 2023 and December 31, 2022,

authorized at June 30, 2023 and December 31, 2022,

0 shares issued and outstanding

Common stock, $ 0.0001 par value, 70,000,000 shares authorized at March 31, 2023

Common stock, $ 0.0001 par value, 70,000,000 shares authorized at June 30, 2023

and December 31, 2022, 13,648,425 and 10,955,904 shares issued

and outstanding at March 31, 2023 and December 31, 2022, respectively

and outstanding at June 30, 2023 and December 31, 2022, respectively

Additional paid-in capital

7 unchanged sentences

Co ndensed Consolidated Statements of Operations

For the Three Months Ended March 31,

For the Three Months Ended June 30,

Six Months Ended

Operating expenses:

9 unchanged sentences

Other income, net

Deemed dividend on warrant modification

Net loss attributable to MAIA Biotechnology, Inc.

Deemed dividend on warrant

Net loss attributable to MAIA

Biotechnology, Inc.

Net loss per share

Basic and diluted

Weighted average common shares outstanding Basic and

Weighted average common shares

outstanding Basic and diluted

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

3 unchanged sentences

Three Months Ended

Six Months Ended

Foreign currency translation adjustment

4 unchanged sentences

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

For the Three Months Ended

March 31, 2023

Preferred Stock

For the Three and Six Months Ended

June 30, 2023

Additional Paid-In Capital

7 unchanged sentences

Balance at March 31, 2023

Issuance of restricted stock

Issuance of common shares in connection with follow-on offering, net of $ 1,593,016 of issuance costs

Issuance of warrants to underwriter in connection with follow-on offering

Stock-based compensation expense

Issuance of stock options to satisfy accrued bonus

Foreign currency translation adjustment

Balance at June 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)

For the Three Months Ended

March 31, 2022

Preferred Stock

For the Three and Six Months Ended

June 30, 2022

Additional Paid-In Capital

Accumulated Deficit

Accumulated Other Comprehensive Income

Accumulated Other Comprehensive Income (Loss)

Stockholders'

8 unchanged sentences

Balance at March 31, 2022

Issuance of common shares upon exercise of warrants

Issuance of common shares in connection with Equity Financing

Stock-based compensation expense

Foreign currency translation adjustment

Balance at June 30, 2022

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

2 unchanged sentences

Condensed Consolidated S tatements of Cash Flows

Three Months Ended

Six Months Ended

Cash flows from operating activities:

Net loss, including noncontrolling interests

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

Stock-based compensation

Consulting expense for restricted shares issued

Issuance of restricted stock

Change in fair value of warrant liability

4 unchanged sentences

Accrued expenses

Deferred offering costs

Deferred compensation

Net cash used in operating activities

1 unchanged sentence

Proceeds from issuance of common stock, net of transaction

Deferred offering costs

Proceeds from exercise of stock options

Proceeds from exercise of warrants

Proceeds from sale of common stock in initial public offering

Payment of initial public offering transaction costs

Payment on loan payable to officer

Proceeds from sale of common stock in follow-on offering

Payment of follow-on offering transactions costs

Net cash provided by financing activities

3 unchanged sentences

Cash at end of period

Supplemental disclosure of cash flow information:

Options issued for accrued bonus

Warrants issued to underwriters in connection with the follow-on offering

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

22 unchanged sentences

Going Concern Considerations

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

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

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

To date the Company has incurred recurring losses, negative cash flow from operations and has accumulated a deficit of $ 48,324,148 from the Company’s inception through March 31, 2023.

As of March 31, 2023, the Company had $ 7,586,312 in cash and cash equivalents.

To date the Company has incurred recurring losses, negative cash flow from operations and has accumulated a deficit of ($ 52,847,772 ) from the Company’s inception through June 30, 2023.

As of June 30, 2023, the Company had $ 9,146,156 in cash and cash equivalents.

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

34 unchanged sentences

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

At March 31, 2023 and December 31, 2022 , substantially all of the Company’s cash was deposited in accounts at one financial institution.

