What changed in MAIA Biotechnology, Inc.'s 10-K — 2023 vs 2024
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Paragraph-level year-over-year comparison of MAIA Biotechnology, Inc.'s 2023 and 2024 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2024 report.
+121 added−95 removedSource: 10-K (2025-03-21) vs 10-K (2024-03-21)
Top changes in MAIA Biotechnology, Inc.'s 2024 10-K
121 paragraphs added · 95 removed · 47 edited across 1 sections
- Item 1C. Cybersecurity+121 / −95 · 47 edited
Item 1C. Cybersecurity
Cybersecurity — threats and controls disclosure
47 edited+74 added−48 removed52 unchanged
Item 1C. Cybersecurity
Cybersecurity — threats and controls disclosure
47 edited+74 added−48 removed52 unchanged
2023 filing
2024 filing
Biggest changeFor the year ended December 31, 2022, net cash used in operating activities was approximately $12,096,000, which consisted of a consolidated net loss of approximately $15,769,000 offset by non-cash charges of approximately $3,320,000 which primarily includes approximately $2,319,000 in stock-based compensation, approximately $1,099,000 of expense related to the ratchet share issuance, offset by a gain of approximately $98,000 related to the changes in fair value of the warrant liability.
Biggest changeCash Flows Cash Flows Years Ended December 31, 2024 and 2023 Years Ended December 31, 2024 2023 Net cash flows used in operating activities $ (15,704,461 ) $ (13,071,016 ) Net cash flows provided by financing activities 18,176,609 9,270,901 Effect of foreign currency exchange rate changes on cash (21,545 ) (117 ) Net increase (decrease) in cash $ 2,450,603 $ (3,800,232 ) Operating Activities For the year ended December 31, 2024, net cash used in operating activities was approximately $15,704,000, which consisted of a consolidated net loss of approximately $23,255,000 offset by non-cash charges of approximately $7,550,000 which primarily includes approximately $1,913,000 in stock-based compensation, approximately $179,000 of expense related restricted shares issued for consulting services, and a loss of approximately $6,683,000 related to the changes in fair value of the warrant liability, and the loss on fair value of warrants over proceeds of approximately $13,000.
Total changes in operating assets and liabilities of approximately $3,086,000 were primarily driven by an approximate $472,000 increase in accounts payable, an approximate $2,170,000 increase in an accrued expenses an approximate decrease of $158,000 in Australian research and development incentives receivable and an approximate $285,000 decrease in prepaid expenses and other current assets.
Total changes in operating assets and liabilities of approximately $3,086,000 were primarily driven by an approximate $472,000 increase in accounts payable, an approximate $2,170,000 increase in accrued expenses, an approximate decrease of $158,000 in Australian research and development incentives receivable, and an approximate $285,000 decrease in prepaid expenses and other current assets.
Financing Activities Net cash provided by financing activities for the year ended December 31, 2023 was approximately $9,271,000 consisted primarily of gross proceeds from the sale of common stock of approximately $5,750,000 in a public offering, proceeds from issuance of common stock of approximately $4,000,000 in a registered direct offering, gross proceeds of approximately of $1,667,000 in an at-the-market offering facility through our sales agent for such facility, and approximately $1,000 from the proceeds from exercising of stock options, offset by approximately $2,147,000 of offering costs paid.
Net cash provided by financing activities for the year ended December 31, 2023 was approximately $9,271,000 and consisted primarily of gross proceeds from the sale of common stock of approximately $5,750,000 in a public offering, proceeds from issuance of common stock of approximately $4,000,000 in a registered direct offering, gross proceeds of approximately of $1,667,000 in an at-the-market offering facility through our sales agent for such facility, and approximately $1,000 from the proceeds from exercising of stock options, offset by approximately $2,147,000 of offering costs paid.
The following Company directors participated in the aforementioned private placement as follows: (i) Stan Smith purchased 170,940 Director Shares and 170,940 Director Warrants for an aggregate purchase price of $200,0000; (ii) Louie Ngar Yee purchased 170,940 Director Shares and 170,940 Director Warrants for an aggregate purchase price of $200,000; (iii) Cristian Luput purchased 69,282 Director Shares and 69,282 Director Warrants for an aggregate purchase price of $81,060 (iv) Steven Chaouki purchased 34,641 Director Shares of common stock and 34,461 Director Warrants for an aggregate purchase price of $40,530 and (v) Ramiro Guerrero purchased 6,928 Director Shares and 6,928 Director Warrants for an aggregate purchase price of $8,106.
The following Company directors participated in the aforementioned private placement as follows: (i) Stan Smith purchased 170,940 shares and 170,940 warrants for an aggregate purchase price of $200,0000; (ii) Louie Ngar Yee purchased 170,940 shares and 170,940 warrants for an aggregate purchase price of $200,000; (iii) Cristian Luput purchased 69,282 shares and 69,282 warrants for an aggregate purchase price of $81,060 (iv) Steven Chaouki purchased 34,641 shares of common stock and 34,461 warrants for an aggregate purchase price of $40,530 and (v) Ramiro Guerrero purchased 6,928 shares and 6,928 warrants for an aggregate purchase price of $8,106.
