MAIA Biotechnology (MAIA) risk factors, FY2025 10-K

MAIA Biotechnology's FY2025 10-K, filed Mar 23, 2026, lists 79 risk factors in 9 groups. Against the prior year's 92: 16 new, 29 dropped, 27 substantially reworded.

Open MAIA in Gloom →
MAIA Biotechnology's chart, financials and news, free in your browser.Open MAIA in Gloom →
Risk factors listed
799 groups
New this year
16vs 92 last year
Dropped
29since the prior 10-K
Substantially reworded
27of those kept
Section length
39k wordsItem 1A

What the changes say

  • MAIA added significant risk disclosures regarding its new corporate treasury policy of acquiring and staking digital assets like Solana.

What changed since the prior 10-K

New

  • New

    Competition from other companies staking and utilizing digital assets in their treasury plan

    Competition from other companies staking and utilizing digital assets in their treasury plan could adversely affect us.

  • NewRisks Related to Development, Clinical Trials, Manufacturing and Regulatory Approval

    Our product candidates are based on novel technologies, which make it difficult to predict the timing, results and cost of product candidate development and likelihood of obtaining regulatory approval

    Our product candidates are based on novel technologies, making clinical development timelines, costs, and regulatory approval difficult to predict.

  • NewRisks Related to Development, Clinical Trials, Manufacturing and Regulatory Approval

    Development of ateganosine could take longer, be more expensive, or become impractical if the FDA requires the use of an FDA-approved companion diagnostic test in conjunction with treatment with ateganosine

    Developing ateganosine could take longer or become impractical if the FDA requires an approved companion diagnostic test.

  • NewRisks Related to Development, Clinical Trials, Manufacturing and Regulatory Approval

    Even if we obtain FDA approval for ateganosine or any other candidates in the United States, we may never obtain approval for or commercialize ateganosine or any other development candidate in any other jurisdiction, which would limit our ability to realize their full global market potential

    We may fail to obtain regulatory approval or commercialize ateganosine and other candidates in international jurisdictions outside the United States.

  • NewRisks Relating to Investing in Digital Securities

    The launch of central bank digital currencies (“CBDCs”) may adversely impact our business

    The launch of central bank digital currencies could eliminate or reduce the demand for private-sector crypto currencies like Solana.

  • NewRisks Relating to Investing in Digital Securities

    Absent federal regulations, there is a possibility that any digital asset we acquire may be classified as a “security.” Any classification of any digital asset we acquire as a “security” would subject us to additional regulation and could materially impact the operation of our business

    Digital assets we acquire, such as Solana, might be classified as securities, subjecting us to additional regulation.

  • NewRisks Relating to Investing in Digital Securities

    If we were deemed to be an investment company under the 1940 Act, applicable restrictions likely would make it impractical for us to continue segments of our business as currently contemplated

    We could be deemed an investment company under the 1940 Act, making it impractical to continue segments of our business.

  • NewRisks Relating to Investing in Digital Securities

    We may be subject to regulatory developments related to crypto assets and crypto asset markets, which could adversely affect our business, financial condition, and results of operations

    Regulatory developments related to crypto assets and markets could adversely affect our business and digital asset prices.

  • NewRisks Relating to Investing in Digital Securities

    Cryptocurrency assets are less liquid than our existing cash and cash equivalents and may not be able to serve as a source of liquidity for us to the same extent as cash and cash equivalents

    Cryptocurrency assets are less liquid than cash and may not serve as a reliable source of liquidity during market instability.

  • NewRisks Relating to Investing in Digital Securities

    We are not subject to legal and regulatory obligations that apply to investment companies such as mutual funds and exchange-traded funds, or to obligations applicable to investment advisers

    We are not subject to legal and regulatory obligations that apply to investment companies, giving our board broad discretion over policies.

  • NewRisks Relating to Investing in Digital Securities

    We have recently shifted the focus of our operations to include a treasury policy under which our resources will be allocated to digital assets

    We have recently shifted operations to include a treasury policy allocating resources to digital assets with a limited operating history.