At June 30, 2023 and December 31, 2022 , substantially all of the Company’s cash was deposited in accounts at one financial institution.

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.

As of March 31, 2023 and December 31, 2022 , cash includes cash in a depository bank account;

the Company has no cash equivalents as of March 31, 2023 or December 31, 2022 .

As of June 30, 2023 and December 31, 2022 , cash includes cash in a depository bank account;

the Company had no cash equivalents as of June 30, 2023 or December 31, 2022 .

Fair Value Measurements

8 unchanged sentences

These valuations require significant judgment.

Fair value measurements discussed herein are based upon certain market assumptions and pertinent information available to management as of and during the three months ended March 31, 2023, and as of and during the twelve months ended December 31, 2022.

Fair value measurements discussed herein are based upon certain market assumptions and pertinent information available to management as of and during the six months ended June 30, 2023, and as of and during the twelve months ended December 31, 2022.

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

The fair value of warrants issued for services is estimated based on the Black-Scholes model during the three months ended March 31, 2022 and the three months ended March 31, 2023 .

The fair value of warrants issued for services is estimated based on the Black-Scholes model during the six months ended June 30, 2023 .

The estimated fair value of warrants issued to underwriters and embedded features, represented Level 3 measurements.

10 unchanged sentences

The Company periodically confirms the accuracy of its estimates with the service providers and makes adjustments if necessary.

The significant 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.

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.

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.

36 unchanged sentences

and global economic and capital market conditions.

During the three months ended March 31, 2023, 40,500 restricted shares of common stock were issued.

There were no issuances of restricted stock awards during three months ended March 31, 2022.

During the six months ended June 30, 2023, 137,021 restricted shares of common stock were issued for consulting services .

There were no issuances of restricted stock awards during the six months ended June 30, 2022.

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

8 unchanged sentences

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

Valuation allowances are provided, if based upon the weight of available evidence, it is more likely than not

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

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

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

3 unchanged sentences

Deferred Offering Costs

Deferred offering costs are included in other assets and consist of legal, accounting, underwriting fees and other costs incurred through the December 31, 2022 and the March 31, 2023 balance sheet date that are directly related to a planned follow-on offering and will be charged to additional paid-in capital upon the completion of the follow-on offering.

Deferred offering costs are included in other assets and consist of legal, accounting, underwriting fees and other costs.

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, 2023.

Deferred offering costs incurred through the June 30, 2023 balance sheet are directly related to a proposed second follow-on offering that will be charged to additional paid-in capital upon the completion of the offering.

Net Loss Per Share

5 unchanged sentences

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

Three Months Ended

Six Months Ended

Shares issuable upon exercise of stock options

Shares issuable upon exercise of warrants

Unvested restricted stock awards

Recent Accounting Standards

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

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.

In February 2016, the FASB issued ASU No.

2016-02, as amended, Leases (“Topic 842”), which applies to all leases.

Under Topic 842, a right-of-use asset and lease obligation will be recorded for all leases, whether operating or financing leases, while the statement of operations will reflect lease expense for operating leases and amortization and interest expense for financing leases.

Topic 842 is effective for public entities for fiscal years beginning after December 15, 2018 and periods beginning after December 15, 2021 for all other entities.

Entities are required to use a modified retrospective approach of adoption for leases that exist or are entered into after the beginning of the earliest comparative period in the financial statements.

The Company adopted this new standard as of January 1, 2022.

At the inception of an arrangement the Company determines whether the arrangement is or contains a lease based on the circumstances present.

Currently none of the Company’s operating lease commitments are subject to the new standard as its leases are short-term in nature (i.e., less than twelve months).

RELATED PARTY TRANSACTIONS

Certain of our directors and executive officers have adopted written plans, known as Rule 10b5-1 plans, in which they have contracted with a broker to buy shares of our common stock on a periodic basis.