In October and November 2023, the Company issued and sold an aggregate of 758,388 shares of common stock through ThinkEquity LLC (“ThinkEquity”), pursuant to the terms of an “at-the-market" Sales Agreement, dated September 1, 2023 (the “Sales Agreement”), by and between the Company and ThinkEquity, the Company’s sale agent thereunder, for which the Company received aggregate gross proceeds of approximately $1.7 million.
In October and November 2023, we issued and sold an aggregate of 758,388 shares of common stock through ThinkEquity LLC (“ThinkEquity”), pursuant to the terms of an “at-the-market" Sales Agreement, dated September 1, 2023 (the “Sales Agreement”), by and between the Company and ThinkEquity, the Company’s sale agent thereunder, for which the Company received aggregate gross proceeds of approximately $1.7 million.
These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources.
These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments 93 about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources.
On November 17, 2023, the Company issued and sold an aggregate of 2,424,243 shares of common stock in a registered direct offering pursuant to securities purchase agreements, for which the Company received aggregate gross proceeds of $4 million. H.C. Wainwright was the placement agent for the registered direct offering.
On November 17, 2023, we issued and sold an aggregate of 2,424,243 shares of common stock in a registered direct offering pursuant to securities purchase agreements, for which the Company received aggregate gross proceeds of $4 million. H.C. Wainwright was the placement agent for the registered direct offering.
Our customers, suppliers, subcontractors, and business partners face similar cybersecurity threats, and a cybersecurity incident impacting us or any of these entities could materially adversely affect our operations, performance, and results of operations. These cybersecurity threats and related risks make it imperative that we expend resources on cybersecurity.
Our customers, suppliers, subcontractors, and business partners face similar cybersecurity threats, and a cybersecurity incident impacting us or any of 83 these entities could materially adversely affect our operations, performance, and results of operations. These cybersecurity threats and related risks make it imperative that we expend resources on cybersecurity.
The preparation of these financial statements requires us to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The most significant estimates in the Company’s financial statements relate to the valuation of stock options and warrants and accruals for 89 outsourced research and development activities.
The preparation of these financial statements requires us to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The most significant estimates in the Company’s financial statements relate to the valuation of stock options and warrants and accruals for outsourced research and development activities.
Accordingly, there is substantial doubt about the Company’s ability to continue as a going concern within one year after these financial statements are issued. Sale 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.
Accordingly, there is substantial doubt about the Company’s ability to continue as a going concern within one year after these financial statements are issued. Sale of Common Stock On April 27, 2023, we sold 2,555,500 shares of the Company’s common stock at a price of $2.25 per share in an underwritten public offering.
To date, there have been no material differences between our estimates and the amount actually incurred. 90 Item 7A . Quantitative and Qualitative Disclosures About Market Risk. We are a smaller reporting company, as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required by this Item. Item 8 .
To date, there have been no material differences between our estimates and the amount actually incurred. 94 Item 7A . Quantitative and Qualitative Disclosures About Market Risk. We are a smaller reporting company, as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required by this Item. Item 8 .
Regardless of the outcome, such proceedings or claims can have an adverse impact on us because of defense and settlement costs, diversion of resources and other factors, and there can be no assurances that favorable outcomes will be obtained. Item 4 . Mine Safety Disclosures. Not applicable 81 PART II Item 5 .
Regardless of the outcome, such proceedings or claims can have an adverse impact on us because of defense and settlement costs, diversion of resources and other factors, and there can be no assurances that favorable outcomes will be obtained. Item 4 . Mine Safety Disclosures. Not applicable 84 PART II Item 5 .
Following the selection of 180 mg/cycle as the optimal dose in December 2023, all patients were subsequently enrolled at the 180mg/cycle dose and trial enrollment was completed ahead of schedule. • On March 6, 2024, Company announced interim efficacy data for THIO-101 Phase 2 trial in NSCLC.
Following the selection of 180 mg/cycle as the optimal dose in December 2023, all patients were subsequently enrolled at the 180mg/cycle dose and trial enrollment was completed ahead of schedule. • On March 6, 2024, we announced interim efficacy data for THIO-101 Phase 2 trial in NSCLC.
Management’s Evaluation of our Disclosure Controls and Procedures Under the supervision of and with the participation of our management, including our Chief Executive Officer, who is our principal executive officer, and our Head of Finance, who is our principal financial officer, we conducted an evaluation of the effectiveness of our disclosure controls and procedures as of December 31, 2023, the end of the period covered by this Annual Report.
Management’s Evaluation of our Disclosure Controls and Procedures Under the supervision of and with the participation of our management, including our Chief Executive Officer, who is our principal executive officer, and our Head of Finance, who is our principal financial officer, we conducted an evaluation of the effectiveness of our disclosure controls and procedures as of December 31, 2024, the end of the period covered by this Annual Report.