  • NewRisks Relating to Investing in Digital Securities

    Competition from other companies staking and utilizing digital assets in their treasury plans

    We expect to contend with other companies focused on developing digital asset staking operations, increasing competition.

  • NewRisks Relating to Investing in Digital Securities

    We may fail to develop and execute successful investment or trading strategies

  • NewRisks Relating to Investing in Digital Securities

    We may make, or otherwise be subject to, trade errors

  • NewRisks Relating to Our Common Stock

    Our failure to maintain effective internal control over financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act could have a material adverse effect on our business, financial condition, and results of operations

  • NewRisks Relating to Our Common Stock

    Unstable global market and economic conditions may have serious adverse consequences on our business, financial condition and results of operations

Dropped

  • Dropped

    The successful commercialization of THIO and any other candidate we develop will depend in part on the extent to which governmental authorities and health insurers establish adequate coverage, reimbursement levels, and pricing policies

  • Dropped

    We intend to rely on third parties to conduct, supervise and monitor our clinical trials. If those third parties do not successfully carry out their contractual duties, or if they perform in an unsatisfactory manner, it may harm our business

  • Dropped

    The limited public company experience of our management team could adversely impact our ability to comply with the reporting requirements of U.S. securities laws, which could have a materially adverse effect on our business

    Commercialization depends on adequate health insurer coverage, reimbursement levels, and pricing policies.

  • DroppedRisks Related to Our Financial Position and Need for Additional Capital

    acquire or in-license or invent other candidates or technologies

  • DroppedRisks Related to Our Financial Position and Need for Additional Capital

    Our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern, which may hinder our ability to obtain future financing

    Reliance on third parties to conduct clinical trials and dependency on UTSW license agreements.

  • DroppedRisks Related to Our Financial Position and Need for Additional Capital

    sales and marketing activities necessary for successful product commercialization. Consequently, predictions about our future success or viability may not be as accurate as they could be if we had a history of successfully developing and commercializing pharmaceutical products

  • DroppedRisks Related to Development, Clinical Trials, Manufacturing and Regulatory Approval

    manufacturing sufficient quantities of THIO for use in clinical trials

  • DroppedRisks Related to Development, Clinical Trials, Manufacturing and Regulatory Approval

    the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval

    Limited public company experience of management and NYSE American listing risks.

  • DroppedRisks Related to Development, Clinical Trials, Manufacturing and Regulatory Approval

    permissible in certain circumstances, particularly in oncology, but such circumstances are exceptional and FDA may not agree with that proposed approach, and thus we may be required to conduct two phase 3 trials

  • DroppedRisks Related to Development, Clinical Trials, Manufacturing and Regulatory Approval

    the FDA or comparable foreign regulatory authorities may disagree with our efficacy interpretation of our drug; or

    Risks related to acquiring, in-licensing, or inventing other candidates and ongoing net losses.

  • DroppedRisks Related to Development, Clinical Trials, Manufacturing and Regulatory Approval

    if the FDA determines that our labeling is false or misleading in any particular way

    Independent registered public accounting firm expressed substantial doubt about going concern.

  • DroppedRisks Related to Development, Clinical Trials, Manufacturing and Regulatory Approval

    our reputation may suffer

  • DroppedRisks Related to Development, Clinical Trials, Manufacturing and Regulatory Approval

    injunctions or the imposition of civil or criminal penalties

  • DroppedRisks Related to Commercialization

    form more advantageous strategic alliances

    Transitioning from research to commercial activities and lack of pharmaceutical commercial history.

  • DroppedRisks Related to Commercialization

    on our investment in our product candidates. If reimbursement is not available or is available only at limited levels, we may not be able to successfully commercialize our product candidates and may not be able to obtain a satisfactory financial return on our product candidates

  • DroppedRisks Related to Commercialization

    any restrictions on the use of our product together with other medications

  • DroppedRisks Related to Commercialization

    any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing personnel

  • DroppedRisks Related to Commercialization

    unforeseen costs and expenses associated with creating an independent sales and marketing organization

    Manufacturing sufficient quantities of THIO for clinical trials and potential trial suspensions.