Our other directors and executive officers may also adopt Rule 10b5-1 plans in which they contract with a broker to buy or sell shares of our common stock on a periodic basis.

Certain of our directors and executive officers previously adopted written plans, known as Rule 10b5-1 plans, in which they have contracted with a broker to buy shares of our common stock on a periodic basis.

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

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

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

2 unchanged sentences

ACCRUED EXPENSES

As of March 31, 2023 and December 31, 2022, accrued expenses consisted of the following:

As of June 30, 2023 and December 31, 2022, accrued expenses consisted of the following:

Professional fees

1 unchanged sentence

Total accrued expenses

Accrued Bonus

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:

Fair value at March 31, 2023

Fair value at June 30, 2023

Warrant liability

1 unchanged sentence

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):

Years Ended March 31,

Three months ended June 30,

Six months ended June 30,

Warrant liabilities:

Balance, beginning of period

Warrant liability

Gain on fair value of warrant liability

Reclassification of warrant liability to equity

Balance, end of period

13 unchanged sentences

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.

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 gross proceeds of $ 1,500,000 prior to deducting underwriting discounts, commissions, and other offering expenses.

After deducting the underwriting discount and other offering expenses payable by the Company, the total net proceeds for the initial public offering and the overallotment were $ 9,093,830 .

ThinkEquity LLC (“ThinkEquity”) served as underwriter in the offering.

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.

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 .

Follow-on Offering

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.

ThinkEquity LLC served as underwriter in the offering.

The total net proceeds of the offering were approximately $ 4,398,000 , after deducting underwriting discounts, commissions, and other offering expenses.

MAIA Biotechnology, Inc.

Restricted Stock Awards

During the three months ended March 31, 2022 , MAIA recognized $ 52,500 of stock compensation expense related to 29,168 of MAIA’s restricted shares granted to the founders.

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.

There are no unvested restricted shares as of March 31, 2023.

During the six months ended June 30, 2022 , MAIA recognized $ 52,500 of stock compensation expense related to 29,168 of MAIA’s restricted shares granted to the founders.

During the six months ended June 30, 2023 , the company expensed $ 488,600 to consulting for investor relations related to the grant of 137,021 restricted shares of common stock.

There are no unvested restricted shares as of June 30, 2023.

MAIA Stock Warrants

5 unchanged sentences

The value of the warrant modification to the 144,497 warrants was calculated using the Black-Scholes-Merton option pricing model.

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 three months ended March 31, 2022 and is reflected as “Deemed dividend on warrant modification”

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 six months ended June 30, 2022 and is reflected as “Deemed dividend on warrant modification”

in the accompanying statement of operations.

5 unchanged sentences

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.

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.

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

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

As of March 31, 2023 and December 31, 2022 the Company remeasured the warrant liability resulting in a value of $ 224,399 and $ 245,341 respectively.

The gain on remeasurement of the warrant liability in the amount of $ 20,942 was included in other income.

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.

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

The Representative’s Warrants are liability classified instruments and were initially recorded 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 %.

As of June 30, 2023 and December 31, 2022 the Company remeasured the warrant liability resulting in a value of $ 121,600 and $ 245,341 respectively.

The gain on remeasurement of the warrant liability in the amount of $ 123,741 was included in other income for the six months ended June 30, 2023.

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”).

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.

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 %.

Balance at January 1, 2023

Balance at March 31, 2023

Balance at June 30, 2023

MAIA Biotechnology, Inc.

3 unchanged sentences

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

The terms of the MAIA 2018 Plan continue to govern the 1,924,500 options outstanding in the plan of March 31, 2023.

The terms of the MAIA 2018 Plan continue to govern the 1,924,500 options outstanding in the plan of June 30, 2023.

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

1 unchanged sentence

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

The terms of the MAIA 2020 Plan continue to govern the 3,983,023 options outstanding in the plan as of March 31, 2023 .

The terms of the MAIA 2020 Plan continue to govern the 3,957,710 options outstanding in the plan as of June 30, 2023.