As of December 31, 2023, our principal executive officer and principal financial officer, conducted an evaluation of the effectiveness of our internal control over financial reporting based on the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated Framework – 2013 (1992 Framework).
As of December 31, 2024, our principal executive officer and principal financial officer, conducted an evaluation of the effectiveness of our internal control over financial reporting based on the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated Framework – 2013 (1992 Framework).
Based on the evaluation of our disclosure controls and procedures as of December 31, 2023, our Chief Executive Officer and Head of Finance concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Based on the evaluation of our disclosure controls and procedures as of December 31, 2024, our Chief Executive Officer and Head of Finance concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
We have generated no revenues as of 87 December 31, 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.
We have generated no revenues as of December 31, 2024. 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.
Changes in Internal Control over Financial Reporting There were no changes in our internal control over financial reporting that occurred during the quarter ended December 31, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting 91 This Annual Report on Form 10-K does not include an attestation report of the Company’s registered public accounting firm regarding internal control over financial reporting.
Changes in Internal Control over Financial Reporting There were no changes in our internal control over financial reporting that occurred during the quarter ended December 31, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting 95 This Annual Report on Form 10-K does not include an attestation report of the Company’s registered public accounting firm regarding internal control over financial reporting.
Our initial disease target is lung cancer, a serious medical condition with an incidence of over 235,000 new cases in the US in 2021, representing 12.4% of all cancers, and over 131,000 deaths, or 21.7% of all cancers. Worldwide, lung cancer incidence is over 2,200,000 per year (ranking second only after breast cancer), and mortality over 1,800,000 (ranking first).
Our initial disease target is lung cancer, a serious medical condition with an incidence of over 236,000 new cases in the US in 2022, representing 12.3% of all cancers, and over 130,000 deaths, or 21.4% of all cancers. 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).
The Company lacks company-specific historical and implied volatility information. Therefore, we estimate our expected stock volatility based on the historical volatility of a publicly traded set of peer companies. Two of the assumptions used in the Black-Scholes-Merton valuation model are historical volatility and fair value of common stock.
The Company lacks sufficient company-specific historical and implied volatility information. Therefore, we estimate our expected stock volatility based on the historical volatility of a publicly traded set of peer companies, while corroborating these volatilities with our actual limited historical volatility information. Two of the assumptions used in the Black-Scholes-Merton valuation model are historical volatility and fair value of common stock.
Based on the Company’s cash reserves as December 31, 2023 of $7,150,695 million and current financial condition as of the date of the Annual Report on Form 10-K, 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.
Based on the Company’s cash reserves as December 31, 2024 of $9,601,298 and current financial condition as of the date of the Annual Report on Form 10-K, 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.
Item 6 . [Reserved] 82 Item 7 . Management’s Discussion and Analysis of Financial Condition and Results of Operations. You should read the following discussion together with our financial statements and the related notes included elsewhere in this Annual Report on Form 10-K.
Issuers Purchases of Equity Securities None. Item 6 . [Reserved] 85 Item 7 . Management’s Discussion and Analysis of Financial Condition and Results of Operations. You should read the following discussion together with our consolidated financial statements and the related notes included elsewhere in this Annual Report on Form 10-K.
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information and Holders Our common stock is traded on NYSE American under the symbol “MAIA”. As of March 21, 2024, 20,002,826 shares of the Company’s common stock were issued and outstanding and were owned by approximately 136 holders of record.
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information and Holders Our common stock is traded on NYSE American under the symbol “MAIA”. As of March 21, 2025, 29,587,314 shares of the Company’s common stock were issued and outstanding and were owned by approximately 161 holders of record.
Wainwright & Co., LLC (“Wainwright”), to sell shares of common stock, par value $0.0001 per share (the “Shares”) having an aggregate sales price of up to $1,445,000, from time to time, through an “at-the-market offering” program under which H.C. Wainwright will act as sales agent.
Wainwright & Co., LLC (“Wainwright”), to sell shares of our Common Stock having an aggregate sales price of up to $1,445,000, from time to time, through an “at-the-market offering” program under which Wainwright will act as sales agent.
Based on this assessment and implementation of our remediation plans, management concluded that, as of December 31, 2023, our internal controls over financial reporting were effective.
Based on this assessment, management concluded that, as of December 31, 2024, our internal controls over financial reporting were effective.
Our headquarters is in Chicago, Illinois where we currently lease office space with approximately 124 square feet under a six month lease starting in October 2023, under which we currently pay $3,000 per month.
Our headquarters is in Chicago, Illinois where we currently lease office space with approximately 124 square feet under a twelve month lease starting in April 2024, under which we currently pay $3,200 per month.
We cannot make any assurances that additional financings will be available to us and, if available, on acceptable terms or at all. This could negatively impact our business and operations and could also lead to the reduction of our operations.
We may seek to fund our operations through public equity, private equity, or debt financings, as well as other sources. We cannot make any assurances that additional financings will be available to us and, if available, on acceptable terms or at all. This could negatively impact our business and operations and could also lead to the reduction of our operations.