  • DroppedRisks Related to Commercialization

    certain expenses including, among others, expenses for travel, translation and insurance; and

  • DroppedRisks Related to Our Dependence on Third Parties

    adequate CMO or another acceptable solution in time, our clinical trials could be delayed, or our commercial activities could be harmed

  • DroppedRisks Related to Healthcare Laws and Other Legal Compliance Matters

    generally not changed, tax losses generated in calendar year 2018 and beyond will only be able to offset 80% of taxable income. This change may require us to pay federal income taxes in future years despite generating a loss for federal income tax purposes in prior years

  • DroppedRisks Related to Our Intellectual Property

    our obligation to pay UTSW fees associated with the prosecution, maintenance, or filing of the patents and patent applications we have licensed

    FDA approval policies or regulations significantly changing clinical data requirements.

  • DroppedRisks Related to Our Intellectual Property

    the priority of invention of patented technology

    Potential FDA disagreements on trial design requiring additional Phase 3 trials.

  • DroppedRisks Related to Our Intellectual Property

    the patents of third parties or pending or future applications of third parties, if issued, may have an adverse effect on our business

    FDA or foreign regulatory authorities disagreeing with our drug efficacy interpretation.

  • DroppedRisks Relating to Our Common Stock

    a limited amount of news and analyst coverage; and

    FDA determining labeling is false or misleading and high clinical failure rates.

  • DroppedRisks Relating to Our Common Stock

    changing economic conditions

  • DroppedRisks Relating to Our Common Stock

    establish advance notice requirements for nominations for election to our board of directors or for proposing matters that can be acted on by stockholders at stockholder meetings

  • DroppedRisks Relating to Our Common Stock

    In the case of an issuer who had annual revenue of less than $100 million during the most recently completed fiscal year for which audit financial statements are available, had a public float as calculated under paragraph (1) or (2) of this definition that was either zero or less than $700 million

    Reputation suffering from various clinical or commercialization failures.

  • DroppedRisks Relating to Our Common Stock

    We are currently operating in a period of economic uncertainty and capital markets disruption, which has been significantly impacted by geopolitical instability due to the ongoing military conflict between Russia and Ukraine and Israel and Hamas

Reworded

  • 100% rewrittenRisks Related to Our Financial Position and Need for Additional Capital

    We have a limited operating history and no history of commercializing pharmaceutical products, which may make it difficult to evaluate the prospects for our future viability

    Replaced reliance on THIO with details on Delaware incorporation in August 2018 and preparation for ateganosine clinical studies.

  • 100% rewrittenRisks Related to Development, Clinical Trials, Manufacturing and Regulatory Approval

    We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success

    Changed focus from general FDA approval unpredictability to prioritizing research programs due to limited financial and managerial resources.

  • 100% rewrittenRisks Related to Commercialization

    A variety of risks associated with operating internationally could materially adversely affect our business

    Replaced third-party misconduct and CMO dependence with specifics on Australian and Romanian subsidiaries established in 2021 and 2022.

  • 100% rewrittenRisks Related to Our Intellectual Property

    Changes in patent laws or patent jurisprudence could diminish the value of patents in general, thereby impairing our ability to protect our product candidates

    Added specific mention of the America Invents Act (AIA) transition to a first-to-file system in March 2013.

  • 96% rewrittenRisks Related to Our Intellectual Property

    Intellectual property rights do not address all potential threats to our competitive advantage

    Replaced trade secret sharing and third-party license risks with specific examples of intellectual property limitations.

  • 81% rewrittenRisks Relating to Our Common Stock

    Changes in accounting standards and subjective assumptions, estimates and judgments by management related to complex accounting matters may materially impact reporting of our financial condition and results of operations

    Removed the separate Sarbanes-Oxley Section 404 internal control risk paragraph from the end of the accounting standards risk.