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

1 unchanged sentence

2021 Equity Incentive Plan (the “MAIA 2021 Plan’’) with 1,909,518 shares of common stock reserved for issuance.

As of March 31, 2023 there are 599,126 shares of common stock available for future issuance under the MAIA 2021 Plan and 1,310,392 options are outstanding in the MAIA 2021 Plan.

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”) ;

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

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

As of June 30, 2023 there are 1,992,709 shares of common stock available for future issuance under the MAIA 2021 Plan and 1,899,115 options are outstanding in the MAIA 2021 Plan.

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

1 unchanged sentence

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.

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

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

2 unchanged sentences

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

As of March 31, 2023, only stock options have been awarded pursuant to the MAIA stock award plans.

The following table summarizes the activity and information regarding MAIA’s outstanding and exercisable options for the three months ended March 31, 2023:

As of June 30, 2023, only stock options have been awarded pursuant to the MAIA stock award plans.

The following table summarizes the activity and information regarding MAIA’s outstanding and exercisable options for the six months ended June 30, 2023:

Balance at January 1, 2023

Cancelled/forfeited

Balance at March 31, 2023

Options exercisable at March 31, 2023

During the three months ended March 31, 2023, the fair value of our common stock is based on the closing price of the common stock in the public market.

During the three months ended March 31, 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.

Balance at June 30, 2023

Options exercisable at June 30, 2023

During the six months ended June 30, 2023, the fair value of our common stock is based on the closing price of the common stock in the public market.

During the six months ended June 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.

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”).

2 unchanged sentences

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.

From January 27 to March 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 March 31, 2022.

The value of option grants is calculated using the Black-Scholes option pricing model with the following assumptions for options granted during the three months ended March 31, 2023 and 2022:

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.

From June 1 to June 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.

The value of option grants is calculated using the Black-Scholes-Merton option pricing model with the following assumptions for options granted during the six months ended June 30, 2023 and 2022:

Risk-free interest rate

3.64 %- 4.23 %

2.14 %- 3.06 %

Expected term (in years)

3 unchanged sentences

Expected dividend yield

The weighted-average grant date fair value of stock options issued during the three months ended March 31, 2023 and 2022 was $ 3.27 and $ 5.78 , respectively.

As of March 31, 2023 , the total unrecognized compensation related to unvested employee and non-employee stock option awards granted was $ 5,097,294 , which the Company expects to recognize over a weighted average period of approximately 3.3 years.

The weighted-average grant date fair value of stock options issued during the six months ended June 30, 2023 and 2022 was $ 3.26 and $ 5.97 , respectively.

As of June 30, 2023, the total unrecognized compensation related to unvested employee and non-employee stock option awards granted was $ 4,494,698 , which the Company expects to recognize over a weighted average period of approximately 3.1 years.

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

Three Months Ended

For the Three Months

Ended June 30,

For the Six Months

Ended June 30,

General and administrative

13 unchanged sentences

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 .

As of March 31, 2023, no assignment has occurred and none of the defined milestones have been completed and therefore no payments are due to UTSW related to the milestones.

As of June 30, 2023, no assignment has occurred and none of the defined milestones have been completed and therefore no payments are due to UTSW related to the milestones.

The 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.

5 unchanged sentences

As of March 31, 2023, no assignment has occurred and none of the defined milestones have been completed and therefore no payments are due to UTSW related to the milestones.

As of June 30, 2023, no assignment has occurred and none of the defined milestones have been completed and therefore no payments are due to UTSW related to the milestones.

11 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.

As of March 31, 2023 neither party has terminated the agreement.

As of June 30, 2023 neither party has terminated the agreement.

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

2 unchanged sentences

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

As of March 31, 2023, and December 31, 2022, the Company had a full valuation allowance against its deferred tax assets.

For the three months ended March 31, 2023 and 2022 , the Company recorded zero income tax expense.