Our actual results may differ materially from those currently anticipated and expressed in such forward-looking statements as a result of a number of factors, including those which we discuss under “Risk Factors” and elsewhere in this Annual Report on Form 10-K.
Our actual results may differ materially from those currently anticipated and expressed in such forward-looking statements as a result of a number of factors, including those which we discuss under “Risk Factors” and elsewhere in this Annual Report on Form 10-K. Overview We are a clinical stage biotechnology company engaged in the discovery, development and commercialization of therapies targeting cancer.
Total changes in operating assets and liabilities of approximately $353,000 were primarily driven by an approximate $211,000 increase in accounts payable, and an approximate $916,000 increase in accrued expenses, offset by an approximate increase of $269,000 in Australian research and development incentives receivable and an approximate $505,000 increase in prepaid expenses and other current assets.
Total changes in operating assets and liabilities of approximately $1,238,000 were primarily driven by an approximate $119,000 decrease in accounts payable, an approximate $980,000 decrease in an accrued expenses, an approximate decrease of $57,000 in Australian research and development incentives receivable, and an approximate $196,000 increase in prepaid expenses and other current assets.
General and administrative expenses General and administrative expenses increased by approximately $2,927,000 or 48% from approximately $6,144,000 for the year ended December 31, 2022 to approximately $9,070,000 for the year ended December 31, 2023.
General and administrative expenses General and administrative expenses decreased by approximately $2,122,000 (or approximately 23%) from approximately $9,070,000 for the year ended December 31, 2023 to approximately $6,948,000 for the year ended December 31, 2024.
The Common Warrants are exercisable at a price per Share of $1.30, which price represents the greater of the book or market value of the stock on the date the Purchase Agreement was executed (subject to customary adjustments as set forth in the Investor Warrants, which do not include any provisions relating to price protection), are exercisable commencing six months following issuance and have a term of five years from the initial exercise date.
The warrants are exercisable at a price per Share of $1.30, which price represents the greater of the book or market value of the stock on the date the purchase agreement was executed, are exercisable commencing six-months following issuance and have a term of five and a half years from the initial issuance date.
Liquidity and Capital Resources The following table presents selected financial information and statistics as of and for the years ended December 31, 2023 and 2022: Years Ended December 31, 2023 and 2022 As of December 31, 2023 2022 Balance Sheet Data: Cash 7,150,695 10,950,927 Working capital (1) 2,626,899 8,539,131 Total assets 7,566,852 12,022,040 Accrued bonus 786,999 1,094,582 Deferred compensation — — Total stockholders' equity 477,511 8,507,793 (1) We define working capital as current assets less current liabilities.
Liquidity and Capital Resources The following table presents selected financial information and statistics as of and for the years ended December 31, 2024 and 2023: Years Ended December 31, 2024 and 2023 As of December 31, 2024 2023 Balance Sheet Data: Cash $ 9,601,298 $ 7,150,695 Working capital (1) 6,322,441 2,626,899 Total assets 10,155,279 7,566,852 Accrued bonus 941,098 786,999 Total stockholders' equity 3,634,636 477,511 (1) We define working capital as current assets less current liabilities.
Cash Flows Cash Flows years ended December 31, 2023 and 2022 Years Ended December 31, 2023 2022 Net cash flows used in operating activities $ (13,071,016 ) $ (12,096,104 ) Net cash flows provided by financing activities 9,270,901 12,477,169 Effect of foreign currency exchange rate changes on cash (117 ) (4,430 ) Net increase in cash and cash equivalents $ (3,800,232 ) $ 376,635 Operating Activities For the year ended December 31, 2023, net cash used in operating activities was approximately $13,071,000, which consisted of a consolidated net loss of approximately $19,773,000 offset by non-cash charges of approximately $3,616,000 which primarily includes approximately $3,089,000 in stock-based compensation, approximately $732,000 of expense related restricted shares issued for consulting services, and a gain of approximately $205,000 related to the changes in fair value of the warrant liability.
For the year ended December 31, 2023, net cash used in operating activities was approximately $13,071,000, which consisted of a consolidated net loss of approximately $19,773,000 offset by non-cash charges of approximately $6,702,000 which primarily includes approximately $3,089,000 in stock-based compensation, approximately $732,000 of expense related restricted shares issued for consulting services, and a gain of approximately $205,000 related to the changes in fair value of the warrant liability.
Capital Resources Our Ability to Continue as a Going Concern As of December 31, 2023, our available cash totaled approximately $7,151,000 which represented a decrease of approximately $3,800,000 compared to December 31, 2022. As of December 31, 2023, we had working capital of approximately $2,627,000 which represents a decrease of approximately $5,912,000 compared to December 31, 2022.
Capital Resources Our Ability to Continue as a Going Concern As of December 31, 2024, our available cash totaled approximately $9,601,000 which represented an increase of approximately $2,451,000 compared to December 31, 2023. As of December 31, 2024, we had working capital of approximately $6,322,000 which represents an increase of approximately $3,696,000 compared to December 31, 2023.