  • 78% rewrittenRisks Relating to Our Common Stock

    Anti-takeover protections in our amended and restated certificate of incorporation and our amended and restated bylaws, or our contractual obligations may discourage or prevent a takeover of our Company, even if an acquisition would be beneficial to our stockholders

    Retained the anti-takeover protections risk with minimal stylistic wording changes regarding charter and bylaws.

  • 76% rewrittenRisks Related to Development, Clinical Trials, Manufacturing and Regulatory Approval

    We have never obtained marketing approval for a development candidate and we may be unable to obtain, or may be delayed in obtaining, marketing approval for any of our development candidates

    Retained the marketing approval risk with minimal stylistic wording changes regarding FDA review of NDAs.

  • 70% rewrittenRisks Related to Commercialization

    If we are unable to establish sales, marketing and distribution capabilities either on our own or in collaboration with third parties, we may not be successful in commercializing ateganosine, if approved

    Was: If we are unable to establish sales, marketing and distribution capabilities either on our own or in collaboration with third parties, we may not be successful in commercializing THIO, if approved

  • 66% rewrittenRisks Related to Development, Clinical Trials, Manufacturing and Regulatory Approval

    Clinical trials are expensive, time-consuming and difficult to design and implement, and involve an uncertain outcome

  • 65% rewrittenRisks Related to Development, Clinical Trials, Manufacturing and Regulatory Approval

    The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming, expensive, and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for ateganosine or any other candidates, our business will be substantially harmed

    Was: The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming, expensive, and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for THIO or any other candidates, our business will be substantially harmed

  • 52% rewrittenRisks Related to Our Intellectual Property

    We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop, manufacture and market our product candidates

  • 52% rewrittenRisks Related to Our Intellectual Property

    If we fail to comply with any of our obligations under the license agreements, or we are subject to a bankruptcy or dissolution, UTSW may have the right to terminate their respective license agreements, in which event we would not be able to market any product candidates covered by the licenses

  • 49% rewrittenRisks Related to Our Financial Position and Need for Additional Capital

    We have incurred losses since inception and anticipate that we will continue to incur losses for the foreseeable future. We are not currently profitable, and we may never achieve or sustain profitability

  • 44% rewrittenRisks Related to Commercialization

    We face significant competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail to compete effectively

  • 41% rewrittenRisks Related to Healthcare Laws and Other Legal Compliance Matters

    Recent legislation may materially adversely affect our financial condition, results of operations and cash flows

  • 39% rewrittenRisks Relating to Our Common Stock

    We are considered a “smaller reporting company” and are exempt from certain disclosure requirements, which could make our stock less attractive to potential investors

  • 35% rewrittenRisks Relating to Our Common Stock

    Future sales of our common stock, or the perception in the public markets that these sales may occur, could cause the market price for our common stock to decline

  • 33% rewrittenRisks Related to Our Financial Position and Need for Additional Capital

    We will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of ateganosine

    Was: We will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of THIO

  • 32% rewrittenRisks Related to Our Financial Position and Need for Additional Capital

    Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates

  • 31% rewrittenRisks Related to Commercialization

    We may face early generic competition for ateganosine or our other products

    Was: We may face early generic competition for THIO or our other products

  • 28% rewrittenRisks Related to Development, Clinical Trials, Manufacturing and Regulatory Approval

    We are heavily dependent on the success of ateganosine, our most advanced candidate, which is still under clinical development, and if this drug does not receive regulatory approval or is not successfully commercialized, our business may be harmed

    Was: We are heavily dependent on the success of THIO, our most advanced candidate, which is still under clinical development, and if this drug does not receive regulatory approval or is not successfully commercialized, our business may be harmed

  • 26% rewrittenRisks Related to Commercialization

    Even if ateganosine or any candidate we develop receives marketing approval, it may fail to achieve market acceptance by physicians, patients, third-party payors or others in the medical community necessary for commercial success