No tax benefit has been recorded in relation to the pre-tax losses for three months ended March 31, 2023 and 2022 , due to full valuation allowance to offset any deferred tax assets.

SUBSEQUENT EVENTS

Issuance of Common Stock

On April 3, 2023, the Company entered into an agreement with Acorn Management Partners, LLC for professional relations services, pursuant to which the Company agreed to issue 43,000 restricted shares of common stock on April 6, 2023 and an additional $ 45,000 worth of restricted shares of common stock, with the number of shares of the Company to be determined by dividing the $ 45,000 by the closing price in six months and again nine months after the execution date of the contract unless the contract is terminated.

On April 6, 2023, the Company entered into an agreement with Outside the Box Capital Inc.

for media services, pursuant to which we agreed to issue $ 50,000 worth of restricted shares of common stock on April 11, 2023, the effective date of the agreement.

Based on the closing price of common stock on April 11, 2023, 13,021 restricted shares of common stock were issued.

An additional $ 50,000 worth of restricted shares of common stock will be issued on June 11, 2023 if the agreement is not terminated.

On April 16, 2023, the Company issued 18,000 restricted shares of common stock to FON Consulting, an assignee of FORCE Family Office, LLC, for investor services through July 16, 2023.

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.

ThinkEquity LLC (“ThinkEquity”) served as underwriter of the offering.

The aggregate net proceeds of the offering were approximately $ 5.1 million, after deducting underwriting discounts and expenses.

The shares of common stock were offered, issued and sold to the public pursuant to the Registration Statement on Form S-1, as amended from time to time (File No.

The Company intends to use the net proceeds from the offering to fund the ongoing clinical trials of THIO, pre-clinical development of second-generation of telomere targeting compounds, and other research and development activities, as well as for working capital and other general corporate purposes.

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 (the “Representative’s Warrants”).

The Representative’s Warrants are exercisable beginning on October 24, 2023 , and expire on April 24, 2028 , pursuant to the terms and conditions of the Representative’s Warrants.

As of June 30, 2023, and December 31, 2022, the Company had a full valuation allowance against its deferred tax assets.

For the six months ended June 30, 2023 and 2022 , the Company recorded zero income tax expense.

No tax benefit has been recorded in relation to the pre-tax losses for the six months ended June 30, 2023 , due to full valuation allowance to offset any deferred tax assets.

Management’s Discussion and Analysis of Financial Condition and Results of Operations.

22 unchanged sentences

In the first quarter 2021, we initiated our clinical supply manufacturing (CMC) under Good Manufacturing Practices (GMP) conditions to provide clinical supply for THIO-101 and other development needs.

In the First Quarter 2022, we completed the Crossover Round for total proceeds of approximately $2.4 million.

In the first half of 2022, we completed a crossover round consisting of sales of 274,840 shares of our common stoack at a price of $9 per shares for total proceeds of approximately $2.5 million.

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.

2 unchanged sentences

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.

Orphan Drug Designation provides certain 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.

Orphan Drug Designation provides certain 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.

if the drug is ultimately approved for its designated indication.

In May 2022, we completed the Additional Round for total proceeds of approximately $99,999.

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.

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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.

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

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.

In real-world clinical practice, observed survival in such heavily pretreated patients is 3-4 months.

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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.

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.

They have remained free of disease progression for 10.2 and 8.5 months, respectively, without requiring any additional therapy.

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.

For contrast, in similar heavily treated NSCLC patients, typical disease control rates (DCR) are in the 25-35% range.

Impact of the War in Ukraine on Our Operations

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Because of the highly uncertain and dynamic nature of these events, the Company terminated any planned research activities in Russia.

Financial Operations Overview and Analysis for the Three Months Ended March 31, 2023 and 2022

Comparison of the three months ended March 31, 2023 and 2022

Financial Operations Overview and Analysis for the Three and Six Months Ended June 30, 2023 and 2022

Comparison of the three months ended June 30, 2023 and 2022

Three Months Ended

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Loss from operations

Other income (expense):

Other (expense) income:

Interest expense

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Other income, net

Net loss attributable to MAIA

Biotechnology, Inc.