In the latest data available (January 8, 2024), the overall response rate (ORR), characterized as partial or complete response to therapy, was 38% (3 out of 8 patients) in the efficacy evaluable population for combination THIO 180mg + cemiplimab in third-line treatment for NSCLC patients who failed treatment with immune checkpoint inhibitors in prior lines of therapy, with or without chemotherapy. • On March 11, 2024, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain accredited investors (the “Investors”) for the issuance and sale in a private placement (the “Private Placement”) of (i) 2,043,587 shares (the “Investor Shares”) of the Company’s common stock, par value $0.0001 per share (“Common Stock”), and (ii) warrants (the “Investor Warrants”) to purchase up to 2,043,587 shares of the Company’s Common Stock, at a price per share of $1.17 for an aggregate purchase price of approximately $2.4 million.
In the latest data available (January 8, 2024), the overall response rate (ORR), characterized as partial or complete response to therapy, was 38% (3 out of 8 patients) in the efficacy evaluable population for combination THIO 180mg + cemiplimab in third-line treatment for NSCLC patients who failed treatment with immune checkpoint inhibitors in prior lines of therapy, with or without chemotherapy. • On March 14, 2024, we issued and sold 2,496,318 shares of our Common Stock and warrants to purchase 2,496,318 shares of our Common Stock in a private placement to certain accredited investors and certain of our directors pursuant to securities purchase agreements dated March 11, 2024 at a price per share of $1.17 for which we received gross proceeds of approximately $2.92 million.
The Common Warrants are exercisable at a price per Share of $1.30, which price represents the greater of the book or market value of the stock on the date the Purchase Agreement was executed (subject to customary adjustments as set forth in the Investor Warrants, which do not include any provisions relating to price protection), are exercisable commencing six months following issuance and have a term of five years from the initial exercise date.
The warrants are exercisable at a price per Share of $2.55, which price represents the greater of the book or market value of the stock on the date the purchase agreement was executed, are exercisable commencing six-months following issuance and have a term of five and a half years from the initial issuance date.
As of the date of this Annual Report, the Company has sold 507,754 shares of common stock at an average price of $1.47 per share, resulting in aggregate gross proceeds of approximately $745,250 . • On February 22, 2024, the Company announced completion of enrollment in Phase 2 THIO-101 go-to-market clinical trial.
As of the date of this Annual Report, we have sold 3,940,683 shares of our Common Stock under the ATM Agreement at an average price of $2.95 per share, resulting in aggregate gross proceeds of approximately $11,633,086, for which we paid Wainwright $348,993 in commissions resulting in net proceeds to us of approximately $11,284,093. • On February 22, 2024, we announced completion of enrollment in Phase 2 THIO-101 go-to-market clinical trial.
Payment of future cash dividends, if any, will be at the discretion of the board of directors after taking into account various factors, including our financial condition, operating results, current and anticipated cash needs, the requirements of current or then-existing debt instruments and other factors the board of directors deems relevant Recent Sales of Unregistered Securities On August 15, 2023, the Company renewed the agreement with FORCE Family Office, LLC (“Force”) for the provision of investor relations services from August 15, 2023 and ending 6 months after unless terminated earlier, pursuant to which the Company issued 20,000 restricted shares of common stock on August 15, 2023.
Payment of future cash dividends, if any, will be at the discretion of the board of directors after taking into account various factors, including our financial condition, operating results, current and anticipated cash needs, the requirements of current or then-existing debt instruments and other factors the board of directors deems relevant.
The increase was primarily related to an increase in payroll expense of approximately $658,000 related to accrued severance booked for an Officer terminated in 2023, the increase in clinical expenses related to the clinical trial startup of THIO of approximately $331,000, an increase in Scientific pre-clinical research of approximately $529,000, and an increase in stock based compensation of approximately $696,000 related to accelerated vesting of stock options for a terminated Officer, offset by a decrease of other expenses related to research and development of approximately $35,000.
The decrease was primarily related to a decrease in payroll expense of approximately $1,610,000 related to the decrease in the headcount of research and development employees and the reversal of the accrued bonus that was not paid, a decrease in stock based compensation of approximately $954,000 as no bonuses were paid in stock compensation in 2024, a decrease in Scientific pre-clinical research of approximately $630,000, a decrease of other expenses related to research and development of approximately $34,000, offset by the increase in clinical expenses related to the clinical trial of THIO of approximately $2,054,000, and the increase in professional fees of $71,000.
The increase in other income (expense), net was primarily the result of approximately $107,000 of income for the change in fair value of the warrant liability, a decrease by approximately $137,000 of expense related to the Australian research and development incentives for the year ended December 31, 2023 offset by approximately $33,000 of net interest income for the year ended December 31, 2023.