    Was: Even if THIO or any candidate we develop receives marketing approval, it may fail to achieve market acceptance by physicians, patients, third-party payors or others in the medical community necessary for commercial success

  • 26% rewrittenRisks Relating to Our Common Stock

    Certain stockholders who are also officers and directors of the Company may have significant control over our management

  • 24% rewrittenRisks Relating to Our Common Stock

    If we are unable to comply with the continued listing requirements of the NYSE American, then our Common Stock would be delisted from the NYSE American, which would limit investors’ ability to effect transactions in our Common Stock and subject us to additional trading restrictions

  • 22% rewrittenRisks Related to Development, Clinical Trials, Manufacturing and Regulatory Approval

    Even if we obtain regulatory approval for ateganosine or any development candidate, we will still face extensive and ongoing regulatory requirements and obligations and any development candidates, if approved, may face future development and regulatory difficulties

    Was: Even if we obtain regulatory approval for THIO or any development candidate, we will still face extensive and ongoing regulatory requirements and obligations and any development candidates, if approved, may face future development and regulatory difficulties

  • 21% rewrittenRisks Related to Development, Clinical Trials, Manufacturing and Regulatory Approval

    Interim, topline and preliminary data from our clinical trials may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data

All 79 risk factors

Headings as the filing states them, in filing order.

Other

  1. 01Competition from other companies staking and utilizing digital assets in their treasury planNew

Risks Related to Our Financial Position and Need for Additional Capital

  1. 02We have incurred losses since inception and anticipate that we will continue to incur losses for the foreseeable future. We are not currently profitable, and we may never achieve or sustain profitability49% rewritten
  2. 03We will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of ateganosine33% rewritten
  3. 04Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates32% rewritten
  4. 05We have a limited operating history and no history of commercializing pharmaceutical products, which may make it difficult to evaluate the prospects for our future viability100% rewritten

Risks Related to Development, Clinical Trials, Manufacturing and Regulatory Approval

  1. 06We are heavily dependent on the success of ateganosine, our most advanced candidate, which is still under clinical development, and if this drug does not receive regulatory approval or is not successfully commercialized, our business may be harmed28% rewritten
  2. 07Pandemics, such as COVID-19, may adversely impact our business, results of operations, financial condition, liquidity and cash flows and that of our clients
  3. 08Clinical trials are expensive, time-consuming and difficult to design and implement, and involve an uncertain outcome66% rewritten
  4. 09Our product candidates are based on novel technologies, which make it difficult to predict the timing, results and cost of product candidate development and likelihood of obtaining regulatory approvalNew
  5. 10Interim, topline and preliminary data from our clinical trials may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data21% rewritten
  6. 11We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success100% rewritten
  7. 12We may not be successful in our efforts to identify or discover additional product candidates in the future
  8. 13The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming, expensive, and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for ateganosine or any other candidates, our business will be substantially harmed65% rewritten
  9. 14Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control
  10. 15Results of preclinical studies, early clinical trials or analyses may not be indicative of results obtained in later trials
  11. 16The market opportunities for ateganosine, if approved, may be smaller than we anticipate
  12. 17We have never obtained marketing approval for a development candidate and we may be unable to obtain, or may be delayed in obtaining, marketing approval for any of our development candidates76% rewritten
  13. 18Development of ateganosine could take longer, be more expensive, or become impractical if the FDA requires the use of an FDA-approved companion diagnostic test in conjunction with treatment with ateganosineNew
  14. 19Even if we obtain FDA approval for ateganosine or any other candidates in the United States, we may never obtain approval for or commercialize ateganosine or any other development candidate in any other jurisdiction, which would limit our ability to realize their full global market potentialNew
  15. 20Even if we obtain regulatory approval for ateganosine or any development candidate, we will still face extensive and ongoing regulatory requirements and obligations and any development candidates, if approved, may face future development and regulatory difficulties22% rewritten
  16. 21We may seek a Breakthrough Therapy designation for ateganosine from the FDA. However, we might not seek such designation or be granted the designation by the FDA if sought, and even if we are granted the designation, it may not lead to a faster development or regulatory review or approval process

