What changed in this filing

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Item 1. Financial Statements

2023-11-07 compared with 2023-08-08 · 193 added, 118 removed, 552 unchanged (36% of the section changed)

3 unchanged sentences

Condensed Consolidated Balance Sheets

September 30,

Current assets:

14 unchanged sentences

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

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

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

0 shares issued and outstanding

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 June 30, 2023 and December 31, 2022, respectively

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

September 30, 2023 and December 31, 2022, 13,761,123 and 10,955,904

shares issued and outstanding at September 30, 2023 and December 31, 2022,

Additional paid-in capital

7 unchanged sentences

Co ndensed Consolidated Statements of Operations

For the Three Months Ended June 30,

Six Months Ended

For the Three Months Ended September 30,

Nine Months Ended

September 30,

Operating expenses:

1 unchanged sentence

General and administrative expenses

Ratchet share expense

Total operating expenses

18 unchanged sentences

Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

Foreign currency translation adjustment

4 unchanged sentences

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

For the Three and Six Months Ended

June 30, 2023

For the Three and Nine Months Ended

September 30, 2023

Additional Paid-In Capital

1 unchanged sentence

Accumulated Other Comprehensive Loss

Stockholders'

Total Stockholders' Equity

Balance at December 31, 2022

10 unchanged sentences

Balance at June 30, 2023

Issuance of common shares upon exercise of stock options

Issuance of restricted stock

Stock-based compensation expense

Foreign currency translation adjustment

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)

For the Three and Six Months Ended

June 30, 2022

For the Three and Nine Months Ended

September 30, 2022

Additional Paid-In Capital

1 unchanged sentence

Accumulated Other Comprehensive Income (Loss)

Stockholders'

Total Stockholders' Equity

Balance at December 31, 2021

12 unchanged sentences

Balance at June 30, 2022

Issuance of common shares upon exercise of stock options

Issuance of common shares in connection with initial public offering, net of $ 2,749,905 issuance cost

Issuance of ratchet share

Stock-based compensation expense

Foreign currency translation adjustment

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

Six Months Ended

Nine Months Ended

September 30,

Cash flows from operating activities:

1 unchanged sentence

Stock-based compensation

Issuance of restricted stock

Issuance of ratchet shares

Consulting expense for restricted shares issued

Change in fair value of warrant liability

6 unchanged sentences

Cash flows from financing activities:

Proceeds from issuance of common stock, net of transaction

Proceeds from issuance of common stock, net of transaction costs

Deferred offering costs

1 unchanged sentence

Proceeds from exercise of warrants

Proceeds from sale of common stock in initial public offering

Payment of initial public offering transaction costs

Proceeds from sale of common stock in follow-on offering

6 unchanged sentences

Supplemental disclosure of cash flow information:

Previously paid issuance costs in connection with the initial public offering

Warrants issued to underwriters in connection with the initial public offering

Options issued for accrued bonus

26 unchanged sentences

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 ($ 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 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.

As of September 30, 2023, the Company had $ 6,104,587 in cash and cash equivalents and working capital of approximately $ 2,483,179 .

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

17 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.

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

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

9 unchanged sentences

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

The resulting foreign currency translation adjustment is included in shareholders’

The resulting foreign currency translation adjustment is included in stockholders’

equity as accumulated other comprehensive loss.

2 unchanged sentences

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

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

At September 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 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 .

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

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

Fair Value Measurements

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

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

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.

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These valuations require significant judgment.

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

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 .

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

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

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

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

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

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and global economic and capital market conditions.

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.

During the nine months ended September 30, 2023 , 248,969 restricted shares of common stock were issued for consulting services.

There were no issuances o f restricted stock awards during the nine months ended September 30, 2022.

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

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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.

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.

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.