The increase was primarily related to the change in the fair value of the warrant liability of approximately 90 $6,888,000, a loss on fair value of warrants over proceeds of approximately $13,000, a reduction in the Australia research and development incentives of approximately $97,000 and an increase of interest income, net of approximately $291,000.
Net cash provided by financing activities for the year ended December 31, 2022 was approximately $12,477,000 consisted primarily of gross proceeds from the sale of common stock in the initial public offering of approximately $11,500,000, net proceeds from issuance of common stock of approximately of $2,474,000 in a crossover round, proceeds from issuance of common stock upon exercise of warrants of approximately $385,000, and approximate $440,000 decrease in deferred offering costs, and stock options of approximately $84,000, offset by approximately $2,406,000 of initial public offering costs paid.
Financing Activities Net cash provided by financing activities for the year ended December 31, 2024 was approximately $18,177,000 and consisted primarily of approximately $8,643,000 in gross proceeds from private placement offerings, proceeds from the at-the-market offering of approximately $10,112,000, proceeds from the exercise of stock options of $217,000, and were offset by approximately $795,000 of offering costs.
As of the date of this filing, the Company has sold 507,754 shares of common stock at an average price of $1.47 per share, resulting in aggregate gross proceeds of approximately $745,250.
Between February 14, 2024 and March 31, 2024, we sold 507,754 shares of Common Stock at an average price of approximately $1.47 per share, resulting in aggregate gross proceeds of approximately $745,251 under the ATM Agreement dated February 14, 91 2024, for which we paid Wainwright approximately $22,357 in commissions resulting in net proceeds to us of approximately $722,894.
Financial Operations Overview and Analysis For the Years Ended December 31, 2023 and 2022 Comparison of the Years Ended December 31, 2023 and 2022 Years Ended December 31, Change 2023 2022 Dollars Percentage Operating expenses: Research and development expenses $ 11,112,257 $ 8,933,314 $ 2,178,943 24% General and administrative expenses 9,070,124 6,143,527 2,926,597 48% Ratchet share expense — 1,099,360 (1,099,360 ) (100)% Total operating costs and expenses 20,182,381 16,176,201 4,006,180 25% Loss from operations (20,182,381 ) (16,176,201 ) (4,006,180 ) 25% Other income (expense): Interest expense (6,863 ) (6,967 ) 104 (1)% Interest income 34,490 1,870 32,620 1744% Australian research and development incentives 176,719 313,625 (136,906 ) (44)% Change in fair value of warrant liability 205,130 98,394 106,736 108% Other income (expense), net 409,476 406,922 2,554 1% Net loss (19,772,905 ) (15,769,279 ) (4,003,626 ) 25% Deemed dividend on warrant modifications — (450,578 ) 450,578 (100)% Net loss attributable to MAIA Biotechnology, Inc. shareholders $ (19,772,905 ) $ (16,219,857 ) $ (3,553,048 ) 22% 86 Operating Expenses Research and development expenses Research and development expenses increased by approximately $2,179,000 or 24%, from approximately $8,933,000 for the year ended December 31, 2022 to approximately $11,112,000 for the year ended December 31, 2023.
Financial Operations Overview and Analysis For the Years Ended December 31, 2024 and 2023 Comparison of the Years Ended December 31, 2024 and 2023 Years Ended December 31, Change 2024 2023 Dollars Percentage Operating expenses: Research and development expenses $ 10,009,229 $ 11,112,257 $ (1,103,028 ) (10)% General and administrative expenses 6,947,981 9,070,124 (2,122,143 ) (23)% Total operating costs and expenses 16,957,210 20,182,381 (3,225,171 ) (16)% Loss from operations (16,957,210 ) (20,182,381 ) 3,225,171 (16)% Other income (expense): Interest expense (57 ) (6,863 ) 6,806 (99)% Interest income 318,367 34,490 283,877 823% Australian research and development incentives 79,954 176,719 (96,765 ) (55)% Change in fair value of warrant liability (6,682,758 ) 205,130 (6,887,888 ) (3358)% Loss on fair value of warrants over proceeds (12,952 ) — (12,952 ) (100)% Other income (expense), net (6,297,446 ) 409,476 (6,706,922 ) (1638)% Net loss $ (23,254,656 ) $ (19,772,905 ) $ (3,481,751 ) 18% Operating Expenses Research and development expenses Research and development expenses decreased by approximately $1,103,000 (or approximately 10%) from approximately $11,112,000 for the year ended December 31, 2023 to approximately $10,009,000 for the year ended December 31, 2024.
On March 11, 2024, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain accredited investors (the “Investors”) for the issuance and sale in a private placement (the “Private Placement”) of (i) 2,043,587 shares (the “Investor Shares”) of the Company’s common stock, par value $0.0001 per share (“Common Stock”), and (ii) warrants (the “Investor Warrants”) to purchase up to 2,043,587 shares of the Company’s Common Stock, at a price per share of $1.17 for an aggregate purchase price of approximately $2.4 million.