Risks Related to Commercialization

  1. 22We face significant competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail to compete effectively44% rewritten
  2. 23We may face early generic competition for ateganosine or our other products31% rewritten
  3. 24Even if ateganosine or any candidate we develop receives marketing approval, it may fail to achieve market acceptance by physicians, patients, third-party payors or others in the medical community necessary for commercial success26% rewritten
  4. 25If we are unable to establish sales, marketing and distribution capabilities either on our own or in collaboration with third parties, we may not be successful in commercializing ateganosine, if approved70% rewritten
  5. 26A variety of risks associated with operating internationally could materially adversely affect our business100% rewritten

Risks Related to Our Dependence on Third Parties

  1. 27We intend to continue to rely on third parties to conduct, supervise and monitor our clinical trials. If those third parties do not successfully carry out their contractual duties, or if they perform in an unsatisfactory manner, it may harm our business
  2. 28The number and type of our collaborations could adversely affect our attractiveness to future collaborators or acquirers and the loss of, or a disruption in our relationship with, any one or more collaborators could harm our business

Risks Related to Healthcare Laws and Other Legal Compliance Matters

  1. 29Enacted and future healthcare legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our development candidates, if approved, and may affect the prices we may set
  2. 30Since its enactment, there have been judicial and Congressional challenges to certain aspects of the ACA, and we expect there will be additional challenges and amendments to the ACA in the future. It is uncertain the extent to which any such changes may impact our business or financial condition
  3. 31Our business operations and current and future relationships with investigators, healthcare professionals, consultants, third-party payors, patient organizations, and customers will be subject to applicable healthcare regulatory laws, which could expose us to penalties
  4. 32Any clinical trial programs we conduct or research collaborations we enter into in the European Economic Area may subject us to the General Data Protection Regulation
  5. 33We are subject to environmental, health and safety laws and regulations, and we may become exposed to liability and substantial expenses in connection with environmental compliance or remediation activities
  6. 34Recent legislation may materially adversely affect our financial condition, results of operations and cash flows41% rewritten

Risks Related to Our Intellectual Property

  1. 35If we fail to comply with any of our obligations under the license agreements, or we are subject to a bankruptcy or dissolution, UTSW may have the right to terminate their respective license agreements, in which event we would not be able to market any product candidates covered by the licenses52% rewritten
  2. 36Our proprietary position for our product candidates currently depends in part upon licenses to patents protecting methods of use, which may not prevent a competitor or other third party from using the same product candidate for another use
  3. 37Our patents may be challenged in courts or in patent offices which could result in the invalidation, narrowing or unenforceability of our patents and our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours
  4. 38We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop, manufacture and market our product candidates52% rewritten
  5. 39Changes in patent laws or patent jurisprudence could diminish the value of patents in general, thereby impairing our ability to protect our product candidates100% rewritten
  6. 40Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
  7. 41We enjoy only limited geographical protection with respect to certain patents and we may not be able to protect our intellectual property rights throughout the world
  8. 42If we do not obtain patent term extension in the United States under the Hatch-Waxman Act and in foreign countries having similar legislation, thereby potentially extending the term of marketing exclusivity for our product candidates, our business may be materially harmed
  9. 43Intellectual property rights do not address all potential threats to our competitive advantage96% rewritten
  10. 44If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected
  11. 45We may need to license certain intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms
  12. 46We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of their former employers or other third parties
  13. 47Our proprietary information may be lost, or we may suffer security breaches

Risks Related to Our Employees, Managing Our Growth and Our Operations

  1. 48Our future success depends on our ability to retain our key personnel and to attract, retain and motivate qualified personnel
  2. 49We expect to expand our development, regulatory, and sales and marketing capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations
  3. 50We may engage in acquisitions that could disrupt our business, cause dilution to our stockholders or reduce our financial resources
  4. 51Our business and operations would suffer in the event of system failures