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:

Six Months Ended

Nine Months Ended

September 30,

Shares issuable upon exercise of stock options

11 unchanged sentences

ACCRUED EXPENSES

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

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

September 30,

Professional fees

7 unchanged sentences

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

Fair value at June 30, 2023

Fair value at September 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):

Three months ended June 30,

Six months ended June 30,

Three Months Ended

September 30,

Nine Months Ended

September 30,

Warrant liabilities:

23 unchanged sentences

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

On September 1, 2023, the Company entered into an “at-the-market”

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.

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.

333-273984) filed by the Company with the SEC on August 15, 2023 and declared effective by the SEC on August 23, 2023.

As of September 30, 2023, no sales have been executed.

Share Repurchase Program

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.

As of September 30, 2023 no shares have been repurchased.

MAIA Biotechnology, Inc.

Restricted Stock Awards

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.

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.

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.

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

MAIA Stock Warrants

4 unchanged sentences

or (b) immediately prior to the closing of a change of control.

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

The value of the warrant modification to th e 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 nine months ended September 30, 2022 and is reflected as “Deemed dividend on warrant modification”

in the accompanying statement of operations.

6 unchanged sentences

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 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.

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.

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.

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”).

2 unchanged sentences

Balance at January 1, 2023

Balance at June 30, 2023

Balance at September 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 June 30, 2023.

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.

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 3,957,710 options outstanding in the plan as of June 30, 2023.

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 .

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

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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.

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, 2021.

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.

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

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

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

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.

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

As of June 30, 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:

As of September 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 nine months ended September 30, 2023:

Options Outstanding

Balance at January 1, 2023

Cancelled/forfeited

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.

Balance at September 30, 2023

Options exercisable at September 30, 2023

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.

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.

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”).

3 unchanged sentences

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:

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.

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:

Risk-free interest rate

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Expected dividend yield

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.

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.

As of September 30, 2023, the total unrecognized compensation

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.

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

For the Three Months

Ended June 30,

For the Six Months

Ended June 30,

Three Months Ended

Nine Months Ended

September 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 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.

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.

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 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.

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.

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

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

As of September 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 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.

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

For the nine months ended September 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 nine months ended September 30, 2023 , due to full valuation allowance to offset any deferred tax assets.

SUBSEQUENT EVENT

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.

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 .

The C ompany anticipates that the at-the-market offering will continue throughout the next reporting period.

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.

Investors should consider the potential impact of these events on their assessments of the Company’s financial condition and performance .

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

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FIN ANCIAL CONDITION AND RESULTS OF OPERATIONS

You should read the following discussion together with our financial statements and the related notes included elsewhere in this Quarterly Report on Form 10-Q.

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Worldwide, lung cancer incidence is over 2,200,000 per year (ranking second only after breast cancer), and mortality over 1,800,000 (ranking first).

Specifically, we are targeting Non-Small Cell Lung Cancer (NSCLC), which represents 85% of all lung cancers.

Specifically, we are targeting NSCLC, which represents 85% of all lung cancers.

We accomplished the following key milestones:

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In the first quarter 2021, we entered into a Drug Supply Agreement with Regeneron Pharmaceuticals, Inc.

Under this agreement, Regeneron will provide cemiplimab (LIBTAYO;

Under this agreement, Regeneron will provide cemiplimab (Libtayo Ò

anti-PD-1 checkpoint inhibitor) at no charge for the THIO-101 trials, testing THIO administration for immune activation followed by cemiplimab in NSCLC.

This drug supply agreement replaces direct drug purchase expense that we would be otherwise required to incur.

In exchange, Regeneron received development exclusivity in NSCLC for the duration of the trial which is expected to be two years, meaning we cannot conduct trials in NSCLC with another checkpoint inhibitor during the time of the trial.

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.

All other areas of study and development in any other tumor types remain open.

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 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.

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.

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.

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.

In March 2022, the U.S.

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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.

ODD 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.

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On July 28, 2022, the Company’s shares of common stock began trading on the NYSE American under the symbol MAIA.

On August 1, 2022, the Company sold 2,000,000 shares of common stock at $5.00 per share for net proceeds of $10,000,000 in an initial public offering prior to deducting underwriting discounts, commissions, and other offering expenses.