On March 14, 2024, we issued and sold 2,496,318 shares of our Common Stock and warrants to purchase 2,496,318 shares of our Common Stock in a private placement to certain accredited investors and to our participating directors pursuant to securities purchase agreements dated March 11, 2024 at a price $1.17 per share, for which we received gross proceeds of approximately $2.92 million.
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. We may seek to fund our operations through public equity, private equity, or debt financings, as well as other sources.
In addition, Sylvia Guerrero, the sister of one of the Company directors purchased 5,341 shares and 5,341 warrants for an aggregate purchase price of approximately $10,000. 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.
The Private Placement closed on March 14, 2024, and the combined gross proceeds from the Private Placement was approximately $2.92 million, prior to deducting offering expenses payable by the Company. 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.
THIO-103 is a Phase 2 clinical trial planned to evaluate treatment with THIO in first-line patients for both NSCLC and SCLC. Impact of the War in Ukraine on Our Operations 89 The short and long-term implications of Russia’s invasion of Ukraine are difficult to predict at this time.
The increase was primarily attributable to an increases in payroll expense of approximately $562,000 related to accrued severance booked for an Officer terminated in 2023, the net increase in stock based compensation of approximately $74,000 related to accelerated vesting of stock options for a terminated Officer offset by the reduction of stock based compensation for the Board of Directors, a net increase in professional fees of approximately $74,000 related to an increase in legal fees offset by a reduction in audit fees, and an increase in other expenses of $2,217,000 related to an increase in Investor Relations expense incurred and Directors & Officers Insurance.
The decrease was primarily related to a decrease in other expenses of approximately $951,000 related to lower investor relations and insurance expenses, a decrease in payroll expense of approximately $795,000 relating to the decreased headcount of general and administrative employees and the reversal of the accrued bonus, a decrease in stock-based compensation of approximately $222,000, and a decrease in professional fees of approximately $154,000, Other income (expense), net Other income (expense), net increased by approximately $6,707,000 (or approximately 1638%) from other income, net of approximately $410,000 for the year ended December 31, 2023 to other expense, net of approximately $6,297,000 for the year ended December 31, 2024.
Removed
Pursuant to the agreement, the Company also agreed to issue an additional 20,000 restricted shares of common stock on the 3-month anniversary of the date of the agreement unless the agreement is terminated beforehand. The agreement was not renewed at the February 14, 2024 renewal date.
Added
Recent Sales of Unregistered Securities On November 13, 2024, we issued 28,488 restricted shares of common stock to FGMK, LLC in consideration of services rendered having a value of $67,990.
Removed
On August 15, 2023, the Company entered into an agreement with Laidlaw & Company for investor services, pursuant to which the Company issued 12,500 restricted shares of common stock on August 15, 2023 and agreed to issue an additional 12,500 restricted shares of common stock to be issued 180 days following the date of the agreement.
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We did not receive any proceeds for the issuance of these shares were issued on November 13, 2024 for $67,990 of services performed and invoices to the Company by FGMK for accounting, tax and valuation services. No underwriters were involved in the foregoing issuances of securities.
Removed
The agreement was not renewed after the initial three-month term. The additional 12,500 restricted shares of common stock were issued on March 18, 2024.
Added
Specifically, we are targeting Non-Small Cell Lung Cancer (“NSCLC”), which represents 85% of all lung cancers. THIO (6-thio-dG or 6-thio-2 ‘-deoxyguanosine), our lead asset, is an investigational dual mechanism of action drug candidate incorporating telomere targeting and immunogenicity. We are a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer.
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On March 8, 2023, the Company entered into an agreement with The Money Channel NYC Inc. for media services, pursuant to which the Company agreed to issue 22,500 shares of common stock on March 8, 2023 and an additional 22,500 shares of common stock every ninety days after the execution date of the contract until termination of the agreement.
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THIO (6-thio-dG or 6-thio-2 ‘-deoxyguanosine), our lead asset, is an investigational dual mechanism of action drug candidate incorporating telomere targeting and immunogenicity. In July 2022, the first patient was administered with THIO in our Phase 2 human trial (THIO-101) in Australia.
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On June 8, 2023, September 6, 2023, and December 5, 2023, the Company issued 22,500 restricted shares of common stock on each of these dates pursuant to the agreement. The agreement was terminated on February 24, 2024 and no more stock will be issued.
Added
In December 2022, regulatory authorities in three European countries, Hungary, Poland, and Bulgaria, approved the implementation of THIO-101, Phase 2 clinical trial evaluating THIO in patients with Non-Small Cell Lung Cancer (NSCLC). Patients with advanced NSCLC will be treated first with THIO followed a few days later by the immune checkpoint inhibitor Libtayo® (cemiplimab), manufactured and commercialized by Regeneron.
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On September 21, 2023, the Company entered into a twelve-month agreement with IRTH Communications, LLC for investor relation services, pursuant to which we issued $100,000 worth of restricted shares of common stock, with the number of shares of the Company determined by dividing $100,000 by the average closing price of the Company’s common stock for the ten trading days immediately prior to the execution of the agreement.