Operating Expenses

Research and development expenses

Research and development expenses increased by approximately $480,000 or 23%, from approximately $2,119,000 for the three months ended June 30, 2022 to approximately $2,599,000 for the three months ended June 30, 2023.

The increase was primarily related to an increase in scientific research of approximately $443,000, an increase in payroll and bonus expenses of approximately $196,000 related to the increased headcount of additional research and development employees, an increase in stock-based compensation costs of approximately $58,000, and an increase of approximately $31,000 in other expenses offset by a decrease in Clinical and Scientific research of approximately $206,000 due to less THIO-101 trial start-up fees, and a decrease in consulting of approximately $42,000.

General and administrative expenses

General and administrative expenses increased by approximately $743,000, or 56% from approximately $1,323,000 for the three months ended June 30, 2022 to approximately $2,065,000 for the three months ended June 30, 2023.

The increase was primarily related to an increase other expenses of approximately $727,000 related to the costs of operating a public company, and an increase in payroll expense of approximately $134,000, offset by a decrease in stock-based compensation of approximately $24,000 and professional fees of approximately $94,000.

Other expense, net

Other income, net increased by approximately $5,000 or 4% from other income of approximately $136,000 for the three months ended June 30, 2022 to other income of approximately $141,000 for the three months ended June 30, 2023.

The increase was primarily related to the gain from the change in the fair value of the warrant liability of approximately $103,000 offset by a reduction in the Australia research and development incentives of approximately $96,000 and an increase in interest expense of approximately $2,000.

Comparison of six months ended June 30, 2023 and 2022

Six Months Ended

Operating expenses:

Research and development

General and administrative

Total operating costs and expenses

Loss from operations

Other (expense) income:

Interest expense

Interest income

Australian research and

development incentives

Change in fair value of warrant

Other income, net

Deemed dividend on warrant

modifications

Net loss attributable to MAIA

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Research and development expenses

Research and development expenses increased by approximately $119,000 or 6%, from approximately $2,077,000 for the three months ended March 31, 2022 to approximately $2,196,000 for the three months ended March 31, 2023.

The increase was primarily related to an increase in payroll and bonus expenses of approximately $462,000 related to the increased headcount of additional research and development employees and an increase in stock-based compensation costs of approximately $8,000 offset by a decrease in Clinical and Scientific research of approximately $227,000 due less THIO-101 trial start-up fees, and a decrease in consulting and other fees of approximately $124,000.

Research and development expenses increased by approximately $599,000 or 14%, from approximately $4,197,000 for the six months ended June 30, 2022 to approximately $4,795,000 for the six months ended June 30, 2023.

The increase was primarily related to an increase in pre-clinical expenses of approximately $662,000 due to an increase in pre-clinical activities, an increase in payroll related expenses and bonus expense of approximately $658,000 related to increased headcount of development employees during the six months ended June 30, 2023, an increase in stock-based compensation of approximately $67,000, and an increase of approximately $40,000 in other expenses offset by decreases in other clinical expenses of approximately $652,000 due to lower start-up costs for the THIO-101 trial, and a decrease in professional fees of approximately $176,000.

General and administrative expenses

General and administrative expenses increased by approximately $622,000, or 46% from approximately $1,366,000 for the three months ended March 31, 2022 to approximately $1,988,000 for the three months ended March 31, 2023.

The increase was primarily related to an increase in payroll expense of approximately $278,000, an increase in other expenses of approximately $580,000 related to the costs of operating as a public company, offset by a decrease in stock-based compensation of approximately $184,000 and professional fees of approximately $52,000.

General and administrative expenses increased by approximately $1,365,000 or 51% from approximately $2,289,000 for the six months ended June 30, 2022 to approximately $4,054,000 for the six months ended June 30, 2023.