Risks Relating to Investing in Digital Securities

  1. 52The launch of central bank digital currencies (“CBDCs”) may adversely impact our businessNew
  2. 53Absent federal regulations, there is a possibility that any digital asset we acquire may be classified as a “security.” Any classification of any digital asset we acquire as a “security” would subject us to additional regulation and could materially impact the operation of our businessNew
  3. 54If we were deemed to be an investment company under the 1940 Act, applicable restrictions likely would make it impractical for us to continue segments of our business as currently contemplatedNew
  4. 55We may be subject to regulatory developments related to crypto assets and crypto asset markets, which could adversely affect our business, financial condition, and results of operationsNew
  5. 56Cryptocurrency assets are less liquid than our existing cash and cash equivalents and may not be able to serve as a source of liquidity for us to the same extent as cash and cash equivalentsNew
  6. 57We are not subject to legal and regulatory obligations that apply to investment companies such as mutual funds and exchange-traded funds, or to obligations applicable to investment advisers New
  7. 58We have recently shifted the focus of our operations to include a treasury policy under which our resources will be allocated to digital assetsNew
  8. 59Competition from other companies staking and utilizing digital assets in their treasury plansNew
  9. 60We may fail to develop and execute successful investment or trading strategiesNew
  10. 61We may make, or otherwise be subject to, trade errorsNew

Risks Relating to Our Common Stock

  1. 62If we are unable to comply with the continued listing requirements of the NYSE American, then our Common Stock would be delisted from the NYSE American, which would limit investors’ ability to effect transactions in our Common Stock and subject us to additional trading restrictions24% rewritten
  2. 63We have a trading symbol for our common stock (“MAIA”) and our common stock is currently listed on the NYSE American
  3. 64The price of our common stock may be volatile
  4. 65We could be subject to securities class action litigation
  5. 66Future sales of our common stock, or the perception in the public markets that these sales may occur, could cause the market price for our common stock to decline35% rewritten
  6. 67We do not intend to pay dividends for the foreseeable future, and our ability to pay dividends to our stockholders is restricted by applicable laws and regulations
  7. 68Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us
  8. 69We may, in the future, issue additional capital stock, which would reduce investors’ percent of ownership and may dilute our share value
  9. 70Certain stockholders who are also officers and directors of the Company may have significant control over our management 26% rewritten
  10. 71Anti-takeover protections in our amended and restated certificate of incorporation and our amended and restated bylaws, or our contractual obligations may discourage or prevent a takeover of our Company, even if an acquisition would be beneficial to our stockholders78% rewritten
  11. 72We are considered a “smaller reporting company” and are exempt from certain disclosure requirements, which could make our stock less attractive to potential investors39% rewritten
  12. 73We are considered an “emerging growth company,” and the reduced reporting requirements applicable to emerging growth companies may make our common stock less attractive to investors
  13. 74Changes in accounting standards and subjective assumptions, estimates and judgments by management related to complex accounting matters may materially impact reporting of our financial condition and results of operations81% rewritten
  14. 75Our failure to maintain effective internal control over financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act could have a material adverse effect on our business, financial condition, and results of operationsNew
  15. 76The lack of public company experience of our management team could adversely impact our ability to comply with the reporting requirements of U.S. securities laws, which could have a materially adverse effect on our business
  16. 77Unanticipated changes in the insurance market or factors affecting self-insurance reserve estimates could have a material adverse effect on our business, financial condition and results of operations
  17. 78Unstable global market and economic conditions may have serious adverse consequences on our business, financial condition and results of operationsNew
  18. 79Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults or non-performance by financial institutions or transactional counterparties, could adversely affect our business, financial condition and results of operations

Other MAIA Biotechnology 10-Ks

  • FY2024 10-K risk factors
    92 risks

    MAIA Biotechnology is a clinical-stage biopharmaceutical company dependent on the success of its lead cancer candidate, THIO.

    Filed Mar 21, 2025

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.