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Cemiplimab is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. Cemiplimab has been approved in the United States and the rest of the world for multiple cancer indications, including NSCLC. In February 2021, we signed a clinical supply agreement with Regeneron to receive cemiplimab at no cost, which represents a significant cost-savings for the study.
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A total of 56,948 restricted shares of common stock were issued. On November 14, 2023, the Company issued 20,000 restricted shares of common stock to FON Consulting, an assignee of FORCE Family Office, LLC for investor services through February 14, 2024. No underwriters were involved in the foregoing issuances of securities.
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In return, we have granted Regeneron exclusive development rights in combination with PD-1 inhibitors for NSCLC for the study period.
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See “Cautionary Note Regarding Forward-Looking Statements.” Overview We are a clinical stage biotechnology company engaged in the discovery, development and commercialization of therapies targeting cancer.
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Based on the clinical data generated by our THIO-101 trial, we plan to seek filing for an accelerated approval of THIO in the United States for the treatment of patients with advanced NSCLC in 2026, but even if granted, accelerated approval status does not guarantee an accelerated review or marketing approval by the Food and Drug Administration (FDA).
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Specifically, we are targeting Non-Small Cell Lung Cancer (NSCLC), which represents 85% of all lung cancers. We accomplished the following key milestones: • In November 2018, the Company in-licensed THIO from University of Texas Southwestern, in Dallas.
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We plan to initiate a Phase 3 pivotal trial in 2025, named THIO-104, to evaluate the efficacy of THIO administered in sequence with a checkpoint inhibitor (CPI) in third-line non-small cell lung cancer (NSCLC) patients who are resistant to checkpoint inhibitors and chemotherapy which could lead filing for early full commercial approval in 2026 and final analysis could lead to filing for full commercial approval in 2027.
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The patent license is global and exclusive for the duration of the patients’ lives. • In 2019, the Company generated the first data for THIO demonstrating complete regression with no recurrence when administered in advance of atezolizumab (TecentriQ®; Genentech), in colorectal and lung cancer preclinical models. • In the First Quarter 2020, the Company filed a provisional patent application for THIO in sequential combination with checkpoint inhibitors, covering all tumor types.
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The multicenter, open-label, pivotal Phase 3 trial is designed to provide a direct comparison to chemotherapy in a 1:1 randomization of up to 300 patients.
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The patent was allowed in the US in the First Quarter 2021 and expires in 2041, excluding any patent term adjustment or patent extension. • In the first quarter 2021, the Company entered into a Drug Supply Agreement with Regeneron Pharmaceuticals, Inc.
Added
In addition, the originally planned Phase 2 clinical trial in multiple tumor indications (THIO-102) is now divided into different trials for one tumor indication each: hepatocellular carcinoma (HCC), colorectal cancer (CRC) and small cell lung cancer (SCLC).
Removed
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.
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Phase 2 clinical trials in HCC, CRC and SCLC are planned to be initiated in 2026, evaluating treatment with THIO administered in sequence with BeiGene's immune checkpoint inhibitor, tislelizumab. Clinical trials with other solid tumors (ST), such as breast, prostate, gastric, pancreatic and ovarian, may still be considered for potential future trials.
Removed
In exchange, Regeneron received development exclusivity in NSCLC for the duration of the trial meaning we cannot conduct trials in NSCLC with another checkpoint inhibitor during the time of the trial.
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We were incorporated in Delaware in August 2018, and have operations in Chicago, Illinois, with some of our team members setup virtually and working remotely in California, North Carolina, and New Jersey, among others. Our principal executive office is located at 444 West Lake Street, Suite 1700, Chicago, IL 60606, and our phone number is (312) 416-8592.
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All other areas of study and development in any other tumor types remain open. • In the First Quarter 2021, the Company 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, the Company 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 $2.4 million. • In the first quarter 2022, THIO received approval by the Bellberry Human Research Ethics Committee in Australia to initiate the THIO-101 Phase 2 clinical study. • In March 2022, the U.S.
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In July 2021, we established a wholly-owned Australian subsidiary, MAIA Biotechnology Australia Pty Ltd., to conduct various preclinical and clinical activities for the development of our product candidates. ln April 2022, we established a wholly owned Romanian subsidiary, MAIA Biotechnology Romania S.R.L. to conduct various preclinical and clinical activities for the development of our product candidates.
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Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to THIO for the treatment of hepatocellular carcinoma, and in May 2022, the FDA granted ODD to THIO for the treatment of small-cell lung cancer.
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Our website address is www.MAIABiotech.com. The information contained on our website is not incorporated by reference into this prospectus supplement, and you should not consider any information contained on, or that can be accessed through, our website as part of this prospectus supplement or in deciding whether to purchase our securities.
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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.
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We accomplished the following key milestones in the fiscal year ended December 31, 2024 and the first quarter of 2025: • On January 17, 2024, we announced new interim data for our ongoing THIO-101 Phase 2 trial in non-small cell lung cancer (NSCLC).
Removed
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. • In May 2022, the Company 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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