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

We believe we have raised sufficient capital to fund the THIO-101 lead-in and preliminary efficacy of the phase 2 THIO-101 trial.

In November 2022, we completed a pre-Investigational New Drug (pre-IND) meeting with the U.S.

Food and Drug Administration (FDA) for the planned U.S.

expansion of the THIO-101 Phase 2 trial evaluating THIO, an investigational telomere-targeting agent, in patients with advanced non-small cell lung cancer (NSCLC).

In November 2022, we completed a pre-Investigational New Drug meeting with the FDA for the planned U.S.

expansion of the THIO-101 Phase 2 trial evaluating THIO, an investigational telomere-targeting agent, in patients with advanced NSCLC.

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.

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was well tolerated with no dose-limiting toxicities or significant treatment-related adverse events reported.

On April 18, 2023, we published data in HCC (liver cancer) models:

as monotherapy, THIO achieved complete and durable responses in Hepatocellular Carcinoma (HCC), the dominant histology in primary liver cancer (90%), in in vivo models.

On April 18, 2023, we published data in Hepatocellular Carcinoma (”HCC”) (liver cancer) models:

as monotherapy, THIO achieved complete and durable responses in HCC, the dominant histology in primary liver cancer (90%), in in vivo models.

When combined with Libtayo®, duration of response was further potentiated.

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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

The short and long-term implications of Russia’s invasion of Ukraine are difficult to predict at this time.

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

On August 23, 2023, our universal shelf registration statement on Form S-3 (File No.

333-273984) (the “From S-3”) for possible future offerings was declared effective by the SEC.

As of September 30, 2023, no securities have been issued pursuant to the Form S-3.

On September 1, 2023, the Company entered into an “at-the-market”

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.

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.

As of September 30, 2023, no sales have been executed.

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.

The Company expects to fund repurchases by using cash on hand and expected cash flow to be generated in the future.

As of September 30, 2023, no repurchases have been executed.

On October 3, 2023, the Company announced that the FDA has cleared its IND application for THIO to be evaluated in the U.S.

as part of THIO-101, the Company’s ongoing global phase 2 clinical study in patients with advanced NSCLC.

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.

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.

Impact of the War in Ukraine and War in Israel on Our Operations

The short and long-term implications of war in Ukraine and war in Israel are difficult to predict at this time.

The imposition of sanctions and counter sanctions may have an adverse effect on the economic markets generally and could impact our business, financial condition, and results of operations.

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

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

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

Financial Operations Overview and Analysis for the Three and Nine Months Ended September 30, 2023 and 2022

Comparison of three months ended September 30, 2023 and 2022

Three Months Ended

September 30,

Operating expenses:

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General and administrative

Ratchet share expense

Total operating costs and expenses

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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.

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.

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.

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.

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.

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.

Ratchet Expense

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.

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.

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

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.

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.

Comparison of nine months ended September 30, 2023 and 2022

Nine Months Ended

September 30,

Operating expenses:

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General and administrative

Ratchet share expense

Total operating costs and expenses

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Research and development expenses

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.

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.

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.

General and administrative expenses

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.

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.

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.

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

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.

Ratchet Expense

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.

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.

Other expense, net

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.

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.

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.

Liquidity and Capital Resources

Our Ability to Continue as a Going Concern

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.

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.

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.

We have generated no revenues as of September 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 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.

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.

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

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

On September 1, 2023, the Company entered into an “at-the-market”

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.

As of September 30, 2023, no sales have been executed.

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 six months ended June 30, 2023 and 2022

Six Months Ended

Cash Flows for nine months ended September 30, 2023 and 2022

Nine Months Ended

September 30,

Net cash flows used in operating activities

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Operating Activities

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.

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.

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.

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

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.

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.

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.

Financing Activities

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.

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.

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.

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.

Critical Accounting Policies and Significant Judgments and Estimates

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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