The increase was primarily attributable to the increased costs to create additional infrastructure to support our operations as a public company.

Increases included an increase in payroll, bonus expenses and benefits of approximately $412,000 related to an increase in headcount over the same period last year, and an increase in other expenses of approximately $1,307,000 primarily related to investor relations and insurance required to operate as a public company, offset by a decrease in professional fees of approximately $147,000 and in stock-based compensation expense of approximately $208,000.

Other expense, net

Other income, net increased by approximately $38,000 or 127% from other income of approximately $30,000 for the three months ended March 31, 2022 to other income of approximately $67,000 for the three months ended March 31, 2023.

The increase was primarily related to increases in the Australia research and development incentives of approximately $22,000 and a gain on the change in the fair value of the warrant liability of approximately $21,000 offset by increases to interest expense of approximately $5,000.

Other income expense, increased by approximately $43,000 or 26% from approximately $166,000 of other income for the six months ended June 30, 2022 to approximately $208,000 of other income for the six months ended June 30, 2023.

The change in other income, net was primarily the result of approximately $124,000 of income related to change in fair value of the warrant liability for the six months ended June 30, 2023 offset by the approximately $74,000 decrease of the income related to the Australian research and development incentive and an approximately $7,000 increase in interest expense.

Liquidity and Capital Resources

Our Ability to Continue as a Going Concern

As of March 31, 2023, our cash totaled approximately $7,586,000 which represented a decrease of approximately $3,365,000 compared to December 31, 2022.

As of March 31, 2023, we had working capital of approximately $4,567,000 which represents a decrease of approximately $3,972,000 compared to December 31, 2022.

We have generated no revenues as of March 31, 2023.

As of June 30, 2023, our cash totaled $9,146,156 which represented a decrease of approximately $1,805,000 compared to December 31, 2022.

As of June 30, 2023, we had working capital of approximately $6,503,000 which represents a decrease of approximately $2,036,000 compared to December 31, 2022.

We have generated no revenues as of June 30, 2023.

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.

Based on the Company’s cash reserves as March 31, 2023 of approximately $7,586,000 million and current financial condition as of the date of the Quarter 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.

Based on the Company’s cash reserves as June 30, 2023 of $9,146,156 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.

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

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Sales of Common Stock

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.

ThinkEquity LLC (“ThinkEquity”) served as underwriter of the offering.

The aggregate net proceeds of the offering were approximately $5.1 million, after deducting underwriting discounts and estimated offering expenses.

The shares of common stock were offered, issued and sold to the public pursuant to the Registration Statement on Form S-1, as amended from time to time (File No.

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 (the “Representative’s Warrants”).

The Representative’s Warrants are exercisable beginning on October 24, 2023, and expire on April 24, 2028, pursuant to the terms and conditions of the Representative’s Warrants.

During January and February 2022, the Company sold 263,729 shares of common stock at $9 per share for gross proceeds of $2,373,561 before transaction costs and expenses.

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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.

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 warrants are exercisable beginning on January 23, 2023, and expire on July 27, 2027, pursuant to the terms and conditions of the warrants.

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.

ThinkEquity served as underwriter of the offering.

The aggregate net proceeds of the offering were approximately $4.4 million, after deducting underwriting discounts and offering expenses.

The warrants are exercisable beginning on October 24, 2023, and expire on April 24, 2028, pursuant to the terms and conditions of the warrants

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.

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This could negatively impact our business and operations and could also lead to the reduction of our operations.

Cash Flows three months ended March 31, 2023 and 2022

Three Months Ended

Cash Flows six months ended June 30, 2023 and 2022

Six Months Ended

Net cash flows used in operating activities

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Operating Activities

For the three months ended March 31, 2023, net cash used in operating activities was approximately $3,361,000, which consisted of a consolidated net loss of approximately $4,117,000 offset by non-cash charges of approximately $538,000 in stock-based compensation, approximately $164,000 of expense to issue stock to consultants offset by the remeasurement of the warrant liability of approximately $21,000.

Total changes in operating assets and liabilities of approximately $76,000 were driven by an approximate $154,000 decrease in prepaid expense and other assets, and an approximate $499,000 net increase in accounts payable and accrued expenses offset by an approximate $51,000 increase in the Australia research and development incentives receivable and by an increase of approximately $526,000 in deferred offering costs.

For the three months ended March 31, 2022, net cash used in operating activities was approximately $2,808,000, which consisted of a net loss of approximately $3,414,000 offset by non-cash charges of approximately $713,000 in stock-based compensation.

Total changes in operating assets and liabilities of approximately $107,000 were primarily driven by an approximate $286,000 net increase in accrued expenses and accounts payable and an approximate decrease of $3,000 in deferred compensation offset by an increase in deferred offering costs of approximately $262,000 and prepaid expenses and other current assets of approximately $134,000.

For the three months ended March 31, 2023 the effect of foreign currency exchange rate changes on cash decreased the cash balance as of March 31, 2023 by approximately $4,000.

For the six months ended June 30, 2023, net cash used in operating activities was approximately $5,920,000, which consisted of a consolidated net loss of approximately $8,641,000 offset by non-cash charges of approximately $1,157,000 in stock-based compensation, approximately 974,000 of stock options issued to satisfy the accrued bonus, approximately $488,000 of expense to issue stock to consultants offset by the remeasurement of the warrant liability of approximately $124,000.

Total changes in operating assets and liabilities of approximately $225,000 were driven by an approximate $309,000 decrease in prepaid expense and other assets, and an approximate $7,000 net increase in accounts payable and accrued expenses offset by an approximate $91,000 increase in the Australia research and development incentives receivable.

For the six months ended June 30, 2022, net cash used in operating activities was approximately $4,827,000, which consisted of a net loss of approximately $6,720,000 offset by non-cash charges of approximately $1,298,000 in stock-based compensation.

Total changes in operating assets and liabilities of approximately $594,000 were driven by an approximate $962,000 increase in accounts payable and accrued liabilities, offset by an approximate $203,000 increase in prepaid expenses and other assets and an approximate increase of $165,000 in Australia research and development incentives receivables.

For the six months ended June 30, 2023 the effect of foreign currency exchange rate changes on cash decreased the cash balance as of June 30, 2023 by approximately $3,000 versus approximately $8,000 for the six months ended June 30, 2022.

Financing Activities

Net cash provided by financing activities was approximately $0 and $2,531,000 for the three months ended March 31, 2023 and 2022, respectively.

Total net cash provided by financing activities for three months ended March 31, 2022 consisted of proceeds for issuance of common stock net of transactions costs totaling approximately

$2,373,000, proceeds from exercise of stock options of approximately $48,000 and proceeds from the exercise of warrants of $110,000.

Net cash provided by financing activities was approximately $4,120,000 and $2,411,000 for the six months ended June 30, 2023 and 2022, respectively.

Total net cash provided by financing activities for the six months ended June 30, 2023 consisted primarily of approximately $4,398,000 net proceeds from the follow-on offering offset by an approximate $278,000 decrease in deferred offering costs.

Total net cash provided by financing activities for six months ended June 30, 2022 consisted of proceeds for issuance of common stock net of transactions costs totaling

approximately $2,474,000, proceeds from exercise of stock options of approximately $48,000 and proceeds from the exercise of warrants of $385,000 offset by an approximate $496,000 decrease in deferred offering costs.

Critical Accounting Policies and Significant Judgments and Estimates

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To the extent there are material differences between these estimates, judgments or assumptions and actual results, our financial statements will be affected.

For a discussion of our critical accounting estimates, please read Part II, Item 7., Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on March 24, 2023.

For a discussion of our critical accounting estimates, please read Part II, Item 7 —

Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on March 24, 2023.

There have been no material changes to the critical accounting estimates previously disclosed in such report.

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

What changed 10-Q

Item 1. Financial Statements